Land: Frankrike
Språk: engelsk
Kilde: HMA (Heads of Medicines Agencies)
betamethasone 0 , gentamicin 0
Schering-Plough Animal Health
QS02CA9
Ear ointment
betamethasone and antiinfectives
2011-11-23
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT OTOMAX EAR DROPS SUSPENSION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH ML OF THE VETERINARY MEDICINAL PRODUCT CONTAINS: ACTIVE SUBSTANCE: Gentamicin base (as sulfate) 2640 IU Betamethasone (as valerate) 0.88 mg Clotrimazole 8.80 mg EXCIPIENT(S): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops suspension. A smooth, uniform, white to off-white viscous suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dog: Treatment of acute external otitis. Also for treatment of short term exacerbation of the acute signs of chronic external otitis of bacterial and fungal origin due to bacteria susceptible to gentamicin, such as Staphylococcus intermedius, and fungi susceptible to clotrimazole, in particular _Malassezia pachydermatis. _ 4.3 CONTRAINDICATIONS Do not administer to dogs with a perforated ear drum. Do not administer in the case of known hypersensitivity to any of the ingredients See also section 4.7. See also section 4.8 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Contact with eyes should be avoided. In case of accidental contact, flush with plenty water. Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Before Les hele dokumentet