FrancophonIA/ELRC3.0 huggingface dataset:
English: Induction therapy (de novo Ph+ ALL)
Danish: Induktionsbehandling (de novo Ph+ ALL)
English: DEX (6 mg/m2/day PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 8-28
Danish: DEX (6 mg/m2/dag p.o.): dag 1-5; 29-33 6-MP (75 mg/m2/dag, p.o.): dag 8-28
English: (24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20
Danish: (24 timer), dag 1, 15; 6-MP 25 mg/m2 oral, dag
English: Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Danish: Nydiagnostiseret Ph+ ALL: I et kontrolleret studie (ADE10) hvor imatinib blev sammenlignet med kemoterapi-induktion hos 55 nydiagnostiserede patienter i alderen 55 år og derover, gav imatinib brugt som monoterapi anledning til en signifikant højere ratio af hæmalogisk respons end kemopterapi (96,3% vs. 50%, p=0,0001).
English: How long to take Imatinib Actavis
Danish: Hvor længe skal du tage Imatinib Actavis
English: If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
Danish: Hvis der opstår alvorlige ikke-hæmatologiske bivirkninger ved behandling med imatinib, skal behandlingen seponeres, indtil bivirkningerne er ophørt Herefter kan behandlingen genoptages alt efter den oprindelige alvorlighed af bivirkningen.
English: For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Danish: Imatinib monoterapi med 600 mg/dag er sikker og effektiv hos voksne patienter med recidiverende eller refraktiv Ph+ALL, og kan gives indtil der sker sygdomsprogression.
English: days 3-5; MTX 15 mg intrathecal, day 1; methylprednisolone 40 mg intrathecal, day 1
Danish: dag 3-5; MTX 15 mg intrathecal, dag 1; Methylprednisolon 40 mg intrathecal, dag 1
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: What you need to know before you take Imatinib Actavis
Danish: Det skal du vide, før du begynder at tage Imatinib Actavis
English: Imatinib Actavis contains sodium
Danish: Imatinib Actavis indeholder natrium
English: Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
Danish: Tredobbelt i.t.-terapi (aldersjusteret): dag 1, 29 VCR (1,5 mg/m2, i.v.
English: Clinical studies in DFSP One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Danish: Der er udført et åbent multicenter fase II-klinisk forsøg (studie B2225) med inklusion af 12 patienter med DFSP, som blev behandlet med imatinib 800 mg daglig.
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/m2 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: The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 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: Active substances that may have their plasma concentration altered by imatinib:
Danish: Aktive stoffer hvis plasmakoncentration kan ændres af imatinib:
English: DAUN (45 mg/m2/day bolus, IV): days 1 and 2
Danish: DAUN (45 mg/m2/dag bolus, i.v.
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: Stoffer der hæmmer cytochrom P450 isoenzym CYP3A4-aktivitet (f.eks. proteasehæmmere som f.eks. indinavir, lopinavir/ritonavir, ritonavir, saquinavir, teleprevir, nelfinavir, boceprevir; azol-antimykotika inklusiv ketoconazol, itraconazol, , posaconazol, voriconazol; bestemte makrolider som f.eks. erythromycin, clarithromycin og telithromycin) kan nedsætte metabolismen og øge koncentrationen af imatinib.
English: of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Danish: Elimination Baseret på fremkomne stof(fer) efter oral dosis af 14-mærket imatinib, genfandtes ca. 81 % af dosis inden for 7 dage i fæces (68 % af dosis) og urin (13 % af dosis).
English: Haemolytic anaemia, thrombotic microangiopathy
Danish: Hæmolytisk anæmi, trombotisk mikroangiopati
English: - Pain or swelling in your abdomen, flatulence, heartburn or constipation.
Danish: - Smerte eller oppustning af maven, luft i maven, halsbrand eller forstoppelse.
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/m2 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: The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m2 once daily (not exceeding 400 mg once daily) or 340 mg/m2 once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Danish: Analysen bekræftede, at imatinib-eksponeringen hos børn, som fik 260 mg/m2 en gang daglig (højst 400 mg en gang daglig) eller 340 mg/m2 en gang daglig (højst 600 mg en gang daglig),
English: Posology for HES/CEL The recommended dose of imatinib is 100 mg/day for adult patients with HES/CEL.
