Figure 1 Structural Formula Of Liraglutide (Figure 1)
Liraglutide Injection, Solution
Product Images NDC 14403-3400
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Product Visual Gallery
This gallery contains 27 technical images submitted to the FDA as part of the official labeling for Liraglutide (NDC 14403-3400). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Hybio Pharmaceutical Co., Ltd. (pingshan Factory), 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
Figure 2 (Figure 2)
Figure 3 (Figure 3)
Figure 4 (Figure 4)
This text provides information about the comparison of Liraglutide Injection (1.2 mg and 1.8 mg) with Sitagliptin 100 mg over a specific time period in weeks. It mentions a p-value of less than 0.0001 for Liraglutide Injection compared to Sitagliptin, with values derived from a change from baseline ANCOVA model. The data seems to be used in a clinical or research setting to evaluate the effectiveness of these medications.*
Liraglutide Injection Carton Label For Three (Liraglutide Injection Carton Label Three Syringes)
Description: This text provides information about Liraglutide Injection, a medication containing 6mg/mL of Liraglutide. It includes details about the ingredients, storage instructions, dosage information, and warnings. The medication is delivered via a prefilled pen for subcutaneous use, with options for different doses. It also emphasizes refrigeration and proper disposal after use. The text also mentions not transferring the medication to a syringe, indicating it is meant for single patient use only.*
Liraglutide Injection (Pen)
This is information related to the Liraglutide Injection Pen, including details about the needle and contact information for Hikma Pharmaceuticals USA Inc. If you encounter any challenges with using the pen, you can reach out to the provided contact number for assistance.*
Stepa-b (Step A B)
This text provides step-by-step instructions for using a liraglutide injection pen. It covers important steps such as checking the pen, ensuring the liquid in the cartridge is clear, and attaching the needle properly. The instructions also mention hygiene practices like washing hands before use and wiping the rubber stopper with an alcohol swab. Following these guidelines can help ensure safe and effective use of the liraglutide injection pen.*
Stepc (Step C)
This text provides instructions for using a medical pen device. The step described involves dialing to the Flow Check Symbol, which is done only once for each new pen and required the first time you use a new pen. The process involves aligning the black line of the flow check symbol with the pointer. It is important to note that the flow check symbol does not administer the dose as prescribed by the healthcare provider. To select the dose prescribed by the healthcare provider, the user should continue to Step G under "Routine Use".*
Stepd (Step D)
The text provides instructions on preparing the pen for liraglutide injection. It explains how to tap the cartridge gently to remove air bubbles and align the dose correctly by pressing the dose button. If no drop of the injection appears, it suggests using a new pen and contacting Hikma Pharmaceuticals USA Inc. The user is then instructed to proceed to "Routine Use" under Step G.*
Stepe-f (Step E F)
This text provides instructions on how to use a liraglutide injection pen. It includes steps for checking the pen, washing hands, checking the pen label, inspecting the injection in the cartridge, and attaching the needle to the pen. The text emphasizes the importance of ensuring the liquid in the cartridge is clear, colorless, and free of particles before use.*
Stepend (Step End)
This text provides guidelines for proper disposal of used liraglutide injection pen and needles. It emphasizes the importance of using an FDA-cleared sharps disposal container and provides criteria for alternative household containers. It also highlights the need to follow community guidelines for disposal and warns against reusing or sharing needles. For further information on safe sharps disposal and state-specific guidelines, the FDA's website is recommended as a resource. It advises against disposing of sharps containers in household trash or recycling them.*
Stepend2 (Step End2)
This text provides instructions on how to properly handle and store a liraglutide injection pen. It mentions to put the pen cap on after removing the needle and to store the pen without the needle attached. Refilling the pen is not recommended as it is prefilled and disposable. Additionally, it advises against trying to repair or disassemble the pen and to keep it away from dust, dirt, and liquids. If cleaning is necessary, wiping the outside of the pen with a clean, damp cloth is suggested.*
Stepg (Step G)
This text provides detailed instructions on how to use a Liraglutide injection pen, including steps on removing needle caps, selecting the correct dose (0.6 mg, 1.2 mg, or 1.8 mg), and adjusting the dose if needed. It also reminds users not to throw away the outer needle cap, to be cautious when dialing the dose, and not to press the dose button inadvertently.*
Steph (Step H)
This text provides instructions on how to inject a dose of medication, likely liraglutide, into the skin in the stomach, thigh, or upper arm. It emphasizes using the correct injection technique as instructed by a healthcare provider and not injecting the medication into a vein or muscle. The text also details pressing the dose button correctly and warns against touching the dose display with other fingers to prevent blocking the injection.*
Stepi-j (Step I J)
This text provides instructions on how to properly administer a liraglutide injection. It explains the importance of keeping the dose button pressed down for 6 seconds, rotating injection sites, and safely removing and disposing of the needle after each use. Additionally, it addresses common concerns such as seeing a drop of injection at the needle tip and applying light pressure if blood appears after removing the needle.*
Table 1 Adverse Reactions Reported In ≥ 5% Of Adult Patients Treated With Liraglutide Injection For Type 2 (Table 1)
This is a table displaying adverse reactions percentages for Placebo and Liraglutide doses of 1.2mg and 1.8mg. The data includes the comparison of different reactions such as nausea, diarrhea, headache, among others. The calculations reveal the cumulative proportions across studies using Cochran-Mantel-Haenszel weights.*
