PALONOSETRON injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

PALONOSETRON HYDROCHLORIDE (UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R)

Disponible desde:

Fresenius Kabi USA, LLC

Designación común internacional (DCI):

PALONOSETRON HYDROCHLORIDE

Composición:

PALONOSETRON 0.25 mg in 5 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Palonosetron Hydrochloride (HCl) Injection is indicated for: •    Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses •    Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses Palonosetron HCl Injection is indicated for prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.  Efficacy beyond 24 hours has not been demonstrated. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively.  In patients where nausea and vomiting must be avoided during the postoperative period, Palonosetron HCl Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.  Palonosetron HCl Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its compon

Resumen del producto:

How Supplied Palonosetron Hydrochloride Injection is clear and colorless and is supplied in single-dose vials and pre-filled syringe as follows: NDC Number        Strength                                                      Package 63323-942-05        0.25 mg per 5 mL (0.05 mg per mL)         10 vials per carton 63323-942-42        0.25 mg per 5 mL (0.05 mg per mL)         1 pre-filled syringe per carton 63323-942-90        0.25 mg per 5 mL (0.05 mg per mL)         10 pre-filled syringes per carton Storage •  Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. •  Protect from freezing. •  Protect from light.

Estado de Autorización:

New Drug Application

Ficha técnica

PALONOSETRON - PALONOSETRON INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PALONOSETRON HYDROCHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PALONOSETRON HYDROCHLORIDE
INJECTION.
PALONOSETRON HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Palonosetron Hydrochloride (HCl) Injection is a serotonin-3 (5-HT )
receptor antagonist indicated in adults for:
• Moderately emetogenic cancer chemotherapy -- prevention of acute
and delayed nausea and vomiting associated with
initial and repeat courses. (1.1)
• Highly emetogenic cancer chemotherapy -- prevention of acute
nausea and vomiting associated with initial and repeat
courses. (1.1)
• Prevention of postoperative nausea and vomiting (PONV) for up to
24 hours following surgery. Efficacy beyond 24
hours has not been demonstrated. (1.2)
DOSAGE AND ADMINISTRATION
Chemotherapy-Induced Nausea and Vomiting
• The recommended adult dosage is 0.25 mg as a single intravenous
dose administered over 30 seconds. Dosing should
occur approximately 30 minutes before the start of chemotherapy. (2.1)
Postoperative Nausea and Vomiting
• The recommended adult dosage is 0.075 mg as a single intravenous
dose administered over 10 seconds immediately
before the induction of anesthesia. (2.1)
Instructions for Administration
• For a dose of 0.25 mg, use the entire contents (5 mL) of the
pre-filled syringe. Do not use the pre-filled syringe to
administer a dose less than 0.25 mg. Use the single-dose vial to
administer a dose of 0.075 mg. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 0.25 mg palonosetron in 5 mL (0.05 mg/mL) in a single-dose
vial or a pre-filled syringe. (3)
CONTRAINDICATIONS
Hypersensitivity to the drug or any of its components. (4)
WARNINGS AND PRECAUTIONS
• Hypersensitivity reactions, including anaphylaxis, have been
reported with or without known hypersensitivity to other
select