METALYSE Powder and solvent for solution for injection Ref.[9393] Active ingredients: Tenecteplase

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany

Product name and form

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.

Qualitative and quantitative composition

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
Concentrated phosphoric acid
Polysorbate 20
Trace residue from manufacturing process: Gentamicin

Solvent:

Water for injections

Pack sizes and marketing

Metalyse 8 000 units (40 mg) powder and solvent for solution for injection

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.

Metalyse 10 000 units (50 mg) powder and solvent for solution for injection

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.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany

Marketing authorization dates and numbers

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

Drugs

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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