Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4672

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001225

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.

23-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-JUN-23

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 23-Jun-2023, a veterinarian contacted Elanco regarding a possible adverse reaction and a perceived lack of efficacy to K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 08-Jun-2023 after the dog was groomed, the pet owner applied K9 advantix II Large Dog to the dog.

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

Labrador Retriever/Poodle crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

20

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Parasitism

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

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

Immediately after application the 8 year old, 20kg, neutered, male, Labrador Retriever/Poodle crossbred dog, who had a tick on him, with a history of epilepsy, had application site pruritus and was rubbing. The signs lasted 7 days and the dog recovered. On 21-Jun-2023 the pet owner found 6 attached ticks on the dog, the pet owner put the ticks in a jar and they were dead approximately 12 hours later. On 22-Jun-2023 3 more attached ticks were found on the dog. The dog lives in an area known to have a heavy burden of ticks. He lives on a farm and runs in the fields of tall grass daily.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here