Gobivaz 50 mg solution for injection in Pre-filled pen – patient leaflet, side effects, dosage

what it is used for

substance called golimumab. of medicines called ‘TNF blocke es:

uding ankylosing spondylitis an

d older, GOBIVAZ is used for the the action of a protein called ‘tum esses of the body, and blocking

ammatory disease of the joints. I do not respond well enough to t ith another medicine called met ptoms of your disease.

your bones and joints.

ction

matory disease of the joints, usua e active psoriatic arthritis you wil medicines, you may be given G ptoms of your disease.

your bones and joints.

ction

non-radiographic axial spondy

n-radiographic axial spondyloar r non-radiographic axial spondyl gh to these medicines, you may ptoms of your disease.

ction.

atory disease of the bowel. If yo

ough to these medicines, you wi

thic arthritis

ic arthritis is an inflammatory dis e idiopathic arthritis you will first ou will be given GOBIVAZ in co

rs’. It is used in adults for the tre

d non-radiographic axial spondyl

treatment of polyarticular juveni our necrosis factor alpha’ (TNF-it can reduce the inflammation in

f you have active rheumatoid art hese medicines, you may be giv hotrexate to:

lly accompanied by psoriasis, a l first be given other medicines. OBIVAZ to:

loarthritis

thritis are inflammatory diseases oarthritis, you will first be given o be given GOBIVAZ to:

u have ulcerative colitis you will

ll be given GOBIVAZ to treat you

ease that causes joint pain and s be given other medicines. If you mbination with methotrexate to tr

2. What you need to know bef

ore you use GOBIVAZ

nsitive) to golimumab or any of t

B) or any other severe infection. vere heart failure.

e above applies to you, talk to yo

st or nurse before using GOBIVA

if you already have or get any s infection include fever, cough, s burning feeling when urinating. re easily while using GOBIVAZ. ore rapidly and may be more se

if symptoms of TB appear durin istent cough, weight loss, tiredn ported in patients treated with G es for TB. Your doctor will test yo

tell your doctor if you have ever has TB.

u are at risk of TB, you may be tr

a carrier or if you have or have ha you might be at risk of contract u for HBV.

rs such as GOBIVAZ may result ng in some cases.

d to an area where infections cau lled histoplasmosis, coccidioido r doctor if you don’t know if thes

er been diagnosed with lympho

er TNF blockers, your risk for de atoid arthritis and other inflamm n average risk of developing lym

he other ingredients of this medi

ur doctor, pharmacist or nurse b

Z

ymptoms of infection, during or a hortness of breath, flu-like sympt

vere. In addition, some previous

g or after your treatment. ess, fever or night sweats. OBIVAZ, in rare occasions even i u to see if you have TB. Your doc

had TB, or if you have been in c

eated with medicines for TB befo

d HBV before you are given GO ing HBV.

in reactivation of HBV in patients

sed by specific type of fungi tha mycosis, or blastomycosis), are e fungal infections are common

ma (a type of blood cancer) or a

veloping lymphoma or another c atory diseases, who have had th phoma.

ere have been cases of cancers, F-blocking agents, which somet n rare occasions, a specific and s served in patients taking other T is type of cancer has usually res own as azathioprine or 6-mercap th GOBIVAZ.

tients with severe persistent asth ay be at increased risk for cance heavy smoker, you should discus u.

me patients treated with golimu pearance of the skin or growths

failure

our doctor straight away if you g de shortness of breath or swellin w and worsening congestive he ese patients died.

ou have mild heart failure and y ctor.

ous system disease

our doctor straight away if you h se such as multiple sclerosis. Sy mbness or tingling in any part of

ations or dental procedures lk to your doctor if you are going ll your surgeon or dentist perform em your Patient Card.

mmune disease

our doctor if you develop sympto and tiredness.

n rare occasions, people treated

d disease

me patients the body may fail to

o stop bleeding. If you develop a our doctor right away. Your doct are not sure if any of the above

nations

o your doctor if you have had, or u should not receive certain (live rtain vaccinations may cause inf at higher risk for getting such a ring pregnancy. It is important th ur GOBIVAZ use so they can de

o your child’s doctor regarding v nations before using GOBIVAZ.

