国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
PALONOSETRON HYDROCHLORIDE (UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R)
Accord Healthcare, Inc.
PALONOSETRON HYDROCHLORIDE
PALONOSETRON 0.25 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
NDC # 16729-365-66, Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial individually packaged in a carton. Storage
New Drug Application Authorized Generic
PALONOSETRON HYDROCHLORIDE- PALONOSETRON HYDROCHLORIDE INJECTION ACCORD HEALTHCARE, INC. ---------- 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 ( 阅读完整的文件