Composition, form of production and packaging
Liofilizate for the preparation of a slurry for s / w administration and naked scarification application in the form of a porous mass of grayish-white or yellowish-white color with a brownish hue.
1 amp.
lyophilized suspension of live vaccine strain Bacillus anthracis STI-1 100 subcutaneous or 10 dermal vaccination doses
Auxiliary substances: sucrose - 10% r-r (stabilizer).
The composition of the solvent: 30% solution of glycerol.
100 subcutaneous or 10 dermal vaccination doses - ampoules (5) complete with a solvent (1 ml amp 5 pcs.) - packs of cardboard.
Liofilizate for the preparation of a slurry for s / w administration and naked scarification application in the form of a porous mass of grayish-white or yellowish-white color with a brownish hue.
1 amp.
lyophilized suspension of live vaccine strain Bacillus anthracis STI-1 200 subcutaneous or 20 skin vaccination doses
Auxiliary substances: sucrose - 10% r-r (stabilizer).
The composition of the solvent: 30% solution of glycerol.
200 subcutaneous or 20 dermal vaccination doses - ampoules (5) complete with a solvent (1 ml amp 5 pcs.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
The anthrax vaccine alive after a double application with an interval of 20-30 days causes the formation of specific immunity lasting up to 1 year.
INDICATIONS
Specific prophylaxis of anthrax in people from 14 years of age. Vaccination is carried out in a planned manner and according to epidemic indications.
Planned vaccinations are subject to:
- persons working with live cultures of the causative agent of anthrax, with infected laboratory animals or investigating materials infected with anthrax;
- persons who slaughter cattle, engaged in harvesting, collecting, storing, transporting, processing and selling raw materials of animal origin;
- persons who perform the following works on enzootic territories in Siberia:
- maintenance of public livestock;
- agricultural, agro- and hydro-reclamation, construction and other works connected with excavation and moving of soil;
- harvesting, fishing, geological, prospecting, expeditionary.
In the planned order, vaccination is carried out in the first quarter of the year, because The most dangerous in regard to infection with anthrax in dysfunctional sites is the spring-summer season.
DOSING MODE
Vaccination is conducted by the average medical staff under the guidance of a doctor.
Scheduled vaccination. Primary immunization is carried out by scarifying method twice with an interval of 20-30 days, revaccination - once a year by subcutaneous way.
Vaccination for epidemic indications is carried out subcutaneously. If necessary, revaccination is carried out once a year by the subcutaneous route.
Before use, every ampoule with the vaccine is carefully examined. The vaccine can not be used if the ampoule's integrity is damaged, the appearance of the dry and dissolved drug changes (presence of foreign inclusions, unbreakable clots and flakes), absence of a label, expiration of the shelf life, violation of the storage regime.
1. Vaccination by the cutaneous (scarification) method.
Based on the number of vaccine doses, the contents of the ampoule (vial) immediately before use are resuspended in a solvent - a sterile 30% aqueous solution of glycerol by means of a syringe with a needle for intramuscular injection (No. 0840). In a vial (bottle) with 10 cutaneous doses, 0.5 ml is added and 20 ml doses 1.0 ml of the solvent and shaken to form a homogeneous suspension of grayish-white or yellowish-white color with a brownish hue. The dissolution time of the vaccine should not exceed 5 minutes. A diluted vaccine, preserved under aseptic conditions, can be used for 4 hours.
The inoculation is performed on the outer surface of the middle third of the shoulder. The place of inoculation is treated with 70% alcohol. The use of other disinfectant solutions is not allowed. After evaporation of alcohol with a sterile tuberculin syringe with a thin and short needle (No. 0415), without touching the skin, apply one drop (0.025 ml) of diluted vaccine to 2 places of future incisions at a distance of 3-4 cm to the horizontal surface of the shoulder. The skin is slightly pulled and a sterile ospivyvatelnym feather through each drop of the vaccine makes two parallel incisions (at a distance of 3-5 mm), 10 mm long, so that they do not bleed (the blood can act only in the form of small dewdrops). The flat side of the vaccination pen is rubbed into the incisions for 30 seconds and allowed to dry for 5-10 minutes./ For each vaccine use a separate disposable pen. It is forbidden to use needles, scalpels it. Instead of feathers. P.
2. Vaccination by subcutaneous route.
It is strictly forbidden to use a vaccine diluted for dermal application!
