Nouvelle déclaration d'incident
No de la demande: 2017-3268
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2015-US0061956
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: GEORGIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-151
Nom du produit: Advantage II small cat
Liquide
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Shorthair
1
Femme
9
3.18
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Persisted until death
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 4-Nov-2015, a 9 year old, 7 pound, neutered, female, Domestic Shorthair feline, in fair condition with a concomitant medical condition of fleas, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application, in approximately Nov 2015, the cat exhibited a behavior change. The cat was examined by a veterinarian and a blood profile showed low calcium level and anemia. On 4-Dec-2015, the product was reapplied. On 4-Dec-2015, approximately 6 hours post application, the cat was vocalizing, hypersalivating, kicking her hind legs (behavioral disorder NOS), and urinated on the couch (inappropriate urination). The cat was bathed in an unspecified type of liquid dish soap. On 6-Dec-2015 the cat started having seizures and died at home. A necropsy was not performed. Follow up received on 3rd Dec 2015: No further information is expected. Case is closed.
Mort
N - Unlikely Reported behavioural change is unspecific and may have various other causes. Low calcium level and anemia are not expcted after product application as signs are not in line with pharmaco toxicological product profile. Time to onset is unknown in this case. Later observed behavioural signs may have occurred due to product sensation or smell. Time to onset is short. Hypersalivation after suspected ingestion of product. Sign is consistent with distaste reaction. Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures 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 seizures are not expected. Death is also not expected after product application, as inconsistent with pharmacotoxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Animal involved in this case was in fair condition. Though later reported behavioural signs are deemed to be product related, the more severe signs seizure and death are considered not product related, a product relation deemed to be unlikely.