FrancophonIA/ELRC3.0 huggingface dataset:
English: Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Procoralan or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Danish: Hypericum perforatum eller perikon (naturmedicin for depression) medicin, der forlænger QT-intervallet i ekg til behandling af enten hjerterytmeforstyrrelser eller andre sygdomme, som f.eks.: - quinidin, disopyramid, ibutilid, sotalol, amiodaron (til behandling af forstyrrelser af hjertets rytme) - bepridil (til behandling af angina pectoris) - visse lægemidler til behandling af angst, skizofreni eller andre alvorlige sindslidelser (fx pimozid, ziprasidon og sertindol) - malariamidler (fx mefloquin eller halofantrin) - intravenøs erythromycin (et antibiotikum) - pentamidin (et lægemiddel mod parasitter) - cisaprid (mod mavesyre-reflux fra mavesæk til spiserør) nogle typer vanddrivende medicin (diuretika), der kan medføre nedsat kaliumniveau i blodet, såsom furosemid, hydrochlorthiazid, indapamid (anvendt til at behandle ødemer og højt blodtryk)
English: Suomi/Finland Servier Finland Oy Puh/Tel: +358 (0)9 279 80 80
Danish: Puh/Tel: +358 (0)9 279 80 80
English: NAME OF THE MEDICINAL PRODUCT Procoralan 5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Procoralan 5 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Procoralan 7.5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Procoralan 7,5 mg filmovertrukne tabletter
English: Procoralan 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Danish: Procoralan 5 mg: En filmovertrukket tablet indeholder 5 mg ivabradin (hvilket svarer til 5,390 mg ivabradin som hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Procoralan 5 mg film-coated tablets ivabradine
Danish: LÆGEMIDLETS NAVN Procoralan 5 mg filmovertrukne tabletter ivabradin
English: Procoralan 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Danish: Procoralan 7,5 mg: En filmovertrukket tablet indeholder 7,5 mg ivabradin (hvilket svarer til 8,085 mg ivabradin som hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Procoralan 7.5 mg film-coated tablets ivabradine
Danish: LÆGEMIDLETS NAVN Procoralan 7,5 mg filmovertrukne tabletter ivabradin
English: What Procoralan is and what it is used for What you need to know before you take Procoralan How to take Procoralan
Danish: Det skal De vide, før De begynder at tage Procoralan Sådan skal De tage Procoralan Bivirkninger
English: - if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heart beat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
Danish: Tag ikke Procoralan hvis De er allergisk over for ivabradin eller et af de øvrige indholdsstoffer i Procoralan (angivet i punkt 6) hvis Deres hjertefrekvens i hvile før behandlingen er for langsom (under 70 slag i minuttet) hvis De lider af kardiogent shock (en hjertesygdom, som skal behandles på hospital) hvis De lider af forstyrrelser i hjertets rytme hvis De får et hjerteanfald hvis De lider af meget lavt blodtryk hvis De lider af ustabil hjertekrampe (en alvorlig form med hyppige brystsmerter, der opstår både under hvile og anstrengelse) hvis De lider af hjertesvigt, og Deres tilstand for nylig er forværret hvis Deres hjerterytme udelukkende styres af en pacemaker hvis De lider af svære leverproblemer hvis De allerede tager medicin til behandling af svampeinfektioner (fx ketoconazol, itraconazol), makrolidantibiotika (fx josamycin, clarithromycin, telithromycin eller erythromycin givet oralt) eller medicin til behandling af hiv-infektioner (som fx nelfinavir, ritonavir) eller nefazodon (medicin til behandling af depressioner) eller diltiazem, verapamil (bruges til for højt blodtryk eller angina pectoris) hvis De er en kvinde i den fødedygtige alder og ikke anvender sikker prævention; hvis De er gravid eller forsøger at blive gravid; hvis De ammer.
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration
English: Pack size
Danish: Pakningsstørrels
English: The infusion should last around 15 minutes.
Danish: Infusionen bør vare cirka 15 minutter.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Respreeza on 20 August 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Respreeza den 20. august 2015.
English: Other information about Respreeza
Danish: Andre oplysninger om Respreeza
English: The full EPAR for Respreeza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Respreeza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Respreeza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Respreeza.
English: Allergic reactions have been observed during treatment, some of which were severe.
Danish: Under behandlingen er der iagttaget allergiske reaktioner, hvoraf nogle var svære.
English: Subsequent infusions can be given by a caregiver or by the patient.
Danish: Efterfølgende infusioner kan gives af en omsorgsgiver eller af patienten selv.
