Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4879

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001043

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.

06-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-APR-23

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 6 Jun 2023, the veterinary clinic staff member contacted Elanco regarding a possible adverse effect of Advantage Multi 55 (Imidacloprid, Moxidectin) and K9 Advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On 18 Apr 2023 the owner applied the dog's first dose of K9 Advantix ll Large Dog. On 19 Apr 2023 the owner applied the dog's first dose of Advantage Multi 55. On 15 May 2023 the owners applied the dog's second dose of K9 Advantix ll. On 17 May 2023 the dog was administered a tablet of moxidectin + pyrantel + sarolaner.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

18.3

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Other
  • Specify - Tense abdomen

• General
  • Symptom - Adipsia

• Gastrointestinal System
  • Symptom - Anorexia

• Nervous and Muscular Systems
  • Symptom - Anxiety

• Skin
  • Symptom - Paresthesia

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting

• General
  • Symptom - Lethargy
  • Symptom - Pica
  • Symptom - Biting

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

Fully Recovered / Complètement 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 19 Apr 2023, the 9 month old, 18.3 kg, neutered male Border Collie dog began nibbling its back shortly after application, diagnosed by the veterinarian as application site paraesthesia. On 20 Apr 2023 the dog was not eating or drinking and was lethargic. On 22 Apr 2023 the pet owner reported the dog was more energetic and was eating. Later on 22 Apr 2023 the dog had one bout of diarrhoea. On 23 Apr 2023 the dog began vomiting. There was garbage and undigested food in the vomitus; the owner reported the dog was chewing random clothing items around the house (pica). The dog's appetite was noted to be normal. On 25 Apr 2023 a physical examination was sought. The dog had a mildly tense abdomen and was noted to be nervous (anxiety); otherwise there were no abnormal findings. The dog was treated with famotidine and a gastrointestinal diet . The vomiting stopped the same day. On 16 May 2023 the owners verbally reported the dog had diarrhoea and had vomited once. On 20 May 2023 and 26 May 2023 the owners verbally reported the dog still had diarrhoea. On an unknown date at the end of May, the dog was fully recovered.

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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