Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: BPL Bioproducts Laboratory GmbH, Dornhofstraße 34, 63263, Neu-Isenburg, Germany
Coagadex 250 IU powder and solvent for solution for injection.
Coagadex 500 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. Powder vial containing white or off-white powder. Solvent vial containing clear colourless liquid. |
Each vial contains nominally 250 IU or 500 IU human coagulation factor X.
Coagadex contains approximately 100 IU/mL human coagulation factor X after reconstitution with 2.5 mL (250 IU) or 5 mL (500 IU) sterilised water for injections.
Produced from the plasma of human donors.
Excipients with known effect: Coagadex contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor X |
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. |
| List of Excipients |
|---|
|
Powder: Citric acid Solvent: Water for injections |
Powder vial: 250 IU or 500 IU of human coagulation factor X in a type I glass vial stoppered with a halobutyl rubber stopper, oversealed with a snap-off polypropylene cap and aluminium lacquered skirt.
Solvent vial: 2.5 mL or 5 mL solution in a type I glass vial sealed with a halobutyl rubber stopper and an overseal.
Transfer Device (Mix2Vial).
Coagadex 250 IU:
1 vial 250 IU human coagulation factor X powder for solution for injection
1 vial 2.5 mL water for injections
1 Transfer Device (Mix2Vial)
Coagadex 500 IU:
1 vial 500 IU human coagulation factor X powder for solution for injection
1 vial 5 mL water for injections
1 Transfer Device (Mix2Vial)
Not all pack sizes may be marketed.
BPL Bioproducts Laboratory GmbH, Dornhofstraße 34, 63263, Neu-Isenburg, Germany
EU/1/16/1087/001
EU/1/16/1087/002
Date of first authorisation: 16 March 2016
| Drug | Countries | |
|---|---|---|
| COAGADEX | Austria, Estonia, Croatia, Ireland, Lithuania, Poland, United Kingdom |
© 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.
