Traduction de «serious adverse reactions in blood » (Néerlandais → Français) :

serious adverse reactions in blood donors and recipients of blood components ●● Proposing measures for the evaluation of
serious adverse reactions in blood donors and recipients of blood components ●● Proposing measures for the evaluation of

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

Het ontwikkelen van procedures voor de begeleiding van de aanvragen en voor de opvolging van de studies (Suspected Unexpected Serious Adverse Reaction - SUSAR, inspecties, normen voor eenheden waar klinische studies worden uitgevoerd);
Mettant sur pied des procédures pour l’encadrement des demandes et le suivi des études (Suspected Unexpected Serious Adverse Reaction - SUSAR, inspections, normes pour les unités où des études cliniques sont effectuées) ;

Daarnaast rapporteerden 67 sponsors die klinische proeven uitvoerden binnen de Europese Economische Ruimte (EER) vermoede gevallen van onverwachte ernstige bijwerkingen (suspected unexpected serious adverse reactions – SUSAR’s) aan de EudraVigilance-module voor klinische proeven (EudraVigilance Clinical Trial Module – EVCTM).
De plus, 67 promoteurs d’essais cliniques au sein de l’Espace économique européen (EEE) ont signalé des effets indésirables graves inattendus présumés (SUSAR) au module d’essais cliniques d’EudraVigilance (EVCTM).

Biovigilance ●● The reporting of serious adverse reactions in
Biovigilance ●● The reporting of serious adverse reactions in

De meest frequent gemelde, aan de behandeling gerelateerde, ernstige nadelige reactie (Serious Adverse Reaction of SAR) was dehydratie (4%), wat door 5 patiënten ondervonden was.
L'EIG associé au traitement le plus fréquemment rapporté a été la déshydratation (4 %) observée chez 5 patients.

Versie 7. 0 van EudraVigilance verscheen in mei 2004, met onder meer een module voor klinische proeven (EVCTM) ter ondersteuning van de elektronische rapportage van vermoede gevallen van onverwachte ernstige bijwerkingen (suspected unexpected serious adverse reactions - SUSAR’s) die zich tijdens klinische proeven voordoen.
La version 7.0 d'EudraVigilance a été lancée en mai 2004 et comprend un module d'essais cliniques (EVCTM) afin de soutenir la transmission électronique de rapports sur des effets indésirables graves inattendus présumés (SUSAR) survenus durant des essais cliniques.

serious adverse events associated with the collection, testing, processing, storage and distribution of blood or blood components that may have an effect on their quality or safety ●● Collecting and evaluating information about
serious adverse events associated with the collection, testing, processing, storage and distribution of blood or blood components that may have an effect on their quality or safety ●● Collecting and evaluating information about

Ernstige cutane bijwerkingen (Serious Cutaneous Adverse Reactions, SCAR’s): stevens-johnsonsyndroom (SJS) en toxische epidermale necrolyse (TEN) werden gerapporteerd (zie rubriek 4.4).
Des réactions indésirables cutanées graves (SCAR) : Syndrome de Stevens-Johnson (SSJ) et nécrolyse épidermique toxique (NET) ont été rapportées (voir rubrique 4.4):

haemovigilance data and monitoring their implementation ●● The first annual report of the Haemovigilance Centre was published in 2007 Since November 2005, hospitals and blood establishments have been required to report to the Belgian Centre for Haemovigilance of the FAMHP serious reactions during the collection or administration of blood components and serious events relating to the quality or safety of blood components.
haemovigilance data and monitoring their implementation ●● The first annual report of the Haemovigilance Centre was published in 2007 Since November 2005, hospitals and blood establishments have been required to report to the Belgian Centre for Haemovigilance of the FAMHP serious reactions during the collection or administration of blood components and serious events relating to the quality or safety of blood components.