Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - hyrimoz

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Generated Narrative: MedicinalProductDefinition mpd5e2325446e1313077f0f1d0c6c251e8

identifier: http://ema.europa.eu/identifier/EU/1/18/1286/007

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Hyrimoz 20 mg solution for injection in pre-filled syringe

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d5e2325446e1313077f0f1d0c6c251e8

identifier: http://ema.europa.eu/identifier/EU/1/18/1286/007

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - hyrimoz

Attesters

7. Instructions for use

What is in this leaflet

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

Hyrimoz contains the active substance adalimumab, a medicine that acts on your body s immune (defence) system. Hyrimoz is intended for the treatment of the following inflammatory diseases:

polyarticular juvenile idiopathic arthritis,

enthesitis-related arthritis

paediatric plaque psoriasis,

paediatric Crohn s disease,

paediatric non-infectious uveitis. The active substance in Hyrimoz, 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 (TNF ), which is present at increased levels in the inflammatory diseases listed above. By attaching to TNF , Hyrimoz blocks its action and reduces the inflammation in these diseases. Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood. Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and 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 Hyrimoz to treat their polyarticular juvenile idiopathic arthritis or 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. Hyrimoz 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. Paediatric Crohn s disease Crohn s disease is an inflammatory disease of the gut. Hyrimoz is used to treat moderate to severe Crohn s disease in children and adolescents 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 Hyrimoz to reduce the signs and symptoms of his/her disease. Paediatric non-infectious uveitis Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. The inflammation leads 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). Hyrimoz works by reducing this inflammation. Hyrimoz is used to treat children from 2 years of age with chronic non-infectious uveitis 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 Hyrimoz to reduce the signs and symptoms of his/her disease.

Do not use Hyrimoz

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 tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important that you tell your doctor if your child shows symptoms of infections, e.g. 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 doctor if your child has had or has a serious heart condition (see Warnings and precautions ). Warnings and precautions Talk to your doctor or pharmacist before using Hyrimoz. Allergic reaction

If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Hyrimoz and contact your doctor immediately, since in rare cases, these reactions can be life-threatening. Infection

If your child has an infection, including long-term or localised infection (for example leg ulcer), consult your doctor before starting Hyrimoz. If you are unsure, contact your doctor.

Your child might get infections more easily while he/she is receiving Hyrimoz treatment. This risk may increase if your child s lung function is reduced. These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).

In rare cases, these infections may be life-threatening. It is important to tell your doctor if your child shows symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend temporarily stopping Hyrimoz. Tuberculosis (TB)

As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check your child for signs and symptoms of tuberculosis before starting Hyrimoz. 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 doctor if your child has ever had tuberculosis, or if he/she has been in close contact with someone who has had tuberculosis. Tuberculosis can develop during therapy even if your child has had preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately. Travel/recurrent infection

Tell your doctor if your child has lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.

Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections. Hepatitis B virus

Tell your 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 contracting HBV. Your doctor should test your child for HBV. Adalimumab can reactivate HBV infection in people who carry this 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 procedures

If your child is about to have surgery or dental procedures tell your doctor that your child is taking Hyrimoz. Your doctor may recommend temporarily stopping Hyrimoz. Demyelinating disease

If your child has or develops demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Hyrimoz. Tell your doctor immediately if he/she experiences symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body. Vaccine

Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Hyrimoz in case they cause infections. Check with your 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 Hyrimoz. If your child receives Hyrimoz while she is pregnant, her baby may be at higher risk for getting an infection for up to about five months after the last dose she received during pregnancy. It is important that you tell her baby's doctors and other health care professionals about your child s Hyrimoz use during herpregnancy so they can decide when her baby should receive any vaccine. Heart failure

It is important to tell your doctor if your child has had or has a serious heart condition. If your child has mild heart failure and is being treated with Hyrimoz, the heart failure status must be closely monitored by your doctor. If your child develops 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 stop bleeding. If your child develops a fever that does not go away, or he/she bruises or bleeds very easily or looks 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 TNF 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 your child takes Hyrimoz, the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma has been observed in patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your doctor if your child is taking azathioprine or mercaptopurine with Hyrimoz.

