The BCG vaccine is administered intradermally at a dose of 0.05 mg in 0.1 ml of the applied solvent (sodium chloride solution 0.9% for injections).
Vaccination is administered to healthy newborn children on the 3rd-7th day of life (usually on the day of discharge from the maternity hospital) in areas with an incidence of tuberculosis of over 80 per 100 000 population. With a lower incidence of tuberculosis, the vaccination of the population is carried out with BCG-M.
Children who are not vaccinated during the newborn period receive a vaccine BSC-M after recovery. Children aged 2 months and older are pre-Mantoux test with 2 TE purified tuberculin in standard dilution and vaccinate only tuberculosis.
Children aged 7 and 14 years who have a negative reaction to the Mantoux test with 2 TE PPD-L are subject to revaccination. Mantoux reaction is considered negative in the complete absence of infiltration, hyperemia or in the presence of a prick of an internal reaction (1 mm). Infected with mycobacteria tuberculosis, children who have a negative reaction to the Mantoux test, are not subject to revaccinations.The interval between setting the Mantoux test and booster should be at least 3 days and not more than 2 weeks.
Vaccinations must be carried out by specially trained and certified medical personnel of maternity hospitals (departments), prehumans nursing departments, children's 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. When carrying out revaccination at school, all of the above requirements must be met. To avoid contamination with living mycobacteria BCG, it is inadmissible to combine one day inoculation against tuberculosis with other parenteral manipulations.
The fact of the vaccination (revaccination) is recorded in the prescribed registration forms with the date of vaccination, the name of the vaccine, the manufacturer, the serial number, and the expiration date of the preparation.
For vaccination (revaccination) use disposable sterile tuberculin syringes with a capacity of 1 ml with thin short 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% chloramine solution or 3% solution of hydrogen peroxide), and then centrally destroyed. It is forbidden to use for other purposes instruments 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 BCG vaccination are not admitted to the vaccination room (maternity hospital) and vaccine room (polyclinic) on the day of vaccination. On the day of vaccination (revaccination) BCG in the vaccine room (room) is prohibited to conduct other preventive vaccinations.
Ampoules with the vaccine are carefully examined before opening.
The drug is not applicable for:
- no marking on the ampoule or improper filling;
- expired shelf life;
- presence of cracks and incisions on the ampoule;
- change in the physical properties of the drug (color change, wrinkled tablet, etc.).
The vaccine is dissolved immediately before use with a sterile sodium chloride solution 0.9% for injection, applied to the vaccine. The solvent must be clear, colorless and free from foreign inclusions.
The vaccine is sealed under vacuum: The neck and head of the ampoule are wiped off with alcohol. First, saw 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.
The vaccine is sealed under an inert gas: The neck and head of the ampoule are wiped off with alcohol. Break off the neck of the ampoule over the ring or break point, wrapping the head in a sterile gauze napkin.
To obtain a dose of 0.05 mg BCG in 0.1 ml in an ampoule containing 20 doses of the vaccine, 2 ml of 0.9% sodium chloride solution for injections is transferred with a sterile syringe, and 1 ml of sodium chloride solution into an ampoule containing 10 doses of the vaccine 0.9% for injections.The vaccine should dissolve within 1 min. Flakes are allowed, which must be broken with a 3-4-fold stirring with a syringe (do not allow air to enter the syringe). The dissolved vaccine should have the appearance of a coarsely dispersed white suspension with a grayish tinge of color. In the presence of a diluted formulation of large flakes, which are not broken at 3-4 times the stirring with a syringe or the vial sediment vaccine destroy without using.
The diluted vaccine must be protected from sunlight and daylight (for example, a cylinder of black paper). The diluted vaccine is suitable for use no more than 1 hour after dilution 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. Unused vaccine destroyed by boiling for 30 minutes autoclaving at 126 ° C for 30 minutes or immersing in ampoules uncovered disinfecting solution (5% solution of bleach or 3% solution of hydrogen peroxide) for 60 min.
For each inoculation, 0.2 ml (2 doses) of the diluted vaccine is taken into the tuberculin syringe,then about 0.1 ml of the vaccine is released 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 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 ° alcohol. The needle is injected upwards in the superficial 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 within 15-20 minutes.
REACTION FOR INTRODUCTION
Normally, local specific reaction in the form of infiltrate, papules, pustules, and ulcers measuring 5-10 mm in diameter develops sequentially in vaccinated BCG vaccines at the place of intracutaneous administration of BCG in 4-6 weeks. The reaction is reversed within 2-3 months, sometimes even longer.The revaccinated local reaction develops after 1-2 weeks. The reaction site should be protected from mechanical irritation, especially during water procedures.
90-95% of the vaccinated on-site grafts form a superficial scar, up to 10 mm in size.