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  • Avaxim 160 U
    / Medici


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    0.5 ml

    not in the basket chart 1006

    Related information


    Dosage

    The recommended dosage for subjects over the age of 15 is 0.5 ml.
    The initial protection is obtained after one single injection.
    In order to obtain a long-term protection against infections caused by the Hepatitis A virus, in adolescents over the age of 15 and in adults, a booster dose should be administered, preferably between 6 and 12 months after the first vaccination and can be administered up to 36 months after the first vaccination. It is estimated that anti-VHA antibodies persist several years (at least 10 years) after the second dose (booster).
    This vaccine can also be administered as a booster dose of the Hepatitis A vaccination in subjects over the age of 15 who have received the first injection with the combined Typhoid Fever (Vi purified polysaccharide) and Hepatitis A (inactivated) vaccine between 6 and 36 months earlier.
    Method of administration: Because the vaccine is adsorbed, it is recommended to administer this vaccine by the intramuscular route (IM) to minimise local reactions.
    The recommended injection site is the deltoid muscle.
    In exceptional cases, the vaccine may be administered by the subcutaneous route in patients suffering from thrombocytopenia or in patients at risk of haemorrhage.
    The vaccine is not to be injected into the buttocks because of the variability of this anatomical site (presence of varying amounts of adipose tissue), nor administered intradermally, since these methods of administration may induce a weaker immune response.
    Do not inject by the intravascular route: ensure that the needle does not penetrate a blood vessel.
    This vaccine must not be mixed with other vaccines in the same syringe.


    Indications

    This vaccine is indicated for active immunisation against infection caused by the hepatitis A virus in adolescents over the age of 15 and in adults.
    The vaccine does not protect against infection caused by hepatitis B, hepatitis C, or hepatitis E viruses, or any other known liver pathogens.
    Transmission of the hepatitis A virus is usually through the ingestion of contaminated water or food.
    Persons in contact with contaminated subjects are usually infected through the oro-faecal route.
    The possibility of transmission by blood or by sexual con (oral-anal relations) has also been demonstrated.
    This vaccine should be administered in accordance with official recommendations.


    Contra-Indications

    The usual contraindications to all vaccinations: vaccination should be postponed in the case of fever, acute disease or progressive chronic disease.
    Hypersensitivity to one of the vaccine components or following a previous injection of this vaccine.


    Special Precautions

    Do not inject by the intravascular route: ensure that the needle does not penetrate a blood vessel.
    As with any vaccination, it is recommended to have an adrenaline solution for injection available in the event of an anaphylactic reaction.
    The vaccine is not to be injected into the buttocks because of the variability of this anatomical site (presence of varying amounts of adipose tissue), nor administered intradermally, since these methods of administration may induce a weaker immune response.
    The immune response to the vaccine may be reduced in patients receiving immunosuppressant drugs or suffering from immune deficiency disorders.
    In such cases it is recommended to postpone the vaccination until the end of the treatment or to make sure the subject is well protected. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended if the underlying disease still allows an antibody response, even if the response might be limited.
    Because of the incubation period of the disease, infection may already be present at the time of vaccination, although not detected. In such a case, vaccination may have no effect on the development of hepatitis A.
    The use of this vaccine in subjects suffering from liver diseases should be considered with caution, as no studies have been performed in such subjects.
    In exceptional cases, the vaccine may be administered by the subcutaneous route in patients suffering from thrombocytopenia or in patients at risk of haemorrhage.
    As each dose contains traces of neomycin, caution should be exercised when the vaccine is administered to subjects with hypersensitivity to this antibiotic.


    Side Effects

    The undesirable effects reported during clinical trials were generally moderate, of short duration, and resolved without treatment.
    Local reactions at the injection site: The most frequent local reaction was pain, sometimes associated with erythema. The appearance of a nodule at the injection site has been observed in very rare cases.
    General reactions: Moderate fever, asthenia, headaches, myalgia or arthralgia and gastro-intestinal disorders were the most often reported general reactions.
    Mild, reversible elevation of serum transaminase has been observed on rare occasions; exceptional cutaneous reactions such as pruritus, rash or urticaria have been observed.
    Reactions were less frequently reported after the booster injection than after the first dose.
    In subjects seropositive for hepatitis A virus, this vaccine was as well tolerated as in seronegative subjects.


    Drug interactions

    Immunoglobulins may be administered simultaneously with the vaccine as long as two separate injection sites are used. Seroprotection rates are not modified but antibody titres may be lower than those obtained when the vaccine is administered alone.
    As the vaccine is inactivated, association with other inactivated vaccine(s) at a different injection site does not generally result in any interaction.
    This vaccine can be administered simultaneously, but at two separate sites, with a typhoid polysaccharide vaccine (Typhim Vi) or a recombinant hepatitis B vaccine obtained by cloning and expression of the viral gene in Saccharomyces cerevisiae yeast without modification of the immune response to either antigen.
    This vaccine can be administered simultaneously, but at two separate sites, with a live and stabilized yellow fever vaccine.
    This vaccine can be used as a booster dose in subjects who have received primary vaccination with another inactivated hepatitis A vaccine.


    Pregnancy and Lactation

    Pregnancy: No reliable data are available on teratogenesis in animals.
    To date, there are no sufficiently relevant clinical data available to assess a potential vaccine-related malformation or foetotoxic effect of the hepatitis A vaccine, when it is administered during pregnancy.
    As a precautionary measure, it is preferable not to use this vaccine during pregnancy except in case of a major contamination risk.
    Lactation: The use of this vaccine is possible during lactation.


    Overdose

    Not applicable


    Important notes

    Incompatibilities: As no compatibility study has been performed, this vaccine must not be mixed with other medicinal products.
    Shelf life: 3 years.
    Storage: Store in a refrigerator (between +2°C and +8°C). Do not freeze.


    Manufacturer
    Sanofi Pasteur
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