Nouvelle déclaration d'incident
No de la demande: 2020-5485
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2020-US0055123 (Report 672757)
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: ARKANSAS
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar Large Dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Boxer (German Boxer)
1
Homme
7
34.019
kg
Cutanée
>15 min <=2 hrs / >15 min <=2 h
>30 min <=2 hrs / >30 min <=2 h
Système
Unknown / Inconnu
Inconnu
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately one hour post administration, the dog exhibited a seizure, lateral recumbency, lethargy, and was minimally responsive. Approximately two hours post administration, the dog died.
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. Further reported lateral recumbency, minimal response and lethargy are not expected following product application. However, in this case, they are likely associated with reported seizures. Later reported death is not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Other unrelated causes must be considered in this case. Considering low level of information (e.g. animal health status and necropsy details are unknown), a relation to this case is considered unassessable.