Palonosetron Injection, Solution
Product Images NDC 68001-355

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Palonosetron (NDC 68001-355). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bluepoint Laboratories, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Palonosetron HCl Injection (0.25mg_5ml) Carton Rev 02-2018 (025carton)

Packaging label for Palonosetron Hydrochloride Injection 0.25 mg/5 mL (0.05 mg/mL) by BluePoint Laboratories. The label specifies this is for intravenous injection only and contains one 5 mL single-dose sterile vial. It includes storage instructions, ingredients, manufacturer information (Dr. Reddy's Laboratories Ltd., India), and barcodes.*

FDA Label Image

Palonosetron HCl Injection (0.25mg_5ml) Label Rev 02-2018 (025vial)

Label for Palonosetron Hydrochloride Injection, 0.25 mg/5 mL (0.05 mg/mL) single-dose sterile vial for intravenous use. Label includes storage instructions (20°C to 25°C), protection from light and freezing, barcode, lot and expiration placeholders, and is marked Rx only. Manufactured by Dr. Reddy's Laboratories Ltd. for BluePoint Laboratories.*

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Image 01

A data table titled 'Common Adverse Reactions in Adults with Receiving MEC or HEC' comparing the percentage of adverse reactions among patients treated with Palonosetron hydrochloride injection 0.25 mg intravenously (N=633), Ondansetron 32 mg intravenously (N=410), and Dolasetron 100 mg intravenously (N=194). Adverse reactions listed include headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, and insomnia with corresponding percentages for each treatment group.*

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Image 02

A data table titled 'Common Adverse Reactions in Trials of Adults with Postoperative Nausea and Vomiting' comparing adverse reaction rates between Palonosetron hydrochloride injection 0.075 mg intravenously (N=336) and placebo (N=369). It lists adverse reactions including electrocardiogram QT prolongation, bradycardia, headache, and constipation with corresponding percentages for both groups.*

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Image 03

Pharmacokinetics parameters table showing values for Palonosetron Hydrochloride Injection after intravenous infusion in pediatric cancer patients, organized by age groups (<2 years, 2-<6 years, 6-<12 years, 12-<17 years). Parameters include concentration (CT), AUC, clearance, and volume of distribution (Vss) with sample sizes indicated.*

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Image 04

A data table showing prevention of acute nausea and vomiting (0 to 24 hours) in adults associated with moderately and highly emetogenic chemotherapy in studies 1, 2, and 3. It compares complete response rates between Palonosetron hydrochloride injection 0.25 mg intravenously and comparators Ondansetron or Dolasetron, including number of subjects, percent with complete response, p-values, and 97.5% confidence interval differences in complete response rates.*

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Image 05

Table showing complete response rates for prevention of delayed nausea and vomiting (24 to 120 hours) associated with moderately emetogenic chemotherapy in adults. It compares Palonosetron hydrochloride injection 0.25 mg intravenously to Ondansetron 32 mg and Dolasetron 100 mg intravenously in two studies, including sample sizes, response percentages, p-values, and confidence intervals for differences in response rates.*

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Image 06

A data table titled "Prevention of Overall Nausea and Vomiting (0 to 120 Hours) Associated with MEC in Adults in Studies 1 and 2: Complete Response Rates" showing results for palonosetron hydrochloride injection 0.25 mg intravenously versus comparators ondansetron and dolasetron in moderately emetogenic chemotherapy. The table lists study numbers, treatment groups, sample sizes (N), percent with complete response, p-values, and includes a confidence interval plot of differences in complete response rates.*

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Image 07

A data table titled 'Prevention of Acute Nausea and Vomiting (0 to 24 Hours) Associated with Emetogenic Chemotherapy in Pediatric Patients: Complete Response Rates.' It compares the complete response rates of Palonosetron hydrochloride injection (20 mcg/kg IV, N=165) at 59.4% to Ondansetron (0.15 mg/kg for 3 IV doses, N=162) at 58.6%, with a difference of 0.36% [97.5% Confidence Interval: -11.7%, 12.4%].*

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Image 08

Table presenting complete response rates for prevention of postoperative nausea and vomiting in adults, comparing Palonosetron hydrochloride injection 0.075 mg intravenously to placebo. It shows data for two time intervals: 0 to 24 hours and 24 to 72 hours, including number/percentage of responders, difference, and p-values.*

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Structure (Structure)

Chemical structure of Palonosetron, showing its molecular framework including rings and functional groups with a hydrochloride (HCl) designation.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.