Nouvelle déclaration d'incident
No de la demande: 2017-6504
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0036592
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: KANSAS
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-150
Nom du produit: Advantage II Kitten
Autre (préciser)
spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Shorthair
1
Homme
0.229
1.13
kg
Cutanée
Unknown / Inconnu
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 21-Jun-2017, a 12 week old, 2.5 pound, neutered, male, Domestic Shorthair feline, in unknown condition, with a concomitant medical condition of fleas, was administered 1 tube of Advantage II Kitten (Imidacloprid-Pyriproxyfen) topically by the owner. On 22-Jun-2017, the kitten exhibited lethargy; the owner bathed the kitten in dish soap 4 times. Approximately 1 hour post bathing, the lethargy worsened and the kitten was unable to stand on the rear limbs. The cat was not examined by a veterinarian and the clinical signs continued. On 23-Jun-2017, the kitten died. No known necropsy was performed.
Mort
O - Unclassifiable/unassessable Reported lethargy is an unspecific sign and may have multiple potential causes in an animal. Given the time to onset the sign may a behavioral response to the product being applied. However sign worsened to ataxia, which is not expected with appropriate topical product use. Further death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. 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 for death with two days is too long for product relation. Other causes should be considered. Considering all aspects, a product involvement is deemed to be unassessable.