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

Προτάσεις

SPC, UK: DEXDOR (2013)

Εκδότης

Εκδότης Orion Pharma (UK) Limited
Διεύθυνση Oaklea Court, 22 Park Street, Newbury, Berkshire, RG14 1EA, UK
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Περιεχόμενα

Name of the medicinal product

Dexdor 100 micrograms/ml concentrate for solution for infusion.

Qualitative and quantitative composition

Each 1 ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine. ...

Pharmaceutical form

Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colourless solution, ...

Therapeutic indications

For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal ...

Posology and method of administration

For hospital use only. Dexdor should be administered by healthcare professionals skilled in the management ...

Contraindications

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

Special warnings and precautions for use

Dexdor is intended for use in an intensive care setting and use in other environments is not recommended. ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Co-administration of dexmedetomidine with anaesthetics, ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of dexmedetomidine in pregnant women. Studies in animals ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Summary of the safety profile The most frequently reported adverse reactions with dexmedetomidine are ...

Overdose

Several cases of dexmedetomidine overdose have been reported both in the clinical trial and the post-marketing ...

Pharmacodynamic properties

Pharmacotherapeutic group: Psycholeptics, other hypnotics and sedatives ATC code: N05CM18 Dexmedetomidine ...

Pharmacokinetic properties

The pharmacokinetics of dexmedetomidine has been assessed following short term IV administration in healthy ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...

List of excipients

Sodium chloride Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

3 years After dilution Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after ...

Nature and contents of container

2 ml Type I glass ampoules. 2, 5 or 10 ml Type I glass vials (with filling volumes of 2, 4 and 10 ml), ...

Special precautions for disposal and other handling

Ampoules and vials are intended for single patient use only. Preparation of solution Dexdor can be diluted ...

Marketing authorization holder

Orion Corporation Orionintie 1 FI-02200 Espoo Finland

Marketing authorization number(s)

EU/1/11/718/001-007

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 September 2011

Date of revision of the text

21 March 2013
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.