FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Glustin, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Glustin, pioglitazon, gør (fedt-, muskel- og lever)cellerne mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: Glustin must not be used in patients who have problems with their liver, patients who have had heart failure (when the heart does not work as well as it should) or patients with diabetic ketoacidosis (a complication of diabetes).
Danish: Glustin må ikke anvendes til patienter, som har problemer med deres lever, patienter, som har hjerteinsufficiens (når hjertet ikke fungerer så godt, som det burde), eller patienter med diabetisk ketoacidose (en komplikation ved diabetes).
English: The doses of Glustin may need to be adjusted when given with some other medicines such as gemfibrozil (used to lower cholesterol) or rifampicin (an antibiotic used to treat tuberculosis).
Danish: Doserne af Glustin skal muligvis justeres, når de gives sammen med visse andre lægemidler såsom gemfibrozil (anvendes til at nedsætte kolesteroltallet) eller rifampicin (et antibiotikum, som anvendes til behandling af tuberkulose).
English: The most common side effects with Glustin (seen in between 1 and 10 patients in 100) are upper respiratory tract infection (colds), hypoaesthesia (reduced sense of touch), visual disturbance, bone fractures and increased weight.
Danish: De hyppigste bivirkninger ved Glustin (som optræder hos mellem 1 og 10 patienter ud af 100) er infektioner i de øvre luftveje (forkølelse), hypoæstesi (nedsat følesans), synsforstyrrelser, knoglefrakturer og vægtforøgelse.
English: Glustin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Glustin on its own was shown to be as effective as metformin and gliclazide.
Danish: Glustin førte til et fald i mængden af HbA1c, hvilket viser, at blodglukoseniveauerne var blevet reduceret ved doser a 15, 30 og 45 mg. Glustin anvendt alene viste sig at være lige så effektivt som metformin og gliclazid.
English: At subsequent reviews prescribers should confirm that benefits to patients are maintained.
Danish: Lægen skal ved efterfølgende kontroller bekræfte, at patienten stadig får gavn af behandlingen.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I undersøgelserne måltes mængden i blodet af et stof kaldet glykosyleret hæmoglobin (HbA1c), som viser, hvor godt blodglukosen er reguleret.
English: • together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: • sammen med insulin, til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
English: Why has Glustin been approved?
Danish: Hvorfor blev Glustin godkendt?
English: Glustin has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies.
Danish: Glustin er blevet sammenlignet med placebo (en virkningsløs behandling), metformin og gliclazid (et sulfonylurinstof) i en række undersøgelser.
English: What is the risk associated with Glustin?
Danish: Hvilken risiko er der forbundet med Glustin?
English: For the full list of all side effects reported with Glustin, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Glustin fremgår af indlægssedlen.
English: • on its own in patients for whom metformin (another diabetes medicine) is not suitable;
Danish: • som enebehandling til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet
English: Glustin also improved the glucose control obtained in type 2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea.
Danish: Glustin forbedrede også den regulering af blodglukosen, som opnås ved type 2 diabetes, når det blev føjet til en eksisterende behandling med et sulfonylurinstof, insulin eller metformin eller til kombinationen af metformin og et sulfonylurinstof.
English: Some studies also looked at combining Glustin with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea.
Danish: I visse undersøgelser så man også på kombinationen af Glustin med et sulfonylurinstof, insulin eller metformin eller med kombinationen af metformin og et sulfonylurinstof.
English: What is Glustin?
Danish: Hvad er Glustin?
English: • together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite treatment with two medicines by mouth;
Danish: • sammen med både metformin og et sulfonylurinstof hos patienter, som ikke reguleres tilfredsstillende, selv om de tager to lægemidler gennem munden
English: • in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
Danish: • i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene, eller sammen med et sulfonylurinstof (en anden type lægemiddel mod diabetes), hvor metformin ikke er egnet til patienter, som ikke er tilfredsstillende reguleret med et sulfonylurinstof alene
English: What is Glustin used for?
Danish: Hvad anvendes Glustin til?
English: The company that markets Glustin will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Danish: Materialet skal redegøre for den mulige risiko for hjertesvigt og blærekræft ved lægemidler, der indeholder pioglitazon, kriterier for udvælgelse af patienterne og behovet for regelmæssig gennemgang og indstilling af behandlingen, hvis patienten ikke længere har gavn af den. I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Glustin.
English: How has Glustin been studied?
Danish: Hvordan blev Glustin undersøgt?
English: What benefit has Glustin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Glustin?
English: How is Glustin used?
Danish: Hvordan anvendes Glustin?
English: How does Glustin work?
Danish: Hvordan virker Glustin?
English: 6 Month 20191
Danish: 6 May 20191
English: Mean follow-up was 569 days.
Danish: Den gennemsnitlige opfølgningsperiode var på 569 dage.
English: It is not known if your medicine may harm your unborn baby.
Danish: Det vides ikke, om medicinen kan skade dit ufødte barn.
English: [Product name] should not be used during pregnancy.
Danish: [Produktnavn] bør ikke anvendes under graviditet.
English: If you are pregnant (or think that you may be), are planning to become pregnant, or are breast feeding, you should not take [product name].
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, må du ikke tage [produktnavn].
English: Adopted at the 8-11 April 2019 PRAC
Danish: Vedtaget på PRAC's møde den 8.-11. april 2019
English: These may cause increased blood levels of [active substance].
Danish: Disse midler kan øge mængden af [aktivt stof] i blodet.
English: As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required (see sections 4.4 and 4.5).
Danish: Da modafinil kan nedsætte effektiviteten af orale kontraceptiva, er alternative, supplerende former for prævention nødvendige (se punkt 4.4 og 4.5).
English: A reduction in the dose of [active substance] may be necessary based on monitoring of side-effects during concomitant treatment (see section 4.4).
Danish: Det kan blive nødvendigt at reducere dosis af [aktivt stof] efter monitorering af bivirkningerne ved samtidig behandling (se punkt 4.4).
English: What you need to know before you take Eliquis/Lixiana/Roteas Warnings and precautions
Danish: Det skal du vide, før du begynder at tage Eliquis/Lixiana/Roteas Advarsler og forsigtighedsregler
English: No events were reported in patients randomized to warfarin.
Danish: Der sås ingen hændelser hos de patienter, der var randomiseret til warfarin.
English: Patients with high risk triple positive antiphospholipid syndrome
Danish: Højrisikopatienter med tredobbelt positiv antifosfolipidsyndrom
English: Modafinil - Evaluation of data on foetal outcomes including congenital anomalies from a single observational study in the US (EPITT no 19367)
Danish: Modafinil - evaluering af data vedrørende udfald af graviditeter, herunder medfødte misdannelser, fra et enkelt observationsstudie i USA (EPITT nr. 19367)
English: There is limited data on the use of modafinil in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af modafinil til gravide kvinder.
English: Based on limited human experience from a pregnancy registry and spontaneous reporting modafinil is suspected to cause congenital malformations when administered during pregnancy.
Danish: Baseret på begrænsede humane data fra et graviditetsregister og spontane indberetninger mistænkes modafinil for at forårsage medfødte misdannelser, hvis det anvendes under graviditet.
English: 59 patients were randomized to rivaroxaban 20 mg (15 mg for patients with creatinine clearance (CrCl) <50 mL/min) and 61 to warfarin (INR 2.0- 3.0).
Danish: 59 patienter var randomiseret til rivaroxaban 20 mg (15 mg for patienter med en kreatinin-clearance (CrCl) på < 50 ml/min), og 61 patienter var randomiseret til warfarin (INR 2,0-3,0).
English: Modafinil is suspected to cause birth defects if taken during pregnancy.
Danish: Modafinil mistænkes for at forårsage misdannelser, hvis det anvendes under graviditet.
English: Major bleeding occurred in 4 patients (7%) of the rivaroxaban group and 2 patients (3%) of the warfarin group.
Danish: Der sås større blødning hos 4 patienter (7 %) i rivaroxaban-gruppen og hos 2 patienter (3 %) i warfarin-gruppen.
English: What you need to know before you take [product name] Pregnancy and breast-feeding
Danish: Det skal du vide, før du begynder at tage [produktnavn] Graviditet og amning
English: 4.5 Interaction with other medicinal products and other forms of interaction Thus, caution should be exercised when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Der bør derfor udvises forsigtighed ved samtidig behandling med CYP2C19-hæmmere (f.eks. omeprazol, esomeprazol, fluconazol, fluvoxamin, lansoprazol, ticlopidin) eller cimetidin.
English: Thromboembolic events occurred in 12% of patients randomized to rivaroxaban (4 ischaemic strokes and 3 myocardial infarctions).
Danish: Der sås tromboemboliske hændelser hos 12 % af de patienter, der var randomiseret til rivaroxaban (4 iskæmiske slagtilfælde og 3 myokardieinfarkter).
English: What you need to know before you take Xarelto/Pradaxa Take special care with Xarelto/Pradaxa - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Danish: Det skal du vide, før du begynder at tage Xarelto/Pradaxa Vær ekstra forsigtig med at tage Xarelto/Pradaxa - hvis du ved, at du har en sygdom, der hedder antifosfolipidsyndrom (en forstyrrelse i immunsystemet, der giver øget risiko for blodpropper), skal du sige det til lægen, som vil vurdere, om behandlingen skal ændres.
English: Modafinil is not recommended for use during pregnancy or in women of childbearing potential unless they are using effective contraception.
Danish: Modafinil bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: The trial was terminated prematurely after the enrolment of 120 patients due to an excess of events among patients in the rivaroxaban arm.
Danish: Efter inklusion af 120 patienter, blev studiet standset før tid, fordi patienterne i rivaroxaban-gruppen oplevede for mange hændelser.
English: In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Danish: Navnlig for patienter, der er tredobbelt positive (for lupus antikoagulans, anticardiolipin-antistoffer og anti-beta 2-glykoprotein I-antistoffer), kan behandling med DOAK være forbundet med øget forekomst af recidiverende trombotiske hændelser i forhold til behandling med vitamin K-antagonister.
English: In an investigator sponsored, randomized open-label multicenter study with blinded endpoint adjudication, rivaroxaban was compared to warfarin in patients with a history of thrombosis, diagnosed with antiphospholipid syndrome and at high risk for thromboembolic events (positive for all 3 antiphospholipid tests: lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies).
Danish: I et åbent, investigator-sponseret, randomiseret multicenterstudie med blindet bedømmelse af endepunkter blev rivaroxaban sammenlignet med warfarin hos patienter med tidligere trombose, der var diagnosticerede med antifosfolipidsyndrom, og som havde høj risiko for tromboemboliske hændelser (positive for alle 3 antifosfolipidtest: lupus antikoagulans, antikardiolipin-antistoffer og antibeta 2-glykoprotein I-antistoffer).
English: Women of childbearing potential have to use effective contraception.
Danish: Fertile kvinder skal anvende sikker prævention.
English: Rivaroxaban/dabigatran etexilate
Danish: Rivaroxaban/dabigatranetexilat
English: Direct acting Oral Anticoagulants (DOACs) including rivaroxaban/apixaban/edoxaban/dabigatran etexilate are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Danish: Direkte virkende orale antikoagulantia (DOAK), herunder rivaroxaban/apixaban/edoxaban/dabigatranetexilat, anbefales ikke til patienter med tidligere trombose, som er diagnosticerede med antifosfolipidsyndrom.
English: Selective serotonin reuptake inhibitors: citalopram; escitalopram - Drug interaction with fluconazole (EPITT no
Danish: Selektive serotoningenoptagelseshæmmere: citalopram, escitalopram - lægemiddelinteraktion med fluconazol (EPITT nr. 19327)
English: Direct-acting oral anticoagulants (DOACs): apixaban; dabigatran etexilate; edoxaban; rivaroxaban - Recurrent thrombosis in patients with antiphospholipid syndrome (EPITT no 19320)
Danish: Direkte virkende orale antikoagulantia (DOAK): apixaban, dabigatranetexilat, edoxaban, rivaroxaban - recidiverende trombose hos patienter med antifosfolipidsyndrom (EPITT nr. 19320)
English: Rivaroxaban/apixaban/edoxaban/dabigatran etexilate
Danish: Rivaroxaban/apixaban/edoxaban/dabigatranetexilat
English: Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke).
Danish: Det skal du vide, før du begynder at tage [produktnavn] Brug af anden medicin sammen med [produktnavn] Cimetidin, lansoprazol og omeprazol (til behandling af mavesår), fluconazol (til behandling af svampeinfektioner), fluvoxamin (mod depression) og ticlopidin (nedsætter risikoen for slagtilfælde).
English: If you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Danish: Vær ekstra forsigtig med at tage Eliquis/Lixiana/Roteas - hvis du ved, at du har en sygdom, der hedder antifosfolipidsyndrom (en forstyrrelse i immunsystemet, der giver øget risiko for blodpropper), skal du sige det til lægen, som vil vurdere, om behandlingen skal ændres.
English: Harmful for those suffering from alcoholism.
Danish: Skadeligt for dem, der lider af alkoholisme.
English: More severe reactions may occur.
Danish: Mere alvorlige reaktioner kan forekomme.
English: An updated RMP shall be submitted by 31 October 2019.
Danish: En opdateret RMP skal indsendes senest den 31 oktober 2019.
English: • if the number of white blood cells is too low.
Danish: • hvis antallet af hvide blodlegemer er for lavt,
English: Date of first authorisation: 27 November 1995 Date of latest renewal: 27 November 2005
Danish: Dato for første tilladelse: 27. november 1995 Dato for seneste fornyelse: 27. november 2005
English: Tumour size 2 cm >2 cm
Danish: Tumorstørrelse 2 cm >2 cm
English: a From the GETUG AFU15 study
Danish: a fra GETUG AFU15 studiet
English: Summary of the safety profile for all indications
Danish: Resume af sikkerhedsprofilen for alle indikationer
English: Each blister pack contains:
Danish: Hver blisterpakning indeholder:
English: • hair loss: in most cases normal hair growth should return.
Danish: • Hårtab: I de fleste tilfælde vil normal hårvækst vende tilbage.
English: a Time to event variables: Stratified log-rank test.
Danish: a Tid til hændelsesvariabler: stratificeret log-rank test.
English: The dose will depend on your weight and your general condition.
Danish: Dosis vil afhænge af din vægt og din almene tilstand.
English: None of these increases in frequency reached 10% difference with the control arm.
Danish: Ingen af disse frekevensstigninger nåede en 10 % forskel med kontrolarmen.
English: TAXOTERE contains alcohol.
Danish: TAXOTERE indeholder alkohol.
English: TAXOTERE will be administered to you by a healthcare professional.
Danish: TAXOTERE vil blive administreret af personale med en sundhedsfaglig uddannelse.
English: An effective method of contraception should be used during treatment.
Danish: Der bør anvendes effektiv kontraception under behandlingen.
English: Second episode: discontinue treatment.
Danish: Anden episode: Afbryd behandlingen
English: This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Danish: Dette er fordi TAXOTERE eller den anden medicin måske ikke virker så godt som forventet, og du måske lettere får bivirkninger.
English: Ask your doctor for advice before being given any medicine.
Danish: Spørg din læge til råds, før du tager nogen form for medicin.
English: • 2 years.
Danish: • 2 år.
English: Meeting relative indication for chemotherapy a
Danish: Opfylder relativ indikation for kemoterapi a
English: TAXOTERE concentrate
Danish: TAXOTERE koncentrat
English: • rises in blood sugar levels (diabetes)
Danish: • Stigning i blodsukkerniveauet (diabetes)
English: The events were spontaneously reversible within 3 months.
Danish: Tilfældene var spontant reversible inden for 3
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -forhold brugerens ansvar.
English: If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
Danish: Hvis patienten fortsætter med at få disse reaktioner ved 60 mg/m bør behandlingen stoppes.
English: • 3 years.
Danish: • 3 år.
English: A total of 790 male patients were allocated to the 2 treatment groups.
Danish: I alt blev 790 mandlige patienter tildelt til de 2 behandlingsgrupper.
English: The safety and efficacy of TAXOTERE in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Danish: TAXOTEREs sikkerhed og virkning ved nasofaryngealt karcinom hos børn i alderen 1 måned til under 18 år er endnu ikke klarlagt.
English: Cases of permanent alopecia (frequency not known) have been reported.
Danish: Tilfælde af permanent alopeci (hyppighed ikke kendt) er rapporteret.
English: A total of 1006 patients with KPS  60 were randomised to the following treatment groups:
Danish: I alt 1006 patienter med KPS  60 blev randomiseret i følgende behandlingsgrupper:
English: Time to clinical progressionc
Danish: Tid til klinisk progressionc
English: STAMPEDE study
Danish: STAMPEDE studie
English: You must not breast-feed while you are treated with TAXOTERE.
Danish: Du må ikke amme, mens du behandles med TAXOTERE.
English: The solvent is a colourless solution.
Danish: Solvensen er en farveløs opløsning.
English: For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Danish: For docetaxel /Carboplatin-kombinationen kunne der hverken bevises ekvivalent eller non-inferior effekt sammenlignet med referencebehandlingen kombination VCis.
English: Surgery on the primary site of disease and/or neck could be considered at any time following completion of CRT.
Danish: Kirurgisk indgreb på det primære sygdomssted og/eller hals kunne overvejes når som helst efter endt CRT.
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE.
Danish: Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene helbredstilstand og din reaktion på TAXOTERE.
English: Patients should be informed about the signs and symptoms of serious skin manifestations and closely monitored.
Danish: Patienter skal informeres om tegn og symptomer for alvorlige hud manifestationer og monitoreres tæt.
English: The infusion will last approximately one hour during which you will be in the hospital.
Danish: Infusionen tager ca. en time, hvor du skal være på hospitalet.
English: If crystals appear, the solution must no longer be used and shall be discarded.
Danish: Hvis der forekommer krystaller, må opløsningen ikke længere anvendes og den skal kasseres.
English: • Standard of care alone
Danish: • Standardpleje alene
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Danish: Informer din læge eller hospitalsfarmaceut, hvis du tager eller for nylig har taget nogen anden form for medicin, herunder også medicin, som ikke er på recept.
English: For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Danish: I kombination med trastuzumab, vises de bivirkninger (alle grader), som er rapporteret hos  10 %.
English: The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Danish: Behandlingscyklus var på 3 uger for TCF-armen og 4 uger for CF-armen.
English: CHAARTED study
Danish: CHAARTED studie
English: INFORMATION IN BRAILLE
Danish: INFORMATION I BRAILLE SKRIFT
English: The premix solution should be used immediately after preparation.
Danish: Præmixen skal bruges straks efter tilberedning.
English: DFS data were not statistically significant but were still associated with a positive trend in favour of TAC.
Danish: Data for DFS var ikke statistisk signifikante men blev alligevel forbundet med en positiv tendens til fordel for TAC.
English: • raised liver enzymes (hence the need for regular blood tests)
Danish: • Forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver)
English: ER/PR-negative or Grade 3 or tumour size >5 cm
Danish: ER/PR-negativ eller grad 3 eller tumorstørrelse >5 cm
English: Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Danish: Din læge vil beregne din legemsoverflade i m og bestemme den dosis, du skal have.
English: Acute leukaemia / Myelodysplastic syndrome.
Danish: Akut leukæmi / myelodysplastisk syndrom