Nouvelle déclaration d'incident
No de la demande: 2015-3758
Numéro de référence du titulaire d'homologation: 2015CK239
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Boulevard
Ville: Missisaugua
État: ON
Pays: Canada
Code postal /Zip: L4W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 1556-155
Nom du produit: Seresto Collar - large dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
labrador
1
Homme
4.5
94
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
<=30 min / <=30 min
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Immediately following administration the dog began to hypersalivate. On 22Mar2015 the dog developed generalized weakness and ataxia.On 23Mar2015 the dog's clinical sign became worse and the collar was removed. He was examined by the regular veterinarian where he was bathed. During the bath the dog fell (weakness) and was unable to stand (ataxia).On 24Mar2015 the dog was taken to a neurologist were he continued to be ataxic, weak and he developed minor muscle tremors. No treatments or diagnostics were performed.Follow up received on 25 Apr 2015. On an unknown date in Apr 2015, the canine died. No necropsy was performed. No further information expected. This case is closed.
Mort
N - Unlikely. Hypersalivation and generalized weakness are unspecific signs and may have numerous other causes. Reported neurological signs are not anticipated with appropriate topical product administration. No oral product exposure reported. Even with oral product exposure only transient gastrointestinal signs but no neurological signs would be expected. Time to onset is short for hypersalivation but exceptionally long for other signs. Signs continued for long duration and even after collar removal. 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 death 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. Necropsywas not performed. Considering the known product profile and time to onset, sufficient information exists to conclude that the product did not cause the event. Considering all aspects, a product involvement was ruled out.