Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2832

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_001062

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.

18-APR-24

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 18 Apr 2024 an animal owner phoned Elanco to report a potential adverse event involving Advantage Multi 55 (Imidacloprid, Moxidectin) and K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On 08 Apr 2024, a dog was administered one tube of Advantage Multi 55 (Imidacloprid, Moxidectin) by the owner to the skin, correctly applied according to label. At noon on an unknown date in Apr 2024, the owner applied a tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog's skin. The product was not used according to label (misuse: Overdose).

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Havanese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

9.45

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• General
  • Symptom - Discomfort

• Nervous and Muscular Systems
  • Symptom - Restlessness

• General
  • Symptom - Pacing

• Skin
  • Symptom - Irritated skin

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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

Approximately 5 hours post K9 advantix II application, the 5 year old, 9.45 kilogram, male neutered Havanese dog, in good condition with a recent history of ingesting a chicken bone, experienced restlessness, pacing and seemed uncomfortable. The owner washed the area of application with a mild dog shampoo and the symptoms improved. On approximately 13 Apr 2024 the dog was showing signs of application site irritation. The owner washed the application site again and started applying a topical diphenhydramine cream which alleviated the symptoms. No veterinary examination was performed. On 18 Apr 2024 the dog was improving with regular diphenhydramine topical application but symptoms were ongoing. At the time of reporting no veterinary examination had been performed and there was no veterinarian's opinion on level of suspicion of either Advantage Multi 55 (Imidacloprid, Moxidectin) and K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) acting as the causal agent.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here