FrancophonIA/ELRC3.0 huggingface dataset:
English: “Functional gastrointestinal disorders” defines a heterogeneous group of individual diseases, ranging from functional oesophageal, gastric, intestinal, biliary, pancreatic to functional anorectal disorders, with a wide range of different underlying pathophysiologies and symptomatic entities that require different treatment modalities.
Danish: "Funktionelle lidelser i mave-tarm-kanalen" er betegnelsen for en heterogen gruppe af individuelle sygdomme, der strækker sig fra funktionelle lidelser i øsofagus, mave, tarm, galdeveje og bugspytkirtel til funktionelle anorektale lidelser med en lang række forskellige underliggende patofysiologier og symptomer, der kræver forskellige behandlingsmåder.
English: In this regards, the SmPC is amended to reflect that efficacy in children has not been established;
Danish: I den forbindelse ændres produktresuméet for at afspejle, at virkningen hos børn ikke er klarlagt.
English: In addition, in the absence of valid statistical evaluations and given the paucity of elements contributing to support the robustness and the strength of the results, the CHMP was, neither able to draw reliable conclusions with regards to the efficacy of Symbioflor 2, nor to establish whether Symbioflor 2 is efficacious in IBS in general or any sub-type of IBS.
Danish: Endvidere var CHMP - i mangel af gyldige statistiske evalueringer og i betragtning af de sparsomme elementer til støtte for resultaternes pålidelighed og styrke - hverken i stand til at drage sikre konklusioner med hensyn til virkningen af Symbioflor 2 eller til at fastslå, hvorvidt Symbioflor 2 er effektivt ved IBS generelt eller nogen undertyper af IBS.
English: • The CHMP also noted that results of the observational study in children older than 4 years with IBS suggested a possible efficacy of Symbioflor 2.
Danish: • CHMP bemærkede også, at resultaterne af observationsundersøgelsen hos børn med IBS, der var over 4 år gamle, tydede på en mulig virkning af Symbioflor 2.
English: • Functional disturbances of the gastrointestinal tract and irritable bowel syndrome (Colon irritable) (AT).
Danish: • Funktionelle lidelser i mave-tarm-kanalen og irritabel tyktarmssyndrom (irritabel tyktarm) (AT).
English: The CHMP also noted that results of the observational study in children older than 4 years with IBS suggested a possible efficacy of Symbioflor 2.
Danish: CHMP bemærkede også, at resultaterne af observationsundersøgelsen hos børn med IBS, der var over 4 år gamle, tydede på en mulig virkning af Symbioflor 2.
English: • Regulation of the immune system, gastrointestinal disorders, irritable bowel syndrome (DE).
Danish: • Regulering af immunsystemet, lidelser i mave-tarm-kanalen og irritabel tyktarmssyndrom (DE).
English: • Acknowledging the limitations of the established efficacy profile of Symbioflor 2, the CHMP requested the MAH to conduct a well-designed and adequately powered multi-centre, double blind, randomised, placebo controlled post approval efficacy study allowing for relevant subpopulation analyses to confirm the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, gender, disease severity and address the sustainability of efficacy to confirm the efficacy of Symbioflor 2 in IBS;
Danish: • CHMP anerkendte begrænsningerne ved den fastlagte virkningsprofil for Symbioflor 2 og anmodede derfor indehaveren af markedsføringstilladelsen om at foretage en veltilrettelagt multicenter-, dobbeltblindet, randomiseret, placebokontrolleret virkningsundersøgelse med et tilstrækkeligt antal forsøgsdeltagere efter godkendelsen for at muliggøre relevante underpopulationsanalyser med henblik på at bekræfte virkningen af Symbioflor 2 til behandling af IBS generelt i forhold til undertyper af sygdommen såsom IBS C og IBS D, køn og sygdommens sværhedsgrad og om at undersøge virkningens varighed for at bekræfte virkningen af Symbioflor 2 ved IBS.
