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Mononine®
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Manufacturer: CSL Behring |
| Generic
Name: Coagulation Factor IX (Human) - Monoclonal |
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Indications: - Mononine®,
is indicated for the prevention
and control of bleeding in
Factor IX deficiency, also known
as Hemophilia B or Christmas
Disease.
- Mononine® is not
indicated in the treatment or
prophylaxis of Hemophilia A
patients with inhibitors to
Factor VIII.
- Mononine®, contains
non-detectable levels of Factors
II, VII and X (<0.0025 IU per
Factor IX unit using standard
coagulation assays) and is
, therefore, not indicated for
replacement therapy of these
clotting factors.
- Mononine® is also not indicated
in the treatment or reversal of coumarin-induced anticoagulation
or in a hemorrhagic state caused
by hepatitis-induced lack of
production of liver dependent
coagulation factors.
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| How
Supplied: Factor products are supplied in vials sizes of varying International Units (iu). Vial sizes (iu sizes) may change with each new lot of product manufactured. Vial sizes may range from approximately 200 - 1500 iu per vial. |
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| Product |
Size |
NDC Numbers |
PI |
MSDS |
| Mononine® |
500 unit vial |
00053-7668-02 |
PI |
MSDS |
| Mononine® |
1000 unit vial |
00053-7668-04 |
PI |
MSDS |
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| Clinical Data:
For any questions or for
further information related to Mononine®,
Coagulation Factor
IX (Human), clinical pharmacology, additional indications and
usages, contraindications,
warnings, precautions, adverse
reactions, dosage,
administration and/or storage
of this product, please
contact
BDI Pharma or call
1-800-948-9834. |
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