natgillin/translations-raw huggingface dataset:
Samtidig anvendelse af rifampicin eller andre stærke CYP3A4-induktorer og imatinib bør undgås. 
Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
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. 
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.
Der var i samme publikation oplysning om længere varende opfølgningsdata fra 12 MDS/MPD-patienter med PDGFR-omlejring (5 patienter fra studie B2225). 
The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Imatinib medac er et lægemiddel, der indeholder et aktivt stof kaldet imatinib. 
Imatinib medac is a medicine containing an active substance called imatinib.
Der sås milde til moderate stigninger i transaminaser og lette stigninger i kolesterol, triglycerider, totale protein- og albuminniveauer hos begge dyrearter. 
Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Det er vigtigt, at du tager det så længe, lægen, apotekspersonalet eller sygeplejersken fortæller dig, at du skal. 
It is important that you do this as long as your doctor, pharmacist or nurse tells you to.
• Usædvanligt hårtab eller udtynding af håret. 
• Unusual hair loss or thinning.
• CML i kronisk fase efter fejlslagen interferonalpha-behandling eller i accelereret fase. 
• CML in the chronic phase after failure of interferon-alpha therapy, or in the accelerated phase.
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. 
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.
Der sås hyppigere myelosuppression hos CML-patienter end hos GIST-patienter, hvilket sandsynligvis skyldes primærsygdommen. 
There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease.
Tag ikke Imatinib medac: • hvis du er allergisk over for imatinib eller et af de øvrige indholdsstoffer i Imatinib medac 
Do not take Imatinib medac: • if you are allergic to imatinib or any of the other ingredients of this medicine (listed in
Akut respirationssvigt 
Acute respiratory failure
Behandling med imatinib kan seponeres eller dosis kan reduceres, som anbefalet i pkt. 
Treatment with imatinib may be interrupted or the dose may be reduced, as recommended in section 4.2.
1800 mg til 3200 mg (så høj som 3200 mg dagligt i 6 dage): Svaghed, myalgi, øget kreatininfosfokinase, øget bilirubin, gastrointestinale smerter. 
1800 mg to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
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. 
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.
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. 
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.
DFSP er en kræftform i vævet under huden, hvor visse celler vokser ukontrolleret. 
DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.
• Øjensmerter eller svækkelse af dit syn, blødning i øjet. 
• Eye pain or deterioration in vision, bleeding in the eyes.
Behandling af CML-patienter med imatinib har været associeret med neutropeni eller trombocytopeni. 
Treatment of CML patients with imatinib has been associated with neutropenia or thrombocytopenia.
Overfladiske ødemer var et hyppigt fund i alle undersøgelser og blev primært beskrevet som værende periorbitale eller ødemer i nedre ekstremiteter. 
Superficial oedemas were a common finding in all studies and were described primarily as periorbital or lower limb oedemas.
• Øvrige indholdsstoffer: Crospovidon (type A), lactosemonohydrat, magnesiumstearat. 
• The other ingredients are crospovidone (type A), lactose monohydrate, magnesium stearate.
En af disse intermediatorer var også positiv i muselymfomtesten. 
One of these intermediates was also positive in the mouse lymphoma assay.
Herpes zoster, herpes simplex, nasopharyngitis, pneumoni 
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia
• Kronisk myeloid leukæmi (CML) i blastkrise. 
• Chronic myeloid leukaemia (CML) in blast crisis.
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). 
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).
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKEANVENDT LÆGEMIDDEL ELLER AFFALD HERAF 
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/876/001 
MARKETING AUTHORISATION NUMBER (S) EU/1/13/876/001
• Aktivt stof: imatinib (som mesilat). 
• The active substance is imatinib (as mesilate).
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. 
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.
Genoptag behandling med imatinib 600 mg. 3. 
Resume treatment with imatinib at 600 mg.
Nyrefunktionen bør derfor vurderes før behandlingsstart med imatinib og monitoreres omhyggeligt under behandlingen med særligt fokus på patienter, der har risikofaktorer for nedsat nyrefunktion. 
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.
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. 
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.
• Under behandlingen anbefales det, at kvinder som kan blive gravide, anvender effektiv 
• Women who might become pregnant are advised to use effective contraception during
Hvis der opstår alvorlige ikke-hæmatologiske bivirkninger ved behandling med imatinib, skal behandlingen seponeres, indtil bivirkningerne er ophørt. 
If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
Toksicitetsundersøgelser med gentagen dosering viste milde til moderate hæmatologiske forandringer hos rotter, hunde og aber, ledsaget af knoglemarvsændringer hos rotter og hunde. 
Multiple dose toxicity studies revealed mild to moderate haematological changes in rats, dogs and monkeys, accompanied by bone marrow changes in rats and dogs.
Studie ADE04 Præfase 
Study ADE04 Prephase
Hvor længe skal du tage Imatinib medac Bliv ved med at tage Imatinib medac hver dag, så længe som din læge har foreskevet det. 
How long to take Imatinib medac Keep taking Imatinib medac every day for as long as your doctor tells you.
Konsoliderende behandling II, IV 
Consolidation therapy II, IV
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. 
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.
Enkelte tilfælde af overdosering med imatinib er blevet spontant rapporteret i litteraturen. 
Isolated cases of imatinib overdose have been reported spontaneously and in the literature.
6-MP 60 mg/m² oral, dag 26-46 
6-MP 60 mg/m oral, days 26-46
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. 
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.
Imatinib blev in vitro vist at være en kompetitiv hæmmer af markørsubstrater for CYP2C9, CYP2D6 og CYP3A4/5. 
Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Imatinib medac kan gøre det samme ved andre lægemidler. 
Imatinib medac may do the same to some other medicines.
Imatinib kan også hæmme cellulære signaler medieret ved aktivering af disse receptorkinaser. 
Imatinib can also inhibit cellular events mediated by activation of these receptor kinases.
Patienter med let, moderat eller svært nedsat leverfunktion bør gives den mindste anbefalede dosis på 400 mg dagligt. 
Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily.
Der sås øget incidens af opportunistiske infektioner ved kronisk imatinib-behandling. 
An increased rate of opportunistic infections was observed with chronic imatinib treatment.
Stop imatinib indtil ANC ≥1,5 x 10 
Stop imatinib until ANC ≥ 1.5 x 10
Der er utilstrækkelige data fra anvendelse af imatinib til gravide kvinder. 
There are limited data on the use of imatinib in pregnant women.
Tabel 2 Respons i et studie med voksne CML-patienter 
Table 2 Response in adult CML study
• voksne patienter med inoperabel dermatofibrosarkom protuberans (DFSP) og voksne patienter med recidiverende og/eller metastaserende DFSP som ikke er tilgængelig for kirurgi. 
• adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
Ved en dosis på 60 mg/kg, havde hunrotterne et signifikant føtaltab efter implantation og et reduceret antal levende fostre. 
At a dose of 60 mg/kg, female rats had significant postimplantation foetal loss and a reduced number of live foetuses.
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. 
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.
Imatinib medac kan hjælpe dig med at bekæmpe denne tilstand. 
Imatinib medac can help you to fight this condition.
De voksne patienter, som er beskrevet i publiceret litteratur blev behandlet med enten 400 mg (fire tilfælde) eller 800 mg (et tilfælde) imatinib dagligt. 
The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
I tilfælde af overdosis bør patienten observeres og passende symptomatisk behandling institueres. 
In the event of overdose the patient should be observed and appropriate symptomatic treatment given.
Dosisøgninger fra 100 mg til 400 mg kan overvejes, hvis der ikke er observeret bivirkninger, og respons på behandlingen vurderes som værende utilstrækkeligt. 
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.
Tilstanden blev rapporteret som værende reversibel ved indgift af systemiske steroider, understøttelse af kredsløbet og midlertidigt stop af imatinib. 
The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib.
Imatinibs virkning på resultatet af knoglemarvstransplantation er ikke fastlagt. 
The effect of imatinib on the outcome of bone marrow transplantation has not been determined.
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. 
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.
Myelodysplastiske/myeloproliferative sygdomme med PDGFR-omlejring kan være forbundet med høje eosinofiltal. 
Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels.
Uomdannet imatinib er ansvarlig for ca. 25 % af dosis (5 % urin og 20 % fæces), resten er metabolitter. 
Unchanged imatinib accounted for 25 % of the dose (5 % urine, 20 % faeces), the remainder being metabolites.
Det bør bemærkes, at GIST-patienter kan have levermetastaser, hvilket kan medføre leverinsufficiens. 
It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.
Imatinib hæmmer signaleringen og vækst af celler, der drives af dysreguleret PDGFR og Abl kinaseaktivitet. 
Imatinib inhibits signalling and proliferation of cells driven by dysregulated PDGFR and Abl kinase activity.
• Myelodysplastiske/myeloproliferative sygdomme (MDS/MDP). 
• Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Tabel 3 Kemoterapiregime anvendt i kombination med imatinib 
Table 3 Chemotherapy regimen used in combination with imatinib
Neutropeni og trombocytopeni-toksicitet 
Neutropenia and thrombocytopenia toxicity
Disse virkninger sås ikke ved doser ≤ 30 mg/kg. 
These effects were not seen at doses ≤ 30 mg/kg.
Der er ingen kontrollerede undersøgelser, der har vist klinisk bedring såsom forbedring af sygdomsrelaterede symptomer eller øget overlevelse. 
There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Dette sås ikke ved doser ≤ 20 mg/kg. 
This was not seen at doses ≤ 20 mg/kg.
Samtidig anvendelse af stærke CYP3A4-induktorer og imatinib bør derfor undgås (se pkt. 
Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).
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. 
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.
På tidspunktet for den oprindelige analyse, havde 3 af 4 patienter med konstateret PDGFR-omlejring opnået hæmatologisk respons (2 CHR og 1 PHR). 
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).
Sikkerhedsdatabasen for børn med Ph+ ALL er meget begrænset. 
The safety database for children with Ph+ ALL is very limited though no new safety concerns have been identified.
Behandlingen bør initieres af en læge med erfaring i behandling af patienter med maligne hæmatologiske lidelser og/eller maligne sarkomer eller som passende. 
Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.
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. 
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.
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. 
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.
Undersøg om cytopeni er relateret til leukæmi (marv-aspirat eller biopsi). 
Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).
• Hurtig vægtøgning. 
• Rapid weight gain.
Studie ADE10 Præfase 
Study ADE10 Prephase
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. 
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.
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. 
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.
Patienter, som behandles med imatinib og bekymrer sig om deres fertilitet under imatinib-behandling, bør konsultere deres læge. 
Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
Der er i kliniske undersøgelser set øget incidens af disse hændelser hos ældre patienter og hos patienter med hjertesygdom i anamnesen. 
In clinical trials, there was an increased incidence of these events in older people and those with a prior history of cardiac disease.
Hvis responsraten beregnes ud fra patienter med mindst en valid parametervurdering er reponsraten for CHR, CCyr og MR henholdvis 20/22 (90,9 %), 9/9 (100 %) og 
When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17 (64.7%), respectively.
Maksimale plasmakoncentrationer af imatinib er hos patienter 2-4 µmol/l, og hæmning af CYP2D6 og/eller CYP3A4/5-medieret metabolisme af samtidigt administrerede lægemidler er derfor mulig. 
Maximal plasma concentrations of imatinib in patients are 2-4 μmol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered medicinal products is possible.
Anvendelse til børn: Der er ingen erfaring med behandling af børn under 2 år med CML, og børn under 1 år med Ph+ ALL (se pkt. 
Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ ALL below 1 year of age (see section 5.1).
• børn med Ph+ CML i kronisk fase efter manglende effekt af alfa-interferonbehandling, eller i 
• paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
Med undtagelse af nyligt diagnosticerede patienter med CML i kronisk fase, er der ikke gennemført kontrollerede undersøgelser, der har vist klinisk bedring eller øget overlevelse ved disse sygdomme. 
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
imatinib blev administreret periodisk i kohorte 1-5 med stigende varighed og tidligere start med imatinib fra kohorte til kohorte; kohorte 1 fik den mindst intensive imatinibbehandling og kohorte 5 den mest intensive (længste varighed i dage med kontinuerlig, daglig imatinibdosering i de første kemobehandlingsforløb). 
imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
• voksne og børn med Ph+ CML i blastkrise. 
• adult and paediatric patients with Ph+ CML in blast crisis.
Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka Józefa Piłsudskiego 5 Str. 95-200 Pabianice 
Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka Józefa Piłsudskiego 5
Alderen hos disse patienter varierede fra 2 til 79 år. 
The age of these patients ranged from 2 to 79 years.
Der blev set PDGFRomlejring hos 11 patienter, 9 af disse opnåede CHR og 1 PHR. 
In eleven patients PDGFR gene rearrangements were detected, 9 of them achieved a CHR and 1 PHR.
Disse er en gruppe af sygdomme i blodet, hvor nogle blodlegemer begynder at vokse ukontrolleret. 
These are a group of blood diseases in which some blood cells start growing out of control.
• Brystsmerter, uregelmæssig hjerterytme (tegn på hjerteproblemer). 
• Chest pain, irregular heart rhythm (signs of heart problems).
I alt 51 børn med nydiagnosticeret og ubehandlet CML i kronisk fase blev inkluderet i en åben, multicenter, enkeltarmet fase II-undersøgelse. 
A total of 51 paediatric patients with newly diagnosed and untreated CML in chronic phase have been enrolled in an open-label, multicentre, single-arm phase II trial.
Imatinib er en protein-kinasehæmmer, som potent hæmmer Bcr-Abl tyrosinkinasen in vitro, in vivo og på cellulært niveau. 
Imatinib is a protein kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Af disse 117 patienter var 61 positive for FIP1L1-PDGFRα fusionkinase. 
In 61 of these 117 patients FIP1L1-PDGFRα fusion kinase was identified.
Når imatinib blev kombineret med højdosis kemoterapi hos Ph+ ALL patienter, sås forbigående levertoksicitet i form af forhøjet transaminase og hyperbilirubinæmi. 
When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Der har efter markedsføring været rapporter om spontane aborter og medfødte abnormaliteter hos spædbørn født af kvinder, som har taget Imatinib medac. 
There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib.