Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)
Norbrook Laboratories Limited
QS02CA06
MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)
10.0/3.0/1
Ear Drops Suspension
POM
Canine
Dexamethasone and antiinfectives
Antibacterial
Authorised
2015-07-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT NorOtic Ear Drops, Suspension for Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCES: Marbofloxacin........................................................... 3.0 mg Clotrimazole............................................................ 10.0 mg Dexamethasone......................................................... 0.9 mg (equivalent to dexamethasone acetate..................... 1.0 mg) EXCIPIENTS Propyl gallate (E310)……………………………………… 1.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear drops, suspension Homogenous beige to yellow oily suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of otitis externa of both bacterial and fungal origin respectively due to bacteria sensitive to marbofloxacin, and fungi especially_ Malassezia pachydermatis_ sensitive to clotrimazole. The product should be used based on susceptibility testing of isolated bacteria. 4.3 CONTRAINDICATIONS Do not use in dogs suffering from perforation of the tympanic membrane. Do not use in case of hypersensitivity to the active substances or to any of the excipients. See section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The external ear canal should be meticulously cleaned and dried before treatment. Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lue koko asiakirja