BCG-M tuberculosis vaccine, 0.025 mg/dose, 20 doses, 5 pcs.

Living mycobacteria of BCG-1 strain, multiplying in the body of the vaccinated person, lead to the development of long-term immunity to tuberculosis.

Indications

Active specific prevention of tuberculosis.

Active ingredient

Composition

1 dose contains:

the active ingredient:

live mycobacteria of BCG-1 vaccine strain 0.025 mg BCG germ cells

auxiliary substances:

sodium glutamate monohydrate (stabilizer) – not more than 0.15 mg.

1 dose is 0.1 ml of diluted suspension; the drug does not contain preservatives and antibiotics; it is available in a set with solvent – sodium chloride solution for injection of 0.9%

How to take, the dosage

The BCG-M vaccine is administered intradermally in a dose of 0.025 mg in 0.1 ml diluent.

The BCG-M vaccine is given:

Children who have not been vaccinated in the first days of life shall be vaccinated during the first two months in a children’s clinic or other health facility without prior tuberculin-diagnosis.
Children aged 2 months and older require a preliminary Mantoux test with 2 units of PPD-L before vaccination.

Infants with a negative reaction to tuberculin are vaccinated. The reaction is considered negative if there is no infiltration (hyperemia) or a prick reaction (1.0 mm). The interval between the Mantoux test and vaccination should be at least 3 days and no more than 2 weeks.

The dry vaccine is diluted immediately before use with sterile 0.9% sodium chloride solution attached to the vaccine. The diluent should be clear, colorless and free of foreign substances.

The BCG-M vaccine is administered strictly intradermally at the border of the upper and middle thirds of the outer surface of the left shoulder after pretreatment of the skin with 70° alcohol.

Injection under the skin is unacceptable because it can cause a cold abscess.
It is forbidden to apply a bandage and treat with iodine and other disinfectant solutions where the vaccine is injected.

Reaction to administration
A specific reaction develops at the site of intradermal administration of BCG-M vaccine in the form of a papule 5-10 mm in diameter.
In newborns a normal inoculation reaction appears after 4-6 weeks. The reaction will undergo reversal within 2-3 months, sometimes even longer.
The place of reaction should be protected from mechanical irritation, especially during water procedures.
In 90-95% of vaccinated persons a superficial scar up to 10.0 mm in diameter should form on the vaccination site.
Complications after vaccination are rare and are usually of local nature.

Interaction

Other prophylactic vaccinations can be carried out at an interval of at least 1 month before (with the exception of vaccination against viral hepatitis B) and after BCG-M vaccination.

Contraindications

Persons temporarily exempt from vaccination should be taken under observation and registration, and vaccinated after full recovery or removal of contraindications. If necessary, appropriate clinical and laboratory examinations are performed.

Children not vaccinated during the newborn period receive BCG-M vaccine after the removal of contraindications.

Other preventive vaccinations can be carried out at an interval of at least 1 month before (except vaccination against viral hepatitis B) and after BCG-M vaccination

Side effects

A local specific reaction develops consistently at the site of intradermal injection of BCG-M vaccine in the form of an infiltrate, papule, pustule, ulcer 5-10 mm in diameter. In the primary vaccinated the normal inoculation reaction appears after 4-6 weeks.

The site of the reaction should be protected from mechanical irritation, especially during water procedures. The reaction reverses within 2-3 months, sometimes for longer periods. In 90-95% of those vaccinated, a superficial scar up to 10 mm in diameter forms at the vaccination site.

The complications after vaccination are rare and usually local (lymphadenitis – regional, more often axillary, sometimes supra- or subclavian, ulcers, cold abscesses, subcutaneous infiltrates, keloid scar).

Very rare are persistent and non-fatal BCG infection (lupus, ostitis), post-BCG allergic syndrome that occurs soon after vaccination (nodular erythema, ring granuloma, rash), in some cases – generalized BCG lesions in congenital immunodeficiency. Complications are detected at different times after vaccination – from a few weeks to a year or more.