Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-0484

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002876

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.

27-NOV-23

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

26-NOV-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)

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PMRA Registration No. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II 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.

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 27-Nov-2023, a veterinarian contacted Elanco regarding a possible adverse reaction to K9 Advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a cat. On 26-Nov-2023 the pet owner applied K9 Advantix ll to the cat (misuse type: species). The cat was also receiving 5 mg oral prednisone daily.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

4.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• Gastrointestinal System
  • Symptom - Vomiting

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

15. Outcome of the incident

Fully Recovered / Complètement 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 26-Nov-2023, an unknown time after administration of K9 Advantix II, the 1.5 year old, 4.2 kg, neutered, male, Domestic Longhair cat, with pre-existing allergies, became ataxic. On 27 Nov 2023, the cat was drooling, had vomited, and was tremoring. The cat was admitted to the hospital, bathed with dish soap, and treated with intravenous fluids, intravenous diazepam, and oral methocarbamol. The cat was discharged from hospital later the same day. On 28 Nov 2023, the cat had a recheck examination and was considered completely recovered.

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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