Benefix Kit
Product Images NDC 58394-636

37 FDA label images from Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 37 technical images submitted to the FDA as part of the official labeling for Benefix (NDC 58394-636). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Wyeth Biopharma Division Of Wyeth Pharmaceuticals 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 (Benefix 01)

Figure (Benefix 01)
An instructional diagram showing a hand holding a vial and a syringe, demonstrating a step in the preparation or administration process for BeneFIX (coagulation factor IX recombinant) kit by Wyeth BioPharma Division.*
FDA Label Image

Figure (Benefix 02)

Figure (Benefix 02)
An instructional diagram showing a vial being held upright with a syringe or device above it, with arrows indicating the direction to insert or connect. The image appears to demonstrate a preparation or administration step for BeneFIX, a coagulation factor IX (recombinant) kit by Wyeth BioPharma.*
FDA Label Image

Figure (Benefix 03)

Figure (Benefix 03)
An instructional illustration showing the steps to assemble or activate a medical kit. The image depicts a hand pulling a plunger back on a syringe attached to a vial, with directional arrows indicating motion. This is consistent with preparing a medication kit, such as the BeneFIX coagulation factor IX recombinant kit.*
FDA Label Image

Figure (Benefix 04)

Figure (Benefix 04)
An instructional diagram showing two hands holding an ampule, demonstrating the proper technique to snap off the top of the ampule by applying pressure at the neck, indicated by an arrow pointing upwards.*
FDA Label Image

Figure (Benefix 05)

Figure (Benefix 05)
An instructional diagram showing a hand peeling back the protective foil from the top of a vial, illustrating the first step in preparing the BeneFIX coagulation factor ix (recombinant) kit for use.*
FDA Label Image

Figure (Benefix 06)

Figure (Benefix 06)
An instructional diagram illustrating the preparation of a BeneFIX coagulation factor IX (recombinant) kit. It shows a vial and a syringe with a needle above it, indicating the steps to attach the needle to the vial for reconstitution or administration preparation.*
FDA Label Image

Figure (Benefix 07)

Figure (Benefix 07)
An instructional diagram showing a hand holding a syringe above a vial, with an arrow pointing downward indicating the syringe being inserted into the vial. This likely illustrates a step for withdrawing medication from the vial for BeneFIX, a coagulation factor IX (recombinant) plasma derivative kit by Wyeth BioPharma.*
FDA Label Image

Figure (Benefix 08)

Figure (Benefix 08)
An instructional illustration showing a hand holding a syringe vertically with an arrow pointing downwards, indicating a step likely related to medication preparation or administration in a kit.*
FDA Label Image

Figure (Benefix 09)

Figure (Benefix 09)
An instructional illustration showing a person holding a vial and inserting a needle or syringe into it, likely depicting preparation steps for administering BeneFIX (coagulation factor IX recombinant) kit.*
FDA Label Image

Figure (Benefix 10)

Figure (Benefix 10)
An instructional diagram showing a hand holding a syringe connected by tubing to an intravenous catheter inserted into an arm, illustrating the administration process of an intravenous infusion kit.*
FDA Label Image

Figure 1 (Benefix 11)

Figure 1 (Benefix 11)
A bar chart showing mean IU/dL per IU/kg over months on study, with data points at 0, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months. Each bar includes a sample size (N) above it, indicating the number of subjects at each time point.*
FDA Label Image

Figure (Benefix 12)

Figure (Benefix 12)
An instructional illustration showing a hand holding a vial with a stopper being removed by pulling upward. The image demonstrates the step of removing the stopper from a vial before use.*
FDA Label Image

Figure (Benefix 13)

Figure (Benefix 13)
An instructional diagram showing the first step of the BeneFIX kit preparation. It depicts a vial at the bottom with a cap and a stopper, and above it, a hand holding a device or syringe poised for installation or injection into the vial. Arrows indicate the direction of motion for connecting the device to the vial.*
FDA Label Image

Figure (Benefix 14)

Figure (Benefix 14)
An instructional illustration showing a hand twisting and inserting a syringe into a vial, indicating the correct technique to prepare an injection. The image uses arrows to guide the steps in attaching the syringe to the vial stopper.*
FDA Label Image

Figure (Benefix 15)

Figure (Benefix 15)
Instructional illustration showing two hands holding parts of a kit, with an arrow indicating pulling or separating action. The image likely demonstrates a step in preparing or assembling the BeneFIX kit, which contains coagulation factor IX (recombinant).*
FDA Label Image

