FrancophonIA/ELRC3.0 huggingface dataset:
English: It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with Febuxostat Krka and your doctor may wish to consider necessary measures: - Mercaptopurine (used to treat cancer) - Azathioprine (used to reduce immune response) - Theophylline (used to treat asthma)
Croatian: Posebno je važno da obavijestite svog liječnika ili ljekarnika ako uzimate lijekove koji sadrže neku od sljedećih tvari, s obzirom na to da one mogu stupiti u interakciju s lijekom Febuxostat Krka i Vaš liječnik će možda morati poduzeti potrebne mjere: - merkaptopurin (koristi se za liječenje karcinoma) - azatioprin (koristi se za smanjivanje imunološkog odgovora)
English: In healthy subjects concomitant use of febuxostat and naproxen 250 mg twice daily was associated with an increase in febuxostat exposure (Cmax 28%, AUC 41% and t1/2 26%).
Croatian: U zdravih ispitanika istodobna primjena febuksostata i naproksena 250 mg dvaput dnevno bila je povezana s povećanjem izloženosti febuksostatu (Cmax 28%, AUC 41% i t1/2 26%).
English: In general, febuxostat pharmacokinetic parameters estimated by these analyses are consistent with those obtained from healthy subjects, indicating that healthy subjects are representative for pharmacokinetic/pharmacodynamic assessment in the patient population with gout.
Croatian: Općenito, farmakokinetički parametri febuksostata čija je procjena rađena tim analizama konzistentni su s onima dobivenima u zdravih ispitanika, što upućuje na to da su zdravi ispitanici reprezentativni za procjenu farmakokinetike/farmakodinamike u populaciji bolesnika koji boluju od gihta.
English: Febuxostat Krka should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment.
Croatian: Krka treba uvesti dva dana prije početka citotoksične terapije i nastaviti s uzimanjem najmanje 7 dana; međutim liječenje može biti produljeno do 9 dana u skladu s trajanjem kemoterapije, prema kliničkoj procjeni.
English: Keeping uric acid levels low by taking Febuxostat Krka once every day stops crystals building up, and over time it reduces symptoms.
Croatian: Održavanjem niskih razina mokraćne kiseline uzimanjem lijeka Febuxostat Krka jednom dnevno sprječava se nakupljanje kristala urata, a simptomi se s vremenom smanjuju.
English: Primary endpoints were serum uric acid area under the curve (AUCsUA1-8) and change in serum creatinine (sC) level both from baseline to Day 8.
Croatian: Primarni ishodi bili su površina ispod krivulje za mokraćnu kiselinu u serumu (AUCsMK1-8) i promjena razine serumskog kreatinina (sK), oboje od početnih vrijednosti do dana 8.
English: Excipient(s) with known effect - lactose: 109 mg
Croatian: Pomoćna tvar s poznatim učinkom - laktoza: 109 mg
English: In clinical studies the use of naproxen or other NSAIDs/Cox-2 inhibitors was not related to any clinically significant increase in adverse events.
Croatian: U kliničkim ispitivanjima, primjena naproksena ili drugih nesteroidnih protuupalnih lijekova/inhibitora Cox-2 nije bila povezana s klinički značajnim povećanjem učestalosti štetnih događaja.
English: Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32% decrease in Cmax, but no significant change in AUC was observed.
Croatian: Pokazalo se da istodobni unos antacida koji sadržavaju magnezijev hidroksid i aluminijev hidroksid odgađa apsorpciju febuksostata (za oko 1 sat) i dovodi do 32%-tnog smanjenja Cmax, ali nisu uočene značajne promjene AUC-a.
English: Talk to your doctor or pharmacist before taking Febuxostat Krka: - if you have or have had heart failure or heart problems or stroke, - if you have or have had kidney disease and/or serious allergic reaction to Allopurinol (a medicine used for the treatment of gout),
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Febuxostat Krka: - ako imate ili ste imali zatajenje srca, druge srčane bolesti ili moždani udar - ako imate ili ste imali bubrežnu bolest i/ili ozbiljnu alergijsku reakciju na alopurinol (lijek za liječenje gihta)
English: - if you have or have had liver disease or liver function test abnormalities, - if you are being treated for high uric acid levels as a result of Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood), - if you have thyroid problems.
Croatian: - ako imate ili ste imali bolest jetre ili abnormalne rezultate pretraga funkcije jetre - ako ste se liječili zbog visokih razina mokraćne kiseline uzrokovanih Lesch-Nyhanovim sindromom (rijetkom nasljednom bolesti kod koje postoji prevelika količina mokraćne kiseline u krvi) - ako imate problema sa štitnjačom.
