Nouvelle déclaration d'incident
No de la demande: 2023-6554
Numéro de référence du titulaire d'homologation: 2023-CA-000219 and 2023-CA-000220
Nom du titulaire (nom légal complet, aucune abbréviation): Wellmark International
Adresse: 100 Stone Road West, Suite 111
Ville: Guelph
État: Ontario
Pays: Canada
Code postal /Zip: N1G 5L3
Incident chez un animal domestique
Pays: CANADA
État: NEWFOUNDLAND
ARLA No d'homologation 26493 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: Zodiac Powerspot Flea And Tick Control For Dogs Over 14 kg
Oui
Inconnu
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Golden Retriever Dog
1
Femme
5
29.5
kg
Cutanée
>24 hrs <=3 days / >24 h <=3 jours
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Unknown / Inconnu
Oui
Non
Unknown/Inconnu
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 12 Jun 2023, the animal owner applied the product topically to the dog. On 13 Jun 2023, the dog developed biting at herself and agitation. On 14 Jun 2023, the dog was bathed with an unspecified, unmedicated pet shampoo. On 15 Jun 2023, the dog was evaluated by a veterinarian and prescribed oclacitinib 16 mg to be given once daily for 4 days. Clinical signs improved but had not resolved at the time of the report. No further information is expected.
Modérée
Assessment: This product has a wide margin of safety and is not expected to cause severe clinical signs. Mild dermal irritation is possible following topical use; the dogas biting at herself is a common manifestation of dermal irritation. Agitation may occur secondary to dermal irritation. Other causes should be considered including underlying conditions such as allergies. Additional information regarding results from the veterinary evaluation may have provided additional insight, but was not available. The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. Signs are expected to be mild and self-limiting.
Propriétaire de l'animal
Dog / Chien
Labrador Retriever and Beagle Crossbreed
1
Femme
2
27
kg
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
<=30 min / <=30 min
Système
Unknown / Inconnu
Non
Non
Unknown/Inconnu
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 12 Jun 2023, the animal owner applied the product topically to the dog. Immediately following application, the dog developed biting at herself and agitation. The dog was bathed with an unspecified unmedicated soothing pet shampoo and clinical signs improved but did not resolve. No further information is expected.
Mineure
The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.