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palonosetron HCl injection Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Prevention of Chemotherapy-Induced Nausea and Vomiting

The recommended dosage of Palonosetron HCl Injection for prevention of nausea and vomiting associated with HEC and MEC in adults and associated with emetogenic chemotherapy, including HEC in pediatric patients 1 month to less than 17 years of age is shown in Table 1.

Table 1: Recommended Dosage of Palonosetron HCl Injection for the Prevention of Nausea and Vomiting Associated with Chemotherapy in Adults and Pediatric Patients 1 Month to Less than 17 Years
AgeDose*Infusion Time
*
Note different dosing units in pediatrics
Adults0.25 mg as a single doseInfuse over 30 seconds beginning approximately 30 minutes before the start of chemotherapy
Pediatrics (1 month to less than 17 years)20 micrograms per kilogram (max 1.5 mg as a single dose)Infuse over 15 minutes beginning approximately 30 minutes before the start of chemotherapy

Postoperative Nausea and Vomiting

The recommended dosage of Palonosetron HCl Injection in adults for PONV is 0.075 mg administered as a single intravenous dose over 10 seconds immediately before the induction of anesthesia.

2.2 Instructions for Intravenous Administration

  • Palonosetron HCl Injection is supplied ready for intravenous administration at a concentration of 0.05 mg/mL (50 mcg/mL).
  • Do not mix Palonosetron HCl Injection with other drugs.
  • Flush the infusion line with normal saline before and after administration of Palonosetron HCl Injection.
  • Inspect Palonosetron HCl Injection visually for particulate matter and discoloration before administration.
  • Discard unused portion.
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