This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Singapore, Tunisia, United Kingdom
The drug OCTAPLEX contains a combination of these active pharmaceutical ingredients (APIs):
|
1
Coagulation factor II
UNII 8FB1K07F16 - PROTHROMBIN
|
|
|
|
2
Proconvertin
UNII 4156XVB4QD - COAGULATION FACTOR VII HUMAN
|
|
|
|
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. |
|
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. |
|
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. |
|
6
Protein S
UNII 90J3F6N5FN - PROTEIN S HUMAN
|
|
|
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 |
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: HR | Agencija za lijekove i medicinske proizvode | Identifier(s): HR-H-107880130 |
| 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.
