FrancophonIA/ELRC3.0 huggingface dataset:
English: 11.1 mg A clear, colourless to light yellow solution.
Danish: Klar, farveløs til let gullig opløsning.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
English: monthly for 13 months;
Danish: månedligt i 13 måneder;
English: There were no differences in response rates between the two dose groups.
Danish: Der sås ingen forskelle i responsrater mellem de to doseringsgrupper.
English: Results are provided in Table 5.
Danish: Resultaterne er angivet i Tabel 5.
English: In addition, children have been treated in two phase I studies and one phase II study.
Danish: Derudover er der behandlet børn i 2 fase I undersøgelser og et fase II studie.
English: Follow all your doctor's instructions carefully, even if they differ from the general information contained in
Danish: Følg omhyggeligt din læges anvisninger, selvom de er forskellige fra den generelle information i
English: Optimal treatment duration is not yet established.
Danish: Optimal behandlingsvarighed er endnu ikke fastlagt.
English: 2 Cytogenetic response criteria:
Danish: 2Cytogenetiske responskriterier:
English: No benefit was observed in the low and very low risk groups.
Danish: Der blev ikke observeret nogle fordele i den lave eller meget lave risikogruppe.
English: * Full follow-up period; NE - Not estimable
Danish: * Fuldstændig opfølgningsperiode; IE - Ikke estimerbar
English: However, these associations are not sufficiently pronounced to warrant dose adjustment.
Danish: Disse associationer er dog ikke tilstrækkeligt udtalte til at udløse dosisjusteringer.
English: If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight
Danish: Hvis du ikke er i stand til at tage medicinen, som din læge har foreskrevet, eller hvis du føler, at du ikke længere behøver den, skal du kontakte din læge med det samme.
English: The median overall survival has not been reached.
Danish: Den mediane overordnede overlevelse er endnu ikke nået.
English: Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
Danish: Patienter, der har lav eller meget lav risiko for tilbagefald, bør ikke få adjuverende behandling.
English: Do not open or crush the capsules unless you have difficulty in swallowing (e.g. in children).
Danish: Du må ikke åbne eller knuse kapslerne medmindre du ikke er i stand til at synke (for eksempel hos børn).
English: In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of
Danish: I de kliniske undersøgelser var 38-40% af patienterne ≥60 år, og 10-12% af patienterne var ≥70 år.
English: No conclusions can be drawn for other less common mutation subgroups due to the low number of observed events.
Danish: Der kan ikke drages nogle konklusioner for andre mindre almindelige mutationsundergrupper på grund af det lille antal observerede tilfælde.
English: Mitotic index data were available for 556 of the 713 intention-to-treat (ITT) population.
Danish: Data fra mitotisk indeks var tilgængelige for 556 ud af 713 i intention-to-treat (ITT) gruppen.
English: The results of subgroup analyses according to the United States National Institutes of Health (NIH) and the Armed Forces Institute of Pathology (AFIP) risk classifications are shown in Table 6.
Danish: Resultaterne fra undergruppen-analysen, der blev vurderet ved risikoklassifikationer ifølge the United States National Institutes of Health (NIH) og the Armed Forces Institute of Pathology (AFIP), er vist i Tabel 6.
English: The long-term effects of prolonged treatment with imatinib on growth in children are unknown.
Danish: Langtidseffekten af langvarig behandling med imatinib på væksten hos børn er ukendt.
English: The current estimate of the median survival of the previously untreated and treated patients was 7.7 and 4.7 months, respectively.
Danish: Den aktuelle estimerede gennemsnitlige overlevelse hos tidligere ”ubehandlede” og ”behandlede patienter” var henholdsvis 7,7 og 4,7
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
English: The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Danish: Translokationen t(17:22) [(q22:q13)], eller dets gen-produkt, var til stede i næsten alle respons på
English: Treatment with imatinib for 36 months was superior to treatment for 12 months in the ITT analysis, i.e. including the entire study population.
Danish: Behandling med imatinib i 36 måneder var superior til behandling i 12 måneder i ITT-analysen, dvs. inklusive hele studiepopulationen.
English: Table 5 Best tumour response in trial STIB2222 (GIST)
Danish: Tabel 5 Bedste tumorrespons i undersøgelse STIB2222 (GIST)
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients
Danish: Leverfunktionen (transaminaser, bilirubin og alkalisk fosfatase) bør monitoreres jævnligt hos patienter
English: Therefore, caution should be recommended when driving a car
Danish: Forsigtighed anbefales derfor, når der føres motorkøretøj eller
English: Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
Danish: Prednisolon 200 mg oral, 5 dage per måned i 13 måneder Alle behandlingsregimer inkluderer administration af steroider mod CNS profylakse.
English: All doses (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
Danish: Alle doser (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
English: No overall survival benefit has been observed.
Danish: Der er ikke blevet observeret nogen fordel i total overlevelse.
English: days 3-5;
Danish: dag 3-5;
English: • Stir with a spoon until the tablets have completely dissolved.
Danish: - Omrør med en ske, indtil tabletterne er opløst fuldstændig.
English: Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
Danish: Sikkerhedsdata fra dette studie synes at være i overensstemmelse med sikkerhedsprofilen for imatinib hos Ph+ ALL
English: could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: A significant number of patients who had stable disease at the time of the interim analysis achieved a partial response with longer treatment (median follow-up 31 months).
Danish: En betydelig gruppe patienter, som havde stabil sygdom ved interimsanalysen opnåede delvist respons med længere behandling (median opfølgningstid på 31 måneder).
English: It is important that you do this as long as your doctor or pharmacist tells you to.
Danish: Det er vigtigt, at du tager det så længe lægen eller apotekspersonalet fortæller dig, at du skal.
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at
Danish: 12 Gy i 8 fraktioner for alle patienter, som er CNS1 og CNS2 ved
English: The effect of stopping treatment after achieving a response has not been investigated.
Danish: Effekt af seponering efter opnåelse af respons er ikke undersøgt.
English: Mean absolute bioavailability for the capsule formulation is 98%.
Danish: Den gennemsnitlige absolutte biotilgængelighed for kapselformuleringen er 98%.
English: It arises from uncontrolled cell growth of the supporting tissues of these organs.
Danish: Den opstår ved en ukontrolleret cellevækst af disse organers bindevæv.
English: Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10% of a therapeutic dose).
Danish: Den totale koncentration af imatinib og metabolitten og spædbørns maksimale daglige indtagelse af mælk taget i betragtning forventes det, at den totale eksponering er lav (~10% af den terapeutiske dosis).
English: For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment.
Danish: For CML og GIST kan din læge foreskrive højere eller lavere dosis afhængigt af, hvordan du reagerer på behandlingen.
English: The risk of recurrence in patients after surgery of their primary GIST was retrospectively assessed based on the following prognostic factors: tumour size, mitotic index, tumour location.
Danish: Risikoen for tilbagefald hos patienter efter operation af deres primære GIST blev retrospektivt vurderet ud fra følgende prognostiske faktorer: tumorstørrelse, mitotisk indeks, tumorplacering.
English: Older people: Imatinib pharmacokinetics have not been specifically studied in older people.
Danish: Ældre patienter: Imatinibs farmakokinetik er ikke specifikt undersøgt hos ældre.
English: In a recent publication updated information from 6 of these 11 patients revealed that all these patients remained in cytogenetic remission (range 32-38 months).
Danish: Opdaterede oplysninger om 6 af disse 11 patienter, som er publiceret for nylig, viste, at alle disse patienter forblev i cytogenetisk remission (32-38 måneder).
English: - If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of
Danish: - Hvis du ikke er i stand til at synke kapslerne, kan du åbne dem og opløse pulveret i et glas
English: There is limited information on imatinib distribution on human milk.
Danish: Der er begrænset information om fordelingen af imatinib i human mælk.
English: Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria.
Danish: Tumorer skulle være målelige i mindst et sygdomsområde og responskarakterisering baseret på SWOG-kriterier (Southwestern Oncology Group).
English: The content of the capsule is white to light yellow granulated powder.
Danish: Kapslens indhold er hvidt til lysegult granuleret pulver.
English: F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
Danish: F1-fertilitet var ikke påvirket, mens der sås et øget antal resorptioner og et nedsat antal levende fostre ved 45 mg/kg/dag.
English: The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Danish: Eksponeringen er ca. 1,5- til 2- fold, svarende til en 1,5-gangs stigning af plasma AGP, som imatinib binder stærkt til.
English: Due to the observational nature of this registry, haematologic, cytogenetic and molecular assessment data were available for 22, 9 and 17 of the 23 enrolled patients, respectively.
Danish: På grund af studiets observationelle karakter var data for hæmatologisk, cytogenetisk og molekylær vurdering tilgængelige for henholdsvis 22, 9 og 17 af de 23 inkluderede patienter.
English: The safety database for children with Ph+ALL is very limited though no new safety
Danish: Sikkerhedsdatabasen for børn med Ph+ ALL er meget begrænset.
English: • Numb or cold toes and fingers (signs of Raynaud's syndrome).
Danish: - Følelsesløse eller kolde tæer og fingre (tegn på Raynaud´s syndrom).
English: Clinical studies in adjuvant GIST
Danish: Kliniske studier vedrørende adjuverende GIST
English: These patients ranged in age from 18 to 83 years old and had a pathologic diagnosis of Kit-positive malignant GIST that was unresectable and/or metastatic.
Danish: Disse patienter var i aldersgruppen 18-83 år og havde en patologisk diagnose af Kit-positiv malignt GIST, der var inoperabelt og/eller metastaserende.
English: The median time of follow-up was 54 months (from date of randomisation to data cut-off), with a total of 83 months between the first patient randomised and the cut-off date.
Danish: Mediantiden til follow-up var 54 måneder (fra dato for randomisering til data cut-off) med i alt 83 måneder mellem den første randomiserede
English: The first 37 patients were started at 400 mg, the protocol was subsequently amended to allow higher dosing and the remaining 223 patients were started at 600 mg.
Danish: De første 37 patienter startede med 400 mg, protokollen blev efterfølgende ændret og tillod højere doser, hvorefter de resterende 223
English: The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet
Danish: Mekanismen og betydningen for mennesker af disse resultater i karcinogenicitetsstudie hos rotter er
English: 36-month treatment arm % (CI)
Danish: 36 måneders behandlingsarm % (CI)
English: • The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
Danish: • adjuverende behandling af voksne patienter, som har signifikant risiko for tilbagefald efter resektion af Kit (CD117)-positiv GIST.
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: While you are taking Imatinib Teva B.V. your doctor will regularly check whether the medicine is working.
Danish: Mens du tager Imatinib Teva B.V., vil din læge regelmæssigt kontrollere, om lægemidlet virker.
English: • Adult patients with Ph+ CML in blast crisis.
Danish: • voksne patienter med Ph+ CML i blastkrise.
English: The majority of paediatric patients treated for GIST lacked data confirming c-kit or PDGFR mutations which may have led to mixed clinical outcomes.
Danish: Hovedparten af de pædiatriske patienter, der blev behandlet for GIST, manglede data, der bekræftede c-Kit eller PDGFR-mutationer, hvilket kan have ført til varierende kliniske udfald.
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: The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
Danish: Mælk/plasmaratio undersøgt i en enkelt patient blev bestemt til at være 0,5 for imatinib og 0,9 for metabolitten, hvilket tyder på en større udskillelse af metabolitten i mælk.
English: • Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Danish: - Pludselig hævelse og rødme af huden (tegn på en hudinfektion kaldet cellulitis).
English: • Once the tablet has dissolved, drink everything in the glass straight away.
Danish: - Når tabletten er opløst, så drik hele glassets indhold med det samme.
English: A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
Danish: Et hovedrespons kombinerer både fuldstændig og partiel respons: Fuldstændig (0% Ph+ metafaser), delvis (1-35%).
English: There were a total of 397 patients consented and randomised to the study (199 patients on 12-month arm and 198 patients on 36-month arm), median age was 61 years (range 22 to 84 years).
Danish: Der var i alt 397 patienter, der gav samtykke og blev randomiseret til studiet (199 patienter i 12 måneders armen og 198 patienter i 36 måneders armen), medianalderen var 61 år (interval fra 22 til 84 år).
English: Study 0102 38-month data Myeloid blast crisis (n=260) % of patients (CI95%)
Danish: Undersøgelse 0102 38 månedsdata Myeloid blastkrise (n=260) % patienter (CI95%)
English: The primary endpoint of the study was recurrence-free survival (RFS), defined as the time from date of randomisation to the date of recurrence or death from any cause.
Danish: Studiets primære endepunkt var recidivfri overlevelse (RFS), defineret som tiden fra randomisering til dato for tilbagefald eller død af enhver årsag.
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: At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months).
Danish: På analysetidspunktet var behandlingsvarighedsmedianen 7 måneder (7 dage til 13 måneder).
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: Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Danish: Blastkrise defineres som ≥30% blaster i blod eller knoglemarv eller ekstramedullær sygdom ud over
English: RFS rates (%) 12 month 24 month Imatinib vs placebo
Danish: RFS rater (%) 12 måneder 24 måneder Imatinib vs. placebo
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 ikkerespondenter, blev CHR observeret hos 20/23 (87%), CCyR hos 9/23 (39,1%) og MR hos 11/23 (47,8%) af patienterne.
English: In this patient population, the presence of hepatic metastases could potentially lead to hepatic insufficiency and reduced metabolism.
Danish: I denne patientpopulation kan levermetastaser potentielt medføre leverinsufficiens og nedsat metabolisme.
English: They may increase or decrease the effect of Imatinib Teva B.V., either leading to increased side effects or making Imatinib Teva B.V. less effective.
Danish: De kan enten øge eller nedsætte virkningen af Imatinib Teva B.V., hvilket kan resultere i enten flere bivirkninger, eller de kan gøre Imatinib Teva B.V.
English: Women of childbearing potential must be advised to use effective contraception during treatment.
Danish: Kvinder i den fertile alder skal tilrådes at anvende sikker kontraception under behandlingen.
English: • Eye pain or deterioration in vision, bleeding in the eyes.
Danish: - Øjensmerter eller svækkelse af dit syn, blødning i øjnene.
English: In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
Danish: Hos voksne bør dosis reduceres fra 400 til 300 mg eller fra 600 til 400 mg, eller fra 800 mg til 600 mg, og hos børn fra 340 til 260 mg/m2/dag.
English: doses)iii: days 2, 3, 16, and 17
Danish: 6 doser)iii: dag 2, 3, 16, og 17
English: As expected on the basis of the study design, no difference was observed in remission duration, disease-free survival or overall survival, although patients with complete molecular response and remaining in minimal residual disease had a better outcome in terms of both remission duration (p=0.01) and disease-free survival (p=0.02).
Danish: Som det var forventet på basis af studiedesignet, sås ingen forskel i varighed af remission, sygdomsfri overlevelse eller generel overlevelse, skønt patienter med komplet molekylær respons og forblivende i minimal residual sygdom havde større udbytte af behandlingen i form af både varighed af remission (p=0,01)
English: Decreased values of albumin caused a reduced clearance (CL/f); and higher levels of WBC led to a reduction of CL/f.
Danish: Fald i albuminværdier forårsagede nedsat clearance (CL/f); og stigninger i leukocyttal forårsagede fald i Cl/f.
English: Treatment with imatinib may be interrupted or the dose may be reduced, as recommended in section
Danish: Behandling med imatinib kan seponeres eller dosis kan reduceres, som anbefalet i pkt.
English: Pharmacotherapeutic group: Protein kinase inhibitors, ATC code: L01XE01
Danish: Farmakoterapeutisk klassifikation: Protein-tyrosinkinasehæmmer, ATC-kode: L01XE01
English: Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic drugs (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: At one year the overall RFS was significantly better for imatinib (97.7%) vs. placebo (82.3%), (p<0.0001).
Danish: På et år var den samlede RFS signifikant bedre for imatinib (97,7%) i forhold til placebo (82,3%), (p<0,0001).
English: Patients should be tested for HBV infection before initiating treatment with Imatinib Teva B.V.
Danish: Patienten bør testes for HBV-infektion før initiering af behandling med Imatinib Teva B.V.
English: Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Danish: Total-bilirubin: = 1,5 ULN ASAT: >ULN (kan være normal eller <ULN hvis total-bilirubin er >ULN)
English: The total number of deaths were 25 for the 12-month treatment arm and 12 for the 36-month treatment arm.
Danish: Det totale antal dødsfald var 25 i 12 måneders behandlingsarmen og 12 i 36 måneders behandlingsarmen.
English: Your doctor has prescribed Imatinib Teva B.V. because you suffer from a serious condition.
Danish: Din læge har udskrevet Imatinib Teva B.V., fordi du lider af en alvorlig sygdom.
English: Patients were included who had a histological diagnosis of primary GIST expressing Kit protein by immunochemistry and a tumour size ≥ 3 cm in maximum dimension, with complete gross resection of primary GIST within 14-70 days prior to registration.
Danish: Patienter, der blev inkluderet, havde en histologisk diagnose af primær GIST, udtrykt som Kit protein ved immunokemi og en tumorstørrelse på ≥3 cm med fuldstændig resektion af primær GIST inden for 14-70 dage før registrering i studiet.
English: Do not stop taking Imatinib Teva B.V. unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Imatinib Teva B.V., medmindre din læge fortæller dig det.
English: The tablet is debossed with “IT” and “4” at each side of the score line.
Danish: Tabletten er præget med ”IT” og ”4” på hver side af delekærven.
English: The plasma protein binding of the N-demethylated metabolite is similar to that of the parent
Danish: Plasmaproteinbindingen af den N-demethylerede metabolit er sammenlignelig med den for hovedkomponenten.
English: Some children and adolescents taking Imatinib Teva B.V. may have slower than normal growth.
Danish: Nogle børn og unge, der får Imatinib Teva B.V., kan vokse langsommere end normalt.
English: Length of treatment in the clinical trial supporting this indication was 36 months (see section 5.1).
Danish: Behandlingsvarigheden i det kliniske forsøg, der ligger til grund for denne indikation, var 36 måneder (se pkt.
English: • Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
Danish: • børn med Ph+ CML i kronisk fase efter manglende effekt af alfa-interferonbehandling, eller i
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Danish: Et observationelt registerstudie (studie L2401) blev udført for at indsamle langsigtede sikkerheds- og effektdata for patienter, som lider af myeloproliferative neoplasier med PDGFR- β rearrangement, og som blev behandlet med imatinib.
English: Paediatric patients: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
Danish: Pædiatriske patienter: I alt 26 pædiatriske patienter i alderen <18 år med enten CML i kronisk fase (n=11) eller CML i blastkrise eller Ph+ akut leukæmi (n=15) blev inkluderet i en fase I undersøgelse med dosis-eskalering.