FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefits in combination with other tuberculosis treatments were shown in published studies presented by the company, two of which were considered to be the main studies for the application.
Danish: Virksomheden fremlagde publicerede undersøgelser, der viser fordelene ved kombination med andre tuberkulosemidler, hvor to af undersøgelserne blev anset for at være hovedgrundlag for ansøgningen.
English: Previously known as Para-aminosalicylic acid Lucane
Danish: Tidligere kendt som Para-aminosalicylsyre Lucane.
English: The CHMP noted that Granupas contains gastro-resistant granules, designed to allow PAS to reach the intestine without being released in the stomach, and thus reduce the potential for side effects.
Danish: CHMP bemærkede, at Granupas indeholder et enterogranulat, som tillader PAS at nå frem til tarmen, uden at det frigives i mavesækken, hvorved de mulige bivirkninger nedsættes.
English: After 12 months, 90% of patients in the combination group did not have the bacteria in their phlegm compared with 51% of patients given a comparable dose of isoniazid alone.
Danish: Efter 12 måneder havde 90 % af patienterne i kombinationsgruppen ikke bakterierne i deres ophostede slim, sammenholdt med 51 % af dem, der kun fik en sammenlignelig dosis af isoniazid.
English: PAS in combination with streptomycin also helped reduce the emergence of resistance to streptomycin: in 89% of patients receiving the combination the bacteria remained responsive to streptomycin, compared with 21% of patients who were given only streptomycin.
Danish: PAS kombineret med streptomycin nedsatte også opståen af resistens over for streptomycin: Hos 89 % af de patienter, der fik kombinationsbehandlingen, forblev bakterierne følsomme over for streptomycin, sammenholdt med 21 % af dem, der kun fik streptomycin.
English: For the full list of all side effects reported with Granupas, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Granupas fremgår af indlægssedlen.
English: In addition, the PAS-isoniazid combination helped reduce the emergence of resistance to isoniazid: after 1 year, while 47% of patients in the isoniazid-only group had resistant bacteria the figure was only 8% in the combination group.
Danish: PAS kombineret med isoniazid nedsatte desuden opståen af resistens over for isoniazid: Efter 1 år var der resistente bakterier hos 47 % af patienterne i den gruppe, der kun fik isoniazid, mod 8 % i kombinationsgruppen.
English: In addition,33% of patients in the combination group had no bacteria detected in their phlegm (sputum) compared with 8% in the PAS group.
Danish: Desuden havde 33 % af patienterne i kombinationsgruppen ingen bakterier i deres ophostede slim, sammenholdt med 8 % i gruppen på PAS.
English: For practical information about using Granupas, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Granupas, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: By interfering and taking the place of this chemical in the processes that make folic acid, para-aminosalicylic acid reduces the amount of folic acid produced and thereby stops or slows the growth of M. tuberculosis.
Danish: Para-aminosalicylsyre indtager paraaminobenzoesyres plads i de processer, hvor der dannes folsyre, og nedsætter derved den mængde folsyre, der dannes, således at væksten af M. tuberculosis standses eller bremses.
English: What benefits of Granupas have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Granupas?
English: At the end of the 6 months, 87% of patients on the combination had improvements in their chest x-rays compared with 56% of patients in the group taking PAS alone.
Danish: Efter 6 måneder viste røntgen af brystkassen bedring hos 87 % af patienterne på kombinationen, sammenholdt med 56 % af patienterne i den gruppe, der kun fik PAS.
English: How is Granupas used?
Danish: Hvordan anvendes Granupas?
English: How does Granupas work?
Danish: Hvordan virker Granupas?
English: • adults (aged 18 years and above) with mild to moderate type-1 Gaucher disease.
Danish: • voksne (på 18 år og derover) med mild til moderat Gauchers sygdom type 1.
English: Miglustat Gen.Orph received a marketing authorisation valid throughout the EU on 10 November 2017.
Danish: Miglustat Gen.Orph fik en markedsføringstilladelse med gyldighed i hele EU den 10. november 2017.
English: Further information on Miglustat Gen.Orph can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/miglustat-genorph.
Danish: Yderligere information vedrørende Miglustat Gen.Orph findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/miglustat-genorph.
English: The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease.
Danish: Lægemidlet fås kun på recept, og behandlingen bør følges af læger med erfaring i håndtering af Gauchers sygdom.
English: • patients of all ages with Niemann-Pick type-C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Danish: • patienter i alle aldre med Niemann-Picks sygdom type C, en potentielt dødelig sygdom, hvor der ophobes glycosphingolipider i hjerneceller og celler andre steder i kroppen.
English: By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Danish: Ved at forhindre enzymet i at virke kan miglustat mindske produktionen af glucosylceramid i cellerne og derved reducere symptomerne på Gauchers sygdom type 1.
English: Because Miglustat Gen.Orph is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Miglustat Gen.Orph er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: This means that Miglustat Gen.Orph contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Zavesca.
Danish: Det betyder, at Miglustat Gen.Orph indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Zavesca.
English: Miglustat Gen.Orph is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Danish: Miglustat Gen.Orph anvendes til behandling af de neurologiske symptomer på sygdommen (symptomer, der påvirker hjernen og nerverne).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Miglustat Gen.Orph has been shown to have comparable quality and to be bioequivalent to Zavesca.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Miglustat Gen.Orph er af sammenlignelig kvalitet og er bioækvivalent med Zavesca.
English: Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
Danish: Begge sygdomme forårsager en ophobning i kroppen af fedtstoffer, der kaldes glycosphingolipider.
English: For more information about using Miglustat Gen.Orph, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Miglustat Gen.Orph, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Miglustat Gen.Orph is used to treat two inherited diseases that affect the way the body handles fats.
Danish: Miglustat Gen.Orph anvendes til behandling af to arvelige sygdomme, der påvirker den måde, kroppen håndterer fedt på.
English: Side effects reported with Miglustat Gen.Orph are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Miglustat Gen.Orph vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: As for every medicine, the company provided studies on the quality of Miglustat Gen.Orph.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Miglustat Gen.Orph.
English: Studies on the benefits and risks of the active substance in Gaucher disease have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Miglustat Gen.Orph.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet Zavesca, og de behøver ikke blive gentaget for Miglustat Gen.Orph.
English: As for all medicines, data on the use of Miglustat Gen.Orph are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Miglustat Gen.Orph løbende overvåget.
English: The active substance in Miglustat Gen.Orph, miglustat, blocks an enzyme called glucosylceramide synthase.
Danish: Det aktive stof i Miglustat Gen.Orph, miglustat, blokerer virkningen af enzymet glucosylceramidsyntase.
English: Miglustat Gen.Orph is available as 100 mg capsules to be taken by mouth.
Danish: Miglustat Gen.Orph fås som 100 mg-kapsler, der tages gennem munden.
English: Miglustat Gen.Orph is used in patients who cannot receive the standard treatment of enzymereplacement therapy (ERT);
Danish: Miglustat Gen.Orph anvendes til patienter, der ikke kan få standardbehandling med enzymsubstitutionsterapi (ERT)
English: Other information about Miglustat Gen.Orph
Danish: Andre oplysninger om Miglustat Gen.Orph
English: Therefore, the Agency's view was that, as for Zavesca, the benefit of Miglustat Gen.Orph outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Miglustat Gen.Orph opvejer de identificerede risici som for Zavesca, og at det kan godkendes til anvendelse i EU.
English: Miglustat Gen.Orph is used to treat the following patients:
Danish: Miglustat Gen.Orph anvendes til behandling af følgende patienter:
English: Miglustat Gen.Orph is a ‘generic medicine'.
Danish: Miglustat Gen.Orph er et "generisk lægemiddel".
English: An overview of Miglustat Gen.Orph and why it is authorised in the EU
Danish: Oversigt over Miglustat Gen.Orph, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Miglustat Gen.Orph?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Miglustat Gen.Orph?
English: What is Miglustat Gen.Orph and what is it used for?
Danish: Hvad er Miglustat Gen.Orph, og hvad anvendes det til?
