Nouvelle déclaration d'incident
No de la demande: 2015-3870
Numéro de référence du titulaire d'homologation: 2015TH282
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Blvd
Ville: Mississauga
État: ON
Pays: Canada
Code postal /Zip: L9W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar - large dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Non
Autre
Dog / Chien
Rottweiler
5
Inconnu
0
Inconnu
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 29-Jun-2013, 6 year old, 90 pound, intact female, Rottweiler canine, in good condition, with no known concomitant medical conditions, had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around the neck by the owner.On an unknown date in July the dog was bred, and became pregnant. The collar was worn continuously through the pregnancy which is an off label use of the product.On the evening if 04Oct2013 through 05Oct2013, the dog whelped a litter of 7 puppies,which were exposed to the treated bitch, all were under weight. All began to nurse immediately after birth. Within 6-8 hours of birth the pups were no longer nursing and were moving away from the bitch. The owner began syringe feeding by placing drops of milk in the mouth. Then pups were arching their backs and having respiratory distress within 12 hours. 5 pups died by 06 Oct 2013. The bitch and pups were not examined by a veterinarian. No necropsy was performed.
Mort
O - Unclassifiable/unassessable Off-label use as collar was worn during pregnancy and lactation by bitch and newborn puppies had contact to treated bitch. Laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not produced any effects on fertility or reproduction and showed no teratogenic, or foetotoxic effects. Thus, no side effects are expected with use on pregnant or lactating bitches,however the safety of the veterinary medicinal product has not been established in target animals during pregnancy and lactation. The collar was tolerated well by the bitch during pregnancy. Fatal outcome of puppies is neither expected nor in line with pharmaco-toxicological product profile and rather due to other causes. No necropsy of dead puppies performed, however numerous other causes have to be considered. In the end, a product relation is deemed to be not assessable.