Monoclate-P®
Antihemophilic Factor (Human) Factor VIII:C Pasteurized Monoclonal Antibody Purified
Monoclate-P
® is indicated for the treatment of classical hemophilia
(hemophilia A).
- Over a decade of clinical experience and efficacy supported by over 1 billion international units (IU) of use1
- The manufacturing process combines nature's own design - the human factor VIII molecule - with innovations in laboratory engineering: monoclonal antibody purification and pasteurization designed to remove and inactivate lipid-enveloped and certain non-lipid-enveloped viruses
- A demonstrated level of consistent potency
- Potency ranges, diluent volumes, and peel-off labels designed for patient convenience
NDC Number |
Product Description |
0053-7656-01 |
Approximately 250 IU per bottle |
0053-7656-02 |
Approximately 500 IU per bottle |
0053-7656-04 |
Approximately 1000 IU per bottle |
Important Safety Information
Monoclate-P® is contraindicated in patients with known hypersensitivity to mouse protein.
Products of this type are known to cause allergic reactions, mild chills, nausea or stinging at the infusion site. In
some cases, inhibitors of FVIII may occur.
Monoclate-P® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease agent, cannot be completely eliminated.
Reference: 1. ZLB Behring. Data on file.
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Frequently Asked Questions for Monoclate-P®
null 19 August 2008