Nouvelle déclaration d'incident
No de la demande: 2015-6127
Numéro de référence du titulaire d'homologation: 2015KP244
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Blvd. East
Ville: Mississauga
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. 11556-152
Nom du produit: Advantage II Large Cat
Liquide
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Autre
Cat / Chat
unknown
1
Homme
13
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
>1 mo and <= 2mos / >1 mois et < = 2mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 02-May-2015, the cat became pruritic and had fleas. On approximately 10-Jun-2015, the cat was administered 1 tube of the product topically. On approximately 25-Jun-2015, the cat had pale mucous membranes, collapsed, then died. It is unknown if a necropsy was performed. The reason for the initial call was to discuss use of this product on other pets and not to report the death of the patient. No further information is expected. This case is closed.
Mort
Pruritus is not expected with appropriate topical product use. If any, skin reactions would be located at the application site. Further reported pale mucous membrane is an unspecific sign, and may have multiple potential other causes in animal. Collapse and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Time to onset for serious signs is too long (15 days). Other causes are more probable. Cat might have died due to geriatric condition. Moreover, the reason for the initial call was to discuss use of this product on other pets and not to report the death of the patient. Presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Regular treatments for at least a 6-week period are necessary in order to break the flea development circle and number/frequency of previous applications was not reported. Unknown if re-infestation from infested environment (e.g. by means of other untreated animals, wildlife) occurred. Even though some information (such as necropsy results) missing, overall a product connection is deemed to be unlikely.