Genpharm BCG Vaccine Caution For Usage

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.