BCG

BCG VACCINE (vaccine tuberculosis)

The vaccine is formulated of live tuberculosis bacteria (strain BCG-1), lyophilized in 1.5% sodium glutaminate. The preparation appears like a loose, hygroscopic, white or slightly beige powder or dry pellet. An immunizing dose contains 0.05 mg BCG in 0.1 ml solvent.

Biological and Immunological Properties
After immunization, live bacteria of BCG-1 strain propagate, increasing in numbers. This provide quantity of main antigenes, enough to stimulate developing of long lasting specific immunity against tuberculosis.

Administrating and Dosage
BCG vaccine is to be injected intracutaneously with a single dose of 0.05 mg of vaccine diluted in 0.1 ml of 0.9% saline. Primary immunization of normal and healthy newborns is to be done on the 4-7 day of postnatal period.
Healthy children, adolescents and adults, showing negative results of Mantoux test with 2 TE PPD-L are subjected to immunization and reimmunization with the BCG vaccine. The reaction of Mantoux test is negative if the infiltrated area with hyperemia is absent, or the spot of injection is less than 1 mm in.

Reimmunization
The rest period between taking the Mantoux test and next session of reimmunization with tuberculosis vaccine has to be at least 3 days but no longer than 2 weeks. The first round of reimmunization is carried out at the age of 7 years; the second round is scheduled on the age of 11-12 years; and the third one at the age of 16-17 years.
Following reimmunizations may be performed with intervals of 5-7 years until the age of 30 yrs.

Adverse Reactions
A May be observed a papule, vesicle or pustule of 5-10 mm in diameter, formed at the very spot of injection. The effect in newborns typically (as a postimmunization response) can be seen in 4-6 weeks after prime immunization; during reimmunization the reaction might be seen in 1-2 weeks or even earlier. The reactions usually dissapear within 2-3 weeks, sometimes it takes a longer period.
The very site of injection must be preserved from mechanical irritation and kept in dry.
For the 90-95% of immunized patients the infiltration has 10 mm in diameter, while it is formed on the spot after injection.
Most of side effects and rare cases of complications following the immunization manifest themselves as a local reactions.

Package
Kit contains ampoule with 1 mg of dry vaccine (20 doses per 1 mg) and a vial with diluent (2 ml, 0.9% NaCl); or ampoule with 0.5 mg of dry vaccine (10 doses per 0.5 mg) and a vial with diluent (1 ml). One box contains 5 ampoules with BCG vaccine and 5 vials of diluent with 0.9% NaCl (saline).

Storage and Shipment
Store at temperature not higher than 4oC. Conventional shipping of live bacterial preparations.

Expiration
Shelf life of the product is 2 years from the date of manufacturing.