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HUMIRA 40mg for S.C. Injection Syringe 0.8mL
2014-01-15 11:37:13 来源: 作者: 【 】 浏览:572次 评论:0
Manufacturer's name : Eisai Co., Ltd. 620006808
Revised: 11/2010
 
Brand name : HUMIRA 40mg for S.C. Injection Syringe 0.8mL
 Active ingredient: Adalimumab (genetical recombination)
 Dosage form: colorless limpid or slightly opalescent injectable solution in prefilled syringe
 Printings on wrapping:  

Effects of this medicine

This medicine suppresses function of TNF-α, which is one of possible primary causative substances in rheumatoid arthritis, psoriasis, ankylosing spondylitis and crohn's disease. TNF (tumor necrosis factor) is one of cytokines existing inside of the body even in a healthy one, and involved in activities of immunity and development of inflammation or pain.
It is usually used in the treatment of patients with rheumatoid arthritis, psoriasis vulgaris, psoriasis arthropica, ankylosing spondylitis or crohn's disease who had insufficient response to conventional therapy.

Before using this medicine, tell your doctor/pharmacist

  • If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
    If you are a patient with infections such as plural sepses or suspected of them.
    If you are a patient with tuberculosis or a history of it.
    If you are a patient with demyelinating disease such as multiple sclerosis or a personal or a family history of it.
    If you are a patient with hematologic disease or a hepatitis B virus carrier.
    If you have just received live vaccine.
    If you have congestive heart failure.
  • 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 rheumatoid arthritis, for adults, the usual adult dosage is 1 syringe (40 mg of the active ingredient) per dose injected subcutaneously every two weeks. The dosage may be increased up to 80 mg at a time if the effect is insufficient.
    For psoriasis vulgaris, or psoriasis arthropica, for adults, the usual adult dosage is an initial dose of 2 syringes (80 mg of the active ingredient), followed by 1 syringe (40 mg of the active ingredient) per dose, injected subcutaneously every two weeks. The dosage may be increased up to 80 mg at a time if the effect is insufficient.
    For ankylosing spondylitis, for adults, the usual adult dosage is 1 syringe (40 mg of the active ingredient) per dose injected subcutaneously every two weeks. The dosage may be increased up to 80 mg at a time if the effect is insufficient.
    For crohn's disease, for adults, the usual adult dosage is an initial dose of 4 syringes (160 mg of the active ingredient), followed by 2 syringes (80 mg of the active ingredient) two weeks later from the initial dose, injected subcutaneously. Two weeks later begin 1 syringe (40 mg of the active ingredient) per dose, injected subcutaneously every two weeks.
    Strictly follow the instructions of your doctor/pharmacist.
  • Injection site should be changed every time you inject the medicine. Do not inject to sensitive area of skin, wound site, skin rash or a psoriasis lesion. Do not massage the subcutaneous injection site.
  • You need to inject in the area of at least 3 cm apart from the last injection site.
  • Missed dose: Consult your doctor if you missed an injection.
  • Overdose: If you injected too much of the medicine (more than ordered), check with your doctor/pharmacist.
  • Others: Do not stop injecting the medicine without the instructions of your doctor.

Precautions while using this medicine

  •  

Side effects of this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: nasopharyngitis, rash, injection site reaction (erythema, itch, rash, bleeding, swelling), upper respiratory tract infection, etc.In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop using your medicine and check with your doctor immediately.
  • chill, sudden high fever with shivering, cough, sputum [severe infections such as sepsis or pneumonia]
  • prolonged slight fever or cough (2 weeks or over), general malaise, weight loss [tuberculosis]
  • joint pain, muscular pain, skin eruption [lupus-like syndrome]
  • reduced vision, double vision, numbness, pain, paralysis [demyelinating disease]
  • breathing difficulty, urticaria, swelling around the eye or lip [severe allergic reaction]
  • malaise, loss of appetite, yellowness in the skin and/or the white of the eye [fulminant hepatitis, hepatic dysfunction, jaundice, hepatic insufficiency]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.

Storage and other information

  • Keep the medicine out of the reach of children. Store it away from light and freeze, at temperature of 2 to 8 ℃.
  • Discard the remainder. Do not store them. Ask the pharmacist how to discard.
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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