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ACTILYSE Powder and solvent for solution (2018)

Active ingredients: Alteplase

Product Name and Form

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.

Pharmaceutical form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
Alteplase

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.

List of excipients

Powder:

Arginine
Phosphoric acid (for pH-adjustment)
Polysorbate 80

Solvent:

Water for injections

Pack sizes and Marketing

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)

Presentations:

10 mg:

1 vial with 467 mg powder for solution for injection and infusion

1 vial with 10 ml of water for injections

20 mg:

1 vial with 933 mg powder for solution for injection and infusion

1 vial with 20 ml of water for injections

1 transfer cannula

50 mg:

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.

Marketing authorization holder
Authorization dates

Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire RG12 8YS

Date of first authorisation: 12 October 1988
Date of last renewal: 26 April 2009

Marketing authorization number:

PL 00015/0120