Patient leaflet - Posatex
B. PACKAGE LEAFLET
PACKAGE LEAFLET FOR:
Posatex ear drops suspension dogs
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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
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Posatex, ear drops suspension for dogs
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3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Orbifloxacin
8.5 mg/mL
0.9 mg/mL
0.9 mg/mL
Mometasone furoate (as monohydrate)
Posaconazole
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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.
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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.
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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.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dogs
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8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Auricular use.
One drop contains 267 ^g orbifloxacin, 27 ^g mometasone furoate and 27 ^g 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.
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9. ADVICE ON CORRECT ADMINISTRATION
The external ear canal should be meticulously cleaned and dried before treatment. Excess hair around the treatment area should be cut.
After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate the lower part of the ear canal.
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10. WITHDRAWAL PERIOD
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use after the expiry date, which is stated on the label.
Shelf-life after first opening the bottle:
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8.8 mL: Once opened use within 7 days.
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17. 5 and 35.1 mL: Once opened use within 28 days.
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12. SPECIAL WARNINGS
Special warnings for each target species:
Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.
Special precautions for use in animals :
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 drugs 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 trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed healing.
Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
Wash hands carefully after applying the veterinary medicinal product. Avoid skin contact. In case of accidental exposure, rinse the affected area with copious quantities of water.
Pregnancy :
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Do not use during the whole or part of the pregnancy.
Lactation :
The use of the veterinary medicinal product is not recommended during lactation.
Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of orbifloxacin. Fluoroquinolones are known to cross the placenta and to be distributed into milk.
Fertility :
Studies to determine the effect of orbifloxacin on fertility in dogs have not been conducted.
Do not use in breeding animals.
Interaction with other medicinal products and other forms of interaction: No data available.
Overdose (symptoms, emergency procedures, antidotes) :
Administration of the recommended dose (4 drops per ear) 5 times daily for 21 consecutive days to dogs weighing 7.6 to 11.4 kg bodyweight caused a slight decrease in serum cortisol response after adrenocorticotropic hormone (ACTH) administration in an ACTH stimulation test. Discontinuation of treatment will result in a complete return to normal adrenal response.
Incompatibilities :
None known. Studies with a range of proprietary ear cleaners have shown no chemical incompatibilities.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION