FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil,
Slovenian: Zato je pri uporabi imatiniba skupaj s substrati CYP3A4 z ozko terapevtsko širino (na primer s ciklosporinom, pimozidom, takrolimusom, sirolimusom, z ergotaminom, diergotaminom, s fentanilom, z alfentanilom, s terfenadinom, z bortezomibom, docetaksel in s kinidinom).
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 10
Slovenian: 9/l) in trombocitopenija 4. stopnje (koncentracija bili odkriti nevtropenija 4. stopnje (ANC < 0,5 x 10
English: Plasma pharmacokinetics
Slovenian: Plazemska farmakokinetika
English: Musculoskeletal and connective tissue disorders Very common: Muscle spasm and cramps, musculoskeletal pain including myalgia
Slovenian: mišični spazmi in krči, mišično-skeletne bolečine, vključno z mialgijo artralgijo in bolečinami v kosteh pogosti:
English: ANC = absolute neutrophil count a occurring after at least 1 month of treatment
Slovenian: ANC = absolutno število nevtrofilcev (absolute neutrophil count)
English: Dizziness, paraesthesia, taste disturbance, hypoaesthesia
Slovenian: vrtoglavost, parestezije, motnje okušanja, hipestezije občasni:
English: Intensification block 2 (9 weeks)
Slovenian: 2. intenzifikacijski blok (9 tednov)
English: • If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still mineral water or apple juice.
Slovenian: • Če kapsul ne morete pogoltniti, jih lahko odprete in vsebino zmešate v kozarec navadne
English: Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Slovenian: Bolnike je treba pred začetkom zdravljenja z zdravilom imatiniba testirati glede okužbe z virusom hepatitisa B. Pri bolnikih s pozitivno serologijo na hepatitis B (vključno z bolniki z aktivno boleznijo) in bolnikih, pri katerih se med zdravljenjem test glede okužbe z virusom hepatitisa B izkaže za pozitivnega, se je treba pred začetkom zdravljenja posvetovati s strokovnjaki za obolenja jeter in zdravljenje hepatitisa B. Pri prenašalcih virusa hepatitisa B, pri katerih je potrebno zdravljenje z zdravilom imatiniba, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glej poglavje 4.8).
English: MESNA IV days 29-33
Slovenian: ): 29.-33. dan
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/m daily.
Slovenian: Ti bolniki so bili stari od starosti novorojenčka do 14 let, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 400 do 520 mg/m na dan.
English: 5) Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML.
Slovenian: 5) O plevralnem izlivu so pogosteje poročali pri bolnikih z GIST in pri bolnikih s transformacijo KML (kronična mieloična levkemija v pospešeni fazi: KML-AP in kronična mieloična levkemija v blastni krizi: KML-BC) kot pri bolnikih s kroničnim potekom KML.
English: Intensification block 1 (9 weeks)
Slovenian: 1. intenzifikacijski blok (9 tednov)
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m
Slovenian: 9/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 260 mg/m².
English: 8) Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
Slovenian: 8) Poročali so o nekaj primerih odpovedi jeter in nekroze jeter s smrtnim izidom.
English: There have been case reports of growth retardation occurring in children and pre-adolescents receiving imatinib.
Slovenian: Pri otrocih in mladostnikih pred puberteto, ki so prejemali imatinib, so poročali o posameznih primerih zaostajanja v rasti.
English: However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML.
Slovenian: Pogostejše so pri bolnikih s pospešeno fazo KML ali blastno krizo kot pri bolnikih s kronično fazo KML.
English: 7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Slovenian: 7, spahovanje, melena, ezofagitis, ascites, želodčna razjeda, hematemeza, vnetje ustnice, disfagija,
English: Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
Slovenian: V 3 publikacijah so objavljeni podatki petih (5) bolnikov z DFSP s preureditvijo gena za PDGFR.
English: Remission induction DEX 10 mg/m oral, days 6-7, 13-16; i.v.
Slovenian: indukcija remisije DEX 10 mg/m² peroralno, 6.-7., 13.-16. dan; IDA 8 mg/m² i.v.
English: When and how to take Imatinib medac • Take Imatinib medac with a meal.
Slovenian: Kdaj in kako jemati zdravilo Imatinib medac
English: Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry
Slovenian: flatulenca, napihnjen trebuh, gastroezofagealni refluks, obstipacija, suha občasni:
English: The liver was a target organ in rats and dogs.
Slovenian: Pri podganah in psih so bila tarčni organ jetra.
English: Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Slovenian: Pri uporabi imatiniba z zaviralci družine CYP3A4 je potrebna previdnost.
English: 9/l and platelets ≥ 20 x 10
Slovenian: 9/l in trombociti ≥ 20 x 10
English: • Pain or swelling in your abdomen, flatulence, heartburn or constipation.
Slovenian: • bolečine v trebuhu ali napihnjen trebuh, vetrovi, zgaga ali zapeka,
English: Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered.
Slovenian: Zato je pri bolnikih s HES/CEL in bolnikih z visokimi koncentracijami eozinofilcev v povezavi z MDS/MPD pred uporabo imatiniba potrebno razmisliti o pregledu pri specialistu kardiologu, izvedbi ehokardiograma in določitvi serumskega troponina.
English: (0.5 h), days 7, 8, 14, 15; i.v., days 22-25, 29-32
Slovenian: (0,5 ur), 7., 8., 14., 15. dan;
English: The recommended dose of imatinib is 100 mg/day for patients with HES/CEL.
Slovenian: Priporočeni odmerek imatiniba pri bolnikih s HES/CEL je 100 mg/dan.
English: Pleural effusion
Slovenian: PRETISNI OMOT
English: Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.
Slovenian: Pri vseh bolnikih je treba upoštevati standardne prakse in postopke za spremljanje in zdravljenje krvavitev, saj sta povečana ožiljenost in nagnjenost h krvavitvam del naravnega in kliničnega poteka GIST.
English: What Imatinib medac looks like and contents of the pack Imatinib medac 100 mg hard capsules are gelatin capsules of size “3” with orange body and cap. Imatinib medac 400 mg hard capsules are gelatin capsules of size “00” with caramel body and cap. Imatinib medac 100 mg capsules are supplied in packs containing 60 capsules in blisters.
Slovenian: Izgled zdravila Imatinib medac in vsebina pakiranja Imatinib medac 100 mg trde kapsule so želatinske kapsule velikosti ”3” z oranžnim trupom in pokrovčkom.
English: Do not take Imatinib medac: • if you are allergic to imatinib or any of the other ingredients of this medicine (listed in
Slovenian: • če ste alergični na imatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: (24 h), day 1, and Ara-C 2 g/m i.v.
Slovenian: (24 ur), 1.dan in Ara-C 2 g/m² i.v.
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Slovenian: 9/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 400 mg.
English: The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
Slovenian: Ovojnico kapsule za 100 mg kapsulo sestavljajo želatina, rumeni železov oksid (E172), titanov dioksid (E171) in rdeči železov oksid (E172).
English: Based on the available data, no predisposing factors (e.g. tumour size, tumour location, coagulation disorders) have been identified that place patients with GIST at a higher risk of either type of haemorrhage.
Slovenian: velikost tumorja, lokacija tumorja, motnje strjevanja krvi), zaradi katerih bi bili ti bolniki izpostavljeni večjemu tveganju za eno od obeh oblik krvavitve.
English: Clinical monitoring should be considered when administering imatinib to patients treated with metoprolol.
Slovenian: Pri bolnikih, ki se zdravijo z metoprololom, je treba razmisliti o kliničnem nadzoru, kadar jim damo imatinib.
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
Slovenian: trombocitemija, limfopenija, depresija kostnega mozga, eozinofilija,
English: Consolidation therapy DEX 10 mg/m oral, days 1-5; Vindesine 3 mg/m i.v., day 1;
Slovenian: DEX 10 mg/m² peroralno, 1.-5. dan; vindezin 3 mg/m² i.v., 1. dan;
English: The capsule shell for 400 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
Slovenian: Ovojnico kapsule za 400 mg kapsulo sestavljajo želatina, rumeni železov oksid (E172), titanov dioksid (E171), rdeči železov oksid (E172) in črni železov oksid (E172).
English: If any of these apply to you, tell your doctor before taking Imatinib medac.
Slovenian: Če kaj od zgoraj navedenega velja za vas, se še pred jemanjem zdravila Imatinib medac posvetujte s svojim zdravnikom.
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, nonrandomised phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Slovenian: Pediatrični bolniki: V odprto, nerandomizirano, multicentrično študijo faze III z oznako I2301 in z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do
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
Slovenian: akutna febrilna nevtrofilna dermatoza (Sweetov sindrom), sprememba barve nohtov, angionevrotični edem, mehurčkast izpuščaj, multiformni eritem, levkocitoklastični vaskulitis, Stevens-Johnsonov sindrom, akutna generalizirana eksantemska pustuloza (AGEP) pogostnost neznana: sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, izpuščaj zaradi zdravila z eozinofilijo in sistemskimi simptomi (DRESS - drug rash with eosinophilia and systemic symptoms)*
English: Imatinib medac is also a treatment for adults for:
Slovenian: Zdravilo Imatinib medac je tudi zdravilo za odrasle:
English: Investigations Very common: Weight increased
Slovenian: Preiskave zelo pogosti: pogosti: občasni:
English: In the rest of this leaflet, we will use the abbreviations when talking about these diseases.
Slovenian: V nadaljnjem besedilu tega navodila za uporabo so bolezni navedene s kraticami.
English: 9/l and platelets ≥ 75 x 10
Slovenian: 9/l in koncentracija trombocitov ≥ 75 x 10
English: All patients received imatinib and consolidation chemotherapy (see Table 3) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
Slovenian: Ravni transkriptov bcr-abl so bile po 8 tednih v obeh krakih enake.
English: Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
Slovenian: V 4 publikacijah so objavljeni podatki petih (5) bolnikov z MDS/MPD s preureditvijo gena za PDGFR.
English: The starting dose is 600 mg to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) once a day.
Slovenian: Začetni odmerek je 600 mg, kar vzamete kot 6 kapsul po 100 mg (ali 1 kapsulo po 400 mg in
English: • Joint pain with swelling.
Slovenian: • bolečine v sklepih z otekanjem.
English: Partial
Slovenian: Delen
English: (24 h), day 1; Etoposide 250 mg/m i.v.
Slovenian: (24 ur), 1. dan; etopozid 250 mg/m² i.v.
English: Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules
Slovenian: Imatinib medac 100 mg trde kapsule Imatinib medac 400 mg trde kapsule
English: Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81 % of the dose was recovered within 7 days in faeces (68 % of dose) and urine (13 % of dose).
Slovenian: 81 % odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
English: VCR (1.5 mg/m 2/day, IV): days 1, 8, and 15 DAUN (45 mg/m 2/day bolus, IV): days 1 and 2
Slovenian: ): 1., 8. in 15. dan DAUN (45 mg/m 2/dan bolus, i.v.
English: Total bilirubin: >3-10 ULN AST: any
Slovenian: zmerna celotni bilirubin: > 1,5-3,0 ULN AST: kakršnakoli težka celotni bilirubin: >3-10 ULN AST: kakršnakoli ULN = zgornja meja normalnih vrednosti, specifična za ustanovo AST = aspartat-aminotransferaza
English: Reinduction block 1 (3 weeks)
Slovenian: 1. reindukcijski blok (3 tedne)
English: Talk to your doctor before taking Imatinib medac:
Slovenian: Ne jemljite zdravila Imatinib medac:
English: Reinduction block 2 (3 weeks)
Slovenian: 2. reindukcijski blok (3 tedne)
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (lahko prizadene do 1 bolnika od 10 bolnikov):
English: Skin and subcutaneous tissue disorders Very common: Periorbital oedema, dermatitis/eczema/rash
Slovenian: periorbitalni edemi, dermatitis/ekcem/izpuščaj pogosti:
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Slovenian: 9/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 300 mg.
