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Solymbic (adalimumab) – Package leaflet - L04AB04

Updated on site: 10-Oct-2017

Medication nameSolymbic
ATC CodeL04AB04
Substanceadalimumab
ManufacturerAmgen Europe B.V.

Package leaflet: Information for the user

SOLYMBIC 20 mg solution for injection in pre-filled syringe SOLYMBIC 40 mg solution for injection in pre-filled syringe adalimumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given SOLYMBIC and during treatment with SOLYMBIC. Keep this Patient Alert Card with you.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

What is in this leaflet

1.What SOLYMBIC is and what it is used for

2.What you need to know before you use SOLYMBIC

3.How to use SOLYMBIC

4.Possible side effects

5.How to store SOLYMBIC

6.Contents of the pack and other information

1.What SOLYMBIC is and what it is used for

SOLYMBIC contains the active substance adalimumab, a selective immuno suppressive agent.

SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis (patients weighing either 23 to 28 kg or 47 kg and greater), Crohn’s disease in adults and children, ulcerative colitis and non-infectious uveitis affecting the back of the eye. It is a medicine that decreases the inflammation process of these diseases. The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognise and bind to other unique proteins.

Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and non-infectious uveitis affecting the back of the eye.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

SOLYMBIC is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, 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 SOLYMBIC to treat your rheumatoid arthritis.

SOLYMBIC can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

SOLYMBIC slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Usually, SOLYMBIC is used with methotrexate. If your doctor determines that methotrexate is inappropriate, SOLYMBIC can be given alone.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints.

SOLYMBIC is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years. 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 SOLYMBIC to treat your enthesitis-related arthritis.

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.

SOLYMBIC is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your disease.

Psoriatic arthritis

Psoriatic arthritis is an inflammation of the joints associated with psoriasis.

SOLYMBIC is used to treat psoriatic arthritis in adults. SOLYMBIC slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Plaque psoriasis in adults and children

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.

SOLYMBIC is used to treat moderate to severe plaque psoriasis in adults. SOLYMBIC is also used to treat severe plaque psoriasis in children and adolescents weighing either 23 to 28 kg or 47 kg or greater 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.

SOLYMBIC is used to treat hidradenitis suppurativa in adults. SOLYMBIC can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.

Crohn’s disease in adults and children

Crohn’s disease is an inflammatory disease of the digestive tract.

SOLYMBIC is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your Crohn’s disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the bowel.

SOLYMBIC is used to treat ulcerative colitis in adults. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your disease.

Non-infectious uveitis affecting the back of the eye

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. SOLYMBIC is used to treat adults with non-infectious uveitis with inflammation affecting the back of the eye. This 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). SOLYMBIC works by reducing this inflammation.

2. What you need to know before you use SOLYMBIC

Do not use SOLYMBIC:

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

-if you have a severe infection, including active tuberculosis (see “Warnings and precautions”).

It is important that you tell your doctor if you have symptoms of infections, e.g. 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 SOLYMBIC:

-If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more SOLYMBIC and contact your doctor immediately.

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

-You might get infections more easily while you are receiving SOLYMBIC treatment. This risk may increase if your lung function is impaired. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, 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 recommend temporary discontinuation of SOLYMBIC.

-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 SOLYMBIC. 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 Alert Card. 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. Tuberculosis can develop during therapy even if you have received 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.

-Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis coccidioidomycosis or blastomycosis are endemic.

-Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.

-Advise 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 contracting HBV. Your doctor should test you for HBV. SOLYMBIC can cause reactivation of HBV in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

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

-If you are about to undergo surgery or dental procedures please inform your doctor that you are taking SOLYMBIC. Your doctor may recommend temporary discontinuation of SOLYMBIC.

-If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive SOLYMBIC. 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.

-Certain vaccines may cause infections and should not be given while receiving SOLYMBIC. Please check with your doctor before you receive any vaccines. It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating SOLYMBIC therapy. If you received SOLYMBIC 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 dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your SOLYMBIC use during your pregnancy so they can decide when your baby should receive any vaccine.

-If you have mild heart failure and you are being treated with SOLYMBIC, 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.

-In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.

