País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
florfenicol, Terbinafine hydrochloride, Mometasone furoate
Bayer Animal Health GmbH
QS02CA91
florfenicol, terbinafine hydrochloride, mometasone furoate
Dogs
Otologicals, Corticosteroids and antiinfectives in combination
For the treatment of acute canine otitis externa or acute exacerbations of recurrent otitis caused by mixed infections of susceptible strains of bacteria sensitive to florfenicol (Staphylococcus pseudintermedius) and fungi sensitive to terbinafine (Malassezia pachydermatis).
Revision: 2
Authorised
2019-12-10
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: NEPTRA EAR DROPS SOLUTION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Bayer Animal Health GmbH 51368 Leverkusen Germany Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324, 24106 Kiel Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Neptra ear drops solution for dogs florfenicol/terbinafine hydrochloride/mometasone furoate 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS One dose (1 ml) contains 16.7 mg florfenicol, 16.7 mg terbinafine hydrochloride (equivalent to 14.9 mg terbinafine base) and 2.2 mg mometasone furoate. Clear, colourless to yellow, slightly viscous liquid. 4. INDICATION(S) For the treatment of acute canine otitis externa or acute exacerbations of recurrent otitis caused by mixed infections of susceptible strains of bacteria sensitive to florfenicol ( _Staphylococcus _ _pseudintermedius_ ) and fungi sensitive to terbinafine ( _Malassezia pachydermatis_ ). 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances, to other corticosteroids or to any of the excipients. Do not use if the ear drum is perforated. Do not use in dogs with generalised demodicosis. Do not use in pregnant or breeding animals. 6. ADVERSE REACTIONS 18 Vocalisation, head shaking and application site pain shortly after product application have been reported very rarely in spontaneous (pharmacovigilance) reports. Ataxia, internal ear disorder, nystagmus, emesis, application site erythema, hyperactivity, anorexia and application site inflammation and eye disorders (such as eye irritation, blepharospasm, conjunctivitis, corneal ulcer, keratoconjunctivitis sicca) were reported very rarely in spontaneous (pharmacovigilance) reports. . The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treate Leia o documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Neptra ear drops solution for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1 ml) contains: ACTIVE SUBSTANCES: Florfenicol: 16.7 mg Terbinafine hydrochloride: 16.7 mg, equivalent to terbinafine base: 14.9 mg Mometasone furoate: 2.2 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops, solution. Clear, colourless to yellow, slightly viscous liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of acute canine otitis externa or acute exacerbations of recurrent otitis caused by mixed infections of susceptible strains of bacteria sensitive to florfenicol ( _Staphylococcus _ _pseudintermedius_ ) and fungi sensitive to terbinafine ( _Malassezia pachydermatis_ ). 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances, to other corticosteroids or to any of the excipients. Do not use if the ear drum is perforated. Do not use in dogs with generalised demodicosis. Do not use in pregnant or breeding animals. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Bacterial and fungal otitis is often secondary to other conditions. In animals with a history of recurrent otitis externa, the underlying causes of the condition such as allergy or anatomical conformation of the ear must be addressed in order to avoid ineffective treatment with a veterinary medicinal product. In cases of parasitic otitis, an appropriate acaricidal treatment should be implemented. Ears must be cleaned before administration of the product. It is recommended not to repeat ear cleaning until 28 days after administration of the product. In clinical trials, only saline was used for ear cleaning before treatment initiation with the veterinary medicinal product. 3 This combination is intended for the treatment of acute otitis when mixed infections caused by _Staphylococcus pseudintermedius _ susceptible to florfenicol a Leia o documento completo