natgillin/translations-raw huggingface dataset:
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 Glivec.
Pri približno 2, 5% bolnikov z na novo diagnosticirano CML, ki so jemali zdravilo Glivec, so poročali o pojavih težke retence tekočine (plevralni izliv, edemi, pljučni edem, ascites, površinski edem).
Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated.
Bolnika z znaki ali simptomi, ki kažejo na odpoved srca, je treba pregledati in zdraviti.
In patients with hypereosinophilic syndrome (HES) and cardiac involvement, isolated cases of cardiogenic shock/ left ventricular dysfunction have been associated with the initiation of imatinib therapy.
Pri bolnikih s hipereozinofilnim sindromom (HES) in boleznijo srca je v posameznih primerih v povezavi z uvedbo zdravljenja z imatinibom prišlo do kardiogenega šoka/ disfunkcije levega prekata.
As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/ risk of imatinib therapy should be considered in the HES/ CEL population before treatment initiation.
Ker so občasno poročali o s srcem povezanih neželenih dogodkih z imatinibom, je treba pri populaciji bolnikov s HES/ CEL pred uvedbo zdravljenja pretehtati razmerje med koristjo in tveganjem.
Myelodysplastic/ myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels.
Mielodisplastične/ mieloproliferativne bolezni s preureditvijo gena za PDGFR so lahko povezane z visokimi koncentracijami eozinofilcev.
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.
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.
If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1– 2 mg/ kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
V primeru nenormalnega izvida katere od teh preiskav je potrebno razmisliti o kontrolnem pregledu pri kardiologu in sočasni profilaktični uporabi steroidov s sistemskim
In the GIST clinical trial, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8).
V kliničnem preskušanju GIST so poročali tako o gastrointestinalnih kot o intratumorskih krvavitvah (glejte poglavje 4. 8).
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.
Na podlagi razpoložljivih podatkov niso ugotovili nikakršnih predispozicijskih dejavnikov (na primer velikost tumorja, lokacija tumorja, motnje koagulacije), ki bi pri bolnikih z GIST povečali tveganje katere od teh dveh vrst krvavitev.
Laboratory tests Complete blood counts must be performed regularly during therapy with Glivec.
Laboratorijske preiskave Med zdravljenjem z zdravilom Glivec je treba redno opravljati kompletne hemograme.
Treatment of CML patients with Glivec has been associated with neutropenia or thrombocytopenia.
Zdravljenje bolnikov s CML z zdravilom Glivec je povezano z nevtropenijo ali s trombocitopenijo.
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.
Vendar je pojavljanje teh citopenij verjetno v zvezi s stadijem bolezni, ki jo zdravimo.
Treatment with Glivec may be interrupted or the dose may be reduced, as
Pogostejše so pri bolnikih s pospešeno fazo CML ali blastno krizo kot pri bolnikih s kronično fazo CML.
7 recommended in section 4.2.
Zdravljenje z zdravilom Glivec lahko prekinemo ali odmerek zmanjšamo, kot je priporočeno v poglavju 4. 2.
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving Glivec.
Delovanje jeter (transaminaze, bilirubin, alkalna fosfataza) je treba pri bolnikih, ki dobivajo zdravilo Glivec, redno spremljati.
In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
Kaže, da je pri bolnikih z okvarjenim delovanjem ledvic izpostavljenost imatinibu v plazmi višja kot pri bolnikih z normalnim delovanjem ledvic, verjetno zato, ker je pri teh bolnikih zvišana vrednost alfa kislega glikoproteina (AGP- alpha- acid glycoprotein) v plazmi, proteina, ki veže imatinib.
The dose can be reduced if not tolerated (see section 4.2 and 5.2).
Odmerek je mogoče znižati, če ga bolnik ne prenaša dobro (glejte poglavji 4. 2 in 5. 2).
Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e. g. ketoconazole, itraconazole, erythromycin, clarithromycin) could decrease metabolism and increase imatinib concentrations.
Snovi, ki zavirajo aktivnost izoencima CYP3A4 citokroma P450 (na primer ketokonazol, itrokonazol, eritromicin, klaritromicin), bi lahko zmanjševale presnovo in zviševale koncentracije imatiniba.
There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Pri zdravih osebah se je izpostavljenost imatinibu značilno povečala (povprečna Cmax in AUC imatiniba sta se povečali za 26% oziroma 40%), kadar je bil uporabljen z enim samim odmerkom ketokonazola (zaviralec CYP3A4).
