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Ondansetron Injection
Product Images NDC 0404-9930
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Product Visual Gallery
This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 0404-9930). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Henry Schein, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
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This is a table providing information about the recommended dose and administration of Ondansetron Injection for the prevention of postoperative nausea and vomiting in different populations including adults, pediatric patients aged one month to 12 years and those over 12 years old. The table provides instructions, timing and the recommended dose for each population. The second administration of a second intravenous dose of 4 mg ondansetron postoperatively in adult patients who received a 4 mg prophylactic dose does not provide additional control of nausea and vomiting. It is noted that the prevention of nausea and vomiting was only studied in pediatric patients who had not received prophylactic ondansetron.*
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The text presents a table showing the therapeutic response to prevent postoperative nausea and vomiting in adult patients using ondansetron 4mg intravenous and placebo. The table contains the number of patients, emetic episodes, and nausea assessments for study 1 and study 2. The treatment response over a 24-hour postoperative period is also included, and the p-value is less than 0.05 for both studies.*
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This is a table presenting therapeutic response in the prevention of postoperative nausea and vomiting in pediatric patients aged 2 to 12 years. The table shows the number of patients in each study, their response to treatment with Ondansetron and Placebo, and the corresponding p-values. The response to treatment was measured over 24 hours. The text also mentions that failure was defined as one or more emetic episodes, rescued, or withdrawn, and that nausea was measured as none, mild or severe.*
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The text describes a table (Table 12) that presents the therapeutic response of Ondansetron 4mg in preventing postoperative vomiting in adult patients, as compared to Placebo. The table includes data from two different studies (#1 and #2), and shows the number of patients, treatment response, emetic episodes, median time to the first emetic episode, and nausea score over a 24-hour postoperative period. The results indicate that Ondansetron is effective in preventing vomiting and reducing nausea in adult patients after surgery, as compared to Placebo.*
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Table 13 shows the therapeutic response of ondansetron and placebo in preventing further postoperative nausea and vomiting in pediatric patients aged 2 to 12 years. The study involved 180 patients, with 96 (53%) of the ondansetron group reporting no emetic episodes over 24 hours, compared to only 42 (23%) of the placebo group. The study concluded that ondansetron was significantly more effective than placebo in preventing postoperative nausea and vomiting in pediatric patients.*
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This is a table displaying the adverse reactions reported in adult patients who were given ondansetron at a dosage of three 0.15-mg/kg doses. The table shows the number of adult patients who experienced each reaction and compares ondansetron with metoclopramide and placebo. The adverse reactions reported are diarrhea, headache, and fever.*
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Table 3 shows a list of Adverse Reactions that were reported in 22% of adult patients receiving Ondansetron at a dosage of 4mg intravenously over two to five minutes. These reactions occurred at a greater frequency than those in the Placebo group. Headache, drowsiness/sedation, and injection site reaction were the most commonly reported reactions, followed by fever, cold sensation, pruritus, and paresthesia. It is worth noting that the rates of these reactions were not significantly different between those taking Ondansetron and those taking placebo. Patients were receiving multiple medications including perioperative and postoperative medication.*
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This is a table presenting pharmacokinetic data in healthy adult volunteers. The data is divided into three age groups- 19-40 years, 41-75 years, and >75 years. The table presents the Peak Plasma Concentration, Mean Elimination Half-life and Plasma Clearance values for each age group.*
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This table presents pharmacokinetics data for pediatric cancer patients aged 1 month to 18 years. It includes information on the number of subjects, age groups, geometric mean, mean and other statistics on the clearance (L/h/kg), volume of distribution (Lkg), and percentage of patients for population PK patients who are cancer versus surgery patients.*
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This is a table presenting pharmacokinetic data of pediatric surgical patients aged between 1 month to 12 years. The table includes the sample size (N), age group, geometric mean, and mean values of different parameters such as (L/h/kg), (Lkg), and (L).*
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The text describes Table 7 which presents the results of a clinical trial for chemotheraphy-induced nausea and vomiting prevention in single-day cisplatin therapy for adult patients using ondansetron and placebo. The table shows the number of patients and their treatment responses, emetic episodes, and median times to first emetic episode and nausea scores. The therapeutic response rates of the two groups are significantly different with a p-value of 0.001. Patients who received ondansetron have lesser emetic episodes and an improved global satisfaction with control of nausea and vomiting compared to those who received placebo.*
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This text describes a medical study that tested the efficacy of high dose and moderate dose chemotherapy treatments, using Ondansetron Injection for nausea management in patients. Other chemotherapeutic agents were also included. The study did not find any significant difference between the two treatments in terms of response, and efficacy was based on an "all-patients-treated" analysis. The study also used a visual analog scale to assess nausea and satisfaction. The median was undefined due to the high number of patients with rescues or emetic episodes.*
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This table shows therapeutic responses in preventing vomiting induced by cisplatin in adults by comparing Ondansetron injection and Metoclopramide injection treatments. The number of patients, treatment response, the number of emetic episodes, median number of emetic episodes, median time to first emetic episode, global satisfaction with control of nausea and vomiting, acute dystonic reactions, and akathisia are provided for both treatments. P-values for comparison of treatments with respect to different categories are also given.*
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The text discusses the use of cisplatin and other chemotherapeutic agents such as cyclophosphamide, etoposide, and fluorouracil in patients. It states that 68% of patients received additional chemotherapeutic agents besides cisplatin. There was no significant difference found in the types of chemotherapy used that could explain the differences in patient response. The text also briefly mentions a visual analog scale assessment, with a numeric scale for measuring satisfaction.*
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This text provides a table with therapeutic response data related to the prevention of chemotherapy-induced nausea and vomiting in adults who received single-day cyclophosphamide therapy. The table compares the effects of Ondansetron versus Placebo and reports the number of patients, treatment response, emetic episodes, median time, nausea scores, and global satisfaction. The efficacy was calculated based on an analysis of all-treated-patients. The type of chemotherapy did not vary between the treatments. The text provides a definition for the visual analog scale assessments used for nausea and satisfaction.*
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ONDANSETRON is a medication that comes in a single-use vial and should be protected from light. It is for IV or IM use only and should be kept in a bag until the time of use. It should be stored at controlled room temperature (36 degrees to 86 degrees Fahrenheit). The lot number is LOTH XXXKXXXKXX with the original manufacturer's lot being XK-XXK-XX. This medication is manufactured by Apotex and its GTIN is (01))0000000000000C with the SER-(21)00000000000K and LOT:(10)X000K EXP (17)0000K. It is important to retain and read the manufacturer's instructions before using this medication. If you are unsure about usage or have any questions, please contact your healthcare professional.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
