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

Vaccine anthrax combined, lyophilizate for The preparation of a suspension for subcutaneous administration is a mixture of live spores of a vaccine strain Bacillus anthracis STI-1 (500 million spores in the ampoule) and purified concentrated protective anthrax antigen (350 IDs50 for white mice in an ampoule) adsorbed on an aluminum hydroxide gel (not more than 25 mg in an ampoule), stabilizer: sucrose (0.2 g in an ampoule).

Description:The porous mass is grayish white in color.
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 combined provides the formation of specific immunity 7 days after the vaccination 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 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, fishing, geological, prospecting, expeditionary.

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 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.

Dosing and Administration:

Vaccination is conducted by the average medical staff under the guidance of a doctor. Primary immunization is carried out once per subcutaneously with syringe or needle-free methods.

Revaccination is carried out once. The first three revaccinations are performed annually. All subsequent revaccinations are carried out once every two years.

Before use, every ampoule with the vaccine is carefully examined. The vaccine can not be used if the integrity of the ampoule is damaged, the appearance of the preparation changes (foreign particles, unraveled lumps and flakes), the absence of a label, the expiration date. The ampoule with the vaccine is wiped 70% alcohol, saw the neck of the ampoule, cover with a sterile swab, break off the filed end of the ampoule.Using a sterile syringe with a needle in the ampoule, add 5.0 ml of the solvent - sterile sodium chloride solution 0.9% and shaken to form a homogeneous suspension of grayish-white color. The time of expansion of the vaccine should not exceed 5 minutes. Dissolved vaccine, preserved in aseptic conditions, can be used for 4 hours.

1. Vaccination with a syringe method. A 0.5 ml vaccine is injected subcutaneously into the area of ​​the lower corner of the left scapula using a disposable syringe. The skin at the injection site is treated with 70% alcohol. Before each selection of the vaccine, the ampoule is shaken. The injection site is treated with 5% tincture of iodine.

2. Vaccination without a needle. The vaccine in a volume of 0.5 ml is injected subcutaneously into the outer surface of the upper third of the shoulder with a needleless injector with a protector, while strictly observing the instructions for its use. The place of administration of the vaccine before and after injection is treated as with a syringe method of vaccination.

The unused vaccine, used disposable syringes and needles must be inactivated 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 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 ° 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 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 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 a pressure of 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 vaccination at the injection site, soreness, hyperemia,less often - infiltration with a diameter of up to 50 mm.

Side effects:

It can be manifested in the first day after vaccination with malaise, headache and an increase in body temperature to 38.5 ° C.

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.

Form release / dosage:Lyophilizate for the preparation of a suspension for subcutaneous administration.
Packaging:

For 10 doses in the ampoule, the solvent - sodium chloride solution 0.9% - 6 ml in the ampoule.

The package contains 5 ampoules of vaccine, 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, out of reach of 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-009268/08
Date of registration:21.11.2008 /05.11.2014
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
Illustrated instructions
    Instructions
    Up