Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2818

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000966

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.

11-APR-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

24-MAR-22

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)

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PMRA Registration No. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Extra Large Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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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 11 Apr 2024, the attending veterinarian contacted Elanco to report an adverse reaction in a canine patient that had been treated with K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On 24 March 2022, a dog was administered 1 tube of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) via the topical route, by the owner for parasite control and monthly until the month of December 2022. In March 2023, the patient was administered 1 tube of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) via the topical route, by the owner for parasite control and monthly until the month of December 2023. On 1 Apr 2024, the patient was administered 1 tube of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) via the topical route, by the owner for parasite control. The product was used correctly each time.

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

Golden Retriever / Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

38.1

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 / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Irritated skin

• General
  • Symptom - Discomfort

• Skin
  • Symptom - Itchy skin
  • Symptom - Lesion
  • Symptom - Discolouration
  • Specify - Application site hair coat discolouration

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

Immediately after each application in 2022, the 5-year-old, 38.1 kg, neutered, male, Golden Retriever/Poodle-unspecified dog, in a good condition, with no concomitant conditions, developed application site irritation, discomfort and general itchiness. The patient recovered from all signs 48 hours after administration. No veterinary exam or treatment was done. Immediately after each application in 2023, the dog developed application site irritation, discomfort and general itchiness. The patient recovered from all signs 48 hours after administration. No veterinary exam had been done. Treatment consisted of vitamin E and oral diphenhydramine post application. Immediately post application on 01Apr2024, the dog exhibited application site irritation, discomfort and general itchiness. On 10 Apr 2024, the patient was examined and found to have application site hair coat discoloration and application site lesion. Treatment consisted of oclacitinib and cefaseptin. The patient remains under treatment and clinical signs were ongoing at the time of completing the report. The attending vet's suspicion that K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) has a causal association with the clinical signs is high.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here