AMSPARITY 20 MG SOLUTION FOR INJECTION IN PRE FILLED SYRINGE - patient leaflet, side effects, dosage

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).

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,

• 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,

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Manufacturer

Pfizer Service Company BVBA

Hoge Wei 10

Zaventem 1930

Belgium

United Kingdom

For any information about this medicine, please contact:

Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.

Telephone 01304 616161.

This leaflet was last revised in 07/2021.

Ref: bAY 2_0

INSTRUCTIONS FOR USE

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.