FrancophonIA/ELRC3.0 huggingface dataset:
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/m² dagligt.
English: Studies in animals have however shown reproductive toxicity (see section 5.3) and the potential risk for the foetus is unknown.
Danish: Dyreforsøg har dog påvist reproduktionstoksicitet (se pkt.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF
English: What you need to know before you take Imatinib medac
Danish: Det skal du vide, før du begynder at tage Imatinib medac
English: (24 h), day 1, and Ara-C 2 g/m i.v.
Danish: (24 timer), dag 1, og Ara-C 2 g/m² i.v.
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/m² dagligt eller doser, der lå i intervallet fra 200 til 400 mg dagligt.
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/m² dagligt.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan forekomme flere end 1 ud af 10 personer):
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 imatinib (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: Triple IT therapy (age-adjusted): day 1
Danish: Tredobbelt i.t.-terapi (aldersjusteret): dag 1
English: One open label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib 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 imatinib i en blandet patientpopulation med livstruende sygdomme forbundet med Abl, Kit eller PDGFR protein-tyrosinkinaser.
English: (3 h, q 12 h), days 1-3; i.v.
Danish: (3 timer, q 12 timer), dag 1-3;
English: Biochemistry
Danish: Biokemi
English: 9/l and platelets ≥ 75 x 10
Danish: 9/l og trombocytter ≥75 x 10
English: If you take more Imatinib medac than you should If you have accidentally taken too many capsules, talk to your doctor straight away.
Danish: Hvis du ved et uheld har indtaget for mange kapsler, skal du kontakte din læge med det samme.
English: The dose can be reduced if not tolerated (see section 4.2 and 5.2).
Danish: Dosis kan reduceres, hvis den ikke tolereres (se pkt.
English: For doses of 400 mg and above (see dosage recommendation below) a 400 mg capsule (not divisible) is available.
Danish: Der findes en 400 mg kapsel (uden delekærv) til doser på 400 mg og derover (se dosisanbefalingen herunder).
English: Induction therapy (de novo Ph+ ALL)
Danish: Studie AAU02 Induktionsbehandling (de novo Ph+ ALL)
English: Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia.
Danish: Der sås svær levertoksicitet hos hunde behandlet i 2 uger, inkluderende forhøjede leverenzymer, hepatocellulær nekrose, galdevejsnekrose samt galdevejshyperplasia.
English: • Rash.
Danish: • Kløe.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Lægemidlet bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for lactasemangel (Lapp-lactasemangel) eller glucose/galactosemalabsorption.
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
Danish: Trombocytæmi, lymfopeni, knoglemarvsdepression, eosinofili,
English: Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation at a concentration of 125 μg/ml.Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay.
Danish: Der sås positiv genotoksisk effekt med imatinib i en in vitro pattedyrscelleundersøgelse (kinesisk hamsterovarium) for clastogenicitet (kromosomafvigelser) ved metabolisk aktivering ved en koncentration på 125 μg/ml.
English: Imatinib medac is also a treatment for adults for:
Danish: Imatinib medac er også en behandling til voksne med:
English: Triple IT therapy (age-adjusted): days 1, 29
Danish: Tredobbelt i.t.-terapi (aldersjusteret): dag 1, 29
English: (n = 5), 340 mg/m2/day (n = 7) and 570 mg/m 2/day (n = 5).
Danish: Patienterne blev behandlet med imatinib-doser på 260 mg/m²/dag (n=5), 340 mg/m²/dag (n=9), 440 mg/m²/dag (n = 7) og 570 mg/m²/dag (n = 5).
English: Weakness, pyrexia, anasarca, chills, rigors
Danish: Svaghed, pyreksi, anasarka, kuldegysninger og kulderystelser
English: Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol.
Danish: Forsigtighed tilrådes dog ved CYP2D6-substrater med et snævert terapeutisk vindue som f.eks. metoprolol.
English: Intensification block 1 (9 weeks)
Danish: Intensivering blok 1 (9 uger)
English: Marketing Authorisation Holder medac
Danish: Indehaver af markedsføringstilladelsen medac
English: Intensification block 2 (9 weeks)
Danish: Intensivering blok 2 (9 uger)
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 10
Danish: Der sås 4. grads neutropeni (ANC <0,5 x 10
English: Organ function impairment
Danish: Nedsat organfunktion
English: CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4
Danish: CPM (250 mg/m²/dosis q12h x 4 doser, i.v.
