Nouvelle déclaration d'incident
No de la demande: 2018-0474
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0078510 (Report 464761)
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: PENNSYLVANIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto large dog
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Boxer (German Boxer)
1
Femme
7
27.216
kg
Cutanée
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
Système
Persisted until death
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in Oct 2017, the canine exhibited a behavioral change, difficulty breathing, seizures, foaming at the mouth. The owner performed CPR 3 times and during CPR the canine urinated and defecated, the third attempt at CPR was unsuccessful and the canine died. No known necropsy was performed. Due to the nature of the communication and in order to avoid further strain on the relationship with the reporting party, no further information will be sought. No further information is expected. Case is closed.
Mort
N - Unlikely Reported signs of behavioral change may occur initially after collar application. But time to onset seems too long. Further reported involuntary urination, involuntary defecation, foaming at the mouth, and difficulty breathing are not expected after product application and rather associated with seizure that the dog experienced. However, 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 and were requested by authorities to be content of the EU SPC. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application. 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. Subsequently 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. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Considering the product profile and long time to onset, product involvement is deemed unlikely.