FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.75 mg/ml Solution for infusion
Danish: EU/1/99/109/001 Integrilin 0.75 mg/ml Infusionsvæske, opløsning Intravenøs anvendelse Hæteglas (glas) 100 ml 1 Hæteglas EU/1/99/109/002 Integrilin 2 mg/ml
English: Content
Danish: EU-numre
English: Pharmaceutical Form
Danish: Lægemiddel form
English: EMA/CHMP/774318/2018 EMEA/H/C/004682
Danish: EMA/522792/2018 EMEA/H/C/004682
English: In the latter group, there is a lack of authorised therapies.
Danish: I den sidstnævnte gruppe mangler der godkendte behandlinger.
English: Lung function was measured after 4 weeks and 8 weeks of treatment.
Danish: Lungefunktionen blev målt efter 4 og 8 ugers behandling.
English: As a result, these secretions become thick and cause blockage.
Danish: Som følge deraf bliver disse sekreter tykke og medfører blokering.
English: The doses may also need to be adjusted in patients with reduced liver function.
Danish: Det kan også være nødvendigt at justere dosis hos patienter med nedsat leverfunktion.
English: As for all medicines, data on the use of Symkevi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Symkevi løbende overvåget.
English: It is 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: Det anvendes også hos patienter, der har arvet F508delmutationen 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: Other information about Symkevi
Danish: Andre oplysninger om Symkevi
English: FEV1 is the maximum amount of air a person can breathe out in one second and is a measure of how well the lungs work.
Danish: FEV1 er den maksimale mængde luft, som en person kan udånde på et sekund, og er et mål for, hvor godt lungerne virker.
English: The main measure of effectiveness was based on improvement in patients' FEV1.
Danish: Det primære mål for virkning var forbedring af patienternes FEV1.
English: Therefore, the European Medicines Agency decided that Symkevi'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 Symkevi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For more information about using Symkevi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Symkevi, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The most common side effects with Symkevi (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Danish: De hyppigste bivirkninger ved Symkevi (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine og betændelse i næse og svælg (nasofaryngitis).
English: What measures are being taken to ensure the safe and effective use of Symkevi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Symkevi?
English: Side effects reported with Symkevi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Symkevi vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Further information on Symkevi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Symkevi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: An overview of Symkevi and why it is authorised in the EU
Danish: En oversigt over Symkevi, og hvorfor det er godkendt i EU
English: Symkevi is available as tablets.
Danish: Symkevi fås som tabletter.
English: What is Symkevi and what is it used for?
Danish: Hvad er Symkevi, og hvad anvendes det til?
English: The recommended daily dose is one tablet of Symkevi in the morning and one ivacaftor tablet (150 mg) in the evening, about 12 hours later.
Danish: Den anbefalede daglige dosis er én Symkevi-tablet om morgenen og én ivacaftor-tablet (150 mg) om aftenen ca. 12 timer senere.
English: Build-up of thick and sticky secretions in the lungs causes inflammation and long-term infection.
Danish: Ophobning af tykt og klæbrigt sekret i lungerne medfører betændelse og langvarig infektion.
English: Cystic fibrosis is rare, and Symkevi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 February 2017.
Danish: Cystisk fibrose er sjælden, og Symkevi blev udpeget som "lægemiddel til sjældne sygdomme" den 27. februar 2017.
English: Why is Symkevi authorised in the EU?
Danish: Hvorfor blev Symkevi godkendt i EU?
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 lægemidlerne, en gennemsnitlig stigning i FEV1 på 3,4 procentpoint sammenholdt med et fald på 0,6 procentpoint hos de patienter, der fik placebo.
English: In the former group, Symkevi could especially be a treatment option for those who cannot take a combination of ivacaftor and lumacaftor (another cystic fibrosis medicine), due to side effects or interactions with other medicines they are taking.
Danish: I den førstnævnte gruppe kan Symkevi være en behandlingsmulighed især for dem, der ikke kan tage en kombination af ivacaftor og lumacaftor (et andet lægemiddel mod cystisk fibrose) som følge af bivirkninger eller interaktioner med andre lægemidler, som de tager.
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Danish: Cystisk fibrose er en arvelig sygdom med svære virkninger på lungerne, fordøjelsessystemet og andre organer.
English: These actions make 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: Symkevi 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: Symkevi bør kun ordineres af en læge med erfaring i behandling af cystisk fibrose og kun til patienter, som vides at have de ovennævnte mutationer.
English: Symkevi should be taken together with another medicine containing 150 mg ivacaftor alone.
Danish: Symkevi bør tages sammen med et andet lægemiddel, der indeholder 150 mg ivacaftor alene.
English: Each tablet contains 100 mg tezacaftor and 150 mg ivacaftor.
Danish: Hver tablet indeholder 100 mg tezacaftor og 150 mg ivacaftor.
English: The doses of Symkevi and ivacaftor 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 blive nødvendigt at justere Symkevi- og ivacaftor-doserne, hvis patienten også tager en type lægemiddel, der kaldes "moderat eller stærk CYP3A-hæmmer" som f.eks. antibiotika eller et lægemiddel mod svampeinfektioner.
English: The mutations reduce the number of CFTR proteins on the cell surface or affect the way the protein works.
Danish: Mutationerne nedsætter antallet af CFTR-proteiner på celleoverfladen eller påvirker den måde, som proteinet virker på.
English: What are the risks associated with Symkevi?
Danish: Hvilke risici er der forbundet med Symkevi?
English: Symkevi is a medicine used to treat cystic fibrosis in patients aged 12 years and above.
Danish: Symkevi er et lægemiddel, der anvendes til at behandle cystisk fibrose hos patienter i alderen 12 år og derover.
English: Symkevi contains the active substances tezacaftor and ivacaftor.
Danish: Symkevi indeholder de aktive stoffer tezacaftor og ivacaftor.
English: One of the active substances in Symkevi, tezacaftor, increases the number of CFTR proteins on the cell surface and the other, ivacaftor, increases the activity of the defective CFTR protein.
Danish: Det ene aktive stof i Symkevi, tezacaftor, øger antallet af CFTR-proteiner på celleoverfladen, og det andet, ivacaftor, øger aktiviteten af det defekte CFTR-protein.
English: Patients who took Symkevi and 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 ivacaftor alone and a reduction of 0.3 percentage points in patients who took placebo.
Danish: De patienter, der fik Symkevi og ivacaftor, havde en gennemsnitlig stigning i FEV1 på 6,5 procentpoint sammenholdt med en stigning på 4,4 procentpoint hos patienter, der fik ivacaftor alene, og et fald på 0,3 procentpoint hos patienter, der fik placebo.
English: For the full list of side effects and restrictions with Symkevi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Symkevi fremgår af indlægssedlen.
English: Cystic fibrosis is caused by mutations in the CFTR gene.
Danish: Cystisk fibrose skyldes en mutation i CFTR-genet.
English: Symkevi, taken with ivacaftor, was compared with ivacaftor taken alone and with placebo.
Danish: Symkevi taget sammen med ivacaftor blev sammenlignet med ivacaftor taget alene og med placebo.
English: Symkevi is used in patients who have a mutation (change) called F508del in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Danish: Symkevi anvendes hos patienter, der har en forandring (mutation), som hedder F508del i genet for et protein, der hedder "cystisk fibrose transmembranøs konduktansregulator" (CFTR).
English: This gene makes the CFTR protein, which works on the surface of cells to regulate the production of mucus and digestive juices.
Danish: Dette gen fremstiller CFTR-proteinet, som virker på overfladen af celler ved at regulere produktionen af slim og fordøjelsesvæsker.
English: How is Symkevi used?
Danish: Hvordan anvendes Symkevi?
English: In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.
Danish: I tarmen medfører blokering af kanalerne fra bugspytkirtlen langsom fordøjelse og dårlig vækst.
English: How does Symkevi work?
Danish: Hvordan virker Symkevi?
English: Cystic fibrosis affects the cells that produce mucus and digestive juices.
Danish: Cystisk fibrose angriber de celler, der producerer slim og fordøjelsesvæsker.
English: Symkevi is 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: Symkevi anvendes hos patienter, der har arvet F508del-mutationen fra begge forældre og derfor har mutationen i begge kopier af CFTR-genet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symkevi 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 Symkevi.
English: The first study involved 510 patients with cystic fibrosis who have inherited the F508del mutation from both parents.
Danish: Det første studie omfattede 510 patienter med cystisk fibrose, som har arvet F508del-mutationen fra begge forældre.
English: What benefits of Symkevi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Symkevi?
English: Symkevi, taken with ivacaftor, was compared with placebo (a dummy treatment).
Danish: Symkevi taget sammen med ivacaftor blev sammenlignet med placebo (ikke-aktivt stof).
English: The second study involved 248 patients with cystic fibrosis who have inherited the F508del mutation from one parent and who also have another CFTR mutation.
Danish: Det andet studie omfattede 248 patienter med cystisk fibrose, som har arvet F508del-mutationen fra den ene forælder, og som også har en anden CFTR-mutation.
English: Symkevi is an effective treatment for patients with cystic fibrosis who have inherited the F508del mutation from both parents or patients who have the F508del mutation from one parent and certain other mutations.
Danish: Symkevi er en effektiv behandling for patienter med cystisk fibrose, som har arvet F508del-mutationen fra begge forældre, eller patienter, der har arvet F508del-mutationen fra den ene forælder, og som samtidig har visse andre mutationer.
English: Symkevi taken together with ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above.
Danish: Det er i to hovedstudier af patienter i alderen 12 år og derover med cystisk fibrose påvist, at Symkevi taget sammen med ivacaftor er effektivt til at forbedre lungefunktionen.
English: Further information on Sutent's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om de nuværende anvendelser af Sutent findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: In addition, the medicine has known side effects that affect patients' quality of life.
Danish: Desuden har lægemidlet kendte bivirkninger, der påvirker patienternes livskvalitet.
English: Sutent has been authorised since July 2006 and contains the active substance sunitinib.
Danish: Sutent har været godkendt siden juli 2006 og indeholder det aktive stof sunitinib.
English: What is Sutent?
Danish: Hvad er Sutent?
English: What was Sutent expected to be used for?
Danish: Hvad forventedes Sutent anvendt til?
English: The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Danish: Det aktive stof i Sutent, sunitinib, er en protein-kinasehæmmer.
English: There are no consequences for Sutent in its authorised uses.
Danish: Der er ingen konsekvenser ved brug af Sutent i de godkendte indikationer.
English: Sutent is a cancer medicine currently authorised for treating the following cancers:
Danish: Sutent er et kræftlægemiddel, der i øjeblikket er godkendt til behandling af følgende kræfttyper:
English: Patients were treated for around a year and the study looked at how long it took for the cancer to come back (disease-free survival).
Danish: Patienterne blev behandlet i ca. et år, og studiet så på, hvor lang tid der gik, før kræften vendte tilbage (sygdomsfri overlevelse).
English: The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew the application.
Danish: Virksomheden havde anmodet om en revurdering af den negative udtalelse, men denne revurdering var endnu ikke afsluttet, da virksomheden trak sin ansøgning tilbage.
English: What is happening with Sutent for treatment in other uses?
Danish: Hvad sker der med Sutent til behandling af andre sygdomme?
English: This means that it blocks specific enzymes known as protein kinases that are involved in the growth and spread of cancer cells and the development of new blood vessels supplying them.
Danish: Det betyder, at det blokerer specifikke enzymer, der er kendt som proteinkinaser, og som er involveret i væksten og spredningen af kræftceller og udviklingen af de nye blodkar, der forsyner disse.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing because the data provided do not allow the CHMP to conclude that the benefit outweighs the risks.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den trak ansøgningen tilbage som følge af, at de fremlagte data ikke gør det muligt for CHMP at konkludere, at fordelen opvejer risiciene.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Sutent.
Danish: Virksomheden har oplyst CHMP om, at beslutningen ikke vil få konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Sutent.
English: By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.
Danish: Ved at blokere disse enzymer reducerer Sutent kræftens vækst og spredning og afskærer den blodforsyning, som sætter kræftcellerne i stand til at vokse.
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas);
Danish: • pankreatiske neuroendokrine tumorer (tumorer i de hormonproducerende celler i bugspytkirtlen)
English: On 26 June 2018, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend use of Sutent to the treatment of patients at high risk of kidney cancer returning after surgery.
Danish: Den 26. juni 2018 meddelte Pfizer Limited Udvalget for Lægemidler til Mennesker (CHMP), at det ønsker at tilbagetrække sin ansøgning om udvidet anvendelse af Sutent til behandling af patienter med høj risiko for recidiv af nyrekræft efter operation.
English: • gastrointestinal stromal tumour (a cancer of the stomach and bowel);
Danish: • gastrointestinal stromal tumor (kræft i maven og tarmen)
English: When data from patients at highest risk of cancer returning were looked at separately, the benefits of Sutent were still not convincing.
Danish: Når man så separat på data for de patienter, der havde den højeste risiko for tilbagevenden af kræft, var fordelene ved Sutent stadig ikke overbevisende.
English: • metastatic renal cell carcinoma (kidney cancer that has spread to other parts of the body).
Danish: • metastatisk nyrecellekræft (nyrekræft, der har spredt sig til andre dele af kroppen).
English: The company presented results of a main study comparing Sutent with placebo (a dummy treatment) in 615 patients at high risk of their kidney cancer coming back after surgery.
Danish: Virksomheden fremlagde resultaterne af et hovedstudie, der sammenlignede Sutent med placebo (ikke-aktivt stof) hos 615 patienter med høj risiko for tilbagevenden af deres nyrekræft efter operation.
English: The CHMP considered that the evidence that Sutent delays the return of the cancer was not convincing.
Danish: CHMP var af den opfattelse, at evidensen for Sutents forsinkelse af kræftens tilbagevenden ikke var overbevisende.
English: Sutent was expected to be used to delay or prevent the return of kidney cancer in patients who have had surgery and are at high risk of their cancer coming back.
Danish: Sutent forventedes anvendt til at forsinke eller forebygge tilbagevendende nyrekræft hos patienter, som er blevet opereret, og som har høj risiko for, at kræften vender tilbage.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Sutent not be changed to add the treatment of patients at high risk of kidney cancer returning after surgery.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede, at markedsføringstilladelsen for Sutent ikke blev ændret med tilføjelse af indikationen behandling af patienter med høj risiko for tilbagevenden af nyrekræft efter operation.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Sutent in the treatment of patients at high risk of kidney cancer returning after surgery did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Sutent til behandling af patienter med høj risiko for tilbagevenden af nyrekræft efter operation ikke opvejede risiciene.
English: How does Sutent work?
Danish: Hvordan virker Sutent?
English: After first opening: 100 days
Danish: Efter første åbning: 100 dage
English: The usual supportive measures should be employed.
Danish: De sædvanlige understøttende foranstaltninger bør iværksættes.
English: Never change the dose yourself.
Danish: Du må aldrig selv ændre dosen.
English: These responses are delayed and reduced beyond the normal limits.
Danish: Disse responser er forsinkede og reduceret til under de normale grænser.
English: Males may be at greater risk than females.
Danish: Mænd kan have en større risiko end kvinder.
English: The maximum recommended dose should not be exceeded.
Danish: Den maksimalt anbefalede dosis bør ikke overskrides.
English: Date of first authorisation: 20 September 2018
Danish: Dato for første markedsføringstilladelse: 20. september 2018
English: They are not specific to the paediatric population.
Danish: De er ikke specifikke for den pædiatriske population.
English: Such patients may respond to a lower maintenance dose.
Danish: Sådanne patienter kan reagere på en lavere vedligeholdelsesdosis.
English: Crospovidone type B Mannitol
Danish: Crospovidon type B Mannitol
English: If it is almost time for the next dose, just give one dose.
Danish: Hvis det næsten er tid til den næste dosis, skal du kun give én dosis.
English: The following table presents the main findings at inclusion and the first and last conclusive evaluations in the evaluable population (n=524):
Danish: Nedenstående tabel viser de primære fund ved inklusion og de første og sidste konklusive vurderinger i den evaluerbare population (n = 524):
English: Children (from 8 to 12 years old)
Danish: Børn (i alderen 8-12 år)
English: Do not give a double dose to make up for a forgotten tablet.
Danish: Du må ikke give en dobbeltdosis som erstatning for den glemte tablet.
English: Time to reach maximum plasma concentrations (tmax) is approximately 1 hour.
Danish: Tid til maksimal plasmakoncentration (tmax) er ca. 1 time.
English: Adjustment of dose should be considered.
Danish: Tilpasning af dosen bør overvejes.
English: Severe cases are potentially disabling.
Danish: Svære tilfælde er potentielt invaliderende.
English: Always check the label and the size of the tablets to make sure you are giving the right dose.
Danish: Tjek altid etiketten og størrelsen på tabletterne for at sikre dig, at du giver den rigtige dosis.
English: Special attention should be paid to the tablet size to correctly identify the strength.
Danish: Der bør rettes særlig opmærksomhed mod tabletstørrelsen med henblik på at identificere den korrekte styrke.
English: There is no direct correlation between plasma concentration and efficacy.
Danish: Der er ingen direkte korrelation mellem plasmakoncentration og virkning.
English: The degree of visual field constriction may be severe and this may have practical consequences for the patient.
Danish: Graden af konstriktion af synsfeltet kan være alvorlig, og dette kan have praktiske konsekvenser for patienten.
English: Measures to remove unabsorbed medicinal product should be considered.
Danish: Foranstaltninger til fjernelse af ikke-absorberet lægemiddel bør overvejes.
English: Therefore, vision assessment is required at baseline (no later than 4 weeks after starting treatment) and at least every 6 months while on therapy.
Danish: Derfor er en undersøgelse af synet nødvendig ved baseline (ikke senere end 4 uger efter påbegyndelse af behandlingen) og mindst hver 6. måned under behandlingen.
English: It is important that you tell the doctor promptly if there is any change in your child's vision.
Danish: Det er vigtigt, at du siger det til lægen med det samme, hvis der sker ændringer i dit barns syn.
English: Use only water to prepare solution.
Danish: Brug kun vand til klargøring af opløsningen.