Nouvelle déclaration d'incident
No de la demande: 2017-3256
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2015-US0053356
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: CALIFORNIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-152
Nom du produit: Advantage II large cat
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Medium Hair
1
Homme
6
6.5
kg
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
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 the frequency of reapplication of the product and not to report the death of the patient. On an unknown date in approximately Sep2015, a 6 year old, 12 pound, neutered, male, Domestic Mediumhair feline, in fair condition, with fleas, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On approximately 06Oct2015, the cat passed away. A necropsy was not performed. No further information expected. Case closed.
Mort
N - Unlikely The information regarding the death of the cat was casually provided during an inquiry as the reason for the initial call was to discuss the frequency of reapplication of the product and not to report the death of the patient. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Exact time to onset is unknown but seems long (at least 6 days). Overall, even though, some information is missing (e.g. necropsy), considering known safety profile of the product, product relation is unlikely.