Nouvelle déclaration d'incident
No de la demande: 2018-5516
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0052533 (Report 518845)
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: GEORGIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-151
Nom du produit: advantageII small cat
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-152
Nom du produit: advantageII large cat
Liquide
Oui
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
Persisted until death
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately one year post application of advantageII small cat, in Jun-2018, the cat developed generalized pruritus. On approximately 4 days post application of advantageII large cat, 30-Aug-2018, the cat died. No known necropsy was performed.
Mort
Advantage Plus Spot-on 0.4 ml (40 mg Imi / 2 mg Pyri) Cat <= 4 kg : N - Unlikely Generalized pruritus or 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 exceptionally long for pruritus. Death reported after reapplication of the different pipette size of the product. 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 over dosage tolerated by cats without showing any side effect. Moreover, the initial call to Bayer Animal Health was to discuss product use on another cat and not to report the death in this event. Time to onset is long. Overall, a product relation is unlikely. Advantage Plus Spot-on 0.8 ml (80 mg Imi / 4 mg Pyri) Cat > 4 kg : N - Unlikely Pruritus was reported on previous product application before a year hence not related to the product. Death reported after reapplication of the different pipette size of the product. 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 over dosage tolerated by cats without showing any side effect. Moreover, the initial call to Bayer Animal Health was to discuss product use on another cat and not to report the death in this event. Time to onset is long. Overall, a product relation is unlikely.