The drug immediately before use is resuspended in 1 ml of sterile sodium chloride solution of 0.9%. Ampoule (vial) is shaken to form a uniform suspension of grayish-white or yellowish-white color with a brownish tinge. The contents of the ampoule (vial) are transferred by sterile syringe into a sterile vial of sodium chloride with 0.9% solution for injections. In the case of using an ampoule (vial) containing 200 subcutaneous vaccination doses, the suspension is transferred to a vial of 99 ml, and containing 100 subcutaneous graft doses - into a vial with 49 ml of a solvent.
In the syringe method, a vaccine in a volume of 0.5 ml is injected subcutaneously into the region of the lower angle of the scapula. The skin at the injection site is treated with 70% alcohol. Before each selection of the vaccine, the vial is shaken. The injection site is lubricated with 5% tincture of iodine. In the needle-free method, a 0.5 ml vaccine is injected into the outer surface of the upper third of the shoulder with a needleless tectonator with a tread, with strict adherence to the instructions for their use. The site of administration of the vaccine before and after injection is treated, as in the subcutaneous route.
Unused vaccine, used disposable syringes and feathers must be inactivated by autoclaving at a temperature of (132 + 2) В° C and a pressure of 2.0 kG / m for 90 minutes.
Parts of the needleless injector in contact with the vaccine are immersed in a 6% solution of hydrogen peroxide with the addition of 0.5% detergent such as "Progress" or "Astra" for 1 hour at a temperature of at least 50 В° C. The solution is used once. Then pre-sterilization treatment of the injector is carried out:
a) rinsing under running water for 0.5 min;
b) soaking at full immersion in a washing solution at a temperature of 50 В° C for 15 minutes. Recipe 1 liter of detergent solution: 17 g perhydrol (27.5 g 33% hydrogen peroxide), 5 g detergent and 978 ml water;
c) washing in a washing solution with a ruff or a cotton-tampon swab
each item for 0.5 min;
d) rinsing under running water for 10 minutes;
e) rinsing with distilled water for 0.5 min each item;
e) Drying until the moisture disappears completely.
Sterilization of the parts of the needleless injector is carried out by autoclaving at a temperature of (132 В± 2) В° C and a pressure of 2.0 kG / m 2 for 90 minutes.
SIDE EFFECT
It can be manifested in the first day after inoculation with malaise, headache and fever to 38.5 В° C.
Reaction to administration
Vaccinations with the vaccine can be accompanied by local reactions, the intensity of which depends on the individual characteristics of the vaccinated. After 24-48 hours after epicutaneous vaccination, hyperemia, infiltration with subsequent formation of yellowish-colored crusts along the course of incisions may occur at the site of vaccine administration. After 24-48 hours after subcutaneous vaccination, soreness, hyperemia, and infre- rata with a diameter of up to 50 mm can occur at the injection site.
CONTRAINDICATIONS
- acute infectious and non-infectious diseases - vaccinations are given no earlier than 1 month after recovery (remission);
- Primary and secondary immunodefitschity. In the treatment of steroids, antimetabolites, X-ray therapy, vaccinations are given no earlier than 6 months after the end of therapy;
- malignant neoplasms and malignant diseases of the blood;
- systemic connective tissue diseases;
- common relapsing skin diseases;
- diseases of the endocrine system;
- pregnancy and lactation;
In each individual case for diseases not included in this list, vaccination is carried out only with the permission of the appropriate specialist doctor.
In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of vaccinated with mandatory thermometry.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
DRUG INTERACTION
The interval between vaccination against anthrax and the introduction of other vaccines should be at least one month, and for children's contingents - at least two months. The vaccine is sensitive to antibiotics, and therefore immunization against the use of antibiotics is not allowed.
TERMS OF RELEASE FROM PHARMACY
For treatment and preventive and sanitary facilities.
TERMS AND CONDITIONS OF STORAGE
Store in accordance with SP 3.3.2.1248-03 at a temperature of 0 to 8 В° C in a place inaccessible to children.
Shelf life in ampoules under vacuum is 4 years; in ampoules and vials without a vacuum - 3 years.
Transport in accordance with SP 3.3.2.1248-03 at a temperature of 0 to 8 В° C. Transportation is allowed for up to 20 days at a temperature of no higher than 25 В° C.
