FrancophonIA/ELRC3.0 huggingface dataset:
English: If any of these affect you severely, tell your doctor.
Slovenian: Če se pri vas kateri od zgoraj navedenih neželenih učinkov pojavi v hujši obliki, obvestite zdravnika.
English: Excipients
Slovenian: ciklusih
English: Plasma pharmacokinetics
Slovenian: Farmakokinetika imatiniba
English: The usual starting dose is 600 mg to be taken as one capsule of 400 mg plus 2 capsules of 100 mg once a day.
Slovenian: Običajni začetni odmerek je 600 mg, ki se vzame kot eno 400 mg kapsulo plus dve 100 mg kapsuli enkrat na dan.
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Slovenian: protin, hiperurikemija, hiperkalciemija, hiperglikemija, hiponatriemija redki hiperkaliemija, hipomagneziemija
English: Clinical studies in Ph+ ALL
Slovenian: Odmerjanje pri Ph+ ALL pri otrocih
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).
Slovenian: potencialno tveganje za človeški plod pa je neznano, je treba ženskam v rodni dobi svetovati, naj pri odpiranju kapsul pazljivo ravnajo z vsebino in se izogibajo stiku zdravila z očmi preko rok ali vdihavanju zdravila (glejte poglavje 4.6).
English: Posology for HES/CEL The recommended dose of imatinib is 100 mg/day for adult patients with HES/CEL.
Slovenian: Priporočeni odmerek zdravila Imatinib Actavis pri odraslih bolnikih s HES/CEL je 100 mg/dan.
English: Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172).
Slovenian: Ovojnica kapsule: hipromeloza, titanov dioksid (E171), rumeni železov oksid (E172).
English: The starting dose is 400 mg to be taken as 4 capsules once a day.
Slovenian: Začetni odmerek je 400 mg, ki ga vzamete kot 4 kapsule enkrat na dan.
English: The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Slovenian: Začetni odmerek je 100 mg, ki ga vzamete kot eno 100 mg tableto enkrat na dan.
English: Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Slovenian: pogosti omotica, parestezije, motnje okušanja, hipestezije občasni migrena, somnolenca, sinkopa, periferna nevropatija, motnje spomina, išias, sindrom nemirnih nog, tremor, možganska krvavitev redki zvišan intrakranialni tlak, konvulzije, optični nevritis pogostnost neznana: možganski edem*
English: If you have accidentally taken too many capsules, talk to your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Imatinib Actavis, kot bi smeli Če ste pomotoma vzeli preveč kapsul, se nemudoma posvetujte s svojim zdravnikom.
English: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Slovenian: metotreksat (20 mg/m2/teden, peroralno): 8., 15., 22., 29., 36., 43. in 50. dan vzdrževalno zdravljenje (8-tedenski ciklusi) 6.-12. ciklus
English: Imatinib Actavis 50 mg hard capsules Each hard capsule contains 50 mg imatinib (as mesilate).
Slovenian: Imatinib Actavis 50 mg trde kapsule Ena kapsula vsebuje 50 mg imatiniba (v obliki mesilata).
English: Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Slovenian: Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
English: The usual starting dose is 600 mg to be taken as 6 tablets once a day.
Slovenian: Običajni začetni odmerek je 600 mg, ki se vzame kot 6 tablet enkrat na dan.
English: - Painful and/or blistering skin lesions - Slowing of growth in children and adolescents.
Slovenian: - rdečina in/ali otekanje dlani in podplatov, lahko z občutkom mravljinčenja in s pekočo bolečino, - boleče spremembe na koži z ali brez nastanka mehurjev, - upočasnjena rast pri otrocih in mladostnikih.
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
Slovenian: pankreatitis redki kolitis, ileus, vnetna bolezen črevesa pogostnost neznana: ileus/zapora črevesja*, gastrointestinalna perforacija*, divertikulitis*, žilne ektazije antruma želodca (GAVE)*
English: and/or platelets < 10 x 109/L
Slovenian: 9/l in/ali koncentracija trombocitov < 10 x 109/l
English: The starting dose is 400 mg, to be taken as 8 capsules once a day.
Slovenian: Začetni odmerek je 400 mg, ki ga vzamete kot 8 kapsul enkrat na dan.
English: In the event of recurrence of ANC < 1.0 x 109/L and/or platelets < 50 x 109/L, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
Slovenian: Če se pojav/a ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 260 mg/m2.
English: Severe elevation of transaminases (<5%) or bilirubin (<1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Slovenian: Navadno so to urejali z zmanjšanjem odmerka ali s prekinitvijo zdravljenja (mediano trajanje teh epizod je bilo približno en teden).
English: The starting dose is 400 mg to be taken as 4 tablets once a day.
Slovenian: Začetni odmerek je 400 mg, ki ga vzamete kot 4 tablete enkrat na dan.
English: Imatinib Actavis 100 mg hard capsules Each hard capsule contains 100 mg imatinib (as mesilate).
Slovenian: Imatinib Actavis 100 mg trde kapsule Ena kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Slovenian: Pri bolnikih z mieloproliferativnimi neoplazmami s preureditvijo PDGFR-β, ki so se zdravili z imatinibom, je bila izvedena opazovalna študija (študija L2401) in sicer uvedba registra za dolgoročno zbiranje podatkov o varnosti in učinkovitosti.
English: Hard capsule with orange opaque cap and body imprinted with 400 mg in black ink.
Slovenian: Trda kapsula z neprosojnim oranžnim pokrovčkom in telesom kapsule s črnim napisom “400 mg”.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1
Slovenian: CP 200 mg/m2 i.v., 3., 4., 5. dan; MTX 12 mg intratekalno, 1. dan indukcija remisije
English: Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Slovenian: Ena filmsko obložena tableta vsebuje 400 mg imatiniba (v obliki mesilata).
English: Imatinib Actavis 50 mg capsules imatinib
Slovenian: Imatinib Actavis 50 mg kapsule imatinib
English: - Eye pain or deterioration in vision, bleeding in the eyes.
Slovenian: zamegljen vid občasni draženje očesa, bolečine v očesu, orbitalni edem, krvavitev v beločnico,
English: Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Slovenian: Srčne bolezni občasni palpitacije, tahikardija, kongestivno popuščanje srca3, pljučni edem redki aritmija, atrijska fibrilacija, zastoj srca, miokardni infarkt, angina pektoris, perikardialni izliv pogostnost neznana: perikarditis*, tamponada srca*
English: Imatinib Actavis 100 mg hard capsules EU/1/13/825/003
Slovenian: Imatinib Actavis 100 mg trde kapsule EU/1/13/825/003
English: The starting dose is 100 mg, to be taken as one capsule of 100 mg once a day.
Slovenian: Začetni odmerek je 100 mg, ki ga vzamete kot eno 100 mg kapsulo enkrat na dan.
English: VCR (1.5 mg/m2/day, IV): days 1, 29
Slovenian: VCR (1,5 mg/m2/dan, i.v.
English: (1 h), days 1-3; vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21; prednisolone 60 mg/m2/day oral
Slovenian: (1 ura), 1.-3. dan; vinkristin 1,3 mg/m2 i.v., 1., 8., 15., 21. dan; prednizolon 60 mg/m2/dan peroralno konsolidacijsko dravljenje izmenična kemoterapija: visokoodmerna kemoterapija z MTX 1 g/m2
English: The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
Slovenian: Prvih 37 bolnikov je začelo zdravljenje s 400 mg, protokol je bil pozneje dopolnjen, tako da je omogočal večje odmerjanje, tako da je preostalih 223 bolnikov začelo zdravljenje s 600 mg. Primarna učinkovitostna spremenljivka je bila stopnja hematološkega odziva, opisanega bodisi kot popolni hematološki odziv, kot odsotnost dokazov levkemije (tj. izginotje blastov iz kostnega mozga in krvi, a brez popolnega okrevanja periferne krvi kot pri popolnem odzivu) ali kot vrnitev v kronično fazo KML.
English: Induction therapy I DEX 10 mg/m2 oral, days 1-5; VCR 2 mg i.v., days 6, 13, 20; daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Slovenian: MTX 15 mg intratekalno, 1. dan indukcijsko zdravljenje I DEX 10 mg/m2 peroralno, 1.-5. dan; VCR 2 mg i.v., 6., 13., 20. dan; daunorubicin 45 mg/m2 i.v., 6.-7., 13.-14. dan indukcijsko zdravljenje II CP 1 g/m2 i.v.
English: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6
Slovenian: Bolezni prebavil zelo pogosti navzea, driska, bruhanje, dispepsija, bolečine v trebuhu6
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Slovenian: pogosti flatulenca, napihnjen trebuh, gastroezofagealni refluks, obstipacija, suha usta, gastritis občasni stomatitis, razjede ustne sluznice, krvavitev iz prebavil7, spahovanje, melena,
English: Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Slovenian: Ovojnica kapsule: hipromeloza, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid
English: - Painful and/or blistering skin lesions.
Slovenian: - boleče spremembe na koži z ali brez nastanka mehurjev,
English: Black iron oxide (E172) Propylene glycol Ammonia solution Potassium hydroxide
Slovenian: Tiskarska barva šelak črni železov oksid (E172) propilenglikol raztopina amonijaka kalijev hidroksid
English: Stop imatinib until ANC ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.
Slovenian: Prekinite zdravljenje z imatinibom dokler ni ANC ≥ 1,5 x 109/l in koncentracija trombocitov ≥ 75 x 109/l.
English: Imatinib Actavis 400 mg capsules imatinib
Slovenian: Imatinib Actavis 400 mg kapsule imatinib
English: The starting dose is 600 mg to be taken as one capsule of 400 mg plus 2 capsules of 100 mg once a day.
Slovenian: Začetni odmerek je 600 mg, ki ga vzamete kot eno 400 mg kapsulo plus dve 100 mg kapsuli enkrat na dan.
English: The starting dose is 600 mg to be taken as 6 tablets once a day.
Slovenian: Začetni odmerek je 600 mg, ki ga vzamete kot 6 tablet enkrat na dan.
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
Slovenian: Ara-C 40 mg intratekalno, 1., 8., 15., 22. dan; metilprednizolon 40 mg intratekalno, 1., 8., 15., 22. dan konsolidacija (novo odkrita Ph+ ALL)
English: Capsule shell Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172)
Slovenian: Ovojnica kapsule hipromeloza titanov dioksid (E171) rumeni železov oksid (E172)
English: 2.7% of patients, respectively, and grade 3 thrombocytopenia in 0.7% of patients.
Slovenian: Stopnje so odkrili pri 7,5 % oziroma 2,7 % bolnikov, trombocitopenijo 3.
English: Imatinib Actavis 100 mg capsules imatinib
Slovenian: Imatinib Actavis 100 mg kapsule imatinib
English: How to store Imatinib Actavis
Slovenian: Shranjevanje zdravila Imatinib Actavis
English: Ifosfamide (1.8 g/m2/day, IV): days 1-5
Slovenian: ): 1.-5. dan ifosfamid (1,8 g/m2/dan, i.v.
English: Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg,
Slovenian: Imatinib je bil teratogen pri podganah, če so ga dobivale med organogenezo v odmerkih ≥ 100 mg/kg, kar je približno enako največjemu kliničnemu odmerku 800 mg/dan, izračunanemu na podlagi telesne površine.
English: The recommended starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Slovenian: Priporočeni začetni odmerek je 600 mg, ki se vzame kot 1-krat 400 mg tableto in 2-krat 100 mg tableti enkrat na dan.
English: days 3-5; MTX 15 mg intrathecal, day 1;
Slovenian: MTX 15 mg intratekalno, 1.
English: PEG-ASP (2500 IUnits/m2, IM): day 4
Slovenian: ): 3. in 4. dan PEG-ASP (2500 i.e./m2,i.m.
English: The starting dose is 400 mg to be taken as one capsule once a day.
Slovenian: Začetni odmerek je 400 mg, ki ga vzamete kot eno kapsulo enkrat na dan.
English: The usual starting dose is 600 mg to be taken as 12 capsules once a day.
Slovenian: Običajni začetni odmerek je 600 mg, ki se vzame kot 12 kapsul enkrat na dan.
English: If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.
Slovenian: Če je vaš dnevni odmerek 800 mg (8 kapsul), morate vzeti 4 kapsul zjutraj in 4 kapsul zvečer.
English: Considering the limited safety database, the adverse events thus far reported in children are consistent with the known safety profile in adult patients with Ph+ ALL.
Slovenian: vendar se podatki v njej ujemajo z varnostnimi lastnostmi zdravila pri odraslih bolnikih s Ph+ ALL.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once a day, depending on how you respond to treatment.
Slovenian: Vaš zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot 4 tablete enkrat na dan, odvisno od vašega odziva na zdravljenje.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 8 capsules once a day, depending on how you respond to treatment.
Slovenian: Vaš zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot 8 kapsul enkrat na dan, odvisno od vašega odziva na zdravljenje.
English: days 2, 3, 16, and 17
Slovenian: (0,5 ure), 7., 8., 14., 15.
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.
Slovenian: karbamazepin, rifampicin, fenobarbital ali Hypericum perforatum, znana tudi kot šentjanževka), lahko pomembno zmanjša izpostavljenost imatinibu, kar potencialno poveča tveganje za neuspešnost zdravljenja.
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
Slovenian: ): 1. in 29. dan DEX (6 mg/m2/dan, peroralno): 1.-5. dan in 29.-33. dan 6-MP (75 mg/m2/dan, peroralno): 11.-56. dan (prekiniti 6-MP na 6.-10. dan obsevanja glave z začetkom štetja na 1. dan 5. ciklusa; ponovno začeti 6MP na 1. dan po zaključenem obsevanju glave.)
English: Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Slovenian: pogosti navali rdečice, krvavitev občasni hipertenzija, hematom, subduralni hematom, hladni distalni deli udov, hipotenzija, Raynaudov fenomen pogostnost neznana: tromboza/embolija*
English: Alternating chemotherapy course: high dose chemotherapy with MTX 1 g/m2 i.v.
Slovenian: Dan; prednizolon 60 mg/m2/dan peroralno konsolidacijsko dravljenje izmenična kemoterapija: visokoodmerna kemoterapija z MTX 1 g/m2
English: The starting dose is 100 mg, to be taken as one tablet once a day.
Slovenian: Začetni odmerek je 100 mg, ki ga vzamete kot 1 tableto enkrat na dan.
English: Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).
Slovenian: V zvezi z zaviralci BCR-ABL tirozin-kinaze so poročali o reaktivaciji hepatitisa B. V nekaterih primerih je prišlo do akutne odpovedi jeter ali fulminantnega hepatitisa in posledično do presaditve jeter ali smrtnega izida (glejte poglavje 4.4).
English: Each hard capsule contains 100 mg of imatinib (as mesilate).
Slovenian: Ena trda kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
English: Each hard capsule contains 400 mg of imatinib (as mesilate).
Slovenian: Ena trda kapsula vsebuje 400 mg imatiniba (v obliki mesilata).
English: - Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Slovenian: - otrpli ali hladni prsti (znaki Raynaudovega sindroma), - nenadna oteklina in pordelost kože (znaki kožne okužbe z imenom flegmona (celulitis), - težave s sluhom,
English: - Weight gain.
Slovenian: - Navodilo shranite.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day, depending on how you respond to treatment.
Slovenian: Vaš zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot eno 400 mg tableto enkrat na dan, odvisno od vašega odziva na zdravljenje.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one capsule of 400 mg once a day, depending on how you respond to treatment.
Slovenian: Vaš zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot eno 400 mg kapsulo enkrat na dan, odvisno od vašega odziva na zdravljenje.
English: Sodium stearyl fumarate Silica, hydrophobic colloidal Silica, colloidal anhydrous
Slovenian: Jedro tablete mikrokristalna celuloza kopovidon krospovidon natrijev stearilfumarat hidrofoben koloidni silicijev dioksid brezvodni koloidni silicijev dioksid
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: se posvetujte s svojim zdravnikom ali s farmacevtom.
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4
Slovenian: ): 1. in 2. dan CPM (250 mg/m2/odmerek vsakih 12 ur x 4 odmerki, i.v.
English: L-ASP (6000 IUnits/m2, IM): day 44
Slovenian: ): 43. in 44. dan L-ASP (6000 i.e./m2, i.m.
English: The usual starting dose is 600 mg to be taken as 6 capsules once a day.
Slovenian: Običajni začetni odmerek je 600 mg, ki se vzame kot 6 kapsul enkrat na dan.
English: The starting dose is 400 mg to be taken as one tablet once a day.
Slovenian: Začetni odmerek je 400 mg, ki ga vzamete kot 1 tableto enkrat na dan.
English: Each hard capsule contains 50 mg of imatinib (as mesilate).
Slovenian: Ena trda kapsula vsebuje 50 mg imatiniba (v obliki mesilata).
English: The starting dose is 600 mg to be taken as 12 capsules once a day.
Slovenian: Začetni odmerek je 600 mg, ki ga vzamete kot 12 kapsul enkrat na dan.
English: Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Slovenian: Ta študija je vključevala 7 bolnikov z MDS/MPD, ki so bili zdravljeni z odmerkom zdravila Imatinib Actavis 400 mg na dan. Trije bolniki so dosegli popolni hematološki odziv (CHR), en bolnik pa je dosegel delni hematološki odziv (PHR - partial haematological response).
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 4 capsules once a day, depending on how you respond to treatment.
Slovenian: Vaš zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot 4 kapsule enkrat na dan, odvisno od vašega odziva na zdravljenje.
English: In the event of recurrence of ANC < 1.0 x 109/L and/or platelets < 50 x 109/L, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Slovenian: Če se pojav/a ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z zdravilom Imatinib Actavis z zmanjšanim odmerkom 400 mg.
English: Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to < 18 years) treated with imatinib in combination with chemotherapy.
Slovenian: Študija AIT07 je bila multicentrična, odprta, randomizirana študija faze II/III, v katero so vključili
English: The starting dose is 100 mg, to be taken as one capsule once a day.
Slovenian: Začetni odmerek je 100 mg, ki ga vzamete kot 1 kapsulo enkrat na dan.
English: The starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Slovenian: Začetni odmerek je 600 mg, ki ga vzamete kot eno 400 mg tableto in dve100 mg tableti enkrat na dan.
English: - Swelling such as round your ankles or puffy eyes.
Slovenian: - otekanje, na primer otekline okrog gležnjev ali oči, - povečanje telesne mase.
English: Imatinib Actavis 100 mg film-coated tablets
Slovenian: Imatinib Actavis 100 mg filmsko obložene tablete
English: Printing ink: shellac glaze-45%, black iron oxide (E172), propylene glycol, ammonium Hydroxide 28%.
Slovenian: Tiskarska barva: šelak-45%, črni železov oksid (E172),
English: Do not take Imatinib Actavis:
Slovenian: Ne jemljite zdravila Imatinib Actavis
English: respectively.
Slovenian: Stopnje.
English: - Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
Slovenian: - bolečine v sklepih z otekanjem, - suha usta, suha koža ali suhe oči, - zmanjšana ali povečana občutljivost kože, - navali vročine, mrazenje ali nočno znojenje.
English: Each tablet contains 400 mg imatinib (as mesilate).
Slovenian: Ena tableta vsebuje 400 mg imatiniba (v obliki mesilata).
English: Each tablet contains 100 mg imatinib (as mesilate).
Slovenian: Ena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
English: The starting dose is 600 mg to be taken as 6 capsules once a day.
Slovenian: Začetni odmerek je 600 mg, ki ga vzamete kot 6 kapsul enkrat na dan.
English: The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Slovenian: Plazemska farmakokinetika Po peroralnem dajanju zdravim prostovoljcem je bil t1/2 približno 18 ur, kar kaže na ustreznost enega odmerka na dan. Zvečevanje povprečne AUC z večanjem odmerka je bilo po peroralnem dajanju linearno in sorazmerno odmerku v območju 25-1.000 mg imatiniba.
English: ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
Slovenian: ): 22.-26. dan G-CSF (5 μg/kg, s.c.):27.-36. dan oziroma do ANC > 1500 po doseženem najnižjem številu
English: In the event of recurrence of ANC < 1.0 x 109/L and/or platelets < 50 x 109/L, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Slovenian: Če se pojav/a ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/lponovi/ta, ponovite točko 1 in spet začnite zdravljenje z zdravilom Imatinib Actavis z zmanjšanim odmerkom 300 mg.
English: Cranial irradiation (Block 5 only)
Slovenian: akutnimi levkemijami (n=15).
English: Imatinib Actavis 100 mg hard capsules
Slovenian: Imatinib Actavis 100 mg trde kapsule
English: Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people): - Chest pain, irregular heart rhythm (signs of heart problems).
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) ali redki (pojavijo se lahko pri največ 1 od
English: Hard capsule of size 00 with orange opaque colour cap and body imprinted with “400 mg” in black ink.
Slovenian: Trda kapsula velikosti 00 s pokrovčkom neprosojne oranžne barve in telesom kapsule s črnim napisom
English: You may become more sensitive to the sun while taking Imatinib Actavis.
Slovenian: Med jemanjem zdravila Imatinib Actavis lahko postanete občutljivejši na sonce.
English: Imatinib Actavis 400 mg hard capsules
Slovenian: Imatinib Actavis 400 mg trde kapsule
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.
Slovenian: Pri približno 2,5 % bolnikov z na novo diagnosticirano KML, ki so jemali imatinib, so poročali o pojavih hude retence tekočine (plevralni izliv, edemi, pljučni edem, ascites, površinski edem).
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Slovenian: ezofagitis, ascites, želodčna razjeda, hematemeza, vnetje ustnice, disfagija,