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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Cordarone 100mg and 200mg Tablets (2012)

Εκδότης

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

Name of the medicinal product

Cordarone x 100. Cordarone x 200.

Qualitative and quantitative composition

Cordarone X 100 contain 100mg of amiodarone hydrochloride. Cordarone X 200 contain 200mg of amiodarone ...

Pharmaceutical form

Tablet. Round, white tablet with a breakline on one side, imprinted with 100 or 200 on the other.

Therapeutic indications

Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral ...

Posology and method of administration

Adults It is particularly important that the minimum effective dose be used. In all cases the patient ...

Contraindications

Sinus bradycardia and sino-atrial heart block. In patients with severe conduction disturbances (high ...

Special warnings and precautions for use

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose ...

Interaction with other medicinal products and other forms of interaction

Some of the more important drugs that interact with amiodarone include warfarin, digoxin, phenytoin and ...

Pregnancy and lactation

Pregnancy There are insufficient data on the use of amiodarone during pregnancy in humans to judge any ...

Effects on ability to drive and use machines

The ability to drive or to operate machinery may be impaired in patients with clinical symptoms of amiodarone-induced ...

Undesirable effects

The following adverse reactions are classified by system organ class and ranked under heading of frequency ...

Overdose

Little information is available regarding acute overdosage with oral amiodarone. Few cases of sinus bradycardia, ...

Pharmacodynamic properties

Amiodarone hydrochloride is an antiarrhythmic. No controlled paediatric studies have been undertaken. ...

Pharmacokinetic properties

Amiodarone is strongly protein bound and the plasma half life is usually of the order of 50 days. However ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included ...

List of excipients

Lactose monohydrate Maize starch Povidone Colloidal anhydrous silica Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

60 months.

Special precautions for storage

The tablets should be protected from light.

Nature and contents of container

Cordarone X tablets are supplied in blister packs of 28 tablets packed in cardboard cartons.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK

Marketing authorization number(s)

Cordarone x 100: PL 04425/0644 Cordarone x 200: PL 04425/0645

Date of first authorization / renewal of the authorization

6 July 2010

Date of revision of the text

6 April 2011
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.