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【求助】国外药品说明书
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karl2100(金币+1,VIP+0):多谢提供！ 10-23 20:54
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Table of Contents 1. NAME OF THE MEDICINAL PRODUCT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 3. PHARMACEUTICAL FORM 4. CLINICAL PARTICULARS 4.1 Therapeutic indications 4.2 Posology and method of administration 4.3 Contraindications 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 4.6 Pregnancy and lactation 4.7 Effects on ability to drive and use machines 4.8 Undesirable effects 4.9 Overdose 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties 5.2 Pharmacokinetic properties 5.3 Preclinical safety data 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients 6.2 Incompatibilities 6.3 Shelf life 6.4 Special precautions for storage 6.5 Nature and contents of container 6.6 Special precautions for disposal and other handling 7. MARKETING AUTHORISATION HOLDER 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10. DATE OF REVISION OF THE TEXT Go to top of the page1. NAME OF THE MEDICINAL PRODUCT AAA Sore Throat Spray Go to top of the page2. QUALITATIVE AND QUANTITATIVE COMPOSITION Benzocaine 1.5mg Go to top of the page3. PHARMACEUTICAL FORM Aerosol spray with metered dose Go to top of the page4. CLINICAL PARTICULARS Go to top of the page4.1 Therapeutic indications Symptomatic temporary relief of pain associated with sore throat pain and minor infections Go to top of the page4.2 Posology and method of administration Adults (including elderly): Spray two metered doses every two to three hours if required (not more than sixteen doses in every 24 hours) or as directed by the physician. Children: Children 6 – 12 years: One metered dose every two to three hours if required (not more than eight doses in every 24 hours) or as directed by the physician. Not suitable for children under 6 years. Route of administration Topical application to the mucosa of the mouth and throat by means of a metered dose aerosol. Product should not be administered for more than 7 consecutive days. Can be shaken before use. Go to top of the page4.3 Contraindications Known hypersensitivity to benzocaine Go to top of the page4.4 Special warnings and precautions for use This preparation should not be administered to children under 6 years or used for more than seven consecutive days unless directed by a physician. If the sore throat is severe, persistent or accompanied by fever or headache, a physician should be consulted before the use of this product. Avoid spraying into the eyes. Avoid inhalation of the product. Go to top of the page4.5 Interaction with other medicinal products and other forms of interaction Benzocaine is an ester which on hydrolysis produces p-aminobenzoic acid, so it should not be used in patients being treated with sulphonamides. Go to top of the page4.6 Pregnancy and lactation There is no evidence, at present, of hazard from benzocaine in pregnancy. However, only very limited data is available. Therefore it should not be used in pregnancy unless considered essential by a physician. Go to top of the page4.7 Effects on ability to drive and use machines None Go to top of the page4.8 Undesirable effects Hypersensitivity reactions to benzocaine have been reported. Go to top of the page4.9 Overdose There have been no reports of overdosage with AAA Spray. Systemic effects are unlikely. Go to top of the page5. PHARMACOLOGICAL PROPERTIES Go to top of the page5.1 Pharmacodynamic properties Benzocaine is a surface anaesthetic of the ester type. It has found frequent use as lozenges or solution to treat pain arising from various throat and mouth conditions. Go to top of the page5.2 Pharmacokinetic properties Benzocaine is sparingly soluble in water with toxicity about a tenth that of cocaine. It is not readily absorbed from mucus membranes. It is an ester which on hydrolysis produced p-aminobenzoic acid. Go to top of the page5.3 Preclinical safety data None stated Go to top of the page6. PHARMACEUTICAL PARTICULARS Go to top of the page6.1 List of excipients Cetylpyridinium chloride Glycerin Ethanol Clove bud oil Menthol crystals Sodium saccharin 450 Peppermint cremophor Water Go to top of the page6.2 Incompatibilities None Go to top of the page6.3 Shelf life 24 months Go to top of the page6.4 Special precautions for storage Keep away from a naked flame. Store in a cool place Go to top of the page6.5 Nature and contents of container White aluminium can with 100ml pumps, white high density polypropylene folding arm activator and white high density polyethylene cap. Go to top of the page6.6 Special precautions for disposal and other handling Go to top of the page7. MARKETING AUTHORISATION HOLDER Manx Pharma Ltd Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom Go to top of the page8. MARKETING AUTHORISATION NUMBER(S) PL 15833/0001 Go to top of the page9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 1 September 1997 Go to top of the page10. DATE OF REVISION OF THE TEXT March 2008 原文：http://emc.medicines.org.uk/medi ... +Sore+Throat+Spray/ |
4楼2009-10-23 19:22:30
5楼2009-10-24 10:28:56