DESCRIPTION
BCG Vaccine is a live freeze-dried vaccine derived from attenuated strain of mycobacterium bovis. (Bacillus Calmette Gueri) used for the prevention of tuberculosis. The vaccine meets the requirements of WHO when tested by the methods outlined in WHO, TRS (1987), 771 (1988).

COMPOSITION
Live, attenuated BCG Vaccine (Bacillus Calmette Gueri strain)
Each 0.1 ml contains between: 1x10⁵ and 33x10⁵ C.F.U.
Reconstitute with Sodium Chloride Injection
Dose: 0.05 ml, Intradermal for infants under one year old

RECONSTTUTION
BCG Vaccine vial of 10 doses (0.05 ml) for infants under one year old, to be reconstituted with 0.5 ml of sodium chloride injection.
BCG Vaccine vial of 20 doses (0.05 ml) for infants under one year old, to be reconstituted with 1 ml of sodium chloride injection.

Carefully invert the vial a few times to resupend freeze-dried BCG. Gently swirl the vial of resupended vaccine before drawing up each subsequent dose. The resulting suspension should be homogenous, slightly opaque and colourless. Reconsitute only with diluent provided by manufactures. Using an incorrect diluent may result in damage to the vaccine and / or serious reactions to those receiving the vaccine. Use immediately after reconstitution. If the vaccine is not used immediately then it should be stored in the dark at 2° to 8° C for no longer 6 hours (1 immunisation session).
Any opened vial remaining at the end of a vaccination session (within six hours of reconstitution) must be discarded

DOSAGE AND ADMINISTRATION
The vaccine is intended to be injected strictly via the intradermal route, avoiding the subcutaneous route.
The vaccination dose is 0.05 ml for children under one year of age including the new born, of the reconstituted vaccine given intrademally. The skin should not be cleaned with antiseptic. The vaccine should be preferably given with a tuberculin syringe or 25G/26G sterile needle and syringe.
Skin testing with tuberculin is not generally carried out before giving BCG, but when performed, those who are found to be positive reactors need not to be immunised.

INTRADERMAL INJECTION TECHNIQUE
The skin is stretched between thumb and forefinger and sterile needle (25 G or 26 G) inserted bevel upwards for about 2mm into superficial layers of the dermis (almost parallel with the surface). Raised blanched bleb showing tips of hair follicle is a sign of correct injection. The site of injection is at insertion of the deltoid muscle into the humerus. Sites higher on the arm are likely to lead to keloid formation.

INDICATIONS AND IMMUNIZATION SCHEDULE
BCG Vaccine should be given routinely to all infants at risk of early exposure to tuberculosis. This vaccine should be given soon after the child is born. BCG administered early in life provides high level of protection particularly against sever forms of childhood tuberculosis and tubercular meningitis. In countries with low prevalence of tuberculosis, BCG vaccination should be restricted to high-risk groups such as hospital personnel and tuberculin negative contacts of known cases of tuberculosis. The vaccine can be given simultaneously with DTP, DT, TT, Measles, Polio and Hepatitis B vaccines, but at a separate site.

ADVERSE EVENTS
Adverse events occur in 1-10% of individuals who receive BCG and vary depending upon dosage, method of administration and age of vaccinee. Lymphadenitis can also occur. Lymphangitis can occur if the vaccine is administered too close to the shoulder and is characterized by streaking from site of injection towards the regional lymph nodes. Lymphadenopathy of regional lymph nodes, which resolves spontaneously, occurs occasionally in young children. Osteomyelitis has been reported to occur rarely (one case per million vaccines) and most frequently in neonates. Disseminated BCG infection, which can be fatal, occurs rarely in 1-10 cases per 10 million vaccines and is more common in immunodeficient children.

CONTRAINDICATIONS AND PRECAUTIONS
BCG vaccine is contraindicated in hypogamma- globulinemia, congenital immunodeficiency, sarcoidosis, leukaemia, generalized malignancy, HIV infections or any other disorder in which natural immune response is altered, as also those on immunosuppressive therapy, corticosteroids, radiotheraphy. In chronic eczema or other dermatological disease, the vaccine can be given in a healthy area of skin.
Keloid and lupoid reactions may also occur at the site of injection and such children should not be revaccinated.
SPECIAL CASE OF CHILDREN BORN TO HIV SEROPOSITIVE MOTHERS.
The obligatory passage of maternal antibodies of the lgG type through the placenta makes it impossible to interpret the serology of the child until the age of about 9-10 months (persistence of the maternal antibodies has been detected up to 14 months). It is therefore necessary to wait until the child has been found to be seronegative, as determined by immuno-transfer (Western Blot) with the support, if necessary, of techniques for detecting the viral genome, before confirming that the child is not infected. If the child is not infected BCG vaccine is contraindicated irrespective of the child’s condition, given the potential risk of development of ’’BCG-itis’’ in the vaccinated child. The advice of a specialized medical team is required.
Neither absence of BCG scar formation nor negative PPD reaction is indicative pf poor BCG uptake. There is no need to repeat BCG inoculation in babies who do not develop BCG scar as advocated in the guidelines of IAP1996.

DRUG INTERACTIONS AND OTHER INTERACTIONS
The BCG vaccine may not be routinely given to any child exposed early to the risk of contact with the disease (tuberculosis).
In order to avoid possible interactions between several medicinal products, any other ongoing treatment should be systematically reported to your doctor.
There is no indication to vaccinate women during pregnancy. Breast-feeding can continue despite vaccination with BCG vaccine.
As a general rule, during pregnancy and breast-feeding, it is always recommended to ask your doctor’s advice before using a medicinal product..

SIDE EFFECTS
A local reaction is normal. Following BCG vaccination, 2 to 3 weeks later a papule develops at the site of vaccination and increases slowly in size of a diameter of 4-8 mm in 5 weeks. It then subsides or breaks into a shallow ulcer covered with a crust. Healing occurs spontaneously in 6-12 weeks leaving a permanent, tiny round scar 2-10 mm in diameter. In rare cases an abcess may appear at the point of injection, or satellite adenitis, leading in exceptional cases to suppuration. Exceptional cases of lupus vulgaris at the point of injection have been reported. Inadvertent subcutaneous injection produces abcess formation and may lead to ugly scars. A risk generalised reaction to BCG exists in immunodepressed individuals vaccinated with BCG or living in contact with a vaccinated individual.

STORAGE
BCG Vaccine (Freeze-dried) should be stored in dark between 2°C and 8°C. It is even more stable if stored in temperatures as low as -20°C. Protect from light. The diluent should not be frozen, but should be kept cool.

SHELF LIFE
24 months from the date of last satisfactory potency test if stored in a dark place at recommended temperature.

PRESENTATION
10 dose vial plus diluent (0.5 ml)
2 0 dose vial plus diluent (1 ml)