FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: V študijo I2301, odprto, nerandomizirano, multicentrično preizkušanje faze III z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do 22 let) s Ph+ ALL in jih zdravili z imatinibom (340 mg/m2/dan) v kombinaciji z intenzivno kemoterapijo po indukcijskem zdravljenju.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: (E172), talc, titanium dioxide (E171) and iron oxide red (E172))
Slovenian: (E172), smukec, titanov dioksid (E171) in rdeči železov oksid (E172).
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.
Slovenian: mg na dan pri bolnikih, pri katerih je pri manjših odmerkih 400 mg ali 600 mg na dan bolezen napredovala, vplivalo na varnostni profil imatiniba.
English: - The other ingredients are calcium hydrogen phosphate anhydrous, crospovidone and magnesium stearate.
Slovenian: - Druge sestavine zdravila so brezvodni kalcijev hidrogenfosfat, krospovidon in magnezijev stearat.
English: They may increase or decrease the effect of Imatinib Teva B.V., either leading to increased side effects or making Imatinib Teva B.V. less effective.
Slovenian: in zato bodisi povečajo verjetnost za nastanek neželenih učinkov, bodisi zmanjšajo učinkovitost zdravila Imatinib Teva B.V..
English: At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95% on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to
Slovenian: Pri klinično pomembnih koncentracijah imatiniba je bila vezava na plazemske beljakovine na podlagi poskusov in vitro približno 95-odstotna, večina imatiniba se je vezala na albumine in kisli glikoprotein
English: This Ki value is far higher than the expected plasma levels of imatinib in patients; consequently no interaction is expected upon co-administration of either 5-fluorouracil or paclitaxel and imatinib.
Slovenian: Ta vrednost Ki je mnogo večja kot pričakovane plazemske koncentracije imatiniba pri bolnikih, zato po sočasnem dajanju bodisi 5-fluorouracila ali paklitaksela in imatiniba ni
English: 3 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
Slovenian: 3 Dogodke v zvezi s srcem, vključno s kongestivno odpovedjo srca, so na podlagi enote bolnik leto pogosteje opažali pri bolnikih s transformacijo KML kot pri bolnikih s kroničnim potekom
English: • Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of
Slovenian: • pediatričnih bolnikov z na novo diagnosticirano kronično mieloično levkemijo (KML), s prisotnim kromosomom Philadelphia (bcr-abl) (Ph+), pri katerih presaditev kostnega mozga kot zdravljenje prve izbire ne pride v poštev;
English: Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16;
Slovenian: daunorubicin 30 mg/m2 i.v., 1.-3., 15.-16. dan;
English: then resume treatment at 200 mg/m2.
Slovenian: odmerek zmanjšajte na 200 mg/m2.
English: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.
Slovenian: Imatinib je tudi zaviralec receptorskih tirozin-kinaz za rastni faktor iz trombocitov (PDGF - plateletderived growth factor), PDGF-R in zavira celične dogodke, ki jih posreduje PDGF.
English: CHR: In study 0102 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease]
Slovenian: CHR v študiji 0102 [ANC ≥ 1,5 x 109/l, trombociti ≥ 100 x 109/l, brez blastov v krvi, BM blasti < 5 % in brez bolezni zunaj kostnega mozga]
English: Other medicines and Imatinib Teva B.V.
Slovenian: Druga zdravila in zdravilo Imatinib Teva B.V.
English: 11 Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
Slovenian: 10 Mišično-skeletne bolečine in z njimi povezane dogodke so pogosteje opažali pri bolnikih s 11 Poročali so o primerih s smrtnim izidom pri bolnikih z napredovalo boleznijo, s hudimi okužbami, hudo nevtropenijo in z drugimi resnimi spremljajočimi stanji.
English: There is no experience with the treatment of children below 2 years of age.
Slovenian: mlajših od 2 let, ni nobenih izkušenj.
English: (1 h) days 4-5;
Slovenian: (1 ura) 4.-5. dan;
English: Description of selected adverse reactions Hepatitis B reactivation
Slovenian: reaktivacija hepatitisa B*
English: When needed, discontinuation of Imatinib Teva B.V. treatment may be considered.
Slovenian: Če je treba, velja razmisliti o prekinitvi zdravljenja z zdravilom Imatinib Teva B.V.
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to
Slovenian: Vseh 65 bolnikov z dokazano FIP1L1-PDGFRα fuzijsko kinazo je doseglo popolni hematološki odziv in ga ohranilo mesece (od več kot 1 mesec do več kot 44 mesecev, ocenjeno v času poročanja).
English: then resume treatment at 300 mg.
Slovenian: odmerek zmanjšajte na 300 mg.
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.
Slovenian: (24 ur), 1., 15. dan; 6-MP 25 mg/m peroralno, 1.-20. dan Konsolidacijsko zdravljenje II, IV Ara-C 75 mg/m2 i.v.
English: (q
Slovenian: V
English: You may feel dizzy or drowsy or get blurred vision while taking this medicine.
Slovenian: lahko postanete omotični ali zaspani ali se vam zamegli vid.
English: • Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood
Slovenian: • bledica, občutek utrujenosti in zasoplost in temen urin (znaki pomanjkanja rdečih krvničk),
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: 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 Imatinib Teva B.V., je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glejte
English: platelets < 10 x 109/l
Slovenian: koncentracija trombocitov < 50 x 109/l
English: Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and non-glandular stomach.
Slovenian: Tarčni organi za neoplastične spremembe so bili: ledvice, sečni mehur, sečnica, žleze prepucija in klitorisa, tanko črevo, obščitnične žleze, nadledvične žleze in ne
English: Renal insufficiency: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Slovenian: Bolniki s poslabšanim delovanjem ledvic ali bolniki na dializi naj za začetni odmerek prejmejo najmanjši priporočeni odmerek 400 mg na dan.
English: - if you have ever had or might now have a hepatitis B infection.
Slovenian: - če ste kdaj bili ali ste sedaj okuženi z virusom hepatitisa B. Zdravilo Imatinib Teva B.V.
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
Slovenian: vrtoglavost, parestezije, motnje okušanja, hipestezije migrena, somnolenca, sinkopa, periferna nevropatija, motnje spomina, išias, sindrom nemirnih nog, tremor, možganska krvavitev zvišan intrakranialni tlak, konvulzije, optični nevritis možganski edem*
English: Out of the 12 patients enrolled, 9 responded, one completely and 8 partially.
Slovenian: bolnikih, pri enem do popolnega in pri 8 do delnega.
English: Figure 2 Kaplan-Meier estimates for overall survival (ITT population)
Slovenian: Ocena celotnega preživetja po Kaplan-Meierjevi metodi (populacija z namenom število tveganju izpostavljenih bolnikov : število dogodkov
English: 600 mg)
Slovenian: (začetni odmerek 600 mg)
English: There were no special safety findings in paediatric clinical trials.
Slovenian: V pediatričnih kliničnih preskušanjih ni bilo
English: The plasma protein binding of the N-demethylated metabolite is similar to that of the parent
Slovenian: Vezava N-demetiliranega presnovka na plazemske beljakovine je podobna kot pri izhodni spojini.
English: Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Slovenian: V kontrolirani študiji (ADE10) imatiniba v primerjavi z indukcijo s kemoterapijo pri 55 bolnikih z novo odkrito boleznijo, ki so bili stari 55 let ali več, je imatinib kot edino zdravilo povzročil značilno večji delež bolnikov s popolnim hematološkim odzivom kot kemoterapija (96,3 % v primerjavi s 50
English: Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated
Slovenian: Srčne bolnike, bolnike z dejavniki tveganja za odpoved srca ali bolnike z anamnezo ledvične odpovedi je potrebno skrbno opazovati.
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
Slovenian: kronična faza KML pri pediatričnih bolnikih (ob odmerku 340 mg/m2)
English: (24 h), day 1;
Slovenian: (24 ur), 1. dan,
English: Therefore, caution should be exercised in patients with cardiac
Slovenian: Zato je pri bolnikih z motnjami delovanja srca potrebna previdnost.
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib until
Slovenian: tedne in še vedno ni povezana z levkemijo, prekinite zdravljenje z imatinibom,
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)),
English: The amount of Imatinib Teva B.V. given will depend on your child's condition, body weight and height.
Slovenian: bo odvisna od otrokovega stanja, telesne mase in višine.
English: Prednisolone 60 mg/m2/day oral Alternating chemotherapy course: high dose chemotherapy with MTX 1 g/m2 i.v.
Slovenian: prednizolon 60 mg/m2/dan peroralno izmenična kemoterapija: visokoodmerna kemoterapija z i.v.
English: 6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
Slovenian: Odmerek 6400 mg (enkraten odmerek): v literaturi je opisan en primer pri enem bolniku, pri katerem je prišlo do navzee, bruhanja, bolečin v trebuhu, zvišane telesne temperature, otekanja v obraz,
English: Imatinib Teva B.V. is a medicine containing an active substance called imatinib.
Slovenian: je zdravilo, ki vsebuje učinkovino z imenom imatinib.
