FrancophonIA/ELRC3.0 huggingface dataset:
English: Only use the capsules with the inhaler provided in this pack (Enurev
Danish: Brug kun kapslerne sammen med den vedlagte inhalator (Enurev
English: This belongs to a group of medicines called bronchodilators.
Danish: Enurev Breezhaler tilhører en gruppe lægemidler, der kaldes bronkodilatorer.
English: No specific side effects have been reported when Enurev Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
Danish: Der er ikke blevet indberettet yderligere bivirkninger, når Enurev Breezhaler er blevet brugt sammen med anden medicin til behandling af KOL, som fx behovsinhalatorer (fx salbutamol), methylxanthiner (fx theophyllin) og/eller orale og inhalerede steroider (fx prednisolon).
English: What Enurev Breezhaler contains - The active substance is glycopyrronium bromide.
Danish: Enurev Breezhaler indeholder - Aktivt stof: glycopyrroniumbromid.
English: Your Seebri Breezhaler Inhaler pack contains:
Danish: Din Enurev Breezhaler inhalatorpakning indeholder:
English: Enurev Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium (as glycopyrronium bromide)
Danish: Enurev Breezhaler 44 mikrogram inhalationspulver, hårde kapsler glycopyrronium (som glycopyrroniumbromid)
English: What Enurev Breezhaler looks like and contents of the pack Enurev Breeyhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Danish: Enurev Breezhaler 44 mikrogram inhalationspulver, hårde kapsler er gennemsigtige og orange og indeholder et hvidt pulver.
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis Enurev Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see sections 4.4 and 5.2).
Danish: Hos patienter med svært nedsat nyrefunktion eller slutstadiet af nyresygdom, som kræver dialyse, må Enurev Breezhaler udelukkende bruges, hvis den forventede fordel opvejer den potentielle risiko, eftersom den systemiske eksponering for glycopyrronium kan være øget hos denne population (se pkt.
English: Enurev Breezhaler was found to decrease dyspnoea and leg discomfort when exercising as measured using Borg scales.
Danish: Enurev Breezhaler viste sig at kunne reducere dyspnø og ubehag i benene under motion målt ved Borg-skalaer.
English: At 12 weeks (primary endpoint), Enurev Breezhaler increased trough FEV1 by 108 ml in the 6-month study and by 97 ml in the 12-month study compared to placebo (both p<0.001).
Danish: Ved 12 uger (primært endepunkt) øgede Enurev Breezhaler dal-FEV1 med 108 ml i studiet på 6 måneder og med 97 ml i studiet på 12 måneder sammenlignet med placebo (begge med p<0,001).
English: Enurev Breezhaler is recommended to be administered, at the same time of the day each day.
Danish: Det anbefales at tage Enurev Breezhaler på samme tidspunkt hver dag.
English: Enurev Breezhaler 44 micrograms inhalation powder, hard capsules
Danish: Enurev Breezhaler 44 mikrogram inhalationspulver, hårde kapsler
English: In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Enurev Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p<0.001).
Danish: I en samlet analyse af de første 6 måneders behandling i studierne på 6 og 12 måneder forlængede Enurev Breezhaler statistisk signifikant varigheden til første moderate eller svære eksacerbation og reducerede hyppigheden af moderate eller svære KOL-eksacerbationer sammenlignet med placebo (0,53 eksacerbationer/år mod 0,77 eksacerbationer/år, p<0,001).
English: In the 6-month study, Enurev Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p<0.001).
Danish: I studiet på 6 måneder forøgede Enurev Breezhaler FEV1 efter første dosis med 93 ml inden for 5 minutter og 144 ml inden for 15 minutter fra doseringen sammenlignet med placebo (begge med p<0,001).
English: If you forget to use Enurev Breezhaler
Danish: Hvis du har glemt at bruge Enurev Breezhaler
English: Enurev Breezhaler 44 mcg inhalation powder glycopyrronium
Danish: Enurev Breezhaler 44 mikrog inhalationspulver glycopyrronium
English: In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Enurev Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4).