peutic infectious agents

o your doctor if you have recentl t (such as BCG instillation used f

ic reactions

our doctor straight away if you d toms of an allergic reaction may allowing or breathing, skin rash, me of these reactions may be se me of these reactions occurred

ren

VAZ is not recommended for chi use it has not been studied in thi

r medicines and GOBIVAZ

ll your doctor or pharmacist if yo y other medicines to treat rheum kylosing spondylitis, non-radiogr u should not take GOBIVAZ with edicines are used for the treatme ll your doctor or pharmacist if yo u should not receive certain (live are not sure if any of the above

nancy and breast-feeding

o your doctor before using GOBI u are pregnant or are planning t e effects of this medicine in preg coming pregnant by using adeq t GOBIVAZ injection. GOBIVAZ s fore starting breast-feeding, you u must stop breast-feeding if you ou received GOBIVAZ during yo portant that you tell your baby’s e baby receives any vaccine (for are pregnant or breast-feeding, armacist for advice before taking

ng and using machines

VAZ has minor influence on you you take GOBIVAZ. If this happe

IVAZ contains sorbitol

tol intolerance

medicine contains 20.5 mg sorbi on for the user

jection in pre-fill

including unusual types, in chil imes resulted in death.

evere type of lymphoma called NF-blockers. Most of these patie ulted in death. Almost all of thes topurine. Tell your doctor if you ma, chronic obstructive pulmon r with GOBIVAZ treatment. If you s with your doctor whether treat mab have developed certain kind on the skin occur during or after et new or worsening symptoms o g of your feet.

art failure has been reported with ou are being treated with GOBIV ave ever been diagnosed with or mptoms may include changes in your body. Your doctor will deci to have any operations or denta ing the procedure that you are ms of a disease called lupus. Sy with TNF blockers have develop produce enough of the blood ce fever that does not go away, bru or may decide to stop treatment. applies to you, talk to your docto are due to have a vaccine. ) vaccines while using GOBIVAZ ections. If you received GOBIVA n infection for up to approximatel at you tell your baby's doctors a cide when your baby should rece accinations for your child. If pos y received or are scheduled to re or the treatment of cancer).

evelop symptoms of an allergic r include swelling of the face, lips hives, swelling of the hands, feet rious or, rarely, life-threatening. after the first administration of G ldren less than 2 years of age wi s group.

u are using, have recently used atoid arthritis, polyarticular juven aphic axial spondyloarthritis, or medicines containing the active nt of rheumatic diseases. u are taking any other medicines ) vaccines while using GOBIVAZ applies to you, talk to your docto

VAZ if:

o become pregnant while using nant women. If you are being tre uate contraception during your t hould only be used during preg r last treatment with GOBIVAZ m are to be given GOBIVAZ. ur pregnancy, your baby may ha doctors and other health care pr more information see section on think you may be pregnant or ar this medicine.

r ability to drive and use tools or ns, do not drive or use any tools tol (E420) in each pre-filled pen. ed pen dren and teenage patients taking hepatosplenic T-cell lymphoma h nts were adolescent or young ad e patients had also received med are taking azathioprine or 6-mer ary disease (COPD), or are heav have severe persistent asthma, ment with a TNF blocker is appro s of skin cancer. If any changes therapy, tell your doctor.

f heart failure. Symptoms of hea

TNF blockers, including GOBIV

AZ, you must be closely monitor develop symptoms of a demyeli your vision, weakness in your a de if you should receive GOBIVA l procedures.

having treatment with GOBIVAZ mptoms include persistent rash, ed lupus.

lls that help your body fight infec ise or bleed very easily or look v r or pharmacist before using GO

.

Z while you were pregnant, your y six months after the last dose nd other health care professiona ive any vaccine.

sible, your child should be up to ceive treatment with a therapeut eaction after your treatment with , mouth or throat which may cau or ankles.

OBIVAZ th polyarticular juvenile idiopathi or might use any other medicine ile idiopathic arthritis, psoriatic a ulcerative colitis.

substance anakinra or abatacep that affect your immune system .

r or pharmacist before using GO

GOBIVAZ. There is limited inform ated with GOBIVAZ, you must av reatment and for at least 6 month nancy if it is clearly necessary fo ust be at least 6 months ago.

ve a higher risk for getting an inf ofessionals about your GOBIVAZ vaccination).

e planning to have a baby, ask y machines. Dizziness may howev or machines.

as been ult males. icines captopurine y smokers COPD or are priate for in the rt failure

AZ. Some of ed by your nating rms or legs Z.

by showing fever, joint tions or help ery pale,

BIVAZ.

baby may you received ls about date with all ic infectious

GOBIVAZ. se difficulty c arthritis s, including rthritis, t. These

.

