BENEFIX® How Supplied/Storage and Handling (Coagulation Factor IX (Recombinant))

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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.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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