Danish: Dosering ved HES/CEL Den anbefalede dosis af imatinib er 100 mg/dag til voksne patienter med HES/CEL.
English: Active substances that may increase imatinib plasma concentrations:
Danish: Aktive stoffer der kan øge plasmakoncentrationen af imatinib:
English: Specifar ABEE Τηλ: +30 2105401500
Danish: Ελλάδα Τηλ: +30 2105401500
English: 15 mg intrathecal, days 1, 8, 15, 22; Ara-C 40 mg intrathecal, days 1, 8, 15, 22; methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Danish: 1, 8, 15, 22; Ara-C 40 mg intrathecal, dag 1, 8, 15, 22; Methylprednisolon 40 mg intrathecal, dag 1, 8, 15, 22
English: Other medicines and Imatinib Actavis
Danish: Brug af anden medicin sammen med Imatinib Actavis
English: Weakness, pyrexia, anasarca, chills, rigors
Danish: Svaghed, pyrexia, anasarka, kuldegysninger og kulderystelser
English: There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Danish: Der ikke gennemført kontrollerede undersøgelser, der har vist klinisk bedring eller øget overlevelse ved disse sygdomme.
English: Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Danish: Lignende resultater blev observeret hos patienter med maligne gliomer behandlet med imatinib samtidig med indtagelse af enzyminducerende antiepileptiske lægemidler (EIAEDs) som carbamazepin, oxcarbazepin og phenytoin Plasma AUC for imatinib blev reduceret med 73 % sammenlignet med patienter som ikke blev behandlet med EIAEDs.
English: - The other ingredients are: Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous).
Danish: - Øvrige indholdsstoffer: Kapselindhold: mikrokrystallinsk cellulose, copovidon, crospovidon, natriumstearylfumarat, silica (vandskyende kolloid, kolloid vandfri).
English: - Nose bleeds.
Danish: - Næseblod.
English: Shellac Glaze-45% Black iron oxide (E172) Propylene glycol Ammonium Hydroxide 28%
Danish: Shellac Glaze-45% Sort jernoxid (E172) Propylenglycol Ammoniumhydroxid 28%
English: - Bruising.
Danish: - Udslæt.
English: Return to chronic phase (RTC) Major cytogenetic response2
Danish: (RTC) Cytogenetisk hovedrespons2
English: (3 h), day 1; daunorubicin 60 mg/m2 i.v.
Danish: (3 timer), dag 1; Daunorubicin 60 mg/m2 i.v.
English: Common (may affect up to 1 in 10 people): - Anorexia, weight loss or a disturbed sense of taste.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 brugere): - Appetitløshed, vægttab eller smagsforstyrrelser.
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, non-randomised 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-randomiseret fase III sekventielt kohorte-forsøg.
English: Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8; prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28; MTX
Danish: Daunorubicin 30 mg/m2 i.v., dag 1-3, 15-16; VCR 2 mg total dose i.v., dag 1, 8, 15, 22; CP 750 mg/m2 i.v., dag 1, 8; Prednison 60 mg/m2 oral, dag 1-7, 15-21; IDA 9 mg/m2 oral, dag 1-28; MTX 15 mg intrathecal, dag
English: Active substances that may decrease imatinib plasma concentrations:
Danish: Aktive stoffer der kan reducere plasmakoncentrationen af imatinib:
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Danish: Trombocytæmi, lymfopeni, knoglemarvsdepression, eosinofili, lymfadenopati
English: (q 12 h), days 2-3, for
Danish: (q 12 timer), dag 2-3, i 4
English: (1 h), days 1-5; VM26 60 mg/m2 i.v.
Danish: (1 time), dag 1-5; VM26 60 mg/m2 i.v.
English: Posology for DFSP The recommended dose of imatinib is 800 mg/day for adult patients with DFSP.
Danish: Dosering ved DFSP Den anbefalede dosis af imatinib er 800 mg/dag til voksne patienter med DSFP.
English: Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.
Danish: Patienterne bør, på baggrund af risikoen for øget bivirkningsincidens ved højere doser, monitoreres tæt efter dosistitrering.
