Nouvelle déclaration d'incident
No de la demande: 2017-7480
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0066638 (Report 452128)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: PENNSYLVANIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-151
Nom du produit: Advantage II Small Cat
Autre (préciser)
Spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Unknown
1
Femme
21
2.722
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
<=30 min / <=30 min
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 10-Sep-2017, a 21 year old, 6 pound, neutered, female, cat, of unknown breed and condition, with a concomitant medical condition of arthritis, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On 07-Oct-2017, the cat exhibited difficulty walking, dragging the hind limbs and dies. No known necropsy was performed. No further information is expected; the case is closed. Note: The reporting party contacted Bayer Animal Health to inquire about product use and efficacy on another pet and not to report the death of this animal.
Mort
N - Unlikely Reported walking difficulty and hind limb paralysis are not expected after from a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke serious neurological signs in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But paralysis is not expected. Walking difficulty may be associated with concomitant arthritis and paralysis. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. 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. Time to onset is not suggestive of product relation. Moreover, the reason for initial call was to inquire about product use and efficacy on another pet and not to report the death of this geriatric animal. Even though no necropsy is available, sufficient information exists to rule out product relation completely. Overall, a product relation consider as unlikely.