Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2810

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000909

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-APR-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

25-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)

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PMRA Registration No. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Medium 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.

1

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 Apr 2024, a pet owner contacted Elanco to report an adverse reaction with K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: From an unknown date in Jun2022 to an unknown date in Nov2022, the pet owner applied 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog monthly. The product was used correctly. From an unknown date in Jun2023 to an unknown date in Nov2023, the pet owner, once again, applied 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog monthly. The product was used correctly. On 25Mar2024 the dog was administered a Leptospirosis vaccine and a Lyme vaccine, by the veterinarian. On 01Apr2024 the pet owner, once again, applied 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog. 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Cocker Spaniel / Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

8.2

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

• Gastrointestinal System
  • Symptom - Loss of appetite

• Nervous and Muscular Systems
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Vomiting

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 25Feb2024 the 3 year old, 8.2 kilogram, neutered female, Cocker Spaniel /Poodle crossbred dog, had a seizure and was examined at an emergency veterinary clinic. It is unknown if treatments were performed at this time. On 01Apr2024, 2 hours after application, the dog vomited 3 times and then the vomiting resolved. On 02Apr2024 the dog had 2 seizures and a decreased appetite. On 03Apr2024 the dog had another seizure. On 04Apr2024 the dog was seen by a veterinarian. A blood test was performed and the results were all within normal limits. The dog was prescribed Phenobarbital. The dog remains under treatment. The veterinarian's suspicion that K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) has a causal association with the clinical signs is low.

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To be determined by Registrant

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

Major

19. Provide supplemental information here