MULTAQ Film-coated tablets (2018)
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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 also contains 41.65 mg of lactose (as monohydrate). For the full list of excipients, see section ...
Pharmaceutical form
Film-coated tablet (tablet). White, oblong shaped tablets, engraved with a double wave marking on one side and "4142"code on the other side.
Therapeutic indications
MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile ...
Posology and method of administration
Treatment should be initiated and monitored only under specialist supervision (see section 4.4). Treatment with MULTAQ can be initiated in an outpatient setting. Treatment with Class I or III antiarrhythmics ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Second- or third-degree atrio-ventricular block, complete bundle branch block, distal block, sinus node dysfunction, ...
Special warnings and precautions for use
Careful monitoring during dronedarone administration is recommended by regular assessment of cardiac, hepatic and pulmonary function (see below). If AF reoccurs discontinuation of dronedarone should be ...
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 of CYP 3A4 have the potential to interact on dronedarone. Dronedarone is a moderate inhibitor of CYP ...
Fertility, pregnancy and lactation
Women of child bearing potential and Pregnancy There are no or limited amount of data from the use of dronedarone in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). ...
Effects on ability to drive and use machines
MULTAQ has no or negligible influence on the ability to drive and use machines. However, ability to drive and use machines may be affected by adverse reactions such as fatigue.
Undesirable effects
Summary of the safety profile Assessment of intrinsic factors such as gender or age on the incidence of any treatment emergent adverse reactions showed an interaction for gender (female patients) for the ...
Overdose
It is not known whether dronedarone and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration). There is no specific antidote available. In the event of overdose, ...
Pharmacodynamic properties
Pharmacotherapeutic group: cardiac therapy, antiarrhythmic class III ATC code: C01BD07 Mechanism of action In animals, dronedarone prevents atrial fibrillation or restores normal sinus rhythm depending ...
Pharmacokinetic properties
Absorption Following oral administration in fed condition, dronedarone is well absorbed (at least 70%). However due to presystemic first pass metabolism, the absolute bioavailability of dronedarone (given ...
Preclinical safety data
Dronedarone had no genotoxic effects, based on one in vivo micronucleus test in mice and four in vitro tests. In 2-year oral carcinogenicity studies, the highest dronedarone dose administered for 24 months ...
List of excipients
Tablet core: Hypromellose (E464) Maize starch Crospovidone (E1202) Poloxamer 407 Lactose monohydrate Colloidal anhydrous silica Magnesium stearate(E572) Tablet coat: Hypromellose (E464) Macrogol 6000 ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Opaque PVC/Aluminium blister in packs of 20, 50 and 60 film-coated tablets. Opaque PVC/Aluminium perforated unit dose blister in packs of 100x1 film-coated tablets. Not all pack sizes may be marketed. ...
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-aventis groupe, 54, rue La Boétie, F-75008, Paris, France
Marketing authorization number(s)
EU/1/09/591/001 Cartons of 20 film-coated tablets EU/1/09/591/002 Cartons of 50 film-coated tablets EU/1/09/591/003 Cartons of 60 film-coated tablets EU/1/09/591/004 Cartons of 100 1 film-coated tablets ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 November 2009 Date of latest renewal: 22 September 2014
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