Anthrax live vaccine (Lyophilisate) Instructions for Use

Marketing Authorization Holder

48 TsNII of the Ministry of Defense of Russia FSU (Russia)

ATC Code

J07AC01 (Anthrax antigen)

Dosage Forms

	Anthrax live vaccine	Lyophilisate for preparation of suspension for subcutaneous administration and cutaneous scarification application 100 subcutaneous or 10 cutaneous doses: 5 amp. in a kit with solvent
		Lyophilisate for preparation of suspension for subcutaneous administration and cutaneous scarification application 200 subcutaneous or 20 cutaneous doses: 5 amp. in a kit with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of suspension for subcutaneous administration and cutaneous scarification application in the form of a porous mass of grayish-white or yellowish-white color with a brownish tint.

Excipients: sucrose – 10% solution (stabilizer).

Solvent composition: 30% glycerol solution.

100 subcutaneous or 10 cutaneous immunization doses – ampoules (5) in a kit with solvent (1 ml amp. 5 pcs.) – cardboard packs.

Lyophilisate for preparation of suspension for subcutaneous administration and cutaneous scarification application in the form of a porous mass of grayish-white or yellowish-white color with a brownish tint.

Excipients: sucrose – 10% solution (stabilizer).

Solvent composition: 30% glycerol solution.

200 subcutaneous or 20 cutaneous immunization doses – ampoules (5) in a kit with solvent (1 ml amp. 5 pcs.) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of anthrax

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Anthrax live vaccine after double application with an interval of 20-30 days causes the formation of specific immunity lasting up to 1 year.

Indications

Specific prevention of anthrax in humans from 14 years of age. Vaccination is carried out routinely and for epidemiological indications.

The following are subject to routine vaccination

• Persons working with live cultures of the anthrax pathogen, with infected laboratory animals, or conducting research on materials infected with the anthrax pathogen;
• Persons engaged in animal slaughter, procurement, collection, storage, transportation, processing, and sale of raw materials of animal origin;
• Persons performing the following work in territories enzootic for anthrax
• Servicing public livestock;
• Agricultural, agro- and hydro-reclamation, construction, and other work related to excavation and movement of soil;
• Procurement, hunting, geological, survey, expeditionary work.

Routine vaccination is carried out in the first quarter of the year, as the spring-summer season is the most dangerous for anthrax infection in disadvantaged areas.

ICD codes

Dosage Regimen

Vaccination is performed by paramedical personnel under the guidance of a physician.

Routine vaccination. Primary immunization is carried out by the scarification method twice with an interval of 20-30 days, revaccination – once a year by the subcutaneous method.

Vaccination for epidemiological indications is carried out by the subcutaneous method. If necessary, revaccination is carried out once a year by the subcutaneous method.

Before use, each ampoule with the vaccine is carefully inspected. The vaccine must not be used if the integrity of the ampoule is damaged, if the appearance of the dry and dissolved preparation is changed (presence of foreign inclusions, non-dispersible lumps and flakes), if the label is missing, if the expiration date has passed, or if the storage conditions have been violated.

1. Vaccination by the cutaneous (scarification) method.

Depending on the number of immunization doses, the contents of the ampoule (vial) are resuspended in the solvent – sterile 30% aqueous glycerol solution – immediately before use using a syringe with a needle for intramuscular injection (No. 0840). 0.5 ml of solvent is added to an ampoule (vial) with 10 cutaneous doses, and 1.0 ml to an ampoule with 20 cutaneous doses, and shaken until a homogeneous suspension of grayish-white or yellowish-white color with a brownish tint is formed. The dissolution time of the vaccine should not exceed 5 minutes. The diluted vaccine, stored under aseptic conditions, can be used within 4 hours.

The vaccination is performed on the outer surface of the middle third of the upper arm. The vaccination site is treated with 70% alcohol. The use of other disinfectant solutions is not allowed. After the alcohol has evaporated, using a sterile tuberculin syringe with a thin and short needle (No. 0415), without touching the skin, one drop (0.025 ml) of the diluted vaccine is applied to 2 sites of future scratches, 3-4 cm apart, on the horizontally positioned surface of the upper arm. The skin is slightly stretched and with a sterile vaccinostyle, through each drop of vaccine, two parallel scratches (3-5 mm apart) 10 mm long are made so that they do not bleed (blood may appear only in the form of small dewdrops). Using the flat side of the vaccinostyle, the vaccine is rubbed into the scratches for 30 seconds and allowed to dry for 5-10 minutes. A separate disposable vaccinostyle is used for each vaccinee. It is prohibited to use needles, scalpels, etc., instead of vaccinostyles.

