OCTAPLEX

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Singapore, Tunisia, United Kingdom

Active ingredients

The drug OCTAPLEX contains a combination of these active pharmaceutical ingredients (APIs):

1 Coagulation factor II
UNII 8FB1K07F16 - PROTHROMBIN
Read about Thrombin
2 Proconvertin
UNII 4156XVB4QD - COAGULATION FACTOR VII HUMAN
Read about Coagulation factor VII
3 Monoclonal antibody purified
UNII 6U90Y1795T - COAGULATION FACTOR IX HUMAN

Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitamin-K dependent coagulation factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X.

Read about Coagulation factor IX
4 Stuart-Prower factor
UNII 0P94UQE6SY - COAGULATION FACTOR X HUMAN

Coagulation factor X is derived from human plasma and used as a replacement for the naturally existing coagulation factor X in patients with hereditary factor X deficiency.

Read about Coagulation factor X
5 Protein C
UNII 3Z6S89TXPW - PROTEIN C

Protein C is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. Protein C exerts its effect by the inactivation of the activated forms of factors V and VIII which leads to a decrease in thrombin formation. Protein C has also been shown to have profibrinolytic effects.

Read about Protein C
6 Protein S
UNII 90J3F6N5FN - PROTEIN S HUMAN
Read about Protein S

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
B02BD01 Coagulation factor IX, II, VII and X in combination B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors
Discover more medicines within B02BD01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 535300401137315
Country: CA Health Products and Food Branch Identifier(s): 02294664, 02434970
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 27-MBE-0915
Country: EE Ravimiamet Identifier(s): 1230174, 1664232
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 66447, 80417
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 064742, 399482
Country: FR Base de données publique des médicaments Identifier(s): 60259993, 67877234
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 151214, 325005
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1022335, 1074454, 1075279
Country: NL Z-Index G-Standaard Identifier(s): 16168054
Country: NL Z-Index G-Standaard, PRK Identifier(s): 130524, 71935
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100139798, 100354717
Country: SG Health Sciences Authority Identifier(s): 14933P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 10043031H

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.