natgillin/translations-raw huggingface dataset:
In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST.
Pri odraslih in pediatričnih bolnikih temelji učinkovitost imatiniba na celotni hematološki in citogenetični odzivnosti in preživetju brez napredovanja bolezni pri KML, na hematološki in citogenetični odzivnosti pri Ph+ ALL, MDS/MPD, na hematološki odzivnosti pri HES/CEL ter na objektivni odzivnosti odraslih bolnikov z neresektabilnimi in/ali metastatskimi GIST in DFSP ter na preživetju brez ponovitve bolezni pri adjuvantnem zdravljenju GIST.
The length of the capsule is from 19.1 mm to 19.7 mm and the width is 6.91 mm.
Kapsula je dolga od 19,1 mm do 19,7 mm in široka 6,91 mm.
Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1).
Izkušenj pri otrocih s KML, mlajših od 2 let, in pri otrocih s Ph+ALL, mlajših od 1 leta, ni (glejte poglavje 5.1).
The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Izkušnje z uporabo imatiniba pri bolnikih z MDS/MPD v povezavi s preureditvijo genov za PDGFR je zelo malo (glejte poglavje 5.1).
• Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
• pediatričnih bolnikov s Ph+ KML v kronični fazi po neuspelem zdravljenju z interferonom alfa, ali v pospešeni fazi ali blastni krizi;
NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver.
NEL enaki kriteriji kot za CHR, a ANC ≥ 1 x 109/l in trombociti ≥ 20 x 109/l RTC < 15 % blastov v BM in PB, < 30 % blastov+promielocitov v BM in PB, < 20 % bazofilcev v PB, brez bolezni zunaj kostnega mozga, razen v vranici in jetrih.
Prednisolone 200 mg oral, 5 days per month for 13
prednizolon 200 mg peroralno, 5 dni na mesec v obdobju 13 mesecev
The expiry date refers to the last day of the month.
Navodilo je bilo nazadnje revidirano dne
- Chronic myeloid leukaemia (CML).
- kronične mieloične levkemije (KML).
Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Vključili so 260 bolnikov z mieloidno blastno krizo.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of
• oslabelost mišic in mišični spazmi z nepravilnim ritmom bitja srca (znaki spremenjenih vrednosti
Longer duration of the treatment (> 36 months) may delay the onset of further recurrences; however the impact of this finding on the overall survival remains unknown.
Daljše trajanje zdravljenja (> 36 mesecev) bi lahko podaljšalo čas do nadaljnjih ponovitev bolezni,
The effect of stopping treatment after the achievement of a complete cytogenetic response has not been
Učinek prekinitve zdravljenja po doseženem popolnem citogenetičnem
At one year the overall RFS was significantly better for imatinib (97.7%) vs. placebo (82.3%), (p<0.0001).
Po enem letu je bilo preživetje brez ponovitve bolezni statistično značilno boljše v skupini z imatinibom (97,7%) v primerjavi s skupino s placebom (82,3%), (p<0,0001).
One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count
Pri enem 3 leta starem dečku, ki je bil izpostavljen enkratnemu odmerku 400 mg, je prišlo do bruhanja, driske in anoreksije, pri drugem 3 leta starem dečku, ki je bil izpostavljen enkratnemu odmerku 980 mg, pa je prišlo do zmanjšane koncentracije levkocitov in driske.
Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6% vs.
Pri bolnikih v 5. kohorti (n=50) je neprekinjena vsakodnevna izpostavljenost imatinibu zgodaj v poteku zdravljenja v kombinaciji s kemoterapijo povečala delež bolnikov s 4-letnim preživetjem brez dogodkov (EFS - event-free survival) v primerjavi z zgodovinskimi kontrolami (n=120), kjer so bolniki prejeli standardno kemoterapijo brez imatiniba (69,6 % v primerjavi z 31,6 %).
- Imatinib Teva B.V. is not recommended during pregnancy unless clearly necessary as it may harm your baby.
v nosečnosti ni priporočena, če to ni nujno potrebno, saj lahko škoduje vašemu otroku.
