Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Actavis Group PTC ehf, ReykjavÃkurvegi 76-78, 220 Hafnarfjordur, Iceland
Rapilysin 10 U powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. White powder and clear colourless liquid (water for injections). |
1 vial contains 10 U* reteplase ** in 0.56 g powder.
1 prefilled syringe contains 10 ml water for injections.
The reconstituted solution contains 1 U reteplase per ml.
For the full list of excipients, see section 6.1.
* Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents.
** Recombinant plasminogen activator produced in Escherichia coli by recombinant DNA technology.
| Active Ingredient | Description | |
|---|---|---|
| Reteplase |
Reteplase is a recombinant plasminogen activator that catalyzes the cleavage of endogenous plasminogen to generate plasmin. This plasminogenolysis occurs preferentially in the presence of fibrin. Plasmin in turn degrades fibrin, which is the main component of the matrix of thrombi, thereby exerting its thrombolytic action. |
| List of Excipients |
|---|
|
Powder: Tranexamic acid Solvent: Water for injections |
Each pack contains:
2 colourless glass vials (type I) with a rubber (butyl) closure and an aluminium flip-off cap, containing 0.56 mg of powder.
2 pre-filled glass syringes (borosilicate, type I) for single use, with a bromobutyl plunger stopper and a bromobutyl rubber tip cap, containing 10 ml of solvent.
2 reconstitution spikes.
2 needles 19 G1.
Actavis Group PTC ehf, ReykjavÃkurvegi 76-78, 220 Hafnarfjordur, Iceland
EU/1/96/018/001
Date of first authorisation: 29 August 1996
Date of last renewal: 29 August 2006
| Drug | Countries | |
|---|---|---|
| RAPILYSIN | Austria, Australia, Cyprus, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, New Zealand, Poland, Turkey |
© 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.
