Source: Medicines Authority (MT) Revision Year: 2020 Publisher: Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium
OCTANINE 500 IU, 500 IU powder and solvent for solution for injection.
OCTANINE 1000 IU, 1000 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. The powder is white or pale yellow also appearing as a friable solid. |
The product contains approximately 100 IU/ml human coagulation factor IX when reconstituted with 5 ml water for injections (Ph.Eur.).
The product contains approximately 100 IU/ml human coagulation factor IX when reconstituted with 10 ml water for injections (Ph.Eur.).
OCTANINE is produced from plasma of human donors.
The potency (IU) is determined using the European Pharmacopoeia one stage clotting test, in comparison with an international standard from the World Health Organisation (WHO). The specific activity of OCTANINE is approximately 100 IU/mg protein.
Excipients with known effect: This medicinal product contains up to 69 mg sodium for 1 vial OCTANINE 500 IU and up to 138 mg sodium for 1 vial OCTANINE 1000 IU.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor IX |
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. |
| List of Excipients |
|---|
|
Powder: Heparin Solvent: Water for injections |
OCTANINE comes as a combination package consisting of two cartons held together with a plastic film.
OCTANINE 500 IU:
Carton 1: powder in a 30 ml vial (type I glass), with a stopper (chlorobutyl or bromobutyl rubber) and a flip off cap (aluminium); package leaflet.
+
Carton 2: 5 ml of solvent (water for injections) (type I or type II glass), with a stopper (chlorobutyl or bromobutyl rubber) and a flip off cap (aluminium).
OCTANINE 1000 IU:
Carton 1: powder in a 30 ml vial (type I glass), with a stopper (chlorobutyl or bromobutyl rubber) and a flip off cap (aluminium); package leaflet.
+
Carton 2: 10 ml of solvent (water for injections) (type I or type II glass), with a stopper (chlorobutyl or bromobutyl rubber) and a flip off cap (aluminium).
Carton 2 also contains the following medical devices:
Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium
OCTANINE 500 IU: MA1219/00801
OCTANINE 1000 IU: MA1219/00802
Date of first authorisation: 05.04.2010
Date of last renewal: 28.11.2014
| Drug | Countries | |
|---|---|---|
| OCTANINE | Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, Croatia, Israel, Lithuania, Malta, Poland, Romania, Turkey, South Africa |
© 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.
