Nouvelle déclaration d'incident
No de la demande: 2021-2286
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2021-US0005931 (Report 688082)
Nom du titulaire (nom légal complet, aucune abbréviation): Elanco
Adresse: 150 Research Lane, Suite 120
Ville: Guelph
État: ON
Pays: Canada
Code postal /Zip: N1G 4T2
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. 11556-155
Nom du produit: Seresto collar Cat
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date post administration, in approximately 2020, the feline exhibited seizures. On an unknown date post seizures, in approximately 2020, the feline passed away. It is unknown if a necropsy was performed
Mort
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorders such as seizure after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Further, fatal outcome of death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Overdose of 5 collars around the neck of adult cats for an 8 months period and in 10 week old kittens for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Many information is missing in this case e.g. animal details, time to onset, death details and necropsy. Considering limited information provided, the product involvement is considered as unassessable.