Active substanceVaccine for the prevention of plagueVaccine for the prevention of plague
Dosage form: & nbsplyophilizate for the preparation of a suspension for injection, cutaneous scarification and inhalation
Composition:

Vaccine plague alive, lyophilizate for the preparation of a suspension for injections, cutaneous scarification and inhalation, is a lyophilized live culture of a vaccine strain of a plague germ Yersinia pestis EV line NIIEG; stabilizers: sucrose, gelatin, thiourea.

Description:

The porous mass is grayish white in color.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

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.

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.

Contraindications:

Acute infectious and non-infectious diseases, chronic diseases in the acute stage - vaccinations are given no earlier than 1 month after recovery (remission).

Primary and secondary immunodeficiencies. When treating with steroid drugs, antimetabolites, chemotherapy and X-ray therapy - vaccinations are given no earlier than 6 months after the end of treatment.

Systemic diseases of connective tissue.

Malignant neoplasms and malignant blood diseases.

Common recurrent skin diseases (with cutaneous immunization).

Chronic diseases of the respiratory system (with inhalation immunization).

Allergic diseases (bronchial asthma, anaphylactic shock, Quincke's edema in the anamnesis).

Pregnancy and lactation.

Dosing and Administration:

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

Vaccination with dermal, subcutaneous and intradermal routes

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.

Depending on the age of the vaccine and the mode of administration, the following doses of the vaccine are used.

DOSES FOR VACCINATION

Age vaccinated

The dose of vaccine (the number of living microbial cells) for the introduction of a ...

intracutaneous

subcutaneous

dermal

inhalation

14-60

years1)

1 dose - 300 million live microbial cells (lm.k.) in 0.1 ml

1 dose - 300 million zł.k. in 0.5 ml

1 dose - 3 billion zm.k. in 0.15 ml (3 drops)

1 dose - 5 billion zm.k. in 0.15 ml

Older than 60 years

1/3 of the dose - 100 million zm.k. in 0.1 ml

Do not vaccinate

1 dose - 3 billion zm.k. at

0.15 ml (3 drops)

Do not vaccinate

10-13

years

1/2 doses - 150 million zm.k. in 0.1 ml

Do not vaccinate

1 dose - 3 billion zm.k. in 0.15 ml (3 drops)

Do not vaccinate

7-9 years

1/3 of the dose, 100 million zm.k. in 0.1 ml

Do not vaccinate

2/3 of the dose - 2 billion zm.k. in 0.1 ml (2 drops)

Do not vaccinate

2-6 years

1/3 of the dose - 100 million zm.k. in 0.1 ml

Do not vaccinate

1/3 of the dose - 1 billion zm.k. in 0.05 ml (1 drop)

Do not vaccinate

Note. 1) - women who are breastfeeding are vaccinated only with the skin

Nesting method

Vaccination is carried out on the outer surface of the middle third of the shoulder as follows: the adult osprivivivatelnym pen slightly scrape (before reddening) the surface layer of the epidermis in 3 areas of skin, pre-treated 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 1 or 2 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, etc. instead of feathers.

Subcutaneous mode

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 with the needleless injector BI-3M with the anti-infectious protector PPI-2 in the upper third of the arm behind the deltoid muscle.

Intradermal route

The number of doses and volume of the solvent for adolescents from 14 years of age and adults to 60 years of age 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 is administered to adults and children in the volume of 0.1 ml intradermally to the external surface area of ​​the left arm arm after treatment of the skin with 70 ° ethyl alcohol with a needleless injector BI-3M with an anti-infective PPI-2 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, height from 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 using a pneumatic spray gun of ejection 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 atm until the suspension is completely consumed in the tank. 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 overalls, 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.

Reaction to administration

After the cutaneous vaccination, after 24-48 hours at the injection site, hyperemia and infiltration can occur, followed by the formation of brownish crusts in the course of incisions.

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 Inoculation may be accompanied by a small vesicular rash along the incisions, sometimes an infiltrate appears in the skin at the site of the inoculation. 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, soreness, infiltration with a diameter of up to 50 mm, less often - an increase in regional lymph nodes. Local reactions occur after 6-10 hours, reach full development in 24-48 hours and disappear after 4-5 days. The general reaction is expressed in malaise, headache, fever, up to 37.5 ° C, in one percent vaccinated to (38.0-39.0) ° C, 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 duration of the reaction 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 for 5-7 days, and more common in the initially vaccinated.

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.

Interaction:

It is not allowed to administer a plague live vaccine combined with the use of antibiotics of 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.

Form release / dosage:Lyophilizate for the preparation of a suspension for injection, cutaneous scarification and inhalation.
Packaging:

In ampoules of 2 ml (80 to 430 subcutaneous doses for adults).

The package contains 10 ampoules, instructions for use and an ampoule knife.

Storage conditions:

Store in accordance with SP 3.3.2.1248-03 at a temperature of 0 to 8 ° C in a place inaccessible to children.

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 0 to 8 ° C.

Shelf life:3 years.
The drug with expired shelf life is not subject to application.
Terms of leave from pharmacies:For hospitals
Registration number:LSR-005759/08
Date of registration:22.07.2008 / 19.08.2013
Expiration Date:Unlimited
The owner of the registration certificate:Stavropol Scientific Research Anti-Plague Institute, FGUZ Stavropol Scientific Research Anti-Plague Institute, FGUZ Russia
Manufacturer: & nbsp
Information update date: & nbsp13.01.2017
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