Figure (Benefix 16)

Figure (Benefix 16)
Illustration depicting a hand peeling back a protective seal or cover from the top of a vial, with an arrow indicating the upward removal direction. This instructional image is related to the BeneFIX coagulation factor IX (recombinant) kit by Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC.*
FDA Label Image

Figure (Benefix 17)

Figure (Benefix 17)
An instructional illustration showing the preparation of BeneFIX coagulation factor ix (recombinant) kit, including a vial and syringe components being assembled for reconstitution or administration.*
FDA Label Image

Figure (Benefix 18)

Figure (Benefix 18)
An instructional diagram illustrates a hand holding and connecting two components of a medical kit, showing a step in assembling or preparing the BeneFIX coagulation factor IX (recombinant) plasma derivative kit from Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC.*
FDA Label Image

Figure (Benefix 19)

Figure (Benefix 19)
An instructional illustration showing a step in the preparation of BeneFIX, a kit containing recombinant coagulation factor IX. The image depicts hands manipulating a vial and a connecting device, with a downward arrow indicating direction, likely demonstrating how to attach or mix components within the kit.*
FDA Label Image

Figure (Benefix 20)

Figure (Benefix 20)
An instructional illustration showing a close-up of hands administering an injection into an arm, demonstrating the proper technique for subcutaneous administration.*
FDA Label Image

Figure (Benefix 21)

Figure (Benefix 21)
An instructional illustration depicts a hand holding a syringe connected to tubing with a connector, suggesting preparation or administration of an injectable solution. The simple line drawing suggests sterile technique or assembly of components for intravenous use.*
FDA Label Image

Figure (Benefix 22)

FDA Label Image

Benefix 22a

Benefix 22a
Label for BeneFIX 1000 IU kit containing coagulation factor IX (recombinant) for Factor IX replacement. The label indicates single-use, room temperature storage (36 to 86°F), and no preservatives. It includes manufacturing information by Wyeth Pharmaceuticals LLC, a Pfizer subsidiary, and a QR code. The label features product identification codes, lot, and expiration date fields.*
FDA Label Image

Benefix 22b

Benefix 22b
Label for a 5 mL syringe of 0.234% Sodium Chloride Diluent intended for use with BeneFIX (coagulation factor IX recombinant) kits. The label states the product is sterile, nonpyrogenic, contains no preservatives, and is manufactured for Wyeth Pharmaceuticals LLC, a Pfizer subsidiary. Manufacturing is by Vetter Pharma-Fertigung GmbH & Co. KG in Germany. The label includes a lot number area, barcodes, and US government license information.*
FDA Label Image

Benefix 22c

Benefix 22c
Packaging label for BeneFIX 1000 IU Range Coagulation Factor IX (Recombinant) Kit by Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. The label indicates room temperature storage, contains a single-use vial with a 5 mL prefilled diluent syringe, and highlights that the product contains no plasma or albumin. The label includes instructions for Factor IX Replacement Therapy only and features the Pfizer logo.*
FDA Label Image

Benefix 22d

Benefix 22d
Label for BeneFIX 2000 IU kit containing coagulation factor IX (recombinant) plasma derivative. The label indicates single use, no preservatives, room temperature storage, and is produced by Wyeth Pharmaceuticals LLC, a Pfizer subsidiary. It includes a barcode, lot and expiration date fields, and states usage is only with provided diluent syringe for Factor IX replacement therapy.*
FDA Label Image

Benefix 22e

Benefix 22e
Label for a 5 mL sodium chloride diluent syringe intended for use with BeneFIX (coagulation factor IX recombinant) kits. The syringe is sterile, nonpyrogenic, and preservative-free. Manufactured by Vetter Pharma-Fertigung GmbH & Co. KG in Germany, for Wyeth Pharmaceuticals LLC, a Pfizer subsidiary.*
FDA Label Image

Benefix 22f

Benefix 22f
Packaging label for BeneFIX 2000 IU Range kit containing coagulation factor IX (recombinant) for Factor IX replacement therapy. The label indicates it is a plasma derivative with no plasma or albumin. The kit includes one single-use vial and a prefilled diluent syringe. Storage instructions specify room temperature (2 to 30°C or 36 to 86°F). The labeler is Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, with Pfizer branding present.*
FDA Label Image

Benefix 22g

Benefix 22g
Label for BeneFIX 500 IU kit containing coagulation factor IX (recombinant), a plasma derivative. The label notes room temperature storage, single use, and no preservatives. It is manufactured by Wyeth Pharmaceuticals, a Pfizer subsidiary, for factor IX replacement therapy. The label includes a barcode, QR code, and storage instructions between 2 to 30°C (36 to 86°F).*
FDA Label Image

Benefix 22h

Benefix 22h
Label for a 5 mL disposable syringe of 0.234% Sodium Chloride Diluent used with BeneFIX (coagulation factor IX recombinant). The label states the product is sterile, nonpyrogenic, preservative-free, and manufactured for Wyeth Pharmaceuticals LLC. Manufacturing sites in Germany are also listed, along with a US government license number. The label includes lot and expiration date fields.*
FDA Label Image

Benefix 22i

Benefix 22i
Packaging label for BeneFIX 500 IU Range Kit containing coagulation factor IX (recombinant) by Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. The kit includes one single-use vial and a 5-mL prefilled diluent syringe for reconstitution. The label highlights room temperature storage, absence of plasma and albumin, and is marked for Factor IX Replacement Therapy only. The label also displays the Pfizer logo and storage instructions at 2 to 30 °C (36 to 86 °F).*
FDA Label Image

Principal Display Panel (250 IU SINGLE USE VIAL LABEL)

Principal Display Panel (250 IU SINGLE USE VIAL LABEL)
Label for BeneFIX 250 IU kit containing coagulation factor IX (recombinant), a plasma derivative for Factor IX replacement. The label shows storage instructions at 2 to 30°C, notes it is for single use with no preservatives, and is manufactured by Wyeth Pharmaceuticals LLC, a Pfizer subsidiary. It includes lot and expiration placeholders and instructs to reconstitute only with the diluent syringe provided.*
FDA Label Image

Paa023493.jpg (Benefix 24)

Paa023493.jpg (Benefix 24)
Label for 0.234% Sodium Chloride Diluent, 5 mL disposable syringe designed for use with BeneFIX (coagulation factor ix recombinant) kits. The label includes manufacturing and distributor information from Wyeth Pharmaceuticals LLC, and Vetter Pharma-Fertigung GmbH & Co. KG in Germany. It states the product is sterile, nonpyrogenic, preservative-free, and for prescription use only.*
FDA Label Image

Principal Display Panel (250 IU Kit Carton)

Principal Display Panel (250 IU Kit Carton)
BeneFIX 250 IU Range kit packaging label for coagulation factor IX (recombinant) by Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. The label indicates room temperature storage and no plasma or albumin content. The kit includes one single-use vial with 5 mL prefilled diluent syringe. Storage instructions specify 2 to 30°C (36 to 86°F). The product is for Factor IX Replacement Therapy only and intended for intravenous administration. Pfizer logo is present on the label.*
FDA Label Image

Principal Display Panel (500 IU SINGLE USE VIAL LABEL)

Principal Display Panel (500 IU SINGLE USE VIAL LABEL)
Label for BeneFIX 3000 IU Kit containing coagulation factor IX (recombinant) by Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. The label shows dosage strength, storage instructions at room temperature, and note indicating use for Factor IX replacement. Manufactured by Pfizer subsidiary with NDC 58394-137-03, includes barcode and lot/expiration placeholders.*
FDA Label Image

Principal Display Panel (500 IU Kit Carton)

Principal Display Panel (500 IU Kit Carton)
Label for a 5 mL syringe of 0.234% Sodium Chloride Diluent intended for use with BeneFIX, coagulation factor IX (recombinant). The label specifies the diluent as sterile, nonpyrogenic, and preservative-free. It includes manufacturing details for Wyeth Pharmaceuticals LLC and Vetter Pharma-Fertigung GmbH & Co. KG in Germany, with a lot number and barcodes.*
FDA Label Image

Principal Display Panel (1000 IU SINGLE USE VIAL LABEL)

Principal Display Panel (1000 IU SINGLE USE VIAL LABEL)
The packaging label for BeneFIX 3000 IU Kit contains Coagulation Factor IX (Recombinant) for Factor IX Replacement Therapy only. It features room temperature storage instructions and highlights that it contains no plasma or albumin. The kit includes one vial of sterile BeneFIX, one 5 mL prefilled diluent syringe, and various reconstitution accessories. The label shows the Pfizer logo and storage conditions of 2 to 30°C (36 to 86°F).*

* 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.