fety of high doses of a monoclonal antibody-purified factor IX concentrate. Am J Hematol 49:92-94, 1995.
Shapiro AD, Ragni MV, Lusher JM, Culbert S, Koerper MA, Bergman GE, Hannan MM. Safety and Efficacy of Monoclonal Antibody Purified Factor IX Concentrate in Previously Untreated Patients with Hemophilia B. Thrombosis and Haemostasis 75:30-35, 1996.
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Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767
US Patent No. 5,055,557
Revised January, 2007
13925-04
Package Label - Principal Display Panel - MID
NDC 0053-7668-02
One vial with diluent
Mononine®
Coagulation Factor IX
(Human)
Monoclonal Antibody Purified
For Intravenous Administration Only. Rx only
Storage: Mononine® stored in a refrigerator at 2-8°C (36-46°F) is
stable for the period indicated by the expiration date on the label.
Within this period Mononine® may be stored at room temperature not
to exceed 25°C (77°F), for up to 1 month. Avoid freezing.
Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767
CSL Behring
Package Label - Principal Display Panel - HIGH
NDC 0053-7668-04
One vial with diluent
Mononine®
Coagulation Factor IX
(Human)
Monoclonal Antibody Purified
For Intravenous Administration Only. Rx only
Storage: Mononine® stored in a refrigerator at 2-8°C (36-46°F) is
stable for the period indicated by the expiration date on the label.
Within this period Mononine® may be stored at room temperature
not to exceed 25°C (77°F), for up to 1 month. Avoid freezing.
Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767
CSL Behring
MONONINE
coagulation factor ix human injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0053-7668
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name B |
