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  • Havrix 1440
    / GSK


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 1 ml

    not in the basket chart 9393 8126

    Related information


    Dosage

    Adults (16 years and over): Primary immunisation consists of a single dose given intramuscularly. This provides anti-HAV antibodies for at least one year. This vaccine confers protection against hepatitis A within 2-4 weeks. In order to obtain more persistent immunity, a booster dose is recommended between 6 and 12 months after primary immunisation. Although a booster should be given within 6-12 months of the initial vaccination, it has been shown that immunocompetent subjects given a booster up to 3 years after the initial vaccination can develop similar antibody levels to subjects given a booster within the recommended time period. Subjects given a booster up to 5 years after initial vaccination can also show a satisfactory antibody response but approximately 30% of individuals receiving a delayed booster have no detectable anti-HAV antibodies prior to booster dosing.
    It is unnecessary to restart the primary vaccination schedule if the booster is administered within 5 years of the primary vaccination. Current recommendations do not support the need for further booster vaccination among immunocompetent subjects after a 2-dose vaccination course. The results described above should be considered to apply only to immunocompetent adults. This vaccine can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine. In the event of a subject being exposed to a high risk of contracting hepatitis A within 2 weeks of the primary immunisation dose human normal immunoglobulin may be given simultaneously with this vaccine at different injection sites.
    Children/adolescents (1-15 years): This vaccine is not recommended (Havrix 720 Junior should be used).
    Method of administration: The vaccine should be injected intramuscularly in the deltoid region. The vaccine should never be administered intravenously.


    Indications

    Active immunisation against infections caused by Hepatitis A virus. The vaccine is particularly indicated for those at increased risk of infection or transmission.


    Contra-Indications

    Hypersensitivity to the active substance, to any of the excipients or to neomycin (present at traces).


    Special Precautions

    Immunisation should be postponed in subjects suffering from an acute severed febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
    As for all vaccinations, appropriate medication e.g. epinephrine (adrenaline) should be readily available for immediate use in case of anaphylaxis. It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation. It is not known whether this vaccine will prevent hepatitis A in such cases. In haemodialysis patients and in subjects with an impaired immune system, adequate anti-HAV antibody titres may not be obtained after the primary immunisation and such patients may therefore require administration of additional doses of vaccine. Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.


    Side Effects

    Headache, Drowsiness, gastrointestinal symptoms, nausea, diarrhea.
    See prescribing information for full details.


    Drug interactions

    This vaccine  must not be mixed with other vaccines in the same syringe.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are limited amount of data from the use of this vaccine in pregnant women. The use of this vaccine may be considered during pregnancy, if necessary.
    Lactation: It is unknown whether this vaccine is excreted in human milk.
    See prescribing information for full details.


    Overdose

    Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.


    Important notes

    Storage: Store at 2°C- 8°C in a refrigerator. Do not freeze. Shake well before use.


    Manufacturer
    GlaxoSmithKline Biologicals S.A., Rixensart, Belgium
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