Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany
Metalyse 8 000 units (40 mg) powder and solvent for solution for injection.
Metalyse 10 000 units (50 mg) powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. The powder is white to off-white. The solvent is clear and colourless. |
Metalyse 8 000 units (40 mg) powder and solvent for solution for injection: Each vial contains 8 000 units (40 mg) tenecteplase.
Each pre-filled syringe contains 8 mL solvent.
Metalyse 10 000 units (50 mg) powder and solvent for solution for injection: Each vial contains 10 000 units (50 mg) tenecteplase.
Each pre-filled syringe contains 10 mL solvent.
The reconstituted solution contains 1 000 units (5 mg) tenecteplase per mL.
Potency of tenecteplase is expressed in units (U) by using a reference standard which is specific for tenecteplase and is not comparable with units used for other thrombolytic agents.
Tenecteplase is a fibrin-specific plasminogen activator produced in a Chinese hamster ovary cell line by recombinant DNA technology.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tenecteplase |
Tenecteplase is a recombinant fibrin-specific plasminogen activator that is derived from native t-PA by modifications at three sites of the protein structure. It binds to the fibrin component of the thrombus (blood clot) and selectively converts thrombus-bound plasminogen to plasmin, which degrades the fibrin matrix of the thrombus. Tenecteplase has a higher fibrin specificity and greater resistance to inactivation by its endogenous inhibitor (PAI-1) compared to native t-PA. |
| List of Excipients |
|---|
|
Powder: Arginine Solvent: Water for injections |
20 mL glass vial type I, with a coated (B2-42) grey rubber stopper and a flip-off cap filled with powder for solution for injection. Each vial contains 40 mg tenecteplase. 10 mL plastic pre-filled syringe with 8 mL of solvent. Sterile vial adapter.
20 mL glass vial type I, with a coated (B2-42) grey rubber stopper and a flip-off cap filled with powder for solution for injection. Each vial contains 50 mg tenecteplase. 10 mL plastic pre-filled syringe with 10 mL of solvent. Sterile vial adapter.
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany
Metalyse 8 000 units (40 mg) powder and solvent for solution for injection: EU/1/00/169/005
Metalyse 10 000 units (50 mg) powder and solvent for solution for injection: EU/1/00/169/006
Date of first authorisation: 23 February 2001
Date of last renewal: 23 February 2006
| Drug | Countries | |
|---|---|---|
| METALYSE | Austria, Australia, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, 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.
