FrancophonIA/ELRC3.0 huggingface dataset:
English: bromocriptine (used in the treatment of Parkinson's disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (e.g. for HIV and hepatitis C such as ritonavir, indinavir, boceprevir, and telaprevir).
Slovenian: bromokriptin (za zdravljenje parkinsonove bolezni in različnih hormonskih motenj), danazol (za zdravljenje ginekoloških bolezni) ali zaviralce proteaz (npr. za zdravljenje okužb z virusom HIV in virusom hepatitisa C, kot so ritonavir, indinavir, boceprevir in telaprevir).
English: Patients at high immunological risk of graft loss were not studied in sufficient number in the ciclosporin elimination-Rapamune maintenance studies and are not recommended for this treatment regimen.
Slovenian: Število bolnikov z velikim imunološkim tveganjem za zavrnitev presadka v študijah ukinitve ciklosporina-vzdrževalnega zdravljenja z zdravilom Rapamune ni bilo zadostno zato taka shema zdravljenja za njih ni priporočljiva.
English: What Rapamune looks like and contents of the pack Rapamune oral solution is a pale yellow to yellow solution supplied in a 60 mL bottle.
Slovenian: Peroralna raztopina zdravila Rapamune je bledo rumena do rumena raztopina, ki je na voljo v 60 ml steklenici.
English: Inducers of CYP3A4 (such as rifampin or rifabutin) increase the metabolism of sirolimus and decrease sirolimus levels.
Slovenian: Induktorji CYP3A4 (kot sta rifampicin in rifabutin) zvečajo presnovo sirolimusa in tako zmanjšajo njegovo koncentracijo.
English: 30 dosing syringes 1 syringe adapter 1 carrying case
Slovenian: 30 odmernih brizg 1 nastavek za brizgo 1 škatla za hranjenje brizge
English: Your doctor will also perform tests to monitor your kidney function, your blood fat (cholesterol and/or triglycerides) levels and possibly your liver function, during treatment with Rapamune.
Slovenian: Prav tako bo v času zdravljenja z zdravilom Rapamune s preiskavami spremljal delovanje vaših ledvic, nivo krvnih maščob (holesterola in/ali trigliceridov), morda tudi delovanje vaših jeter.
English: Multiple-dose administration of verapamil and sirolimus oral solution significantly affected the rate and extent of absorption of both medicinal products.
Slovenian: Uporaba večkratnih odmerkov verapamila in peroralne raztopine sirolimusa je pomembno vplivala na razmerje in obseg absorpcije obeh zdravil.
English: Following administration of the Rapamune oral solution, sirolimus is rapidly absorbed, with a time to peak concentration of 1 hour in healthy subjects receiving single doses and 2 hours in patients with stable renal allografts receiving multiple doses.
Slovenian: Po uporabi peroralne raztopine zdravila Rapamune se sirolimus hitro absorbira in doseže največjo koncentracijo v krvi pri zdravih prostovoljcih po enkratnem odmerku v 1 uri, pri bolnikih s stabilnim alogenim presadkom ledvice po večkratnih odmerkih pa v 2 urah.
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).
Slovenian: Vključevanje v skupino bolnikov z izračunano izhodiščno GFR, manjšo od 40 ml/min, so zaradi varnostnih razlogov prekinili (glejte poglavje 4.8).
English: Rapamune contains lactose and sucrose
Slovenian: Zdravilo Rapamune vsebuje laktozo in saharozo
English: St. John's Wort (Hypericum perforatum).
Slovenian: pripravke šentjanževke (Hypericum perforatum).
English: Renal function was not better in the treatment arms with de novo sirolimus without a calcineurin inhibitor.
Slovenian: Ledvična funkcija v skupini z zdravljenjem s sirolimusom de novo brez zaviralca kalcinevrina se ni izboljšala.
English: Each mL contains up to 25 mg of ethanol, approximately 350 mg of propylene glycol (E1520), and 20 mg of soya oil.
Slovenian: Pomožne snovi z znanim učinkom: 1 ml vsebuje do 25 mg etanola, približno 350 mg propilenglikola (E1520) in 20 mg sojinega olja.
English: Hypersensitivity (including angioedema, anaphylactic reaction, and anaphylactoid reaction)
Slovenian: Bolezni imunskega sistema preobčutljivost (vključno z angioedemom, anafilaktično reakcijo in anafilaktoidno reakcijo)
English: Insert the syringe adapter into the bottle until it is flush with the top of the bottle.
Slovenian: V steklenico namestite nastavek za odmerno brizgo, tako da je zgornji rob nastavka v isti ravnini z vrhom steklenice.
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).
Slovenian: V skupini po ukinitvi ciklosporina je bila zavrnitev, dokazana s prvo biopsijo, pomembno pogostejša kot v skupini z vzdrževalnim zdravljenjem s ciklosporinom v času od randomizacije do 12 mesecev po randomizaciji (9,8 % proti 4,2 %).
