Orgaran (2012)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	Merck Sharp & Dohme Limited
Διεύθυνση	Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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