Active substanceVaccine for the prevention of tularemiaVaccine for the prevention of tularemia
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  • Tularemia live vaccine
    lyophilizate in / skin cutaneous 
  • Dosage form: & nbsplyophilizate for the preparation of a suspension for intradermal administration and skin scarification application
    Composition:

    The preparation is a lyophilized culture of live microbes of the tularemia vaccine strain Francisella tularensis 15 NIIEG.

    One dose for the cutaneous scarification application is 0.1 ml and contains (2.0 ± 0.5) x 108 live microbial cells, the dose for intradermal administration is 0.1 ml and contains (1.0 ± 0.1) x 107 living microbial cells.

    Excipients (based on 1 skin dose): sucrose 0.0033 g, sodium glutamate monohydrate 0.00495 g, thiourea 0.00165, gelatin 0.0033 g.

    Available complete with a solvent - water for injections.

    Description:

    It has the appearance of a porous mass of white with a yellow shade of color.

    Pharmacotherapeutic group:MIBP vaccine
    ATX: & nbsp
  • Other vaccines for the prevention of bacterial infections
  • Pharmacodynamics:

    The vaccine, after 20-30 days after vaccination, ensures the development of immunity lasting up to 5 years.

    Pharmacokinetics:

    No information.

    Indications:

    Prevention of tularemia from 7 years of age (from 14 years - in the outbreaks of field type).

    Vaccination is subject to the population residing in the enzootic tularemia territories, as well as those arriving on these territories who perform the following works: agricultural, irrigation and drainage, construction, other works for excavating and moving soil, harvesting, fishing, geological, survey, expedition, deratization and disinsection , logging, clearing and improvement of the forest, recreation and recreation areas of the population.

    Contraindications:

    - Postponed tularemia in the anamnesis. Positive serological or skin-allergic reaction to tularemia;

    - acute infectious and non-infectious diseases, chronic diseases at the stage of exacerbation - vaccinations are given no earlier than 1 month after recovery (remission);

    - Primary and secondary immunodeficiencies. In the treatment of steroids, antimetabolites, chemo- and X-ray therapy, vaccinations are given no earlier than 6 months after the end of treatment;

    - systemic connective tissue diseases;

    - malignant neoplasms and malignant diseases of the blood;

    - common relapsing skin diseases;

    - allergic diseases (bronchial asthma, anaphylactic shock, Quincke's edema in the anamnesis);

    - pregnancy and lactation.

    Carefully:There is no information.
    Pregnancy and lactation:

    The use of the drug is contraindicated.

    Dosing and Administration:

    Vaccination is carried out once dermally or intradermally. Revaccination is carried out according to the indications after 5 years with the same dose.

    In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccine with mandatory thermometry. At a temperature above 37 ° C, the graft is delayed. If necessary, conduct a laboratory examination.

    Before each vaccination, the vaccinee is required to determine the presence of specific immunity with the help of one of the serological or skin-allergic reactions. Inoculations are subject to negative reaction.

    The vaccine is recorded in the prescribed registration forms with the name of the drug, the date of vaccination, the dose, the name of the manufacturer, the serial number, the reaction to the vaccination.

    Skin Vaccination:

    Dry vaccine is diluted with water for injection, which is drug, at a rate of 0.1 ml per dose. The ampoule is shaken for 3 minutes until a homogeneous suspension is formed.

    The inoculation is carried out on the outer surface of the middle third of the shoulder. The skin before inoculation is treated with alcohol or a mixture of alcohol with ether, the use of other disinfectants is not allowed. After evaporation of the alcohol with ether, one drop of the diluted vaccine is applied to the treated area of ​​the skin with a sterile eyedropper in two places at a distance of 30-40 mm from each other. The skin of the shoulder is slightly stretched and a pair of parallel incisions of 10 mm in length are made through each drop of the vaccine, using a sterile scarifier (ospothrivial pen).

    The serrations should not bleed, the blood should act only in the form of small dewdrops. The flat side of the ospothrivial pen, the vaccine is rubbed into the notches for 30 seconds and allowed to dry for 5-10 minutes.

    Intradermal vaccination:

    For intradermal needle-free administration, the vaccine is diluted in the same way as for cutaneous scarification application. Then, with a sterile syringe, 1 ml is transferred to a sterile injection bottle, to which 19 ml of sodium chloride solution for injection is added 0.9%. 20 ml of the obtained suspension contains 200 dosesvaccines for intradermal administration. The injection site of the vaccine is pretreated with alcohol or a mixture of alcohol and ether. The vaccine is injected intradermally in a volume of 0.1 ml into the outer surface of the middle third of the arm according to the instructions for the use of the BI-3M injector with the anti-infectious protector PPI-2 under the regime intended for intradermal administration.

    Precautions for use

    It is strictly prohibited to inject the vaccine diluted for cutaneous scarifying application intradermally!

    It is not possible to use a vaccine whose package integrity is damaged, with changed physical properties (foreign impurities, insoluble flakes), expired, if storage conditions are violated.

    Opening of ampoules and the procedure for administering the drug are carried out with strict adherence to aseptic and antiseptic rules. A diluted vaccine, preserved with aseptic rules, can be used for 2 hours.

    Given the possibility of developing an anaphylactic shock, in some highly sensitive individuals, the vaccinated should be under medical supervision for at least 30 minutes.Vaccination sites should be provided with anti-shock therapy.

    Side effects:

    Local reaction in case of skin grafting should develop in all vaccinated. On the spot incisions from 4-5 days, and in some vaccinated - at a later date (up to 10 days) - develops hyperemia and edema with a diameter of up to 15 mm. In the course of incisions, vesicles as large as millet grains may appear. From 10-15 days on a place of an inoculation the crust is formed, local phenomena subsided, after branch of a crust on a skin, remains a hem.

    Sometimes there may be a slight short-term increase and soreness of the regional lymph nodes.

    With a negative result along the incisions, only a small red within 1-2 days is noted.

    With the intradermal route of administration, a local reaction of up to 9 days is characterized by mild hyperemia and skin infiltration up to 40 mm in diameter, rarely by regional lymph nodes.

    The general reaction occurs in isolated cases from 3-4 days and is expressed by malaise, headache, rarely - a short-term rise in temperature to 38 ° C. These phenomena disappear after 2-3 days.It is extremely rare in vaccinated in the third to fourth week after vaccination, there are general and local reactions of an allergic nature.

    In individuals who have previously suffered from tularemia or revaccinated, the general and local reactions to vaccination develop more rapidly. The extinction of grafting reactions in this case is faster than in those who were vaccinated initially.

    Vaccination of the vaccine with cutaneous scarification application is checked after 5-7 days, and in case of absence of skin reaction - repeatedly for 12-15 days.

    Evaluation of results of intradermal vaccination are carried out 4-5 days after vaccination. A positive reaction is the presence of hyperemia and infiltration with a diameter of at least 5 mm. Persons with a lack of a positive vaccination result are subject to re-vaccination 30 days after the determination of the presence of specific immunity.

    Overdose:

    Not installed.

    Interaction:

    Simultaneous dermal vaccination of adults with live vaccines against tularemia, brucellosis and plague (in different parts of the body) is allowed.

    Special instructions:

    Special precautions for the destruction of unused medicinal product

    Ampules with unused vaccine are inactivated by boiling for 30 minutes, then they are disposed of in accordance with SanPiN 2.1.7.728-99 "Rules for Collection, Storage and Disposal of Waste, Treatment and Prevention Facilities."

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

    No information.

    Form release / dosage:Lyophilizate for the preparation of a suspension for intradermal administration and cutaneous scarification
    Packaging:

    For 15-50 cutaneous doses in the ampoule.

    Water for injection - 5 ml in an ampoule.

    Issued in the kit. The kit consists of 1 ampoule of vaccine and 1 ampoule of water for injection. For 5 sets in a pack together with instructions for use and a knife ampoule or scarifier ampoule. When packaging ampoules with a ring or opening point, the ampoule opener or ampoule scapegrator is not inserted.

    Storage conditions:

    In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children.

    Transportation conditions

    In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:For hospitals
    Registration number:P N002348 / 01
    Date of registration:20.05.2009 / 01.02.2012
    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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