Active substanceVaccine for the prevention of herpetic infectionsVaccine for the prevention of herpetic infections
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  • Vitaherpavak
    lyophilizate in / skin 
  • Gerpovax
    lyophilizate in / skin 
    SPbNIIVS FMBA, FSUE     Russia
  • Dosage form: & nbsplyophilizate for the preparation of a solution for intradermal administration
    Composition:

    In one inoculation dose (0.2 ml) contains:

    Active components:

    Specific antigens of the herpes simplex virus (HSV) of types I and II (strain "US" and strain "VN" respectively) obtained by reproduction in culture of transplantable kidney cells of the African green monkey (VERO B), formaldehyde inactivated and lyophilized with the addition of a sucrose-gelatinous medium as a stabilizer.

    Excipients:

    formaldehyde no more than 200 mcg / ml; gentamycin sulfate is not more than 40 μg / ml, sucrose is not more than 0.075 g / ml; gelatin not more than 0.01 g / ml.

    Description:

    Amorphous mass from light yellow to pink. It is hygroscopic.

    Pharmacotherapeutic group:MIBP vaccine
    ATX: & nbsp

    J.07.B.X   Other vaccines for the prevention of viral infections

    Pharmacodynamics:

    The vaccine stimulates cellular mechanisms of resistance of the human body to the herpes simplex virus type I and II.

    Indications:

    The vaccine is designed to prevent the recurrence of herpetic infection.

    Contraindications:
    1. Herpetic infection in the active stage (relapse). Vaccination is performed no earlier than 14 days after the disappearance of clinical manifestations; at ophthalmoherpes - not earlier, than in 1 month
    2. Acute infectious and non-infectious diseases. (Vaccination is performed no earlier than 30 days after recovery)
    3. Chronic diseases in the stage of exacerbation or decompensation
    4. Malignant neoplasms
    5. Pregnancy
    6. Allergy to gentamicin and other antibiotics of the aminoglycoside group
    Dosing and Administration:

    Vaccination is carried out in medical and health institutions for the purpose and under the supervision of a doctor. The vaccine is used in remission, no earlier than 10 days after the complete disappearance of clinical manifestations of herpetic infection, with ophthalmoherpes no earlier than 1 month.

    The contents of the vial are dissolved in 0.3 ml of a solvent (sterile water for injections). To do this, the solvent is injected into the vial of the vaccine using a syringe with a needle, which is then shaken until the contents are completely dissolved. The dissolved preparation should be opalescent liquid pink or pink with a yellow shade of color.Visible mechanical inclusions should be absent. The dissolved vaccine is not subject to storage.

    The preparation is not suitable for use in vials with broken integrity, marking, color change, expired shelf life, and improper storage.

    Opening of the vial, dissolution of the drug and the vaccination procedure are carried out with strict adherence to aseptic rules. The drug is injected intradermally into the inner surface of the forearm in a single dose of 0.2 ml.

    The main cycle of vaccination consists of 5 injections, which are carried out with an interval of 7 days. The repeated cycle is carried out after 7-10 days according to the same scheme.

    After 6 months, a second course of vaccination is carried out, consisting of two cycles of 5 injections.

    Patients with severe form of herpetic infection (relapse every month or 1 time in 2-3 months) the drug is administered with an interval of at least 10 days.

    Side effects:
    After the introduction of the vaccine, local and general reactions may develop in individuals.
    Local reaction:
    It is manifested by skin hyperemia with a diameter of up to 2 cm during the first day and a mild short-term burning at the injection site.
    The general reaction can be expressed in a slight increase in temperature (not above 37.5 ° C), weakness, without treatment.
    If there are more severe local and general reactions or the development of exacerbation of recurrence of herpetic infection, the drug should be stopped. Vaccination can be continued after 14 days after the complete disappearance of clinical manifestations of herpes infection and a general reaction to the administration of the vaccine.
    Interaction:
    Cases of incompatibility with other drugs have not been identified.
    Form release / dosage:Lyophilizate for the preparation of a solution for intradermal administration.
    Packaging:In vials of 0.3 ml. One inoculation dose is 0.2 ml. In a pack of 5 bottles and instructions for use.
    Storage conditions:
    The preparation is stored in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C, out of reach of children.
    Conditions of transportation.
    The preparation is transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Short-term, no more than three days, transportation at a temperature of 9 to 18 ° C is allowed. Do not freeze.
    Shelf life:2 years. The drug is not eligible for use with expired use.
    Terms of leave from pharmacies:On prescription
    Registration number:P N003193 / 01
    Date of registration:25.11.2008 / 19.01.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:VITAFARMA FIRM, CJSC VITAFARMA FIRM, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.02.2017
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