くすりのしおり

Self-injection
Revised: 9/2018

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
ENBREL 10mg for S.C. Injection
 Active ingredient:
Etanercept(genetical recombination)
 Dosage form:
white freeze-dry powder injectable preparation
 Print on wrapping:

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 polyarticular-course juvenile idiopathic arthritis and moreover, prevents the damage of joints and bones in rheumatoid arthritis.
It is usually used to treat rheumatoid arthritis and active, polyarticular-course juvenile idiopathic arthritis.

Before using this medicine, be sure to tell your doctor and pharmacist

  • 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.
  • If you are pregnant or breastfeeding.
  • 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.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • For treatment of rheumatoid arthritis: In general, for adults, dissolve 10 to 25 mg of the active ingredient into 1 mL of water for injection at a time and subcutaneously inject once a day on two different days (3 or 4 days apart) in the same week, or dissolve 25 to 50 mg into 1 mL of water for injection at a time and subcutaneously inject once a day, once a week.
    For treatment of active, polyarticular-course juvenile idiopathic arthritis: In general, for children, inject subcutaneously 0.2 to 0.4 mg/kg of the active ingredient once a day on two different days (3 or 4 days apart) in the same week. Each dose for children should not exceed 25 mg.
    Strictly follow the instructions in either case.
  • Choose a different injection site each time. (Inject at least 3 cm apart from the previous injected site.)
  • Avoid injecting into an irritable skin site, or a site with wound, redness or induration (a site is harder than around).
  • Do not massage the injected site after injection.
  • Use this medicine immediately after it is dissolved. If you need to store the medicine after it is dissolved, store 2 to 8 degrees Celsius (in the refrigerator) and use the medicine within 6 hours after opening. Before use, leave this medicine at room temperature for about 15 to 30 minutes.
  • You may self-inject this medicine (self injection), only if you prefer to and the doctor has confirmed that you meet certain criteria for self-injection.
  • If you miss a dose, consult with your doctor, pharmacist or nurse.
  • If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop using this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Do not receive live vaccines (such as rubella/mumps vaccines) due to infection risk of the virus. If you wish to receive live vaccines for prevention, inform and consult with your doctor that you are using this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include infections (nasopharyngitis, bronchitis, etc.), injection site reactions (erythema, swelling, pain, itching), rash, pruritus, headache, diarrhea, constipation, abdominal pain, dizziness, abnormal liver function (general malaise, loss of appetite, etc.) 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 reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • chills, fever, general malaise [sepsis, pneumonia (including pneumocystis pneumonia), opportunistic infections such as fungal infection]
  • persistent slight fever, persistent cough (for 2 weeks or more), general malaise [tuberculosis]
  • redness (general), general edema, breathing difficulty [serious allergic reactions]
  • persistent fever, sore throat, paleness of the face [serious blood disorders]
  • vision loss/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.

Storage conditions and other information

  • Keep out of reach of children. Store at 2 to 8 degrees Celsius (in the refrigerator) and avoid freezing.
  • Discard the remainder. Do not store them. Consult with the pharmacist and the medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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