English: Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Slovenian: Povečanje odmerka s 600 mg na največ 800 mg (odmerjanih po 400 mg dvakrat na dan) pri bolnikih v blastni krizi lahko pride v poštev, če bolnik nima hude neželene reakcije na zdravilo in hude nevtropenije ali trombocitopenije, ki ni povezana z levkemijo, v sledečih okoliščinah: napredovanje bolezni (kadarkoli); odsotnost zadovoljivega hematološkega odziva po najmanj 3 mesecih zdravljenja;
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
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
English: Relapsed/refractory Ph+ ALL: When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30% (9% complete) and a major cytogenetic response rate of 23%.
Slovenian: Zdravljenje z imatinibom kot edinim zdravilom pri bolnikih z relapsom/neodzivno Ph+ ALL je povzročilo pri 53 od 411 za oceno odziva primernih bolnikov stopnjo hematološkega odziva 30 % (v 9 % popolni hematološki odziv) in stopnjo pomembnega citogenetičnega odziva 23 %.
English: For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment.
Slovenian: Pri zdravljenju KML ali GIST vam lahko zdravnik predpiše večji ali manjši odmerek, odvisno od tega,
English: Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (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).
Slovenian: Previdnost je potrebna pri uporabi imatiniba z zaviralci proteaze, azolnimi antimikotiki, določenimi makrolidi, s substrati CYP3A4 z ozkim terapevtskim oknom (na primer s ciklosporinom, pimozidom, takrolimusom, sirolimusom, ergotaminom, diergotaminom, fentanilom, alfentanilom, terfenadinom, bortezomibom, docetakselom, kinidinom) ali z varfarinom in drugimi derivati kumarina (glejte poglavje 4.5).
English: The age of these patients ranged from 8 to 18 years and imatinib was given in both adjuvant and metastatic settings at doses ranging from 300 to 800 mg daily.
Slovenian: Ti bolniki so bili stari od 8 do 18 let, imatinib pa so prejemali tako v okviru adjuvantnega zdravljenja kot v okviru zdravljenja metastaz, in sicer v odmerkih od 300 mg do
English: • The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
Slovenian: • zdravljenje odraslih bolnikov z neresektabilnimi in/ali metastatskimi malignimi gastrointestinalnimi stromalnimi tumorji (GIST), pozitivnimi na Kit (CD 117);
English: See section 4.
Slovenian: Preglednica 7
English: 1 Pneumonia was reported most commonly in patients with transformed CML and in patients with
Slovenian: 1 O pljučnici so najpogosteje poročali pri bolnikih s transformacijo KML in pri bolnikih z GIST.
English: Study 0102 38-month data Myeloid blast crisis (n=260) % of patients (CI95%)
Slovenian: Študija 0102 podatki pri 38 mesecih mieloidna blastna kriza (n = 260)
English: There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Slovenian: Izkušenj pri otrocih s Ph pozitivno ALL je malo, pri otrocih z MDS/MPD, DFSP
English: If you forget to take Imatinib Teva B.V. - If you forget a dose, take it as soon as you remember.
Slovenian: Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: Imatinib Teva is also a treatment for adults and children for: - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Slovenian: je tudi zdravilo za odrasle in otroke: - z akutno limfoblastno levkemijo s prisotnim kromosomom Philadelphia (Ph pozitivna
English: Prednisolone 60 mg/m oral, days 1-5
Slovenian: prednizolon 60 mg/m peroralno, 1.-5. dan
English: MTX 12 mg intrathecal, day 1 DEX 10 mg/m2 oral, days 6-7, 13-16;
Slovenian: MTX 12 mg intratekalno, 1. dan DEX 10 mg/m2 peroralno, 6.-7., 13.-16. dan;
English: Haematological experts in the management of this disease should supervise the therapy throughout all phases
Slovenian: V vseh fazah naj zdravljenje nadzira hematolog, strokovnjak za vodenje te bolezni.
English: There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Slovenian: Pri ponovnem odmerjanju se kinetika imatiniba ni spreminjala, kopičenje pa je bilo pri enem odmerku na dan v stanju dinamičnega
English: Patients should be tested for HBV infection before initiating treatment with Imatinib Teva B.V.
Slovenian: Bolnike je treba pred začetkom zdravljenja z zdravilom Imatinib Teva B.V.
English: DEX 10 mg/m2 oral, days 6-7, 13-16;
Slovenian: DEX 10 mg/m2 peroralno, 6.-7., 13.-16. dan;
English: GIST.
Slovenian: ul.
English: Based on preliminary population pharmacokinetic analysis in GIST patients, there were three variables (albumin, WBC and bilirubin) found to have a statistically significant relationship with imatinib pharmacokinetics.
