Nouvelle déclaration d'incident
No de la demande: 2019-2295
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0011293 (Report 553426)
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
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
Non
Propriétaire de l'animal
Dog / Chien
Chihuahua X Beagle crossbred dog
1
Femme
11
8.618
kg
Cutanée
>3 days <=1 wk / >3 jours <=1 sem
>3 days <=1 wk / >3 jours <=1 sem
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 05-Aug-2018, the dog exhibited a seizure and died. It is not known if the dog was evaluated by a veterinarian, or if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The intent of the call was to inquire about product use in general and not to report this event. Follow up received on 3rd Apr 2019: No more information is expected; this case is closed.
Mort
N - Unlikely 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/convulsions 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. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Outcome was the consequence of alternative cause seizure in this geriatric animal and thus, sufficient information exists to rule out product involvement. Considering long time to onset, a product involvement is unlikely.