Table 10 (Table 10)
This text provides information about a clinical study comparing the effects of Liraglutide injection, Metformin, and Rosiglitazone on parameters such as HbA1c levels, fasting plasma glucose, and body weight. The study included data on baseline measurements, changes from baseline, differences from placebo, percentage of patients achieving HbA1c <7%, and confidence intervals. The results show improvements in HbA1c levels, fasting plasma glucose, and body weight in the treatment arms compared to placebo. The study had a total of 178 participants in the Liraglutide arm, 177 participants in the Metformin arm, and 175 participants in the Rosiglitazone arm.*
Table 11 (Table 11)
This text provides detailed information on a clinical trial involving Liraglutide Injection at 1.8 mg in combination with insulin compared to a placebo in combination with insulin and/or oral antidiabetic drugs (OAD). The evaluation includes data on HbA1c levels, FPG levels, treatment discontinuation rates, and the proportion of participants achieving HbA1c < 7%. It also describes the statistical methods used for analysis, including the intent-to-treat population and multiple imputation. The results indicate a significant difference in outcomes between the treatment groups.*
Table 12 (Table 12)
This text provides results from a clinical study comparing the effects of Liraglutide Injection plus metformin and basal insulin to a placebo plus metformin and basal insulin on HbA1c levels and fasting plasma glucose (FPG) over 26 weeks. It includes data on baseline and end-of-treatment values for HbA1c and FPG, adjusted mean changes from baseline, treatment differences, percentage of patients achieving HbA1c <7%, and details on the statistical analysis methods used. The study concludes with a significant p-value of <0.001.*
Table 2 Adult Incidence (%) And Rate (episodes/patient Year) Of Hypoglycemia In 26-week Combination Therapy Placebo-controlled Trials (Table 2)
This text provides information on a study comparing the effects of Liraglutide Injection in combination with different medications (Metformin, Glimepiride, and Rosiglitazone) on patients who are able or not able to self-treat. The study includes data on the percentage of patients in each group and their ability to self-treat, as well as the definition of "not able to self-treat" as an event requiring the assistance of another person for treatment.*
Table 3 (Table 3)
Table 4 (Table 4)
This data presents results from a clinical study comparing the effectiveness of different treatments for managing diabetes. The study included groups receiving injections of Liraglutide, Metformin, Placebo, and Glimepiride. Parameters evaluated include changes in HbA1c levels, fasting plasma glucose levels, and body weight over the course of the study. Results show the impact on these parameters for each treatment group compared to baseline and against the placebo or Glimepiride plus Metformin groups. The analysis also includes the percentage of patients achieving target HbA1c levels. Additionally, information on the study population, adjusted means, confidence intervals, and statistical significance levels is provided. The study's intention-to-treat population was divided into different treatment arms to assess the efficacy and safety of the treatments.*
Table 5 (Table 5)
This is a comparison of the efficacy of Liraglutide Injection with Sitagliptin Injection combined with Metformin in a clinical trial. The study involved a total of 218 patients in the Liraglutide group, 219 patients in the Sitagliptin group, and 21 patients in the Liraglutide plus Metformin group. The results show changes in HbA1c levels and fasting plasma glucose levels from baseline, with adjusted means provided for comparison. Patients in the Liraglutide group show a greater reduction in HbA1c levels compared to the Sitagliptin group. Additionally, the study indicates a significantly lower fasting plasma glucose level reduction in the Liraglutide group compared to Sitagliptin. The statistical significance of these findings is supported by the p-value provided.*
Table 6 (Table 6n)
This text provides data comparing the efficacy of Tosulin detemir, Liraglutide Injection, and Metformin in the treatment of diabetes. It includes information on HbA1c levels, fasting plasma glucose levels, and the percentage of patients achieving HbA1c less than 7%. The data is presented for the Tatent-to-Treat Population and includes baseline values, changes from baseline, and differences between treatment arms. Confidence intervals and statistical significance (p-value) are also mentioned.*
Table 7 (Table 7)
This text appears to be a comparison of the effects of Liraglutide with other treatments on parameters like HbA1c, Fasting Plasma Glucose, and Body Weight in a clinical trial. Liraglutide showed a significant difference from placebo and glimepiride arm in terms of HbA1c reduction, fasting plasma glucose levels, and body weight. The study involved a total of 234 participants in the Liraglutide group. The results suggest that Liraglutide may be an effective option for managing diabetes.*
Table 8 (Table 8)
The text provides results from a study including different treatment arms with Liraghutide, Metformin, and Glimepiride for patients with diabetes. It includes data on HbA1c levels, Fasting Plasma Glucose, and Body Weight for the intent-to-treat population. The results compare the treatment arms to placebo and show differences and confidence intervals for the various measurements. The study also mentions least squares mean adjustments and highlights that the optimal titration regimen was not achieved for 80% of patients with insulin glargine. Some p-values are provided to indicate statistical significance.*
Table 9 (Table 9)
This is a comparative study evaluating the effectiveness of Liraglutide Injection and Exenatide in combination with metformin and/or sulfonylurea in patients with diabetes. The study includes data such as baseline HbA1c levels, change in HbA1c levels, percentage of patients achieving HbA1c <7%, fasting plasma glucose levels, and statistical significance of differences. Results suggest that Liraglutide may lead to a slightly greater reduction in HbA1c levels compared to Exenatide in this population.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
