Nouvelle déclaration d'incident
No de la demande: 2021-3786
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2021-US0027196 (Report 709273)
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. 11556-155
Nom du produit: Seresto small dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Yorkshire Terrier
1
Femme
10
2.223
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On unspecified date post application, in 2020, the dog exhibited intermittent seizures. The canine was examined by a veterinarian and was within normal limits. No treatments were performed. On an unspecified date post application in 2020, the dog died. No necropsy was performed. No more information is expected and this case is closed.
Mort
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures were reported in connection with product use in dogs. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause 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. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Further, death is also not expected following appropriate topical product application as inconsistent with products pharmacological profile. Other causes must be considered geriatric dog. Considering limited information available (unknown time to onset, health status, medical history), a product involvement is considered unassessable.