Nouvelle déclaration d'incident
No de la demande: 2016-0696
Numéro de référence du titulaire d'homologation: 2015KP331
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
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-119
Nom du produit: advantage 20
Liquide
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Miniature Schnauzer
1
Femme
6
20
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 15 Nov 2009 the dog developed bloody diarrhea. The attending veterinarian stated the dog had pancreatitis from a recent food change. It is not known if any treatments were performed. The diarrhea resolved within 2 days. On approximately 01 Feb 2010 the dog had a subsequent product application of Advantage 20. On approximately 20 Feb 2010 the dog was seen by the attending veterinarian and diagnosed with uroliths. The dog was anesthetized with an unspecified anesthetic and the uroliths were surgically removed. On an unknown date in 2012, the dog had another surgery to remove more uroliths. On 01 Oct 2013, the dog had 1 tube of Advantage II Medium Dog (imidacloprid-pyriproxyfen)applied topically by the owner. In Aug 2014 the dog began having seizures. In Sept 2014, the dog developed a behavioral change. In Nov 2014, the dog began to inappropriately urinate and defecate. The dog was seen by the attending veterinarian. Bloodwork was performed and revealed elevated triglycerides. The dog was also diagnosed with a heart murmur. An unspecified dewormer, probiotic, and heart medication were prescribed. In April 2015, the dog developed watery diarrhea. In May 2015, the dog was found deceased. No necropsy was performed. The purpose of the call to Bayer Animal Health was not to report the death of this dog but to inquire about the use of Advantage II Medium Dog on another dog in the home. No more information is expected. Case is closed.
Mort
Reported signs bloody diarrhea, pancreatitis and later diagnosed uroliths are not expected after product application as signs are not in line with pharmaco toxicological product profile. As per veterinarian pancreatitis was due to recent food change. Time to onset is long. Seizures and heart murmur are also not anticipated with topical use of product as not consistent with its pharmacological/toxicological product profile. Other reported signs, abnormal blood parameter, behavioural signs and watery diarrhea are unspecific and may have various other causes. Death 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. 20-fold overdosage tolerated by dogs without showing any side effect. Dog involved in this case was geriatric, which may have caused death of the animal. Time to onset is exceptionally long ( 5 years after last application of the product). The purpose of the call to Bayer Animal Health was not to report the death of this dog but to inquire about the use of Advantage II Medium Dog on another dog in the home. Although no necropsy was performed, considering all aspects a product relation deemed to be unlikely.