English: The use of Rapamune may lead to increased levels of cholesterol and triglycerides (blood fats) in your blood that may require treatment.
Slovenian: Uporaba zdravila Rapamune lahko povzroči zvišane ravni holesterola in trigliceridov (krvnih maščob) v krvi, ki jih bo morda treba zdraviti.
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).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Most patients who received 2 mg of Rapamune 4 hours after ciclosporin had whole blood trough concentrations of sirolimus within the 4 to 12 ng/mL target range (expressed as chromatographic assay values).
Slovenian: Večina bolnikov, ki je prejemala 2 mg zdravila Rapamune 4 ure po ciklosporinu, je imela najmanjše koncentracije sirolimusa v stanju dinamičnega ravnovesja v polni krvi znotraj ciljnega razpona od 4 do 12 ng/ml (izražene v vrednostih kromatografske metode).
English: Inducers of CYP3A4 may increase the metabolism of sirolimus and decrease sirolimus blood levels (e.g. St. John's Wort (Hypericum perforatum), anticonvulsants: carbamazepine, phenobarbital, phenytoin).
Slovenian: Induktorji CYP3A4 lahko povečajo presnovo sirolimusa in zmanjšajo njegove koncentracije v krvi (npr. šentjanževka (Hypericum perforatum), antikonvulzivi: karbamazepin, fenobarbital, fenitoin).
English: Plasma S-(-) verapamil Cmax and AUC were both increased 1.5-fold, and tmax was decreased 24%.
Slovenian: Vrednosti Cmax in AUC S-(-)verapamila v plazmi sta se povečali za 1,5-krat, vrednost tmax pa se je zmanjšala za 24 %.
English: Rapamune oral solution contains up to 3.17 vol % ethanol (alcohol).
Slovenian: Peroralna raztopina zdravila Rapamune vsebuje do 3,17 volumskih % etanola (alkohola).
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).
Slovenian: V klinični študiji pri bolnikih s presajenimi jetri, randomiziranih na prehod s sheme na podlagi inhibitorja kalcinevrina (CNI - Calcineurin Inhibitor) na shemo na podlagi sirolimusa v primerjavi z nadaljevanjem sheme na podlagi CNI, 6-144 mesecev po presaditvi jeter niso uspeli dokazati superiornosti v hitrosti glomerulne filtracije (GFR), prilagojeni glede na izhodiščno vrednost po 12 mesecih (-4,45 ml/min oziroma -3,07 ml/min).
English: Effective contraception must be used during Rapamune therapy and for 12 weeks after Rapamune has been stopped (see section 4.5).
Slovenian: Med zdravljenjem z zdravilom Rapamune in še 12 tednov po koncu zdravljenja z zdravilom Rapamune je treba uporabljati učinkovito metodo kontracepcije (glejte poglavje 4.5).
English: It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months.
Slovenian: Priporočeno je, da se na začetku zdravilo Rapamune 2 do 3 mesece kombinira z mikroemulzijo ciklosporina in kortikosteroidi.
English: Lymphangioleiomyomatosis (LAM)
Slovenian: Limfangioleiomiomatoza (LAM)
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.
Slovenian: Vsebino odmerne brizge iztisnite v steklen ali plastičen kozarec, v katerem je najmanj 60 ml vode ali pomarančnega soka.
English: Rapamune oral solution contains soya oil.
Slovenian: Peroralna raztopina zdravila Rapamune vsebuje sojino olje.
English: To minimise variability, Rapamune tablets should be taken consistently with or without food.
Slovenian: Za zmanjšanje variabilnosti je treba tablete zdravila Rapamune vedno jemati bodisi s hrano bodisi brez nje.
English: See section 4
Slovenian: PRILOGA III
English: The use of live vaccines should be avoided with the use of Rapamune.
Slovenian: Med uporabo zdravila Rapamune se je treba izogibati uporabi živih cepiv.
English: Rapamune was assessed in a 36-month controlled clinical study enrolling renal transplant patients below 18 years of age considered at high-immunologic risk, defined as having a history of one or more acute allograft rejection episodes and/or the presence of chronic allograft nephropathy on a renal biopsy.
Slovenian: Zdravilo Rapamune so ocenjevali v 36-mesečni nadzorovani klinični študiji, v katero so bili vključeni bolniki po ledvični presaditvi, mlajši od 18 letin z velikim imunološkim tveganjem, kar pomeni z anamnezo ene ali več epizod akutne zavrnitve alogenega presadka in/ali prisotnostjo kronične nefropatije alogenega presadka ob ledvični biopsiji.
English: Sirolimus whole blood trough concentrations should be measured in 10 to 20 days, with dosage adjustment to maintain concentrations between 5 to 15 ng/mL.
