TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.

The intact vials of BCG VACCINE should be stored refrigerated at 2-8°C (36-46°F). Data on file, Organon Teknika Corporation LLC, Durham, NC. The use of TICE BCG may cause tuberculin sensitivity. High risk was defined as two occurrences of tumor within 56 weeks, any stage T1 tumor, or three or more tumors presenting simultaneously. The sterile, single-use multiple puncture device is for use with the BCG VACCINE only. TICE BCG has not been evaluated for its carcinogenic, mutagenic potentials or impairment of fertility. Patients should be instructed to increase fluid intake in order to "flush" the bladder in the hours following BCG treatment. For acute local or systemic reactions suggesting active infection, an infectious disease specialist experienced in BCG complications should be consulted. A Randomized Prospective Study Comparing Intravesical Instillations of Mitomycin-C, BCG-Tice, and BCG-RIVM in pTa-pT1 Tumours and Primary Carcinoma. Each vial contains 1 to 8 × 10 8 CFU, which is equivalent to approximately 50 mg (wet weight), as lyophilized (freeze-dried) powder, NDC 0052-0602-02. Systemic toxicity with TICE BCG was markedly increased compared to that of MMC, with 181 events for TICE BCG compared to 80 for MMC. The papules reach a maximum diameter (about 3 mm) after 4 to 6 weeks, after which they may scale and slowly subside. There are no data to suggest that the acute, local urinary tract toxicity common with BCG is due to mycobacterial infection and antituberculosis drugs (e.g., isoniazid) should not be used to prevent or treat the local, irritative toxicities of TICE BCG. JAMA 1997;278:833-837. Health care workers should be informed about (a) the lack of data regarding the efficacy of preventive therapy for MDR-TB infections and (b) the risks of drug toxicity associated with multi-drug preventive therapy regimens. All suspected adverse reactions to BCG vaccination should be reported to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 and to the Vaccine Adverse Event Reporting System (VAERS); telephone 1-800-822-7967. Accidental overdosages if treated immediately with anti-tuberculous drugs have not led to complications. Children with a family history of immune deficiency disease should not be vaccinated; if they are, an infectious disease specialist should be consulted and anti-tuberculous therapy administered if clinically indicated.{18}.

Twenty-four (24) subjects returned for follow-up testing with PPD 10 tuberculin units (10 TU) 8 weeks after vaccination. Fatal disseminated BCG infection has occurred at a rate of 0.06–1.56 cases per million doses; these deaths occurred primarily among immunocompromised persons. In a prospective trial using the TICE® strain of BCG VACCINE, Rosenthal, et al., studied 1,716 vaccinated and 1,665 non-vaccinated infants, all born at the Cook County Hospital in Chicago and followed for 12–23 years.

A separate area for the preparation of the BCG VACCINE suspension is recommended. The Advisory Committee on Immunization Practices (ACIP) and the Advisory Committee for the Elimination of Tuberculosis has recommended that BCG vaccination be considered in the following circumstances. TICE BCG contains live, attenuated mycobacteria. Following vaccination with BCG, initial skin lesions usually appear within 10–14 days and consist of small red papules at the vaccination site. In: Rom, WN, Garay, SM (eds. If the immune status of an elderly patient, or any patient, is in question, the BCG vaccination should be held until the immune status of the patient has been evaluated. Safety and effectiveness of TICE BCG for the treatment of superficial bladder cancer in pediatric patients have not been established. DESCRIPTION. The final preparation prior to freeze drying also contains lactose. This incidence rate represented the fifth consecutive year that number of reported TB cases had declined and a 26% decrease since the peak in 1992. BCG vaccination should not be given to individuals previously infected with M. tuberculosis. Rawls WH, Lamm DL, Lowe BA, Crawford ED, Sarosdy MF, Montie JE, Grossman HB, Scardino PT. NEJM 1997;337:315-320. BCG LIVE (FOR INTRAVESICAL USE). A sharp rise in the tuberculin reaction since the latest test should be further investigated (except in the immediate post-vaccination period). Other reported clinical experience has not identified differences in response between elderly and younger patients. Intravesical TICE BCG has been used as a therapy for, and prophylaxis against, recurrent tumors in patients with carcinoma in situ (CIS) of the urinary bladder, and to prevent recurrence of Stage TaT1 papillary tumors of the bladder at high risk of recurrence. Twenty-one (21) out of 22 converted to PPD positive at a level greater than 5mm for a skin test conversion rate of 95%.{17}. This agent contains live bacteria and should be protected from direct sunlight. The local and systemic adverse reactions reported in a review of 674 patients with superficial bladder cancer, including 153 patient with carcinoma in situ , are summarized in Table V. The following adverse events were reported in

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