Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2868

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_001135

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-APR-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

20-APR-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. 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 23Apr2024, an animal owner contacted Elanco to report an adverse reaction with K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 20Apr2024, the animal owner applied 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog. The product was used correctly. No concomitant products were administered.

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

Border Collie/ Australian Shepherd crossbred dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

17.5

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

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Dry skin
  • Symptom - Red skin
  • Symptom - Discolouration
  • Symptom - Pruritus

• Gastrointestinal System
  • Symptom - Diarrhea

• General
  • Symptom - Fever

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

On 20Apr2024, 30 minutes after application, the 2.5 year old, 17.5 kg, intact female, Border Collie/ Australian Shepherd crossbred dog developed liquid diarrhea and had application site pruritus. On 21Apr2024 the dog was lethargic. The dog was examined by a veterinarian. At the time of the examination the dog was febrile. Dexamethasone, Gabapentin, and an unspecified probiotic were dispensed. The owner bathed the dog with an unspecified shampoo. While bathing the dog the owner noticed application site redness, application site hair coat discolouration, and application site dry skin. At the time of the report the dog remained under treatment.

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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