BIVAZ.

ation about oid s after the r you.

ection. It is use before our doctor er occur pharmacist if date each

GOBIVAZ pens)

ame date e GOBIVAZ opalescent w small his happens, a directly rks.

t different your doctor

3. How to use GOBIVAZ

ys use this medicine exactly as y re not sure.

much GOBIVAZ is given

matoid arthritis, psoriatic arthritis adiographic axial spondyloarthri e recommended dose is 50 mg onth.

lk to your doctor before taking y atment.

If you weigh more than 100 kg, t given once a month, on the sam rticular juvenile idiopathic arthriti r patients weighing at least 40 k ch month.

lk to your doctor before you take atment.

our doctor or pharmacist has told

, and axial spondyloarthritis, incl tis:

(the content of 1 pre-filled pen) g our fourth dose. Your doctor will he dose might be increased to 1 e date each month.

s in children 2 years of age and g, the recommended dose is 50 the fourth dose. Your doctor will

you. Check with your doctor or uding ankylosing spondylitis and iven once a month, on the same determine if you should continue

00 mg (the content of 2 pre-filled older:

mg given once a month, on the s determine if you should continu

CMO code CMO

2D

code

Needle shield Thin hidden

needle

Viewing window

E

xpiration date on label

Body grip area

ct GOBIVAZ, you must be train self. If you have not been traine aining session.

e-filled pen

e injection site

e 1) shows what the pre-filled pe

ed by a healthcare professiona d, please contact your doctor,

n looks like.

l to prepare an nurse or

ourself two

igh and the other

ourself four

er the other.

the last day of the

x for 30 minutes out

e or in hot water).

ab, a cotton ball or

Chec

• Lo

  (h tra

• Yo

• Do

  tal

• C
• Yo

• Yo

  un

• Do

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  inj

  D

Wash

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• Wi
• All
• Do
• In
• Th
• Th

Rem

• W
• Do

• Do

  or

Figure 1 pre-filled pen

pen at any time.

m the pre-filled pen until immedi re-filled pen back on if removed

led pens

ake sure

ns and strength is correct ou will get one 50 mg pre-filled p you will get two 50 mg pre-filled different sites for these injections ) and give the injections one righ you will get four 50 mg pre-filled rent sites for these injections and

ted or written on the carton. ndicated as “EXP”) on the pre-fil en if the expiry date has passed. r doctor or pharmacist for assist

lid on the blister.

broken. Please contact your doct

-filled pen to reach room temp

allow the pre-filled pen to sit at

pen in any other way (for examp d pen’s cap while allowing it to r

ent ready

can get the rest of your equipme ner.

ately before the injection. to avoid bending the needle.

en

pens and you will need to give y (e.g. one injection in the right th t after the other.

pens and you will need to give y give the injections one right aft

led pen.

The printed expiry date refers to ance.

or or pharmacist.

erature

room temperature outside the bo

le, do not warm it in a microwav each room temperature.

nt ready, including an alcohol sw

k the liquid in the pre-filled pe

ok through the viewing window t aving a pearl-like shine) and colo nslucent or white particles of pro u will also notice an air bubble, not use the pre-filled pen if the k to your doctor or pharmacist.

hoosing and preparing the inje

u can inject the medicine into th u can use the stomach (abdome derneath the belly button. not inject into areas where the multiple injections are required fo ection sites.

O NOT inject into the arm to avoi

hands and clean the injection

ash your hands thoroughly with s pe the injection site with an alco ow the skin to dry before injectin not touch this area again before

jecting the medicine

e cap should not be removed un e medicine should be injected w

ove the cap (figure 3)

hen you are ready to inject, pull t not put the cap back on becau not use the pre-filled pen if it is pharmacist.

n

o make sure that the liquid in the urless to light yellow. The solutio tein.

which is normal.

liquid is the wrong colour, cloudy ction site (see figure 2)

e front of the middle thighs.

1. n)

   below the belly button, excep skin is tender, bruised, red, scaly r a single administration, the inje

   Injectable areas

   Figure 2 d failure of the pre-filled pen and site

oap and warm water.

hol swab.

g. Do not fan or blow on the clea giving the injection.

til you are ready to inject the me ithin 5 minutes after the cap has he cap off and throw it away afte se it may damage the needle insi dropped without the cap in plac

Figure 3

pre-filled pen is clear to slightly n can be used if it contains a fe

, or contains larger particles. If t t for approximately the 5 cm are

, hard or has scars or stretch ma ctions should be administered a

/or unintentional injury.

n area.

dicine.

been removed.

r your injection.

de the pre-filled pen.

e. If this happens please contact

Ulcerative colitis

• The table below shows how you will usually use this medicine.

  Initial treatment A starting dose of 200 mg (the contents of 4 pre-filled pens)

  followed by 100 mg (the contents of 2 pre-filled pens) 2 weeks later.

  Maintenance treatment • In patients weighing less than 80 kg, 50 mg (the contents of 1 pre-filled pen) 4 weeks after your last treatment, then every

  4 weeks thereafter. Your doctor may decide to prescribe 100 mg (the contents of 2 pre-filled pens), depending on how

  well GOBIVAZ works for you.

  • In patients weighing 80 kg or more, 100 mg (the contents of 2 pre-filled pens) 4 weeks after your last treatment, then every

    4 weeks thereafter.

How GOBIVAZ is given

• GOBIVAZ is given by injection under the skin (subcutaneously).

• At the start, your doctor or nurse may inject GOBIVAZ. However, you and your doctor may decide that you may

  inject GOBIVAZ yourself. In this case you will get training on how to inject GOBIVAZ yourself. Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed “Instructions for Use” at the end of this leaflet.

If you use more GOBIVAZ than you should

If you have used or been given too much GOBIVAZ (either by injecting too much on a single occasion, or by using it too often), talk to your doctor or pharmacist straight away. Always take the outer carton and this leaflet with you, even if it is empty.

If you forget to use GOBIVAZ

If you forget to use GOBIVAZ on your planned date, inject the forgotten dose as soon as you remember. Do not use a double dose to make up for a forgotten dose.

When to inject your next dose:

• If you are less than 2 weeks late, inject the forgotten dose as soon as you remember and stay on your original

  schedule.

• If you are more than 2 weeks late, inject the forgotten dose as soon as you remember and talk to your doctor or

  pharmacist to ask when you need to take the next dose.

If you are not sure what to do, talk to your doctor or pharmacist.

If you stop using GOBIVAZ

If you are considering stopping GOBIVAZ, talk to your doctor or pharmacist first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience serious side effects and may require treatment. The risk of certain side effects is greater with the 100 mg dose compared with the 50 mg dose. Side effects may appear up to several months after the last injection.

Tell your doctor straight away if you notice any of the following serious side effects of GOBIVAZ which include:

• allergic reactions which may be serious, or rarely, life-threatening (rare). Symptoms of an allergic reaction

  may include swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles. Some of these reactions occurred after the first administration of GOBIVAZ.

• serious infections (including TB, bacterial infections including serious blood infections and pneumonia,

  severe fungal infections and other opportunistic infections) (common). Symptoms of an infection can include fever, tiredness, (persistent) cough, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning feeling when urinating.

• reactivation of hepatitis B virus if you are a carrier or have had hepatitis B before (rare). Symptoms can

  include yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever, feeling sick, being sick, and feeling very tired.

• nervous system disease such as multiple sclerosis (rare). Symptoms of nervous system disease can include

  changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.

• cancer of the lymph nodes (lymphoma) (rare). Symptoms of lymphoma can include swelling of the lymph

  nodes, weight loss, or fever.

• heart failure (rare). Symptoms of heart failure can include shortness of breath or swelling of your feet.

• signs of immune system disorders called:

  • lupus (rare). Symptoms can include joint pain or a rash on cheeks or arms that is sensitive to the sun.

  • sarcoidosis (rare). Symptoms can include a persistent cough, being short of breath, chest pain, fever,

    swelling of your lymph nodes, weight loss, skin rashes, and blurred vision.

• swelling of small blood vessels (vasculitis) (rare). Symptoms can include fever, headache, weight loss, night

  sweats, rash, and nerve problems such as numbness and tingling.

• skin cancer (uncommon). Symptoms of skin cancer can include changes in the appearance of your skin or

  growths on your skin.

• blood disease (common). Symptoms of blood disease can include a fever that does not go away, bruising or

  bleeding very easily or looking very pale.

