Alteplase
Therapeutic Alteplase from the original Actilyse® commercial drug.
Reference Standard as Aliquots
Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot
| Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2023.02 |
Actilyse® DE |
0.4 mg |
Unit: aliquot(s) |
264,00 €
/aliquot
|
Biosimilars as Aliquots
Access Batch Specific Analytical Information
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Product Information
Here you will find the product information for the reference product.
Actilyse® / Alteplase Reference Product
| Drug name | Actilyse® |
| INN | Alteplase |
| API type | Glycoprotein |
| Pharmacotherapeutic group | Antithrombotic agents |
| ATC code | B01AD02 |
| Target | Plasminogen activator (rt-PA) |
| General function | Treat acute ischemic stroke, acute ST-elevation myocardial infarction (a type of heart attack), pulmonary embolism associated with low blood pressure, and blocked central venous catheter. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source www.medicines.org.uk) | The active ingredient of Actilyse is alteplase a recombinant human tissue-type plasminogen activator, a glycoprotein, which activates plasminogen directly to plasmin. When administered intravenously, alteplase remains relatively inactive in the circulatory system. Once bound to fibrin, it is activated, inducing the conversion of plasminogen to plasmin leading to the dissolution of the fibrin clot. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source www.medicines.org.uk) | Due to its relative fibrin-specificity alteplase at a dose of 100 mg leads to a modest decrease of the circulating fibrinogen levels to about 60 % at 4 hours, which is generally reverted to more than 80 % after 24 hours. Plasminogen and alpha-2-antiplasmin decrease to about 20 % and 35 % respectively after 4 hours and increase again to more than 80 % at 24 hours. A marked and prolonged decrease of the circulating fibrinogen level is only seen in few patients. |
| Original license holder | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany |
| Marketing authorisation numbers | PL 14598/0183 |
| Marketing authorisation holder | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany |
| Name of the manufacturer of the biological active substance | Information not available |
| Name and address of the manufacturer(s) responsible for batch release | Information not available |
| Max shelf life | 3 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Powder Arginine Phosphoric acid (for pH adjustment) Polysorbate 80 Solvent Water for injections |
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