Adynovate Kit
Product Images NDC 0944-4628

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 42 technical images submitted to the FDA as part of the official labeling for Adynovate (NDC 0944-4628). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Takeda Pharmaceuticals Amercia, 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.

Product Images & Figures Index

FDA Label Image

Figure A (Adynovate 01)

Figure A (Adynovate 01)
Illustration showing a hand holding an ADYNOVATE vial assembly, including a sterile water vial with a blue cap and an external housing for reconstitution of the Antihemophilic Factor (Recombinant) PEGylated product.*
FDA Label Image

Figure B (Adynovate 02)

Figure B (Adynovate 02)
An instructional illustration showing a person holding a medical device kit with both hands. The top hand is pressing down on the device with an arrow indicating downward pressure, suggesting how to operate or activate the device inside the ADYNOVATE kit.*
FDA Label Image

Figure C (Adynovate 03)

Figure C (Adynovate 03)
An instructional illustration showing a hand holding an ADYNOVATE kit component, demonstrating a twisting motion indicated by a curved arrow. The image likely depicts part of the preparation or administration process for the Antihemophilic Factor (Recombinant) PEGylated kit by Takeda Pharmaceuticals America, Inc.*
FDA Label Image

Figure D (Adynovate 04)

Figure D (Adynovate 04)
An instructional diagram showing steps for using a medical kit syringe. Step 1 involves removing a blue cap from a vial or container. Step 2 shows rotating the syringe plunger. The illustration is likely related to preparing or administering ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated kit components.*
FDA Label Image

Figure E (Adynovate 05)

Figure E (Adynovate 05)
An instructional illustration showing a syringe connected to a vial adapter, demonstrating the process of transferring liquid medication. The syringe is oriented horizontally with an arrow pointing to the right, indicating the direction of liquid flow.*
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Image (Adynovate 06)

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Image (Adynovate 07)

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Image (Adynovate 08)

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Image (Adynovate 09)

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Image (Adynovate 10)

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Image (Adynovate 11)

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Image (Adynovate 12)

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Image (Adynovate 13)

Image (Adynovate 13)
An illustration of the ADYNOVATE kit showing a hand holding the assembled device. The diagram labels key components including the ADYNOVATE vial, external housing, blue cap, and sterile water vial, highlighting the kit's design to facilitate preparation for administration.*
FDA Label Image

Image (Adynovate 14)

Image (Adynovate 14)
An instructional illustration showing hands demonstrating how to use a device, likely related to administering or preparing the product ADYNOVATE (Antihemophilic Factor, Recombinant, PEGylated). The diagram emphasizes pressing or pushing down on the top of the device as indicated by a downward arrow.*
FDA Label Image

Image (Adynovate 15)

Image (Adynovate 15)
An instructional illustration showing a hand holding a medical device component with an arrow indicating a rotating or twisting motion. The image likely demonstrates how to operate or assemble a part of the ADYNOVATE kit.*
FDA Label Image

Image (Adynovate 16)

Image (Adynovate 16)
An instructional diagram showing a step-by-step process for using a medical kit. Step 1 involves removing a blue cap from a vial. Step 2 shows a syringe being rotated or twisted, indicating preparation for use. The vial and syringe are components likely included in the ADYNOVATE kit by Takeda Pharmaceuticals America, Inc.*
FDA Label Image

Image (Adynovate 17)

Image (Adynovate 17)
An instructional illustration showing a syringe connected to a vial or cartridge device, likely depicting the extraction of medication from the vial. A black arrow points to the right, indicating the direction of syringe insertion or fluid withdrawal.*
FDA Label Image

Image (Adynovate 18)

Image (Adynovate 18)
An instructional illustration showing a gloved hand applying or removing a square adhesive patch from the inner forearm of a patient with a tourniquet applied above the elbow. The image likely depicts a step in preparing the arm for venipuncture or infusion.*
FDA Label Image

Image (Adynovate 19)

Image (Adynovate 19)
An illustration showing a healthcare professional wearing gloves preparing an injection. A syringe is being held in one hand, connected by tubing to a needle or cannula inserted into a patient's arm.*
FDA Label Image

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)
Packaging label for ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, a plasma derivative kit by Takeda Pharmaceuticals America, Inc. The label includes product branding with a purple banner, product usage instructions indicating lyophilized powder for reconstitution, storage conditions, and contents. It also shows an image of the preassembled BAXJECT III system used for administration. The label details that the kit contains ADYNOVATE, sterile water for injection, one microbore infusion set, and one package insert.*
FDA Label Image

