FrancophonIA/ELRC3.0 huggingface dataset:
English: Finally, in addition to lowering glucose levels, studies showed that adding ertugliflozin to metformin helped patients reduce bodyweight.
Danish: Endelig viste studierne, at tilsætning af ertugliflozin til metformin bidrog til at nedsætte patienternes legemsvægt foruden at nedsætte glukoseniveauet.
English: • patients who are already taking ertugliflozin and metformin as separate tablets.
Danish: • patienter, der i forvejen får ertugliflozin og metformin som separate tabletter Segluromet indeholder to aktive stoffer, ertugliflozin og metformin.
English: • A second study found that adding ertugliflozin to a combination of sitagliptin (another diabetes medicine) and metformin was more effective than placebo.
Danish: • Et andet studie viste, at det var mere effektivt at tilføje ertugliflozin end placebo til en kombination af metformin og et andet sukkersygelægemiddel, sitagliptin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Uptravi on 12 May 2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Uptravi den 12. maj 2016.
English: The full EPAR for Uptravi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Uptravi 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 Uptravi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Uptravi.
English: Uptravi is available as tablets (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms).
Danish: Uptravi fås som tabletter (200, 400, 600, 800, 1 000, 1 200, 1 400 og 1 600 mikrogram).
English: Other information about Uptravi
Danish: Andre oplysninger om Uptravi
English: What is Uptravi and what is it used for?
Danish: Hvad er Uptravi, og hvad anvendes det til?
English: It must also not be used in patients who have had a stroke within the last 3 months.
Danish: Lægemidlet må heller ikke gives til patienter, der har haft et slagtilfælde i løbet af de seneste 3 måneder.
English: These effects are mild or moderate and are most frequently seen while the dose of Uptravi is being increased.
Danish: Disse bivirkninger er milde eller moderate og ses oftest, når dosen af Uptravi øges.
English: It is not intended to provide practical advice on how to use Uptravi.
Danish: Det er ikke en praktisk vejledning i, hvordan Uptravi bør anvendes.
English: What measures are being taken to ensure the safe and effective use of Uptravi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Uptravi?
English: If stopping treatment with Uptravi, the dose should be reduced gradually.
Danish: Hvis behandling med Uptravi skal stoppes, bør dosen reduceres gradvist.
English: The main measure of effectiveness was based on the number of patients whose disease worsened or who died during treatment or shortly after treatment had ended.
Danish: Virkningen blev hovedsagelig målt på det antal patienter, hvis sygdom forværredes, eller som døde i løbet af behandlingen eller kort tid efter behandlingsstop.
English: Patients were given either Uptravi or placebo (a dummy treatment) for around 70 weeks.
Danish: Patienterne fik enten Uptravi eller placebo (ikke-aktiv behandling) i ca. 70 uger.
English: Overall, 24.4% (140 out of 574) of patients treated with Uptravi either died or showed signs of worsening disease compared with 36.4% (212 out of 582) of patients treated with placebo.
Danish: Andelen af Uptravi-behandlede patienter, der enten døde eller viste tegn på sygdomsforværring, var 24,4 % (140 ud af 574) sammenlignet med 36,4 % (212 ud af 582) af de placebo-behandlede patienter.
English: Compared with other medicines in the same class which are given into a vein, Uptravi has the advantage of being given by mouth.
Danish: Sammenlignet med andre lægemidler i samme klasse, der indgives i en blodåre, har Uptravi den fordel, at det tages gennem munden.
English: Uptravi contains the active substance selexipag.
Danish: Uptravi indeholder det aktive stof selexipag.
English: Patients may tolerate treatment better if they take their tablets with food and take the first tablet of an increased dose in the evening rather than the morning.
Danish: Patienterne tåler muligvis behandlingen bedre, hvis de tager tabletterne sammen med mad og ved dosisøgning tager den første tablet om aftenen frem for om morgenen.
English: What are the risks associated with Uptravi?
Danish: Hvilke risici er der forbundet med Uptravi?
English: Why is Uptravi approved?
Danish: Hvorfor blev Uptravi godkendt?
English: Regarding safety, the side effects with Uptravi are considered acceptable.
Danish: For så vidt angår sikkerheden, anses bivirkningerne ved Uptravi for at være acceptable.
English: If the patient cannot tolerate an increased dose, the doctor may have to reduce it.
Danish: Hvis patienten ikke kan tåle en større dosis, kan det være nødvendigt, at lægen nedsætter ned igen.
English: The ‘class' reflects the severity of the disease: ‘class II' involves slight limitation of physical activity while ‘class III' involves marked limitation of physical activity.
Danish: "Funktionsklassen" afspejler sygdommens sværhedsgrad: Ved klasse II er der let nedsat fysisk aktivitet, ved klasse III mærkbart nedsat fysisk aktivitet.
English: Patients with severely reduced liver function should not take Uptravi.
Danish: Patienter med svært nedsat leverfunktion bør ikke tage Uptravi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Uptravi'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 Uptravi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Patients with moderately reduced liver function should start with 200 micrograms once daily.
Danish: Patienter med moderat nedsat leverfunktion bør starte med 200 mikrogram én gang dagligt.
English: Although the CHMP noted a small apparent increase in the rate of death for patients taking Uptravi when compared with placebo, they considered that this was due to chance or to the way the study was designed and therefore did not impact the benefits or risks of the medicine.
Danish: Selv om CHMP bemærkede en lille stigning i forekomsten af dødsfald blandt Uptravi-behandlede patienter sammenlignet med placebo, anser udvalget dette for at være tilfældigt eller en følge af undersøgelsens udformning og er derfor af den overbevisning, at dette ikke har nogen indvirkning på fordelene og risiciene ved lægemidlet.
English: Treatment should be started at a dose of 200 micrograms twice a day, approximately 12 hours apart.
Danish: Behandlingen bør startes med en dosis på 200 mikrogram to gange dagligt med cirka 12 timers mellemrum.
English: Any prescriber of Uptravi will have to register first with the company that markets Uptravi before being able to prescribe it.
Danish: Læger, der ordinerer Uptravi, skal først registreres hos virksomheden, der markedsfører Uptravi, før de kan ordinere det.
English: These materials will also include a guide and diary to be given to patients to help them keep track of the number of tablets to take and explain how doses should be increased.
Danish: Disse materialer vil også omfatte en vejledning og dagbog til patienterne, der kan hjælpe dem med at holde styr på det antal tabletter, som de skal tage, og forklare dem, hvordan doserne bør øges.
English: It can be used in combination with other medicines called endothelin receptor antagonists (ERA) or phosphodiesterase type-5 (PDE-5) inhibitors or on its own for patients for whom these medicines are not suitable.
Danish: Det kan bruges i kombination med andre lægemidler, der kaldes endothelin-receptorantagonister (ERA) eller phosphodiesterase type 5 (PDE-5)hæmmere, eller alene til patienter, til hvem disse lægemidler ikke er egnede.
English: The active substance in Uptravi, selexipag, is a ‘prostacyclin receptor agonist'.
Danish: Det aktive stof i Uptravi, selexipag, er en "prostacyklin-receptoragonist".
English: The dose is then increased weekly, as long as it is tolerated, to a maximum of 1,600 micrograms twice daily, which is then continued afterwards.
Danish: Dosen øges derefter hver uge, så længe som patienten kan tåle det, op til en maksimal dosis på 1 600 mikrogram to gange dagligt, som så fastholdes.
English: The diary contains boxes for the patient to mark the number and strength of tablets they take each day.
Danish: Dagbogen indeholder felter, hvor patienten kan notere antallet og styrken af de tabletter, som han/hun tager hver dag.
English: For more information about treatment with Uptravi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Uptravi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company will provide educational materials for the healthcare professionals who will prescribe and dispense the medicine to help them prescribe the medicine correctly and avoid medication errors.
Danish: Virksomheden skal udlevere oplysningsmateriale til sundhedspersoner, som ordinerer og udleverer lægemidlet, så de ordinerer lægemidlet korrekt og undgår fejlmedicinering.
English: If tolerated, this dose can be increased weekly.
Danish: Hvis denne dosis tåles, kan den øges én gang om ugen.
English: Uptravi must not be taken at the same time as medicines, such as gemfibrozil, that are strong blockers (inhibitors) of the liver enzyme CYP2C8.
Danish: Uptravi må ikke tages samtidig med andre lægemidler som f.eks. gemfibrozil, som er stærke blokkere (hæmmere) af leverenzymet CYP2C8.
English: Uptravi can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Danish: Uptravi udleveres kun efter recept, og behandlingen bør kun iværksættes og overvåges af en læge med erfaring i behandling af pulmonal arteriel hypertension.
English: The most common side effects with Uptravi (which may affect more than 1 in 10 people) are headache, diarrhoea, nausea and vomiting, jaw pain, myalgia (muscle pain), pain in the limbs, arthralgia (joint pain) and flushing.
Danish: De hyppigste bivirkninger ved Uptravi (som kan forekomme hos flere end 1 ud af 10 patienter) er hovedpine, diarré, kvalme og opkastning, smerter i kæben, muskelsmerter, smerter i arme og ben, ledsmerter og hedeture.
English: It must not be used in patients with severe arrhythmias (unstable heartbeat) or defects in the heart valves.
Danish: Uptravi må ikke anvendes til patienter med alvorlige arytmier (ustabil hjerterytme) eller defekter i hjerteklapperne.
English: Uptravi must not be used in patients who have had a heart attack within the last 6 months, severe coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle) or unstable angina (a severe type of chest pain).
Danish: Uptravi må ikke gives til patienter, som har haft et hjerteanfald inden for de seneste 6 måneder, alvorlig kranspulsåre-sygdom (hjertesygdom forårsaget af blokering af de blodårer, der forsyner hjertemuskulaturen) eller ustabil angina pectoris (en alvorlig form for brystsmerter).
English: By attaching to prostacyclin receptors, Uptravi also widens the blood vessels and so lowers the pressure inside them, improving symptoms of the disease.
Danish: Ved at binde til prostacyklin-receptorer udvider Uptravi også blodkarrene og sænker således blodtrykket i dem, hvilket forbedrer symptomerne på sygdommen.
English: Uptravi has been shown to be more effective than placebo at preventing worsening of PAH, on its own and when used in addition to an ERA and/or a PDE-5 inhibitor.
Danish: Det er påvist, at Uptravi virker bedre end placebo til at forhindre forværring af pulmonal arteriel hypertension, både når det gives alene og i kombination med en ERA og/eller en PDE-5-hæmmer.
English: For the full list of restrictions and side effects reported with Uptravi, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og indberettede bivirkninger ved Uptravi fremgår af indlægssedlen.
English: For patients with other heart problems, Uptravi must only be used under close medical supervision.
Danish: Patienter med andre former for hjerteproblemer må kun få Uptravi, hvis de følges tæt af en læge.
English: What benefits of Uptravi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Uptravi?
English: This means that it works in a similar way to prostacyclin, a naturally occurring substance that regulates blood pressure by attaching to receptors in the muscles of blood vessel walls, causing the vessels to relax and widen.
Danish: Det betyder, at stoffet virker på næsten samme måde som prostacyklin, der er et naturligt forekommende stof, som regulerer blodtrykket ved at binde sig til receptorer i muskulaturen i blodkarvæggen, hvilket får blodkarrene til at slappe af og udvide sig.
English: The benefits of Uptravi for PAH were shown in one main study involving 1,156 patients with PAH.
Danish: Fordelene ved behandling med Uptravi ved pulmonal arteriel hypertension er påvist i en hovedundersøgelse med 1 156 patienter med pulmonal arteriel hypertension.
English: Uptravi is a medicine used to treat adults with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Danish: Uptravi er et lægemiddel, der anvendes til at behandle voksne patienter med pulmonal arteriel hypertension (unormalt højt blodtryk i lungernes arterier).
English: Patients were either previously untreated or receiving treatment with other PAH medicines (ERA or PDE-5 inhibitors).
Danish: Patienterne havde enten ikke været i behandling før eller var i behandling med andre lægemidler mod pulmonal arteriel hypertension (ERA eller PDE-5-hæmmere).
English: How is Uptravi used?
Danish: Hvordan anvendes Uptravi?
English: For practical information about using Uptravi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Uptravi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Uptravi is used in patients with functional class II or III PAH.
Danish: Uptravi anvendes til patienter med pulmonal arteriel hypertension i funktionsklasse II eller III.
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Danish: Pulmonal arteriel hypertension er en invaliderende sygdom, hvor der sker en alvorlig forsnævring af blodkarrene i lungerne.
English: How does Uptravi work?
Danish: Hvordan virker Uptravi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Uptravi 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 med henblik på sikker og effektiv anvendelse af Uptravi.
English: Patients with PAH currently have very limited treatment options; therefore there is a high unmet medical need.
Danish: Patienter med pulmonal arteriel hypertension har på nuværende tidspunkt meget begrænsede behandlingsmuligheder.
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Danish: Efter Kommissionens beslutning vil medlemslandenes kompetente myndigheder, i overensstemmelse med referencelandet, opdatere produktinformationen som påkrævet.
English: Summary of product characteristics, labelling and package leaflet
Danish: Produksresumé, mærkning og indlægsseddel
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det gældende produktresumé, mærkning og indlægsseddel er de endelige versioner udarbejdet under den koordinerende gruppeprocedure.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Danish: Bemærk: Produktresume, etikettering og indlægsseddel herunder er den gældende version på tidspunktet for Kommissionens beslutning.
English: Transdermal use metering pump (PP/LDPE);
Danish: Doseringspumpe (PP/LDPE)
English: 1 metering pump
Danish: doseringspumpe
English: There is no clear correlation between formulations and indications.
Danish: Der er ingen klar sammenhæng mellem formuleringer og indikationer.
English: Retrieved from http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Articl e_45_work-sharing/Metoclopramid_Art.45_PdAR_Update.pdf
Danish: Retrieved from http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/ Article_45_work-sharing/Metoclopramid_Art.45_PdAR_Update.pdf
English: As such, a dose reduction of 75% would be necessary.
Danish: I dette tilfælde vil en dosisreduktion på 75 % være påkrævet.
English: Oral liquid formulations
Danish: Orale flydende formuleringer
English: There is no clinical data available to allow for a discussion on this point.
Danish: Der findes ikke kliniske data, der giver mulighed for diskussion af dette punkt.
English: The French Competent Authority considered it particularly important that the therapeutic indications and safety information be made consistent across Member States.
Danish: De franske kompetente myndigheder fandt det navnlig vigtigt, at de terapeutiske indikationer og sikkerhedsoplysninger blev bragt i indbyrdes overensstemmelse i alle medlemsstater.
English: Metoclopramide has been authorised in the European Union since the 1960's and marketing authorisations currently exist in all Member States as well as in Norway and Iceland.
Danish: Metoclopramid har været godkendt i EU siden 1960'erne og er omfattet af markedsføringstilladelser i alle medlemsstaterne foruden Norge og Island.
English: Safety data
Danish: Sikkerhedsdata
English: For this indication and population, it is considered particularly important that oral formulations are available.
Danish: Til denne indikation og population anses det for særlig vigtigt at råde over orale formuleringer.
English: Furthermore, existing studies included a very small number of patients and focused on a small duration of treatment.
Danish: Desuden omfattede de eksisterende undersøgelser kun et meget lille antal patienter og en kort behandlingsperiode.
English: In children there is also a significant number of reported cases of overdose.
Danish: For børn er der desuden indberettet et betydeligt antal tilfælde af overdosering.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for metoclopramide-containing medicinal products.
Danish: • udvalget fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende metoclopramid,
English: This posology applies to all oral formulations and is not dependent on body weight.
Danish: Denne dosering gælder alle orale formuleringer og er ikke afhængig af legemsvægt.
English: If an appropriate measuring device is used as recommended, there will be no need to count drops.
Danish: Når en egnet doseringsanordning anvendes som anbefalet, er det ikke nødvendigt at tælle dråber.
English: Combination products are also approved, but this procedure focused on the assessment of the monocomponent products.
Danish: Også kombinationsprodukter er godkendt, men ved denne procedure omfatter vurderingen kun monokomponentprodukterne.
English: The authorised indications for the concerned products are different but can broadly be grouped in the following way:
Danish: De godkendte indikationer for de berørte produkter er forskellige, man kan bredt inddeles således:
English: It was noted by the Committee that a formulation of suppositories dosed at 20mg is currently approved in some Member States.
Danish: Udvalget konstaterede, at en formulering som suppositorier med styrken 20 mg er godkendt i visse medlemsstater.
English: • Contraindication in neonates;
Danish: • Kontraindikation hos nyfødte
English: Overall summary of the scientific evaluation of metoclopramide-only containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler med metoclopramid som eneste aktive indholdsstof (se bilag I)
English: For this particular indication in the paediatric population, both the parenteral and the oral pharmaceutical forms may be appropriate.
Danish: Til denne særlige indikation hos den pædiatriske population kan både de parenterale og orale lægemiddelformer være egnede.
English: Metoclopramide can therefore be used during pregnancy, if clinically justified.
Danish: Metoclopramid kan derfor anvendes under graviditet, hvis det er klinisk begrundet.
English: • Limiting the maximum concentration/dosing in certain formulations to ensure that patients are not unintentionally exposed to doses higher than the single recommended dose for the product.
Danish: • Begrænsning af den maksimale koncentration/dosering for visse formuleringer for at sikre, at patienterne ikke utilsigtet udsættes for højere doser end den anbefalede enkeltdosis af produktet.
English: Although the clinical significance is uncertain, patients should be monitored for adverse reactions.
Danish: Skønt den kliniske betydning heraf er usikker, bør patienterne overvåges for bivirkninger.
English: The slow administration of intravenous doses as a slow bolus over at least 3 minutes lowers the risk of all dystonic reactions.
Danish: Langsom intravenøs administration af dosis som en bolus i løbet af mindst 3 minutter mindsker risikoen for alle dystoniske reaktioner.
English: In this scenario where the unintended misuse is already taking place, to include a contraindication in the product information alongside a statement in the labelling is unlikely to be sufficient to change administration habits.
Danish: I dette scenarie, hvor utilsigtet fejlanvendelse allerede finder sted, vil tilføjelse af en kontraindikation i produktinformationen sammen med en anvisning i mærkningen næppe være tilstrækkelig til at ændre administrationsmønsteret.
English: Therefore use of metoclopramide should be reserved for situations where alternative treatments have not been effective or cannot be administered.
Danish: Derfor bør anvendelsen af metoclopramid forbeholdes situationer, hvor andre behandlinger ikke har været effektive eller ikke kan anvendes.
English: For severe hepatic impairment, the existing recommendation for 50% dose reduction is appropriate.
Danish: Ved svær leverfunktionsnedsættelse er den eksisterende anbefaling om 50 % dosisreduktion passende.
English: However, for patients with moderate to severe impairment (ClCr 15-60 ml/min), a 50% reduction remains appropriate.
Danish: For patienter med moderat til svær nyrefunktionsnedsættelse (ClCr 15-60 ml/min) vil en reduktion på 50 % dog fortsat være passende.
English: Therefore the risk to newborns cannot be excluded and metoclopramide should be avoided at the end of pregnancy.
Danish: Risiko for nyfødte kan derfor ikke udelukkes, og metoclopramid bør undgås i den sidste del af graviditeten.
English: This was based on insufficient evidence of efficacy in children in the concerned indications and on the safety issue of neurological symptoms.
Danish: Dette var baseret på utilstrækkeligheden af evidensen for virkning hos børn til de berørte indikationer og sikkerhedsproblemet bestående i neurologiske symptomer.
English: Adjuvant to surgical and radiological procedures
Danish: Adjuvans til kirurgiske og radiologiske procedurer