English: Tablet dimension: approximatelly 16 mm × 8 mm.
Croatian: Dimenzije tablete: približno 16 mm x 8 mm.
English: The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see section 5.2).
Croatian: Djelotvornost i sigurnost nisu u potpunosti procijenjeni u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min, vidjeti dio 5.2).
English: The endpoints (primary and secondary) were analysed according to the intention-to-treat (ITT) analysis including all subjects who were randomized and received at least one dose of double-blind study medication.
Croatian: Mjere ishoda (primarne i sekundarne) analizirane su u populaciji predviđenoj za liječenje (engl. intent to treat, ITT), koja je uključivala sve ispitanike koji su bili randomizirani i koji su primili barem jednu dozu lijeka u dvostruko slijepom ispitivanju.
English: The efficacy of febuxostat was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study described below) that were conducted in 4101 patients with hyperuricaemia and gout.
Croatian: Djelotvornost febuksostata dokazana je u tri pivotalna ispitivanja faze 3 (niže su opisana dva pivotalna ispitivanja APEX i FACT, i dodatno CONFIRMS ispitivanje) koja su provedena na 4101 bolesniku s hiperuricemijom i gihtom.
English: Tablet dimension: approximatelly 19 mm × 8 mm.
Croatian: Dimenzije tablete: približno 19 mm x 8 mm.
English: Pancytopenia, thrombocytopenia, agranulocytosis*
Croatian: Pancitopenija, trombocitopenija, agranulocitoza*
English: Febuxostat Krka 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers.
Croatian: Krka 120 mg tablete se koriste i za liječenje i prevenciju visoke razine mokraćne kiseline u krvi koja se može pojaviti kada počnete dobivati kemoterapiju za rak krvi.
English: The plasma protein binding of febuxostat is approximately 99.2%, (primarily to albumin), and is constant over the concentration range achieved with 80 and 120 mg doses.
Croatian: Vezanje febuksostata na proteine plazme je oko 99,2%, (ponajprije na albumin) i konstantno je u rasponu koncentracije koja se postiže dozama od 80 i 120 mg.
English: The effect of Febuxostat Krka on human fertility is unknown.
Croatian: Učinak lijeka Febuxostat Krka na plodnost u čovjeka nije poznat.
English: In patients in whom the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
Croatian: U bolesnika u kojih je brzina stvaranja urata znatno povećana (npr. maligna bolest i njezino liječenje, Lesch-Nyhanov sindrom), apsolutna koncentracija ksantina u urinu u rijetkim se slučajevima može povećati u dovoljnoj mjeri da uslijedi njegovo taloženje u urinarnom traktu.
English: Continue to take Febuxostat Krka every day even when you are not experiencing gout flare or attack.
Croatian: Nastavite uzimati Febuxostat Krka svaki dan, čak i ako nemate napade gihta.
English: If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with Febuxostat Krka.
Croatian: Ako trenutačno imate napad gihta (nagla pojava jake boli, osjetljivosti, crvenila, topline i otoka zgloba), pričekajte da se napad gihta smiri prije nego što počnete liječenje lijekom Febuxostat Krka.
English: Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that Febuxostat Krka does not adversely affect performance.
Croatian: Bolesnici trebaju postupati s oprezom tijekom upravljanja vozilima i strojevima i sudjelovanja u opasnim aktivnostima, sve dok nisu prilično sigurni da Febuxostat Krka kod njih ne utječe negativno na provedbu tih aktivnosti.
English: Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000) adverse reactions occurring in patients treated with febuxostat are listed below.
Croatian: Česte (≥ 1/100 i < 1/10), manje česte (≥ 1/1000 i < 1/100) i rijetke ( 1/10 000 i < 1/1000) nuspojave koje se pojavljuju kod bolesnika liječenih febuksostatom navedene su ispod.
English: Following multiple oral doses of febuxostat, the Cmax and AUC were 24% and 12% higher in females than in males, respectively.
Croatian: Nakon višekratnih oralnih doza febuksostata, Cmax i AUC su bili 24%, odnosno 12% viši u žena nego u muškaraca.
English: As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome is not recommended.
Croatian: Kako nema iskustva o primjeni febuksostata, ne preporučuje se njegova primjena u bolenika s Lesch-Nyhanovim sindromom.
