Adalimumab Kit
Product Images NDC 83257-021

Product Visual Gallery

This gallery contains 27 technical images submitted to the FDA as part of the official labeling for Adalimumab (NDC 83257-021). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biocon Biologics 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. Study Ra-iii Acr 20 Responses Over 52 Weeks (Image 01)

A line graph depicting the percentage of ACR20 responders over time (weeks) up to 48 weeks. It features two data series represented by solid squares and open circles, showing their respective response trends across the study period.*

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Figure 2. Asas 20 Response By Visit, Study As-i (Image 02)

A line chart comparing the percentage of ASAS 20 response over 26 weeks between Adalimumab and Placebo groups. The X-axis represents time in weeks, and the Y-axis shows the percentage response. The Adalimumab group shows a higher response rate throughout the period compared to the Placebo group.*

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Hulio Pen Logo (Image 03)

Adalimumab-fkjp Pen Injection kit label showing the product name prominently. The label identifies the active ingredient as adalimumab-fkjp and indicates the dosage form as pen injection. The labeler is Biocon Biologics Inc.*

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Pen Instructions For Use Figure A (Image 04)

An instructional diagram of an Adalimumab-fkjp pen injection illustrating key parts such as the orange indicator inside the barrel, fill marker, viewing window, and orange activator with a caution for needle inside. It also labels a small inner gray cap and a protective clear cap, providing visual guidance on the pen injection device components and handling.*

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Pen Instructions For Use Figure B (Image 05)

An instructional diagram depicting a close-up view of a medical device with a small window revealing an orange indicator. The image includes placeholder expiration date (EXP: YYYY-MM) and lot number (LOT: 0000000000) fields, labeled as Figure B. It appears to be part of a kit associated with Adalimumab by Biocon Biologics Inc.*

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Pen Instructions For Use Figure C (Image 06)

An instructional diagram of the Adalimumab-fkjp pen injection highlighting the fill marker and medicine inside the device. The diagram notes that it is normal to see one or more bubbles in the medicine reservoir.*

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Pen Instructions For Use Figure D (Image 07)

An instructional anatomical illustration showing recommended injection sites for Adalimumab on a simplified human figure. Shaded areas indicate the abdomen (at least 2 inches from the belly button) and both thighs as suitable injection locations.*

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Pen Instructions For Use Figure E (Image 08)

An instructional illustration showing hands holding an Adalimumab-fkjp kit component. The left hand is pulling a cap or cover away from a part on the right hand, which holds a device labeled with the product name. The arrow indicates the direction to remove the cap or cover.*

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Pen Instructions For Use Figure F (Image 09)

An instructional illustration showing the recommended squeeze sites for subcutaneous injection on the abdomen or thighs. It includes a silhouette of a human body highlighting the injection areas and a close-up drawing of a hand pinching the skin to prepare for injection.*

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Pen Instructions For Use Figure G (Image 10)

An instructional diagram showing the proper 90-degree angle positioning of a syringe for injecting Adalimumab medication into the skin. The diagram features one hand holding the syringe and the other hand stabilizing the injection site on the arm.*

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Pen Instructions For Use Figure H (Image 11)

An instructional illustration showing the use of an Adalimumab injection device from a kit by Biocon Biologics Inc. The image depicts a hand pressing the injection pen against the skin, triggering the first click sound indicating the start of the injection.*

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Pen Instructions For Use Figure I (Image 12)

Instructional illustration for Adalimumab kit showing a hand holding the syringe down, with a timer count from 1 to 10 seconds, highlighting the need to hold down for 10 seconds until a second click and the orange indicator are visible.*

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Pen Instructions For Use Figure J (Image 13)

An instructional illustration labeled Figure J shows a hand holding a syringe above an arm, with an arrow pointing upward indicating the syringe is being pulled away from the injection site on the arm, demonstrating part of an injection process.*

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Hulio Syringe Logo (Image 14)

Label text showing the proprietary name Adalimumab-fkjp followed by the word Injection, indicating it is an injectable dosage form. The label is simple with bold black text on a white background.*

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Instructions For Use Figure A (Image 15)