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 TNF blocker. If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate. Autoimmune diseases

On rare occasions, treatment with Hyrimoz could result in lupus-like syndrome. Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur. Children and adolescents Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis below the age of 2 years. Do not give Hyrimoz to children with paediatric plaque psoriasis or paediatric ulcerative colitis below the age of 4 years. Do not give Hyrimoz to children with paediatric Crohn s disease below the age of 6 years. Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended. Other medicines and Hyrimoz Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines. Hyrimoz can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs). Your child should not take Hyrimoz 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

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

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

Hyrimoz 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.

Hyrimoz can be used during breast-feeding.

If your child receives Hyrimoz during her pregnancy, the baby may have a higher risk for getting an infection.

It is important that you tell her baby s doctors and other health care professionals about her Hyrimoz 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 Hyrimoz may have a minor influence on the ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Hyrimoz. Hyrimoz contains sodium This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 ml dose, that is to say essentially sodium-free .

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Hyrimoz is available as a 40 mg pen as well as 20 mg and 40 mg pre-filled syringes for patients to administer a full 20 mg or 40 mg dose. Polyarticular juvenile idiopathic arthritis Age and body weight How much and how often to take? Notes Children, adolescents and adults from 2 years of age weighing 30 kg or more 40 mg every other week Not applicable Children, adolescents from 2 years of age weighing 10 kg to less than 30 kg 20 mg every other week Not applicable Enthesitis-related arthritis Age and body weight How much and how often to take? Notes Children, adolescents and adults from 6 years of age weighing 30 kg or more 40 mg every other week Not applicable Children, 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 and 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 and body weight How much and how often to take? Notes Children and adolescent from 6 to 17 years of age weighing 40 kg or more First dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting two weeks later. If a faster response is required your doctor may prescribe a first dose of 160 mg (as four 40 mg injections in one day or 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 dose 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 every other week starting two weeks later. If a faster response is required, your doctor may prescribe a first dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg 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. Paediatric non-infectious uveitis Age and 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 with methotrexate Your doctor may also prescribe a first dose of 80 mg which may be administered one week prior to the start of the usual dose. Children and adolescents from 2 years of age weighing less than 30 kg 20 mg every other week with methotrexate Your doctor may also prescribe a first dose of 40 mg which may be administered one week prior to the start of the usual dose. Method and route of administration Hyrimoz is administered by injection under the skin (by subcutaneous injection). Detailed instructions on how to inject Hyrimoz are provided in section 7, Instructions for use . If you use more Hyrimoz than you should If you accidentally inject Hyrimoz more frequently than you should, call your doctor or pharmacist and explain that your child has received more medication than required. Always take the outer carton of medicine with you, even if it is empty. If you forget to use Hyrimoz If you forget to give your child an injection, you should inject the next dose of Hyrimoz as soon as you remember. Then take your child s next dose as you would have on the originally scheduled day, had you not forgotten a dose. If you stop using Hyrimoz The decision to stop using Hyrimoz should be discussed with your child s doctor. The symptoms may return upon stopping treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 up to 4 months or more after the last Hyrimoz injection. Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:

severe rash, hives;

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 doesn't heal;

signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness. The following side effects 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. 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)

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;

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);

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-Barr
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) 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.

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. 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 syringe in the outer carton in order to protect from light. Alternative Storage: When needed (for example when you are travelling), Hyrimoz may be stored at room temperature (up to 25 C) for a maximum period of 21 days be sure to protect it from light. Once removed from the refrigerator for room temperature storage, your pre-filled syringe must be used within 21 days or discarded, even if it is later returned to the refrigerator. You should record the date when your pre- filled syringe is first removed from the refrigerator, and the date after which it should be discarded. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Hyrimoz contains

The active substance is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in 0.4 ml of solution.

