2 1200 IU 500 IU 10 mL
63833-617-02 2400 IU 1000 IU 15 mL
When stored at temperatures up to 25°C (77°F), Humate-P is stable for 24 months up to the expiration date printed on its label. Do not freeze.
This product does not contain a preservative and should be used within 3 hours after reconstitution.
17PATIENT COUNSELING INFORMATION
Inform patients that Humate-P is made from human plasma (part of the blood) and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain that the risk that Humate-P may transmit an infectious agent has been reduced by screening plasma donors, by testing the donated plasma for certain virus infections, and by inactivating and/or removing certain viruses during manufacturing (see Warnings and Precautions [5.4]).
Inform patients that some viruses, such as B19V and HAV, may be particularly difficult to remove or inactivate. Advise patients, especially pregnant women and immune-compromised individuals, to report low-grade fever, rash, joint pain, anorexia, nausea, vomiting, fatigue, and jaundice (see Warnings and Precautions [5.4]).
Manufactured by:
CSL Behring GmbH
35041 Marburg, Germany
US License No. 1765
Distributed by:
CSL Behring LLC
Kankakee, IL 60901 USA
Mix2Vial is a trademark of West Pharmaceuticals Services, Inc.
Principal Display Panel - 250 IU Carton
NDC 63833-615-02
One Vial and Diluent
Antihemophilic Factor/
von Willebrand Factor
Complex (Human)
HUMATE-P®
Powder for Reconstitution
For intravenous use only.
I.U. VWF:RCo/vial
I.U. FVIII/vial
Expires:
Lot no.:
CSL Behring
Principal Display Panel - 500 IU Carton
NDC 63833-616-02
One Vial and Diluent
Antihemophilic Factor/
von Willebrand Factor
Complex (Human)
HUMATE-P®
Powder for Reconstitution
For intravenous use only.
I.U. VWF:RCo/vial
I.U. FVIII/vial
Expires:
Lot no.:
CSL Behring
Principal Display Panel - 1000 IU Carton
NDC 63833-617-02
One Vial and Diluent
Antihemophilic Factor/
von Willebrand Factor
Complex (Human)
HUMATE-P®
Powder for Reconstitution
For intravenous use only.
I.U. VWF:RCo/vial
I.U. FVIII/vial
Expires:
Lot no.:
CSL Behring
HUMATE-P
antihemophilic factor/von willebrand factor complex (human) kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63833-615
Packaging
# NDC Package Description Multilevel Packaging
1 63833-615-02 1KITIn1CARTON None
QUANTITY OF PARTS
Part# Package Quantity Total Product Quantity
Part1 1VIAL 5mL
Part2 1VIAL, SINGLE-DOSE 5mL
Part 1of2
HUMATE-P
antihemophilic factor/von willebrand factor complex (human) injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX(ANTIHEMOPHILIC FACTOR HUMANandVON WILLEBRAND FACTOR HUMAN) HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX 80[iU] in1mL
Inactive Ingredients
Ingredient Name Strength
Glycine 33mg in1mL
Sodium Citrate 9.3mg in1mL
Sodium Chloride 5.3mg in1mL
albumin (human) 16mg in1mL
Product Characteristics
Color Scor
