16 HOW SUPPLIED/STORAGE AND HANDLING
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.
|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.