ALPHANINE SD FOR INJECTION 500 IU/VIAL

Product Information

Registration Status: Active

ALPHANINE SD FOR INJECTION 500 IU/VIAL is approved to be sold in Singapore with effective from 1996-07-10. It is marketed by GRIFOLS ASIA PACIFIC PTE LTD, with the registration number of SIN08961P.

This product contains Factor Ix (Human) 500 iu per 10ml vial in the form of INJECTION, POWDER, FOR SOLUTION. 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.

Factor Ix (Human)

Description

Factor IX (or Christmas factor) is one of the serine proteases of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes hemophilia B.

Indication

Factor IX is used to treat Christmas disease. Factor IX deficiency is treated by injection factor IX produced from human plasma. Tranexamic acid may be of value in patients undergoing surgery who have inherited factor IX deficiency in order to reduce the perioperative risk of bleeding.

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

Antihemophilic factor B | Coagulation factor IX (human) | Factor IX (Human) | Human coagulation factor IX | Coagulation Factor IX 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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank