Freeze dried BCG Vaccine is a preparation of live bacteria derived from the culture of attenuated strain of Mycobacterium bovis BCG. It is used for the prevention of childhood tuberculosis. The vaccine complies with the requirements of Indian Pharmacopoeia.

Description:

White Pellet or Powder which, when reconstituted yields an opalescent and homogenous suspension.

Composition:

Each reconstituted vial contains 1.5 to 6 million Colony Forming Units (CFU) of Mycobacterium bovis BCG.

Dose :

• 0.05 ml for Infants under one month of age
• 0.1 ml for children over one month and above

Presentation :

    Vaccine: 10 Doses/vial

    Diluent: Injection Sodium Chloride Injection I.P.

Reconstitution :

Before reconstitution check the color indication in the Vaccine Vial Monitor (VVM) sticker over the Flip-Off Cap. The condition overview of the VVM is given below.

                                 

Reconstitute only with the entire quantity of Diluent Sodium Chloride Injection IP supplied. The vaccine must be used as soon as possible, and any reconstituted vaccine along with the container remaining at the end of the immunization session (within three hours) should be treated as Biomedical waste and discarded safely.

The reconstituted vaccine must be protected from daylight and should be kept between 2° C to 8 ° C.

Composition per vial :

• • • BCG: 1.5-6 Million CFU
    • Monosodium L-Glutamate:3 mg

Administration:

BCG vaccine is intended to be injected strictly through Intra dermal route by the trained vaccinator.

Immunization Schedule:

For maximum protection, this vaccine should be given as soon as after birth. It can be given at the same time along with other vaccines such as DPT, DT, TT, Measles, Polio vaccines (OPV & IPV), Hepatitis-B and Yellow fever

Side Effects :

A local reaction at the vaccination site is normal after BCG vaccination. A small tender red swelling appears at the site of the injection which gradually changes to a small vesicle and then an ulcer in 2-4 weeks. The reaction usually subsides within two to five months and practically, in all children leaves a superficial scar of 2-10 mm in diameter.

Rarely nodules may persist and ulcerate. Occasionally enlargement of auxiliary lymph may appear in 2 – 4 months following immunization. The inadvertent subcutaneous injection produces abscess formation and may lead to ugly retracted scars.

Contraindications:

The vaccine is contraindicated in those with cell-mediated immune deficiency. Keloid and Lupoid reactions may occur at the site of injection and such children should not be revaccinated.  

HIV-infected, non-symptomatic infants should be immunized with the BCG vaccine according to standard schedules. Infants with clinical (symptomatic) AIDS should not receive the BCG vaccine.

Storage:

BCG vaccine should be stored and transported between +2 °C and +8°C. It is even more stable if stored in temperatures as low as -20°C. The diluent should not be frozen but should be kept cool.  Protect the vaccine from light.

Shelf Life:

24 Months from the date of manufacture if stored at 2°C to 8°C in dark.

ProductChart

Vaccine I.P. (10 dose/vial)& Diluent (Sodium chloride I.P.)

                                                                             

Inner carton:

                                         

Outer carton: