くすりのしおり

Injection
Published: 6/2018

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 :
HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.5mL
 Active ingredient:
Recombinant adsorbed hepatitis b vaccine(yeast origin)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine creates antibodies against hepatitis B virus in advance to prevent infection caused by hepatitis B virus.
It is usually used to prevent hepatitis B, maternal-fetal transmission of hepatitis B virus, development of hepatitis B after accidental contamination by HBs and HBe antigen-positive blood.

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 fever or acute disease.
  • 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 prevention of hepatitis B: In general, for children 10 years or older, inject subcutaneously or intramuscularly twice at an interval of 4 weeks, subsequently inject subcutaneously or intramuscularly the third dose after 20 to 24 weeks of the first dose.
    For prevention of hepatitis B after accidental contamination by blood of patients with hepatitis B: In general, for children 10 years or older, inject subcutaneously or intramuscularly a total of 3 times: the first time, within 7 days after the onset of accident; the second time, a month after the first dose; the third time, 3 to 6 months after the first dose.
    For children under 10 years old, use HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL. In any case, strictly follow the instructions.
  • Use in combination with human anti-HBs immunoglobulin to prevent hepatitis B after accidental contamination by blood of patients with hepatitis B.
  • Receive an antibody test about 1 to 2 months after the third vaccination. Get an additional vaccination when you are not actively immunized with HBs antibody.
  • Be sure to receive medical interview, temperature check and consultation before vaccination.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include injection site reaction (pain, redness, itch, swelling), fatigue, fever, erythema, headache and lassitude of hands. If any of these symptoms occur, consult with your doctor or pharmacist.
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.
  • breathing difficulty, cold sweat, blue in the face [shock, anaphylaxis]
  • double vision, rolling of the eyeball, general malaise, fever, headache, feeling sick at the stomach, tingling of limbs, loss of perception of limbs, lassitude of limbs [multiple sclerosis, acute disseminated encephalomyelitis, myelitis, optic neuritis, Guillain-Barre syndrome, peripheral neuropathy]
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

  • Avoid heavy exercise on the day of vaccination and keep the injection site clean. Pay attention to health surveillance after vaccination and consult with your doctor as soon as possible when an abnormal injection site reaction occurs, your condition changes and unusual symptoms such as high fever and convulsion occur.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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