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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Xomolix 2.5mg/ml solution for injection (2012)

Εκδότης

Εκδότης ProStrakan
Διεύθυνση Galabank Business Park, Galashiels, TD1 1QH
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Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Xomolix 2.5 mg/ml solution for injection.

Qualitative and quantitative composition

Each millilitre of the solution contains 2.5 mg droperidol. Excipient: sodium < 23 mg per ml. For a full ...

Pharmaceutical form

Solution for injection. Clear colourless solution, free from visible particles. The pH of droperidol ...

Therapeutic indications

Prevention and treatment of post-operative nausea and vomiting in adults and, as second line, in children ...

Posology and method of administration

For intravenous use. Prevention and treatment of post-operative nausea and vomiting (PONV) Adults: 0.625 ...

Contraindications

Droperidol is contraindicated in patients with: Hypersensitivity to droperidol or to any of the excipients; ...

Special warnings and precautions for use

Central Nervous System Droperidol may enhance CNS depression produced by other CNS-depressant drugs. ...

Interaction with other medicinal products and other forms of interaction

Contraindicated for concomitant use Medicinal products known to prolong the QTc interval should not be ...

Pregnancy and lactation

Pregnancy In a prospective study, 80 patients suffering from hyperemesis gravidarum received high doses ...

Effects on ability to drive and use machines

Droperidol has major influence on the ability to drive and use machines. Patients should not drive or ...

Undesirable effects

The most frequently reported events during clinical experience are incidents of drowsiness and sedation. ...

Overdose

Symptoms The manifestations of droperidol overdose are an extension of its pharmacologic actions. Symptoms ...

Pharmacodynamic properties

Pharmacotherapeutic group: Butyrophenone derivatives ATC code: N05AD08 Droperidol is a butyrophenone ...

Pharmacokinetic properties

The action of a single intravenous dose commences 2-3 minutes following administration. The tranquillising ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose ...

List of excipients

Mannitol Tartaric acid Sodium hydroxide (for pH adjustment) Water for injections

Incompatibilities

Incompatible with barbiturates. This medicinal product must not be mixed with other medicinal products ...

Shelf life

Unopened: 3 years. After first opening: For immediate use. Following dilution: Compatibility of droperidol ...

Special precautions for storage

Store in the original package.

Nature and contents of container

Type I amber glass ampoules containing 1 ml solution for injection, in packs of 5 and 10 ampoules. Not ...

Special precautions for disposal and other handling

For single use only. Any unused solution should be discarded. The solution should be inspected visually ...

Marketing authorization holder

ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Tel. +44 (0)1896 664000

Marketing authorization number(s)

PL 16508/0036

Date of first authorization / renewal of the authorization

28.01.2008

Date of revision of the text

10/2009
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.