English: Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Danish: Gynækomasti, erektil dysfunktion, menoragi, uregelmæssig menstruation, seksuel dysfunktion, smerter i brystvorterne, brystforstørrelse, skrotalt ødem
English: Active substances that may decrease imatinib plasma concentrations 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 imatinib, 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 imatinib og dermed potentielt øge risikoen for terapeutisk svigt.
English: One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib 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 imatinib hos en blandet patientpopulation med livstruende sygdomme forbundet med Abl-, Kit- eller PDGFR-proteintyrosinkinaser.
English: DEX (6 mg/m 2/day, PO): days 1-5; 29-33
Danish: DEX (6 mg/m²/dag, p.o.): dag 1-5; 29-33
English: Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Danish: Patienterne blev behandlet med imatinib (340 mg/m²/dag) i kombination med intensiv kemoterapi efter induktionsbehandling.
English: Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.
Danish: I tilfælde af svær neutropeni og trombocytopeni anbefales dosisreduktion eller seponering af behandlingen, som angivet i nedenstående tabel: Dosisjusteringer på grund af neutropeni og trombocytopeni Terapeutisk indikation
English: Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
Danish: I tre publikationer var der rapporteret om fem (5) patienter med DFSP og PDGFR-omlejringer.
English: For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day can be given until disease progression occurs.
Danish: Imatinib monoterapi med 600 mg/dag kan gives til voksne patienter med recidiverende eller refraktiv Ph+ALL, indtil der sker sygdomsprogression.
English: 9/l) were observed in 3.6 % and < 1 % of patients, respectively.
Danish: 9/l) hos henholdsvis 3,6 % og <1 % af patienterne med nydiagnosticeret CML i kronisk fase.
English: Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23 % (90 %CI [1.16 - 1.30]).
Danish: 400 mg imatinib to gange dagligt havde en inhibitorisk effekt på CYP2D6-medieret metoprololmetabolisme, som gav en stigning af Cmax og AUC
English: The capsule shell for 400 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
Danish: Kapselskallen (til 400 mg kapslen) består af gelatine, gul jernoxid (E172), titanidioxid (E171) rød jernoxid (E172) og sort jernoxid (E172).
English: Pericarditis*, cardiac tamponade* Vascular disorders
Danish: Perikardit*, hjertetamponade*
English: • Stomach pain with feeling sick (nausea).
Danish: • Mavesmerter med kvalme.
English: Close monitoring of growth in paediatric patients under treatment with imatinib is recommended (see section 4.8).
Danish: Hos børn, der er i behandling med imatinib, anbefales tæt monitorering af væksten (se pkt.
English: Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules
Danish: Imatinib medac 100 mg hårde kapsler Imatinib medac 400 mg hårde kapsler
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
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
English: The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
Danish: Kapselskallen (til 100 mg kapslen) består af gelatine, gul jernoxid (E172), titanidioxid (E171) rød jernoxid (E172).
English: The starting dose is 600 mg to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) once a day.
Danish: • Hvis du behandles for Ph-positiv ALL: Startdosis er 600 mg, som skal tages som 6 kapsler med 100 mg (eller 1 kapsel med 400 mg plus 2 kapsler med 100 mg) én gang dagligt.
English: IV or PO q6h x 6 doses)iii:
Danish: eller p.o. q6h x 6 doses)iii: dag 2 og 3
English: DEX (6 mg/m 2/day, PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 1-56 Methotrexate (20 mg/m 2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
Danish: = intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6-MP = 6-mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er <0,1 μM, Gy= Gray
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen, på apoteket eller sygeplejersken.
English: What Imatinib medac contains
Danish: Imatinib medac indeholder:
English: 10) Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Danish: 10 Muskuloskeletale smerter og relaterede hændelser blev observeret oftere hos patienter med
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m
Danish: 9/l, gentag trin 1 og genoptag <50 x 10 behandling med imatinib i en reduceret dosis på 260 mg/m².
English: • Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel
Danish: • Have kvalme med diarré og opkastning, mavesmerter eller feber (tegn på tarmproblemer).
English: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Danish: Forhøjet serumkreatinin, forhøjet serumkreatinkinase og forhøjetserumlaktatdehydrogenase, forhøjet alkalisk fosfatase
English: • Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
Danish: • Kvalme opkastninger, diarré eller fordøjelsesbesvær.
English: GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Danish: De gastrointestinale tumorer kan have været blødningskilden ved den gastrointestinale blødning (se pkt.
