EPIRUBICIN HYDROCHLORIDE- epirubicin hydrochloride injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

EPIRUBICIN HYDROCHLORIDE (UNII: 22966TX7J5) (EPIRUBICIN - UNII:3Z8479ZZ5X)

Pieejams no:

Sandoz Inc

SNN (starptautisko nepatentēto nosaukumu):

EPIRUBICIN HYDROCHLORIDE

Kompozīcija:

EPIRUBICIN HYDROCHLORIDE 2 mg in 1 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

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.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

EPIRUBICIN HYDROCHLORIDE- EPIRUBICIN HYDROCHLORIDE INJECTION, SOLUTION
SANDOZ INC
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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_
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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
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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
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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