Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE ACETATE PH. EUR. (EQUIVALENT TO DEXAMETHASONE)
Krka, d.d., Novo mesto
QS02CA06
MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE ACETATE PH. EUR. (EQUIVALENT TO DEXAMETHASONE)
3mg/10mg/1mg
Ear Drops Suspension
POM
Canine
Dexamethasone and antiinfectives
Authorised
2017-01-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Otoxolan ear drops, suspension for dogs Marbofloxacin/Clotrimazole/Dexamethasone acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of suspension contains: ACTIVE SUBSTANCES: Marbofloxacin 3.0 mg Clotrimazole 10.0 mg Dexamethasone acetate 1.0 mg (equivalent to Dexamethasone 0.9 mg) EXCIPIENTS: Propyl gallate (E310) 1.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear drops, suspension. Off yellow, opalescent, viscous 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. 4.3 CONTRAINDICATIONS Do not use in dogs suffering from perforation of the tympanic membrane. Do not use in cases of hypersensitivity to the active substances, to other azole antifungal agents or to any other fluoroquinolones or to any of the excipients. Do not administer to pregnant or lactating bitches. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _3 Διαβάστε το πλήρες έγγραφο