Nouvelle déclaration d'incident
No de la demande: 2016-0698
Numéro de référence du titulaire d'homologation: 2015KP333
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L4W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: advantage (unknown)
Liquide
Oui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Autre
Cat / Chat
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
<=30 min / <=30 min
Système
>3 days <=1 wk / >3 jours <=1 sem
Inconnu
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 5 minutes post administration, the cat licked the application site and had a seizure and a change in behavior. The cat was taken to a veterinary clinic and received unspecified treatments. Approximately 1 week post administration, the cat recovered. On an unknown date in approximately 2014, the 18 year old cat passed away. It is unknown if a necropsy was performed. Limited information was provied by the reporting party as she was not calling to report the incident but had questions about product efficacy. No further information expected. Case closed.
Mort
Serious nervous system disorders such as seizures are not anticipated with topical use of Advantage as not consistent with its pharmacological/toxicological product profile. The application procedure and associated stress may trigger seizures in animals with a respective disposition. But that may occur with any other product. Due to oral exposure of the product, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But seizures are not expected. Other reported behavioral sign may have occurred as consequence of seizures. Time to onset is short. However, in case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (14 years). Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. Animal involved in this case may have died due to advanced age (18 years). Time to onset for death is also not suggestive of product relation either. Reason for initial call not to report the incident but to ask questions about product efficacy. Even though no necropsy was performed, sufficient information exists to ruled out product relation completely. Overall, a product relation considered as unlikely.