Irinotecan Hydrochloride Injection, Solution
Product Images NDC 60505-6128

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 60505-6128). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

2ml-carton (2ml Carton)

Label for Irinotecan Hydrochloride Injection, USP 40 mg/2 mL (20 mg/mL) intravenous solution by Apotex Corp. The label shows a 2 mL vial, mentions use as a single-dose vial with discard of unused portion, and cautions it is a cytotoxic agent for intravenous use only. Storage instructions, dilution requirement before use, and inactive ingredients are also detailed on the label.*

FDA Label Image

2ml-container (2ml Container)

Label for Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL) in a 2 mL vial. The injection is indicated for intravenous use only and is a cytotoxic agent. Manufactured by Qilu Pharmaceutical (Hainan) Co., Ltd. and labeled for Apotex Corp. The label includes barcode and lot, expiration placeholders.*

FDA Label Image

5ml-carton (5ml Carton)

Packaging label for Irinotecan Hydrochloride Injection USP 100 mg/5 mL (20 mg/mL) intravenous solution. The label notes single-dose 5 mL vial, storage instructions, manufacturing information by Qilu Pharmaceutical and Apotex Corp., warnings for intravenous use only and cytotoxic agent caution. The label also lists inactive ingredients and notes the need for dilution before use.*

FDA Label Image

5ml-container (5ml Container)

Label for Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL) intravenous solution in a 5 mL vial. The product is marked for single-dose use and is labeled as a cytotoxic agent. Manufactured by Qilu Pharmaceutical (Hainan) Co., Ltd, for Apotex Corp., Weston, Florida.*

FDA Label Image

Figure 1

A survival curve graph comparing first-line treatment with Irinotecan/5-FU/LV versus 5-FU/LV alone over time in months. The y-axis represents the probability of survival, and the x-axis shows time in months up to 42. Two curves depict survival probabilities for each treatment group, indicating statistical comparison with a p value less than 0.05 by log-rank test.*

FDA Label Image

Figure 2

A survival curve chart comparing two treatment groups: Irinotecan/5-FU/LV and 5-FU/LV. The y-axis shows probability from 0.0 to 1.0, and the x-axis shows time in months from 0 to 30. The graph indicates survival probability decreases over time for both groups, with Irinotecan/5-FU/LV having a higher survival probability at most time points. The chart is identified as Figure 2 from Study 2 and includes a p-value of less than 0.05 indicating statistical significance.*

FDA Label Image

Figure 3. Survival Second-line Irinotecan Vs Best Supportive Care (bsc) Study 7 (Figure 3)

A Kaplan-Meier survival curve comparing Second-Line Irinotecan injection (labeled as Irinotecan) versus Best Supportive Care (BSC) in a clinical study. The x-axis shows months of follow-up, and the y-axis shows survival probability. The graph shows higher survival probability over time for Irinotecan compared to BSC, with median survival of 9.2 months for Irinotecan and 6.5 months for BSC. The study includes 189 patients for Irinotecan and 90 for BSC, with a p-value of 0.0001 indicating statistical significance.*

FDA Label Image

Figure 4. Survival Second-line Irinotecan Vs Infusional 5-fu Study 8 (Figure 4)

A Kaplan-Meier survival curve comparing second-line treatment with Irinotecan and Infusion 5-FU, showing probability of survival over 21 months. The plot includes sample sizes (Irinotecan: 127, 5-FU: 129), median follow-up times (Irinotecan: 15 months, 5-FU: 8.5 months), and median survival (Irinotecan: 10.8 months). A p-value of 0.035 from a log-rank test is noted.*

FDA Label Image

Irinotecan Hydrochloride Structural Formula (Irinotecan Hydrochloride)

Chemical structure of Irinotecan Hydrochloride showing its molecular framework with labeled chemical groups, including chlorine and water molecules as part of the compound.*

* 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.