Instruction for use: Vaccinum tuberculosis (BCG-M) cryodesiccatum

Dosage form: Lyophilizate for the preparation of a suspension for intradermal administration

Active substance: Vaccinum ad prophylaxim tuberculosis

ATX

J07AN01 Tuberculosis live attenuated vaccine

Pharmacological group:

Vaccines, serums, phages and toxoids

The nosological classification (ICD-10)

Z23.2 The need for immunization against tuberculosis [BCG]

Composition

Lyophilizate for the preparation of a suspension for intradermal administration 1 dose

active substance: Live mycobacteria vaccine strain BCG-1 0.025 mg of BCG microbial 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; Is supplied complete with a solvent - sodium chloride solution for injection 0.9%

Description of dosage form

Porous mass, powdery or in the form of a thin openwork tablet of white or cream color. It is hygroscopic.

Pharmacological (immunobiological) properties

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

Indication of the drug Vaccinum tuberculosis (BCG-M) cryodesiccatum

Active specific prevention of tuberculosis.

Contraindications

Birth weight less than 2 kg;

Acute diseases and exacerbation of chronic diseases. Vaccination is postponed until the disappearance of clinical manifestations of acute diseases and exacerbations of chronic diseases (intrauterine infection, purulent-septic diseases, hemolytic disease of neonates of moderate and severe form, severe lesions of the nervous system with severe neurological symptoms, generalized skin lesions);

Immunodeficiency status (primary);

Malignant neoplasms (with the appointment of immunosuppressants and radiation therapy, the vaccine is given no earlier than 6 months after the end of treatment);

Generalized BCG infection, found in other children in the family;

HIV infection in a child with clinical manifestations of secondary diseases (AIDS);

HIV infection in a newborn mother who was not receiving antiretroviral therapy during pregnancy.

Persons temporarily released from vaccinations should be monitored and recorded and vaccinated after full recovery or withdrawal of contraindications. If necessary, conduct appropriate clinical and laboratory examinations.

Application of pregnancy and breastfeeding

Application during pregnancy and during breastfeeding is contraindicated.

Side effects

At the site of intradermal administration of the BCG-M vaccine, a local specific reaction in the form of an infiltrate, papules, pustules, ulcers measuring 5-10 mm in diameter is developed sequentially. In the initially vaccinated, the normal vaccination reaction appears after 4-6 weeks. The reaction site should be protected from mechanical irritation, especially during water procedures. The reaction is reversed within 2-3 months, sometimes even longer. 90-95% of vaccinated on-site grafts form a superficial scar to 10 mm in diameter.

Complications after vaccination are rare and usually have a local character (lymphadenitis - regional, often axillary, sometimes supra- or subclavian, ulcers, cold abscesses, subcutaneous infiltrates, keloid scar). It is very rare that there is a persistent and dessinized BCG infection without a lethal outcome (lupus, ostitis), a post-BCG syndrome of an allergic nature that occurs shortly after vaccination (erythema nodosum, annular granuloma, rash), in some cases - generalized BCG lesion with congenital immunodeficiency ... Complications are detected at different times after vaccination - from several weeks to a year or more.

Interaction

Other prophylactic vaccinations can be performed at intervals of at least 1 month before (except for vaccination against hepatitis B virus) and after vaccination with BCG-M.

Dosing and Administration

Intradermally, in a dose of 0.025 mg in a volume of 0.1 ml.

The vaccine BCG-M is inoculated with:

1. In maternity hospitals - all healthy newborns on the 3rd-7th day of life on the eve or on the day of discharge from the maternity home in territories with an incidence of tuberculosis of no more than 80 per 100,000 population.

2. In maternity hospitals - newborns with a body weight of 2 kg or more, while restoring the original 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 (2nd stage of nursing) - children with a body weight of 2.3 kg and more before discharge from the hospital.

4. In children's polyclinics - children who have not received anti-tuberculosis vaccination in the hospital for medical contraindications and are subject to vaccination in connection with the removal 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 setting of 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 infiltrate (hyperemia) or presence of a knock-off reaction (1 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 designated room after a pediatrician examines the children. 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 data of anamnesis. 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 the 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 0.9% sodium chloride solution applied to the vaccine. The solvent should be clear, colorless and free of 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 the ampoule with the vaccine, sterile syringe is transferred with 2 ml of 0.9% sodium chloride solution. The vaccine should dissolve within 1 min. Flakes are allowed, which must 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 for not 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 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 vaccine can be administered to only one child.

The BCG-M 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 injected upward 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, which usually disappears after 15-20 minutes, should form.

Precautions for use

Administration of the drug is not permissible, because Thus forming 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 prohibited 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 vaccination are not allowed into the vaccination room.

Ampoules with the vaccine are carefully examined before opening. The drug is not applicable:

- in 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 serial number (alphanumeric designation), date of issue, expiration date);

- expired shelf life;

- the presence of cracks and incisions on the ampoule;

- changes in the physical properties of the drug (color change). It is forbidden to apply the dressing and treatment with the solution of iodine and other disinfectant solutions of the site of administration of the vaccine during the development of the local grafting reaction: infiltration, papules, pustules, ulcers, which parents must be warned about.

More detailed information about the vaccine prophylaxis of tuberculosis is presented in Order No. 109 of the Ministry of Health of the Russian Federation "On the improvement of anti-tuberculosis measures in the Russian Federation" of March 21, 2003.

Overdose

Not installed.

Special instructions

Information about the possible effect of the drug on the ability to drive vehicles, mechanisms. Not applicable. The drug is used to vaccinate children.

Special precautions for the destruction of unused medicinal product. The unused vaccine is destroyed by boiling for 30 minutes, autoclaving at 126 ° C for 30 minutes, or immersing the opened ampoules in a disinfectant solution (5% solution of Chloramine B or 3% hydrogen peroxide solution) for 60 minutes.

Release form

Lyophilizate for the preparation of a suspension for intradermal administration of 0.025 mg / dose. For 0.5 mg (20 doses) in the ampoule. It comes with a solvent - sodium chloride solution for injection 0.9%. Solvent - 2 ml in the ampoule.

The set consists of 1 amp. Vaccine and 1 amp. Solvent.

For 5 sets in a pack of cardboard. In a pack put knife ampoule or scarifier ampoule.

Manufacturer

FGUP NPO Microgen of the Ministry of Health and Social Development of Russia.

Complaints on the quality of the drug, with mandatory indication of the serial number and release date, as well as cases of increased reactogenicity or the development of complications, should be reported to the Federal Service for Supervision of Health and Social Development (Roszdravnadzor) and to the manufacturer's address With subsequent submission of medical documentation.

Conditions of supply of pharmacies

For treatment and prevention institutions.

Storage conditions of the drug Vaccinum tuberculosis (BCG-M) cryodesiccatum

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Vaccinum tuberculosis (BCG-M) cryodesiccatum

1 year.

Do not use after the expiry date printed on the package.