EPIRUBICIN HYDROCHLORIDE injection

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Hikma Pharmaceuticals USA Inc.

INN (Jina la Kimataifa):

EPIRUBICIN HYDROCHLORIDE

Tungo:

EPIRUBICIN HYDROCHLORIDE 2 mg in 1 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Epirubicin Hydrochloride Injection, USP 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, other anthracyclines, or anthracenediones [see Adverse Reactions (6.2)].  Teratogenic Effects: Pregnancy Category D. See ‘Warnings and Precautions’ section. Epirubicin hydrochloride 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 basi

Bidhaa muhtasari:

Epirubicin Hydrochloride Injection, USP is available in glass single-use vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths: NDC 0143-9202-01 ; 50 mg/25 mL single use vial; individually boxed. NDC 0143-9203-01 ; 200 mg/100 mL single use vial; individually boxed. Store refrigerated between 2ºC and 8ºC (36ºF and 46ºF). Do not freeze. Protect 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 25ºC). Solution for injection should be used within 24 hours after removal from refrigeration. Manufactured by : THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany Distributed by : West-Ward Pharmaceuticals Eatontown, NJ 07724 USA Revised January 2016 127.207.013/00

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

EPIRUBICIN HYDROCHLORIDE- EPIRUBICIN HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA 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, USP
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)
INDICATIONS AND USAGE
Epirubicin Hydrochloride Injection, USP 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
Administer intravenously in repeated 3 to 4 week cycles, either total
dose on Day 1 of each cycle or divided equally and
given on Days 1 and 8 of each cycle (2) .
The recommended starting dose of epirubicin hydrochloride injection is
100 to 120 mg/m . Dosage reductions are
possible when given in certain combinations(2.1).
Dosage adjustments after the first treatment cycle should be made
based on hematologic and nonhematologic toxicities
(2.2).
Reduce dose in patients with hepatic impairment (2.2 , 8.6 , 12.3 ).
Consider lower doses in patients with severe renal impairment (2.2,
8.7 , 12.3 ).
DOSAGE FORMS AND STRENGTHS
Single use vials containing 2 mg epirubicin hydrochloride per mL as a
sterile, preservative-free, rea