English: Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid.
Croatian: Mokraćna kiselina je krajnji proizvod metabolizma purina u ljudi i stvara se u kaskadi hipoksantin  ksantin  mokraćna kiselina.
English: Rash (including various types of rash reported with lower frequencies, see below) Uncommon
Croatian: Osip (uključujući razne tipove osipa s manjom učestalošću, vidjeti niže u tekstu)
English: No dose adjustment is needed based on gender.
Croatian: Nije potrebna prilagodba doze s obzirom na spol.
English: Incidence of overall treatment-emergent signs and symptoms and adverse drug reactions was 67.6% vs 64.7% and 6.4% vs 6.4% with febuxostat and allopurinol respectively.
Croatian: Incidencija svih znakova i simptoma te nuspojava opaženih nakon početka liječenja bila je 67,6% naspram 64,7% i 6,4% naspram 6,4% na febuksostatu odnosno na alopurinolu.
English: In the additional phase 3 CONFIRMS study, for which results became available after the marketing authorisation for febuxostat was first issued, the primary efficacy endpoint was the proportion of patients whose serum urate level was < 6.0 mg/dL at the final visit.
Croatian: U dodatnom ispitivanju faze 3, CONFIRMS, za koje su rezultati postali dostupni nakon odobrenja za stavljanje febuksostata u promet, primarni ishod ispitivanja bio je omjer bolesnika u kojih je na zadnjoj kontroli razina urata u serumu bila < 6,0 mg/dl.
English: Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson Syndrome, occur since early withdrawal is associated with a better prognosis.
Croatian: Liječenje febuksostatom treba odmah prekinuti ako se pojave ozbiljne alergijske reakcije/reakcije preosjetljivosti, uključujući Stevens-Johnsonov sindrom, jer je raniji prekid liječenja povezan s boljom prognozom.
English: Oral use Febuxostat Krka should be taken by mouth and can be taken with or without food.
Croatian: Febuxostat Krka treba uzimati na usta i može se uzimati s hranom ili bez nje.
English: Thus, coadministration of febuxostat with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Croatian: Zato se ne očekuje da će istodobna primjena febuksostata s drugim supstratima CYP2D6 zahtijevati prilagodbu doze tih spojeva.
English: There were no clinically significant differences in the percent decrease in serum uric acid concentration in healthy subjects irrespective of their renal function (58% in the normal renal function group and 55% in the severe renal dysfunction group).
Croatian: Nisu postojale klinički značajne razlike u postotnom smanjenju koncentracije mokraćne kiseline u serumu u zdravih ispitanika, neovisno o njihovoj bubrežnoj funkciji (58% u skupini s urednom funkcijom bubrega i 55% u skupini s teškim oštećenjem funkcije bubrega).
English: Co-administration of febuxostat 80 mg and theophylline 400 mg single dose in healthy subjects showed absence of any pharmacokinetic interaction (see section 4.5).
Croatian: Istodobna primjena 80 mg febuksostata i jednokratne doze teofilina od 400 mg u zdravih ispitanika pokazala je da nema farmakokinetičkih interakcija (vidjeti dio 4.5).
English: If you have developed Stevens-Johnson Syndrome with the use of febuxostat, you must not be re-started on Febuxostat Krka at any time.
Croatian: Ako se tijekom primjene febuksostata razvio Stevens-Johnsonov sindrom, ne smijete više nikada započeti terapiju lijekom Febuxostat Krka.
English: A numerical greater incidence of investigator-reported cardiovascular APTC events (defined endpoints from the Anti-Platelet Trialists' Collaboration (APTC) including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) was observed in the febuxostat total group compared to the allopurinol group in the APEX and FACT studies (1.3 vs. 0.3 events per 100 Patient Years (PYs)), but not in the CONFIRMS study (see section 5.1 for detailed characteristics of the studies).
Croatian: Brojčano veća incidencija kardiovaskularnih APTC događaja koje su prijavili ispitivači (definirane mjere ishoda prema Anti-Platelet Trialists' Collaboration (APTC), uključujući kardiovaskularnu smrt, nefatalni infarkt miokarda, nefatalni moždani udar) uočena je u ukupnoj skupini koja je primala febuksostat, u usporedbi sa skupinom koja je primala alopurinol, u ispitivanjima APEX i FACT (1,3 u odnosu na 0,3 događaja na 100 bolesnik/godina), ali ne i u CONFIRMS ispitivanju (vidjeti dio 5.1 za detaljne karakteristike ispitivanja).
