Nouvelle déclaration d'incident
No de la demande: 2018-0453
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0077186 (Report 463264)
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
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
German Shepherd Dog
1
Femme
3
26.036
kg
Cutanée
>3 days <=1 wk / >3 jours <=1 sem
>24 hrs <=3 days / >24 h <=3 jours
Système
>24 hrs <=3 days / >24 h <=3 jours
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 09 Dec 2017, the dog's rear leg was observed to be moving abnormally and had a seizure, which resolved in approximately 5 minutes. On 10 Dec 2017, the dog was foaming at the mouth and coughing. On 11 Dec 2017, the dog was found deceased in the morning. A gross necropsy did not reveal any abnormalities, however the brain was not visualized and the heart was not evaluated. Follow up received on 28th Dec 2017: On 28-Dec-2017, the results of the histopathology report did not reveal any abnormalities or cause of death. A toxicology screen was negative as well and the heart was still being evaluated. Comments from pathologist: There are no significant changes, the congestion in various organs is likely related to agonal changes. The interlobular and periarterioloar hemorrhage are also likely agonal changes. A cause of death cannot be determined from the tissues submitted. The tissues did not include brain (history of seizures) or myocardium (acute, unexpected death). Follow up received on 09th Jan 2018: Comments from pathologist: There are no significant changes, the congestion in various organs is likely related to agonal changes. The interlobular and periarterioloar hemorrhage are also likely agonal changes. No pathologic diagnosis can be assigned to the myocardium. A cause of death cannot be determined from the tissues submitted. The tissues did not include the brain (history of seizures). No more information is expected; this case is closed.
Mort
O-Unassessable: 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. 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. 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. Involuntary movement may be associated with reported seizures. Foaming at mouth and coughing are unspecific signs and may have numerous other causes. Further death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Product has wide margin of safety. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Necropsy findings later revealed congestion in various organs, interlobular and periarterioloar hemorrhage which are likely agonal changes related to death. Cause of death could not be detected, unfortunately brain tissue was not evaluated. Time to onset is short for initial reported signs. Overall considering all aspects, a product involvement is remains unassessable.