National manufacturer of
immunobiological products in Russia
En
National manufacturer of
immunobiological products in Russia

Live smallpox vaccine

Trade name

Smallpox vaccine

Dosage form

Lyophilisate for preparation of solution for intracutaneous administration and application to scarified skin, in combination with solvent.

Shelf life

Vaccine – 2 years; solvent – 3 years.

Manufacturer

NPO Microgen, 8, Ivanovskogo str., Tomsk, Tomsk Region, 634040 Russia 634040

Presentation

Lyophilisate for preparation of solution for intracutaneous administration and application to scarified skin, in combination with solvent. 20 doses of vaccine (0.2 ml) per ampoule. 0.3 ml of solvent in a double-end capillary ampoule. 5 ampoules of the vaccine and 5 ampoules of the solvent, or 10 ampoules of the vaccine and 10 ampoules of the solvent in each package. Each package has a package insert, an ampoule cutter and a glass stick.

Ingredients

1 vaccination dose contains:

Active ingredient: smallpox vaccine virus - not less than 106of smallpox generating units (SGU).

Excipient: peptone – stabilizer – in the final concentration of 5-10%.

The vaccine is available in combination with the solvent – 50% glycerol solution.

1 ml of the solvent contains:

Active ingredient: Glycerin - 563 mg.

Excipient: McIlvain phosphate-citrate buffer
0.004 М – up to 1 ml

Note.
Composition of the McIlvain phosphate-citrate buffer 0,004 M:
Citric acid monohydrate - 0,042 mg; sodium hydrogenphosphate dodecahydrate - 0.641 mg; water - up to 1 ml.

Indications

Prevention of smallpox on epidemic indications. Vaccination (revaccination) of persons working with smallpox viruses and animal smallpox viruses pathogenic to humans.