Nouvelle déclaration d'incident
No de la demande: 2018-5498
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0047160 (Report 512859)
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
Inconnu
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
Unknown
1
Homme
12
5.443
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Persisted until death
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 1 day post application in 2018, the cat exhibited application site alopecia and application site lesion. Two months post application in 2018, the cat exhibited generalized alopecia and died. No necropsy was performed. No further information is expected. This case is closed. Follow up received on 21st Aug 2018: Approximately 1 day post application in 2018, the cat exhibited application site alopecia and application site lesion. Two months post application in 2018, the cat exhibited generalized alopecia and died. No necropsy was performed. Due to the nature of the communication and in order to avoid further strain on the relationship with the reporting party, no further information will be sought. No further information is expected. Case is closed. Note: No quality issues were noted upon product investigation.
Mort
O - Unclassifiable/unassessable Pruritus is not expected with appropriate topical product use. If any, skin reactions would be located at the application site. Skin disorders in this case rather associated with current flea infestation. However, presence of fleas is not a sign of inefficacy. Regular treatments for at least a 6-week period are necessary in order to break the flea development circle. Otherwise preexisting pupae may still emerge from the environment and re-infest the pet. Efficacy against fleas can be expected only after this period. Moreover, in this case time to onset is unknown however likely more than 4 weeks, the claimed efficacy period. A dermal reaction at the application site in a particularly sensitive animal may occur. Alopecia on other than the application site is not anticipated with topical product administration. 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. Furthermore the cat involved in this case was geriatric. Time to onset post re-application for application site disorders was short however long for other reported signs. Considering some information (e.g. state of heath, product details and necropsy results) missing, an overall product relation is unassessable.