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Dosage form: & nbsplyophilizate for the preparation of a suspension for subcutaneous administration
Composition:

Vaccine E typhitis-typhoid combined live (LHSV-E), a lyophilizate for the preparation of a suspension for subcutaneous administration, is a suspension of live rickettsia Provacek vaccine strain Madrid E, grown in the tissue of yolk sacs developing chick embryos, in combination with soluble antigen from Rickettsia Procachek virulent strain Braunl , lyophilized in sterile, fat-free cow's milk.

One inoculation dose of 0.25 ml contains from 1000 to 100000 minimal infectious doses of rickettsia for chicken embryos (MIDe) and at least 16 antigenic units of soluble antigen when titrated in the complement fixation reaction.

Excipient: milk cow fat-free sterile.
Description:

The porous mass in the form of a tablet from light yellow to dark-Brown color.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Inactivated whole bacteria of typhus
  • Pharmacodynamics:

    Immunobiological properties

    Single administration of the vaccine is accompanied by the development of specific immunity for 15-30 days after vaccination.

    Indications:

    Specific prophylaxis of typhus in the age of 18 to 60 years.

    The vaccine is used for epidemiological indications in situations that threaten typhus infection, as well as for the protection of laboratory The staff working with the Ricquets of Provachek.

    Contraindications:

    - Acute infectious and non-infectious diseases; chronic diseases in the acute stage. Vaccinations are carried out not earlier than a month from the moment of recovery or remission;

    - allergic diseases (according to anamnesis): bronchial asthma, atopic dermatitis, pollinosis, etc .; allergy to chicken protein;

    - degenerative and progredient diseases of the nervous system;

    - kidney and adrenal gland diseases;

    - systemic connective tissue diseases;

    - immunodeficiency states (primary and secondary);

    - pregnancy and lactation.

    The possibility of vaccinating people suffering from diseases not listed in this list of contraindications is determined by the doctor, based on the health status of the vaccinated person.

    Immediately before vaccination, the doctor conducts a thorough medical examination with thermometry and a survey of vaccinees to identify contraindications. At a temperature above 37 ° C vaccinations are not carried out.

    Vaccinations are carried out not earlier than 1 month after the previous immunization with other prophylactic drugs.

    Dosing and Administration:

    The vaccine is injected once subcutaneously into the subscapular region at a dose of 0.25 ml.

    Revaccination is carried out at a dose of 0.25 ml not earlier than 1 year after vaccination.

    Precautions for use

    Before use, every ampoule with the vaccine is carefully scanned. If there are cracks in the ampoule, foreign inclusions, unusual coloring vaccine and other defects, as well as broken labeling and expired shelf life, this ampoule is rejected and rendered harmless by boiling for 30 minutes or by immersing the broken ampoule in a 3% solution of chloramine for 1 day.

    In the ampoule with the vaccine, 5 ml of sodium chloride of the solvent for the preparation of dosage forms for injection, 0.9%, immediately before vaccination. The vaccine should dissolve within 2 minutes to form a homogeneous suspension of light yellow color. With longer dissolution, as well as the presence of unbreakable flakes in the dissolved preparation, the contents of the ampoule are not subject to application and must be destroyed, as indicated above.

    Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. The dissolved vaccine is usable for 30 minutes when stored under a sterile tissue at room temperature and for 60 minutes while storing it at a temperature of 2 to 8 ° C. Dissolved and not used during this period, the vaccine is destroyed by the methods indicated above.

    The vaccination is recorded in the appropriate registration forms with the date, dose, manufacturer, serial number, response to vaccination.

    Side effects:

    Local response to the introduction can be observed in the form of a slight swelling or infiltration of tissues without clear boundaries and pain in 10-20% of the vaccinated.

    Early common reactions occurring in the next 6-72 hours after inoculation in 7-12% of vaccinated patients can be expressed in a one-two-day rise in temperature to subfebrile and complaints of weakness and dizziness.

    Late general reactions, which are a manifestation of a vaccinal infection, appear later 9-18 (rarely later) day after vaccination in 2-3% of vaccinated patients and are expressed in fever over 1-4 days, headache, malaise; often - pain in the muscles.

    When revaccination of GADG-E reaction to the introduction of the vaccine is usually not observed.

    Interaction:

    Not identified.

    Special instructions:
    Effect on the ability to drive transp. cf. and fur:

    Influence on the ability to drive vehicles, mechanisms is not established.

    Form release / dosage: Lyophilizate for the preparation of a suspension for subcutaneous administration (complete with a solvent).
    Packaging:

    Vaccine E typhnotifose combined alive - 20 doses in ampoules.

    Solvent - Sodium chloride for the preparation of dosage forms for injection 0.9% - 5 ml in ampoules.

    5 ampoules of the vaccine and 5 ampoules of the solvent are placed in a pack of cardboard with a scapegrator ampoule and instructions for use (it is allowed to not pack the ampoules with notches, rings and dots for opening the scarifier).

    Storage conditions:

    The vaccine is stored in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children. Freezing is not allowed.

    Transportation conditions

    The vaccine is transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

    Shelf life:

    2 years.

    The drug with expired shelf life is not subject.

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-001379
    Date of registration:29.08.2011 / 22.12.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp13.01.2017
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