FrancophonIA/ELRC3.0 huggingface dataset:
English: Rapamune 0.5 mg coated tablets 2 years.
Croatian: Rapamune 0,5 mg obložene tablete 2 godine.
English: 4.4 Special warnings and precautions for use Rapamune has not been adequately studied in renal transplant patients at high immunological risk, therefore use is not recommended in this group of patients (see section 5.1).
Croatian: Rapamune nije odgovarajuće ispitan u bolesnika s transplantiranim bubregom i visokim imunološkim rizikom te se stoga ne preporučuje u te skupine bolesnika (vidjeti dio 5.1).
English: The use of Rapamune was associated with increased serum cholesterol and triglycerides that may require treatment.
Croatian: Primjena Rapamunea bila je povezana s povišenim razinama kolesterola i triglicerida u serumu, što može zahtijevati i liječenje.
English: Sirolimus is extensively metabolised by O-demethylation and/or hydroxylation.
Croatian: O-demetilacijom i/ili hidroksilacijom.
English: The risk may be increased as the trough sirolimus level increases.
Croatian: Rizik može biti povećan s porastom najniže razine sirolimusa.
English: Such inhibitors include certain antifungals (e.g. clotrimazole, fluconazole, itraconazole, voriconazole), certain antibiotics (e.g. troleandomycin, telithromycin, clarithromycin), certain protease inhibitors (e.g. ritonavir, indinavir, boceprevir, telaprevir), nicardipine, bromocriptine, cimetidine, and danazol.
Croatian: Ti inhibitori uključuju određene antimikotike (npr. klotrimazol, flukonazol, itrakonazol, vorikonazol), određene antibiotike (npr. troleandomicin, telitromicin, klaritromicin), određene inhibitore proteaze (npr. ritonavir, indinavir, boceprevir, telaprevir), nikardipin, bromokriptin, cimetidin i danazol.
English: Co-administration of sirolimus and ketoconazole is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena sirolimusa i ketokonazola (vidjeti dio 4.4).
English: The longer half-lives observed in hepatically impaired patients delay reaching steady state.
Croatian: Dulji poluvijekovi uočeni u bolesnika s oštećenjem jetre odgađaju postizanje stanja dinamičke ravnoteže.
English: Seven major metabolites, including hydroxyl, demethyl, and hydroxydemethyl, are identifiable in whole blood.
Croatian: U punoj krvi je moguće identificirati sedam glavnih metabolita, uključujući hidroksil, demetil i hidroksidemetil.
English: antibiotics or antifungal medicines used to treat infection e.g. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole.
Croatian: neke druge imunosupresivne lijekove antibiotike ili antimikotike za liječenje infekcije, npr. klaritromicin, eritromicin, telitromicin, troleandomicin, rifabutin, klortrimazol, flukonazol, itrakonazol.
English: BOTTLE LABEL: 60 mL BOTTLE
Croatian: NALJEPNICA NA BOCI: BOCA OD 60 ml
English: Clinical studies with Rapamune oral solution did not include a sufficient number of patients above 65 years of age to determine whether they will respond differently than younger patients (see section 5.2).
Croatian: Nije uključen dovoljan broj bolesnika starijih od 65 godina u klinička ispitivanja s oralnom otopinom Rapamunea da bi bilo moguće odrediti hoće li oni odgovoriti drugačije od mlađih bolesnika (vidjeti dio 5.2).
English: Co-administration of sirolimus (2 mg single dose) with multiple-dose administration of oral voriconazole (400 mg every 12 hours for 1 day, then 100 mg every 12 hours for 8 days) in healthy subjects has been reported to increase sirolimus Cmax and AUC by an average of 7-fold and 11-fold respectively.
Croatian: Opisano je da istodobna primjena sirolimusa (jednokratna doza od 2 mg) s višekratnim dozama oralnog vorikonazola (400 mg svakih 12 sati tijekom 1 dana, a potom 100 mg svakih 12 sati tijekom 8 dana) u zdravih osoba dovodi do porasta Cmax sirolimusa za prosječno 7 puta, a AUC-a za 11 puta.
English: Grapefruit juice affects CYP3A4-mediated metabolism and must, therefore, be avoided.
