FrancophonIA/ELRC3.0 huggingface dataset:
English: o Capsule shell: Iron oxide yellow (E172), titanium dioxide (E171), glycerol 85%, sorbitol syrup special, gelatin.
Danish: o Kapslen: Jernoxid, gul (E172), titandioxid (E171), glycerol 85%, sorbitol specialsyrup, gelatine.
English: Sandimmun concentrate for solution for infusion contains castor oil which may cause severe allergic reactions.
Danish: Sandimmun indeholder polyoxyleret ricinusolie og ethanol Sandimmun koncentrat til infusionsvæske indeholder polyoxyleret ricinusolie, som kan forårsage alvorlige allergiske reaktioner.
English: What Sandimmun is and what it is used for What you need to know before you take Sandimmun How to take Sandimmun
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Sandimmun Sådan får du Sandimmun Bivirkninger
English: The total dose each day for adults is usually 5 mg per kilogram body weight.
Danish: Den totale daglige dosis er sædvanligvis 5 mg pr. kilogram kropsvægt.
English: o Capsule shell: Iron oxide red (E172), titanium dioxide (E 171), glycerol 85%, sorbitol syrup special, gelatin.
Danish: o Kapslen: Jernoxid, rød (E172), titandioxid (E 171), glycerol 85%, sorbitol specialsyrup, gelatine.
English: During treatment with ciclosporin, vaccination may be less effective.
Danish: Effekten af vaccinationer kan være nedsat under behandling med ciclosporin.
English: Experience with Sandimmun in children with atopic dermatitis is limited.
Danish: Der er kun begrænset erfaring med brug af Sandimmun hos børn med atopisk dermatitis.
English: • Stomach ulcer.
Danish: • Mavesår.
English: • if you have kidney problems.
Danish: • hvis du har nyreproblemer.
English: Rare side effects: These side effects may affect between 1 and 10 in every 10,000 people.
Danish: Sjældne bivirkninger: Disse bivirkninger kan forekomme hos mellem 1 og 10 ud af 10.000 personer.
English: Myalgia, muscle cramps
Danish: Muskelsvaghed, myopati
English: Following dilution, the solution should be used immediately.
Danish: Efter fortynding skal infusionsvæsken anvendes straks.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, brown-yellow oleaginous concentrate.
Danish: Klart, brun-gult olieagtigt koncentrat.
English: The total dose each day is usually between 2.5 mg per kilogram of your body weight and 5 mg per kilogram body weight.
Danish: Den totale daglige dosis er sædvanligvis mellem 2,5 mg og 5mg pr. kilogram kropsvægt.
English: For monitoring ciclosporin levels in whole blood, a specific monoclonal antibody (measurement of parent compound) is preferred; a high-performance liquid chromatography (HPLC) method, which also measures the parent compound, can be used as well.
Danish: Et specifikt monoklonalt antistof (måling af moderstoffet) foretrækkes til monitorering af fuldblodsciclosporinkoncentration.
English: Except in patients with sight-threatening endogenous uveitis and in children with nephrotic syndrome, the total daily dose must never exceed 5 mg/kg.
Danish: Den samlede daglige dosis må aldrig overstige 5 mg/kg, medmindre der er tale om patienter med synstruende endogen uveitis eller børn med nefrotisk syndrom.
English: Musculoskeletal and connective tissue disorders Common
Danish: Hud og subkutane væv
English: Uncommon side effects: These side effects may affect between 1 and 10 in every 1,000 people.
Danish: Ikke almindelige bivirkninger: Disse bivirkninger kan forekomme hos mellem 1 og 10 ud af 1.000 personer.
English: When a blister is opened, a characteristic smell is noticeable; this is normal and does not mean that there is anything wrong with the capsule.
Danish: Dette er normalt og betyder ikke, at der er noget i vejen med kapslen.
English: The total dose each day is usually between 3 mg per kilogram of your body weight and 5 mg per kilogram body weight.
Danish: Den totale daglige dosis er sædvanligvis mellem 3 mg og 5 mg pr. kilogram kropsvægt.
English: Feeling numb or tingling.
Danish: Udseende og pakningsstørrelser
English: Check with your doctor if you are not sure.
Danish: Spørg lægen eller på apoteket, hvis der er noget, du er i tvivl om.
