FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Lynparza, olaparib, blocks the action of enzymes called human poly (ADP ribose) polymerase (PARP), which help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division.
Danish: Det aktive stof i Lynparza, olaparib, blokerer virkningen af enzymer, der kaldes humane poly-(ADPribose)-polymeraser (PARP'er), som hjælper med at reparere beskadiget dna i cellerne (både normale celler og kræftceller) under celledelingen.
English: The company that markets Lynparza will carry out studies to further confirm the benefit, including long-term benefit, of the medicine in patients with ovarian cancer.
Danish: Virksomheden, der markedsfører Lynparza, vil udføre studier for yderligere at bekræfte fordelen, herunder på lang sigt, hos patienter med kræft i æggestokkene.
English: For more information about using Lynparza, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Lynparza, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Treatment may be interrupted or stopped or the dose reduced if certain side effects develop.
Danish: Hvis der optræder visse bivirkninger, kan behandlingen afbrydes eller stoppes, eller dosen nedsættes.
English: What is Lynparza and what is it used for?
Danish: Hvad er Lynparza, og hvad anvendes det til?
English: Why is Lynparza authorised in the EU?
Danish: Hvorfor er Lynparza godkendt i EU?
English: Lynparza was effective in a study involving 302 patients with HER2-negative breast cancer with BRCA1/2 mutations whose cancer had spread.
Danish: Lynparza var effektivt i et studie med 302 patienter med HER2-negativ brystkræft med BRCA1/2mutationer, hvis kræft havde bredt sig.
English: • treatment of breast cancer which is HER2-negative and that has spread beyond the original site in patients with mutations in BRCA1 or BRCA2 genes who have been treated with certain breast cancer medicines (unless these medicines were not suitable).
Danish: • behandling af brystkræft, som er HER2-negativ, og som har bredt sig ud over det oprindelige område hos patienter med mutationer i BRCA1- eller BRCA2-genet, der er blevet behandlet med visse brystkræftlægemidler (medmindre disse lægemidler ikke var egnede).
English: What are the risks associated with Lynparza?
Danish: Hvilke risici er der forbundet med Lynparza?
English: In ovarian, fallopian tube or peritoneal cancers, Lynparza can also delay the next cycle of platinum chemotherapy.
Danish: Ved æggestok-, æggeleder- eller bughindekræft kan Lynparza også udskyde den næste serie af platinbaseret kemoterapi.
English: For the full list of side effects and restrictions with Lynparza, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Lynparza fremgår af indlægssedlen.
English: Patients treated with Lynparza lived on average 7.0 months without their disease getting worse compared with 4.2 months for patients treated with the doctor's choice of another cancer medicine.
Danish: De patienter, der blev behandlet med Lynparza, levede gennemsnitligt i 7,0 måneder uden forværring af sygdommen, sammenholdt med 4,2 måneder for de patienter, der blev behandlet med et andet kræftlægemiddel, som lægen havde valgt.
English: • continuing treatment of high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb) and the peritoneum (membrane lining the abdomen) in:
Danish: • fortsat behandling af højmalign (hurtigtvoksende) kræft i æggestokkene, æggelederne (som forbinder æggestokkene med livmoderen) og bughinden (den hinde, der beklæder bugvæggens inderside):
English: Studies show that Lynparza increases the time patients live without their disease getting worse after treatment with platinum-based chemotherapy has reduced or cleared the cancer:
Danish: Studier har vist, at Lynparza øger den tid, som patienterne lever uden sygdomsforværring, efter at kræften er blevet mindre eller er forsvundet som følge af behandlingen med platinbaseret kemoterapi:
English: • In a third study involving 391 patients with advanced cancer who had BRCA1/2 mutations, the disease had not got worse in around 74% of patients who took Lynparza for 2 years compared with 35% of patients on placebo.
Danish: • I et tredje studie med 391 patienter med fremskreden kræft, som havde BRCA1/2-mutationer, var sygdommen ikke forværret hos omkring 74 % af de patienter, der tog Lynparza i 2 år, sammenlignet med 35 % af de patienter, der tog placebo.
