Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5106

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001225

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.

07-JUL-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

22-JUN-22

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 07 Jul 2022 a veterinary clinic staff member contacted Elanco to report an adverse event involving K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) use in a dog. On 17-Jun-2022, a dog was administered 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the animal owner.

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

English Cocker Spaniel

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

12.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Anorexia

• General
  • Symptom - Other
  • Specify - Enlarged lymph nodes
  • Symptom - Pale mucous membrane colour

• Blood
  • Symptom - Anemia

• Liver
  • Symptom - Hyperbilirubinemia

• Renal System
  • Symptom - Other
  • Specify - Creatinine decreased

• Liver
  • Symptom - Elevated liver enzymes

• Blood
  • Symptom - Other
  • Specify - Anisocytosis
  • Symptom - Other
  • Specify - Spherocytosis
  • Symptom - Other
  • Specify - Elevated reticulocytes
  • Symptom - Other
  • Specify - Positive agglutination test

• General
  • Symptom - Other
  • Specify - Enlarged spleen

• Cardiovascular System
  • Symptom - Tachycardia

• Renal System
  • Symptom - Blood in urine
  • Symptom - Urine discoloration

• Blood
  • Symptom - Hypokalemia

• General
  • Symptom - Jaundice

• Cardiovascular System
  • Symptom - Heart murmur

• Blood
  • Symptom - Leukocytosis
  • Specify - Neutrophilia

• Renal System
  • Symptom - Proteinuria
  • Symptom - Other
  • Specify - White blood cells in the urine

• General
  • Symptom - Other
  • Specify - Enlarged pancreas

• Liver
  • Symptom - Hepatomegaly

• General
  • Symptom - Other
  • Specify - Mottled spleen

• Renal System
  • Symptom - Other
  • Specify - Kidney disease

• Cardiovascular System
  • Symptom - Other
  • Specify - Premature ventricular contractions

• Blood
  • Symptom - Other
  • Specify - Elevated lactate

• Respiratory System
  • Symptom - Tachypnea
  • Symptom - Dyspnea

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Euthanised / Euthanasie

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 22 Jun 2022 the 10 year old, 12.2 kilogram, intact, male, English Cocker Spaniel canine/dog, in fair condition, with concomitant medical conditions of waxing and waning malaise, experienced vomiting, was anorexic, and lethargic. On 23 Jun 2022 the signs persisted and the dog was seen by a veterinarian who found the dog had enlarged submandibular lymph nodes and pale mucus membranes. Bloodwork revealed a low hematocrit (14%), elevated bilirubin, decreased creatinine, elevated alanine aminotransferase, low red blood cell count, anisocytosis (coded as abnormal cytology), spherocytosis, and elevated reticulocytes. The dog had a positive agglutination test. An ultrasound revealed an enlarged spleen. The dog tested negative for tick borne disease and the veterinarian suspected Immune Mediated Hemolytic Anemia. The dog was treated with intravenous maropitant, intravenous dexamethasone, subcutaneous famotidine, oral sulcralfate, and was dispensed prednisone, maropitant citrate, clopidogrel, and famotidine. On 25 Jun 2022 the dog was seen by the attending veterinarian and the hematocrit had decreased to 10% and the dog was transferred to a a veterinary referral hospital where the dog was given a blood transfusion and started on cyclosporine. The referral veterinarian noted the dog was tachycardic. On 26 Jun 2022 the dog was given 2 additional blood transfusions and experienced blood in urine, had pigmented urine (coded as abnormal urine color), was hypokalemic, and was icteric. On 27 Jun 2022 the dog was found to have a heart murmur, neutrophilia, proteinuris, and red and white blood cells in the urine. An abdominal ultrasound revealed an enlarged pancreas and liver and the spleen was mottled, while the kidneys showed signs of early kidney disease. The dog was administered 2 additional blood transfusions. On 28 Jun 2022 the signs persisted and the dog developed premature ventricular contractions. The dog was treated with lidocaine. The dog was found to have elevated lactate. The dog developed tachypnea and dyspnea and the dog was euthanized.

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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