FrancophonIA/ELRC3.0 huggingface dataset:
English: Thyme and primula root preparations may also be found in additional combinations with other herbal substances in some herbal medicines.
Danish: Tilberedninger af timian og primularod findes desuden kombineret med andre droger i visse plantelægemidler.
English: How do thyme and primula root work as a medicine?
Danish: Hvordan virker timian og primularod som lægemiddel?
English: For more information about treatment with thyme and 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 timian og primularod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: In its assessment, the HMPC also considered clinical studies with thyme and primula root medicines in children.
Danish: I sin vurdering har HMPC også lagt vægt på kliniske undersøgelser af anvendelsen af lægemidler med timian og primularod til børn.
English: What evidence supports the use of thyme and primula root medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af timian og primularod?
English: What are thyme and primula root?
Danish: Hvad er timian og primularod?
English: If symptoms last longer than one week during the use of the medicine for chesty coughs a doctor or pharmacist should be consulted.
Danish: Hvis symptomerne varer længere end én uge under brug af lægemidlet til behandling af hoste med slim, bør du kontakte din læge eller dit apotek.
English: For practical information about using thyme and primula root combination 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 en kombination af timian og primularod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Therefore, the HMPC conclusions on the use of these thyme and primula root medicines for coughs associated with colds are based on their long-standing use.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med timian og primularod til behandling af hoste i forbindelse med forkølelse er derfor baseret på den mangeårige traditionelle anvendelse.
English: The HMPC conclusions on the use of certain other thyme and primula root preparations for coughs associated with colds are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af visse andre tilberedninger af timian og primularod til behandling af hoste i forbindelse med forkølelse er baseret på lægemidlernes "traditionelle anvendelse".
English: The HMPC conclusions on the use of certain thyme and primula root preparations for productive coughs are based on their ‘well-established use'.
Danish: HMPC's konklusioner om anvendelsen af visse tilberedninger af timian og primularod til behandling af hoste med slim er baseret på den "almindeligt anerkendte anvendelse".
English: The HMPC concluded that certain thyme and primula root preparations can be used as an expectorant (a medicine that helps bring up phlegm) for productive (chesty) coughs in adults.
Danish: HMPC har konkluderet, at visse tilberedninger af en kombination af timian og primularod kan anvendes som slimløsnende middel til at fremme ophostning af slim hos voksne.
English: The HMPC also concluded that other thyme and primula root preparations can be used for coughs associated with colds based on long-standing use of these medicines.
Danish: På baggrund af den mangeårige anvendelse har HMPC desuden konkluderet, at andre tilberedninger af timian og primularod kan anvendes til behandling af hoste i forbindelse med forkølelse.
English: The recommended dose is one tablet taken once a day for 12 weeks.
Danish: Den anbefalede dosis er én tablet én gang dagligt i 12 uger.
English: The full EPAR for Epclusa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Epclusa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Epclusa was well tolerated with a favourable safety profile.
Danish: Epclusa var veltolereret og havde en positiv sikkerhedsprofil.
English: This compared with 84% of patients who were treated with Epclusa alone.
Danish: Til sammenligning gjaldt dette kun for 84 % af de patienter, der blev behandlet med Epclusa alene.
English: This is a summary of the European public assessment report (EPAR) for Epclusa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Epclusa.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Epclusa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Epclusa opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Epclusa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Epclusa?
English: • rifampicin, rifabutin (antibiotics);
Danish: • rifampicin og rifabutin (antibiotika)
English: Clearance of the virus was seen for all genotypes including genotype 3.
Danish: Fjernelsen af virusset gælder alle genotyper, herunder genotype 3.
English: Other information about Epclusa
Danish: Andre oplysninger om Epclusa:
English: It is not intended to provide practical advice on how to use Epclusa.
Danish: Det er ikke en praktisk vejledning i, hvordan Epclusa bør anvendes.
