FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on population pharmacokinetic analysis in CML patients, there was a small effect of age on the volume of distribution (12 % increase in patients > 65 years old).
Danish: Populationsfarmakokinetiske analyser hos CML-patienter har vist, at alder har en lille effekt på fordelingsvolumen (12 % stigning hos patienter >65 år).
English: While you are taking Imatinib medac, your doctor will regularly check whether the medicine is working.
Danish: Mens du tager Imatinib medac, vil din læge regelmæssigt kontrollere, om lægemidlet virker.
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a
Danish: • Genopblussen (reaktivering) af hepatitis B-infektion, hvis du tidligere har haft hepatitis B
English: This was a population of heavily pretreated patients, as 46 % had received prior BMT and 73 % a prior multi-agent chemotherapy.
Danish: Det var en population af patienter, der i udtalt grad tidligere havde modtaget anden behandling, eftersom 46 % tidligere havde modtaget BMT og 73 % tidligere havde modtaget multi-stof kemoterapi.
English: Clinical studies in HES/CEL
Danish: Kliniske undersøgelser vedrørende HES/CEL
English: When female rats were dosed 14 days prior to mating and through to gestational day 6, there was no effect on mating or on number of pregnant females.
Danish: Når hunrotter doseredes 14 dage inden parring og vedvarende til gestationsdag 6, sås ingen effekt på parringen eller antallet af gravide hunner.
English: 95 (37 %) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“pretreated patients”) whereas 165 (63 %) had not (“untreated patients”).
Danish: 95 (37 %) havde tidligere modtaget kemoterapi til behandling af enten accelereret fase eller blastkrise (”tidligere behandlede patienter”), hvorimod 165 (63 %) ikke havde (”ubehandlede patienter”).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in theagreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: The plasma AUC for imatinib decreased by 73 % compared to patients not on EIAEDs.
Danish: Plasma AUC for imatinib blev reduceret med 73 % sammenlignet med patienter som ikke blev behandlet med EIAEDs.
English: • Do not breast-feed during the treatment with Imatinib medac as there is limited information on the distribution of imatinib into the breast milk.
Danish: • Du må ikke amme, mens du er i behandling med Imatinib medac, da der kun er begrænsede oplysninger om fordelingen af imatinib i human mælk.
English: ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Danish: ULN = laboratoriets øvre normalgrænse ASAT = aspartataminotransferase
English: Use in adults Your doctor will tell you exactly how many capsules of Imatinib medac to take.
Danish: Brug til voksne Din læge vil fortælle dig, præcis hvor mange Imatinib medac-kapsler, du skal tage.
English: Dose adjustment for adverse reactions in all indications in adults and paediatric patients
Danish: Dosisjustering i forbindelse med bivirkninger ved alle indikationer hos voksne og pædiatriske patienter
English: These events can usually be managed with either a reduction of the dose or an interruption of treatment with imatinib, but can in rare cases lead to permanent discontinuation of treatment.
Danish: Disse episoder kan sædvanligvis behandles med enten dosisreduktion eller seponering af imatinib, men kan i sjældne tilfælde medføre permanent seponering af behandlingen.
English: The data was similar when re-analysed to include only those patients age 55 or older.
Danish: Der blev opnået samme data ved reanalyse med inklusion kun af patienter i en alder af over 55 år.
English: *, interstitial lung disease*
Danish: *, interstitiel lungesygdom*
English: In an observational study in the CML paediatric population, a statistically significant decrease (but of uncertain clinical relevance) in median height standard deviation scores after 12 and 24 months of treatment was reported in two small subsets irrespective of pubertal status or gender.
Danish: I et observationsstudie i den pædiatriske population med CML blev der rapporteret et statistisk signifikant fald (men med usikker klinisk relevans) i resultaterne for standardafvigelse af medianhøjde efter 12 og 24 måneders behandling i to små undergrupper, uanset pubertetsstatus og køn.
English: Rare: Not known:
Danish: Sjælden: Ikke kendt:
English: • If you are a woman who is pregnant or might get pregnant and are trying to open the capsules for your children or another patient unable to swallow, you should handle the contents with caution in order to avoid skin-eye contact or inhalation.
Danish: • Hvis du er kvinde og er gravid eller planlægger at blive gravid, skal du være forsigtig, når du åbner kapslerne for dit barn eller en anden patient, som ikke kan sluge kapslen, og håndterer indholdet for at undgå hud- og øjenkontakt eller indånding af pulveret.
English: The median duration of the neutropenic and thrombocytopenic episodes usually ranged from 2 to 3 weeks, and from 3 to 4 weeks, respectively.
Danish: Den gennemsnitlige varighed af neutropeni- og trombocytopeniepisoderne varierede sædvanligvis fra henholdsvis 2-3 uger og 3-4 uger.
English: Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Danish: En specialist i leversygdomme og i behandling af hepatitis B skal konsulteres, før behandling initieres hos patienter med positiv hepatitis B-serologi (herunder patienter med aktiv sygdom), og hvis patienten testes HBV-positiv under behandlingen.
English: An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
Danish: Yderligere 4 HES patienter blev fundet FIP1L1-PDGFRα positive i 3 andre publicerede kasuistikker.
English: There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Danish: Der var ingen ændringer i imatinibs kinetik ved gentagen dosering, og akkumulering var 1,5-2,5 gange ved steady-state ved dosering 1 gang dagligt.
English: Do not stop taking Imatinib medac unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Imatinib medac, medmindre din læge fortæller dig det.
English: The overall survival is 65 months since diagnosis (range 25-234).
Danish: Den generelle overlevelse er 65 måneder, når diagnosen er stillet (varierende mellem 25-234 måneder.
English: In this study, 31 % of patients achieved a haematological response (36 % in previously untreated patients and 22 % in previously treated patients).
Danish: I denne undersøgelse opnåede 31 % af patienterne et hæmatologisk respons (36 % af de tidligere ”ubehandlede patienter” og 22 % af de ”tidligere behandlede patienter”).
English: When assuming conservatively that patients with missing data were non-responders, CHR was observed in 20/23 (87%) patients, CCyR in 9/23 (39.1%) patients, and MR in 11/23 (47.8%) patients, respectively.
Danish: Ved en konservativ antagelse af at patienter med manglende data er ikke-respondenter, blev CHR observeret hos 20/23 (87 %), CCyR hos 9/23 (39,1 %) og MR hos 11/23 (47,8 %) af patienterne.
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvenskategorier er defineret ved brug af følgende konvention: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Dermatofibrosarcoma protuberans (DFSP).
Danish: • Dermatofibrosarkom protuberans (DFSP).
English: The age of the DFSP patients ranged from 23 to 75 years; DFSP was metastatic, locally recurrent following initial resective surgery and not considered amenable to further resective surgery at the time of study entry.
Danish: Alderen hos patienterne med DFSP varierede fra 23 til 75 år; DFSP var på tidspunktet for inklusion i studiet metastaseret, recidiveret lokalt efter initial resektionskirurgi og vurderet som ikke modtagelig for yderligere resekterende kirurgi.
English: • Newly diagnosed CML for whom bone marrow transplantation is not considered as the first line of treatment;
Danish: • Nydiagnosticeret CML, hvor knoglemarvstransplantation ikke overvejes som første behandlingsvalg.
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving imatinib.
Danish: Leverfunktionen (transaminaser, bilirubin og alkalisk fosfatase) bør monitoreres jævnligt hos patienter i imatinib-behandling.
English: However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by reducing the dose of imatinib.
Danish: Disse ødemer var dog sjældent svære og kunne behandles med diuretika, andre understøttende tiltag eller ved at reducere dosis af imatinib.
English: Days 2 and 3
Danish: ): dag 2 og 3
English: Treatment with imatinib may then be continued at a reduced daily dose.
Danish: Behandling med imatinib kan da genoptages ved reduceret daglig dosis.
English: There was high between-patient variability in plasma imatinib AUC levels after an oral dose.
Danish: Der var stor variabilitet patienterne i mellem i plasmaimatinib AUC efter en oral dosis.
English: The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Danish: Imatinibs sikkerhed og virkning hos børn med MDS/MPD, DFSP og HES/CEL under 18 år er ikke klarlagt i kliniske forsøg.
English: Eleven patients achieved rapid CHR; ten had complete resolution of cytogenetic abnormalities and a decrease or disappearance of fusion transcripts as measured by RT-PCR.
Danish: Elleve patienter opnåede hurtig CHR; hos 10 patienter var cytogenetiske abnormaliteter svundet fuldstændig og der sås mindskning eller forsvinden af fusion-transcripts målt med RT-PCR.
English: The median time to progression in the overall population of 411 patients with relapsed/refractory Ph+ ALL ranged from 2.6 to 3.1 months, and median overall survival in the 401 evaluable patients ranged from 4.9 to 9 months.
Danish: Mediantid før progression varierede i den samlede population af 411 patienter med recidiverende/refraktær Ph+ ALL fra 2,6 til 3,1 måned, og median for samlet overlevelse hos de 401 evaluerbare patienter varierede fra 4,9 til 9 måneder.
English: 6+7) Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
Danish: 6+7 Abdominalsmerter og gastrointestinalblødning blev oftest observeret hos patienter med GIST.
English: Patients with mild and moderate impairment of renal function appear to have a higher plasma exposure than patients with normal renal function.
Danish: Patienter med mild og moderat nedsat nyrefunktion ser ud til at have større plasmaeksponering end patienter med normal nyrefunktion.
English: This Ki value is far higher than the expected plasma levels of imatinib in patients, consequently no interaction is expected upon co-administration of either 5-fluorouracil or paclitaxel and imatinib.
Danish: Denne Ki værdi er langt højere end de forventede plasmaniveauer af imatinib hos patienter, og der forventes derfor ingen interaktion i forbindelse med samtidig administration af hverken 5-fluorouracil eller paclitaxel og imatinib.
English: However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 10
Danish: Incidensen af cytopeni hang imidlertid også tydeligt sammen med sygdomsstadiet, idet hyppighed af 3. eller 4. grads neutropeni (ANC <1,0 x 10
English: • Muscle cramps or joint, muscle or bone pain, during Imatinib medac treatment or after you have stopped taking Imatinib medac
Danish: • Muskelkramper eller led-, muskel- eller knoglesmerter mens du er i behandling med Imatinib medac, eller efter du er stopped med at tage Imatinib medac.
English: Tell your doctor straight away if you get any of the following:
Danish: Kontakt din læge med det samme, hvis du oplever nogle af de følgende bivirkninger:
English: Clinical monitoring should be considered when administering imatinib to patients treated with metoprolol.
Danish: Klinisk monitorering skal overvejes ved administration af imatinib til patienter, der behandles med metoprolol.
English: 21 patients were treated with imatinib 400 mg daily, while the other 3 patients received lower doses.
Danish: 21 patienter blev behandlet med 400 mg imatinib dagligt, mens 3 patienter fik en lavere dosis.
English: However, some of these reactions may be serious or lifethreatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Danish: I nogle tilfælde kan disse tilstande dog være alvorlige eller livstruende, og flere patienter med blastkrise døde med en kompleks anamnese af pleuraekssudat, kongestivt hjerteinsufficiens og nyresvigt.
English: No specific dose recommendation is necessary in older people.
Danish: Specifik dosisjustering er ikke nødvendig til ældre patienter.
English: • Headache or feeling tired.
Danish: • Hovedpine eller følelse af træthed.
English: Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 μM).
Danish: Imatinib interfererede ikke med biotransformationen af 5-fluorouracil, men hæmmede paclitaxelmetabolismen på grund af kompetitiv hæmning af CYP2C8 (Ki = 34,7 µm).
English: Hard capsule
Danish: Hård kapsel
English: Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44 %) and 3 (33 %) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77 %.
Danish: Af 9 patienter med kronisk fase CML og tilgængelige cytogenetiske data opnåede henholdsvis 4 (44 %) og 3 (33 %) fuldstændigt og delvist cytogenetisk respons, med en McyR-rate på 77 %.
English: If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Danish: Hvis der opstår stigninger i bilirubin >3 x IULN (institutional upper limit of normal) eller i levertransaminaser >5 x IULN, skal imatinib seponeres, indtil bilirubinniveauerne er faldet til <1,5 x IULN og transaminaseniveauer til <2,5 x IULN.
English: Therefore, caution should be exercised in patients with cardiac dysfunction.
Danish: Der bør derfor udvises forsigtighed hos patienter med kardiel dysfunktion.
English: The effect of bodyweight on the clearance of imatinib is such that for a patient weighing 50 kg the mean clearance is expected to be 8.5 l/h, while for a patient weighing 100 kg the clearance will rise to 11.8 l/h.
Danish: Kropsvægtens betydning for clearance af imatinib er således, at for patienter, der vejer 50 kg, forventes den gennemsnitlige clearance at være 8,5 l/t, mens den for patienter, der vejer 100 kg, vil stige til 11,8 l/t.
English: Following oral administration in healthy volunteers, the t½ was approximately 18 h, suggesting that once-daily dosing is appropriate.
Danish: Efter oral administration til raske frivillige var t½ ca. 18 timer, hvilket indikerer, at dosering 1 gang dagligt er passende.
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19 - 60) and 47 months (range 16-59), respectively.
Danish: Hæmatologisk og cytogenetisk respons er bibeholdt i en periode varende fra henholdsvis 19-60 måneder (median 49 måneder) og 16-59 måneder (median 47 måneder).
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. Do not store above 30 °C.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteret efter Exp.
English: Women of childbearing potential Women of childbearing potential must be advised to use effective contraception during treatment.
Danish: Kvinder i den fertile alder Kvinder i den fertile alder skal tilrådes at anvende sikker kontraception under behandlingen.
English: Imatinib medac will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Danish: Imatinib medac vil kun blive ordineret til dig af en læge med erfaring i behandlingen af kræft i blodet eller kræftknuder.
English: At the same dose, the number of stillborn pups as well as those dying between postpartum days 0 and 4 was increased.
Danish: Der sås ved samme dosis øgning i antallet af dødfødte unger, såvel som i antallet af unger der døde postpartum mellem dag 0 og dag 4.
English: Some medicines can interfere with the effect of Imatinib medac when taken together.
Danish: Nogle lægemidler kan påvirke virkningen af Imatinib medac, når de bruges samtidigt.
English: The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound.
Danish: Plasmaproteinbindingen af den N-demethylerede metabolit er sammenlignelig med den for hovedkomponenten.
English: BM = bone marrow, PB = peripheral blood
Danish: BM = Knoglemarv; PB = Perifert blod.
English: There is very limited experience in children with MDS/MPD and DFSP.
Danish: Der er meget begrænset erfaring med børn med MSD/MPD og DFSP.
English: In addition a further 24 patients with MDS/MPD were reported in 13 publications.
Danish: Derudover er yderligere 24 patienter med MDS/MPD beskrevet i 13 publikationer.
English: No histopathological changes were seen in rat liver.
Danish: Der sås ingen histopatologiske forandringer i rottelever.
English: In addition, mortality was observed in juvenile animals (around weaning phase) at approximately 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m
Danish: Derudover sås mortalitet hos unge dyr (omkring afvænningsfasen) ved ca. 2 gange den gennemsnitlige pædiatriske eksponering ved den højest anbefalede dosis på 340 mg/m².
English: The in vitro results showed that CYP3A4 was the major human P450 enzyme catalysing the biotransformation of imatinib.
Danish: In vitro resultater viste, at CYP3A4 var det primære P450-enzym i katalyseringen af biotransformationen af imatinib.
English: Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Danish: Lignende resultater blev observeret hos patienter med maligne gliomer behandlet med imatinib samtidig med indtagelse af enzyminducerende antiepileptiske lægemidler (EIAEDs) som carbamazepin, oxcarbazepin og phenytoin.
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to 44+ months censored at the time of the reporting).
Danish: Alle 65 FIP1L1-PDGFRα fusionkinase-positive patienter opnåede CHR, som vedvarede i måneder (varighed fra 1+ til 44+ måneder censureret på opgørelsestidspunktet).
English: Imatinib medac can reduce the number of white blood cells, so you might get infections more easily.
Danish: Imatinib medac kan nedsætte antallet af hvide blodlegemer, så du lettere kan få infektioner.
English: At the time of analysis, the median treatment duration was 47 months (24 days - 60 months).
Danish: På opgørelsestidspunktet var medianen for behandlingstiden 47 måneder (24 dage - 60 måneder).
English: Grade 3 and 4 neutropenia was seen in 7.5 % and 2.7 % of patients, respectively, and grade 3 thrombocytopenia in 0.7 % of patients.
Danish: Grad 3 og 4 neutropeni sås hos henholdsvis 7,5 % og 2,7 % af patienterne og grad 3 trombocytopeni hos 0,7 % af patienterne.
English: The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
Danish: Den primære effektvariabel var graden af hæmatologisk hovedrespons, rapporteret enten som fuldstændigt hæmatologisk respons, intet tegn på leukæmi (f.eks. clearance af blaster fra knoglemarv og blod, men uden fuldstændig restitution i perifert blod som ved fuldstændigt respons) eller remission til CML i kronisk fase.
English: • Unexpected bleeding or bruising (when you have not hurt yourself).
Danish: • Hvis du oplever uventede blødninger eller blå mærker (når du ikke er kommet til skade).
English: The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).
Danish: Behandlingen kan enten gives til dit barn som én daglig dosis, eller alternativt kan den daglige dosis deles og gives to gange (halvdelen om morgenen og den anden halvdel om aftenen).
English: However, since the effects of low-dose exposure of the infant to imatinib are unknown, women taking imatinib should not breast-feed.
Danish: Da effekten af lavdosiseksponering af imatinib hos spædbarnet er ukendt, bør kvinder, der tager imatinib, ikke amme.
English: In GIST patients (study B2222), 6.8 % of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8 % of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Danish: Der blev hos GIST patienter (studie B2222) observeret stigning i grad 3 eller 4 ALAT (alaninaminotransferase) hos 6,8 % og stigning i grad 3 eller 4 ASAT (aspartataminotransferase) hos 4,8 %.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 1 capsule of 400 mg once a day, depending on how you respond to treatment.
Danish: Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 1 kapsel med 400 mg én gang dagligt, afhængigt af hvordan du responderer på behandlingen.
English: Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with imatinib.
Danish: Patienter skal advares om, at de kan opleve bivirkninger som svimmelhed, sløret syn eller døsighed under behandling med imatinib.
English: An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken.
Danish: Uventede, hurtige vægtstigninger bør undersøges nøje, og om nødvendigt bør understøttende terapi indledes, og relevante indgreb foretages.
English: When imatinib is co-administered with other medicinal products, there is a potential for drug interactions.
Danish: Når imatinib administreres sammen med andre lægemidler, er der risiko for lægemiddelinteraktioner.
English: Dosing for children should be on the basis of body surface area (mg/m2).
Danish: Dosering hos børn bør baseres på legemsoverflade (mg/m²).
English: There is limited information on imatinib distribution on human milk.
Danish: Der er begrænset information om udskillelsen af imatinib i human mælk.
English: Studies on patients receiving imatinib and its effect on fertility and gametogenesis have not been performed.
Danish: Der er ikke udført studier med patienter, der fik imatinib, og dets virkning på fertilitet og gametogenese.
English: In the event of overdose, the patient should be observed and appropriate supportive treatment given.
Danish: I tilfælde af overdosering bør patienten observeres, og der bør gives relevant understøttende behandling.