Patient leaflet - Amsparity

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Amsparity 20 mg solution for injection in pre-filled syringe adalimumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects your child may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before your child starts using this medicine because it contains important information.

– Keep this leaflet. You may need to read it again.
– Your child’s doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before your child is given Amsparity and during treatment with Amsparity. Keep this patient reminder card with you or your child.
– If you have any further questions, ask your child’s doctor or pharmacist.
– This medicine has been prescribed for your child only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as your child.

– If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Amsparity is and what it is used for
2. What you need to know before your child uses Amsparity
3. How to use Amsparity
4. Possible side effects
5. How to store Amsparity
6. Contents of the pack and other information

1. What Amsparity is and what it is used for

Amsparity contains the active substance adalimumab, a medicine that acts on your child’s body’s immune (defence) system.

Amsparity is intended for the treatment of the following inflammatory diseases:

polyarticular juvenile idiopathic arthritis
paediatric enthesitis-related arthritis
paediatric plaque psoriasis
paediatric Crohn’s disease
paediatric uveitis

The active ingredient in Amsparity, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body.

The target of adalimumab is another protein called tumour necrosis factor (TNFa), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFa, Amsparity blocks its action and reduces the inflammation in these diseases.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood.

Amsparity is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Amsparity to treat his/her polyarticular juvenile idiopathic arthritis.

Paediatric enthesitis-related arthritis

Paediatric enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

Amsparity is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Amsparity to treat his/her enthesitis-related arthritis.

Paediatric plaque psoriasis

Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.

Amsparity is used to treat severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.

Paediatric Crohn’s disease

Crohn’s disease is an inflammatory disease of the gut.

Amsparity is used to treat Crohn’s disease in children and adolescents aged 6 to 17 years.

If your child has Crohn’s disease, your child will first be given other medicines. If your child does not respond well enough to these medicines, your child will be given Amsparity to reduce the signs and symptoms of his/her Crohn’s disease.

Paediatric uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Amsparity works by reducing this inflammation.

Amsparity is used to treat children and adolescents with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.

Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Amsparity to reduce the signs and symptoms of his/her disease.

2. What you need to know before your child uses Amsparity

Do not use Amsparity

if your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in

section 6).

if your child has a severe infection, including active tuberculosis, sepsis (blood poisoning) or

opportunistic infections (unusual infections associated with a weakened immune system). It is important that you tell your child’s doctor if your child has symptoms of infections, for example, fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).

if your child has moderate or severe heart failure. It is important to tell your child’s doctor if

your child has had or has a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your child’s doctor or pharmacist before using Amsparity.

It is important that you and your child’s doctor record the brand name and batch number of your child’s medication.

Allergic reactions

If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness,

swelling or rash, do not inject more Amsparity and contact your child’s doctor immediately, since in rare cases, these reactions can be life threatening.

Infections

If your child has an infection, including long-term infection or an infection in one part of the

body (for example, leg ulcer), consult your child’s doctor before starting Amsparity. If you are unsure, contact your child’s doctor.

Your child might get infections more easily while he/she is receiving Amsparity treatment. This risk may increase if your child has problems with his/her lungs. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections (unusual infectious organisms), and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to tell your child’s doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems. Your child’s doctor may recommend temporarily stopping Amsparity.

Tuberculosis (TB)

As cases of tuberculosis have been reported in patients treated with adalimumab, your child’s doctor will check your child for signs and symptoms of tuberculosis before starting Amsparity. This will include a thorough medical evaluation including your child’s medical history and screening tests (for example, chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your child’s patient reminder card.
It is very important that you tell your child’s doctor if your child has ever had tuberculosis, or if

he/she has been in close contact with someone who has had tuberculosis. If your child has active tuberculosis, do not use Amsparity.

Tuberculosis can develop during therapy even if your child had treatment for the prevention of

tuberculosis.

If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of

energy, mild fever), or any other infection appear during or after therapy tell your child’s doctor immediately.

Travel / recurrent infection

Tell your child’s doctor if your child has lived or travelled in regions where fungal infections

such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic (found).

Tell your child’s doctor if your child has had infections which keep coming back or other

conditions that increase the risk of infections.

You and your child’s doctor should pay special attention to signs of infection while your child is being treated with Amsparity. It is important to tell your child’s doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Hepatitis B

Tell your child’s doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of getting HBV. Your child’s doctor should test your child for HBV. Adalimumab can reactivate HBV infection in people who carry the virus. In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.

Surgery or dental procedure

If your child is about to have surgery or dental procedures, tell your child’s doctor that he/she is

taking Amsparity. Your child’s doctor may recommend temporarily stopping Amsparity.

Demyelinating disease

If your child has or develops a demyelinating disease (a disease that affects the insulating layer

around the nerves, such as multiple sclerosis), your child’s doctor will decide if he/she should receive or continue to receive Amsparity. Tell your child’s doctor immediately if your child gets symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.

Vaccination

Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses that

may cause infections and should not be given during treatment with Amsparity. Check with your child’s doctor before your child receives any vaccines. It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Amsparity. If your child received Amsparity while she was pregnant, her baby may be at higher risk for getting an infection for up to about five months after the last Amsparity dose she received during pregnancy. It is important that you tell her baby's doctors and other health care professionals about your child’s Amsparity use during her pregnancy so they can decide when her baby should receive any vaccine.

Heart failure

It is important to tell your child’s doctor if your child has had or has a serious heart condition. If

your child has mild heart failure and is being treated with Amsparity, his/her heart failure status must be closely monitored by your child’s doctor. If he/she develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of his/her feet), you must contact your child’s doctor immediately.

Fever, bruising, bleeding or looking pale

In some patients the body may fail to produce enough of the blood cells that fight off infections

or help your child to stop bleeding. If your child develops a fever that does not go away, bruises or bleeds very easily or looks very pale, call your child’s doctor right away. Your child’s doctor may decide to stop treatment.

Cancer

There have been very rare cases of certain kinds of cancer in children and adults taking

adalimumab or other TNFa blockers. People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affects blood cells and bone marrow). If your child takes Amsparity the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your child’s doctor if your child is taking azathioprine or mercaptopurine with Amsparity.

In addition, cases of non-melanoma skin cancer have been observed in patients taking

adalimumab. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your child’s doctor.

There have been cases of cancers, other than lymphoma in patients with a specific type of lung

disease called chronic obstructive pulmonary disease (COPD) treated with another TNFa blocker. If your child has COPD, or is a heavy smoker, you should discuss with your child’s doctor whether treatment with a TNFa blocker is appropriate for your child.

Autoimmune disease

On rare occasions, treatment with Amsparity could result in lupus-like syndrome. Contact your

child’s doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Other medicines and Amsparity

Tell your child’s doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

Amsparity can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

Your child should not take Amsparity with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions. If you have questions, please ask your child’s doctor.

Pregnancy and breast-feeding

Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Amsparity treatment.

If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.

Amsparity should only be used during a pregnancy if needed.

According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.

Amsparity can be used during breast-feeding.

If your child receives Amsparity during her pregnancy, her baby may have a higher risk for getting an infection. It is important that you tell her baby’s doctor and other health care professionals about her Amsparity use during her pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Amsparity may have a small effect on your child’s ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Amsparity.

Amsparity contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free’.

3. How to use Amsparity

Always use this medicine exactly as your child’s doctor, nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure.

The recommended doses for Amsparity in each of the approved uses are shown in the following table. Your child’s doctor may prescribe another strength of Amsparity if your child needs a different dose.

Amsparity is injected under the skin (subcutaneous use).

Polyarticular juvenile idiopathic arthritis
Age or body weight	How much and how often to take?	Notes
Children and adolescents from 2 years of age weighing 30 kg or more	40 mg every other week	Not applicable
Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg	20 mg every other week	Not applicable

Paediatric enthesitis-related art	iritis
Age or body weight	How much and how often to take?	Notes
Children and adolescents from 6 years of age weighing 30 kg or more	40 mg every other week	Not applicable

Paediatric enthesitis-related art	iritis
Age or body weight	How much and how often to take?	Notes
Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg	20 mg every other week	Not applicable

Paediatric plaque psoriasis
Age or body weight	How much and how often to take?	Notes
Children and adolescents from 4 to 17 years of age weighing 30 kg or more	First dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.	Not applicable
Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg	First dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week.	Not applicable

Paediatric Crohn’s disease
Age or body weight	How much and how often to take?	Notes
Children and adolescents from 6 to 17 years of age weighing 40 kg or more	First dose of 80 mg, followed by 40 mg two weeks later. If a faster response is required, your child’s doctor may prescribe a first dose of 160 mg, followed by 80 mg two weeks later. Thereafter, the usual dose is 40 mg every other week.	Your child’s doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Children and adolescents from 6 to 17 years of age weighing less than 40 kg	First dose of 40 mg, followed by 20 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 80 mg, followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every other week.	Your child’s doctor may increase the dose frequency to 20 mg every week.

Paediatric uveitis
Age or body weight	How much and how often to take?	Notes
Children and adolescents from 2 years of age weighing less than 30 kg	20 mg every other week	Your child’s doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week. Amsparity is recommended for use in combination with methotrexate.
Children and adolescents from 2 years of age weighing 30 kg or more	40 mg every other week	Your child’s doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week. Amsparity is recommended for use in combination with methotrexate.

