DANAPAROID SODIUM Solution for injection (2016)
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Περιεχόμενα
Name of the medicinal product
Danaparoid Sodium 750 anti-Xa units/0.6 ml, solution for injection.
Qualitative and quantitative composition
Danaparoid Sodium contains danaparoid sodium, which is a non-heparin mixture of low molecular weight sulphated glycosaminoglycuronans derived from animal mucosa, comprising heparan sulphate, dermatan sulphate ...
Pharmaceutical form
Solution for injection.
Therapeutic indications
Prevention of deep vein thrombosis and its possible consequences in patients undergoing general or orthopaedic surgery. Treatment of thrombo-embolic disorders in patients who require urgent parenteral ...
Posology and method of administration
Non-HIT patients (DVT prophylaxis) In general Danaparoid Sodium should be administered by subcutaneous injection at a dose of 750 anti-factor Xa units, twice daily for 7 to 10 days or until the risk of ...
Contraindications
As with heparins, in patients receiving Danaparoid Sodium for treatment rather than for prophylaxis, locoregional anaesthesia in elective surgical procedures is contra-indicated. severe haemorrhagic diathesis, ...
Special warnings and precautions for use
Danaparoid Sodium should not be used if an in vitro test for the heparin-induced antibody in the presence of Danaparoid Sodium is positive in patients with thrombocytopenia induced by heparin or heparin-like ...
Interaction with other medicinal products and other forms of interaction
In clinical studies no clinically significant interactions with other medications have been found. Danaparoid Sodium may be used together with oral anticoagulants, drugs which interfere with platelet function ...
Pregnancy and lactation
Pregnancy Danaparoid Sodium has been used in over 60 pregnancies (starting during the first trimester in almost 50% of the pregnancies, the second trimester in approximately 20% of the pregnancies and ...
Effects on ability to drive and use machines
Danaparoid Sodium is not known to have any effect on the ability to drive and use machines.
Undesirable effects
Enhanced bleeding or haematoma may occur at the operation site. Bruising and/or pain may occur at injection sites. Within each frequency grouping, undesirable effects are presented in order of decreasing ...
Overdose
In the event of serious bleeding other than caused by a surgical error, Danaparoid Sodium should be stopped and transfusion of fresh frozen plasma or, if uncontrollable, plasmapheresis should be considered. ...
Pharmacodynamic properties
Danaparoid sodium has been shown both in animal models and in human studies to be an effective antithrombotic substance. At therapeutic doses danaparoid sodium has no or only a minor effect on haemostatic ...
Pharmacokinetic properties
Pharmacokinetic studies have primarily been based on the kinetics of relevant anticoagulant activities of danaparoid sodium, because no specific chemical assay methods are available. In animal models the ...
Preclinical safety data
The results of pre-clinical studies do not add to the information included in the other sections of the SmPC.
List of excipients
Sodium sulphite Sodium chloride Hydrochloric acid Water
Incompatibilities
When administered as an intravenous bolus or infusion, Danaparoid Sodium should be given separately and not mixed with other drugs. However, Danaparoid Sodium is compatible with, and therefore can be added ...
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Do not freeze. Keep the ampoules in the outer carton to protect from light.
Nature and contents of container
1-ml glass ampoules containing 750 anti-factor Xa units (0.6ml) danaparoid sodium per ampoule (1250 anti-factor Xa units/ml) in packs of 10 or 20 ampoules.
Special precautions for disposal and other handling
See section 4.2.
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0057
Date of first authorization / renewal of the authorization
14 April 1993/09 October 1998
Date of revision of the text
01/2016
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