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1 vial with powder contains: 50 mg alteplase (corresponding to 29,000,000 IU).
Alteplase is produced by recombinant DNA technique using a Chinese hamster ovary cell-line. The specific activity of alteplase in-house reference material is 580,000 IU/mg. This has been confirmed by comparison with the second international WHO standard for t-PA. The specification for the specific activity of alteplase is 522,000 to 696,000 IU/mg.
The reconstituted preparation is a clear and colourless to pale yellow solution.
Excipients/Inactive Ingredients: Powder: Arginine, Phosphoric acid (for pH-adjustment), Polysorbate 80.
Solvent: Water for injections.