English: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Danish: Palpitationer, takykardi, hjerteinsufficiens3, lungeødem
English: Imatinib Actavis is indicated for the treatment of - paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
Danish: Imatinib Actavis er indiceret til behandling af - børn med nydiagnosticeret Philadelphiakromosom (bcr-abl) positiv (Ph+) kronisk myeloid leukæmi
English: Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Danish: ULN = laboratoriets øvre normalgrænse ASAT = aspartataminotransferase
English: - Stomach pain with feeling sick (nausea).
Danish: - Mavesmerter med kvalme.
English: In Ph+ ALL patients, there is clinical experience of co-administering imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Danish: 5.1) til patienter med Ph+ ALL, men specifikke interaktionsstudier mellem imatinib og kemoterapiregimer er ikke tilstrækkeligt karakteriseret.
English: - Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
Danish: - Have kvalme med diarré og opkastning, mavesmerter eller feber (tegn på tarmproblemer).
English: Handling of opened capsules by women of child-bearing potential Since studies in animals have shown reproductive toxicity, and the potential risk for the human foetus is unknown, women of child-bearing potential who open capsules should be advised to handle the contents with caution and avoid skin-eye contact or inhalation (see section 4.6).
Danish: Da dyreforsøg har vist reproduktionstoksicitet, og den potentielle risiko for humane fostre er ukendt, bør kvinder i den fødedygtige alder tilrådes at udvise forsigtighed ved åbning af kapsler og håndtering af indholdet, og undgå hud- og øjenkontakt eller inhalation (se pkt.
English: DEX (6 mg/m2/day, PO): days 1-5; 29-33
Danish: DEX (6 mg/m2/dag, p.o.): dag 1-5; 29-33
English: Your doctor will tell you exactly how many tablets of Imatinib Actavis to take.
Danish: Din læge vil fortælle dig, præcis hvor mange Imatinib Actavis-tabletter, du skal tage.
English: NEL Same criteria as for CHR but ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB,
Danish: RTC <15 % blaster I BM og PB, <30 % blaster + promyelocytter in BM og PB, <20 % basofilocytter i
English: Pack sizes: The capsules are supplied in aluminium blister packs of 30 or 90 capsules.
Danish: Kapslerne findes i blisterpakninger af aluminium med 30 eller 90 kapsler.
English: The doctor will tell you how many tablets of Imatinib Actavis to give to your child.
Danish: Lægen vil fortælle dig, hvor mange Imatinib Actavis-tabletter, du skal give dit barn.
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: Printing ink: shellac, black iron oxide (E172), propylene glycol, ammonia solution, potassium hydroxide.
Danish: Prægeblæk: shellac, sort jernoxid (E172), propylenglycol, ammoniakopløsning, kaliumhydroxid.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. filmovertrukket tablet, dvs. det er i det væsentlige natrium-frit.
English: Induction therapy CP 1.2 g/m2 i.v.
Danish: Induktionsbehandling CP 1,2 g/m2 i.v.
English: Joint and muscle stiffness
Danish: Stivhed i led og muskler
English: Remission induction DEX 10 mg/m2 oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14; IDA 8 mg/m2 i.v.
Danish: Remissionsinduktion DEX 10 mg/m2 oral, dag 6-7, 13-16; VCR 1 mg i.v., dag 7, 14; IDA 8 mg/m2 i.v.
English: Printing ink: shellac glaze-45%, black iron oxide (E172), propylene glycol, ammonium Hydroxide 28%.
Danish: Prægeblæk: shellac glaze-45%, sort jernoxid (E172), propylenglycol, ammonium hydroxid 28%.
English: The doctor will tell you how many capsules of Imatinib Actavis to give to your child.
Danish: Lægen vil fortælle dig, hvor mange Imatinib Actavis-kapsler, du skal give dit barn.
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: G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44
Danish: G-CSF (5 μg/kg, s.c.): dag 27-36, eller indtil ANC >1500 post nadir ARA-C (3 g/m2, q12h, i.v.
English: Iron oxide yellow (E172) Titanium dioxide (E171) Iron oxide red (E172) Lecithin (soya) (E322) Xanthan gum (E415)
Danish: Jernoxid, gul (E 172) Titandioxid (E171) Jernoxid, rød (E 172) Lecithin (soya) (E322) Xanthangummi (E415)
English: EU/1/13/825/003 24 capsules EU/1/13/825/004 48 capsules EU/1/13/825/019 60 capsules EU/1/13/825/005 96 capsules EU/1/13/825/006 120 capsules EU/1/13/825/007 180 capsules
Danish: EU/1/13/825/003 24 kapsler EU/1/13/825/004 48 kapsler EU/1/13/825/019 60 kapsler EU/1/13/825/005 96 kapsler EU/1/13/825/006 120 kapsler EU/1/13/825/007 180 kapsler
English: (1 h), days 1-3; vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21; prednisolone 60 mg/m2/day oral
Danish: (1 time), dag 1-3; Vinkistin 1,3 mg/m2 i.v., dag 1, 8, 15, 21; Prednisolon 60
English: Pack sizes: The tablets are supplied in aluminium blister packs of 10, 30, 60 or 90 film-coated tablets.
Danish: Pakningsstørrelser Tabletterna findes i blisterpakninger af aluminium med 10, 30, 60 eller 90 filmovertrukne tabletter
English: (1 h) days 4-5; Ara- C 2x 2 g/m2 i.v.
Danish: (1 time) dag 4-5; Ara-C 2x 2 g/m2 i.v.
English: Imatinib Actavis 400 mg film-coated tablets 21 month
Danish: Imatinib Actavis 400 mg filmovertrukne tabletter 21 måneder
English: (24 h), day 1; etoposide 250 mg/m2 i.v.
Danish: (24 timer), dag 1; Etoposid 250 mg/m2 i.v.
English: Imatinib Actavis 50 mg hard capsules Imatinib Actavis 100 mg hard capsules Imatinib Actavis 400 mg hard capsules
Danish: Imatinib Actavis 50 mg hårde kapsler Imatinib Actavis 100 mg hårde kapsler Imatinib Actavis 400 mg hårde kapsler
English: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions
Danish: Pustuløst udslæt, kontusion, øget svedtendens, urticaria, ecchymose, let til knubs og mærker, hypotrichosis, hypopigmentering af huden, dermatitis exfoliativa, onychoclasi, folliculitis, petechier, psoriasis, purpura, hyperpigmentering af huden, bulløst udslæt
English: (3 h), days 1-4; mitoxantrone 10 mg/m i.v.
Danish: (3 timer), dag 1-4; Mitoxantron 10 mg/m i.v.
English: How much Imatinib Actavis to take Use in adults
Danish: Den sædvanlige dosis af Imatinib Actavis er Brug til voksne
English: Your doctor will tell you exactly how many capsules of Imatinib Actavis to take.
Danish: Din læge vil fortælle dig, præcis hvor mange Imatinib Actavis-kapsler, du skal tage.
English: Black iron oxide (E172) Propylene glycol Ammonia solution Potassium hydroxide
Danish: Sort jernoxid (E172) Propylenglycol Ammoniakopløsning Natriumhydroxid
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Tabel 1 Opsummering af bivirkninger
English: aANC < 0.5 x 109/L and/or platelets < 10 x 109/L
Danish: aANC < 0,5 x 109/l og/eller trombocytter < 10 x 109/l
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 imatinib, potentially increasing the risk of therapeutic failure.
Danish: Stoffer, der inducerer CYP3A4-aktivitet (f.eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital, fosphenytoin, primidon eller Hypericum perforatum), kan signifikant reducere følsomheden for imatinib og dermed potentielt øge risikoen for terapeutisk svigt.
English: (24 h), day 4;
Danish: (1 time) dag 4-5;
English: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Danish: Forhøjet serumkreatinin, forhøjet serumkreatinfosfokinase og øget serumlaktatdehydrogenase, forhøjet alkalisk fosfatase
English: Imatinib Actavis 100 mg film-coated tablets 2 years
Danish: Imatinib Actavis 100 mg filmovertrukne tabletter 2 år
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/L) and thrombocytopenia (platelet count < 10 x 109/L) were observed in 3.6% and < 1% of patients, respectively.
Danish: Der sås 4. grads neutropeni (ANC <0,5 x 109/l) og trombopeni (trombocyttal <10 x 109/l) hos henholdsvis 3,6 % og < 1 % af patienterne med nydiagnosticeret CML i kronisk fase.
English: - Dry mouth, dry skin or dry eye. - Decreased or increased skin sensitivity.
Danish: - Mundtørhed, tør hud eller tørre øjne.
English: Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Danish: Flatulens, abdominal udspilling, gastrooesophageal refluks, obstipation, mundtørhed, gastritis
English: Renal failure chronic
Danish: Kronisk nyresvigt
English: (24 h), day 1, Ara-C 1 g/m2 i.v.
Danish: (24 timer), dag 1, Ara-C 1 g/m2 i.v.
English: Ifosfamide (1.8 g/m2/day, IV): days 1-5
Danish: Ifosfamid (1,8 g/m2/dag, i.v.
English: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
Danish: (24 timer), dag 4; DEX 40 mg/dag på dag 1-4 og 11-14, supplerende med MTX 1 g/m2 i.v.
English: EU/1/13/825/015 10 tablets EU/1/13/825/016 30 tablets EU/1/13/825/017 60 tablets EU/1/13/825/018 90 tablets
Danish: EU/1/13/825/015 10 tabletter EU/1/13/825/016 30 tabletter EU/1/13/825/017 60 tabletter EU/1/13/825/018 90 tabletter
English: Rare
Danish: Svær
English: GENERAL CLASSIFICATION FOR SUPPLY
Danish: Forhøjede leverenzymer
English: PEG-ASP (2500 IUnits/m2, IM): day 4
Danish: PEG-ASP (2.500 IE/m2, i.m.
English: (24 h), day 1, and Ara-C 2 g/m2 i.v.
Danish: (24 timer), dag 1, og Ara-C 2 g/m2 i.v.
English: Haematological experts in the management of this disease should supervise the therapy throughout all phases of care.
Danish: Gennem alle faser af omsorgen bør behandlingen overvåges af hæmatologiske eksperter, som er ansvarlige for denne sygdom.
English: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22 VP-16 (100 mg/m2, IV): days 29-33
Danish: Methotrexat (20 mg/m2/uge, p.o.): dag 8, 15, 22 VP-16 (100 mg/m2, i.v.
English: Imatinib Actavis 400 mg hard capsules Al/PVC-PVDC blister.
Danish: Imatinib Actavis 400 mg hårde kapsler Aluminium/PVC/PVDC blister.
English: In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.
Danish: Hos 4 % af GIST-patienterne blev undersøgelsesmedicinen seponeret på grund af lægemiddelrelaterede bivirkninger.
English: (3 h), days 1-4; mitoxantrone 10 mg/m2 i.v.
Danish: (3 timer), dag 1-4; Mitoxantron 10 mg/m2 i.v.
English: Stop imatinib until ANC ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.
Danish: Seponer imatinib indtil ANC ≥ 1.5 x 109/l og trombocytter ≥ 75 x 109/l.
English: Sodium stearyl fumarate Silica, hydrophobic colloidal Silica, colloidal anhydrous
Danish: Natriumstearylfumarat Silica, vandskyende kolloid Silica, kolloid vandfri
English: Imatinib Actavis 50 mg hard capsules Al/PVC/Aclar blister.
Danish: Imatinib Actavis 50 mg hårde kapsler Aluminium/PVC/aclar blister.
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 children (based on AUC) at 340 mg/m2/day.
Danish: Renale adenomer/carcinomer, papillomaer i blæren og urinrøret, adenocarcinomer i tyndtarmen, adenomer i bisskjoldbruskkirtlerne, de benigne og maligne tumorer i binyremarven og ikke-kirtellignende ventrikelpapillomaer/carcinomer blev observeret ved 60 mg/kg/dag.
English: Prephase
Danish: Præfase
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Danish: Stomatitis, mundulcera, gastrointestinalblødning7, sure opstød, melæna, betændelse i spiserøret, ascites, mavesår, hæmatemese, cheilitis, dysfagi, pankreatitis
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Danish: LISTE OVER HJÆLPESTOFFER LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE)
English: EU/1/13/825/008 10 tablets EU/1/13/825/009 20 tablets EU/1/13/825/010 30 tablets EU/1/13/825/011 60 tablets EU/1/13/825/012 90 tablets EU/1/13/825/013 120 tablets EU/1/13/825/014 180 tablets
Danish: EU/1/13/825/008 10 tabletter EU/1/13/825/009 20 tabletter EU/1/13/825/010 30 tabletter EU/1/13/825/011 60 tabletter EU/1/13/825/012 90 tabletter EU/1/13/825/013 120 tabletter EU/1/13/825/014 180 tabletter