Bcg İntraVesical 120 Mcg

Description

Bcg İntraVesical 120 Mcg

1. Clinical information
1.1 Therapeutic indications

Bacillus Calmette-Guerin treatment of primary or simultaneous carcinoma at the site of the bladder and high-grade and / or recurrent superficial papillary transition cell carcinoma (Stage Ta (grade 2 or 3) or T1 (grade 1, 2 or 3) after transurethral resection) .

Bacillus Calmette-Guerin is recommended only for stage Ta grade 1 papillary tumors when it is decided that there is a high risk of tumor recurrence.

1.2 Posology and method of administration

Adults and the elderly
The contents of a reconstituted and diluted vial of Bacillus Calmette-Guerin are dropped into the bladder as indicated.
Induction therapy
Weekly vaccination with Bacillus Calmette-Guerin for the first 6 weeks.
When using superficial urothelial cell carcinoma of the bladder as an adjuvant therapy after TUR (see “Therapeutic indications”), Bacillus Calmette-Guerin treatment should be started 10 to 15 days after TUR is performed. Treatment should not be started until mucosal lesions heal after TUR heals. Treatment should also be delayed in case of gross hematuria or major bladder irritability.

Maintenance therapy

Maintenance therapy consists of weekly vaccination with Bacillus Calmette-Guerin for 3 consecutive weeks at 3, 6 and 12 months after the start of treatment. The need for maintenance therapy every 6 months after the first year of treatment should be assessed on the basis of tumor classification and clinical response.

Pediatric population
No data

Method of Application
Intravesical vaccination

Insert a catheter into the bladder through the urethra and empty the bladder completely. Connect the 50 ml syringe containing the prepared Bacillus Calmette-Guerin suspension to the catheter and inoculate the suspension into the bladder. If there is no closed system transfer device, 50 ml of Bacillus Calmette-Guerin suspension is delivered to the bladder by gravity flow. Remove the catheter after instillation. The dropped Bacillus Calmette-Guerin suspension should remain in the bladder for 2 hours. During this time, it should be noted that the grafted Bacillus Calmette-Guerin suspension has sufficient contact with the entire mucosal surface of the bladder. Therefore, the patient should not be immobilized or, if there is a patient who has stepped on the bed, should be turned from the back to his stomach or vice versa every 15 minutes. Two hours later,
Urine should be canceled in a sitting position for 6 hours after treatment and two glasses of household bleach should be added to the toilet before washing. Bleach and urine should be left in the toilet for 15 minutes before washing.
NOTE: The patient should not take any fluids starting 4 hours before instillation until the bladder is allowed to empty (eg 2 hours after instillation).