-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 that have had the disease for a long time may have a higher than average risk of getting lymphoma (a type of cancer that affects the lymph system), and leukaemia (a type of cancer that affects the blood and bone marrow). If you take SOLYMBIC 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 some 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 SOLYMBIC. In addition, 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.

The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.

In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.

Children and adolescents

-Vaccinations: if possible children should be up to date with all vaccinations before using SOLYMBIC.

-Do not use the 20 mg or 40 mg pre-filled syringe if doses other than 20 mg or 40 mg are recommended.

Other medicines and SOLYMBIC

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

SOLYMBIC can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

You should not take SOLYMBIC with medicines containing the active substance, anakinra or abatacept. If you have questions, please ask your doctor.

Pregnancy and breast-feeding

The effects of SOLYMBIC in pregnant women are not known and so the use of SOLYMBIC in pregnant women is not recommended. You are advised to avoid becoming pregnant and must use

adequate contraception while using SOLYMBIC and for at least 5 months after the last SOLYMBIC treatment. If you become pregnant, you should consult your doctor.

It is not known whether SOLYMBIC passes into breast milk.

If you are a breast-feeding mother, you should stop breast-feeding during SOLYMBIC treatment and for at least 5 months after the last SOLYMBIC treatment. If you received SOLYMBIC 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 SOLYMBIC use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).

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

Driving and using machines

SOLYMBIC may have a minor influence on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking SOLYMBIC.

SOLYMBIC contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodium- free’.

3.How to use SOLYMBIC

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

SOLYMBIC is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg given every other week as a single dose.

In rheumatoid arthritis, methotrexate is continued while using SOLYMBIC. If your doctor determines that methotrexate is inappropriate, SOLYMBIC can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your SOLYMBIC therapy, your doctor may decide to give 40 mg every week.

Children with enthesitis-related arthritis

The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis, aged 6 to 17 years depends on the height and weight of the child. Your child’s doctor will tell you the correct dose to use.

Adults with psoriasis

The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject SOLYMBIC for as long as your doctor has told you. Depending on your response, your doctor may increase the dose frequency to 40 mg every week.

Children or adolescents with plaque psoriasis

The recommended dose of SOLYMBIC for patients aged 4 to 17 years with plaque psoriasis depends on the weight of your child. SOLYMBIC should only be used in patients weighing either 23 to 28 kg or 47 kg and greater. Your child’s doctor will tell you the correct dose to use.

Adults with hidradenitis suppurativa

The usual dose regimen for hidradenitis suppurativa is an initial 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 an 80 mg dose (as two 40 mg injections on the same day) two weeks later. After two further weeks,

continue with a dose of 40 mg every week. It is recommended that you use an antiseptic wash daily on the affected areas.

Adults with Crohn’s disease

The usual dose regimen for Crohn’s disease is 80 mg initially followed by 40 mg every other week two weeks later. If a faster response is required, your doctor may prescribe an initial 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 two weeks later, and thereafter as 40 mg every other week. Depending on your response, your doctor may increase the dose frequency to 40 mg every week.

Children or adolescents with Crohn's disease

Children or adolescents weighing less than 40 kg:

The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in 1 day) followed by 40 mg two weeks later.

Thereafter, the usual dose is 20 mg every other week. Depending on your response, your doctor may increase the dose frequency to 20 mg every week.

Children or adolescents weighing 40 kg or more:

The usual dose regimen is 80 mg initially followed by 40 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in 1 day or as two 40 mg injections per day for 2 consecutive days) followed by 80 mg two weeks later.

Thereafter, the usual dose is 40 mg every other week. Depending on your response, your doctor may increase the dose frequency to 40 mg every week.

Adults with ulcerative colitis

The usual SOLYMBIC dose for adults with ulcerative colitis is 160 mg initially (dose can be administered as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg two weeks later, then 40 mg every other week. Depending on your response, your doctor may increase the dose to 40 mg every week.

Adults with non-infectious uveitis

The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject SOLYMBIC for as long as your doctor has told you.

In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using SOLYMBIC. SOLYMBIC can also be given alone.

Method and route of administration

SOLYMBIC is administered by injection under the skin (subcutaneous injection).

If you use more SOLYMBIC than you should

If you accidentally inject SOLYMBIC more frequently than told to by your doctor or pharmacist, you should call your doctor or pharmacist and tell him/her that you have taken more. Always take the outer carton of this medicine with you, even if it is empty.

