Product Information
Registration Status: ActiveSIN09048P
PROFILNINE FOR INJECTION 1000 IU/10ml is approved to be sold in Singapore with effective from 1996-11-28. It is marketed by GRIFOLS ASIA PACIFIC PTE LTD, with the registration number of SIN09048P.
This product contains Factor Ix 1000 iu per 10ml vial in the form of INJECTION. It is approved for INTRAVENOUS use.
This product is manufactured by GRIFOLS BIOLOGICALS LLC. in UNITED STATES, andINSTITUTO GRIFOLS in SPAIN.
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 Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication
For treatment of hemophilia (Christmas disease).
Mechanism of Action
Coagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
Clearance
8.62 ± 1.7
Active Ingredient/Synonyms
Coagulation factor IX (recombinant) | Coagulation factor IX recombinant human | Factor IX (Recombinant) | nonacog alfa | nonacog gamma | Recombinant factor IX | Coagulation Factor IX (Recombinant) |
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.