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    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    1 X 0.5 ml

    not in the basket chart 45684

    Related information


    Dosage

    Primary vaccination schedule: The primary vaccination schedule is the same for all persons from the age of 16 onwards and consists of three doses of this vaccine.
    The first and second dose should be given at a 1 to 3 month interval.
    If there is a need to achieve an immune response rapidly, the second dose may be given two weeks after the first dose.
    After the first two doses sufficient protection for the ongoing tick season is to be expected.
    The third dose should be given 5 to 12 months after the second vaccination. After the third dose protection is expected to last for at least 3 years.
    To achieve immunity before the beginning of the seasonal tick activity, which is in spring, the first and second doses should preferably be given in the winter months. The vaccination schedule should ideally be completed with the third vaccination within the same tick season or at the least before the start of the following tick season.
    1st dose, 0.5 ml on the elected date.
    2nd dose, 0.5 ml -1 to 3 months after the 1st vaccination (rapid vaccination schedule -14 days after the 1st vaccination).
    3rd dose, 0.5 ml-5 to 12 months after the 2nd  vaccination (rapid vaccination schedule- 5 to 12 months after the 2nd vaccination).
    Booster doses
    Persons from 16 to 60 years of age: The first booster dose should be given 3 years after the third dose.
    Sequential booster doses should be given every 5 years after the last booster dose.
    Booster dose 16 to < 60 years: 1st booster 0.5 ml -3 years after the 3rd  vaccination. Sequential booster doses 0.5 ml every 5 years.
    Booster dose ≥ 60 years: All booster doses 0.5 ml – every 3 years.
    Extending the interval between any of the doses (primary vaccination schedule and booster doses) may leave subjects with inadequate protection against infection.
    However, in the case of an interrupted vaccination schedule of at least two previous vaccinations, a single catch-up dose is sufficient to continue the vaccination schedule.
    Persons with impaired immune system (including those undergoing immunosuppressive therapy).
    There are no specific clinical data on which to base dose recommendations. However, consideration may be given to determining the antibody concentration at four weeks after the second dose and administering an additional dose if there is no evidence of seroconversion at this time. The same applies to any of the following doses.
    Method of administration: The vaccine should be given by intramuscular injection into the upper arm (deltoid muscle).
    In exceptional cases only (in subjects with a bleeding disorder or in subjects receiving prophylactic anticoagulation), the vaccine may be administered subcutaneously.
    Care must be taken to avoid accidental intravascular administration.
    See prescribing information for full details.


    Indications

    Active (prophylactic) immunization of adolescents from 16 years of age and adults against tick-borne encephalitis (TBE).
    The vaccine is to be given on the basis of official recommendations regarding the need for, and timing of, vaccination against TBE.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Cross allergies with aminoglycosides other than neomycin and gentamycin should be considered.
    Severe hypersensitivity to egg and chick proteins (anaphylactic reaction after oral ingestion of egg protein) may cause severe allergic reactions in sensitized individuals.
    TBE vaccination should be postponed if the person is suffering from a moderate or severe acute illness (with or without fever).


    Special Precautions

    As with all vaccines that are administered by injection, appropriate emergency treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
    Non-severe allergy to egg protein does not usually constitute a contraindication to vaccination with this vaccine. Nevertheless, such persons should only be vaccinated under appropriate supervision and facilities for emergency management of hypersensitivity reactions should be available.
    The levels of potassium and sodium are at less than 1 mmol per dose, i.e., essentially “potassium and sodium-free”.
    Intravascular administration must be avoided as this might lead to severe reactions, including hypersensitivity reactions with shock.
    The recommended route of administration is intramuscular.
    Fever may occur in children after the first immunization in particular in the very young. In general, the fever subsides within 24 hours. Fever rates reported after the second vaccination are generally lower as compared to the fever rates after the first vaccination. In children with a history of fever convulsions or high fever following vaccinations, antipyretic prophylaxis or treatment may be considered.
    A protective immune response may not be elicited in persons undergoing immunosuppressive therapy.
    Whenever serological testing is considered necessary in order to determine the need for sequential doses, assays should be performed in an experienced, qualified laboratory. This is because cross reactivity with pre-existing antibodies due to natural exposure or previous vaccination against other flaviviruses (e.g. Japanese encephalitis, Yellow fever, Dengue virus) may give false positive results.
    In case of a known or suspected auto-immune disease in the intended recipient, the risk of TBE infection must be weighed against the risk that this vaccine might have an adverse effect on the course of the auto-immune disease.
    Caution is required when considering the need for vaccination in children with pre-existing cerebral disorders such as active demyelinating disorders or poorly controlled epilepsy.
    There is no data concerning post exposure prophylaxis with this vaccine.
    As with all vaccines, this vaccine  may not completely protect all vaccines against the infection that it is intended to prevent. For details on product administration in persons with impaired immune system and persons undergoing immunosuppressive therapy please.
    See prescribing information for full details.


    Side Effects

    Injection site reactions, myalgia, arthralgia, headache, nausea, vomiting, abdominal pain, pyrexia, fatigue, malaise.
    See prescribing information for full details.


    Drug interactions

    No interaction studies with other vaccines or medicinal products have been performed.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no data from the use of this vaccine  in pregnant women.
    LactationIt is unknown whether this drug is excreted in human milk.        


    Overdose

    No case of overdose has been reported. However, due to the presentation of the vaccine, accidental overdose in terms of volume is unlikely.


    Manufacturer
    Pfizer Manufacturing Austria GmbH, Austria
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