BCG Vaccine

BCG Vaccine (Freeze Dried)

Connaught

Attenuated Tubercle Bacillus

Active Immunizing Agent

Action And Clinical Pharmacology: BCG Vaccine (Freeze-Dried) for intracutaneous administration, as prepared by Connaught Laboratories Limited, is made from a culture of an attenuated strain of living bovine tubercle bacillus (Bacillus Calmette-Gurin). It is supplied as a freeze-dried product ready for immediate use following reconstitution with the accompanying diluent, which consists of sterile phosphate-buffered saline.

The manufacturing and testing procedures used by Connaught for freeze-dried BCG vaccine comply with the recommendations of WHO as stipulated in WHO Technical Report Series No. 638, 1979: Revised Requirements for Dried BCG Vaccine.

Indications And Clinical Uses: For the vaccination of tuberculin negative individuals against tuberculosis. Administer only to individuals who have not been infected by the tubercle bacillus or to individuals who are tuberculin negative.

BCG Vaccination has no value in the treatment of tuberculous disease.

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 potentially infectious 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 test are negative.

Contra-Indications: 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. BCG vaccination should not be combined with vaccination against other diseases. After vaccination with another antigen, there should be a sufficient time interval to allow any reaction that results to subside before BCG vaccine is administered. Conversely, if BCG vaccine is given first, vaccination with other antigens should not be carried out until the reaction to the BCG vaccine has subsided.

BCG Vaccine (Freeze-Dried) should not be administered to the following: (a) individuals with primary immunodeficiency e.g.: agammaglobulinemia, dysgammaglobulinemia, hypogammaglobulinemia, and symptomatic HIV (Human Immunodeficiency Virus [HTLV-III/LAV]) infections. (b) individuals undergoing treatment with immunosuppressive agents of any kind. (c) children and young adults who are immunosuppressed in association with AIDS or other clinical manifestation of HIV (Human Immunodeficiency Virus [HTLV-III/LAV]) infection.

Manufacturers’ Warnings In Clinical States: BCG vaccination has no value in the treatment of tuberculous disease.

Precautions: Administer BCG Vaccine (Freeze-Dried) 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).

Pregnancy: 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 Reactions: Intracutaneous vaccination produces a small indurated papule 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 abscess may soften and may open spontaneously producing an ulcer. If an abscess forms, it may be punctured with 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. Some enlargement of the regional lymph nodes usually accompanies the lesions at the vaccination site. This was observed in 25% in a recent study in newborn infants. Spontaneous regression usually occurs after a period of several months. If, however, perforation and persistent suppuration accompany enlargement of the regional lymph glands, antituberculous chemoprophylaxis is indicated. Surgical excision of the lymph glands is not recommended.

Dosage And Administration: The freeze-dried vaccine is reconstituted by introducing the diluent supplied into the vial of vaccine (see instructions for reconstitution).

Cleanse the outer surface of the upper arm with alcohol and allow to dry. Using a 1 mL syringe with a 26 gauge needle, inject the recommended dose of reconstituted vaccine indicated below into the most superficial layers of the skin (intracutaneously) at one site. The bevelled side of the needle should face upwards.

The recommended dose for newborns and infants is 0.05 mL (0.05 mg). Children over 12 months of age and adults should be given the 0.1 mL (0.1 mg) dose. Do not inject s.c.

Reconstitution of Freeze-Dried Vaccine and Withdrawal from Rubber-Stoppered Vial: Do not remove the rubber stopper from the vial.

Apply a sterile piece of cotton moistened with a suitable antiseptic to the surface of the rubber stoppers of the vials of diluent and vaccine. Allow the antiseptic to act for at least 5 minutes. Draw into a sterile syringe a volume of air equal to the volume of the diluent in the vial. Pierce the center of the rubber stopper in the vial containing the diluent with the sterile needle of the syringe, invert the vial, slowly inject into it the air contained in the syringe, and, keeping the point of the needle immersed, withdraw into the syringe 1.5 mL of the diluent supplied. Then holding the syringe-plunger steady, withdraw the needle from the vial. Inject this volume of diluent into the vial of freeze-dried vaccine. Shake the vial gently until a fine, even suspension results. Withdraw the required dose of the reconstituted vaccine into the syringe.

Revaccination: If an individual remains tuberculin negative to the Mantoux test for 3 months or longer after vaccination, it is advisable to repeat the vaccination. The development of tuberculin sensitivity as measured by the Mantoux test confirms that the vaccine has established a primary infection in that individual.

Where BCG vaccination has been followed by a satisfactory level of tuberculin sensitivity a few months after vaccination, there is no current indication that revaccination is necessary within 5 to 10 years. In areas where young children are vaccinated, a second vaccination is sometimes given between the ages of 12 to 15 years.

Interpretation of Tuberculin Test: “After BCG vaccination, it is usually not possible to distinguish between a tuberculin reaction caused by virulent supra-infection and one resulting from persistent postvaccination sensitivity. Therefore, caution is advised in attributing a positive skin test to BCG (except in the immediate postvaccination period), especially if the vaccinee has recently been exposed to infective tuberculosis.”

Availability And Storage: Multidose vial plus diluent. The freeze-dried vaccine should be kept in a refrigerator at a temperature of not more than 8°C. The vaccine should not be used after the expiration date marked on the vial, otherwise it may be inactive. The vaccine should be used immediately after reconstitution and any reconstituted vaccine not used within 8 hours must be discarded. The reconstituted vaccine should be maintained at 4°C. At no time should the freeze-dried or reconstituted vaccine be exposed to sunlight, direct or indirect. Exposure to artificial light should be kept to a minimum.

BCG Vaccine (Freeze Dried) Connaught Attenuated Tubercle Bacillus Active Immunizing Agent

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