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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Orgaran (2012)

Εκδότης

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

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 ...

Pharmaceutical form

Solution for injection.

Therapeutic indications

Prevention of deep vein thrombosis and its possible consequences in patients undergoing general or orthopaedic ...

Posology and method of administration

a) Non-HIT patients (DVT prophylaxis) In general Orgaran® should be administered by subcutaneous injection ...

Contraindications

As with heparins, in patients receiving Orgaran® for treatment rather than for prophylaxis, locoregional ...

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 ...

Interaction with other medicinal products and other forms of interaction

In clinical studies no clinically significant interactions with other medications have been found. Orgaran ...

Pregnancy and lactation

Pregnancy Orgaran has been used in over 60 pregnancies (starting during the first trimester in almost ...

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 ...

Overdose

In the event of serious bleeding other than caused by a surgical error, Orgaran® should be stopped and ...

Pharmacodynamic properties

Danaparoid sodium has been shown both in animal models and in human studies to be an effective antithrombotic ...

Pharmacokinetic properties

Pharmacokinetic studies have primarily been based on the kinetics of relevant anticoagulant activities ...

Preclinical safety data

The results of pre-clinical studies do not add to the information included in the other sections of the ...

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 ...

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 ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.