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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Pradaxa 75 mg hard capsules (2012)

Εκδότης

Εκδότης Boehringer Ingelheim Limited
Διεύθυνση Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Pradaxa 75 mg hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate). Excipients: Each hard capsule ...

Pharmaceutical form

Hard capsule. Imprinted capsules with light blue, opaque cap and cream-coloured, opaque body of size ...

Therapeutic indications

Primary prevention of venous thromboembolic events in adult patients who have undergone elective total ...

Posology and method of administration

Posology Prevention of Venous Thromboembolism (VTE): Patients following elective knee replacement surgery ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Patients with ...

Special warnings and precautions for use

Hepatic impairment Patients with elevated liver enzymes > 2 ULN were excluded in controlled clinical ...

Interaction with other medicinal products and other forms of interaction

Anticoagulants and antiplatelet aggregation agents There is no or only limited experience with the following ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of Pradaxa in pregnant women. Studies in animals have ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

A total of 10.084 patients were treated in 4 actively controlled VTE prevention trials with at least ...

Overdose

Doses of dabigatran etexilate beyond those recommended, expose the patient to increased risk of bleeding. ...

Pharmacodynamic properties

Pharmacotherapeutic group: direct thrombine inhibitors ATC code: B01AE07 Dabigatran etexilate is a small ...

Pharmacokinetic properties

After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...

List of excipients

Capsule fill: Tartaric acid Acacia Hypromellose Dimeticone 350 Talc Hydroxypropylcellulose Capsule shell: ...

Incompatibilities

Not applicable.

Shelf life

Blister and bottle: 3 years Once the bottle is opened, the medicinal product must be used within 4 months. ...

Special precautions for storage

Blister: Store in the original package in order to protect from moisture Bottle: Store in the original ...

Nature and contents of container

Cartons containing 1, 3, or 6 blister strips (10 1, 30 1, 60 1) in perforated aluminium unit dose ...

Special precautions for disposal and other handling

When taking Pradaxa capsules out of the blister pack, the following instructions should be followed: ...

Marketing authorization holder

Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany

Marketing authorization number(s)

EU/1/08/442/001 EU/1/08/442/002 EU/1/08/442/003 EU/1/08/442/004 EU/1/08/442/017

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 March 2008

Date of revision of the text

08/2012
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.