Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5553

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001432

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.

17-JUL-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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 17-Jul-2023 an attending veterinarian contacted Elanco regarding possible adverse effects to K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 55 (Imidacloprid, Moxidectin) in a dog and reported: On approximately 01-Jun-2019, a dog was seasonally started on 1 tube of Advantage Multi 55 (Imidacloprid, Moxidectin) topically by the owner once monthly from approximately 01-Jun to 01-Oct in 2019 and 2020. On approximately 02-Jun-2019 the dog was also administered 1 tube of K9 Advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner once monthly from approximately 02-Jun to 02-Oct in 2019 and 2020. On approximately 24-May-2023 the dog was once again started on 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner once monthly. On approximately 01-Jun-2023 the dog was started on ivermectin/pyrantel orally by the owner once monthly.

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

Welsh Springer Spaniel

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

17.3

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

• Skin
  • Symptom - Itchy skin
  • Symptom - Irritated skin

• Gastrointestinal System
  • Symptom - Diarrhea

• Skin
  • Symptom - Hair loss

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Meningoencephalomyelitis of unknown etiology

• General
  • Symptom - Abnormal behaviour

• Nervous and Muscular Systems
  • Symptom - Skittish

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 an unknown date in approximately Jun 2019, post Advantage Multi and post K9 Advantix II applications, the 5 year old, 17.3 kg, neutered, female, Welsh Springer Spaniel dog, in fair condition, with unknown concomitant medical conditions, developed application site itchiness and irritation with each application that lasted for a few days and then resolved but would resume with each treatment. On an unknown date the dog began to have intermittent episodes of diarrhea. No further details were provided. On approximately 01 Jan 2021 the dog presented to the attending veterinarian with alopecia on the ventral chest, which the veterinarian said was resolved after a few months. On approximately 30 Jan 2023 the dog was diagnosed with Meningoencephalomyelitis of Unknown Etiology (MUE). It was started on prednisone as treatment. On approximately 01 Jun 2023 the dog was started on ivermectin/pyrantel orally by the owner once monthly. On approximately 05 Jun 2023 the dog became itchy all over its body and started losing hair on its thighs, sternum, armpits and around its collar area. On approximately 10 Jun 2023 the dog became skittish and scared of the kitchen (abnormal behavior).On 11 Jul 2023 the dog was re-checked by the attending veterinarian who found that the dog was no longer itchy but had remaining hair loss on the thighs, sternum, armpits and around its collar region.

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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