New incident report
Incident Report Number: 2024-2891
Registrant Reference Number: CAN-ZZELANCO-CA2024_001220
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 1919 Minnesota Court, Suite 401
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L5N 0C9
Domestic Animal
Country: CANADA
Prov / State: UNKNOWN
PMRA Registration No. 29778 PMRA Submission No. EPA Registration No.
Product Name: K9 Advantix II Medium Dog
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Pomeranian
1
Male
5
5.9
kg
Skin
Unknown / Inconnu
>30 min <=2 hrs / >30 min <=2 h
System
Unknown / Inconnu
Yes
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 29Apr2024, one hour after application, the 5 year old, 5.9kg, neutered male, Pomeranian dog, was panting and restless. The dog was seen by a veterinarian who found the dog had an elevated heart rate (180bpm) (tachycardia). The dog was given a bath with an unspecified shampoo, and was also given an unspecified sedative. On 30Apr2024 the dog was seen at an emergency veterinary clinic. On 30Apr2024, at the veterinary clinic, the dog was administered Gabapentin and Trazadone. Following the administration of the Trazadone, the dog became hyperactive, threw his head back abnormally (abnormal behavior), and had an unsteady gait (ataxia). An unknown time after onset, the dog recovered without treatment. The dog was bathed with dish soap and the veterinarian recommended giving Diphenhydramine. On 01May2024 the dog's heart rate had decreased to 140bpm. but the dog was still restless and panting. On 02May2024 the pet owner reported the dog was having difficulty sleeping because he was agitated. On 02May2024 the dog was seen by the veterinarian and administered two injections of Diphenhydramine and was bathed with a dish soap. The injection of Diphenhydrmine made the dog hyperactive. The owner reported that, after the bath, the application site was still greasy. The pet owner bathed the dog again with dish soap. The pet owner reported the dog was still panting. The dog was whining (vocalizing) and clingy (abnormal behavior), but the agitation and sleep disturbance had improved. On 03May2024 the pet owner bathed the dog with dish soap. The agitation, restlessness, panting, and sleep disturbance had improved but did not resolve. The outcome of this case is unknown.
Moderate