Kesimpta Injection, Solution
Product Images NDC 0078-1007

Product Visual Gallery

This gallery contains 26 technical images submitted to the FDA as part of the official labeling for Kesimpta (NDC 0078-1007). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novartis Pharmaceuticals Corporation, 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: Time To First 3-month Confirmed Disability Progression By Treatment Full Analysis Set (Omb157g 01)

This appears to be a comparison of the risks and event rates for two drugs, KESIMPTA and Teriflunomide, with 544 and 932 individuals respectively. The Kaplan-Meier estimate of cumulative event rate is shown across 33 months, and the risk reduction percentage for KESIMPTA is reported to be 4%.*

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Principal Display Panel Ndc 0078-1007-68 Rx Only Kesimpta® (ofatumumab) Injection 20 mg/0.4 mL Single-dose Prefilled Sensoready® Pen For Subcutaneous Use Only Sterile Solution (Contains No Preservatives Carton contains: 1 Single-dose Prefilled Sensoready ® Pen, Prescribing Information, Instructions for Use, and Medication Guide Attention: Dispense with enclosed Medication Guide. REFRIGERATE NOVARTIS)

Kesimpta is a prescription drug that comes in a single-dose prefilled Sensoready Pen. It contains 20mg of ofatumumab, and other inactive ingredients including arginine, sodium edetate, polysorbate 80, sodium acetate, sodium chloride, and Water for injection. It is stored refrigerated at 2°C to 8°C until the time of use to protect it from light. Prior to injection, it should be inspected for visible particles or cloudiness. It should not be shaken or frozen. The drug should be discarded after use. The pH is adjusted using hydrochloric acid. It is intended for subcutaneous use only, and should be kept out of reach of children. For more details, refer to the prescribing information and medication guide. For queries, visit www.ksimpta.com or call 1-838-NOW-NOVA (1-838-669-6682).*

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Figure J (Omb157g 03)

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Figure A (Omb157g 04)

The text describes various components of a needle, including a needle guard, a cap with a viewing window, and an internal needle cover. It is likely referring to a medical device such as a syringe or an injection pen.*

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Figure B (Omb157g 05)

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Figure C (Omb157g 06)

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Figure D (Omb157g 07)

This text is a short phrase indicating the presence of a "viewing window". It doesn't provide further context or details, but suggests that there may be a feature or device with a window through which something can be seen.*

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Figure E (Omb157g 08)

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Figure F (Omb157g 09)

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Figure G (Omb157g 10)

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Figure H (Omb157g 11)

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Figure I (Omb157g 12)

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Correct/incorrect Image (Omb157g 13)

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Figure I (Omb157g 14)

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Figure J (Omb157g 15)

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Figure K (Omb157g 16)

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Figure L (Omb157g 17)

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Figure M (Omb157g 18)

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Figure A (Omb157g 19)

This appears to be a description of a syringe with features such as finger grips, needle cap, plunger head and syringe guard body with wings. It also mentions a viewing window for the medication and a label with an expiration date.*

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Figure B (Omb157g 20)

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Figure C (Omb157g 21)

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Figure D (Omb157g 22)

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Figure E (Omb157g 23)

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Figure F (Omb157g 24)

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Figure G (Omb157g 25)

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Figure H (Omb157g 26)

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