Irinotecan Hydrochloride Injection, Solution
Product Images NDC 60505-6128

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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)

2ml-carton (2ml Carton)
Irinotecan Hydrochloride Injection is a cytotoxic agent used for intravenous treatment. The entire package contains 15 single-dose 2mL vials to be discarded if unused. Before use, each vial must be diluted. The drug should be protected from light and freezing and stored in its original carton until use. The solution should be adjusted with sodium hydroxide and/or hydrochloric acid, depending on the necessary pH level. The manufacturer is Qi Pharmacedice and the supplier is Apotex Corp.*
FDA Label Image

2ml-container (2ml Container)

2ml-container (2ml Container)
This is labeled as a 2mL vial of Irinotecan Hydrochloride, an injection used intravenously, manufactured by Apotex Corp. The dosage and other relevant information should be seen in the accompanying prescribing information. It is a cytotoxic agent that must be diluted before use and is for single-use only.*
FDA Label Image

5ml-carton (5ml Carton)

5ml-carton (5ml Carton)
This is a description of medication identified by its NDC number. It is Irinotecan Hydrochloride Injection, an intravenous cytotoxic agent used for treating cancer. The medication is packaged in a 5 mL vial and should be stored between 20°C and 26°C. The drug should be diluted before use and should only be used intravenously. The dosage is dependent on information provided on the prescription, and the unused portion should be discarded. Some inactive ingredients include sorbitol powder, lactic acid, and water for injection. The drug manufacturer is Apotex Corporation and the medication is made in Halkou, China. The description also includes warnings and instructions for damaged contents.*
FDA Label Image

5ml-container (5ml Container)

5ml-container (5ml Container)
This is a description of a 5mL vial of Irinotecan Hydrochloride Injection, USP of strength 100 mg/5 ML(20 mg/mL) meant for intravenous use only. It is a cytotoxic agent that needs to be diluted before use. The vial is a single-dose only, and unused portions must be discarded. The prescribing information should be consulted for the usual dosage. The manufacturer is Qilu Pharmaceutical (Hainan) Co., Ltd., located in Haikou, China. It is manufactured for Apotex Corp. in Weston, Florida, USA, and has a unique GTIN barcode and lot number.*
FDA Label Image

Figure 1

FDA Label Image

Figure 2

Figure 2
The text describes Figure 2 from Study 2, which compares the survival rates of patients treated with Irinotecan/5-FU/LV versus those treated with 5-FU/LV only. The figure shows survival rates over a period of 27 time points, with data points at 3-month intervals. The log-rank test was used to analyze the data.*
FDA Label Image

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

Figure 3. Survival Second-line Irinotecan Vs Best Supportive Care (bsc) Study 7 (Figure 3)
The text describes a survival study comparing second-line Irinotecan treatment and Best Supportive Care for patients. Study 7 involved 188 patients and the median follow-up time was 13 months. The percent survival is not available due to errors. The median survival in months for Irinotecan was 9.2 and for BSC was 6.5. There were 21 patients for which the outcome is not clear from the given text.*
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Figure 4. Survival Second-line Irinotecan Vs Infusional 5-fu Study 8 (Figure 4)

Figure 4. Survival Second-line Irinotecan Vs Infusional 5-fu Study 8 (Figure 4)
This is a comparison study between the survival rates of two drugs - Irinotecan and Infusion 5-FU - as the second-line treatment. The study included 127 patients who received Irinotecan and 129 patients who received Infusion 5-FU. The median follow-up time was 15 months. The graph shows the survival rates over time measured in months (0-21). The median survival time for Irinotecan was 108 months and for Infusion 5-FU was 85 months. The statistical analysis showed a significant difference (p=0.035), indicating that Irinotecan has a higher probability of improving survival compared to Infusion 5-FU as the second-line treatment.*
FDA Label Image

Irinotecan Hydrochloride Structural Formula (Irinotecan Hydrochloride)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.