SYNER-KINASE Powder for solution for injection or infusion Ref.[9391] Active ingredients: Urokinase

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Syner-Medica Ltd, Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, Telephone No: +44 (0) 208 655 6380, Fax No: +44 (0) 208 655 6398

Product name and form

Syner-KINASE 10,000 IU powder for solution for injection/infusion.
Syner-KINASE 25,000 IU powder for solution for injection/infusion.
Syner-KINASE 100,000 IU powder for solution for injection/infusion.
Syner-KINASE 250,000 IU powder for solution for injection/infusion.
Syner-KINASE 500,000 IU powder for solution for injection/infusion.

Pharmaceutical Form

White powder for solution for injection or infusion.

Qualitative and quantitative composition

Each vial contains 10,000, 25,000, 100,000, 250,000 or 500,000 IU of urokinase produced from human urine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Urokinase

Urokinase is a highly purified form of naturally occurring human urokinase extracted from urine. It is a thrombolytic agent which converts plasminogen into plasmin (fibrinolysin) a proteolytic enzyme that breaks down fibrin as well a fibrinogen and other plasma proteins.

List of Excipients

Mannitol
Disodium edetate
Disodium phosphate dodecahydrate
Sodium hydroxide

Pack sizes and marketing

All single pack presentations are contained in borosilicate clear type 1 (8 ml) glass vials closed with chlorobutyl rubber stoppers and sealed with an aluminium flip-off cap.

Each vial size is colour coded:

10,000 IU – Grey
25,000 IU – Orange
100,000 IU – Green
250,000 IU – Red
500,000 IU – Purple

Marketing authorization holder

Syner-Medica Ltd, Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, Telephone No: +44 (0) 208 655 6380, Fax No: +44 (0) 208 655 6398

Marketing authorization dates and numbers

Syner-KINASE 10,000 IU powder for solution for injection/infusion: 20675-0006
Syner-KINASE 25,000 IU powder for solution for injection/infusion: 20675-0001
Syner-KINASE 100,000 IU powder for solution for injection/infusion: 20675-0002
Syner-KINASE 250,000 IU powder for solution for injection/infusion: 20675-0003
Syner-KINASE 500,000 IU powder for solution for injection/infusion: 20675-0004

2006-09-21

Drugs

Drug Countries
SYNER-KINASE Malta, United Kingdom

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