Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-5710
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001512
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.
25-JUL-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
17-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)
PMRA Registration No. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
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 25 Jul 2023, a veterinary technician contacted Elanco regarding a possible adverse reaction to Advantage Multi 100 (Imidacloprid, Moxidectin) and K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen), administered topically by the owner to a dog. On 16 Jun 2023 the owner applied the dog's first dose of K9 Advantix II Extra Large Dog. On 23 Jun 2023 the owners applied the first dose of Advantage Multi 100 (Imidacloprid, Moxidectin). On 16 Jul 2023 the owners applied the second dose of K9 Advantix II Extra Large Dog.
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
Golden Retriever
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1.67
7. Weight (provide a range if necessary )
29.3
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Vocalizing
- Symptom - Hyperactivity
- Skin
- Symptom - Dermatitis
- Specify - Crusting
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
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 17 Jun 2023, the 1.67 year old, 29.3 kg, neutered female, Golden Retriever dog was excitable (hyperactivity), vocalizing, and was mildly itchy.
The itchiness lasted 2-3 days and the vocalization and excitability lasted one week. On 23 Jun 2023, after administration of Advantage Multi 100 (Imidacloprid, Moxidectin), the dog became itchy again. The itchiness resolved within one week. On 16 Jul 2023, immediately after the second application of K9 Advantix II, the dog became itchy. The pet owner administered diphenhydramine and the signs improved but persisted. The itchiness resolved about 1 week later. On 25 Jul 2023 the owner reported the dog had some crusting.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here