IDARUBICIN HYDROCHLORIDE injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

IDARUBICIN HYDROCHLORIDE (UNII: 5VV3MDU5IE) (IDARUBICIN - UNII:ZRP63D75JW)

Disponibil de la:

Teva Parenteral Medicines, Inc.

INN (nume internaţional):

IDARUBICIN HYDROCHLORIDE

Compoziție:

IDARUBICIN HYDROCHLORIDE 1 mg in 1 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

Idarubicin Hydrochloride Injection, USP is a sterile, clear, orange-red, isotonic parenteral preservative-free solution for intravenous use only and is available as below: Contains no preservative. Discard unused portion. Store under refrigeration 2° to 8°C (36° to 46°F). Protect from light. Retain in carton until time of use.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

IDARUBICIN HYDROCHLORIDE- IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
----------
IDARUBICIN
HYDROCHLORIDE INJECTION, USP
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, USP contains idarubicin
hydrochloride, USP and is a
sterile, semi-synthetic, preservative-free solution (PFS)
antineoplastic anthracycline for
intravenous use. Chemically, idarubicin hydrochloride, USP is 5,
12-Naphthacenedione,
9-acetyl-7-[(3-amino-2,3,6-trideoxy-α-L-_lyxo_-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-
6,9,11-trihydroxyhydrochloride, (7S-_cis_). The structural formula is
as follows:
C
H
NO •HCl M.W. 533.95
Idarubicin Hydrochloride Injection, USP is a sterile, clear,
orange-red, isotonic parenteral
preservative-free s