Substances that are inducers of CYP3A4 activity could increase metabolism and decrease imatinib plasma concentrations.
Snovi, ki inducirajo aktivnost CYP3A4, bi lahko povečale presnovo in zmanjšale plazemske koncentracije imatiniba.
Co-medications which induce CYP3A4 (e. g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St.
Sočasno zdravljenje z zdravili, ki inducirajo CYP3A4 (na primer deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ali Hypericum perforatum, znan tudi pod imenom šentjanževka), lahko znatno zmanjša izpostavljenost zdravilu Glivec in s tem potencialno poveča tveganje za neuspešnost zdravljenja.
John’ s Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.
Predzdravljenje z večkratnimi odmerki rifampicina 600 mg, ki jim je sledil en 400- miligramski odmerek zdravila Glivec, je povzročilo zmanjšanje Cmax oziroma AUC( 0- ∞) za vsaj 54% oziroma 74% zadevnih vrednosti brez zdravljenja z rifampicinom.
Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of Glivec resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Podobne rezultate so opažali pri bolnikih z malignim gliomom, ki so jih zdravili z zdravilom Glivec, sočasno pa so jemali tudi antiepileptična zdravila, ki inducirajo encime.
Similar results were observed in patients with malignant gliomas treated with Glivec while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbamazepine and phenytoin.
Taka zdravila so karbamazepin, okskarbamazepin in fenitoin.
The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Pri teh bolnikih se je AUC imatiniba v plazmi zmanjšal za 73% v primerjavi z bolniki, ki niso jemali antiepileptičnih zdravil, ki inducirajo encime.
Active substances that may have their plasma concentration altered by Glivec Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Učinkovine, katerih plazemske koncentracije lahko zdravilo Glivec spremeni Imatinib povečuje povprečno Cmax in AUC simvastatina (substrat CYP3A4) 2- krat oziroma 3, 5- krat, kar kaže na to, da imatinib zavira CYP3A4.
Therefore, caution is recommended when administering Glivec with CYP3A4 substrates with a narrow therapeutic window (e. g. cyclosporin or pimozide).
Zato je pri uporabi zdravila Glivec skupaj s substrati CYP3A4 z ozko terapevtsko širino (na primer s ciklosporinom ali pimozidom) priporočljiva previdnost.
Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e. g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i. e. statins, etc.).
Zdravilo Glivec lahko zviša plazemske koncentracije drugih zdravil, ki jih presnavlja CYP3A4 (na primer triazolo- benzodiazepinov, dihidropiridinskih blokatorjev kalcijevih kanalčkov, nekaterih zaviralcev reduktaze HMG- CoA, tj. statinov, itn.).
Because warfarin is metabolised by CYP2C9, patients who require anticoagulation should receive low-molecular-weight or standard heparin.
8 Ker varfarin presnavlja CYP2C9, naj bolniki, pri katerih je potrebna antikoagulantna terapija, dobivajo nizkomolekularni ali standardni heparin.
Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]).
Imatinib je v odmerku 400 mg dvakrat dnevno zaviral presnovo metoprolola s CYP2D6, tako da sta se Cmax in AUC metoprolola povečala za približno 23% (90% IZ [1, 16- 1, 30]).
In vitro, Glivec inhibits paracetamol O-glucuronidation (Ki value of 58.5 micromol/ l at therapeutic levels).
In vitro zdravilo Glivec zavira paracetamol O- glukuronidacijo (vrednost Ki pri terapevtskih koncentracijah je 58, 5 mikromolov/ l).
Caution should therefore be exercised when using Glivec and paracetamol concomitantly, especially
Zato je pri sočasni uporabi zdravila Glivec in paracetamola potrebna previdnost, posebno pri velikih odmerkih paracetamola.
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when Glivec is co-administered (see section 4.4).
Pri bolnikih, ki so po tiroidektomiji prejemali levotiroksin, je lahko ob sočasni uporabi zdravila Glivec izpostavljenost levotiroksinu v plazmi zmanjšana (glejte poglavje 4. 4).
In Ph+ ALL patients, there is clinical experience of co-administering Glivec with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Kljub temu, da klinične izkušnje s sočasno uporabo zdravila Glivec in kemoterapije pri bolnikih s Ph+ ALL obstajajo (glejte poglavje 5. 1), pa interakcije med imatinibom in posameznimi kemoterapevtskimi shemami niso dobro opredeljene.
Imatinib adverse events, i. e. hepatotoxicity, myelosuppression or others, may increase and it has been reported that concomitant use with L-asparaginase could be associated with increased hepatotoxicity (see section 4.8).
