FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Repatha (which may affect up to 1 in 100 people) are nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), back pain, joint pain, flu and reactions at the site of injection.
Danish: De hyppigste bivirkninger ved Repatha (som kan forekomme hos op til 1 ud af 100 personer) er nasopharyngitis (betændelse i næse og svælg), infektion de i øvre luftveje (næse og svælg), rygsmerter, ledsmerter, influenza og reaktioner på injektionsstedet.
English: For adults and children aged 12 years and above with homozygous familial hypercholesterolaemia, the initial recommended dose is 420 mg once a month.
Danish: Til voksne og børn fra 12-års alderen med homozygot familiær hyperkolesterolæmi er den anbefalede startdosis 420 mg én gang om måneden.
English: Repatha also helps to reduce other fatty substances from blood in patients with mixed dyslipidaemia.
Danish: Repatha hjælper også med til at reducere blodets indhold af andre fedtstoffer hos patienter med blandet dyslipidæmi.
English: In patients with atherosclerotic heart disease, Repatha reduced the number of cardiovascular events, in particular heart attacks and strokes.
Danish: Hos patienter med aterosklerotisk hjertesygdom mindskede Repatha antallet af hjerte-kar-hændelser, navnlig hjerteanfald og slagtilfælde.
English: Some of the studies looked at Repatha taken on its own, while others studied Repatha in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins.
Danish: Nogle af studierne så på Repatha alene, mens andre så på Repatha i kombination med andre fedtsænkende lægemidler, herunder patienter på den maksimalt anbefalede dosis af statiner.
English: Repatha is used in combination with a statin or a statin and other fat-lowering medicines.
Danish: Repatha anvendes i kombination med et statin, eller med et statin sammen med andre fedtstofnedsættende lægemidler.
English: Repatha is available as a solution for injection in pre-filled syringes (140 mg), pre-filled pens (140 mg) and cartridges (420 mg).
Danish: Repatha leveres som injektionsvæske i fyldte sprøjter (140 mg), fyldte injektionspenne (140 mg) og cylinderampuller (420 mg).
English: The injection is given under the skin of the abdomen, thigh or upper arm.
Danish: Injektionen gives under huden på maven, i låret eller i overarmen.
English: Repatha was studied in more than 27,500 patients with a history of established cardiovascular disease.
Danish: Repatha er undersøgt hos over 27 500 patienter med bekræftet tidligere hjerte-kar-sygdom.
English: One of these studies showed that Repatha given together with other fat-lowering medicines reduced fat levels in the blood after 12 weeks of treatment (around 15 to 32% more than placebo given on top of other fat-lowering medicines).
Danish: Et af disse studier viste, at Repatha givet sammen med andre fedtsænkende lægemidler nedsatte fedtindholdet i blodet efter 12 ugers behandling (ca. 1532 % mere end placebo givet i tillæg til andre fedtsænkende lægemidler).
English: For the full list of side effects and restrictions with Repatha, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Repatha fremgår af indlægssedlen.
English: It is also used to reduce the risk of heart problems in patients with atherosclerosis (thickened arterial walls) who have had a heart attack, stroke or other problems of the circulatory system (atherosclerotic heart disease).
Danish: Det anvendes desuden til at reducere risikoen for hjerteproblemer hos patienter, der har fortykkede arterievægge (aterosklerose) og har haft et hjerteanfald, slagtilfælde eller andre problemer med kredsløbet (aterosklerotisk hjertesygdom).
English: The Agency noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, Repatha showed an important reduction in LDLcholesterol levels, which is a known risk factor for cardiovascular disease.
Danish: Udvalget bemærkede, at Repatha i alle studierne hos patienter med primær hyperkolesterolæmi og blandet dyslipidæmi væsentligt nedsatte LDL-kolesterolindholdet, der er en kendt risikofaktor for kardiovaskulære sygdomme.
English: In homozygous familial hypercholesterolaemia, Repatha was studied in 2 main studies involving 155 patients, which included 14 children older than 12 years.
Danish: Ved homozygot familiær hyperkolesterolæmi blev Repatha undersøgt i to hovedstudier, der omfattede 155 patienter, hvoraf 14 var børn fra 12-års alderen.
English: It is used to reduce blood fat levels in patients with primary hypercholesterolaemia (high blood cholesterol levels caused by a genetic abnormality), homozygous familial hypercholesterolaemia (a severe form of high blood cholesterol inherited from both parents) and mixed dyslipidaemia (abnormal levels of different fats, including cholesterol).
Danish: Det anvendes til at reducere blodets indhold af fedtstoffer hos patienter med højt kolesterolindhold i blodet som følge af en genetisk afvigelse (primær hyperkolesterolæmi), en svær form for højt kolesterolindhold i blodet, der arves fra begge forældre (homozygot familiær hyperkolesterolæmi) og unormal mængde af forskellige fedtstoffer, herunder kolesterol (blandet dyslipidæmi).
English: What are the risks associated with Repatha?
Danish: Hvilke risici er der forbundet med Repatha?
English: In this population, including some children above 12 years, Repatha showed a consistent reduction in LDLcholesterol levels beyond what can be achieved with existing fat-lowering medicines.
Danish: Hos denne patientgruppe, herunder nogle børn over 12 år, nedsatte Repatha konsekvent LDLkolesterolindholdet mere end hvad eksisterende, fedtsænkende lægemidler er i stand til.
English: Repatha is a medicine for lowering levels of fats in the blood.
Danish: Repatha er et lægemiddel beregnet til at sænke blodets indhold af fedtstoffer.
English: In primary hypercholesterolaemia and mixed dyslipidaemia, Repatha was studied in 9 main studies involving around 7,400 adult patients, including patients with heterozygous familial disease.
Danish: Hvad angår primær hyperkolesterolæmi og blandet dyslipidæmi blev Repatha undersøgt i ni hovedstudier med ca. 7 400 voksne patienter, herunder patienter med heterozygot familiær sygdom.
English: The recommended dose for adults with primary hypercholesterolaemia, mixed dyslipidaemia and atherosclerotic heart disease is either 140 mg every two weeks or 420 mg (the contents of three prefilled syringes or one cartridge) once a month.
Danish: Den anbefalede dosis til voksne med primær hyperkolesterolæmi, blandet dyslipidæmi og aterosklerotisk hjertesygdom er enten 140 mg hver anden uge eller 420 mg (indholdet af tre fyldte sprøjter eller én cylinderampul) én gang om måneden.
English: How is Repatha used?
Danish: Hvordan anvendes Repatha?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Repatha have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Repatha.
English: What benefits of Repatha have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Repatha?
English: How does Repatha work?
Danish: Hvordan virker Repatha?
English: If symptoms last
Danish: Hvis symptomerne varer længere end
English: Some specific preparations may be used in children between 4 and 12 years of age.
Danish: Visse bestemte tilberedninger kan anvendes hos børn fra 4 til 12 år.
English: Primula veris L. and/or Primula elatior (L.) Hill, radix
Danish: Primula veris L. og/eller Primula elatior (L.) Hill, radix
English: Primula root EMA/424238/2016
Danish: Primularod EMA/424238/2016
English: Primula root
Danish: Primularod
English: Most primula root preparations should only be used in adults and adolescents over the age of 12 years.
Danish: De fleste lægemidler indeholdende primularod bør kun anvendes hos voksne og børn over 12 år.
English: longer than one week or worsen during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Danish: en uge eller forværres under brug af lægemidlet, bør der søges råd hos en læge eller på apoteket.
English: Primula root is the common name for the underground parts of the plant Primula veris L. and/or Primula elatior (L.) Hill.
Danish: Primularod er det almindelige navn for de underjordiske dele af planten Primula veris L. og/eller Primula elatior (L.) Hill.
English: What is primula root?
Danish: Hvad er primularod?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/424238/2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Information on the use and licensing of primula root medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder primularod, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing primula root.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder primularod.
English: Other information about primula root medicines
Danish: Andre oplysninger om lægemidler, der indeholder primularod
English: Any applications for the licensing of medicines containing primula root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder , skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Primula root preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af primularod findes desuden kombineret med andre droger i visse plantelægemidler.
English: Herbal medicines containing these primula root preparations are usually available as herbal tea to be drunk and in liquid or solid forms to be taken by mouth.
Danish: Plantelægemidler med primularod i disse tilberedninger fås normalt som urtete beregnet til at drikke eller i flydende eller fast form til anvendelse gennem munden.
English: Detailed instructions on how to take primula root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med primularod bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Further information on the HMPC assessment of primula root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder primularod, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på det europæiske lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of primula root.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af primularod.
English: Further information on the risks associated with these primula root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder primularod, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions only cover primula root preparations which are obtained by drying and comminuting (reducing into tiny pieces) the underground parts or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or methanol) to dissolve compounds and form a liquid extract.
Danish: HMPC's konklusioner omfatter kun tilberedninger af primularod, som fremstilles ved tørring og findeling af de underjordiske dele eller ved at udtrække stoffer fra plantematerialet i et opløsningsmiddel (såsom ethanol eller methanol).
English: The HMPC conclusions on the use of these primula root medicines for coughs are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med primularod er baseret på disse lægemidlers "traditionelle anvendelse" til hoste.
English: How are primula root medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder primularod, i EU?
English: The solvent is then either fully or partially evaporated to obtain a dry or soft extract.
Danish: Ved fremstilling af tørekstrakt / blødt ekstrakt fordampes opløsningsmidlet herefter helt / delvist for at opnå det tørre / bløde ekstrakt.
English: This summary is not intended to provide practical advice on how to use medicines containing primula root.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder primularod, skal anvendes.
English: What are the risks associated with primula root medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder primularod?
English: What evidence supports the use of primula root medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af primularod?
English: In its assessment, the HMPC considered laboratory studies which showed primula root increased production of airway secretions, making phlegm less thick and easier to expel.
Danish: HMPC har vurderet laboratorieundersøgelser, der viste, at primularod øgede mængden af sekret i luftvejene, således at slimen blev mindre tyk og lettere at hoste op. Der er ingen kliniske undersøgelser med tilberedninger, der kun indeholder primularod.
English: For more information about treatment with primula root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder primularod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC concluded that, on the basis of its long-standing use, these primula root preparations can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at primularod i disse tilberedninger kan anvendes som slimløsnende middel (ekspektorans) ved hoste i forbindelse med forkølelse.
English: For practical information about using primula root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med primularod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Date of first authorisation: 17 January 2007 Date of latest renewal: 22 November 2011
Danish: Dato for første markedsføringstilladelse: 17. januar 2007 Dato for seneste fornyelse: 22. november 2011
English: See also information under the heading “Do not take Exforge”.
Danish: Se også information under overskriften ”Tag ikke Exforge”.
English: It is recommended to take Exforge with some water.
Danish: Det anbefales at tage Exforge med lidt vand.
English: You should never take Exforge again.
Danish: Du bør aldrig tage Exforge igen.
English: After the transitional period of 2 years, a limit for NDMA of maximum 0.03 ppm should be implemented.
Danish: Efter overgangsperioden på to år bør en grænseværdi for NDMA på højst 0,03 ppm implementeres.
English: In two long-term follow-up studies the effect of Exforge was maintained for over one year.
Danish: I to langtids-og opfølgningsstudier blev effekten af Exforge opretholdt i over et år.
English: You can take Exforge with or without food.
Danish: - Du kan tage Exforge med eller uden mad.
English: Over 1,400 hypertensive patients received Exforge once daily in two placebo-controlled trials.
Danish: Mere end 1.400 hypertensive patienter har fået Exforge en gang daglig i to placebokontrollerede studier.
English: Exforge with food and drink
Danish: Exforge sammen med mad og drikke
English: Exforge is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Exforge frarådes i den tidlige periode af graviditeten (de første 3 måneder), og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på din baby, hvis det tages efter tredje måned af graviditeten.
English: N-nitrosodimethylamine (NDMA)
Danish: N-nitrosodimethylamin (NDMA)
English: Exforge and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Danish: Exforge og ældre patienter (65 år og derover) Din læge bør udvise forsigtighed, når dosis øges.
English: Do not use any Exforge pack that is damaged or shows signs of tampering.
Danish: Brug ikke pakninger med Exforge, som er beskadiget eller viser tegn på åbning.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Danish: Alder, køn, race eller body mass indeks (≥30 kg/m 2, <30 kg/m 2) havde ingen indflydelse på Exforges virkning.
English: If you have taken too many tablets of Exforge, or if someone else has taken your tablets, consult a doctor immediately.
Danish: Hvis du har taget for mange Exforge-tabletter, eller hvis andre har taget dine tabletter, skal du kontakte en læge med det samme.
English: Correction of this condition prior to administration of Exforge or close medical supervision at the start of treatment is recommended.
Danish: Det anbefales, at denne tilstand korrigeres før administration af Exforge, eller at der foretages tæt medicinsk overvågning ved behandlingens start.
English: Children and adolescents The use of Exforge in children and adolescents is not recommended (aged below 18 years old).
Danish: Børn og unge Brug af Exforge til børn og unge frarådes (under 18 år).
English: Stopping your treatment with Exforge may cause your disease to get worse.
Danish: Hvis du holder op med at tage Exforge, kan det resultere i, at din sygdom bliver værre.
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Exforge.
Danish: Hvis der samtidig gives et diuretikum, kan risikoen for lithiumtoksicitet muligvis være yderligere øget med Exforge.
English: Do not take Exforge with grapefruit or grapefruit juice.
Danish: Tag ikke Exforge sammen med grapefrugt eller grapefrugtjuice.
English: If you get these symptoms, stop taking Exforge and contact your doctor straight away.
Danish: Hvis du får disse symptomer, skal du stoppe med at tage Exforge og kontakte din læge med det samme.
English: Exforge has not been studied in any patient population other than hypertension.
Danish: Exforge er ikke undersøgt i andre patientgrupper end hypertension.
English: Exforge should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Danish: Exforge skal seponeres straks hos patienter, som udvikler angioødem, og behandlingen bør ikke genoptages.
English: The usual dose of Exforge is one tablet per day.
Danish: Den sædvanlige dosis af Exforge er én tablet daglig.
English: There is no experience of overdose with Exforge.
Danish: Der er ingen erfaring med overdosering af Exforge.
English: Your doctor will normally advise you to stop taking Exforge before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Exforge, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
English: No drug-drug interaction studies have been performed with Exforge and other medicinal products.
Danish: Der er ikke udført lægemiddelinteraktionsstudier med Exforge og andre lægemidler.
English: Abrupt withdrawal of Exforge has not been associated with a rapid increase in blood pressure.
Danish: Pludselig seponering af Exforge er ikke blevet forbundet med hurtig blodtryksstigning.
English: The recommended dose of Exforge is one tablet per day.
Danish: Den anbefalede dosis af Exforge er én tablet daglig.
English: The safety of Exforge has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Danish: Exforges sikkerhed er blevet evalueret i fem kontrollerede kliniske studier med 5.175 patienter, hvoraf 2.613 modtog valsartan i kombination med amlodipin.
English: To date there is no experience of the safe use of Exforge in patients who have had a recent kidney transplantation.
Danish: På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Exforge til patienter, som kort tid forinden har modtaget nyretransplantation.
English: If you think you may be allergic, talk to your doctor before taking Exforge.
Danish: Hvis du tror, du er allergisk, skal du tale med din læge, inden du tager Exforge.
English: if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for valsartan eller et af de øvrige indholdsstoffer i Exforge (angivet i punkt 6).
English: Exforge should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Danish: Exforge skal anvendes med forsigtighed ved behandling af hypertension hos patienter med unilateral eller bilateral nyrearteriestenose eller stenose i en enkelt nyre, da blod-urea og serum-kreatinin kan stige hos disse patienter.
English: Do not take Exforge if you are allergic to amlodipine or to any other calcium channel blockers.
Danish: Tag ikke Exforge - hvis du er allergisk over for amlodipin eller andre calciumantagonister.
English: Exforge tablets contain two substances called amlodipine and valsartan.
Danish: Exforge tabletter indeholder to stoffer, som kaldes amlodipin og valsartan.
English: The rate and extent of absorption of Exforge are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Danish: Hastigheden og graden af Exforge-absorptionen er ækvivalent med valsartans og amlodipins biotilgængelighed, når de gives som individuelle tabletter.
English: Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Exforge as well, even if not observed in clinical trials or during the post-marketing period.
Danish: Bivirkninger, som tidligere er indrapporteret for hver enkelt af de individuelle komponenter (amlodipin eller valsartan), kan også være potentielle bivirkninger med Exforge, selv i de tilfælde, hvor de ikke er set i kliniske studier eller i perioden efter markedsføring.