Composition, form of production and packaging
Liofilizate for the preparation of a suspension for injections, cutaneous scarifying application and inhalations in the form of a porous mass of grayish-white color.
1 dose (0.5 ml)
lyophilized live culture of the vaccine strain of the plague microbe Yersinia pestis EV line NIIEG 80-430 subcutaneous doses for adults
Excipients: sucrose, gelatin, thiourea.
80-430 subcutaneous doses for adults - ampoules of 2 ml (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
The vaccine causes the development of immunity to the plague lasting up to one year.
Prevention of plague.
Inoculations are subject to:
- children from 2 years old and adults living in enzootic plague territories;
- persons working with live cultures of the causative agent of the plague.
Vaccination is performed once by subcutaneous, dermal, intradermal or inhalation methods. Revaccination is performed by the cutaneous method in one year, in case of an unfavorable epidemic situation, after 6 months.
Vaccination by dermal, subcutaneous and intradermal methods.
Before opening, each ampoule is scanned. Do not use the drug whose package integrity is damaged, with altered physical properties (foreign impurities, insoluble flakes), expired, if the storage regime is violated.
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 of vaccine The dose of vaccine (the number of living microbial cells) for the introduction of a ...
intradermal subcutaneous cutaneous inhalation
14-60 years 1 1 dose - 300 million live microbial cells (lm.k.) in 0.1 ml 1 dose - 300 million zm.k. in 0.5 ml of 1 dose - 3 billion zm.k. in 0.15 ml (3 drops) 1 dose -5 billion zm.k. in 0.15 ml
Over 60 years old 1/3 of the dose is 100 million zЕ‚.k. in 0.1 ml Do not inoculate 1 dose - 3 billion zm.k. in 0.15 ml (3 drops) Do not inoculate
10-13 years 1/2 doses -150 million zЕ‚.k. in 0.1 ml Do not inoculate 1 dose - 3 billion zm.k. in 0.15 ml (3 drops) Do not inoculate
7-9 years old 1/3 of the dose -100 million zЕ‚.k. in 0.1 ml Not grafted 2/3 of the dose - 2 billion zm.k. in 0.1 ml (2 drops) Do not inoculate
2-6 years 1/3 of the dose -100 million zm.k. in 0.1 ml Do not inoculate 1/3 of the dose - 1 billion zm.k. in 0.05 ml (1 drop) Not inoculated
NOTE 1 - women who are breast-feeding are vaccinated only with dermatitis
Vaccination is carried out on the outer surface of the middle third of the shoulder in the following way: the adult osprivivivatelnym pen slightly scrape (before reddening) the surface layer of the epidermis in 3 areas of skin, previously treated with 70 "ethyl alcohol.The distance between sites is from 3 to 4 cm , the area of вЂ‹вЂ‹the area from 1 to 1.5 cm 2. When vaccinating children, the epidermis is scraped off on 1 or 2 skin areas.
For each area of вЂ‹вЂ‹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.
The 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 В° 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.
The number of doses and the 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 outer surface of the left arm arm after treatment of the skin with 70 В° ethanol using a needleless injector BI-3M with a protector of anti-infective PPI-2 or a 1 ml syringe with a thin needle with a short cut .
Vaccination is carried out in special rooms of stationary or temporary type with volume from 50 to 150 m 3 , height from 2.5 to 4.5 m (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 room volume (0.1 ml per 1 m 3 of room) is 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 В± 3) Г—10 6 live microbial cells.
The number of people immunized in one session is calculated from 1.4 to 2 m 3 per 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.
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 В° C.
After subcutaneous and intradermal inoculations, local reactions may occur in the form of hyperemia, pain, infiltration up to 50 mm in diameter, and 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 В° C, in one percent vaccinated to (38.0-39.0) В° 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 В° C, and very rarely up to 40 В° 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 В° C) and strong (increase in body temperature above 38.5 В° 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.
- 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 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 (with cutaneous immunization);
- chronic respiratory diseases (with inhalation immunization);
- allergic diseases (bronchial asthma, anaphylactic shock, Quincke's edema in the anamnesis);
- pregnancy and lactation.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR CHILDREN
Children from 2 years old are subject to the vaccination.
It is not allowed to administer the 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.
TERMS OF RELEASE FROM PHARMACY
For treatment and preventive and sanitary facilities.
TERMS AND CONDITIONS OF STORAGE
Store in accordance with SP 126.96.36.1998-03 at a temperature of 0 to 8 В° C in a place inaccessible to children. Shelf life - 3 years.
Transport in accordance with SP 188.8.131.528-03 at a temperature of 0 to 8 В° C.