Active ingredients: Alteplase
Actilyse 10 mg: Powder and solvent for solution for injection and infusion
Actilyse 20 mg: Powder and solvent for solution for injection and infusion
Actilyse 50 mg: Powder and solvent for solution for injection and infusion
Powder and solvent for solution for injection and infusion.
The powder is presented as a colourless to pale yellow lyophilizate cake.
1 vial with powder contains:
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.
For a full list of excipients, see section 6.1.
Alteplase is a recombinant human tissue-type plasminogen activator, a glycoprotein, which activates plasminogen directly to plasmin. Once bound to fibrin, it is activated, inducing the conversion of plasminogen to plasmin leading to the dissolution of the fibrin clot.
Powder for solution:
Arginine
Phosphoric acid, dilute
Polysorbate 80
Solvent:
Water for injections
The pH of the reconstituted solution is 7.3 ± 0.5.
Powder for solution: 10 ml, 20 ml or 50 ml sterilised glass vials, sealed with sterile siliconised grey butyl-type stoppers with aluminium/plastic flip-off caps.
Solvent: The water for injections is filled into either 10 ml, 20 ml or 50 ml vials, depending on the size of the powder vials. The water for injections vials are sealed with rubber stoppers and aluminium/plastic flip-off caps.
Transfer cannulas (included with pack sizes of 20 mg and 50 mg only)
10 mg:
20 mg:
50 mg:
Not all pack sizes may be marketed.
Boehringer Ingelheim Limited
Ellesfield Avenue
Bracknell
Berkshire RG12 8YS
Date of first authorisation: 12th October 1988
Date of last renewal: 26th April 2004
PL 00015/0120