Method and route of administration

Amsparity is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Amsparity, the Instructions for Use, are provided at the end of this leaflet.

If you use more Amsparity than you should

If you accidentally inject your child with Amsparity more frequently than you should, call your child’s doctor or pharmacist and explain that your child has taken more than required. Always take the outer carton of the medicine with you, even if it is empty.

If you forget to use Amsparity

If you forget to give your child an Amsparity injection, you should inject the next dose of Amsparity as soon as you remember. Then give your child’s next dose as you would have on the originally scheduled day, had you not forgotten a dose.

If your child stops using Amsparity

The decision to stop using Amsparity should be discussed with your child’s doctor. Your child’s symptoms may return upon stopping treatment.

If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Amsparity injection.

Seek medical attention urgently, if you notice any of the following signs:

severe rash, hives or other signs of allergic reaction;
swollen face, hands, feet;
trouble breathing, swallowing;
shortness of breath with physical activity or upon lying down or swelling of the feet.

Tell your child’s doctor as soon as possible, if you notice any of the following:

signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning

on urination, feeling weak or tired or coughing;

symptoms of nerve problems such as tingling, numbness, double vision, or arm or leg weakness;
signs of skin cancer such as a bump or open sore that does not heal;
signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,

paleness.

The signs and symptoms described above can represent the side effects listed below, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people)

injection site reactions (including pain, swelling, redness or itching);
respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
headache;
abdominal (belly) pain;
nausea and vomiting;
rash;
pain in the muscles or joints.

Common (may affect up to 1 in 10 people)

serious infections (including blood poisoning and influenza);
intestinal infections (including gastroenteritis);
skin infections (including cellulitis and shingles);
ear infections;
mouth infections (including tooth infections and cold sores);
reproductive tract infections;
urinary tract infection;
fungal infections;
joint infections;
benign tumours;
skin cancer;
allergic reactions (including seasonal allergy);
dehydration;
mood swings (including depression);
anxiety;
difficulty sleeping;
sensation disorders such as tingling, prickling or numbness;
migraine;
symptoms of nerve root compression (including low back pain and leg pain);
vision disturbances;
eye inflammation;
inflammation of the eye lid and eye swelling;
vertigo (sensation of room spinning);
sensation of heart beating rapidly;
high blood pressure;
flushing;
haematoma (a solid swelling with clotted blood);
cough;
asthma;
shortness of breath;
gastrointestinal bleeding;
dyspepsia (indigestion, bloating, heart burn);
acid reflux disease;
sicca syndrome (including dry eyes and dry mouth);
itching;
itchy rash;
bruising;
inflammation of the skin (such as eczema);
breaking of finger nails and toe nails;
increased sweating;
hair loss;
new onset or worsening of psoriasis;
muscle spasms;
blood in urine;
kidney problems;
chest pain;
oedema (a build-up of fluid in the body which causes the affected tissue to swell);
fever;
reduction in blood platelets which increases risk of bleeding or bruising;
impaired healing.

Uncommon (may affect up to 1 in 100 people)

opportunistic (unusual) infections (which include tuberculosis and other infections) that occur

when resistance to disease is lowered;

neurological infections (including viral meningitis);
eye infections;
bacterial infections;
diverticulitis (inflammation and infection of the large intestine);
cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of

skin cancer);

immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a

condition called sarcoidosis);

vasculitis (inflammation of blood vessels);
tremor (shaking);
neuropathy (nerve damage);
stroke;
double vision;
hearing loss, buzzing;
sensation of heart beating irregularly such as skipped beats;
heart problems that can cause shortness of breath or ankle swelling;
heart attack;
a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;
lung diseases causing shortness of breath (including inflammation);
pulmonary embolism (blockage in an artery of the lung);
pleural effusion (abnormal collection of fluid in the pleural space);
inflammation of the pancreas which causes severe pain in the abdomen and back;
difficulty in swallowing;
facial oedema (swelling of the face);
gallbladder inflammation, gallbladder stones;
fatty liver (build up of fat in liver cells);
night sweats;
scar;
abnormal muscle breakdown;
systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,

joints and other organ systems);

sleep interruptions;
impotence;
inflammations.

Rare (may affect up to 1 in 1,000 people)

leukaemia (cancer affecting the blood and bone marrow);
severe allergic reaction with shock;
multiple sclerosis;
nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barre syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
heart stops pumping;
pulmonary fibrosis (scarring of the lung);
intestinal perforation (hole in the wall of the gut);
hepatitis (liver inflammation);
reactivation of hepatitis B infection;
autoimmune hepatitis (inflammation of the liver caused by the body’s own immune system);
cutaneous vasculitis (inflammation of blood vessels in the skin);
Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering

rash);

facial oedema (swelling of the face) associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus-like syndrome;
angioedema (localised swelling of the skin);
lichenoid skin reaction (itchy reddish-purple skin rash).

Not known (frequency cannot be estimated from available data)

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Merkel cell carcinoma (a type of skin cancer);
Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s

sarcoma most commonly appears as purple lesions on the skin.

liver failure;
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle

weakness);

weight gain (for most patients, the weight gain was small).

Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

low blood measurements for white blood cells;
low blood measurements for red blood cells;
increased lipids in the blood;
raised liver enzymes.

Common (may affect up to 1 in 10 people)

high blood measurements for white blood cells;
low blood measurements for platelets;
increased uric acid in the blood;
abnormal blood measurements for sodium;
low blood measurements for calcium;
low blood measurements for phosphate;
high blood sugar;
high blood measurements for lactate dehydrogenase;
autoantibodies present in the blood;
low blood potassium.

Uncommon (may affect up to 1 in 100 people)

raised bilirubin measurement (liver blood test).

Rare (may affect up to 1 in 1,000 people)

low blood measurements for white blood cells, red blood cells and platelet count.

Reporting of side effects

If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amsparity

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label / blister / carton after EXP.

Store in a refrigerator (2°C –8°C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example, when travelling), a single Amsparity pre-filled syringe may be stored at room temperature (up to 30°C) for a maximum period of 30 days -be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 30 days or discarded , even if it is returned to the refrigerator.

You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your child’s doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Amsparity contains

The active substance is adalimumab.

The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose, edetate disodium dihydrate, L-methionine, polysorbate 80, and water for injections.

What the Amsparity pre-filled syringe looks like and contents of the pack

Amsparity 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as a sterile solution of 20 mg adalimumab dissolved in 0.4 ml solution.

The Amsparity pre-filled syringe is a glass syringe containing a clear, colourless to very light brown solution of adalimumab.

The Amsparity pre-filled syringe is available in a pack containing 2 pre-filled syringes with 2 alcohol pads.

Amsparity may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Pfizer Service Company BVBA

Hoge Wei 10

Zaventem 1930

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Luxembourg/Luxemburg

Pfizer NV/SA

Tél/Tel: +32 (0)2 554 62 11

Česká Republika

Pfizer, spol. s r.o.

Tel: +420–283–004–111

Danmark

Pfizer ApS

Tlf: +45 44 201 100

Deutchland

PFIZER PHARMA GmbH

Tel: +49 (0)30 550055–51000

Kùnpoç

PFIZER EAAAZ A.E. (CYPRUS BRANCH)

Tql: +357 22 817690

Magyarország

Pfizer Kft.

Tel: +36 1 488 3700

Malta

Vivian Corporation Ltd.

Tel: +356 21344610

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Efc^rapufl

n$aň3ep ^WKceMOypr CAP^, KnoH Etnrapua

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Ten: +359 2 970 4333

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15–0

EXXáóa

PFIZER EAAAZ A.E.

TnX.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00

España

Pfizer S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L

Tel: +40 (0) 21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: +385 1 3908 777

Slovenija

Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana

Tel: +386 (0)1 52 11 400

Ireland

Pfizer Healthcare Ireland

Tel: +1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská Republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421 2 3355 5500

Ísland

Icepharma hf.

Tel: +354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Latvija

Pfizer Luxembourg SARL filiäle Latvijä

Tel. +371 67035775

United Kingdom (Northern Ireland)

Pfizer Limited

Tel: +44 (0)1304 616161

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. +3705 2514000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

INSTRUCTIONS FOR USE

Amsparity (adalimumab) 20 mg

Single-dose Pre-filled Syringe, for subcutaneous injection

Keep this leaflet. These instructions show step-by-step how to prepare and give an injection.

Store Amsparity pre-filled syringe in the refrigerator between 2°C to 8°C.

Store Amsparity pre-filled syringe in the original carton until use to protect from direct sunlight. If needed, for example when you and your child are traveling, you may store Amsparity pre-filled syringe at room temperature up to 30°C for up to 30 days.

Keep Amsparity, injection supplies, and all other medicines out of the reach of children.

Amsparity for injection comes in a disposable single use pre-filled syringe that contains a single dose of medicine.

Do not try to inject Amsparity to your child until you have read and understood the Instructions for Use. If your child’s doctor, nurse or pharmacist decides that you may be able to give injections of Amsparity to your child at home, you should receive training on the correct way to prepare and inject Amsparity.

It is also important to talk to your child’s doctor, nurse or pharmacist to be sure you understand your child’s Amsparity dosing instructions. To help you remember when to inject Amsparity, you can mark your calendar ahead of time. Talk to your child’s doctor, nurse or pharmacist if you have any questions about the correct way to inject Amsparity.

