Field study: In a controlled, double-masked field safety study, owners administered PROFENDER Topical Solution to 606 cats. Adverse reactions reported by the cat owners included licking/ excessive grooming in 18 cats (3.0%), scratching treatment site in 15 cats (2.5%), salivation in 10 cats (1.7%), lethargy in 10 cats (1.7%), alopecia in 8 cats (1.3%), agitation/nervousness in 7 cats (1.2%), vomiting in 6 cats (1.0%), diarrhea in 3 cats (0.5%), eye irritation in 3 cats (0.5%), respiratory irritation in 1 cat (0.2%) and shaking/tremors in 1 cat (0.2%). All adverse reactions were self-limiting.
Laboratory effectiveness studies: One cat died 10 days after receiving PROFENDER Topical Solution. The necropsy showed chronic active cholangiohepatitis. While the use of the drug did not appear to be the direct cause of death, treatment with the drug cannot be ruled out as a contributing factor (See PRECAUTIONS). One cat treated with a vehicle placebo (formulation minus the active ingredients) showed salivation, gagging, lethargy and a swollen tongue.
Foreign Market Experience: The following adverse events were reported voluntarily during post-approval use of the product in foreign markets: application site reaction (hair loss, dermatitis, pyoderma, edema, and erythema), salivation, pruritus, lethargy, vomiting, diarrhea, dehydration, ataxia, loss of appetite, facial swelling, rear leg paresis, seizures, hyperesthesia, twitching, and death.
Post-Approval Experience: The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are listed in decreasing order of reporting frequency in cats: Application site reaction (hair loss, dermatitis, pyoderma, edema, and erythema), hypersalivation, lethargy/depression, vomiting, ataxia, anorexia, trembling/twitching, diarrhea, mydriasis, fever, hyperactivity/nervousness. In some cases, death has been reported as an outcome of the adverse events listed. For a complete listing of adverse reactions for Profender Topical Solution reported to the CVM see: http://ift.tt/2sSI9OO.
This listing includes Adverse Events reported to CVM for products, such as Profender, that contain the combined active ingredients emodepside and praziquantel. Listings by active ingredient may represent more than one brand name.
To report suspected adverse events and/or obtain a copy of the MSDS or for technical assistance, call Bayer Animal Health at 1-800-633-3796.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://ift.tt/1N0hYJY.
Close PROFENDER (Emodepside/Praziquantel) Solution PROFENDER (Emodepside/Praziquantel) Kit [Bayer HealthCare LLC Animal Health Division]
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