FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving mogamulizumab have experienced drug rash (drug eruption), some of which were severe and/or serious.
Danish: Patienter, der fik mogamulizumab, har oplevet lægemiddelinduceret udslæt, hvoraf nogle tilfælde var svære og/eller alvorlige.
English: In clinical trial patients with other T-cell lymphomas there have been reports of stress cardiomyopathy (one case) and acute myocardial infarction (one case).
Danish: Der har været rapporter om stress-kardiomyopati (et tilfælde) og akut myokardieinfarkt (et tilfælde) i kliniske studier hos patienter med andre T-cellelymfomer.
English: Overall response rate (confirmed CR + PR, %) 95% CI
Danish: Overordnet responsrate (bekræftet CR + PR, %) 95% CI
English: What POTELIGEO is and what it is used for What you need to know before you use POTELIGEO How POTELIGEO is given Possible side effects
Danish: Det skal du vide, før du begynder at bruge POTELIGEO Sådan gives POTELIGEO
English: Overall response rate (confirmed CR + PR, %) 95% CI P-valuea Lymph nodes n=136
Danish: Overordnet responsrate (bekræftet CR + PR, %) 95% CI P-værdia Lymfeknuder n=136
English: Response in the viscera could not be evaluated due to limited efficacy data in subjects with visceral involvement; the benefit-risk of mogamulizumab in subjects with visceral involvement is currently undetermined due to lack of data.
Danish: Benefit/risk-forholdet for anvendelse af mogamulizumab til patienter med inddragelse af viscera er således ikke klarlagt aktuelt på grund af manglende data.
English: It should be administered by intravenous infusion only, over at least 60 minutes.
Danish: POTELIGEO er beregnet til intravenøs anvendelse og må kun administreres som en intravenøs infusion over et tidsrum på mindst 60 minutter.
English: Overall response rate (confirmed CR + PR, %) 95% CI P-valuea Viscera n=6
Danish: Overordnet responsrate (bekræftet CR + PR, %) 95% CI P-værdia Viscera n=6
English: When mogamulizumab has been administered to patients with T-cell lymphomas other than MF or SS, serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in less than 1% of patients during clinical trials, and also reported during the post-marketing period; some of these cases were reported with fatal outcomes.
Danish: Der er rapporteret om alvorlige hudreaktioner, herunder Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN), hos mindre end 1% af patienter med andre T-cellelymfomer end MF eller SS behandlet med mogamulizumab i kliniske studier og desuden i perioden efter markedsføringen af produktet.
English: The most frequently reported adverse reactions were infusion-related reaction and rash (drug eruption); most of these reactions were non-serious and Grades 1 or 2.
Danish: De fleste af disse bivirkninger var ikke alvorlige og grad 1 eller 2.
English: • Periodic safety update reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger
English: Reporting suspected adverse reactions
Danish: Indberetning af formodede bivirkninger
English: Response Rate (n, %)
Danish: Progressionsfri overlevelse (%)
English: Further information about the EU-wide safety review:
Danish: Yderligere oplysninger om den EU-dækkende sikkerhedsgennemgang:
English: It is currently available in the European Union (EU) in a number of different formulations.
Danish: Union (EU) i en række forskellige formuleringer.
English: 25 September 2013 EMA/592685/2013
Danish: Den 25. september 2013 EMA/592685/2013
English: • You should not stop taking your treatment without talking to your doctor.
Danish: • Du skal ikke holde op med at tage lægemidlet uden at have talt med lægen.
English: The safety of NSAIDs has been closely monitored by regulatory authorities in the EU.
Danish: Sikkerheden af NSAID er blevet tæt overvåget af lægemiddelmyndighederne i EU.
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Danish: Patientens behov for symptomatisk lindring og responsen på behandlingen bør revurderes regelmæssigt.
English: New safety advice for diclofenac
Danish: Nye sikkerhedsanvisninger for diclofenac
English: Limitations in the data had made it hard to quantify the risk initially, but a consistent picture was emerging by the time of the 2012 review.
Danish: I begyndelsen havde begrænsninger i dataene vanskeliggjort kvantificering af risikoen, men ved afslutningen af gennemgangen i 2012 begyndte der at tegne sig et sammenhængende billede.
English: Speak to your prescriber at your next scheduled appointment.
Danish: Tal med lægen om det ved den næste planlagte konsultation.
English: Diclofenac is an NSAID.
