Active Ingredient: BCG vaccine
BCG vaccine is indicated for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (Stage Ta (grade 2 or 3) or T1 (grade 1, 2 or 3)) after transurethral resection.
BCG vaccine is only recommended for stage Ta grade 1 papillary tumours, when there is judged to be a high risk of tumour recurrence.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Urethral, 50 milliliters bCG vaccine, once weekly, over the duration of 6 weeks.
Weekly instillation during the first 6 weeks.
When used as an adjuvant therapy after TUR of a superficial urothelial cell carcinoma of the bladder, treatment with BCG vaccine should be started between 10 and 15 days after performing the TUR. Treatment should not be started until mucosal lesions after TUR have healed. Treatment should also be delayed in cases of gross haematuria or major bladder irritability.
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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