Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4899

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001078

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.

08-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

05-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 8 Jun 2023, the veterinary technician contacted Elanco regarding a possible adverse effect of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On 5 Apr 2023 the dog was vaccinated (details not provided) and received a tablet of Interceptor Plus 23/228 (milbemycin oxime, praziquantel) administered orally in the clinic. On 3 Jun 2023 the dog was administered its first dose of K9 Advantix ll Extra Large Dog; the dose was confirmed applied topically by a clinic staff member.

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

Husky - Siberian Crossbreed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

35

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Skin
  • Symptom - Dermatitis

• Ear
  • Symptom - Other
  • Specify - Ear inflammation

• Eye
  • Symptom - Discharge eye

• Nervous and Muscular Systems
  • Symptom - Recumbent

• Blood
  • Symptom - Other
  • Specify - Hypophosphataemia
  • Symptom - Hypokalemia
  • Symptom - Hyperglycemia

• Nervous and Muscular Systems
  • Symptom - Fasciculations

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Muscle twitching
  • Symptom - Ataxia
  • Symptom - Shaking
  • Symptom - Muscle weakness

• Respiratory System
  • Symptom - Tachypnea

• Skin
  • Symptom - Skin sensitivity

• Ear
  • Symptom - Other
  • Specify - Ear twitching

• General
  • Symptom - Polydipsia

• Respiratory System
  • Symptom - Abnormal lung sounds

• Nervous and Muscular Systems
  • Symptom - Head bobbing

• General
  • Symptom - Pain

• Renal System
  • Symptom - Polyuria

• General
  • Symptom - Subdued

• Nervous and Muscular Systems
  • Symptom - Head shaking

• Skin
  • Symptom - Pruritus

• Ear
  • Symptom - Other
  • Specify - Ear infection

• General
  • Symptom - Licking

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 5 Jun 2023, the 7 year old, 35 kg, neutered male Husky crossbreed dog presented to an after hours clinic in lateral recumbency with muscle fasciculations, eyelid twitching (twitching), drooling and ear flicking (coded as ear twitching). The dog was treated with acepromazine, atropine, propofol all administered intravenously, and phenobarbital orally. Bloodwork revealed normal complete blood count with hyperglycemia of 8.3 mmol/L, hypophosphatemia of 0.78 mmol/L and hypokalemia 3.6 mmol/L (reference ranges not provided). The dog was discharged 8 hours later. On 6 Jun 2023, a recheck exam was done at the dog's regular vet. The pet owner reported the dog drank an excessive amount of water after discharge from the after hours clinic. The dog was ataxic, had muscle weakness, had purulent ocular discharge, was shaking when walking and was sensitive to the touch. Physical examination was considered normal apart from an elevated respiratory rate of 58 per minute (tachypnea) with increased lung sounds, and the dog was quiet (subdued). Heart rate, temperature, capillary refill time, mucous membrane colour were all normal. The dog was hospitalized on intravenous fluids and oral phenobarbital was continued. Application sites were washed with dish soap. On 7 Jun 2023 the dog was improved but not completely recovered; it was discharged from hospital. On 9 Jun 2023 at a recheck examination the dog was noted to have head bobbing and pain in the left hind leg in addition to the improved but ongoing ataxia. The dog continued to be polydipsic and was also polyuric, suspected to be due to the phenobarbital. Ocular discharge was resolved. The dog had lick dermatitis at the site of the intravenous catheter. Meloxicam was prescribed for the pain and a topical over the counter antibiotic ointment was prescribed for the lick dermatitis. On 16 Jun 2023 the dog was considered fully recovered apart from ongoing lick dermatitis. Additionally the dog was shaking its head and scratching its ears which were mildly inflamed, suspected due to an ear infection by the attending veterinarian.

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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