Description
BCG vaccine is a live freeze-dried vaccine which contains attenuated live Mycobacterium bovis (Bacillus Calmette Guerin = BCG) strain Paris No. 1173-P2.
Indication
Active immunization against tuberculosis
Composition
After reconstituted with 4 ml diluent, each ml of vaccine contains :
Live bacillus BCG 0.375 mg
Sodium glutamate 1.875 mg
Sodium chloride 9 mg
Vaccine should be injected intracutaneously at insertio of M. Deltoideus.
Dosage :
Infants < 1 year : 0.05 ml
Children > 1 year : 0.1 ml
Re-vaccination should be done at the age of :
5 - 7 year with dose 0.1 ml
12 - 15 year with dose 0.1 ml
Dosage and Administration
By means of 5 ml sterile and dry syringe equipped with a long needle; add diluent into ampoule filled with freeze dried BCG vaccine(see leaflet). Add 4 ml of diluent for babies ( up to 1 year ) and 2 ml for children.
Side Effects
BCG immunization will not cause general symptoms such as fever. The following one to two weeks, induration and erythema occur at the site of injection which will be converted into pustula and become ulcer. It is not necessary to treat this wound since it will be healed spontaneously by leaving a scar. Occasionally swelling of the lymphatic glands below the axilla and/or neck occurs, solid, painless and without fever . Those are normal reactions which do not need medication and will spontaneously disappear. Though rare lymphadenitis suppurative may occur due to over dose or subcutaneously administration to infants less than 1 year. This process has characteristic as a quiet process and spontaneously recover without therapy.
Contraindications
The presence of acute/chronic dermatologic diseases such as eczema, furunculosis, etc., and those suffering from tuberculosis.
Storage and Expiry
Keep at temperatures between 2o and 8oC, freezer is preferable. BCG vaccine should be transported in cool condition (2o - 8oC) and protect from direct/indirect sunlight. Expiry date : 1 year Note : Reconstituted vaccine : 1. Have to be used within 3 hours, and it should be kept in cool condition (2o - 8oC, do not freeze) at the mean time. 2. After 3 hours, the remaining vaccine should be discarded.
Presentation
Freeze-dried vaccine in ampoule with 4 ml diluent in ampoule.
