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The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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Brand name :
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ENBREL 50mg Pen 1.0mL for S.C. Injection
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Active ingredient:
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Etanercept (genetical recombination)
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Dosage form:
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colorless to clear pale yellow injectable preparation in Pen
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Effects of this medicine
This medicine suppresses action of TNF, which is considered to be a primary factor that is related to immune mechanism, inflammation and pain, improves symptoms associated with rheumatoid arthritis and prevents the damage of joints and bones.
Usually, used for treatment of rheumatoid arthritis.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have: infection, tuberculosis, demyelinating disorders such as multiple sclerosis, optic nerve inflammation or its past history, congestive heart failure, blood disorders or its past history, a history of interstitial pneumonia, cancer or its past history.
If you have received live vaccines (such as rubella/mumps vaccines) just before use of the medicine.
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If you are pregnant or breastfeeding.
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If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
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In general, for adults, subcutaneously inject 1 kit (50 mg of the active ingredient) once a day, once a week. Strictly follow the instructions.
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The contents of a kit should be used all at once.
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Avoid injection to the site overlapped to previously injected sites (Inject the medicine at least 3cm apart from the previous injected site).
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Do not massage the injected site after receiving the injection.
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Patients can self-inject the medicine (self injection), only if the doctor has confirmed that patient meets certain criteria for the self-injection.
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If you miss a dose, consult with your doctor or pharmacist.
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If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist.
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Do not stop using this medicine unless your doctor instructs you to do so.
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Precautions while taking this medicine
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Do not receive live vaccines (such as rubella/mumps vaccines) because of infection risk of the virus. If you will receive live vaccines for prevention, inform your doctor that you are using the medicine and consult with him or her.
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Possible adverse effects of this medicine
The most commonly reported adverse reactions include infections (nasopharyngitis and bronchitis), injection site reactions (erythema, swelling, pain and itching), rash, pruritus, headache, diarrhea, constipation, abdominal pain, dizziness, abnormal liver function (general malaise and anorexia) and fever. If any of these symptoms occur, consult with your doctor or pharmacist. Do not scratch or touch the injection site.
The symptoms described below are rarely seen as initial symptoms of the adverse effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
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Chills, fever, dullness (general)[sepsis, pneumonia (including pneumocystis pneumonia), opportunistic infections such as fungal infection]
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persistent slight fever, persistent cough (for more than 2 weeks), dullness (general)[tuberculosis]
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redness (general), swelling (general), breathlessness[serious allergic reactions]
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persistent fever, sore throat, paleness of the face [serious blood disorders]
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decreased vision/diplopia, numbness/pain/motor paralysis[demyelinating disorders]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
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Storage conditions and other information
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Keep out of the reach of children. Store at 2-8℃ and avoid light and freezing.
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Discard the remainder. Do not store them. For unused medicines, seek advice of your pharmacist or healthcare provider about proper disposal of drugs.
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