Nouvelle déclaration d'incident
No de la demande: 2021-2539
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2021-US0013505 (Report 694648)
Nom du titulaire (nom légal complet, aucune abbréviation): Elanco
Adresse: 150 Research Lane, Suite 120
Ville: Guelph
État: ON
Pays: Canada
Code postal /Zip: N1G 4T2
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. 11556-155
Nom du produit: Seresto collar cat
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-152
Nom du produit: advantage II large cat
Autre (préciser)
COLLAR and spot-onOui
Autres unités: COLLAR and tube
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Femme
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post collar application, in 2020, the cat had diabetes and died 2 weeks later. Treatments and diagnostics performed are unknown. No necropsy was performed.
Mort
Advantage: O - Unclassifiable/unassessable Diabetes and later reported death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Time to onset for diabetes is unknown and it is long for death. Other causes should be considered. In the end, considering limited information (time to onset, necropsy report and animal health status), case is considered to be unassessable. Seresto: O - Unclassifiable/unassessable Diabetes and death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10-week old kittens and 7- week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Time to onset for diabetes is unknown and it is long for death. Hence, other causes should be considered for this fatal outcome. Considering the product profile, product involvement is deemed rather unlikely, however due to limited information (time to onset, necropsy report and animal health status), case is considered to be unassessable.