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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Multaq 400mg tablets (2012)

Εκδότης

Εκδότης SANOFI
Διεύθυνση 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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Περιεχόμενα

Name of the medicinal product

MULTAQ 400 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 400 mg of dronedarone (as hydrochloride). Excipient with known effect: Each tablet ...

Pharmaceutical form

Film-coated tablet (tablet). White, oblong shaped tablets, engraved with a double wave marking on one ...

Therapeutic indications

MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically ...

Posology and method of administration

Treatment should be initiated and monitored only under specialist supervision (see section 4.4). Treatment ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Second- or ...

Special warnings and precautions for use

Careful monitoring during dronedarone administration is recommended by regular assessment of cardiac, ...

Interaction with other medicinal products and other forms of interaction

Dronedarone is primarily metabolised by CYP 3A4 (see section 5.2). Therefore, inhibitors and inducers ...

Fertility, pregnancy and lactation

Fertility Dronedarone was not shown to alter fertility in animal studies. Women of child bearing potential ...

Interaction with other medicinal products and other forms of interaction

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

Undesirable effects

a. Summary of the safety profile The safety profile of dronedarone 400 mg twice daily in patients with ...

Overdose

It is not known whether dronedarone and/or its metabolites can be removed by dialysis (hemodialysis, ...

Pharmacodynamic properties

Pharmacotherapeutic group: antiarrhythmic ATC code: C01BD07 Mechanism of action In animals, dronedarone ...

Pharmacokinetic properties

Absorption Following oral administration in fed condition, dronedarone is well absorbed (at least 70%). ...

Preclinical safety data

Dronedarone had no genotoxic effects, based on one in vivo micronucleus test in mice and four in vitro ...

List of excipients

Core of the tablets: Hypromellose (E464) maize starch crospovidone (E1202) poloxamer 407 lactose monohydrate ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

20, 50 and 60 film-coated tablets in opaque PVC/Aluminium blister packs 100 1 film-coated tablets in ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. ...

Marketing authorization holder

Sanofi 54, rue La Boétie F-75008 Paris France

Marketing authorization number(s)

EU/1/09/591/001 Cartons of 20 film-coated tablets. EU/1/09/591/003 Cartons of 60 film-coated tablets. ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 November 2009

Date of revision of the text

14 November 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.