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  • Hepatect CP
    / Kamada


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    40 ml X 50 IU/ml

    partial basket chart 80939 8359

    Related information


    Dosage

    Prevention of hepatitis B re-infection after liver transplantation for hepatitis B induced liver failure:
    In adults: 10 000 IU on the day of transplantation, peri-operatively then 2000-10 000 IU (40-200 ml)/day for 7 days, and as necessary to maintain antibody levels above 100-150 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients.
    In children: Posology should be adjusted according to body surface area, on the basis of 10 000 IU/1.73m².
    Immunoprophylaxis of hepatitis B:
    Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: At least 500 IU (10 ml), depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 – 72 hours.
    Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier-mother, at birth or as soon as possible after birth: 30-100 IU (0.6-2 ml)/kg. The hepatitis B immunoglobulin administration may be repeated until seroconversion following vaccination.
    In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected on the same day as human hepatitis B immunoglobulin, however in different sites.
    In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 IU (10 ml) to adults and 8 IU (0.16 ml)/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/ml.
    Method of administration: Hepatect CP should be infused intravenously at an initial rate of 0.1 ml/kg/hr for 10 minutes.
    If well tolerated, the rate of administration may gradually be increased to a maximum of 1 ml/kg/hr.
    Clinical experience in newborns of hepatitis B virus carrier mothers has shown, that Hepatect CP intravenously used at an infusion rate of 2 ml in-between 5 to 15 minutes has been well tolerated.


    Indications

    Prohylaxis against hepatitis B in adults and children over two years of age who have not been vaccinated against hepatitis B (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis B by accidental contact with hepatitis B virus containing material following percutaneous exposure (e.g., accidental needle stick) or direct mucous membrane contact. When the administration of an intramuscular hepatitis B immunoglobin is not possible. The immunoglobin should be administered in association with hepatitis B vaccine. Prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis B virus. Immunoprophylaxis of hepatitis B in the newborn of a hepatitis B virus carrier mother.

     


    Contra-Indications

    Hypersensitivity to any of the components.
    Hypersensitivity to human immunoglobulins.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    Live attenuated virus vaccines: Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps, measles and varicella for a period of up to 3 months. After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
    Human hepatitis B immunoglobulin should be administrated three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the administration of human hepatitis B immunoglobulin.


    Pregnancy and Lactation

    Pregnancy: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Intravenous immunoglobulin G have been shown to cross the placenta, increasingly in the third trimester. Clinical experience with immunoglobulins
    suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
    Breast-feeding: Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.


    Overdose

    Consequences of an overdose are not known.


    Manufacturer
    Biotest AG
    Licence holder
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