Nouvelle déclaration d'incident
No de la demande: 2019-5077
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0045981 (Report 588597)
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: NEW YORK
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage II (cat-unspecified)
Autre (préciser)
spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
In approximately Aug-2013, post administration, the cat exhibited seizures and hypersalivation. The feline was evaluated by a veterinarian and unknown diagnostics and treatments were provided. On an unknown date in approximately Aug-2013, the seizures and hypersalivation resolved. On an unknown date in approximately 2017, the cat died. No necropsy was performed.
Mort
Serious nervous system disorders such as seizures are not anticipated with topical administration of product. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But seizures are not expected. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Hypersalivation likely associated with seizures. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Time to onset is unknown for initial reported seizures and long for death. Considering low level of information (e.g. animal details, health status, medical history and necropsy details are unknown), a relation to this case is considered as unassessable.