English: − women whose cancer had come back (relapsed) after previous treatment and in whom platinum-based chemotherapy has reduced or cleared the cancer;
Danish: − hos kvinder, hvis kræft var vendt tilbage (var recidiverende) efter tidligere behandling, og hos hvem platinbaseret kemoterapi havde reduceret eller fjernet kræften
English: The doses in milligrams are different for the tablets and capsules.
Danish: Tabletterne og kapslerne har ikke samme doser i milligram.
English: Generally the outcome is poor for patients with ovarian, fallopian tube or peritoneal cancers and for patients with HER2-negative breast cancer with BRCA mutations whose cancer has spread.
Danish: Generelt set er prognosen dårlig for patienter med æggestok-, æggeleder- eller bughindekræft og for patienter med HER2-negativ brystkræft med BRCA-mutationer, hvis kræft har bredt sig.
English: How is Lynparza used?
Danish: Hvordan anvendes Lynparza?
English: − in newly diagnosed women with advanced cancer with mutations (changes) in one or both genes known as BRCA1 and BRCA2 who have been treated with platinum-based chemotherapy and in whom this treatment has reduced or cleared the cancer;
Danish: − hos kvinder med nydiagnosticeret fremskreden kræft med mutationer (ændringer) i BRCA1og/eller BRCA2-genet, som er blevet behandlet med platinbaseret kemoterapi, og hos hvem denne behandling har reduceret eller fjernet kræften.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lynparza have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Lynparza.
English: • A study of 295 patients with relapsed cancer of the ovary, fallopian tube or peritoneum found that those receiving Lynparza lived on average for 19.1 months without their disease getting worse compared with 5.5 months for patients receiving placebo (a dummy treatment).
Danish: • Et studie med 295 patienter med recidiverende kræft i æggestokkene, æggelederne eller bughinden viste, at de patienter, som fik Lynparza, levede gennemsnitligt i 19,1 måneder uden sygdomsforværring, sammenholdt med 5,5 måneder for patienter, der fik placebo (en uvirksom behandling).
English: • In another study involving 265 patients with relapsed cancer, those who took Lynparza lived on average for 8.4 months without their disease getting worse compared with 4.8 months for patients on placebo.
Danish: • I et andet studie med 265 patienter med recidiverende kræft levede de patienter, der fik Lynparza, i gennemsnit 8,4 måneder uden sygdomsforværring sammenholdt med 4,8 måneder hos patienter, der fik placebo.
English: What benefits of Lynparza have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Lynparza?
English: How does Lynparza work?
Danish: Hvordan virker Lynparza?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vimpat on 29 August 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vimpat den 29. august 2008.
English: The full EPAR for Vimpat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Vimpat findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can also be used in patients who are temporarily unable to take the tablets or syrup.
Danish: Det kan også anvendes til patienter, som midlertidigt ikke kan tage tabletter eller syrup.
English: Other information about Vimpat
Danish: Andre oplysninger om Vimpat
English: What is Vimpat and what is it used for?
Danish: Hvad er Vimpat, og hvad anvendes det til?
English: Vimpat lacosamide
Danish: Vimpat lacosamid
English: This is a summary of the European public assessment report (EPAR) for Vimpat.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vimpat.
English: What measures are being taken to ensure the safe and effective use of Vimpat?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vimpat?
English: It is not intended to provide practical advice on how to use Vimpat.
Danish: Det er ikke en praktisk vejledning i, hvordan Vimpat bør anvendes.
English: Why is Vimpat approved?
Danish: Hvorfor blev Vimpat godkendt?
English: It contains the active substance lacosamide.
Danish: Det indeholder det aktive stof lacosamid.
English: The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Danish: Det vides endnu ikke helt præcist, hvordan lacosamid virker, men stoffet synes at reducere aktiviteten i de natriumkanaler (porer på overfladen af nervecellerne), der muliggør overførsel af elektriske impulser mellem nerveceller.
English: What are the risks associated with Vimpat?
Danish: Hvilke risici er der forbundet med Vimpat?