English: Epclusa must not be used together with the following medicines, as they may reduce the levels of sofosbuvir and velpatasvir in the blood and thereby reduce the effectiveness of Epclusa:
Danish: Epclusa må ikke anvendes sammen med følgende lægemidler, da de kan reducere koncentrationen af sofosbuvir og velpatasvir i blodet og dermed virkningen af Epclusa:
English: Results showed that patients treated for 12 weeks with Epclusa in combination with ribavirin obtained the best results, with around 94% of patients (82 out of 87) testing negative for the virus 12 weeks after the end of treatment.
Danish: Resultaterne viste, at de patienter, der blev behandlet i 12 uger med Epclusa i kombination med ribavirin, opnåede de bedste resultater, idet ca. 94 % af patienterne (82 ud af 87) havde en negativ test for virusset 12 uger efter behandlingsafslutning.
English: Why is Epclusa approved?
Danish: Hvorfor blev Epclusa godkendt?
English: Epclusa can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Danish: Epclusa udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af patienter med kronisk hepatitis C.
English: What is Epclusa and what is it used for?
Danish: Hvad er Epclusa, og hvad anvendes det til?
English: Epclusa is available as tablets which contain 400 mg sofosbuvir and 100 mg velpatasvir.
Danish: Epclusa fås som tabletter, der indeholder 400 mg sofosbuvir og 100 mg velpatasvir.
English: Sofosbuvir blocks the action of an enzyme called ‘NS5B RNA-dependent RNA polymerase', while velpatasvir targets a protein called ‘NS5A'.
Danish: Sofosbuvir blokerer enzymet "NS5B RNA-afhængig RNA-polymerase", mens velpatasvir virker på proteinet "NS5A".
English: Epclusa on its own has been shown to be highly effective in clearing the hepatitis C virus from the blood of patients whose liver is able to work adequately.
Danish: Det er påvist, at Epclusa givet alene er meget effektivt til at fjerne hepatitis C-virusset fra blodet hos patienter, hvis lever fungerer tilstrækkeligt.
English: Epclusa has been investigated in three main studies involving a total of 1,446 patients infected with hepatitis C (genotypes 1 to 6) whose liver was still able to work adequately but some of whom had compensated liver cirrhosis.
Danish: Epclusa er blevet undersøgt i tre hovedundersøgelser med i alt 1 446 patienter med hepatitis C (genotype 1-6), hvis lever stadig fungerede tilstrækkeligt, men hvor nogle af dem havde kompenseret levercirrose.
English: For more information about treatment with Epclusa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Epclusa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substances in Epclusa, sofosbuvir and velpatasvir, block two proteins essential for the hepatitis C virus to multiply.
Danish: De aktive stoffer i Epclusa, sofosbuvir og velpatasvir, blokerer to proteiner, som hepatitis C-virusset behøver for at formere sig.
English: What are the risks associated with Epclusa?
Danish: Hvilke risici er der forbundet med Epclusa?
English: By blocking these proteins, Epclusa stops the hepatitis C virus from multiplying and infecting new cells.
Danish: Ved at blokere disse proteiner forhindrer Epclusa hepatitis Cvirusset i at formere sig og inficere nye celler.
English: An additional study was carried out in 267 hepatitis C patients whose liver was not working properly (Child-Pugh class B cirrhosis).
Danish: Der blev gennemført en yderligere undersøgelse hos 267 patienter med hepatitis C, hvis lever ikke fungerede normalt (Child-Pugh B-cirrose).
English: Looking at the results of the studies together, 98% of patients (1,015 out of 1,035) taking Epclusa for 12 weeks tested negative for the virus 12 weeks after the end of treatment.
Danish: De samlede resultater af undersøgelserne viser, at 98 % af de patienter (1 015 ud af 1 035), der tog Epclusa i 12 uger, havde en negativ test for virusset 12 uger efter behandlingsafslutning.
English: Hepatitis C virus occurs in several varieties (genotypes) and Epclusa can be used to treat hepatitis C caused by all genotypes of the virus.
Danish: Hepatitis C-virus optræder i forskellige varianter (genotyper), og Epclusa kan anvendes til at behandle alle genotyper af virusset.
English: Epclusa contains the active substances sofosbuvir and velpatasvir.
Danish: Epclusa indeholder de aktive stoffer sofosbuvir og velpatasvir.
English: Clearance was also very high in patients whose liver is not working properly (Child-Pugh class B cirrhosis), when treated with Epclusa in combination with ribavirin.
Danish: Fjernelsen var også meget omfattende hos patienter, hvis lever ikke fungerede normalt (Child-Pugh B-cirrose), når de fik Epclusa sammen med ribavirin.
English: For practical information about using Epclusa, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Epclusa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Epclusa is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.
Danish: Epclusa er et lægemiddel mod virus (et antiviralt lægemiddel), der anvendes til behandling af voksne med kronisk hepatitis C, der er en smitsom sygdom, som angriber leveren og forårsages af hepatitis Cvirus.
English: Epclusa is taken with another medicine called ribavirin in patients with decompensated liver disease (when the liver is not working properly).
Danish: Epclusa gives sammen med et andet lægemiddel (ribavirin) hos patienter med dekompenseret leversygdom (dvs. leveren fungerer ikke normalt).
English: For the full list of side effects or restrictions with Epclusa, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Epclusa fremgår af indlægssedlen.
English: • St John's wort (a herbal preparation used for depression and anxiety).
Danish: • prikbladet perikon (et naturlægemiddel til behandling af depression og angst).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Epclusa have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Epclusa.
English: What benefits of Epclusa have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Epclusa?
English: The addition of ribavirin to Epclusa may also be considered for patients who have compensated liver cirrhosis (scarring of the liver but the liver is still able to work adequately) and are infected with genotype 3 hepatitis C virus, a variety which is more difficult to treat.
Danish: Det kan også overvejes at give samtidig ribavirinbehandling til Epclusa-behandlede patienter, der har kompenseret levercirrose (ardannelse på leveren, men hvor leveren stadig fungerer tilstrækkeligt), og som er inficeret med hepatitis C-virus genotype 3,
English: How is Epclusa used?
Danish: Hvordan anvendes Epclusa?
English: How does Epclusa work?
Danish: Hvordan virker Epclusa?
English: 112 capsules
Danish: 112 kapsler
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration
English: Capsule, soft
Danish: 40 mg Kapsel, blød
English: 95% confidence interval
Danish: 95% Konfidensinterval
English: • have a severe heart problem.
Danish: • har et alvorligt hjerteproblem.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Danish: UNIK IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC:
English: This medicinal product does not require any special storage condition.
Danish: Dette lægemiddel kræver ingen særlige opbevaringsforhold.
English: • if you are taking riociguat.
Danish: • hvis De tager riociguat.
English: Not Known hypotension
Danish: Ikke kendt hypotension
English: There are no adequate and well controlled studies in lactating women.
Danish: Der findes ikke tilstrækkelige og godt kontrollerede studier med ammende kvinder.
English: • Severe hypotension (blood pressure < 90/50 mmHg) at initiation.
Danish: • Svær hypotension (blodtryk <90/50 mmHg) ved initiering.
English: The tablets are marked with M on one side and SL over 20 on the other.
Danish: Tabletterne er mærket M på den ene side og SL over 20 på den anden side.
English: In-vitro studies
Danish: In vitro studier
English: Microcrystalline cellulose (PH 102)
Danish: Mikrokrystallinsk cellulose (PH 102)
English: • if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
Danish: • hvis De for nylig har haft et slagtilfælde, eller et hjerteanfald, eller hvis De har svær leversygdom eller meget lavt blodtryk (<90/50 mmHg).
English: • Blood thinning medicines (for example warfarin) although these did not result in any side effect.
Danish: • blodfortyndende medicin (f.eks. warfarin), selv om det ikke resulterede i bivirkninger.
English: • have a rare inherited eye disease (retinitis pigmentosa).
Danish: • har en sjælden, arvelig øjensygdom (retinitis pigmentosa).
English: In case of clinical deterioration in spite of Mysildecard treatment, alternative therapies should be considered.
Danish: I tilfælde af klinisk forværring på trods af Mysildecard-behandling, bør alternative behandlingsmuligheder overvejes.
English: Children Mysildecard should not be given to children below 1 year of age.
Danish: Mysildecard bør ikke gives til børn under 1 år.
English: Manufacturer:
Danish: Fremstiller :
English: The causes of deaths were related to
Danish: Dødsårsagerne var relateret til PAH.
English: Mysildecard is for oral use only.
Danish: Mysildecard er kun beregnet til oral anvendelse.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Mylan Hungary Kft.
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Mylan Hungary Kft.
English: • have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
Danish: • har sygdom forårsaget af blokeret eller forsnævret vene i lungerne og ikke en blokeret eller forsnævret arterie.
English: • have low blood pressure at rest.
Danish: • har lavt blodtryk i hvile.
English: Physicians should advise patients who forget to take Mysildecard to take a dose as soon as possible and then continue with the normal dose.
Danish: Lægen skal informere patienter, der glemmer at tage Mysildecard, om at tage dosis hurtigst muligt og derefter fortsætte med at tage den normale dosis.
English: Mysildecard with food and drink You should not drink grapefruit juice while you are being treated with Mysildecard.
Danish: Brug af Mysildecard sammen med mad og drikke De må ikke drikke grapefrugtjuice, mens De er i behandling med Mysildecard.
English: Patients with left ventricular ejection fraction < 45% or left ventricular shortening fraction < 0.2 were not studied.
Danish: Patienter med venstre ventrikulær uddrivningsfraktion <45% eller venstre ventrikulær forkortningsfraktion <0,2% blev ikke undersøgt.
English: If you forget to take Mysildecard, take a dose as soon as you remember, then continue to take your medicine at the usual times.
Danish: Hvis De glemmer at tage Mysildecard, så tag en dosis, så snart De kommer i tanke om det, og fortsæt så med at tage Deres medicin til den sædvanlige tid.
English: Mylan S.A.S 117 Allee des parcs 69800 Saint Priest France
Danish: Mylan S.A.S 117 Allee des parcs 69800 Saint Priest Frankrig
English: • Recent history of stroke or myocardial infarction,
Danish: • Nyligt overstået slagtilfælde eller myokardieinfarkt.
English: A white, round, biconvex film-coated tablet (approximately 6.5 mm diameter), debossed with M on one side of the tablet and SL over 20 on the other side.
Danish: En hvid, rund, bikonveks filmovertrukken tablet (ca. 6,5 mm diameter), præget med M på den ene side af tabletten og SL over 20 på den anden side.
English: • if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).
Danish: • hvis De på noget tidspunkt tidligere har haft tab af synet på grund af problemer med blodtilførslen til nerven i øjet, tilstanden kaldes non-arteritis anterior iskæmisk opticusneuropati (NAION).
English: Of the 278 patients randomised, 277 patients received at least 1 dose of study drug.
Danish: randomiserede patienter fik 277 patienter mindst 1 dosis af studiemedicinen.
English: • take medicines for erectile dysfunction.
Danish: • tager medicin for impotens (erektil dysfunktion).
English: Film coat: hypromellose (6mPas), titanium dioxide (E171) and triacetin.
Danish: Filmovertræk: Hypromellose (6 mPas), titandioxid (E171) og triacetin.
English: Mysildecard film-coated tablets are white and round in shape.
Danish: Mysildecard filmovertrukne tabletter er hvide og runde.
English: Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.
Danish: Behandling af voksne patienter med pulmonal arteriel hypertension klassificeret som WHO-funktionsklasse II og III, til at forbedre det fysiske funktionsniveau.
English: Mysildecard brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Danish: Mysildecard nedsætter blodtrykket i lungerne ved at udvide blodkarrene i lungerne.
English: Mysildecard passes into your breast milk at very low levels and would not be expected to harm your baby.
Danish: Mysildecard udskilles i meget lave koncentrationer i modermælken og forventes ikke at skade Deres barn.
English: • have high blood pressure in the blood vessels in the lungs.
Danish: • har for højt blodtryk i blodkarrene i lungerne.
English: Taking more Mysildecard than you should may increase the risk of known side effects.
Danish: Hvis De tager mere Mysildecard, end De skal, kan det øge risikoen for bivirkninger.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Mysildecard, before driving or using machines.
Danish: Da der er rapporteret svimmelhed og ændret syn i kliniske studier med sildenafil, bør patienter være opmærksomme på, hvordan de reagerer på Mysildecard, inden de kører bil eller betjener maskiner.
English: Mysildecard can cause dizziness and can affect vision.
Danish: Mysildecard kan give svimmelhed og kan påvirke synet.
English: Mysildecard has moderate influence on the ability to drive and use machines.
Danish: Mysildecard påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: • if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
Danish: • hvis De tager medicin til behandling af svampeinfektioner som f.eks. ketoconazol eller itraconazol eller medicin som indeholder ritonavir (mod hiv).
English: No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects.
Danish: Der er ingen kliniske data tilgængelige omhandlende bivirkninger hos ammede barn, men indtagne mængder forventes ikke at give anledning til bivirkninger.
English: PVC-Al blister packs containing 90 or 300 film-coated tablets.
Danish: PVC-Al blisterpakker indeholdende 90 eller 300 filmovertrukne tabletter.
English: Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels.
Danish: Data fra en ammende kvinde indikerer, at sildenafil og den aktive metabolit M-desmethylsildenafil bliver udskildt i modermælk i meget lave koncentrationer.
English: The tablets are provided in blisters in packs containing 90, 300 and (90 x 1) tablets.
Danish: Tabletterne findes i blistere i pakninger med 90, 300 og (90 × 1) tabletter.
English: The safety and efficacy of sildenafil in children below 1 year of age has not been established.
Danish: Pædiatrisk population Sildenafils sikkerhed og virkning hos børn under 1 år er ikke klarlagt.
English: Mysildecard is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Danish: Mysildecard anvendes til at behandle voksne, børn og unge fra 1-17 år med for højt blodtryk i blodkarrene i lungerne (pulmonal arteriel hypertension).
English: 90 film-coated tablets 300 film-coated tablets 90 x 1 film-coated tablets
Danish: 90 filmovertrukne tabletter 300 filmovertrukne tabletter 90 × 1 filmovertrukket tablet
English: Non-clinical data revealed no special hazard for humans based on conventional studies of fertility (see section 5.3).
Danish: Præ-kliniske data tyder ikke på særlig risiko for mennesker baseret på konventionelle fertilitetsstudier (se pkt.
English: Suddenly stopping your treatment with Mysildecard may lead to your symptoms getting worse.
Danish: Hvis De pludseligt stopper med at tage Mysildecard, kan Deres symptomer blive forværret.
English: Limited data suggests that the abrupt discontinuation of sildenafil is not associated with rebound worsening of pulmonary arterial hypertension.
Danish: Data fra et begrænset antal antyder, at en pludselig afbrydelse af sildenafil-behandlingen ikke er forbundet med et forværret tilbagefald af pulmonal arteriel hypertension.
English: Of those sildenafil treated subjects developmentally able to perform the CPET 59/114 subjects (52%) had not shown any deterioration in Peak VO2 from start of sildenafil.
Danish: Af de forsøgspersoner, der havde fået sildenafil, og som udviklingsmæssigt var i stand til at udføre CPET-testen, havde 59/114 (52%) forsøgspersoner ikke vist forværring i maksimal VO2 fra initieringen af sildenafil-behandlingen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1134/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/16/1134/001