Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
orbifloxacin, Mometasone furoate, posaconazole
Intervet International BV
QS02CA91
orbifloxacin, mometasone furoate, posaconazole
Dogs
Otologicals
Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis.
Revision: 9
Authorised
2008-06-23
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET FOR: POSATEX EAR DROPS SUSPENSION 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: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Manufacturer for the batch release: Vet Pharma Friesoythe Sedelsberger Straße 2 26169 Friesoythe Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Posatex, ear drops suspension for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Orbifloxacin 8.5 mg/mL Mometasone furoate (as monohydrate) 0.9 mg/mL Posaconazole 0.9 mg/mL 4. INDICATIONS Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular _Malassezia _ _pachydermatis. _ 5. CONTRAINDICATIONS Do not use if the eardrum is perforated. Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones. 6. ADVERSE REACTIONS Mild erythematous lesions have been observed. The use of auricular preparations may be associated with hearing impairment, usually temporary, and primarily in geriatric dogs. 19 If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Dogs 8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Auricular use. One drop contains 267 µg orbifloxacin, 27 µg mometasone furoate and 27 µg posaconazole. Shake well before use. With dogs weighing less than 2 kg, apply 2 drops to the ear once a day. With dogs weighing 2-15 kg, apply 4 drops to the ear once a day. With dogs weighing 15 kg or more, apply 8 drops to the ear once a day. Treatment should continue for 7 consecutive days. 9. ADVICE ON CORRECT ADMINISTRATION The external ear canal should be meticulously cl Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Posatex ear drops suspension for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Orbifloxacin 8.5 mg/mL Mometasone furoate (as monohydrate) 0.9 mg/mL Posaconazole 0.9 mg/mL EXCIPIENTS: Paraffin liquid For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops suspension White to off-white viscous suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular _Malassezia _ _pachydermatis._ 4.3 CONTRAINDICATIONS Do not use if the eardrum is perforated. Do not use in case of hypersensitivity to the active substances, to any of the ingredients, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones. Do not use (during the whole or part of the pregnancy). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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 3 Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. It is prudent to reserve fluoroquinolones for the treatment of clinical conditions, which have responded poorly or are expected to respond poorly to other classes of antibiotics. Use of the product should be based on susceptibility testing of isolated bacteria, and/or other appropriate diagnostic tests. _ _ Quinolone class veterinary medicinal products have been associated with cartilage erosions in weight- bearing joints and other forms of arthropathy in immature animals of various species. Therefore do not use in animals less than 4 months of age. Prolonged and intensive use of topical corticosteroids preparation is known to t Preberite celoten dokument