FrancophonIA/ELRC3.0 huggingface dataset:
English: How is Flixabi used?
Danish: Hvordan anvendes Flixabi?
English: • rheumatoid arthritis (an immune-system disease causing inflammation of the joints).
Danish: • reumatoid artritis (leddegigt, en sygdom i immunsystemet, der medfører inflammation (betændelsesreaktion) i leddene).
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Danish: • psoriatisk artritis (en sygdom, som fremkalder røde, afskallende pletter på huden og betændelse i leddene)
English: • psoriasis (a disease causing red, scaly patches on the skin).
Danish: • psoriasis (en sygdom, der giver røde, skællende hudområder).
English: This may take about 10 minutes.
Danish: Det kan tage ca. 10 minutter.
English: • Then drink it straight away.
Danish: • Drik det derpå straks.
English: Some cases have been fatal.
Danish: Visse tilfælde har været dødelige.
English: • Every 3 months thereafter
Danish: • Hver 3. måned derefter
English: You should have these tests:
Danish: Du skal have foretaget disse test:
English: Then take the next dose at the normal time.
Danish: Tag derpå den næste dosis på det sædvanlige tidspunkt.
English: • If you start taking medicines that affect your heart
Danish: • Hvis du begynder at tage medicin, som påvirker dit hjerte
English: 31.3% of patients had stable disease for at least 8 weeks.
Danish: 31,3 % af patienterne oplevede stabil sygdom i mindst 8 uger.
English: Monitoring of your blood and your heart:
Danish: Monitorering af blod og hjerte:
English: • Take Caprelsa about the same time each day.
Danish: • Tag Caprelsa på ca. samme tidspunkt hver dag.
English: The objective response rate observed was 43.8%, all of which were partial responses.
Danish: Den observerede objektive responsrate var 43,8 %, hvoraf alle var delvist respons.
English: These do not usually cause symptoms but your doctor may want to monitor them.
Danish: Disse forårsager sædvanligvis ikke symptomer, men lægen vil måske ønske at overvåge dem.
English: 19.3 months
Danish: 19,3 måneder
English: Some people who are taking Caprelsa become more sensitive to the sun.
Danish: Nogle mennesker, som tager Caprelsa, bliver mere følsomme over for solen.
English: These may be signs of a change in the electrical activitiy of your heart.
Danish: Dette kan være tegn på en ændring i dit hjertes elektriske aktivitet.
English: This can cause sunburn.
Danish: Dette kan forårsage solskoldning.
English: Only use water, do not use any other liquids.
Danish: Brug kun vand - brug ikke nogen andre væsker.
English: N=Number of events/number of randomised patients
Danish: N=Antal bivirkninger/antal randomiserede patienter
English: 52/100 80.4 months a Overall response rate = complete + partial responses.
Danish: 52/100 80,4 måneder a Samlet responsrate = komplette + partielle respons.
English: • Stroke or other conditions where the brain may not get enough blood.
Danish: • Slagtilfælde eller andre tilstande, hvor hjernen måske ikke får tilstrækkeligt med blod.
English: The following side effects may be shown in tests that may be carried out by your doctor:
Danish: Følgende bivirkninger kan påvises i test, som din læge kan udføre:
English: What to do if you forget to take a tablet depends on how long it is until your next dose.
Danish: Hvad du skal gøre, hvis du glemmer at tage en tablet afhænger af, hvor lang tid der er indtil din næste dosis:
English: Most (95% of the patients) had metastatic disease.
Danish: De fleste (95 % af patienterne) havde metastatisk sygdom.
English: ECGs and blood tests should also be obtained as clinically indicated during this period and afterwards.
Danish: EKG'er og blodprøver bør også indhentes som klinisk indiceret i løbet af denne periode og efterfølgende.
English: The primary efficacy outcome was ORR according to RECIST v 1.0.
Danish: Det primære effektmål var ORR ifølge RECIST v 1.0.
English: RET mutation status in Study 58
Danish: RET-mutationsstatus i studie 58
English: If you have trouble swallowing the tablet, you can mix it with water as follows:
Danish: Hvis du har problemer med at sluge tabletten, kan du blande den med vand på følgende måde:
English: This section includes only data derived from completed studies where patient exposure is known.
Danish: Dette punkt omfatter kun data fra afsluttede studier, hvor patienteksponeringen er kendt.
English: This is because Caprelsa may harm an unborn child.
Danish: Caprelsa kan nemlig skade det ufødte barn.
English: Keep in mind Caprelsa may make you feel tired, weak, or cause blurred vision.
Danish: Husk, at Caprelsa kan få dig til at føle dig træt, svag eller forårsage sløret syn.
English: The remaining 49 patients (49%) were censored in the analysis of PFS.
Danish: De resterende 49 patienter (49 %) blev censureret i analysen af PFS.
English: The total daily dose in children must not exceed 300 mg.
Danish: Den samlede daglige dosis til børn må ikke overstige 300 mg.
English: • Put the tablet into the water.
Danish: • Læg tabletten i vandet.
English: - It is important that you keep the Alert Card with you during treatment.
Danish: - Det er vigtigt, at du har informationskortet liggende hos dig under behandlingen.
English: QTc interval should be carefully assessed prior to initiation of treatment.
Danish: QTc-intervallet bør vurderes nøje før indledning af behandlingen.
English: This is seen on an electrocardiogram (ECG).
Danish: Dette kan ses på et elektrokardiogram (EKG).
English: • If you are sensitive to the sun.
Danish: • Hvis du er følsom over for sollys.
English: There is no experience with Caprelsa in patients 5-8 years of age in this study.
Danish: Der er ingen erfaring med Caprelsa hos patienter i alderen 5-8 år i dette studie.
English: Patients aged 5-18 years should be dosed according to the nomogram in Table 1.
Danish: Patienter i alderen 5-18 år bør doseres ifølge nomogrammet i tabel 1.
English: The recommended dose is 300 mg once a day, taken with or without food at about the same time each day.
Danish: Den anbefalede dosis er 300 mg én gang dagligt, taget med eller uden føde på nogenlunde samme tidspunkt hver dag.
English: • Severe skin reactions affecting large areas of your body.
Danish: • Alvorlige hudreaktioner, der påvirker store områder af kroppen.
English: This cuts off the supply of food and oxygen to the tumour.
Danish: Det afskærer forsyningen af næring og ilt til tumoren.
English: Patients should be monitored for hypertension and controlled as appropriate.
Danish: Patienter skal monitoreres for hypertension og kontrolleres efter behov.
English: Periodic monitoring of alanine aminotransferase is recommended.
Danish: Periodisk monitorering af alaninaminotransferase anbefales.
English: Temporary or permanent discontinuation of therapy may be necessary in patients with heart failure.
Danish: Midlertidig eller permanent seponering af behandlingen kan være nødvendig hos patienter med hjerteinsufficiens.
English: ** including two deaths in patients with QTc > 550 ms (one due to sepsis and one due to heart failure)
Danish: ** inklusive to dødsfald hos patienter med QTc >550 ms (det ene pga. sepsis og det andet pga. hjertesvigt).
English: The median PFS for patients randomised to placebo was 19.3 months.
Danish: Den mediane PFS for patienter randomiseret til placebo var 19,3 måneder.
English: CTN less than 500 pg/ml
Danish: CTN mindre end 500 pg/ml
English: Insomnia, Depression
Danish: Søvnløshed, depression
English: For a further supply, a new prescription is required.
Danish: For yderligere udlevering kræves en ny recept.
English: 7 day schedule:
Danish: 7 dages doseringsskema:
English: Dose increase (mg)b when tolerated well after 8 weeks at starting dose
Danish: Dosisøgning (mg)b ved god tolerans efter 8 uger med startdosis
English: Therefore, RET mutation testing is recommended.
Danish: Det anbefales derfor at teste for RET-mutation.
English: First QTc prolongations occurred most often in the first 3 months of treatment, but continued to first occur after this time.
Danish: Den første QTc-forlængelse indtraf sædvanligvis i løbet af de første 3 måneder af behandlingen, men forekom også første gang efter dette tidspunkt.
English: The doctor will tell you how many tablets of Caprelsa to give to your child.
Danish: Lægen vil fortælle dig, hvor mange Caprelsa-tabletter dit barn skal have.
English: Use caution before driving or using machines.
Danish: Udvis forsigtighed ved kørsel eller arbejde med maskiner.
English: The side effects of Caprelsa are listed in Section 4.
Danish: Bivirkningerne ved Caprelsa er angivet i punkt 4.
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Danish: Du kan også finde disse oplysninger på det patientinformationskort, du har fået af din læge.
English: • If your doctor or pharmacist changes your dose of Caprelsa
Danish: • Hvis din læge eller apotekspersonalet ændrer din dosis af Caprelsa
English: The treatment may either be given to your child as a once-daily dose, an every other day dosing or a repeating 7-day schedule as indicated in the dosing guide that has been given to you by your doctor.
Danish: Dit barn kan enten få dosis en gang dagligt, hver anden dag eller efter et gentaget 7-dages skema som vist i den doseringsguide, som du har fået af lægen.
English: • Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or a high temperature (fever).
Danish: • Svær åndenød eller pludselig forværring af åndenød, muligvis med hoste eller høj temperatur (feber).
English: Caprelsa may also act directly on cancer cells to kill them or slow down their growth.
Danish: Caprelsa kan også virke direkte på cancercellerne ved at dræbe dem eller hæmme deres vækst.
English: Disease control rate = response rate + stable disease at 24 weeks.
Danish: Sygdomskontrol(rate)= responsrate + stabil sygdom ved 24 uger.
English: The analysis was performed using a logistic regression model with treatment as the only factor.
Danish: Analysen blev udført vha. en logistisk regressionsmodel med behandling som den eneste faktor.
English: Eight percent of patients had a dose reduction due to QTc prolongation.
Danish: 8 % af patienterne fik reduceret dosis pga. QTc-forlængelse.
English: Any residues in the glass are to be mixed with half a glass of water and swallowed.
Danish: Eventuelle rester i glasset skal blandes med et halvt glas vand og indtages.
English: No adjustment in starting dose is required for elderly patients.
Danish: Der kræves ingen justering i startdosis til ældre patienter.
English: • Inflammation of a follicle, especially a hair follicle.
Danish: • Betændelse i en follikel, især en hårsæk.
English: The 300 mg daily dose can be reduced to 200 mg (two 100 mg tablets), and then to 100 mg if necessary.
Danish: Den daglige dosis på 300 mg kan reduceres til 200 mg (to 100 mg tabletter) og derefter til 100 mg, hvis det er nødvendigt.
English: The tablet is to be dropped in water, without crushing, stirred until dispersed (approximately 10 minutes) and the resultant dispersion swallowed immediately.
Danish: Tabletten skal lægges i vandet uden at knuse den, omrøres indtil den er opløst (ca. 10 minutter), hvorefter opløsningen indtages straks.
English: If a dose is missed, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis glemmes, skal den tages, så snart patienten kommer i tanker om det.
English: • Toxins in the blood as a complication of infection.
Danish: • Giftstoffer i blodet som en komplikation til infektion.
English: Patients with documented RET mutation (n=187)
Danish: Patienter med dokumenteret RETmutation (n=187)
English: Your doctor may also prescribe other medicines to help control your side effects.
Danish: Din læge kan også ordinere andre lægemidler for at hjælpe med at kontrollere bivirkningerne.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Danish: Fortæl det straks til din læge, hvis du oplever en af følgende bivirkninger - det kan være, du behøver akut medicinsk behandling:
English: Only patients with CTN ≥ 500 pg/mL (conventional units) or ≥ 146.3 pmol/L (international standard units) were enrolled.
Danish: Kun patienter med CTN ≥ 500 pg/ml (konventionelle enheder) eller ≥ 146,3 pmol/l (internationale standardenheder) blev inkluderet.
English: Do not take Caprelsa if any of the above applies to you.
Danish: Tag ikke Caprelsa, hvis et eller flere af disse punkter gælder for dig.
English: The PFS primary endpoint, ORR and DCR were based on centralized, independent blinded review of the imaging data.
Danish: Det primære PFS-effektmål, ORR og DCR var baseret på en centraliseret, uafhængig blindet gennemgang af billeddata.
English: Due to the increased thrombotic risk in patients with cancer, the use of anticoagulation is frequent.
Danish: På grund af den øgede tromboserisiko hos patienter med cancer er anvendelsen af antikoagulerende midler hyppig.
English: Your doctor may prescribe a medicine to treat this.
Danish: Din læge kan ordinere et lægemiddel til at behandle dette.
English: However, fatigue and blurred vision have been reported and those patients who experience these symptoms should observe caution when driving or using machines.
Danish: Der er dog rapporteret træthed og sløret syn, og patienter, som oplever sådanne symptomer, skal udvise forsigtighed, når de fører motorkøretøj og betjener maskiner.
English: Care should be taken with sun exposure by wearing protective clothing and/or sunscreen due to the potential risk of phototoxicity reactions associated with vandetanib treatment.
Danish: Der bør udvises forsigtighed ved eksponering for sollys ved at bære beskyttende beklædning og/eller solcreme på grund af den potentielle risiko for fototoksiske reaktioner forbundet med behandling med vandetanib.
English: The primary objective of this study was to demonstrate an improvement in progression-free survival (PFS) with vandetanib compared to placebo.
Danish: Det primære formål med dette studie var at påvise en forbedring i progressionsfri overlevelse (PFS) med vandetanib sammenlignet med placebo.
English: If you take more Caprelsa than you have been prescribed, talk to a doctor or go to a hospital straight away.
Danish: Hvis du tager mere Caprelsa, end du har fået ordineret, skal du straks tale med lægen eller tage på hospitalet.
English: After having well tolerated the first 1 or 2 cycles of therapy (1 cycle = 28 days), the remaining patients continued on 100 mg/m2 of treatment.
Danish: Efter at have tolereret de første 1 eller 2 behandlingscyklusser godt (1 cyklus = 28 dage) fortsatte de resterende patienter med 100 mg/m2.
English: If it gets severe, tell your doctor straight away.
Danish: Hvis det bliver alvorligt, skal du straks fortælle lægen det.
English: • The recommended dose is 300 mg each day.
Danish: • Den sædvanlige dosis er 300 mg hver dag.
English: Whilst the study size is small owing to the rarity of MTC in children, it is considered representative of the target population.
Danish: Studiet er lille, fordi MTC hos børn er sjælden, men det anses som repræsentativt for målgruppen.
English: If high blood pressure cannot be controlled with medical management, vandetanib should not be restarted until the blood pressure is controlled medically.
Danish: Hvis højt blodtryk ikke kan kontrolleres med medicinsk behandling, bør brugen af vandetanib ikke genoptages, før blodtrykket er kontrolleret medicinsk.
English: Within a 21 day collection period after a single dose of 14C-vandetanib, approximately 69% was recovered with 44% in faeces and 25% in urine.
Danish: Inden for en 21-dages indsamlingsperiode efter en enkelt dosis af 14C-vandetanib var ca. 69 % genfundet med 44 % i afføringen og 25 % i urinen.
English: If you have trouble swallowing the tablet
Danish: Hvis du har svært ved at sluge tabletten
English: They are seen in 8% of people taking Caprelsa for medullary thyroid cancer.
Danish: Det ses hos 8 % af personer, som tager Caprelsa mod medullær thyreoideacancer.
English: Date of latest renewal: 15 January 2019
Danish: Dato for første markedsføringstilladelse: 17. februar 2012 Dato for seneste fornyelse: 15. januar 2019
English: Your doctor may tell you to take Caprelsa at a lower or increased dose (such as two 100 mg tablets or one 100 mg tablet).
Danish: Din læge vil muligvis fortælle dig, at du skal tage Caprelsa i en lavere eller højere dosis (såsom to 100 mg tabletter eller én 100 mg tablet).
English: Mild to moderate skin reactions can be managed by symptomatic treatment, or by dose reduction or interruption.
Danish: Lette til moderate hudreaktioner kan behandles symptomatisk eller ved dosisreduktion eller -afbrydelse.
English: Recommended dosing regimens and dose modifications are presented in Table 1.
Danish: Anbefalet dosisregime og dosisjusteringer er vist i tabel 1.
English: • If you have high blood pressure.
Danish: • Hvis du har for højt blodtryk
English: There is no specific treatment in the event of overdose with vandetanib and possible symptoms of overdose have not been established.
Danish: Der findes ikke nogen specifik behandling i tilfælde af overdosering med vandetanib, og mulige symptomer på overdosering er ikke blevet fastlagt.
English: To make sure there is no medicine left, refill the glass halfway with water and drink it.
Danish: For at sikre dig at der ikke er nogen medicin tilbage, skal du fylde glasset halvt op med vand igen, og drikke det.
English: Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
Danish: Patienten må ikke tage en dobbeltdosis (to doser på samme tid) som erstatning for en glemt dosis.
English: In addition to this leaflet you will be given the Patient Alert Card, which contains important safety information that you need to know before you are given Caprelsa and during treatment with Caprelsa.
Danish: Ud over denne indlægsseddel vil du modtage et patientinformationskort, som indeholder vigtige sikkerhedsoplysninger, du skal kende til, før du behandles med Caprelsa og under behandling med Caprelsa.
English: Table 3: Summary of other efficacy findings in study 58 ORRa
Danish: Tabel 3: Oversigt over centrale effektfund i studie 58 ORRa
English: Cardiac impairment was defined as patients with previous cardiovascular abnormality.
Danish: Påvirkning af hjertet blev defineret som patienter med tidligere kardiovaskulær abnormalitet.
English: This study included 331 patients with unresectable locally advanced or metastatic MTC.
Danish: Dette studie omfattede 331 patienter med inoperabel lokalt fremskreden eller metastatisk MTC.
English: Clinical data from MTC
Danish: Kliniske data fra MTC
English: The majority of elevations resolve while continuing treatment, others usually resolve after a 1-2 week interruption in therapy.
Danish: Størstedelen af forhøjelserne forsvinder under den fortsatte behandling, og andre forsvinder sædvanligvis efter en afbrydelse af behandlingen på 1-2 uger.
English: • A type of rash that affects the hands and feet (hand foot syndrome).
Danish: • En type udslæt, som påvirker hænder og fødder (hånd- og fodsyndrom).
English: • A type of diarrhoea (colitis).
Danish: • En bestemt type diarré (colitis).
English: QTcF prolongation was > 20 ms in over 91% of patients, > 60 ms in 35%, > 100 ms in 1.7%.
Danish: QTcF-forlængelsen var >20 ms hos over 91 % af patienterne, >60 ms hos 35 %, >100 ms hos 1,7 %.
English: PVC/ PVDC/Alu blisters, sealed with aluminium foil, each containing 30 film-coated tablets.
Danish: PVC/ PVDC/aluminiumblisterkort, forseglet med aluminiumsfolie, hver indeholdende 30 filmovertrukne tabletter.
English: Excretion of the dose was slow and further excretion beyond 21 days would be expected based on the plasma half-life.
Danish: Udskillelse af dosis var langsom, og yderligere udskillelse efter 21 dage må forventes baseret på plasmahalveringstiden.
English: • Stir the tablet until it has dispersed into the water.
Danish: • Rør tabletten rundt, indtil den er jævnt fordelt i vandet.
English: • How to use the daily tracker table (including examples of a completed daily tracker);
Danish: • Hvordan kalenderen til afkrydsning af den daglige dosis anvendes (herunder eksempel på en udfyldt kalender);
English: In order to confirm the efficacy and safety of Caprelsa in RET-negative patients, the MAH should submit:
Danish: For at bekræfte Caprelsas virkning og sikkerhed hos RET-negative patienter skal MAH indsende:
English: Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
Danish: Behandling af gravide kvinder bør kun fortsættes, hvis den potentielle gavnlige effekt for moderen opvejer risikoen for fosteret.
English: • As instructed by your doctor or pharmacist
Danish: • Ifølge lægens eller apotekspersonalets instruktioner
English: In view of the associated risks, it is important to limit treatment with vandetanib to patients who are in real need for treatment, i.e. with a symptomatic-aggressive course of the disease.
Danish: På grund af de associerede risici er det vigtigt at begrænse behandling med vandetanib til de patienter, som har et reelt behov for behandlingen, dvs. som har et symptomatisk og aggressivt sygdomsforløb.
English: • The general daily tracker for 14 days and blank copies of the daily tracker.
Danish: • Generel kalender til 14 dage og blanke eksemplarer af kalenderen.
English: Elevation of systolic and diastolic blood pressure was observed in rats and dogs.
Danish: Der blev observeret forhøjede systoliske og diastoliske blodtryk hos rotter og hunde.
English: If you get side effects always tell your doctor.
Danish: Hvis du får bivirkninger, skal du altid fortælle det til lægen.
English: • Patients with a QTc interval over 480 msec.
Danish: • Patienter med QTc-interval over 480 ms.
English: Patients were treated with vandetanib or placebo until they reached objective disease progression.
Danish: Patienterne blev behandlet med vandetanib eller placebo, indtil de nåede objektiv sygdomsprogression.
English: • How CAPRELSA is used / administered;
Danish: • Hvordan Caprelsa anvendes/administreres;
English: Objective response rate (vandetanib arm)
Danish: Objektiv responsrate (vandetanib-arm)
English: • Regularly during Caprelsa treatment
Danish: • Regelmæssigt under behandlingen med Caprelsa
English: Most patients (81.3%) had undergone partial or total thyroidectomy prior to study entry.
Danish: Størstedelen af patienterne (81,3 %) havde gennemgået hel eller delvis tyroidektomi inden studieinklusion.
English: • Blurred vision, including mild changes in the eye which can lead to blurred vision (corneal opacity).
Danish: • Sløret syn, inklusive lette forandringer i øjnene, som kan føre til sløret syn (uklarhed af hornhinden).
English: Routine anti-diarrhoeal agents are recommended for the treatment of diarrhoea.
Danish: Standardmidler mod diarré anbefales til behandling af diarré.
English: - if you have a heart problem that you were born with called ‘congenital long QTc syndrome'.
Danish: - hvis du er født med et hjerteproblem kaldet ”medfødt langt QTc-syndrom”.
English: In ex vivo plasma samples from colorectal cancer patients at steady state exposure after 300 mg once daily, the mean percentage protein binding was 93.7% (range 92.2 to 95.7%).
Danish: I ex vivo-plasmaprøver fra patienter med kolorektalcancer ved steadystate-eksponering efter 300 mg én gang dagligt var den gennemsnitlige procentvise proteinbinding 93,7 % (i området 92,2 til 95,7 %).
English: • Protein or blood in your urine (shown in a urine test).
Danish: • Protein eller blod i urinen (ses ved en urinprøve).
English: In consideration of the high intra-individual variability of the response to anticoagulation, and the possibility of interaction between vitamin K antagonists and chemotherapy, an increased frequency of the INR (International Normalised Ratio) monitoring is recommended, if it is decided to treat the patient with vitamin K antagonists.
Danish: I betragtning af den høje intraindividuelle variabilitet af responsen på antikoagulation, og muligheden for interaktion mellem K-vitamin-antagonister og kemoterapi, anbefales en øget frekvens af monitoreringen af INR (International Normaliseret Ratio), hvis det besluttes at behandle patienten med K-vitamin-antagonister.