Description
Release form
lyophilisate for the preparation of a suspension for intradermal administration.
Packaging
5 ampoules with solvent.
Pharmacological action of
The vaccine is a live mycobacterium of the BCG vaccine strain, which, when propagated in the vaccinated organism, leads to the development of long-term immunity to tuberculosis.
Indications
Specific tuberculosis prophylaxis.
Contraindications
Vaccination
1. Prematurity – birth weight less than 2500 g
2. Intrauterine malnutrition III-IV degree.
3. Acute diseases. Vaccination is postponed until the end of the acute manifestations of the disease and exacerbation of chronic diseases (intrauterine infection, purulent-septic diseases, hemolytic disease of newborns of moderate and severe form, severe damage to the nervous system with severe neurological symptoms, generalized skin lesions, etc.).
4. Immunodeficiency state (primary), malignant neoplasms.
When prescribing immunosuppressants and radiation therapy, vaccination is carried out no earlier than 6 months after the end of treatment.
5. Generalized BCG infection detected in other children in the family.
6. HIV infection in the mother of the newborn.
Children with contraindications for BCG vaccination are vaccinated with BCG-M vaccine following the instructions for this vaccine.
Revaccination
1. Acute infectious and non-infectious diseases, exacerbation of chronic diseases, including allergic ones. Vaccination is carried out 1 month after recovery or the onset of remission.
2. Immunodeficiency states, malignant blood diseases and neoplasms.
When prescribing immunosuppressants and radiation therapy, vaccination is carried out no earlier than 6 months after the end of treatment.
3. Patients with tuberculosis, persons who have had tuberculosis and infected with mycobacteria.
4. Positive and doubtful reaction to the Mantoux test with 2 TE PPD-L.
5. Complications of previous BCG vaccine administration.
In contact with infectious patients in the family, child care facility, etc. vaccinations are carried out at the end of the quarantine period or the maximum period of the incubation period for this disease.
Persons temporarily exempted from vaccinations should be monitored and registered, and after complete recovery or removal of contraindications. If necessary, conduct appropriate clinical and laboratory examinations.
Special instructions
When using immunosuppressants and radiation therapy, the vaccine is given 6 months after the end of treatment.
After an acute illness or remission in a chronic disease, revaccination is carried out after 1 month.
When contacting infectious patients in a family or children’s institution, vaccinations are given at the end of the quarantine period or the maximum incubation period for this disease.
Other prophylactic vaccinations may be given with an interval of at least 1 month before and after BCG revaccination.
Persons temporarily exempted from vaccinations should be taken under supervision and registration and vaccinated after full recovery or removal of contraindications. If necessary, conduct appropriate clinical and laboratory examinations.
Composition
1 amp. 1 dose of
live mycobacteria of the BCG-1 vaccine strain * 1 mg 50 Ñg
* – live mycobacteria of the BCG-1 vaccine strain is lyophilized in a 1.5% solution of sodium glutaminate.
Solvent: 0.9% sodium chloride solution – 2 ml.
Dosage and administration
The vaccine is administered strictly intradermally in accordance with the accepted vaccination schedule.
A bandage or treatment with iodine or other disinfectant solutions is prohibited at the injection site.
Side effects
Rarely: local allergic reactions.
In case of violation of the vaccine administration technique (subcutaneous administration), a cold abscess may form.
Storage conditions
The drug is stored in accordance with SP 3.3.2.1248-03, at a temperature of 0 to 8 ° C, out of the reach of children.
Transported in accordance with SP 3.3.2.1248-03 at a temperature of 0 to 8 ° C.
Expiration
2 years.
Deystvuyuschee substances
Vaccine for Prevention tuberculosis
