natgillin/translations-raw huggingface dataset:
Hos patienter med hypereosinofilt syndrom (HES) med skjult infiltration af HES-celler i myokardiet, har der været isolerede tilfælde af kardiogent shock/dysfunktion af venstre ventrikel i forbindelse med HES-celledegranulering ved initiering af imatinibterapi. 
In patients with hypereosinophilic syndrome (HES) with occult infiltration of HES cells within the myocardium, isolated cases of cardiogenic shock/left ventricular dysfunction have been associated with HES cell degranulation upon the initiation of imatinib therapy.
Da der er rapporteret tilfælde af hjertebivirkninger med imatinib, bør der foretages en nøje benefit/risk-vurdering hos HES/CEL-populationen før påbegyndelse af behandling. 
As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Nyreinsufficiens: Patienter med nedsat nyrefunktion eller i dialyse bør gives den mindste anbefalede dosis på 400 mg dagligt som startdosis. 
Renal insufficiency: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Der har været case-rapporter med væksthæmning hos børn og præ-teenagere, der fik imatinib. 
There have been case reports of growth retardation occurring in children and pre-adolescents receiving imatinib.
Forsigtighed anbefales hos thyreoidektomerede patienter, som får levothyroxin og imatinib. 
Caution is recommended in thyroidectomy patients receiving levothyroxine and imatinib.
* Denne type bivirkninger er hovedsageligt blevet rapporteret efter markedsføring af Imatinib medac. 
* These types of reactions have been reported mainly from post-marketing experience with imatinib.
Når imatinib indtages i forbindelse med et måltid med høj fedtprocent, reduceres absorptionen af imatinib minimalt (11 %'s fald i Cmax og forlængelse af tmax med 1,5 time), med et lille fald i AUC (7,4 %) sammenlignet med fastende. 
When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11 % decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4 %) compared to fasting conditions.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med imatinib i alle undergrupper af den pædiatriske population med Philadelphia-kromosom (bcr-abl translokation)-positiv kronisk myeloid leukæmi (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Behandlingen kan gives én gang dagligt eller alternativt deles i to - én dosis om morgenen og én om aftenen. 
Treatment can be given as a once daily dose or alternatively the daily dose may be split into two administrations - one in the morning and one in the evening.
Kapselskal Gelatine 
Capsule shell
Klassificering af nedsat leverfunktion: 
Liver dysfunction classification:
• Hypereosinofil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL). 
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Undersøgelse hos en kardiolog, optagelse af ekkokardiogram og bestemmelse af serumtroponin bør derfor overvejes hos patienter med MDS/MPD, som har høje eosinofiltal, før der gives imatinib. 
Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered.
Denne kliniske effekt var efter 2 ugers behandling forbundet med en højere reduktion i bcr-abl transskriptionen hos de imatinibbehandlede patienter end i kemoterapiarmen (p = 0,02). 
This clinical effect was associated with a higher reduction in bcr-abl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p = 0.02).
Behandlingsvarighed: I kliniske undersøgelser fortsattes behandling med imatinib indtil sygdomsprogression. 
Treatment duration: In clinical trials, treatment with imatinib was continued until disease progression.
De 23 patienter som var inkluderet i registerstudiet, fik Imatinib medac med en daglig mediandosis på 264 mg (dosisområde: 100 til 400 mg) med en median varighed på 7,2 år (behandlingstid 0,1 til 12,7 år). 
The 23 patients enrolled in this registry received imatinib at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
In vitro hæmmer imatinib aktiviteten fra cytochrom-P450-isoenzymet CYP2D6 ved koncentrationer svarende til dem, der påvirker CYP3A4-aktivitet. 
In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
In vitro hæmmer imatinib O-glucuronidationen af paracetamol med en Ki-værdi på 58,5 mikromol/l. 
In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Den accelererede fase er en mellemfase mellem den kroniske fase og indtræden af blastkrisen og anses som det første tegn på resistens over for behandlingen. 
Accelerated phase is an intermediate phase among the chronic phase and the onset of the blast crisis; it is considered as the first manifestation of resistance to therapy.
Imatinib metaboliseres primært i leveren, og kun 13 % udskilles via nyrerne. 
Metabolism of imatinib is mainly hepatic, and only 13 % of excretion is through the kidneys.
CML i accelereret fase og blastkrise og Ph+ ALL (startdosis 600 mg) 
Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)
Patienter med hjertesygdom 
Patients with cardiac disease
Niveauet for ingen observeret effekt (NOEL) var 15 mg/kg/dag for både moderdyr og F1 generation (en ¼ af den maksimale humane dosis på 800 mg). 
The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the maximum human dose of 800 mg).
Konsoliderende behandling (de novo Ph+ ALL) 
Consolidation (de novo Ph+ ALL)
Imatinib var teratogent hos rotter ved administration under organgenese ved doser ≥ 100 mg/kg, ca. svarende til den maksimale kliniske dosis på 800 mg/dag, baseret på legemsoverfladeareal. 
Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Øgningen i gennemsnitlig AUC ved dosisøgning efter oral administration var lineær og dosisproportional i intervallet 25-1.000 mg imatinib. 
The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Diverse bivirkninger, som for eksempel pleuraekssudat, ascites, lungeødem og hurtig vægtstigning med eller uden overfladiske ødemer, kan kollektivt betegnes som ”væskeretention”. 
Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “fluid retention”.
Tilfælde af leverskade, inklusive leversvigt og levernekrose er blevet observeret med imatinib. 
Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib.
Se indlægssedlen for nærmere oplysninger. 
See package leaflet for further information.
Der er ingen erfaring med behandling af CML hos børn under 2 år. 
There is no experience in children with CML below 2 years of age.
• Muskelkramper med feber, rød-brun urin, smerter eller svaghed i dine muskler (tegn på 
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of
På grund af den mulige forekomst af tumorlysesyndrom (TLS) anbefales korrektion af klinisk signifikant dehydrering og behandling af forhøjede urinsyreniveauer før påbegyndelse af behandling med imatinib (se pkt. 
Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see section 4.8).
Kontinuerlig daglig eksponering for imatinib tidligt i behandlingsforløbet i kombination med kemoterapi hos kohorte 5-patienter (n=50) forbedrede den 4-årige hændelsesfri overlevelse (EFS) sammenlignet med en historisk kontrolgruppe (n=120), der fik standard-kemoterapi uden imatinib (hhv. 69,6 % vs. 31,6 %). 
Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6 % vs. 31.6 %, respectively).
Doser på 400 mg og 600 mg bør administreres 1 gang dagligt, mens daglige doser på 800 mg bør administreres som 400 mg 2 gange dagligt, én dosis om morgenen og én dosis om aftenen. 
Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Imatinib givet i kombination med kemoterapi-induktion (se Tabel 3) resulterede i en komplet hæmatologisk responsrate på 93 % (147 ud af 158 evaluerbare patienter), og i en væsentlig cytogenetisk responsrate på 90 % (19 ud af 21 evaluerbare patienter). 
Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93 % (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90 % (19 out of 21 evaluable patients).
Bærere af HBV, hvor behandling med imatinib er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt. 
Carriers of HBV who require treatment with imatinib should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Colitis, ileus, inflammatorisk tarmsygdom 
Colitis, ileus, inflammatory bowel disease
Køn har ingen betydning for imatinibs kinetik. 
There is no effect of gender on the kinetics of imatinib.
• Kraftigt nedsat urinmængde, følelse af tørst (tegn på nyreproblemer). 
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• Hedeture, kulderystelser eller natlig svedtendens. 
• Hot flushes, chills or night sweats.
Imatinib og dets metabolitter udskilles kun i ubetydelig grad via nyrerne. 
Imatinib and its metabolites are not excreted via the kidney to a significant extent.
Disse er sygdomme i blodet, i hvilke visse blodlegemer (kaldet eosinofile celler) begynder at vokse ukontrolleret. 
These are blood diseases in which some blood cells (named eosinophils) start growing out of control.
3 På patientårsbasis blev kardielle hændelser, herunder hjerteinsufficiens, observeret oftere hos patienter med transformeret CML end hos patienter med kronisk CML. 
3) On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
I dette studie indgik 7 patienter med MDS/MPD, som blev behandlet med 400 mg imatinib dagligt. 
This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Må ikke opbevares ved temperaturer over 30 °C. 
Do not store above 30 ºC.
Den cirkulerende hovedmetabolit i mennesker er N-demethyl-piperazinderivatet, som udviser samme potens in vitro som det stof, den er afledt af. 
The main circulating metabolite in humans is the N-demethylated piperazine derivative, which shows similar in vitro potency to the parent.
Disse tilfælde blev sædvanligvis behandlet ved midlertidigt at tilbageholde behandling med imatinib, og behandle med diuretika og andre relevante, understøttende tiltag. 
These reactions can usually be managed by withholding imatinib temporarily and with diuretics and other appropriate supportive care measures.
Bedring blev rapporteret for: hjerte, nervesystem, hud/subkutant væv, respiratoriske/ thorakale/ mediastinale, muskuloskeletale/bindevævs/kar og gastrointestinale organsystemer. 
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Behandlingsvarighed: I det eneste kliniske studie, der er udført indtil nu, fortsattes behandlingen med imatinib indtil sygdomsprogression (se pkt. 
Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Imatinibs effekt er hos voksne og børn baseret på generelle hæmatologiske og cytogene responsrater og progressionsfri overlevelse ved CML, på hæmatologiske og cytogenetiske responsrater ved Ph+ ALL, MDS/MPD, på hæmatologiske responsrater ved HES/CEL, på objektive responsrater hos voksne med inoperabel og/eller metastaserende DFSP. 
In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP.
Der er ingen kontrollerede forsøg med pædiatriske patienter med DFSP. 
There are no controlled trials in paediatric patients with DFSP.
Niveauet for ingen observeret effekt (NOEL) var 15 mg/kg/dag. 
The no observed effect level (NOEL) was 15 mg/kg/day.
Da imatinib blev givet som ”salvage therapy” til patienter, som ikke responderede eller som responderede dårligt på kemoterapi, opnåedes komplet hæmatologisk respons hos 9 (81,8 %) ud af 11 patienter. 
When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8 %) out of 11 achieving a complete haematological response.
(2 timer, q 12 timer), dag 2-3 (total af 8 omgange) 
(2 h, q 12 h), days 2-3 (total of 8 courses)
Derudover angav investigatorerne symptomatisk bedring af andre organdysfunktioner i kasuistikkerne. 
Additionally, improvements in symptomatology and other organ dysfunction abnormalities were reported by the investigators in the case reports.
Der er ingen kontrollerede forsøg med pædiatriske patienter med MDS/MPD. 
There are no controlled trials in paediatric patients with MDS/MPD.
9/l) og trombocytopeni (trombocyttal <50 x 10 9/l) var 4-6 gange højere ved blastkrise og accelereret fase (59-64 % og 44-63 % for henholdsvis neutropeni og trombopeni) end ved sammenligning med nydiagnosticerede patienter med kronisk fase CML (16,7 % 9/l) og trombopeni neutropeni og 8,9 % trombocytopeni). 
9/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64 % and 44-63 % for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7 % neutropenia and 8.9 % thrombocytopenia).
Sammenligningen af AUC(0-24) på dag 8 og dag 1 ved 340 mg/m²/dag dosisniveauet viste en 1,7 gang højere lægemiddelakkumulering efter gentagen dosering, én gang dagligt. 
The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold accumulation after repeated once-daily dosing.
Histopatologiske undersøgelser af de afdøde rotter afslørede kardiomyopati (begge køn), kronisk progressiv nefropati (hunner) og papillomaer på forhuden som hovedårsag til død eller begrundelse for aflivning. 
Histopathological examination of decedents revealed cardiomyopathy (both sexes), chronic progressive nephropathy (females) and preputial gland papilloma as principal causes of death or reasons for sacrifice.
Tidligere gastrointestinale indgrebs påvirkning af imatinibabsorptionen er ikke undersøgt. 
The effect of prior gastrointestinal surgery on imatinib absorption has not been investigated.
I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST, oplevede 7 (5 %) af patienterne CTC grad 3-4: gastrointestinale blødninger (3 patienter), intratumorale blødninger (3 patienter) eller begge dele (1 patient). 
In the study in patients with unresectable and/or metastatic GIST, 7 (5 %) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
Baseret på in vitro undersøgelser, bindes, ved kliniske relevante koncentrationer af imatinib, ca. 95 % til plasmaproteiner, hovedsagelig albumin og alfa-syre-glycoprotein, med en mindre binding til lipoproteiner. 
At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95 % on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Plasmaeksponeringen synes at være højere hos patienter med nedsat nyrefunktion end hos patienter med normal nyrefunktion, formentlig på grund af forhøjede plasmaniveauer af alpha-acid glucoprotein (AGP), et imatinib-bindende protein, hos disse patienter. 
In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
Der sås forhøjet se-carbamid og se-creatinin hos adskillige af disse dyr. 
Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Når imatinib kombineres med højdosis kemoterapi, ses en øget forekomst af alvorlige leverreaktioner. 
When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected.
Niveauet for ingen observeret effekt (NOEL) var 30 mg/kg/dag. 
The no observed effect level (NOEL) was 30 mg/kg/day.
I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST rapporteredes anæmi grad 3 og 4 hos henholdsvis 5,4 % og 0,7% af patienterne, hvilket kan hænge sammen med gastrointestinal eller intra-tumoral blødning, i hvert fald hos enkelte af patienterne. 
In the study in patients with unresectable and/or metastatic GIST, grade 3 and 4 anaemia was reported in 5.4 % and 0.7 % of patients, respectively, and may have been related to gastrointestinal or intratumoural bleeding in at least some of these patients.
• Hævelse, som fx af anklerne eller omkring øjnene. 
• Swelling such as round your ankles or puffy eyes.
Kronisk nyresvigt Det reproduktive system og mammae 
Renal failure chronic Reproductive system and breast disorders
6400 mg (enkeltdosis): Der er beskrevet et tilfælde i litteraturen om en patient, der fik kvalme, opkastning, abdominalsmerter, feber, hævelse af ansigt, nedsat neutrofiltal, stigning i transaminaser. 
6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
Imatinib medac 400 mg hårde kapsler EU/1/13/876/002 
Imatinib medac 400 mg hard capsules EU/1/13/876/002
Udskillelse af fri imatinib er sandsynligvis sammenlignelig for patienter med nedsat nyrefunktion og dem med normal nyrefunktion, eftersom udskillelse via nyren kun udgør en mindre elimineringsvej for imatinib (se pkt. 
The free drug clearance of imatinib is probably similar between patients with renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
Imatinib medac 100 mg hårde kapsler EU/1/13/876/001 
Imatinib medac 100 mg hard capsules EU/1/13/876/001
Disse patienters alder varierede fra 20 til 72 år. 
The age of these patients ranged from 20 to 72 years.
Den anbefalede dosis af imatinib er 600 mg/dag til voksne patienter i blastkrise. 
The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis.
I dette studie blev 14 patienter med HES/CEL behandlet med 100 mg1.000 mg imatinib dagligt. 
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Der fandtes i en 39-ugers undersøgelse med aber ingen NOAEL (no observed adverse effect level/niveau ved ingen observeret bivirkningseffekt) ved den laveste dosis på 15 mg/kg, ca. 1/3 af den maksimale humane dosis på 800 mg baseret på legemsoverfladeareal. 
In a 39-week monkey study, no NOAEL (no observed adverse effect level) was established at the lowest dose of 15 mg/kg, approximately one-third the maximum human dose of 800 mg based on body surface.
Imatinib medac er indiceret til behandling af 
Imatinib medac is indicated for the treatment of
1200 mg til 1600 mg (varighed varierer mellem 1 og 10 dage): Kvalme, opkastning, diarré, rødme, erytem, ødem, hævelse, træthed, muskelkramper, trombocytopeni, pancytopeni, abdominalsmerter, hovedpine, nedsat appetit. 
1200 mg to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Ileus/intestinal obstruktion*, gastrointestinal perforation*, diverticulitis*, 
Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric Hepatobiliary disorders
Der var ingen særlige sikkerhedsmæssige fund i kliniske undersøgelser med børn. 
There were no special safety findings in paediatric clinical trials.
Pakningen må ikke anvendes, hvis den er beskadiget, eller der er tegn på, at pakningen har været åbnet. 
Do not use any pack that is damaged or shows signs of tampering.
Behandlingsskema: Eksisterende data har vist, at imatinib er effektiv og sikker ved administration af 600 mg/dag i kombination med kemoterapi i induktionsfasen, i konsoliderings- og vedligeholdelsesfaser af kemoterapi (se pkt. 
Treatment schedule: On the basis of the existing data, imatinib has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for patients with newly diagnosed Ph+ ALL.
(3 timer, q 12 timer), dag 5 
(3 h, q 12 h), day 5
I et 2-års carcinogenicitetsstudie i rotter resulterede administration af imatinib på 15, 30 og 60 mg/kg/dag i en signifikant reduktion i levetiden ved 60 mg/kg/dag for hanner og for hunner ved ≥ 30 mg/kg/dag. 
In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥ 30 mg/kg/day.
Der sås signifikant øgning i følsomhed for imatinib (gennemsnitlig Cmax og AUC for imatinib steg med henholdsvis 26 % og 40 %) hos raske frivillige ved samtidig administration af enkeltdosis ketoconazol (en CYP3A4-hæmmer). 
There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Crospovidon (type A) Lactosemonohydrat Magnesiumstearat 
Crospovidone (type A) Lactose monohydrate Magnesium stearate
Baseret på den poolede farmakokinetiske populationsanalyse hos børn med hæmatologiske sygdomme (CML, Ph+ ALL eller andre hæmatologiske sygdomme behandlet med imatinib) stiger imatinibclearance med stigende legemsoverflade. 
Based on pooled population pharmacokinetic analysis in paediatric patients with haematological disorders (CML, Ph+ ALL, or other haematological disorders treated with imatinib), clearance of imatinib increases with increasing body surface area (BSA).
Alle patienter opnåede komplet hæmatologisk respons, komplet cytogenetisk repons og/eller komplet molekylært respons. 
All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Vedligeholdelse (8-ugers cykler) Cyklus 6-12 
Maintenance (8-week cycles) Cycles 6-12