Danish: Hos patienter med svært nedsat nyrefunktion (eGFR <30 ml/min/1,73 m2), inklusive dem med slutstadiet af nyresygdom, som kræver dialyse, må Enurev Breezhaler kun anvendes, hvis den forventede fordel opvejer den potentielle risiko (se pkt.
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Enurev Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Danish: En samlet analyse af de pivotale studier på 6 og 12 måneder viste, at en statistisk signifikant større procentdel af patienter på Enurev Breezhaler reagerede med en forbedring på 4 point eller mere i SGRQ sammenlignet med placebo ved uge 26 (henholdsvis 57,8 % og 47,6 %, p<0,001).
English: In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Enurev Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
Danish: I en samlet analyse af de pivotale studier på 6 og 12 måneder reagerede en statistisk signifikant større procentdel af patienterne, der fik Enurev Breezhaler, med en forbedring på 1 point eller mere i TDI-fokalscoren ved uge 26 sammenlignet med placebo (henholdsvis 58,4 % og 46,4 %, p<0,001).
English: In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Enurev Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Danish: Hos patienter med svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed på under 30 ml/min/1,73 m herunder patienter med slutstadiet af nyresygdom, hvor dialyse er påkrævet, må Enurev Breezhaler kun bruges, hvis den forventede fordel opvejer den potentielle risiko (se punkt 5.2).
English: Instructions for use of Enurev Breezhaler inhaler
Danish: Brugsanvisning til Enurev Breezhaler-inhalator
English: Patients with hepatic impairment Clinical studies have not been conducted in patients with hepatic impairment.
Danish: Der er ikke udført kliniske studier hos patienter med nedsat leverfunktion.
English: What you need to know before you use Enurev Breezhaler
Danish: Det skal du vide, før du begynder at bruge Enurev Breezhaler
English: • One Seebri Breezhaler inhaler
Danish: • En Enurev Breezhaler inhalator
English: In clinical studies with Enurev Breezhaler, paradoxical bronchospasm was not observed.
Danish: Der er ikke observeret paradoks bronkospasme i kliniske studier med Enurev Breezhaler.
English: What Enurev Breezhaler is and what it is used for What you need to know before you use Enurev Breezhaler How to use Enurev Breezhaler Possible side effects
Danish: Det skal du vide, før du begynder at bruge Enurev Breezhaler Sådan skal du bruge Enurev Breezhaler Bivirkninger
English: Although no formal drug interaction studies have been performed, Enurev Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.
Danish: Der er ikke udført formelle interaktionsstudier, men Enurev Breezhaler er blevet anvendt sammen med andre KOL-lægemidler, herunder sympatomimetiske bronkodilatorer, methylxanthiner samt orale og inhalerede steroider, uden kliniske tegn på lægemiddelinteraktioner.
English: 2) Reports have been received from post-approval marketing experience in association with the use of Enurev Breezhaler.
Danish: 2) Rapporteret efter markedsføring i forbindelse med brug af Enurev Breezhaler og indberettet frivilligt fra en population af ukendt størrelse.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid Enurev Breezhaler nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: - COPD is a long-term disease and you should use this medicine every day and not only when you have breathing problems or other symptoms of COPD.
Danish: Hvor længe skal du fortsætte med Enurev Breezhaler-behandling - Fortsæt med at bruge dette lægemiddel, så længe din læge siger, at du skal gøre det. - KOL er en kronisk sygdom, og du skal bruge dette lægemiddel hver dag og ikke blot, når du har åndedrætsbesvær eller andre symptomer på KOL.
English: How much Enurev Breezhaler to use
Danish: Så meget Enurev Breezhaler skal du tage
English: Cardiac disorders Atrial fibrillation
Danish: Hjerte Atrieflimren
English: How to use Enurev Breezhaler
Danish: Sådan skal du bruge Enurev Breezhaler
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Enurev Breezhaler Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The dose is 3 capsules per day, taken together at the same time each day.
Danish: Dosen er 3 kapsler, der tages samtidigt på samme tidspunkt hver dag.
