Nouvelle déclaration d'incident
No de la demande: 2019-5917
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0052324 (Report 595283)
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: VIRGINIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Labrador Retriever
1
Homme
7
42.63
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 05-Aug-2019, the dog exhibited a seizure. On an unspecified date in approximately 2019, the dog exhibited approximately four more seizures. On 01-Sep-2019, the dog exhibited a seizure for approximately 30 minutes and the dog died. The dog was not evaluated by a veterinarian and no treatments were performed. No necropsy was performed.
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. Time to onset is short. Later reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. In this case death may be the consequence of alternative causes of seizures. Time to onset is long. Considering all aspects, a product involvement is unassessable.