Freeze-dried

BCG Vaccine

Composition

Each ml of reconstituted BCG vaccine consists of:

-LiveMycobacterium bovisBCG Pasteur strain 1173P2: 0.75 mg

-Sodium L-glutamate monohydrate: 3.75 mg

-Magnesium Sulfate, 7H2O: 125 µg

-Dipotassium hydrogen phosphate: 125 µg

-L-asparagine monohydrate: 1 mg

-Ferro ammonium citrate: 12.5 µg

-Glycerol: 18.4 mg

-Citric acid monohydrate: 0.5 mg

-Water for injection up to1 ml

Dosage Form

White color freeze-dried powder.

Pharmacological Information

BCG vaccine is a freeze-dried powder containing Bacillus Calmette and Guérin (BCG), strain 1173P2 which is a live, attenuated strain ofMycobacterium bovis. The BCG vaccine is delivered in vials, each ml of reconstituted vaccine containing 1.5 -  6X106 colony forming units (CFU) of BCG. No preservatives have been added. BCG has a stimulating effect on the macrophage functions and activates natural killer (NK) cells and T-lymphocytes.

Dosage and Aministration

Transfer 2 ml diluent (Sauton solution) into the vaccine vial with a sterile syringe and shake the vial gently and mix the ingredients. This vaccine is for intradermal (Id) use only. Dose for children below one year is 0.05 ml of the reconstituted vaccine and for other is 0.1 ml. Use a sterile syringe and a sterile fine short needle (26G, 25G10 mm) for each injection; injection must be made in the distal part of the deltoid muscle (in arm). Antiseptic should be allowed to evaporate completely from the skin before injection is made. Injection should be made slowly into the upper layer of skin. Deep injection increases the risk of abscess and adenitis formation. Any reconstituted BCG vaccine must be discarded after 4 hours of reconstitution.

Indications

In countries where tuberculosis is endemic, BCG vaccine injection is recommended to neonates and PPD negative individuals. In other locations, vaccination is advised for people who have continuous contact with tuberculosis patients (high-risk groups), and cannot receive prophylactic therapy of isoniazid.

Warnings

This product is biologic and should be discarded with safety consideration.

Side Effects

Normally, a red nodule area appears at the site of injection, changing to a small vesicle and ulcer after 2-4 weeks that recovers after 2-5 months. Eventually, all cases leave a small superficial scar (2-10 mm diameter). Occasionally 2-4 months after injection, enlargement of axillary lymph nodes may be appeared that should be referred to the center of vaccination for recording and guidance. In individual with immune disorders, widespread infection and osteomyelitis may be developed.

Contraindications

The vaccine is contraindicated with (congenital or acquired)

cell-mediated immune deficiency. In HIV cases (without clinical symptoms) vaccination is the same as a normal person but others should not be vaccinated. Also this vaccine should not be administered in cases with significant fever and positive tuberculin reaction.

Pregnancy & Lactation

Although no harmful effect of BCG vaccine on the fetus has been observed, vaccination during pregnancy is not recommended unless there is an excessive risk of unavoidable exposure to infective tuberculosis.

Storage Condition & Shelf Life

Freeze-dried BCG vaccine and the diluent must be stored at 2-8°C and protected from sunlight and diffuse daylight to avoid any vaccine failure. The expiry date (2 years) indicated on the label of vials only applies if vials are stored under these conditions. The reconstituted vaccine can be stored for up to 4 hours when refrigerated at 2-8°C and protected from light. Unused solution should be discarded after 4 hours.

Packaging

Each large box contains 10 medium boxes, each medium box contains 50 vials of 1.5 mg lyophilized BCG vaccine.