Gaois

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6 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #620726

    IATE #1146946
    frithghníomh díobhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    frithghníomh díobhálach in aghaidh druga Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    adverse Reaktion | negative Auswirkung | Nebenwirkung
    de
    adverse reaction | adverse drug reaction | ADR | undesirable effect
    en
    Definition response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function Reference "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use"
    effet indésirable | effet nocif
    fr
    Definition une réaction nocive et non voulue à un médicament, se produisant aux posologies normalement utilisées chez l'homme pour la prophylaxie, le diagnostic ou le traitement d'une maladie ou pour la restauration, la correction ou la modification d'une fonction physiologique Reference "Directive 2001/83/CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain CELEX:32001L0083/FR"
    Comment "Les termes ""réaction indésirable"" et ""effet indésirable"" ne sont pas synonymes: un produit exerce un ""effet"" qui se manifeste par une ""réaction"" chez le patient."
  2. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product

    #641589

    IATE #3502882
    frithghníomh díobhálach amhrasta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    mutmaßliche Nebenwirkung
    de
    suspected adverse reaction | SAR
    en
    Definition adverse reaction in respect of which there is at least a reasonable possibility of there being a causal relationship between a medicinal product and the event Reference "COM-Terminology Coordination, based on: Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use "
    Comment "See also: adverse reaction"
    effet indésirable présumé
    fr
    Definition effet indésirable pour lequel un lien de causalité entre l’événement et le médicament ne peut être exclu Reference COM-Document interne: ENTR/2008/80076/02/02
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #601819

    IATE #137521
    frithghníomh díobhálach neamhthuartha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    unexpected adverse reaction
    en
    Definition "adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics" Reference "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #601818

    IATE #137520
    frithghníomh trom díobhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    schwerwiegende Nebenwirkung
    de
    Comment Term defined -- Term defined --
    serious adverse reaction
    en
    Definition "adverse reaction that is life-threatening" Reference "COM-Terminology Coordination,, based on:- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use- Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products"
    Comment It results in death or a persistent or significant disability or incapacity; manifests itself as a congenital anomaly/birth defect; or, in the case of the treatment of humans, requires inpatient hospitalisation or prolongation of existing hospitalisation or, in the case of the treatment of animals, results in permanent or prolonged signs in the animals treated
    effet indésirable grave
    fr
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #639123

    IATE #2222817
    frithghníomh trom díobhálach amhrasta neamhthuartha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    mutmaßliche unerwartete schwerwiegende Nebenwirkung
    de
    suspected unexpected serious adverse reaction | SUSAR | suspected serious unexpected adverse drug reaction | serious suspected unexpected adverse drug reaction
    en
    Definition "suspected adverse reaction related to an investigational medicinal product which occurs in the course of a clinical trial, and which is both unexpected and serious" Reference "COM-EN, based on:Voisin Consulting Life Sciences (VCLS) > resources > glossary > suspected unexpected serious adverse reaction (SUSAR) (9.3.2022)"
    Comment Reports of these reactions are subject to expedited submission to health authorities.
    SUSAR | suspicions d'effets indésirables graves inattendus
    fr
  6. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648662

    IATE #3543181
    frithghníomh trom díobhálach neamhthuartha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    unerwartete schwerwiegende Nebenwirkung
    de
    Definition schwerwiegende Nebenwirkung, deren Art, Schweregrad oder Ergebnis nicht den Referenzinformationen zur Unbedenklichkeit entspricht Reference COM-Internes Dokument SANCO-2012-80155-00-01 (Verordnung über klinische Prüfungen mit Humanarzneimitteln)
    unexpected serious adverse reaction
    en
    Definition "serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information" Reference "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC"
    effet indésirable grave et inattendu
    fr
    Definition "effet indésirable grave [ IATE:137520 ] dont la nature, la gravité ou l'issue ne concorde pas avec les informations de référence relatives à la sécurité" Reference COM-Document interne: SANCO-2012-80155-00-04BR>Règlement relatif aux essais cliniques de médicaments à usage humain