English: What are the benefits and risks of Miglustat Gen.Orph?
Danish: Hvilke fordele og risici er der forbundet med Miglustat Gen.Orph?
English: Why is Miglustat Gen.Orph authorised in the EU?
Danish: Hvorfor blev Miglustat Gen.Orph godkendt i EU?
English: Miglustat Gen.Orph is intended for long-term use.
Danish: Miglustat Gen.Orph er beregnet til langtidsbehandling.
English: Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Danish: Det medfører, at et glycosphingolipid kaldet glucosylceramid ophobes forskellige steder i kroppen, f.eks. i milten, leveren og knoglerne.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Miglustat Gen.Orph 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 Miglustat Gen.Orph.
English: How has Miglustat Gen.Orph been studied?
Danish: Hvordan blev Miglustat Gen.Orph undersøgt?
English: How is Miglustat Gen.Orph used?
Danish: Hvordan anvendes Miglustat Gen.Orph?
English: How does Miglustat Gen.Orph work?
Danish: Hvordan virker Miglustat Gen.Orph?
English: These can usually be treated by your doctor.
Danish: Disse kan sædvanligvis behandles af Deres læge.
English: Date of first authorisation: 19 July 2006 Date of latest renewal: 21 July 2011
Danish: Dato for første markedsføringstilladelse: 19. juli 2006 Dato for seneste fornyelse: 21. juli 2011
English: The absolute bioavailability is not known.
Danish: Den absolutte biotilgængelighed er ikke kendt.
English: Similar effects were not induced in adult dogs.
Danish: Lignende effekter opstod ikke i voksne hunde.
English: The tablets should be swallowed with a glass of water.
Danish: Tabletterne bør sluges med et glas vand.
English: This medicine may also affect the results of some blood tests.
Danish: Dette lægemiddel kan også påvirke resultaterne af visse blodprøver.
English: - If you have high blood pressure.
Danish: - hvis De har et højt blodtryk.
English: Monitoring of renal function should be considered.
Danish: Monitorering af nyrefunktionen bør overvejes.
English: All Grades*
Danish: Alle grader*
English: The nominal alpha value for this analysis was 0.0094.
Danish: Den nominelle alfa-værdi for denne analyse var 0,0094.
English: - If you have diabetes.
Danish: - hvis De har diabetes.
English: Tell your doctor if any of these affect you.
Danish: Fortæl det til Deres læge, hvis noget af dette berører Dem.
English: Laboratory parameter, (in % of samples investigated)
Danish: Laboratorieparameter, (i % af undersøgte prøver)
English: Your doctor will decide when to start with Nexavar again.
Danish: Deres læge vil beslutte, hvornår De skal starte med Nexavar igen.
English: - If you are going to have surgery, or if you had an operation recently.
Danish: - hvis De skal opereres, eller De for nylig er blevet opereret.
English: Such events are either uncommon or less frequent than uncommon.
Danish: Disse bivirkninger er enten ikke almindelige eller mindre hyppige end ikke almindelige.
English: In some cases this was not associated with apparent intra-abdominal tumour.
Danish: I nogle tilfælde havde dette ikke forbindelse med en synlig intraabdominal tumor.
English: It is important to take this medicine at about the same times each day, so that there is a steady amount in the bloodstream.
Danish: Det er vigtigt at tage dette lægemiddel omkring samme tid hver dag, så der er en jævn mængde i blodet.
English: The study was stopped after a planned interim analysis of OS had crossed the prespecified efficacy boundary.
Danish: Studiet blev stoppet efter, at en planlagt interim analyse af OS havde overskredet den præspecificerede effektgrænse.
English: Sorafenib should not be used during pregnancy unless clearly necessary, after careful consideration of the needs of the mother and the risk to the foetus.
Danish: Sorafenib bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt og i så fald kun efter nøje overvejelse af moderens behov og risikoen for fostret.
English: The primary endpoints were overall survival and progression-free survival (PFS).
Danish: De primære endepunkter var samlet overlevelse og progressionsfri overlevelse (PFS).
