FrancophonIA/ELRC3.0 huggingface dataset:
English: - Do not open the hard capsules unless you are unable to swallow them.
Danish: - Åbn ikke de hårde kapsler medmindre du ikke kan synke dem.
English: Months since randomisation
Danish: Måneder efter randomisering
English: More than 60% of all patients were Caucasian and 25% of all patients were Asian.
Danish: Over 60 % af alle patienterne var kaukasier og 25 % af alle patienterne var asiater.
English: Accelerated phase
Danish: Accelereret fase
English: The total daily dose you give to your child must not exceed 800 mg.
Danish: Den totale daglige dosis, du giver til dit barn, må ikke overstige 800 mg.
English: (Best response rate)
Danish: (Bedste responsrate)
English: Dose adjustments or modifications
Danish: Dosisjusteringer eller -ændringer
English: Different strengths of Tasigna hard capsules can be combined to attain the desired dose.
Danish: Forskellige styrker af Tasigna hårde kapsler kan kombineres for at opnå den ønskede dosis.
English: Older people (age 65 years and over) Tasigna can be used by people aged 65 years and over at the same dose as for other adults.
Danish: Ældre (65 år og derover) Tasigna kan bruges af personer i alderen 65 år og derover med samme dosis som for andre voksne.
English: However, percentages with one decimal precision are used to identify terms with a frequency of at least 5% and to classify terms according to frequency categories.
Danish: Dog er procenter med en decimals præcision brugt til at indentificere termer med en frekvens på mindst 5 % og for at klassificere termer efter frekvenskategorier.
English: This medicine contains lactose (also known as milk sugar).
Danish: Denne medicin indeholder lactose (også kendt som mælkesukker).
English: The doctor will calculate the correct dose to use and tell you which and how many capsules of Tasigna to give to your child.
Danish: Lægen vil beregne den korrekte dosis og fortælle dig, hvilke og hvor mange kapsler Tasigna dit barn skal have.
English: Time since TFR (weeks)
Danish: Tid siden TFR (uger)
English: Censored observations
Danish: Censurerede observationer
English: These medicines should be avoided during your treatment with Tasigna.
Danish: Disse lægemidler bør undgås under behandling med Tasigna.
English: In general the changes in clinical chemistry were fully reversible after a four-week recovery period and the histological alterations showed partial reversibility.
Danish: Generelt var ændringerne i den kliniske kemi fuldt reversible efter en fire-ugers restitutionsperiode, og de histologiske ændringer viste partiel reversibilitet.
English: Rifampicin and nilotinib should not be used concomitantly.
Danish: Rifampicin og nilotinib må ikke anvendes samtidig.
English: No major differences were observed for safety and efficacy in patients ≥65 years of age as compared to adults aged 18 to 65 years.
Danish: Der blev ikke observeret nogen større forskelle med hensyn til sikkerhed og virkning hos patienter ≥65 år sammenlignet med voksne i alderen 18-65 år.
English: If you are taking any of these, your doctor might prescribe other alternative medicines.
Danish: Hvis du tager nogle af disse lægemidler, kan din læge ordinere andre alternative lægemidler.
English: Similar events were observed in post-marketing reports.
Danish: Lignende hændelser er blevet rapporteret post-marketing.
English: In the event of overdose, the patient should be observed and appropriate supportive treatment given.
Danish: I tilfælde af overdosering skal patienten observeres og passende støttende behandling gives.
English: Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
Danish: Behandlingen bør fortsættes, så længe klinisk fordel heraf ses, eller indtil der opstår uacceptable toksiske reaktioner.
English: Nilotinib absorption following oral administration was approximately 30%.
Danish: Nilotinib-absorptionen efter oral administration var omkring 30 %.
English: Taking Tasigna at the same time each day will help you remember when to take your hard capsules.
Danish: Hvis du tager Tasigna på samme tidspunkt hver dag, vil du nemmere kunne huske, hvornår du skal tage de hårde kapsler.
English: At 12 months At 24 months At 36 months At 48 months At 60 months At 72 months
Danish: Ved 12 måneder Ved 24 måneder Ved 36 måneder Ved 48 måneder Ved 60 måneder Ved 72 måneder
English: Treatment-free Survival (%)
Danish: Behandlingsfri overlevelse (%)
English: Some side effects could be serious.
Danish: Nogle bivirkninger kan blive alvorlige
English: Laboratory tests and monitoring
Danish: Laboratorietests og monitorering
English: Do not take a double dose to make up for a forgotten hard capsule.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte hårde kapsel.
English: Do not stop taking this medicine unless your doctor tells you to do so.
Danish: Hold ikke op med at tage dette lægemiddel, medmindre lægen siger, at du skal gøre det.
English: Randomisation was stratified by Sokal risk score at the time of diagnosis.
Danish: Randomiseringen blev stratificeret af Sokal risikoscoren ved tidspunktet for diagnosen.
English: Of these patients 30/36 (83%) were treatment resistant not intolerant.
Danish: Af disse patienter var 30/36 (83 %) behandlingsresistente, ikke intolerante.
English: Overall, 73% of patients were imatinib-resistant, while 27% were imatinib-intolerant.
Danish: Overordnet var 73 % af patienterne imatinib-resistente, mens 27 % var imatinib-intolerante.
English: Table 12 Response in CML
Danish: Tabel 12 Respons hos CML
English: Tasigna has no or negligible influence on the ability to drive and use machines.
Danish: Tasigna har ingen eller ubetydelig virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: The doctor will monitor growth at regular visits.
Danish: Lægen vil under regelmæssige besøg holde øje med væksten.
English: Table 9 Best CCyR rate
Danish: Tabel 9 Bedste CCyR rate
English: Your doctor may prescribe a lower dose depending on how you respond to treatment.
Danish: Din læge kan have anvist en lavere dosis afhængig af den måde du reagerer på behandlingen.
English: Interaction studies have only been performed in adults.
Danish: Interaktionsstudier er kun foretaget med voksne patienter.
English: The primary efficacy endpoint was major molecular response (MMR) at 12 months.
Danish: Det primære effektendepunkt var major molekulært respons (MMR) ved 12 måneder.
English: It is unknown whether nilotinib is excreted in human milk.
Danish: Det er ukendt, om nilotinib udskilles i human mælk.
English: These adverse reactions are included based on clinical relevance.
Danish: Disse bivirkninger er medtaget ud fra klinisk relevans.
English: Steady-state conditions were essentially achieved by day 8.
Danish: Steady state blev nået på dag 8.
English: Patients should be advised to seek immediate medical attention if they experience acute signs or symptoms of cardiovascular events.
Danish: Patienter skal informeres om at søge læge omgående, hvis de oplever akutte tegn eller symptomer på kardiovaskulære hændelser.
English: Continue taking Tasigna every day for as long as your doctor tells you.
Danish: Tag Tasigna hver dag, så længe din læge siger, at du skal gøre det.
English: Nilotinib did not have effects on CNS or respiratory functions.
Danish: Nilotinib havde ingen indvirkning på CNS- eller respirationsfunktionerne.
English: This is because Tasigna could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Tasigna kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: Approximately 12% of subjects in the clinical study were 65 years of age or over.
Danish: Cirka 12 % af patienterne i det kliniske studie var 65 år eller derover.
English: - Do not take any food together with the hard capsules.
Danish: - Du må ikke spise mad sammen med de hårde kapsler.
English: Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Danish: De fleste af bivirkningerne er lette til moderate og forsvinder generelt efter nogle få dages eller ugers behandling.
English: No patient had a LVEF of <45% during treatment nor an absolute reduction in LVEF of more than
Danish: Ingen patienter havde LVEF <45 % under behandlingen eller en absolut reduktion i LVEF på mere end 15 %.
English: Body Surface Area (BSA)
Danish: Kropsoverfladeareal (BSA)
English: There are no or limited amount of data from the use of nilotinib in pregnant women.
Danish: Der er ingen eller utilstækkelige data fra anvendelse af nilotinib til gravide kvinder.
English: Tasigna was administered on a continuous basis (twice daily 2 hours after a meal and with no food for at least one hour after administration) unless there was evidence of inadequate response or disease progression.
Danish: Tasigna blev administreret kontinuerligt (2 gange dagligt 2 timer efter et måltid og uden mad i mindst en time efter administrationen), medmindre der var tegn på utilstrækkelig respons eller sygdomsprogression.
English: Tasigna is available in the following pack sizes:
Danish: Tasigna fås i følgende pakningsstørrelser:
English: The rates of response for the two treatment arms are reported in Table 12.
Danish: Responsraterne for de to behandlingsarme er anført i tabel 12.
English: Total gastrectomy
Danish: Total gastrektomi
English: Median duration of treatment was 561 days for CP patients and 264 days for AP patients (see Table 10).
Danish: Denne mediane behandlingsvarighed var 561 dage for CP-patienter og 264 dage for AP-patienter (se tabel 10).
English: Only minor liver alterations were seen in mice or rats treated for up to 26 weeks.
Danish: Der sås kun mindre leverforandringer hos mus eller rotter, som blev behandlet i op til 26 uger.
English: Stopping Tasigna without your doctor's recommendation places you at risk for worsening of your disease which could have life-threatening consequences.
Danish: Hvis du stopper med Tasigna uden lægens anbefaling, bliver du udsat for en risiko for forværring af sygdommen, som kan have livstruende konsekvenser.
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Danish: Hvis det anvendes under graviditet, skal patienten informeres om den potentielle risiko for fosteret.
English: Unchanged nilotinib accounted for 69% of the dose.
Danish: Uforandret nilotinib udgjorde 69 % af dosis.
English: Take the hard capsules: - twice a day (approximately every 12 hours); - at least 2 hours after any food; - then wait 1 hour before eating again.
Danish: Tag de hårde kapsler: - 2 gange om dagen (ca. hver 12. time) - mindst 2 timer efter ethvert indtag af mad - vent derefter 1 time, før du spiser igen.
English: If you are the parent of a child who is being treated with Tasigna, tell the doctor if any of the above conditions apply to your child.
Danish: Hvis du er forælder til et barn, der behandles med Tasigna, skal du fortælle lægen, hvis noget af ovenstående gælder for dit barn.
English: Be sure to discuss with your doctor, nurse, and/or pharmacist if you are considering stopping Tasigna.
Danish: Du skal være sikker på, at du har snakket med lægen, sygeplejersken og/eller apotekspersonalet, hvis du overvejer at stoppe med Tasigna.
English: In addition, the toxicity profile in juvenile rats was comparable to that observed in adult rats.
Danish: I tillæg hertil var toksicitetsprofilen hos de unge rotter sammenlignelig med den hos voksne rotter.
English: Bioavailability/bioequivalence studies
Danish: Biotilgængelighed/bioækvivalens studier
English: Therefore the risk that nilotinib causes photosensitisation in patients is considered very low.
Danish: Derfor anses risikoen for, at nilotinib forårsager fotosensibilisering hos patienterne for meget lav.
English: Complete blood counts should be performed every two weeks for the first 2 months and then monthly thereafter, or as clinically indicated.
Danish: Der bør tages fuldstændigt blodbillede hver anden uge i de første 2 måneder og derefter en gang om måneden eller som klinisk indiceret.
English: Tasigna should not be used during pregnancy unless the clinical condition of the woman requires treatment with nilotinib.
Danish: Tasigna bør ikke anvendes under graviditet, medmindre den kliniske situation hos kvinden kræver behandling med nilotinib.
English: MMR rates by different time points (including patients who achieved MMR at or before those time points as responders) are presented in the cumulative incidence of MMR (see Figure 1).
Danish: Raterne for MMR ved forskellige tidspunkter (inklusive patienter, der opnåede MMR ved eller før disse tidspunkter som respondenter) er angivet i den kumulative insidens af MMR (se figur 1).
English: Subsequent analyses reflect when patients completed 24, 36, 48, 60 and 72 months of treatment (or discontinued earlier).
Danish: Efterfølgende analyser afspejler, når patienter har fuldført 24, 36, 48, 60 og 72 måneders behandling (eller afsluttet tidligere).
English: There is no experience with the use of this medicine in children below 2 years of age.
Danish: Der er ingen erfaring med brug af dette lægemiddel til børn under 2 år.
English: No ECG changes or hepatotoxicity were reported.
Danish: Der var ikke indrapporteret ECG-forandringer eller hepatotoksicitet.
English: Toxic hepatitis
Danish: Toksisk hepatitis
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to nilotinib exposure.
Danish: Da disse bivirkninger er indrapporteret frivilligt fra en population af ukendt størrelse, er det ikke altid muligt at give et pålideligt estimat for deres hyppighed eller fastlægge en kausal sammenhæng med eksponering for nilotinib.
English: If event occurs after dose reduction, consider discontinuing treatment.
Danish: Hvis en hændelse opstår efter dosisreduktion, overvej da at afbryde behandlingen.
English: System organ class/
Danish: Systemorganklasse/
English: These medicines need to be taken separately from Tasigna: - H2 blockers, which decrease the production of acid in the stomach.
Danish: Denne medicin skal tages adskilt fra Tasigna: - H2-blokkere, der nedsætter syreproduktionen i maven.
English: Prolongation of the QT interval or an irregular heart beat may lead to sudden death.
Danish: Forlængelse af QT-interval eller en uregelmæssig hjerterytme kan føre til pludselig død.
English: Food may enhance the absorption of Tasigna and therefore increase the amount of Tasigna in the blood, possibly to a harmful level.
Danish: Mad kan forøge absorptionen af Tasigna og derfor øge mængden af Tasigna i blodet, muligvis til et skadeligt niveau.
English: The pharmacokinetic exposure of nilotinib following a single or multiple doses appeared to be comparable between paediatric patients from 2 years to <10 years and from ≥10 years to <18 years.
Danish: Den farmakokinetiske eksponering af nilotinib efter en enkelt eller flere doser syntes at være sammenlignelig mellem pædiatriske patienter fra 2 år til < 10 år og fra ≥ 10 år til < 18 år.
English: Efficacy data in patients with CML-BC are not yet available.
Danish: Effektdata fra patienter med CML-BC er endnu ikke tilgængelige.
English: The blood-to-plasma ratio of nilotinib is 0.71.
Danish: Nilotinibs blod-plasma-ratio er 0,71.
English: No effects were seen in ECG measurements in dogs or monkeys treated for up to 39 weeks or in a special telemetry study in dogs.
Danish: Der sås ingen virkning på EKG-målinger af hunde eller aber, der havde modtaget behandling i op til 39 uger, eller i et særligt telemetristudie af hunde.
English: - if you suffer from lack of potassium or magnesium.
Danish: - hvis du lider af kalium- eller magnesiummangel.
English: The median time on treatment was approximately 70 months in the nilotinib treatment groups and 64 months in the imatinib group.
Danish: Den mediane behandlingstid var ca. 70 måneder for nilotinib-grupperne og 64 måneder for imatinib-gruppen.
English: - if you have had a surgical procedure involving the removal of the entire stomach (total gastrectomy).
Danish: - hvis du har gennemgået operation, der involverer fjernelse af hele mavesækken (total gastrektomi).
English: Metabolism and nutrition disorders Decreased appetite **
Danish: Metabolisme og ernæring Nedsat appetit**
English: Nilotinib is the main circulating component in the serum.
Danish: Nilotinib er den vigtigste cirkulerende komponent i serum.
English: If any of these apply to you or your child, tell your doctor.
Danish: Hvis noget af det gælder for dig eller dit barn, skal du fortælle det til din læge.
English: The hard capsules should be swallowed whole with water.
Danish: De hårde kapsler skal sluges hele med vand.
English: Among these 88 patients, 86 patients restarted nilotinib treatment and 2 patients permanently discontinued the study.
Danish: Blandt de 88 patienter genoptog 86 patienter behandlingen med nilotinib, og 2 patienter udtrådte permanent af studiet.
English: Post-marketing experience
Danish: Erfaringer efter markedsføring
English: Do not take Tasigna - if you are allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Tasigna - hvis du er allergisk over for nilotinib eller et af de øvrige indholdsstoffer i Tasigna (angivet i punkt 6).
English: For all Sokal risk groups, the MMR rates at all time points remained consistently higher in the two nilotinib groups than in the imatinib group.
Danish: MMR-raten for alle Sokal-risikogrupper ved alle tidspunkter forblev konstant højere i de to nilotinib-grupper end i imatinib-gruppen.
English: Peak concentrations of nilotinib are reached 3 hours after oral administration.
Danish: Maksimumkoncentrationerne af nilotinib nås 3 timer efter oral administration.
English: Pregnancy and breast-feeding - Tasigna is not recommended during pregnancy unless clearly necessary.
Danish: Graviditet og amning - Tasigna frarådes under graviditet, medmindre det er strengt nødvendigt.
English: The apparent elimination half-life estimated from the multiple-dose pharmacokinetics with daily dosing was approximately 17 hours.
Danish: Den tilsyneladende eliminationshalveringstid, estimeret ud fra flerdosisfarmakokinetik med daglig dosering, var ca. 17 timer.
English: Prolongation of the QT interval may expose patients to the risk of fatal outcome.
Danish: Forlængelse af QT-intervallet kan udsætte patienten for risikoen for fatalt udfald.
English: The primary data analysis time point was when all 846 patients completed 12 months of treatment (or discontinued earlier).
Danish: Det primære dataanalyse-tidspunkt var, da alle 846 patienter havde afsluttet 12 måneders behandling (eller afsluttet tidligere).
English: Show them the pack of hard capsules and this package leaflet.
Danish: Vis dem pakken med de hårde kapsler og denne indlægsseddel.
English: Other medicines and Tasigna Tasigna may interfere with some other medicines.
Danish: Brug af anden medicin sammen med Tasigna Tasigna kan påvirke visse andre lægemidler.
English: If test results warrant therapy, physicians should follow their local standards of practice and treatment guidelines.
Danish: Hvis prøveresultaterne indicerer behandling, bør lægen følge den lokale standardpraksis og behandlingsvejledning.
English: If you have any questions about how Tasigna works or why it has been prescribed for you or your child, ask your doctor.
Danish: Hvis du har spørgsmål til, hvordan Tasigna virker, eller hvorfor det er ordineret til dig eller dit barn, skal du spørge din læge.
English: 60-month analysis
Danish: 60 måneders analyse
English: Only patients who were in MMR at a specific time point are included as responders for that time point.
Danish: Kun patienter, der var i MMR på et bestemt tidspunkt, er inkluderet som respondenter på det pågældende tidspunkt.
English: Your doctor will regularly evaluate your treatment and decide whether you should continue to take Tasigna.
Danish: Din læge vil regelmæssigt evaluere din behandling og beslutte, om du skal fortsætte med at tage Tasigna.
English: Your doctor should assess the level of fats (lipids) and sugar in your blood before initiating treatment with Tasigna and during treatment.
Danish: Din læge bør vurdere niveauet af fedtstoffer (lipider) og sukker i blodet, før du starter på behandling med Tasigna og under behandlingen.
English: Monitoring during Tasigna treatment
Danish: Overvågning under Tasigna-behandling
English: Growth retardation in paediatric population
Danish: Væksthæmning hos den pædiatriske population
English: Cumulative incidence of MMR, %
Danish: Kumulativ forekomst af MMR, %
English: Tumour lysis syndrome
Danish: Tumor lysis-syndrom
English: Mainly reversible increases in cholesterol levels were seen in rats, dogs and monkeys.
Danish: Der sås hovedsageligt reversible kolesterolniveauer hos rotter, hunde og aber.
English: As compared to an oral drink solution (pH of 1.2 to 1.3), relative bioavailability of nilotinib capsule is approximately 50%.
Danish: Sammenlignet med en oral opløsning (pH 1,2 til 1,3) er den relative biotilgængelighed af nilotinibkapsler ca. 50 %.
English: Median duration of MCyR was 32.7 months.
Danish: Median varighed af MCyR var 32,7 måneder.
English: - Do not use this medicine after the expiry date which is stated on the carton and blister.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter EXP.
English: Tasigna hard capsules contain lactose.
Danish: Tasigna hårde kapsler indeholder lactose.
English: MCyR rate was 30% with a median time to response of 2.8 months.
Danish: MCyR-raten var 30 % med en median tid til respons på 2,8 måneder.
English: CML is a cancer of the blood which makes the body produce too many abnormal white blood cells.
Danish: CML er en form for blodkræft, som får kroppen til at producere for mange unormale hvide blodlegemer.
English: Dose in mg (twice daily)
Danish: Dosis i mg (2 gange daglig)
English: The MMR rate at 12, 24, 36, 48, 60 and 72 months is presented in Table 7.
Danish: Raten for MMR ved 12, 24, 36, 48, 60 og 72 måneder er præsenteret i tabel 7.
English: Besides standard study parameters, evaluations of developmental landmarks, CNS effects, mating and fertility were performed.
Danish: Udover standard studieparametre udførtes også evalueringer af udviklingstrin, CNS effekter, parrings og fertilitetspåvirkning.
English: Nilotinib is also a substrate for the multi-drug efflux pump, P-glycoprotein (P-gp).
Danish: Nilotinib er også substrat for multiefflukspumpen P-glykoprotein (P-gp).
English: - if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the QT interval”.
Danish: - hvis du har en hjertesygdom, f.eks. et unormalt elektrisk signal kaldet ”QT-forlængelse”.
English: Figure 1 Cumulative incidence of MMR
Danish: Figur 1 Kumulativ incidens af MMR
English: If you have taken more Tasigna than you should have, or if someone else accidentally takes your hard capsules, contact a doctor or hospital for advice straight away.
Danish: Hvis du har taget mere Tasigna, end du skal, eller hvis en anden kommer til at tage dine hårde kapsler, skal du straks kontakte en læge eller et hospital for at få vejledning.
English: One resistant or intolerant CML patient progressed to AP/BC after about 10 months on treatment.
Danish: En resistent eller intolerant CML-patient udviklede AP/BC efter ca. 10 måneders behandling.
English: Eligible patients who are confirmed to express the typical BCR-ABL transcripts, e13a2/b2a2 or e14a2/b3a2, can be considered for treatment discontinuation.
Danish: Egnede patienter med bekræftet ekspression af de typiske BCR-ABL-transkripter, e13a2/b2a2 eller e14a2/b3a2, kan komme i betragtning til seponering af behandlingen.
English: Up to 0.32 m
Danish: Op til 0,32 m
English: Patients were within six months of diagnosis and were previously untreated, with the exception of hydroxyurea and/or anagrelide.
Danish: Patienterne havde fået stillet diagnosen indenfor de seneste 6 måneder og var hidtil ikke behandlet, dog med undtagelse af hydroxyurea og/eller anagrelid.
English: The absolute bioavailability of nilotinib has not been determined.
Danish: Nilotinibs absolutte biotilgængelighed er ikke blevet klarlagt.