FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Danish: Til patienter, der ikke er i stand til at synke de filmovertrukne tabletter, kan tabletterne opløses i et glas almindeligt vand eller æblejuice.
English: : intravenous
Danish: : intravenøs
English: Clinical studies in MDS/MPD
Danish: Kliniske undersøgelser vedrørende MDS/MPD
English: • Difficulty hearing.
Danish: • Hørebesvær.
English: A further 6 DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Danish: Yderligere seks patienter, behandlet med imatinib, er blevet beskrevet i 5 publicerede kasuistikker, alderen varierede fra 18 måneder til 49 år.
English: The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Danish: Den totale daglige dosis til børn og unge må ikke overstige 800 mg ved CML og 600 mg ved Ph+ ALL.
English: Long-term treatment with imatinib may be associated with a clinically significant decline in renal function.
Danish: Langtidsbehandling med imatinib kan være forbundet med en klinisk signifikant nedsættelse af nyrefunktionen.
English: Clinical studies in Ph+ ALL
Danish: Kliniske studier ved Ph+ ALL
English: The decreases in white blood cell (WBC) and neutrophil counts occurred mainly during the first six weeks of therapy, with values remaining relatively stable thereafter.
Danish: Fald i leukocytter (WBC) og neutrofiltal sås primært i løbet af de første 6 uger af behandlingen, herefter sås relativ stabilisering af værdierne.
English: Patients with advanced stages of malignancies may have numerous confounding medical conditions that make causality of adverse reactions difficult to assess due to the variety of symptoms related to the underlying disease, its progression, and the co-administration of numerous medicinal products.
Danish: Patienter med fremskredne stadier af maligne lidelser kan frembyde en kompleks blanding af sygdomsbilleder, der kan gøre det svært at vurdere årsagen til bivirkninger på grund af prævalens og stor mangeartethed af symptomer relateret til den underliggende sygdom, sygdommens progression og samtidig administration af adskillige lægemidler.
English: HES/CEL (starting dose 100 mg)
Danish: HES/CEL (start dosering 100 mg)
English: Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.
Danish: Patienterne bør monitoreres tæt under dosiseskaleringen, da der er mulighed for øget forekomst af bivirkninger ved højere doseringer.
English: • Chronic renal failure.
Danish: • Kronisk nyresvigt.
English: There are no controlled trials demonstrating a clinical benefit or increased survival.
Danish: Der er ingen kontrollerede undersøgelser, der påviser klinisk gavn eller øget overlevelse.
English: Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
Danish: På grund af kendte øgede risici for blødning i forbindelse med brug af imatinib (f.eks. hæmoragi) bør patienter med behov for antikoagulantia, have lavmolekylært heparin eller standardheparin i stedet for coumarinderivater som warfarin.
English: Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
Danish: Samtidig anvendelse af rifampicin eller andre stærke CYP3A4-induktorer og imatinib bør undgås.
English: Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.
Danish: Patienter med hjertesygdom, risikofaktorer for hjerteinsufficiens eller nyreinsufficiens i anamnesen skal monitoreres omhyggeligt, og alle patienter, som har symptomer forenelige med hjerte- eller nyreinsufficiens, bør undersøges og behandles.
English: The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Danish: Der var i samme publikation oplysning om længere varende opfølgningsdata fra 12 MDS/MPD-patienter med PDGFR-omlejring (5 patienter fra studie B2225).
English: Imatinib medac is a medicine containing an active substance called imatinib.
Danish: Imatinib medac er et lægemiddel, der indeholder et aktivt stof kaldet imatinib.
English: Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Danish: Der sås milde til moderate stigninger i transaminaser og lette stigninger i kolesterol, triglycerider, totale protein- og albuminniveauer hos begge dyrearter.
English: It is important that you do this as long as your doctor, pharmacist or nurse tells you to.
Danish: Det er vigtigt, at du tager det så længe, lægen, apotekspersonalet eller sygeplejersken fortæller dig, at du skal.
English: • Unusual hair loss or thinning.
Danish: • Usædvanligt hårtab eller udtynding af håret.
English: • CML in the chronic phase after failure of interferon-alpha therapy, or in the accelerated phase.
Danish: • CML i kronisk fase efter fejlslagen interferonalpha-behandling eller i accelereret fase.
English: Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.
Danish: Da øget vaskularisering og blødningstendens er en del af det kliniske billede ved GIST, bør der hos alle patienter anvendes standardtiltag og -procedurer for monitorering og behandling af blødning.
English: There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease.
Danish: Der sås hyppigere myelosuppression hos CML-patienter end hos GIST-patienter, hvilket sandsynligvis skyldes primærsygdommen.
English: Do not take Imatinib medac: • if you are allergic to imatinib or any of the other ingredients of this medicine (listed in
Danish: Tag ikke Imatinib medac: • hvis du er allergisk over for imatinib eller et af de øvrige indholdsstoffer i Imatinib medac
English: Acute respiratory failure
Danish: Akut respirationssvigt
English: Treatment with imatinib may be interrupted or the dose may be reduced, as recommended in section 4.2.
Danish: Behandling med imatinib kan seponeres eller dosis kan reduceres, som anbefalet i pkt.
English: 1800 mg to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Danish: 1800 mg til 3200 mg (så høj som 3200 mg dagligt i 6 dage): Svaghed, myalgi, øget kreatininfosfokinase, øget bilirubin, gastrointestinale smerter.
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.
English: All patients received imatinib and consolidation chemotherapy (see Table 3) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
Danish: Alle patienter blev efter induktion behandlet med imatinib og standard kemoterapi (se Tabel 3), og bcr-abl transskriptionerne var identiske i de to arme efter 8 ugers behandling.
English: DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.
Danish: DFSP er en kræftform i vævet under huden, hvor visse celler vokser ukontrolleret.
English: • Eye pain or deterioration in vision, bleeding in the eyes.
Danish: • Øjensmerter eller svækkelse af dit syn, blødning i øjet.
English: Treatment of CML patients with imatinib has been associated with neutropenia or thrombocytopenia.
Danish: Behandling af CML-patienter med imatinib har været associeret med neutropeni eller trombocytopeni.
English: Superficial oedemas were a common finding in all studies and were described primarily as periorbital or lower limb oedemas.
Danish: Overfladiske ødemer var et hyppigt fund i alle undersøgelser og blev primært beskrevet som værende periorbitale eller ødemer i nedre ekstremiteter.
English: • The other ingredients are crospovidone (type A), lactose monohydrate, magnesium stearate.
Danish: • Øvrige indholdsstoffer: Crospovidon (type A), lactosemonohydrat, magnesiumstearat.
English: One of these intermediates was also positive in the mouse lymphoma assay.
Danish: En af disse intermediatorer var også positiv i muselymfomtesten.
English: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia
Danish: Herpes zoster, herpes simplex, nasopharyngitis, pneumoni
English: • Chronic myeloid leukaemia (CML) in blast crisis.
Danish: • Kronisk myeloid leukæmi (CML) i blastkrise.
English: In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study).
Danish: Cytopeni hos CML-patienter, særligt neutropeni og trombocytopeni, har været gennemgående fund i alle undersøgelser med tegn på større hyppighed ved doser ≥750 mg (fase I undersøgelse).
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKEANVENDT LÆGEMIDDEL ELLER AFFALD HERAF
English: MARKETING AUTHORISATION NUMBER (S) EU/1/13/876/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/876/001
English: • The active substance is imatinib (as mesilate).
Danish: • Aktivt stof: imatinib (som mesilat).
English: Based on the available data, no predisposing factors (e.g. tumour size, tumour location, coagulation disorders) have been identified that place patients with GIST at a higher risk of either type of haemorrhage.
Danish: Der er, baseret på tilgængelige data, ikke identificeret disponerende faktorer (for eksempel tumorstørrelse, tumorplacering, koagulationsforstyrrelser), der kan placere GIST-patienter i en højere risikogruppe for nogen af blødningstyperne.
English: Resume treatment with imatinib at 600 mg.
Danish: Genoptag behandling med imatinib 600 mg. 3.
English: Renal function should, therefore, be evaluated prior to the start of imatinib therapy and closely monitored during therapy, with particular attention to those patients exhibiting risk factors for renal dysfunction.
Danish: Nyrefunktionen bør derfor vurderes før behandlingsstart med imatinib og monitoreres omhyggeligt under behandlingen med særligt fokus på patienter, der har risikofaktorer for nedsat nyrefunktion.
English: In adults the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg, or from 800 mg to 600 mg, and in paediatric patients from 340 mg to 260 mg/m2/day.
Danish: Hos voksne bør dosis reduceres fra 400 mg til 300 mg eller fra 600 mg til 400 mg, eller fra 800 mg til 600 mg, og hos pædiatriske patienter fra 340 mg til 260 mg/m²/dag.
English: • Women who might become pregnant are advised to use effective contraception during
Danish: • Under behandlingen anbefales det, at kvinder som kan blive gravide, anvender effektiv
English: If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
Danish: Hvis der opstår alvorlige ikke-hæmatologiske bivirkninger ved behandling med imatinib, skal behandlingen seponeres, indtil bivirkningerne er ophørt.
English: Multiple dose toxicity studies revealed mild to moderate haematological changes in rats, dogs and monkeys, accompanied by bone marrow changes in rats and dogs.
Danish: Toksicitetsundersøgelser med gentagen dosering viste milde til moderate hæmatologiske forandringer hos rotter, hunde og aber, ledsaget af knoglemarvsændringer hos rotter og hunde.
English: Study ADE04 Prephase
Danish: Studie ADE04 Præfase
English: How long to take Imatinib medac Keep taking Imatinib medac every day for as long as your doctor tells you.
Danish: Hvor længe skal du tage Imatinib medac Bliv ved med at tage Imatinib medac hver dag, så længe som din læge har foreskevet det.
English: Consolidation therapy II, IV
Danish: Konsoliderende behandling II, IV
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
Danish: 6-MP (75 mg/m²/dag, p.o.): dag 11-56 (tilbagehold 6-MP i de 6-10 dage med kraniebestråling med start dag 1 i cyklus 5.
English: Isolated cases of imatinib overdose have been reported spontaneously and in the literature.
Danish: Enkelte tilfælde af overdosering med imatinib er blevet spontant rapporteret i litteraturen.
English: 6-MP 60 mg/m oral, days 26-46
Danish: 6-MP 60 mg/m² oral, dag 26-46
English: Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP.
Danish: Vedvarende aktivering af PDGF receptoren eller Abl-protein-tyrosinkinase, der opstår på grund af en fusion med andre proteiner eller konstitutiv produktion af PDGF er blevet impliceret i patogenesen af MDS/MPD, HES/CEL og DFSP.
English: Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Danish: Imatinib blev in vitro vist at være en kompetitiv hæmmer af markørsubstrater for CYP2C9, CYP2D6 og CYP3A4/5.
English: Imatinib medac may do the same to some other medicines.
Danish: Imatinib medac kan gøre det samme ved andre lægemidler.
English: Imatinib can also inhibit cellular events mediated by activation of these receptor kinases.
Danish: Imatinib kan også hæmme cellulære signaler medieret ved aktivering af disse receptorkinaser.
English: Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily.
Danish: Patienter med let, moderat eller svært nedsat leverfunktion bør gives den mindste anbefalede dosis på 400 mg dagligt.
English: An increased rate of opportunistic infections was observed with chronic imatinib treatment.
Danish: Der sås øget incidens af opportunistiske infektioner ved kronisk imatinib-behandling.
English: Stop imatinib until ANC ≥ 1.5 x 10
Danish: Stop imatinib indtil ANC ≥1,5 x 10
English: There are limited data on the use of imatinib in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af imatinib til gravide kvinder.
English: Table 2 Response in adult CML study
Danish: Tabel 2 Respons i et studie med voksne CML-patienter
English: • adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
Danish: • voksne patienter med inoperabel dermatofibrosarkom protuberans (DFSP) og voksne patienter med recidiverende og/eller metastaserende DFSP som ikke er tilgængelig for kirurgi.
English: At a dose of 60 mg/kg, female rats had significant postimplantation foetal loss and a reduced number of live foetuses.
Danish: Ved en dosis på 60 mg/kg, havde hunrotterne et signifikant føtaltab efter implantation og et reduceret antal levende fostre.
English: In the F1 offspring, at the same dose level, mean body weights were reduced from birth until terminal sacrifice and the number of litters achieving criterion for preputial separation was slightly decreased.
Danish: I F1afkommet var den gennemsnitlige kropsvægt ved samme dosisniveau reduceret fra fødsel til aflivning og antallet af kuld der opfyldte kriteriet for præputial separation var let nedsat.
English: Imatinib medac can help you to fight this condition.
Danish: Imatinib medac kan hjælpe dig med at bekæmpe denne tilstand.
English: The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Danish: De voksne patienter, som er beskrevet i publiceret litteratur blev behandlet med enten 400 mg (fire tilfælde) eller 800 mg (et tilfælde) imatinib dagligt.
English: In the event of overdose the patient should be observed and appropriate symptomatic treatment given.
Danish: I tilfælde af overdosis bør patienten observeres og passende symptomatisk behandling institueres.
English: Dose increases from 100 mg to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Danish: Dosisøgninger fra 100 mg til 400 mg kan overvejes, hvis der ikke er observeret bivirkninger, og respons på behandlingen vurderes som værende utilstrækkeligt.
English: The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib.
Danish: Tilstanden blev rapporteret som værende reversibel ved indgift af systemiske steroider, understøttelse af kredsløbet og midlertidigt stop af imatinib.
English: The effect of imatinib on the outcome of bone marrow transplantation has not been determined.
Danish: Imatinibs virkning på resultatet af knoglemarvstransplantation er ikke fastlagt.
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 medac.
English: Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels.
Danish: Myelodysplastiske/myeloproliferative sygdomme med PDGFR-omlejring kan være forbundet med høje eosinofiltal.
English: Unchanged imatinib accounted for 25 % of the dose (5 % urine, 20 % faeces), the remainder being metabolites.
Danish: Uomdannet imatinib er ansvarlig for ca. 25 % af dosis (5 % urin og 20 % fæces), resten er metabolitter.
English: It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.
Danish: Det bør bemærkes, at GIST-patienter kan have levermetastaser, hvilket kan medføre leverinsufficiens.
English: Imatinib inhibits signalling and proliferation of cells driven by dysregulated PDGFR and Abl kinase activity.
Danish: Imatinib hæmmer signaleringen og vækst af celler, der drives af dysreguleret PDGFR og Abl kinaseaktivitet.
English: • Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Danish: • Myelodysplastiske/myeloproliferative sygdomme (MDS/MDP).
English: Table 3 Chemotherapy regimen used in combination with imatinib
Danish: Tabel 3 Kemoterapiregime anvendt i kombination med imatinib
English: Neutropenia and thrombocytopenia toxicity
Danish: Neutropeni og trombocytopeni-toksicitet
English: These effects were not seen at doses ≤ 30 mg/kg.
Danish: Disse virkninger sås ikke ved doser ≤ 30 mg/kg.
English: There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Danish: Der er ingen kontrollerede undersøgelser, der har vist klinisk bedring såsom forbedring af sygdomsrelaterede symptomer eller øget overlevelse.
English: This was not seen at doses ≤ 20 mg/kg.
Danish: Dette sås ikke ved doser ≤ 20 mg/kg.
English: Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).
Danish: Samtidig anvendelse af stærke CYP3A4-induktorer og imatinib bør derfor undgås (se pkt.
English: However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML.
Danish: Disse cytopenier opstår imidlertid sandsynligvis relateret til det sygdomsstadie, der behandles, og er hyppigere hos patienter med CML i accelereret fase eller blastkrise end hos patienter med CML i kronisk fase.
English: At the time of the original analysis, three of the four patients with detected PDGFR gene rearrangements developed haematological response (2 CHR and 1 PHR).
Danish: På tidspunktet for den oprindelige analyse, havde 3 af 4 patienter med konstateret PDGFR-omlejring opnået hæmatologisk respons (2 CHR og 1 PHR).
English: The safety database for children with Ph+ ALL is very limited though no new safety concerns have been identified.
Danish: Sikkerhedsdatabasen for børn med Ph+ ALL er meget begrænset.
English: Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.
Danish: Behandlingen bør initieres af en læge med erfaring i behandling af patienter med maligne hæmatologiske lidelser og/eller maligne sarkomer eller som passende.
English: One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count and diarrhoea.
Danish: En 3-årig dreng, der fik en enkelt dosis på 400 mg, oplevede opkastning, diarré og appetitløshed, og en anden 3-årig dreng, der fik en enkelt dosis på 980 mg, oplevede nedsat antal hvide blodlegemer og diarré.
English: Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to < 18 years) treated with imatinib in combination with chemotherapy.
Danish: Studie AIT07 var et multicenter, åbent, randomiseret, fase II/III-studie, der inkluderede 128 patienter (1 til <18 år), som fik behandling med imatinib i kombination med kemoterapi.
English: Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).
Danish: Undersøg om cytopeni er relateret til leukæmi (marv-aspirat eller biopsi).
English: • Rapid weight gain.
Danish: • Hurtig vægtøgning.
English: Study ADE10 Prephase
Danish: Studie ADE10 Præfase
English: In clinical trials in CML, discontinuation of the investigational medicinal product for treatment-related adverse reactions was observed in 2.4 % of newly diagnosed patients, 4 % of patients in late chronic phase after failure of interferon therapy, 4 % of patients in accelerated phase after failure of interferon therapy and 5 % of blast crisis patients after failure of interferon therapy.
Danish: I kliniske undersøgelser i CML blev der hos 2,4 % af nydiagnosticerede patienter, hos 4% af patienterne i sen kronisk fase efter svigtende interferonbehandling, hos 4 % af patienterne i accelereret fase efter svigtende interferonbehandling og hos 5 % af patienterne i blastkrise efter svigtende interferonbehandling observeret efter seponering af undersøgelsesmedicinen på grund af behandlingsrelaterede bivirkninger.
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54 % and 74 %, of the respective values without rifampicin treatment.
Danish: Præbehandling med gentagne doser af rifampicin 600 mg efterfulgt af enkeltdosis imatinib 400 mg resulterede i fald i Cmax og AUC(0-∞) på mindst 54 % og 74 % af værdierne uden rifampicinbehandling.
English: Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
Danish: Patienter, som behandles med imatinib og bekymrer sig om deres fertilitet under imatinib-behandling, bør konsultere deres læge.
English: In clinical trials, there was an increased incidence of these events in older people and those with a prior history of cardiac disease.
Danish: Der er i kliniske undersøgelser set øget incidens af disse hændelser hos ældre patienter og hos patienter med hjertesygdom i anamnesen.