PALONOSETRON HYDROCHLORIDE injection

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Accord Healthcare, Inc.

INN (International ime):

PALONOSETRON HYDROCHLORIDE

Sastav:

PALONOSETRON 0.25 mg in 5 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Palonosetron Hydrochloride 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 Hydrochloride Injection is indicated for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. Palonosetron Hydrochloride 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 Hydrochlorid

Proizvod sažetak:

NDC # 16729-365-66, Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial individually packaged in a carton. Storage

Status autorizacije:

New Drug Application Authorized Generic

Svojstava lijeka

PALONOSETRON HYDROCHLORIDE- PALONOSETRON HYDROCHLORIDE INJECTION
ACCORD HEALTHCARE, INC.
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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
RECENT MAJOR CHANGES
Indication ( 1.2) 05/2014
Dosage and Administration, Pediatric Cancer Patients ( 2.1) 05/2014
Warnings and Precautions ( 5.2) 09/2014
INDICATIONS AND USAGE
Palonosetron Hydrochloride 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 ( 1.3)
Palonosetron Hydrochloride Injection is indicated in pediatric
patients aged 1 month to less than 17 years
for:
Prevention of acute nausea and vomiting associated with initial and
repeat courses of emetogenic
cancer chemotherapy, including highly emetogenic cancer chemotherapy (
1.2)
DOSAGE AND ADMINISTRATION
Chemotherapy-Induced Nausea and Vomiting ( 2.1)
Age
Dose
Infusion Time
Adults
0.25 MG x 1
Infuse over 30 SECONDS beginning approx.
30 min before the start of chemo
Pediatrics
(1 month to less than 17 years)
20 MICROGRAMS PER
KILOGRAM (max 1.5 mg) x 1
Infuse over 15 MINUTES beginning approx.
30 min before the start of chemo
Note different dosing units in pediatrics
Postoperative Nausea and Vomiting ( 2.1)
Adult Dosage: a single 0.075 mg intravenous dose administered over 10
seconds immediately before
the induction of anesthesia.
DOSAGE FORMS AND STRENGTHS
0.25 mg/5mL (free base) single-use vial (