For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg film-coated tablet is
Za odmerke, drugačne od 400 mg in 800 mg (glejte spodaj navedeno priporočeno odmerjanje), so na voljo 100 mg filmsko obložene tablete.
In this study 147 patients were enrolled and randomised to receive either 400 mg or 600 mg orally once daily for up to 36 months.
V to študijo so vključili 147 bolnikov, ki so bili razporejeni po metodi naključne izbire, da so dobivali bodisi po 400 mg bodisi po 600 mg zdravila na dan peroralno v obdobju do 36 mesecev.
There are no controlled trials in paediatric patients with c-Kit positive GIST.
Pri pediatričnih bolnikih s c-Kit-pozitivnim GIST niso opravili nobenega kontroliranega preskušanja.
However if it is nearly time for the next dose, - Then continue with your normal schedule.
Če je že skoraj čas za naslednjiodmerek, izpustite pozabljeni odmerek.
Seventeen (17) patients with GIST (with or without Kit and PDGFR mutations) were reported in 7 publications.
V 7 publikacijah so objavljeni podatki sedemnajstih (17) bolnikov z GIST (z mutacijo genov Kit oziroma PDGFR ali brez njiju).
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients
Delovanje jeter (aminotransferaze, bilirubin, alkalna fosfataza) je treba pri bolnikih, ki dobivajo
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Metabolism of imatinib is mainly hepatic, and only 13% of excretion is through the kidneys.
Presnova imatiniba poteka predvsem v jetrih in le 13 % se ga imatiniba izloča skozi ledvice.
The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Celotni dnevni odmerek pri otrocih ne sme preseči 800 mg pri zdravljenju KML in 600 mg pri zdravljenju Ph pozitivne ALL.
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Navajali so izboljšanje na področju srca, živčevja, kože/podkožnega tkiva, dihalnega/torakalnega/mediastinalnega organskega sistema, mišičnoskeletnega/vezivno tkivnega
It is important that you do this as long as your doctor or pharmacist tells you to.
Pomembno je, da zdravilo jemljete tako dolgo, kot vam naroči zdravnik, farmacevt ali medicinska sestra.
Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Predzdravljenje z večkratnimi odmerki rifampicina 600 mg, ki jim je sledil en 400-miligramski odmerek imatiniba, je povzročilo zmanjšanje Cmax oziroma AUC(0-∞) za vsaj 54 %
5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed
5 O plevralnem izlivu so pogosteje poročali pri bolnikih z GIST in bolnikih s transformacijo
For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Bolnikom, ki ne morejo pogoltniti filmsko obloženih tablet, lahko njihovo vsebino razredčimo v kozarcu navadne vode ali jabolčnega soka.
In addition, thirty-six (36) months of imatinib treatment significantly prolonged overall survival (OS) compared to 12 months of imatinib treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 7, Figure 2).
Poleg tega je šestintrideset (36) mesecev zdravljenja z imatinibom statistično značilno bolj podaljšalo celotno preživetje v primerjavi z 12-mesečnim zdravljenjem z imatinibom (razmerje tveganj = 0,45 [0,22, 0,89], p=0,0187) (preglednica 8, slika 2).
Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see
Zaradi možnosti, da pride do sindroma tumorske lize, je pred začetkom zdravljenja z imatinibom priporočeno odpraviti klinično pomembno dehidriranost in veliko koncentracijo sečne kisline (glejte
One of these intermediates was also positive in the mouse lymphoma assay.
Eden od teh vmesnih produktov je bil pozitiven tudi v testu mišjega
Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Omejeno število bolnikov so vključili v študije prve faze (n=10).
Imatinib can also inhibit cellular events mediated by activation of these receptor kinases.
Imatinib lahko zavira tudi celične dogodke, ki jih omogoča aktivacija
- Myelodysplastic/myeloproliferative diseases (MDS/MPD).
- z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD).
Do not use any pack that is damaged or shows signs of tampering.
Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali so vidni znaki odprtja ovojnine.
In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
Pri odraslih je treba zmanjšati odmerek s 400 mg na 300 mg ali s 600 mg na 400 mg ali z 800 mg na 600 mg, pri otrocih pa s 340 mg/m2/dan na
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/l) and thrombocytopenias (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).
