Nouvelle déclaration d'incident
No de la demande: 2017-3234
Numéro de référence du titulaire d'homologation: US-BAYERBAH-2017-405843
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: FLORIDA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-151
Nom du produit: advantage II small cat
Autre (préciser)
Spot-on solutionOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Homme
18
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
2016-06-06 12:54:34 by Z, A : Call notes:The owner did mention a previous cat who did have a flea allergies who has since died at 18 yrs old. The animal was evaluated at the veterinarian at an unknown time, and the animal was taken home where he died. She had used the product on this animal and I was unable to determine when she placed it before the cat died, or even if she placed the product. No known necropsy was performed. Event Narrative: On an unknown date in 2016, an 18 year old, male feline, who had concomitant flea allergies, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unknown date in 2016, the cat was evaluated by the veterinarian, then died at home. No k nown necropsy was performed. Reason for use of drug: Adverse Reaction-Other Reproductive status: Unknown Case status: Closed Concomitant medications: UNK No more information is expected. The case is closed [Contact categorisation: Owner / Producer / Employee]
Mort
N - Unlikely Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. No signs of allergic/anaphylactic reaction reported. 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. Further, animal involved in this case was geriatric which may be the likely cause of death reported. Finally even though some information is not available (animal details, health condition, time to onset and necropsy report), considering the known product profile sufficient information exists to rule out product relation completely. Considering all aspects, a product involvement is unlikely.