Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
epirubicin hydrochloride (UNII: 22966TX7J5) (epirubicin - UNII:3Z8479ZZ5X)
Greenstone, LLC
epirubicin hydrochloride
epirubicin hydrochloride 2 mg in 1 mL
PRESCRIPTION DRUG
New Drug Application Authorized Generic
EPIRUBICIN HYDROCHLORIDE- EPIRUBICIN HYDROCHLORIDE INJECTION, SOLUTION GREENSTONE, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EPIRUBICIN HCL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPIRUBICIN HCL. EPIRUBICIN HCL (EPIRUBICIN HYDROCHLORIDE INJECTION) INITIAL U.S. APPROVAL: 1999 WARNING: SEVERE OR LIFE-THREATENING HEMATOLOGICAL AND OTHER ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ Severe local tissue necrosis associated with extravasation during administration (5.9) Myocardial toxicity, manifested in its most severe form by potentially fatal congestive heart failure (CHF) (5.3) Secondary acute myelogenous leukemia (AML) (5.4) Reduce dosage in patients with impaired hepatic function (5.5) Severe myelosuppression (5.2) Administer only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents (5) RECENT MAJOR CHANGES Boxed Warning 09/2011 Dosage and Administration, Preparation and Administration (2.3) 09/2011 Warnings and Precautions, Injection-Related Reactions, Hematologic, Cardiac, Secondary Leukemia, Coadministration with Cimetidine, Pregnancy, Male Fertility and Reproductive Outcomes, laboratory Testing, Inflammation following Irradiation (5.1, 5.2, 5.3, 5.4, 5.11, 5.12, 5.13, 5.14, 5.15) 09/2011 Warnings and Precautions, Male Fertility and Reproductive Outcomes (5.13) 11/2011 Drug Interactions, Cadioactive Compounds, cimetidine, other Cytotoxic Drugs, Radiation Therapy, Concomitant Therapies-Hepatic Function (7.1, 7.2, 7.3, 7.4, 7.5) 09/2011 INDICATIONS AND USAGE Epirubicin HCl Injection is an anthracycline topoisomerase II inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer (1.1). DOSAGE AND ADMINISTRATION Administer intravenously in repeated 3- to 4-week cycles, either total dose on Day 1 of each cycle or divided equally and given Les hele dokumentet