Clinical and pharmacological group: & nbsp

Vaccines, serums, phages and toxoids

Included in the formulation
  • Vaccine plague alive
    lyophilizate d / inhal. for injections cutaneous 
  • Vaccine plague alive
    lyophilizate d / inhal. for injections cutaneous 
  • Vaccine plague alive
    pills inwards 
  • АТХ:

    J.07.A.K.01   Plague bacteria whole inactivated

    J.07.A.K   Vaccine for the prevention of plague

    Pharmacodynamics:

    The vaccine causes the development of immunity to the plague lasting up to one year.

    Pharmacokinetics:

    No data.

    Indications:

    Prevention of plague.

    Vaccinations are subject to children from 2 years old and adults living in enzootic in the plague areas, as well as persons working with live cultures of the causative agent of the plague.

    XXI.Z20-Z29.Z23.3   The need for immunization against plague

    Contraindications:

    - 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. When treating with steroid drugs, antimetabolites, chemo- and roentgenotherapy - 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 (with cutaneous immunization);

    - chronic respiratory diseases (with inhalation immunization);

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

    - pregnancy and lactation.

    Carefully:

    No data.

    Pregnancy and lactation:

    Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Vaccination is performed once by subcutaneous, dermal, intradermal or inhalation methods. Revaccination is performed by the dermal method in one year, with an unfavorable epidemic situation - after 6 months.

    Vaccination by dermal, subcutaneous and intradermal methods.

    Before opening, each ampoule is scanned. The drug whose package integrity is damaged, with altered physical properties (impurities, non-dissolving flakes), with expired shelf life, if the storage regime is violated, is not to be used.

    Opening of ampoules and the procedure for administering the drug are carried out with strict adherence to aseptic and antiseptic rules.The diluted vaccine, preserved with observance of the rules of asepsis, can be used within 2 hours. Transfer of the opened ampoule from one room to another is not allowed. The unused vaccine is destroyed by boiling for 30 minutes.

    Immediately before immunization, the vaccine is diluted with 1.8 ml of 0.9% sodium chloride solution for injection. The drug should completely dissolve within 3 minutes. Ampules with the vaccine are shaken. The dissolved vaccine is a homogeneous suspension without foreign impurities and flakes. The resulting slurry is taken with a sterile syringe from the ampoule and transferred to a sterile vial containing 0.9% sodium chloride solution for injection in a volume corresponding to that indicated on the label of the box for the appropriate route of administration. This takes into account the volume of 0.9% sodium chloride solution used to prepare the initial dilution.

    Dummy method:

    Vaccination is carried out on the outer surface of the middle third of the shoulder as follows: the adult ospivprivivatelnym pen slightly scrape (before reddening) the surface layer of the epidermis in three areas of skin, previously treated with 70% ethyl alcohol.The distance between the sites is from 3 to 4 cm, the area of ​​the site is from 1 to 1.5 cm2. When vaccinating children, the epidermis is scraped off on one or two skin areas.

    For each area of ​​the scarified skin, 1 drop of vaccine is pipetted by pipetting, then 4 horizontal and 4 vertical linear incisions of 1 cm are applied crosswise through each drop of the vaccine using a dropwise vaccine. Then the vaccine drops are carefully rubbed into scarified skin for several seconds and given dry for 5 minutes. The incisions should be shallow so that they do not bleed (the blood can only act as small dewdrops). For each vaccine use a single disposable ospovyvivatelnoe feather. It is forbidden to use needles, scalpels and the like instead of feathers.

    Subcutaneous route:

    It is strictly forbidden to use a vaccine diluted for dermal application.

    The skin at the injection site is pre-treated with 70% ethyl alcohol. The vaccine is injected with a syringe below the angle of the scapula or a needleless injector with an anti-infectious protector in the upper third of the shoulder behind the deltoid muscle.

    Intradermal route:

    The number of doses and volume of the solvent for adolescents from 14 years and adults to 60 years are indicated on the box label. For vaccination of children aged 10-13 years, the volume of the solvent at the second dilution is doubled, for vaccination of children aged 2 to 9 years and adults over 60 years, the volume of the solvent is tripled. The vaccine for adults and children is administered in the volume of 0.1 ml intradermally to the area of ​​the outer surface of the left arm arm after treatment of the skin with 70% ethyl alcohol using a needleless injector with anti-infectious protector or a 1 ml syringe with a thin needle with a short cut.

