Active substanceVaccine for the prevention of anthraxVaccine for the prevention of anthrax
Dosage form: & nbsplyophilizate for the preparation of a suspension for subcutaneous administration and cutaneous scarification application
Composition:

The anthrax alive vaccine, the lyophilizate for the preparation of the suspension for subcutaneous administration and the cutaneous scarification application, is a lyophilized live suspension of a vaccine strain Bacillus anthracis STI-1.

Stabilizer - 10% sucrose solution.

Description:The porous mass is grayish-white or yellowish-white with a brownish tinge.
Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.A.C   Vaccine for the prevention of anthrax

J.07.A.C.01   Sibiriazvenny antigen

Pharmacodynamics:

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 engaged in the slaughter of livestock, engaged in harvesting, collecting, storing, transporting, processing and selling raw materials of animal origin;

- persons performing 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, field, geological, survey, 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.

Contraindications:

1. Acute infectious and non-infectious diseases - vaccinations are given no earlier than 1 month after recovery (remission).

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

3. Malignant neoplasms and malignant blood diseases.

4. Systemic diseases of connective tissue.

5. Common recurrent skin diseases.

6. Diseases of the endocrine system.

7. Pregnancy and lactation.

In each individual case with diseases not included in this list, vaccination is carried out only by permission. 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.

Dosing and Administration:

Vaccination is conducted by the average medical staff under the guidance of a doctor.

Routine 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 subcutaneous way. 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,non-breaking lumps and flakes), the absence of a label, the expiry of the shelf life, the 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 stretched and a sterile ospreprivivatelnym pen through each drop of the vaccine make 2 parallel incisions (at a distance of 3-5 mm) in length 10 mm 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, etc. instead of feathers.

2. Subcutaneous vaccination.

Categorically It is forbidden to use a vaccine diluted for dermal administration!

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. Contents of the ampoule (vial) with a sterile syringe Transfer to a sterile vial of sodium chloride solution of 0.9% for injection. In the case of using an ampoule (vial) containing 200 subcutaneous grafting 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.

With the syringe method a 0.5 ml vaccine is injected subcutaneously into the region of the lower corner of the scapula. The skin at the injection site was treated with 70% alcohol. Before each selection of the vaccine, the vial is shaken. Place the injections with a 5% tincture of iodine.

With a needle-less method a 0.5 ml vaccine is injected into the outer surface of the upper third of the shoulder with a needleless injector with a tread, with strict adherence to the instructions for its use. The place of administration of the vaccine before and after injection is treated, as in the subcutaneous route.

The unused vaccine, used disposable syringes and feathers are subject to mandatory inactivation by autoclaving at a temperature of (132 ± 2) ° C and a pressure of 2.0 kG / m2 within 90 minutes.

Parts of the needleless injector in contact with the vaccine are immersed in 6% solution of hydrogen peroxide with 0.5% detergent type "Progress" or "Astra" for 1 hour at a temperature of not less than 50 ° C. The solution is used once. Then the 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 ° C for 15 minutes. Recipe 1 L of washing solution: 17 g of perhydrol (27.5 g of 33% hydrogen peroxide), 5 g of detergent and 978 ml of water;

c) washing in a washing solution with a ruff or a cotton-tampon swab of each object for 0.5 minutes;

d) rinsing under running water for 10 minutes;

e) rinsing with distilled water for 0.5 minutes each item;

e) Drying until the moisture disappears completely.

Sterilization of the parts of a needleless injector is carried out by autoclaving at a temperature of (132 ± 2) ° C and pressure 2.0 kG / m2 within 90 minutes.

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.

Side effects:

It can be manifested in the first day after inoculation with malaise, headache and fever to 38.5 ° C.

Interaction:Interval between vaccinesinaciaShe should be treated with at least one month against the anthrax and with the introduction of other vaccines, and at least two months for children's contingents.
The vaccine is sensitive to antibiotics, and therefore immunization against the background of the use of antibiotics is not allowed.
Form release / dosage:Lyophilizate for the preparation of a suspension for subcutaneous administration and cutaneous scarification application.
Packaging:

200 subcutaneous or 20 dermal vaccination doses in an ampoule (vial) (solvent - 30% glycerol solution at 1.5 ml in an ampoule) or 100 subcutaneous or 10 dermal vaccination doses in an ampoule (vial) (solvent - 30% glycerol solution of 1.0 ml in the ampoule).

The package contains 5 ampoules (bottles) of vaccine and 5 ampoules of the solvent, 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. Transportation is allowed for up to 20 days at a temperature of no higher than 25 ° C.

Shelf life:In ampoules under vacuum - 4 years; in ampoules and vials without a vacuum - 3 years.
The drug with expired shelf life is not subject to application.
Terms of leave from pharmacies:For hospitals
Registration number:P N001273 / 01
Date of registration:01.07.2008 / 02.09.2014
Expiration Date:Unlimited
The owner of the registration certificate:48 CSRI MINISTRY OF THE RUSSIAN FEDERATION 48 CSRI MINISTRY OF THE RUSSIAN FEDERATION Russia
Manufacturer: & nbsp
Information update date: & nbsp13.01.2017
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