Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-6274
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2021_000907
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
15-SEP-21
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
Unknown
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 15 Sep 2021 Elanco was made aware of an adverse event involving K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a canine/ dog. On 01-Apr-2021, a 5 month old, 26 kg, intact, male, Rottweiler canine/dog, in unknown condition, was administered 1 tube of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner. On 05 Jan 2021 and 19 Feb 2021 the dog received 1 tablet of Interceptor Plus 11.5/114 (milbemycin oxime, praziquantel) orally by the owner. On 05 Feb 2021 the dog was administered 1 tablets of Interceptor 11.5 mg (milbemycin oxime) orally by the owner. On an unknown date between 19 Feb 2021 and 01 Apr 2021 the dog was administered an unknown dose of alfoxalaner.
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
Rottweiler
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.41
7. Weight (provide a range if necessary )
26
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
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?
Unknown
14. b) How long was the animal hospitalized?
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 28 Apr 2021 the pet owner reported the dog experienced diarrhea an unknown time after application. On an unknown date between 19 Feb 2021 and 01 Apr 2021 the dog was administered an unknown dose of alfoxalaner and experienced diarrhea.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here