FrancophonIA/ELRC3.0 huggingface dataset:
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: - Gastrointestinal stromal tumours (GIST).
Danish: - Ondartede bindevævstumorer i mavetarmsystemet (gastrointestinale stromal tumorer (GIST)).
English: Imatinib Teva B.V. is a medicine containing an active substance called imatinib.
Danish: er et lægemiddel, der indeholder et aktivt stof kaldet imatinib.
English: The recommended dose of Imatinib Teva B.V. is 400 mg/day for adult patients with MDS/MPD.
Danish: er 400 mg/dag til voksne patienter med MDS/MPD.
English: Store below 30°C
Danish: Må ikke opbevares ved temperaturer over 30°C.
English: • Pain or swelling in your abdomen, flatulence, heartburn or constipation.
Danish: - Smerte eller oppustning af maven, luft i maven, halsbrand eller forstoppelse.
English: • Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data): - Kombination af omfattende svært udslæt, følelse af at være syg, feber, højt indhold af visse hvide blodlegemer eller gul hud eller øjne (tegn på gulsot) med stakåndethed, brystsmerter/ubehag, svært nedsat urinproduktion og tørst osv. (tegn på en behandlingsrelateret allergisk reaktion).
English: Dizziness, paraesthesia, taste disturbance, hypoaesthesia Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage Increased intracranial pressure, convulsions, optic neuritis
Danish: Svimmelhed, paræstesi, smagsforstyrrelser, hypoæstesi Migræne, døsighed, synkope, perifer neuropati, hukommelsessvigt, iskias, restless leg syndrome, tremor, hjerneblødning Øget interkranielt tryk, kramper, synsnervebetændelse
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-radomiseret fase III sekventielt kohorte-forsøg.
English: 10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in
Danish: 10 Muskuloskeletale smerter og relaterede hændelser blev observeret oftere hos patienter med CML end hos patienter med GIST.
English: What you need to know before you take Imatinib Teva B.V.
Danish: Det skal du vide, før du begynder at tage Imatinib Teva B.V.
English: 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 = 6mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethane 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: Your doctor will discuss with you the possible risks of taking Imatinib Teva B.V. during pregnancy.
Danish: Din læge vil fortælle dig om de mulige risici, der er forbundet med brug af Imatinib Teva B.V.
English: Triple IT therapy (age-adjusted): days 1 and 22 VP-16 (100 mg/m2/day, IV): days 22-26
Danish: Tredobbelt i.t.-terapi (aldersjusteret): dag 1 og 22 VP-16 (100 mg/m2/dag, i.v.
English: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Danish: • voksne patienter med myelodysplastisk syndrom/myeloproliferative sygdomme (MDS/MPD)
English: Imatinib Teva B.V. is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Danish: anvendes også til behandling af voksne med: - Myelodysplastiske/myeloproliferative sygdomme (MDS/MDP).
English: - Chronic myeloid leukaemia (CML).
Danish: er en behandling mod: - Kronisk myeloid leukæmi (CML).
English: C/C, n. 4, Poligono Industrial Malpica
Danish: C/C, n. 4, Poligono Industrial Malpica 50016 Zaragoza
English: Not known (frequency cannot be estimated from the available data):
Danish: meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Description of selected adverse reactions Hepatitis B reactivation
Danish: Reaktivering af hepatitis B*
English: If cytopenia persists for 2 weeks, reduce further to 200 mg/m2.
Danish: Hvis cytopeni vedvarer i 2 uger, reducer dosis yderligere til 200 mg/m2.
English: Active substances that may increase imatinib plasma concentrations 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: The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Danish: Der er kun begrænset erfaring med imatinib hos patienter med MDS/MPD forbundet med PDGFR-omlejring (se pkt.
English: Neoplasm benign, malignant and unspecified (including cysts and polyps) Rare:
Danish: cyster og polypper) Sjælden:
English: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction,
Danish: Palpitationer, takykardi, hjerteinsufficiens3, lungeødem Arytmi, atrieflimren, hjertestop, myokardieinfarkt, angina pectoris,
English: The recommended dose of Imatinib Teva B.V. is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST.
Danish: er 400 mg/dag for adjuverende behandling af voksne efter resektion af GIST.
English: Imatinib Teva B.V. can reduce the number of white blood cells, so you might get infections more easily.
Danish: kan nedsætte antallet af hvide blodlegemer, så du lettere kan få infektioner.
English: (3 h, q 12 h), days
Danish: (3 timer, q 12 timer), dag
English: All patients achieved complete haematological response, cytogenetic response and/or
Danish: Alle patienter opnåede komplet hæmatologisk respons, cytogenetisk repons og/eller klinisk respons.
English: (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 4.5).
Danish: 4.5), CYP3A4-substrater med et snævert terapeutisk vindue (f.eks. ciclosporin, pimozid, tacrolimus, sirolimus, ergotamin, dihydroergotamin, fentanyl, alfentanil, terfenadin, bortezomib, docetaxel, quinidin) eller warfarin og andre coumarin-derivater (se pkt.
English: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase
Danish: Forhøjet serumkreatinin, forhøjet serumkreatinkinase og forhøjet serumlaktatdehydrogenase, forhøjet alkalisk fosfatase
English: Imatinib administration to patients without the genetic translocation generally results in no
Danish: Der ses generelt ingen bedring ved indgift af imatinib til patienter uden genetisk translokation.
English: Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Danish: Methylprednisolon 40 mg intrathecal, dag 1, 8, 15, 22
English: The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients in blast crisis.
Danish: er 600 mg/dag til voksne patienter i blastkrise.
English: The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients with Ph+ ALL.
Danish: er 600 mg/dag til voksne patienter med Ph+ ALL.
English: Respiratory, thoracic and mediastinal disorders Pleural effusion5, pharyngolaryngeal pain, pharyngitis Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary Acute respiratory failure11*, interstitial lung disease* Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6
Danish: Pleuraekssudat5, faryngolaryngeale smerter, pharyngitis Pleuralgi, lungefibrose, pulmonal hypertension, pulmonal blødning respirationssvigt11*, interstitiel lungesygdom* Kvalme, diarré, opkast, dyspepsi, abdominalsmerter6
English: • Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva B.V. or after you have stopped taking Imatinib Teva B.V.
Danish: - Muskelkramper eller led-, muskel- eller knoglesmerter, mens du er i behandling med Imatinib
English: (1 h) days 4-5;
Danish: (1 time) dag 4-5; i.v.
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: MTX 12 mg intrathecal, day 1
Danish: MTX 15 mg intrathecal, dag 1;
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 imatinib.
Danish: Fra tilgængelige sikkerhedsdata ser det ikke ud til, at sikkerhedsprofilen for imatinib 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: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m2 i.v.
Danish: (24 timer), dag 4; DEX 40 mg/dag på dag 1-4 og 11-14, supplerende med MTX 1 g/m2
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 imatinib, 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 imatinib og dermed potentielt øge risikoen for terapeutisk svigt.
English: GIST.
Danish: ul.
English: Carriers of HBV who require treatment with Imatinib Teva B.V. should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Danish: er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt.
English: Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.
Danish: Kronisk myeloid leukæmi er en type leukæmi, hvor nogle bestemte unormale hvide blodlegemer (der kaldes myeloide
English: If any of these apply to you, tell your doctor before taking Imatinib Teva B.V.
Danish: Hvis noget af det ovenstående gælder for dig, skal du fortælle din læge det, før du tager Imatinib
English: L-ASP (6000 IUnits/m2, IM): day 44
Danish: L-ASP (6.000 IE/m2, i.m.
English: Dose adjustments for neutropenia and thrombocytopenia:
Danish: Dosisjusteringer på grund af neutropeni og trombocytopeni
English: Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Danish: Ara-C 40 mg intrathecal, dag 1, 8, 15, 22;
English: Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).
Danish: Samtidig anvendelse af stærke CYP3A4 induktorer og imatinib bør
English: PLIVA Croatia Ltd.
Danish: Pliva Hrvatska d.o.o.
English: (starting dose 340 mg/m2)
Danish: Der anbefales en dosis på 340 mg/m2
English: (24 h), day 1, and Ara-C 2 g/m2 i.v.
Danish: (24 timer), dag 1, og Ara-C 2 g/m i.v.
English: The doctor will tell you how many tablets of Imatinib Teva B.V. to give to your child.
Danish: Lægen vil fortælle dig, hvor mange Imatinib Teva B.V.-tabletter, du skal give dit barn.
English: Your doctor will tell you exactly how many tablets of Imatinib Teva B.V. to take.
Danish: Din læge vil fortælle dig, præcis hvor mange Imatinib Teva B.V.-tabletter, du skal tage.
English: MTX 15 mg intrathecal, days 1, 8, 15, 22;
Danish: MTX 15 mg intrathecal, dag 1, 8, 15, 22;
English: If cytopenia persists for 2 weeks, reduce further to 300 mg. 4.
Danish: Hvis cytopeni vedvarer i 2 uger, reducer dosis yderligere til 300 mg. 4.
English: When and how to take Imatinib Teva B.V. - Take Imatinib Teva B.V. with a meal.
Danish: Hvornår og hvordan skal du tage Imatinib Teva B.V.
English: Other medicines and Imatinib Teva B.V.
Danish: Brug af anden medicin sammen med Imatinib Teva B.V.
English: The doctor will tell you how many capsules of Imatinib Teva B.V. to give to your child.
Danish: Lægen vil fortælle dig, hvor mange Imatinib Teva B.V.-kapsler, du skal give dit barn.
English: If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in
Danish: Hvis din daglige dosis er 800 mg (8 tabletter), skal du tage 4 tabletter om morgenen og 4 tabletter om aftenen.
English: Traces of the dissolved tablets may be left behind in the glass.
Danish: Spor af de opløste tabletter
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 Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP) Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and
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 Akut febril neutrofil dermatose (Sweets syndrom), misfarvning af negle, angioødem, vesikulært udslæt, erythema multiforme, leukocytoklastisk vasculitis, Stevens-Johnson syndrom, akut generaliseret eksantematøs
English: The dose of 340 mg/m2 daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Danish: daglig til børn med Ph+ ALL (totaldosis på 600 mg må ikke overskrides).
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, q 12 timer, i.v.
English: Anaphylactic shock* Blood and lymphatic system disorders
Danish: Anafylaktisk shock*
English: Your doctor will tell you exactly how many capsules of Imatinib Teva B.V. to take.
Danish: Din læge vil fortælle dig, præcis hvor mange Imatinib Teva B.V.-kapsler, du skal tage.
English: Pharmacokinetics in children
Danish: Farmakokinetik hos GIST-patienter
English: CHR: In study 0102 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5%
Danish: 1Hæmatologiske responskriterier (hvert respons skal bekræftes ≥4 uger): CHR: Undersøgelse 0102 [ANC ≥1,5 x 109/l, trombocytter ≥100 x 109/l, ingen blaster i blodet, BM
English: Imatinib Teva B.V. 100 mg film-coated tablets Pack sizes of 60 or 120 film-coated tablets in blisters.
Danish: 100 mg filmovertrukne tabletter Pakningsstørrelser indeholdende 60 eller 120 filmovertrukne tabletter i blisterpakninger.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5;
Danish: DEX 10 mg/m2 oral, dag 1-5; CP 200 mg/m i.v., dag 3, 4, 5; MTX 12 mg intrathecal, dag 1
English: Pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Danish: Pakningsstørrelser indeholdende 20x1, 60x1, 120x1 eller 180x1 filmovertrukne tabletter i perforeret
English: If you take more Imatinib Teva B.V. than you should If you have accidentally taken too many tablets, talk to your doctor straight away.
Danish: Hvis du ved et uheld har indtaget for mange tabletter, skal du kontakte din læge med det samme.
English: If you take more Imatinib Teva B.V. 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: Imatinib Teva B.V. 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters.
Danish: 100 mg hårde kapsler fås i blisterpakninger med 60 eller 120 hårde kapsler.
English: The recommended dose of Imatinib Teva B.V. is 100 mg/day for adult patients with HES/CEL.
Danish: er 100 mg/dag til voksne patienter med HES/CEL.
English: - If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as 6 capsules once a day.
Danish: - Hvis du behandles for Ph-positiv ALL: Startdosis er 600 mg, som skal tages som 6 kapsler én gang daglig.
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
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,
English: If you forget to take Imatinib Teva B.V. - If you forget a dose, take it as soon as you remember.
Danish: - Hvis du glemmer at tage en dosis, så tag den, så snart du kommer i tanker om det.
English: - If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as 6 tablets once a day.
Danish: - Hvis du behandles for Ph-positiv ALL: Startdosis er 600 mg, som skal tages som 6 tabletter én gang daglig.
English: Check with your doctor or pharmacist if you are
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: Pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Danish: Pakningsstørrelser indeholdende 20x1, 60x1, 120x1 eller 180x1 hårde kapsler i perforeret
English: Population pharmacokinetics
Danish: Imatinib farmakokinetik
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 timer x 4, i.v.
English: Liver function tests
Danish: Afvigelser i laboratorieværdier
English: (24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20 Consolidation therapy II, IV Ara-C 75 mg/m2 i.v.
Danish: (1 time) dag 1; Ara-C 60 mg/m2 i.v., dag 22-25, 29-32 Konsoliderende behandling I, III, V MTX 500 mg/m2 i.v.
English: If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second
Danish: Hvis din daglige dosis er 800 mg (2 tabletter), skal du tage 1 tablet om morgenen og 1 tablet om aftenen.
English: Imatinib Teva B.V. 400 mg film-coated tablets Pack sizes of 30 or 90 film-coated tablets in blisters.
Danish: 400 mg filmovertrukne tabletter Pakningsstørrelser indeholdende 30 eller 90 filmovertrukne tabletter i blisterpakninger.
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m 3.
Danish: Hvis cytopeni ikke er leukæmirelateret, reducer imatinib-dosis til 260 mg/m 3.
English: The length of the film-coated tablet is approximately 20 mm and the width is approximately 10 mm.
Danish: Den filmovertrukne tablet har en længde på ca. 20 mm og en vidde på ca. 10 mm. Imatinib Teva B.V.
English: Imatinib Teva B.V. 100 mg film-coated tablets are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Danish: 100 mg filmovertrukne tabletter fås i perforerede enkeltdosisblisterpakninger med 20x1, 60x1, 120x1 eller 180x1 filmovertrukne tabletter.
English: • Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
Danish: - Kraftige mavesmerter, blod i opkast, afføring eller urin, sortfarvet afføring (tegn på mave-tarm
English: (24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20
Danish: (24 timer), dag 1, 15; oral, dag 1-20
English: Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters.
Danish: 400 mg hårde kapsler fås i blisterpakninger med 30 eller 90 hårde kapsler.
English: Pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Danish: Pakningsstørrelser indeholdende 30x1 eller 90x1 filmovertrukne tabletter i perforeret
English: In adult patients, Imatinib Teva B.V. is intended for use in the most advanced phase of the disease (blast crisis).
Danish: beregnet til brug i den mest fremskredne fase af sygdommen (blastkrise).
English: The usual starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a
Danish: Den sædvanlige startdosis er 600 mg, som skal tages som 1 tablet a 400 mg og 2 tabletter a
English: Non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Danish: Ikke-transparent orange kapsel præget i sort blæk med 7629 på kapselbunden og præget i sort blæk med TEVA på kapselhætten.
English: G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
Danish: G-CSF (5 μg/kg, s.c.): dag 4-13, eller indtil ANC >1500 post nadir VCR (1,5 mg/m2/dag, i.v.
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4
Danish: CPM (250 mg/m2/dosis q12 timer x 4 doser, i.v.
English: Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP) Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and
Danish: Akut febril neutrofil dermatose (Sweets syndrom), misfarvning af negle, angioødem, vesikulært udslæt, erythema multiforme, leukocytoklastisk vasculitis, Stevens-Johnson syndrom, akut generaliseret eksantematøs
English: • Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
Danish: - Kvalme opkastninger, diarré eller fordøjelsesbesvær.
English: The usual starting dose is 600 mg to be taken as one capsule of 400 mg plus 2 capsules of 100 mg
Danish: Den sædvanlige startdosis er 600 mg, som skal tages som 1 kapsel a 400 mg og 2 kapsler a
English: If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4
Danish: Hvis din daglige dosis er 800 mg (8 kapsler), skal du tage 4 kapsler om morgenen og 4 kapsler om aftenen.
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 1 tablet a 100 mg én gang daglig.
English: The starting dose is 100 mg, to be taken as one capsule of 100 mg once a day.
Danish: Startdosis er 100 mg, som skal tages som 1 kapsel a 100 mg én gang daglig.