Tuberculosis vaccine for sparing primary immunization (BCG-M) (Vaccinum BCG-M)

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

The vaccine BCG-M is inoculated with:

1. In the maternity homes of all healthy newborns on the 3rd-7th day of life on the eve or on the day of discharge from the maternity hospital in areas with a TB incidence rate not higher than 80 per 100 000 population;

2. In maternity hospitals of newborns with a body weight of 2000 grams and more, with the restoration of the initial body weight (after its physiological decline), on the eve or on the day of discharge from the hospital;

3. In the departments of nursing preterm neonatal medical hospitals (the second stage of nursing) - children with a body weight of 2300 g and more before discharge from the hospital;

4. In children's polyclinics, children who have not received an anti-tuberculosis vaccination in the hospital for medical contraindications and are subject to vaccination in connection with the withdrawal of contraindications.

Children who were not vaccinated in the first days of life are vaccinated within the first two months in a children's polyclinic or other medical and preventive institution without preliminary tuberculosis diagnostics.

Children aged 2 months and older before vaccination need a preliminary Mantoux sample with 2 tuberculin units of purified tuberculin in standard dilution. Vaccinated children with a negative reaction to tuberculin. The reaction is considered negative in the complete absence of infiltration (hyperemia) or the presence of a knock-off reaction (1.0 mm).The interval between the Mantoux test and vaccination should be at least 3 days and not more than 2 weeks.

Vaccinations should be carried out by specially trained medical personnel of maternity hospitals (departments), nursing departments of preterm, pediatric polyclinics or feldsher-midwife stations. Vaccination of newborns is carried out in the morning hours in a specially allocated room after examination of children by a pediatrician. In polyclinics, the selection of children for vaccination is preliminarily conducted by a doctor (paramedic) with obligatory thermometry on the day of vaccination, taking into account medical contraindications and history data. If necessary, consult with specialist doctors, blood and urine tests. To avoid contamination with living mycobacteria BCG, it is inadmissible to combine one day inoculation against tuberculosis with other parenteral manipulations.

The fact of vaccination is recorded in the established registration forms with the date of vaccination, the manufacturer, the serial number and the expiration date of the vaccine.

Immediately before use, the vaccine is diluted with sodium chloride with a solvent to prepare the 0.9% injection dosage forms attached to the vaccine.The solvent must be clear, colorless and free from foreign inclusions.

The neck and ampoule head are wiped with 95% ethyl alcohol. The vaccine is sealed under vacuum, so first cut and carefully, using tweezers, break off the place of sealing. Then they saw out and break off the neck of the ampoule, wrapping the sawn end in a sterile gauze napkin.

In a vial with a vaccine, 2 ml of sodium chloride of a solvent is transferred with a sterile syringe to prepare dosage forms for injection of 0.9%. The vaccine should dissolve within 1 min. Flakes are allowed, which should be broken with 2-4-fold stirring with a syringe. The dissolved vaccine has the appearance of a turbid coarse dispersion of light yellow color. If large flakes are present in the diluted preparation and do not break with a 3-4-fold stirring with a syringe, or the sludge is not used, the ampoule is destroyed.

The diluted vaccine should be protected from the effects of natural light (for example, a cylinder of black paper) and used immediately after dilution. The diluted vaccine is suitable for use no more than 1 hour when stored under aseptic conditions at a temperature of 2 to 8 ° C.It is compulsory to keep a record indicating the time of dilution of the drug and the destruction of the ampoule with the vaccine.

For one inoculation, 0.2 ml (2 doses) of the diluted vaccine is collected for one inoculation with a tuberculin syringe, then 0.1 ml of the vaccine is ejected through a needle into a sterile cotton swab to expel the air and bring the syringe plunger to the desired calibration of 0.1 ml. Before each set, the vaccine should be gently mixed 2-3 times with a syringe. A single syringe can be administered to only one child.

The BCG-M vaccine is administered strictly intracutaneous at the border of the upper and middle third of the outer surface of the left shoulder after preliminary treatment of the skin with 70% ethyl alcohol. The needle is injected upwards in the surface layer of stretched skin. First, a small amount of vaccine is administered to make sure that the needle has entered exactly intracutaneously, and then the entire dose of the drug (0.1 ml in total). With the correct technique of administration, a papule of whitish color with a diameter of 7-9 mm should be formed, disappearing usually after 15-20 minutes.

Precautions for use

The introduction of the drug under the skin is unacceptable, as this produces a "cold" abscess.

For vaccination use disposable sterile tuberculin syringes with a capacity of 1 ml with thin needles with a short cut. To apply the solvent to the ampoule with the vaccine, use a disposable sterile syringe with a capacity of 2 ml with a long needle. It is forbidden to use syringes and needles with expired shelf life and insulin syringes that do not have a calibration in ml. It is forbidden to vaccinate with a needleless injector. After each injection, a syringe with a needle and cotton swabs are soaked in a disinfectant solution (5% solution of Chloramine B or 3% hydrogen peroxide solution), and then centrally destroyed. It is forbidden to use tools for other purposes, intended for vaccination against tuberculosis. The vaccine is stored in the refrigerator (under lock and key) in the vaccination room. Persons who are not related to vaccination are not allowed into the vaccination room.

Ampoules with the vaccine are carefully examined before opening.

The drug is not applicable for:

- the absence of marking on the ampoule or incorrect filling of the marking (should contain the abbreviated name of the drug (BCG-M vaccine), the number of doses, the dosage is 0.025 mg / dose, series number (alphanumeric designation), date of issue, expiration date);

- expired shelf life;

- presence of cracks and incisions on the ampoule;

- changes in the physical properties of the drug (color change, etc.).

It is forbidden to apply a dressing and treatment with a solution of iodine and other disinfectants solutions of the place of administration of the vaccine during the development of the local vaccination reaction: infiltrate, papules, pustules, ulcers, which must be sure to warn the child's parents.