BENEFIX® How Supplied/Storage and Handling

(Coagulation Factor IX (Recombinant))

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

BeneFIX, Coagulation Factor IX (Recombinant), is supplied in kits that include single-use vials which contain nominally 250, 500, 1000, 2000, or 3000 IU per vial with sterile pre-filled diluent syringe, vial adapter reconstitution device, sterile infusion set, and two (2) alcohol swabs, one bandage, and one gauze pad. The drug product, diluents for injection and the rest of components included within the BeneFIX 250, 500, 1000, 2000 or 3000 IU kit are not made from natural rubber and natural rubber latex. Actual factor IX activity in IU is stated on the label of each vial.

BeneFIX

Nominal Strengths

Color Code

Kit NDC Number

250 International Units

Yellow

58394-633-03

500 International Units

Blue

58394-634-03

1000 International Units

Green

58394-635-03

2000 International Units

Red

58394-636-03

3000 International Units

Grey

58394-637-03

Storage and Handling

Product kit as packaged for sale

•
Store BeneFIX at room temperature or under refrigeration, at a temperature of 2 to 30°C (36 to 86°F).
•
Do not freeze to prevent damage to the diluent syringe.
•
Do not use BeneFIX after the expiration date on the label.

Product after reconstitution

The product does not contain a preservative and should be used within 3 hours.

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Prescribing Information
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Health Professional Information

How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

BeneFIX, Coagulation Factor IX (Recombinant), is supplied in kits that include single-use vials which contain nominally 250, 500, 1000, 2000, or 3000 IU per vial with sterile pre-filled diluent syringe, vial adapter reconstitution device, sterile infusion set, and two (2) alcohol swabs, one bandage, and one gauze pad. The drug product, diluents for injection and the rest of components included within the BeneFIX 250, 500, 1000, 2000 or 3000 IU kit are not made from natural rubber and natural rubber latex. Actual factor IX activity in IU is stated on the label of each vial.

BeneFIX

Nominal Strengths

Color Code

Kit NDC Number

250 International Units

Yellow

58394-633-03

500 International Units

Blue

58394-634-03

1000 International Units

Green

58394-635-03

2000 International Units

Red

58394-636-03

3000 International Units

Grey

58394-637-03

Storage and Handling

Product kit as packaged for sale

•
Store BeneFIX at room temperature or under refrigeration, at a temperature of 2 to 30°C (36 to 86°F).
•
Do not freeze to prevent damage to the diluent syringe.
•
Do not use BeneFIX after the expiration date on the label.

Product after reconstitution

The product does not contain a preservative and should be used within 3 hours.
Medication Guide

Health Professional Information

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