Nouvelle déclaration d'incident
No de la demande: 2017-3255
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2015-US0053355
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
Non
Propriétaire de l'animal
Cat / Chat
Other (Cat)
1
Femme
5
4.082
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 Aug2015, a 5 year old, 9 pound, neutered, female, Himalayan feline, in fair condition, with fleas, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. This was an off label use of the product as it is considered an overdose for this feline. On approximately 22Sep2015, the cat passed away. A necropsy was not performed. No further information expected. Case closed.
Mort
N - Unlikely Death 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. Animal involved in this case was in fair condition. The initial call to Bayer Animal Health was to discuss the frequency of reapplication of the product and not to report the death of the patient. Time to onset is also not suggestive of product relation either. Hence even though no necropsy was performed, sufficient information exists to ruled out product relation completely and product involvement is considered as unlikely