IDARUBICIN HYDROCHLORIDE - idarubicin hydrochloride injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Fresenius Kabi USA, LLC

INN (Kansainvälinen yleisnimi):

IDARUBICIN HYDROCHLORIDE

Koostumus:

IDARUBICIN HYDROCHLORIDE 1 mg in 1 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Idarubicin Hydrochloride Injection, USP 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.

Tuoteyhteenveto:

Idarubicin Hydrochloride Injection, USP contains no preservative and is for single dose only. REFRIGERATE AT:  2 ° to 8 °C (36 ° to 46 °F). Protect from light (keep in outer carton). The container closure is not made with natural rubber latex.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

IDARUBICIN HYDROCHLORIDE - IDARUBICIN HYDROCHLORIDE INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
----------
IDARUBICIN HYDROCHLORIDE INJECTION, USP
For intravenous use only.
Rx 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 and is a sterile, semi-
synthetic, preservative-free solution (PFS) antineoplastic
anthracycline for intravenous use. Chemically,
idarubicin hydrochloride 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:
Idarubicin Hydrochloride Injection, USP is a sterile, red-orange,
isotonic parenteral preservative-free
solution, available in 5 mL (5 mg), 10 mL (10 m