English: In summary, in the absence of valid statistical evaluation and given the risk of bias and the paucity of elements contributing to support the robustness and the strength of the results (the evidence being based on a single pivotal trial), the CHMP was not able to confidently draw a conclusion with regards to the efficacy of Symbioflor 2 in IBS or a sub-type of IBS.
Danish: I mangel af en gyldig statistisk evaluering og i betragtning af risikoen for bias og de sparsomme elementer til støtte for resultaternes pålidelighed og styrke (idet evidensen byggede på en enkelt hovedundersøgelse) var CHMP kort sagt ikke i stand til at drage en sikker konklusion med hensyn til virkningen af Symbioflor 2 ved IBS eller en undertype af IBS.
English: In the absence of relevant data submitted by the MAH and in view of the uncertainties about proof of efficacy in Study S2, the CHMP concluded that these results cannot be extrapolated from adults to children or to adolescents.
Danish: Eftersom indehaveren af markedsføringstilladelsen ikke havde fremsendt relevante data, og eftersom der var usikkerhed omkring beviset for virkningen i S2undersøgelsen, konkluderede CHMP, at disse resultater ikke kan ekstrapoleres fra voksne til børn eller unge.
English: The CHMP acknowledged the MAH's proposal to delete this indication as, in the absence of any data to support the treatment of functional gastrointestinal disorders, a positive benefit-risk balance of Symbioflor 2 could not be established;
Danish: CHMP anerkendte indehaveren af markedsføringstilladelsens forslag om at slette denne indikation, da det ikke kunne fastlægges, at der var et positivt benefit/risk-forhold for Symbioflor 2, eftersom der ikke forelå nogen data til støtte for behandlingen af funktionelle lidelser i mave-tarm-kanalen.
English: In the absence of relevant data submitted by the MAH to support the paediatric use and in view of the uncertainties about the benefit-risk in Study S2 conducted in adult patients only, the CHMP concluded that extrapolation of the results from adults to children or adolescents was not justified.
Danish: Eftersom indehaveren af markedsføringstilladelsen ikke havde fremsendt relevante data til støtte for pædiatrisk anvendelse, og eftersom der var usikkerhed omkring benefit/risk-forholdet i S2-undersøgelsen, der udelukkende blev foretaget med voksne patienter, konkluderede CHMP, at resultaterne ikke kan ekstrapoleres fra voksne til børn eller unge.
English: The SmPC was amended to reflect that efficacy in children has not been established.
Danish: Produktresuméet blev ændret for at afspejle, at virkningen hos børn og unge ikke er klarlagt.
English: The CHMP was of the opinion that a significant number of adverse events would have been expected to be reported in this study due to the underlying disease regardless of the safety profile of Symbioflor 2.
Danish: Efter CHMP's opfattelse ville man - uanset sikkerhedsprofilen for Symbioflor 2 - have forventet, at et betydeligt antal uønskede hændelser blev rapporteret i denne undersøgelse som følge af den underliggende sygdom.
English: Indication in the treatment of functional gastrointestinal disorders
Danish: Indikation til behandling af funktionelle lidelser i mave-tarm-kanalen
English: Furthermore, the CHMP requested that the MAH conduct a well-designed and adequately powered multi-centre, double blind, randomised, placebo controlled post approval efficacy study allowing for relevant subpopulation analyses to assess the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, gender, disease severity and address the sustainability of efficacy to confirm the efficacy of Symbioflor 2 in IBS.
Danish: CHMP anmodede endvidere indehaveren af markedsføringstilladelsen om at foretage en veltilrettelagt multicenter-, dobbeltblindet, randomiseret, placebokontrolleret virkningsundersøgelse med et tilstrækkeligt antal forsøgsdeltagere efter godkendelsen for at muliggøre relevante underpopulationsanalyser med henblik på at vurdere virkningen af Symbioflor 2 til behandling af IBS
English: The European Commission granted a marketing authorisation valid throughout the European Union for Iscover on 15 July 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Iscover den 15. juli 1998.
English: The full EPAR for Iscover can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Iscover findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Iscover is converted into its active form in the body.
