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Rx Item-Tice Bcg 50Mg Vial By Merck For Intravesical Use (Cancer Treatment)

NDC 00052-0602-02 UPC/GTIN No.3-00520-60202-0 Mfg.Part No.60202BRAND: TICE BCG  NDC: 00052-0602-02,52060202 UPC: 3-00520-60202-0,300520602020 Merck & Co.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Tice Bcg 50Mg Vial By Merck For Intravesical Use (Cancer Treatment)

$188.48$171.26

Item No.:RX947929, Item No. RX150526, 150526, NDC No.: 00052-0602-02, 00052-602-02, 0005260202, 00052060202, 0602-02, 060202 UPC No. 3-00520-60202-0, 300520-602020, 300520602020, Rx Item-Tice Bcg 50Mg Vial By Merck For Intravesical Use (Cancer Treatment) Only Physician, Pharmacy Or Licensed Facility Can purchase this RX Item Brand/Generic: , Drug Category: Antineoplastic Agents Drug Class: 10000000 Antineoplastic Agents

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TICE BCG- bacillus calmette-guerin substrain tice live antigen powder, for suspension
Organon USA Inc.

WARNING

TICE� BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION sections).

BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG (see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections).

DESCRIPTION



TICE� BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. 1 The TICE strain was developed at the University of Illinois from a strain originated at the Pasteur Institute.

The medium in which the BCG organism is grown for preparation of the freeze-dried cake is composed of the following ingredients: glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, and iron ammonium citrate. The final preparation prior to freeze drying also contains lactose. The freeze-dried BCG preparation is delivered in glass vials, each containing 1 to 8 � 108 colony forming units (CFU) of TICE BCG which is equivalent to approximately 50 mg wet weight. Determination of in vitro potency is achieved through colony counts derived from a serial dilution assay. A single dose consists of 1 reconstituted vial (see DOSAGE AND ADMINISTRATION).

For intravesical use the entire vial is reconstituted with sterile saline. TICE BCG is viable upon reconstitution.

No preservatives have been added.

CLINICAL PHARMACOLOGY

TICE� BCG induces a granulomatous reaction at the local site of administration. 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. The precise mechanism of action is unknown.
TICE BCG Indications and Usage

TICE� BCG is indicated for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.

TICE BCG is not indicated for papillary tumors of stages higher than T1.

CONTRAINDICATIONS

TICE� BCG should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., AIDS, leukemia, lymphoma) cancer therapy (e.g., cytotoxic drugs, radiation), or immunosuppressive therapy (e.g., corticosteroids).

Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization.

TICE BCG should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out in individuals who are PPD positive before starting treatment with TICE BCG.
DOSAGE AND ADMINISTRATION

The dose for the intravesical treatment of carcinoma in situ and for the prophylaxis of recurrent papillary tumors consists of 1 vial of TICE� BCG suspended in 50 mL preservative-free saline.

Do not inject subcutaneously or intravenously.

NDC 00052-0602-02 UPC/GTIN No.3-00520-60202-0 Mfg.Part No.60202
RX ITEM-Tice Bcg 50Mg Vial By Merck For
NDC 00052-0602-02 UPC/GTIN No.3-00520-60202-0 Mfg.Part No.60202

BRAND: TICE BCG  NDC: 00052-0602-02,52060202 UPC: 3-00520-60202-0,300520602020 Merck & Co.
Tice Bcg 50Mg Vial By Merck For Intraves
BRAND: TICE BCG NDC: 00052-0602-02,52060202 UPC: 3-00520-60202-0,300520602020 Merck & Co.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
BCG LIVE INTRAVESIC VIAL
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