Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2827

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_001037

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.

16-APR-24

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

19-JAN-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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantage II pipette size unknown

• 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 16Apr2024, a clinic staff member contacted Elanco to report an adverse reaction with Advantage II pipette size unknown (Imidacloprid, Pyriproxyfen) in a dog. On 01Jan2024 the owner applied 1 tube of Advantage II pipette size unknown (Imidacloprid, Pyriproxyfen) to the dog. On 22Feb2024 the owner applied 1 tube of Advantage II pipette size unknown (Imidacloprid, Pyriproxyfen) to the dog. On 01Apr2024 the owner applied 1 tube of Advantage II pipette size unknown (Imidacloprid, Pyriproxyfen) to the dog.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Australian Shepherd / Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

28.4

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

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

11. List all symptoms

System

• Skin
  • Symptom - Pruritus
  • Symptom - Dry skin

• Gastrointestinal System
  • Symptom - Vomiting

• Renal System
  • Symptom - Blood in urine

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

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 19Jan2024, the 3 year old, 28.4 kg, neutered male, Australian Shepherd/Poodle crossbred dog, with concomitant fleas and a history of seizures every 6 months since 2022, presented, at the veterinary clinic, for acute onset of hematuria. Urinalysis was performed, urine was red and cloudy, trace protein, white and red blood cells (collectively coded under Haematuria). The owner reported the dog was also pruritic. It is unknown if the pruritus was at the application site. The dog was sedated with Dexmedetomidine and abdominal radiographs were taken. No concerning findings were identified in the radiographs. An in clinic urinalysis was performed and results showed hematuria. The dog was given an intramuscular injection of atipamezole hydrochloride to reverse the sedation. Chinese herbs (details not provided) were dispensed as treatment. On 21Jan2024 the hematuria resolved. Gabapentin was dispensed in preparation for the following days cystocentesis. On 22Jan2024 the dog was given Dexmedetomidine and Butorphanol by intravenous route. The dog had an abdominal ultrasound, with no identified abnormal findings. Urine was collected via cystocentesis and sent for a urine culture. On 01Feb2024 the results of the urine culture were negative. On 24Feb2024 the dog had hematuria and was pruritic. It is unknown if the pruritus was at the application site. The pet owner administered Chinese herbs to the dog. On 25Feb2024 the dog recovered. On 04Apr2024 the dog developed hematuria and pruritus on the abdomen. On an unknown date the hematuria resolved. On 08Apr2024 the dog vomited bile one time and then recovered. On 15Apr2024 the dog was seen by the veterinarian. The pruritus had improved but not resolved and the dog had dry scales in the fur on the dorsal lumbar back (coded as dry skin). At the tme of completing this report the hematuria and vomiting had resolved. The pruritus and dry skin were ongoing.

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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