Source: Medicines & Healthcare Products Regulatory Agency (GB) | Revision Year: 2018 | Publisher: Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire RG12 8YS
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. The reconstituted preparation is a clear and colourless to pale yellow solution.
1 vial with powder contains:
10 mg alteplase (corresponding to 5,800,000 IU) or
20 mg alteplase (corresponding to 11,600,000 IU) or
50 mg alteplase (corresponding to 29,000,000 IU), respectively
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 the 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.
Phosphoric acid (for pH-adjustment)
Water for injections
Powder: 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: For the 10 mg, 20 mg and 50 mg presentations, 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 presentations of 20 mg and 50 mg only)
1 vial with 467 mg powder for solution for injection and infusion
1 vial with 10 ml of water for injections
1 vial with 933 mg powder for solution for injection and infusion
1 vial with 20 ml of water for injections
1 transfer cannula
1 vial with 2333 mg powder for solution for injection and infusion
1 vial with 50 ml of water for injections
1 transfer cannula
Not all presentations may be marketed.
Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire RG12 8YS
Date of first authorisation: 12 October 1988
Date of last renewal: 26 April 2009
© 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.