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Outline
What is the generic name?
(COAGULATION FACTOR IX (RECOMBINANT), GLYCOPEGYLATED)
What is the Trade Name for (COAGULATION FACTOR IX (RECOMBINANT), GLYCOPEGYLATED)?
REBINYN
What are the Indications for (COAGULATION FACTOR IX (RECOMBINANT), GLYCOPEGYLATED)?
- 1 INDICATIONS AND USAGE REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding Limitations of Use : REBINYN is not indicated for routine prophylaxis in the treatment of patients with hemophilia B. REBINYN is not indicated for immune tolerance induction in patients with hemophilia B. REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding Limitations of Use : REBINYN is not indicated for routine prophylaxis in the treatment of patients with hemophilia B. REBINYN is not indicated for immune tolerance induction in patients with hemophilia B ( 1 ).
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References: https://open.fda.gov/
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