English: No other major concerns have been identified about the safety of the medicine.
Danish: Der har ikke været andre større sikkerhedsmæssige betænkeligheder med dette lægemiddel.
English: What measures are being taken to ensure the safe and effective use of Respreeza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Respreeza?
English: The recommended dose of Respreeza is 60 mg per kilogram body weight, given once a week.
Danish: Den anbefalede dosis af Respreeza er 60 mg pr. kg legemsvægt én gang ugentligt.
English: The company that markets Respreeza will carry out a further study to assess whether an increased dose of 120 mg/kg may lead to improved effects compared with the currently recommended dose.
Danish: Virksomheden, som markedfører Respreeza, skal udføre en yderligere undersøgelse for at vurdere, om en øget dosis på 120 mg/kg kan give en bedre virkning end den nuværende anbefalede dosis.
English: The decrease in lung density after 24 months was around 2.6 g/l in patients who received Respreeza, compared with a decrease of around 4.2 g/l in patients receiving placebo.
Danish: Faldet i lungernes vægtfylde efter 24 måneder var cirka 2,6 g/l hos de patienter, der fik Respreeza, sammenholdt med et fald på cirka 4,2 g/l hos dem, der fik placebo.
English: It is not intended to provide practical advice on how to use Respreeza.
Danish: Det er ikke en praktisk vejledning i, hvordan Respreeza bør anvendes.
English: What is Respreeza and what is it used for?
Danish: Hvad er Respreeza, og hvad anvendes det til?
English: Why is Respreeza approved?
Danish: Hvorfor blev Respreeza godkendt?
English: Allergic reactions were the main safety concern with Respreeza, but advice on how to manage this risk has been included in the product information.
Danish: Allergiske reaktioner var det vigtigste sikkerhedsproblem med Respreeza, men produktinformationen indeholder anvisninger om, hvordan denne risiko håndteres.
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Respreeza'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 Respreeza opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The most common side effects with Respreeza (which may affect up to 1 in 10 people) are dizziness, headache, dyspnoea (shortness of breath) and nausea.
Danish: De hyppigste bivirkninger ved Respreeza (som kan forekomme hos op til 1 ud af 10 personer) er svimmelhed, hovedpine, stakåndethed (dyspnø) og kvalme.
English: What are the risks associated with Respreeza?
Danish: Hvilke risici er der forbundet med Respreeza?
English: For more information about treatment with Respreeza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Respreeza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Respreeza is used to slow down damage to the lungs in patients with severe disease.
Danish: Respreeza anvendes til at bremse beskadigelsen af lungerne hos patienter med svær sygdom.
English: Respreeza human alpha1-proteinase inhibitor
Danish: Respreeza human alpha1-proteinasehæmmer
English: For the full list of all side effects and restrictions with Respreeza, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Respreeza fremgår af indlægssedlen.
English: Because of the risk of severe allergic reactions, Respreeza must not be used in patients who are lacking IgA, a protein in the blood, and who have developed antibodies against it because these patients are more prone to allergic reactions.
Danish: Da der er risiko for svære allergiske reaktioner, må Respreeza ikke anvendes til patienter, der mangler et protein i blodet, der kaldes IgA, og som har udviklet antistoffer mod det, fordi de er mere tilbøjelige til at få allergiske reaktioner.
English: Respreeza is available as a powder and solvent to be made into a solution for infusion (drip) into a vein.
Danish: Respreeza leveres som et pulver og en solvens til fremstilling af en opløsning, der indgives ved infusion (drop) i en vene.
English: For practical information about using Respreeza, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Respreeza, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Respreeza, human alpha1-proteinase inhibitor, is a natural protein in the blood which protects lung tissue from damage.
Danish: Det aktive stof i Respreeza, human alpha1-proteinasehæmmer, er et naturlig protein i blodet, som beskytter lungevævet mod beskadigelse.
English: The main study with Respreeza showed that the medicine is effective at slowing down the damage to the lungs in patients with alpha1-proteinase inhibitor deficiency, and this effect is considered relevant for patients with severe disease.
Danish: Hovedundersøgelsen med Respreeza viste, at lægemidlet er effektivt til at nedsætte beskadigelsen af lungerne hos patienter med mangel på alpha1-proteinasehæmmer, og denne virkning anses for at være relevant hos patienter med svær sygdom.
English: Lung density is an indicator of the extent of lung damage: the bigger the decrease in lung density, the greater is the damage to the lung.
Danish: Lungernes vægtfylde er en indikator for omfanget af lungebeskadigelsen: Jo større fald i lungernes vægtfylde, desto større lungebeskadigelse.
English: How is Respreeza used?
Danish: Hvordan anvendes Respreeza?
English: What benefits of Respreeza have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Respreeza?
English: Respreeza is a medicine used in adults with alpha1-proteinase inhibitor deficiency, an inherited disorder that can cause lung problems such as increasing shortness of breath and which may also affect the liver.
Danish: Respreeza er et lægemiddel, der anvendes hos voksne med den arvelige sygdom alpha1proteinaseinhibitormangel, der kan medføre lungeproblemer såsom voksende stakåndethed, og som også kan påvirke leveren.
English: The first infusion should be given under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Danish: Den første infusion bør gives under opsyn af en sundhedsperson med erfaring i behandling af mangel på alpha1-proteinasehæmmer.
English: It is obtained from human blood and works by replacing the protein that is lacking in patients with alpha1-proteinase inhibitor deficiency.
Danish: Det fås fra blodet hos mennesker og virker ved at erstatte det protein, der mangler hos patienter med alpha1-proteinasehæmmermangel .
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Respreeza have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Respreeza.
English: In the study, Respreeza was compared with placebo (a dummy treatment) and the main measure of effectiveness was the decrease in lung density.
Danish: I undersøgelsen blev Respreeza sammenlignet med virkningsløs behandling (placebo).
English: Respreeza contains the active substance human alpha1-proteinase inhibitor.
Danish: Respreeza indeholder det aktive stof human alpha1-proteinasehæmmer.
English: How does Respreeza work?
Danish: Hvordan virker Respreeza?
English: Respreeza has been shown to slow down lung damage in one main study involving 180 patients with lung damage due to alpha1-proteinase inhibitor deficiency.
Danish: Det er i en hovedundersøgelse hos 180 patienter med lungebeskadigelse som følge af mangel på alpha1-proteinasehæmmer blevet påvist, at Respreeza bremser lungebeskadigelsen.
English: It must not be used in patients with:
Danish: Det må ikke anvendes til patienter med:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emselex on 22 October 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Emselex den 22. oktober 2004.
English: The full EPAR for Emselex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Emselex findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Emselex.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Emselex.
English: The recommended starting dose of Emselex is 7.5 mg once a day.
Danish: Den anbefalede startdosis af Emselex er 7,5 mg én gang om dagen.
English: At the start of the studies, the patients had around 16 incontinence episodes per week.
Danish: Ved undersøgelsens start havde patienterne ca. 16 episoder om måneden.
English: After 12 weeks of treatment, patients receiving Emselex 7.5 mg or 15 mg had 8.8 (68%) or 10.6 (77%) fewer episodes of incontinence per week, respectively, and patients receiving placebo had 7 or 7.5 (54 or 58%) fewer episodes per week.
Danish: Efter 12 ugers behandling havde patienter, der fik Emselex 7,5 mg eller 15 mg, 8,8 (68 %) eller 10,6 (77 %) færre episoder af inkontinens pr. uge, og patienter, der fik placebo, havde 7 eller 7,5 (54 eller 58 %) færre episoder pr. uge.
English: The main measure of effectiveness was the change in the number of incontinence episodes per week.
Danish: Hovedmålet for virkningen var ændringen i det ugentlige antal inkontinensepisoder.
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 Emselex.
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 Emselex.
English: It is available as prolongedrelease tablets (7.5 mg and 15 mg).
Danish: Det leveres som depottabletter (7,5 mg og 15 mg).
English: The most common side effects with Emselex (seen in more than 1 patient in 10) are dry mouth and constipation.
Danish: De hyppigste bivirkninger ved Emselex (som ses hos flere end 1 ud af 10 patienter) er tør mund og forstoppelse.
English: When the results from all four studies were combined, Emselex was more effective in reducing the number of incontinence episodes than placebo.
Danish: Når resultaterne af alle fire undersøgelser lægges sammen, var Emselex mere effektivt end placebo til at mindske antallet af episoder med ufrivillig vandladning.
English: EPAR summary for the public darifenacin
Danish: EPAR - sammendrag for offentligheden darifenacin
English: For more information about treatment with Emselex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Emselex, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: ‘Prolonged-release' means that darifenacin is released slowly from the tablet over a few hours.
Danish: Depottabletter betyder, at stoffet darifenacin langsomt frigives fra tabletten i løbet af få timer.
English: Emselex was used at various doses (from 3.75 mg to 30 mg a day) and compared with placebo (a dummy treatment) or with tolterodine (another medicine used in this condition).
Danish: Emselex blev anvendt i forskellige doseringer (fra 3,75 mg til 30 mg dagligt) og sammenlignet med placebo (en virkningsløs behandling) eller med tolterodin (et andet lægemiddel, der anvendes til behandling af denne lidelse).
English: Emselex must not be taken by patients who are also taking medicines that could affect the way that Emselex is broken down in the body, such as protease inhibitors (used to treat HIV infection, such as ritonavir), or ketoconazole or itraconazole (used to treat fungal infections).
Danish: Emselex må ikke anvendes til patienter, som også tager lægemidler, der kan påvirke den måde, hvorpå Emselex nedbrydes i kroppen, f.eks. proteasehæmmere (lægemidler mod hiv-infektion som f.eks. ritonavir) eller ketoconazol eller itraconazol (lægemidler til behandling af svampeinfektioner).
English: The Committee decided that Emselex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede, at fordelene ved Emselex opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for Emselex.
English: The active substance in Emselex, darifenacin, is an anticholinergic medicine.
Danish: Det aktive stof i Emselex, darifenacin, er et antikolinergisk lægemiddel.
English: • toxic megacolon (a very serious complication of colitis).
Danish: • toksisk megacolon (en meget alvorlig komplikation af tyktarmsbetændelse).
English: Emselex is a medicine that contains the active substance darifenacin.
Danish: Emselex er et lægemiddel, der indeholder det aktive stof darifenacin.
English: It is used to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the syndrome.
Danish: Det anvendes til behandling af den urge-inkontinens (pludselig manglende kontrol over vandladningen), øgede vandladningshyppighed og øgede pludselige vandladningstrang, som er knyttet til syndromet.
English: Other information about Emselex
Danish: Andre oplysninger om Emselex:
English: Emselex must not be used in people who are hypersensitive (allergic) to darifenacin or any of the other ingredients.
Danish: Emselex må ikke anvendes til patienter, som er overfølsomme (allergiske) over for darifenacin eller andre af indholdsstofferne.
English: Emselex has been studied in four main studies in a total of 2,078 male and female patients with symptoms of overactive bladder.
Danish: Der er gennemført fire hovedundersøgelser af Emselex hos i alt 2 078 mandlige og kvindelige patienter med symptomer på overaktiv blære.
English: This helps Emselex to prevent unwanted urination.
Danish: Derved medvirker Emselex til at forebygge ufrivillig vandladning.
English: Emselex is used in adults with overactive bladder syndrome.
Danish: Emselex anvendes hos voksne patienter med overaktiv blæresyndrom.
English: The CHMP concluded that Emselex showed an effectiveness similar to that of other anticholinergic medicines used in overactive bladder syndrome.
Danish: CHMP konkluderede, at Emselex' virkning svarede til andre antikolinergiske lægemidler mod overaktiv blæresyndrom.
English: What is the risk associated with Emselex?
Danish: Hvilken risiko er der forbundet med Emselex?
English: • urinary retention (difficulty passing urine);
Danish: • urinretention (manglende evne til at lade vandet)
English: • severe ulcerative colitis (severe inflammation of the gut causing ulcers and bleeding);
Danish: • svær colitis ulcerosa (alvorlig tyktarmsbetændelse, der medfører sårdannelse og blødning)
English: Why has Emselex been approved?
Danish: Hvorfor blev Emselex godkendt?
English: For the full list of all side effects reported with Emselex, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Emselex fremgår af indlægssedlen.
English: • severe liver problems;
Danish: • svær leversygdom
English: • myasthenia gravis (a disease causing muscle weakness);
Danish: • patienter med myasthenia gravis (en sygdom, der giver muskelsvækkelse)
English: This leads to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions.
Danish: Dette giver en større blærekapacitet og ændrer den måde, hvorpå blæremusklerne trækker sig sammen, når blæren fyldes.
English: What is Emselex?
Danish: Hvad er Emselex?
English: • uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment);
Danish: • ukontrolleret snævervinklet grøn stær (for højt væsketryk i øjet, selv når det behandles)
English: • gastric retention (when the stomach does not empty properly);
Danish: • ventrikelretention (manglende evne til at tømme mavesækken ordentligt)
English: How has Emselex been studied?
Danish: Hvordan blev Emselex undersøgt?
English: What benefit has Emselex shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Emselex?
English: What is Emselex used for?
Danish: Hvad anvendes Emselex til?
English: It blocks a receptor called the ‘muscarinic M3 receptor'.
Danish: Det blokerer en receptor i kroppen kaldet den muskarine M3-receptor, og dermed afslappes de muskler, der presser urinen ud af blæren.