BCG VACCINE powder for injection with diluent

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain), Quantity: 1.5 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: monosodium glutamate monohydrate

Administration route:

Intradermal

Units in package:

1 vial vaccine with diluent

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BCG Vaccine is recommended for active immunisation in high risk groups. The NHMRC recommendation for BCG vaccination are: BCG is recommended for use in 3 groups of infants: . Aboriginal and Torres Strait Islander neonates in regions of high incidence; . Neonates born to patients with leprosy; . Children under the age of 5 years who will be travelling to live in countries of high tuberculosis prevalence for long periods. BCG vaccination should be considered for the following children and adolescents: .Neonates who will be living in a household which includes immigrants or visitors recently arrived from countries of high prevalence (this also applies to neonates in families who have returned to visit the homes of relatives in countries of high prevalence); . Children and adolescents aged less than 16 years who continue to be exposed to a patient with active tuberculosis, and where the child or adolescent cannot be placed on isoniazid therapy or the active case has organisms resistant to both isoniazid and rifampicin. In addition to the above categories, there are other groups of individuals who are at increased risk of tuberculosis, but for whom the value of BCG vaccine is less certain. These groups are: . Health care workers with a high risk of exposure to tuberculosis, such as staff of chest clinics and tuberculosis wards, physiotherapists, diagnostic laboratory staff, autopsy room staff, and most medical and nursing staff of public hospitals; . Travellers over the age of 5 years who will spend prolonged periods in countries of high tuberculosis prevalence. . A tuberculin test should be performed prior to BCG vaccination in all individuals, except in infants under 6 months of age. Only subjects in whom a test dose of 10 units produces less than 5mm of induration should receive BCG. BCG vaccination has no value in the treatment of tuberculosis disease.

Product summary:

Visual Identification: A white powdery freeze-dried plug.; Container Type: Vial; Container Material: Other composite material; Container Life Time: 32 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1996-01-11