Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2881
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_001189
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
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
25-APR-24
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
25-APR-24
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No. 29780
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
Units: mL
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
On 25Apr2024, a pet owner contacted Elanco to report an extra label use and an adverse reaction with K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On 25Apr2024, the pet owner administered 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) orally to the dog. The product was not used correctly (Route). No concomitant products were administered.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
crossbred Old English Sheep Dog/ Poodle
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1.5
7. Weight (provide a range if necessary )
13.6
kg
8. Route(s) of exposure
Oral
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Ataxia
- Symptom - Muscle tremors
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On 25Apr2024, 4 hours after administration, the 1.5 year old, 13.6kg, neutered female, Old English Sheepdog/ Poodle crossbred dog became ataxic and had tremors. The dog was examined by a veterinarian and dispensed Maropitant and Famotidine. On 26Apr2024 the tremors had improved but not resolved and the dog was still ataxic. The outcome of this case is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here