Nouvelle déclaration d'incident
No de la demande: 2019-2324
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0014474 (Report 556357)
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: OHIO
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
Bulldog
1
Femme
6
30.617
kg
Cutanée
>24 hrs <=3 days / >24 h <=3 jours
>24 hrs <=3 days / >24 h <=3 jours
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
15Apr2019, the dog had a seizure and passed away. No necropsy was performed.
Mort
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorder such as seizure 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. 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. Reported fatal outcome of death is also 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 not even seizures. Merely gastrointestinal signs may occur. Further, 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. Considering the product profile, product involvement is deemed unlikely, however due to short time to onset a product relation is considered as unassessable.