Active Ingredient: BCG vaccine
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Urethral, 50 milliliters bCG vaccine, once weekly, over the duration of 6 weeks.
Regimen B: Urethral, 50 milliliters bCG vaccine, once weekly, over the duration of 3 weeks.
Weekly instillation during the first 6 weeks.
Maintenance treatment consists of weekly instillation with BCG vaccine during 3 consecutive weeks at months 3, 6, and 12 after initiation of the treatment. The need for maintenance treatment every 6 months beyond the first year of treatment should be evaluated on the basis of tumour classification and clinical response.
Insert a catheter via the urethra into the bladder and drain the bladder completely.
Connect the syringe containing the prepared BCG suspension to the catheter and instil the suspension into the bladder. If a closed-system transfer device is not available, the suspension is instilled into the bladder by gravity flow. After instillation, remove the catheter.
The instilled suspension must remain in the bladder for a period of 2 hours. During this period care should be taken that the instilled suspension has sufficient contact with the whole mucosal surface of the bladder. Therefore, the patient should not be immobilised or, in case of a bed-ridden patient, should be turned over from back to abdomen and vice versa every 15 minutes. After two hours, have the patient void the instilled suspension in a sitting position.
Urine should be voided in a sitting position for 6 hours after treatment and two cups of household bleach should be added to the toilet before flushing. The bleach and urine should be left to stand in the toilet for 15 minutes before flushing.
NOTE: The patient must not ingest any fluid for a period starting 4 hours prior to instillation, until bladder evacuation is permitted (i.e. 2 hours after instillation).
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