Nouvelle déclaration d'incident
No de la demande: 2019-2318
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0014213 (Report 556216)
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: PENNSYLVANIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage II (dog-unspecified)
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage (dog-unspecified)
Autre (préciser)
spot onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Chow Chow X Akita crossbred dog
1
Femme
15
27.216
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application, in approximately Sep-2014, the dog developed swollen joints. The dog was evaluated by a veterinarian and it was determined the arthritis had worsened On an unspecified date post application, in approximately Feb-2015, the dog died. No known necropsy was performed. The intent of the call was to inquire about product use in general and not to report this event. No further information expected, case is closed.
Mort
Advantage Plus Spot-on pipette size unknown N - Unlikely Arthritis, swollen joints and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. However, arthritis was reported before product application, hence not product related. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Time to onset is too long. Hence, other causes must be considered in this geriatric animal. Furthermore the intent of the call was to inquire about product use in general and not to report this event. Considering overall aspects, a product relation is unlikely. Advantage Spot-on pipette size unknown N - Unlikely Arthritis, later reported swollen joints and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Time to onset unknown for arthritis but exceptionally long (4 years and more) for later reported swollen joints and death. Other causes must be considered in this geriatric animal. Furthermore the intent of the call was to inquire about product use in general and not to report this event. Considering overall aspects, a product relation is deemed unlikely.