natgillin/translations-raw huggingface dataset:
Den aktuelle estimerede gennemsnitlige overlevelse hos tidligere ”ubehandlede” og ”behandlede patienter” var henholdsvis 7,7 og 4,7 
The current estimate of the median survival of the previously untreated and treated patients was 7.7 and 4.7 months, respectively.
Hvis det anvendes under graviditet, skal patienten informeres om den potentielle risiko for 
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Translokationen t(17:22) [(q22:q13)], eller dets gen-produkt, var til stede i næsten alle respons på 
The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Behandling med imatinib i 36 måneder var superior til behandling i 12 måneder i ITT-analysen, dvs. inklusive hele studiepopulationen. 
Treatment with imatinib for 36 months was superior to treatment for 12 months in the ITT analysis, i.e. including the entire study population.
Tabel 5 Bedste tumorrespons i undersøgelse STIB2222 (GIST) 
Table 5 Best tumour response in trial STIB2222 (GIST)
Leverfunktionen (transaminaser, bilirubin og alkalisk fosfatase) bør monitoreres jævnligt hos patienter 
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients
Forsigtighed anbefales derfor, når der føres motorkøretøj eller 
Therefore, caution should be recommended when driving a car
Prednisolon 200 mg oral, 5 dage per måned i 13 måneder Alle behandlingsregimer inkluderer administration af steroider mod CNS profylakse. 
Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
Alle doser (n=147) 400 mg (n=73) 600 mg (n=74) n (%) 
All doses (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
Der er ikke blevet observeret nogen fordel i total overlevelse. 
No overall survival benefit has been observed.
dag 3-5; 
days 3-5;
- Omrør med en ske, indtil tabletterne er opløst fuldstændig. 
• Stir with a spoon until the tablets have completely dissolved.
Sikkerhedsdata fra dette studie synes at være i overensstemmelse med sikkerhedsprofilen for imatinib hos Ph+ ALL 
Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt. 
could cause hepatitis B to become active again, which can be fatal in some cases.
En betydelig gruppe patienter, som havde stabil sygdom ved interimsanalysen opnåede delvist respons med længere behandling (median opfølgningstid på 31 måneder). 
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).
Det er vigtigt, at du tager det så længe lægen eller apotekspersonalet fortæller dig, at du skal. 
It is important that you do this as long as your doctor or pharmacist tells you to.
12 Gy i 8 fraktioner for alle patienter, som er CNS1 og CNS2 ved 
12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at
Effekt af seponering efter opnåelse af respons er ikke undersøgt. 
The effect of stopping treatment after achieving a response has not been investigated.
Den gennemsnitlige absolutte biotilgængelighed for kapselformuleringen er 98%. 
Mean absolute bioavailability for the capsule formulation is 98%.
Den opstår ved en ukontrolleret cellevækst af disse organers bindevæv. 
It arises from uncontrolled cell growth of the supporting tissues of these organs.
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). 
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).
For CML og GIST kan din læge foreskrive højere eller lavere dosis afhængigt af, hvordan du reagerer på behandlingen. 
For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment.
Risikoen for tilbagefald hos patienter efter operation af deres primære GIST blev retrospektivt vurderet ud fra følgende prognostiske faktorer: tumorstørrelse, mitotisk indeks, tumorplacering. 
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.
Ældre patienter: Imatinibs farmakokinetik er ikke specifikt undersøgt hos ældre. 
Older people: Imatinib pharmacokinetics have not been specifically studied in older people.
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). 
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).
- Hvis du ikke er i stand til at synke kapslerne, kan du åbne dem og opløse pulveret i et glas 
- If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of
Der er begrænset information om fordelingen af imatinib i human mælk. 
There is limited information on imatinib distribution on human milk.
Tumorer skulle være målelige i mindst et sygdomsområde og responskarakterisering baseret på SWOG-kriterier (Southwestern Oncology Group). 
Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria.
Kapslens indhold er hvidt til lysegult granuleret pulver. 
The content of the capsule is white to light yellow granulated powder.
F1-fertilitet var ikke påvirket, mens der sås et øget antal resorptioner og et nedsat antal levende fostre ved 45 mg/kg/dag. 
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.
Eksponeringen er ca. 1,5- til 2- fold, svarende til en 1,5-gangs stigning af plasma AGP, som imatinib binder stærkt til. 
The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
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. 
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.
Sikkerhedsdatabasen for børn med Ph+ ALL er meget begrænset. 
The safety database for children with Ph+ALL is very limited though no new safety
- Følelsesløse eller kolde tæer og fingre (tegn på Raynaud´s syndrom). 
• Numb or cold toes and fingers (signs of Raynaud's syndrome).
Kliniske studier vedrørende adjuverende GIST 
Clinical studies in adjuvant GIST
Disse patienter var i aldersgruppen 18-83 år og havde en patologisk diagnose af Kit-positiv malignt GIST, der var inoperabelt og/eller metastaserende. 
