FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of side effects and restrictions with Ziextenzo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Ziextenzo fremgår af indlægssedlen.
English: Laboratory studies comparing Ziextenzo with Neulasta have shown that the active substance in Ziextenzo is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Ziextenzo med Neulasta, har vist, at det aktive stof i Ziextenzo svarer til det aktive stof i Neulasta, hvad angår struktur, renhed og biologisk aktivitet.
English: In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Ziextenzo is equivalent to that of Neulasta in reducing the duration of neutropenia.
Danish: Desuden har studier med brystkræftpatienter i behandling med kemoterapi vist, at Ziextenzo er lige så effektivt som Neulasta til at reducere varigheden af neutropeni.
English: Studies have also shown that giving Ziextenzo produces similar levels of the active substance in the body to giving Neulasta.
Danish: Studier har også vist, at Ziextenzo giver samme niveau af det aktive stof i kroppen som Neulasta.
English: How is Ziextenzo used?
Danish: Hvordan anvendes Ziextenzo?
English: What benefits of Ziextenzo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ziextenzo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ziextenzo 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 Ziextenzo.
English: How does Ziextenzo work?
Danish: Hvordan virker Ziextenzo?
English: Ziextenzo is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Danish: Ziextenzo er et lægemiddel, der anvendes hos kræftpatienter til behandling af neutropeni (lavt antal neutrofiler, en type hvide blodlegemer).
English: The medicine was also shown to have an acceptable safety profile.
Danish: Det er desuden påvist, at lægemidlet har en acceptabel sikkerhedsprofil.
English: Kalydeco received a marketing authorisation valid throughout the EU on 23 July 2012.
Danish: Kalydeco fik en markedsføringstilladelse med gyldighed i hele EU den 23. juli 2012.
English: The Agency also noted, however, that there were limited data on the longer-term effects of the medicine and that further data should be provided by the company.
Danish: Agenturet bemærkede også, at der kun er begrænsede data om de langsigtede virkninger af lægemidlet, og at virksomheden skal fremskaffe yderligere data.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu308556.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/en/medicines/human/orphan-designations/eu308556.
English: As for all medicines, data on the use of Kalydeco are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Kalydeco løbende overvåget.
English: Further information on Kalydeco can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/kalydeco.
Danish: Yderligere information om Kalydeco findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/kalydeco.
English: Other information about Kalydeco
Danish: Andre oplysninger om Kalydeco
English: What measures are being taken to ensure the safe and effective use of Kalydeco?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kalydeco?
English: One of the studies was in patients aged over 12 years, while the other was in patients aged between 6 and 11 years.
Danish: Det ene omfattede patienter over 12 år, mens det andet omfattede patienter i alderen 6-11 år.
English: The European Medicines Agency therefore decided that the benefits of Kalydeco are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Kalydeco opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For infants and children aged 6 months and above and weighing 5 to 25 kg, the granules should be used.
Danish: Hos spædbørn og børn i alderen 6 måneder og derover, som vejer 5-25 kg, bør granulatet anvendes.
English: This makes mucus and digestive juices less thick, thereby helping to relieve symptoms of the disease.
Danish: Dette gør slim og fordøjelsesvæsker tyndere og hjælper derved med at lindre symptomerne på sygdommen.
English: The company that markets Kalydeco is conducting a study in children who were aged 2 to 5 years at the start of treatment to assess long-term effects of early treatment.
Danish: Den virksomhed, der markedsfører Kalydeco, gennemfører i øjeblikket et studie af børn, der er 2-5 år gamle ved behandlingsstart, for at vurdere den langsigtede effekt af tidlig behandling.
English: They should be mixed with 5 ml of soft food or liquid to make a suspension to be taken by mouth.
Danish: Det bør blandes med 5 ml blød mad eller væske, og denne blanding tages gennem munden.
English: Positive results have also been shown with Kalydeco granules in a study involving 19 children aged 1 to 2 years and 11 children aged 6 months to 1 year.
Danish: Der er også set positive resultater med Kalydeco-granulat i et studie, som omfattede 19 børn i alderen 1-2 år og 11 børn i alderen 6 måneder til 1 år.
English: Side effects reported with Kalydeco are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Kalydeco vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Cystic fibrosis is rare, and Kalydeco was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 July 2008.
Danish: Cystisk fibrose er sjælden, og Kalydeco blev udpeget som "lægemiddel til sjældne sygdomme" den 8. juli 2008.
English: The tablets are used in adults and children aged 6 years and above and weighing 25 kg or more.
Danish: Tabletterne anvendes til voksne og til børn i alderen 6 år og derover, som vejer 25 kg eller derover.
English: No difference was seen between placebo and Kalydeco for children aged 6 years and above.
