Nouvelle déclaration d'incident
No de la demande: 2013-3097
Numéro de référence du titulaire d'homologation: 2013AM097
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 77 Belfield Rd
Ville: Toronto
État: ON
Pays: Canada
Code postal /Zip: M9W 1G6
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. 11556-128
Nom du produit: Advantage II Small dog
Liquide
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Maltese
1
Femme
10
Inconnu
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 01-Jan-2010 a 10 year old, unknown weight, spayed, female, Maltese canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Adavntage (dog unspecified) once topically by the owner. The owner continued to apply the product on an unknown basis yearly. On approximately 01-Mar-2010 the dog had difficulty breathing. The dog was examined by the veterinarian and diagnosed with Chronic obstructive pulmonary disease. The veterinarian prescribed an unknown dose of prednisone and an unknown dose of theophylline at that time. These treatments were used as needed. On 07-Nov-2012 the patient was administered an unknown amount of moxidectin injectable by the attending vet. On 15-Jan-2013 the dog was administered a distemper/parvo vaccination, a lepto vaccination, and a flu vaccination by the attending vet, and was prescribed neomycin/polymyxin B/dexamethasone drops to be applied to the eyes for conjunctivitis. The dog was also administered 1 tube of Advantage II Smal Dog (Imidacloprid-Pyrifroxyfen) once topically by the owner. On 16-Jan-2013 the dog was listless, vomiting, and had soft stool. The owner contacted the veterinarian who advised that the dog be examined but the owner declined. 2 hours later the owner contacted the veterinarian and adivsed that the dog was uncomfortable and again declined an exam. 3 hours later the owner called and advised bloody diarrhea and wanted to wait until the next morning to have her examined. On 17-Jan-2013 the dog was examined by the veterinarian. Radiographs showed a dense mass cranial to the right kidney and excess gas in the intra-intestinal area. A fecal was performed and was negative. 20 minutes later the dog collapsed with respiratory distress. The veterinarian administered .5cc of doxapram intramuscular and .3cc of epinephrine intramuscular. The dog was intubated. 5 minutes later the dog passed away. On gross necropsy performed by the veterinarian the dog was found to have hemorrhagic enteritis, an enlarged heart, and an adrenal gland tumor.
Mort
Reported signs and fatal outcome not expected after topical application of Advantage, as inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 20- fold overdosage tolerated by dogs without showing any side effect. Product used on animal before without causing any signs. Though time to onset appears close, chronology and prior health status of dog also argue against product relation. Necropsy revealed hemorrhagic enteritis, enlarged heart, and adrenal gland tumour. Finally, product relation can be completely excluded.