Nouvelle déclaration d'incident
No de la demande: 2017-4034
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0012469
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: LOUISIANA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: advantage II pipette size unknown
Autre (préciser)
Spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Himalayan
1
Femme
16
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 unspecified date in 2016, a 16 year old, neutered, female, Himalayan feline, of unknown weight, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date in 2016, post application, the cat died. A necropsy was not 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. Case is closed. Note: Previous exposure was well tolerated by animal.
Mort
N - Unlikely Death is inconsistent with pharmaco-toxicological product profile and experience. 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. Involved animal is geriatric. Previous exposure was well tolerated by animal. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Even though some information (time to onset and necropsy results) missing, considering known product safety profile and unexpected fatal outcome, a product involvement is deemed to be unlikely.