Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2264

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000487

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.

01-MAR-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

26-FEB-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. 27584      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Extra Large Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 01-Mar-2024, a clinic staff member contacted Elanco regarding a possible adverse reaction to Advantage II Extra Large Dog (Imidacloprid, Pyriproxyfen). On 26-Feb-2024, the pet owner applied a partial tube of Advantage II Extra Large Dog (Imidacloprid, Pyriproxyfen) to the cat (misuse species and intentional misuse).

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

2.11

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Difficulty getting up

• Renal System
  • Symptom - Lack of control of urination

• Cardiovascular System
  • Symptom - Tachycardia

• General
  • Symptom - Hyperthermia

• Eye
  • Symptom - Protrusion of the third eyelid

• Nervous and Muscular Systems
  • Symptom - Trembling

• General
  • Symptom - Dehydration

• Blood
  • Symptom - Other
  • Specify - Eosinopenia
  • Symptom - Other
  • Specify - Low reticulocyte count
  • Symptom - Leukopenia
  • Specify - Lymphopenia
  • Symptom - Blood urea nitrogen decreased
  • Symptom - Other
  • Specify - Hyperglobulinemia

• Renal System
  • Symptom - Other
  • Specify - Bilateral renal pelvis dilation

• Nervous and Muscular Systems
  • Symptom - Recumbent

• Renal System
  • Symptom - Urinary incontinence

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Not recovered / Non 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 26-Feb-2024, an unknown time after application, the 0.33 year old, 2.11 kilograms, intact male, domestic short hair, cat with fleas, became lethargic, anorexic, ataxic, and was unable to stand. On 29-Feb-2024 the cat was seen by the veterinarian and found to have urinary incontinence, tachycardia (232bpm), hyperthermia (39.8 degrees celcius), prolapsed nictatating membranes, was trembling, and dehydrated. The cat was hospitalized and given subcutaneous fluids, 0.21ml of Maropitant intravenously and prescribed oral Maropitant, oral Meloxicam, Capstar, and transdermal Mertazapine. Blood tests were performed and the results showed, eosinopenia, low reticulocytes, lymphopenia, decreased BUN, and a slight hyperglobulinemia . An ultrasound showed bilateral dilation of the renal pelvis (coded as abnormal ultrasound finding).

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To be determined by Registrant

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

Major

19. Provide supplemental information here