Nouvelle déclaration d'incident
No de la demande: 2017-5042
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0038674
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: KENTUCKY
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-152
Nom du produit: Advantage II Large cat
Autre (préciser)
spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Bengal
1
Homme
10
4.99
kg
Cutanée
Unknown / Inconnu
>30 min <=2 hrs / >30 min <=2 h
Système
<=30 min / <=30 min
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in 2013, a 10 year old, 11 pound, neutered, male, Bengal feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. Approximately 1 hour post application, the cat had a seizure for approximately 1 minute and resolved. On an unknown date in 2013, post application, the cat died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss use of the product not to report the death in this event. No more information is expected. This case is closed. Note: Previous exposure was well tolerated by cat.
Mort
N - Unlikely Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. 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. Further, previous exposure was well tolerated by cat. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. 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. The cat died of old age. Animal owner does not believe in product connection as the case was reported long time (4 years) after the event and the reason for the initial call was to discuss use of the product not to report the death in this event. Time to onset is short for seizure but unknown for death. Considering known safety product profile, a product involvement is unlikely.