English: Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172)
Slovenian: Ovojnica kapsule želatina rumeni železov oksid (E172) titanov dioksid (E171) rdeči železov oksid (E172) črni železov oksid (E172)
English: G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
Slovenian: G-CSF (5 μg/kg, s.c.): 4.-13. dan oziroma do ANC > 1500 po doseženem najnižjem številu
English: In the event of recurrence of ANC < 1.0 x 10
Slovenian: Če se pojav/a ANC < 1,0 x 10
English: VCR (1.5 mg/m 2/day, IV): days 1, 29
Slovenian: VCR (1,5 mg/m 2/dan, i.v.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Zdravilo Imatinib medac vsebuje laktozo monohidrat Če vam je zdravnik povedal, da ne prenašate nekaterih vrst sladkorjev, se obrnite na svojega zdravnika, preden vzamete to zdravilo.
English: Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172)
Slovenian: Ovojnica kapsule želatina rumeni železov oksid (E172) titanov dioksid (E171) rdeči železov oksid (E172)
English: 2/day PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 8-28 Methotrexate (20 mg/m 2/week, PO): days 8, 15, 22
Slovenian: ): 1. in 29. dan 2/dan, peroralno): 1.-5. dan in 29.-33. dan 2/dan, peroralno): 8.-28. dan 2/teden, peroralno): 8., 15. in 22. dan metotreksat (20 mg/m
English: The dose is 800 mg per day, to be taken as 1 capsule of 400 mg in the morning and 1 capsule of
Slovenian: • Če se zdravite zaradi DFSP: Odmerek je 800 mg na dan, kar vzamete kot 1 kapsulo po 400 mg zjutraj in 1 kapsulo po
English: Weight decreased
Slovenian: odpoved jeter
English: Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
Slovenian: hemoragij) naj bolniki, pri katerih je potrebna antikoagulantna terapija, namesto kumarinskih derivatov, n.pr.
English: • Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel
Slovenian: • občutek slabosti s siljenjem na bruhanje (navzea) z drisko, in bruhanjem, bolečine v trebuhu ali povišana telesna temperatura (znaki težav s črevesjem),
English: However, always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Slovenian: Seveda pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika, farmacevta ali medicinske sestre.
English: The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis.
Slovenian: Priporočeni odmerek imatiniba za odrasle bolnike v blastni krizi je 600 mg/dan.
English: Imatinib medac 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Slovenian: Imatinib medac 100 mg trde kapsule Ena trda kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
English: Marketing Authorisation Holder medac
Slovenian: Imetnik dovoljenja za promet z zdravilom medac
English: NAME OF THE MEDICINAL PRODUCT Imatinib medac 400 mg hard capsules Imatinib
Slovenian: IME ZDRAVILA Imatinib medac 400 mg trde kapsule imatinib
English: (1 h), days 1-5; i.v.
Slovenian: ): 1.-5. dan 2/dan, i.v.
English: Tell your doctor straight away if you get any of the following:
Slovenian: Če pride do katerega od naslednjih neželenih učinkov, takoj obvestite zdravnika:
English: Pharmacokinetics of imatinib
Slovenian: Zdravilo Imatinib
English: Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Slovenian: Pri mnogih od teh živali sta se zvišala sečnina in kreatinin.
English: 9/l and/or platelets < 50 x 10
Slovenian: 9/l in/ali koncentracija trombocitov < 50 x 10
English: Common: Uncommon:
Slovenian: nespečnost občasni:
English: DEX (6 mg/m 2/day, PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 1-56 Methotrexate (20 mg/m 2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
Slovenian: = intramuskularno, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6-merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA= natrijev 2-merkaptoetan sulfonat, iii= oziroma dokler koncentracija MTX ni < 0,1 μM, Gy= Gray
English: Imatinib medac 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
Slovenian: Imatinib medac 400 mg trde kapsule Ena trda kapsula vsebuje 400 mg imatiniba (v obliki mesilata).
English: Imatinib medac is also a treatment for children and adolescents for:
Slovenian: Zdravilo Imatinib medac je tudi zdravilo za otroke in mladostnike:
English: NAME OF THE MEDICINAL PRODUCT Imatinib medac 100 mg hard capsules Imatinib
Slovenian: IME ZDRAVILA Imatinib medac 100 mg trde kapsule imatinib
English: i.v.