Croatian: Sok od grejpa utječe na metabolizam posredovan enzimom CYP3A4 te ga stoga mora izbjegavati.
English: Co-administration of sirolimus with strong inhibitors of CYP3A4 (such as ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampin, rifabutin) is not recommended (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena sirolimusa sa snažnim inhibitorima enzima CYP3A4 (kao što su ketokonazol, vorikonazol, itrakonazol, telitromicin ili klaritromicin) ili induktorima enzima CYP3A4 (kao što su rifampin, rifabutin) (vidjeti dio 4.5).
English: Kidney damage with low blood cell counts (thrombocytopaenic purpura/haemolytic uraemic syndrome)
Croatian: Oštećenje bubrega sa sniženim brojem krvnih stanica (trombocitopenična purpura/hemolitičkouremijski sindrom)
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva artralgija osteonekroza
English: Several assay methodologies have been used to measure the whole blood concentrations of sirolimus.
Croatian: U upotrebi je nekoliko metoda testiranja za određivanje koncentracije sirolimusa u punoj krvi.
English: Co-administration of sirolimus and rifampicin is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena sirolimusa i rifampicina (vidjeti dio 4.4).
English: Rapamune 1 mg coated tablets 3 years.
Croatian: Rapamune 1 mg obložene tablete 3 godine.
English: Safety was assessed in a controlled clinical study enrolling renal transplant patients below 18 years of age considered of high immunologic risk, defined as a history of one or more acute allograft rejection episodes and/or the presence of chronic allograft nephropathy on a renal biopsy (see section 5.1).
Croatian: Sigurnost primjene ispitana je u kontroliranom kliničkom ispitivanju koje je uključivalo bolesnike s presađenim bubregom u dobi ispod 18 godina s povišenim imunološkim rizikom, što je definirano s jednom ili više epizoda akutnog odbacivanja alopresatka i/ili prisutnost kronične nefropatije alopresatka potvrđene biopsijom u anamnezi (vidjeti dio 5.1).
English: Tablet core: lactose monohydrate, macrogol, magnesium stearate, talc Tablet coating: macrogol, glycerol monooleate, pharmaceutical glaze, calcium sulfate, microcrystalline cellulose, sucrose, titanium dioxide, poloxamer 188, -tocopherol, povidone, carnauba wax, Printing ink (Shellac, Iron Oxide Red, Propylene Glycol [E1520], Concentrated Ammonia Solution, Simethicone).
Croatian: Jezgra tablete: laktoza hidrat, makrogol, magnezijev stearat, talk Ovojnica tablete: makrogol, glicerolmonooleat, sredstvo za oblaganje, kalcijev sulfat, mikrokristalična celuloza, saharoza, titanijev dioksid, poloksamer 188, -tokoferol, povidon, karnauba vosak, tinta za označavanje (šelak, crveni željezov oksid, propilenglikol [E1520], koncentrirana otopina amonijaka, simetikon).
English: Enrollment in the patient stratum with baseline calculated GFR below 40 mL/min was discontinued due to an imbalance in safety events (see section 4.8).
Croatian: Uključivanje bolesnika u skupinu s početnom brzinom glomerularne filtracije manjom od 40 ml/min prekinuto je zbog neravnoteže u učestalosti nuspojava (vidjeti dio 4.8).
English: The risk may increase as the trough sirolimus level increases.
Croatian: Rizik može rasti s porastom najniže terapijske razine sirolimusa.
English: Polysorbate 80 (E433) and phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids, and ascorbyl palmitate).
Croatian: Polisorbat 80 (E433) i fosal 50 PG (fosfatidilkolin, propilenglikol [E1520], mono- i digliceridi, etanol, masne kiseline soje i askorbilpalmitat).
English: Impairments of sperm parameters have been observed among some patients treated with Rapamune.
Croatian: U bolesnika liječenih Rapamuneom uočeni su poremećaji parametara sperme.
English: Plasma S-(-) verapamil Cmax and AUC were both increased 1.5-fold, and tmax was decreased 24%.
Croatian: Cmax i AUC verapamila u plazmi bile su povećane 1,5 puta, dok je tmax smanjen za 24%.
English: Serious liver damage
Croatian: Oštećenje jetre
English: There have been reports of impaired or delayed wound healing in patients receiving Rapamune, including lymphocele in renal transplant patients and wound dehiscence.
Croatian: U bolesnika koji primaju Rapamune prijavljeno je poremećeno ili sporije zacjeljivanje rana uključujući limfokelu u bolesnika s transplantiranim bubregom i dehiscijenciju rana.
English: EU/1/01/171/013 30 tablets EU/1/01/171/014 100 tablets
Croatian: EU/1/01/171/013 30 tableta EU/1/01/171/014 100 tableta
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use, were as follows: pancreatic islet cell vacuolation, testicular tubular degeneration, gastrointestinal ulceration, bone fractures and calluses, hepatic haematopoiesis, and pulmonary phospholipidosis.
Croatian: Nuspojave koje nisu zabilježene u kliničkim ispitivanjima, ali su zapažene u životinja pri razinama izloženosti sličnim razinama izloženosti u ljudi i s mogućom važnošću za kliničku primjenu uključivale su: pojavu vakuola u stanicama otočića gušterače, testikularnu tubularnu degeneraciju, gastrointestinalne ulceracije, prijelome kostiju i kaluse, hepatalnu hematopoezu i pulmonalnu fosfolipidozu.
English: Concomitant immunosuppressive agents included mycophenolate mofetil, azathioprine, and corticosteroids.
Croatian: Istodobno primijenjeni imunosupresivni lijekovi uključivali su mofetilmikofenolat, azatioprin i kortikosteroide.
English: Patients with a body mass index (BMI) greater than 30 kg/m2 may be at increased risk of abnormal wound healing based on data from the medical literature.
Croatian: Prema podacima iz medicinske literature, bolesnici s indeksom tjelesne mase (BMI) većim od 30 kg/m2 mogu imati povećan rizik od nepravilnog zacjeljivanja rana.
English: A clinical study in liver transplant patients randomised to conversion from a calcineurin inhibitor (CNI)-based regimen to a sirolimus-based regimen versus continuation of a CNI-based regimen 6-144 months post-liver transplantation failed to demonstrate superiority in baseline-adjusted GFR at 12 months (-4.45 mL/min and -3.07 mL/min, respectively).
Croatian: Kliničko ispitivanje u bolesnika s presađenom jetrom koji su bili liječeni inhibitorom kalcineurina u trajanju od 6 do 144 mjeseca nakon transplantacije, nakon čega su bili randomizirani u skupinu kojoj je inhibitor kalcineurina zamijenjen sirolimusom i skupinu koja je nastavila liječenje inhibitorom kalcineurina, nakon 12 mjeseci ispitivanja na temelju mjerenja glomerularne filtracije prilagođene početnoj vrijednosti nije uspjelo dokazati superiornost liječenja sirolimusom (-4,45 ml/min, odnosno3,07 ml/min).
English: INFORMATION IN BRAILLE Rapamune 1 mg/mL
Croatian: Rapamune 1 mg/ml
English: Rapamune has no known influence on the ability to drive and use machines.
Croatian: Nisu poznati učinci Rapamunea na sposobnost upravljanja vozilima i rada sa strojevima.
English: To minimise variability, Rapamune tablets should be taken consistently with or without food.
Croatian: Kako bi se promjene koncentracije svele na najnižu mjeru, tablete Rapamunea se moraju uzimati dosljedno uvijek s hranom ili uvijek bez nje.
English: Hepatic impairment
Croatian: Zloćudna bolest
English: As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Croatian: Potrebno je ograničiti izlaganje sunčevom svjetlu kao i ultraljubičastom (UV) zračenju nošenjem zaštitne odjeće i upotrebom sredstava za sunčanje s visokim faktorom zaštite, kao što je uobičajeno u bolesnika s povećanim rizikom od raka kože.