If you forget to use SOLYMBIC

If you forget to give yourself an injection, you should inject it 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 SOLYMBIC

The decision to stop using SOLYMBIC should be discussed with your doctor. Your symptoms may return upon discontinuation.

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

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last SOLYMBIC 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 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 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 side effects (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 side effects (may affect up to 1 in 10 people):

serious infections (including blood poisoning and influenza);

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;

sensation of heart beating rapidly;

high blood pressure;

flushing;

haematoma;

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;

fever;

reduction in blood platelets which increases risk of bleeding or bruising;

impaired healing.

Uncommon side effects (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;

neuropathy;

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;

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 side effects (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-Barré 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;

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 associated with allergic reactions;

erythema multiforme (inflammatory skin rash);

lupus-like syndrome.

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);

liver failure;

worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).

Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

Very common side effects (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 side effects (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.

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

low blood measurements for white blood cells, red blood cells and platelet count.

Not known (frequency cannot be estimated from available data):

liver failure.

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.

5.How to store SOLYMBIC

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and 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.

Store in the original carton in order to protect from light.

A single SOLYMBIC pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The pre-filled syringe must be protected from light, and discarded if not used within the 14-day period.

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.

6. Contents of the pack and other information

What SOLYMBIC contains

-The active substance is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in 0.4 mL of solution or 40 mg of adalimumab in 0.8 mL of solution.

-The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.

What SOLYMBIC looks like and contents of the pack

SOLYMBIC is a clear and colourless to slightly yellow solution.

Each pack contains 1 single-use 20 mg pre-filled syringe (with yellow plunger rod).

Each pack contains 1, 2, 4 or 6 single-use 40 mg pre-filled syringes (with blue plunger rod).

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Marketing Authorisation Holder:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Manufacturer:

Amgen Technology Ireland UC

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

s.a. Amgen n.v.

Amgen Switzerland AG Vilniaus filialas

Tel/Tél: +32 (0)2 7752711

Tel: +370 5 219 7474

България

Luxembourg/Luxemburg

Амджен България ЕООД

s.a. Amgen

Тел.: +359 (0)2 424 7440

Belgique/Belgien

 

Tel/Tél: +32 (0)2 7752711

Česká republika

Magyarország

Amgen s.r.o.

Amgen Kft.

Tel: +420 221 773 500

Tel.: +36 1 35 44 700

Danmark

Malta

Amgen, filial af Amgen AB, Sverige

Amgen B.V.

Tlf: +45 39617500

The Netherlands

 

Tel: +31 (0)76 5732500

Deutschland

Nederland

AMGEN GmbH

Amgen B.V.

Tel.: +49 89 1490960

Tel: +31 (0)76 5732500

Eesti

Norge

Amgen Switzerland AG Vilniaus filialas

Amgen AB

Tel: +372 586 09553

Tel: +47 23308000

Ελλάδα

Österreich

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.

Amgen GmbH

Τηλ.: +30 210 3447000

Tel: +43 (0)1 50 217

España

Polska

Amgen S.A.

Amgen Biotechnologia Sp. z o.o.

Tel: +34 93 600 18 60

Tel.: +48 22 581 3000

France

Portugal

Amgen S.A.S.

Amgen Biofarmacêutica, Lda.

Tél: +33 (0)9 69 363 363

Tel: +351 21 4220550

Hrvatska

România

Amgen d.o.o.

Amgen România SRL

Tel: +385 (0)1 562 57 20

Tel: +4021 527 3000

Ireland

Slovenija

Amgen Limited

AMGEN zdravila d.o.o.

United Kingdom

Tel: +386 (0)1 585 1767

Tel: +44 (0)1223 420305

 

Ísland

Slovenská republika

Vistor hf.

Amgen Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 321 114 49

Italia

Suomi/Finland

Amgen S.r.l.

Amgen AB, sivuliike Suomessa/Amgen AB, filial

Tel: +39 02 6241121

i Finland

 

Puh/Tel: +358 (0)9 54900500

Kύπρος

Sverige

C.A. Papaellinas Ltd

Amgen AB

Τηλ.: +357 22741 741

Tel: +46 (0)8 6951100

Latvija

United Kingdom

Amgen Switzerland AG Rīgas filiāle

Amgen Limited

Tel: +371 257 25888

Tel: +44 (0)1223 420305

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.

