国家: 英国
语言: 英文
来源: VMD (Veterinary Medicines Directorate)
Chlorocresol, Lidocaine Hydrochloride, Phenoxyethanol, Zinc Oxide
Petlife International Ltd
QD08AE99
Chlorocresol, Lidocaine Hydrochloride, Phenoxyethanol, Zinc Oxide
Cream
AVM-GSL - Authorised Veterinary Medicine – General Sales List
Cats, Dogs
Antiseptic
Authorized
1995-10-04
Revised: August 2008 AN: 01063/2008 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Otodex Skin Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance(s) Chlorocresol 0.500% w/w Phenoxyethanol 0.720% w/w (constituent of Phenonip preservative, see below) Zinc Oxide 9.000% w/w Lidocaine Hydrochloride 0.050% w/w Excipients Quinoline Yellow dye 0.005% w/w Phenonip (preservative) 1.000% w/w (comprising 0.720% w/w phenoxyethanol (above) and 0.28%w/w mixed hydroxybenzoate esters) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. Pale yellow, oily cream with the odour of fern for topical application. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES As an aid in the treatment of eczema, sore spots, abrasions and minor burns. Revised: August 2008 AN: 01063/2008 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES NONE. 4.5 SPECIAL PRECAUTIONS FOR USE _i) Special precautions for use in animals_ For external use only. Use sparingly in cases where large areas of skin are damaged or affected. _ii) Special precautions to be taken by the person administering the _ _veterinary medicinal product to animals_ Wash hands after use. In the event of accidental eye contact wash immediately with copious amounts of water. If the skin or eye irritation persists – seek medical attention showing the product label to the doctor. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Cats are particularly susceptible to CNS effect, of phenols, including vomiting, in coordination, depression and coma. When Chlorocresol has been absorbed systemically treatment should be symptomatic. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Not contraindicated during pregnancy but should not be used during lactation. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Contact with non-ionic surfactants may reduce the activity of certain phenols. 4.9 AMOUNTS TO BE ADMINISTERED AND ADMINIS 阅读完整的文件