Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2891

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_001220

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.

30-APR-24

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

29-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. 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 30Apr2024, a pet owner contacted Elanco to report an adverse reaction with K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On 29Apr2024, the pet owner applied 1 tube of K9 advantix II Medium 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

Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

5.9

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Respiratory System
  • Symptom - Panting

• Nervous and Muscular Systems
  • Symptom - Restlessness

• Skin
  • Symptom - Other
  • Specify - Application site greasy fur

• Nervous and Muscular Systems
  • Symptom - Agitation

• General
  • Symptom - Insomnia
  • Specify - Difficulty sleeping
  • Symptom - Hyperactivity
  • Symptom - Abnormal behaviour

• Nervous and Muscular Systems
  • Symptom - Anxiety

• General
  • Symptom - Vocalizing

• Cardiovascular System
  • Symptom - Tachycardia

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Clingy

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

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

On 29Apr2024, one hour after application, the 5 year old, 5.9kg, neutered male, Pomeranian dog, was panting and restless. The dog was seen by a veterinarian who found the dog had an elevated heart rate (180bpm) (tachycardia). The dog was given a bath with an unspecified shampoo, and was also given an unspecified sedative. On 30Apr2024 the dog was seen at an emergency veterinary clinic. On 30Apr2024, at the veterinary clinic, the dog was administered Gabapentin and Trazadone. Following the administration of the Trazadone, the dog became hyperactive, threw his head back abnormally (abnormal behavior), and had an unsteady gait (ataxia). An unknown time after onset, the dog recovered without treatment. The dog was bathed with dish soap and the veterinarian recommended giving Diphenhydramine. On 01May2024 the dog's heart rate had decreased to 140bpm. but the dog was still restless and panting. On 02May2024 the pet owner reported the dog was having difficulty sleeping because he was agitated. On 02May2024 the dog was seen by the veterinarian and administered two injections of Diphenhydramine and was bathed with a dish soap. The injection of Diphenhydrmine made the dog hyperactive. The owner reported that, after the bath, the application site was still greasy. The pet owner bathed the dog again with dish soap. The pet owner reported the dog was still panting. The dog was whining (vocalizing) and clingy (abnormal behavior), but the agitation and sleep disturbance had improved. On 03May2024 the pet owner bathed the dog with dish soap. The agitation, restlessness, panting, and sleep disturbance had improved but did not resolve. The outcome of this case is unknown.

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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