XOMOLIX Solution for injection (2018)
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) <u>Adults:</u> 0.625 mg to 1.25 mg (0.25 to 0.5 ml). <u>Elderly:</u> 0.625 mg (0.25 ml). <u>Renal/hepatic impairment:</u> ...
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: Class IA antiarrhythmics ...
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
<u>Unopened:</u> 3 years. <u>After first opening:</u> For immediate use. <u>Following dilution:</u> Compatibility of droperidol with morphine sulphate in 0.9% sodium chloride (14 days at room temperature) ...
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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