BCG ONCO VaccineUROVAC (BCG for Immunotherapy BP)

Description: UROVAC - BCG for Immunotherapy BP (Intravesical) is a live freeze-dried preparation made from Bacillus Calmette-Guerin strain, which is an attenuated strain of Mycobacterium bovis. The BCG is propagated as a live attenuated strain obtained as a primary seed (Strain ' Danish 1331). Bacillus Calmette-Guerin (BCG) immunotherapy has been widely accepted as the optimal treatment for carcinoma in situ and high grade superficial transitional Urinary Bladder Carcinoma. It is not intended as an immunizing agent for the prevention of tuberculosis. UROVAC - BCG for Immunotherapy BP is not a vaccine for the prevention of cancer.

Composition: Each vial contains 40 mg of BCG, having 1 - 8 x 108 CFU. 5% Sodium glutamate is used as the stabilizer. Reconstitute each vial with 50 mL of Sodium Chloride (0.9% w/v) injection.

Indications: Carcinoma in situ of urinary bladder prophylaxis and treatment, BCG is used intravesically for prophylaxis and treatment of primary multifocal, high grade and relapsed superficial transitional bladder carcinoma. It is used to reduce the frequency of tumor recurrence after transurethral resection and to eliminate existing tumors, including Ta and T1 tumors and carcinoma in situ (CIS tumors) with or without associated papillary tumors. It is not indicated for the treatment of papillary tumors occurring alone or for prevention of papillary tumors after transurethral resection.

Dosage Form: Freeze-Dried Lyophilized preparation.

Dosage & Administration: Per instillation, the contents of 2 or 3 vials (80 mg-120 mg) are required. Reconstitute each vial with 50 mL sodium chloride injection for instillation into the urinary bladder. Intravesical treatment with UROVAC - BCG for Immunotherapy BP should begin between 7 to 14 days after biopsy or Trans Urethral Resection (TUR).

Draw 1 mL of sterile diluent (preservative free 0.9% w/v Sodium chloride injection) into a syringe and add to one vial of BCG for Immunotherapy BP to resuspend. Leave them in contact for about 1 min. Then mix the suspension by withdrawing it into the syringe and expelling it gently back into the vial 2 or 3 times. Dilute the reconstituted product in an additional 49 mL of diluent, bringing the total volume to 50 mL.

Precautions should be taken particularly in common preparation areas, to avoid cross contamination of parenteral products with UROVAC - BCG for Immunotherapy BP. UROVAC - BCG for Immunotherapy BP should not be handled by persons with an immunological deficiency. Exposure to artificial light should be kept to a minimum period of time. The resuspended BCG for Immunotherapy BP should be used immediately after preparation. Discard unused portion after two hours.

Contraindications: Active tuberculosis, Immunodeficiency/immunosuppressive therapy, trauma to the urinary bladder, a patient with fever needs careful evaluation before therapy is instituted, safety of this mode of therapy in pregnant women, nursing mothers and children has not be evaluated.

Storage: UROVAC - BCG for Immunotherapy BP should be stored in dark between 2-8'C. Do not expose to light. Use immediately after reconstitution. UROVAC- BCG for Immunotherapy BP has a shelf life of 24 months, provided it is stored in dark between 2-8'C and protected from light.

WARNING: THIS PREPARATION SHOULD NOT BE USED AS A VACCINE AGAINST TUBERCULOSIS