Danish: Iscover omdannes til sin aktive form i kroppen.
English: This is a summary of the European public assessment report (EPAR) for Iscover.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Iscover.
English: This showed that Iscover reduces the risk of an event.
Danish: Dette viser, at Iscover mindsker risikoen for en hændelse.
English: The best dose to use in these patients has not been determined.
Danish: Det er endnu ikke blevet fastsat, hvilken dosis det er bedst at anvende til disse patienter.
English: In CAPRIE, there were 939 events in the Iscover group, and 1,020 in the aspirin group.
Danish: I CAPRIEundersøgelsen var der 939 hændelser i Iscover-gruppen og 1 020 i aspirin-gruppen.
English: Other information about Iscover
Danish: Andre oplysninger om Iscover
English: Iscover was more effective than aspirin at preventing new ischaemic events.
Danish: Iscover var mere effektivt end aspirin til forebyggelse af nye iskæmiske hændelser.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Iscover.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Iscover.
English: For more information about treatment with Iscover, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Iscover, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that fewer patients will have new ischaemic events if they receive Iscover than if they receive aspirin.
Danish: Dette betyder, at færre patienter vil få nye iskæmiske hændelser, når de får Iscover, end hvis de får aspirin.
English: Iscover is used to prevent problems caused by blood clots in adults who have:
Danish: Iscover anvendes til forebyggelse af problemer forårsaget af blodpropper hos voksne, som
English: The CHMP decided that Iscover's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Iscover opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: For genetic reasons, some patients may not be able to convert Iscover as effectively as others, which could reduce their response to the medicine.
Danish: Visse patienter er af genetiske årsager måske ikke i stand til at omdanne Iscover lige så effektivt som andre og reagerer måske ikke lige så godt på lægemidlet.
English: In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Iscover instead of aspirin.
Danish: Ca. 10 patienter ud af 1 000 vil med andre ord undgå en ny iskæmisk hændelse to år efter, at de er begyndt at tage Iscover i stedet for aspirin.
English: The standard dose of Iscover is one 75-mg tablet once a day.
Danish: Standarddosis af Iscover er en tablet a 75 mg en gang dagligt.
English: Iscover is a medicine that contains the active substance clopidogrel.
Danish: Iscover er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: Iscover can be started between a few days and 35 days after the attack;
Danish: Behandling med Iscover kan indledes få dage efter anfaldet og indtil 35 dage efter
English: Iscover should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients.
Danish: Iscover bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for clopidogrel eller andre af indholdsstofferne.
English: For the full list of all side effects reported with Iscover, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Iscover fremgår af indlægssedlen.
English: Iscover can be started between seven days and six months after the stroke;
Danish: Behandling med Iscover kan indledes syv dage efter slagtilfældet og indtil seks måneder efter
English: The most common side effects with Iscover (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured.
Danish: De hyppigste bivirkninger ved Iscover (der optræder hos mellem 1 og 10 patienter af 100) er hæmatom (blodsamling under huden), epistaksis (næseblod), gastrointestinale blødninger (blødninger i mave eller tarm), diarré, mavesmerter, dyspepsi (halsbrand), blå mærker og blødning på punkturstedet.
English: What is the risk associated with Iscover?
Danish: Hvilke risici er der forbundet med Iscover?
English: In ST segment elevation myocardial infarction, fewer patients on Iscover had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Danish: Ved myokardieinfarkt med forhøjelse af ST-segmentet havde færre af de Iscover-behandlede patienter hændelser end de placebo-behandlede patienter (262 mod 377 i CLARITY-undersøgelsen og 2 121 mod 2 310 i COMMIT-undersøgelsen).
English: Why has Iscover been approved?
Danish: Hvorfor blev Iscover godkendt?
English: Iscover has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted for up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Iscover with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Danish: Iscover blev også sammenlignet med placebo i to undersøgelser af patienter med forhøjelse af ST-segmentet: CLARITY, som omfattede over 3 000 patienter, og som varede i op til otte dage, og COMMIT, som omfattede næsten 46 000 patienter, og i løbet af hvilken patienterne fik Iscover med eller uden metoprolol (et andet lægemiddel anvendt ved hjerteproblemer eller forhøjet blodtryk) i op til fire uger.
English: Iscover as an anticoagulant has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral artery disease.
Danish: Iscover blev som antikoagulerende middel sammenlignet med aspirin i en undersøgelse kaldet CAPRIE, hvori der indgik ca. 19 000 patienter, som inden for den seneste tid havde haft et hjerteanfald eller et iskæmisk slagtilfælde, eller som havde påvist perifer arteriesygdom.
English: In the study in atrial fibrillation patients, Iscover taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke.
Danish: I undersøgelsen af atrieflimren nedsatte Iscover taget sammen med aspirin risikoen for nye hændelser med 11 % sammenlignet med placebo taget sammen med aspirin, idet slagtilfælde tegnede sig for den største nedsættelse (28 %).
English: The active substance in Iscover, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Iscover, clopidogrel, er en trombocytfunktionshæmmer.
English: In atrial fibrillation, Iscover has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy.
Danish: Iscover blev til atrieflimren sammenlignet med placebo (begge taget sammen med aspirin) i en hovedundersøgelse, som omfattede ca. 7 500 patienter, der havde mindst en risikofaktor for vaskulære hændelser, og som ikke kunne tåle vitamin K-antagonistterapi.
English: In acute coronary syndrome, Iscover has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year).
Danish: Ved akut koronart syndrom blev Iscover sammenlignet med placebo (en virkningsløs behandling) i en undersøgelse, som omfattede godt 12 000 patienter med non-ST-segment elevation, hvoraf 2 172 fik en stent indsat i løbet af undersøgelsen (CURE-undersøgelsen varede i op til et år).
English: What is Iscover?
Danish: Hvad er Iscover?
English: What benefit has Iscover shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Iscover?
English: In acute coronary syndrome and atrial fibrillation, Iscover is used together with aspirin, the dose of which should not be higher than 100 mg.
Danish: Ved akut koronart syndrom og atrieflimren anvendes Iscover sammen med aspirin.
English: What is Iscover used for?
Danish: Hvad anvendes Iscover til?
English: How has Iscover been studied?
Danish: Hvordan blev Iscover undersøgt?
English: How is Iscover used?
Danish: Hvordan anvendes Iscover?
English: To retain protection, horses need to be revaccinated.
Danish: For at beskyttelsen kan vare ved, skal hestene vaccineres igen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza Te on 8 July 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Equilis Prequenza Te den 8. juli 2005.
English: The effectiveness of the current formulation of the vaccine has been assessed in additional laboratory studies.
Danish: Virkningen af den nuværende formulering af vaccinen er blevet vurderet i supplerende laboratorieundersøgelser.
English: It contains inactivated (killed) whole virus of two equine influenza (flu) strains (‘A/equine-2/South Africa/4/03' and ‘A/equine-2/Newmarket/2/93') and tetanus toxoid (chemically inactivated toxin from the tetanus bacterium).
Danish: Den indeholder inaktiverede hele vira fra to hesteinfluenzastammer (‘A/equine-2/South Africa/4/03' og "A/equine-2/Newmarket21/93" og tetanustoksoid (kemisk inaktiveret toksin fra stivkrampebakterien).
English: The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, (i.e. which did not receive the vaccine or received a competitive product).
Danish: Undersøgelserne sammenlignede også kliniske symptomer og virusudskillelse hos en gruppe af vaccinerede dyr med en kontrolgruppe (dyr, der ikke havde fået vaccinen, eller som havde fået et konkurrerende produkt).
English: The withdrawal period for Equilis Prequenza Te is zero days.
Danish: Tilbageholdelsestid for Equilis Prequenza Te er nul dage.
English: The toxoid is a toxin processed in order to remove its toxic effect, but still allow it to be recognised by the immune system.
Danish: Dette toksoid er et toksin, der er blevet bearbejdet på en måde, så dets toksiske virkning er fjernet, men så det stadig kan genkendes af immunsystemet.
