País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
IDARUBICIN HYDROCHLORIDE (UNII: 5VV3MDU5IE) (IDARUBICIN - UNII:ZRP63D75JW)
Fresenius Kabi USA, LLC
IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
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.
Abbreviated New Drug Application
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 Leia o documento completo