English: Caution is required when febuxostat is used in patients with alteration of thyroid function (see section 5.1).
Croatian: Potreban je oprez pri primjeni febuksostata u bolesnika s promijenjenom funkcijom štitne žlijezde (vidjeti dio 5.1).
English: Febuxostat showed a superior and faster urate lowering activity compared to allopurinol.
Croatian: Febuksostat je pokazao superiorno i brže djelovanje na sniženje urata u odnosu na alopurinol.
English: Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects.
Croatian: Primjena febuksostata (80 mg ili 120 mg jednom dnevno) s varfarinom nije utjecala na farmakokinetiku varfarina u zdravih ispitanika.
English: You should not take Febuxostat Krka if you are breast feeding, or if you are planning to breastfeed.
Croatian: Nemojte uzimati Febuxostat Krka ako dojite ili planirate dojiti.
English: In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
Croatian: U pivotalnom ispitivanju sindroma tumorske lize primjenjivao se febuksostat u dozi od 120 mg dnevno u bolesnika koji su podvrgnuti različitim kemoterapijskim režimima, uključujući i monoklonska protutijela.
English: Febuxostat 80 mg can be used in patients concomitantly treated with theophylline without risk of increasing theophylline plasma levels.
Croatian: Febuksostat od 80 mg može se koristiti u bolesnika istodobno liječenih teofilinom bez rizika od porasta razine teofilina u plazmi.
English: There were no significant changes observed in AUC of febuxostat or its metabolites following multiple oral doses of febuxostat in elderly as compared to younger healthy subjects.
Croatian: Nisu uočene značajne promjene AUC-a febuksostata ili njegovih metabolita nakon primjene višekratnih oralnih doza febuksostata u starijih bolesnika u odnosu na mlađe, zdrave ispitanike.
English: film-coated tablet
Croatian: Filmom obložena tableta
English: There was high dose maternal toxicity accompanied by a reduction in weaning index and reduced development of offspring in rats at approximately 4.3 times human exposure.
Croatian: Postojala je maternalna toksičnost praćena smanjenim indeksom odbića i smanjenim razvojem mladunaca u štakora kod doza oko 4,3 puta većih od izloženosti u ljudi.
English: If you stop taking Febuxostat Krka
Croatian: Ako prestanete uzimati Febuxostat Krka
English: No dose adjustment is required in the elderly (see section 5.2).
Croatian: Nije potrebno prilagođavanje doze u starijih osoba (vidjeti dio 5.2).
English: Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase Rare
Croatian: Dijabetes melitus, hiperlipidemija, smanjen apetit, povećanje tjelesne težine
English: Febuxostat Krka is available in boxes containing 14, 28, 56 or 84 film-coated tablets in blisters.
Croatian: Krka je dostupan u kutijama koje sadrže 14, 28, 56 ili 84 filmom obložene tablete u blisterima.
English: As there has been no experience in organ transplant recipients, the use of febuxostat in such patients is not recommended (see section 5.1).
Croatian: Budući da nema iskustva o primjeni lijeka u primatelja transplantiranih organa, ne preporučuje se primjena febuksostata u tih bolesnika (vidjeti dio 5.1).
English: In vitro studies with human liver microsomes showed that those oxidative metabolites were formed primarily by CYP1A1, CYP1A2, CYP2C8 or CYP2C9 and febuxostat glucuronide was formed mainly by UGT 1A1, 1A8, and 1A9.
Croatian: Ispitivanja in vitro s humanim jetrenim mikrosomalnim enzimima pokazala su da prvenstveno CYP1A1, CYP1A2, CYP2C8 ili CYP2C9 stvaraju te oksidacijske metabolite, a UGT 1A1, 1A8 i 1A9 prvenstveno stvaraju febuksostat glukuronid.
English: The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
Croatian: Djelotvornost i sigurnost febuksostata nije ispitivana u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
English: What Febuxostat Krka looks like and contents of the pack Febuxostat Krka 80 mg film-coated tablets (tablets) are off pink, oval, biconvex, film-coated tablets scored on one side.
Croatian: Kako Febuxostat Krka izgleda i sadržaj pakiranja Febuxostat Krka 80 mg filmom obložene tablete (tablete) su prljavo ružičaste, ovalne, bikonveksne, filmom obložene tablete s urezom na jednoj strani.