English: The company also provided data to support dosing of Vimpat in children from 4 years of age and supportive results from studies of the safety of Vimpat in this population.
Danish: Virksomheden har også fremlagt data til at understøtte doseringen af Vimpat hos børn i alderen 4 år og opad samt understøttende resultater fra undersøgelsen af Vimpat i denne population.
English: It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain).
Danish: Vimpat kan anvendes til behandling af partielle anfald med eller uden sekundær generalisering (hvor anfaldet efterfølgende spreder sig til andre dele af hjernen).
English: Vimpat infusion can be used to begin treatment.
Danish: Vimpatinfusionen kan anvendes som indledende behandling.
English: This was found to be 90% in those taking Vimpat and 91% in those taking carbamazepine.
Danish: Dette var tilfældet hos 90 % af dem, der fik Vimpat, og 91 % af dem, der fik carbamazepin.
English: If treatment with Vimpat has to be stopped, the dose should be gradually reduced.
Danish: Hvis behandlingen med Vimpat skal afbrydes, skal dosis nedtrappes lidt efter lidt.
English: This compared with 23% of the patients taking placebo.
Danish: Det samme var tilfældet hos 23 % af dem, der fik placebo.
English: It explains how the Agency assessed the medicine to recommend its authorisation and its conditions of use.
Danish: Det forklarer, hvordan agenturet vurderede lægemidlet for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne.
English: This action may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.
Danish: Dette kan forhindre anormal elektrisk aktivitet i at spredes i hjernen og derigennem mindske risikoen for epileptiske anfald.
English: Vimpat was more effective than placebo (a dummy treatment) at reducing seizures in three main studies involving a total of 1,308 patients aged 16 years and above also taking other epilepsy medicines.
Danish: Vimpat var mere effektivt end placebo (virkningsløs behandling) til at reducere antallet af anfald i tre hovedundersøgelser med i alt 1 308 patienter i alderen 16 år og derover, der også fik andre lægemidler mod epilepsi.
English: The active substance in Vimpat, lacosamide, is an epilepsy medicine.
Danish: Det aktive stof i Vimpat, lacosamid, er et lægemiddel mod epilepsi.
English: The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.
Danish: Dosen på 600 mg var lige så effektiv som 400 mg-dosen, men gav flere bivirkninger.
English: Around 78% of Vimpat-treated and 83% of carbamazepine-treated patients did not have a seizure for 12 months.
Danish: Ca. 78 % af dem, der fik Vimpat, og 83 % af dem, der fik carbamazepin, fik ikke anfald i 12 måneder.
English: If the doctor decides that a faster effect is needed, treatment in some patients with Vimpat may be started with a higher first dose (called a loading dose).
Danish: Hvis lægen beslutter, at der er behov for en hurtigere virkning, kan behandlingen med Vimpat indledes med en højere initialdosis (kaldet en støddosis).
English: Vimpat is given on its own or combined with other medicines for epilepsy.
Danish: Vimpat gives alene eller i kombination med andre lægemidler mod epilepsi.
English: In younger patients weighing less than 50 kg, the dose is based on body weight, and treatment may be started with the syrup.
Danish: Til yngre patienter på under 50 kg kan dosis baseres på legemsvægten, og behandlingen kan indledes med syruppen.
English: The most common side effects with Vimpat (seen in more than 1 patient in 10) are dizziness, headache, diplopia (double vision) and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Vimpat (som optræder hos flere end 1 ud af 10 patienter) er svimmelhed, hovedpine, dobbeltsyn (diplopi) og kvalme.
English: The European Medicines Agency decided that Vimpat, used alone or added to other epilepsy medicines, had been shown to be effective in the treatment of partial onset seizures.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Vimpat anvendt alene eller i tillæg til andre lægemidler mod epilepsi har vist sig effektivt til behandling af partielle anfald.
English: Taking the known side effects into account, the Agency considered Vimpat's benefits to be greater than its risks and recommended that it be given marketing authorisation.
Danish: I betragtning af de kendte bivirkninger konkluderede agenturet, at fordelene ved Vimpat opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The main measure of effectiveness was the proportion of patients who did not have a seizure for at least 6 months after reaching a stable dose.
Danish: Det vigtigste mål for virkningen var antallet af patienter, som ikke fik anfald i mindst seks måneder efter at være nået op på en stabil dosis.
English: An additional study in 118 patients was carried out to test that starting treatment with doses of 200 mg Vimpat by infusion, followed by regular doses taken by mouth, can be applied safely and that adequate levels in the body are achieved.
Danish: Der blev gennemført en yderligere undersøgelse med 118 patienter for at teste, at støddosen på 200 mg Vimpat givet ved infusion, efterfulgt af almindelige doser taget gennem munden, kan anvendes sikkert, og at der opnås et passende indhold i kroppen.
English: The usual starting dose in adults and older children (weighing at least 50 kg) is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines.
Danish: Den sædvanlige startdosis til voksne og større børn (der vejer mindst 50 kg) er 50 mg to gange dagligt, som kan øges hver uge indtil en maksimal dosis på 300 mg to gange dagligt, hvis det anvendes alene, eller 200 mg to gange dagligt, hvis det gives sammen med andre lægemidler mod epilepsi.
English: Patients were given Vimpat by mouth at a dose of 200 mg, 400 mg or 600 mg a day, or placebo in addition to their existing treatment of up to three other epilepsy medicines.
Danish: Patienterne fik Vimpat taget gennem munden i doser på 200 mg, 400 mg eller 600 mg dagligt, eller placebo i tillæg til den eksisterende behandling med op til tre andre lægemidler mod epilepsi.
English: A fourth study involving 888 recently diagnosed patients showed that Vimpat, used on its own by mouth at a dose of 200 mg to 600 mg a day, was at least as effective as carbamazepine, another medicine for epilepsy.
Danish: En fjerde undersøgelse med 888 nyligt diagnosticerede patienter viste, at Vimpat anvendt alene taget gennem munden i en dosis på 200 mg til 600 mg dagligt var mindst ligeså effektiv som carbamazepin, et andet lægemiddel mod epilepsi.
English: Vimpat must not be used in people who have second or third degree AV block (a type of heart rhythm disorder).
Danish: Vimpat må ikke anvendes til patienter, der har anden- eller tredjegrads AV-blok (en form for forstyrrelse af hjerterytmen).
English: Vimpat can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg), as a syrup (10 mg/ml) and as a solution for infusion (drip) into a vein.
Danish: Vimpat udleveres kun efter recept og fås som tabletter (50 mg, 100 mg, 150 mg og 200 mg), som syrup (10 mg/ml) og som en opløsning til infusion (drop i en vene).
English: Taking the results of the three main studies together, 34% of the patients taking Vimpat 200 mg a day and 40% of the patients taking Vimpat 400 mg a day with their existing treatment had a reduction in their seizures by at least half.
Danish: Hvis man ser på resultaterne af de tre hovedundersøgelser tilsammen, opnåede 34 % af de patienter, der fik 200 mg Vimpat dagligt, og 40 % af de patienter, der fik 400 mg Vimpat dagligt i tillæg til den eksisterende behandling, en reduktion på mindst 50 % af antallet af anfald.
English: For more information about treatment with Vimpat read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vimpat, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Vimpat is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 4 years and older.
Danish: Vimpat er lægemiddel mod epilepsi til behandling af partielle anfald (epileptiske anfald, der udspringer fra en bestemt del af hjernen) hos epilepsipatienter i alderen 4 år og opefter.
English: For practical information about using Vimpat, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vimpat, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects and restrictions with Vimpat, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Vimpat fremgår af indlægssedlen.
English: How is Vimpat used?
Danish: Hvordan anvendes Vimpat?
English: What benefits of Vimpat have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vimpat?
English: The main measure of effectiveness was the number of patients whose number of seizures was at least halved after 12 weeks of treatment with a stable dose.
Danish: Det primære mål for virkningen var antallet af patienter, der mindst opnåede en halvering af antallet af epileptiske anfald efter 12 ugers behandling med en stabil dosis.