An instructional diagram showing the components of an Adalimumab-fkjp prefilled syringe kit labeled with parts such as the plunger, fill marker, medicine, strength and expiration date, needle cap, and needle safety feature. The inset illustrates two syringe volumes, 0.4 mL and 0.8 mL, noting the syringe amount should match the prescription.*

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Instructions For Use Figure B (Image 16)

An illustration labeled Figure B showing a 40 mg/0.8 mL prefilled syringe of Adalimumab. The syringe includes designated areas for the expiration date (EXP: YYYY-MM) and lot number (LOT: 0000000) along with a barcode below these fields.*

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Instructions For Use Figure C (Image 17)

An instructional diagram labeled Figure C depicting a syringe with a plunger and barrel. The diagram highlights the fill marker and shows medicine within the syringe barrel. A note indicates it is normal to see one or more medicine fill levels.*

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Instructions For Use Figure D (Image 18)

An instructional diagram showing recommended injection sites for Adalimumab. The image highlights three areas on a human figure: the abdomen, with a note to stay 2 inches away from the belly button, and both thighs, each marked as suitable injection areas.*

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Instructions For Use Figure E (Image 19)

An instructional illustration showing two hands: one holding a syringe, and the other holding a safety cap or protective cover, demonstrating the removal of the cap from the syringe needle. The figure is labeled as Figure E.*

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Instructions For Use Figure F (Image 20)

Illustration showing a hand pinching the skin at the injection site on the abdomen or thighs for administering a drug. A small figure depicts the recommended injection area on the human body, highlighting the abdomen and thighs. The image is labeled as Figure F and titled 'Squeeze Site.'*

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Instructions For Use Figure G (Image 21)

An instructional diagram showing the correct technique to inject a substance using a syringe at a 45-degree angle into the skin. The illustration includes a hand holding the syringe and positioning it at the specified angle relative to the skin surface.*

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Instructions For Use Figure H (Image 22)

An instructional illustration showing a person holding a prefilled syringe and administering an injection into the skin, likely demonstrating subcutaneous injection technique for Adalimumab kit usage.*

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Instructions For Use Figure I (Image 23)

An instructional illustration showing a hand holding a syringe with an arrow indicating the needle being pulled away and the syringe plunger being pulled back, likely demonstrating steps for preparing the Adalimumab kit for injection.*

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Adalimumab-fkjp Prefilled Syringe Carton (20 mg/0.4 mL)

The packaging label for Adalimumab-fkjp Injection, a 20 mg/0.4 mL syringe kit by Biocon Biologics Inc. The label indicates 2 single-dose prefilled syringes for subcutaneous use, includes usage instructions and storage information, and features the Biocon Biologics logo and barcodes.*

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Adalimumab-fkjp Prefilled Syringe Carton (40 mg/0.8 mL)

Packaging label for Adalimumab-fkjp Injection, a kit containing 2 single-dose prefilled syringes each with 40 mg/0.8 mL dosage form for subcutaneous use. The label shows Biocon Biologics Inc as the labeler with storage and usage instructions, barcode, and variable data printing information. The design includes the proprietary name, dosage strength, NDC number 83257-021-42, and administration details.*

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Adalimumab-fkjp Prefilled Pen (40 mg/0.8 mL)

Packaging label for Adalimumab-fkjp Pen Injection kit, containing 40 mg/0.8 mL dosage. The label indicates it is for subcutaneous use only and includes 2 single-dose prefilled pens. The product is manufactured by Biocon Biologics Inc. The label also contains storage instructions, usage guidance, and a variable data box for printing GTIN, serial number, expiration date, and lot number.*

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Figure 3: Kaplan-meier Curves Summarizing Time To Treatment Failure On Or After Week 6 (study Uv I) Or Week 2 (study Uv Ii) (Image 27)

Two Kaplan-Meier plots showing treatment failure rates over 20 months from two studies, Study UV I and Study UV II, comparing placebo and Adalimumab treatments. The vertical axis is treatment failure rate (%) and the horizontal axis is time in months. Both studies indicate lower failure rates with Adalimumab than placebo throughout the treatment period.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.