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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Valdoxan (2012)

Εκδότης

Εκδότης Servier Laboratories Limited
Διεύθυνση Rowley, Wexham Springs, Framewood Road, Wexham, Slough, SL3 6PJ
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Περιεχόμενα

Name of the medicinal product

Valdoxan 25 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 25 mg of agomelatine. Excipient: lactose monohydrate 61.84 mg For a ...

Pharmaceutical form

Film-coated tablet [tablet]. Orange-yellow, oblong, film-coated tablet with blue imprint of company logo ...

Therapeutic indications

Treatment of major depressive episodes in adults. Valdoxan is indicated in adults.

Posology and method of administration

Posology The recommended dose is 25 mg once daily taken orally at bedtime. After two weeks of treatment, ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Hepatic impairment (i.e. cirrhosis ...

Special warnings and precautions for use

Use in paediatric population Valdoxan is not recommended in the treatment of depression in patients under ...

Interaction with other medicinal products and other forms of interaction

Potential interactions affecting agomelatine Agomelatine is metabolised mainly by cytochrome P450 1A2 ...

Fertility, pregnancy and lactation

Fertility Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility. ...

Effects on ability to drive and use machines

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

Undesirable effects

In clinical trials, over 3,900 depressed patients have received Valdoxan. Adverse reactions were usually ...

Overdose

There is limited experience with agomelatine overdose. Experience with agomelatine in overdose has indicated ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other antidepressants ATC-code: N06AX22 Mechanism of action Agomelatine is ...

Pharmacokinetic properties

Absorption and bioavailability Agomelatine is rapidly and well (≥ 80%) absorbed after oral administration. ...

Preclinical safety data

In mice, rats and monkeys sedative effects were observed after single and repeated administration at ...

List of excipients

Tablet core: Lactose monohydrate Maize starch Povidone Sodium starch glycolate type A Stearic acid Magnesium ...

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

Aluminium/PVC blister packed in cardboard boxes (calendar). Packs containing 7, 14, 28, 42, 56, 84 and ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France

Marketing authorization number(s)

EU/01/08/499/001-008

Date of first authorization / renewal of the authorization

19/02/2009

Date of revision of the text

03/2012
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.