Formula & 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.

Product Options

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 and Storage

30 Months / 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