CIRCADIN 2 mg cp LP - VIDAL
CIRCADIN 2 mg cp LP - VIDAL"
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Les données non cliniques issues des études conventionnelles de pharmacologie de sécurité, toxicologie en administration répétée, génotoxicité, cancérogenèse, et des fonctions de
reproduction et de développement, n'ont pas révélé de risque particulier pour l'homme. Des effets n'ont été observés chez l'animal qu'à des expositions considérées
comme suffisamment supérieures à l'exposition maximale observée chez l'homme, et ont peu de signification clinique. L'étude de cancérogenèse chez le rat n'a pas révélé
d'effets pouvant avoir une signification clinique chez l'homme. En toxicologie de la reproduction, l'administration orale de mélatonine à la souris femelle, à la rate ou à la
lapine n'a provoqué aucun effet indésirable chez les nouveau-nés, selon les mesures de la viabilité des fœtus, des anomalies squelettiques et viscérales, du rapport des sexes, du poids
de naissance et du développement physique, fonctionnel et sexuel ultérieur. Un léger effet sur la croissance et la viabilité post-natales est apparu chez le rat avec des doses très élevées,
équivalant à approximativement 2 000 mg/jour chez l'homme.
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