XYLOCAINE Spray (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Xylocaine 10 mg Spray.
Qualitative and quantitative composition
Lidocaine 10 mg/metered dose. Excipient(s) with known effect: Each depression also delivers 1 mg of propylene glycol (an excipient of the banana essence). Also contains ethanol. For the full list of excipients, ...
Pharmaceutical form
Non-sterile solution for topical application supplied in a pump spray, with nozzles for single use in an individual patient.
Therapeutic indications
General This product is non-sterile and therefore not recommended for use prior to procedures that require aseptic techniques. For the prevention of pain associated with the following procedures: Otorhinolaryngology: ...
Posology and method of administration
As with any local anaesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated or elderly patients and children should be given doses commensurate with ...
Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to local anaesthetics of the amide-type.
Special warnings and precautions for use
Excessive dosage, or short intervals between doses, may result in high plasma levels and serious adverse effects. Absorption from mucous membranes is variable but is especially high from the bronchial ...
Interaction with other medicinal products and other forms of interaction
Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics e.g. antiarrhythmic drugs such as mexiletine, since ...
Pregnancy and lactation
Pregnancy There is no, or inadequate evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence, and animal studies have shown no hazard. ...
Effects on ability to drive and use machines
Xylocaine Spray has minor influence on the ability to drive and use machines. Depending on the dose, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion ...
Undesirable effects
In extremely rare cases amide-type local anaesthetic preparations have been associated with allergic reactions (in the most severe instances anaphylactic shock). Local irritation at the application site ...
Overdose
Acute systemic toxicity Toxic reactions originate mainly in the central nervous and the cardiovascular systems. Central nervous system toxicity is a graded response with symptoms and signs of escalating ...
Pharmacodynamic properties
Pharmacotherapeutic group (ATC code): N01BB02 Lidocaine, like other local anaesthetics, causes a reversible blockade of impulse propagation along nerve fibres by preventing the inward movement of sodium ...
Pharmacokinetic properties
Absorption Lidocaine is absorbed following topical administration to mucous membranes; its rate and extent of absorption being dependent upon the concentration and total dose administered, the specific ...
Preclinical safety data
Lidocaine is a well-established active ingredient. In animal studies the toxicity noted after high doses of lidocaine consisted of effects on the central nervous and cardiovascular systems. No drug related ...
List of excipients
Ethanol Macrogol 400 Essence of banana (contains propylene glycol) Levomenthol Saccharin Water purified
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. During storage at temperatures below +8°C precipitation may occur. The precipitate dissolves on warming up to room temperature.
Nature and contents of container
50 ml glass spray bottles (approx. 500 spray doses) with a metering spray pump. The package includes a single use plastic spray nozzle approximately 120 mm long. Additional short spray nozzles are available ...
Special precautions for disposal and other handling
The spray nozzle is bent to ensure correct spray function. Do not try to alter the shape as this could affect its performance. The nozzle must not be shortened, as it will affect the spray function. Nozzles ...
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0086
Date of first authorization / renewal of the authorization
Date of first authorisation: 25<sup>th</sup> August 1989 Date of last renewal: 7<sup>th</sup> May 2002
Date of revision of the text
30/10/2018
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