Slovenian: MESNA i.v.
English: Palpitations, tachycardia, cardiac failure congestive 3, pulmonary oedema
Slovenian: palpitacije, tahikardija, kongestivno popuščanje srca
English: How to store Imatinib medac
Slovenian: Shranjevanje zdravila Imatinib medac
English: A total of 51 paediatric patients with newly diagnosed and untreated CML in chronic phase have been enrolled in an open-label, multicentre, single-arm phase II trial.
Slovenian: V odprto, multicentrično preskušanje faze II z eno skupino so vključili skupno 51 pediatričnih bolnikov z na novo diagnosticirano in nezdravljeno KML v kronični fazi.
English: 9/l and/or platelets < 10 x 10
Slovenian: 9/l in/ali koncentracija trombocitov < 10 x 10
English: DEX (6 mg/m2/day, PO): days 1-7 and 15-21
Slovenian: zdravljenje (prilagojeno na starost): 1. in 15. dan DEX (6 mg/m2/dan, peroralno): 1.-7. dan in 15.-21. dan
English: The dose of
Slovenian: IME ZDRAVILA
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 zdravilom Imatinib medac, je bila izvedena opazovalna študija (študija L2401) in sicer uvedba registra za dolgoročno zbiranje podatkov o varnosti in učinkovitosti.
English: Consolidation block 2 (3 weeks)
Slovenian: 2. konsolidacijski blok (3 tedne)
English: 9/l) and thrombocytopenias (platelet count < 50 x 10
Slovenian: 9/l) in trombocitopenija (koncentracija trombocitov < 50 x 10
English: Table 1 Tabulated summary of adverse reactions Infections and infestations
Slovenian: Preglednica 1 Preglednica neželenih učinkov
English: VCR 2 mg i.v., days 6, 13, 20; Daunorubicin 45 mg/m i.v., days 6-7, 13-14
Slovenian: daunorubicin 45 mg/m² i.v., 6.-7., 13.-14. dan indukcijsko zdravljenje II
English: • Rash.
Slovenian: • modrice,
English: Active substances that may decrease imatinib plasma concentrations 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: Snovi, ki inducirajo aktivnost CYP3A4 (na primer deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ali Hypericum perforatum, znan tudi pod imenom šentjanževka),
English: Consolidation block 1 (3 weeks)
Slovenian: 1. konsolidacijski blok (3 tedne)
English: • Muscle cramps or joint, muscle or bone pain, during Imatinib medac treatment or after you have stopped taking Imatinib medac
Slovenian: Imatinib medac ali po prenehanju jemanja zdravila,
English: Thrombosis/embolism* Respiratory, thoracic and mediastinal disorders
Slovenian: pogostnost neznana: tromboza/embolija* Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti: občasni:
English: • Nose bleeds.
Slovenian: • krvavitve iz nosu,
English: Imatinib medac 100 mg hard capsules Size “3” hard capsules with orange body and cap. Imatinib medac 400 mg hard capsules Size “00” hard capsules with caramel body and cap.
Slovenian: Imatinib medac 100 mg trde kapsule Oranžen trup in pokrovček, trde kapsule velikosti ”3”.
English: • Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or
Slovenian: • izcedek iz oči s srbenjem, rdečino in otekanjem (vnetje očesne veznice), prekomerno solzenje
English: Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Slovenian: plevritična bolečina, pljučna fibroza, pljučna hipertenzija, pljučna krvavitev pogostnost neznana: akutna respiratorna odpoved
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 (povprečno trajanje teh epizod je bilo približno en teden).
English: • Rapid weight gain.
Slovenian: • povečanje telesne mase.
English: Triple IT therapy (age-adjusted): days 1, 29
Slovenian: zdravljenje (prilagojeno na starost): 1. in 29. dan 2/dan, i.v.
English: VP-16 (100 mg/m2/day, IV): days 1-5
Slovenian: VP-16 (100 mg/m i.v.