Danish: Der sås ingen forskel mellem placebo og Kalydeco hos børn i alderen 6 år og derover.
English: An overview of Kalydeco and why is it authorised in the EU
Danish: En oversigt over Kalydeco, og hvorfor det er godkendt i EU
English: Kalydeco can only be obtained with a prescription.
Danish: Kalydeco fås kun på recept.
English: For more information about using Kalydeco, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Kalydeco, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The most common side effects with Kalydeco (which may affect more than 1 in 10 people) are headache, sore throat, upper respiratory tract infection (nose and throat infection), nasal congestion, abdominal (belly) pain, nasopharyngitis (inflammation of the nose and throat), diarrhoea, dizziness, rash, bacteria in sputum (phlegm) and an increase in certain liver enzymes.
Danish: De hyppigste bivirkninger ved Kalydeco (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, ondt i halsen, infektion i de øvre luftveje (næse og svælg), tilstoppet næse, mavesmerter, betændelse i næse og svælg, diarré, svimmelhed, udslæt, bakteriefyldt opspyt og øget koncentration af visse leverenzymer.
English: Kalydeco is available as tablets (150 mg) and as granules (25, 50, and 75 mg) in a sachet.
Danish: Kalydeco fås som tabletter (150 mg) og som granulat i breve (25, 50 og 75 mg).
English: What is Kalydeco and what is it used for?
Danish: Hvad er Kalydeco, og hvad anvendes det til?
English: Why is Kalydeco authorised in the EU?
Danish: Hvorfor er Kalydeco godkendt i EU?
English: The active substance in Kalydeco, ivacaftor, increases the activity of the defective CFTR protein.
Danish: Det aktive stof i Kalydeco, ivacaftor, øger aktiviteten af det defekte CFTR-protein.
English: Kalydeco contains the active substance ivacaftor.
Danish: Kalydeco indeholder det aktive stof ivacaftor.
English: The doses of Kalydeco may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines for fungal infections.
Danish: Det kan være nødvendigt at justere Kalydeco-dosen, hvis patienten også tager en såkaldt moderat eller stærk CYP3A-hæmmer (f.eks. antibiotika eller svampemidler).
English: Kalydeco is a medicine used to treat cystic fibrosis, an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Danish: Kalydeco er et lægemiddel til behandling af cystisk fibrose, der er en arvelig sygdom med svær indvirkning på lungerne, fordøjelsessystemet og andre organer.
English: The main measure of effectiveness in these studies was based on improvements in patients' FEV1.
Danish: Det primære mål for virkning i disse studier var forbedring af patienternes FEV1.
English: What are the risks associated with Kalydeco?
Danish: Hvilke risici er der forbundet med Kalydeco?
English: The study found that Kalydeco granules resulted in increased bodyweight and a decreased amount of chloride contained in sweat.
Danish: Studiet viste, at Kalydeco-granulat gav øget legemsvægt og nedsat mængde klorid i sved.
English: Patients with cystic fibrosis have low bodyweight due to problems with digestion of food and high levels of chloride in sweat due to CFTR not working properly.
Danish: Patienter med cystisk fibrose har lav legemsvægt, da de har problemer med at fordøje maden, og et højt niveau af klorid i sved, fordi CFTR-proteinet ikke fungerer, som det skal.
English: The dose and frequency depends on whether Kalydeco is used alone or together with tezacaftor / ivacaftor.
Danish: Dosis og doseringshyppighed afhænger af, om Kalydeco anvendes alene eller sammen med tezacaftor/ivacaftor.
English: For the full list of side effects and restrictions with Kalydeco, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Kalydeco fremgår af indlægssedlen.
English: Serious side effects include abdominal pain and increased liver enzymes.
Danish: Alvorlige bivirkninger omfatter mavesmerter og øget niveau af leverenzymer.
English: It should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above.
Danish: Kalydeco bør kun ordineres af en læge med erfaring i behandling af cystisk fibrose og bør kun gives til patienter, der har fået konstateret ovennævnte mutationer.
English: The main measure of effectiveness was based on improvement in patients' FEV1.
Danish: Virkningen blev hovedsageligt bedømt på forbedring af patienternes FEV1.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
English: The two medicines are used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene.
Danish: De to lægemidler anvendes hos patienter, der har arvet F508del-mutationen fra begge forældre og derfor har mutationen i begge kopier af CFTR-genet.
English: Patients who took Kalydeco and tezacaftor / ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took Kalydeco alone and a reduction of 0.3 percentage points in patients who took placebo.
Danish: De patienter, der fik Kalydeco og tezacaftor/ivacaftor, havde en gennemsnitlig stigning i FEV1 på 6,5 procentpoint sammenholdt med en stigning på 4,4 procentpoint hos patienter, der fik Kalydeco alene, og et fald på 0,3 procentpoint hos patienter, der fik placebo.
English: Two of the studies involved 219 patients with cystic fibrosis who had the G551D mutation.
Danish: To af studierne omfattede 219 patienter med cystisk fibrose, der havde G551D-mutationen.
English: Kalydeco used on its own or together with tezacaftor / ivacaftor has been shown to improve lung function in patients with specific mutations.
Danish: Det er påvist, at Kalydeco anvendt alene eller sammen med tezacaftor/ivacaftor forbedrer lungefunktionen hos patienter med specifikke mutationer.
English: Another study investigated Kalydeco granules in 34 patients aged between 2 and 5 years of age who had cystic fibrosis due to a G551D or S549N mutation.
Danish: Et yderligere studie undersøgte Kalydeco-granulat hos 34 patienter i alderen 2-5 år, som havde cystisk fibrose forårsaget af G551D- eller S549N-mutation.
English: Kalydeco, taken with tezacaftor / ivacaftor, was compared with placebo.
Danish: Kalydeco taget sammen med tezacaftor/ivacaftor blev sammenlignet med placebo.
English: In the studies, Kalydeco was compared with placebo (a dummy treatment).
Danish: I studierne blev Kalydeco sammenlignet med placebo (ikke-aktivt stof).
English: The fourth study involved 69 patients aged 6 years and above with cystic fibrosis who had the R117H mutation.
Danish: Det fjerde studie omfattede 69 patienter i alderen 6 år og derover med cystisk fibrose, der havde R117H-mutationen.
English: Kalydeco, taken with tezacaftor / ivacaftor, was compared with Kalydeco taken alone and with placebo.
Danish: Kalydeco taget sammen med tezacaftor/ivacaftor blev sammenlignet med Kalydeco taget alene og med placebo.
English: How is Kalydeco used?
Danish: Hvordan anvendes Kalydeco?
English: The third study involved 39 patients over 6 years of age with cystic fibrosis due to several mutations other than G551D.
Danish: Det tredje studie omfattede 39 patienter over 6 år med cystisk fibrose, der skyldtes flere andre mutationer end G551D.
English: Kalydeco is also used together with another cystic fibrosis medicine containing the active substances tezacaftor and ivacaftor to treat patients with cystic fibrosis aged 12 years and above who have a mutation called F508del in the CFTR gene.
Danish: Kalydeco anvendes også sammen med et andet lægemiddel mod cystisk fibrose, der indeholder de aktive stoffer tezacaftor og ivacaftor, til behandling af patienter i alderen 12 år og derover med cystisk fibrose, der har den såkaldte F508del-mutation i CFTR-genet.
English: Kalydeco is used on its own to treat cystic fibrosis in patients aged 6 months and above who have one of nine mutations (changes) in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Danish: Kalydeco anvendes som enkeltstofbehandling hos patienter i alderen 6 måneder og derover med cystisk fibrose, som har en af ni mutationer (forandringer) i genet for proteinet CFTR ("cystic fibrosis transmembrane conductance regulator").
English: Similar results were seen in patients aged between 6 and 11 years, where Kalydeco treatment led to an improvement of 12.5 percentage points more than with placebo.
Danish: Tilsvarende resultater blev opnået hos patienter i alderen 6-11 år, hvor Kalydeco-gruppen oplevede en forbedring, der var 12,5 procentpoint højere end i placebo-gruppen.
English: After 8 weeks of treatment patients who took Kalydeco had an average improvement of 10.7 percentage points more than those who took placebo.
Danish: Efter 8 ugers behandling oplevede de patienter, der fik Kalydeco, en gennemsnitlig forbedring på 10,7 procentpoint mere end de patienter, der fik placebo.
English: After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.
Danish: Efter 24 ugers behandling havde de patienter, der fik disse lægemidler, en gennemsnitlig stigning i FEV1 på 3,4 procentpoint, sammenholdt med et fald på 0,6 procentpoint hos de patienter, der fik placebo.
English: However, when analysing the subset of patients aged 18 years and above alone, an average improvement of around 5.0 percentage points was seen in patients who took Kalydeco compared with patients who took placebo.
Danish: Ved specifik analyse af en undergruppe af patienter på 18 år og derover sås dog en gennemsnitlig forbedring på ca. 5,0 procentpoint hos patienter, der fik Kalydeco, sammenholdt med placebo.
English: They are also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.
Danish: De anvendes også hos patienter, der har arvet F508del-mutationen fra én forælder og samtidig har én af følgende mutationer i CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, eller 3849+10kbC→T.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kalydeco 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 Kalydeco.
English: Kalydeco is also used on its own to treat patients with cystic fibrosis aged 18 years and above who have the R117H mutation in the CFTR gene.
Danish: Kalydeco anvendes også som enkeltstofbehandling hos patienter i alderen 18 år og derover med cystisk fibrose, som har R117H-mutationen i CFTR-genet.
English: F508del mutation from both parents or F508del mutation from one parent and P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G or 3849+10kbC→T mutations
Danish: F508del-mutation fra begge forældre eller F508del-mutation fra én forælder og mutation P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G eller 3849+10kbC→T
English: How does Kalydeco work?
Danish: Hvordan virker Kalydeco?
English: What benefits of Kalydeco have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Kalydeco?
English: The mutations are: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N and S549R (also known as gating mutations).
Danish: Der er tale om følgende mutationer: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N og S549R (såkaldt gating-mutationer).
English: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H mutations
Danish: Mutationerne G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R og R117H
English: After 24 weeks of treatment, patients aged 12 years and older who took Kalydeco had an average improvement in FEV1 of 10.6 percentage points more than those who took placebo.
Danish: Hos patienter i alderen 12 år og derover var den gennemsnitlige forbedring af FEV1 efter 24 ugers behandling 10,6 procentpoint højere i Kalydeco-gruppen end i placebo-gruppen.
English: Kalydeco was shown to be effective at improving lung function in 4 main studies involving patients with cystic fibrosis who had various mutations.
Danish: Fire hovedstudier af patienter med cystisk fibrose, der havde forskellige mutationer, viste, at Kalydeco er effektivt til at forbedre lungefunktionen.
English: Kalydeco taken together with tezacaftor / ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above with the the F508del mutation.
Danish: Det er i to hovedstudier af patienter i alderen 12 år og derover med cystisk fibrose, og som havde F508del-mutationen, påvist, at Kalydeco taget sammen med tezacaftor/ivacaftor er effektivt til at forbedre lungefunktionen.
English: Invented nameStrength Pharmaceutical Form Route of Administration
Danish: Lægemiddelform
English: Immediate Packaging Pack size blister (PVC/PVDC/alu) 100 x 1 tablet (unit dose)
Danish: Brilique 90 mg Filmovertrukket tablet Oral anvendelse enkeltdosisblister (PVC/PVDC/alu)
English: Information on how to do this has been included in the product information.
Danish: Information om, hvordan dette gøres, er medtaget i produktinformationen.
English: Further information on LysaKare can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lysakare.
Danish: Yderligere information om LysaKare findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/lysakare.
English: Other information about LysaKare
Danish: Andre oplysninger om LysaKare
English: As for all medicines, data on the use of LysaKare are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af LysaKare løbende overvåget.
English: Side effects with LysaKare are usually mild or moderate.
Danish: Bivirkningerne ved LysaKare er sædvanligvis lette eller moderate.
English: What is LysaKare and what is it used for?
Danish: Hvad er LysaKare, og hvad anvendes det til?
English: The most common side effects with LysaKare (which may affect more than 1 in 10 people) are nausea and vomiting.
Danish: De hyppigste bivirkninger ved LysaKare (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme og opkastning.
English: LysaKare (arginine / lysine)
Danish: LysaKare (arginin/lysin)
English: What measures are being taken to ensure the safe and effective use of LysaKare?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af LysaKare?
English: The European Medicines Agency therefore decided that LysaKare's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved LysaKare opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of LysaKare and why it is authorised in the EU
Danish: En oversigt over LysaKare, og hvorfor det er godkendt i EU
English: LysaKare must not be given to patients with high levels of potassium in the blood if this has not been corrected before treatment.
Danish: LysaKare må ikke gives til patienter med højt kaliumindhold i blodet, hvis dette ikke er korrigeret før behandling.
English: LysaKare can only be obtained with a prescription and should only be given by a healthcare professional experienced in the use of radioactive medicines.
Danish: LysaKare fås kun på recept og bør kun indgives af en sundhedsperson med erfaring i brug af radioaktive lægemidler.
English: Why is LysaKare authorised in the EU?
Danish: Hvorfor er LysaKare godkendt i EU?
English: Side effects reported with LysaKare are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved LysaKare vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: LysaKare is for use in adults and contains the active substances arginine and lysine.
Danish: LysaKare bruges hos voksne og indeholder de aktive stoffer arginin og lysin.
English: For more information about using LysaKare, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af LysaKare, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: LysaKare is also associated with hyperkalaemia (high blood potassium levels), but the frequency of this side effect is not known.
Danish: LysaKare forbindes også med hyperkaliæmi (højt kaliumindhold i blodet), men hyppigheden af denne bivirkning kendes ikke.
English: LysaKare is given by infusion (drip) in to a vein over 4 hours.
Danish: LysaKare indgives ved infusion (drop) i en vene i løbet af fire timer.