Product Information
Registration Status: ActiveSIN15829P
FIBRYGA POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL is approved to be sold in Singapore with effective from 2019-10-16. It is marketed by WELLCHEM PHARMACEUTICALS PTE LTD, with the registration number of SIN15829P.
This product contains Human Fibrinogen 1 g in the form of INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by Octapharma Pharmazeutika Produktionsges.m.b.H in SWEDEN, and(powder) in AUSTRIA.
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
Fibrinogen concentrate (human) is a hematological agent. It works by replacing a certain protein in the blood that helps with blood clotting. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. It is a physiological substrate for three enzymes: plasmin, factor XIIIa and thrombin. it is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Indication
For the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Mechanism of Action
Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. The native molecule is a dimer and consists of three pairs of polypeptide chains (Aα, Bβ and γ). Fibrinogen is a physiological substrate of three enzymes: thrombin, factor XIIIa, and plasmin. During the coagulation process, thrombin cleaves the Aα and Bβ chains releasing fibrinopeptides A and B (FPA and FPB, respectively). FPA is separated rapidly and the remaining molecule is a soluble fibrin monomer (fibrin I). The slower removal of FPB results in formation of fibrin II that is capable of polymerization that occurs by aggregation of fibrin monomers. The resulting fibrin is stabilized in the presence of calcium ions and by activated factor XIII, which acts as a transglutaminase. Factor XIIIa-induced cross-linking of fibrin polymers renders the fibrin clot more elastic and more resistant to fibrinolysis. Cross-linked fibrin is the end result of the coagulation cascade, and provides tensile strength to a primary hemostatic platelet plug and structure to the vessel wall.
Pharmacokinetics
- Absorption
- Cmax is 140 mg/dL
- Distribution
- Mean volume of distribution is 52.7 mL/kg.
- Metabolism
- Elimination
Clearance
0.59 mL/h/kg
Active Ingredient/Synonyms
Coagulation Factor I | Factor I (fibrinogen) | Factor I human | Fibrinogen | Fibrinogen (human) | Fibrinogen Concentrate (Human) | Fibrinogen concentrate human | Fibrinogen human | Fibrinogen human plasma-derived | Fibrinogen, human | Human fibrinogen | Fibrinogen 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.