Nouvelle déclaration d'incident
No de la demande: 2021-2299
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2021-US0006112 (Report 688175)
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: GEORGIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar Small dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Chihuahua
1
Femme
11
4.082
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 20Feb2021, the dog was anorexic, began to have seizures and died before she could be examined by a veterinarian. No necropsy was performed.
Mort
O - Unclassifiable/unassessable Reported anorexia is unspecific and may have numerous other causes. The product is not anticipated to cause serious neurological disorders such as seizures or death. This signs are not expected 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. Considering low level of information (e.g. animal details, medical history and necropsy report are unknown), a product relation for the case is unassessable.