Principal Display Panel (Barrel Label)

Principal Display Panel (Barrel Label)
This image shows a drug information panel for ADYNOVATE (Antihemophilic Factor [Recombinant], PEGylated) KIT. It includes instructions for intravenous administration, indicating the product and diluent are preassembled in the BAXJECT III system. The image also depicts simple three-step illustrations for use: pressing, swirling, and flipping with withdrawing the syringe. The label notes it is Rx only, with placeholders for lot number, expiration date, and IU.*
FDA Label Image

Principal Display Panel (Blister Label)

Principal Display Panel (Blister Label)
Packaging label for ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated in a kit dosage form. The label indicates it is for intravenous administration only, single use, and includes instructions not to open until use or if packaging is damaged. The product is labeled by Takeda Pharmaceuticals America, Inc., with the brand name displayed prominently in white text on a purple background.*
FDA Label Image

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)
Packaging label for ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated kit by Takeda Pharmaceuticals America, Inc. The label includes product identification, usage instructions for intravenous administration, storage and handling details, excipient information, and trademark and patent notices. The design features a purple and white color scheme with the Shire logo and kit illustrations.*
FDA Label Image

Principal Display Panel (Barrel Label)

Principal Display Panel (Barrel Label)
Label for ADYNOVATE (Antihemophilic Factor [Recombinant], PEGylated) kit by Takeda Pharmaceuticals America, Inc. The label includes instructions for intravenous administration using the BAXJECT III system with diagrams for pressing, swirling, and flipping to withdraw the product. It contains space for IU, lot, and expiration information and is marked Rx only.*
FDA Label Image

Principal Display Panel (Blister Label)

Principal Display Panel (Blister Label)
ADYNOVATE kit packaging label displaying its proprietary name and active ingredient Antihemophilic Factor (Recombinant), PEGylated. The label indicates it is for intravenous administration only and single-use, with storage and usage instructions. The labeler is Takeda Pharmaceuticals America, Inc., formerly Shire.*
FDA Label Image

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)
Packaging label for ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] kit by Takeda Pharmaceuticals America, Inc. The label includes product information such as dosage form as a kit, storage instructions, reconstitution details, and manufacturer address. The design features purple and white backgrounds with Shire branding and a product image of the preassembled BAXJECT III system used for infusion.*
FDA Label Image

Principal Display Panel (Barrel Label)

Principal Display Panel (Barrel Label)
ADYNOVATE kit label for Antihemophilic Factor (Recombinant), PEGylated, intended for intravenous administration only. The label shows the product name, usage instructions indicating the ADYNOVATE and diluent are preassembled in the BAXJECT III system, and user directions to see the package insert. It includes stepwise illustrations for use with the BAXJECT III system: press, swirl, and flip & withdraw. The label features the Shire logo and indicates the product is Rx only.*
FDA Label Image

Principal Display Panel (Blister Label)

Principal Display Panel (Blister Label)
Label for ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated kit, a plasma derivative for intravenous administration. Label includes usage instructions, single use indication, NDC 0944-4626-02, and is manufactured by Takeda Pharmaceuticals America, Inc. The label also shows lot, expiration, and IU fields for tracking.*
FDA Label Image

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)
Packaging label for ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated kit by Takeda Pharmaceuticals America, Inc. The label includes dosing instructions, storage information, and details about the lyophilized powder and preassembled BAXJECT III system. The label features the Shire logo and notes the product is for intravenous use after reconstitution, single use only, and contains no preservatives.*
FDA Label Image

Principal Display Panel (Barrel Label)

Principal Display Panel (Barrel Label)
Label for ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated kit by Takeda Pharmaceuticals America, Inc. The label includes instructions for intravenous use with pictorial guidance on pressing, swirling, and withdrawing steps. Additional text notes that ADYNOVATE and diluent are preassembled in the BAXJECT III system, with directions to see the package insert. The label features the Shire logo and marked sections for lot, IU, and expiration date, along with a pink stamped message 'NO COAT.'*
FDA Label Image

Principal Display Panel (Blister Label)

