FrancophonIA/ELRC3.0 huggingface dataset:
English: Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Slovenian: Tri bolnice (2 %), ki so dobivale docetaksel, so zdravljenje prekinile zaradi zastajanja tekočine, 15 prejemnic (9 %) doksorubicina pa je prekinilo zdravljenje zaradi kardiotoksičnih učinkov (trije primeri usodnega zastojnega srčnega popuščanja).
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Slovenian: Poročali so o diseminirani intravaskularni koagulaciji (DIK), pogosto v povezavi s sepso ali odpovedjo več organov.
English: Each carton contains:
Slovenian: Kaj vsebuje navodilo:
English: Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Slovenian: Opisali so zelo redke primere hepatitisa, včasih s smrtnim izidom, pri bolnikih z ţe prej obstoječo boleznijo jeter.
English: In about 20% of these cases there were no risk factors for acute renal failure concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
Slovenian: V pribliţno 20 % teh primerov ni bilo nobenih dejavnikov tveganja za akutno ledvično odpoved, sočasnih nefrotoksičnih zdravil in bolezni prebavil.
English: No cases were reported in patients who received fluorouracil, doxorubicin and cyclophosphamide.
Slovenian: Nobenih sprememb niso zabeleţili pri bolnicah, ki so prejemale fluorouracil, doksorubicin in ciklofosfamid.
English: When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Slovenian: V kombinaciji z docetakselom je bil očistek karboplatina za pribliţno 50 % večji od vrednosti, opisanih med monoterapijo s karboplatinom.
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Slovenian: Podatki o reverzibilnosti so na voljo za 35,3 % bolnikov, pri katerih so se po zdravljenju z docetakselom kot samostojno učinkovino v odmerku 100 mg/m pojavili nevrotoksični učinki.
English: In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients with lymphoedema at the end of the chemotherapy.
Slovenian: V študiji GEICAM 9805 so še trajajoč limfedem zabeleţili pri 4 od 5 bolnic z limfedemom na koncu kemoterapije.
English: The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Slovenian: Podatke o neţelenih učinkih, ki so morda ali verjetno povezani z uporabo docetaksela, so zbrali pri:
English: For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Slovenian: Pri bolnikih, ki doţivijo zapleteno nevtropenijo (podaljšano nevtropenijo, febrilno nevtropenijo ali okuţbo) je treba razmisliti o uporabi G-CSF in zmanjšanju odmerka (glejte poglavje 4.2).
English: The use of docetaxel should be confined to units specialised in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy (see section 6.6).
Slovenian: Docetaksel se sme uporabljati samo v enotah, specializiranih za citotoksično kemoterapijo in samo pod nadzorom zdravnika, izkušenega v uporabi onkološke kemoterapije (glejte poglavje 6.6).
English: An effective method of contraception should be used during treatment.
Slovenian: Kontracepcija pri moških in ţenskah Med zdravljenjem se mora uporabljati učinkovita metoda kontracepcije.
English: Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Slovenian: Prednizon ali prednizolon v peroralnem odmerku 5 mg dvakrat dnevno se daje neprekinjeno (glejte poglavje 5.1).
English: Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Slovenian: Pri bolnikih, ki so dobivali docetaksel vsake 3 tedne, so ugotovili značilno daljše celotno preţivetje v primerjavi s tistimi, ki so se zdravili z mitoksantronom.
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Slovenian: Incidenca naslednjih neţelenih učinkov (vse stopnje) - letargije, stomatitisa in nevtropenične okuţbeje bila pri bolnikih, starih 65 let ali več, za ≥ 10 % večja kot pri mlajših bolnikih.
English: Reconstituted solution must be further diluted in the infusion diluent before administration.
Slovenian: Rekonstituirano raztopino je treba pred uporabo dodatno razredčiti v vehiklu.
English: The concentrate is a clear viscous, yellow to brown-yellow solution.
Slovenian: Koncentrat je bistra, viskozna, rumena do rjavorumena raztopina.
English: Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
Slovenian: In vitro docetaksel dokazano zmoti celično mikrotubulno mreţje, nujno za mitotično in interfazno celično delovanje.
English: Docetaxel Teva Pharma will be given by infusion into one of your veins (intravenous use).
Slovenian: Zdravilo Docetaxel Teva Pharma boste dobili v infuziji v eno od ven (intravenska uporaba).
English: Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Slovenian: Febrilna nevtropenija se je pojavila pri 17,2 % bolnikov, nevtropenična okuţba pa pri 13,5 % bolnikov, ne glede na uporabo G-CSF.
English: Patients with impaired vision should undergo a prompt and complete ophthalmologic examiniation.
Slovenian: Bolniki z okvaro vida morajo takoj opraviti popoln oftalmološki pregled.
