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
Biofactor Streptokinase is indicated in adults.
Acute myocardial infarction: within 12 hours of onset with persistent ST-segment elevation or recent left bundle-branch block.
Note: No statement on therapy outcome can be made for administration beyond the time window indicated above.
The safety and efficacy of Biofactor Streptokinase have not been sufficiently established in children. Due to low levels of plasminogen in newborns and in children with acquired plasminogen deficiency and due to the potential of streptokinase for allergic/anaphylactic reactions, it is not recommended in neonates, infants and children.
A single dose of 1.5 million IU streptokinase should be infused intravenously over one hour.
A bolus of 20,000 IU streptokinase should be followed by a maintenance infusion of 2,000 IU to 4,000 IU per minute over 30 to 90 minutes depending on the achievement of coronary artery patency.
The administration of streptokinase may be intravenous or intracoronary.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Upon reconstitution with physiological saline a clear solution, colourless to yellowish, is obtained.
Note: When thrombolytic therapy is necessary and a high antibody concentration against streptokinase is present or when recent streptokinase therapy has been given (more than 5 days and less than one year previously), homologous fibrinolytics should be used (see sections 4.4 and 4.8).
Treatment with aspirin (150 mg daily) for at least 4 weeks is recommended for prophylaxis after streptokinase therapy for acute myocardial infarction. The first dose should be given as soon as possible after the myocardial infarction.
Long-term overdosage of streptokinase may induce the risk of rethrombosis by prolonged decrease of plasminogen. See also section 4.8 and 5.1.
Shelf life: The shelf-life of unopened vials of Biofactor Streptokinase 1 500 000 is 3 years.
Do not store above +25°C and do not freeze.
Do not store the reconstituted solution for more than 24 hours in a refrigerator at +2°C to +8°C.
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.
The contents should be dissolved in 4-5 ml of physiological saline or water for injection. The solution should be swirled gently to facilitate quick reconstitution, but care should be taken to avoid foaming.
Biofactor Streptokinase may be given by intravenous infusion in 50-200 ml of physiological saline, 5% glucose solution, 5% fructose solution, or Ringer-lactate solution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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