natgillin/translations-raw huggingface dataset:
400 mg imatinib to gange dagligt havde en inhibitorisk effekt på CYP2D6-medieret metoprololmetabolisme, som gav en stigning af Cmax og AUC 
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]).
Kapselskallen (til 400 mg kapslen) består af gelatine, gul jernoxid (E172), titanidioxid (E171) rød jernoxid (E172) og sort jernoxid (E172). 
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).
Perikardit*, hjertetamponade* 
Pericarditis*, cardiac tamponade* Vascular disorders
• Mavesmerter med kvalme. 
• Stomach pain with feeling sick (nausea).
Hos børn, der er i behandling med imatinib, anbefales tæt monitorering af væksten (se pkt. 
Close monitoring of growth in paediatric patients under treatment with imatinib is recommended (see section 4.8).
Imatinib medac 100 mg hårde kapsler Imatinib medac 400 mg hårde kapsler 
Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules
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 
G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
Kapselskallen (til 100 mg kapslen) består af gelatine, gul jernoxid (E172), titanidioxid (E171) rød jernoxid (E172). 
The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
• 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. 
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.
eller p.o. q6h x 6 doses)iii: dag 2 og 3 
IV or PO q6h x 6 doses)iii:
= 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 
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
Er du i tvivl, så spørg lægen, på apoteket eller sygeplejersken. 
• If you have any further questions, ask your doctor, pharmacist or nurse.
Imatinib medac indeholder: 
What Imatinib medac contains
10 Muskuloskeletale smerter og relaterede hændelser blev observeret oftere hos patienter med 
10) Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
9/l, gentag trin 1 og genoptag <50 x 10 behandling med imatinib i en reduceret dosis på 260 mg/m². 
9/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m
• Have kvalme med diarré og opkastning, mavesmerter eller feber (tegn på tarmproblemer). 
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel
Forhøjet serumkreatinin, forhøjet serumkreatinkinase og forhøjetserumlaktatdehydrogenase, forhøjet alkalisk fosfatase 
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
• Kvalme opkastninger, diarré eller fordøjelsesbesvær. 
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
De gastrointestinale tumorer kan have været blødningskilden ved den gastrointestinale blødning (se pkt. 
GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Plasmaeksponeringen af levothyroxin kan muligvis mindskes, når imatinib gives samtidig til thyreoidektomerede patienter (se pkt. 
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Det er rapporteret, at samtidig brug med L-asparaginase kan være associeret med øget hepatotoksicitet (se pkt. 
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).
MESNA (360 mg/m²/dosis hver 3 time, x 8 doser/dag, i.v. 
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5
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. 
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.
Hypertension, hæmatom, subduralt hæmatom, kuldefornemmelser i ekstremiteter, hypotension, Raynaud's syndrom 
Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
I dyremodeller, hvor der anvendes Bcr-Abl-positive tumorceller, har stoffet som enkeltstof in vivo antitumoraktivitet. 
In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
9l og trombocytter ≥20 x 10 
9/l and platelets ≥ 20 x 10
• Kraftige mavesmerter, blod i opkast, afføring eller urin, sortfarvet afføring (tegn på mave-tarm 
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of
• Hvis du er bekymret for din frugtbarhed, mens du tager Imatinib medac, skal du kontakte din 
• Patients who are concerned about their fertility while taking Imatinib medac are advised to
Kvalme, diarré, opkast, dyspepsi, abdominalsmerter 
Gastrointestinal disorders Very common: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain
Alt efter bivirkningernes sværhedsgrad kan behandlingen derefter genoptages. 
Thereafter, treatment can be resumed as appropriate depending on the initial severity of the event.
(1 time), dag 28-31, 
(1 h), days 28-31, 35-38, 42-45;
17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE 
UNIQUE IDENTIFIER - 2D BARCODE {2D barcode carrying the unique identifier included.}
9/l, gentag trin 1 og genoptag <50 x 10 behandling med imatinib i en reduceret dosis på 300 mg. 