After proper training, the Amsparity injection can be given by your child or given by another person, for example, a family member or friend.

1. Supplies you need

You will need the following supplies for each injection of Amsparity. Find a clean, flat surface to place the supplies on.

o 1 Amsparity pre-filled syringe in a tray, inside the carton

o 1 alcohol swab, inside the carton

o 1 cotton ball or gauze pad (not included in the Amsparity carton)

o A suitable sharps container (not included in the Amsparity carton).

Important: If you have any questions about your child’s Amsparity pre-filled syringe or medicine, talk to your child’s doctor, nurse or pharmacist.

2. Getting ready

Remove Amsparity carton from the refrigerator.
Open the carton and take out the tray containing the pre-filled syringe.
Check the carton and tray; do not use if:

o the expiration date has passed

o it has been frozen or thawed

o it has been dropped, even if it looks undamaged

o it has been out of the refrigerator for more than 30 days

o it appears to be damaged

o the seals on a new carton are broken.

If any of the above apply, dispose of the pre-filled syringe in the same way as a used syringe.

You will need a new pre-filled syringe to give your child’s injection.

Wash your hands with soap and water, and dry completely.

If you have any questions about your child’s medicine, please talk to your child’s doctor, nurse or pharmacist.

Peel back the paper seal on the tray.
Remove 1 pre-filled syringe from the tray and put the original carton with any unused pre-filled

syringes back in the refrigerator.

Do not use the syringe if it appears to be damaged.
The pre-filled syringe may be used straight from the refrigerator.
You may find that using the pre-filled syringe at room temperature reduces stinging or

discomfort. Leave the pre-filled syringe at room temperature away from direct sunlight for 15 to 30 minutes before your child’s injection.

Do not remove the needle cover from the pre-filled syringe until you are ready to inject.

Always hold the pre-filled syringe by the barrel to prevent damage.

Look carefully at your child’s medicine in the window.
Gently tilt the pre-filled syringe back and forth to check the medicine.
Do not shake the pre-filled syringe. Shaking can damage your child’s medicine.
Make sure the medicine in the pre-filled syringe is clear and colourless to very light brown and

free from flakes or particles. It is normal to see one or more air bubbles in the window. Do not attempt to remove air bubbles.

If you have any questions about your child’s medicine, please talk to your child’s doctor, nurse or pharmacist.

Choose a different site each time you give your child an injection.
Do not inject into bony areas or areas on your child’s skin that are bruised, red, sore (tender) or

hard. Avoid injecting into areas with scars or stretch marks.

o If your child has psoriasis, do not inject directly into any raised, thick, red, or scaly skin

patches or lesions on your child’s skin.

Do not inject through your child’s clothes.
Wipe the injection site with the alcohol swab.
Allow the injection site to dry.
Hold the pre-filled syringe by the syringe barrel. Carefully pull the needle cover straight off and away from your body when you are ready to inject.
It is normal to see a few drops of medicine at the needle tip when you remove the needle cover.
Throw the needle cover away into a sharps disposal container.

Note: Be careful when you handle the pre-filled syringe to avoid an accidental needle stick injury.

Gently pinch up a fold of skin in the cleaned injection site area.
Insert the needle to its full depth into the skin, at a 45 degree angle, as shown.
After the needle is inserted, release the pinched skin.

Important: Do not re-insert the needle into your child’s skin. If the needle has already been inserted into the skin and you change your mind about where to inject, you will need a replacement pre-filled syringe.

Using slow and constant pressure, push the plunger rod all the way down until the barrel is

empty. It usually takes 2 to 5 seconds to deliver the dose.

Note: It is recommended to hold the pre-filled syringe in the skin for an additional 5 seconds after the plunger has been pressed down completely.

Pull the needle out of the skin at the same angle at which it entered.
Check that your child’s medicine has completely emptied from the pre-filled syringe.
Never re-insert the needle.
Never re-cap the needle.

Note: If the grey stopper is not in the position shown, you may not have injected all of your child’s medicine. Talk to your child’s doctor, nurse or pharmacist right away.

Dispose of the syringe straight away as instructed by your child’s doctor, nurse or pharmacist

and in accordance with local health and safety laws.

Look closely at your child’s injection site. If there is blood, use a clean cotton ball or gauze pad

to press lightly on the injection area for a few seconds.

Do not rub the site.

Note: Store any unused syringes in the refrigerator in the original carton.

See over for

Package leaflet: Information for the patient

Package leaflet: Information for the patient

Amsparity 40 mg/0.8 ml solution for injection adalimumab

Read all of this leaflet carefully before your child starts using this medicine because it contains important information.

– Keep this leaflet. You may need to read it again.
– Your child’s doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before your child is given Amsparity and during treatment with Amsparity. Keep this patient reminder card with you or your child.
– If you have any further questions, ask your child’s doctor or pharmacist.
– This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child.
– If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Amsparity is and what it is used for
2. What you need to know before your child uses Amsparity
3. How to use Amsparity
4. Possible side effects
5. How to store Amsparity
6. Contents of the pack and other information

1. What Amsparity is and what it is used for

Amsparity contains the active substance adalimumab, a medicine that acts on your child’s body’s immune (defence) system.

Amsparity is intended for the treatment of the following inflammatory diseases:

polyarticular juvenile idiopathic arthritis
paediatric enthesitis-related arthritis
paediatric plaque psoriasis
adolescent hidradenitis suppurativa
paediatric Crohn’s disease
paediatric ulcerative colitis
paediatric uveitis

The active ingredient in Amsparity, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood.

Paediatric enthesitis-related arthritis

Paediatric enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

Paediatric plaque psoriasis

Amsparity is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.

Adolescent hidradenitis suppurativa

Hidradenitis suppurativa (sometimes called acne inversa) is a long-term and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Amsparity is used to treat hidradenitis suppurativa in adolescents from 12 years of age. Amsparity can reduce the number of nodules and abscesses your child has, and the pain that is often associated with the disease. Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Amsparity.

Paediatric Crohn’s disease

Crohn’s disease is an inflammatory disease of the gut.

Amsparity is used to treat Crohn’s disease in children and adolescents aged 6 to 17 years.

Paediatric ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine. Amsparity is used to treat moderate to severe ulcerative colitis in children aged 6 to 17 years. Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Amsparity to reduce the signs and symptoms of his/her disease.

Paediatric uveitis

Amsparity is used to treat children and adolescents with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.

Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Amsparity to reduce the signs and symptoms of his/her disease.

2. What you need to know before your child uses Amsparity

Do not use Amsparity

if your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in

section 6).

if your child has a severe infection, including active tuberculosis, sepsis (blood poisoning) or

if your child has moderate or severe heart failure. It is important to tell your child’s doctor if

your child has had or has a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your child’s doctor or pharmacist before using Amsparity.

It is important that you and your child’s doctor record the brand name and batch number of your child’s medication.

Allergic reactions

If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness,

swelling or rash, do not inject more Amsparity and contact your child’s doctor immediately, since in rare cases, these reactions can be life threatening.

Infections

If your child has an infection, including long-term infection or an infection in one part of the

body (for example, leg ulcer), consult your child’s doctor before starting Amsparity. If you are unsure, contact your child’s doctor.

Your child might get infections more easily while he/she is receiving Amsparity treatment. This

risk may increase if your child has problems with his/her lungs. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections (unusual infectious organisms), and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to tell your child’s doctor ifyour child gets symptoms such as fever, wounds, feeling tired or dental problems. Your child’s doctor may recommend temporarily stopping Amsparity.

Tuberculosis (TB)

As cases of tuberculosis have been reported in patients treated with adalimumab, your child’s doctor will check your child for signs and symptoms of tuberculosis before starting Amsparity. This will include a thorough medical evaluation including your child’s medical history and screening tests (for example chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your child’s patient reminder card.
It is very important that you tell your child’s doctor if your child has ever had tuberculosis, or if he/she has been in close contact with someone who has had tuberculosis. If your child has active tuberculosis, do not use Amsparity.
Tuberculosis can develop during therapy even if your child had treatment for the prevention of tuberculosis.
If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your child’s doctor immediately.

Travel / recurrent infection

Tell your child’s doctor if your child has lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic (found).
Tell your child’s doctor if your child has had infections which keep coming back or other conditions that increase the risk of infections.
You and your child’s doctor should pay special attention to signs of infection while your child is

being treated with Amsparity. It is important to tell your child’s doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Hepatitis B

Tell your child’s doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of getting HBV. Your child’s doctor should test your child for HBV. Adalimumab can reactivate HBV infection in people who carry the virus. In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.

Surgery or dental procedure

If your child is about to have surgery or dental procedures, tell your child’s doctor that he/she is

taking Amsparity. Your child’s doctor may recommend temporarily stopping Amsparity.

Demyelinating disease

If your child has or develops a demyelinating disease (a disease that affects the insulating layer

Vaccination

Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses that

may cause infections and should not be given during treatment with Amsparity. Check with your child’s doctor before your child receives any vaccines. It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Amsparity. If your child received Amsparity while she was pregnant, her baby may be at higher risk for getting an infection for up to about five months after the last Amsparity dose she received during pregnancy. It is important that you tell her baby’s doctors and other health care professionals about your child’s Amsparity use during her pregnancy so they can decide when her baby should receive any vaccine.

