SII-Onco-BCG Dosage/Direction for Use

Treatment should be started 2-3 weeks after performing TURBT. The treatment schedule is weekly repeated instillation with SII-ONCO-BCG (120 mg) during first 6 weeks, followed by 3 consecutive weekly instillations at 3 months, at 6 months and thereafter every 6 months up to 36 months. This means that a patient who stays tumor free after the initial resection will receive a total of 27 instillations in a period of three years.
The duration and frequency of maintenance treatment should be evaluated on the basis of tumor classification and clinical diagnosis.
RECONSTITUTION: Add 1 ml of sterile isotonic preservative free saline (0.9% NaCl) by means of a sterile syringe to the contents of 1 vial of SII-ONCO-BCG and allow to stand for few minutes. Then gently swirl the vial until a homogenous suspension is obtained (Caution: Avoid forceful agitation). The above procedure may be repeated to reconstitute each subsequent vial/s used.
PREPARATION OF SOLUTION FOR INSTILLATION: Transfer the reconstituted suspension from the vial into a 50 ml syringe. Rinse the empty vial with 1 ml of sterile isotonic saline. Add the rinse fluid to the reconstituted suspension in the 50 ml syringe.
The previously mentioned procedure may be repeated for each subsequent vial/s used.
Finally dilute the content of the 50 ml syringe (by adding sterile physiological saline solution) up to a total volume of 50 ml. Mix the suspension carefully. The suspension is now ready to use.
METHOD OF ADMINISTRATION: Insert a catheter by aseptic technique through urethra into bladder and drain completely. Attach 50 ml syringe containing the prepared solution to the catheter and instill into bladder slowly by gravity where it should be retained for 2 hours. Patient should not ingest any fluid 4 hours before and 2 hours after instillation and should lie on their stomach for first 15 mins after instillation. Patient may have frequent position changes on either sides every 15 mins in order to distribute the medication properly throughout the bladder. Thereafter, the patient should be made to void the instilled contents in sitting position. If there is any bleeding or any other signs of traumatic injury, treatment should be postponed for at least 1 week.