Anthrax vaccive

Anthrax vaccine, LIVE (strain STI)

The product is supplied as live spores of anthrax vaccinating strain STI, or spores lyophilized in 10% saccharose solution in water. The vaccine appears like homogenous, white, loose powder or pellet. By addition of 0.9% sodium chloride solution (isotonic saline) or 30% aqueous glycerol solution it forms homogenous suspension with no inclusions, non-breakable lumps, flakes or particles.

Immunological properties
Two inoculations of live dried anthrax vaccine administered with interval of 20-30 days usually produce efective status of immunity, lasting for 1 year.

Directions
Preventive anti-anthrax vaccination of individuals might be performed from the age of 14 to 60. The vaccination may be either scheduled immunization or the measure taken upon sertain epidemiological indications.

Dosage and administering
Vaccine can be administered epicutaneously by a scratch (scarification) during the scheduled (preventive) vaccination or subcutaneously (with either syringe or jet injector) in according to epidemiological indications. Initial immunization is to be carried out twice with the interval of 20-30 days; revaccination is performed as a single inoculation (not as frequent as once in a year). Single epicutaneous dose of the vaccine (0.05 ml) or one subcutaneous doze (0.5 ml) should contain 400-600 millions spores and 40-60 millions spores correspondingly. The dose used for revaccination is the same as for initial inoculation. The rest or not used vaccine must be destroyed with boiling for at least 2 hrs or authoclaved at 120°C for 45 min.

Contraindications
Permanent contraindications to vaccination include: malignancy, cancer, blood diseases, severe somatic disorders and all kind of immunodeficient conditions. Chronic dermatic diseases are considered as a direction to avoid epicutaneous (scarification) way of vaccinating. Vaccination is not allowed during the pregnancy. Persons with symptoms of acute infectious or non-infectious diseases and sharp periods of chronic diseases may not be vaccinated until 1 month after recovery. Persons who take course of treatment with corticosteroids, antimetabolites or radiotherapy may be vaccinated in 12 months after the therapy ends (if no other restrictions applied). The interval between vaccinating with anthrax vaccine and administrating any other vaccines has to be at least one month and for adolescents – at least two months. In order to reveal possible restrictions to vaccination all the patients should be interviewed and examined by licensed physician with thermometry on the very day of vaccination with the anthrax vaccine.

Package
1.0 ml of vaccine in ampoule with 20 doses for epicutaneous vaccination or with 200 doses for subcutaneous vaccination without diluent or in 1.5 ml of diluent – 30% aqueous glycerin solution. 1.0 ml of vaccine in ampoule with 10 doses for epicutaneous vaccination or with 100 doses for subcutaneous vaccination without diluent or in 1.0 ml of diluent – 30% aqueous glycerin solution. Dry vaccine without diluent might be used only for subcutaneous administration.
Pack contains either 10 ampoules of vaccine without diluent or 5 ampoules of vaccine with 5 ampoules of diluent (instruction enclosed).

Storage and transportation
Keep from light in dry place at the temperature of 0-10°C. Vaccine may be transported by all kinds of top-closed transports at proper temperature. Storage at the temperature around 25°C longer than for 20 days should be avoided. Shelf life of the product is 4 years, then 2 years, upon retesting the activity.