Nouvelle déclaration d'incident
No de la demande: 2015-4043
Numéro de référence du titulaire d'homologation: 2015KP070
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Blvd. East
Ville: Mississauga
État: ON
Pays: Canada
Code postal /Zip: L4W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage (unknown size)
Liquide
Oui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Autre
Cat / Chat
Domestic Shorthair
1
Homme
12
19
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
<=30 min / <=30 min
Système
>30 min <=2 hrs / >30 min <=2 h
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Immediately post application, the cat exhibited hypersalivation and agitation. Approximately 1 hour post application, the signs resolved. Approximately 1 day post application, the cat exhibited application site alopecia.
Mort
At an unspecified time post application, in 2009, the cat died of unknown causes. No treatments or diagnostics were performed. No necropsy was performed. The owner initially called to inquire about another Bayer Animal Health product and not to report the death of this pet. No more information is expected. Case is closed. Hypersalivation after suspected ingestion of product. Sign consistent with a distaste reaction. Additional reported agitation may be a behavioural response to the product sensation or to the product smell. Application site alopecia may be a dermal reaction at the application site in a particular sensitive animal. Time to onset consistent for these initial signs. However, death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported either. 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 in case of suspected product involvement, adverse event would have been reported in close proximity and not long time (6 years) after. Exact time to onset of death is unknown but seems exceptionally long. Moreover, the reason for the initial call was to inquire about another Bayer Animal Health product and was not to report the death of this cat. Further, the patient in consideration was a geriatric animal. Finally, even though some information (e.g. necropsy results) was missing, considering the most prominent sign death which characterizes this case, no plausible connection can be made to the product and a product relation is deemed to be unlikely.