Product Name: Kogenate FS

Formulation & Concentration: antihemophilic factor (recombinant)

Manufacturer: Bayer Healthcare

Indications
“Control and prevention of bleeding episodes in adults and children (0-16 years) with Hemophilia A; Peri-operative management in adults and children with Hemophilia A; Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with Hemophilia A with no pre-existing joint damage.”

Vial Size NDC # Size
250 IU 0026-3782-20 2.5ml
500 IU 0026-3783-30 2.5ml
1000 IU 0026-3785-50 2.5ml
2000 IU 0026-3786-60 5ml
250 IU w/ Bioset 0026-3792-20 2.5ml
500 IU w/ Bioset 0026-3793-30 2.5ml
1000 IU w/ Bioset 0026-3795-50 2.5ml
2000 IU w/ Bioset 0026-3796-60 5ml
3000 IU w/ Bioset 0026-3797-70 5ml

Shelf Life
30 Months

Storage
“Product as Packaged for Sale:
Store Kogenate® FS at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Kogenate® FS may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F, such as in home treatment
situations. The starting date of room temperature storage should be clearly recorded on the unopened product carton.
Once stored at room temperature, the product must not be returned to the refrigerator. The shelf-life then expires after the
storage at room temperature, or the expiration date on the product vial, whichever is earlier. Do not use Kogenate® FS
after the expiration date indicated on the vial. Do not freeze. Protect from extreme exposure to light and store the lyophilized powder in the carton prior to use. Product After Reconstitution: Administer Kogenate® FS within 3 hours after reconstitution. It is recommended to use the administration set provided”

Full Prescribing Information:
Kogenate FS Full Prescribing Information.