ACTILYSE Ref.[2482] Active ingredients: Alteplase

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: Boehringer Ingelheim Limited Ellesfield Avenue Bracknell Berkshire RG12 8YS

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.

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 a full list of excipients, see section 6.1.

Active Ingredient 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 for solution:

Arginine
Phosphoric acid, dilute
Polysorbate 80

Solvent:

Water for injections
The pH of the reconstituted solution is 7.3 ± 0.5.

Pack sizes and marketing

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)

Pack sizes

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 pack sizes may be marketed.

Marketing authorization holder

Boehringer Ingelheim Limited
Ellesfield Avenue
Bracknell
Berkshire RG12 8YS

Marketing authorization dates and numbers

PL 00015/0120

Date of first authorisation: 12th October 1988

Date of last renewal: 26th April 2004

Drugs

Drug Countries
ACTILYSE Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa
 
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