מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
TRIAMCINOLONE ACETONIDE, SALICYLIC ACID
Le Vet Beheer B.V.
QD07XB02
TRIAMCINOLONE ACETONIDE, SALICYLIC ACID
2.0/20.0
Ear Drops Solution
POM
Canine, Feline
Triamcinolone
Corticosteroid
Authorised
2017-03-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Recicort 1.77 mg/ml + 17.7 mg/ml ear drops, solution for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCES: Triamcinolone acetonide 1.77 mg Salicylic acid 17.7 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear drops, solution. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Otitis externa. Symptomatic treatment of seborrhoeic dermatitis of the auricle. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to corticosteroids, salicylic acid or to any of the excipients. Do not use in animals with perforated tympanic membrane, as the product may be ototoxic. Do not use in dogs with demodicosis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES For an effective treatment of otitis externa it is essential that the ear canal is meticulously cleaned and dried before first treatment to remove cerumen and/or exudate. Excess hair around the treatment area should be clipped if necessary. For an effective treatment of seborrhoeic dermatitis existing scale and or exfoliative debris should be removed. Hair surrounding or covering the lesions may need to be clipped to enable the veterinary medicinal product to reach the affected skin. Otitis externa and seborrhoeic dermatitis may be primary disorders, but can also occur as a result of underlying disorders or disease processes (e.g. allergic disorders, endocrine disorders, neoplasia). Furthermore, infections (bacterial, parasitic or fungal) commonly occur concurrently with seborrhoeic dermatitis or may complicate cases of otitis externa. Therefore it is essential to identify any underlying disease process and initiate specific treatment if considered necessary. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ קרא את המסמך השלם