Bacillus of Calmette and Guerin (BCG) Vaccine
Generic Name:
Bacillus Calmette-Guerin
Description:
A live, attenuated culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis is the BCG VACCINE for percutaneous use.
Tuberculosis (TB) is caused by a bacterium called Mycobacterium tuberculosis. Bacteria usually attack the lungs, but tuberculosis can attack any part of the body, including the kidneys, spine, and brain. Not everyone who is infected with tuberculosis becomes sick. As a result, there are two conditions associated with tuberculosis.
Latent tuberculosis infection (LTBI) and tuberculosis disease. Without proper treatment, tuberculosis disease can be fatal.
Bacillus Calmette-Guerin Vaccine I.P. Freeze-dried live vaccine
Derived from an attenuated strain of Mycobacterium bovis. TUBERVAC used for
Prevention of tuberculosis. The vaccine meets WHO requirements. and I.P.when
Tested according to standards specified by W.H.O.
Composition:
Live, attenuated BCG Vaccine (Bacillus Calmette-Guerin Strain)
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Diluent: Sodium Chloride Injection I.P.
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Pharmaceutical Form:
Powder for suspension
Method of Administration:
Vaccine administered through intradermally.
Dosage:
The vaccination dose is 0.05 ml for children under one year of age including the new born and 0.1 ml for children over one year of age and adults of reconstituted vaccine.
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Presentation:
20 dose vial (0.05ml) with diluent
10 dose vial (0.1 ml) with diluent
Possible Side Effects:
A local reaction is normal. Following BCG vaccination, 2 to 3 weeks later a papule develops at the site of vaccination and increases slowly in size to a diameter of 4-8 mm in 5 weeks. It then subsides or breaks into a shallow ulcer covered with a crust. Healing occurs spontaneously in 6-12 weeks leaving a permanent, tiny round scar 2-10 mm in diameter. In rare cases an abscess may appear at the point of injection, or satellite adenitis, leading in exceptional cases to suppuration.
Contraindications:
This vaccine is contraindicated in hypogamma-globulinemia, congenital immunodeficiency, sarcoidosis, leukaemia, generalised malignancy, HIV infections or any other disorder in which natural immune response is alterted, as also those on immunosuppressive therapy, corticosteroids, radiotherapy. In chronic eczema or other dermatological disease, the vaccine can be given in a healthy area of the skin. Keloid and lupoid reactions may also occur at the site of injection and such children should not be revaccinated.
Shelf Life:
The vaccine has a 24-month shelf life from the date of production
Storage:
Stored in dark between +2º and +8ºC. Protect from light. The diluent should not be frozen, but should be kept cool.
