Inflectra Injection, Powder, Lyophilized, For Solution
Product Images NDC 0069-0809

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Inflectra (NDC 0069-0809). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pfizer Laboratories Div Pfizer 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.

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Figure 1 (Inflectra 01)

This appears to be a graphical display of clinical trial data comparing the effectiveness of Infliximab at different dosages to placebo in maintaining treatment response for patients. The data shows a statistically significant improvement in response rates for patients taking Infliximab at dosages of either 5 or 10 mg/kg, compared to those on placebo. The response rates are also tracked over time.*

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Figure 2 (Inflectra 02)

This appears to be a graph showing the percentage of patients who had not lost response for a certain treatment (possibly infliximab) compared to a placebo maintenance. The graph shows a significant difference between the two treatments at week 54.*

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Figure 3 (Inflectra 03)

This appears to be a graph or chart displaying the proportion of patients for a certain treatment over a period of time. The treatment options are "Placebo" and "Infliximab 5 mg/kg". The chart displays the proportion of patients on the y-axis and the weeks on the x-axis, with each week denoted by the letter "T". There are also numbers 2, 6, 12, and 18 underneath each "T". Without more context or further information, the purpose and meaning of the graph/chart cannot be determined.*

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Figure 4 (Inflectra 04)

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Logo (Inflectra 05)

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Principal Display Panel (100 mg Vial Label)

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Principal Display Panel (100 mg Vial Carton)

NDC 0069-0809-01 is the product identifier for Inflectra*, which is an injection containing 100 mg per vial. This injection is for intravenous infusion only and is a single-dose vial. The unused portion must be discarded. The recommended dosage for this product can be found in the insert. This injection needs to be reconstituted and diluted before intravenous infusion. The product needs to be refrigerated at 2°C to 8°C. The unopened vial can be stored for a single period of up to 6 months, not exceeding the expiry date, at up to 30°C. The manufacturer is CELLTRION, Inc. and the distributor is Pfizer Labs, a division of Pfizer Inc. in New York City.*

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Inflectra 08

Inflectra is an injectable medication used for intravenous infusion that comes in a single-dose vial with 100 mg per vial. It contains 405 mg of polysorbate and sodium. It is recommended to store this medication at a temperature between 2°C to 8°C. If stored properly, it can be kept for up to 6 months. The medication should be given over at least 2 hours. The unused portion should be discarded. It is distributed by Pfizer laboratories and has a unique 11 digit code.*

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