Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2798
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000839
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.
02-APR-24
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
Unknown
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. 27586
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II Large Cat
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
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 02Apr2024, a clinic staff member contacted Elanco via phone call intending to report an adverse reaction with Advantage II Large Cat (Imidacloprid, Pyriproxyfen). The following was reported: On 23Jan2024, the cat was administered 1 vial of frunevetmab, via the subcutaneous route, by the attending veterinarian. On unknown dates in Feb2024 and Mar2024, the pet owner applied 1 tube of Advantage II Large Cat (Imidacloprid, Pyriproxyfen), to the cat. The product was used correctly.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Mediumhair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10
7. Weight (provide a range if necessary )
5.54
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- Symptom - Pruritus
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?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Not recovered / Non rétabli
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 an unknown date, the 10-year-old, 5.54 kg, neutered female, domestic mediumhair cat, in good condition with no medical history, had developed application site prutirus, application site hair loss, and hair loss above both eyes. On 01Apr2024 the cat was examined by the veterinarian and was given an injection of Dexamethasone. Blood work was performed and the results were all within normal limits. The cat remains under treatment.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here