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.
Mediantiden til follow-up var 54 måneder (fra dato for randomisering til data cut-off) med i alt 83 måneder mellem den første randomiserede 
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.
De første 37 patienter startede med 400 mg, protokollen blev efterfølgende ændret og tillod højere doser, hvorefter de resterende 223 
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.
Mekanismen og betydningen for mennesker af disse resultater i karcinogenicitetsstudie hos rotter er 
The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet
36 måneders behandlingsarm % (CI) 
36-month treatment arm % (CI)
• adjuverende behandling af voksne patienter, som har signifikant risiko for tilbagefald efter resektion af Kit (CD117)-positiv GIST. 
• The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
Plasma AUC for imatinib blev reduceret med 73% sammenlignet med patienter, som ikke blev behandlet med EIAEDs. 
The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Mens du tager Imatinib Teva B.V., vil din læge regelmæssigt kontrollere, om lægemidlet virker. 
While you are taking Imatinib Teva B.V. your doctor will regularly check whether the medicine is working.
• voksne patienter med Ph+ CML i blastkrise. 
• Adult patients with Ph+ CML in blast crisis.
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. 
The majority of paediatric patients treated for GIST lacked data confirming c-kit or PDGFR mutations which may have led to mixed clinical outcomes.
Dosering hos børn bør baseres på legemsoverflade (mg/m2). 
Dosing for children should be on the basis of body surface area (mg/m2).
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. 
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.
- Pludselig hævelse og rødme af huden (tegn på en hudinfektion kaldet cellulitis). 
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
- Når tabletten er opløst, så drik hele glassets indhold med det samme. 
• Once the tablet has dissolved, drink everything in the glass straight away.
Et hovedrespons kombinerer både fuldstændig og partiel respons: Fuldstændig (0% Ph+ metafaser), delvis (1-35%). 
A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
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). 
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).
Undersøgelse 0102 38 månedsdata Myeloid blastkrise (n=260) % patienter (CI95%) 
Study 0102 38-month data Myeloid blast crisis (n=260) % of patients (CI95%)
Studiets primære endepunkt var recidivfri overlevelse (RFS), defineret som tiden fra randomisering til dato for tilbagefald eller død af enhver årsag. 
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.
Uventede, hurtige vægtstigninger bør undersøges nøje, og om nødvendigt bør understøttende terapi indledes og relevante indgreb foretages. 
An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken.
På analysetidspunktet var behandlingsvarighedsmedianen 7 måneder (7 dage til 13 måneder). 
At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months).
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. 
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.
Blastkrise defineres som ≥30% blaster i blod eller knoglemarv eller ekstramedullær sygdom ud over 
Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
RFS rater (%) 12 måneder 24 måneder Imatinib vs. placebo 
RFS rates (%) 12 month 24 month Imatinib vs placebo
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. 
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.
I denne patientpopulation kan levermetastaser potentielt medføre leverinsufficiens og nedsat metabolisme. 
In this patient population, the presence of hepatic metastases could potentially lead to hepatic insufficiency and reduced metabolism.
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. 
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.
Kvinder i den fertile alder skal tilrådes at anvende sikker kontraception under behandlingen. 
Women of childbearing potential must be advised to use effective contraception during treatment.
- Øjensmerter eller svækkelse af dit syn, blødning i øjnene. 
• Eye pain or deterioration in vision, bleeding in the eyes.
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. 
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.
6 doser)iii: dag 2, 3, 16, og 17 
doses)iii: days 2, 3, 16, and 17
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) 
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).
Fald i albuminværdier forårsagede nedsat clearance (CL/f); og stigninger i leukocyttal forårsagede fald i Cl/f. 
Decreased values of albumin caused a reduced clearance (CL/f); and higher levels of WBC led to a reduction of CL/f.
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
Farmakoterapeutisk klassifikation: Protein-tyrosinkinasehæmmer, ATC-kode: L01XE01 
Pharmacotherapeutic group: Protein kinase inhibitors, ATC code: L01XE01
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. 
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.
På et år var den samlede RFS signifikant bedre for imatinib (97,7%) i forhold til placebo (82,3%), (p<0,0001). 
At one year the overall RFS was significantly better for imatinib (97.7%) vs. placebo (82.3%), (p<0.0001).
Patienten bør testes for HBV-infektion før initiering af behandling med Imatinib Teva B.V. 
Patients should be tested for HBV infection before initiating treatment with Imatinib Teva B.V.
Total-bilirubin: = 1,5 ULN ASAT: >ULN (kan være normal eller <ULN hvis total-bilirubin er >ULN) 
Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Det totale antal dødsfald var 25 i 12 måneders behandlingsarmen og 12 i 36 måneders behandlingsarmen. 
The total number of deaths were 25 for the 12-month treatment arm and 12 for the 36-month treatment arm.
Din læge har udskrevet Imatinib Teva B.V., fordi du lider af en alvorlig sygdom. 
Your doctor has prescribed Imatinib Teva B.V. because you suffer from a serious condition.
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. 
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.
Du må ikke stoppe med at tage Imatinib Teva B.V., medmindre din læge fortæller dig det. 
Do not stop taking Imatinib Teva B.V. unless your doctor tells you to.
Tabletten er præget med ”IT” og ”4” på hver side af delekærven. 
The tablet is debossed with “IT” and “4” at each side of the score line.
Plasmaproteinbindingen af den N-demethylerede metabolit er sammenlignelig med den for hovedkomponenten. 
The plasma protein binding of the N-demethylated metabolite is similar to that of the parent
Nogle børn og unge, der får Imatinib Teva B.V., kan vokse langsommere end normalt. 
Some children and adolescents taking Imatinib Teva B.V. may have slower than normal growth.
Behandlingsvarigheden i det kliniske forsøg, der ligger til grund for denne indikation, var 36 måneder (se pkt. 
Length of treatment in the clinical trial supporting this indication was 36 months (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
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. 
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.
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.
Derfor anbefales tæt monitorering af væksten hos børn, der er i behandling med imatinib (se pkt. 
Therefore, close monitoring of growth in children under imatinib treatment is recommended (see section
Efter oral administration til raske frivillige var t½ ca. 18 timer, hvilket indikerer, at dosering 1 gang daglig er passende. 
Following oral administration in healthy volunteers, the t½ was approximately 18 h, suggesting that oncedaily dosing is appropriate.
- Usædvanligt hårtab eller udtynding af håret. 
• Unusual hair loss or thinning.
- Hvis du oplever uventede blødninger eller blå mærker (når du ikke er kommet til skade). 
• Unexpected bleeding or bruising (when you have not hurt yourself).
Hvis responsraten beregnes ud fra patienter med mindst en valid parametervurdering, er reponsraten for CHR, CCyr og MR henholdsvis 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
Hvis dosis tolereres, kan den øges ved manglede effekt (se pkt. 
If tolerated, the dose can be increased for lack of efficacy (see
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).
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter frekvens med de hyppigste først. 
Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent
Hos GIST-patienter var optagelsen ved steady-state 1,5 gange højere end den observeret hos CMLpatienter ved samme dosis (400 mg daglig). 
In patients with GIST steady-state exposure was 1.5-fold higher than that observed for CML patients for the same dosage (400 mg daily).
Tabletten er præget med ”IT” og ”1” på hver side af delekærven. 
The tablet is debossed with “IT” and “1” at each side of the score line.
I denne undersøgelse inkluderedes 147 patienter, der randomiseredes til enten 400 mg eller 600 mg oralt en gang daglig, i op til 36 måneder. 
In this study 147 patients were enrolled and randomised to receive either 400 mg or 600 mg orally once daily for up to 36 months.
3Fuldstændigt cytogenetisk respons bekræftet ved endnu en cytogenetisk knoglemarvsundersøgelse udført mindst 1 måned efter den initiale knoglemarvsundersøgelse. 
3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study
Antallet af Imatinib Teva B.V.-kapsler afhænger af barnets tilstand, kropsvægt og højde. 
The amount of Imatinib Teva B.V. given will depend on your child's condition, body weight and height.
Tabel 6 Resumé af RFS-analyse for det kliniske forsøg Z9001 ved NIH og AFIP 
Table 6 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
- hvis du er allergisk over for imatinib eller et af de øvrige indholdsstoffer i dette lægemiddel 
- if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
I tilfælde af overdosering bør patienten observeres, og der bør gives relevant understøttende 
In the event of overdose, the patient should be observed and appropriate supportive treatment given.
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), 
Frequency categories are defined using the following convention: very common (≥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).
Hovedparten af patienterne, som opnåede CCyR, udviklede dette mellem 3. og 10. måned med en mediantid til respons på 5,6 måneder 
The majority of patients who achieved a CCyR developed the CCyR between months 3 and 10 with a median time to response based on the Kaplan-Meier estimate of 5.6 months.
Baseret på fremkomne stof(fer) efter oral dosis af 14C-mærket imatinib, genfandtes ca. 81% af dosis inden for 7 dage i fæces (68% af dosis) og urin (13% af dosis). 
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Median tid til svigtende behandling hos respondenter var 122 uger (95% konfidensinterval 106-147), mens i den overordnede studiepopulation var 84 uger (95% konfidensinterval 71-109). 
Median time to treatment failure in responders was 122 weeks (95% C.I 106-147), while in the overall study population it was 84 weeks (95% C.I 71-109).
Som adjuverende behandling blev imatinib undersøgt i et multicenter, dobbeltblindet, længerevarende placebokontrolleret fase III klinisk forsøg (Z9001), der involverede 773 patienter. 
In the adjuvant setting, imatinib was investigated in a multicentre, double-blind, long-term, placebocontrolled phase III study (Z9001) involving 773 patients.