9/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Studie AUS01 Induktions-konsoliderende behandling 
Study AUS01
Imatinib medac er en behandling til voksne, børn og unge mod: 
Imatinib medac is a treatment for adults and children and adolescents for:
8 Der er rapporteret tilfælde af letalt leversvigt og levernekrose. 
8) Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
Hvornår og hvordan skal du tage Imatinib medac 
When and how to take Imatinib medac • Take Imatinib medac with a meal.
Konsolidering blok 2 (3 uger) 
Consolidation block 2 (3 weeks)
Konsolidering blok 1 (3 uger) 
Consolidation block 1 (3 weeks)
PEG-ASP (2.500 IE/m², i.m. 
PEG-ASP (2500 IUnits/m2, IM): day 4
Reinduktion blok 2 (3 uger) 
Reinduction block 2 (3 weeks)
I fire publikationer var der rapporteret om fem (5) patienter med MDS/MPD forbundet med PDGFR-omlejring. 
Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
Induktionsbehandling I 
Therapeutic indication
VP-16 (100 mg/m²/dag, i.v. 
VP-16 (100 mg/m2/day, IV): days 1-5
Reinduktion blok 1 (3 uger) 
Reinduction block 1 (3 weeks)
LÆGEMIDLETS NAVN Imatinib medac 400 mg hårde kapsler imatinib 
NAME OF THE MEDICINAL PRODUCT Imatinib medac 400 mg hard capsules Imatinib
LÆGEMIDLETS NAVN Imatinib medac 100 mg hårde kapsler imatinib 
NAME OF THE MEDICINAL PRODUCT Imatinib medac 100 mg hard capsules Imatinib
Imatinib medac er også en behandling til børn og unge med: 
Imatinib medac is also a treatment for children and adolescents for:
ARA-C (3 g/m²/dosis q 12 h x 4, i.v. 
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Meget almindelig: Almindelig: 
Very common: Headache Common:
Hver 400 mg hård kapsel Imatinib medac indeholder 400 mg imatinib (som mesilat). 
Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate).
): dag 1 og 15 Leucovorin (75 mg/m² i time 36, i.v. 
Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Farmakokinetik hos børn 
Pharmacokinetics in paediatric patients
Start 6-MP den første dag 
Start 6-MP the 1st day after cranial irradiation completion.)
Hos 4 % af GIST-patienterne blev undersøgelsesmedicinen seponeret på grund af behandlingsrelaterede bivirkninger. 
In GIST the investigational medicinal product was discontinued for imatinib-related adverse reactions in 4 % of patients.
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. 
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
• 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). 
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Nyrer og urinveje 
Pleural effusion
Disse patienter fik imatinib i en periode varierende mellem 24 dage og 60 måneder (median 47 måneder). 
These patients received imatinib for a median of 47
Periorbitalt ødem, dermatitis/eksem/udslæt 
Skin and subcutaneous tissue disorders Very common: Periorbital oedema, dermatitis/eczema/rash
• voksne patienter med myelodysplastisk syndrom/myeloproliferative sygdomme (MDS/MPD) 
• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Imatinib medac 400 mg hårde kapsler Hver hård kapsel indeholder 400 mg imatinib (som mesilat). 
Imatinib medac 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
(q 12 timer), dag 2-3, i 4 cyklus 
(q 12 h), days 2-3, for
I et oralt præ- og postnatalt udviklingsstudie med rotter sås rødt, vaginalt udflåd i gruppen med 
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.
Imatinib medac 100 mg hårde kapsler Hver hård kapsel indeholder 100 mg imatinib (som mesilat). 
Imatinib medac 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Den sædvanlige dosis af Imatinib medac er 
Other medicines and Imatinib medac
Imatinibs farmakokinetik 
Pharmacokinetics of imatinib
7, sure opstød, melæna, betændelse i spiserøret, ascites, mavesår, hæmatemese, cheilitis, dysfagi, 
7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Hver 100 mg hård kapsel Imatinib medac indeholder 100 mg imatinib (som mesilat). 
Each 100 mg hard capsule of Imatinib medac contains 100 mg imatinib (as mesilate).
Hjælpestof(fer), som behandleren skal være opmærksom på Imatinib medac 100 mg hårde kapsler Hver hårde kapsel indeholder 12,518 mg lactosemonohydrat. 
Imatinib medac 100 mg hard capsules Each hard capsule contains 12.518 mg lactose monohydrate.
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. 
Transformed CML is the stage of the disease after its progression from chronic phase to accelerated phase (AP) or blast crisis (BC).
9/l, gentages trin 1 og imatinib <50 x 10 reintroduceres med nedsat dosering på 400 mg. 
9/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Ifosfamid (1,8 g/m²/dag, i.v. 
Ifosfamide (1.8 g/m2/day, IV): days 1-5
Afvigelser i laboratorieværdier 
Laboratory test abnormalities
9/l trombocytter <50 x 10 
9/l) and thrombocytopenias (platelet count < 50 x 10
Flatulens, abdominal udspiling, gastrooesophageal refluks, obstipation, mundtørhed, gastritis 
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry
(24 timer), dag 4; 
(24 h), days 1, 15;
Daunorubicin 45 mg/m² i.v., dag 6-7, 13 
VCR 2 mg i.v., days 6, 13, 20; Daunorubicin 45 mg/m i.v., days 6-7, 13-14
• Hvis du behandles for DSFP: Dosis er 800 mg pr. dag, der skal tages som 1 kapsel med 400 mg om morgenen og 1 kapsel 
The dose is 800 mg per day, to be taken as 1 capsule of 400 mg in the morning and 1 capsule of
• Hvis du behandles for HES/CEL: Startdosis er 100 mg, som skal tages som 1 kapsel med 100 mg én gang dagligt. 
The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day.
I tre publikationer var der rapporteret om tre (3) patienter med HES og CEL forbundet med PDGFR-omlejring. 
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3 publications.
Imatinib medac 100 mg hårde kapsler Hårde kapsler str. ”3” med orange under- og overdel. 
Imatinib medac 100 mg hard capsules Size “3” hard capsules with orange body and cap. Imatinib medac 400 mg hard capsules Size “00” hard capsules with caramel body and cap.
Imatinib medac 100 mg hårde kapsler Kapselindhold 
Imatinib medac 100 mg hard capsules Capsule content
Imatinib medac 400 mg hårde kapsler Kapselindhold 
Imatinib medac 400 mg hard capsules Capsule content
(0,5 time), dag 7, 8, 14, 
(0.5 h), days 7, 8, 14, 15; i.v., days 22-25, 29-32
0,3-2 gange den gennemsnitlige pædiatriske eksponering ved den højest anbefalede dosis på 340 mg/m². 
In the juvenile toxicology study, effects upon growth, delay in vaginal opening and preputial separation were observed at approximately 0.3 to 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hårde kapsel indeholder 100 mg imatinib (som mesilat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg of imatinib (as mesilate).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hårde kapsel indeholder 400 mg imatinib (som mesilat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 400 mg of imatinib (as mesilate).
Reaktivering af hepatitis B* Benigne, maligne og uspecificerede tumorer (inkl. 
Neoplasm benign, malignant and unspecified (including cysts and polyps)
• Hvis du behandles for MDS/MPD: Startdosis er 400 mg, som skal tages som 1 kapsel med 400 mg én gang dagligt. 
The starting dose is 400 mg, to be taken as 1 capsule of 400 mg once a day.
Dette gælder også medicin, som ikke er købt på recept (såsom paracetamol), inklusive naturlægemidler (såsom perikon). 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John's Wort).
Yderligere er 162 patienter med HES/CEL i alderen 11 til 78 år omtalt i 35 publicerede kasuistikker og behandlingsserier. 
A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Der bør udvises forsigtighed ved behandling af patienter med svært nedsat nyrefunktion. 
Patients with severe renal impairment should be treated with caution.
Patienternes alder varierede fra 25 til 
The age of these patients ranged from 25 to 72 years.
Hvis du har glemt at tage Imatinib medac 
How to store Imatinib medac
Hæmoragisk corpus luteum/ hæmoragisk ovariecyste Almene symptomer og reaktioner på administrationsstedet 
Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administration site conditions Very common: Fluid retention and oedema, fatigue
Brug af anden medicin sammen med Imatinib medac Fortæl altid lægen, på apoteket eller sygeplejersken, hvis du tager anden medicin eller har gjort det for nylig. 
During treatment with Imatinib medac, tell your doctor straight away if you put on weight very quickly.
Hos ca. 2,5 % af nyligt diagnosticerede CML-patienter i behandling med imatinib er der rapporteret tilfælde af svær væskeretention (pleuraekssudat, ødem, pulmonalt ødem, ascites, perifert ødem). 
Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5 % of newly diagnosed CML patients taking imatinib.
): dag 1-5 
days 3-5;
De blev behandlet med imatinib i doser fra 75 mg til 800 mg dagligt. 
Patients were treated at doses of imatinib of 260 mg/m2/day
• Flåd fra øjet med kløe, rødme og hævelse (betændelse af øjets bindehinde), øget tåreflåd eller 
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or
DFSP 
medac
Methotrexat (5 g/m² over 24 timer, i.v. 
Methotrexate (5 g/m over 24 hours, IV): days 1 and 15 at hour 36, IV; 15 mg/m
9/l og trombocytter ≥20 x 10 9/l og genoptag herefter behandlingen med 300 mg. 
9/l, then resume treatment at 300 mg.
VCR 2 mg total dose i.v., dag 1, 8, 15, 22; CP 750 mg/m² i.v., dag 1, 8; 
i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22;
Gul jernoxid (E 172) Titandioxid (E 171) Rød jernoxid (E 172) 
Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172)
Nyresmerter, hæmaturi, akut nyresvigt, øget vandladningsfrekvens 
Renal pain, haematuria, renal failure acute, urinary frequency increased
Gul jernoxid (E 172) Titandioxid (E 171) Rød jernoxid (E 172) Sort jernoxid (E 172) 
Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172)
MTX 15 mg intrathecal, dag 1, 8, 15, 22; Ara-C 40 mg intrathecal, dag 1, 8, 15, 22; Methylprednisolon 40 mg intrathecal, dag 1, 8, 15, 22 
MTX 15 mg intrathecal, days 1, 8, 15, 22;
(3 timer), dag 1-4; 
(1 h) days 4-5;
VCR (1,5 mg/m²/dag, i.v. 
VCR (1.5 mg/m 2/day, IV): days 1, 29
• Udslæt. 
• Bruising.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug. 
Read the package leaflet before use.
• børn med nydiagnosticeret Philadelphia-kromosom (bcr-abl) positiv (Ph+) kronisk myeloid leukæmi (CML), for hvilke knoglemarvstransplantation ikke anses for førstevalgsbehandling. 
chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as
DEX 10 mg/m² oral, dag 6-7, 13-16; VCR 1 mg i.v., dag 7, 14; 
Remission induction DEX 10 mg/m oral, days 6-7, 13-16; i.v.
NEL: Samme kriterier som for CHR, men ANC ≥1 x 10 
9/l, no blood blasts, BM blasts < 5 % and no extramedullary disease] NEL: Same criteria as for CHR but ANC ≥ 1 x 10
Dette vil hjælpe med at beskytte dig mod maveproblemer, når du tager Imatinib medac. 
Your doctor will discuss with you the possible risks of taking Imatinib medac during
Den anbefalede dosis af imatinib er 600 mg/dag til voksne patienter med Ph+ ALL.Gennem alle faser af omsorgen bør behandlingen overvåges af hæmatologiske eksperter, som er ansvarlige for denne sygdom. 
The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
Tumorlysesyndrom 
Liver dysfunction
(3 timer), dag 1; Daunorubicin 60 mg/m² i.v. 
(3 h), days 1-4; Mitoxantrone 10 mg/m i.v.
Dosering ved HES/CEL hos voksne patienter Den anbefalede dosis af imatinib er 100 mg/dag til voksne patienter med HES/CEL. 
The recommended dose of imatinib is 100 mg/day for patients with HES/CEL.
Blod og lymfesystem 
Tumour lysis syndrome
Imatinib medac 100 mg hårde kapsler er gelatinekapsler i størrelse ”3” med orange over- og underdel. 
What Imatinib medac looks like and contents of the pack Imatinib medac 100 mg hard capsules are gelatin capsules of size “3” with orange body and cap. Imatinib medac 400 mg hard capsules are gelatin capsules of size “00” with caramel body and cap. Imatinib medac 100 mg capsules are supplied in packs containing 60 capsules in blisters.
gastric antral vascular ectasia (GAVE)* 
terfenadine, bortezomib, docetaxel and quinidine).
G-CSF (5 μg/kg, s.c.): dag 27-36, eller indtil ANC >1500 post nadir ARA-C (3 g/m², q12h, i.v. 
Triple IT therapy (age-adjusted): days 1 and 22 2/day, IV): days 22-26 2/day, IV): days 22-26 2/day, IV): days 22-26 G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir 2, q12h, IV): days 43, 44 2, IM): day 44
Men hvis det næsten er tid til at tage den næste dosis, skal du springe den glemte dosis over. 
However if it is nearly time for the next
4.4, 4.8 og 5.2). 
The dose can be reduced if not tolerated (see sections 4.4, 4.8 and 5.2).
månedligt i 13 måneder; Prednisolon 200 mg oral, 5 dag per måned i 13 måneder 
Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
VCR 1,3 g/m² i.v., dag 1; Prednisolon 60 mg/m² oral, dag 1-5 
Consolidation therapy DEX 10 mg/m oral, days 1-5; Vindesine 3 mg/m i.v., day 1;
= intravenøs, s.c. = subkutan, i.t. 
Induction-consolidation therapy i.v.
(24 timer), dag 1, 15; 6-MP 25 mg/m² oral, dag 1-20 
over 24 hours, IV): days 1 and 15 at hour 36, IV; 15 mg/m
Øjenirritation, øjensmerter, orbitalt ødem, sclerablødning, retinablødning, 
Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
(1 time), dag 1-3; 
(1 h), days 1-5; i.v.
(1 time) dag 1; Ara-C 60 mg/m² i.v., dag 22-25, 29-32 
2/day PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 8-28 Methotrexate (20 mg/m 2/week, PO): days 8, 15, 22
Afhængigt af den sygdom, der behandles, kan patienterne også gives andre lægemidler. 
Depending on the condition being treated, the patients can also be given other medicines.
MabThera fik en markedsføringstilladelse med gyldighed i hele EU den 2. juni 1998. 
MabThera received a marketing authorisation valid throughout the EU on 2 June 1998.
Yderligere information om MabThera findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/mabthera. 
Further information on MabThera can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/mabthera.
Som for alle lægemidler bliver data vedrørende brugen af MabThera løbende overvåget. 
As for all medicines, data on the use of MabThera are continuously monitored.
I et andet studie hos 117 patienter så man nærmere på andelen af patienter, hvis sygdom vendte tilbage inden for 28 måneder. 
A second study in 117 patients looked at the proportion of patients whose condition came back within 28 months.
Andre oplysninger om MabThera 
Other information about MabThera
Patienter med blodkræft kan skifte til en injektion under huden, efter at de har fået en komplet dosis af infusionen. 
Patients with blood cancers can switch to an injection given under the skin after they have received one full dose of the infusion.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af MabThera? 
What measures are being taken to ensure the safe and effective use of MabThera?