Nouvelle déclaration d'incident
No de la demande: 2018-5512
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0051765 (Report 517781)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: MICHIGAN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Cat
Autre (préciser)
COLLAROui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Longhair
1
Homme
7
4.99
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 21-Aug-2018, the cat developed seizures and application site bleeding skin. Approximately 10 minutes post-onset of the clinical signs, the cat passed away. The collar was removed.
Mort
O - Unclassifiable/unassessable Transient mild application site disorders may occur in sensitive animals after product application but the described application site bleeding is not typically seen with product use. Scratching/self-trauma may have contributed to sign. 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 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 and were requested by authorities to be content of the EU SPC. 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. 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 failure, 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. Oral exposure to the collar is not expected to cause serious signs either. Death was likely the consequence of seizure activity and pre-existing heart condition. Time to onset is long. Overall product involvement is considered unassessable.