Nouvelle déclaration d'incident
No de la demande: 2018-2051
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0012281 (Report 477946)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississauga
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Professionnel de la santé
Dog / Chien
Australian Shepherd crossbred
1
Homme
9
27.851
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Oui
Oui
15
Day(s) / Jour(s)
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 07Apr2018, the dog exhibited 1 seizure for approximately 5 minutes and resolved and emesis (multiple). The owner removed the collar. On 08Apr2018. the dog was examined by an emergency veterinarian, unspecified bloodwork and a urinalysis were performed and the dog had azotemia, elevated blood urea nitrogen, elevated creatinine, elevated ALT, leukocytosis, and bacteria in the urine. The dog was diagnosed with a urinary tract infection. The dog was administered unknown doses of subcutaneous fluids, and injections of famotidine maropitant citrate and diluted Baytril (enrofloxacin) 100 mg/mL Antimicrobial Injectable Solution (off label by species). The clinical signs continued unchanged. Follow up received on 24th Apr 2018: On 10Apr2018, the vomiting resolved. On 20Apr2018, the owner replaced the collar. On 23Apr2018, the dog began vomiting, began to have mild neurologic episodes and became lethargic. The owner removed the collar. On 24Apr2018, the dog presented to the veterinarian. An intravenous catheter was placed and the dog was administered 0.9% sodium chloride fluids, 3.0 ml of maropitant citrate, and 1.4 ml of famotadine. Approximately 12 hours post treatments, the canine passed away. A necropsy was not performed.
Mort
O-Unassessable: The product is not anticipated to cause serious neurological disorder such as seizure after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures/convulsions were reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Diagnosed abnormal blood and renal parameters are not expected as inconsistent with product's pharmacotoxicological profile. They may be cause or at least associated with the seizure activity (e.g. hepatic disorder, infection) or coincidental findings. The product is unlikely related with the urinary tract infection and associated signs. Further recurrence after reapplication of collar is not anticipated after appropriate topical product administration. Lethargy could be a secondary effect. Later reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Time to onset is short for initial sign. However, long for later reported signs. Considering the various clinical signs and no necropsy was performed, a final assessment of the case is not possible and case is considered unassessable.