Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany
Metalyse 10,000 units powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. The powder is white to off-white. |
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: L-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 50 mg tenecteplase.
10 ml plastic pre-filled syringe with 10 ml of solvent.
Sterile vial adapter.
Sterile needle for single use.
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany
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 |
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