FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that it blocks the proteasome, which is a system within the cells that breaks down proteins that are no longer needed.
Danish: Det betyder, at det blokerer proteasomet, som er cellernes system til at nedbryde proteiner, der ikke længere er brug for.
English: For more information about using Kyprolis, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Kyprolis, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Cancer cells have an increased need to produce and break down proteins because they multiply rapidly.
Danish: Kræftceller har et øget behov for at producere og nedbryde proteiner, fordi de formerer sig hurtigt.
English: An overview of Kyprolis and why it is authorised in the EU
Danish: En oversigt over Kyprolis, og hvorfor det er godkendt i EU
English: The European Medicines Agency decided that Kyprolis' benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Kyprolis opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Kyprolis can only be obtained with a prescription and treatment must be supervised by a doctor experienced in the treatment of cancer.
Danish: Kyprolis udleveres kun efter recept, og behandlingen skal overvåges af en læge med erfaring i behandling af kræft.
English: The Agency noted the unmet medical need for patients with multiple myeloma who no longer improve with the available therapies.
Danish: Agenturet bemærkede det uopfyldte behandlingsbehov hos patienter med myelomatose, som ikke længere bedres med de tilgængelige behandlinger.
English: Regarding safety, although side effects, including severe effects, were seen with treatment involving Kyprolis, these were considered acceptable and manageable.
Danish: Hvad angår sikkerheden, er der en række bivirkninger, herunder svære bivirkninger, ved behandling med Kyprolis, men de vurderes at være acceptable og håndterbare.
English: Multiple myeloma is rare, and Kyprolis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 June 2008.
Danish: Myelomatose er en sjælden sygdom, og Kyprolis blev udpeget som "lægemiddel til sjældne sygdomme" den 3. juni 2008.
English: Side effects reported with Kyprolis are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Kyprolis vurderes omhyggeligt, og der tages i givet fald nødvendige forholdsregler for at beskytte patienterne.
English: When carfilzomib stops the proteasome from breaking down proteins in the cancer cells, the proteins build up and cause the cells to die, slowing down the growth of the cancer.
Danish: Når carfilzomib forhindrer proteasomet i at nedbryde proteiner i kræftcellerne, ophobes proteinerne, og det får cellerne til at dø og sinker kræftens vækst.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Yderligere oplysninger om lægemidler til sjældne sygdomme findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: Why is Kyprolis authorised in the EU?
Danish: Hvorfor blev Kyprolis godkendt i EU?
English: What are the risks associated with Kyprolis?
Danish: Hvilke risici er der forbundet med Kyprolis?
English: What is Kyprolis and what is it used for?
Danish: Hvad er Kyprolis, og hvad anvendes det til?
English: From cycle 13 onwards, the doses on day 8 and 9 are omitted if Kyprolis is used with lenalidomide and dexamethasone.
Danish: Fra cyklus 13 og fremefter gives doserne ikke på dag 8 og 9, hvis Kyprolis anvendes med lenalidomid og dexamethason.
English: The most serious side effects include toxic effects on the heart, lungs and liver, and hypertension (high blood pressure) that can be severe.
Danish: De alvorligste bivirkninger omfatter giftige virkninger på hjertet, lungerne og leveren samt forhøjet blodtryk (eventuelt i svær grad).
English: Further information on Kyprolis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Kyprolis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reportsDenne oversigt blev sidst ajourført i
English: It considered that the increase in time without the disease getting worse with Kyprolis was clinically meaningful.
Danish: Agenturet vurderede, at Kyprolis' forøgelse af den tid, hvor sygdommen ikke forværres, er klinisk meningsfuld.
English: The active substance in Kyprolis, carfilzomib, is a proteasome inhibitor.
Danish: Det aktive stof i Kyprolis, carfilzomib, er en proteasomhæmmer.
English: Kyprolis contains the active substance carfilzomib.
Danish: Kyprolis indeholder det aktive stof carfilzomib.
English: The most common side effects with Kyprolis (which may affect more than 1 in 5 people) are anaemia (low red blood cell counts), tiredness, nausea, diarrhoea, thrombocytopenia (low blood platelet counts), fever, dyspnoea (difficulty breathing), respiratory tract (airways) infection, cough and neutropenia (low levels of neutrophils, a type of white blood cell).
