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ENBREL 10mg for S.C. Injection
2014-04-06 07:33:01 来源: 作者: 【 】 浏览:399次 评论:0
Manufacturer's name : Takeda Chemical Industries, Ltd. 621934101
Revised: 10/2010
 
Brand name : ENBREL 10mg for S.C. Injection
 Active ingredient: Etanercept (genetical recombination)
 Dosage form: white freeze-dry powder injectable preparation
 Printings on wrapping: 生物 エンブレル 皮下注用10mg

Effects of this medicine

This medicine suppresses immune systems and action of TNF, a cytokine in the body, which is considered to be a primary factor of inflammation and pain.
Usually, used for treatment of rheumatoid arthritis and active, polyarticular-course juvenile idiopathic arthritis.

Before using this medicine, tell your doctor/pharmacist

  • If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
    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 using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)

Dosage regimen (proper use of this medicine)

  • Your dosage regimen is:(order of your doctor)
  •  
  • General dosage regimen: For treatment of rheumatoid arthritis, 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, 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 of your doctor/pharmacist in either case.
  • Avoid injection to the site overlapped to previously injected sites (Inject the medicine at least 3 cm apart from the previous injected site).
  • Do not massage the injected site after giving the injection.
  • Patients can self-inject the medicine (self injection), only if the doctor has confirmed that patient meets certain criteria for the self-injection.
  • Missed dose: If you missed an injection, check with your doctor/pharmacist or nurse.
  • Overdose: If you used too much of the medicine (more than ordered), check with your doctor/pharmacist.
  • Others: Do not stop your medication without the instructions of your doctor.

Precautions while using this medicine

  • 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.
  •  

Side effects of this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: injection site reactions (rash, swelling, pain, itching), dizziness, etc. Most of these symptoms will recover spontaneously for 2-3 days. Do not scratch or touch the injection site. If a severe swelling or pain is observed, consult with doctor, pharmacist or nurse.In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.
  • sudden high fever with chill and trembling, blood pressure decrease[sepsis]
  • persistent slight fever, persistent cough (for more than 2 weeks), dullness (general)[tuberculosis including extrapulmonary tuberculosis]
  • fever, dullness (general), breathlessness[pneumonia, opportunistic infection]
  • rash (general), swelling (general), breathlessness[serious allergic reactions]
  • persistent fever, sore throat, paleness of the face [serious blood disorders]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.

Storage and other information

  • Keep out of the reach of children. Store at 2-8℃ and avoid freezing.
  • Discard the remainder. Do not store them. If you dispose of unused medicines, seek advice of your pharmacist about proper disposal of drugs.
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency. 
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