Treatment of flat urothelial cell carcinoma in situ of urinary bladder & as adjunct therapy following transurethral resection of primary or relapsing superficial non-invasive papillary tumors that are limited to the bladder mucosa (stage Ta or T1).
Intravesical Start 2-3 wk after TURBT 120 mg wkly during 1st 6 wk, followed by 3 consecutive wkly instillation at 3 mth, at 6 mth & every 6 mth up to 36 mth thereafter.
Impaired immune response (congenital or caused by disease, drugs or other therapy), +ve HIV serology & +ve tuberculin reaction in conjunction w/ existing active TB, urinary bladder trauma, UTI. On going treatment w/ anti-TB agents. Careful evaluation of patients w/ fever before therapy. Pregnancy & lactation. Childn.
Do not administer IV, SC or IM. Not intended for immunization. Do not expose to light before & after reconstitution. Use aseptic technique during reconstitution, prep & administration. Before the 1st instillation, tuberculin test should be performed. Delay treatment in patients who experience traumatic catheterization till mucosal damage has healed. Adequate HIV assays in patients at risk of HIV infection. Refrain from sexual intercourse for 1 wk after instillation or use a condom.
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