BCG Vaccine (Freeze-Dried)

DESCRIPTION

BCG vaccine is a freeze-dried vaccine which contains live attenuated of Mycobacterium bovis (Bacillus Calmette-Guerin), Paris strain.

Composition
Each ampoule of vaccine contains :
Live attenuated Bacillus :

  • Calmette-Guerin 1.5 mg

Diluent consist of :

  • Sodium Chloride 0.9 %

Indication
Active immunization against tuberculosis.

Mechanism of action
Stimulates the body to produce antibody against tuberculosis.

Side effects
The local reaction after BCG immunization is normal.

A small tender red swelling appears at the injection site, which than changes to a small vesicle, and than become ulcer in 2-4 weeks. This reaction usually disappears after 2-5 months, and generally in a child will result a scare with 2-10 mm in diameter.

Rarely the nodus and ulcer keep remaining. Occasionally, enlargement of axillary lymph nodes may appear in 2-4 months following immunization.

Very rarely, enlarged lymph nodes suppurate. Inadvertent subcutaneous injection may produce abscess formation and may lead to scarring.

Contraindication

  • Immune-deficiency.
  • Individuals infected with human immunodeficiency virus (HIV), both asymptomatic and symptomatic should not be vaccinated with BCG.

Drug interaction
Not reported.

Storage

  • BCG vials (freeze dried) must be stored at temperatures between +2°C to +8°C.
  • The vials of vaccine and the diluent should be transported together. However the diluent must not be frozen; it should be kept at room temperature.
  • The vaccine must be protected from light.
  • Expiry date 1 year.
  • Once reconstituted, BCG vaccine should be used immediately or within 3 hours, and the remaining vial vaccine must be discarded.

PRESENTATION

• Box @ 5 ampoules of BCG vaccine + 5 ampoules of diluent (4 mL)

• Box@ 10 ampoules of BCG vaccine + Box @ 10 ampoules of diluent (4 mL)