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Generated Narrative: Bundle TEST PURPOSES ONLY - humira

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identifier: http://ema.europa.eu/identifier/EU/1/03/256/022

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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

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Generated Narrative: Composition composition-en-3a3583227b4c5b0887f1e0d38269b469

identifier: http://ema.europa.eu/identifier/EU/1/03/256/022

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - humira

Attesters

7. Injecting Humira

What is in this leaflet

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

Humira contains the active substance adalimumab. Humira is intended for the treatment of the inflammatory diseases described below:

Polyarticular juvenile idiopathic arthritis

Enthesitis-related arthritis

Paediatric plaque psoriasis

Paediatric Crohn s disease

Paediatric uveitis The active ingredient in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target. The target of adalimumab is a protein called tumour necrosis factor (TNF ), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNF , Humira decreases the process of 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. Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. 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 Humira to treat his/her polyarticular juvenile idiopathic arthritis. Your doctor will decide if Humira should be used with methotrexate or alone. Enthesitis-related arthritis Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone. Humira is used to treat enthesitis-related arthritis in patients from 6 years of age. 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 Humira to treat his/her enthesitis-related arthritis. Paediatric plaque psoriasis Plaque psoriasis is a 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. Humira is used to treat severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable. Paediatric Crohn s disease Crohn s disease is an inflammatory disease of the digestive tract. Humira 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 Humira to reduce the signs and symptoms of his/her disease. Paediatric uveitis Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. Humira is used to treat children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front 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). Humira works by reducing this inflammation. Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.

Do not use Humira:

If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

If your child has active tuberculosis or other severe infections (see Warnings and precautions ). It is important that you tell your doctor if your child has symptoms of infections, for example, fever, wounds, feeling tired, dental problems.

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 Humira. Allergic reactions

If your child gets allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your 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 doctor before starting Humira. If you are unsure, contact your doctor.

Your child might get infections more easily while he/she is receiving Humira 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

severe infection in the blood (sepsis) In rare cases, these infections can be life-threatening. It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Humira for some time.

Tell your doctor if your child lives or travels in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.

Tell your doctor if your child has had infections which keep coming back or other conditions that increase the risk of infections.

Your child and his/her doctor should pay special attention to signs of infection while your child is being treated with Humira. It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems. Tuberculosis

As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check your child for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your child s medical history and appropriate 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 your child has been in close contact with someone who has had tuberculosis. If your child has active tuberculosis, do not use Humira.

Tuberculosis can develop during therapy even if your child has received 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 doctor immediately. Hepatitis B

Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV or if you think he/she might be at risk of getting HBV.

Your doctor should test your child for HBV. In people who carry HBV, Humira can cause the virus to become active again.

In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
Surgery or dental procedure

If your child is about to have surgery or dental procedures please inform your doctor that your child is taking Humira. Your doctor may recommend temporary discontinuation of Humira. 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 doctor will decide if he/she should receive or continue to receive Humira. Tell your doctor immediately if your child experiences symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body. Vaccinations

Certain vaccines may cause infections and should not be given while receiving Humira.

Check with your doctor before your child receives any vaccines.

It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Humira.

If your child received Humira while she was pregnant, her baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose she received during pregnancy. It is important that you tell her baby's doctors and other health care professionals about your child s Humira use during her pregnancy so they can decide when her baby should receive any vaccine. Heart failure

If your child has mild heart failure and is being treated with Humira, his/her heart failure status must be closely monitored by your doctor. It is important to tell your doctor if your child has had or has a serious heart condition. If he/she develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if your child should receive Humira. 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. Your doctor may decide to stop treatment. If your child develops a fever that does not go away, develops light bruises or bleeds very easily or looks very pale, call your doctor right away. Cancer

There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.

People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).

If your child takes Humira 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 Humira. Some of those patients were also treated with azathioprine or 6- mercaptopurine.

Tell your doctor if your child is taking azathioprine or 6-mercaptopurine with Humira.

Cases of non-melanoma skin cancer have been observed in patients taking Humira.

If new skin lesions appear during or after therapy or if existing lesions 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 for your child. Autoimmune disease

On rare occasions, treatment with Humira could result in lupus-like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur. Other medicines and Humira Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines. Your child should not take Humira with medicines containing the following active substances due to increased risk of serious infection: anakinra abatacept. Humira can be taken together with: methotrexate certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations) steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs). 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 Humira 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.

Humira 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 Humira during pregnancy compared with mothers with the same disease who did not receive Humira.

Humira can be used during breast-feeding.