Danish: De hyppigste bivirkninger ved Kyprolis (som kan forekomme hos mere end 1 ud af 5 personer) er anæmi (lavt antal røde blodlegemer), træthed, kvalme, diarré, trombocytopeni (lavt antal blodplader), feber, vejrtrækningsbesvær, luftvejsinfektioner, hoste og lavt antal neutrofiler (en type hvide blodlegemer).
English: Other serious side effects are dyspnoea, acute kidney injury, tumour lysis syndrome (a complication due to the breakdown of cancer cells), infusion-related reactions, thrombocytopenia, internal bleeding, posterior reversible encephalopathy syndrome (a brain disorder that can cause headache, confusion, fits and loss of vision, and which may improve over time) as well as thrombotic microangiopathy and TTP/HUS (diseases involving problems with the blood clotting system).
Danish: Andre alvorlige bivirkninger er vejrtrækningsbesvær, akut nyreskade, tumorlysesyndrom (en komplikation, der skyldes nedbrydningen af kræftceller), infusionsrelaterede reaktioner, lavt antal blodplader, indre blødning og et sygdomskompleks med hovedpine, forvirring, krampeanfald og synstab, som kan bedres over tid (posteriort reversibelt encefalopatisyndrom), samt propper i små blodkar (trombotisk mikroangiopati) og TTP/HUS, der er sygdomme, som giver problemer med blodets størkningsevne.
English: Treatment may need to be stopped or the dose reduced, if the disease gets worse or the patient has severe side effects.
Danish: Hvis sygdommen forværres, eller hvis patienten får svære bivirkninger, kan det være nødvendigt at stoppe behandlingen eller nedsætte dosen.
English: The study showed that Kyprolis is effective at prolonging the time patients lived without their disease getting worse (progression-free survival): patients receiving Kyprolis with lenalidomide and dexamethasone lived on average for 26.3 months without their disease getting worse, compared with 17.6 months for patients receiving lenalidomide plus dexamethasone.
Danish: Undersøgelsen viste, at Kyprolis er effektivt til at forlænge den tid, som patienterne lever, før sygdommen forværres igen (progressionsfri overlevelse): De patienter, der fik Kyprolis sammen med lenalidomid og dexamethason, levede i gennemsnit 26,3 måneder, uden at sygdommen forværredes, sammenholdt med 17,6 måneder for dem, der kun fik lenalidomid og dexamethason.
English: Kyprolis is a cancer medicine used together with the medicines lenalidomide and dexamethasone or with dexamethasone alone, to treat multiple myeloma (a cancer of the bone marrow).
Danish: Kyprolis er et lægemiddel, der anvendes i kombination med lenalidomid og dexamethason eller med dexamethason alene til at behandle knoglemarvskræft af typen myelomatose.
English: What benefits of Kyprolis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kyprolis?
English: Another study in 929 multiple myeloma patients whose disease had got worse after previous treatment compared the combination of Kyprolis and dexamethasone with bortezomib and dexamethasone.
Danish: I en anden undersøgelse med 929 patienter med myelomatose, hvis sygdom var blevet forværret efter forudgående behandling, blev en kombination af Kyprolis og dexamethason sammenlignet med bortezomib og dexamethason.
English: Kyprolis taken together with lenalidomide and dexamethasone has been compared with lenalidomide plus dexamethasone in one main study involving 792 patients with multiple myeloma whose disease had got worse after previous treatment.
Danish: Behandling med Kyprolis i kombination med lenalidomid og dexamethason er blevet sammenlignet med behandling med lenalidomid plus dexamethason i én hovedundersøgelse hos 792 patienter med myelomatose, hos hvem sygdommen var blevet værre efter forudgående behandling.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kyprolis 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 Kyprolis.
English: How does Kyprolis work?
Danish: Hvordan virker Kyprolis?
English: How is Kyprolis used?
Danish: Hvordan anvendes Kyprolis?
English: Kyprolis is available as a powder to be made up into a solution for infusion (drip) into a vein.
Danish: Kyprolis fås som et pulver til fremstilling af en infusionsvæske, der indgives via et intravenøst drop.
English: The study showed that the combination of Kyprolis and dexamethasone is more effective at improving progression-free survival than bortezomib and dexamethasone: patients receiving Kyprolis plus dexamethasone lived for an average of 18.7 months without their disease getting worse, compared with 9.4 months for patients receiving bortezomib and dexamethasone.
Danish: Undersøgelsen viste, at en kombination af Kyprolis og dexamethason er mere effektiv til at forbedre progressionsfri overlevelse end bortezomib og dexamethason.
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands
Danish: Rivium Westlaan 142 2909 LD Capelle a/d IJssel
English: Lagoas Park
Danish: Lagoas Park Edifício 10
English: Vinci Farma, S.A. (Grupo Pfizer)
Danish: Vinci Farma, S.A. (Grupo Pfizer) Avda.
English: Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris
Danish: Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France
English: Laboratorios Pfizer, Lda., Lagoas Park
Danish: Laboratorios Pfizer, Lda., Lagoas Park Edifício 10
English: Floridsdorfer Hauptstrasse 1 1210 Wien
Danish: Floridsdorfer Hauptstrasse 1
English: CT13 9NJ United Kingdom200 mg/100ml Solution for Infusion
Danish: CT13 9NJ United Kingdom200 mg/5ml Pulver til suspension
English: Netherlands
Danish: The Netherlands
English: Pfizer SA
Danish: Pfizer.
English: Solution for Intravenous Infusion
Danish: Intravenøst anvendelse
English: s r.o., Stroupežnického 17
Danish: s r.o., Stroupežnického 17 150 00 Prague 5
English: Boulevard de la Plaine 17 1050 Brussels Belgium200 mg/100ml Solution for Infusion
Danish: 1050 Brussels Belgium200 mg/5ml Pulver til suspension
English: Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg, Luxembourg
Danish: 51, Avenue J. F. Kennedy
English: Diflucan i.v.-100mg 100 mg/50 ml
Danish: Diflucan i.v.100mg
English: Boulevard de la Plaine 17 1050 Brussels Belgium
Danish: 1050 Brussels Belgium
English: Diflucan 50 mg/5 mlTrockensaft
Danish: Diflucan 50 mg/5 ml - Trockensaft
English: Diflucan 2mg/ml
Danish: Diflucan 2mg/ml 2 mg/ml
English: Diflucan 2 mg/ml
Danish: Diflucan 2 mg/ml 2 mg/ml
English: Diflucan 100 mg
Danish: Diflucan 100 mg 100 mg Kapsler
English: Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko Athens
Danish: Grækenland Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko Athens
English: Diflucan 150 mg
Danish: Diflucan 150 mg 150 mg Kapsler
English: Diflucan 50 mg
Danish: Diflucan 50 mg 50 mg Kapsler
English: Slovak Republic Pfizer Europe MA EEIG Ramsgate Road
Danish: Pfizer Europe MA EEIG
English: Diflucan mg/5 ml polvo para suspensión oral
Danish: 50 mg/5ml Pulver til oral suspension
English: In these two studies, patients were treated for four weeks.
Danish: I disse to undersøgelser blev patienterne behandlet i fire uger.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cayston on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cayston den 21. september 2009
English: Other information about Cayston:
Danish: Andre oplysninger om Cayston:
English: This document is a summary of the European public assessment report (EPAR) for Cayston.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cayston.
English: The additional study produced results that were consistent with those of the main studies.
Danish: Resultaterne af den yderligere undersøgelse stemte overens med resultaterne af de to hovedundersøgelser.
English: Aztreonam has been available as an injection since the 1980s as an ‘arginine salt'.
Danish: Aztreonam har kunnet fås som injektion siden 1980'erne som et ”argininsalt”.
English: Cayston is given three times a day for four weeks, with at least four hours between each dose.
Danish: Cayston indgives tre gange dagligt i fire uger, og der skal gå mindst fire timer mellem hver enkelt dosis.
English: It contains the active substance aztreonam.
Danish: Det indeholder det aktive stof aztreonam.
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 Cayston.
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 Cayston.
English: EPAR summary for the public aztreonam
Danish: EPAR - sammendrag for offentligheden aztreonam
English: The active substance in Cayston, aztreonam, is an antibiotic that belongs to the group ‘beta-lactams'.
Danish: Det aktive stof i Cayston, aztreonam, er et antibiotika, som tilhører gruppen af ”beta-lactamer”.
English: An improvement in lung function was also seen in children aged six to 17 years, both after four weeks of treatment and after three treatment cycles.
Danish: Desuden sås en forbedring i lungefunktionen hos børn i alderen 6-17 år , både efter fire ugers behandling og efter tre behandlingsserier.
English: For more information about treatment with Cayston, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cayston, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This prevents the bacteria from building their cell walls, which kills them.
Danish: Dette forhindrer bakterierne i at opbygge deres cellevægge, hvilket dræber bakterierne.
English: The full EPAR for Cayston can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cayston findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The CHMP decided that Cayston's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Cayston er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cayston.
English: Cayston must not be used in people who are hypersensitive (allergic) to aztreonam or any of the other ingredients.
Danish: Cayston må ikke anvendes til personer, som er overfølsomme (allergiske) over for aztreonam eller andre af indholdsstofferne.
English: In Cayston, aztreonam is available as a ‘lysine salt', which makes it possible for the antibiotic to be breathed directly into the lungs without causing irritation.
Danish: I Cayston fås aztreonam som et ”lysinsalt”, hvilket gør det muligt at indånde antibiotikaen direkte i lungerne uden at forårsage irritation.
English: Because the number of patients with bacterial lung infection in cystic fibrosis is low, the disease is considered ‘rare', and Cayston was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 June 2004.
Danish: Da antallet af patienter med bakteriel lungeinfektion i forbindelse med cystisk fibrose er lavt, betragtes sygdommen som "sjælden", og Cayston blev udpeget som "lægemiddel til sjældne sygdomme" den 21. juni 2004.
English: What is the risk associated with Cayston?
Danish: Hvilken risiko er der forbundet med Cayston?
English: This leads to problems with the digestion and absorption of food, resulting in poor growth, and long-term infection and inflammation of the lungs because of excess mucus not being cleared away.
Danish: Dette medfører problemer med fordøjelsen og optagelsen af næringsstoffer fra føden, hvilket fører til dårlig vækst og langvarig infektion og inflammation af lungerne, fordi overskydende slim ikke føres væk.
English: In the first study, the main measure of effectiveness was how long it took before the patients needed other antibiotics by inhalation or injection into a vein.
Danish: I den første undersøgelse var det primære effektmål, hvor lang tid det tog, inden patienterne fik behov for andre antibiotika til indgivelse ved inhalation eller injektion i en vene.
English: It works by attaching to proteins on the surface of the P. aeruginosa bacteria.
Danish: Det virker ved at binde sig til proteiner på overfladen af P. aeruginosa-bakterierne.
English: The CHMP concluded that there was an unmet medical need for new antibiotics in patients with cystic fibrosis, since many of these patients have already developed resistance to other antibiotics by the time they reach adulthood, and because P. aeruginosa lung infections are a cause of severe health problems in patients with cystic fibrosis.
Danish: CHMP konkluderede, at der var et udækket medicinsk behov for nye antibiotika til patienter med cystisk fibrose, da mange af disse patienter allerede har udviklet resistens over for andre antibiotika, når de når voksenalderen, og fordi P. aeruginosa-lungeinfektioner er årsag til alvorlige helbredsproblemer hos patienter med cystisk fibrose.
English: In patients with cystic fibrosis, P. aeruginosa infections usually start in the first 10 years of life and can cause long-term lung problems.
Danish: Hos patienter med cystisk fibrose starter P. aeruginosa-infektionerne normalt inden for de første 10 leveår og kan forårsage langvarige lungeproblemer.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Cayston 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 Cayston findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: If the doctor thinks that further treatment cycles with Cayston are needed after the first course, a gap of four weeks is recommended after every four-week treatment cycle with Cayston.
Danish: Hvis lægen mener, at der er behov for flere behandlingsserier med Cayston efter den første serie, anbefales en pause på fire uger efter hver fire ugers behandlingsserie med Cayston.
English: A third main study involving 268 patients (including 59 children from six to 17 years of age) compared Cayston with another inhaled antibiotic (tobramycin nebuliser solution).
Danish: I en tredje hovedundersøgelse med 268 patienter (heraf 59 børn i alderen 6-17 år) blev Cayston sammenlignet med et andet antibiotikum (tobramycin inhalationsvæske).
English: In the first study, the patients who received Cayston required other antibiotics after 92 days, compared with 71 days for the patients who received placebo.
Danish: I den første undersøgelse fik de patienter, som blev behandlet med Cayston, behov for andre antibiotika efter 92 dage, sammenlignet med 71 dage for de patienter, der fik placebo.
English: The third study showed that Cayston compared favourably with the comparator antibiotic: after four weeks of treatment, the increase in FEV1 adjusted for age, height and sex was 8.35% with Cayston and 0.55% with the comparator; after three treatment cycles, the increase with Cayston was 2.05% compared with a decrease of 0.66% with the comparator.
Danish: Den tredje undersøgelse viste, at Cayston var overlegen i forhold til det antibiotikum, det blev sammenlignet med: Efter 4-ugers behandling var stigningen i FEV1, korrigeret for alder, højde og køn, 8,35 % med Cayston og 0,65 % med sammenligningslægemidlet; efter tre behandlingsserier var stigningen med Cayston 2,05 %, sammenholdt med en stigning på 0,66 % med sammenligningslægemidlet.
English: In cystic fibrosis, the patient's lungs produce too much thick mucus, which allows bacteria to grow more easily.
Danish: Ved cystisk fibrose danner patientens lunger for meget tykt slim, som giver bakterierne lettere mulighed for at vokse.
English: Why has Cayston been approved?
Danish: Hvorfor blev Cayston godkendt?
English: Cayston is to be used with a nebuliser (a special machine that changes the solution into an aerosol that the patient can breathe in).
Danish: Cayston anvendes sammen med en nebulisator (en særlig maskine, hvori opløsningen omdannes til aerosol, som patienten kan indånde).
English: Cayston is a powder and solvent that are made up into a nebuliser solution.
Danish: Cayston er et pulver og en solvens, der blandes til en opløsning til nebulisator.
English: In the second study, the main measure of effectiveness was how the patients rated their respiratory symptoms on a standard scale for cystic fibrosis.
Danish: I den anden undersøgelse var det primære effektmål, hvordan patienterne bedømte deres åndedrætssymptomer på en standardskala for cystisk fibrose.
English: If the patient takes multiple inhaled treatments the bronchodilator should always be taken first, followed by a mucolytic (a medicine to make mucus thinner) and Cayston last.
Danish: Hvis patienten bruger flere forskellige inhalationslægemidler, skal bronkodilatoren altid tages først, efterfulgt af et mukolytisk middel (et lægemiddel, der gør slimen mere tyndtflydende), og til sidst Cayston.
English: The most common side effects with Cayston (seen in more than 1 patient in 10) are wheezing, cough, pharyngolaryngeal pain (pain in the throat and voice box), nasal congestion (blocked nose), dyspnoea (difficulty breathing) and fever.
Danish: De hyppigste bivirkninger ved Cayston (som optræder hos flere end 1 ud af 10 patienter) er hiven efter vejret, hoste, smerter i hals og strubehoved, stoppet næse, dyspnø (vejrtrækningsbesvær) og feber.
English: For the full list of all side effects reported with Cayston, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Cayston fremgår af indlægssedlen.
English: In the second study, respiratory symptoms improved in the patients who received Cayston, compared with the patients who received placebo.
Danish: I den anden undersøgelse forbedredes åndedrætssymptomerne for de patienter, som fik Cayston, i forhold til de patienter, som fik placebo.
English: It looked at how well the lungs worked, the amount of P. aeruginosa bacteria in the patients' mucus and their respiratory symptoms.
Danish: I undersøgelsen så man på, hvor godt lungerne fungerede, mængden af P. aeruginosa-bakterier i patienternes slim og patienternes åndedrætssymptomer.