Traduction de «adverse effects and adverse » (Néerlandais → Français) :

Healthcare professionals and consumers of medicines and health products need to be made aware of the utility and obligation (in the case of materiovigilance and haemovigilance) of reporting adverse effects and adverse events associated with the use of medicines and health products to the FAMHP. Furthermore, the report form should be made easy to complete
Healthcare professionals and consumers of medicines and health products need to be made aware of the utility and obligation (in the case of materiovigilance and haemovigilance) of reporting adverse effects and adverse events associated with the use of medicines and health products to the FAMHP. Furthermore, the report form should be made easy to complete

The prevention of adverse effects and adverse events attributable to the use of medicines and health products is closely linked with information for healthcare professionals and the public regarding the risks associated with the use of medicines and health products.
The prevention of adverse effects and adverse events attributable to the use of medicines and health products is closely linked with information for healthcare professionals and the public regarding the risks associated with the use of medicines and health products.

Bij een subcutaan fertiliteitsonderzoek bij ratten werden er geen effecten bij de mannetjes gerapporteerd, maar bij de vrouwtjes was de fertiliteit verminderd en er werd een NOAEL (no observed adverse effect level = niveau waarop geen bijwerkingen worden waargenomen) van 5 mg/kg vastgesteld.
Au cours de l’étude de fertilité chez le rat après administration par voie sous-cutanée, aucun effet n'a été rapporté chez le mâle.Une altération de la fertilité a été observée chez la femelle, la dose sans effet indésirable étant de 5 mg/kg.

The evaluation of oncological adverse effects (as well as the evaluation of the Periodic Safety Update Report – PSUR, Annual Safety Report - ASR, Suspected Unexpected Serious Adverse Reaction
The evaluation of oncological adverse effects (as well as the evaluation of the Periodic Safety Update Report – PSUR, Annual Safety Report - ASR, Suspected Unexpected Serious Adverse Reaction

De 'No Observed Adverse Effect Levels (NOAEL)' voor deze bevindingen waren subtherapeutisch of maximaal 5 keer de klinische blootstelling bij de mens (op basis van AUC). Andere bevindingen betroffen een effect op de lever (verhoging van levertransaminasen) en de retinafunctie, en kans op fosfolipidose in meerdere organen zonder correlatieve toxiciteiten.
Les doses sans effet nocif observé (No Observed Adverse Effect Levels, NOAEL) pour ces observations ont été soit sous-thérapeutiques soit jusqu'à 5 fois l'exposition clinique chez l'homme sur la base de l'AUC. D'autres observations ont révélé un effet sur le foie (augmentation des transaminases hépatiques) et sur la fonction rétinienne, et un risque de phospholipidose dans plusieurs organes, sans toxicités corrélatives.

At the end of 2007 the FAMHP initiated a programme for specific monitoring of new medicines (“black triangle” – symbol included in the BCFI-CBIP annotated drugs formulary – Gecommentarieerd Geneesmiddelenrepertorium – Répertoire Commenté des Médicaments) with the aim of encouraging healthcare professionals to report adverse effects of medicines with a new active substance to the FAMHP.
At the end of 2007 the FAMHP initiated a programme for specific monitoring of new medicines (“black triangle” – symbol included in the BCFI-CBIP annotated drugs formulary – Gecommentarieerd Geneesmiddelenrepertorium – Répertoire Commenté des Médicaments) with the aim of encouraging healthcare professionals to report adverse effects of medicines with a new active substance to the FAMHP.

Each report of an adverse effect is now processed in two phases. For the first phase “preparing” the electronic report approximately 60 % of the backlog has been removed.
Each report of an adverse effect is now processed in two phases. For the first phase “preparing” the electronic report approximately 60 % of the backlog has been removed.

Actively monitoring adverse effects and/or
Actively monitoring adverse effects and/or

Blootstelling aan nilotinib bij vrouwtjes bij “No-Observed-Adverse-Effect-Levels” was in het algemeen minder of gelijk aan die bij de mens bij 800 mg/dag.
Chez les femelles, l’exposition au nilotinib, aux doses n’induisant aucun effet indésirable, était généralement inférieure ou égale à l’exposition observée chez l’homme à une dose de 800 mg/jour.

2007 also saw the launch of the new methodology for detecting and evaluating serious adverse effects, and it is now vital to put this into practice as soon as possible.
2007 also saw the launch of the new methodology for detecting and evaluating serious adverse effects, and it is now vital to put this into practice as soon as possible.