Nouvelle déclaration d'incident
No de la demande: 2015-6125
Numéro de référence du titulaire d'homologation: 2015KP242
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
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
12
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
>3 days <=1 wk / >3 jours <=1 sem
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 03Jun2015, the pruritus improved. On approximately 8Jun2015, the pruritus worsened. On approximately 12Jun2015, the cat was lethargic, vocalizing and felt feverish. The cat was take to a veterinarian and administered 2 unknown injections. On approximately 13Jun2015, the lethargy worsened and the cat had difficulty breathing. The cat was taken to an emergency veterinary clinic, radiographs were performed and showed pulmonary changes, the cat had a temperature of 106 degrees Fahrenheit, and the cat died at the clinic. No necropsy was performed. No further information is expected; this case is closed. Note from LDSM: The veterinarian suspected pneumonia or feline heart worm disease. No quality issues were noted upon product investigation.
Mort
Location of pruritus is unknown but generalized pruritus is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Pruritus was pre existing which improved initially and then worsened which is not expected either. Lethargy and vocalization are unspecific signs and may have various other causes. Fever, difficulty in breathing and radiograph finding of pulmonary changes are not expected as not inline with pharmaco toxicological product profile. Similarly, death is inconsistent with pharmaco-toxicological product profile and experience. 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. Time to onset long. The veterinarian suspected pneumonia or feline heart worm disease. Finally, even though necropsy was not performed, considering the most prominent sign death, no plausible connection can be made to the product and a product relation is deemed to be unlikely.