Heart failure

It is important to tell your child’s doctor if your child has had or has a serious heart condition. If

Fever, bruising, bleeding or looking pale

In some patients the body may fail to produce enough of the blood cells that fight off infections

Cancer

There have been very rare cases of certain kinds of cancer in children and adults taking

In addition, cases of non-melanoma skin cancer have been observed in patients taking

adalimumab. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your child’s doctor.

There have been cases of cancers, other than lymphoma in patients with a specific type of lung

Autoimmune disease

On rare occasions, treatment with Amsparity could result in lupus-like syndrome. Contact your

child’s doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Other medicines and Amsparity

Tell your child’s doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

Pregnancy and breast-feeding

Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Amsparity treatment.

If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.

Amsparity should only be used during a pregnancy if needed.

Amsparity can be used during breast-feeding.

Driving and using machines

Amsparity may have a small effect on your child’s ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Amsparity.

Amsparity contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free’.

3. How to use Amsparity

Always use this medicine exactly as your child’s doctor, nurse or pharmacist has told you. Check with your child’s doctor, nurse or pharmacist if you are not sure. Your child’s doctor may prescribe another strength of Amsparity if your child needs a different dose.

Amsparity is injected under the skin (subcutaneous use).

Children and adolescents with polyarticular juvenile idiopathic arthritis

Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg

The recommended dose of Amsparity is 20 mg every other week.

Children and adolescents from 2 years of age weighing 30 kg or more

The recommended dose of Amsparity 40 mg every other week.

Children and adolescents with enthesitis-related arthritis

Children and adolescents from 6 years of age weighing 15 kgto less than 30 kg

The recommended dose of Amsparity is 20 mg every other week.

Children and adolescents from 6 years of age weighing 30 kgor more

The recommended dose of Amsparity is 40 mg every other week.

Children and adolescents with psoriasis

Children and adolescents from 4 to 17 years of age weighing 15 kgto less than 30 kg

The recommended dose of Amsparity is an initial dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week.

Children and adolescents from 4 to 17 years of age weighing 30 kgor more

The recommended dose of Amsparity is an initial dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.

Adolescents with hidradenitis suppurativa from 12 to 17 years of age, weighing 30 kg or more

The recommended dose of Amsparity is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

It is recommended that you use an antiseptic wash daily on the affected areas.

Children and adolescents with Crohn’s disease

Children and adolescents from 6 to 17 years of age weighing less than 40 kg

The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your child’s doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg starting two weeks later.

Thereafter, the usual dose is 20 mg every other week. If this dose does not work well enough, your child’s doctor may increase the dose frequency to 20 mg every week.

Children and adolescents from 6 to 17 years of age weighing 40 kgor more

The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later. If a faster response is required, your child’s doctor may prescribe an initial dose of 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week. If this dose does not work well enough, your child’s doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents with ulcerative colitis

Children and adolescents from 6 years of age weighing less than 40 kg

The usual Amsparity dose is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg (as one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.

Patients who turn 18 years of age while on 40 mg every other week, should continue their prescribed dose.

Children and adolescents from 6 years of age weighing 40 kg or more

The usual Amsparity dose is 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) initially, followed by 80 mg (as two 40 mg injections in one day) two weeks later. Thereafter the usual dose is 80 mg every other week.

Patients who turn 18 years of age while on 80 mg every other week, should continue their prescribed dose.

Children and adolescents with chronic non-infectious uveitis from 2 years of age

Children and adolescents from 2 years of age weighing less than 30 kg

The usual dose of Amsparity is 20 mg every other week with methotrexate.

Your child’s doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.

Children and adolescents from 2 years of age weighing 30 kgor more

The usual dose of Amsparity is 40 mg every other week with methotrexate.

Your child’s doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.

Method and route of administration

Amsparity is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Amsparity are provided in the ‘Instructions for use’.

If you use more Amsparity than you should

If you accidentally inject your child with a larger amount of Amsparity liquid, or if you inject Amsparity more frequently than you should, call your child’s doctor or pharmacist and explain that your child has taken more than required. Always take the outer carton or the vial of the medicine with you, even if it is empty.

If you use less Amsparity than you should

If you accidentally inject your child with a smaller amount of Amsparity liquid, or if you inject your child with Amsparity less frequently than you should, call your child’s doctor or pharmacist and explain that your child has taken less than required. Always take the outer carton or the vial of the medicine with you, even if it is empty.

If you forget to use Amsparity

If your child stops using Amsparity

The decision to stop using Amsparity should be discussed with your child’s doctor. Your child’s symptoms may return upon stopping treatment.

If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.

4. Possible side effects

Seek medical attention urgently, if you notice any of the following signs:

severe rash, hives or other signs of allergic reaction;
swollen face, hands, feet;
trouble breathing, swallowing;
shortness of breath with physical activity or upon lying down or swelling of the feet.

Tell your child’s doctor as soon as possible, if you notice any of the following:

signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on

urination, feeling weak or tired or coughing;

symptoms of nerve problems such as tingling, numbness, double vision, or arm or leg weakness;
signs of skin cancer such as a bump or open sore that does not heal;
signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.

The signs and symptoms described above can represent the side effects listed below, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people)

injection site reactions (including pain, swelling, redness or itching);
respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
headache;
abdominal (belly) pain;
nausea and vomiting;
rash;
pain in the muscles or joints.

Common (may affect up to 1 in 10 people)

serious infections (including blood poisoning and influenza);
intestinal infections (including gastroenteritis);
skin infections (including cellulitis and shingles);
ear infections;
mouth infections (including tooth infections and cold sores);
reproductive tract infections;
urinary tract infection;
fungal infections;
joint infections;
benign tumours;
skin cancer;
allergic reactions (including seasonal allergy);
dehydration;
mood swings (including depression);
anxiety;
difficulty sleeping;
sensation disorders such as tingling, prickling or numbness;
migraine;
symptoms of nerve root compression (including low back pain and leg pain);
vision disturbances;
eye inflammation;
inflammation of the eye lid and eye swelling;
vertigo (sensation of room spinning);
sensation of heart beating rapidly;
high blood pressure;
flushing;
haematoma (a solid swelling with clotted blood);
cough;
asthma;
shortness of breath;
gastrointestinal bleeding;
dyspepsia (indigestion, bloating, heart burn);
acid reflux disease;
sicca syndrome (including dry eyes and dry mouth);
itching;
itchy rash;
bruising;
inflammation of the skin (such as eczema);
breaking of finger nails and toe nails;
increased sweating;
hair loss;
new onset or worsening of psoriasis;
muscle spasms;
blood in urine;
kidney problems;
chest pain;
oedema (a build-up of fluid in the body which causes the affected tissue to swell);
fever;
reduction in blood platelets which increases risk of bleeding or bruising;
impaired healing.

Uncommon (may affect up to 1 in 100 people)

opportunistic (unusual) infections (which include tuberculosis and other infections) that occur

when resistance to disease is lowered;

neurological infections (including viral meningitis);
eye infections;
bacterial infections;
diverticulitis (inflammation and infection of the large intestine);
cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of

skin cancer);

immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a

condition called sarcoidosis);

vasculitis (inflammation of blood vessels);
tremor (shaking);
neuropathy (nerve damage);
stroke;
double vision;
hearing loss, buzzing;
sensation of heart beating irregularly such as skipped beats;
heart problems that can cause shortness of breath or ankle swelling;
heart attack;
a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel;
lung diseases causing shortness of breath (including inflammation);
pulmonary embolism (blockage in an artery of the lung);
pleural effusion (abnormal collection of fluid in the pleural space);
inflammation of the pancreas which causes severe pain in the abdomen and back;
difficulty in swallowing;
facial oedema (swelling of the face);
gallbladder inflammation, gallbladder stones;
fatty liver (build up of fat in liver cells);
night sweats;
scar;
abnormal muscle breakdown;
systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,

joints and other organ systems);

sleep interruptions;
impotence;
inflammations.

Rare (may affect up to 1 in 1,000 people)

leukaemia (cancer affecting the blood and bone marrow);
severe allergic reaction with shock;
multiple sclerosis;
nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barre syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
heart stops pumping;
pulmonary fibrosis (scarring of the lung);
intestinal perforation (hole in the wall of the gut);
hepatitis (liver inflammation);
reactivation of hepatitis B infection;
autoimmune hepatitis (inflammation of the liver caused by the body’s own immune system);
cutaneous vasculitis (inflammation of blood vessels in the skin);
Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering

rash);

facial oedema (swelling of the face) associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus-like syndrome;
angioedema (localised swelling of the skin);
lichenoid skin reaction (itchy reddish-purple skin rash).

Not known (frequency cannot be estimated from available data)

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Merkel cell carcinoma (a type of skin cancer);
Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s

sarcoma most commonly appears as purple lesions on the skin.

liver failure;
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness);
weight gain (for most patients, the weight gain was small).

Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

low blood measurements for white blood cells;
low blood measurements for red blood cells;
increased lipids in the blood;
raised liver enzymes.

Common (may affect up to 1 in 10 people)

high blood measurements for white blood cells;
low blood measurements for platelets;
increased uric acid in the blood;
abnormal blood measurements for sodium;
low blood measurements for calcium;
low blood measurements for phosphate;
high blood sugar;
high blood measurements for lactate dehydrogenase;
autoantibodies present in the blood;
low blood potassium.

Uncommon (may affect up to 1 in 100 people)

raised bilirubin measurement (liver blood test).

Rare (may affect up to 1 in 1,000 people)

low blood measurements for white blood cells, red blood cells and platelet count.

Reporting of side effects

If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amsparity

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label / carton after EXP.

Store in a refrigerator (2°C –8°C). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example, when travelling), a single Amsparity vial may be stored at room temperature (up to 30°C) for a maximum period of 30 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the vial must be used within 30 days or discarded , even if it is returned to the refrigerator.

You should record the date when the vial is first removed from refrigerator and the date after which it should be discarded.

6. Contents of the pack and other information

What Amsparity contains

The active substance is adalimumab.

The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose, edetate disodium dihydrate, L-methionine, polysorbate 80, and water for injections.

What the Amsparity vial looks like and contents of the pack

Amsparity 40 mg solution for injection in vials is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.

The Amsparity vial is a glass vial containing a clear, colourless to very light brown solution of adalimumab. One pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 vial adapter and 2 alcohol pads.

Amsparity may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Pfizer Service Company BVBA

Hoge Wei 10

Zaventem 1930

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Kinpoç

Luxembourg/Luxemburg

Pfizer NV/SA

Tél/Tel: +32 (0)2 554 62 11

PFIZER EAAAÏ A.E. (CYPRUS BRANCH) Tql: +357 22 817690

Česká Republika

Pfizer, spol. s r.o.

Tel: +420–283–004–111

Magyarország

Pfizer Kft.

Tel: +36 1 488 3700

Danmark

Pfizer ApS

Tlf: +45 44 201 100

Malta

Vivian Corporation Ltd.

Tel: +356 21344610

Deutchland

PFIZER PHARMA GmbH

Tel: +49 (0)30 550055–51000

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Efc^rapufl

n$aň3ep ^WKceMOypr C’ÀP.H, K.toh Etnrapua

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Ten: +359 2 970 4333

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15–0

EÀÀàôa

PFIZER EAAAZ A.E.

TnX.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00

España

Pfizer S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L

Tel: +40 (0) 21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: +385 1 3908 777

Slovenija

Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana

Tel: +386 (0)1 52 11 400

Ireland

Pfizer Healthcare Ireland

Tel: +1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská Republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421 2 3355 5500

Ísland

Icepharma hf.

Tel: +354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Latvija

Pfizer Luxembourg SARL filiäle Latvijä

Tel. +371 67035775

United Kingdom (Northern Ireland)

Pfizer Limited

Tel: +44 (0)1304 616161

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. +3705 2514000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

INSTRUCTIONS FOR USE

Instructions for preparing and giving an injection of Amsparity:

The following instructions explain how to inject Amsparity. Please read the instructions carefully and follow them step by step.

After proper training, the injection can be self-administered or given by another person, for example a family member or friend.

Failure to perform the following steps as described may cause contamination which may lead to infection of your child.

This injection should not be mixed in the same syringe or vial with any other medicine.

1) Setting up

Make sure you know the proper amount (volume) needed for dosing. If you do not know the amount, STOP HERE and talk to your child’s doctor, nurse or pharmacist for further instruction.
You will need a special container for waste, such as a sharps container or as instructed by your child’s doctor, nurse or pharmacist. Place the container on your work surface.
Wash your hands thoroughly.
Remove one box containing one syringe, one vial adapter, one vial, two alcohol pads and one needle from the carton. If there is a second box in the carton for a future injection, place it back in the refrigerator immediately.
Look at the expiry date on the box to be used. DO NOT use any item after the date shown on the box.
Set up the following items on a clean surface, DO NOT take them out of their individual packaging yet.

o One 1 ml syringe (1)

o One vial adapter (2)

o One vial for paediatric use of Amsparity for injection (3)

o Two alcohol pads (4)

o One needle (5)

Amsparity is a liquid that is clear and colourless to very light brown and free from flakes or particles.

DO NOT use if the liquid has flakes or particles in it.

2) Preparing the Amsparity dose for injection

General handling: DO NOT dispose of any waste items until after the injection is completed.

Prepare the needle by partially peeling the package open from the end closest to the yellow

syringe connector. Peel the package just far enough to expose the yellow syringe connector. Set the package down with the clear side of the package facing up.

Pop off the plastic cap from the vial to see the top of the vial stopper.
Use one of the alcohol pads to wipe the vial stopper. DO NOT touch the vial stopper after

wiping with the alcohol pad.

Peel the cover off the vial adapter package but do not take out the vial adapter.
Hold the vial with the vial stopper facing up.
With the vial adapter still in the clear package, attach it to the vial stopper by pushing down until the vial adapter snaps in place.
When you are sure the adapter is attached to the vial, lift off the package from the vial adapter.
Gently set the vial with vial adapter down on your clean work surface. Be careful that it does not

fall over. DO NOT touch the vial adapter.

Prepare the syringe by partially peeling the package open from the end closest to the white plunger rod.
Peel the clear package just far enough to expose the white plunger rod, but do not take the syringe out of the package.
Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml). NEVER pull past the 0.9 ml position regardless of prescribed dose.
You will set the volume to the prescribed dose in a later step.
DO NOT pull the white plunger rod completely out of the syringe.

NOTE:

If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your child’s Amsparity provider for a replacement. DO NOT try to reinsert the white plunger rod.

Dose + 0.1 ml

DO NOT use the white plunger rod to remove the syringe from the package. Hold the syringe on the graduated area and pull the syringe from its package. DO NOT set the syringe down at any time.
While holding the vial adapter firmly, insert the syringe tip into the vial adapter and twist the syringe clockwise with one hand until firm. DO NOT over-tighten.
While holding the vial, push the white plunger rod all the way down. This step is important to get the proper dose.

Hold the white plunger rod in and turn the vial and syringe upside down.

SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose. This is

important to get the proper dose. You will set the volume to the prescribed dose in step 4, Dose Preparation. If, for example the prescribed dose is 0.5 ml, pull the white plunger rod out to 0.6 ml. You will see the liquid medication from the vial go into the syringe.

Push the white plunger rod all the way back in to push the liquid medication back into the vial. Again, SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose, this is important to get the proper dose and important in order to prevent air bubbles or air gaps in the liquid medication. You will set the volume to the prescribed dose in step 4, Dose Preparation.
If you see remaining air bubbles or air gaps in the liquid medication in the syringe, you may repeat this process up to 3 times. DO NOT shake the syringe.

NOTE:

If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your Amsparity provider for a replacement. DO NOT try to reinsert the white plunger rod.

While still holding the syringe upright at the graduated area, remove the vial adapter with the vial by twisting the vial adapter off with the other hand. Be sure to remove the vial adapter with the vial from the syringe. DO NOT touch the tip of the syringe.
If a large air bubble or air gap can be seen near the syringe tip, SLOWLY push the white

plunger rod into the syringe until fluid begins to enter the syringe tip. DO NOT push the white plunger rod past the dose position.

For example, if the prescribed dose is 0.5 ml, DO NOT push the white plunger rod past the 0.5 ml position.
Check to see that the fluid remaining in the syringe is at least the prescribed dose volume. If the remaining volume is less than the prescribed dose volume, DO NOT use the syringe and talk to your child’s doctor, nurse or pharmacist.
With your free hand, pick up the needle package with the yellow syringe connector facing down.
Keeping the syringe up, insert the syringe tip into the yellow syringe connector and twist the

syringe as indicated by the arrow in the picture until firm. The needle is now attached to the syringe.

Pull the needle package off, but DO NOT remove the clear needle cap.
Place the syringe on your clean work surface. Continue with injection site and dose preparation

immediately.

3) Choosing and preparing an injection site

Choose a site on the thigh or stomach. DO NOT use the same site that was used for the last injection.
The new injection site should be given at least 3 cm from the last injection site.
DO NOT inject in an area where the skin is reddened, bruised, or hard. This may mean there is an infection and therefore you should talk to your child’s doctor.

o If your child has psoriasis, do not inject directly into any raised, thick, red, or scaly skin patches or lesions on the skin.

To reduce the chance of infection, wipe the injection site with the other alcohol pad. DO NOT touch the area again before injecting.
4) Dose Preparation

Pick up the syringe with the needle pointing up.
Use your other hand to flip the pink needle cover down toward the syringe.
Remove the clear needle cap by pulling it straight up with your other hand.
The needle is clean.
DO NOT touch the needle.
DO NOT set the syringe down at any time after the clear needle cap is off.
DO NOT try to put the clear needle cap back on the needle.
Hold the syringe at eye-level with the needle pointing up to see the amount clearly. Be careful not to squirt the liquid medication into your eye.
Recheck the prescribed medication amount.
Push the white plunger rod gently into the syringe until the syringe contains the prescribed amount of liquid. Excess liquid may come out of the needle while the white plunger rod is being pushed. DO NOT wipe off the needle or the syringe.

5) Injecting Amsparity

With the free hand, gently grasp the cleaned area of skin and hold firmly.
With the other hand, hold syringe at 45-degree angle to skin.
With one quick, short motion, push needle all the way into skin.
Let go of the skin in your hand.
Using slow and constant pressure, push the white plunger rod to inject the liquid medication until the syringe is empty.
When the syringe is empty, remove the needle from skin, being careful to pull it out at the same

angle as when it was inserted.