Slovenian: (albumin, WBC in bilirubin) ugotovili, da so statistično signifikantno povezane s farmakokinetiko imatiniba.
English: Study AAU02 Induction therapy (de novo Ph+ ALL) Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16;
Slovenian: Študija AAU02 Indukcijsko zdravljenje daunorubicin 30 mg/m2 i.v., 1.-3., 15.-16. dan;
English: Triple IT therapy (age-adjusted): days 1 and 22 VP-16 (100 mg/m2/day, IV): days 22-26
Slovenian: zdravljenje (prilagojeno na starost): 1. in 22. dan VP-16 (100 mg/m2/dan, i.v.
English: MTX 15 mg intrathecal, day 1 DEX 10 mg/m2 oral, days 1-5;
Slovenian: MTX 15 mg intratekalno, 1. dan DEX 10 mg/m2 peroralno, 1.-5. dan;
English: Traces of the dissolved tablets may be left behind in the glass.
Slovenian: Sledove raztopljenih tablet lahko
English: For doses of 400 mg and above (see dosage recommendation below) a 400 mg film-coated tablet is available.
Slovenian: Za odmerke 400 mg in več (glejte spodaj navedeno priporočeno odmerjanje) so na voljo 400 mg
English: Imatinib Teva B.V. can reduce the number of white blood cells, so you might get infections more easily.
Slovenian: vam lahko zmanjša število belih krvnih celic, zato lahko laže pride do okužbe,
English: • Chest pain, irregular heart rhythm (signs of heart problems).
Slovenian: • bolečine v prsnem košu, neredno bitje srca (znaki težav s srcem),
English: 12-month treatment arm % (CI)
Slovenian: preživetje brez ponovitve bolezni skupina z 12-mesečnim zdravljenjem % (IZ)
English: The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the maximum human dose of 800 mg).
Slovenian: tako na samice-matere kot na generacijo F1 je bil 15 mg/kg/dan (ena četrtina največjega odmerka za
English: All patients achieved complete haematological response, cytogenetic response and/or
Slovenian: Pri vseh bolnikih je prišlo do popolnega hematološkega odziva, do citogenetičnega odziva in/ali do kliničnega odziva.
English: Therefore, close monitoring of growth in children under imatinib treatment is recommended (see section
Slovenian: Zato je pri otrocih, ki prejemajo imatinib, priporočeno natančno spremljanje njihove rasti (glejte poglavje 4.8).
English: The recommended dose of Imatinib Teva B.V. is 400 mg/day for adult patients with MDS/MPD.
Slovenian: pri odraslih bolnikih z MDS/MPD je 400 mg/dan.
English: Figure 1 Kaplan-Meier estimates for primary recurrence-free survival endpoint (ITT population)
Slovenian: Ocena primarnega cilja opazovanja preživetja brez ponovitve bolezni po Kaplan Meierjevi metodi (populacija z namenom zdravljenja -ITT)
English: Non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Slovenian: Neprozorna oranžna kapsula, s črno oznako 7629 na telesu kapsule in s črno oznako TEVA na pokrovčku kapsule.
English: There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Slovenian: Razen za na novo diagnosticirano KML v kronični fazi ni kontroliranih kliničnih preskušanj, ki bi dokazovala klinično koristnost, na primer izboljšanje bolezenskih simptomov ali povečano preživetje.
English: Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Slovenian: AST: > IULN (lahko je normalna ali < IULN, če je celotni bilirubin > IULN) celotni bilirubin: > 1,5-3,0 IULN AST: kakršnakoli celotni bilirubin: > 3-10 IULN AST: kakršnakoli
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: Snovi, ki inducirajo aktivnost CYP3A4 (na primer deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ali Hypericum perforatum, znan tudi pod imenom šentjanževka), lahko znatno zmanjšajo izpostavljenost imatinibu in s tem potencialno povečajo tveganje za neuspešnost zdravljenja.
English: If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in
Slovenian: Če je vaš dnevni odmerek 800 mg (8 tablet), morate vzeti 4 tablete zjutraj in 4 tablete zvečer.
English: Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
Slovenian: Imatinib se presnavlja predvsem v jetrih.
English: Non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Slovenian: Neprozorna oranžna kapsula, s črno oznako 7630 na telesu in s črno oznako TEVA na pokrovčku kapsule.
English: The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Slovenian: Odrasli bolniki, o katerih so pisali v objavljeni literaturi, so bili zdravljeni z odmerki bodisi 400 mg (v 4 primerih) ali pa 800 mg (v 1 primeru) imatiniba na dan. Do odziva je prišlo pri petih (5) bolnikih, pri 3 do popolnega in pri 2 do delnega.