English: Tetanus is an acute, often fatal disease caused by the toxin (poison) produced by the bacterium Clostridium tetani.
Danish: Stivkrampe er en akut, ofte dødelig sygdom, der skyldes toksin (gift), som dannes af bakterien Clostridium tetani.
English: The duration of protection was five months after primary vaccination and 12 months after the first revaccination for equine influenza and 17 months after primary vaccination and 24 months after the first revaccination for tetanus.
Danish: Varigheden af beskyttelse var fem måneder efter basisvaccination og 12 måneder efter den første revaccination mod hesteinfluenza og 17 måneder efter basisvaccination og 24 måneder efter den første revaccination mod stivkrampe.
English: The current formulation of Equine Prequenza Te has been shown to produce similar results to those shown in the initial studies.
Danish: Den nuværende formulering af Equine Prequenza Te har vist sig at give resultater, der svarer til dem, der blev opnået i de oprindelige undersøgelser.
English: The vaccine also contains an ‘adjuvant' to enhance the immune response.
Danish: Vaccinen indeholder desuden et "adjuvans", der forstærker immunforsvaret.
English: Equilis Prequenza Te contains inactivated whole virus of the influenza strains against which the vaccine is indicated.
Danish: Equilis Prequenza Te indeholder inaktiverede hele vira fra de influenzastammer, som vaccinen er indiceret til.
English: Horses developed protective levels of antibodies two weeks after primary vaccination.
Danish: Hestene dannede beskyttende niveauer af antistoffer to uger efter basisvaccination.
English: When a horse is given the vaccine, the immune system recognises the virus and toxoid as ‘foreign' and makes antibodies against them.
Danish: Når en hest får vaccinen, opfatter immunsystemet virussen og toksoiden som ‘fremmede' og danner antistoffer mod dem.
English: Equilis Prequenza Te is a vaccine for use in horses.
Danish: Equilis Prequenza Te er en vaccine til heste.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza Te exceeded the risks for the approved indications and the Committee recommended that Equilis Prequenza Te be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Equilis Prequenza Te opvejer risiciene, når det anvendes til den godkendte indikation, og anbefalede udstedelse af markedsføringstilladelse for Equilis Prequenza Te .
English: The viruses included in the current formulation of Equilis Prequenza Te are grown in mammalian cells, unlike those in the initial formulation, which were grown in hens' eggs.
Danish: Viraene i den aktuelle formulering af Equilis Prequenza Te dyrkes i pattedyrceller i modsætning til dem i den oprindelige formulering, som blev dyrket i hønseæg.
English: The vaccine also contains purified tetanus toxoid.
Danish: Vaccinen indeholder også oprenset tetanustoksoid.
English: Regarding tetanus, the main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid.
Danish: Med hensyn til tetanus var det primære effektmål produktionen af beskyttende antistoffer over for tetanustoksoid.
English: The main measure of effectiveness of Equilis Prequenza Te against equine influenza was the production of protective levels of antibodies against the influenza components.
Danish: Det primære effektmål for Equilis Prequenza Te mod hesteinfluenza var produktionen af beskyttende niveauer af antistoffer over for influenzabestanddelene.
English: Equilis Prequenza Te
Danish: Equilis PrequenzaTe
English: Horses are very susceptible to tetanus.
Danish: Heste er meget følsomme over for stivkrampe.
English: The safety of the initial formulation of Equilis Prequenza Te was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age.
Danish: Sikkerheden af Equilis Prequenza Te blev undersøgt i adskillige undersøgelser under laboratorie- og feltbetingelser hos et stort antal heste fra tomånedersalderen og opefter.
English: For the full vaccination schedule see the package leaflet.
Danish: Den fuldstændige vaccinationsplan fremgår af indlægssedlen.
English: For ethical reasons no challenge (infection) experiment was performed against tetanus.
Danish: Af etiske grunde blev der ikke udført nogen eksponeringsundersøgelse (inficering) mod stivkrampe.