Check that your child’s medicine has completely emptied from the pre-filled syringe.
Gently flip the pink needle cover up, over the needle and snap into place, and set the syringe with needle on the work surface. DO NOT put the clear needle cap back on the needle.
Using a piece of gauze, apply pressure over the injection site for 10 seconds. A little bleeding may occur. DO NOT rub the injection site. Use a plaster if you want to.

6) Throwing away supplies

You will need a special container for waste, such as a sharps container or as instructed by your

child’s doctor, nurse or pharmacist.

Put the syringe with needle, vial and vial adapter into a special sharps container. DO NOT put these items into regular household waste.
The syringe, needle, vial and vial adapter MUST NEVER be reused.
Keep the special container out of the sight and reach of children at all times.
Throw away all other used items into your regular household waste.

Package leaflet: Information for the patient

Amsparity 40 mg solution for injection in pre-filled syringe adalimumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– Your doctor will also give you a patient reminder card, which contains important safety

information that you need to be aware of before you are given Amsparity and during treatment with Amsparity. Keep this patient reminder card with you.

– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Amsparity is and what it is used for
2. What you need to know before you use Amsparity
3. How to use Amsparity
4. Possible side effects
5. How to store Amsparity
6. Contents of the pack and other information

1. What Amsparity is and what it is used for

Amsparity contains the active substance adalimumab, a medicine that acts on your body’s immune (defence) system.

Amsparity is intended for the treatment of the following inflammatory diseases:

rheumatoid arthritis,
polyarticular juvenile idiopathic arthritis,
paediatric enthesitis-related arthritis,
ankylosing spondylitis,
axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
psoriatic arthritis,
psoriasis,
hidradenitis suppurativa,
Crohn’s disease,
ulcerative colitis and
non-infectious uveitis.

The active ingredient in Amsparity, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Amsparity is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, you will be given Amsparity to treat your rheumatoid arthritis.

Amsparity can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Amsparity can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.

Usually, Amsparity is used with methotrexate. If your doctor considers that methotrexate is inappropriate, Amsparity can be given alone.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood.

Amsparity is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years. Patients may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, patients will be given Amsparity to treat their polyarticular juvenile idiopathic arthritis.

Paediatric enthesitis-related arthritis

Paediatric enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

Amsparity is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years. Patients may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, patients will be given Amsparity to treat their enthesitis-related arthritis.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.

Amsparity is used in adults to treat these conditions. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Amsparity to reduce the signs and symptoms of your disease.

Psoriatic arthritis

Psoriatic arthritis is an inflammation of the joints associated with psoriasis.

Amsparity is used to treat psoriatic arthritis in adults. Amsparity can slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Plaque psoriasis in adults and children

Amsparity is used to treat moderate to severe plaque psoriasis in adults. Amsparity is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.

Hidradenitis suppurativa in adults and adolescents

Amsparity is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. Amsparity can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease. You may first be given other medicines. If these medicines do not work well enough, you will be given Amsparity.

Crohn’s disease in adults and children

Crohn’s disease is an inflammatory disease of the gut.

Amsparity is used to treat Crohn’s disease in adults and children aged 6 to 17 years.

If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Amsparity to reduce the signs and symptoms of your Crohn’s disease.

Ulcerative colitis in adults and children

Ulcerative colitis is an inflammatory disease of the large intestine.

Amsparity is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis you may first be given other medicines. If these medicines do not work well enough, you will be given Amsparity to reduce the signs and symptoms of your disease.

Non-infectious uveitis in adults and children

Amsparity is used to treat

adults with non-infectious uveitis with inflammation affecting the back of the eye.
children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the

front of the eye.

You may first be given other medicines. If these medicines do not work well enough, you will be given Amsparity to reduce the signs and symptoms of your disease.

2. What you need to know before you use Amsparity

Do not use Amsparity

if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in

section 6).

if you have a severe infection, including active tuberculosis, sepsis (blood poisoning) or

opportunistic infections (unusual infections associated with a weakened immune system). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).

if you have moderate or severe heart failure. It is important to tell your doctor if you have had or

have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Amsparity.

It is important that you and your doctor record the brand name and batch number of your medication.

Allergic reactions

If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness,

swelling or rash, do not inject more Amsparity and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.

Infections

If you have an infection, including long-term infection or an infection in one part of the body

(for example, leg ulcer), consult your doctor before starting Amsparity. If you are unsure, contact your doctor.

You might get infections more easily while you are receiving Amsparity treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections (unusual infectious organisms) and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend temporarily stopping Amsparity.

Tuberculosis (TB)

As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Amsparity. This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your patient reminder card.
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have

been in close contact with someone who has had tuberculosis.

Tuberculosis can develop during therapy even if you have had preventative treatment for

tuberculosis.

If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of

energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Travel / recurrent infection

Tell your doctor if you have lived or travelled in regions where fungal infections such as

histoplasmosis, coccidioidomycosis or blastomycosis are endemic (found).

Tell your doctor if you have infections which keep coming back or other conditions that increase

the risk of infections.

You should pay special attention to signs of infection while you are being treated with Amsparity. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Hepatitis B virus

Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV

infection or if you think you might be at risk of getting HBV. Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.

Age over 65 years

If you are over 65 years you may be more susceptible to infections while taking Amsparity. You

and your doctor should pay special attention to signs of infection while you are being treated with Amsparity. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Surgery or dental procedures

If you are about to have surgery or dental procedures, tell your doctor that you are taking

Amsparity. Your doctor may recommend temporarily stopping Amsparity.

Demyelinating disease

If you have or develop demyelinating disease (a disease that affects the insulating layer around

the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Amsparity. Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccination

Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses that

may cause infections and should not be given during treatment with Amsparity. Check with your doctor before you receive any vaccines. It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Amsparity. If you receive Amsparity while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy. It is important that you tell your baby’s doctors and other health care professionals about your Amsparity use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart failure

It is important to tell your doctor if you have had or have a serious heart condition. If you have

mild heart failure and you are being treated with Amsparity, your heart failure status must be closely monitored by your doctor. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.

Fever, bruising, bleeding or looking pale

In some patients the body may fail to produce enough of the blood cells that fight off infections

or help you to stop bleeding. If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.

Cancer

There have been very rare cases of certain kinds of cancer in children and adults taking

adalimumab or other TNFa blockers. People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow). If you take Amsparity the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Amsparity.

In addition, cases of non-melanoma skin cancer have been observed in patients taking

adalimumab. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.

There have been cases of cancers, other than lymphoma in patients with a specific type of lung

disease called chronic obstructive pulmonary disease (COPD) treated with another TNFa blocker. Ifyou have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNFa blocker is appropriate for you.

Autoimmune disease

On rare occasions, treatment with Amsparity could result in lupus-like syndrome. Contact your

doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Other medicines and Amsparity

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not take Amsparity with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions. If you have questions, please ask your doctor.

Pregnancy and breast-feeding

You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Amsparity treatment.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.

Amsparity should only be used during a pregnancy if needed.

Amsparity can be used during breast-feeding.

If you receive Amsparity during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your Amsparity use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Amsparity may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Amsparity.

Amsparity contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free’.

3. How to use Amsparity

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor may prescribe another strength of Amsparity if you need a different dose.

Amsparity is injected under the skin (subcutaneous use).

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.

In rheumatoid arthritis, methotrexate is continued while using Amsparity. If your doctor determines that methotrexate is inappropriate, Amsparity can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your Amsparity therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.

Children, adolescents and adults with polyarticular juvenile idiopathic arthritis

Children and adolescents from 2 years of age weighing 10 kgto less than 30 kg

The recommended dose of Amsparity is 20 mg every other week.

Children, adolescents and adults from 2 years of age weighing 30kgor more

The recommended dose of Amsparity is 40 mg every other week.

Children, adolescents and adults with enthesitis-related arthritis

Children and adolescents from 6 years of age weighing 15 kgto less than 30 kg

The recommended dose of Amsparity is 20 mg every other week.

Children, adolescents and adults from 6 years of age weighing 30kgor more

The recommended dose of Amsparity is 40 mg every other week.

Adults with psoriasis

The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject Amsparity for as long as your doctor has told you. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents with plaque psoriasis

Children and adolescents from 4 to 17 years of age weighing 15 kgto less than 30 kg

The recommended dose of Amsparity is an initial dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week.

Children and adolescents from 4 to 17 years of age weighing 30 kgor more

The recommended dose of Amsparity is an initial dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.

Adults with hidradenitis suppurativa

The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections in one day) two weeks later. After two further weeks, continue with a dosage of 40 mg every week or 80 mg every other week, as prescribed by your doctor. It is recommended that you use an antiseptic wash daily on the affected areas.

Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more

It is recommended that you use an antiseptic wash daily on the affected areas.

Adults with Crohn’s disease

The usual dose regimen for Crohn’s disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week starting two weeks later. If a faster response is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents with Crohn’s disease

Children and adolescents from 6 to17 years of age weighing less than 40 kg

The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg starting two weeks later.

Thereafter, the usual dose is 20 mg every other week. If this dose does not work well enough, your doctor may increase the dose frequency to 20 mg every week.

Children and adolescents from 6 to 17 years of age weighing 40 kg or more

The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Adults with ulcerative colitis

The usual Amsparity dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), then 80 mg (as two 40 mg injections in one day) two weeks later, and then 40 mg every other week. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents with ulcerative colitis

Children and adolescents from 6 years of age weighing less than 40 kg

The usual Amsparity dose is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg (as one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.

Patients who turn 18 years of age while on 40 mg every other week, should continue their prescribed dose.

Children and adolescents from 6 years of age weighing 40 kg or more

Patients who turn 18 years of age while on 80 mg every other week, should continue their prescribed dose.

Adults with non-infectious uveitis

The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject Amsparity for as long as your doctor has told you.

In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Amsparity. Amsparity can also be given alone.

Children and adolescents with chronic non-infectious uveitis from 2 years of age

Children and adolescents from 2 years of age weighing less than 30 kg

The usual dose of Amsparity is 20 mg every other week with methotrexate.

Your doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.

Children and adolescents from 2 years of age weighing 30 kgor more

The usual dose of Amsparity is 40 mg every other week with methotrexate.

Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.

Method and route of administration

Amsparity is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Amsparity, the Instructions for Use, are provided at the end of this leaflet.

If you use more Amsparity than you should

If you accidentally inject Amsparity more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required. Always take the outer carton of the medicine with you, even if it is empty.

If you forget to use Amsparity

If you forget to give yourself an injection, you should inject the next dose of Amsparity as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.

If you stop using Amsparity

The decision to stop using Amsparity should be discussed with your doctor. Your symptoms may return upon stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Seek medical attention urgently, if you notice any of the following signs:

severe rash, hives or other signs of allergic reaction;
swollen face, hands, feet;
trouble breathing, swallowing;
shortness of breath with exertion or upon lying down or swelling of the feet.

Tell your doctor as soon as possible , if you notice any of the following:

signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning

on urination, feeling weak or tired or coughing;

symptoms of nerve problems such as tingling, numbness, double vision, or arm or leg weakness;
signs of skin cancer such as a bump or open sore that does not heal;
signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,

paleness.

The signs and symptoms described above can represent the side effects listed below, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people)

injection site reactions (including pain, swelling, redness or itching);
respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
headache;
abdominal (belly) pain;
nausea and vomiting;
rash;
pain in the muscles or joints.

Common (may affect up to 1 in 10 people)

serious infections (including blood poisoning and influenza);
intestinal infections (including gastroenteritis);
skin infections (including cellulitis and shingles);
ear infections;
mouth infections (including tooth infections and cold sores);
reproductive tract infections;
urinary tract infection;
fungal infections;
joint infections;
benign tumours;
skin cancer;
allergic reactions (including seasonal allergy);
dehydration;
mood swings (including depression);
anxiety;
difficulty sleeping;
sensation disorders such as tingling, prickling or numbness;
migraine;
symptoms of nerve root compression (including low back pain and leg pain);
vision disturbances;
eye inflammation;
inflammation of the eye lid and eye swelling;
vertigo (sensation of room spinning);
sensation of heart beating rapidly;
high blood pressure;
flushing;
haematoma (a solid swelling with clotted blood);
cough;
asthma;
shortness of breath;
gastrointestinal bleeding;
dyspepsia (indigestion, bloating, heart burn);
acid reflux disease;
sicca syndrome (including dry eyes and dry mouth);
itching;
itchy rash;
bruising;
inflammation of the skin (such as eczema);
breaking of finger nails and toe nails;
increased sweating;
hair loss;
new onset or worsening of psoriasis;
muscle spasms;
blood in urine;
kidney problems;
chest pain;
oedema (a build-up of fluid in the body which causes the affected tissue to swell);
fever;
reduction in blood platelets which increases risk of bleeding or bruising;
impaired healing.

Uncommon (may affect up to 1 in 100 people)

opportunistic (unusual) infections (which include tuberculosis and other infections) that occur

when resistance to disease is lowered;

neurological infections (including viral meningitis);
eye infections;
bacterial infections;
diverticulitis (inflammation and infection of the large intestine);
cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of

skin cancer);

immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a

condition called sarcoidosis);

vasculitis (inflammation of blood vessels);
tremor (shaking);
neuropathy (nerve damage);
stroke;
double vision;
hearing loss, buzzing;
sensation of heart beating irregularly such as skipped beats;
heart problems that can cause shortness of breath or ankle swelling;
heart attack;
a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel;
lung diseases causing shortness of breath (including inflammation);
pulmonary embolism (blockage in an artery of the lung);
pleural effusion (abnormal collection of fluid in the pleural space);
inflammation of the pancreas which causes severe pain in the abdomen and back;
difficulty in swallowing;
facial oedema (swelling of the face);
gallbladder inflammation, gallbladder stones;
fatty liver (build up of fat in liver cells);
night sweats;
scar;
abnormal muscle breakdown;
systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,

joints and other organ systems);

sleep interruptions;
impotence;
inflammations.

Rare (may affect up to 1 in 1,000 people)

leukaemia (cancer affecting the blood and bone marrow);
severe allergic reaction with shock;
multiple sclerosis;
nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barre syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
heart stops pumping;
pulmonary fibrosis (scarring of the lung);
intestinal perforation (hole in the wall of the gut);
hepatitis (liver inflammation);
reactivation of hepatitis B infection;
autoimmune hepatitis (inflammation of the liver caused by the body’s own immune system);
cutaneous vasculitis (inflammation of blood vessels in the skin);
Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering

rash);

facial oedema (swelling of the face) associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus-like syndrome;
angioedema (localised swelling of the skin);
lichenoid skin reaction (itchy reddish-purple skin rash).

Not known (frequency cannot be estimated from available data)

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Merkel cell carcinoma (a type of skin cancer);
Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s

sarcoma most commonly appears as purple lesions on the skin.

liver failure;
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness);
weight gain (for most patients, the weight gain was small).

Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

low blood measurements for white blood cells;
low blood measurements for red blood cells;
increased lipids in the blood;
raised liver enzymes.

Common (may affect up to 1 in 10 people)

high blood measurements for white blood cells;
low blood measurements for platelets;
increased uric acid in the blood;
abnormal blood measurements for sodium;
low blood measurements for calcium;
low blood measurements for phosphate;
high blood sugar;
high blood measurements for lactate dehydrogenase;
autoantibodies present in the blood;
low blood potassium.

Uncommon (may affect up to 1 in 100 people)

raised bilirubin measurement (liver blood test).

Rare (may affect up to 1 in 1,000 people)

low blood measurements for white blood cells, red blood cells and platelet count.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amsparity

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label / blister / carton after EXP.

Store in a refrigerator (2°C –8°C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example, when you are travelling), a single Amsparity pre-filled syringe may be stored at room temperature (up to 30°C) for a maximum period of 30 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 30 days or discarded , even if it is returned to the refrigerator.

You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Amsparity contains

The active substance is adalimumab.

The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose, edetate disodium dihydrate, L-methionine, polysorbate 80, and water for injections.

What the Amsparity pre-filled syringe looks like and contents of the pack

Amsparity 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.

The Amsparity pre-filled syringe is a glass syringe containing a clear, colourless to very light brown solution of adalimumab. Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 2 (1 spare), 2, 4 or 6 alcohol pads, respectively.

Not all pack sizes may be marketed.

Amsparity may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Pfizer Service Company BVBA

Hoge Wei 10

Zaventem 1930

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Luxembourg/Luxemburg

Pfizer NV/SA

Tél/Tel: +32 (0)2 554 62 11

Česká Republika

Pfizer, spol. s r.o.

Tel: +420–283–004–111

Danmark

Pfizer ApS

Tlf: +45 44 201 100

Deutchland

PFIZER PHARMA GmbH

Tel: +49 (0)30 550055–51000

Kùnpoç

PFIZER EAAAZ A.E. (CYPRUS BRANCH)

Tql: +357 22 817690

Magyarország

Pfizer Kft.

Tel: +36 1 488 3700

Malta

Vivian Corporation Ltd.

Tel: +356 21344610

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Efc^rapufl

n$aň3ep -HroKCCMOypr CAP^, KnoH Etnrapua

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Ten: +359 2 970 4333

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15–0

EXXáóa

PFIZER EAAAZ A.E.

TnX.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00

España

Pfizer S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L

Tel: +40 (0) 21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: +385 1 3908 777

Slovenija

Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana

Tel: +386 (0)1 52 11 400

Ireland

Pfizer Healthcare Ireland

Tel: +1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská Republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421 2 3355 5500

Ísland

Icepharma hf.

Tel: +354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Latvija

Pfizer Luxembourg SARL filiäle Latvijä

Tel. +371 67035775

United Kingdom (Northern Ireland)

Pfizer Limited

Tel: +44 (0)1304 616161

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. +3705 2514000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

INSTRUCTIONS FOR USE

Amsparity (adalimumab) 40 mg

Single-dose Pre-filled Syringe, for subcutaneous injection

Keep this leaflet. These instructions show step-by-step how to prepare and give an injection.

Store your Amsparity pre-filled syringe in the refrigerator between 2°C to 8°C.

Store Amsparity pre-filled syringe in the original carton until use to protect from direct sunlight. If needed, for example when you are traveling, you may store Amsparity pre-filled syringe at room temperature up to 30°C for up to 30 days.

Keep Amsparity, injection supplies, and all other medicines out of the reach of children.

Amsparity for injection comes in a disposable single use pre-filled syringe that contains a single dose of medicine.

