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

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:

• In the maternity hospital premature newborns with a body weight of 2000 grams or more, when the initial body weight is restored – one day before discharge to home.
• In the nursing departments of premature newborns of medical hospitals (2nd stage of nursing) – children with a body weight of 2300 g or more before discharge home from the hospital.
• In children’s clinics – children who have not received TB vaccination in the hospital due to medical contraindications and subject to vaccination in connection with the removal of contraindications.
• In areas with a satisfactory epidemiological situation on tuberculosis BCG-M vaccine is used for the vaccination of all newborns.

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

• Prematurity – birth weight less than 2000 g.
• Acute diseases. Vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases (intrauterine infection, purulent-septic diseases, hemolytic neonatal disease of moderate and severe form, severe lesions of the nervous system with marked neurological symptoms, generalized skin lesions, etc.)
• Immunodeficiency state (primary), malignant tumors.
  If immunosuppressants and radiation therapy are prescribed, the vaccination should not be administered earlier than 6 months after the end of treatment.
• Generalized BCG infection detected in other children in the family.
• HIV infection in the mother.

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

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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.