English: Lower doses should be used in patients with severely reduced kidney function or reduced liver function.
Danish: Patienter med nedsat nyrefunktion eller svært nedsat nyrefunktion bør have en lavere dosis.
English: Two additional studies looked at the appropriate duration of the infusion for Vimpat solution and compared its safety with that of placebo infusions in a total of 199 patients.
Danish: I yderligere to undersøgelser med i alt 199 patienter så man nærmere på, hvilken varighed infusionen af Vimpatopløsningen optimalt skulle have, og sammenlignede sikkerheden ved lægemidlet med sikkerheden ved placeboinfusion.
English: How does Vimpat work?
Danish: Hvordan virker Vimpat?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vimpat 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 Vimpat.
English: For more details see the package leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: Side effects affecting the nervous system such as dizziness may be higher after a loading dose and dizziness was the most common reason for stopping treatment.
Danish: Svimmelhed var den mest almindelige grund til at stoppe behandlingen.
English: Alternative treatments should be considered.
Danish: Alternative behandlinger bør overvejes.
English: Your doctor will check this.
Danish: Din læge vil undersøge dette.
English: They are available in packs of:
Danish: De er tilgængelige i pakninger med:
English: No such effects were observed in adult rats.
Danish: Sådanne virkninger blev ikke observeret hos voksne rotter.
English: These medicinal products should be used with caution.
Danish: Disse lægemidler bør anvendes med forsigtighed.
English: Doses above 1 mg riociguat were not investigated in this study.
Danish: Doser over 1 mg riociguat blev ikke undersøgt i dette studie.
English: A risk to the suckling child cannot be excluded.
Danish: En risiko for et diende barn kan ikke udelukkes.
English: Special considerations for patients who smoke
Danish: Særlige hensyn for patienter, der ryger
English: The relevance of this finding for humans is unknown.
Danish: Betydningen af dette fund for mennesker er ukendt.
English: They can generally be taken with or without food.
Danish: De kan generelt tages sammen med eller uden mad.
English: Current smokers should be advised to stop smoking due to a risk of a lower response.
Danish: Nuværende rygere skal rådes til at holde op med at ryge på grund af risikoen for et lavere respons.
English: Do not take Adempas during pregnancy.
Danish: Tag ikke Adempas under graviditeten.
English: The use of Adempas in children and adolescents (under 18 years of age) should be avoided because efficacy and safety have not been established for this age group.
Danish: Det bør undgås at anvende Adempas til børn og unge (under 18 år), da virkning og sikkerhed ikke er fastlagt for denne aldersgruppe.
English: Your doctor will check if Adempas is suitable for you.
Danish: Din læge vil undersøge, om Adempas er egnet til dig.
English: * fatal pulmonary haemorrhage was reported in uncontrolled long term extension studies
Danish: * fatal lungeblødning blev rapporteret i ikke kontrollerede langtidsforlængelsesstudier
English: The absolute bioavailability of riociguat is high (94%).
Danish: Riociguats absolutte biotilgængelighed er høj (94 %).
English: ATC code: C02KX05
Danish: ATC-kode: C02KX05
English: Until more is known about the implications of these findings the use of riociguat in children and in growing adolescents should be avoided.
Danish: Indtil der kendes mere til implikationerne af disse fund, bør brugen af riociguat undgås hos børn og hos unge, der vokser.
English: Overall, the safety profile observed in the study was comparable with that observed in the pivotal trials, with no serious adverse events reported during the transition period.
Danish: Overordnet set, var den observerede sikkerhedsprofil i studiet sammenlignelig med den sikkerhedsprofil, der blev observeret i de pivotale studier, hvor der ikke var rapporteret alvorlige bivirkninger i overgangsperioden.
English: If you smoke, it is recommended that you stop, as smoking may reduce the effectiveness of these tablets.
Danish: Hvis du ryger, anbefales det at du holder op, da rygning kan reducere virkningen af disse tabletter.
English: There was no evidence of a favourable clinical effect of the combination in the population studied.
Danish: Der var intet bevis for en favorabel klinisk virkning af kombinationen i den undersøgte population.