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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: EMEND 80mg, 125mg hard Capsules (2012)

Εκδότης

Εκδότης Merck Sharp & Dohme Limited
Διεύθυνση Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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

EMEND® 125 mg hard capsules. EMEND® 80 mg hard capsules.

Qualitative and quantitative composition

Each 125 mg capsule contains 125 mg of aprepitant. Each 80 mg capsule contains 80 mg of aprepitant. ...

Pharmaceutical form

Hard capsule. The 125 mg capsule is opaque with a white body and pink cap with “462” and “125 mg” printed ...

Therapeutic indications

Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based ...

Posology and method of administration

Posology EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. ...

Contraindications

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

Special warnings and precautions for use

Patients with moderate to severe hepatic impairment There are limited data in patients with moderate ...

Interaction with other medicinal products and other forms of interaction

Aprepitant (125 mg/80 mg) is a substrate, a moderate inhibitor, and an inducer of CYP3A4. Aprepitant ...

Fertility, pregnancy and lactation

Contraception in males and females The efficacy of hormonal contraceptives may be reduced during and ...

Effects on ability to drive and use machines

EMEND may have minor influence on the ability to drive and use machines. Dizziness and fatigue may occur ...

Undesirable effects

Summary of the safety profile The safety profile of aprepitant was evaluated in approximately 6,500 individuals. ...

Overdose

In the event of overdose, EMEND should be discontinued and general supportive treatment and monitoring ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiemetics and antinauseants ATC code: A04A D12 Aprepitant is a selective ...

Pharmacokinetic properties

Aprepitant displays non-linear pharmacokinetics. Both clearance and absolute bioavailability decrease ...

Preclinical safety data

Pre-clinical data reveal no special hazard for humans based on conventional studies of single and repeated ...

List of excipients

Capsule content Sucrose Microcrystalline cellulose (E 460) Hydroxypropyl cellulose (E 463) Sodium laurilsulfate ...

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

Store in the original package in order to protect from moisture.

Nature and contents of container

Different pack sizes including different strengths are available. 80 mg capsules Aluminium blister containing ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN 11 9BU United Kingdom

Marketing authorization number(s)

80 mg x 1: EU/1/03/262/001 80 mg x 2: EU/1/03/262/002 80 mg x 5: EU/1/03/262/003 125 mg x 1: EU/1/03/262/004 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 11 November 2003 Date of latest renewal: 11 November 2008

Date of revision of the text

December 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.