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Danish: Plasmaeksponeringen af levothyroxin kan muligvis mindskes, når imatinib gives samtidig til thyreoidektomerede patienter (se pkt.
English: Imatinib adverse events, i.e. hepatotoxicity, myelosuppression or others, may increase and it has been reported that concomitant use with L-asparaginase could be associated with increased hepatotoxicity (see section 4.8).
Danish: Det er rapporteret, at samtidig brug med L-asparaginase kan være associeret med øget hepatotoksicitet (se pkt.
English: MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5
Danish: MESNA (360 mg/m²/dosis hver 3 time, x 8 doser/dag, i.v.
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in paediatric patients (based on AUC) at 340 mg/m2/day.
Danish: Renale adenomer/carcinomer, papillomaer i blæren og urinrøret, adenocarcinomer i tyndtarmen, adenomer i biskjoldbruskkirtlerne, de benigne og maligne tumorer i binyremarven og ikke-kirtellignende ventrikelpapillomaer/carcinomer blev observeret ved 60 mg/kg/dag.
English: Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Danish: Hypertension, hæmatom, subduralt hæmatom, kuldefornemmelser i ekstremiteter, hypotension, Raynaud's syndrom
English: In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
Danish: I dyremodeller, hvor der anvendes Bcr-Abl-positive tumorceller, har stoffet som enkeltstof in vivo antitumoraktivitet.
English: 9/l and platelets ≥ 20 x 10
Danish: 9l og trombocytter ≥20 x 10
English: • Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of
Danish: • Kraftige mavesmerter, blod i opkast, afføring eller urin, sortfarvet afføring (tegn på mave-tarm
English: • Patients who are concerned about their fertility while taking Imatinib medac are advised to
Danish: • Hvis du er bekymret for din frugtbarhed, mens du tager Imatinib medac, skal du kontakte din
English: Gastrointestinal disorders Very common: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain
Danish: Kvalme, diarré, opkast, dyspepsi, abdominalsmerter
English: Thereafter, treatment can be resumed as appropriate depending on the initial severity of the event.
Danish: Alt efter bivirkningernes sværhedsgrad kan behandlingen derefter genoptages.
English: (1 h), days 28-31, 35-38, 42-45;
Danish: (1 time), dag 28-31,
English: UNIQUE IDENTIFIER - 2D BARCODE {2D barcode carrying the unique identifier included.}
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Danish: 9/l, gentag trin 1 og genoptag <50 x 10 behandling med imatinib i en reduceret dosis på 300 mg.
English: Study AUS01
Danish: Studie AUS01 Induktions-konsoliderende behandling
English: Imatinib medac is a treatment for adults and children and adolescents for:
Danish: Imatinib medac er en behandling til voksne, børn og unge mod:
English: 8) Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
Danish: 8 Der er rapporteret tilfælde af letalt leversvigt og levernekrose.
English: When and how to take Imatinib medac • Take Imatinib medac with a meal.
Danish: Hvornår og hvordan skal du tage Imatinib medac
English: Consolidation block 2 (3 weeks)
Danish: Konsolidering blok 2 (3 uger)
English: Consolidation block 1 (3 weeks)
Danish: Konsolidering blok 1 (3 uger)
English: PEG-ASP (2500 IUnits/m2, IM): day 4
Danish: PEG-ASP (2.500 IE/m², i.m.
English: Reinduction block 2 (3 weeks)
Danish: Reinduktion blok 2 (3 uger)
English: Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
Danish: I fire publikationer var der rapporteret om fem (5) patienter med MDS/MPD forbundet med PDGFR-omlejring.
English: Therapeutic indication
Danish: Induktionsbehandling I
English: VP-16 (100 mg/m2/day, IV): days 1-5
Danish: VP-16 (100 mg/m²/dag, i.v.
English: Reinduction block 1 (3 weeks)
Danish: Reinduktion blok 1 (3 uger)
English: NAME OF THE MEDICINAL PRODUCT Imatinib medac 400 mg hard capsules Imatinib
Danish: LÆGEMIDLETS NAVN Imatinib medac 400 mg hårde kapsler imatinib
English: NAME OF THE MEDICINAL PRODUCT Imatinib medac 100 mg hard capsules Imatinib
Danish: LÆGEMIDLETS NAVN Imatinib medac 100 mg hårde kapsler imatinib
English: Imatinib medac is also a treatment for children and adolescents for:
Danish: Imatinib medac er også en behandling til børn og unge med:
English: ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Danish: ARA-C (3 g/m²/dosis q 12 h x 4, i.v.
English: Very common: Headache Common:
Danish: Meget almindelig: Almindelig:
English: Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate).
Danish: Hver 400 mg hård kapsel Imatinib medac indeholder 400 mg imatinib (som mesilat).
English: Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Danish: ): dag 1 og 15 Leucovorin (75 mg/m² i time 36, i.v.
English: Pharmacokinetics in paediatric patients
Danish: Farmakokinetik hos børn
English: Start 6-MP the 1st day after cranial irradiation completion.)
Danish: Start 6-MP den første dag
English: In GIST the investigational medicinal product was discontinued for imatinib-related adverse reactions in 4 % of patients.
Danish: Hos 4 % af GIST-patienterne blev undersøgelsesmedicinen seponeret på grund af behandlingsrelaterede bivirkninger.
English: Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section
Danish: 4.5), CYP3A4-substrater med et snævert terapeutisk vindue (f.eks. cyclosporin, pimozid, tacrolimus, sirolimus, ergotamin, diergotamin, fentanyl, alfentanil, terfenadin, bortezomib, docetaxel, quinidin) eller warfarin og andre coumarin-derivater (se pkt.
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Danish: • Kvalme, åndenød, uregelmæssig hjerterytme (puls), uklar urin, træthed og/eller ubehag forbundet med abnorme resultater af laboratorieprøver (f.eks. højt kalium-, urinsyre- og calciumniveau og lavt fosforniveau i blodet).
English: Pleural effusion
Danish: Nyrer og urinveje
English: These patients received imatinib for a median of 47
Danish: Disse patienter fik imatinib i en periode varierende mellem 24 dage og 60 måneder (median 47 måneder).
English: Skin and subcutaneous tissue disorders Very common: Periorbital oedema, dermatitis/eczema/rash
Danish: Periorbitalt ødem, dermatitis/eksem/udslæt
English: • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Danish: • voksne patienter med myelodysplastisk syndrom/myeloproliferative sygdomme (MDS/MPD)
English: Imatinib medac 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
Danish: Imatinib medac 400 mg hårde kapsler Hver hård kapsel indeholder 400 mg imatinib (som mesilat).
English: (q 12 h), days 2-3, for
Danish: (q 12 timer), dag 2-3, i 4 cyklus
English: In an oral pre- and postnatal development study in rats, red vaginal discharge was noted in the 45 mg/kg/day group on either day 14 or day 15 of gestation.
Danish: I et oralt præ- og postnatalt udviklingsstudie med rotter sås rødt, vaginalt udflåd i gruppen med
English: Imatinib medac 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Danish: Imatinib medac 100 mg hårde kapsler Hver hård kapsel indeholder 100 mg imatinib (som mesilat).
English: Other medicines and Imatinib medac
Danish: Den sædvanlige dosis af Imatinib medac er
English: Pharmacokinetics of imatinib
Danish: Imatinibs farmakokinetik
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,
English: Each 100 mg hard capsule of Imatinib medac contains 100 mg imatinib (as mesilate).
Danish: Hver 100 mg hård kapsel Imatinib medac indeholder 100 mg imatinib (som mesilat).
English: Imatinib medac 100 mg hard capsules Each hard capsule contains 12.518 mg lactose monohydrate.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Imatinib medac 100 mg hårde kapsler Hver hårde kapsel indeholder 12,518 mg lactosemonohydrat.
English: Transformed CML is the stage of the disease after its progression from chronic phase to accelerated phase (AP) or blast crisis (BC).
Danish: 1 Pneumoni blev oftest observeret hos patienter med transformeret CML og hos patienter med GIST.Transformeret CML er sygdommens fase efter progression fra den kroniske fase til den accelererede fase (AP) eller blastkrise (BC) 2 Hovedpine var hyppigst hos GIST-patienter.
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Danish: 9/l, gentages trin 1 og imatinib <50 x 10 reintroduceres med nedsat dosering på 400 mg.
English: Ifosfamide (1.8 g/m2/day, IV): days 1-5
Danish: Ifosfamid (1,8 g/m²/dag, i.v.
English: Laboratory test abnormalities
Danish: Afvigelser i laboratorieværdier
English: 9/l) and thrombocytopenias (platelet count < 50 x 10
Danish: 9/l trombocytter <50 x 10