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  Part 1B:SUMMARY OF PRODUCT CHARACTERISTICSPage:1B - 1Product:Auroto Ear Drops Company:Dechra LimitedDate:13.2.07 1.NAME OF VETERINARY MEDICINAL PRODUCT  Auroto Ear Drops Solution 2.QUALITATIVE AND QUANTITATIVE COMPOSITIONActive substances % w/v Thiabendazole4.0Tetracaine Hydrochloride1.0Neomycin Sulphate0.5For a full list of excipients, see section 6.1. 3.PHARMACEUTICAL FORM Ear drops solution. A clear, pale yellow solution. 4.CLINICAL PARTICULARS4.1Target species Dogs and cats. 4.2Indications for use, specifying the target species  Auroto Ear Drops are indicated for the treatment of otitis externa associated with bacteria, fungi andear mites ( Otodectes cynotis)  in dogs and cats. 4.3Contraindications Do not use concomitantly with drugs known to be ototoxic. Do not use for longer than 7 days. Do not use in animals known to be hypersensitive to the active substances. Do not use if the eardrum isperforated. 4.4Special warnings for each target species  Cats: Usage in animals with damaged membranes or perforated tympanum may result in severe reactions.Dogs: Not applicable. DATE ISSUED: March 07 SUPERSEDES ISSUE: 06/11/06  Part 1B:SUMMARY OF PRODUCT CHARACTERISTICSPage:1B - 2Product:Auroto Ear Drops Company:Dechra LimitedDate:13.2.07 4.5Special precautions for usei) Special precautions for use in animals For external use only. Discontinue treatment if hypersensitivity occurs and institute appropriate therapy. Do not use the same container for more than one patient. Do not use for longer than 7 days. Do not use if eardrum is perforated. Prolonged usage may lead to bacterial super infection and cross resistance to other aminoglycosides. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands thoroughly after use.If any splashes enter the eye, wash immediately with copious water.In the event of accidental ingestion – seek medical attention showing the pack leaflet and/or productlabel to the doctor or nurse. iii) Other precautions None. 4.6Adverse reactions (frequency and seriousness)  Ataxia in cats with occasional deafness, vomiting and nystagmus (rare). Usually, though not exclusively, associated with use in animals with perforated eardrums. Hypersensitivity may cause contact dermatitis. Neomycin is ototoxic and may cause deafness if used when the eardrum is perforated. Allergic reaction in hypersensitive individuals. 4.7Use during pregnancy, lactation or lay Do not use in animals of less than 4 kg bodyweight during the first half of pregnancy. 4.8Interaction with other medicinal products and other forms of interaction Incompatible with alkaline products. Do not use concomitantly with drugs known to be ototoxic. 4.9Amounts to be administered and administration route Instil 3 - 5 drops into the external auditory canal twice daily for 7 days; less for smaller animals. Any excess exudate, hair or debris should be carefully removed before application. Do not exceed the recommended dosage. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Topical product therefore not applicable. 4.11Withdrawal periods Not applicable. DATE ISSUED: March 07 SUPERSEDES ISSUE: 06/11/06  Part 1B:SUMMARY OF PRODUCT CHARACTERISTICSPage:1B - 3Product:Auroto Ear Drops Company:Dechra LimitedDate:13.2.07 5.PHARMACOLOGICAL PARTICULARS Pharmacotherapeutic group:  Anti-infectives ATC Vet Code: QS02AA57 5.1Pharmacodynamic properties The product is composed of three ingredients:Thiabendazole has acaricidal and fungicidal activity and is effective against Otodectes cynotis . Neomycin sulphate is a broad spectrum aminoglycoside antibiotic which is particularly effective against Pseudomonas aeruginosa, Staphylococcus aureus, Proteus vulgaris  and some  Streptococci  . Tetracaine hydrochloride is an effective topical local anaesthetic.Thiabendazole is well tolerated when given at the recommended dosage regimes. Side effects on administration to man have included transient anorexia, vomiting, dizziness, drowsiness, and hypersensitivity, none of which have been considered as serious in the dog. The drug is relatively inert with respect to effects on the various systems and organs. Thiabendazole is readily absorbed following aural administration and is also absorbed from the surface of the skin and eye when given topically. The drug is largely metabolised and excreted in the urine. The drug is active against manysaprophytic and pathogenic fungi.Neomycin sulphate is highly effective against bacteria and its spectrum of activity against gram-positive and gram-negative organisms affecting the skin is very broad. It can be used topically in combination with a number of other drugs without causing toxic signs other than what would appear to be an infrequent neomycin sensitivity. It can cause deafness if the tympanum is perforated. Use for prolonged periods may cause super-infection and sensitivity to other aminoglycosides.Tetracaine hydrochloride is an effective topical anaesthetic. It aids in relieving the symptoms of otitisexterna associated with bacteria, fungi and ear mites ( Otodectes cynotis),  which include pain and itching caused by the infection and infestation. It may be absorbed systematically if the tympanum isperforated. 5.2Pharmacokinetic properties  Not applicable. 6.PHARMACEUTICAL PARTICULARS6.1List of excipients Hypophosphorous acidGlycerol EthanolPropylene glycolPurified water  6.2Incompatibilities Incompatible with alkaline products. DATE ISSUED: March 07 SUPERSEDES ISSUE: 06/11/06  Part 1B:SUMMARY OF PRODUCT CHARACTERISTICSPage:1B - 4Product:Auroto Ear Drops Company:Dechra LimitedDate:13.2.07 6.3Shelf life Shelf life of the veterinary medicinal product as packaged for sale: 3 years.Shelf life after opening the immediate packaging: 28 days. 6.4Special precautions for storage Do not store above 25°C. Do not refrigerate. Protect from light.  6.5Nature and contents of immediate packaging Natural low density polyethylene bottle fitted with an integral single drop plug and a white high density polyethylene or polypropylene cap.Pack size: 10 ml or 25 ml.Not all pack sizes may be marketed. 6.6Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate  Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 7.0MARKETING AUTHORISATION HOLDER Dechra Limited,Dechra House,Jamage Industrial Estate,Talke Pits,Stoke-on-Trent,Staffordshire,ST7 1XW,UK.Distributed by:Dechra Veterinary Products, Cartmel Drive,Harlescott,Shrewsbury,Shropshire,SY1 3TB,UK. 8.0MARKETING AUTHORISATION NUMBERS UK: Vm 10434/4022IE: VPA 10799/8/1 DATE ISSUED: March 07 SUPERSEDES ISSUE: 06/11/06

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