English: Figure 1 Mean Serum Uric Acid Levels in Combined Pivotal Phase 3 Studies
Croatian: Slika 1 Srednje vrijednosti razine mokraćne kiseline u serumu u kombiniranim pivotalnim ispitivanjima faze 3
English: Febuxostat 240 mg
Croatian: FbukCoCtt 240 mg
English: Following multiple oral 80 mg once daily doses or a single 120 mg dose with a high fat meal, there was a 49% and 38% decrease in Cmax and a 18% and 16% decrease in AUC, respectively.
Croatian: Nakon višekratnih peroralno primijenjenih doza od 80 mg jednom dnevno ili jednokratne doze od 120 mg uz obrok bogat masnoćama, došlo je do sniženja Cmax od 49%, odnosno 38%, te smanjenja AUC-a od 18%, odnosno 16%.
English: As there has been no experience with febuxostat, its use in these populations is not recommended.
Croatian: Kako nema iskustva o primjeni febuksostata, ne preporučuje se njegova primjena u te populacije bolesnika.
English: No dose adjustment is necessary for febuxostat when administered with hydrochlorothiazide.
Croatian: Nije potrebna prilagodba doze febuksostata kad se primjenjuje zajedno s hidroklorotiazidom.
English: In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see section 5.3).
Croatian: Ispitivanje utjecaja na reprodukciju u životinja, u dozama do 48 mg/kg/dnevno, nisu pokazala štetni učinak na plodnost ovisan o dozi (vidjeti dio 5.3).
English: Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
Croatian: Krka je indiciran za liječenje kronične hiperuricemije, u stanjima kada je već došlo do taloženja urata (uključujući prisutnost tofa i/ili uričnog artritisa, trenutno ili u anamnezi).
English: Atrial fibrillation, palpitations, ECG abnormal, left bundle branch block (see section Tumor Lysis Syndrome), sinus tachycardia (see section Tumor Lysis Syndrome) Rare
Croatian: Atrijska fibrilacija, palpitacije, abnormalni EKG, blok lijeve grane snopa (vidjeti dio Sindrom tumorske lize), sinusna tahikardija (vidjeti dio Sindrom tumorske lize) Rijetko
English: Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine as inhibition of xanthine oxidase by febuxostat may cause increased plasma concentrations of mercaptopurine/azathioprine that could result in severe toxicity.
Croatian: Ne preporučuje se primjena febuksostata u bolesnika istodobno liječenih merkaptopurinom/azatioprinom, jer inhibicija ksantin oksidaze febuksostatom može uzrokovati povišene koncentracije merkaptopurina/azatioprina u plazmi, što može rezultirati teškom toksičnošću.
English: The primary efficacy endpoint in the APEX and FACT studies was the proportion of patients whose last 3 monthly serum uric acid levels were < 6.0 mg/dL (357 μmol/L).
Croatian: Primarni ishod djelotvornosti u ispitivanjima APEX i FACT bio je omjer bolesnika u kojih su razine mokraćne kiseline u serumu u posljednja 3 mjeseca bile < 6,0 mg/dl (357 µmol/l).
English: If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat Krka 120 mg once daily may be considered.
Croatian: Ako je nakon 2 do 4 tjedna mokraćna kiselina u serumu > 6 mg/dl (357 µmol/l), može se razmotriti primjena 120 mg lijeka Febuxostat Krka jednom dnevno.
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 84 filmom obložene tablete
English: If you miss a dose of Febuxostat Krka take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time.
Croatian: Ako ste zaboravili uzeti tabletu Febuxostat Krka, uzmite je čim se sjetite, osim ako je uskoro vrijeme za sljedeću tabletu.
English: concentrations febuxostat does not inhibit other enzymes involved in purine or pyrimidine metabolism, namely, guanine deaminase, hypoxanthine guanine phosphoribosyltransferase, orotate phosphoribosyltransferase, orotidine monophosphate decarboxylase or purine nucleoside phosphorylase.
Croatian: U terapijskim koncentracijama febuksostat ne inhibira druge enzime uključene u metabolizam purina ili pirimidina, tj. gvanin deaminazu, hipoksantin gvanin fosforiboziltransferazu, orotat fosforiboziltransferazu, orotidin monofosfat dekarboksilazu i purin nukleozid fosforilazu.
English: Febuxostat has been shown to potently inhibit both the oxidized and reduced forms of XO. At therapeutic
Croatian: Dokazano je da febuksostat snažno inhibira kako oksidirane tako i reducirane oblike XO.
English: No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Nisu provedena ispitivanja u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).