STREPTOKINASE Powder for solution for infusion (2015)
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Περιεχόμενα
Name of the medicinal product
Biofactor Streptokinase 1 500 000.
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, ...
Pharmaceutical form
Powder for solution for infusion. White to slightly yellow powder.
Therapeutic indications
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 ...
Posology and method of administration
Posology Paediatric population 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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Contraindications to treatment with Biofactor Streptokinase, because of the increased risk of haemorrhage under ...
Special warnings and precautions for use
The following conditions would normally be considered contraindications to streptokinase therapy, but in certain situations the benefits could outweigh the potential risks: recent severe gastrointestinal ...
Interaction with other medicinal products and other forms of interaction
There is an increased risk of haemorrhage in patients who are receiving or who have recently been treated with anticoagulants, e.g. heparin or drugs which inhibit platelet formation or function, e.g. platelet ...
Pregnancy and lactation
Biofactor Streptokinase is contraindicated in pregnancy. There is no evidence of the drugs safety in pregnancy, nor is there evidence from animal work that it is free from hazard. Bleeding and anaphylactic ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The following adverse reactions are based on clinical trial and post-marketing experience. The following standard categories are used: Very common more than 1/10 Common more than 1/100; less than 1/10 ...
Overdose
Long-term overdosage of streptokinase may induce the risk of rethrombosis by prolonged decrease of plasminogen. See also section 4.8 and 5.1.
Pharmacodynamic properties
Pharmacotherapeutic group: Streptokinase (antithrombotic agents, enzymes) ATC code: B01AD01 Biofactor Streptokinase is a highly purified streptokinase derived from β haemolytic streptococci of Lancefield ...
Pharmacokinetic properties
The elimination kinetics of streptokinase follows a biphasic course. A small proportion of the dose is bound to anti-streptokinase antibodies and metabolised with a half-life of 18 minutes while most of ...
Preclinical safety data
In an Ames Test on Biofactor Streptokinase, no evidence of mutagenic potential was found. No other preclinical safety studies have been performed on Biofactor Streptokinase.
List of excipients
Human albumin Aminoacetic acid (glycine) Mannitol
Incompatibilities
No incompatibilities have been reported when Biofactor Streptokinase is used as recommended. This medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: The shelf-life of unopened vials of Biofactor Streptokinase 1 500 000 is 3 years.
Special precautions for storage
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.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
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. ...
Marketing authorization holder
Biofactor GmbH, Rudolf-Huch-Str. 14, D-38667 Bad Harzburg, Germany, Fax: +49 5322 960516, Email: info@biofactor.de
Marketing authorization number(s)
PL 29723/0004
Date of first authorization / renewal of the authorization
26 June 1998/15 May 2009
Date of revision of the text
01 July 2015
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