FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of restrictions and side effects with Tagrisso, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og bivirkninger ved Tagrisso fremgår af indlægssedlen.
English: Tagrisso must not be used together with St. John's wort (a herbal preparation used to treat depression).
Danish: Tagrisso må ikke anvendes sammen med prikbladet perikum (et plantepræparat, der bruges mod depression).
English: Tagrisso has been shown in studies to be effective at shrinking tumors in patients with these mutations and at slowing down the worsening of the cancer.
Danish: Det er i studier påvist, at Tagrisso er effektivt til at få tumorer til at skrumpe hos patienter med disse mutationer og forsinke forværringen af kræften.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tagrisso have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tagrisso.
English: How is Tagrisso used?
Danish: Hvordan anvendes Tagrisso?
English: What benefits of Tagrisso have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Tagrisso?
English: A third study in 419 previously treated patients with T790 mutations looked mainly at how effective Tagrisso was at preventing the cancer from worsening, comparing it with a platinum-based chemotherapy (the standard treatment for NSCLC).
Danish: Et tredje studie med deltagelse af 419 patienter med T790-mutationer undersøgte primært, hvor effektivt Tagrisso var til at forhindre kræften i at blive værre.
English: Tagrisso has been shown to be effective at shrinking tumours in patients with NSCLC and at slowing down the worsening of the cancer.
Danish: Det er påvist, at Tagrisso er effektivt til at gøre tumorer mindre hos patienter med ikke-småcellet lungekræft og forsinke forværringen af kræften.
English: How does Tagrisso work?
Danish: Hvordan virker Tagrisso?
English: The results were as follows:
Danish: Resultaterne var følgende:
English: Further information on Steglatro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Steglatro findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The patient should start with one 5 mg tablet once a day in the morning.
Danish: Patienten begynder med én 5 mg tablet én gang dagligt om morgenen.
English: Steglatro is available as tablets (5 and 15mg).
Danish: Steglatro fås som tabletter (5 og 15 mg).
English: As for all medicines, data on the use of Steglatro is continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Steglatro løbende overvåget.
English: If the patients' glucose level is still too high the dose can be increased to 15 mg once a day.
Danish: Hvis patientens glukoseniveau stadig er for højt, kan dosis sættes op til 15 mg én gang dagligt.
English: A lower dose of ertugliflozin 5 mg was less effective.
Danish: En lavere dosis af ertugliflozin på 5 mg var mindre effektiv.
English: What measures are being taken to ensure the safe and effective use of Steglatro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Steglatro?
English: At the start of the studies, patients' HbA1c was above 7 percentage points.
Danish: Ved begyndelsen af studierne var patienternes HbA1c over 7 procentpoint.
English: For more information about using Steglatro, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Steglatro, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Steglatro are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Steglatro vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: In addition, Steglatro can help some patients lose weight.
Danish: Steglatro kan desuden hjælpe nogle patienter til at tabe sig.
English: The European Medicines Agency concluded that Steglatro‘s benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Steglatro opvejer risiciene, og det kan godkendes til anvendelse i EU
English: The data from this study showed that the effect of ertugliflozin reduces when the kidneys do not work properly.
Danish: Dataene fra dette studie viste, at virkningen af ertugliflozin mindskes, når nyrerne ikke fungerer som de skal.
English: Steglatro contains the active substance ertugliflozin.
Danish: Steglatro indeholder det aktive stof ertugliflozin.
English: Other information about Steglatro
Danish: Andre oplysninger om Steglatro
English: The studies looked mainly at effects on levels of HbA1c (a measure of blood glucose) after 6 months or one year of treatment.
Danish: Studierne undersøgte først og fremmest virkningen på HbA1c-niveauet (et mål for blodets glukoseindhold) efter 6 måneders eller et års behandling.
English: An overview of Steglatro and why it is authorised in the EU
Danish: En oversigt over Steglatro og hvorfor det er godkendt i EU
English: The most common side effects with Steglatro (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system.
Danish: De hyppigste bivirkninger ved Steglatro (som optræder hos mere end 1 ud af 10 personer) er svampeinfektioner i skeden foruden andre infektioner i de kvindelige kønsdele.
English: The result is a high level of glucose in the blood.
Danish: Dette fører til højt glukoseindhold i blodet.
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Ved type 2-sukkersyge producerer kroppen enten ikke nok insulin til at regulere glukoseindholdet i blodet, eller også kan kroppen ikke anvende insulinet effektivt.
English: It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.
Danish: Dette sker gennem blokering af et protein i nyrerne, SGLT2, der normalt transporterer glukose tilbage i blodet fra nyrerne.
English: Steglatro can be used in combination with other diabetes medicines or on its own in patients who cannot take metformin.
Danish: Steglatro kan anvendes i kombination med andre sukkersygelægemidler eller som eneste lægemiddel hos patienter, der ikke tåler metformin.
English: Steglatro can only be obtained with a prescription.
Danish: Steglatro udleveres kun efter recept.
English: What are the risks associated with Steglatro?
Danish: Hvilke risici er der forbundet med Steglatro?
English: For the full list of side effects and restrictions with Steglatro, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Steglatro fremgår af indlægssedlen.
English: What is Steglatro and what is it used for?
Danish: Hvad er Steglatro, og hvad anvendes det til?
English: Why is Steglatro authorised in the EU?
Danish: Hvorfor blev Steglatro godkendt i EU?
English: HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride.
Danish: HbA1c-niveauet faldt med 0,6 point med ertugliflozin, og 0,7 point med glimepirid.
English: The active substance in Steglatro, ertugliflozin, helps to lower blood glucose by making the patient pass out glucose in the urine.
Danish: Det aktive stof i Steglatro, ertugliflozin, medvirker til at sænke glukose i blodet ved at fremkalde udskillelse af glukose i urinen.
English: Several studies in around 4,800 patients with type 2 diabetes have shown that ertugliflozin helps lower glucose levels on its own and in combination with other diabetes medicine.
Danish: Flere studier hos omkring 4 800 patienter med type 2-sukkersyge har vist, at ertugliflozin medvirker til at nedsætte glukoseniveauet, både når det anvendes alene og i kombination med andre sukkersygelægemidler.
English: • A sixth study found that adding the combination of ertugliflozin and sitagliptin to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.
Danish: • Et sjette studie viste, at tilføjelse af kombinationen af ertugliflozin og sitagliptin til diæt og motion var langt mere effektivt end placebo, idet HbA1c-niveauet faldt med mellem 1,6 og 1,7 point med kombinationen af ertugliflozin og sitagliptin, sammenholdt med et fald på 0,4 point med placebo.
English: • A third study found that a combination of ertugliflozin at a 15 mg dose with metformin was about as effective as a combination of metformin with another diabetes medicine, glimepiride.
Danish: • Et tredje studie viste, at ertugliflozin i en dosis på 15 mg kombineret med metformin var omtrent lige så effektivt som en kombination af metformin med et andet sukkersygelægemiddel, glimepirid.
English: Rare cases of diabetic ketoacidosis, a serious condition where the patient has very high blood acid levels, may occur in up to 1 in 1,000 patients.
Danish: i sjældne tilfælde kan der hos op til 1 ud af 1 000 patienter forekomme diabetisk ketoacidose, som er en alvorlig lidelse med meget højt syreindhold i blodet.
English: HbA1c levels fell by between 0.8 and 0.9 points when ertugliflozin was added, compared with a fall of 0.1 with placebo.
Danish: HbA1c-niveauet faldt med mellem 0,8 og 0,9 procentpoint ved tilføjelse af ertugliflozin, sammenholdt med et fald på 0,1 med placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Steglatro have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Steglatro.
English: • A fourth study found that, in patients taking metformin, adding ertugliflozin was as effective as adding sitagliptin, another diabetes medicine, with HbA1c levels falling by around 1 point with both treatments.
