Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1817
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000288
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.
09-FEB-24
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
04-FEB-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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
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 09-Feb-2024, a clinic staff member contacted Elanco regarding a possible adverse reaction to K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) involving a dog and reported the following. On 04-Feb-2024, the pet owner applied the product to the dog in several sites along the back. This was a first time use of the product.
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
Dog / Chien
3. Breed
Great Pyrenees
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2.5
7. Weight (provide a range if necessary )
35
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Skin
- Symptom - Dermatitis
- Specify - Application site hot spot
- Symptom - Pruritus
- Symptom - Red skin
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
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 04-Feb-2024, one hour after application, the 2.5 year old, 35 kg, intact, female, Great Pyrenees dog developed application site licking, application site pruritus, and application site redness. An unknown time after onset, the dog developed an application site hot spot at one of the application sites. On 06-Feb-2024 the dog was seen by the veterinarian and the application site hot spot was shaved and cleaned with chlorhexidine and the dog was prescribed Oclacitinib maleate and Amoxicillin / Clavulanic Acid.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here