Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2811

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000912

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: ONTARIO

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 09-Apr-2024, the animal owner contacted Elanco to report an adverse event in dog involving with K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On 08-Apr-2024, a dog was administered 1 tube/pipette of K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) once, via the topical route, by the owner for flea/tick control. 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

Shih Tzu / Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.91

7. Weight (provide a range if necessary )

10

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Pruritus

• Gastrointestinal System
  • Symptom - Loss of appetite

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 08-Apr-2024, approximately 12 hours post application, the 11 month old, 10 kilograms, neutered female, Shih Tzu/Poodle crossbred dog, in unknown condition, with no concomitant medical conditions, exhibited agitation and rubbing her back on the floor. On 09-Apr-2024, the dog was examined by a DVM and was given an injection of diphenhydramine. When owner returned home the dog was bathed by pet owner with dish soap. On 10-Apr-2023 the dog was re-checked by DVM as dog was still rubbing her back on the floor and was not eating. Diagnostics were performed and were normal. The dog was treated with an injection of dexamethasone. The veterinarian recommended to apply a small amount of vitamin E oil to the affected area (dog's back) once daily for 3 days and apply a small amount of lidocaine cream to the affected the dog's back every 4 hours for 3 days. Applying at separate times away from the Vitamin E oil. The outcome of the canine is unknown. The veterinarian's suspicion that K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) has a causal association with the clinical signs is high.

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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