2. Vaccination by the subcutaneous method.

It is strictly forbidden to use the vaccine diluted for cutaneous application!

The drug is resuspended immediately before use in 1 ml of sterile 0.9% sodium chloride solution. The ampoule (vial) is shaken until a uniform suspension of grayish-white or yellowish-white color with a brownish tint is formed. The contents of the ampoule (vial) are transferred with a sterile syringe into a sterile vial with 0.9% sodium chloride injection solution. When using an ampoule (vial) containing 200 subcutaneous immunization doses, the suspension is transferred into a vial with 99 ml, and when containing 100 subcutaneous immunization doses – into a vial with 49 ml of solvent.

With the syringe method, the vaccine in a volume of 0.5 ml is injected subcutaneously into the area of the lower angle of the scapula. The skin at the injection site is treated with 70% alcohol. The vial is shaken before each withdrawal of the vaccine. The injection site is lubricated with 5% iodine tincture. With the needle-free method, the vaccine in a volume of 0.5 ml is injected into the area of the outer surface of the upper third of the upper arm using a needle-free injector with a protector, strictly following the instructions for their use. The vaccine administration site before and after injection is treated as with the subcutaneous method.

Unused vaccine, used disposable immunization syringes and vaccinostyles are subject to mandatory inactivation by autoclaving at a temperature of (132+2)°C and a pressure of 2.0 kgf/m² for 90 minutes.

Parts of the needle-free injector that came into contact with the vaccine are immersed in a 6% hydrogen peroxide solution with the addition of 0.5% detergent such as “Progress” or “Astra” for 1 hour at a temperature not lower than 50°C (122°F). The solution is used once. Then pre-sterilization treatment of the injector is carried out.

A) rinsing under running water for 0.5 minutes;

B) soaking with complete immersion in a washing solution at a temperature of 50°C (122°F) for 15 minutes. Formulation of 1 liter 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 the washing solution using a brush or cotton-gauze swab for each item for 0.5 minutes;

D) rinsing under running water for 10 minutes;

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

F) drying until moisture completely disappears.

Sterilization of the parts of the needle-free injector is carried out by autoclaving at a temperature of (132±2)°C and a pressure of 2.0 kgf/m² for 90 minutes.

Adverse Reactions

May manifest in the first days after vaccination with malaise, headache and an increase in body temperature up to 38.5°C (101.3°F).

Reaction to administration

Vaccinations with the vaccine may be accompanied by local reactions, the intensity of which depends on the individual characteristics of the vaccinees. 24-48 hours after cutaneous vaccination, hyperemia and infiltration may occur at the site of vaccine administration, followed by the formation of yellowish crusts along the scratches. 24-48 hours after subcutaneous vaccination, pain, hyperemia, and less commonly, infiltration up to 50 mm in diameter may occur at the injection site.

Contraindications

• Acute infectious and non-infectious diseases — vaccinations are carried out no earlier than 1 month after recovery (remission);
• Primary and secondary immunodeficiencies. When treating with steroids, antimetabolites, radiotherapy, vaccinations are carried out no earlier than 6 months after the end of therapy;
• Malignant neoplasms and malignant blood diseases;
• Systemic connective tissue diseases;
• Widespread recurrent skin diseases;
• Diseases of the endocrine system;
• Pregnancy and lactation period;

In each individual case for diseases not included in this list, vaccination is carried out only with the permission of the appropriate medical specialist.

To identify contraindications, the physician (paramedic) on the day of vaccination conducts a survey and examination of the vaccinees with mandatory temperature measurement.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Drug Interactions

The interval between anthrax vaccination and the administration of other vaccines should be at least one month, and for children’s contingents – at least two months. The vaccine is sensitive to antibiotics, therefore immunization against the background of antibiotic use is not allowed.

Storage Conditions

Store in accordance with SP 3.3.2.1248-03 at a temperature from 0 to 8°C (46.4°F) in a place inaccessible to children.

Shelf Life

Shelf life in ampoules under vacuum – 4 years; in ampoules and vials without vacuum – 3 years.

Transport in accordance with SP 3.3.2.1248-03 at a temperature from 0 to 8°C (46.4°F). Transportation for up to 20 days at a temperature not exceeding 25°C (77°F) is allowed.

Dispensing Status

For therapeutic-prophylactic and sanitary-prophylactic institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.