The other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 Hyrimoz contains sodium ). What Hyrimoz looks like and contents of the pack Hyrimoz 20 mg solution for injection (injection) in pre-filled syringe for paediatric use is supplied as a 0.4 ml clear to slightly opalescent, colourless or slightly yellowish solution. Hyrimoz is supplied in a single-use clear type I glass syringe with a stainless steel 29 gauge needle with a needle guard with finger flange, rubber needle cap (thermoplastic elastomer) and plastic plunger rod, containing 0.4 ml of solution. Carton contains 2 pre-filled syringes of Hyrimoz. Not all pack sizes may be marketed. Hyrimoz is available as a pre-filled syringe and a pre-filled pen. Marketing Authorisation Holder Sandoz GmbH Biochemiestr. 6250 Kundl Austria Manufacturer Sandoz GmbH Schaftenau Biochemiestr. 6336 Langkampfen Austria Novartis Pharmaceutical Manufacturing GmbH Biochemiestrasse 6336 Langkampfen Austria For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Sandoz nv/sa T l/Tel: +32 2 722 97 Lietuva Sandoz Pharmaceuticals d.d filialas Tel: +370 5 2636

.: +359 2 970 47 Luxembourg/Luxemburg Sandoz nv/sa T l/Tel.: +32 2 722 97 esk republika Sandoz s.r.o. Tel: +420 225 775 Magyarorsz g Sandoz Hung ria Kft. Tel.: +36 1 430 2Danmark/Norge/ sland/Sverige Sandoz A/S Tlf: +45 63 95 10 Malta Sandoz Pharmaceuticals d.d. Tel: +356 99644Deutschland Hexal AG Tel: +49 8024 908 0 Nederland Sandoz B.V. Tel: +31 36 52 41 Eesti Sandoz d.d. Eesti filiaal Tel: +372 665 2 sterreich Sandoz GmbH Tel: +43 5338 2 SANDOZ HELLAS . . : +30 216 600 5Polska Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 Espa a Sandoz Farmac utica, S.A. Tel: +34 900 456 Portugal Sandoz Farmac utica Lda. Tel: +351 21 000 86 France Sandoz SAS T l: +33 1 49 64 48 Rom nia Sandoz Pharmaceuticals SRL Tel: +40 21 407 51 Hrvatska Sandoz d.o.o. Tel: +385 1 23 53 Slovenija Sandoz farmacevtska dru ba d.d. Tel: +386 1 580 29 Ireland Rowex Ltd. Tel: +353 27 50Slovensk republika Sandoz d.d. - organiza n zlo ka Tel: +421 2 50 70 6Italia Sandoz S.p.A. Tel: +39 02 96Suomi/Finland Sandoz A/S Puh/Tel: +358 10 6133
Sandoz Pharmaceuticals d.d. : +357 22 69 0United Kingdom (Northern Ireland) Sandoz GmbH Tel: +43 5338 2Latvija Sandoz d.d. Latvia fili le Tel: +371 67 892 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. 7. Instructions for use To help avoid possible infections and to ensure that you use the medicine correctly, it is important that you follow these instructions. Be sure that you read, understand, and follow these Instructions for Use before injecting Hyrimoz. Your healthcare provider should show you how to prepare and inject Hyrimoz properly using the pre- filled syringe before you use it for the first time. Talk to your healthcare provider if you have any questions. Your Hyrimoz single-use pre-filled syringe with needle guard and add-on finger flange Figure A: Hyrimoz pre-filled syringe with needle guard and add-on finger flange It is important that you:

do not open the outer box until you are ready to use the syringe.

do not use the syringe if the seals of the blister are broken, as it may not be safe for you to use.

never leave the syringe unattended where others might tamper with it.

if you drop your syringe, do not use it if it looks damaged, or if you dropped it with the needle cap removed.

do not remove the needle cap until just before you give the injection.

be careful not to touch the needle guard wings before use. Touching them may cause the needle guard to be activated too early. Do not remove the finger flange before the injection.

inject Hyrimoz 15 30 minutes after taking it out of the refrigerator for a more comfortable injection.

throw away the used syringe right away after use. Do not re-use a syringe. See 4. Disposing of used syringes at the end of these Instructions for Use. How should you store Hyrimoz?

Store your outer carton of syringes in a refrigerator, between 2 C to 8 C.

When needed (for example when you are travelling), Hyrimoz may be stored at room temperature (up to 25 C) for a maximum period of 21 days be sure to protect it from light. Once removed from the refrigerator for room temperature storage, your pre-filled syringe must be used within 21 days or discarded, even if it is later returned to the refrigerator. You should record the date when your pre-filled syringe is first removed from the refrigerator, and the date after which it should be discarded.

Keep the syringes in the original carton until ready to use to protect from light.

Do not store the syringes in extreme heat or cold.

Do not freeze the syringes. Keep Hyrimoz and all medicines out of the reach of children. What do you need for your injection? Place the following items on a clean, flat surface. Included in your carton is:

Hyrimoz pre-filled syringe/s (see Figure A). Each syringe contains 20 mg/0.4 ml of Hyrimoz. Not included in your carton are (see Figure B):

Alcohol wipe

Cotton ball or gauze

Sharps disposal container Figure B: items not included in the carton See 4. Disposing of used syringes at the end of these Instructions for Use. Before your injection Figure C: needle guard is not activated the syringe is ready for use Figure D: needle guard is activated do not use* In this configuration the needle guard is NOT ACTIVATED. * The syringe is ready for use (see Figure C).* In this configuration the needle guard is ACTIVATED.* DO NOT USE the syringe (see Figure D). Preparing the syringe

For a more comfortable injection, take the blister containing the syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes so that it reaches room temperature.

Take the syringe out of the blister.

Look through the viewing window. The solution should be colourless or slightly yellowish as well as clear to slightly opalescent. Do not use if any particulates and/or discolorations are observed. If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.

Do not use the syringe if it is broken or the needle guard is activated. Return the syringe and the package it came in to the pharmacy.

Look at the expiry date (EXP) on your syringe. Do not use the syringe if the expiry date has passed. Contact your pharmacist if the syringe fails any of the above mentioned checks.

1. Choosing your injection site:

The recommended injection site is the front of your thighs. You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure E).

Choose a different site each time you give yourself an injection.

Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, you should NOT inject directly into areas with psoriasis plaques. Figure E: choose your injection site 2. Cleaning your injection site:

Wash your hands well with soap and water.

Using a circular motion, clean the injection site with an alcohol wipe. Leave it to dry before injecting (see Figure F).

Do not touch the cleaned area before injecting. Figure F: clean your injection site 3. Giving your injection:

Carefully pull the needle cap straight off to remove it from the syringe (see Figure G).

Discard the needle cap.

You may see a drop of liquid at the end of the needle. This is normal. Figure G: pull the needle cap off

Gently pinch the skin at the injection site (see Figure H).

Insert the needle into your skin as shown.

Push the needle all the way in to ensure that the medication can be fully administered. Figure H: insert the needle

Hold the syringe as shown (see Figure I).

Slowly press down on the plunger as far as it will go, so that the plunger head is completely between the needle guard wings.

Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds. Figure I: hold the syringe

Keep the plunger fully pressed down while you carefully lift the needle straight out from the injection site and let go of your skin (see Figure J). Figure J: lift the needle straight out

Slowly release the plunger and allow the needle safety guard to automatically cover the exposed needle (see Figure K).

There may be a small amount of blood at the injection site. You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed. Figure K: slowly release the plunger 4. Disposing of used syringes:

Dispose of the used syringe in a sharps container (closable, puncture-resistant container). For the safety and health of you and others, needles and used syringes must never be re-used.

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. Any unused product or waste material should be disposed of in accordance with local requirements.

If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Hyrimoz. Package leaflet: Information for the patient Hyrimoz 20 mg solution for injection in pre-filled syringe adalimumab 20 mg/0.2 ml 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 doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before your child begins using Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Card with you or your child during your treatment and for 4 months after your child s last injection of Hyrimoz.

If you have any further questions, please ask your 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 s.

If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.