Do not try to inject Amsparity yourself until you have read and understood the Instructions for Use. If your doctor, nurse or pharmacist decides that you or a caregiver may be able to give your injections of Amsparity at home, you should receive training on the correct way to prepare and inject Amsparity. It is also important to talk to your doctor, nurse or pharmacist to be sure you understand your Amsparity dosing instructions. To help you remember when to inject Amsparity, you can mark your calendar ahead of time. Talk to your doctor, nurse or pharmacist if you or your caregiver have any questions about the correct way to inject Amsparity.

After proper training, Amsparity for injection can be self-administered or given by a caregiver.

1. Supplies you need

You will need the following supplies for each injection of Amsparity. Find a clean, flat surface to place the supplies on.

o 1 Amsparity pre-filled syringe in a tray, inside the carton

o 1 alcohol swab, inside the carton

o 1 cotton ball or gauze pad (not included in your Amsparity carton)

o A suitable sharps container (not included in your Amsparity carton).

Important: If you have any questions about your Amsparity pre-filled syringe or medicine, talk to your doctor, nurse or pharmacist.

2. Getting ready

Remove Amsparity carton from the refrigerator.
Open the carton and take out the tray containing your pre-filled syringe.
Check your carton and tray; do not use if:

o the expiration date has passed

o it has been frozen or thawed

o it has been dropped, even if it looks undamaged

o it has been out of the refrigerator for more than 30 days

o it appears to be damaged

o the seals on a new carton are broken.

If any of the above apply, dispose of your pre-filled syringe in the same way as a used syringe.

You will need a new pre-filled syringe to give your injection.

Wash your hands with soap and water, and dry completely.

If you have any questions about your medicine, please talk to your doctor, nurse or pharmacist.

Peel back the paper seal on the tray.
Remove 1 pre-filled syringe from the tray and put the original carton with any unused pre-filled

syringes back in the refrigerator.

Do not use your syringe if it appears to be damaged.
Your pre-filled syringe may be used straight from the refrigerator.
You may find that using your pre-filled syringe at room temperature reduces stinging or discomfort. Leave your pre-filled syringe at room temperature away from direct sunlight for 15 to 30 minutes before your injection.
Do not remove the needle cover from your pre-filled syringe until you are ready to inject.

Always hold the pre-filled syringe by the syringe barrel to prevent damage.

Look carefully at your medicine in the window.
Gently tilt your pre-filled syringe back and forth to check the medicine.
Do not shake your pre-filled syringe. Shaking can damage your medicine.
Make sure the medicine in the pre-filled syringe is clear and colourless to very light brown and

free from flakes or particles. It is normal to see one or more air bubbles in the window. Do not attempt to remove air bubbles.

If you have any questions about your medicine, please talk to your doctor, nurse or pharmacist.

Choose a different site each time you give yourself an injection.
Do not inject into bony areas or areas on your skin that are bruised, red, sore (tender) or hard.

Avoid injecting into areas with scars or stretch marks.

o If you have psoriasis, do not inject directly into any raised, thick, red, or scaly skin patches or lesions on your skin.

Do not inject through your clothes.
Wipe the injection site with the alcohol swab.
Allow the injection site to dry.
Hold the pre-filled syringe by the syringe barrel. Carefully pull the needle cover straight off and

away from your body when you are ready to inject.

It is normal to see a few drops of medicine at the needle tip when you remove the needle cover.
Throw the needle cover away into a sharps disposal container.

Note: Be careful when you handle your pre-filled syringe to avoid an accidental needle stick injury.

Gently pinch up a fold of skin in the cleaned injection site area.
Insert the needle to its full depth into the skin, at a 45 degree angle, as shown.
After the needle is inserted, release the pinched skin.

Important: Do not re-insert the needle into your skin. If the needle has already been inserted into the skin and you change your mind about where to inject, you will need a replacement pre-filled syringe.

Using slow and constant pressure, push the plunger rod all the way down until the barrel is

empty. It usually takes 2 to 5 seconds to deliver the dose.

Note: It is recommended to hold your pre-filled syringe in the skin for an additional 5 seconds after the plunger has been pressed down completely.

Pull the needle out of the skin at the same angle at which it entered.
Check that your medicine has completely emptied from your pre-filled syringe.
Never re-insert the needle.
Never re-cap the needle.

Note: If the grey stopper is not in the position shown, you may not have injected all of your medicine. Talk to your doctor, nurse or pharmacist right away.

Dispose of the syringe straight away as instructed by your doctor, nurse or pharmacist and in

accordance with local health and safety laws.

Look closely at your injection site. If there is blood, use a clean cotton ball or gauze pad to press

lightly on the injection area for a few seconds.

Do not rub the site.

Note: Store any unused syringes in the refrigerator in the original carton.

See over for

Package leaflet: Information for the patient

Package leaflet: Information for the patient

Amsparity 40 mg solution for injection in pre-filled pen adalimumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– Your doctor will also give you a patient reminder card, which contains important safety

information that you need to be aware of before you are given Amsparity and during treatment with Amsparity. Keep this patient reminder card with you.

– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Amsparity is and what it is used for
2. What you need to know before you use Amsparity
3. How to use Amsparity
4. Possible side effects
5. How to store Amsparity
6. Contents of the pack and other information

1. What Amsparity is and what it is used for

Amsparity contains the active substance adalimumab, a medicine that acts on your body’s immune (defence) system.

Amsparity is intended for the treatment of the following inflammatory diseases:

rheumatoid arthritis,
polyarticular juvenile idiopathic arthritis,
paediatric enthesitis-related arthritis,
ankylosing spondylitis,
axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
psoriatic arthritis,
psoriasis,
hidradenitis suppurativa,
Crohn’s disease,
ulcerative colitis and
non-infectious uveitis.

The active ingredient in Amsparity, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Amsparity can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Amsparity can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.

Usually, Amsparity is used with methotrexate. If your doctor considers that methotrexate is inappropriate, Amsparity can be given alone.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood.

Paediatric enthesitis-related arthritis

Paediatric enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.

Psoriatic arthritis

Psoriatic arthritis is an inflammation of the joints associated with psoriasis.

Amsparity is used to treat psoriatic arthritis in adults. Amsparity can slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Plaque psoriasis in adults and children

Hidradenitis suppurativa in adults and adolescents

Crohn’s disease in adults and children

Crohn’s disease is an inflammatory disease of the gut.

Amsparity is used to treat Crohn’s disease in adults and children aged 6 to 17 years.

Ulcerative colitis in adults and children

Ulcerative colitis is an inflammatory disease of the large intestine.

Non-infectious uveitis in adults and children

Amsparity is used to treat

adults with non-infectious uveitis with inflammation affecting the back of the eye.
children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the

front of the eye.

You may first be given other medicines. If these medicines do not work well enough, you will be given Amsparity to reduce the signs and symptoms of your disease.

2. What you need to know before you use Amsparity

Do not use Amsparity

if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in

section 6).

if you have a severe infection, including active tuberculosis, sepsis (blood poisoning) or

if you have moderate or severe heart failure. It is important to tell your doctor if you have had or

have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Amsparity.

It is important that you and your doctor record the brand name and batch number of your medication.

Allergic reactions

If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness,

swelling or rash, do not inject more Amsparity and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.

Infections

If you have an infection, including long-term infection or an infection in one part of the body

(for example, leg ulcer), consult your doctor before starting Amsparity. If you are unsure, contact your doctor.

You might get infections more easily while you are receiving Amsparity treatment. This risk

may increase if you have problems with your lungs. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections (unusual infectious organisms) and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend temporarily stopping Amsparity.

Tuberculosis (TB)

As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Amsparity. This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your patient reminder card.
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have

been in close contact with someone who has had tuberculosis.

Tuberculosis can develop during therapy even if you have had preventative treatment for

tuberculosis.

If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of

energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Travel / recurrent infection

Tell your doctor if you have lived or travelled in regions where fungal infections such as

histoplasmosis, coccidioidomycosis or blastomycosis are endemic (found).

Tell your doctor if you have infections which keep coming back or other conditions that increase

the risk of infections.

You should pay special attention to signs of infection while you are being treated with Amsparity. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Hepatitis B virus

Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV

Age over 65 years

If you are over 65 years you may be more susceptible to infections while taking Amsparity. You

Surgery or dental procedures

If you are about to have surgery or dental procedures, tell your doctor that you are taking

Amsparity. Your doctor may recommend temporarily stopping Amsparity.

Demyelinating disease

If you have or develop demyelinating disease (a disease that affects the insulating layer around

Vaccination

Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses that

Heart failure

It is important to tell your doctor if you have had or have a serious heart condition. If you have

Fever, bruising, bleeding or looking pale

In some patients the body may fail to produce enough of the blood cells that fight off infections

Cancer

There have been very rare cases of certain kinds of cancer in children and adults taking

adalimumab or other TNFa blockers. People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow). If you take Amsparity the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Amsparity.

In addition, cases of non-melanoma skin cancer have been observed in patients taking

adalimumab. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.

There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFa blocker. Ifyou have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNFa blocker is appropriate for you.

Autoimmune disease

On rare occasions, treatment with Amsparity could result in lupus-like syndrome. Contact your

doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Other medicines and Amsparity

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Amsparity treatment.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.

Amsparity should only be used during a pregnancy if needed.

Amsparity can be used during breast-feeding.

Driving and using machines

Amsparity may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Amsparity.

Amsparity contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free’.

3. How to use Amsparity

Amsparity is injected under the skin (subcutaneous use).

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.