Nouvelle déclaration d'incident
No de la demande: 2018-5628
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0050888 (Report 516957)
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: PENNSYLVANIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage II pipette size unknown
Autre (préciser)
Spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
>3 days <=1 wk / >3 jours <=1 sem
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in approximately 2016, the cat was lethargic, disoriented and had generalized pruritus. Approximately 4 days post application, in approximately 2016, the clinical signs resolved without medical intervention. On an unknown date post application, in approximately 2016, the cat died. No known necropsy was performed. No more information is expected. This case is closed. The initial communication with Bayer Animal Health was to discuss product use on additional animals and not to report the death of this feline.
Mort
O - Unclassifiable/unassessable Reported lethargy and disorientation are unspecific and may have various other causes. Pruritus on other than the application site is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Time to onset is unknown, however less than 4 days. Further reported death is inconsistent with pharmaco-toxicological product profile and experience. 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 initial communication with Bayer Animal Health was to discuss product use on additional animals and not to report the death of this feline. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 2 years). Time to onset is too long for death. Other causes are likely. Overall, a product relation is unassessable.