BCG VACCINE (Freeze Dried)

Connaught

Attenuated Tubercle Bacillus

Tuberculosis Prophylaxis

Indications: For the vaccination of tuberculin negative individuals against tuberculosis. Administer only to individuals who have not been infected by the tubercle bacillus and who are negative to the Tuberculin PPD (Mantoux) test. In newborn infants (birth to 21 days) prior tuberculin testing before BCG vaccination is usually not deemed necessary but tuberculin testing should precede vaccination for individuals in all other age groups.

Administration of BCG Vaccine (Freeze dried) is recommended only for tuberculin negative individuals who are repeatedly exposed to untreated or inadequately treated active tuberculosis; communities or groups of persons with high rates of infection, including Indian, Metis and Inuit children, in which other control measures have proven ineffective; health workers at considerable risk of exposure to unrecognized infectious pulmonary tuberculosis or who handle tubercle bacilli or potentiallyinfectious specimens in a laboratory; newborn infants whose mothers have infectious tuberculosis at the time of delivery, although isoniazid prophylaxis is preferred to avoid the necessary separation of mother and infant when BCG is used. However, BCG is recommended if the infecting strain is isoniazid resistant or if compliance with a program of isoniazid prophylaxis cannot be assured. BCG may also be considered for the infant after isoniazid prophylaxis is completed, provided chest radiographs and tuberculin testare negative.

Contraindications: Do not vaccinate individuals suffering general malaise or conditions such as measles, whooping cough, eczema, furunculosis, atopic dermatitis or other exudative or inflammatory dermatologic conditions, acquired or natural immunodeficiency states. BCG vaccination should not be combined with vaccination against other diseases.

Warnings: Has no value in the treatment of tuberculosis disease.

Precautions: Administer intracutaneously. Do not inject s.c. The vaccinated person should avoid contact with all known tuberculous contacts or suspects until the sensitivity to tuberculin is verified (usually within 3 months). Although no harmful effects on the fetus have been observed, use of BCG is not recommended during pregnancy unless there is an excessive risk or unavoidable exposure to infective tuberculosis.

Adverse Effects: A small indurated papule appears in 1 to 3 weeks. In 39% of vaccinated newborns, this induration was 10 to 15 mm in diameter. Ulceration may follow, though with this strain and the proper administration technique ulceration is usually minimal and cold abscesses not observed. If small cold abscesses should appear, spontaneous resorption usually occurs. In a few instances, the abcess may soften and may open spontaneously producing an ulcer. If an abcess forms, it may be puncturedwith a syringe and a fine needle in order to avoid ulceration and scar formation.

Enlargement of the regional lymph glands may occasionally develop after vaccination. Spontaneous regression usually occurs after a period of several months. If, however, perforation and persistent suppuration accompany enlargement of the regional lymph glands, anti-tuberculous chemoprophylaxis is indicated. Surgical excision of the lymph glands is not recommended.

Dosage: Adults and children over 1 year of age: 0.1 mL (100 µg); Infants and children under 1 year of age: 0.05 mL (50 µg), intracutaneously into the outer surface of the upper arm. Repeat vaccination for individuals remaining tuberculin negative to the Mantoux test more than 3 months after the initial vaccination is advisable.

Supplied: Multi-dose vial plus diluent. Store below 8°C. Reconstituted vaccine should be used immediately and any not used by the end of the day should be destroyed. The reconstituted vaccine should be stored at 4°C during the day of reconstitution. Do not expose vaccine to direct or indirect sunlight. Exposure to artificial light should be kept to a minimum.