PRODUCT

QUALITY STATEMENT

BCG Vaccine Laboratory will continuously and consistently thrive to produce BCG Vaccine, both in Quality and Quantity as required for immunization of children against tuberculosis, with compliance of all relevant national regulations associated with Vaccine manufacture.

I. F.D BCG VACCINE ( 10 DOSES) I.P

Description :

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 2010.

Presentation :

  • 50 x 10/20 Doses Vial
  • Diluent : 1 ml Sodium Chloride Injection I.P

RECONSTITUTION :

Before reconstitution check the colour indication in the Vaccine Vial Monitor (VVM) stricker over the Flip off Cap. The condition over view of the VVM is given below. Reconstitute only with 1 ml of Diluent Sodium Chloride Injection IP supplied. The vaccine must be used as soon as possible, and any reconstituted container remaining at the end of the immunization session ( within three hours ) should be discarded by safe biodisposal way. The reconstituted vaccine must be protected from daylight and should be kept between +2 Degree C to +8 Degree C. COMPOSITION : Each 1ml of reconstitute vaccine contains 1x10*6 to 33 x 106 colony Formjing Units (CFU)

DOSE :

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

ADMINISTRATION :

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

IMMUNIZATION SCHEDULE :

For a maximum protection, this vaccine should be given as soon as after birth. It can be given at a 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 in practically all children leaves a superficial scar 2-10 mm in diameter. Rarely, nodule may persist and ulcerate. Occasionally enlargement of axillary lymph may appear in 2-4 months following immunization. Inadvertent subcutaneous injection produced abscess formation and may lead to ugly retracted scars.

CONTRA INDICATIONS:

The vaccine is contra indicated 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 BCG Vaccine according to standard schedules. Infants with clinical (symptomatic) AIDS should not receive BCG Vaccine.

STORAGE:

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

SHELF LIFE :

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

II. BCG THERAPEUTIC (40 MG.)

From the year 1994 BCGVL started manufacturing BCG Therapeutic Vaccine (40mg). This is also a live, freeze-dried preparation of Danish 1331 strain of BCG Mycobacterium bovis, meant for therapeutic use in Carcinoma bladder. Sodium glutamate is used as stabilizer. No preservatives are added.

Indications:

It is mainly indicated for adjuvant therapy in transitional Cell Carcinoma (TCC) of the urinary bladder after a definitive treatment. In selected cases of TCC it may be used for primary therapy also. 1. Superficial/ non-invasive ca.bladder (Stage A or TA), tumors with lamina propria invasion (T1) and selected cases of Stage B1 after TUR 2. Recurrent & multiple superficial TCC of bladder. 3. Ca.insitu of bladder. It is not indicated for treatment of solitary papillary tumors.

Dosage & Administration:

Usual dosage consists of intravesical instillation of 120 mg. BCG (Freeze dried) Therapeutic once a week for six weeks. Contents of three ampoules (40 mg. each) are suspended in 60 ml. Of physiological saline and instilled into the urinary bladder through a urethral catheter. The patient should be instructed to retain the drug in the urinary bladder by not urinating for atleast two hours after instillation and during this period he should frequently alter his position.

Adverse reactions:

Adverse reactions include dysuria, urinary frequency, hematuria and fever which may require interruption or discontinuation of therapy. Contra indications: 1. Active tuberculosis; 2. Immuno deficiency/ Immuno suppressive therapy; 3. Urinary tract infections; 4. Trauma to the urinary bladder; 5. A patient with fever needs careful evaluation before therapy is instituted; 6. Safety of this mode of therapy in pregnant women, nursing mothers and children has not been evaluated.

Important Note:

Intravesical instillation of BCG may lead to systemic BCG infection in immuno-compromised patients. This is a life threatening situation and needs prompt treatment with appropriate therapy.

Precaution:

This preparation contains live attenuated mycobacterium (BCG) and should be viewed BIOHAZARDOUS. All equipments coming in contact with this preparation are to be properly disinfected/ sterilized/ disposed off. Urine voided for 6 hours after instillation also needs to be properly disinfected.

Presentation:

BCG (Freeze-dried) Therapeutic is supplied in a strength of 40 mg./ ampoule.

Storage:

The preparation should be stored between 2�C and 8�C and protected from direct sun light. It should be used immediately after reconstitution. Reconstituted drug, if not used within one session, i.e., 4-6 hours, should be immediately discarded.

You are Visitor No:  Last Updated On: 08/08/2017

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BCG Vaccine Laboratory

Guindy Industrial Estate, Guindy Institutional Area, Guindy, Chennai, Tamil Nadu 600032

Email : bcgvl.tncgn@nic.in

Phone : 044 - 22500476, 044 - 22501189

Website Designed by

Kerala State Electronics Development Corporation Limited

No.86, 1st Floor,Sudarshan Buildings, Pasumpon Muthuramalinga Thevar Rd, Alwarpet, Nandanam, Chennai, Tamil Nadu 600035