FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on information from subsequent clinical studies, the use of Rapamune, mycophenolate mofetil, and corticosteroids, in combination with IL-2 receptor antibody (IL2R Ab) induction, is not recommended in the de novo renal transplant setting (see section 5.1).
Croatian: Na temelju podataka iz kasnijih ispitivanja, primjena Rapamunea, mofetilmikofenolata i kortikosteroida u kombinaciji s indukcijom protutijela protiv IL-2 receptora (IL2R Ab) ne preporučuje se u kontekstu de novo transplantacije bubrega (vidjeti dio 5.1).
English: It is known that malignancies (lymphoma) secondary to the chronic use of immunosuppressive agents can occur and have been reported in patients in rare instances.
Croatian: Poznato je da se zloćudne bolesti (limfomi) mogu javiti kao posljedica kronične primjene imunosupresivnih lijekova te su u rijetkim slučajevima opisane u bolesnika.
English: Patients at low to moderate immunological risk were studied in the phase 3 ciclosporin elimination-Rapamune maintenance study, which included patients receiving a renal allograft from a cadaveric or living donor.
Croatian: Bolesnici s niskim do umjerenim imunološkim rizikom praćeni su u ispitivanju faze 3 u kojem se ukidao ciklosporin uz nastavak terapije održavanja Rapamuneom, koje je uključilo bolesnike koji su dobili alopresadak bubrega od kadaveričnog ili živućeg darivatelja.
English: Carcinogenicity studies conducted in mouse and rat showed increased incidences of lymphomas (male and female mouse), hepatocellular adenoma and carcinoma (male mouse) and granulocytic leukaemia (female mouse).
Croatian: Ispitivanja kancerogenosti provedena u miševa i štakora pokazala su porast incidencije limfoma (mužjaci i ženke miševa), hepatocelularnog adenoma i karcinoma (mužjaci miševa) te granulocitne leukemije (ženke miševa).
English: Suggested ciclosporin trough concentration ranges for the first 2-3 months after transplantation are 150-400 ng/mL (monoclonal assay or equivalent technique) (see section 4.5).
Croatian: Preporučeni raspon najniže koncentracije ciklosporina tijekom prva 2-3 mjeseca nakon transplantacije iznosi 150 - 400 ng/ml (monoklonsko određivanje ili ekvivalentna tehnika) (vidjeti dio
English: Cases of interstitial lung disease (including pneumonitis and infrequently bronchiolitis obliterans organising pneumonia (BOOP) and pulmonary fibrosis), some fatal, with no identified infectious aetiology have occurred in patients receiving immunosuppressive regimens including Rapamune.
Croatian: Zabilježeni su slučajevi intersticijske bolesti pluća (uključujući pneumonitis i, rijetko, obliterirajući bronhiolitis s organiziranom pneumonijom (BOOP) te plućna fibroza), neki od njih sa smrtnim ishodom, bez utvrđenog infektivnog uzroka, u bolesnika koji su primali imunosupresivnu terapiju koja je uključivala Rapamune.
English: The usual dose regimen for Rapamune is a 6 mg single oral loading dose, administered as soon as possible after transplantation, followed by 2 mg once daily until results of therapeutic monitoring of the medicinal product are available (see Therapeutic monitoring of the medicinal product and dose adjustment).
Croatian: Početna terapija (2 do 3 mjeseca nakon transplantacije) Uobičajeni režim doziranja Rapamunea je jednokratna udarna oralna doza od 6 mg, koja se mora primijeniti što je ranije moguće nakon transplantacije, nakon čega slijedi 2 mg jedanput dnevno dok rezultati terapijskog praćenja lijeka ne postanu dostupni (vidjeti Terapijsko praćenje lijeka i prilagodba doze).
English: Following administration of radiolabelled sirolimus, radioactivity is excreted in the milk of lactating rats.
Croatian: Nakon primjene radioizotopom obilježenog sirolimusa opažena je radioaktivnost u mlijeku štakorica za vrijeme laktacije.
English: Should any of these occur together, please contact your physician.
Croatian: Ukoliko se neki od navedenih simptoma pojave zajedno, molimo Vas da se obratite svom liječniku.
