Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-7124

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002272

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-OCT-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-JUN-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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Extra 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.

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 Oct 2023 the pet owner contacted Elanco regarding a possible adverse effect of Advantage Multi 100 (Imidacloprid, Moxidectin) and K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 26 May 2023 the dog was vaccinated for distemper-adenovirus-parainfluenza-parvovirus (DA2PP), Leptospirosis and Bordetella. On 29 May 2023, the dog was prescribed levetiracetam 1000 mg twice daily, however, the pet owners made an error and initially administered only 500 mg twice daily, starting 30 May 2023. On 1 Jun 2023 the owners administered the dog's first dose of Advantage Multi. On 10 Jun 2023 the owners administered the dog's first dose of K9 Advantix ll. On approximately 3 Jul 2023 the owner administered Advantage Multi. On 3 Aug 2023 the owners administered the dog's final dose of Advantage Multi.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Old English Sheep Dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.8

7. Weight (provide a range if necessary )

27.3

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

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Seizure

• Skin
  • Symptom - Itchy skin

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 11 Jun 2023, the 3.8 year old, 27.3 kg, neutered female Old English Sheepdog, with medical history of pre-existing urinary incontinence starting in Nov 2022 for which no diagnostics or treatment had been done, vomiting after leptospirosis vaccinations, seizures, conjunctivitis, and strongly suspected diagnosis of idiopathic epilepsy, had one seizure. On 14 Jun 2023, the owner reported the dog was itchy and trying to rub its back (itchy skin) on everything since application of the K9 Advantix ll. Diphenhydramine was suggested. There was no vet examination. On 22 Jun 2023, the dog had three more seizures. At this time the error in dosing levetiracetam was noted and the dog's levetiracetam dose was increased to the intended 1000 mg twice daily. On approximately 03 Jul 2023, the dog had a seizure after the Advantage Multi application. On 04 Jul 2023, the dog's levetiracetam dose was increased to 1500 mg twice daily. On 05 Jul 2023 the dog was re-assessed by the neurologist. A resting cortisol test was normal and a urine culture was negative. On 10 Jul 2023 the dog had a seizure. On 04 Aug 2023 the dog had 3 seizures. On 20 Aug 2023 the dog had 1 seizure. On 06 Sep 2023 the dog had 1 seizure. On the day of reporting the pet owner also verbally reported that the dog had vomited multiple times since starting Advantage Multi (details could not be recalled by the pet owner) which had stopped once the product was discontinued. As of 02 Oct 2023 the dog was maintained on 1500 mg levetiracetam twice daily.

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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