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Dosage form: & nbsplyophilizate for the preparation of a suspension for cutaneous scarification application
Composition:

One inoculation dose (0.05 ml) - from 5x107 up to 5x109 the minimum infectious doses (MIDe) of Burnett's coxial for chick embryos; components of the drying medium: sucrose - 1%, pasteurized milk - 49%.

Description:

The vaccine is an amorphous mass in the form of a tablet of pink color with a grayish, yellowish or brownish hue.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Other vaccines
  • Pharmacodynamics:PIt is a lyophilized suspension of the live culture of the M-44 vaccine strain of Burnett's coxials grown in yolk sacs of developing chick embryos.

    Immunobiological properties

    A single injection of the vaccine is accompanied by the development of specific immunity 3-4 weeks after vaccination.

    Indications:

    Specific prophylaxis of Ku fever is carried out at the age of 14 years.

    Contingents subject to vaccination:

    - persons carrying out work for the preparation, storage, processing of raw materials and livestock products obtained from farms where diseases of Ku-fever cattle are registered;

    - persons performing work on harvesting, storage and processing of agricultural products in the enzootic territories according to Ku-fever;

    - persons working with live cultures of pathogens of Ku-fever.

    Contraindications:

    - Acute infectious and non-infectious diseases; chronic diseases in the acute stage; Inoculations 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 .; an allergy to a chicken egg;

    - chronic diseases of the upper respiratory tract and lungs;

    - systemic connective tissue diseases;

    - immunodeficiency states (primary and secondary);

    - pregnancy and lactation;

    - malignant diseases.

    The possibility of vaccinating people suffering from diseases not listed in the this list of contraindications, the doctor determines, based on the state of health vaccinated.

    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.

    Pregnancy and lactation:

    Application during pregnancy and during lactation is contraindicated.

    Dosing and Administration:

    The vaccine is given once by the skin method of scarification at a dose of 0.05 ml.

    Revaccination is carried out at a dose of 0.05 ml not earlier than 1 year after the initial vaccination to persons whose serum lacks specific complement-binding antibodies.

    In the ampoule with the vaccine, 0.5 ml of sodium chloride of the solvent for the preparation of medicinal forms for injection 0.9% is added immediately before inoculation. The vaccine should dissolve within 2 minutes to form a thick, homogeneous suspension of pink color with a grayish, yellowish or brownish hue.

    The place of grafting (the outer surface of the middle third of the shoulder) is treated with 70% alcohol or ether solution (the use of other disinfectant solutions is not allowed). After their evaporation, 2 drops of diluted vaccine are applied at a distance of 30-40 mm through an eye dropper or syringe through a needle. Sterile scarifier, through each drop of vaccine applied to the skin, three cross-shaped incisions of 8-10 mm in length are made 3-4 mm apart so that the blood appears through small "dewdrops".The flat side of the scarifier is rubbed into the incision vaccine, after which the vaccine should dry for 5-10 minutes. The subsequent processing of the site is not carried out.

    The dissolved vaccine is usable for 30 minutes when stored under a sterile tissue at room temperature and for 60 minutes when stored at a temperature of 2 to 10 ° C.

    The introduction of the drug is recorded in the prescribed registration forms with an indication of the date of administration, dose, manufacturer, serial number, response to vaccination.

    Side effects:

    The general reaction to the vaccination develops on day 2-3 in individual vaccinated and is expressed in a one-day malaise, chills, headache and an increase in temperature to 37.5 ° C.

    Local reaction, characterized by reddening and nodular swelling in course of incisions, usually develops no less than 90% vaccinated. Duration local reaction is 3-4 days.

    Overdose:

    Not installed.

    Interaction:

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

    Simultaneous inoculations with vaccines against Ku-fever and brucellosis are allowed.

    Brucellosis vaccine is administered in accordance with the instructions for use of the drug in the other hand.

    Special instructions:

    Precautions for use

    Before use, every ampoule with the vaccine is carefully scanned. It is not suitable for use in the presence of cracks in the ampoule, foreign inclusions, unusual coloring vaccine and other defects, as well as broken markings and expired shelf life.

    Special precautions for the destruction of unused medicinal product

    Unused vaccine and also rejected ampoules are opened and rendered harmless by immersion in disinfectant solutions (chloramine solution 3% or sodium hydroxide solution 3%, or hydrogen peroxide solution 6%, or Biodiesel Extra Solution 1% for 1 day) and boiling for 1 hour.

    Effect on the ability to drive transp. cf. and fur:No information.
    Form release / dosage:Lyophilizate for the preparation of a suspension for cutaneous scarification (complete with a solvent).
    Packaging:

    Liofilizate for the preparation of a suspension for cutaneous scarification application - Pabout 10 doses in the ampoule.

    Solvent - sodium chloride solvent for the preparation of dosage forms for injection 0.9% - 5 ml in the ampoule.

    5 ampoules of vaccine and 5 ampoules of solvent in a pack of cardboard box together with a scarifier ampoule and instructions for use.

    When packing ampoules with a ring of fracture or a point for opening, the ampoule scaper is not inserted.
    Storage conditions:

    Storage conditions. In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed. Keep out of the reach of children.

    Conditions of transportation. In accordance with SP 3.3.2.1248-03 at a temperature of from 2 to 8 ° C. Freezing is not allowed.

    Shelf life:

    2 years.

    The drug with expired shelf life is not subject to application.

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-002153
    Date of registration:13.12.2012 / 26.03.2015
    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: & nbsp12.01.2017
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