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Instructions for use:

SOLYMBIC single use pre-filled syringe

For subcutaneous use

 

Guide to parts

 

 

 

Before use

 

After use

 

 

 

Plunger rod

 

Used plunger rod

 

 

 

 

Finger flange

 

 

Label and expiration

Finger flange

 

date

 

 

Label and

 

Used syringe barrel

 

 

expiration date

 

 

Syringe barrel

 

 

 

 

Used needle

Medicine

 

 

Needle

 

 

cap on

 

Needle cap off

 

 

 

 

 

Important: Needle is inside

Important

Before you use a SOLYMBIC pre-filled syringe, read this important information:

Using your SOLYMBIC pre-filled syringe

It is important that you do not try to give the injection unless you or your caregiver has received training.

Do not use a SOLYMBIC pre-filled syringe if it has been dropped on a hard surface. Part of the SOLYMBIC pre-filled syringe may be broken even if you cannot see the break. Use a new SOLYMBIC pre-filled syringe.

The needle cover of the SOLYMBIC pre-filled syringe is made from dry natural rubber, which contains latex. Tell your healthcare provider if you are allergic to latex.

Step 1: Prepare

A. Remove the number of SOLYMBIC

pre-filled syringes you need from the package.

Grab the syringe barrel to remove the syringe from the tray.

Place your finger or thumb on

Grab Here

edge of tray to secure it while

 

you remove the syringe.

 

Put the original package with any unused syringes back in the refrigerator.

For safety reasons:

Do not grasp the plunger rod.

Do not grasp the needle cap.

Do not remove the needle cap until you are ready to inject.

Do not remove the finger flange. This is part of the syringe.

For a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting.

Do not put the syringe back in the refrigerator once it has reached room temperature.

Do not try to warm the syringe by using a heat source such as hot water or microwave.

Do not leave the syringe in direct sunlight.

Do not shake the syringe.

Important: Always hold the pre-filled syringe by the syringe barrel.

B. Inspect the SOLYMBIC

pre-filled syringe.

 

Label expiration

 

Syringe barrel

date

Plunger rod

Needle cap on

Medicine

Finger flange

Always hold the syringe by the syringe barrel.

Make sure the medicine in the syringe is clear and colourless to slightly yellow.

Do not use the syringe if:

-The medicine is cloudy or discoloured or contains flakes, or particles.

-Any part appears cracked or broken.

-The needle cap is missing or not securely attached.

-The expiration date printed on the label has passed.

In all cases, use a new syringe.

C. Gather all materials needed for your injection(s).

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place a new, pre-filled syringe.

You will also need these additional items, as they are not included in the carton:

Alcohol wipes

Cotton ball or gauze pad

Plaster

Sharps disposal container

D. Prepare and clean your injection site(s).

Belly

Thigh

You can use:

Your thigh

Belly, except for a 2 inch (5 centimetres) area around your belly button

Clean your injection site with an alcohol wipe. Let your skin dry.

Do not touch this area again before injecting.

If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.

-Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion.

Step 2: Get ready

E. Pull the needle cap straight out and away from your body when you are ready to inject.

It is normal to see a drop of liquid at the end of the needle.

Do not twist or bend the needle cap.

Do not put the needle cap back onto the syringe.

Do not remove the needle cap from the syringe until you are ready to inject.

Important: Throw the needle cap into the sharps disposal container provided.

F. Pinch your injection site to create a firm surface.

Pinch the skin firmly between your thumb and fingers, creating an area about 2 inch (5 centimetres) wide.

Important: Keep the skin pinched while injecting.

Step 3: Inject

G. Hold the pinch. With the needle cap off, insert the syringe into your skin at 45 to 90 degrees.

Do not place your finger on the plunger rod while inserting the needle.

H. Using slow and constant pressure, push the plunger rod all the way down until it stops moving.

I.When done, release your thumb, and gently lift the syringe off of your skin.

Step 4: Finish

J. Discard the used syringe and the needle cap.

Do not reuse the used syringe.

Do not use any medicine that is left in the used syringe.

Put the used SOLYMBIC syringe in a sharps disposal container immediately after use. Do not throw away (dispose of) the syringe in your household waste.

