Index of drugs

The vaccine is used for protective vaccination against tuberculosis. Vaccination in Poland is obligatory, carried out in accordance with the Protective Vaccine Program approved annually by the Minister of Health. Immunization (complementary) vaccinations in unvaccinated persons should be performed at the earliest possible date, not later than on the age of 15. In the case of BCG vaccination, revaccination is not recommended.

1 dose (0.1 ml) contains 50 μg of semi-dry mass of BCG mycobacteria which corresponds to 150,000 to 600,000 BCG live bacilli (Bacillus Calmette-Guerin), the Brazilian Moreau transplant. 10-dose vaccine.

Tuberculosis vaccine, live, attenuated. After injection, BCG mycobacteria proliferate at the injection site as well as in nearby lymph nodes.
The reaction of the body to the presence of mycobacteria is the emergence of delayed type hypersensitivity called tuberculin allergy and the formation of anti-tuberculosis resistance.

BCG vaccination should not be performed: in people with known hypersensitivity to any component of the vaccine; in newborns with mc. <2000 g; in newborns of HIV infected mothers until the HIV infection is ruled out in the child; in newborns with suspected congenital immunodeficiency; in neonates of mothers treated in the third trimester of pregnancy with such drugs as monoclonal antibodies against TNF-alpha; in people infected with HIV (confirmed or suspected infections, even if they are asymptomatic); in people with primary or secondary immunodeficiency (including deficiency of Interferon gamma or with Di George syndrome); in people during radiotherapy; in patients treated with corticosteroids, during immunosuppressive therapy (including those treated with anti-TNF-alpha monoclonal antibodies such as, for example, infliximab); in people with cancer (eg leukemia, Hodgkin's disease, lymphoma or other cancers of the reticuloendothelial system); in patients after transplantation of bone marrow stem cells and after organ transplantation; in people with severe diseases (including severe malnutrition); Pregnant; in people who have had tuberculosis or in people with a large (over 5 mm) reaction RT23. Vaccinations should be postponed in the case of: newborns in unstable clinical condition until the general state of health is improved (it should be vaccinated before leaving the neonatal unit); during infection with fever; exacerbation of chronic disease; generalized skin infections. Prematurity is not a contraindication for vaccination, it is recommended to vaccinate in this group of patients after reaching the target. 2000 g

The risk of apnea and the need to monitor respiratory function for 48-72 h should be considered when administering the vaccine to very premature premature babies (born ≤ 28 weeks of pregnancy), especially for children with symptoms of immaturity in the respiratory system. Due to the significant benefits of vaccinating this group of infants, vaccination should not be withheld or deferred. The administration of BCG should be postponed for newborns whose mothers took anti-TNF therapy or other potentially immunosuppressive IgG1 antibodies during pregnancy. The doctor decides about the date of vaccination.

The vaccine should not be used during pregnancy. Breastfeeding is not a contraindication to the administration of BCG.

Not known: pustule / pimple pustule at the injection site, abscess at the injection site, generalized BCG infection with osteoarthritis, osteomyelitis, lymph node pain, lymph node necrosis, lymphadenopathy, inflammation / purulent lymphadenitis, anxiety, apnea very immature premature babies (born ≤ 28 weeks of pregnancy), keloid (keloid), fever, ulcer at the injection site. A change at the injection site: infiltration, pimple, and ulcers with frequent leakage of serum usually disappears spontaneously within 3 months after vaccination and does not require treatment.Enlargement of regional axillary lymph nodes up to 15 mm in a vaccinated person is considered to be an expected, correct vaccination reaction. If after BCG vaccination there is a local reaction within 24-48 h and an abscess (within 5-7 days), earlier infection with tuberculosis may be suspected. Injecting the vaccine too high into the upper part of the deltoid increases the risk of keloid. In the case of severe local reactions or inflammation of regional lymph nodes, a medical consultation is required, followed by an individual decision about further treatment, but most often no treatment, because they disappear spontaneously. Severe generalized reactions after administration of BCG are very rare and generally occur in people with impaired immunity. An disseminated BCG infection requires specialist advice, bacteriological diagnosis and the immune system as well as anti-tuberculosis treatment in hospital settings. In the case of post-vaccination changes, which according to the pediatrician meet the criteria of post-vaccination complications, the child should be referred to a consultant who will make the final diagnosis and recommend further proceedings.

The vaccine should be dissolved in 1 ml of isotonic sodium chloride solution. A single dose of the vaccine should be withdrawn into the syringe in a volume of 0.1 ml for one child. Vaccination should be performed by personnel specially trained for intradermal injection. The vaccine should be injected intradermally in the outer 1/3 of the upper left arm. The vaccine must be injected with a special tuberculin syringe with a well-fitting needle. After administration of 0.1 ml of BCG vaccine and the correct technique of vaccination, an intradermal bubble with a diameter of approx. 7 mm should form on the arm. The BCG vaccine should be administered in the region of the deltoid muscle of the left upper limb (in the middle part). Injection of the vaccine into the upper arm may contribute to the formation of keloid. After 2-4 weeks at the vaccination site, 90-95% of vaccinated infiltrates, which persists for several weeks. Usually on the top of infiltration a pimple is formed, followed by ulceration usually with a diameter of 2-5 mm, not exceeding 10 mm. The change heal spontaneously within 2-3 months after inoculation, leaving a whitish scar a few millimeters in diameter. Some people with pustules may have some serous fluid over a longer period of time, which is not a complication and does not require treatment, but rather keeping the place clean.