English: Analyses of demographic data suggest that there is no relationship between pharmacokinetics and age (up to 65 years), gender or body weight.
Danish: Analyser af demografiske data viser, at der ikke er nogen relation mellem farmakokinetik og alder (op til 65 år), køn eller kropsvægt.
English: Cases of renal failure have been reported.
Danish: Tilfælde af nyresvigt har været rapporteret.
English: P-gp-substrates
Danish: P-gp-substrater
English: In vitro binding of sorafenib to human plasma proteins is 99.5 %.
Danish: In vitro er bindingen til human plasmaproteiner 99,5 %.
English: Elderly population No dose adjustment is required in the elderly (patients above 65 years of age).
Danish: Ældre population Der kræves ingen dosisreduktion hos ældre (patienter over 65 år).
English: The reason for the increased concentration in DTC patients is unknown.
Danish: Årsagen til den højere koncentration hos patienter med DTC er ukendt.
English: Do not take this medicine with high fat meals, as this may make Nexavar less effective.
Danish: Tag ikke dette lægemiddel med et måltid med højt fedtindhold, da dette kan gøre Nexavar mindre effektiv.
English: Nexavar may reduce fertility in both men and women.
Danish: Nexavar kan reducere fertiliteten hos både mænd og kvinder.
English: - If you have a heart disorder, such as an abnormal electrical signal called "prolongation of the QT interval".
Danish: - hvis De har en hjerterytmeforstyrrelse såsom et unormalt elektrisk signal, der kaldes ”forlængelse af QT-intervallet”.
English: No complete response (CR) according to RECIST was observed.
Danish: Der blev ikke observeret tilfælde med fuldstændigt respons (complete response, CR) i henhold til RECIST.
English: Nexavar can raise blood pressure, and your doctor will usually monitor your blood pressure and may give you a medicine to treat your high blood pressure.
Danish: Nexavar kan øge blodtrykket, og Deres læge vil som regel følge Deres blodtryk og kan beslutte at give Dem et lægemiddel til behandling af Deres høje blodtryk.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: An interim analysis (second interim analysis) for overall survival was conducted at 367 deaths in 903 patients.
Danish: En interim analyse (anden interim analyse) af samlet overlevelse var udført på 367 dødsfald hos 903 patienter.
English: - If you are taking irinotecan or are given docetaxel, which are also medicines for cancer.
Danish: - hvis De tager irinotecan eller får docetaxel, som også er lægemidler mod cancer.
English: If you have missed a dose, take it as soon as you remember.
Danish: Hvis De har glemt at tage en dosis, så tag den, så snart De opdager det.
English: If it is nearly time for the next dose, forget about the missed one and carry on as normal.
Danish: Hvis det er lige før den næste dosis, se da bort fra den glemte dosis, og fortsæt som normalt.
English: Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og på hver blister efter angiv forkortelsen for udløbsdatoen.
English: Therefore repeat evaluations of benefit and risk is recommended taking anti-tumour activity and tolerability into account.
Danish: Derfor anbefales det at reevaluere fordele og risici og tage antitumoraktivitet og tolerabilitet med i overvejelserne.
English: Following progression, patients were allowed to receive open label sorafenib.
Danish: Efter progression kunne patienterne få open-label-sorafenib.
English: The elimination half-life of sorafenib is approximately 25 - 48 hours.
Danish: Eliminationshalveringstiden af sorafenib er ca. 25 - 48 timer.
English: Eight metabolites of sorafenib have been identified, of which five have been detected in plasma.
Danish: Otte metabolitter af sorafenib er identificeret, hvoraf fem er påvist i plasma.
English: Dermatological toxicities
Danish: Dermatologisk toksicitet
English: Effects of other antibiotics have not been studied, but will likely depend on their ability to interfere with microorganisms with glucuronidase activity.
Danish: Virkningen af andre antibiotika er ikke blevet undersøgt, men disse har sandsynligvis også evnen til at påvirke mikroorganismer med glukuronidaseaktivitet.
English: - If you get chest pain or heart problems.
Danish: - hvis De får brystsmerter eller hjerteproblemer.
