Nouvelle déclaration d'incident
No de la demande: 2020-5403
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2020-US0035733 (Report 652454)
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: TENNESSEE
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Golden Retriever
1
Femme
9
34.473
kg
Cutanée
>24 hrs <=3 days / >24 h <=3 jours
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 17-Jul-2020, the dog exhibited multiple seizures. On 18-Jul-2020, the collar was removed by the animal owner. Approximately 3 hours post removal, the dog exhibited one seizure that resolved approximately 5 minutes post onset. The dog was not evaluated by a veterinarian, no treatments were performed, and the seizures continued. Note: Product used : Seresto collar large dog. Follow-up information received on 30th July 2020: On an unspecified date post removal, in Jul 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. No oral product exposure reported. 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, later reported death is not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Moreover, death may be associated with reported multiple seizures. Death was observed post collar removal. No necropsy was performed. Time to onset is short for seizures but unknown for death. Considering all aspects, product involvement is unassessable. SLEE