Talk with your doctor or pharmacist about proper disposal. There may be local guidelines for disposal.

Do not recycle the syringe or sharps disposal container or throw them into the household waste. Important: Always keep the sharps disposal container out of the sight and reach of children.

K. Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.

Package leaflet: Information for the user

SOLYMBIC 40 mg solution for injection in a pre-filled pen adalimumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given SOLYMBIC and during treatment with SOLYMBIC. Keep this Patient Alert Card with you.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

What is in this leaflet

1.What SOLYMBIC is and what it is used for

2.What you need to know before you use SOLYMBIC

3.How to use SOLYMBIC

4.Possible side effects

5.How to store SOLYMBIC

6.Contents of the pack and other information

1. What SOLYMBIC is and what it is used for

SOLYMBIC contains the active substance adalimumab, a selective immuno suppressive agent.

SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis (patients weighing either 23 to 28 kg or 47 kg and greater), Crohn’s disease in adults and children, ulcerative colitis and non-infectious uveitis affecting the back of the eye. It is a medicine that decreases the inflammation process of these diseases. The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognise and bind to other unique proteins.

Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and non-infectious uveitis affecting the back of the eye.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

SOLYMBIC is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, 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 SOLYMBIC to treat your rheumatoid arthritis.

SOLYMBIC can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

SOLYMBIC slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Usually, SOLYMBIC is used with methotrexate. If your doctor determines that methotrexate is inappropriate, SOLYMBIC can be given alone.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints.

SOLYMBIC is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years. 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 SOLYMBIC to treat your enthesitis-related arthritis.

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.

SOLYMBIC is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your disease.

Psoriatic arthritis

Psoriatic arthritis is an inflammation of the joints associated with psoriasis.

SOLYMBIC is used to treat psoriatic arthritis in adults. SOLYMBIC slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Plaque psoriasis in adults and children

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.

SOLYMBIC is used to treat moderate to severe plaque psoriasis in adults. SOLYMBIC is also used to treat severe plaque psoriasis in children and adolescents weighing either 23 to 28 kg or 47 kg or greater 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.

SOLYMBIC is used to treat hidradenitis suppurativa in adults. SOLYMBIC can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.

Crohn’s disease in adults and children

Crohn’s disease is an inflammatory disease of the digestive tract.

SOLYMBIC is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your Crohn’s disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the bowel.

SOLYMBIC is used to treat ulcerative colitis in adults. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your disease.

Non-infectious uveitis affecting the back of the eye

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. SOLYMBIC is used to treat adults with non-infectious uveitis with inflammation affecting the back of the eye. This 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). SOLYMBIC works by reducing this inflammation.

2. What you need to know before you use SOLYMBIC

Do not use SOLYMBIC:

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

-if you have a severe infection, including active tuberculosis (see “Warnings and precautions”).

It is important that you tell your doctor if you have symptoms of infections, e.g. 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 SOLYMBIC:

-If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more SOLYMBIC and contact your doctor immediately.

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

-You might get infections more easily while you are receiving SOLYMBIC treatment. This risk may increase if your lung function is impaired. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, 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 recommend temporary discontinuation of SOLYMBIC.

-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 SOLYMBIC. 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 Alert Card. 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. Tuberculosis can develop during therapy even if you have received 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.

-Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis coccidioidomycosis or blastomycosis are endemic.

-Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.

-Advise 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 contracting HBV. Your doctor should test you for HBV. SOLYMBIC can cause reactivation of HBV in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

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

-If you are about to undergo surgery or dental procedures please inform your doctor that you are taking SOLYMBIC. Your doctor may recommend temporary discontinuation of SOLYMBIC.

-If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive SOLYMBIC. 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.

-Certain vaccines may cause infections and should not be given while receiving SOLYMBIC. Please check with your doctor before you receive any vaccines. It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating SOLYMBIC therapy. If you received SOLYMBIC 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 dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your SOLYMBIC use during your pregnancy so they can decide when your baby should receive any vaccine.

-If you have mild heart failure and you are being treated with SOLYMBIC, 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.

-In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that does not go away,

bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.

-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 that have had the disease for a long time may have a higher than average risk of getting lymphoma (a type of cancer that affects the lymph system), and leukaemia (a type of cancer that affects the blood and bone marrow). If you take SOLYMBIC 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 some 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 SOLYMBIC. In addition, 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.