Danish: • Et fjerde studie viste, at hos patienter, der fik metformin, var tilføjelse af ertugliflozin lige så effektivt som tilføjelse af et andet sukkersygelægemiddel (sitagliptin), idet HbA1c-niveauet faldt med ca. 1 point med begge behandlinger.
English: How does Steglatro work?
Danish: Hvordan virker Steglatro?
English: Studies showed that Steglatro helps lower glucose levels on its own and in combination with other diabetes medicines.
Danish: Studierne viste, at Steglatro medvirker til at sænke glukoseniveauet, både når det anvendes alene og i kombination med andre sukkersygelægemidler.
English: Steglatro is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes together with diet and exercise.
Danish: Steglatro er lægemiddel mod sukkersyge og anvendes sammen med diæt og motion hos voksne med type 2-sukkersyge til at regulere blodets indhold af sukker (glukose).
English: • A study of ertugliflozin on its own, showed that levels of HbA1c (a measure of blood glucose) fell by between 0.8 points and 1 point in patients who took the medicine compared with a rise of 0.2 points in patients receiving placebo (a dummy treatment).
Danish: • Et studie med ertugliflozin, anvendt alene, viste, at niveauet af HbA1c (et mål for blodets glukoseindhold) faldt med mellem 0,8 point og 1 point hos patienter, der fik lægemidlet, sammenholdt med en stigning på 0,2 point hos dem, der fik virkningsløs behandling (placebo).
English: How is Steglatro used?
Danish: Hvordan anvendes Steglatro?
English: What benefits of Steglatro have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Steglatro?
English: Finally, in addition to lowering glucose levels, studies showed that ertugliflozin can help patients reduce bodyweight.
Danish: Endelig viste studierne, at ertugliflozin bidrog til at nedsætte patienternes legemsvægt foruden at nedsætte glukoseniveauet.
English: • A second study found that in patients taking a combination of ertugliflozin and metformin, HbA1c levels fell by around 0.8 points, compared with reductions of 0.03 when placebo was added to metformin.
Danish: • Endnu et studie viste, at hos patienter, der fik en kombination af ertugliflozin og metformin, faldt HbA1c-niveauet med ca. 0,8 point, sammenholdt med et fald på 0,03, når der i stedet blev tilføjet virkningsløs behandling (placebo) til metformin.
English: • A fifth study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo.
Danish: • Et femte studie viste, at det var mere effektivt at tilføje ertugliflozin end placebo til en kombination af sitagliptin og metformin.
English: • A seventh study showed that ertugliflozin was not more effective than placebo in patients with moderate kidney impairment.
Danish: • Det syvende studie viste, at hos patienter med moderat nedsat nyrefunktion var ertugliflozin ikke var mere effektivt end placebo.
English: Steglatro is not as effective in patients with moderate kidney impairment and should therefore not be started in such patients.
Danish: Hos patienter med moderat nedsat nyrefunktion er Steglatro ikke lige så effektivt.
English: HbA1c levels fell by a further 0.5 points when both medicines were added to metformin.
Danish: Når begge lægemidler blev tilføjet til metformin, faldt HbA1c-niveauet med yderligere 0,5 point.
English: Nausea is more common in women than in men.
Danish: Kvalme er mere almindelig hos kvinder end hos mænd.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xyrem on 13 October 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xyrem den 13. oktober 2005.
English: Both doses should be prepared at the same time before the patient goes to bed.
Danish: Begge doser bør forberedes samtidigt, inden patienten går i seng.
English: This document is a summary of the European Public Assessment Report (EPAR) for Xyrem.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xyrem.
English: The full EPAR for Xyrem can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Xyrem findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Xyrem can also cause respiratory depression (inhibition of breathing).
Danish: Xyrem kan også give respirationsdepression (åndedrætsbesvær).
English: What measures are being taken to ensure the safe and effective use of Xyrem?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xyrem?
English: The second dose is taken 2.5 to 4 hours later.
Danish: Den anden dosis tages 2,5 til 4 timer senere.
English: Xyrem was more effective than placebo in reducing symptoms.
Danish: Xyrem var mere effektivt end placebo til at lindre symptomerne.
English: A risk management plan has been developed to ensure that Xyrem is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Xyrem anvendes så sikkert som muligt.
English: The precise way in which it works is not known, but it is thought to attach to receptor molecules on the surface of some cells in the brain.
Danish: Det vides ikke nøjagtigt, hvordan det virker, men det menes at binde sig til bestemte receptormolekyler på overfladen af visse celler i hjernen.
English: The medicine can only be obtained with a special prescription.
Danish: Lægemidlet udleveres kun efter særlig recept.
English: This improves the symptoms of narcolepsy.
Danish: Dette lindrer symptomerne på narkolepsi.
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 Xyrem.
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 Xyrem.
English: The data obtained in the fibromyalgia studies did not support the use of Xyrem in this condition in the European population.
Danish: De data, som blev opnået i forbindelse med fibromyalgiundersøgelserne, understøttede ikke brugen af Xyrem til behandling af denne lidelse hos den europæiske population.
English: Xyrem is an oral solution that contains the active substance sodium oxybate (500 mg/ml).
Danish: Xyrem er en oral opløsning, der indeholder det aktive stof natriumoxybat (500 mg/ml).
English: Patients taking Xyrem should avoid alcohol, as it can increase Xyrem's effects.
Danish: Patienter, som tager Xyrem, bør undgå alkohol, da det kan øge virkningerne af Xyrem.
English: The effects of Xyrem in narcolepsy and cataplexy have been studied in 707 patients in four studies.
Danish: Virkningen af Xyrem på narkolepsi og katapleksi er blevet undersøgt hos 707 patienter i fire undersøgelser.
English: Patients who have problems with their kidneys should consider a low sodium diet.
Danish: Patienter, som har problemer med deres nyrer, bør overveje en kost med lavt natriumindhold.
English: When taken at bedtime, Xyrem increases deep sleep and increases the amount of time spent asleep at night, whilst reducing the number of sleeping periods during the day.
Danish: Når Xyrem tages ved sengetid, øges den dybe søvn og mængden af den tid, der soves om natten, samtidig med at det reducerer antallet af søvnperioder i løbet af dagen.
English: The study measured the number of cataplexy attacks over two weeks.
Danish: Undersøgelsen målte antallet af katapleksianfald i løbet af to uger.
English: The CHMP decided that Xyrem's benefits are greater than its risks.
Danish: CHMP besluttede, at fordelene ved Xyrem opvejer risiciene.
English: The dose is then adjusted at one- to two-week intervals depending on the patient's response.
Danish: Dosis justeres dernæst med en til to ugers intervaller, afhængigt af patientens respons.
English: Other information about Xyrem:
Danish: Andre oplysninger om Xyrem
English: Cataplexy is a symptom of narcolepsy involving sudden muscle weakness in response to an emotional reaction such as anger, fear, joy, laughter or surprise.
Danish: Katapleksi er et symptom på narkolepsi, der indebærer pludselig muskelslaphed som respons på en følelsesmæssig reaktion såsom vrede, angst, glæde, latter eller overraskelse.
English: Cataplexy can sometimes cause a patient to collapse.
Danish: Katapleksi kan undertiden få en patient til at falde om.
English: This leads to changes in the activity of the brain, bringing about ‘delta' (slow) brain waves and night-time sleep.
Danish: Dette ændrer hjerneaktiviteten og fremmer "delta-hjernebølger" (langsomme hjernebølger) og nattesøvnen.
English: Fibromyalgia is a disease of unknown origin causing long-lasting, widespread pain and painful responses to touch.
Danish: Fibromyalgi er en sygdom af ukendt oprindelse, som forårsager langvarig og udbredt smerte og smerter ved berøring.
English: For more information about treatment with Xyrem, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xyrem, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The Committee recommended that Xyrem be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Xyrem.
English: The first dose of the day is taken at bedtime, at least two to three hours after food.
Danish: Dagens første dosis tages ved sengetid mindst to til tre timer efter et måltid.
English: Before taking the medicine, the patient should dissolve the dose in water to make up a drink.
Danish: Inden lægemidlet tages, skal patienten opløse dosis i vand til en drik.
English: What is the risk associated with Xyrem?
Danish: Hvilken risiko er der forbundet med Xyrem?
English: Xyrem is supplied with a measuring device and a cup.
Danish: Xyrem leveres med en måleanordning og et bæger.
English: The effects of Xyrem have also been studied in fibromyalgia patients with moderate to severe symptoms in two short-term (12-week) studies in 1,121 patients, and one long-term (up to nine months) study in 560 patients.
Danish: Virkningerne af Xyrem er desuden blevet undersøgt hos fibromyalgipatienter med moderate til svære symptomer i forbindelse med to kortvarige (12 uger) undersøgelser af 1 121 patienter og én langvarig (op til ni måneder) undersøgelse af 560 patienter.
English: Xyrem must not be used in patients with major depression, in patients with ‘succinic semialdehyde dehydrogenase deficiency' (a rare metabolic disease), or in patients being treated with opioids (such as some painkillers) or barbiturates (such as some anaesthetics and medicines used to prevent seizures).
Danish: Xyrem må ikke anvendes til patienter med svær depression, til patienter med ”succinylsemialdehyddehydrogenasemangel” (en sjælden stofskiftelidelse) eller til patienter, som behandles med opioider (såsom visse smertestillende midler) eller barbiturater (såsom visse anæstetika og lægemidler til forebyggelse af krampeanfald).
English: Although the 9-g dose was the most effective, it was linked to high levels of side effects, so the Committee recommended a starting dose of 4.5 g per day.
Danish: Selvom en dosis på 9 g havde størst virkning, var den forbundet med øgede bivirkninger, så udvalget anbefalede en startdosis på 4,5 g dagligt.
English: In all of the studies, Xyrem was given at a daily dose between 3 and 9 g and was compared with placebo (a dummy treatment).
Danish: I alle undersøgelser blev Xyrem givet i daglige doser på mellem 3 og 9 g og blev sammenlignet med placebo (en virkningsløs behandling).
English: Xyrem is given at a dose of 4.5 to 9 g per day in two equally divided doses.
Danish: Xyrem gives i en dosis a 4,5 til 9 g pr. dag i to ligeligt fordelte doser.
English: Since the effective dose is close to the dose at which side effects become serious, increases in dose must be carried out strictly and under the supervision of a doctor specialised in the treatment of sleep disorders.
Danish: Da den effektive dosis ligger tæt på den dosis, hvor der er svære bivirkninger, skal dosisøgninger foretages med omhu og under overvågning af en læge, der er specialiseret i behandling af søvnforstyrrelser.
English: The most common side effects with Xyrem (seen in more than 1 patient in 10) are dizziness, headache and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Xyrem (som optræder hos flere end 1 ud af 10 patienter) er svimmelhed, hovedpine og kvalme.
English: The main measure of effectiveness was based on reduction of pain severity and improvement in function.
Danish: Virkningen blev hovedsagelig bedømt på graden af smertelindring og forbedret funktion.
English: Narcolepsy is a sleep disorder that causes excessive daytime sleepiness.
Danish: Narkolepsi er en søvnforstyrrelse, som giver overdreven søvntrang i dagtimerne.
English: The maximum daily dose is 9 g. Patients should usually start with two doses of 2.25 g (4.5 ml) per day.
Danish: Den maksimale dagsdosis er 9 g. Patienten bør normalt starte med to doser à 2,25 g (4,5 ml) pr. dag.