Nouvelle déclaration d'incident
No de la demande: 2017-3271
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2015-US0063232
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
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
Domestic Shorthair
1
Femme
20
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 2012, a 20 year old, neutered, female, Domestic Shorthair feline, in unknown condition, with concomitant hyperthyroidism, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date after product application, in 2012, the cat died. No necropsy was performed. The reporting party did not contact Bayer Animal Health to report the death of the animal but to inquire about product use on another feline within the household. No more information is expected. Case is closed.
Mort
N - Unlikely Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported in close proximity of product application. 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. Moreover the cat was geriatric with concomitant hyperthyroidism which may be the cause for the death of an animal. Moreover in case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. The information regarding the death of the cat was casually provided during an inquiry as the reporting party did not contact Bayer Animal Health to report the death of the animal but to inquire about the product use on another feline within the household. The product was used before without causing any signs. Overall, even though no necropsy was performed considering known safety profile of the product, product relation is considered unlikely.