    Vaccination by inhalation:

    Vaccination is carried out in special rooms of stationary or temporary type in volume from 50 to 150 m3, a height of 2.5 to 4.5 m (the ratio of length and width is not more than 2: 1). These rooms should be adapted for quick ventilation, and stationary inhalation should be equipped with exhaust ventilation.

    The vaccine is diluted with 2 ml of a sterile 10% lactose solution. The ampoule is shaken until a homogeneous suspension is obtained. If any foreign matter is detected, uneven suspension is prohibited.The resulting slurry is transferred to a sterile vial with the volume of 10% lactose solution required for further dilution (as indicated on the box). This takes into account the volume of the 10% lactose solution used to prepare the initial dilution. The temperature of the 10% lactose solution should correspond to the temperature at which the dry preparation was stored prior to dilution.

    The resulting microbial suspension in an amount determined by the volume of the room (0.1 ml per 1 m3 room), poured into the reservoir of the nebulizer. Spraying is carried out by means of a pneumatic atomizer of injection type. The diffuser is installed vertically, with a nozzle upwards, in the center of the room at a height of 80-120 cm from the floor. Spraying is carried out with compressed air at a pressure of 1.2 atmospheres until the suspension is completely consumed in the reservoir. Compressed air is supplied to the nebulizer until the end of the immunization session. The duration of the immunization session is 5 minutes. One man-dose for inhalation application is (5 ± 3) × 106 living microbial cells.

    The number of people immunized in one session is calculated from 1.4 to 2 m3 premises for one person.

    After each immunization session, the inhalation is ventilated for at least 5 minutes. When carrying out immunization in the tent after each session, fold back the curtains for at least 5 minutes. The personnel carrying out the vaccination, if necessary, entering the inhalation during the session and the first 5 minutes after the end, should be dressed in special clothes (underwear, socks, cotton jumpsuits, gas mask, slippers).

    Vaccinations carried out in different ways are registered in established registration forms with the name of the preparation, manufacturer, vaccination date, dose, mode of administration, serial number, expiration date, response to vaccination.

    Side effects:

    Inoculations of the plague live vaccine may be accompanied by both general and local reactions, the intensity of which depends on the method of vaccination.

    Cumulative grafting can be accompanied by a small vesicular rash along the incisions, sometimes an infiltrate appears in the skin at the site of the graft. Regional lymphadenitis is less common. These symptoms begin to appear 8-10 hours after inoculation, reach full development in 23-30 hours.The general reaction occurs on the first day and is expressed by an increase in temperature to 37.5 ° C.

    After subcutaneous and intradermal inoculations, local reactions can occur in the form of hyperemia, pain, infiltration up to 50 mm in diameter, less often - an increase in regional lymph nodes. Local reactions occur in 6-10 hours, reach full development in 24-48 hours and disappear after 4-5 days. The general reaction is expressed in malaise, headache, an increase in temperature to 37.5 ° C, in one percent of the vaccinated to 38.0-39.0 ° C for up to 3 days. Sometimes there is nausea and vomiting.

    After inhalation, a small number of vaccinated people may experience malaise, headache, muscle pain, a fever of 38.5 ° C, and very rarely up to 40 ° C. The reaction duration is 1-3 days. By the time of occurrence, there are two types of reaction: early, developing in the first two days and characteristic for the re-grafted; late, appearing on the 5th-7th day, and more common in the initially vaccinated.

    Overdose:

    No data.

    Interaction:

    It is not allowed to administer a plague live vaccine combined with the use of antibiotics streptomycin,tetracycline and sulfanilamides in therapeutic doses simultaneously and earlier than 14 days after immunization.

    Simultaneous dermal vaccination of adults against plague, brucellosis and tularemia is possible in different parts of the outer surface of the upper third of the shoulder.

    Special instructions:

    Before a mass application, each series of vaccine should be tested on a group of people of 50-100 people, equivalent in age and health condition to the main contingent of vaccinated people. The vaccine can be used for mass vaccination if the number of medium (increase in body temperature to 37.6-38.5 ° C) and strong (increase in body temperature above 38.5 ° C) reactions for its administration does not exceed respectively 29% and 5 % with the subcutaneous route of administration, 1% of the median reactions with dermal administration and 6% of the mean or 4% of the strong reactions for the inhalation method of administration.

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