Orgaran (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | Merck Sharp & Dohme Limited |
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Διεύθυνση | Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU |
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Name of the medicinal product
Orgaran, 750 anti-Xa units, solution for injection.
Qualitative and quantitative composition
Orgaran contains danaparoid sodium, which is a non-heparin mixture of low molecular weight sulphated glycosaminoglycuronans derived from animal mucosa, comprising heparan sulphate, dermatan sulphate and ...
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
a) Non-HIT patients (DVT prophylaxis) In general Orgaran 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 thromboembolism ...
Contraindications
As with heparins, in patients receiving Orgaran for treatment rather than for prophylaxis, locoregional anaesthesia in elective surgical procedures is contra-indicated. severe haemorrhagic diathesis, e.g. ...
Special warnings and precautions for use
Orgaran should not be used if an in vitro test for the heparin-induced antibody in the presence of Orgaran is positive in patients with thrombocytopenia induced by heparin or heparin-like anticoagulants, ...
Interaction with other medicinal products and other forms of interaction
In clinical studies no clinically significant interactions with other medications have been found. Orgaran may be used together with oral anticoagulants, drugs which interfere with platelet function (such ...
Pregnancy and lactation
Pregnancy Orgaran 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 the third ...
Effects on ability to drive and use machines
Orgaran 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, Orgaran should be stopped and transfusion of fresh frozen plasma or, if uncontrollable, plasmapheresis should be considered. Although ...
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 Ph. Eur. Sodium chloride Ph. Eur. Hydrochloric acid Ph. Eur. Water Ph. Eur.
Incompatibilities
When administered as an intravenous bolus or infusion, Orgaran should be given separately and not mixed with other drugs. However, Orgaran is compatible with, and therefore can be added to, infusions of ...
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
Organon Laboratories Limited Cambridge Science Park Milton Road Cambridge CB4 0FL
Marketing authorization number(s)
PL: 0065/0125
Date of first authorization / renewal of the authorization
14 April 1993 / 09 October 1998
Date of revision of the text
20 August 2012