Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
EPIRUBICIN HYDROCHLORIDE (UNII: 22966TX7J5) (EPIRUBICIN - UNII:3Z8479ZZ5X)
Sandoz Inc
EPIRUBICIN HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE 2 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see CLINICAL STUDIES (14.1) ]. Patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: Cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see WARNINGS AND PRECAUTIONS (5.3) ] Previous treatment with maximum cumulative dose of anthracyclines [see WARNINGS AND PRECAUTIONS (5) ]. Hypersensitivity to epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see ADVERSE REACTIONS (6.2) ]. Pregnancy Category D. See ‘WARNINGS AND PRECAUTIONS ’ section. Epirubicin hydrochloride injection can cause fetal harm when administered to a pregnant woman. Administration of 0.8 mg/kg/day intravenously of epirubicin to rats (about 0.04 times the maximum recommended single human dose on a body surface area basis) during
Epirubicin hydrochloride injection is available in clear, USP Type I glass single-use vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths: 50 mg/25 mL single-use vial NDC 66758-042-01 200 mg/100 mL single-use vial NDC 66758-042-02 Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light. Discard unused portion. Remove solution from vial immediately before use. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions. Tests of the diluted solution up to 96 hours at 2°C to 8°C and room temperature (20°C to 25°C) show no significant changes without protection from light. Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15 to 25o C). Solution for injection should be used within 24 hours after removal from refrigeration.
Abbreviated New Drug Application
EPIRUBICIN HYDROCHLORIDE- EPIRUBICIN HYDROCHLORIDE INJECTION, SOLUTION SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EPIRUBICIN HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPIRUBICIN HYDROCHLORIDE INJECTION. EPIRUBICIN HYDROCHLORIDE INJECTION FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1999 WARNING: SEVERE OR LIFE-THREATENING HEMATOLOGICAL AND OTHER ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ • • • • • • INDICATIONS AND USAGE Epirubicin hydrochloride 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). DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS Single use vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution (50 mg/25 mL and 200 mg/100 mL) (3) CONTRAINDICATIONS Patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: baseline neutrophil count < 1500 cells/mm , cardiomyopathy and/or heart failure, recent myocardial infarction, severe arrhythmias; previous treatment with anthracyclines up to the maximum cumulative dose; hypersensitivity to epirubicin, other anthracyclines, or anthracenediones; or severe hepatic dysfunction (4). WARNINGS AND PRECAUTIONS • • • • • 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) Administer intravenously Læs hele dokumentet