Nouvelle déclaration d'incident
No de la demande: 2019-5934
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0056706 (Report 599452)
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: MISSOURI
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar Large
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Mastiff
1
Homme
3
40.823
kg
Cutanée
>15 min <=2 hrs / >15 min <=2 h
>30 min <=2 hrs / >30 min <=2 h
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 1 hour post application, the dog exhibited hypersalivation and a seizure. Approximately 1 minute post onset, the dog died. No known necropsy was performed. No further information is expected. The case is closed.
Mort
B - Possible The product is not anticipated to cause serious neurological disorder 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 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. Hypersalivation is unspecific and in this case likely associated with reported seizures. 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. However, considering extremely short time to onset, hypersalivation, seizure and death may be signs of an anaphylactic shock in this case. Death due to anaphylaxis usually occurs as a result of respiratory obstruction or cardiovascular collapse, or both. Despite hypersalivation here no further signs of anaphylaxis reported which would have occurred in close proximity to the collar application as well. No necropsy has been performed. In the end, as time to onset is extremely short, considering all aspects, a product relation can not completely be excluded and is thus deemed possible.