Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
IDARUBICIN HYDROCHLORIDE (UNII: 5VV3MDU5IE) (IDARUBICIN - UNII:ZRP63D75JW)
Sandoz Inc
IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Idarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.
Idarubicin Hydrochloride Injection: Single Dose Glass Vials: Sterile single use only, contains no preservative. NDC 66758-055-01 5 mg/5 mL vial (1 mg/mL), single vials. NDC 66758-055-03 10 mg/10 mL vial (1 mg/mL), single vials. NDC 66758-055-05 20 mg/20 mL vial (1 mg/mL), single vials. Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light. Retain in carton until time of use. For Sandoz Customer Service call, 1-800-525-8747. Rx only January 2011 REFERENCES 1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society. 1999: 32–41. 2. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. Washington, DC; Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Department of Health and Human Services, Public Health Service Publication NIH 92–2621. 3. AMA Council on Scientific Affairs. Guidelines for Handling Parenteral Antineoplastics. JAMA. 1985; 253: 1590–1591. 4. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. 1987. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115. 5. Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426–428. 6. Jones RB, Frank R, Mass T. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA Cancer J Clin.1983; 33: 258–263. 7. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47:1033–1049. 8. Controlling Occupational Exposure to Hazardous Drugs (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm. 1996; 53: 1669–1685.
Abbreviated New Drug Application
IDARUBICIN HYDROCHLORIDE- IDARUBICIN HYDROCHLORIDE INJECTION SANDOZ INC ---------- IDARUBICIN HYDROCHLORIDE INJECTION RX ONLY FOR INTRAVENOUS USE ONLY WARNINGS 1. Idarubicin Hydrochloride Injection should be given slowly into a freely flowing intravenous infusion. It must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration. 2. As is the case with other anthracyclines the use of Idarubicin Hydrochloride Injection can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have pre-existing cardiac disease. 3. As is usual with antileukemic agents, severe myelosuppression occurs when Idarubicin Hydrochloride Injection is used at effective therapeutic doses. 4. It is recommended that Idarubicin Hydrochloride Injection be administered only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. 5. Dosage should be reduced in patients with impaired hepatic or renal function. (See DOSAGE AND ADMINISTRATION.) DESCRIPTION Idarubicin Hydrochloride Injection contains idarubicin hydrochloride and is a sterile, semi-synthetic, preservative-free solution antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride is 5, 12- Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-Á-L-_lyxo_- hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-_cis_). The structural formula is as follows: Idarubicin Hydrochloride Injection is a sterile, red-orange, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-use-only vials. Eac Lestu allt skjalið