Product Information
Registration Status: ActiveSIN13934P
NOVOSEVEN POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 2MG is approved to be sold in Singapore with effective from 2011-03-17. It is marketed by NOVO NORDISK PHARMA (SINGAPORE) PTE LTD, with the registration number of SIN13934P.
This product contains Eptacog Alfa 2mg in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by Novo Nordisk A/S (DP and solvent in vials) in DENMARK, andVetter Pharma-Fertigung GmbH & Co. KG (PFS Solvent) in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. NovoSeven is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues. Cloned and expressed in hamster kidney cells, the protein is catalytically active in a two-chain form.
Indication
For treatment of hemorrhagic complications in hemophilia A and B
Mechanism of Action
NovoSeven activates the coagulation or clotting cascade by cleaving Factor IX and Factor X, which activates them and then leads to activation of thrombin and fibrin.
Clearance
* 33 - 37 mL/h x kg [healthy] * 1375 +/- 396 mL/hr [severe hemophilia A male children] * 57.3 +/- 9.5 mL/hr/kg [severe hemophilia A male children] * 2767 +/- 385 mL/hr [severe hemophilia A men] * 37.6 +/- 13.1 mL/hr/kg [severe hemophilia A men]
Active Ingredient/Synonyms
Coagulation factor VIIa | Coagulation factor VIIa (recombinant) | Eptacog alfa | Eptacog alfa (activated) | rFVIIa | Coagulation factor VIIa Recombinant Human |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.