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Cóip statach de shonraí a easpórtáiltear ó IATE ó am go chéile atá sa chnuasach seo. Níor cheart glacadh leis gurb ionann i gcónaí an t-eolas a thugtar faoi iontráil anseo agus a bhfuil sa leagan reatha den iontráil ar IATE. Is féidir an leagan reatha sin a cheadú ach cliceáil ar an nasc atá ar thaobh na láimhe deise ag barr gach iontrála. Breis eolais »

8 dtoradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #620726

    IATE #1146946
    frithghníomh díobhálach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    frithghníomh díobhálach in aghaidh druga Tagairt 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
    Sainmhíniú 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 Tagairt "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
    Sainmhíniú 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 Tagairt "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"
    Nóta "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 · AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #644048

    IATE #3518702
    frithghníomhú díobhálach i nduine Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    human adverse reaction
    en
    Sainmhíniú a reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine Tagairt "Directive 2001/82/EC on the Community code relating to veterinary medicinal products, CELEX:02001L0082*/EN"
  3. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research

    #666537

    IATE #3623652
    scagthástáil a dhéanamh ar fhrithghníomhartha díobhálacha tromchúiseacha neamhthuartha amhrasta Tagairt "Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Sainmhíniú frithghníomhartha díobhálacha tromchúiseacha neamhthuartha amhrasta a shainaithint go córasach, ar frithghníomhartha iad lena gceanglaítear measúnú as a dtiocfaidh cinneadh maidir leis an ngá atá le fógra a thabhairt do na Ballstáit tuairiscithe agus do na Ballstáit lena mbaineann Tagairt "Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA"
    Überprüfung von mutmaßlichen unerwarteten schwerwiegenden Nebenwirkungen
    de
    Sainmhíniú "systematische Feststellung von mutmaßlichen unerwarteten schwerwiegenden Nebenwirkungen, die eine Bewertung und anschließende Entscheidung darüber erfordern, ob eine Unterrichtung der berichterstattenden Mitgliedstaaten sowie der betroffenen Mitgliedstaaten erforderlich ist" Tagairt COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    screening of suspected unexpected serious adverse reactions
    en
    Sainmhíniú "systematic identification of suspected unexpected serious adverse reactions that require an assessment leading to a decision on the need to notify the reporting Member States and Member States concerned" Tagairt "Commission Implementing Regulation (EU) 2022/20 laying down rules for the application of Regulation (EU) No 536/2014 as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials"
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #601818

    IATE #137520
    frithghníomh trom díobhálach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    schwerwiegende Nebenwirkung
    de
    Nóta Term defined -- Term defined --
    serious adverse reaction
    en
    Sainmhíniú "adverse reaction that is life-threatening" Tagairt "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"
    Nóta 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|pharmaceutical product

    #641589

    IATE #3502882
    frithghníomh díobhálach amhrasta Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    mutmaßliche Nebenwirkung
    de
    suspected adverse reaction | SAR
    en
    Sainmhíniú 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 Tagairt "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 "
    Nóta "See also: adverse reaction"
    effet indésirable présumé
    fr
    Sainmhíniú effet indésirable pour lequel un lien de causalité entre l’événement et le médicament ne peut être exclu Tagairt COM-Document interne: ENTR/2008/80076/02/02
  6. SOCIAL QUESTIONS|health|pharmaceutical industry

    #639123

    IATE #2222817
    frithghníomh trom díobhálach amhrasta neamhthuartha Tagairt 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
    Sainmhíniú "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" Tagairt "COM-EN, based on:Voisin Consulting Life Sciences (VCLS) > resources > glossary > suspected unexpected serious adverse reaction (SUSAR) (9.3.2022)"
    Nóta Reports of these reactions are subject to expedited submission to health authorities.
    SUSAR | suspicions d'effets indésirables graves inattendus
    fr
  7. SOCIAL QUESTIONS|health|pharmaceutical industry

    #601819

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

    #648662

    IATE #3543181
    frithghníomh trom díobhálach neamhthuartha Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    unerwartete schwerwiegende Nebenwirkung
    de
    Sainmhíniú schwerwiegende Nebenwirkung, deren Art, Schweregrad oder Ergebnis nicht den Referenzinformationen zur Unbedenklichkeit entspricht Tagairt COM-Internes Dokument SANCO-2012-80155-00-01 (Verordnung über klinische Prüfungen mit Humanarzneimitteln)
    unexpected serious adverse reaction
    en
    Sainmhíniú "serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information" Tagairt "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
    Sainmhíniú "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" Tagairt COM-Document interne: SANCO-2012-80155-00-04BR>Règlement relatif aux essais cliniques de médicaments à usage humain