Principal Display Panel (Blister Label)
Label for ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated. The label indicates it is for intravenous administration only and is part of a kit preassembled in the BAXJECT III system. Markings include NDC 0944-4624-02, single use only, and spaces for IU, lot number, and expiration date. The label features the Shire logo and instructions not to use if packaging is opened or damaged.*
FDA Label Image

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)
Packaging label for ADYNOVATE kit containing Antihemophilic Factor (Recombinant), PEGylated. The label shows this is a lyophilized powder for intravenous administration after reconstitution, preassembled in the BAXJECT III system. It includes storage instructions, usage notes, and packaging components. The labeler is Takeda Pharmaceuticals America, Inc.*
FDA Label Image

Principal Display Panel (Barrel Label)

Principal Display Panel (Barrel Label)
ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated kit label by Takeda Pharmaceuticals America, Inc. The label includes instructions for intravenous administration using the BAXJECT III system, with illustrated steps: press, swirl, flip, and withdraw. It notes ADYNOVATE and diluent are preassembled and advises to see the package insert for directions.*
FDA Label Image

Principal Display Panel (Blister Label)

Principal Display Panel (Blister Label)
Packaging label for ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated kit by Takeda Pharmaceuticals America, Inc. The label includes usage instructions indicating intravenous administration only, with cautions about not opening until use and avoiding use if packaging is damaged. It also specifies single-use only and includes areas marked for IU, lot, and expiration information.*
FDA Label Image

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)
Packaging label for ADYNOVATE (Antihemophilic Factor (Recombinant), PEGylated) kit by Takeda Pharmaceuticals America, Inc. The label indicates it is a lyophilized powder for reconstitution, used with BAXJECT III system. The label includes storage instructions, contents, and legal notices, with multiple instances of the Shire logo and emphasis on 'NO COAT' text.*
FDA Label Image

Principal Display Panel (Barrel Label)

Principal Display Panel (Barrel Label)
Label for ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated kit by Takeda Pharmaceuticals America, Inc. Instructions for intravenous administration using the BAXJECT III system are shown, including pressing, swirling, and flipping to withdraw the solution. The label notes the product is for prescription use only (Rx Only).*
FDA Label Image

Principal Display Panel (Blister Label)

Principal Display Panel (Blister Label)
ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated kit packaging label by Takeda Pharmaceuticals America, Inc. Features dosing and usage instructions with warnings such as single use only and to avoid use if packaging is damaged. The label includes the NDC 0944-4625-02 and branding elements from Shire.*
FDA Label Image

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)
Box packaging label for ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated, a plasma derivative kit by Takeda Pharmaceuticals America, Inc. The label includes dosage form as KIT and highlights the product's reconstitution instructions for intravenous administration. Branding is consistent with Shire and Baxalta U.S. Inc. markings. The label also notes refrigeration storage instructions and contains cautionary information and lot details.*
FDA Label Image

Principal Display Panel (Barrel Label)

Principal Display Panel (Barrel Label)
ADYNOVATE (Antihemophilic Factor [Recombinant], PEGylated) kit label with administration instructions for intravenous use. The label shows step-by-step illustrations for preparation using the BAXJECT III system: press, swirl, flip, and withdraw. It includes dosing and manufacturer information for Takeda Pharmaceuticals America, Inc., and states 'For Intravenous Administration Only' with Rx only designation.*
FDA Label Image

Principal Display Panel (Blister Label)

Principal Display Panel (Blister Label)
Label for ADYNOVATE (Antihemophilic Factor [Recombinant], PEGylated) kit by Takeda Pharmaceuticals America, Inc. The label includes instructions for intravenous administration, single use notice, and cautions about packaging integrity. It features the Shire logo and areas designated for IU, lot, and expiration date information.*
FDA Label Image

Principal Display Panel (Antihemophilic Factor Vial Label)

Principal Display Panel (Antihemophilic Factor Vial Label)
Label fragment for ADYNOVATE, showing the nonproprietary name Antihemophilic Factor (Recombinant), PEGylated. The label includes the lot number area and partial branding by Shire. Product type and dosage form details are not visible on this label segment.*
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Principal Display Panel (Sterile Water for Injection Vial Label)

Principal Display Panel (Sterile Water for Injection Vial Label)
Label panel for Sterile Water for Injection by Siegfried Hameln GmbH showing a blank lot number field and a numeric code 0742211. The label includes a blue header with the product name and a bordered area for the lot number.*

* 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.