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BENEFIX® Principal Display Panel (Coagulation Factor IX (Recombinant))

PRINCIPAL DISPLAY PANEL - 1000 IU Vial Label

1000 IU Range

BeneFix®
Coagulation Factor IX (Recombinant)
Room Temperature Storage

No Preservatives
Single Use

Pfizer
Rx only

For Factor IX
Replacement

Principal Display Panel - 1000 IU Vial Label

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label - Kit 58394-635

0.234% Sodium
Chloride Diluent
5 mL

Disposable syringe for
drug diluent use with BeneFix®
Coagulation Factor IX (Recombinant)

Sterile, nonpyrogenic. Contains no
preservatives.

Manufactured for
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
Manufactured by
Vetter Pharma-Fertigung GmbH & Co. KG
Schuetzenstrasse 87, 99-101
88212 Ravensburg, Germany
or
Vetter Pharma-Fertigung GmbH & Co. KG
Eisenbahnstrasse 2-4
88085 Langenargen, Germany
US Govt. License No. 3

Rx only

LOT:
EXP.:

PAA133670

Principal Display Panel - 5 mL Syringe Label - Kit 58394-635

PRINCIPAL DISPLAY PANEL - 1000 IU Kit Carton

One single-use vial with 5-mL prefilled diluent syringe
NDC 58394-635-03

Room Temperature Storage

1000 IU Range

BeneFix®
Coagulation Factor IX (Recombinant)
Room Temperature Storage
No Plasma. No Albumin.

For Intravenous
Administration

Store at 2 to 30º C (36 to 86º F).

For Factor IX Replacement Therapy Only

Reconstitute BeneFix® with the
enclosed sterile prefilled
syringe of 0.234% Sodium
Chloride for Injection, ONLY.

Rx only
Pfizer

Principal Display Panel - 1000 IU Kit Carton

PRINCIPAL DISPLAY PANEL - 2000 IU Vial Label

2000 IU Range

BeneFix®
Coagulation Factor IX (Recombinant)
Room Temperature Storage

No Preservatives
Single Use

Pfizer
Rx only

For Factor IX
Replacement

Principal Display Panel - 2000 IU Vial Label

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label - Kit 58394-636

0.234% Sodium
Chloride Diluent
5 mL

Disposable syringe for
drug diluent use with BeneFix®
Coagulation Factor IX (Recombinant)

Sterile, nonpyrogenic. Contains no
preservatives.

Manufactured for
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
Manufactured by
Vetter Pharma-Fertigung GmbH & Co. KG
Schuetzenstrasse 87, 99-101
88212 Ravensburg, Germany
or
Vetter Pharma-Fertigung GmbH & Co. KG
Eisenbahnstrasse 2-4
88085 Langenargen, Germany
US Govt. License No. 3

Rx only

LOT:
EXP.:

PAA133670

Principal Display Panel - 5 mL Syringe Label - Kit 58394-636

PRINCIPAL DISPLAY PANEL - 2000 IU Kit Carton

One single-use vial with 5-mL prefilled diluent syringe
NDC 58394-636-03

Room Temperature Storage

2000 IU Range

BeneFix®
Coagulation Factor IX (Recombinant)
Room Temperature Storage
No Plasma. No Albumin.

For Intravenous
Administration

Store at 2 to 30º C (36 to 86º F).

For Factor IX Replacement Therapy Only

Reconstitute BeneFix® with the
enclosed sterile prefilled
syringe of 0.234% Sodium
Chloride for Injection, ONLY.

Rx only
Pfizer

Principal Display Panel - 2000 IU Kit Carton

PRINCIPAL DISPLAY PANEL - 500 IU Vial Label

500 IU Range

BeneFix®
Coagulation Factor IX (Recombinant)
Room Temperature Storage

No Preservatives
Single Use

Pfizer
Rx only

For Factor IX
Replacement

Principal Display Panel - 500 IU Vial Label

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label - Kit 58394-634

0.234% Sodium
Chloride Diluent
5 mL

Disposable syringe for
drug diluent use with BeneFix®
Coagulation Factor IX (Recombinant)

Sterile, nonpyrogenic. Contains no
preservatives.

Manufactured for
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
Manufactured by
Vetter Pharma-Fertigung GmbH & Co. KG
Schuetzenstrasse 87, 99-101
88212 Ravensburg, Germany
or
Vetter Pharma-Fertigung GmbH & Co. KG
Eisenbahnstrasse 2-4
88085 Langenargen, Germany
US Govt. License No. 3

Rx only

LOT:
EXP.:

PAA133670

Principal Display Panel - 5 mL Syringe Label - Kit 58394-634

PRINCIPAL DISPLAY PANEL - 500 IU Kit Carton

One single-use vial with 5-mL prefilled diluent syringe
NDC 58394-634-03

Room Temperature Storage

500 IU Range

BeneFix®
Coagulation Factor IX (Recombinant)
Room Temperature Storage
No Plasma. No Albumin.

For Intravenous
Administration

Store at 2 to 30º C (36 to 86º F).

For Factor IX Replacement Therapy Only

Reconstitute BeneFix® with the
enclosed sterile prefilled
syringe of 0.234% Sodium
Chloride for Injection, ONLY.

Rx only
Pfizer

Principal Display Panel - 500 IU Kit Carton

PRINCIPAL DISPLAY PANEL - 250 IU Syringe Label

250 IU Range

BeneFix®
Coagulation Factor IX (Recombinant)

Room Temperature Storage

No Preservatives
Single Use

Pfizer

Rx only

For Factor IX
Replacement

PRINCIPAL DISPLAY PANEL - 250 IU Syringe Label

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label - 58394-633 Kit

0.234% Sodium
Chloride Diluent
5 mL

Disposable syringe for
drug diluent use with BeneFix®
Coagulation Factor IX (Recombinant)

Sterile, nonpyrogenic. Contains no
preservatives.

Manufactured for
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
Manufactured by
Vetter Pharma-Fertigung GmbH & Co. KG
Schuetzenstrasse 87, 99-101
88212 Ravensburg, Germany
or
Vetter Pharma-Fertigung GmbH & Co. KG
Eisenbahnstrasse 2-4
88085 Langenargen, Germany
US Govt. License No. 3

Rx only

LOT:
EXP.:

PAA133670

Principal Display Panel - 5 mL Syringe Label - 58394-633 Kit

PRINCIPAL DISPLAY PANEL - 250 IU Kit Carton

One single-use vial with 5-mL prefilled diluent syringe
NDC 58394-633-03

Room Temperature Storage

250 IU Range

™BeneFix®

Coagulation Factor IX (Recombinant)

Room Temperature Storage

No Plasma. No Albumin.

For Intravenous
Administration

Store at 2 to 30° C (36 to 86° F).

Reconstitute BeneFIX® with the
enclosed sterile prefilled
syringe of 0.234% Sodium
Chloride for Injection, ONLY.

For Factor IX Replacement Therapy Only

Rx only
Pfizer

PRINCIPAL DISPLAY PANEL - 250 IU Kit Carton

PRINCIPAL DISPLAY PANEL - 3000 IU Vial Label

3000 IU Range

BeneFix®
Coagulation Factor IX (Recombinant)
Room Temperature Storage

No Preservatives
Single Use

Pfizer
Rx only

For Factor IX
Replacement

Principal Display Panel - 3000 IU Vial Label

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label - Kit 58394-637

0.234% Sodium
Chloride Diluent
5 mL

Disposable syringe for
drug diluent use with BeneFix®
Coagulation Factor IX (Recombinant)

Sterile, nonpyrogenic. Contains no
preservatives.

Manufactured for
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
Manufactured by
Vetter Pharma-Fertigung GmbH & Co. KG
Schuetzenstrasse 87, 99-101
88212 Ravensburg, Germany
or
Vetter Pharma-Fertigung GmbH & Co. KG
Eisenbahnstrasse 2-4
88085 Langenargen, Germany
US Govt. License No. 3

Rx only

LOT:
EXP.:

PAA133670

Principal Display Panel - 5 mL Syringe Label - Kit 58394-637

PRINCIPAL DISPLAY PANEL - 3000 IU Kit Carton

One single-use vial with 5-mL prefilled diluent syringe
NDC 58394-637-03

Room Temperature Storage

3000 IU Range

BeneFix®
Coagulation Factor IX (Recombinant)
Room Temperature Storage
No Plasma. No Albumin.

For Intravenous
Administration

Store at 2 to 30º C (36 to 86º F).

For Factor IX Replacement Therapy Only

Reconstitute BeneFix® with the
enclosed sterile prefilled
syringe of 0.234% Sodium
Chloride for Injection, ONLY.

Rx only
Pfizer

Principal Display Panel - 3000 IU Kit Carton
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Resources

website
Pfizer Rare Disease Resources
 
website
Benefix Website for Consumers and Patients (including financial assistance information)
 
website
Benefix Website for Healthcare Professionals
 
website
World Federation of Hemophilia
 
website
Guidelines for the Management of Hemophilia
 
website
National Hemophilia Foundation
 
website
Medical and Scientific Advisory Council Recommendations
 
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