Nevtropenija 3. ali 4. stopnje (ANC < 1,0 x 109/l) in trombocitopenija (koncentracija trombocitov < 50 x 109/l) sta bili štirikrat do šestkrat pogostejši v blastni krizi in pospešeni fazi (nevtropenija 59-64 % in trombocitopenija 44-63 %) kot pri na novo diagnosticiranih bolnikih v kronični fazi KML (nevtropenija 16,7 % in trombocitopenija 8,9 %).
What you need to know before you take Imatinib Teva B.V.
Kaj morate vedeti, preden boste vzeli zdravilo Imatinib Teva B.V.
Paediatric patients: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
V preskušanje stopnjevanja odmerka prve faze so vključili skupaj 26 pediatričnih bolnikov, starih < 18 let, bodisi s kronično fazo KML (n=11) bodisi s KML v blastni krizi ali Ph+ akutnimi levkemijami (n=15).
Your doctor will discuss with you the possible risks of taking Imatinib Teva B.V. during pregnancy.
Zdravnik se bo pogovoril z vami o možnih nevarnostih jemanja zdravila Imatinib Teva B.V.
Anorexia
Hematologija
- If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of
Če kapsul ne morete pogoltniti, jih lahko odprete in vsebino zmešate v kozarec navadne vode
Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolobenzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e.
Imatinib lahko zveča plazemske koncentracije drugih zdravil, ki jih presnavlja CYP3A4 (na primer triazolo-benzodiazepinov, dihidropiridinskih zaviralcev kalcijevih kanalčkov, nekaterih zaviralcev reduktaze HMG-CoA, tj. statinov, itd.).
2-3 (total of 8 courses)
2.-3. dan (skupno 8 kur)
There were a total of 397 patients consented and randomised to the study (199 patients on 12-month arm and 198 patients on 36-month arm), median age was 61 years (range 22 to 84 years).
(199 bolnikov v skupino z 12-mesečnim zdravljenjem, 198 bolnikov pa v skupino s 36 mesečnim zdravljenjem), pri čemer je bila srednja vrednost starosti bolnikov 61 let (v okviru od 22 do 84 let).
• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet derived growth factor receptor (PDGFR) gene re-arrangements.
• odraslih bolnikov z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD) v povezavi s preureditvijo genov za receptor za rastni faktor iz trombocitov (PDGFR - platelet
If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Če pride do zvišanja bilirubina na > 3-kratno zgornjo mejo normalnih vrednosti, specifično za ustanovo, (IULN-institutional upper limit of normal) ali zvišanja jetrnih aminotransferaz na > 5-kratno IULN, je treba zdravljenje z imatinibom prekiniti, dokler se koncentracija bilirubina ne vrne na < 1,5kratno IULN oziroma koncentracija aminotransferaz na < 2,5-kratno IULN.
The total number of deaths were 25 for the 12-month treatment arm and 12 for the 36-month treatment arm.
V skupini z 12-mesečnim zdravljenjem je skupno umrlo 25 bolnikov, v skupini s 36-mesečnim zdravljenjem pa 12.
Consolidation therapy I, III, V MTX 500 mg/m i.v.
Konsolidacijsko zdravljenje I, III, V MTX 500 mg/m2 i.v.
Median time to response was 13 weeks (95% C.I.
Mediani čas do odziva je bil 13 tednov (95odstotni interval zaupanja 12-23).
Study AUS01 Induction-consolidation therapy Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Indukcijsko-konsolidacijsko zdravljenje hiper-CVAD shema: CP 300 mg/m2 i.v.
There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Kontroliranih preskušanj, ki bi pokazala klinično koristnost ali izboljšanje preživetja pri teh boleznih,
Stop imatinib until ANC ≥ 1.5 x 109/l and platelets ≥ 75 x 109/l.
Prekinite zdravljenje z imatinibom, dokler ni ANC ≥ 1,5 x 109/l in koncentracija trombocitov ≥ 75 x 109/l.
- Gastrointestinal stromal tumours (GIST).
