Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4934

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001322

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.

20-JUL-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-JAN-21

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 20 Jul 2022 the distributor contacted Elanco regarding a possible adverse effect of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. In 2019, a dog was treated with 6 monthly doses of Advantage Multi 20 starting on an unknown date in approxiamtely Apr 2019. In 2020, the dog was treated with 6 monthly doses of K9 advantix II Medium Dog starting on an unknown date in approximately April 2020. On 27 Jun 2022 the pet owner applied a dose of K9 Advantix ll via the topical route.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Bloody diarrhea

• General
  • Symptom - Dehydration

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Loss of appetite

• General
  • Symptom - Adipsia

• Respiratory System
  • Symptom - Abnormal lung sounds
  • Specify - Increased lung sounds

• General
  • Symptom - Pain

• Blood
  • Symptom - Leukocytosis
  • Symptom - Other
  • Specify - Decreased eosinophils
  • Symptom - Other
  • Specify - Elevated globulins

• Liver
  • Symptom - Elevated liver enzymes

• Blood
  • Symptom - Hyperbilirubinemia
  • Specify - Elevated total bilirubin
  • Symptom - Hypokalemia

• Gastrointestinal System
  • Symptom - Other
  • Specify - Large gall bladder

• General
  • Symptom - Jaundice
  • Symptom - Fever

• Blood
  • Symptom - Anemia

• General
  • Symptom - Discomfort
  • Specify - Uncomfortable abdomen

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?

1

Day(s) / Jour(s)

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 02 Jan 2021 the 9-year-old, 5 kg, neutered, female, Yorkshire Terrier dog, with preexisting dental disease and obesity, was examined for bloody diarrhoea of one day duration. The dog was mildly dehydrated. She was treated with subcutaneous fluids, sucralfate and metronidazole. On 14 Jun 2022 the dog was examined, determined to be healthy, and vaccinated for DA2PP (distemper-adenovirus-parainfluenza-parvovirus) and Rabies. On 28 Jun 2022 the dog vomited. The dog was also not eating or drinking well. The owner bathed the dog with dog shampoo. On 29 Jun 2022 a veterinary examination was sought. On examination the dog was found to have intermittent mildly increased lung sounds, mild dehydration and mildly painful abdomen. Bloodwork was done showing the following abnormalities: low reticulocyte haemoglobin (coded as decreased haemoglobin), elevated white blood cells 21.61 X 10^9 (5.05 - 16.06), decreased eosinophils 0 X 10^9 (0.06-1.23), elevated globulins 52 g/L (25-45) and elevations in ALT 989 U/L (10-125) (elevated liver enzyme), GGT 33 U/L (0-11)(elevated liver enzymes), alkaline phosphatase 1863 U/L (23-212), and total bilirubin 71 umol/L (0 -15). Potassium was low at 3.2 mmol/L (3.5-5.8). The dog was treated with intravenous fluids, sucralfate, meloxicam and cefovecin sodium injection in the hospital. On 30 Jun 2022 ultrasound revealed a large gall bladder. S-Adenosylmethionine + silybin phospholipid tablets were added to the treatment protocol. Vomiting was ongoing, and the dog was treated with maropitant. On examination, the dog was found to be mildly jaundiced. On 01 Jul 2022 there had been no significant improvement; metronidazole was added to the treatment plan. Later in the day the dog was discharged from hospital per the owners wishes. On 05 Jul 2022 the owner reported the dog was drinking well, eating a little and was no longer vomiting. On 03 Aug 2022 the dog was re-examined due to continued picky appetite. Abdomen was found to be uncomfortable on examination. Initially the dog had a mild fever which resolved within the hour. Recheck bloodwork showed the following new abnormalities: decreased red blood cell count (anemia), haematocrit (anemia), and haemoglobin (anemia). White blood cells were further elevated at 33.56 X 10^9. Alkaline phosphatase, GGT and total bilirubin had returned to normal, and ALT was significantly improved at 137 U/L. Eosinophils and potassium remained low. The dog was treated with amoxicillin clavulanate.

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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