Adalimumab-aacf Kit
Product Images NDC 65219-612

Product Visual Gallery

This gallery contains 38 technical images submitted to the FDA as part of the official labeling for Adalimumab-aacf (NDC 65219-612). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Ada08 0001 01)

A line graph comparing the percent of ACR20 responders over time (weeks) between two groups: one receiving 40 mg of a treatment every other week and a placebo group. The treatment group shows a higher and increasing response rate, leveling off around 60%, while the placebo group maintains a lower, relatively stable response near 30%.*

FDA Label Image

Figure 2 (Ada08 0001 02)

A line graph comparing the percentage of ASAS 20 response over 26 weeks between placebo and adalimumab treatment groups. The vertical axis represents the percentage response, while the horizontal axis shows time in weeks, illustrating higher response rates for adalimumab compared to placebo over time.*

FDA Label Image

Figure 3 (Ada08 0001 03)

A line graph depicting treatment failure rates over time (in months) for two groups: placebo and adalimumab. The y-axis represents treatment failure rate percentage, while the x-axis shows treatment duration in months, up to 20. The graph includes patient numbers at risk below the x-axis for both groups at multiple time points.*

FDA Label Image

Figure 3 (Ada08 0001 04)

A line chart depicting treatment failure rates over time in months for patients treated with Adalimumab compared to placebo. The y-axis shows treatment failure percentage, and the x-axis represents time in months. Two curves illustrate lower failure rates for Adalimumab versus placebo across the treatment period.*

FDA Label Image

Figure (Ada08 0001 05)

Instructions for use panel showing the Adalimumab-aacf single dose prefilled pen for subcutaneous injection. It includes the product pronunciation, dosage strength of 40 mg/0.8 mL, and identifies the product as IDACIO (adalimumab-aacf). A partial image of the prefilled pen device is shown on a blue background.*

FDA Label Image

Figure (Ada08 0001 06)

Instructional illustration showing the use of an Adalimumab-aacf subcutaneous injection kit. The diagram labels parts of the injector including the needle cap, transparent syringe housing, syringe plunger, injector body, and injection button before use; and shows the needle, safety guard extended, needle cap, and syringe plunger in the final position after use.*

FDA Label Image

Figure (Ada08 0001 07)

An instructional banner titled "Step 1 Prepare for your injection" showing the first step in an injection preparation process. The text is on a blue background with a yellow arrow pointing right before the step number.*

FDA Label Image

Figure (Ada08 0001 08)

An instructional illustration showing three cotton balls, a folded white cloth, and a red plastic sharps container with a pink lid designed for safe disposal of needles or sharps. The image is labeled as Figure C, likely depicting components or steps related to the use and disposal of subcutaneous injection materials.*

FDA Label Image

Figure (Ada08 0001 09)

An instructional diagram showing a hand inserting a rectangular kit box into a refrigerator compartment, labeled as Figure D. The image suggests refrigeration storage for the kit but does not display text or specific product details.*

FDA Label Image

Figure (Ada08 0001 10)

An illustration showing a close-up of a box with a highlighted section indicating the location of the expiration date, labeled as EXP: YYYY-MM. This visual emphasizes where to find the expiration date on the product packaging.*

FDA Label Image

Figure (Ada08 0001 11)

An instructional illustration labeled Figure F showing hands opening a kit tray. One hand is pulling up on the tray component as indicated by a blue arrow, demonstrating how to remove or access items within the kit.*

FDA Label Image

Figure (Ada08 0001 12)

An instructional illustration showing a hand placing a kit box into a refrigerator. The image indicates proper storage of the product, likely a subcutaneous human prescription drug kit, consistent with refrigeration requirements.*

FDA Label Image

Figure (Ada08 0001 13)

An instructional illustration showing a subcutaneous injection pen with a label indicating a 30-minute waiting period, represented by a clock graphic and the text 'Wait 30 minutes.' The figure is labeled as Figure H.*

FDA Label Image

Figure (Ada08 0001 14)

Instructional graphic showing Step 2 of a process, advising to wash your hands. The design features the text 'Step 2' on a yellow arrow pointing to the right, followed by 'Wash your hands' on a blue background.*

FDA Label Image

Figure (Ada08 0001 15)

An instructional illustration showing a person's hands rinsing or washing under a running faucet with water flowing. The image is labeled as Figure I and demonstrates proper hand washing technique.*

FDA Label Image

Figure (Ada08 0001 16)

An instructional banner labeled 'Step 3' with the directive to 'Check your prefilled pen' displayed on a blue and yellow background. The image is part of a step-by-step guide, likely related to the use or preparation of a medication pen device.*

FDA Label Image

Figure (Ada08 0001 17)

An instructional illustration showing a transparent syringe housing labeled as Figure J in the context of the Adalimumab-aacf subcutaneous kit.*

FDA Label Image

Figure (Ada08 0001 18)

Adalimumab-aacf kit for subcutaneous injection by Fresenius Kabi USA, LLC featuring a white syringe with a yellow cap. The visible label includes the proprietary name Adalimumab-aacf, an expiration date placeholder, and a product code.*

FDA Label Image

Figure (Ada08 0001 19)