The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.

In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.

Children and adolescents

-Vaccinations: if possible children should be up to date with all vaccinations before using SOLYMBIC.

-Do not use the 40 mg pre-filled pen if doses other than 40 mg are recommended.

Other medicines and SOLYMBIC

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

SOLYMBIC can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

You should not take SOLYMBIC with medicines containing the active substance, anakinra or abatacept. If you have questions, please ask your doctor.

Pregnancy and breast-feeding

The effects of SOLYMBIC in pregnant women are not known and so the use of SOLYMBIC in pregnant women is not recommended. You are advised to avoid becoming pregnant and must use adequate contraception while using SOLYMBIC and for at least 5 months after the last SOLYMBIC treatment. If you become pregnant, you should consult your doctor.

It is not known whether SOLYMBIC passes into breast milk.

If you are a breast-feeding mother, you should stop breast-feeding during SOLYMBIC treatment and for at least 5 months after the last SOLYMBIC treatment. If you received SOLYMBIC 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 SOLYMBIC use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).

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

Driving and using machines

SOLYMBIC may have a minor influence on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking SOLYMBIC.

SOLYMBIC contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodium- free’.

3. How to use SOLYMBIC

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

SOLYMBIC is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg given every other week as a single dose.

In rheumatoid arthritis, methotrexate is continued while using SOLYMBIC. If your doctor determines that methotrexate is inappropriate, SOLYMBIC can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your SOLYMBIC therapy, your doctor may decide to give 40 mg every week.

Children with enthesitis-related arthritis

The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis, aged 6 to 17 years depends on the height and weight of the child. Your child’s doctor will tell you the correct dose to use.

Adults with psoriasis

The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject SOLYMBIC for as long as your doctor has told you. Depending on your response, your doctor may increase the dose frequency to 40 mg every week.

Children or adolescents with plaque psoriasis

The recommended dose of SOLYMBIC for patients aged 4 to 17 years with plaque psoriasis depends on the weight of your child. SOLYMBIC should only be used in patients weighing either 23 to 28 kg or 47 kg and greater. Your child’s doctor will tell you the correct dose to use.

Adults with hidradenitis suppurativa

The usual dose regimen for hidradenitis suppurativa is an initial 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 an 80 mg dose (as two 40 mg injections on the same day) two weeks later. After two further weeks,

continue with a dose of 40 mg every week. It is recommended that you use an antiseptic wash daily on the affected areas.

Adults with Crohn’s disease

The usual dose regimen for Crohn’s disease is 80 mg initially followed by 40 mg every other week two weeks later. If a faster response is required, your doctor may prescribe an initial 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 two weeks later, and thereafter as 40 mg every other week. Depending on your response, your doctor may increase the dose frequency to 40 mg every week.

Children or adolescents with Crohn's disease

Children or adolescents weighing less than 40 kg:

The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in 1 day) followed by 40 mg two weeks later.

Thereafter, the usual dose is 20 mg every other week. Depending on your response, your doctor may increase the dose frequency to 20 mg every week.

Do not use the 40 mg pre-filled pen for the 20 mg dose in children or adolescent weighing less than 40 kg with Crohn’s disease. The 20 mg solution for injection in pre-filled syringe can be used for the 20 mg dose.

Children or adolescents weighing 40 kg or more:

The usual dose regimen is 80 mg initially followed by 40 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in 1 day or as two 40 mg injections per day for 2 consecutive days) followed by 80 mg two weeks later.

Thereafter, the usual dose is 40 mg every other week. Depending on your response, your doctor may increase the dose frequency to 40 mg every week.

Adults with ulcerative colitis

The usual SOLYMBIC dose for adults with ulcerative colitis is 160 mg initially (dose can be administered as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg two weeks later, then 40 mg every other week. Depending on your response, your doctor may increase the dose to 40 mg every week.

Adults with non-infectious uveitis

The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject SOLYMBIC for as long as your doctor has told you.

In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using SOLYMBIC. SOLYMBIC can also be given alone.

Method and route of administration

SOLYMBIC is administered by injection under the skin (subcutaneous injection).