- z gastrointestinalnimi stromalnimi tumorji (GIST).
Thereafter, treatment can be resumed as appropriate depending on the initial severity
Nato se lahko zdravljenje spet začne po ustrezni shemi, odvisni
Treatment duration: In clinical trials in GIST patients, treatment with imatinib was continued until disease progression.
Trajanje zdravljenja: V kliničnih preskušanjih pri bolnikih z GIST so zdravljenje z imatinibom nadaljevali, dokler ni začela bolezen napredovati.
A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Opravili so veliko mednarodno odprto nekontrolirano študijo druge faze pri bolnikih s KML, s prisotnim kromosomom Philadelphia (Ph+), v fazi bolezni v blastni krizi.
Thirty-six (36) months of imatinib treatment significantly prolonged RFS compared to 12 months of imatinib treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 7, Figure 1).
Šestintrideset (36) mesecev zdravljenja z imatinibom je statistično značilno bolj podaljšalo preživetje brez ponovitve bolezni v primerjavi z 12 meseci zdravljenja z imatinibom (z razmerjem tveganj 0,46 [0,32, 0,65], p<0,0001) (preglednica 7, slika 1).
Imatinib significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the imatinib group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - non- estimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
Imatinib je statistično značilno podaljšal preživetje brez ponovitve bolezni, saj je bilo v skupini z imatinibom 75% bolnikov brez ponovitve bolezni 38 mesecev v primerjavi z 20 meseci v skupini s placebom (95% IZ: [30 - neocenljivo] oziroma [14 - neocenljivo]); (razmerje tveganj = 0,398 [0,259
Musculoskeletal and connective tissue disorders Muscle spasm and cramps, musculoskeletal pain including myalgia9,
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični spazmi in krči, mišično-skeletne bolečine, vključno z mialgijo9, artralgijo in bolečinami v kosteh10
Immune system disorders Not known:
Bolezni imunskega sistema pogostnost neznana:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
B. POGOJI ALI OMEJITVE GLEDE OSKERBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I : Povzetek glavnih značilnosti zdravila, poglavje 4.2).
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.
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.
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
(E172), talc, titanium dioxide (E171) and iron oxide red (E172))
(E172), smukec, titanov dioksid (E171) in rdeči železov oksid (E172).
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.
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.
- The other ingredients are calcium hydrogen phosphate anhydrous, crospovidone and magnesium stearate.
- Druge sestavine zdravila so brezvodni kalcijev hidrogenfosfat, krospovidon in magnezijev stearat.
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.
in zato bodisi povečajo verjetnost za nastanek neželenih učinkov, bodisi zmanjšajo učinkovitost zdravila Imatinib Teva B.V..
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
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
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.
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
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.
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
• 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
• 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;
Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16;
daunorubicin 30 mg/m2 i.v., 1.-3., 15.-16. dan;
then resume treatment at 200 mg/m2.
odmerek zmanjšajte na 200 mg/m2.
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.
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.
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]
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]
Other medicines and Imatinib Teva B.V.
Druga zdravila in zdravilo Imatinib Teva B.V.
11 Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
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.
There is no experience with the treatment of children below 2 years of age.
mlajših od 2 let, ni nobenih izkušenj.
(1 h) days 4-5;
(1 ura) 4.-5. dan;
Description of selected adverse reactions Hepatitis B reactivation
reaktivacija hepatitisa B*
When needed, discontinuation of Imatinib Teva B.V. treatment may be considered.
Če je treba, velja razmisliti o prekinitvi zdravljenja z zdravilom Imatinib Teva B.V.
All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to
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).
then resume treatment at 300 mg.
odmerek zmanjšajte na 300 mg.
(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.
(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.
(q
V
You may feel dizzy or drowsy or get blurred vision while taking this medicine.
lahko postanete omotični ali zaspani ali se vam zamegli vid.
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood
• bledica, občutek utrujenosti in zasoplost in temen urin (znaki pomanjkanja rdečih krvničk),
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.
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
platelets < 10 x 109/l
koncentracija trombocitov < 50 x 109/l