English: Hyperlipidaemia
Danish: Hyperlipidæmi
English: Capsule shell Iron oxide red (E172) Titanium dioxide (E171) Glycerol 85% Sorbitol syrup special Gelatin
Danish: Jernoxid, rød (E172) Titandioxid (E171) Glycerol 85% Sorbitol, specialsirup Gelatine
English: Capsule shell Iron oxide red (E172) Titanium dioxide (E 171) Glycerol 85% Sorbitol syrup special Gelatin
Danish: Jernoxid, rød (E172) Titandioxid (E 171) Glycerol 85% Sorbitol, specialsirup Gelatine
English: Discontinuation of Sandimmun therapy is recommended if hypertension developing during treatment cannot be controlled with appropriate therapy.
Danish: Yderligere forsigtighedsregler ved atopisk dermatitis Sandimmun skal seponeres, hvis der opstår hypertension under behandlingen, og den ikke kan kontrolleres med passende behandling.
English: Owing to its possible interference with the cytochrome P450 enzyme system, grapefruit juice should be avoided for dilution (see section 4.5).
Danish: Sandimmun oral opløsning bør ikke fortyndes med grapefrugt eller grapejuice på grund af eventuel interaktion med det CYP-enzymsystemet (se pkt.
English: What you need to know before Sandimmun is used
Danish: Det skal du vide, før du får Sandimmun
English: Bone marrow transplantation
Danish: Knoglemarvstransplantation
English: The total dose each day for children is usually 6 mg per kilogram body weight.
Danish: • Børn: Nefrotisk syndrom Den totale daglige dosis for børn er sædvanligvis 6 mg pr. kilogram kropsvægt.
English: Menstrual disturbances, gynaecomastia General disorders and administration site conditions Common
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig Pyreksi, træthed
English: How to take Sandimmun
Danish: Sådan skal du tage Sandimmun
English: Hepatobiliary disorders Common
Danish: Hyperlipidæmi almindelig
English: The usual dose is 60 mg once a day.
Danish: Den normale dosis er 60 mg én gang dagligt.
English: This medicine is the same as Lixiana, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Lixiana, som allerede er godkendt i Den Europæiske Union (EU).
English: The full EPAR for Roteas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Roteas 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 Roteas.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Roteas.
English: Other information about Roteas
Danish: Andre oplysninger om Roteas
English: The effects were studied in one main study, which involved over 21,000 patients for an average of 2.5 years.
Danish: Virkningerne blev undersøgt i én hovedundersøgelse, hvori der deltog over 21 000 patienter i en periode på gennemsnitligt 2,5 år.
English: Bleeding can occur at any site and can be severe or even fatal.
Danish: Blødning kan optræde overalt i kroppen og kan være svær eller endda dødelig.
English: The company that makes Lixiana has agreed that its scientific data can be used for Roteas (‘informed consent').
Danish: Virksomheden, som fremstiller Lixiana, har indvilget i, at dens videnskabelige oplysninger må anvendes for Roteas (informeret samtykke).
English: Roteas is available as tablets (15, 30 and 60 mg) and can only be obtained with a prescription.
Danish: Roteas leveres som tabletter (15 mg, 30 mg og 60 mg) og udleveres kun efter recept.
English: What measures are being taken to ensure the safe and effective use of Roteas?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Roteas?
English: Thrombin is essential for blood clotting.
Danish: Trombin er nødvendigt for blodets størkning.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Roteas'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, at fordelene ved Roteas opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin.
Danish: Det vil sige, at det blokerer enzymet faktor Xa, som medvirker ved dannelsen af trombin.
English: Further episodes were seen in 130 of 4,118 patients given edoxaban (3.2%) and in 146 of 4,122 given warfarin (3.5%).
Danish: Gentagne episoder forekom hos 130 af de 4 118 patienter, som fik edoxaban (3,2 %), og hos 146 af de 4 122, som fik warfarin (3,5 %).
English: It must also not be used in pregnant or breastfeeding women or together with another anticoagulant.
Danish: Det må heller ikke anvendes hos gravide eller ammende kvinder eller sammen med et andet blodfortyndende lægemiddel.
English: It is not intended to provide practical advice on how to use Roteas.
Danish: Det er ikke en praktisk vejledning i, hvordan Roteas bør anvendes.
English: Roteas contains the active substance edoxaban.
Danish: Roteas indeholder det aktive stof edoxaban.
English: What is Roteas and what is it used for?
Danish: Hvad er Roteas, og hvad anvendes det til?
English: Why is Roteas approved?
Danish: Hvorfor blev Roteas godkendt?
English: It is used in patients who have one or more risk factors, such as having had a previous stroke, high blood pressure, diabetes, heart failure or being 75 years old or over;
Danish: Det anvendes hos patienter med en eller flere risikofaktorer, såsom tidligere slagtilfælde, højt blodtryk, sukkersyge, hjertesvigt eller en alder over 75 år
English: Dose adjustments may also need to be made in patients who are switched between Roteas and other anticoagulant medicines.
Danish: Dosistilpasning kan også være nødvendig hos patienter, der skifter mellem Roteas og andre blodfortyndende lægemidler.
English: There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.
Danish: Der var tendens til bedre resultater hos patienter med nedsat nyrefunktion end hos patienter med normal nyrefunktion.
English: Doses should be halved in patients with moderately or severely reduced kidney function, or low body weight or in those who are also taking certain medicines (known as P-gp inhibitors) that can interfere with the removal of edoxaban from the body.
Danish: Dosis bør halveres hos patienter med moderat eller svært nedsat nyrefunktion eller lav legemsvægt og hos patienter, der også får visse lægemidler (såkaldte P-gp-hæmmere), som kan gribe ind i udskillelsen af edoxaban fra kroppen.
English: The active substance in Roteas, edoxaban, is a ‘factor Xa inhibitor'.
Danish: Det aktive stof i Roteas, edoxaban, er en "faktor Xa-hæmmer".
English: Although there was greater a risk of bleeding from the mucosa (tissues lining body cavities such as the nose, gut and vagina), the Committee considered that the risk could be managed with appropriate measures.
Danish: Der var højere risiko for blødning fra slimhinder i kroppens hulrum, såsom næse, tarm og skede, men udvalget fandt, at denne risiko kunne håndteres med passende foranstaltninger.
English: When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 143 patients given Roteas (0.9%) and 157 given warfarin (1%).
Danish: Når man anvendte en anden anbefalet definition af arten af slagtilfælde, optrådte vandrende blodpropper eller slagtilfælde som følge af blodpropper hos 143 patienter, der fik Roteas (0,9 %), og hos 157 (1 %) af dem, der fik warfarin (1 %).
English: For more information about treatment with Roteas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Roteas, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Roteas must not be used in patients who are actively bleeding, have liver diseases that affect blood clotting, have severe uncontrolled high blood pressure or who have a condition putting them at significant risk of major bleeding.
Danish: Roteas må ikke anvendes hos patienter med aktiv blødning, leversygdomme der påvirker blodets størkning, svært ukontrolleret højt blodtryk eller sygdomme der medfører væsentlig risiko for større blødninger.
English: What are the risks associated with Roteas?
Danish: Hvilke risici er der forbundet med Roteas?
English: It will also carry out a study of the effects of the medicine in patients with atrial fibrillation and good kidney function.
Danish: Virksomheden skal desuden foretage en undersøgelse af lægemidlets virkninger hos patienter med atrieflimren og god nyrefunktion.
English: • to prevent stroke (caused by blood clots in the brain) and systemic embolism (blood clots in other organs) in patients with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
Danish: • til forebyggelse af slagtilfælde (som følge af blodpropper i hjernen), og vandrende blodpropper i andre organer (systemisk emboli) hos patienter med uregelmæssige hurtige sammentrækninger af hjertets forkamre (ikke-valvulær atrieflimren).
English: The most common side effects with Roteas (which may affect up to 1 in 10 people) are bleeding from skin and soft tissues, nose (epistaxis) and the vagina.
Danish: De hyppigste bivirkninger ved Roteas (som kan forekomme hos op til 1 ud af 10 personer) er blødning fra hud og underliggende væv, næseblødning og blødning fra skeden.
English: For the full list of all side effects reported with Roteas, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Roteas fremgår af indlægssedlen.
English: By blocking factor Xa, the medicine reduces the levels of thrombin in the blood, which helps treat clots and reduce the risk of them forming in the arteries and veins and leading to DVT, pulmonary embolism, stroke or other organ damage.
Danish: Ved at blokere faktor Xa nedsætter lægemidlet blodets indhold af trombin, hvilket medvirker til behandling af blodpropper og nedsætter risikoen for, at de dannes i arterier og vener og forårsager dyb venetrombose, blodpropper i lungerne, slagtilfælde eller anden organskade.
English: Roteas is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:
Danish: Roteas er et blodfortyndende lægemiddel (et antikoagulans) til forebyggelse af blodpropper.
English: Other common side effects are anaemia (low levels of red blood cells), rash and abnormal results in tests of liver function.
Danish: Andre hyppige bivirkninger er lavt antal røde blodlegemer (anæmi), udslæt og abnorme leverfunktionsprøver.
English: How is Roteas used?
Danish: Hvordan anvendes Roteas?
English: What benefits of Roteas have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Roteas?
English: • to treat deep-vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from re-occurring.
Danish: • til behandling af blodpropper i dybe vener, (dyb venetrombose (DVT), sædvanligvis i benet), behandling af blodpropper i kar, der fører til lungerne (lungeemboli), og forebyggelse af gentagen forekomst af DVT og lungeemboli.
English: The company that markets Roteas will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them.
Danish: Virksomheden, der markedsfører Roteas, skal udlevere oplysningsmateriale til læger, som ordinerer lægemidlet, og advarselskort til patienterne.
English: For practical information about using Roteas, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Roteas, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The medicine has been shown to be at least as effective as warfarin in reducing stroke rates in patients with atrial fibrillation and in preventing further episodes of DVT or pulmonary embolism.
Danish: Lægemidlet er påvist at være mindst lige så effektivt som warfarin til at nedsætte forekomsten af slagtilfælde hos patienter med atrieflimren og forebygge gentagne episoder med dyb venetrombose eller blodpropper i lungerne.
English: The main measure of effectiveness was the number of patients who had another episode of DVT or pulmonary embolism during the study period.
Danish: Virkningen blev hovedsagelig målt på antallet af patienter, der oplevede en gentagen episode med dyb venetrombose eller blodpropper i lungerne i løbet af undersøgelsen.
English: With respect to safety, overall the risk of serious bleeding such as bleeding into the brain was reduced compared with warfarin, although there may be less difference where warfarin treatment is well managed.
Danish: Hvad sikkerheden angår, var der generelt lavere risiko end med warfarin for alvorlig blødning, såsom hjerneblødning.
English: In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Roteas was also found to be as effective as warfarin, in a study involving over 8,200 patients.
Danish: Roteas var desuden lige så effektivt som warfarin til behandling og forebyggelse af blodpropper hos patienter med dyb venetrombose eller blodpropper i lungerne i en undersøgelse med over 8 200 patienter.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Roteas 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 Roteas.
English: Treatment is continued while the benefit outweighs the risk of bleeding, which depends on the condition being treated and any existing risk factors.
Danish: Blødningsrisikoen afhænger af den behandlede sygdom og eventuelle risikofaktorer.
English: The main measure of effectiveness was the rate of stroke or systemic embolism among the patients each year.
Danish: Virkningen blev hovedsagelig målt på den årlige forekomst af slagtilfælde eller af vandrende blodpropper i hele kroppen hos patienterne.
English: Roteas has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation.
Danish: Roteas er påvist at være lige så effektivt som det almindeligt anvendte blodfortyndende lægemiddel warfarin til at forebygge slagtilfælde og blodpropper i hele kroppen ved atrieflimren.
English: How does Roteas work?
Danish: Hvordan virker Roteas?
English: A first systemic embolism or stroke occurred in 182 patients given standard doses of Roteas and in 232 of those given warfarin, corresponding to annual rates for these events of around 1.2% and 1.5% respectively.
Danish: Af de patienter, der fik sædvanlige doser af Roteas, optrådte der første forekomst af vandrende blodpropper i hele kroppen eller slagtilfælde hos 182 petienter, sammenholdt med 232 af de patienter, der fik warfarin.
English: or vice versa.
Danish: eller omvendt.
English: Very rare, not known*
Danish: Meget sjælden, ikke kendt*
English: The median follow-up for both groups was 359 days.
Danish: Median opfølgningen for begge grupper var 359 dage.
English: If a dose is missed:
Danish: Hvis en dosis glemmes:
English: Other side effects include:
Danish: Øvrige bivirkninger omfatter:
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 3 June 2014
Danish: Dato for første markedsføringstilladelse: 21 september 2009 Dato for seneste fornyelse: 03 juni 2014
English: Do not stop the treatment unless your doctor tells you so.
Danish: Du må ikke stoppe behandlingen, medmindre din læge fortæller dig, at du skal gøre det.
English: Thus, the results from this subset are in line with the overall trial results.
Danish: Dermed er resultaterne af denne delkonklusion i overensstemmelse med de overordnede studieresultater.
English: All patients were continued on aspirin and were followed for one year.
Danish: Alle patienter blev fortsat behandlet med aspirin og blev fulgt i et år.
English: None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Danish: Ingen af disse analyser var tilstrækkeligt store til at kunne detektere forskelle i outcome hos poor metabolisers.
English: • Your doctor may order blood tests.
Danish: • kan din læge bede om blodprøver.
English: 8501 Novo mesto Slovenia
Danish: 8501 Novo mesto
English: The patient population included 41.8 % women.
Danish: Patientpopulationen inkluderede 41,8 % kvinder.
English: Children and adolescents Do not give this medicine to children because it does not work.
Danish: Børn og unge Anvend ikke dette lægemiddel til børn, da det er uden effekt på dem.
English: The characteristics of the studied cohort were similar in the 2 groups.
Danish: Karakteristika for den undersøgte kohorte var ens i de 2 grupper.
English: Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Danish: Clopidogrel er blevet evalueret sikkerhedsmæssigt hos mere end 44.000 patienter, der har deltaget i kliniske studier, inklusive over 12.000 patienter, der blev behandlet i mindst 1 år.
English: Cmax occurs approximately 30 to 60 minutes after dosing.
Danish: Cmax opnås ca. 30-60 minutter efter administration.
English: This randomized, open-label trial included 2,610 biomarker-positive ACS patients after successful PCI.
Danish: Dette randomiseret, open-label studie inkluderede 2.610 biomarker-positive ACS-patienter efter vellykket PCI.
English: The ACTIVE-A study included patients who could not receive VKA therapy because they were unable or unwilling to receive the treatment.
Danish: ACTIVE-A studiet inkluderede patienter, som ikke kunne behandles med VKA, fordi de ikke var i stand til eller uvillige til at få behandlingen.
English: The mean CHADS2 score was 2.0 (range 0-6).
Danish: Den gennemsnitlige CHADS2 score var 2,0 (interval 0-6).
English: Contact your doctor immediately if you experience: - fever, signs of infection or extreme tiredness.
Danish: Kontakt din læge med det samme, hvis du oplever: - feber, tegn på infektion eller alvorlig kraftesløshed (asteni).
English: However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Danish: Imidlertid er det på grund af manglen på interaktionsstudier med andre NSAID'er ikke umiddelbart klart, om der er øget risiko for gastrointestinal blødning med alle NSAIDpræparater.
English: The mean time between shunt palliation and first administration of study medicinal product was 20 days.
Danish: Den gennemsnitlige tid fra anlæggelse af palliativ shunt til første administration af studielægemidlet var 20 dage.
English: The most common side effect is bleeding.
Danish: Den almindeligste bivirkning er blødning.
English: Taste disturbances, ageusia
Danish: Smagsforstyrrelser, ageusi
English: Cross-reactions among thienopyridines
Danish: Krydsreaktioner mellem thienopyridiner
English: may be taken with or without food.
Danish: kan tages med eller uden mad.
English: A patient with poor metaboliser status will possess two loss-of-function alleles as defined above.
Danish: En patient med status som poor metaboliser vil besidde to ikke-funktionelle alleller, som beskrevet ovenfor.
English: At Day 14, platelet function testing (PFT) was performed.
Danish: På dag 14 blev blodpladefunktionstestning (PFT) udført.
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Danish: TTP er en potentielt dødelig tilstand, der kræver øjeblikkelig behandling, der omfatter plasmaferese.