English: What Docetaxel Teva Pharma is and what it is used for What you need to know before you use Docetaxel Teva Pharma How to use Docetaxel Teva Pharma Possible side effects
Slovenian: Kaj je zdravilo Docetaxel Teva Pharma in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Teva Pharma Kako uporabljati zdravilo Docetaxel Teva Pharma Moţni neţeleni učinki
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
Slovenian: In vivo docetaksel ni odvisen od reţima in ima širok spekter eksperimentalnega protitumorskega delovanja proti napredovalim mišjim in humanim transplantiranim tumorjem.
English: Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Slovenian: Bolezni krvi in limfatičnega sistema Redki: krvavitve, povezane s trombocitopenijo stopnje 3/4.
English: In case CMO is diagnosed, docetaxel treatment should be discontinued and appropriate treatement initiated (see section 4.8).
Slovenian: Če je diagnosticiran CMO, je treba zdravljenje z docetakselom prekiniti in uvesti ustrezno zdravljenje (glejte poglavje 4.8).
English: If you are a man being treated with Docetaxel Teva Pharma you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.
Slovenian: Če ste moški, ki se zdravi z zdravilom Docetaxel Teva Pharma je priporočljivo, da ne zaplodite otroka med zdravljenjem in v obdobju 6 mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščete nasvet glede ohranitve sperme, ker docetaksel lahko prizadene moško plodnost.
English: The effect of prednisone on the pharmacokinetics of docetaxel administered with standard dexamethasone premedication has been studied in 42 patients.
Slovenian: Učinek prednizona na farmakokinetiko docetaksela, ki so ga aplicirali s standardno premedikacijo z deksametazonom, so študirali pri 42 bolnikih.
English: In non clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
Slovenian: Docetaksel je imel v nekliničnih raziskavah genotoksične učinke in lahko vpliva na plodnost pri moških (glejte poglavje 5.3).
English: Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
Slovenian: Neţeleni učinki na moda, opisani v študijah toksičnosti na glodalcih, nakazujejo, da lahko docetaksel prizadene moško plodnost.
English: An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Slovenian: Opravili so odprto multicentrično randomizirano študijo III. faze za primerjavo monoterapije z docetakselom in paklitaksela pri zdravljenju napredovalega raka dojke pri bolnicah, katerih predhodno zdravljenje je moralo vključevati antraciklin.
English: Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Slovenian: Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da ponavljate obračanje viale vsaj 45 sekund.
English: You must not become pregnant during treatment with this medicine and you must use an effective method of contraception during therapy because Docetaxel Teva Pharma may be harmful for the unborn baby.
Slovenian: Med zdravljenjem s tem zdravilom ne smete zanositi in morate uporabljati zanesljivo metodo kontracepcije, saj lahko zdravilo Docetaxel Teva Pharma škoduje nerojenemu otroku.
English: The solvent for Docetaxel Teva Pharma is water for injections.
Slovenian: Vehikel za zdravilo Docetaxel Teva Pharma je voda za injekcije.
English: - The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol.
Slovenian: - Pomoţni snovi sta polisorbat 80 in 25,1 % (m/m) brezvodnega etanola.
English: Peripheral sensory neuropathy was observed to be ongoing during follow-up in 10 patients out of the 84 patients with peripheral sensory neuropathy at the end of the chemotherapy in the node positive breast cancer study (TAX316).
Slovenian: Še prisotno periferno senzorično nevropatijo so pri spremljanju zabeleţili pri 10 od 84 bolnicah, ki so imele periferno senzorično nevropatijo ob koncu kemoterapije, v študiji pri bolnicah z rakom dojk s pozitivnimi bezgavkami (TAX316).
English: The most commonly reported adverse reactions of Docetaxel Teva Pharma alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Slovenian: Najpogosteje opisani neţeleni učinki na samo zdravilo Docetaxel Teva Pharma so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, slabost, bruhanje, razjede v ustih, driska in utrujenost.
English: Docetaxel is more than 95% bound to plasma proteins.
Slovenian: Več kot 95 % docetaksela se veţe na beljakovine v plazmi.
English: Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Slovenian: Zelo pogosti: hematoloških toksičnih učinkov je bilo več pri bolnikih, ki so dobivali trastuzumab in docetaksel kot pri tistih, ki so dobivali samo docetaksel (32 % nevtropenije stopnje 3/4 v primerjavi z 22 % po merilih NCI-CTC).
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in Phase I studies.
Slovenian: Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m v študijah I.
English: As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis (see section 5.1).
Slovenian: Za preţivetje brez bolezni (DFS - disease-free survival) in celokupno preţivetje (OS - overall survival) ugotovljena korist pri bolnicah z bezgavkami 4+ ni bila statistično značilna, zato končna analiza ni v celoti potrdila pozitivnega razmerja med koristjo in tveganjem TAC pri bolnicah z bezgavkami 4+ (glejte poglavje 5.1).
English: All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Slovenian: Vse tri načine zdravljenja so dajali neprekinjeno v kombinaciji s prednizonom ali prednizolonom 5 mg dvakrat dnevno.
English: Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Slovenian: razlika zdravljenj: 5,4 % [95-% IZ: -1,1; 12,0]
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients.
Slovenian: Po 10 letih spremljanja v študiji TAX316 so akutno levkemijo zabeleţili pri 4 od 744 bolnic, ki so prejemale TAC, in pri 1 od 736 bolnic, ki so prejemale FAC.
English: The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy.
Slovenian: Zmeren oziroma hud zastoj se pozneje pojavi pri bolnikih, ki dobijo premedikacijo (srednji kumulativni odmerek: 818,9 mg/m 2), kot pri tistih, ki je ne (srednji kumulativni odmerek: 489,7 mg/m 2); vendar so ga pri nekaterih bolnikih opisali med zgodnjimi cikli zdravljenja.
English: Pharmachemie BV.
Slovenian: Pharmachemie B.V.
English: Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal products has not been investigated formally, in vitro interactions with tightly protein-bound drugs such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Slovenian: Moţna medsebojna delovanja docetaksela s sočasno uporabljanimi zdravili in vivo sicer niso bila formalno raziskana, vendar medsebojno delovanje z učinkovinami, močno vezanimi na beljakovine - npr. eritromicinom, difenhidraminom, propranololom, propafenonom, fenitoinom, salicilati, sulfametoksazolom in natrijevim valproatomin vitro ni vplivalo na vezavo docetaksela na beljakovine.
English: Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel.
Slovenian: Bolniki, ki so doţiveli hudo preobčutljivostno reakcijo, ne smejo več dobiti docetaksela.
English: Patients receiving TCF should be closely monitored, (see sections 4.2 and 4.8).
Slovenian: Bolnike, ki dobivajo TCF, je treba natančno nadzirati (glejte poglavji 4.2 in 4.8).
English: Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM study.
Slovenian: Spodnja preglednica kaţe, da se je incidenca nevtropenije, febrilne nevtropenije in nevtropeničnih okuţb 4. stopnje zmanjšala pri bolnicah, ki so prejemale primarno profilakso z G-CSF, potem ko je ta postala obvezna v kraku TAC - študija GEICAM.
English: Docetaxel Teva Pharma vials should not be stored above 25°C and should be protected from light.
Slovenian: Viale zdravila Docetaxel Teva Pharma morajo biti shranjene pri temperaturi do 25°C in zaščitene pred svetlobo.
English: D. CONITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Slovenian: Če je potrebni odmerek docetaksela večji od 200 mg, uporabite več infuzijskega vehikla, tako da končna koncentracija ne preseţe koncetracije docetaksela 0,74 mg/ml.
English: What Docetaxel Teva Pharma is and what it is used for
Slovenian: Kaj je zdravilo Docetaxel Teva Pharma in za kaj ga uporabljamo
English: Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Slovenian: Vnetje pljuč se lahko razvije tudi, če se zdravljenje z docetakselom uporablja sočasno z radioterapijo.
English: 2-year Survival (%)
Slovenian: dveletno preţivetje (%)
English: In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Slovenian: Poleg tega so ugotovili, da docetaksel deluje na nekatere, ne pa na vse celične linije z močno izraţenim pglikoproteinom, ki ga kodira gen za odpornost proti več zdravilom.
English: In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as cyclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin.
Slovenian: Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P4503A ali jih ta presnavlja (in tako lahko kompetitivno inhibirajo encim), kot so ciklosporin, terfenadin, ketokonazol, eritromicin in troleandomicin.
English: For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Slovenian: Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši neţeleni učinki (≥ 5 %), povezani z zdravljenjem, o katerih so poročali v fazi III preskušanja pri bolnicah z rakom dojke, pri katerih zdravljenje z antraciklini ni uspelo (glejte povzetek glavnih značilnosti kapecitabina).
English: Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Slovenian: Poročali so o zelo redkih primerih prehodnih motenj vida (bliskanje, bliskajoča svetloba, skotomi), ki so se praviloma pojavili med infundiranjem zdravila in v povezavi s preobčutljivostnimi reakcijami.
English: Single-use vials.
Slovenian: Viale za enkratno uporabo.
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Slovenian: Incidenca z zdravljenjem povezane zvišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala za ≥ 10 % večkrat pri bolnikih, starejših od 75 let, v primerjavi z mlajšimi od 65 let.
English: At a median follow-up time of 77 months, acute leukaemia occurred in 1 of 532 (0.2%) patients who received docetaxel, doxorubicin, and cyclophosphamide in the GEICAM 9805 study.
Slovenian: Akutno levkemijo so po mediano 77 mesečnem spremljanju zabeleţili pri 1 od 532 (0,2 %) bolnicah, ki so prejemale docetaksel, doksorubicin in ciklofosfamid v študiji GEICAM 9805.
English: Each ml of concentrate contains 27.73 mg docetaxel.
Slovenian: En ml koncentrata vsebuje 27,73 mg docetaksela.
English: Solvent Water for injections.
Slovenian: Voda za injekcije.
English: Docetaxel achieves high intracellular concentrations with a long cell residence time.
Slovenian: Docetaksel doseţe visoko znotrajcelično koncentracijo in se dolgo zadrţuje v celicah.
English: 4.2.1 More than one premix vial may be necessary to obtain the required dose for the patient.
Slovenian: 4.2.1 Za odmerek, ki ga potrebuje bolnik, bo morda potrebna več kot ena viala z osnovno raztopino.
English: Arrhythmia (no severe)
Slovenian: aritmija (ne huda)
English: How to store Docetaxel Teva Pharma Contents of the pack and other information
Slovenian: Shranjevanje zdravila Docetaxel Teva Pharma Vsebina pakiranja in dodatne informacije
English: What you need to know before you use Docetaxel Teva Pharma
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Teva Pharma
English: In case of white blood cells disturbances, you may experience associated fever or infections.
Slovenian: Če imate spremenjeno število belih krvnih celic, se lahko pojavijo povišana telesna temperatura ali okuţbe.
English: Cardiac disorders Rare cases of myocardial infarction have been reported.
Slovenian: Srčne bolezni Poročali so o redkih primerih miokardnega infarkta.
English: When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
Slovenian: V kombinaciji uporabljeni docetaksel ne vpliva na očistek doksorubicina ali na koncentracijo doksorubicinola (presnovka doksorubicina) v plazmi.
English: Infusion site reaction; Pain
Slovenian: reakcija na mestu infundiranja, bolečina
English: Without affecting the primary endpoint, overall response rate (32% vs 25%, p=0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p<0.01) and median survival (15.3 months vs 12.7 months; p=0.03).
Slovenian: Docetaksel ni vplival na primarno končno točko, celotni deleţ odziva (32 % v primerjavi s 25 %, p = 0,10), podaljšal pa je srednji čas do napredovanja bolezni (24,6 tedna v primerjavi s 15,6 tedna, p < 0,01) in srednje trajanje preţivetja (15,3 meseca v primerjavi z 12,7 meseca, p = 0,03).
English: Docetaxel clearance was not modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
Slovenian: Pri bolnikih z blagim do zmernim zastajanjem tekočine se očistek docetaksela ni spremenil; za bolnike s hudim zastajenjem tekočine ni podatkov.
English: 4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Slovenian: 4.1.4 Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da ponavljate obračanje viale vsaj 45 sekund.
English: However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
Slovenian: V primeru hudih reakcij, npr. hude hipotenzije, bronhospazma ali generaliziranega izpuščaja oziroma eritema, je treba zdravljenje z docetakselom takoj prekiniti in uporabiti ustrezno terapijo.
English: Based on extrapolation from a pharmacokinetic study with ketoconazole in 7 patients, consider a 50% docetaxel dose reduction if patients require coadministration of a strong CYP3A4 inhibitor such as azole antifungals, ritonavir and some macrolides (clarithromycin, telithromycin).
Slovenian: Na podlagi ekstrapolacije iz farmakokinetične študije s ketokonazolom pri 7 bolnikih pride v poštev 50 % zmanjšanje odmerka docetaksela, če bolnik sočasno potrebuje zdravljenje s kakšnim močnim zaviralcem CYP3A4, npr. kakšnim azolskim antimikotikom, ritonavirjem ali nekaterimi makrolidi (klaritromicin, telitromicin).
English: The mechanism behind this interaction is a CYP3A4 inhibition, the main isoenzyme involved in docetaxel metabolism by ritonavir.
Slovenian: Mehanizem tega medsebojnega delovanja je, da ritonavir zavre CYP3A4, ki je glavni izoencim, vpleten v presnovo docetaksela.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katere koli neţelene učinke, ki niso navedeni v tem navodilu.
English: In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Slovenian: Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro delovanja jeter (ALT, AST ≥ 1,5-kratna ZMRO hkrati z alkalno fosfatazo ≥ 2,5-kratno ZMRO), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).