An instructional graphic showing the text 'Step 4 Choose the injection site' in white and yellow font on a blue gradient background, indicating a step in the process of using a medication kit for subcutaneous injection.*

FDA Label Image

Figure (Ada08 0001 20)

An instructional illustration showing recommended injectable areas for subcutaneous administration. Highlighted injection sites include the abdomen and the front of both thighs. The figure is labeled as Figure L.*

FDA Label Image

Figure (Ada08 0001 21)

Instructional image panel labeled 'Step 5' with text reading 'Clean the injection site.' The background transitions from yellow on the left to blue on the right, with the step number highlighted in yellow and the instruction text in white on blue.*

FDA Label Image

Figure (Ada08 0001 22)

An instructional illustration showing a hand holding a pen-like device near a person's bent knee, indicating injection or application to the subcutaneous tissue near the knee. The label below reads 'Figure M.'*

FDA Label Image

Figure (Ada08 0001 23)

An instructional graphic featuring a yellow arrow with blue text indicating "Step 6" followed by the instruction "Give your injection" on a blue and white gradient background. This appears to be part of a step-by-step guide for administering a subcutaneous injection kit.*

FDA Label Image

Figure (Ada08 0001 24)

Illustration showing hands holding a subcutaneous injection kit for Adalimumab-aacf, demonstrating removal of the cap from the device prior to administration.*

FDA Label Image

Figure (Ada08 0001 25)

An instructional illustration showing a hand holding a prefilled syringe or injector pen resembling a kit for subcutaneous administration. The device is held upright with a finger on the plunger, likely demonstrating proper grip or activation technique for the Adalimumab-aacf kit by Fresenius Kabi USA, LLC.*

FDA Label Image

Figure (Ada08 0001 26)

An instructional diagram illustrating the correct use of the Adalimumab-aacf subcutaneous injection kit. It shows a hand holding the injection device at a 90-degree angle to the skin with a close-up of the needle's safety guard in place before injection.*

FDA Label Image

Figure (Ada08 0001 27)

An instructional illustration showing the proper method for using the Adalimumab-aacf subcutaneous injection kit. The image depicts a hand holding the injection device with an arrow indicating the direction to push down, highlighting the safety guard mechanism before injection.*

FDA Label Image

Figure (Ada08 0001 28)

An instructional illustration showing a hand holding a syringe with instruction to watch the plunger and hold during a subcutaneous injection. A close-up inset highlights the plunger position inside the syringe. The image depicts a step in the injection process, with the injection site shown on skin.*

FDA Label Image

Figure (Ada08 0001 29)

An instructional illustration showing a hand holding a syringe just above skin and pressing the plunger. A close-up inset shows the syringe chamber after injection, indicating to hold the position for 5 more seconds. This diagram demonstrates proper subcutaneous injection technique for the Adalimumab-aacf kit.*

FDA Label Image

Figure (Ada08 0001 30)

An instructional illustration showing the correct use of a subcutaneous injection device. The image depicts a hand pressing the device vertically against the skin to administer the injection, with a close-up inset highlighting the needle tip in contact with the skin surface.*

FDA Label Image

Figure (Ada08 0001 31)

An illustration showing a hand applying a round cotton pad or gauze to a skin area, likely representing a step in preparing the skin for a subcutaneous injection, associated with the use of Adalimumab-aacf kit.*

FDA Label Image

Figure (Ada08 0001 32)

An instructional graphic panel labeled Step 7, titled "Dispose of your prefilled pens," showing guidance on disposal of used subcutaneous injection pens, associated with a medication kit.*

FDA Label Image

Figure (Ada08 0001 33)

An instructional illustration showing a hand holding a vial, positioned above a red sharps disposal container with a white lid. A blue arrow indicates the vial is being placed into the container, demonstrating proper disposal of the vial from the Adalimumab-aacf kit.*

FDA Label Image

Figure (Ada08 0001 34)

Instructional graphic emphasizing Step 8: Document your injection site and date administered. The image features blue and yellow colors with a directional arrow, guiding users to record injection details.*

FDA Label Image

Figure (Ada08 0001 35)

An instructional illustration showing a hand holding a blue pen and writing on a note card with prompts to record the date of administration and injection site, marked as 11/24/22 and left thigh respectively. The figure is labeled as Figure W.*

FDA Label Image

Fresenius Kabi Logo (Ada08 0001 36)

FDA Label Image

Principal Display Panel – 40 mg/0.8 mL Injection (Ada08 0001 37)

Packaging label for Adalimumab-aacf injection kit, 40 mg / 0.8 mL, for subcutaneous use only. The carton contains 2 single-dose prefilled pens with 29 gauge needles, including alcohol preps, prescribing information, medication guide, and instructions for use. Manufactured by Fresenius Kabi USA, LLC.*

FDA Label Image

Principal Display Panel – 0.8 mL Single-dose Prefilled Pen Label (Ada08 0001 38)

Label for Adalimumab-aacf injection, 40 mg/0.8 mL, in a kit dosage form for subcutaneous use. The label includes the product name, strength, bar code, lot and expiration placeholders, NDC 65219-610-02, and identifies Fresenius Kabi USA, LLC as the labeler.*

* 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.