Nouvelle déclaration d'incident
No de la demande: 2016-3602
Numéro de référence du titulaire d'homologation: 2016KP019
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: UNKNOWN
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
Liquide
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Domestic Shorthair
1
Femme
5.5
14
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date post application, in 2012, the cat had a weight loss of 6 pounds. On an unknown date post application, in 2012, the cat was examined by a veterinarian, diagnosed with a liver tumor, administered an unknown anesthesia and the veterinarian performed an ultrasound guided needle biopsy of the liver tumor. The cat was released that evening. On an unknown date post diagnosis, in 2012, the cat returned to the veterinarian and was diagnosed with renal failure. On an unknown date in 2012, the cat died at home. No necropsy was performed. No more information expected. This case is closed. Note: Previous application is well tolerated by the cat.
Mort
Weight loss is not expected after product application as inconsistent with pharmaco toxicological product profile. In this case it may related to later diagnosed liver tumor and renal failure. Liver tumor, renal failure and subsequent death are also not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported. 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. Cat likely died due to underlying medical condition of liver tumor and renal failure. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 4 years). Additionally, previous application is well tolerated by the cat. Finally, even though some information (e.g. time to onset and necropsy results) missing, considering known product profile and unexpected fetal outcome, a product involvement is deemed to be unlikely.