English: Treatment should continue until the disease gets worse.
Danish: Behandlingen bør fortsætte, indtil sygdommen forværres.
English: This is a summary of the European public assessment report (EPAR) for Zejula.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zejula.
English: Zejula is available as capsules (100 mg) to be taken by mouth.
Danish: Zejula fås som kapsler (100 mg), der tages gennem munden.
English: Other information about Zejula
Danish: Andre oplysninger om Zejula
English: Treatment may be interrupted and the dose may be reduced in patients who experience side effects.
Danish: Behandlingen kan afbrydes, og dosen kan reduceres hos patienter, der oplever bivirkninger.
English: The European Medicines Agency therefore decided that Zejula's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Zejula opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Zejula?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zejula?
English: The most common side effects with Zejula (which may affect more than 1 in 10 people) are nausea (feeling sick), thrombocytopenia (low blood platelet counts), tiredness and weakness, anaemia (low red blood cell counts), constipation, vomiting, abdominal (belly) pain, neutropenia (low levels of neutrophils, a type of white blood cell), insomnia (difficulty sleeping), headache, lack of appetite, nasopharyngitis (inflammation of the nose and throat), diarrhoea, dyspnoea (difficulty breathing), hypertension (high blood pressure), dyspepsia (heartburn), back pain, dizziness, cough, urinary tract infection (infection of the structures that carry urine), joint pain, palpitations and dysgeusia (taste disturbances).
Danish: De hyppigste bivirkninger ved Zejula (som kan forekomme hos flere end 1 ud af 10 patienter) er kvalme, lavt antal blodplader, træthed og svaghed, lavt antal røde blodlegemer, forstoppelse, opkastning, mavesmerter, lavt antal neutrofiler (en type hvide blodlegemer), søvnbesvær, hovedpine, appetitløshed, betændelse i næse og svælg, diarré, vejrtrækningsbesvær, forhøjet blodtryk, halsbrand, rygsmerter, svimmelhed, hoste, urinvejsinfektion, ledsmerter, hjertebanken og smagsforstyrrelser.
English: Because the number of patients with ovarian cancer is low, the disease is considered ‘rare', and Zejula was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 August 2010.
Danish: Da antallet af patienter med æggestokkræft er lavt, betragtes sygdommen som "sjælden", og Zejula blev udpeget som "lægemiddel til sjældne sygdomme" den 4. august 2010.
English: Zejula must not be used in women who are breastfeeding.
Danish: Zejula må ikke anvendes hos kvinder, der ammer.
English: The active substance in Zejula, niraparib, blocks the action of enzymes called PARP-1 and PARP-2, which help to repair damaged DNA in cells when the cells divide to make new cells.
Danish: Det aktive stof i Zejula, niraparib, blokerer virkningen af enzymerne PARP-1 og PARP-2, der hjælper med at reparere beskadiget dna i celler, når cellerne deler sig for at lave nye celler.
English: Regarding safety, side effects are generally manageable with dose reductions.
Danish: I forhold til sikkerheden kan bivirkningerne generelt håndteres ved dosisreduktion.
English: Why is Zejula approved?
Danish: Hvorfor blev Zejula godkendt?
English: The medicine is given after treatment with platinumbased medicines, when the tumour is diminishing in size or has completely disappeared.
Danish: Lægemidlet gives efter behandling med platinbaserede lægemidler, når tumoren er skrumpet i størrelse eller er fuldstændigt forsvundet.
English: The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the use of cancer medicines.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen bør iværksættes og følges af en læge med erfaring i brug af kræftmedicin.
English: What is Zejula and what is it used for?
Danish: Hvad er Zejula, og hvad anvendes det til?
English: This may allow the next cycle of platinum-based therapy to be delayed.
Danish: Dermed kan den næste serie platinbaseret behandling udskydes.
English: Patients had undergone treatment with two or more platinum-based therapies, with a lasting response (the cancer had not progressed for at least 6 months) before the last platinum-based therapy.
Danish: Patienterne havde gennemgået behandling med to eller flere platinbaserede lægemidler og haft et vedvarende respons (kræften havde ikke udviklet sig i mindst 6 måneder) før den sidste platinbaserede behandling.
English: It is not intended to provide practical advice on how to use Zejula.
Danish: Det er ikke en praktisk vejledning i, hvordan Zejula bør anvendes.
English: What are the risks associated with Zejula?
Danish: Hvilke risici er der forbundet med Zejula?
English: By blocking PARP enzymes, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.
Danish: Når PARPenzymerne blokeres, kan de ikke reparere det beskadigede dna i kræftcellerne, og derfor dør kræftcellerne.
English: The full EPAR for Zejula can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zejula findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients treated with Zejula lived on average 11.3 months without their disease getting worse compared with 4.7 months in patients treated with placebo (a dummy treatment).
Danish: De patienter, der blev behandlet med Zejula, levede gennemsnitligt i 11,3 måneder uden forværring af sygdommen, sammenholdt med 4,7 måneder for de patienter, der fik placebo (ikke-aktivt stof).
English: For more information about treatment with Zejula, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zejula, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Although treatments for advanced, relapsed ovarian cancer are available, the disease inevitably comes back again.
Danish: Selvom der findes lægemidler mod fremskreden æggestokkræft, der vender tilbage, kan det ikke undgås, at sygdommen kommer tilbage igen.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Zejula can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Zejula findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Zejula has been shown to prolong the time before the disease gets worse again in patients who have responded to platinum-based therapies.
Danish: Det er påvist, at Zejula forlænger den tid, der går, inden sygdommen bliver værre igen, hos patienter, der har reageret på platinbaserede behandlinger.
English: Zejula is a cancer medicine used in adult women with a type of advanced cancer of the ovary called ‘high grade serous epithelial ovarian cancer', including cancer of the fallopian tubes (the tubes connecting the ovaries to the uterus) and cancer of the peritoneum (the membrane lining the abdomen).
Danish: Zejula er et lægemiddel mod kræft, der anvendes hos voksne kvinder med en type fremskreden kræft i æggestokkene, der kaldes høj-grads serøs epitelial æggestokkræft, herunder kræft i æggelederne og bughinden (den hinde, der beklæder bugvæggens inderside).
English: Patients in the study had high grade serous epithelial ovarian cancer, including fallopian tube or peritoneal cancers.
Danish: Patienterne i undersøgelsen havde høj-grads serøs epitelial æggestokkræft, herunder kræft i æggelederne og bughinden.
English: For practical information about using Zejula, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zejula, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Zejula, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zejula fremgår af indlægssedlen.
English: Zejula is used on its own for the ‘maintenance' treatment of patients who have relapsed disease (when the cancer comes back after previous treatment).
Danish: Zejula anvendes alene til vedligeholdelsesbehandling af patienter, hvis sygdom er vendt tilbage efter tidligere behandling.
English: How does Zejula work?
Danish: Hvordan virker Zejula?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zejula 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 Zejula.
English: What benefits of Zejula have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zejula?
English: How is Zejula used?
Danish: Hvordan anvendes Zejula?
English: Zejula has been shown to increase the time patients lived without their disease getting worse in one main study involving 553 patients.
Danish: Det er i en hovedundersøgelse med 553 patienter påvist, at Zejula øger den tid, patienterne lever uden forværring af sygdommen.
English: Serious side effects include thrombocytopenia and anaemia.
Danish: Alvorlige bivirkninger omfatter lavt antal blodplader og lavt antal røde blodlegemer.
English: Summary of overall survival Subject not known to have died [n (%)] Subject observed to have died [n (%)] OS (weeks)
Danish: Individdet ikke erkendt død [n (%)] Individdet erkendt død [n (%)] OS (uger)
English: If you are being treated for:
Danish: Hvis du skal behandles for:
English: You may require medical attention.
Danish: Du kan måske få brug for lægehjælp.
English: NA (NA, NA)
Danish: NA (NA til NA)
English: The median DR and OS had not yet been reached.
Danish: Median DR og OS er endnu ikke nået.
English: Date of first authorisation: 19 July 2006 Date of latest renewal: 9 November 2016
Danish: Dato for første tilladelse: 19. juli 2006 Dato for sidste forlængelse: 9. november 2016
English: None of the subjects achieved complete response or partial response.
Danish: Ingen af personerne opnåede fuldstændigt respons eller delvist respons.
English: Long-term safety in MRCC
Danish: Langtidssikkerhed ved mRCC
English: Not known (frequency cannot be estimated from available data):
Danish: Hyppighed ikke kendt (kan ikke estimeres fra forhåndenværende data):
English: • Difficulty in falling asleep.
Danish: • Besvær med at falde i søvn.
English: e Median not achieved because the data were not yet mature.
Danish: Median er ikke opnået endnu, da data endnu ikke er fuldstændige.
English: From a 2-sided log-rank test.
Danish: Fra en 2-sidet log-rank test.
English: Most of these findings were reversible after 2 to 6 weeks without treatment.
Danish: De fleste fund var reversible efter 2-6 uger uden behandling.
English: The primary efficacy endpoint of this study was ORR.
Danish: Det primære effektendepunkt i dette studie var ORR.
English: The patient should take the usual prescribed dose on the following day.
Danish: Patienten bør tage den sædvanlige, ordinerede dosis den følgende dag.
English: Use of somatostatin analogues was allowed in the study.
Danish: Brug af somatostain-analoger var tilladt i studiet.
English: Decreased appetitei
Danish: Nedsat appetit
English: No significant differences in safety or efficacy were observed between younger and older patients.
Danish: Der ses ingen signifikant forskel i sikkerhed eller virkning mellem yngre og ældre patienter.
English: Patients were treated until disease progression or withdrawal from the study.
Danish: Patienterne blev behandlet indtil sygdomsprogression, eller til de udgik af studiet.
English: Do not take Sutent:
Danish: Tag ikke Sutent:
English: Sepsis and sepsis shock.
Danish: Sepsis og septisk shock
English: Other side effects with Sutent may include:
Danish: Andre bivirkninger ved Sutent kan være:
English: If the diagnosis of SJS or TEN is confirmed, treatment must not be restarted.
Danish: Hvis diagnosen SJS eller TEN er bliver bekræftet, må behandlingen ikke reinitieres.
English: Safety and tolerability
Danish: Sikkerhed og tolerabilitet
English: Sutent can be taken with or without food.
Danish: Sutent kan tages med eller uden mad.
English: Sutent with food and drink
Danish: Brug af Sutent sammen med mad og drikke
English: Fisher's Exact test
Danish: Fishers Exact test
English: • Pain in arms and legs.
Danish: • Smerter i arme og ben.
English: Invasive dental procedures are also an identified risk factor.
Danish: Invasiv tandbehandling er også en kendt risikofaktor.
English: Secondary endpoints included TTP, duration of response (DR) and OS.
Danish: Sekundære endepunkter omfattede TTP, varighed af respons (DR) og OS.
English: The primary active metabolite comprises 23% to 37% of the total exposure.
Danish: Den aktive hovedmetabolit udgør 23-37% af den totale eksponering.
English: • Decreased blood sugar level (see section 2)..
Danish: • Nedsat blodsukkerniveau (se afsnit 2).
English: Sutent is not recommended for people aged under 18.
Danish: Sutent anbefales ikke til børn under 18 år.
English: * Including fatal events.
Danish: *Herunder dødelige tilfælde
English: Daily dose should not exceed 75 mg nor be decreased below 25 mg.
Danish: Den daglige dosis må hverken overskride 75 mg eller være lavere end 25 mg.
English: - If you have diabetes.
Danish: - Hvis du har diabetes (sukkersyge).
English: You must immediately contact your doctor if you experience any of those serious side effects (see also What you need to know before you take Sutent):
Danish: Du skal straks kontakte din læge, hvis du får nogle af disse alvorlige bivirkninger (se også Det skal du vide før du begynder at tage Sutent):