Nouvelle déclaration d'incident
No de la demande: 2021-2324
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2021-US0006958 (Report 689251)
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: CALIFORNIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar Cat
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Shorthair
1
Femme
11
4.536
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 01-Feb-2021, the cat exhibited application site scabs. On 08-Mar-2021, the cat came in from outside in the morning and exhibited 1 seizure that resolved approximately 5 minutes post onset. Approximately 12 hours post onset of the seizure, the cat was found dead in the home. No necropsy was performed. The cat was not examined by a veterinarian and no known treatments were performed.
Mort
O - Unclassifiable/unassessable The reported application site scab may occur in sensitive animals after product application. It is usually mild and transient. Unclear if correct fit of collar was checked periodically as recommended in the product information and thus development of signs not noticed. 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. Overdose of 5 collars around the neck of adult cats for an 8 months period and in 10 week old kittens 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. Later reported death is not expected following appropriate topical product application as inconsistent with products 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. Outcome may be consequence of seizures in this geriatric cat. Considering limited information regarding health status, no Veterinary diagnosis and necropsy details, relation to case is unassessable.