Nouvelle déclaration d'incident
No de la demande: 2020-1513
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2020-US0017133 (Report 631911)
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: SOUTH CAROLINA
Inconnu
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 Shorthair
1
Homme
11
Inconnu
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 an unspecified date in 2019, approximately 1 week post collar placement, the cat exhibited application site alopecia, behavior change, and vomiting. The owner removed the collar. On 05Mar2020 the cat died. It is unknown if a necropsy was preformed. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable The reported application site alopecia may occur in sensitive animals after product application. It is usually mild and transient. Sign and time to onset are consistent. Behavioural change is unspecific and may have numerous other causes. Sign may occur initially after collar Administration, however time to onset rather Long here. Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though mild gastrointestinal signs may occur shortly after product application, they are not expected to appear with long time to onset. No oral product exposure reported. 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. 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Time to onset is long. Other causes must be considered in this geriatric cat (11 years). In summary, a product involvement is considered unassessable.