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SPC, UK: XOMOLIX Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
ProStrakan
Διεύθυνση :
Galabank Business Park, Galashiels, TD1 1QH
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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 (see section 4.4 for further details). For a full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. Clear colourless solution, free from visible particles. The pH of droperidol solution for injection is 3.0-3.8 and has an osmolarity of approximately 300 milliosmol/kg water.

Therapeutic indications

Xomolix is indicated in: Prevention and treatment of post-operative nausea and vomiting (PONV) in adults and, as second line, in children (2 to 11 years) and adolescents (12 to 18 years). Prevention of ...

Posology and method of administration

Posology Prevention and treatment of post-operative nausea and vomiting (PONV) Adults: 0.625 mg to 1.25 mg (0.25 to 0.5 ml). Elderly: 0.625 mg (0.25 ml) Renal/hepatic impairment: 0.625 mg (0.25 ml) Paediatric ...

Contraindications

Droperidol is contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; Hypersensitivity to butyrophenones; Known or suspected prolonged ...

Special warnings and precautions for use

Central Nervous System Droperidol may enhance CNS depression produced by other CNS-depressant drugs. Any patient subjected to anaesthesia and receiving potent CNS depressant medicinal products or showing ...

Interaction with other medicinal products and other forms of interaction

Contraindicated for concomitant use Medicinal products known to cause torsades de pointes through QT prolongation should not be concomitantly administered with droperidol. Examples include Examples include: ...

Fertility, pregnancy and lactation

Pregnancy A limited amount of clinical data have shown no increase of malformative risk. Droperidol has not been shown to be teratogenic in rats. Animal studies are insufficient with respect to the effects ...

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 operate a machine for 24 hours after droperidol administration.

Undesirable effects

The most frequently reported events during clinical experience are incidents of drowsiness and sedation. In addition, less frequent reports of hypotension, cardiac arrhythmias, neuroleptic malignant syndrome ...

Overdose

Symptoms The manifestations of droperidol overdose are an extension of its pharmacologic actions. Symptoms of accidental overdose are psychic indifference with a transition to sleep, sometimes in association ...

Pharmacodynamic properties

Pharmacotherapeutic group: Butyrophenone derivatives ATC code: N05AD08 Droperidol is a butyrophenone neuroleptic. Its pharmacologic profile is characterised mainly by dopamine-blocking and weak α1-adrenolytic ...

Pharmacokinetic properties

The action of a single intravenous dose commences 2-3 minutes following administration. The tranquillising and sedative effects tend to persist for 2 to 4 hours, although alertness may be affected for ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxic or carcinogenic potential, and reproductive toxicity. Electrophysiological in vitro ...

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 except those mentioned in section 6.6.

Shelf life

Unopened: 3 years. After first opening: For immediate use. Following dilution: Compatibility of droperidol with morphine sulphate in 0.9% sodium chloride (14 days at room temperature) has been demonstrated ...

Special precautions for storage

Store in the original package in order to protect from light. For storage conditions after dilution, and first opening of the medicinal product, see section 6.3.

Nature and contents of container

Type I amber glass ampoules containing 1 ml solution for injection, in packs of 10 ampoules.

Special precautions for disposal and other handling

For single use only. Any unused solution should be discarded. The solution should be inspected visually prior to use. Only clear and colourless solutions free from visible particles should be used. For ...

Marketing authorization holder

Kyowa Kirin 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

01/2018

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