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ULTRA CHLORASEPTIC ANAESTHETIC THROAT SPRAY 0.71% Oromucosal Spray (2010)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Prestige Brands (UK) Ltd
Διεύθυνση 3 Scotlands Drive, Farnham Common, Slough, Berkshire, SL2 3ES
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Name of the medicinal product

Ultra Chloraseptic Anaesthetic Throat Spray.

Qualitative and quantitative composition

Benzocaine: 0.71% w/v. For full list of excipients, see 6.1.

Pharmaceutical form

Oromucosal Spray. Direct application to the throat by spraying. Clear, colourless to straw coloured liquid.

Therapeutic indications

Symptomatic relief of sore throat pain.

Posology and method of administration

Posology Adults and children 13 years and over Administer 3 sprays (3mg) to the back of the throat. Repeat every 2-3 hours up to a maximum of 8 doses per day. Children 6-12 years Use only under adult supervision. ...

Contraindications

Children under 6 years. Epiglottitis Known hypersensitivity to benzocaine or any of the other ingredients. Methaemoglobinaemia.

Special warnings and precautions for use

Do not administer to children under 6 years. Do not use for more than 3 consecutive days. Do not spray into eyes. If sore throat is severe or persistent, or accompanied by fever, headache or nausea consult ...

Interaction with other medicinal products and other forms of interaction

None known.

Pregnancy and lactation

Animal studies are insufficient with respect to effects on pregnancy and lactation. The potential risk for humans is unknown. Therefore Ultra Chloraseptic spray is not recommended during pregnancy or breast-feeding. ...

Effects on ability to drive and use machines

None expected.

Undesirable effects

Allergic reactions have been reported very occasionally with benzocaine. There have been occasional reports of temporary breathing difficulty, face or mouth swelling. Methaemoglobinaemia has been reported ...

Overdose

Pronounced reversible anaesthesia would be observed. No systemic adverse effects are expected due to the poor systemic absorption and low administered dose of benzocaine. <u>Treatment of overdose:</u> ...

Pharmacodynamic properties

ATC code: R02AD01 Benzocaine is a local anaesthetic of the ester type. The mode of action is a reversible inhibition of the flux of sodium and potassium ions through the axonal membranes of peripheral ...

Pharmacokinetic properties

Benzocaine is absorbed into the mucosal membranes. After systemic absorption, which is negligible, the drug is thought to be metabolised to ethanol and aminobenzoic acid by plasma esterases. Aminobenzoic ...

Preclinical safety data

No animal data are available on Ultra Chloraseptic spray. Non-clinical studies on benzocaine showed local irritation and sensation, and methaemoglobinaemia at high doses in some species.

List of excipients

Ethanol Macrogol 300 Propylene glycol Glycerol Cetylpyridinium chloride Levomenthol Saccharin sodium Sodium dihydrogen phosphate dihydrate Sodium hydroxide Purified water

Incompatibilities

None known. No data held.

Shelf life

36 months.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Uncoloured, clear or textured Type III glass bottle, containing 15ml of product with a polypropylene/low density polyethylene pump and polypropylene cap. Or Amber, clear Type III glass bottle, containing ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Prestige Brands (UK) Limited, Beechwood, 3 Scotlands Drive, Farnham Common, Slough, Berkshire, SL2 3ES, United Kingdom

Marketing authorization number(s)

PL 18259/0001

Date of first authorization / renewal of the authorization

07 July 2000

Date of revision of the text

24th October 2010
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