English: Rapamune 1 mg/mL oral solution sirolimus
Croatian: Rapamune 1 mg/ml oralna otopina sirolimus
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: EU/1/01/171/009 30 tablets EU/1/01/171/010 100 tablets
Croatian: EU/1/01/171/009 30 tableta EU/1/01/171/010 100 tableta
English: Whole blood sirolimus levels should be closely monitored in the following populations:
Croatian: Terapijsko praćenje lijeka i prilagodba doze Koncentraciju sirolimusa u punoj krvi mora se pažljivo pratiti u sljedećih skupina:
English: In the patient stratum with baseline calculated GFR above 40 mL/min, renal function was not improved overall.
Croatian: Funkcija bubrega u skupini bolesnika s izračunatom početnom vrijednošću brzine glomerularne filtracije većom od 40 ml/min općenito se nije poboljšala.
English: Rapamune 2 mg coated tablets 3 years.
Croatian: Rapamune 2 mg obložene tablete 3 godine.
English: EU/1/01/171/007 30 tablets EU/1/01/171/008 100 tablets
Croatian: EU/1/01/171/007 30 tableta EU/1/01/171/008 100 tableta
English: The rate and extent of sirolimus absorption was significantly increased by ciclosporin A (CsA).
Croatian: Ciklosporin A (CsA) značajno povisuje brzinu i količinu apsorpcije sirolimusa.
English: Impaired healing following transplant surgery has been reported, including fascial dehiscence, incisional hernia, and anastomotic disruption (e.g., wound, vascular, airway, ureteral, biliary).
Croatian: Zabilježeno je narušeno cijeljenje nakon transplantacijskog operativnog zahvata, uključujući dehiscijenciju fascije, kilu na mjestu incizije i razdvajanje anastomoza (npr. rane, krvnih žila, dišnih putova, uretera, žučnih vodova).
English: The rates of premature study discontinuation, adverse events overall (and infections, specifically), and biopsy-proven acute liver graft rejection at 12 months were all significantly greater in the sirolimus conversion group compared to the CNI continuation group.
Croatian: Stope prijevremenog prekida ispitivanja, sve nuspojave (te posebno infekcije) i akutno odbacivanje presađene jetre dokazano biopsijom nakon 12 mjeseci u skupini u kojoj je inhibitor kalcineurina zamijenjen sirolimusom bile su značajno više u skupini koja je primala sirolimus nego u skupini u kojoj je nastavljena primjena inhibitora kalcineurina.
English: With the plunger fully depressed, insert one of the dosing syringes into the opening in the adapter.
Croatian: U otvor na nastavak stavite jednu od dozirnih štrcaljki s potpuno potisnutim klipom.
English: Investigations Blood lactate dehydrogenase increased;
Croatian: Pretrage povišena laktat dehidrogenaza u krvi, povišen kreatinin u krvi
English: In renal transplant patients with delayed graft function, sirolimus may delay recovery of renal function.
Croatian: U bolesnika s transplantiranim bubregom s odgođenom funkcijom presatka, sirolimus može odgoditi oporavak funkcije bubrega.
English: Therefore, absorption and the subsequent elimination of sirolimus may be influenced by substances that affect these proteins.
Croatian: Stoga, tvari koje utječu na navedene proteine mogu utjecati na apsorpciju i daljnju eliminaciju sirolimusa.
English: In a study evaluating the safety and efficacy of conversion from calcineurin inhibitors to sirolimus (target levels of 12 - 20 ng/mL in maintenance renal transplant patients, enrollment was stopped in the subset of patients (n=90) with a baseline glomerular filtration rate of less than 40 mL/min (see section 5.1).
Croatian: U ispitivanju kojim se procjenjivala sigurnost i djelotvornost zamjene terapije inhibitorima kalcineurina sirolimusom (ciljane koncentracije 12 - 20 ng/ml) u bolesnika s održavanjem presatka bubrega, zaustavljeno je uključivanje bolesnika u podskupini (n=90) s početnom brzinom glomerularne filtracije manjom od 40 ml/min (vidjeti dio 5.1).
English: The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, serum lipid abnormalities (including, but not limited to, increased serum triglycerides and cholesterol), and urinary tract infections.
Croatian: Primjena Rapamunea u kombinaciji s inhibitorima kalcineurina i kortikosteroidima bila je povezana s povećanim rizikom pogoršanja funkcije bubrega, poremećajima lipida u serumu (uključujući, između ostaloga, i povišenu razinu triglicerida i kolesterola u serumu) te infekcijama mokraćnog sustava.
