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Generated Narrative: Bundle TEST PURPOSES ONLY - hukyndra

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identifier: http://ema.europa.eu/identifier/EU/1/21/1589/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Hukyndra 40 mg solution for injection in pre-filled syringe

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Generated Narrative: Composition composition-en-f2459f44725cc293d7b9c9def994f1ff

identifier: http://ema.europa.eu/identifier/EU/1/21/1589/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - hukyndra

Attesters

7. Instructions for use

What is in this leaflet

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

Hukyndra contains the active substance adalimumab. Hukyndra is used to treat:

Rheumatoid arthritis

Polyarticular juvenile idiopathic arthritis

Enthesitis-related arthritis

Ankylosing spondylitis

Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Psoriatic arthritis

Plaque psoriasis

Hidradenitis suppurativa

Crohn s disease

Ulcerative colitis

Non-infectious uveitis The active substance in Hukyndra, 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 , Hukyndra decreases the process of inflammation in these diseases. Rheumatoid arthritis Rheumatoid arthritis is an inflammatory disease of the joints. Hukyndra is used to treat moderate to severe rheumatoid arthritis in adults. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Hukyndra. Hukyndra can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment. Hukyndra can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely. Your doctor will decide if Hukyndra should be used with methotrexate or alone. Polyarticular juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints. Hukyndra is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Hukyndra. Your doctor will decide if Hukyndra 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. Hukyndra is used to treat enthesitis-related arthritis in patients from 6 years of age. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Hukyndra. Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine. Hukyndra is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hukyndra. Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis. Hukyndra is used to treat psoriatic arthritis in adults. Hukyndra can slow down the damage to the joints caused by the disease and can help them move more freely. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hukyndra. 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. Hukyndra is used to treat

moderate to severe chronic plaque psoriasis in adults and

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

moderate to severe hidradenitis suppurativa in adults and

moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years Hukyndra can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hukyndra. Crohn s disease Crohn s disease is an inflammatory disease of the digestive tract. Hukyndra is used to treat

moderate to severe Crohn s disease in adults and

moderate to severe Crohn s disease in children and adolescents aged 6 to 17 years. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hukyndra. Ulcerative colitis Ulcerative colitis is an inflammatory disease of the large intestine. Hukyndra is used to treat

moderate to severe ulcerative colitis in adults and

moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hukyndra. Non-infectious uveitis Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. Hukyndra is used to treat

adults with non-infectious uveitis with inflammation affecting the back of the eye

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). Hukyndra works by reducing this inflammation. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hukyndra.

Do not use Hukyndra

If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

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

If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see Warnings and precautions ). Warnings and precautions Talk to your doctor or pharmacist before using Hukyndra. Allergic reactions

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

If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Hukyndra. If you are unsure, contact your doctor.

You might get infections more easily while you are receiving Hukyndra treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include:* tuberculosis* infections caused by viruses, fungi, parasites or bacteria* severe infection in the blood (sepsis) In rare cases, these infections can be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Hukyndra for some time.

Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.

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

If you are over 65 years you may be more likely to get infections while taking Hukyndra. You and your doctor should pay special attention to signs of infection while you are being treated with Hukyndra. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems. Tuberculosis

It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If you have active tuberculosis, do not use Hukyndra.* As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Hukyndra. This will include a thorough medical evaluation including your 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 Patient Reminder Card.* Tuberculosis can develop during therapy even if you have 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 you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.* Your doctor should test you for HBV. In people who carry HBV, adalimumab can cause the virus to become active again.* In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening. Surgery or dental procedures

If you are about to have surgery or dental procedures tell your doctor that you are taking Hukyndra. Your doctor may recommend temporary discontinuation of Hukyndra. Demyelinating disease

If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Hukyndra. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body. Vaccinations

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

If you have mild heart failure and are being treated with Hukyndra, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if you should receive Hukyndra. Fever, bruising, bleeding or looking pale

In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look 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 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 (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).* If you take Hukyndra the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking adalimumab. Some of those patients were also treated with azathioprine or 6-mercaptopurine.* Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Hukyndra.* Cases of non-melanoma skin cancer have been observed in patients taking adalimumab.* 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 you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you. Autoimmune disease

On rare occasions, treatment with Hukyndra 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

Vaccinations: if possible, children should be up to date with all vaccinations before using Hukyndra. Other medicines and Hukyndra Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You should not take Hukyndra with medicines containing the following active substances due to increased risk of serious infection:

anakinra

abatacept. Hukyndra can be taken together with:

methotrexate

certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)

steroids or pain medicine including non-steroidal anti-inflammatory drugs (NSAIDs). If you have questions, please ask your doctor. Pregnancy and breast-feeding

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

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

Hukyndra 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.

Hukyndra can be used during breast-feeding.

If you receive Hukyndra during your pregnancy, your baby may have a higher risk for getting an infection.

It is important that you tell your baby s doctors and other health care professionals about your Hukyndra use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the Warnings and precautions section. Driving and using machines Hukyndra may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Hukyndra. Hukyndra contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 0.4 ml, 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. The recommended doses for Hukyndra in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Hukyndra if you need a different dose. Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight How much and how often to take? Notes Adults 40 mg every other week In rheumatoid arthritis, methotrexate is continued while using Hukyndra. If your doctor decides that methotrexate is inappropriate, Hukyndra can be given alone. If you have rheumatoid arthritis and you do not receive methotrexate with your Hukyndra therapy, your doctor may decide to give Hukyndra 40 mg every week or 80 mg every other week. 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 30 kg or more 40 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 30 kg or more 40 mg every other week Not applicable Plaque psoriasis Age or body weight How much and how often to take? Notes Adults First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose. If you have an inadequate response, your doctor may increase the dose to 40 mg every week or 80 mg every other week. 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 Hidradenitis suppurativa Age or body weight How much and how often to take? Notes Adults First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (two 40 mg injections in one day) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor. It is recommended that you use an antiseptic wash daily on the affected areas. Adolescents from 12 to 17 years of age weighing 30 kg or more First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week later. If you have an inadequate response to Hukyndra 40 mg every other week, your doctor may increase the dose to 40 mg every week or 80 mg every other week. It is recommended that you use an antiseptic wash daily on the affected areas. Crohn s disease Age or body weight How much and how often to take? Notes Children, adolescents and adults from 6 years of age weighing 40 kg or more First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week. Your 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 two weeks later. If a faster response is required, the doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every other week.* Your doctor may increase the dose frequency to 20 mg every week. * * Hukyndra is only available as 40 mg pre-filled syringe, 40 mg pre-filled pen and 80 mg pre-filled syringe. Thus, it is not possible to administer Hukyndra to patients that require less than a full 40 mg dose. Ulcerative colitis Age or body weight How much and how often to take? Notes Adults First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week. Your doctor may increase the dose to 40 mg every week or 80 mg every other week. Children and adolescents from 6 years of age weighing less than 40 kg First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg (one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week. You should continue taking adalimumab at your usual dose, even after turning 18 years of age. Children and adolescents from 6 years of age weighing 40 kg or more First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 80 mg every other week. You should continue taking adalimumab at your usual dose, even after turning 18 years of age. Non-infectious uveitis Age or body weight How much and how often to take? Notes Adults First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose. Corticosteroids or other medicines that influence the immune system may be continued while using Hukyndra. Hukyndra can also be given alone. Children and adolescents from 2 years of age weighing at least 30 kg 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. Hukyndra is recommended for use in combination with methotrexate. Method and route of administration Hukyndra is administered by injection under the skin (by subcutaneous injection). Detailed instructions on how to inject Hukyndra are provided in section 7, Instructions for use . If you use more Hukyndra than you should If you accidentally inject Hukyndra more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more. Always take the outer carton of the medicine with you, even if it is empty. If you forget to use Hukyndra If you forget to give yourself an injection, you should inject the next dose of Hukyndra as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose. If you stop using Hukyndra The decision to stop using Hukyndra should be discussed with your doctor. Your symptoms may return if you stop using Hukyndra. 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 Hukyndra 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 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 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 (localised 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 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

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

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), a single Hukyndra pre-filled syringe may be stored at 20 C to 25 C for a maximum period of up to 30 days be sure to protect it from light. Once removed from the refrigerator for storage at 20 C to 25 C, the syringe must be used within the 30 days or discarded, even if it is returned to the refrigerator. You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded. Do not use this medicine if the liquid is cloudy, discoloured, or has flakes or particles in it. 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 Hukyndra contains

The active substance is adalimumab.

The other ingredients are sodium chloride, sucrose, polysorbate 80, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) What Hukyndra looks like and contents of the pack Hukyndra 40 mg solution for injection in pre-filled syringe with needle guard is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml solution. The Hukyndra pre-filled syringe is a glass syringe containing a solution of adalimumab. Each pack contains 1, 2 or 6 pre-filled syringe(s) packed in a blister, with 1, 2 or 6 alcohol pad(s). Not all pack sizes may be marketed. Hukyndra may be available as a pre-filled syringe and/or a pre-filled pen. Marketing Authorisation Holder STADA Arzneimittel AG Stadastrasse 2 61118 Bad Vilbel Germany Manufacturers Ivers-Lee CSM Marie-Curie-Str.8 79539 L rrach, Germany Alvotech Hf S mundargata 15-Reykjavik, Iceland STADA Arzneimittel AG Stadastrasse 2 61118 Bad Vilbel Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien EG (Eurogenerics) NV T l/Tel: +32 24797Lietuva UAB STADA Baltics Tel: +370 52603 STADA Bulgaria EOOD Te .: +359 29624Luxembourg/Luxemburg EG (Eurogenerics) NV T l/Tel: +32 4797 esk republika STADA PHARMA CZ s.r.o. Tel: +420 257888Magyarorsz g STADA Hungary Kft Tel.: +36 18009Danmark STADA Nordic ApS Tlf: +45 44859Malta Pharma.MT Ltd Tel: +356 21337Deutschland STADAPHARM GmbH Tel: +49 61016Nederland Centrafarm B.V. Tel.: +31 765081Eesti UAB STADA Baltics Tel: +370 52603Norge STADA Nordic ApS Tlf: +45 44859 RAFARM A.E.B.E. : +30 2106776 sterreich STADA Arzneimittel GmbH Tel: +43 136785Espa a Laboratorio STADA, S.L. Tel: +34 934738Polska STADA Poland Sp. z.o o. Tel: +48 227377France EG LABO - Laboratoires EuroGenerics T l: +33 146948Portugal Stada, Lda. Tel: +351 211209Hrvatska STADA d.o.o. Tel: +385 13764Rom nia STADA M&D SRL Tel: +40 213160Ireland Clonmel Healthcare Ltd. Tel: +353 526177Slovenija Stada d.o.o. Tel: +386 15896 sland STADA Arzneimittel AG S mi: +49 61016Slovensk republika STADA PHARMA Slovakia, s.r.o. Tel: +421 252621Italia EG SpA Tel: +39 028310Suomi/Finland STADA Nordic ApS, Suomen sivuliike Puh/Tel: +358 207416 STADA Arzneimittel AG : +30 2106664Sverige STADA Nordic ApS Tel: +45 44859Latvija UAB STADA Baltics Tel: +370 52603United Kingdom (Northern Ireland) STADA Arzneimittel AG Tel: +49 61016This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: