FrancophonIA/ELRC3.0 huggingface dataset:
English: 9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
Romanian: În experiența de după punerea pe piață, s-a observat durere musculo-scheletică în timpul administrării tratamentului cu imatinib sau după întreruperea definitivă a administrării acestuia.
English: Tumour haemorrhage/tumour necrosis* Immune system disorders Not known
Romanian: Cu frecvență necunoscută Hemoragie la nivelul tumorii/necroză la nivelul tumorii* Tulburări ale sistemului imunitar
English: Titanium dioxide (E171) Iron oxide red (E172)
Romanian: Dioxid de titan (E171) Oxid galben de fer (E172)
English: Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3 publications.
Romanian: În 3 publicaţii au fost raportaţi trei (3) pacienţi cu SHE/LEC asociate cu rearanjamente ale genelor FCDP-R.
English: The starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 ½ tablets of 400 mg once a day.
Romanian: Doza iniţială este de 600 mg, administrate sub forma unui comprimat a 400 mg plus 2 comprimate a 100 mg sau sub forma a 1 ½ comprimate de 400 mg o dată pe zi.
English: Table 4 Chemotherapy regimen used in combination with imatinib
Romanian: Tabelul 4 Tratamentul chimioterapic utilizat în asociere cu imatinib Studiul ADE10
English: Anaphylactic shock* Blood and lymphatic system disorders Very common
Romanian: Cu frecvență necunoscută Șoc anafilactic* Tulburări hematologice şi limfatice
English: Cytogenetic response Major response n (%) [95% CI]
Romanian: Răspuns citogenetic Răspuns major n (%)
English: Reproductive system and breast disorders Uncommon
Romanian: Tulburări renale şi ale căilor urinare Mai puţin frecvente
English: Imatinib Teva 400 mg hard capsules Pack sizes of 30 or 90 hard capsules in blisters.
Romanian: Imatinib Teva 400 mg capsule Cutii cu blistere a câte 30 sau 90 capsule.
English: Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 60 or 120 film-coated tablets in blisters.
Romanian: Imatinib Teva 100 mg comprimate filmate este disponibil în cutii cu blistere a câte 60 sau 120 comprimate filmate.
English: In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
Romanian: Dacă NAN revine la < 1,0 x 109/l şi/sau numărul plachetelor < 50 x 109/l, se repetă punctul 1 şi se reia administrarea imatinib cu doza redusă de 260 mg/m2.
English: L-ASP (6000 IUnits/m2, IM): day 44
Romanian: PEG-ASP (2500 IUnităţi/m2, IM): ziua 4
English: 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 ½ tablets of 400 mg once a day.
Romanian: 600 mg, administrate sub forma unui comprimat de 400 mg plus 2 comprimate de 100 mg sau sub forma a 1 ½ comprimate de 400 mg o dată pe zi.
English: • Bruising.
Romanian: • Vânătăi.
English: Dark yellow to brownish orange round film-coated tablets with a score line on one side.
Romanian: Comprimat filmat rotund, de culoare galben închis până la portocaliu-maroniu, cu o linie mediană pe o faţă.
English: Imatinib Teva 100 mg hard capsules imatinib
Romanian: Imatinib Teva 100 mg capsule imatinib
English: Imatinib Teva 400 mg hard capsules imatinib
Romanian: Imatinib Teva 400 mg capsule imatinib
English: Cerebral oedema*
Romanian: pseudoporfirie*
English: Imatinib Teva 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters.
Romanian: Imatinib Teva 400 mg capsule este disponibil în cutii cu blistere a câte 30 sau 90 capsule.
English: Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
Romanian: Prednison 60 mg/m2 oral, zilele 1-7, 15-21;
English: 1200 mg to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Romanian: Adulţi 1200-1600 mg (durata variază între 1 şi 10 zile): greaţă, vărsături, diaree, erupţii cutanate tranzitorii,
English: Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blisters.
Romanian: Imatinib Teva 400 mg comprimate filmate este disponibil în cutii cu blistere a câte 30 sau 90 comprimate filmate.
English: The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day.
Romanian: Doza iniţială este de 100 mg, administrate sub forma unei capsule a 100 mg o dată pe zi.
English: Total bilirubin: > 3-10 ULN
Romanian: Bilirubinemie totală: > 3-10 LSVN AST: orice valoare
English: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m2 i.v.
Romanian: DEX 40 mg pe zi în zilele 1-4 şi 11-14, alternând cu MTX 1 g/m2 i.v. (24 ore), ziua 1, C-Ara 1 g/m2 i.v. (2 ore, q 12
English: 9/l) and thrombocytopenias frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 10 (platelet count < 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Romanian: 9/l) de grad 3 şi 4 fiind de 4 şi de 6 ori mai mare în criza blastică şi faza accelerată (59-64% şi 44-63% pentru neutropenie, respectiv trombocitopenie),
English: - If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 1 capsule once a day.
Romanian: - Dacă sunteţi tratat pentru SMD/NMP: Doza iniţială este de 400 mg, administrate sub forma unei capsule o dată pe zi.
English: Imatinib Teva 100 mg hard capsules are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Romanian: Imatinib Teva 100 mg capsule este disponibil în cutii cu blistere perforate pentru eliberarea unei unităţi de dozare a câte 20x1, 60x1, 120x1 sau 180x1 capsule.
English: What Imatinib Teva looks like and contents of the pack Imatinib Teva 400 mg hard capsules are non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Romanian: Imatinib Teva 400 mg capsule sunt opace, de culoare portocalie, marcate cu cerneală neagră cu 7630
English: 4 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
Romanian: Eritemul facial a fost raportat cel mai frecvent la pacienţii cu GIST, iar hemoragiile (hematom, hemoragie) au fost raportate cel mai frecvent la pacienţii cu GIST şi cu LGC transformată
English: There is very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Romanian: SMD/NMP, PDFS şi SHE/LEC.
English: Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common
Romanian: Insuficienţă hepatică8, necroză hepatică Afecţiuni cutanate şi ale ţesutului subcutanat
English: Imatinib Teva 400 mg film-coated tablets Pack sizes of 30 or 90 film-coated tablets in blisters.
Romanian: Imatinib Teva 400 mg comprimate filmate Cutii cu blistere a câte 30 sau 90 comprimate filmate.
English: What Imatinib Teva looks like and contents of the pack Imatinib Teva 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Romanian: Imatinib Teva 400 mg comprimate filmate sunt rotunde, de culoare galben închis până la portocaliu maroniu, cu o linie mediană.
English: The capsules are approximately 19 mm long and 7 mm wide.
Romanian: Capsulele au lungimea de aproximativ 19 mm și lățimea de aproximativ
English: Study AUS01 Induction-consolidation therapy
Romanian: Studiul AUS01
English: Imatinib Teva 400 mg hard capsules
Romanian: Imatinib Teva 400 mg capsule
English: Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Romanian: C-Ara 40 mg intratecal, zilele 1, 8, 15, 22;
English: What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg hard capsules are non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Romanian: Imatinib Teva 100 mg capsule sunt opace, de culoare portocalie, marcate cu cerneală neagră cu 7629
English: Imatinib Teva 100 mg hard capsules
Romanian: Imatinib Teva 100 mg capsule
English: Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
Romanian: În 4 publicaţii au fost raportaţi cinci (5) pacienţi cu SMD/NMP asociate cu rearanjamente ale genelor FCDP-R.
English: Imatinib Teva 400 mg film-coated tablets imatinib
Romanian: Imatinib Teva 400 mg comprimate filmate imatinib
English: Imatinib Teva 400 mg film-coated tablets
Romanian: Imatinib Teva 400 mg comprimate filmate
English: In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Romanian: Dacă NAN revine la < 1,0 x 109/l şi/sau numărul plachetelor < 50 x 109/l, se repetă punctul 1 şi se reia administrarea imatinib cu doza redusă de 400 mg.
English: How to store Imatinib Teva
Romanian: Cum se păstrează Imatinib Teva
English: The starting dose is 100 mg, to be taken as 1 capsule once a day.
Romanian: Doza iniţială este de 100 mg, administrate sub forma unei capsule o dată pe zi.
English: Cytogenetic response Major response n (%) [95% CI] Complete CyR n (%)
Romanian: Rata RHC n (%) [IÎ 95%]
English: Imatinib Teva 100 mg film-coated tablets imatinib
Romanian: Imatinib Teva 100 mg comprimate filmate imatinib
English: The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.
Romanian: Doza este de 800 mg pe zi (8 comprimate), administrate sub formă de 4 comprimate dimineaţa şi 4 comprimate seara.
English: 600 mg to be taken as 6 tablets once a day.
Romanian: 600 mg, administrate sub formă de 6 comprimate o dată pe zi.
English: Teл: +359 24899585
Romanian: Tlf: +45 44985511
English: Paediatric patients
Romanian: Pacienţii adulţi,
English: EU/1/12/808/033 30 hard capsules EU/1/12/808/034 30 x 1 hard capsules EU/1/12/808/035 90 hard capsules EU/1/12/808/036 90 x 1 hard capsules EU/1/12/808/037 30 hard capsules EU/1/12/808/038 30 x 1 hard capsules EU/1/12/808/039 90 hard capsules EU/1/12/808/040 90 x 1 hard capsules
Romanian: EU/1/12/808/033 30 capsule EU/1/12/808/034 30 x 1 capsule EU/1/12/808/035 90 capsule EU/1/12/808/036 90 x 1 capsule EU/1/12/808/037 30 capsule EU/1/12/808/038 30 x 1 capsule EU/1/12/808/039 90 capsule EU/1/12/808/040 90 x 1 capsule
English: In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Romanian: Dacă NAN revine la < 1,0 x 109/l şi/sau numărul plachetelor < 50 x 109/l, se repetă punctul 1 şi se reia administrarea imatinib cu doza redusă de 300 mg.
English: The dose is 800 mg per day (2 tablets), to be taken as 1 tablet in the morning and a second tablet in the evening.
Romanian: Doza este de 800 mg pe zi (2 comprimate), administrate sub forma unui comprimat dimineaţa şi al doilea comprimat seara.
English: Imatinib Teva 100 mg film-coated tablets
Romanian: Imatinib Teva 100 mg comprimate filmate
English: Return to chronic phase (RTC)
Romanian: Revenire la faza cronică
English: MTX 1.5 g/m2 i.v.
Romanian: MTX 1,5 g/m2 i.v. (24 ore), ziua 1;
English: EU/1/12/808/001 20 x 1 film-coated tablets EU/1/12/808/002 60 film-coated tablets EU/1/12/808/003 60 x 1 film-coated tablets EU/1/12/808/004 120 film-coated tablets EU/1/12/808/005 120 x 1 film-coated tablets EU/1/12/808/006 180 x 1 film-coated tablets EU/1/12/808/007 20 x 1 film-coated tablets EU/1/12/808/008 60 film-coated tablets EU/1/12/808/009 60 x 1 film-coated tablets EU/1/12/808/010 120 film-coated tablets EU/1/12/808/011 120 x 1 film-coated tablets EU/1/12/808/012 180 x 1 film-coated tablets
Romanian: EU/1/12/808/001 20 x 1 comprimate filmate EU/1/12/808/002 60 comprimate filmate EU/1/12/808/003 60 x 1 comprimate filmate EU/1/12/808/004 120 comprimate filmate EU/1/12/808/005 120 x 1 comprimate filmate EU/1/12/808/006 180 x 1 comprimate filmate EU/1/12/808/007 20 x 1 comprimate filmate EU/1/12/808/008 60 comprimate filmate EU/1/12/808/009 60 x 1 comprimate filmate EU/1/12/808/010 120 comprimate filmate EU/1/12/808/011 120 x 1 comprimate filmate EU/1/12/808/012 180 x 1 comprimate filmate
English: What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg film-coated tablets are dark yellow to brownish orange round film-coated tablets with a score line on one side.
Romanian: Imatinib Teva 100 mg comprimate filmate sunt rotunde, de culoare galben închis până la portocaliumaroniu, cu o linie mediană.
English: The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold drug accumulation after repeated once-daily dosing.
Romanian: La copii şi adolescenţi, administrarea unor doze de 260 mg/m2 şi zi, respectiv 340 mg/m2 şi zi a determinat aceeaşi expunere ca administrarea la pacienţii adulţi a unor doze de 400 mg, respectiv 600 mg. Compararea ASC(0-24) în ziua 8 şi ziua 1 la doza de 340 mg/m2 şi zi a evidenţiat o acumulare a medicamentului de 1,7 ori după administrarea de doze zilnice repetate.
English: EU/1/12/808/021 20 x 1 hard capsules EU/1/12/808/022 60 hard capsules EU/1/12/808/023 60 x 1 hard capsules EU/1/12/808/024 120 hard capsules EU/1/12/808/025 120 x 1 hard capsules EU/1/12/808/026 180 x 1 hard capsules EU/1/12/808/027 20 x 1 hard capsules EU/1/12/808/028 60 hard capsules EU/1/12/808/029 60 x 1 hard capsules EU/1/12/808/030 120 hard capsules EU/1/12/808/031 120 x 1 hard capsules EU/1/12/808/032 180 x 1 hard capsules
Romanian: EU/1/12/808/021 20 x 1 capsule EU/1/12/808/022 60 capsule EU/1/12/808/023 60 x 1 capsule EU/1/12/808/024 120 capsule EU/1/12/808/025 120 x 1 capsule EU/1/12/808/026 180 x 1 capsule EU/1/12/808/027 20 x 1 capsule EU/1/12/808/028 60 capsule EU/1/12/808/029 60 x 1 capsule EU/1/12/808/030 120 capsule EU/1/12/808/031 120 x 1 capsule EU/1/12/808/032 180 x 1 capsule
English: Posology for HES/CEL The recommended dose of Imatinib Teva is 100 mg/day for adult patients with HES/CEL.
Romanian: Doza recomandată de Imatinib Teva este de 100 mg pe zi pentru pacienţii adulţi cu SHE/LEC.
English: Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30x1or 90x1 film-coated tablets in perforated unit dose blisters.
Romanian: Imatinib Teva 400 mg comprimate filmate este disponibil în cutii cu blistere perforate pentru eliberarea unei unităţi de dozare a câte 30x1 sau 90x1 comprimate filmate.
English: This is because Imatinib Teva could cause hepatitis B to become active again, which can be fatal in some cases.
Romanian: - dacă luaţi levotiroxină, deoarece v-a fost îndepărtată chirurgical tiroida - dacă ați avut vreodată sau este posibil să aveți în prezent o infecție cu virus hepatitic B. Acest lucru este necesar deoarece Imatinib Teva poate duce la reactivarea hepatitei B, care poate fi letală, în unele cazuri.
English: • Joint pain with swelling.
Romanian: • Dureri ale articulaţiilor, însoţite de umflare a articulaţiilor.
English: The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once a day.
Romanian: Doza iniţială este de 100 mg, administrate sub forma unui comprimat a 100 mg o dată pe zi.
English: doses)iii:
Romanian: 1000 persoane):
English: EU/1/12/808/013 30 film-coated tablets EU/1/12/808/014 30 x 1 film-coated tablets EU/1/12/808/015 90 film-coated tablets EU/1/12/808/016 90 x 1 film-coated tablets EU/1/12/808/017 30 film-coated tablets EU/1/12/808/018 30 x 1 film-coated tablets EU/1/12/808/019 90 film-coated tablets EU/1/12/808/020 90 x 1 film-coated tablets
Romanian: EU/1/12/808/013 30 comprimate filmate EU/1/12/808/014 30 x 1 comprimate filmate EU/1/12/808/015 90 comprimate filmate EU/1/12/808/016 90 x 1 comprimate filmate EU/1/12/808/017 30 comprimate filmate EU/1/12/808/018 30 x 1 comprimate filmate EU/1/12/808/019 90 comprimate filmate EU/1/12/808/020 90 x 1 comprimate filmate
English: DEX 10 mg/m2 oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14;
Romanian: DEX 10 mg/m2 oral, zilele 6-7, 13-16;
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Romanian: DECLARAREA SUBSTANŢEI(SUBSTANȚELOR) ACTIVE Fiecare comprimat filmat conţine imatinib 400 mg (sub formă de mesilat).
English: - If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 1 tablet once a day.
Romanian: - Dacă sunteţi tratat pentru SMD/NMP: Doza iniţială este de 400 mg, administrate sub forma unui comprimat o dată pe zi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Romanian: DECLARAREA SUBSTANŢEI(SUBSTANȚELOR) ACTIVE Fiecare comprimat filmat conţine imatinib 100 mg (sub formă de mesilat).
English: (1 h), days 1-5; VM26 60 mg/m2 i.v.
Romanian: C-Ara 75 mg/m2 i.v. (1 oră), zilele 1-5; VM26 60 mg/m2 i.v. (1 oră), zilele 1-5
English: VCR (1.5 mg/m2/day, IV): days 1, 29 DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 1-56 Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 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
Romanian: = citarabină, CPM = ciclofosfamidă, VCR = vincristină, DEX = dexametazonă, DAUN = daunorubicină, 6-MP = 6-mercaptopurină, E.Coli L-ASP = L-asparaginază, PEG-ASP = PEG asparaginază, MESNA= 2-mercaptoetan sulfonat de sodiu, iii= sau până când nivelul MTX este
English: Imatinib Teva 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Romanian: Imatinib Teva 400 mg capsule este disponibil în cutii cu blistere perforate pentru eliberarea unei unităţi de dozare a câte 30x1 sau 90x1 capsule.
English: monthly for 13 months; Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
Romanian: Prednisolon 200 mg oral, 5 zile pe lună timp de 13 luni
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.
Romanian: boceprevir; antifungice azolice, inclusiv ketoconazol, itraconazol, posaconazol, voriconazol; anumite macrolide cum sunt eritromicină, claritromicină şi telitromicină) pot scădea metabolizarea imatinibului determinând creşterea concentraţiilor plasmatice de imatinib.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 1 capsule of 400 mg once a day, depending on how you respond to treatment.
Romanian: Medicul dumneavoastră poate decide creşterea dozei la 400 mg, administrate sub forma unei capsule a 400 mg o dată pe zi, în funcţie de răspunsul dumneavoastră la tratament.
English: • Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Romanian: • Pacienţilor adulţi cu sindroame mielodisplazice/neoplasme mieloproliferative (SMD/NMP)
English: - Each film-coated tablet of Imatinib Teva contains 400 mg imatinib (as mesilate).
Romanian: - Fiecare comprimat filmat de Imatinib Teva conţine imatinib 400 mg (sub formă de mesilat).
English: Investigations Very common
Romanian: Foarte frecvente
English: If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second tablet in the evening.
Romanian: Dacă doza dumneavoastră zilnică este de 800 mg (2 comprimate), trebuie să luaţi un comprimat dimineaţa şi uncomprimat seara.
English: The dose of 340 mg/m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Romanian: Doza zilnică recomandată este de 340 mg/m2 la copii şi adolescenţi cu LGC în fază cronică şi în fazele avansate ale
English: Other medicines and Imatinib Teva
Romanian: Imatinib Teva împreună cu alte medicamente
English: Posology for DFSP The recommended dose of Imatinib Teva is 800 mg/day for adult patients with DFSP.
Romanian: La pacienţii adulţi cu PDFS, doza recomandată de Imatinib Teva este de 800 mg pe zi.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1
Romanian: Tratament de consolidare I, III, V MTX 500 mg/m2 i.v. (24 ore), zilele 1, 15; 6-MP 25 mg/m2 oral, zilele 1-20
English: - Each film-coated tablet of Imatinib Teva contains 100 mg imatinib (as mesilate).
Romanian: - Fiecare comprimat filmat de Imatinib Teva conţine imatinib 100 mg (sub formă de mesilat).
English: These effects were not seen at doses ≤ 30 mg/kg.
Romanian: Aceste efecte nu s-au observat la doze ≤
English: Posology for MDS/MPD The recommended dose of Imatinib Teva is 400 mg/day for adult patients with MDS/MPD.
Romanian: Doza recomandată de Imatinib Teva este de 400 mg pe zi pentru pacienţii adulţi cu SMD/NMP.
English: 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.
Romanian: La aproximativ 2,5% dintre pacienţii recent diagnosticaţi cu LGC trataţi cu imatinib au fost raportate fenomene de retenţie hidrică severă (revărsat pleural, edem, edem pulmonar, ascită, edem superficial).
English: Pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Romanian: Cutii cu blistere perforate pentru eliberarea unei unităţi de dozare a câte 30x1 sau 90x1 comprimate filmate.
English: - Each hard capsule of Imatinib Teva contains 400 mg imatinib (as mesilate).
Romanian: - Fiecare capsulă de Imatinib Teva conţine imatinib 400 mg (sub formă de mesilat).
English: Paediatric chronic phase CML (at dose 340 mg/m2)
Romanian: (la doza de 340 mg/m2)
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5;
Romanian: CF 200 mg/m2 i.v., zilele 3, 4, 5;
English: ANC < 0.5 x 10
Romanian: Studiul 0110
English: - Each hard capsule of Imatinib Teva contains 100 mg imatinib (as mesilate).
Romanian: - Fiecare capsulă de Imatinib Teva conţine imatinib 100 mg (sub formă de mesilat).
English: There were no special safety findings in paediatric clinical trials.
Romanian: Studiile clinice efectuate la copii și adolescenți nu au indicat rezultate speciale privind siguranţa.
English: A.
Romanian: R).
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.
Romanian: 4.5 Interacţiuni cu alte medicamente şi alte forme de interacţiune Substanţe active care pot creşte concentraţiile plasmatice de imatinib Substanţele care inhibă activitatea izoenzimei CYP3A4 a citocromului P450 (de exemplu: inhibitori de protează cum sunt indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir,
English: (0.5 h), days 7, 8, 14, 15;
Romanian: IDA 8 mg/m2 i.v. (0,5 ore), zilele 7, 8, 14, 15;
English: Study 0110 37-month data Chronic phase, IFN failure (n=532)
Romanian: eşec la IFN (n=532)
English: Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administration site conditions Very common
Romanian: Corp galben hemoragic/chist ovarian hemoragic
English: Pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Romanian: Cutii cu blistere perforate pentru eliberarea unei unităţi de dozare a câte 30x1 sau 90x1 capsule.
English: Headache2
Romanian: Crospovidonă