English: In patients with delayed graft function, sirolimus may delay recovery of renal function.
Croatian: U bolesnika s odgođenom funkcijom presatka, sirolimus može odgoditi oporavak bubrežne funkcije.
English: Instructions on how to dilute Rapamune
Croatian: Upute za razrjeđivanje lijeka Rapamune
English: In severe hepatically impaired patients (Child-Pugh classification C), mean values for sirolimus AUC and t1/2 were increased 210% and 170%, respectively, and CL/F was decreased by 67% compared to normal healthy subjects.
Croatian: U bolesnika s teškim oštećenjem jetre (ChildPugh klasifikacija C) srednja vrijednost za AUC sirolimusa bila je povećana 210%, t1/2 je bio povećan 170%, a CL/F je bio smanjen za 67% u usporedbi s zdravim ispitanicima.
English: Rapamune 1 mg/mL oral solution:
Croatian: Rapamune 1 mg/ml oralna otopina:
English: The Rapamune dose should then be individualised to obtain whole blood trough levels of 4 to 12 ng/mL (chromatographic assay).
Croatian: Doza Rapamunea se potom mora prilagoditi pojedinom bolesniku tako da se dobiju najniže terapijske koncentracije lijeka u punoj krvi od 4 do 12 ng/ml (kromatografska metoda).
English: Do not store above 25ºC.
Croatian: Ne čuvati na temperaturi iznad 25C.
English: Oral solution 60 mL bottle
Croatian: Oralna otopina bočica od 60 ml
English: Posterior reversible encephalopathy syndrome (PRES), a serious nervous system syndrome that has the following symptoms: headache, nausea, vomiting, confusion, seizures, and visual loss.
Croatian: Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka sindrom posteriorne reverzibilne encefalopatije, ozbiljan sindrom živčanog sustava koji ima sljedeće simptome: glavobolja, mučnina, povraćanje, smetenost, napadaji i gubitak vida.
English: Each coated tablet contains 0.5 mg sirolimus.
Croatian: Jedna obložena tableta sadrži 0,5 mg sirolimusa.
English: There was a significantly higher rate of first biopsy-proven rejection in the ciclosporin elimination group compared to the ciclosporin maintenance group during the period post-randomisation to 12 months (9.8% vs. 4.2%, respectively).
Croatian: U razdoblju do 12 mjeseci nakon randomizacije opažena je značajno veća stopa odbacivanja dokazana prvom biopsijom u skupini kojoj je uklonjen ciklosporin u usporedbi sa skupinom koja je nastavila liječenje ciklosporinom (9,8% nasuprot 4,2%).
English: Oedema peripheral;
Croatian: Oralna otopina.
English: Rapamune 0.5 mg coated tablets, Rapamune 1 mg coated tablets, Rapamune 2 mg coated tablets:
Croatian: Rapamune 0,5 mg obložene tablete, Rapamune 1 mg obložene tablete, Rapamune 2 mg obložene tablete:
English: Each Rapamune 0.5 mg coated tablet contains 0.5 mg of sirolimus.
Croatian: Jedna Rapamune 0,5mg obložena tableta sadrži 0,5mg sirolimusa.
English: This study compared Rapamune (dose adjusted to 5-15 ng/mL) with placebo for a 12-month treatment period, followed by a 12-month observation period in patients with TSC-LAM or S-LAM. Eighty-nine (89) patients were enrolled at 13 study sites in the United States, Canada, and Japan of which 81 patients had S-LAM; of these patients with S-LAM, 39 were randomised to receive placebo and 42 to receive Rapamune.
Croatian: Osamdeset devet (89) bolesnika bilo je uključeno u 13 ispitivačkih centara u Sjedinjenim Državama, Kanadi i Japanu od kojih je 81 bolesnik imao S-LAM; od bolesnika sa S-LAM-om, 39 je bilo randomizirano za primanje placeba i 42 bolesnika za primanje Rapamunea.
English: Menstrual disorder (including amenorrhoea and menorrhagia)
Croatian: Poremećaji reproduktivnog sustava i dojki poremećaj menstrualnog ciklusa (uključujući amenoreju i menoragiju)
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: Pulmonary haemorrhage
Croatian: Oštećenje bubrega
English: Each 60 mL bottle contains 60 mg sirolimus.
Croatian: Jedna boca od 60 ml sadrži 60 mg sirolimusa.
English: Whole blood trough sirolimus concentrations, as measured by LC/MS/MS, were significantly correlated (r2=0.85) with AUC,ss.
Croatian: Najniže koncentracije sirolimusa u punoj krvi određene pomoću LC/MS/MS bile su u značajnoj korelaciji (r
English: Each Rapamune 2 mg coated tablet contains 2 mg of sirolimus.
Croatian: Jedna Rapamune 2mg obložena tableta sadrži 2mg sirolimusa.
English: INFORMATION IN BRAILLE Rapamune 0.5 mg
Croatian: Rapamune 0,5 mg
English: INFORMATION IN BRAILLE Rapamune 2 mg
Croatian: Rapamune 2 mg
English: INTERMEDIATE CARTON: 60 mL BOTTLE
Croatian: UNUTARNJA KUTIJA: BOCA OD 60 ml
English: Rifampicin (CYP3A4 inducer)
Croatian: Rifampicin (induktor CYP3A4)
English: EXP Date opened
Croatian: Datum otvaranja
English: Whole blood sirolimus Cmax, tmax, and AUC were increased 4.4-fold, 1.4-fold, and 4.2-fold, respectively.
Croatian: Cmax sirolimusa u krvi povećana je 4,4 puta, tmax 1,4 puta, a AUC 4,2 puta.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: There have also been reports of fluid accumulation, including peripheral oedema, lymphoedema, pleural effusion and pericardial effusions (including haemodynamically significant effusions in children and adults) in patients receiving Rapamune.
Croatian: U bolesnika koji primaju Rapamune prijavljeno je nakupljanje tekućine, uključujući periferni edem, limfedem, pleuralni izljev i perikardijalne izljeve (uključujući hemodinamski značajne izljeve u djece i odraslih).
English: Rapamune 0.5 mg is supplied to you as tan-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 0.5 mg” on one side.
Croatian: Rapamune 0,5 mg je dostupan u obliku obloženih tableta bež boje i trokutastog oblika s oznakom „RAPAMUNE 0,5 mg“ na jednoj strani.
English: The concomitant use of Rapamune with a calcineurin inhibitor may increase the risk of calcineurin inhibitor-induced haemolytic uraemic syndrome/thrombotic thrombocytopenic purpura/thrombotic microangiopathy (HUS/TTP/TMA).
Croatian: Istodobna primjena Rapamunea s inhibitorom kalcineurina može povećati rizik od nastanka hemolitičko-uremijskog sindroma, trombotične trombocitopenične purpure i trombotske mikroangiopatije (HUS/TTP/TMA) koji su izazvani inhibitorom kalcineurina.
English: Cases of BK virus-associated nephropathy, as well as cases of JC virus-associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Rapamune.
Croatian: U bolesnika liječenih imunosupresivima, uključujući Rapamune, zabilježeni su slučajevi nefropatije povezane s BK virusom, kao i slučajevi progresivne multifokalne leukoencefalopatije (PML) povezane s JC virusom.
English: Each coated tablet contains 1 mg sirolimus.
Croatian: Jedna obložena tableta sadrži 1 mg sirolimusa.
English: Sirolimus Cmax, tmax, and AUC were increased 1.4-fold, 1.3-fold, and 1.6-fold, respectively.
Croatian: Cmax sirolimusa bila je povećana 1,4 puta, tmax 1,3 puta, a AUC 1,6 puta.
English: This dose could potentially be harmful for those suffering from alcoholism and should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Croatian: O tome treba voditi računa u trudnica ili dojilja, djece te visokorizičnih skupina ljudi poput bolesnika s bolešću jetre ili epilepsijom.
English: Each coated tablet contains 2 mg sirolimus.
Croatian: Jedna obložena tableta sadrži 2 mg sirolimusa.