STREPTOKINASE Powder for solution for infusion Ref.[8580] Active ingredients: Streptokinase

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Biofactor GmbH, Rudolf-Huch-Str. 14, D-38667 Bad Harzburg, Germany, Fax: +49 5322 960516, Email: info@biofactor.de

Product name and form

Biofactor Streptokinase 1 500 000.

Pharmaceutical Form

Powder for solution for infusion.

White to slightly yellow powder.

Qualitative and quantitative composition

Biofactor Streptokinase 1 500 000 is presented as a powder for solution in vials containing 1.5 million International Units (IU) of purified streptokinase as the active ingredient. For a full list of excipients, see section 6.1.

Highly purified streptokinase is extracted from the culture filtrate of certain strains of the streptococcus group C. It is presented as a white to slightly yellow powder and contains stabilisers.

Active Ingredient Description
Streptokinase

Biofactor streptokinase is a highly purified streptokinase derived from β haemolytic streptococci of Lancefield group C. The activation of the endogenous fibrinolytic system is initiated by the formation of a streptokinase-plasminogen complex. This complex possesses activator properties and converts plasminogen into the proteolytic and fibrinolytic active plasmin.

List of Excipients

Human albumin
Aminoacetic acid (glycine)
Mannitol

Pack sizes and marketing

Biofactor Streptokinase 1 500 000 is supplied in glass vials with rubber closures and aluminium seal with plastic flip-top caps.

Biofactor Streptokinase 1 500 000 is available in packages containing one vial.

Marketing authorization holder

Biofactor GmbH, Rudolf-Huch-Str. 14, D-38667 Bad Harzburg, Germany, Fax: +49 5322 960516, Email: info@biofactor.de

Marketing authorization dates and numbers

PL 29723/0004

26 June 1998/15 May 2009

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