Danish: Diclofenac er et NSAID.
English: The review of systemic diclofenac was initiated on 31 October 2012 at the request of the United Kingdom medicines agency, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af systemiske præparater med diclofenac blev indledt den 31. oktober 2012 på anmodning af Det Forenede Kongeriges lægemiddelstyrelse i medfør af artikel 31 i direktiv 2001/83/EF.
English: New measures aim to minimise cardiovascular risks
Danish: Nye tiltag skal minimere de kardiovaskulære risici.
English: The product information will be amended and healthcare professionals prescribing or dispensing systemic diclofenac will receive further appropriate communication at a national level.
Danish: Produktoplysningerne vil blive ændret, og sundhedspersoner, der ordinerer eller udleverer systemisk diclofenac, vil modtage passende yderligere information på nationalt plan.
English: This applies particularly when diclofenac is used at a high dose and for long-term treatment.
Danish: Navnlig er dette tilfældet, når diclofenac anvendes i høje doser og til langvarig behandling.
English: As diclofenac-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Danish: Da lægemidler indeholdende diclofenac alle er godkendt nationalt, blev PRAC's anbefalinger overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMDh), som vedtog et endeligt standpunkt.
English: A class warning of this risk is in place and the product information for all NSAIDs recommends that these medicines be used at the lowest effective dose for the shortest period of time necessary to control symptoms.
Danish: Der er indført en klasseadvarsel, og i produktinformationen for alle NSAID anbefales det, at disse lægemidler anvendes i den laveste effektive dosis og i den kortest mulige tid, der er nødvendig for at kontrollere symptomerne.
English: • The effectiveness of diclofenac is well established.
Danish: • Effektiviteten af diclofenac er almindelig anerkendt.
English: • In the light of the above, all patients receiving regular diclofenac therapy should be reviewed at the next scheduled appointment.
Danish: • På baggrund af alt ovenstående bør alle patienter, der får regelmæssig behandling med diclofenac, gennemgås ved næste planlagte konsultation.
English: • As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Danish: • Da de kardiovaskulære risici med diclofenac kan øges med øget dosis og eksponeringsvarighed, bør der anvendes den kortest mulige behandlingstid og den laveste effektive daglige dosis.
English: Most formulations are for systemic use (given as treatment throughout the body, such as oral and injectable medicines), which are covered by the current review.
Danish: De fleste formuleringer er til systemisk anvendelse (til behandling af hele kroppen såsom orale præparater og injektionspræparater) som omfattet af denne gennemgang.
English: The latter found that, compared with placebo, the risk of major vascular events was increased by about one third by a COX-2 inhibitor (rate ratio [RR] 1.37, 95% confidence interval [CI] 1.14-1.66; p=0.0009) or diclofenac (1.41, 1.12-1.78; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, 1.312.37; p=0.0001; diclofenac: 1.70, 1.19-2.41; p=0.0032).
Danish: Analysen viste, at i forhold til placebo blev risikoen for større vaskulære hændelser øget med ca. en tredjedel af en COX-2 inhibitor (med et forhold mellem raterne [RR] på 1,37 med 95 % sikkerhedsinterval [SI] 1,14-1,66; p=0,0009) og af diclofenac (1,41, 1,12-1,78; p=0,0036), hovedsagelig som følge af en stigning i større koronare hændelser (coxib-præparater: 1,76, [1,31; 2,37]; p=0,0001; diclofenac: 1,70, [1,19; 2,41]; p=0,0032).
English: The PRAC review of diclofenac was started at the request of the UK medicines regulatory agency, the MHRA, in October 2012 in response to findings from the 2012 review of NSAIDs.
Danish: PRAC's gennemgang af diclofenac blev indledt på foranledning af Det Forenede Kongeriges lægemiddelstyrelse MHRA i oktober 2012 som reaktion på resultaterne af 2012-gennemgangen af NSAID.
English: The overall number of heart attacks in people at moderate risk would be expected to increase by around 3 cases per year for every 1,000 people treated with diclofenac (to 11 per 1,000 people per year).
Danish: Det samlede antal hjerteanfald hos personer med moderat risiko kan forventes at stige med ca. 3 tilfælde årligt for hver 1 000 personer behandlet med diclofenac (dvs. til 11 pr. 1 000 personer pr. år).
English: • If you are on long-term diclofenac treatment you will need to have your treatment reviewed to ensure that it is still right for you.
Danish: • Hvis du er i langvarig behandling med diclofenac, skal du få din behandling gennemgået for at sikre, at den stadig er den rette til dig.
English: About 8 people in 1,000 at moderate risk of heart disease are likely to have a heart attack over one year.
Danish: Af hver 1 000 personer med moderat risiko for hjertesygdom må ca. 8 forventes at få et hjerteanfald i løbet af et år.
English: Diclofenac is effective in reducing inflammation and pain.
Danish: Diclofenac er effektivt til at reducere inflammation og smerter.
English: On 28 June 2013, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority new safety advice for diclofenac-containing medicines that are given by means such as capsules, tablets, suppositories or injections, intended to have an effect on the whole body (known as a systemic effect).
Danish: Den 28. juni 2013 vedtog Koordinationsgruppen Vedrørende Gensidig Anerkendelse og Decentraliserede Godkendelsesprocedurer - human (CMD(h)) ved en flertalsafgørelse nye sikkerhedsanvisninger for lægemidler indeholdende diclofenac som kapsler, tabletter, suppositorier og injektionsvæsker, dvs. lægemiddelformer med tilsigtet virkning på hele kroppen (systemisk virkning).
English: Diclofenac-containing medicines have been authorised by national approval procedures in the EU Member States and have been available for many years under a wide range of trade names.
Danish: Lægemidler indeholdende diclofenac har været godkendt ved nationale procedurer i EUmedlemsstaterne og har været på markedet i mange år under mange forskellige handelsnavne.
English: The CMDh position was sent to the European Commission, which confirmed it and took a final legally binding decision throughout the EU on 25 September 2013.
Danish: CMDh's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og den 25. september 2013 en endelig beslutning, der er retligt bindende i hele EU.
English: If 1,000 patients at moderate risk took diclofenac for a year, there would be about 3 extra cases of heart attack among them, compared with patients not taking diclofenac.
Danish: Hvis 1 000 patienter med moderat risiko tager diclofenac i et år, vil der være ca. 3 ekstra hjertetilfælde blandt dem i forhold til patienter, der ikke tager diclofenac.
English: • Overall, the benefits of this medicine are greater than its risks, but there is a small risk of heart attack or stroke in patients taking systemic diclofenac regularly, especially at high doses (150 mg daily) and for long periods.
Danish: • Overordnet er fordelene ved dette lægemiddel større end dets risici, men der er en lille risiko for hjerteanfald eller slagtilfælde hos patienter, der regelmæssigt bruger diclofenac systemisk, navnlig i høje doser (150 mg dagligt) og i lange perioder.
English: The latest review by the PRAC was therefore initiated specifically to assess the benefit-risk of systemic diclofenac.
Danish: Den seneste gennemgang foretaget af PRAC blev derfor iværksat med særligt henblik på vurdering af benefit/risk-forholdet for systemisk administreret diclofenac.
English: • The PRAC has further reviewed available data including several new case-control and cohort studies, a post-hoc analysis of data from the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term) programme,1 and a meta-analysis2 by the Coxib and traditional NSAID Trialists Collaboration which involved over 600 clinical trials.
Danish: • PRAC har yderligere gennemgået foreliggende data, herunder flere nye case-control- og kohorteundersøgelser, en post hoc-analyse af data fra MEDAL-programmet (Multinational Etoricoxib and diclofenac Arthritis Long-term)1 og en metaanalyse2, der blev udført af Coxib and traditional NSAID Trialists' Collaboration og omfattede over 600 kliniske undersøgelser.
English: The new advice aims to minimise the risks of effects on the heart and circulation from these medicines.
Danish: Med de nye anvisninger skal risiciene ved disse lægemidlers virkninger på hjertet og kredsløbet minimeres.
English: • If you have other risk factors such as high blood pressure, high blood cholesterol, diabetes, or if you smoke, your doctor will need to assess if you should use diclofenac and the best way to take it.
Danish: • Hvis du har andre risikofaktorer såsom højt blodtryk, højt kolesteroltal eller sukkersyge eller er ryger, er det op til lægens vurdering, om du skal anvende diclofenac, og på hvilken måde det er bedst at tage det.
English: As the CMDh position was adopted by majority it was sent to the European Commission, which confirmed it and took a final legally binding decision valid throughout the EU.
Danish: Eftersom CMDh vedtog dette standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som godkendte det og vedtog en retligt bindende beslutning, der er gyldig i hele EU.
English: The cardiovascular risk with any NSAID depends on a person's underlying risk factors, such as high blood pressure and cholesterol levels and also any underlying heart or circulatory conditions.
Danish: For ethvert NSAID afhænger den kardiovaskulære risiko af personens underliggende risikofaktorer såsom højt blodtryk og kolesterolniveau foruden underliggende hjerte- eller kredsløbssygdom.
English: In addition to diclofenac, widely used NSAIDs also include ibuprofen and naproxen.
Danish: Af NSAID med udbredt anvendelse findes foruden diclofenac også ibuprofen og naproxen.
English: • Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
Danish: • Patienter med nævneværdige risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus eller rygning) bør kun behandles med diclofenac efter nøje overvejelse.
English: Overall, compared with placebo, allocation to diclofenac or a coxib caused around three additional major vascular events per 1,000 participants per year, with one such event causing death; in high-risk individuals, about seven or eight more would have a major vascular event, of which two would be fatal.
Danish: I forhold til placebo medfører behandling med diclofenac eller en coxib totalt ca. 3 yderligere større vaskulære hændelser 1 000 deltagere pr. år, heraf ét fatalt; af personer med høj risiko vil der være 7-8 flere, der får en større vaskulær hændelse, heraf to fatale.
English: Traditional NSAIDs act by blocking the effects of the two cyclo-oxygenase (COX) enzymes, known as COX-1 and COX-2, resulting in a reduced production of substances called prostaglandins.
Danish: Traditionelle NSAID virker ved at blokere virkningerne af de to cyclooxygenase- (COX-) enzymer COX-1 og COX-2, hvorved produktionen af prostaglandiner mindskes.
English: Although the risk is likely to be dose-dependent, the PRAC considered that cardiovascular thrombotic risk cannot be excluded across all doses of diclofenac, especially in patients with pre-existing co-morbidities.
Danish: Skønt risikoen må forventes at være dosisafhængig, mente PRAC ikke at det kan udelukkes, at der er kardiovaskulær trombotisk risiko ved alle doser af diclofenac, navnlig hos patienter med præeksisterende komorbiditet.
English: However, data from previous reviews carried out in 2005, 2006 and 2012 suggested an increased relative risk of arterial thromboembolic events which was sometimes greater than for other commonly prescribed NSAIDs and in some cases as great or greater than that seen with certain COX-2 inhibitors.
Danish: De tidligere gennemgange i 2005, 2006 og 2012 tydede imidlertid på en relativt øget risiko for arterielle tromboemboliske hændelser, som var noget højere end for andre sædvanligt ordinerede NSAID og i nogle tilfælde mindst lige så stor som den, der ses med visse COX-2-hæmmere.
English: • Use of diclofenac is contra-indicated in patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.
Danish: • Diclofenac er kontraindiceret ved manifest hjertesvigt (NYHA klasse II-IV), iskæmisk hjertesygdom, perifer arteriel sygdom og cerebrovaskulær sygdom.
English: A subgroup of NSAIDs, called ‘selective COX-2 inhibitors' (also known as ‘coxibs'), acts by blocking the COX-2 enzyme rather than both.
Danish: En undergruppe af NSAID, “selektive COX-2-hæmmere” (også kaldet coxib-præparater) virker ved at blokere COX-2-enzymet frem for begge enzymer.
English: This followed a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) which found that the effects of systemic diclofenac on the heart and circulation are similar to those of selective COX-2 inhibitors, another group of painkillers.
Danish: Dette følger efter en gennemgang foretaget af Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC), som fandt, at virkningerne af systemisk diclofenac på hjertet og kredsløbet svarer til virkningerne af en anden gruppe smertestillende lægemidler, nemlig selektive COX-2-hæmmere.
English: The PRAC therefore recommended that the same precautions already in place to minimise the risks of blood clots in the arteries with selective COX-2 inhibitors should be applied to diclofenac.
Danish: PRAC anbefalede derfor, at de forholdsregler, der allerede er indført for at minimere risiciene for blodpropper i arterierne med selektive COX-2-hæmmere, også skal gælde for diclofenac.
English: The CMDh agreed with the PRAC conclusion that although the benefits of systemic diclofenac still outweigh the risks, those risks were similar to the risks with COX-2 inhibitors, and it endorsed the recommendation that similar precautions should be applied.
Danish: CMDh tilsluttede sig PRAC's konklusion om, at fordelene ved systemisk diclofenac fortsat overstiger risiciene, men da disse risici svarer til risiciene med COX-2-hæmmere, vedtog CMDh anbefalingen om, at der skal gælde samme forholdsregler for diclofenac.
English: Diclofenac is authorised for the relief of pain and inflammation in a wide range of conditions, including arthritic conditions and acute musculoskeletal disorders.
Danish: Diclofenac er godkendt til lindring af smerter og inflammation ved en lang række tilstande, herunder gigtsygdomme og akutte lidelser i muskler og knogler.
English: It belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs' (NSAIDs).
Danish: Diclofenac tilhører gruppen af non-steroide antiinflammatoriske lægemidler (NSAID).
English: However, considering that the cardiovascular risk with systemic diclofenac appears similar to that of selective COX-2 inhibitors, it was considered that any risk minimisation in place for COX-2 inhibitors with respect to cardiovascular risk should also apply to diclofenac.
Danish: I betragtning af, at der ses samme forhøjelse af den kardiovaskulære risiko med diclofenac som med selektive COX-2-hæmmere, fandt udvalget imidlertid, at enhver foranstaltning til minimering af den kardiovaskulære risiko, der finder anvendelse for COX-2-hæmmere, også bør gælde for diclofenac.
English: • The risk with diclofenac is increased more if you are already at higher risk, so use is no longer recommended if you have already had a heart attack or stroke, or have heart failure, blockages to blood vessels to the heart or brain or an operation to clear or bypass such blockages, or circulatory problems that restrict blood flow to your limbs.
Danish: Derfor frarådes du nu at anvende det, hvis du allerede har haft et hjerteanfald eller slagtilfælde, hvis du har hjertesvigt, blokering af blodkarrene til hjertet eller hjernen, hvis du har fået foretaget en operation til at åbne sådanne blokerede kar eller en bypass-operation, eller hvis du har kredsløbsproblemer med nedsat blodtilførsel til arme og ben.
English: • Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150 mg daily) and in long-term treatment.
Danish: • Kliniske undersøgelser og epidemiologiske data tyder på, at brug af diclofenac kan være forbundet med øget risiko for arterielle trombotiske hændelser (f.eks. myokardieinfarkt eller apopleksi), navnlig i høje doser (150 mg dagligt) og ved langtidsbehandling.
English: The latter identified a small increased risk of these cardiovascular side effects with diclofenac compared with other NSAIDsan increase similar to that seen with the COX-2 inhibitors.
Danish: Gennemgangen viste, at risikoen for sådanne kardiovaskulære bivirkninger er lidt højere med diclofenac end med andre NSAID - en forskel svarende til den, der ses med COX-2-hæmmere.
English: Krum H, Swergold G, Gammaitoni A, et al.
Danish: Krum H, Swergold G, Gammaitoni A, et al. Blood pressure and cardiovascular outcomes in patients taking nonsteroidal antiinflammatory drugs.
English: Diclofenac is a widely used medicine for relieving pain and inflammation, particularly in painful conditions such as arthritis.
Danish: Diclofenac har udbredt anvendelse som smertestillende og inflammationsdæmpende middel, navnlig ved smertefulde sygdomme som gigt.
English: Since some prostaglandins are involved in causing pain and inflammation at sites of injury or damage in the body, a reduced production of prostaglandins reduces pain and inflammation.
Danish: Prostaglandiner medvirker til smerter og inflammation de steder i kroppen, hvor der er sket skade.
English: Reviews of these medicines carried out in 2005, 2006 and 2012 have confirmed that NSAIDs as a class are associated with a small increased risk of arterial thromboembolic events (blood clots in the arteries) especially in patients with underlying heart or circulatory conditions or with certain cardiovascular risk factors, which in some cases has led to heart attack or stroke, particularly if used at high dose and for long periods.
Danish: Gennemgange af disse lægemidler i 2005, 2006 og 2012 har bekræftet, at NSAID som klasse er forbundet med en let forhøjet risiko for blodpropper i arterierne (arterielle tromboemboliske hændelser).
English: As the risk is known to be somewhat higher with the subgroup of NSAIDs known as selective COX-2 inhibitors, increased measures to minimise risk are recommended in their product information.
Danish: bestående af selektive COX-2-hæmmere, anbefales der skærpede foranstaltninger til risikominimering i produktinformationen for disse lægemidler.
English: Pharmaceutical form
Danish: filmovertrukne