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Results for bivirkningsindberetninger translation from Danish to English

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Danish

Individuelle bivirkningsindberetninger

English

Individual case safety reports

Last Update: 2014-11-21
Usage Frequency: 1
Quality:

Danish

indsamling, vurdering og indberetning af individuelle bivirkningsindberetninger

English

collection, assessment and reporting of individual case safety reports;

Last Update: 2014-11-21
Usage Frequency: 1
Quality:

Danish

Bivirkningsindberetninger af det markedsførte produkt (fra uopfordrede indberetninger):

English

Side effects reports on the marketed product (from spontaneous reporting):

Last Update: 2012-04-11
Usage Frequency: 1
Quality:

Danish

Der har været spontane bivirkningsindberetninger i form af akut pancreatitis efter markedsføring.

English

There have been spontaneously reported adverse reactions of acute pancreatitis in the post-marketing setting.

Last Update: 2017-04-26
Usage Frequency: 1
Quality:

Danish

Dette omfatter spontane bivirkningsindberetninger såvel som alvorlige hændelser fra igangværende studier.

English

This includes spontaneous case reports as well as serious adverse events from ongoing studies.

Last Update: 2017-04-26
Usage Frequency: 1
Quality:

Danish

Brugertilpassede forespørgsler til støtte for evalueringen af individuelle bivirkningsindberetninger og en række af sager om bivirkningsindberetninger.

English

customised queries supporting the evaluation of individual case safety reports and case series;

Last Update: 2014-11-21
Usage Frequency: 1
Quality:

Danish

Medlemsstaterne og indehaverne af markedsføringstilladelser registrerer de oplysninger, der er nødvendige for at indhente opfølgende oplysninger om individuelle bivirkningsindberetninger.

English

Member States and marketing authorisation holders shall record the details necessary for obtaining follow-up information on individual case safety reports.

Last Update: 2014-11-21
Usage Frequency: 1
Quality:

Danish

CHMP gennemgik de oplysninger, der blev forelagt af indehaverne af markedsføringstilladelserne fra kliniske undersøgelser, epidemiologiske undersøgelser og spontane bivirkningsindberetninger.

English

The CHMP reviewed the data submitted by Marketing Authorisation Holders from clinical trials, epidemiological studies, and spontaneous reporting of adverse drug reactions.

Last Update: 2012-04-12
Usage Frequency: 3
Quality:

Danish

For spontane bivirkningsindberetninger modtaget efter markedsføring er hyppigheden ukendt (kan ikke estimeres ud fra tilgængelige data).

English

For spontaneous reports of undesirable effects from post-marketing experience, the frequency is not known (cannot be estimated from the available data).

Last Update: 2017-04-26
Usage Frequency: 1
Quality:

Danish

Ud over de rapporterede bivirkninger fra kliniske studier er globale frivillige bivirkningsindberetninger, der er modtaget for Bexsero siden markedsføring, med på listen.

English

In addition to reports in clinical trials, worldwide voluntary reports of adverse reactions received for Bexsero since market introduction are included in the list.

Last Update: 2017-04-26
Usage Frequency: 1
Quality:

Danish

EØSU bifalder forslaget om at reducere den administrative byrde i forbindelse med indberetning af bivirkninger og reducere det nuværende dobbelte indrapporteringssystem for individuelle bivirkningsindberetninger via både papirkopier og elektroniske kopier i forskellige medlemslande.

English

The EESC welcomes the proposed initiative to reduce administrative burden with respect to ADR reporting and to decrease the current duplicate reporting system that exists across the EU for Individual Case Summary Reports via both paper and electronic copies across different Member States.

Last Update: 2017-04-06
Usage Frequency: 1
Quality:

Danish

Individuelle bivirkningsindberetninger anvendes til indberetning til Eudravigilance-databasen af formodede bivirkninger ved et lægemiddel, der konstateres hos en enkelt patient på et bestemt tidspunkt.

English

Individual case safety reports shall be used for reporting to the Eudravigilance database suspected adverse reactions to a medicinal product that occur in a single patient at a specific point in time.

Last Update: 2014-11-21
Usage Frequency: 1
Quality:

Danish

Data er præsenteret separat for kræftpatienter, mobilisering af perifere blodstamceller hos raske donorer, SCN patienter og patienter med HIV, som afspejler de forskellige bivirkningsindberetninger profiler i disse populationer.

English

Data are presented separately for cancer patients, PBPC mobilisation in normal donors, SCN patients and patients with HIV, reflecting the different adverse reaction profiles in these populations.

Last Update: 2017-04-26
Usage Frequency: 1
Quality:

Danish

De bør i givet fald validere og bekræfte signaler på grundlag af en undersøgelse af individuelle bivirkningsindberetninger, aggregerede data fra aktive overvågningssystemer eller -undersøgelser samt oplysninger fra litteratur eller andre datakilder.

English

They should validate and confirm signals, as appropriate, based on an examination of individual case safety reports, aggregated data from active surveillance systems or studies, literature information or other data sources.

Last Update: 2014-11-21
Usage Frequency: 1
Quality:

Danish

sikre en proaktiv og forholdsmæssig indsamling af data af høj kvalitet, der har relevans for lægemidlers sikkerhed, gennem risikostyring og struktureret dataindsamling i form af sikkerhedsundersøgelser efter tilladelse til markedsføring, og rationaliserede individuelle bivirkningsindberetninger samt periodiske indberetninger af formodede bivirkninger

English

Ensuring the proactive and proportionate collection of high quality data relevant to the safety of medicines through risk management and structured data collection in the form of post authorisation safety studies, together with rationalised single case and periodic reporting of suspected adverse reactions;

Last Update: 2017-04-06
Usage Frequency: 1
Quality:

Danish

Medlemsstaterne og indehaverne af markedsføringstilladelser sikrer, at individuelle bivirkningsindberetninger er så fyldestgørende som muligt, og kommunikerer alle ajourføringer af disse indberetninger til Eudravigilance-databasen på en nøjagtig og kontrollerbar måde.

English

Member States and marketing authorisation holders shall ensure that individual case safety reports are as complete as possible and shall communicate the updates of those reports to the Eudravigilance database in an accurate and reliable manner.

Last Update: 2014-11-21
Usage Frequency: 1
Quality:

Danish

Da alle data om bivirkninger skal indsendes direkte til Eudravigilance-databasen, vil de periodiske opdaterede sikkerhedsindberetninger ikke indeholde en detaljeret gennemgang af individuelle bivirkningsindberetninger, men derimod en analyse af forholdet mellem fordele og ulemper ved et lægemiddel.

English

As a result of the submission of all adverse reaction data directly to the Eudravigilance database, the scope of periodic safety update reports is amended to become an analysis of the risk-benefit balance of a medicinal product rather than a detailed presentation of individual case reports.

Last Update: 2017-04-06
Usage Frequency: 1
Quality:

Danish

EMEA 2002 CPMP/811/02 Evalueringer af spontane bivirkningsindberetninger viser, at der er en øget indberetningsfrekvens for rabdomyolyse, herunder dødstilfælde, i forbindelse med cerivastatin end i forbindelse med andre statiner.

English

Assessment of spontaneous adverse drug reaction reports shows an increased reporting rate of rhabdomyolysis, including fatal cases, with cerivastatin compared with other statins.

Last Update: 2008-03-04
Usage Frequency: 1
Quality:

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Danish

En analyse af behandlingsrelaterede bivirkninger klassificeret efter tilstedeværelsen af CIAS1- mutation viste, at der ikke var væsentlige forskelle mellem CIAS1- og non-CIAS1-grupperne for så vidt angår den generelle forekomst af bivirkningsindberetninger, der var henholdsvis 7,4 og 9,2.

English

Analysis of treatment-emergent AEs classified by presence of CIAS1 mutation showed that there were no major differences between the CIAS1 and non-CIAS1 groups in overall AE reporting rates, 7.4 and 9.2, respectively.

Last Update: 2017-04-26
Usage Frequency: 1
Quality:

Danish

Kreatininstigninger på >50 % fra baseline.) og ikke summarisk frekvens af bivirkningsindberetning. e f.eks. konjunktival, retinal, intraokulær blødning

English

Creatinine increases of >50% from baseline.) and not crude adverse event report frequency. e e.g. conjunctival, retinal, intraocular bleeding

Last Update: 2017-04-26
Usage Frequency: 1
Quality:

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