Nouvelle déclaration d'incident
No de la demande: 2018-3597
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0036772 (Report 502756)
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: CALIFORNIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-152
Nom du produit: Advantage II Large Cat
Autre (préciser)
spot onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Shorthair
1
Femme
14
6.35
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Persisted until death
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 03-Jul-2018, the cat developed lethargy. On 05-Jul-2018, the cat developed application site erythema, application site alopecia, and a decreased appetite. On 09-Jul-2018, the cat has not been evaluated by a veterinarian and no treatments have been performed. The clinical signs continued. Follow up received on 12th July 2018: On 03-Jul-2018, the cat developed lethargy. On 05-Jul-2018, the cat developed application site erythema, application site alopecia, and a decreased appetite. On11-Jul-2018 the feline was evaluated by a veterinarian and placed on an unknown dose of prednisone. Overnight the feline passed away. No necropsy was performed. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable Though lethargy is an unspecific sign and may have multiple potential other causes in an animal, it may represent a behavioural response to the product sensation. In individual cases, dermal reactions at the application site are possible in animals that are particular sensitive. Reported decrease appetite is rather unspecific but in this case it may be consequence of lethargic status. Further reported death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. In this case, involved cat may have died due to old age (14 years). Though time to onset is consistent for initially reported signs but it is long for death. Other causes must be consider. Overall, considering all aspects, a product relation is deemed to be unassessable.