Genpharm BCG Vaccine

BCG Vaccine is a live freeze-dried vaccine derived from attenuated strain of Mycobacterium bovis (Bacillus Calmette Guerin Moscow strain 361-I) used for the prevention of tuberculosis. The freeze-dried vaccine is white and crystalline in appearance. It contains Sodium Glutamate as stabilizer. The vaccine meets the requirements of W.H.O. when tested by the methods outlined in W.H.O., TRS. 979 (2013).
Composition: Live, attenuated BCG Vaccine (Bacillus Calmette Guerin Strain).
Each 0.1 mL contains between: 2 x 10⁵ and 8 x 10⁵ C.F.U.
Reconstitute with Sodium Chloride Injection.
Dose: 0.05 mL, Intradermal for infants under one year old; 0.1 mL, Intradermal for children over one year of age and adult.

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 severe 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, Hepatitis B, Haemophilus influenzae type b, yellow fever vaccines and vitamin A supplementation, but at a separate site.

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 and 0.1 mL for children over one year of age and adult of the reconstituted vaccine given intradermally. The skin should not be cleaned with antiseptic. The vaccine should be preferably given with a tuberculin syringe or 25 G/26 G or 27 G 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 be immunized.
Intradermal Injection Technique: The skin is stretched between thumb and forefinger and sterile needle (25 G/26 G or 27 G) inserted bevel upwards for about 2 mm into superficial layers of the dermis (almost parallel with the surface). Raised blanched bleb showing tips of hair follicles 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.

BCG vaccine is contraindicated in hypogamma-globulinemia, congenital immunodeficiency, sarcoidosis, leukaemia, generalised malignancy, HIV infections or any other disorder in which natural immune response is altered, as also those on immunosuppressive therapy, corticosteroids, radiotherapy. In chronic eczema or other dermatological disease, the vaccine can be given in a healthy area of the 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: If the child is 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 of 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 IAP 1996.
Immune Deficiency: The vaccine is contraindicated in individuals with cell-mediated immune deficiency.
Individuals known to be infected with human immunodeficiency virus (HIV), either non-symptomatic or symptomatic, should NOT receive BCG vaccine.

Information of Antituberculosis Drugs: The Minimum Inhibitory Concentration (MIC) towards the Mycobacterium bovis BCG Moscow strain 361-I is indicated in mentioned table as follows. (See table.)

Click on icon to see table/diagram/image

In case of systemic or persistent local infection with BCG vaccine occurs, expert advice should be taken for the necessary treatment. BCG Moscow strain 361-I is resistant to pyrazinamide.
Use in Children: Special Case of Children Born to HIV Seropositive Mothers: The obligatory passage of maternal antibodies of the IgG 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.

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 to 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 abscess may appear at the point of injection, or satellite adenitis, leading in exceptional cases to suppuration. Exceptional cases of lupus vulgaris at the injection point have been reported. Inadvertent subcutaneous injection produces abscess 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.

The BCG vaccine may 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 a 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 a doctor's advice before using a medicinal product.

Reconstitution: Tap the vaccine vial gently so as to get the white and crystalline vaccine powder at the bottom of the vial. BCG vaccine vial of 20 doses (0.05 mL) for infants under one year old/10 doses (0.1 mL) for children over one year of age and adult to be reconstituted by adding the entire content of the supplied container of diluent (Sodium Chloride Injection).
Carefully invert the vial a few times to resuspend freeze dried BCG. Gently swirl the vial of resuspended vaccine before drawing up each subsequent dose. The resulting suspension should be homogenous, slightly opaque and colourless. The reconstituted suspension may occasionally show clumps, which is normal characteristic of Mycobacterium bovis. Avoid vigorous shaking which may enhance/aggregate clumps formation. Reconstitute only with diluent provided by manufacturer. 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 must be stored in the dark at 2-8°C for no longer than 6 hours (1 immunisation session).
Any opened vial remaining at the end of a vaccination session (within six hours of reconstitution) must be discarded. The vaccine vial monitor for this type of vaccine is attached to the vial cap and should be discarded when the vaccine is being reconstituted.
The diluent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. In the event of either being observed, discard the diluent or reconstituted vaccine.
The Vaccine Vial Monitor (Optional): Vaccine Vial Monitors: Use: Square is lighter than outer circle.
Discard Point: The colour of the inner square of the VVMs begins with a shade that is lighter than the outer circle and continues to darken with time and/or exposure to heat.
Do not use: Square matches outer circle; Square is darker than outer circle.
Discard Point: Once a vaccine has reached or exceeded the discard point, the colour of the inner square will be the same colour or darker than the outer circle.
Inform the supervisor.
Cumulative heat exposure over time.
Vaccine Vial Monitors (VVMs) are on the cap of BCG Vaccine supplied through Serum Institute of India Pvt. Ltd. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the outer circle, then the vaccine can be used. As soon as the colour of the central square is the same colour as the outer circle or of a darker colour than the outer circle, then the vial should be discarded.

BCG vaccine (Freeze-dried) should be stored in dark between 2° to 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.

Vaccines, Antisera & Immunologicals

L03AX03 - BCG vaccine ; Belongs to the class of other immunostimulants.

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