The BCG vaccine is administered intradermally at a dose of 0.05 mg in a volume of 0.1 ml of solvent (sodium chloride solvent for the preparation of dosage forms for injection 0.9%).
Primary vaccination is carried out to healthy newborn children on the 3rd-7th day of life (usually on the day of discharge from the maternity hospital).
Children who are not vaccinated during the neonatal period due to illnesses receive BCG-M vaccine after recovery. Children aged 2 months and older are pre-tested with Mantoux 2 TE purified tuberculin in standard dilution and vaccinate only tuberculin negative.
Children aged 7 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 knock-off 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 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 physician (paramedic) with obligatory thermometry on the day of vaccination, taking into account medical contraindications and data of anamnesis. If necessary, consult with specialist doctors, blood and urine tests. When conducting revaccination in schools, 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 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.
The vaccine is dissolved immediately before use with a sterile sodium chloride solution for the preparation of 0.9% injection dosage forms attached to the vaccine. The solvent must be clear, colorless and free from foreign inclusions.
The neck and head of the ampoule are wiped off with 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.
To obtain a dose of 0.05 mg of BCG in 0.1 ml of solvent in an ampoule containing 20 doses of the vaccine, 2 ml of sodium chloride of the solvent is transferred with a sterile syringe to prepare dosage forms for injection of 0.9%, and in an ampoule containing 10 doses of the vaccine - 1 ml of sodium chloride of the solvent for the preparation of dosage forms for injection 0.9%. The vaccine should dissolve within 1 min. Flakes are allowed, which should be broken at 3-4 times with a gentle shaking and mixing of the contents by drawing back into the syringe. The dissolved vaccine has the form of a turbid coarse dispersed suspension of light yellow color. If large flakes are present in the diluted preparation and do not break with a 2-4-fold stirring with a syringe, or the sludge is not used, the ampoule is destroyed.
The diluted vaccine should be protected from sunlight and daylight (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 and 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 about 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 graduation of 0.1 ml. Before each set, the vaccine should be gently mixed 2-3 times with a syringe. Vaccination is performed immediately after dialing into the syringe of the vaccination dose. A single syringe can be administered to only one child.
The BCG vaccine is administered strictly intradermally 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 introduced by cutting up into the surface layer of the 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, since it produces a "cold" abscess.
For vaccination (revaccination) 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 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 allowed into the vaccination room.
Ampoules with the vaccine are carefully examined before opening.
The drug is not applicable for:
- the absence of a label on the ampoule or the incorrect filling of the label (on the label of the ampoule with the vaccine indicate: the abbreviated name of the preparation (BCG vaccine), the number of doses, the dosage is 0.05 mg / dose,number of the series (alphanumeric designation), date of issue, expiry date);
- expired shelf life;
- the 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 iodine and other disinfectant solutions at the site of vaccine administration during the development of a local vaccination reaction: infiltrate, papules, pustules, ulcers.
More detailed information on the conduct of vaccine prophylaxis of tuberculosis is presented in the Order of the Ministry of Health of the Russian Federation No. 109 "On the improvement of anti-tuberculosis measures in the Russian Federation" of March 21, 2003.