Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-0466

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002641

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.

02-NOV-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

31-OCT-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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Small 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.

.4

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 2 Nov 2023, the attending veterinarian contacted Elanco regarding an adverse event in a dog following application of K9 Advantix II Small dog (Permethrin, Imidacloprid, Pyriproxyfen). On 30 Oct 2023, a dog presented to a veterinary clinic because of a tick found on the pinna of the right ear. The parasite was removed in clinic and the owner was sent home with a K9 Advantix II pipette to apply at home, which the owner applied that day.

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

Crossbred Maltese/ Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

4.3

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

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Loss of appetite
  • Symptom - Weight loss

• Liver
  • Symptom - Elevated liver enzymes

• Blood
  • Symptom - Hyperphosphatemia

• Renal System
  • Symptom - Creatinine increased

• Blood
  • Symptom - Blood urea nitrogen increased
  • Symptom - Anemia

• Gastrointestinal System
  • Symptom - Vomiting

• Renal System
  • Symptom - Renal failure

• Gastrointestinal System
  • Symptom - Diarrhea

• Blood
  • Symptom - Hypokalemia

• Gastrointestinal System
  • Symptom - Other
  • Specify - Lymphangiectasia

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?

4

Day(s) / Jour(s)

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 31 Oct 2023, the 8 year old, 4.3 kg, spayed female, crossbred Chihuahua/ Maltese dog, with a history of weight loss over the last 3 years, polyuria, polydipsia, periodontal disease, and having had a topical reaction following application of a topical product purchased in a pet store on an unknown date, was very lethargic and did not eat. The owner force fed egg and baby formula which the dog vomited sometime after administration. As the dog's appetite did not improve over the next hours, the pet owner took the dog to an emergency clinic for examination. The result of the examination was unremarkable and the owner was instructed to go to her veterinarian for blood work and additional diagnostics. On 2 Nov 2023, the attending veterinarian examined the dog which now had developed soft stool (diarrhea). The physical exam was unremarkable except for severe periodontal disease, which was known to be pre-existing, and some weight loss compared to previous records dated 2017. A SNAP 4DX test was performed and was negative for all components: heartworm, erlichiosis, babesiosis and anaplasmosis. A leptospirosis in- clinic test was also negative. Blood work results revealed the following: decreased hematocrit (anemia), elevated urea (40.6 mmol; 9.6 mmol max), elevated creatinine (426 umol; 159 umol max), elevated phosphorus (3.2 mmol; 2.2 mmol max), elevated alanine aminotransferase (ALT) (135 U/L; max 125 U/L) and elevated alkaline phosphatase (ALP) (1440 U/L; max 212 U/L) (elevated liver enzymes). The veterinarian diagnosed the dog with renal insufficiency. Urinalysis was performed from a free catch urine sample. The results were considered normal. On 3 Nov 2023, an abdominal ultrasound was done and the result was unremarkable. The patient was maintained on intravenous fluids over the next 4 days. On 6 Nov 2023, the kidney and liver values were back to normal. Complete blood work was not rechecked. The dog's appetite was not completely back to normal but this was considered to be linked to being away from home. All other clinical signs had resolved. The patient was sent home. Complete blood work recheck was planned around 9 Nov 2023. On 3 Nov 2023, an abdominal ultrasound was done at a referral clinic. The results indicated slight changes which in light of the laboratory renal values could indicate a renal injury or a normal change considering the age of the patient. The intestinal mucosa was suggestive of lymphangiectasia (abnormal ultrasound findings). On 9 Nov 2023, recheck blood work was done indicating that the creatinine value was normal and the BUN remained slightly elevated at 9.8 mmol/L (high normal 9.6 mmol/L). The ALT had increased since the initial blood work was done: 522.0 U/L (max: 125 U/L). The ALP had gone down to 679 U/L (212 U/L) but remained elevated. The potassium was lower than normal at 3.0 mmol/L (low normal 3.5 mmol/L). The dog was started on treatment with S-adenosylmethionine (SAMe) and a recheck was planned within one month. On 13 Nov 2023, a conversation with the attending veterinarian indicated that the patient was doing well clinically. The anemia had resolved and the patient was doing well clinically and had a good appetite. On 11 Dec 2023, all blood and biochemistry values were back to normal. The patient's recovery was therefore confirmed on that date.

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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