English: Age, MSKCC prognostic group, ECOG PS and prior therapy did not affect the treatment effect size.
Danish: Alder, MSKCC-prognosegruppe, ECOG PS og tidligere behandling påvirkede ikke størrelsen af behandlingens effekt.
English: Increased lipase and amylase were very commonly reported.
Danish: Rapporter om øget lipase og amylase var meget almindelige.
English: Baseline demographics and patient characteristics were well balanced for both treatment groups.
Danish: Baseline-demografi og patientkarakteristika var afbalancerede mellem de 2 behandlingsgrupper.
English: It is not known whether sorafenib is excreted in human milk.
Danish: Det vides ikke, om sorafenib udskilles i human mælk.
English: Swallow Nexavar tablets with a glass of water, either without food or with a low-fat or moderate fat meal.
Danish: Synk Nexavar tabletterne med et glas vand, enten uden mad eller med et lavt eller moderat fedtholdigt måltid.
English: Time to Progression (TTP) [median, weeks (95% CI)]**
Danish: Tid til progression (TTP) [median, uger (95 % CI)]**
English: One intermediate in the manufacturing process, which is also present in the final active substance (< 0.15 %), was positive for mutagenesis in an in vitro bacterial cell assay (Ames test).
Danish: Et intermediat fra fremstillingsprocessen, som også findes i det endelige aktive stof (< 0,15 %), var positiv for mutagenese i en in vitro test på bakterieceller (Ames test).
English: Your doctor may tell you to stop taking this medicine.
Danish: Deres læge kan beslutte, at De skal stoppe med at tage dette lægemiddel.
English: The safety and efficacy of Nexavar in children and adolescents aged < 18 years have not yet been established.
Danish: Nexavars sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: The PFS analysis was conducted at 342 events in 769 patients.
Danish: PFS-analysen var udført på 342 resultater hos 769 patienter.
English: Environmental Risk assessment studies have shown that sorafenib tosylate has the potential to be persistent, bioaccumulative and toxic to the environment.
Danish: Miljørisikovurderingsstudier har vist, at sorafenibtosylat har potentialet til at være persistent, bioakkumulerende og toksisk for miljøet.
English: 112 film-coated tablets (4 x 28) in transparent (PP/Aluminium) blister packs.
Danish: 112 filmovertrukne tabletter (4 x 28) i transparente (PP/Aluminium) blister.
English: Majority of patients had papillary carcinoma (56.8%), followed by follicular (25.4%) and poorly differentiated carcinoma (9.6%).
Danish: Størstedelen af patienterne havde papillært karcinom (56,8 %) efterfulgt af follikulært karcinom (25,4 %) og ringe differentieret karcinom (9,6 %).
English: It works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing.
Danish: Den virker ved at nedsætte hastigheden af cancercellernes vækst og afskære den blodforsyning, der gør, at cellerne kan vokse.
English: If you are taking warfarin or phenprocoumon, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding.
Danish: Hvis De tager warfarin eller phenprocoumon, som er lægemidler, som fortynder blodet for at forebygge blodpropper, kan der være øget risiko for blødning.
English: Blood pressure should be monitored regularly and treated, if required, in accordance with standard medical practice.
Danish: Blodtrykket skal måles regelmæssigt og om nødvendigt behandles ud fra medicinsk standardpraksis.
English: Sorafenib is mainly eliminated via the liver, and exposure might be increased in this patient population.
Danish: Sorafenib elimineres hovedsageligt via leveren, og eksponeringen kan være øget i disse patientpopulationer.
English: Approximately half of the patients had an ECOG performance status of 0, and half of the patients were in the low risk MSKCC prognostic group.
Danish: Cirka halvdelen af patienterne havde præstationskapacitet svarende til ECOG 0, og halvdelen af patienterne var i den lave MSKCC-prognosegruppe.
English: The risk of reduced plasma concentrations of sorafenib should be considered before starting a treatment course with antibiotics.
Danish: Riskoen for reducerede plasmakoncentrationer af sorafenib bør tages i betragtning, før et behandlingsforløb med antibiotika påbegyndes.