Poročali so, da bi bila lahko sočasna uporaba L- asparaginaze povezana z bolj izraženo toksičnostjo za jetra (glejte poglavje 4. 8).
Pregnancy There are no adequate data on the use of imatinib in pregnant women.
Nosečnost Ni zadostnih podatkov o uporabi imatiniba pri nosečnicah.
Studies in animals have however shown reproductive toxicity (see section 5.3) and the potential risk for the foetus is unknown.
Vendar so študije na živalih pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3) in možno tveganje za plod ni znano.
Glivec should not be used during pregnancy unless clearly necessary.
Zdravila Glivec ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Women of childbearing potential must be advised to use effective contraception during treatment.
Ženskam v plodnem obdobju je treba svetovati, naj med zdravljenjem uporabljajo učinkovito kontracepcijo.
Lactation It is not known whether imatinib is excreted in human milk.
Dojenje Ni znano, ali se imatinib izloča v žensko mleko.
In animals, imatinib and/ or its metabolites were extensively excreted in milk.
Pri živalih so se imatinib in/ ali njegovi presnovki v veliki meri izločali v mleko.
Women who are taking Glivec should therefore not breast-feed.
Zato naj matere, ki jemljejo zdravilo Glivec, ne dojijo.
However, patients should be advised that they may experience undesirable effects such as dizziness or blurred vision during treatment with imatinib.
Vendar je treba bolnikom razložiti, da lahko med zdravljenjem z imatinibom doživijo neželene učinke, na primer vrtoglavost ali meglen vid.
In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy.
V kliničnih preskušanjih pri CML so prekinitev dajanja zdravila zaradi neželenih reakcij, povezanih z zdravilom, zabeležili pri 2, 4% na novo diagnosticiranih bolnikov, 4% bolnikov v pozni kronični fazi po neuspelem zdravljenju z interferonom, 4% bolnikov v pospešeni fazi po neuspelem zdravljenju z
In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.
Pri GIST so preskušano zdravilo ukinili zaradi neželenih reakcij, povezanih z zdravilom, pri 4% bolnikov.
There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease.
Pri bolnikih s CML je bila izrazitejša mielosupresija kot pri bolnikih z GIST, kar je verjetno posledica osnovne bolezni.
In the GIST clinical trial, 7 (5%) patients experienced CTC grade 3/ 4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
V kliničnem preskušanju pri GIST je imelo 7 (5%) bolnikov gastrointestinalne krvavitve CTC stopnje 3/ 4 (3 bolniki), intratumorske krvavitve (3 bolniki) ali obe vrsti krvavitev (1 bolnik).
GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Vir gastrointestinalnih krvavitev so bile morda lokacije gastrointestinalnih tumorjev (glejte poglavje 4. 4).
The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Z zdravilom povezane neželene reakcije o katerih so najpogosteje poročali (≥ 10%), so bile blaga navzea, bruhanje, driska, bolečine v trebuhu, utrujenost, mialgija, mišični krči in izpuščaj.
9 When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Kadar so imatinib uporabljali v kombinaciji z visokoodmerno kemoterapevtsko shemo pri bolnikih s Ph+ ALL, je prišlo do prehodne toksičnosti za jetra v obliki zvišanja transaminaz in hiperbilirubinemije.
Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “ fluid retention”.
Različne neželene reakcije, na primer plevralni izliv, ascites, pljučni edem in hitro naraščanje telesne mase, bodisi s površinskimi edemi bodisi brez njih, imenujemo s skupnim izrazom “ retenca tekočine ”.
However, some of these reactions may be serious or life- threatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Vendar so nekatere od teh reakcij lahko resne ali smrtno nevarne. Več bolnikov z blastno krizo je namreč umrlo z zapleteno klinično anamnezo plevralnega izliva, kongestivnega popuščanja srca in ledvične odpovedi.
Adverse reactions Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Neželeni učinki Neželeni učinki, o katerih so poročali več kot enkrat, so navedeni spodaj po organskih sistemih in po pogostnosti.
Frequencies are defined as: very common (> 1/ 10), common (> 1/ 100, ≤ 1/ 10), uncommon (> 1/ 1,000, ≤ 1/ 100), rare (≤ 1/ 1,000), not known (cannot be estimated from the available data).
Pogostnost je opredeljena kot: zelo pogosti (> 1/ 10), pogosti (> 1/ 100, ≤1/ 10), občasni (> 1/ 1. 000, ≤1/ 100), redki (≤1/ 1. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).