Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2812

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000915

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.

09-APR-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

08-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 09Apr2024, a clinic staff member contacted Elanco to report an adverse reaction with K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 08Apr2024, 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Bichon Frise

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.7

7. Weight (provide a range if necessary )

9.2

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

• Skin
  • Symptom - Irritated skin
  • Symptom - Pruritus

• General
  • Symptom - Hyperactivity

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 08Apr2024, 2 hours after application, the 1.7 year old, 9.2 kilogram, neutered male, Bichon Frise dog had generalized pruritus and was hyperactive. The pet owner bathed the dog with an unspecified shampoo. On 09Apr2024 the dog was seen by the veterinarian and had skin irritation at the base of the tail (this was not an application site), and continued to be hyperactive. The dog was prescribed a triamcinolone - neomycin - nystatin - gramicidin cream for the skin irritation. The veterinarian recommended bathing the dog with dish soap and applying Vitamin E to the application sites. The outcome of this case is unknown. The veterinarian's suspicion that K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) has a causal association with the clinical signs is unknown. Please note the dog had the same product applied in 2023 without issue.

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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