Nouvelle déclaration d'incident
No de la demande: 2017-3237
Numéro de référence du titulaire d'homologation: US-BAYERBAH-2017-406598
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: WASHINGTON
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-152
Nom du produit: Advantage II large cat
Autre (préciser)
Spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Inconnu
Inconnu
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
Caller was difficult to follow. She reported that three of her cats died that previously used the medication but was not calling to report a fatality. She was wondering if the product had an expiration date. She also was confused and that we were also 1-800 Pet Meds and was trying to ask about ordering. Reason for use of drug: Adverse Reaction-Other Reproductive status: Unknown Place of purchase: Other Animal to animal exposure?: Unknown Misuse: NA/Unknown Case status: Closed No more information is expected. The case is closed. No known necropsy was performed. Call Review: Both large and small cat products were found in a drawer from previous pets. She did not clari fy which of the products were used on each of the cats that had died.
Mort
N - Unlikely Death is not anticipated with appropriate product use as inconsistent with the pharmaco-toxicological product 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. Moreover, the information regarding the death of the cat was casually provided during an inquiry, the caller contacted Bayer Animal Health to inquire about expiration date of the used products and not to report death. Overall, even though some information is not provided (animal details, medical history, health status, time to onset and necropsy reports), considering the safety profile of the product, a product relation is unlikely.