English: Safety was assessed in a controlled study involving 89 patients with LAM, of which 81 patients had S-LAM and 42 of whom were treated with Rapamune (see section 5.1).
Croatian: Sigurnost primjene procijenjena je u kontroliranom ispitivanju koje je uključivalo 89 bolesnika s LAM-om, od kojih je 81 bolesnik imao S-LAM i njih 42 liječeno Rapamuneom (vidjeti dio 5.1).
English: For patients with S-LAM, the initial Rapamune dose should be 2 mg/day.
Croatian: U bolesnika koji boluju od S-LAM-a početna doza lijeka Rapamune mora iznositi 2 mg na dan.
English: Inform your doctor if you have difficulty taking the oral solution.
Croatian: Obratite se liječniku ako imate poteškoća s gutanjem oralne otopine.
English: In such patients, when clinically appropriate, Rapamune should be discontinued and an alternative immunosuppressive regimen instituted.
Croatian: U takvih bolesnika mora se prekinuti liječenje Rapamuneom, kada je to klinički pogodno, te započeti zamjenski imunosupresivni protokol.
English: With concentration-control (target concentrations 5 to 15 ng/mL), the median sirolimus concentration at the end of 12 months of treatment was 6.8 ng/mL (interquartile range 5.9 to 8.9 ng/mL; n=37).
Croatian: Uz kontrolu koncentracije (ciljne koncentracije od 5 do 15 ng/ml) medijan koncentracije sirolimusa na kraju liječenja od 12 mjeseci iznosio je 6,8 ng/ml (interkvartilni raspon od 5,9 do 8,9 ng/ml; n = 37).
English: When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts, with or without rash (thrombocytopaenic purpura/haemolytic uraemic syndrome).
Croatian: Kad se uzima s lijekovima koji se zovu inhibitori kalcineurina (ciklosporin ili takrolimus), Rapamune može povećati rizik od oštećenja bubrega sa sniženjem broja krvnih pločica i crvenih krvnih stanica, sa ili bez osipa (trombocitopenična purpura/hemolitičko-uremijski sindrom).
English: Subjects were to receive Rapamune (sirolimus target concentrations of 5 to 15 ng/mL) in combination with a calcineurin inhibitor and corticosteroids or to receive calcineurin-inhibitor-based immunosuppression without Rapamune.
Croatian: Ispitanici su primali Rapamune (ciljna koncentracija sirolimusa od 5 do 15 ng/ml) u kombinaciji s inhibitorom kalcineurina i kortikosteroidima ili su primali imunosupresivnu terapiju inhibitorom kalcineurina bez Rapamunea.
English: Initial Therapy (2 to 3 months post-transplant): In most patients receiving Rapamune tablets with a loading dose of 6 mg followed by an initial maintenance dose of 2 mg, whole blood sirolimus trough concentrations rapidly achieved steady-state concentrations within the recommended target range (4 to 12 ng/mL, chromatographic assay).
Croatian: Početna terapija (2 do 3 mjeseca nakon presađivanja organa): U većine bolesnika koji primaju tablete Rapamune u udarnoj dozi od 6 mg, nakon čega slijedi početna doza održavanja od 2 mg, najniže koncentracije sirolimusa u punoj krvi brzo su postizale stanje dinamičke ravnoteže unutar preporučenog ciljnog raspona (4 do 12 ng/ml, kromatografska metoda).
English: In some cases, the angioedema has resolved upon discontinuation or dose reduction of Rapamune.
Croatian: U određenim se slučajevima angioedem povukao nakon prekida ili smanjenja doze Rapamunea.
English: Sirolimus trough concentration data in 35 renal transplant patients above 65 years of age were similar to those in the adult population (n=822) from 18 to 65 years of age.
Croatian: Podaci o najnižoj koncentraciji sirolimusa u 35 bolesnika s presatkom bubrega starijih od 65 godina života bili su slični onima u odrasle populacije (n = 822) u dobi od 18 do 65 godina života.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinaka Rapamunea na sposobnost upravljanja vozilima i strojevima.
English: A 6 mg loading dose contains up to 150 mg of alcohol which is equivalent to 3.80 mL beer or 1.58 mL wine.
Croatian: Udarna doza od 6 mg sadrži do 150 mg alkohola što odgovara 3,80 ml piva ili 1,58 ml vina.
English: Inhibitors of CYP3A4 may decrease the metabolism of sirolimus and increase sirolimus blood levels.
Croatian: Inhibitori CYP3A4 mogu smanjiti metabolizam sirolimusa i povećati koncentraciju sirolimusa u krvi.
English: In patients with severe hepatic impairment, reduction in maintenance dose by one half is recommended based on decreased clearance (see sections 4.2 and 5.2).
Croatian: U bolesnika s teškim oštećenjem jetre preporučuje se smanjenje doze održavanja na jednu polovicu na temelju smanjenog klirensa (vidjeti dijelove 4.2 i 5.2).
English: In healthy subjects, the mean extent of bioavailability of sirolimus after single-dose administration of the tablet formulation is about 27% higher relative to the oral solution.
Croatian: Srednja vrijednost opsega bioraspoloživosti sirolimusa nakon davanja jednokratne doze u obliku tablete u zdravih osoba je za oko 27% viši u odnosu na oralnu otopinu.
English: In patients with severe hepatic impairment, monitoring should be performed every 5 to 7 days until 3 consecutive trough levels have shown stable concentrations of sirolimus after dose adjustment or after loading dose due to the delay in reaching steady-state because of the prolonged half-life.
Croatian: U bolesnika s ozbiljnim oštećenjem jetre praćenje se mora provoditi svakih 5 do 7 dana nakon prilagodbe doze ili primjene udarne doze sve dok 3 uzastopna mjerenja najniže koncentracije lijeka ne pokažu stabilne koncentracije sirolimusa, jer se u njih zbog produženog poluvijeka kasnije postiže stanje dinamičke ravnoteže.
English: Patients treated with ciclosporin and Rapamune beyond 3 months had higher serum creatinine levels and lower calculated glomerular filtration rates compared to patients treated with ciclosporin and placebo or azathioprine controls.
Croatian: Bolesnici liječeni ciklosporinom i Rapamuneom dulje od 3 mjeseca imali su višu razinu kreatinina u serumu i nižu izračunatu brzinu glomerularne filtracije nego bolesnici liječeni ciklosporinom i kontrolni bolesnici koji su primali placebo ili azatioprin.
English: Each mL contains up to 25 mg of ethanol, approximately 350 mg of propylene glycol (E1520), and 20 mg of soya oil.
Croatian: Pomoćne tvari s poznatim učinkom Jedan ml sadrži do 25 mg etanola, približno 350 mg propilenglikola (E1520) i 20 mg sojinog ulja.
English: All patients who developed PTLD were aged below 18 years.
Croatian: Svi bolesnici koji su razvili posttransplantacijski limfoproliferativni poremećaj bili su mlađi od 18 godina.
English: Undesirable effects observed with prophylaxis of organ rejection in renal transplantation
Croatian: Nuspojave zabilježene pri profilaksi odbacivanja organa kod transplantacije bubrega
English: Clinical studies of Rapamune did not include a sufficient number of patients above 65 years of age to determine whether they will respond differently than younger patients.
Croatian: Klinička ispitivanja s Rapamuneom nisu uključila dovoljan broj bolesnika starijih od 65 godina života da bi se moglo odrediti bi li oni drugačije odgovorili na terapiju od mlađih bolesnika.
English: At 2 years, the rate of non-melanoma skin malignancies was significantly lower in the Rapamune conversion group as compared to the calcineurin inhibitors continuation group (1.8% and 6.9%).
Croatian: Nakon 2 godine stopa zloćudnih bolesti kože, isključujući melanom, bila je značajno niža u skupini prebačenoj na Rapamune u usporedbi sa skupinom u kojoj je nastavljeno liječenje inhibitorima kalcineurina (1,8% i 6,9%).
English: In a retrospective review of hepatic veno-occlusive disease (VOD) in patients who underwent myeloablative stem cell transplantation using cyclosphophamide and total body irradiation, an increased incidence of hepatic VOD was observed in patients treated with Rapamune, especially with concomitant use of methotrexate.
Croatian: U retrospektivnom pregledu jetrene veno-okluzivne bolesti u bolesnika u kojih je napravljena mijeloablativna transplantacija matičnih stanica primjenom ciklofosfamida i zračenjem cijelog tijela, povećana incidencija jetrene veno-okluzivne bolesti uočena je u bolesnika liječenih Rapamuneom, posebno u onih u kojih je istodobno primijenjen i metotreksat.
English: New onset nephrosis (nephrotic syndrome) was also reported (see section 4.8).
Croatian: Također je prijavljena i novonastala nefroza (nefrotski sindrom) (vidjeti dio 4.8).
English: Patients who were successfully withdrawn from ciclosporin had lower serum creatinine levels and higher calculated glomerular filtration rates, as well as lower incidence of malignancy, compared to patients remaining on ciclosporin.
Croatian: Bolesnici u kojih je uspješno ukinut ciklosporin imali su nižu razinu kreatinina u serumu i višu izračunatu brzinu glomerularne filtracije, kao i nižu incidenciju zloćudnih bolesti nego bolesnici koji su nastavili primati ciklosporin.
English: Multiple-dose ketoconazole administration significantly affected the rate and extent of absorption and sirolimus exposure from Rapamune oral solution as reflected by increases in sirolimus Cmax, tmax, and AUC of 4.4-fold, 1.4-fold, and 10.9-fold, respectively.
Croatian: Primjena višekratnih doza ketokonazola značajno je utjecala na brzinu i opseg apsorpcije i izloženost sirolimusu iz Rapamune oralne otopine, što je vidljivo iz porasta Cmax za 4,4 puta, tmax za 1,4 puta i AUC sirolimusa za 10,9 puta.
English: In patients with S-LAM, enrolled patients had moderately advanced lung disease, with baseline FEV1 of 49.2±13.6% (mean ±SD) of the predicted value.
Croatian: Među bolesnicima sa SLAM-om, uključeni bolesnici imali su umjereno uznapredovalu plućnu bolest s početnim FEV1 od 49,2 ± 13,6% (srednja vrijednost ± SD) predviđene vrijednosti.
English: Liver function test abnormal (including alanine aminotransferase increased and aspartate aminotransferase increased)
Croatian: Poremećaji jetre i žuči poremećeni nalazi testova jetrene funkcije (uključujući povišenu alanin aminotransferazu i povišenu aspartat aminotransferazu)
English: Magnesium stearate Talc
Croatian: laktoza hidrat makrogol magnezijev stearat talk
English: Lymphangioleiomyomatosis (LAM)
Croatian: Limfangiolejomiomatoza (LAM)
English: Rapamune contains lactose and sucrose
Croatian: Rapamune sadrži laktozu i saharozu
English: Keep the blister in the outer carton in order to protect from light.
Croatian: Blister čuvati u vanjskom pakovanju radi zaštite od svjetlosti.
English: Rapamune is also used for the treatment of patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or declining lung function.
Croatian: Rapamune se primjenjuje i za liječenje bolesnika koji boluju od sporadične limfangiolejomiomatoze (S-LAM) s umjerenom bolešću pluća ili slabljenjem plućne funkcije.
English: Cases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when sirolimus has been used as part of an immunosuppressive regimen.
Croatian: Opisani su slučajevi dehiscijencije anastomoze bronha, najčešće sa smrtnim ishodom, u bolesnika s de novo transplantacijom pluća, kada je sirolimus primijenjen kao dio imunosupresivne terapije.
English: Do not use this medicine after the expiry date, which is stated on the blister and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji nakon „Rok valjanosti“.
English: There is limited experience on the use of Rapamune in children and adolescents less than 18 years of age.
Croatian: Iskustvo s primjenom lijeka Rapamune u djece i adolescenata mlađih od 18 godina je ograničeno.
English: Insert the syringe adapter into the bottle until it is flush with the top of the bottle.
Croatian: Uvedite nastavak za štrcaljku u bocu tako da bude u istoj ravnini s otvorom grla boce.
English: No clinically significant pharmacokinetic interaction was observed between sirolimus and any of the following substances: acyclovir, atorvastatin, digoxin, glibenclamide, methylprednisolone, nifedipine, prednisolone, and trimethoprim/sulfamethoxazole.
Croatian: Nije opažena klinički značajna farmakokinetička interakcija između sirolimusa i nijedne od sljedećih tvari: aciklovir, atorvastatin, digoksin, glibenklamid, metilprednizolon, nifedipin, prednizolon i trimetoprim/sulfametoksazol.
English: Among these conditions in renal transplant patients are BK virus-associated nephropathy and JC virus-associated progressive multifocal leukoencephalopathy (PML).
Croatian: Navedena stanja u bolesnika s transplantiranim bubregom uključuju nefropatiju povezanu s BK virusom i progresivnu multifokalnu leukoencefalopatiju (PML) povezanu s JC virusom.
English: Empty the contents of the dosing syringe into only a glass or plastic container holding at least 60 mL of water or orange juice.
Croatian: Sadržaj dozirne štrcaljke ispraznite u spremnik koji smije biti samo od stakla ili plastike i u kojem je najmanje 60 ml vode ili soka od naranče.
English: Also contains: lactose monohydrate, sucrose.
Croatian: Također sadrži: laktozu hidrat, saharozu.
English: In a study evaluating conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients, increased urinary protein excretion was commonly observed at 6 to 24 months after conversion to Rapamune (see section 5.1).
Croatian: U ispitivanju u kojem se procjenjivao prelazak s inhibitora kalcineurina na Rapamune u bolesnika koji održavaju presadak bubrega, često je opaženo povećano izlučivanje proteina u urinu 6 do 24 mjeseci poslije prelaska na Rapamune (vidjeti dio 5.1).
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze igalaktoze ili insuficijencijom sukraza-izomaltaza ne bi smjeli uzimati ovaj lijek.
English: Multiples of 0.5 mg tablets should not be used as a substitute for 1 mg and 2 mg tablets, as the different strengths are not directly interchangeable.
Croatian: Ne smije se uzimati više tableta od 0,5 mg u zamjenu za tablete od 1 i 2 mg, jer različite doze nisu zamjenjive.
English: Ovarian cysts and menstrual disorders (including amenorrhoea and menorrhagia) have been reported.
Croatian: Zabilježene su ovarijske ciste i poremećaji menstrualnog ciklusa (uključujući amenoreju i menoragiju).
English: In paediatric patients on dialysis (30% to 50% reduction in glomerular filtration rate) within age ranges of 5 to 11 years and 12 to 18 years, the mean weight-normalised CL/F was larger for younger paediatric patients (580 mL/h/kg) than for older paediatric patients (450 mL/h/kg) as compared with adults (287 mL/h/kg).
Croatian: U dijaliziranih pedijatrijskih bolesnika (smanjena brzina glomerularne filtracije za 30% do 50%) unutar dobnog raspona od 5 do 11 godina i od 12 do 18 godina, prosječni CL/F normiran prema srednjoj vrijednosti tjelesne težine bio je veći u mlađih pedijatrijskih bolesnika (580 ml/h/kg) nego u starijih pedijatrijskih bolesnika (450 ml/h/kg) u usporedbi s odraslima (287 ml/h/kg).
English: (Cyprus Branch) T : +357 22 817690
Croatian: PFIZER ΕΛΛΑΣ Α.Ε. (Cyprus Branch) T : +357 22 817690
English: In some cases, the interstitial lung disease has resolved upon discontinuation or dose reduction of Rapamune.
Croatian: U nekim se slučajevima intersticijska bolest pluća povukla nakon prekida primjene ili smanjivanja doze Rapamunea.
English: Rare reports of fatal hepatic necrosis have been reported with elevated trough sirolimus levels.
Croatian: Zabilježeni su i rijetki slučajevi hepatalne nekroze sa smrtnim ishodom kod povišenih najnižih koncentracija sirolimusa.
English: Sirolimus pharmacokinetic parameters following daily doses of 2 mg Rapamune tablets administered in combination with ciclosporin microemulsion (4 hours prior to Rapamune tablets) and corticosteroids in 13 renal transplant patients, based on data collected at months 1 and 3 after transplantation, were: Cmin,ss 7.39  2.18 ng/mL; Cmax,ss 15.0  4.9 ng/mL; tmax,ss 3.46  2.40 hours; AUC,ss 230  67 ng.h/mL; CL/F/WT, 139  63 mL/h/kg (parameters calculated from LC-MS/MS assay results).
Croatian: Rapamune primijenjenih u kombinaciji s mikroemulzijom ciklosporina (4 sata prije tableta Rapamune) i kortikosteroidima u 13 bolesnika nakon transplantacije bubrega, temeljene na podacima prikupljenima 1 i 3 mjeseca nakon presađivanja organa, bili su slijedeći: Cmin,ss 7,39  2,18 ng/ml; Cmax,ss 15,0  4,9 ng/ml; tmax,ss 3,46  2,40 h; AUC ,ss 230  67 ng•h/ml; CL/F/WT 139  63 ml/h/kg (parametri su izračunati iz rezultata LC-MS/MS metoda).
English: Patients administered Rapamune should be monitored for hyperlipidaemia using laboratory tests and if hyperlipidaemia is detected, subsequent interventions such as diet, exercise, and lipid-lowering agents should be initiated.
Croatian: Bolesnike koji primaju Rapamune mora se nadzirati radi moguće hiperlipidemije uz pomoć laboratorijskih pretraga te, ako se otkrije hiperlipidemija, moraju se poduzeti odgovarajuće mjere kao što je promjena prehrane, tjelovježba i lijekovi za snižavanje lipida.
English: Keep Rapamune oral solution in its original bottle in order to protect from light.
Croatian: Čuvati Rapamune oralnu otopinu u originalnoj boci radi zaštite od svjetlosti.
English: Rapamune is for oral use only.
Croatian: Rapamune je namijenjen samo za peroralnu primjenu.
English: The rate of death in the sirolimus conversion group was higher than the CNI continuation group, although the rates were not significantly different.
Croatian: Stopa smrtnosti u skupini u kojoj je inhibitor kalcineurina zamijenjen sirolimusom bila je viša nego u skupini u kojoj je nastavljena primjena inhibitora kalcineurina, iako stope nisu bile značajno različite.
English: At 12, 24 and 36 months, graft and patient survival were similar for both groups.
Croatian: U obje skupine, preživljavanje presatka i bolesnika bilo je slično nakon 12, 24 i 36 mjeseci.
English: Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant.
Croatian: Rapamune je indiciran za profilaksu odbacivanja organa u odraslih bolesnika s niskim do umjerenim imunološkim rizikom odbacivanja nakon presađivanja bubrega.
English: Inhibitors of P-gp may decrease the efflux of sirolimus from intestinal cells and increase sirolimus levels.
Croatian: Inhibitori P-gp-a mogu smanjiti izbacivanje sirolimusa iz stanica crijeva i tako povećati razinu sirolimusa.
English: It is unknown whether sirolimus is excreted in human milk.
Croatian: Nije poznato izlučuje li se sirolimus u majčino mlijeko.
English: Sirolimus inhibits the activated mTOR pathway and thus the proliferation of LAM cells.
Croatian: Sirolimus inhibira aktivirani mTOR put, a time i proliferaciju stanica LAM-a.
English: Multiple-dose administration of erythromycin and sirolimus oral solution significantly increased the rate and extent of absorption of both medicinal products.
Croatian: Primjena višekratnih doza eritromicina i oralne otopine sirolimusa značajno je povećala brzinu i količinu apsorpcije oba lijeka.
English: Cytochrome P450 isozymes
Croatian: Izoenzimi citokroma P450
English: Then place the capped dosing syringe in the carrying case provided.
Croatian: Potom stavite dozirnu štrcaljku sa zatvaračem u priloženu kutiju za nošenje štrcaljki.
English: During Rapamune therapy with or without CsA, patients should be monitored for elevated lipids, and patients administered an HMG-CoA reductase inhibitor and/or fibrate should be monitored for the possible development of rhabdomyolysis and other adverse reactions, as described in the respective Summary of Product Characteristics of these agents.
Croatian: A ili bez njega, mora se pratiti bolesnike zbog povišenih lipida u serumu, a bolesnike koji primaju inhibitor HMG-CoA reduktaze i/ili fibrat mora se pratiti zbog mogućeg razvoja rabdomiolize i drugih nuspojava koje su opisane u sažetku opisa svojstava lijeka navedenih lijekova.
English: The clearance of sirolimus may be reduced in patients with impaired hepatic function (see section 5.2).
Croatian: Klirens sirolimusa može biti smanjen u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).