Nouvelle déclaration d'incident
No de la demande: 2016-4284
Numéro de référence du titulaire d'homologation: 2016KP163
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: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar - Dog
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Newfoundland
1
Femme
3.5
140
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 hrs <=8 hrs / > 2 h < = 8 h
Système
Persisted until death
Oui
Oui
1
Day(s) / Jour(s)
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 4 hours post administration, the canine exhibited lethargy, vomiting, and anorexia. On 19-Jun-2016, the canine was examined by the veterinarian. Unspecified blood work was performed and revealed no abnormalities. On 20-Jun-2016, the canine examined by the veterinarian. Unspecified radiographs were performed and revealed no abnormalities. The canine was administered an intravenous catheter, started on an unknown fluid solution by intravenous route, administered injections of maropitant citrate and famotidine by unknown route, and hospitalized. On 21-Jun-2016, the canine exhibited agonal breathing and died. On 22 Jun 2016, the attending veterinarian performed a necropsy on the canine and found no gross abnormalities. The heart, liver and kidney were submitted for histopathology. Results are unknown.
Mort
Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Reported systemic signs are likely associated with vomiting than the product. Dyspnoea and death are 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. Time to onset long for the serious sign where as it is short for others. Histopathology results unknown. Considering the product profile, product involvement is deemed unlikely, however due to short time to onset and at present missing alternative cause, a product relation is unassessable.