TERBINAFINE (UNII: G7RIW8S0XP) (TERBINAFINE - UNII:G7RIW8S0XP) įlorfenicol, terbinafine, mometasone furoate solutionįLORFENICOL (UNII: 9J97307Y1H) (FLORFENICOL - UNII:9J97307Y1H) To report suspected adverse drug events and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Elanco at 1-800-422- 9874.įor additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or. The adverse events reported following extra-label use in cats are presented below in decreasing order of reporting frequency:Ītaxia, anorexia, internal ear disorder (head tilt and vestibular), Horner's syndrome (third eyelid prolapse and miosis), nystagmus, lethargy, anisocoria, head shake, emesis, tympanic rupture, and deafness. In dogs, the adverse events reported are presented below in decreasing order of reporting frequency:Įar discharge, head shaking, ataxia, internal ear disorder (head tilt and vestibular), deafness, emesis, nystagmus, pinnal irritation and ear pain, keratoconjunctivitis sicca, vocalization, corneal ulcer, cranial nerve disorder (facial paralysis), tympanic membrane rupture.ĬLARO is not approved for use in cats. Exposure occurred when the dog shook its head after application of CLARO. In humans, accidental exposure leading to corneal ulcers and other ocular injuries such as eye irritation and redness have been reported. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. Not all adverse events are reported to FDA/CVM.
The following adverse events are based on post-approval adverse drug experience reporting for CLARO. The safe use of CLARO in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated. Use with caution in dogs with impaired hepatic function (see Animal Safety). Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see Animal Safety). Signs of internal ear disease such as head tilt, vestibular signs, ataxia, nystagmus, facial paralysis, and keratoconjunctivitis sicca have been reported (see Post-Approval Experience) with the use of CLARO. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. The integrity of the tympanic membrane should be confirmed before administering the product.ĬLARO has been associated with rupture of the tympanic membrane. Proper patient selection is important when considering the benefits and risks of using CLARO. Reducing the potential for splatter of product will help prevent accidental eye exposure in people and dogs and help to prevent ocular injury (see Dosage and Administration, Human Warnings, Post-Approval Experience). Wear eye protection when administering CLARO and restrain the dog to minimize post application head shaking. Do not use in cats (see Post-Approval Experience).
While holding the dropperette in an upright position, remove the cap from the dropperette.Remove single dose dropperette from the package.Verify the tympanic membrane is intact prior to administration.Clean and dry the external ear canal before administering the product.(see Contraindications, Precautions, Post-Approval Experience).Īdminister one dose (1 dropperette) per affected ear. Verify the tympanic membrane is intact prior to administration. Persons near the dog during administration should also take steps to avoid ocular exposure. Splatter may occur if the dog shakes its head following administration. (see Human Warnings, Precautions, Post-Approval Experience). Wear eye protection when administering CLARO. CLARO should be administered by veterinary personnel.
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