If you use more SOLYMBIC than you should

If you accidentally inject SOLYMBIC more frequently than told to by your doctor or pharmacist, you should call your doctor or pharmacist and tell him/her that you have taken more. Always take the outer carton of this medicine with you, even if it is empty.

If you forget to use SOLYMBIC

If you forget to give yourself an injection, you should inject it 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 SOLYMBIC

The decision to stop using SOLYMBIC should be discussed with your doctor. Your symptoms may return upon discontinuation.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last SOLYMBIC 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 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 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 side effects (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 side effects (may affect up to 1 in 10 people):

serious infections (including blood poisoning and influenza);

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;

sensation of heart beating rapidly;

high blood pressure;

flushing;

haematoma;

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;

fever;

reduction in blood platelets which increases risk of bleeding or bruising;

impaired healing.

Uncommon side effects (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;

neuropathy;

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;

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 side effects (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-Barré 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;

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 associated with allergic reactions;

erythema multiforme (inflammatory skin rash);

lupus-like syndrome.

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);

liver failure;

worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).

Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

Very common side effects (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 side effects (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.

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

low blood measurements for white blood cells, red blood cells and platelet count.

Not known (frequency cannot be estimated from available data):

liver failure.

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.

5. How to store SOLYMBIC

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and 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.

Store in the original carton in order to protect from light.

A single SOLYMBIC pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The pre-filled pen must be protected from light, and discarded if not used within the 14-day period.

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.

6. Contents of the pack and other information

What SOLYMBIC contains

-The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.8 mL of solution.

-The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.

What SOLYMBIC looks like and contents of the pack

SOLYMBIC is a clear and colourless to slightly yellow solution.

Each pack contains 1, 2, 4, or 6 single use SureClick pre-filled pens.

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Marketing Authorisation Holder:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Manufacturer:

Amgen Technology Ireland UC

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

s.a. Amgen n.v.

Amgen Switzerland AG Vilniaus filialas

Tel/Tél: +32 (0)2 7752711

Tel: +370 5 219 7474

България

Luxembourg/Luxemburg

Амджен България ЕООД

s.a. Amgen

Тел.: +359 (0)2 424 7440

Belgique/Belgien

 

Tel/Tél: +32 (0)2 7752711

Česká republika

Magyarország

Amgen s.r.o.

Amgen Kft.

Tel: +420 221 773 500

Tel.: +36 1 35 44 700

Danmark

Malta

Amgen, filial af Amgen AB, Sverige

Amgen B.V.

Tlf: +45 39617500

The Netherlands

 

Tel: +31 (0)76 5732500

Deutschland

Nederland

AMGEN GmbH

Amgen B.V.

Tel.: +49 89 1490960

Tel: +31 (0)76 5732500

Eesti

Norge

Amgen Switzerland AG Vilniaus filialas

Amgen AB

Tel: +372 586 09553

Tel: +47 23308000

Ελλάδα

Österreich

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.

Amgen GmbH

Τηλ.: +30 210 3447000

Tel: +43 (0)1 50 217

España

Polska

Amgen S.A.

Amgen Biotechnologia Sp. z o.o.

Tel: +34 93 600 18 60

Tel.: +48 22 581 3000

France

Portugal

Amgen S.A.S.

Amgen Biofarmacêutica, Lda.

Tél: +33 (0)9 69 363 363

Tel: +351 21 4220550

Hrvatska

România

Amgen d.o.o.

Amgen România SRL

Tel: +385 (0)1 562 57 20

Tel: +4021 527 3000

Ireland

Slovenija

Amgen Limited

AMGEN zdravila d.o.o.

United Kingdom

Tel: +386 (0)1 585 1767

Tel: +44 (0)1223 420305

 

Ísland

Slovenská republika

Vistor hf.

Amgen Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 321 114 49

Italia

Suomi/Finland

Amgen S.r.l.

Amgen AB, sivuliike Suomessa/Amgen AB, filial

Tel: +39 02 6241121

i Finland

 

Puh/Tel: +358 (0)9 54900500

Kύπρος

Sverige

C.A. Papaellinas Ltd

Amgen AB

Τηλ.: +357 22741 741

Tel: +46 (0)8 6951100

Latvija

United Kingdom

Amgen Switzerland AG Rīgas filiāle

Amgen Limited

Tel: +371 257 25888

Tel: +44 (0)1223 420305

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.

---------------------------------------------------------------------------------------------------------------------------

Instructions for use:

SOLYMBIC single use SureClick pre-filled pen

For subcutaneous use

Guide to parts

Before use

After use

Blue start button

Expiration date

Expiration date

Yellow window (injection complete)

Window

Medicine

Yellow cap on

Yellow safety guard

Yellow cap off

Important: Needle is inside

Important

Before you use a SOLYMBIC pre-filled pen, read this important information:

Using your SOLYMBIC pre-filled pen

It is important that you do not try to give the injection unless you or your caregiver has received training.

Do not use a SOLYMBIC pre-filled pen if it has been dropped on a hard surface. Part of the SOLYMBIC pre-filled pen may be broken even if you cannot see the break. Use a new SOLYMBIC pre-filled pen.

The needle cover of the SOLYMBIC pre-filled pen is made from dry natural rubber, which contains latex. Tell your healthcare provider if you are allergic to latex.

Step 1: Prepare

A. pre-filled

Remove one SOLYMBIC pen from the package.

Carefully lift the pre-filled pen straight up out of the box.

Put the original package with any unused pre-filled pens back in the refrigerator.

For a more comfortable injection, leave the pre-filled pen at room temperature for 15 to 30 minutes before injecting.

Do not put the pre-filled pen back in the refrigerator once it has reached room temperature.

Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.

Do not shake the pre-filled pen.

Do not remove the yellow cap from the pre-filled pen yet.

B. Inspect the SOLYMBIC pre-filled pen.

Yellow cap on

Window

Medicine

Make sure the medicine in the window is clear and colourless to slightly yellow.

Do not use the pre-filled pen if:

-The medicine is cloudy or discoloured, or contains flakes or particles.

-Any part appears cracked or broken.

-The pre-filled pen has been dropped on a hard surface.

-The yellow cap is missing or not securely attached.

-The expiration date printed on the label has passed.

In all cases, use a new pre-filled pen.

C. Gather all materials needed for your injection.

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place a new, pre-filled pen.

You will also need these additional items, as they are not included in the carton:

Alcohol wipes

Cotton ball or gauze pad

Plaster

Sharps disposal container

D. Prepare and clean your injection site.

Belly

Thigh

You can use:

Your thigh

Belly, except for a 2-inch (5 centimetre) area right around your belly button

Clean your injection site with an alcohol wipe. Let your skin dry.

Do not touch this area again before injecting.

If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.

-Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion.

Step 2: Get ready

E. Pull the yellow cap straight off when you are ready to inject.

It is normal to see a drop of liquid at the end of the needle or yellow safety guard.

Do not twist or bend the yellow cap.

Do not put the yellow cap back onto the pre-filled pen.

Do not remove the yellow cap from the pre-filled pen until you are ready to inject.

F.

Stretch or pinch your injection site to create a firm surface.

Stretch method

Stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches (5 centimetres) wide.

OR

Pinch method

Pinch the skin firmly between your thumb and fingers, creating an area about 2 inches (5 centimetres) wide.

Important: Keep the skin stretched or pinched while injecting.

Step 3: Inject

G. Hold the stretch or pinch. With the yellow cap off,

place the pre-filled pen on your skin at 90 degrees.

Important: Do not touch the blue start button yet.

H. Firmly

push the pre-filled pen down onto the skin until it stops moving.

Important: You must push all the way down but do not touch the blue start button until you are ready to inject.

I. press

When you are ready to inject, the blue start button.

“Click”

J. Keep

pushing down on your skin. Your injection could take about 10 seconds.

~10s

“Click”

The window turns yellow

When the injection is done

Note: After you remove the pre-filled pen from your skin, the needle will be automatically covered.

Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. Call your doctor immediately.

Step 4: Finish

K. Discard the used

pre-filled pen and the yellow cap.

Put the used pre-filled pen in a sharps disposal container immediately after use. Do not throw away (dispose of) the pre-filled pen in your household waste.

Talk with your doctor or pharmacist about proper disposal. There may be local guidelines for disposal.

Do not reuse the pre-filled pen.

Do not recycle the pre-filled pen or sharps disposal container or throw them into the household waste.

Important: Always keep the sharps disposal container out of the sight and reach of children.

L. Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.

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