If your child received Humira 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 Humira 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 Humira may have a small effect on your child s ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Humira.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended doses for Humira in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Humira if your child needs a different dose. Polyarticular juvenile idiopathic arthritis Age or body weight How much and how often to take? Notes Children, adolescents and adults from 2 years of age weighing kg or more 40 mg every other week Not applicable Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg 20 mg every other week Not applicable Enthesitis-related arthritis Age or body weight How much and how often to take? Notes Children, adolescents and adults from 6 years of age weighing kg or more 40 mg every other week Not applicable Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg 20 mg every other week Not applicable Paediatric plaque psoriasis Age or body weight How much and how often to take? Notes Children and adolescents from 4 to 17 years of age weighing kg or more First dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is mg every other week. Not applicable Children and adolescents from 4 to 17 years of age weighing kg to less than 30 kg First dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is mg every other week. Not applicable Paediatric Crohn s disease Age or body weight How much and how often to take? Notes Children and adolescents from 6 to 17 years of age weighing kg or more First dose of 80 mg, followed by 40 mg two weeks later. If a faster response is required, your child s doctor may prescribe a first dose of 160 mg, followed by 80 mg two weeks later. Thereafter, the usual dose is mg every other week. Your child s doctor may increase the dosage to 40 mg every week or 80 mg every other week. Children and adolescents from 6 to 17 years of age weighing less than 40 kg First dose of 40 mg, followed by 20 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 80 mg, followed by mg two weeks later. Thereafter, the usual dose is mg every other week. Your child s doctor may increase the dose frequency to 20 mg every week. Paediatric uveitis Age or body weight How much and how often to take? Notes Children and adolescents from 2 years of age weighing less than 30 kg 20 mg every other week Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week. Humira is recommended for use in combination with methotrexate. Children and adolescents from 2 years of age weighing 30 kg or more 40 mg every other week Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week. Humira is recommended for use in combination with methotrexate. Method and route of administration Humira is administered by injection under the skin (by subcutaneous injection). Detailed instructions on how to inject Humira are provided in section 7 Injecting Humira . If you use more Humira than you should If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that your child has taken more. Always take the outer carton of the medicine with you, even if it is empty. If you forget to use Humira If you forget to give your child an injection, you should inject the next dose of Humira 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 you stop using Humira The decision to stop using Humira should be discussed with your doctor. Your child s symptoms may return if you stop using Humira. 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 at least up to 4 months after the last Humira injection. Tell your doctor immediately if you notice any of the following

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 doctor as soon as possible if you notice any of the following

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

feeling weak or tired

coughing

tingling

numbness

double vision

arm or leg weakness

a bump or open sore that doesn't heal

signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness The symptoms described above can be signs of the below listed side effects, which have been observed with Humira. 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 pain

nausea and vomiting

rash

musculoskeletal pain 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

oral 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

nerve root compression (including low back pain and leg pain)

vision disturbances

eye inflammation

inflammation of the eye lid and eye swelling

vertigo (feeling of dizziness or spinning)

sensation of heart beating rapidly

high blood pressure

flushing

haematoma (collection of blood outside of blood vessels)

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 (swelling)

fever

reduction in blood platelets which increases risk of bleeding or bruising

impaired healing Uncommon (may affect up to 1 in 100 people)

opportunistic 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

cancer that affects the lymph system

melanoma

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

vasculitis (inflammation of blood vessels)

tremor (shaking)

neuropathy (disorder of the nerves)

stroke

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

night sweats

scar

abnormal muscle breakdown

systemic lupus erythematosus (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 eye nerve inflammation and Guillain-Barr syndrome 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 intestine)

hepatitis

reactivation of hepatitis B

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 (early symptoms include malaise, fever, headache and rash)

facial oedema (swelling of the face) associated with allergic reactions

erythema multiforme (inflammatory skin rash)

lupus-like syndrome

angioedema (localized swelling of the skin)

lichenoid skin reaction (itchy reddish-purple skin rash) Not known (frequency cannot be estimated from the 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 Humira 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

elevated 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)

elevated 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 stated on the label/blister/carton after EXP. Store in a refrigerator (2 C 8 C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.
Alternative Storage: When needed (for example, when you are travelling), a single Humira pre-filled syringe may be stored at room temperature (up to 25 C) for a maximum period of 14 days be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.
You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded. Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Humira contains The active substance is adalimumab. The other ingredients are mannitol, polysorbate 80 and water for injections. What the Humira pre-filled syringe looks like and contents of the pack Humira 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as a sterile solution of 20 mg adalimumab dissolved in 0.2 ml solution. The Humira pre-filled syringe is a glass syringe containing a solution of adalimumab.
The Humira pre-filled syringe is available in a pack containing 2 pre-filled syringes with 2 alcohol pads.
Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen. Marketing Authorisation Holder AbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany Manufacturer AbbVie Biotechnology GmbH Knollstrasse 67061 Ludwigshafen Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AbbVie SA T l/Tel: +32 10 477Lietuva AbbVie UAB Tel: +370 5 205 3

.:+359 2 90 30 Luxembourg/Luxemburg AbbVie SA Belgique/Belgien T l/Tel: +32 10 477 esk republika AbbVie s.r.o. Tel: +420 233 098 Magyarorsz g AbbVie Kft. Tel.:+36 1 455 8Danmark AbbVie A/S Tlf: +45 72 30-20-Malta V.J.Salomone Pharma Limited Tel: +356 22983Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (geb hrenfrei) Tel: +49 (0) 611 / 1720-0 Nederland AbbVie B.V. Tel: +31 (0)88 322 2Eesti AbbVie O Tel: +372 623 1Norge AbbVie AS Tlf: +47 67 81 80
AbbVie . . : +30 214 4165 sterreich AbbVie GmbH Tel: +43 1 20589-0 Espa a AbbVie Spain, S.L.U. Tel: +34 91 384 09 Polska AbbVie Sp. z o.o. Tel.: +48 22 372 78 France AbbVie T l: +33 (0) 1 45 60 13 Portugal AbbVie, Lda. Tel: +351 (0)21 1908Hrvatska AbbVie d.o.o. Tel + 385 (0)1 5625 Rom nia AbbVie S.R.L. Tel: +40 21 529 30 Ireland AbbVie Limited Tel: +353 (0)1 4287Slovenija AbbVie Biofarmacevtska dru ba d.o.o. Tel: +386 (1)32 08 sland Vistor hf. Tel: +354 535 7Slovensk republika AbbVie s.r.o. Tel: +421 2 5050 0Italia AbbVie S.r.l. Tel: +39 06 928Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411
Lifepharma (Z.A.M.) Ltd .: +357 22 34 74 Sverige AbbVie AB Tel: +46 (0)8 684 44 Latvija AbbVie SIA Tel: +371 67605United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: