FrancophonIA/ELRC3.0 huggingface dataset:
English: Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the Glivec and IFN arms, respectively.
Danish: Medianvarigheden af førstevalgsbehandling var henholdsvis 82 og 8 måneder i Glivec- og INFarmene syv år efter, at den sidste patient var rekrutteret.
English: In Ph+ ALL patients, there is clinical experience of co-administering Glivec with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Danish: Der er klinisk erfaring med administration af Glivec sammen med kemoterapi til patienter med Ph+ ALL, men specifikke interaktionsstudier mellem imatinib og kemoterapiregimer er ikke tilstrækkeligt karakteriseret.
English: 3, pulmonary oedema
Danish: 3, lungeødem
English: During treatment with Glivec, tell your doctor straight away if you put on weight very quickly.
Danish: Du skal straks fortælle din læge, hvis du meget hurtigt tager på i vægt, mens du er i behandling med Glivec.
English: Iron oxide, red (E172) Shellac
Danish: Jernoxid, rød (E 172) Shellac
English: Posology for MDS/MPD The recommended dose of Glivec is 400 mg/day for adult patients with MDS/MPD.
Danish: Dosering ved MDS/MPD Den anbefalede dosis af Glivec er 400 mg/dag til voksne patienter med MDS/MPD.
English: The recommended dose of Glivec is 600 mg/day for adult patients with Ph+ ALL.
Danish: Den anbefalede dosis af Glivec er 600 mg/dag til voksne patienter med Ph+ ALL.
English: DEX (6 mg/m2/day, PO): days 1-5; 29-33 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: DEX (6 mg/m2/dag, p.o.): dag 1-5; 29-33 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: If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 260 mg/m 3.
Danish: Hvis cytopeni ikke er leukæmirelateret, reducér Glivec-dosis til 260 mg/m 3.
English: High
Danish: Høj
English: DEX 10 mg/m oral, days 1-5;
Danish: DEX 10 mg/m oral, dag 1-5;
English: The most commonly reported ( 10%) drugrelated adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Danish: De mest almindelige rapporterede (10%) lægemiddelrelaterede bivirkninger var i begge patientgrupper: let kvalme, opkastning, diarré, abdominalsmerter, træthed, myalgi og muskelkramper samt udslæt.
English: They are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Danish: De findes i pakninger med 20, 60, 120 eller 180 tabletter, men ikke alle pakningsstørrelser er nødvendigvis tilgængelige i dit land.
English: Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
Danish: Aktive stoffer, der kan øge plasmakoncentrationen af imatinib Stoffer, der hæmmer CYP3A4-aktiviteten (f.eks. proteasehæmmere som f.eks. indinavir, lopinavir/ritonavir, ritonavir, saquinavir, teleprevir, nelfinavir, boceprevir; azol-antimykotika inklusive ketoconazol, itraconazol, posaconazol, voriconazol; visse makrolider som f.eks. erythromycin, clarithromycin og telithromycin), kan nedsætte metaboliseringen og øge koncentrationen af imatinib.
English: VCR 2 mg i.v., days 6, 13, 20; Daunorubicin 45 mg/m i.v., days 6-7, 13-14
Danish: VCR 2 mg i.v., dag 6, 13, 20; Daunorubicin 45 mg/m i.v., dag 6-7, 13-14
English: The starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Danish: Startdosis er 600 mg, som skal tages som én tablet af 400 mg plus 2 tabletter af 100 mg én gang daglig.
English: Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) eller almindelige (kan forekomme hos op til 1 ud af 10 patienter):
English: (3 h, q 12 h), days 1-3;
Danish: (3 timer, q 12 timer), dag 1-3;
English: What Glivec contains - The active substance is imatinib mesilate.
Danish: Glivec indeholder: - Aktivt stof: imatinibmesilat.
English: Posology for CML in children Dosing for children should be on the basis of body surface area (mg/m2).
Danish: Dosering ved CML hos børn Dosering til børn bør baseres på legemsoverfladeareal (mg/m2).
English: Muscle spasm and cramps, musculoskeletal pain including myalgia arthralgia, bone pain
Danish: Muskelspasmer og kramper, muskuloskeletale smerter herunder myalgi artralgi, knoglesmerter
English: VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m i.v., days 1, 8; Prednisone 60 mg/m oral, days 1-7, 15-21;
Danish: VCR 2 mg total dose i.v., dag 1, 8, 15, 22; CP 750 mg/m i.v., dag 1, 8; Prednison 60 mg/m oral, dag 1-7, 15-21;
English: If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 400 mg. 3.
Danish: Hvis cytopeni ikke er leukæmirelateret, reducér Glivec-dosis til 400 mg. 3.
English: Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, nonrandomised phase III trial, and were treated with Glivec (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Danish: Børn: I studie I2301 blev der inkluderet i alt 93 børn, unge og yngre voksne (fra 1 til 22 år) med Ph+ ALL i et åbent, multicenter, ikke-radomiseret fase III sekventielt kohorte-forsøg.
English: If you take more Glivec than you should
Danish: Hvis du har taget for meget Glivec
English: Glivec 400 mg film-coated tablets PVDC/alu blisters
Danish: Glivec 400 mg filmovertrukne tabletter PVDC/alu blister.
English: (24 h), day 1; Etoposide 250 mg/m i.v.
Danish: (24 timer), dag 1; Etoposid 250 mg/m i.v.
English: - The tablet coating is made of red iron oxide (E172), yellow iron oxide (E172), macrogol, talc and hypromellose.
Danish: - Filmovertrækket består af rød jernoxid (E 172), gul jernoxid (E 172), macrogol, talcum og hypromellose.
English: One open label, multicentre, phase II clinical trial (study B2225) was conducted testing Glivec in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Danish: Der er udført et åbent multicenter, klinisk fase II-studie (studie B2225) med henblik på vurdering af Glivec i en blandet patientpopulation med livstruende sygdomme forbundet med Abl, Kit eller PDGFR protein-tyrosinkinaser.
English: Palpitations, tachycardia, cardiac failure congestive
Danish: Palpitationer, takykardi, hjerteinsufficiens
English: Glivec 100 mg hard capsules EU/1/01/198/002-006
Danish: Glivec 100 mg hårde kapsler EU/1/01/198/002-006
English: (q 12 h), days 2-3, for
Danish: (q 12 timer), dag 2-3, i
English: (2 h, q 12 h), days 2-3 (total of 8 courses)
Danish: (2 timer, q 12 timer), dag 2-3 (total af
English: Glivec 100 mg hard capsules Capsule content: Cellulose microcrystalline Crospovidone
Danish: Glivec 100 mg hårde kapsler Kapselindhold: Cellulose, mikrokrystallinsk Crospovidon
English: Posology for HES/CEL The recommended dose of Glivec is 100 mg/day for adult patients with HES/CEL.
Danish: Dosering ved HES/CEL Den anbefalede dosis af Glivec er 100 mg/dag til voksne patienter med HES/CEL.
English: Glivec 100 mg film-coated tablets PVC/alu blisters
Danish: Glivec 100 mg filmovertrukne tabletter PVC/alu blister.
English: Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.
Danish: Samtidig anvendelse af imatinib og lægemidler, der inducerer CYP3A4 (f.eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital eller Hypericum perforatum, også kendt som prikbladet perikum) kan signifikant reducere følsomheden over for Glivec, og dermed potientielt øge risikoen for terapeutisk svigt.
English: Glivec 50 mg hard capsules Capsule content: Cellulose microcrystalline Crospovidone
Danish: Glivec 50 mg hårde kapsler Kapselindhold: Cellulose, mikrokrystallinsk Crospovidon
English: 44.8 21/140 vs. 51/127 0.29 (0.18; 0.49) 94.8 vs. 64.0 80.7 vs. 46.6 AFIP Very Low 20.7 0/52 vs. 2/63
Danish: 44,8 21/140 vs. 51/127 0,29 (0,18; 0,49) 94,8 vs. 64,0 80,7 vs. 46,6
English: - The other ingredients are microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate and anhydrous colloidal silica.
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, magnesiumstearat og vandfri kolloid silica.
English: Glivec 50 mg hard capsules EU/1/01/198/001
Danish: Glivec 50 mg hårde kapsler EU/1/01/198/001
English: (24 h), day 1, Ara-C 1 g/m i.v.
Danish: (24 timer), dag 1, Ara-C 1 g/m i.v.
English: (24 h), day 1, and Ara-C 2 g/m i.v.
Danish: (24 timer), dag 1, og Ara-C 2 g/m i.v.
English: If cytopenia persists for 2 weeks, reduce further to 200 mg/m 4.
Danish: Hvis cytopeni vedvarer i 2 uger, reducér dosis yderligere til 200 mg/m 4.
English: Glivec 50 mg hard capsules Glivec 100 mg hard capsules
Danish: Glivec 50 mg hårde kapsler Glivec 100 mg hårde kapsler
English: The recommended dosage of Glivec is 400 mg/day for adult patients in chronic phase CML.
Danish: Den anbefalede dosis af Glivec er 400 mg/dag til voksne patienter med CML i kronisk fase.
English: If cytopenia persists for 2 weeks, reduce further to 300 mg. 4.
Danish: Hvis cytopeni vedvarer i 2 uger, reducér dosis yderligere til 300 mg. 4.
English: DEX 10 mg/m oral, days 1-5; Vindesine 3 mg/m i.v., day 1;
Danish: DEX 10 mg/m oral, dag 1-5; Vindesin 3 mg/m i.v., dag 1;
English: The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m daily.
Danish: Alderen på disse patienter rangerede fra 3 måneder til 4 år, og imatinib blev givet i en dosis på 50 mg dagligt eller doser, der lå i intervallet fra 92,5 til 340 mg/m dagligt.
English: The recommended dosage of Glivec is 600 mg/day for adult patients in accelerated phase.
Danish: Den anbefalede dosis af Glivec er 600 mg/dag til voksne patienter i accelereret fase.
English: Posology for DFSP The recommended dose of Glivec is 800 mg/day for adult patients with DFSP.
Danish: Dosering ved DFSP Den anbefalede dosis af Glivec er 800 mg/dag til voksne patienter med DSFP.
English: 600 mg to be taken as 12 capsules once a day.
Danish: 600 mg som skal tages som 12 kapsler én gang daglig.
English: Dose increases from 340 mg/m daily to 570 mg/m daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemiarelated neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Danish: Dosisøgning fra 340 mg/m daglig til 570 mg/m daglig (uden at overstige total dosis på 800 mg) kan overvejes hos børn ved fravær af alvorlige bivirkninger og svær ikke-leukæmirelateret neutropeni eller trombocytopeni ved følgende omstændigheder: sygdomsprogression (på ethvert tidspunkt); hvis der ikke er opnået tilfredsstillende hæmatologisk respons efter mindst 3 måneders behandling; hvis der ikke er opnået cytogenetisk respons efter 12 måneders behandling; eller ved tab af tidligere opnået hæmatologisk og/eller cytogenetisk respons.
English: Anaphylactic shock* Blood and lymphatic system disorders Very common:
Danish: Blod og lymfesystem Meget almindelig:
English: IV or PO q6h x 6 doses)iii:
Danish: eller p.o. q6h x 6
English: Methotrexate (5 g/m over 24 hours, IV): day 1
Danish: Methotrexat (5 g/m over 24 timer, i.v.
English: VCR 1.3 g/m2 i.v., day 1; Prednisolone 60 mg/m oral, days 1-5
Danish: VCR 1,3 g/m i.v., dag 1; Prednisolon 60 mg/m oral, dag 1-5
English: The recommended dose of Glivec is 600 mg/day for adult patients in blast crisis.
Danish: Den anbefalede dosis af Glivec er 600 mg/dag til voksne patienter i blastkrise.
English: White to yellow powder in a light yellow to orange-yellow opaque capsule, marked “NVR SH”.
Danish: Hvidt/gult pulver i en lysegul/orangegul, uigennemsigtig kapsel, præget med ”NVR SH”.
English: One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing Glivec in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Danish: Der er udført en åben, multicenter fase II-undersøgelse (studie B2225) med henblik på at vurdere Glivec hos en blandet patientpopulation med livstruende sygdomme forbundet med Abl-, Kit- eller PDGFR-proteintyrosinkinaser.
English: 9/l) and thrombocytopenia (platelet count
Danish: 9/l) og trombocytopeni (trombocyttal <50 x 10
English: Glivec 400 mg film-coated tablets EU/1/01/198/009
Danish: Glivec 400 mg filmovertrukne tabletter EU/1/01/198/009
English: G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15 DEX (6 mg/m2/day, PO): days 1-7 and 15-21
Danish: G-CSF (5 μg/kg, s.c.): dag 5-14, eller indtil ANC >1500 post nadir Tredobbelt i.t.-terapi (aldersjusteret): dag 1 og 15 DEX (6 mg/m2/dag, p.o.): dag 1-7 og 15-21
English: From the safety data available, escalating the dose to 800 mg daily in patients progressing at lower doses of 400 mg or 600 mg daily does not seem to affect the safety profile of Glivec.
Danish: Fra tilgængelig sikkerhedsdata ser det ikke ud til, at sikkerhedsprofilen for Glivec ændres ved optrapning af dosis til 800 mg daglig til patienter, hvis sygdom fremskrider ved de lavere doser på 400 mg eller 600 mg daglig.
English: The printing ink is composed of red iron oxide (E172), shellac, soya lecithin.
Danish: Prægeblækket består af rød jernoxid (E 172), shellac, sojalecithin.
English: (1 h), days 1-3;
Danish: (1 time), dag 1-3;
English: Cellulose microcrystalline Crospovidone Hypromellose Magnesium stearate Silica, colloidal anhydrous
Danish: Hypromellose Magnesiumstearat Silica, kolloid vandfri
English: repeat step 1 and resume Glivec at reduced dose of 260 mg/m
Danish: 9/l, gentag trin 1 og genoptag behandling med Glivec i en reduceret dosis på 260 mg/m
English: 9/l and platelets  75 x 10
Danish: 9/l og trombocytter 75 x 10
English: 9/l, platelets  100 x 10
Danish: 9/l, trombocytter 100 x 10
English: What Glivec looks like and contents of the pack Glivec 50 mg capsules are light yellow to orange-yellow and marked “NVR SH”.
Danish: Glivec 50 mg kapsler er lysegule til orange-gule og præget med ”NVR SH”.
English: Glivec 100 mg film-coated tablets EU/1/01/198/007
Danish: Glivec 100 mg filmovertrukne tabletter EU/1/01/198/007
English: Your doctor will discuss with you the possible risks of taking Glivec during pregnancy.
Danish: Din læge vil fortælle dig om de mulige risici, der er forbundet med brug af
English: Iron oxide, red (E172) Iron oxide, yellow (E172) Macrogol
Danish: Jernoxid, rød (E 172) Jernoxid, gul (E 172) Macrogol
English: Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administration site conditions Very common:
Danish: Hæmoragisk corpus luteum/ hæmoragisk ovariecyste Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
English: The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m daily.
Danish: Alderen på disse patienter rangerede fra nyfødt til 14 år, og imatinib blev givet i en dosis på 50 mg dagligt eller doser, der lå i intervallet fra 400 til 520 mg/m dagligt.
English: What Glivec looks like and contents of the pack Glivec 400 mg film-coated tablets are very dark yellow to brownish-orange oval tablets.
Danish: Glivec 400 mg filmovertrukne tabletter er meget mørkegule til brun-orange ovale tabletter.
English: DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 1-56 Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50
Danish: DEX (6 mg/m2/dag, p.o.): dag 1-5; 29-33 6-MP (75 mg/m2/dag, p.o.): dag 1-56 Methotrexat (20 mg/m2/uge, p.o.): dag 1, 8, 15, 22, 29, 36, 43, 50
English: What Glivec looks like and contents of the pack Glivec 100 mg film-coated tablets are very dark yellow to brownish-orange round tablets.
Danish: Glivec 100 mg filmovertrukne tabletter er meget mørkegule til brun-orange runde tabletter.
English: White to yellow powder in an orange to greyish-orange opaque capsule, marked “NVR SI”.
Danish: Hvidt/gult pulver i en orange/orangegrå, uigennemsigtig kapsel, præget med ”NVR SI”.
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when Glivec is co-administered (see section 4.4).
Danish: Plasmaeksponeringen af levothyroxin kan muligvis mindskes, når Glivec gives samtidig til thyreoidektomerede patienter (se pkt.
English: NIH Low
Danish: NIH Lav
English: Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Danish: Dosisøgninger fra 400 mg til 600 mg eller 800 mg til patienter med CML i kronisk fase, eller fra 600 mg til maksimalt 800 mg (givet som 400 mg 2 gange daglig) til patienter i accelereret fase eller blastkrise kan, hvis der ikke opstår svære bivirkninger og svær ikke-leukæmirelateret neutropeni eller trombocytopeni, overvejes i følgende tilfælde: Sygdomsprogression (til enhver tid), udeblivende tilfredsstillende hæmatologisk respons efter mindst 3 måneders behandling, udeblivende opnåelse af cytogenetisk respons efter 12 måneders behandling, samt hvis tidligere hæmatologisk og/eller cytogenetisk respons ikke genopnås.
English: Adverse reactions
Danish: │││ Censorerede observationer
English: Glivec 50 mg hard capsules Each capsule contains 50 mg imatinib (as mesilate).
Danish: Glivec 50 mg hårde kapsler Hver kapsel indeholder 50 mg imatinib (som mesilat).
English: % of patients
Danish: Antal tilfælde/ Antal patienter
English: The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m daily or doses ranging from 200 to 400 mg daily.
Danish: Alderen på disse patienter rangerede fra 2 til 16 år, og imatinib blev givet i en dosis på 300 mg/m dagligt eller doser, der lå i intervallet fra 200 til 400 mg dagligt.
English: Overall, in patients receiving first-line Glivec, the average daily dose delivered was 406 ± 76 mg.
Danish: Overordnet var den gennemsnitlige daglige dosis 406 ± 76 mg hos patienter som fik Glivec som førstevalg.
English: Three large, international, open-label, non-controlled phase II studies were conducted in patients with Philadelphia chromosome positive (Ph+) CML in advanced, blast or accelerated phase disease, other Ph+ leukaemias or with CML in the chronic phase but failing prior interferon-alpha (IFN) therapy.
Danish: +) CML i fremskreden blastkrise eller accelereret fase, andre Ph leukæmier eller med CML i kronisk fase men tidligere behandlet med alfa-interferonbehandling (IFN) uden effekt.
English: Methylprednisolone 40 mg intrathecal, day 1
Danish: MTX 15 mg intrathecal, dag 1; Methylprednisolon 40 mg intrathecal, dag 1
English: Patients were treated with Glivec 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Danish: Patienterne blev behandlet med Glivec (340 mg/m2/dag) i kombination med intensiv kemoterapi efter induktionsbehandling.
English: DEX (6 mg/m2/day PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 8-28 Methotrexate (20 mg/m2/week, PO): days 8, 15, 22
Danish: DEX (6 mg/m 2/dag p.o.): dag 1-5; 29-33 6-MP (75 mg/m 2/dag, p.o.): dag 8-28 Methotrexat (20 mg/m 2/uge, p.o.): dag 8, 15, 22
English: Glivec 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as mesilate).
Danish: Glivec 400 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 400 mg imatinib (som mesilat).
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Danish: Prednisolon 200 mg oral, 5 dag per måned i 13 måneder Alle behandlingsregimer inkluderer administration af steroider mod CNS profylakse Ara-C: cytosin arabinosid; CP: cyclophosphamid; DEX: dexamethason; MTX: methotrexat; 6MP: 6-mercaptopurin; VM26: teniposid; VCR: vinkristin; IDA: idarubicin; i.v.
English: Glivec 100 mg hard capsules
Danish: Glivec 100 mg hårde kapsler
English: The printing ink is composed of red iron oxide (E172) and shellac.
Danish: Prægeblækket består af rød jernoxid (E 172) og shellac.
English: Glivec 100 mg hard capsules Each capsule contains 100 mg imatinib (as mesilate).
Danish: Glivec 100 mg hårde kapsler Hver kapsel indeholder 100 mg imatinib (som mesilat).
English: 7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Danish: 7, sure opstød, melæna, betændelse i spiserøret, ascites, mavesår, hæmatemese, cheilitis, dysfagi, pankreatitis
English: Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets
Danish: Glivec 100 mg filmovertrukne tabletter Glivec 400 mg filmovertrukne tabletter
English: What Glivec looks like and contents of the pack Glivec 100 mg capsules are orange to greyish-orange and marked “NVR SI”.
Danish: Glivec 100 mg kapsler er orange til orange-grålig og præget med ”NVR SI”.
English: If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as 8 capsules once a day.
Danish: Hvis du er i behandling for CML: Afhængigt af din tilstand er den almindelige startdosis enten 400 mg eller 600 mg: 400 mg som skal tages som 8 kapsler én gang daglig.
English: VCR (1.5 mg/m 2/day, IV): days 1, 8 and 15 DAUN (45 mg/m 2/day bolus, IV): days 1 and 2
Danish: ): dag 1, 8 og 15 DAUN (45 mg/m 2/dag bolus, i.v.
English: repeat step 1 and resume Glivec at reduced dose of 400 mg.
Danish: 9/l, gentages trin 1 og Glivec reintroduceres med nedsat dosering på 400 mg.
English: The capsule shell is composed of gelatin, yellow iron oxide (E172) and titanium dioxide (E171).
Danish: Kapselskallen består af gelatine, gul jernoxid (E 172) og titandioxid (E 171).
English: 9/l and platelets
Danish: 9/l) og trombopeni
English: Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.
Danish: Aktive stoffer, der kan reducere plasmakoncentrationen af imatinib Stoffer, der inducerer CYP3A4-aktivitet (f.eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital, fosphenytoin, primidon eller perikon (Hypericum perforatum), kan signifikant reducere følsomheden for Glivec og dermed potentielt øge risikoen for terapeutisk svigt.
English: The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Danish: Startdosis er 100 mg, som skal tages som én tablet af 100 mg én gang daglig.
English: 0.16 (0.03; 0.70) 97.9 vs. 90.8 97.9 vs. 73.3
Danish: 24,6 2/70 vs. 11/67 0,16 (0,03; 0,70) 97,9 vs. 90,8 97,9 vs. 73,3