• blood cancer (leukaemia) (rare). Symptoms of leukaemia can include fever, feeling tired, frequent infections,

  easy bruising, and night sweats.

Tell your doctor straight away if you notice any of the above symptoms.

The following additional side effects have been observed with GOBIVAZ

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

• Upper respiratory tract infections, sore throat or hoarseness, runny nose

Common side effects (may affect up to 1 in 10 people):

• Abnormal liver tests (increased liver enzymes) found during blood tests done by your doctor
• Feeling dizzy
• Headache
• Feeling numb or having a tingling feeling
• Superficial fungal infections
• Abscess
• Bacterial infections (such as cellulitis)
• Low red blood cell counts
• Low white blood cell counts
• Positive blood lupus test
• Allergic reactions
• Indigestion
• Stomach pain
• Feeling sick (nausea)
• Flu
• Bronchitis
• Sinus infection
• Cold sores
• High blood pressure
• Fever
• Asthma, shortness of breath, wheezing

• Stomach and bowel disorders which include inflammation of the stomach lining and colon which may cause

  fever

• Pain and ulcers in the mouth
• Injection site reactions (including redness, hardness, pain, bruising, itching, tingling and irritation)
• Hair loss
• Rash and itching of the skin
• Difficulty sleeping
• Depression
• Feeling weak
• Bone fractures
• Chest discomfort.

Uncommon side effects (may affect up to 1 in 100 people):

• Kidney infection
• Cancers, including skin cancer and non-cancerous growths or lumps, including skin moles
• Skin blisters
• Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
• Psoriasis (including on the palms of your hand and/or the soles of your feet and/or in the form of skin blisters)
• Low platelet count
• Combined low platelet, red, and white blood cell count
• Thyroid disorders
• Increase in blood sugar levels
• Increase in blood cholesterol levels

• Balance disorders

  • Vision disturbances
  • Inflamed eye (conjunctivitis)
  • Eye allergy
  • Sensation of heart beating irregularly
  • Narrowing of the blood vessels in the heart
  • Blood clots
  • Flushing
  • Constipation
  • Chronic inflammatory condition of the lungs
  • Acid reflux
  • Gall stones
  • Liver disorders
  • Breast disorders
  • Menstrual disorders.

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

• Failure of the bone marrow to produce blood cells
• Severely decreased number of white blood cells
• Infection of the joints or the tissue around them
• Impaired healing
• Inflammation of blood vessels in internal organs
• Leukaemia
• Melanoma (a type of skin cancer)
• Merkel cell carcinoma (a type of skin cancer)
• Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
• Scaly, peeling skin
• Immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• Pain and discolouration in the fingers or toes
• Taste disturbances
• Bladder disorders
• Kidney disorders
• Inflammation of the blood vessels in your skin which results in rash.

Side effects of which the frequency is not known:

• A rare blood cancer affecting mostly young people (hepatosplenic T-cell lymphoma)
• 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
• Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).

Reporting of side effects

If you get 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 www.mhra.gov.uk/yellowcard 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 GOBIVAZ

• 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 and the carton after “EXP”. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Keep the pre-filled pen in the outer carton in order to protect it from light.
• This medicine can also be stored out of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton. Write the new expiry date on the carton including day/month/year (no more than 30 days after the medicine is removed from the refrigerator). Do not return this medicine to refrigerator if it has reached room temperature. Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
• Do not use this medicine if you notice that the liquid is not a clear to light yellow colour, cloudy, or contains foreign particles.
• 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 to protect the environment.

6. Contents of the pack and other information

What GOBIVAZ contains

The active substance is golimumab. One 0.5 mL pre-filled pen contains 50 mg of golimumab. The other ingredients are sorbitol (E420), L-histidine, L-histidine monohydrochloride monohydrate, poloxamer 188 and water for injections. For more information on sorbitol (E420), see Section 2.

What GOBIVAZ looks like and contents of the pack

GOBIVAZ is supplied as solution for injection in a single-use pre-filled pen. GOBIVAZ is available in packs containing 1 pre-filled pen and multipacks containing 3 (3 packs of 1) pre-filled pens. Not all pack sizes may be marketed.

The solution is clear to slightly opalescent (having a pearl-like shine), colourless to light yellow and may contain a few small translucent or white particles of protein. Do not use GOBIVAZ if the solution is discoloured, cloudy or you can see foreign particles in it.

Marketing Authorisation Holder

Advanz Pharma Limited

Unit 17 Northwood House

Northwood Crescent

Dublin 9

D09 V504

Ireland

Manufacturer

Alvotech Hf

Sæmundargata 15-19

Reykjavik, 102

Iceland

This leaflet was last revised in August 2026.

15SEC

1st

CLICK!

15SEC

2nd

CLICK! 90° Prepare to push the pre-filled pen against the skin (see figure 4).

Figure 4

• Pinch the skin with other hand. Prepare to position the pre-filled pen over the injection site so that the orange

  needle shield points toward the injection site.

• Hold the pen so that you can see the inspection window.

Push to inject (see figure 5).

Figure 5

• Push the open end of the pre-filled pen against the skin at a 90-degree angle (see Figure 5).
• Wait for the first “click” that signals the start of injection. You may or may not feel a needle prick.
• Start counting to 15 to ensure that all drug gets injected.

Do not lift the pre-filled pen away from your skin. If you pull the pre-filled pen away from your skin, you may not get your full dose of medicine.

Continue to hold until the orange indicator has stopped moving or you hear the second ‘click’ (see figure 6). It can take up to 15 seconds for you to hear the second ‘click’ sound (indicating that the injection has finished and the needle has gone back into the pre-filled pen).

Figure 6

• Note: If you do not hear the second ‘click’, wait 15 seconds from the time you first press the pre-filled pen

  against the skin and then lift the autoinjector from the injection site.

  Check the viewing window – an orange indicator confirms proper administration (see figure 7)

  • The orange indicator will completely fill in the viewing window.
  • Lift the pre-filled pen from the injection site.

  • Talk to your doctor or pharmacist if the orange indicator is not visible in the window or if you suspect that you may not have received a complete dose. Do not administer a second dose without speaking to your doctor.

    Figure 7

  • After the injection

Use a cotton ball or gauze

• There may be a small amount of blood or liquid at the injection site. This is normal.
• You can press a cotton ball or gauze over the injection site for 10 seconds.
• You may cover the injection site with a small adhesive bandage, if necessary.
• Do not rub your skin.

Throw the pre-filled pen away (see figure 8)

• Place your pen in a sharps container straight away. Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.

If you feel that something has gone wrong with the injection or if you are not sure, talk to your doctor or pharmacist.

Figure 8

AW-LF-0001558 (v0.5) 90° GOBIVAZ Patient Card

This Patient Card contains important safety information that you need to be aware of before and during treatment with GOBIVAZ. Show this card to any doctor involved in your treatment.

1. 1. Infections

When you are treated with GOBIVAZ, you might

get infections more easily. Infections may progress more rapidly and may be more severe. In addition, some previous infections may reappear. 1.1 Prior to GOBIVAZ treatment:

• Tell your doctor if you have an

  infection. You must not be treated with GOBIVAZ if you have

  tuberculosis (TB) or any other

severe infection.

• You should be screened for TB. It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB. Ask your doctor to record the type and date of the last screening(s) for TB below:

Test __________________________________

____________________Date_______________

Result_________________________________

Test __________________________________

____________________Date_______________

Result_________________________________

• Tell your doctor if you know or suspect you

  are a carrier of the hepatitis B virus. 1.2 During and after GOBIVAZ treatment:

• Seek medical attention immediately if you

  develop symptoms of an infection, such as fever, tiredness, (persistent) cough, shortness of breath, or flu-like signs, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning feeling when urinating.

  1. 2. Pregnancy and vaccinations

In case you have received GOBIVAZ while you were pregnant, it is important that you inform your baby’s doctor about it before your baby receives any vaccine. Your baby should not receive a ‘live vaccine’, such as BCG (used to prevent tuberculosis) within 6 months after your last GOBIVAZ injection during pregnancy.

1. 3. Dates of GOBIVAZ treatment

1^st administration:__________________________ Subsequent administrations:

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

1. 4. Other information

Patient’s Name: ___________________________

__________________________________________

Doctor’s Name: ___________________________

__________________________________________

Doctor’s Phone: ___________________________

• Please make sure you also have a list of all other medicines that you are using with you at any visit to a health care professional.
• Keep this card with you for 6 months after the last GOBIVAZ dose, since side effects may occur a long time after your last dose of GOBIVAZ.
• Read the GOBIVAZ package leaflet carefully before you start using this medicine.