Slovenian: Po 10 do 20 dneh je treba izmeriti najmanjše koncentracije sirolimusa v stanju dinamičnega ravnovesja v polni krvi in odmerek prilagoditi tako, da vzdržujemo koncentracije med 5 in 15 ng/ml.
English: Ovarian cysts and menstrual disorders (including amenorrhoea and menorrhagia) have been reported.
Slovenian: Poročali so o ovarijskih cistah in motnjah menstrualnega cikla (vključno z amenorejo in menoragijo).
English: Remove the safety cap from the bottle by squeezing the tabs on the cap and twisting.
Slovenian: Odstranite varnostno zaporko s steklenice tako, da jo stisnete na označenem mestu in zavrtite.
English: In some cases, the interstitial lung disease has resolved upon discontinuation or dose reduction of Rapamune.
Slovenian: V nekaterih primerih je intersticijska bolezen pljuč po prekinitvi zdravljenja z zdravilom Rapamune ali zmanjšanju njegovega odmerka izzvenela.
English: Inhibitors of CYP3A4 (such as ketoconazole, voriconazole, itraconazole, telithromycin, or clarithromycin) decrease the metabolism of sirolimus and increase sirolimus levels.
Slovenian: Zaviralci CYP3A4 (kot so ketokonazol, vorikonazol, itrakonazol, telitromicin ali klaritromicin) zmanjšajo presnovo sirolimusa in tako zvečajo njegovo koncentracijo.
English: Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist.
Slovenian: Zdravljenje sme uvesti in kasneje nadzorovati le ustrezno usposobljen specialist.
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.
Slovenian: Med sirolimusom in naslednjimi učinkovinami niso opazili klinično pomembnih farmakokinetičnih medsebojnih delovanj: aciklovirj, atorvastatin, digoksin, glibenklamid, metilprednizolon, nifedipin, prednizolon in trimetoprim/sulfametoksazol.
English: Pharmacokinetic interactions may be observed with gastrointestinal prokinetic agents, such as cisapride and metoclopramide.
Slovenian: Farmakokinetično medsebojno delovanje lahko opazimo pri prokinetično delujočih učinkovinah z delovanjem na prebavila, kot sta cisaprid in metoklopramid.
English: Once the dosing syringe has been filled with Rapamune oral solution, it should be kept at room temperature, but not above 25C, for maximum 24 hours.
Slovenian: Ko ste brizgo za odmerjanje napolnili s peroralno raztopino zdravila Rapamune, jo lahko pri sobni temperaturi, ki naj ne preseže 25 C, hranite do največ 24 ur.
English: The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients (6-120 months after transplantation) was assessed in a randomised, multicentre, controlled trial, stratified by calculated GFR at baseline (20-40 mL/min vs. above 40 mL/min).
Slovenian: Varnost in učinkovitost prehoda z zaviralcev kalcinevrina na zdravilo Rapamune pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice (6-120 mesecev po presaditvi) so ocenjevali v randomiziranem, multicentričnem nadzorovanem preskušanju, stratificiranem glede na izračunano GFR ob izhodišču (20 ml/min do 40 ml/min v primerjavi z več kot 40 ml/min).
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.
Slovenian: Neželeni učinki, ki jih v kliničnih študijah niso opazili, opazili pa so jih pri živalih pri stopnjah izpostavljenosti, podobnih stopnjam klinične izpostavljenosti in z možnim pomenom za klinično uporabo so bili naslednji: vakuolizacija celic pankreasnih otočkov, degeneracija tubulov v testisih, ulceracije v prebavilih, zlomi kosti in kalusi, jetrna hematopoeza in pljučna fosfolipidoza.
English: Patients taking Rapamune should discontinue breast-feeding.
Slovenian: Bolnice, ki jemljejo zdravilo Rapamune, morajo z dojenjem prenehati.
English: No clinically significant pharmacokinetic interaction was observed between Rapamune oral solution and 0.3 mg norgestrel/0.03 mg ethinyl estradiol.
Slovenian: Pri sočasni uporabi peroralne raztopine zdravila Rapamune in kombinacije 0,3 mg norgestrela in 0,03 mg etinilestradiola niso opazili klinično pomembnega farmakokinetičnega medsebojnega delovanja.
English: The clearance of sirolimus may be reduced in patients with impaired hepatic function (see section 5.2).
Slovenian: Pri bolnikih z okvarjenim delovanjem jeter je očistek sirolimusa lahko zmanjšan (glejte poglavje 5.2).
English: An unacceptably high frequency of PTLD was seen in a paediatric clinical transplant study when full-dose Rapamune was administered to children and adolescents in addition to full-dose calcineurin inhibitors with basiliximab and corticosteroids (see section 4.8).
Slovenian: V pediatrični klinični študiji po presaditvi so opazili nesprejemljivo visoko pogostnost PTLD, ko so otrokom in mladostnikom poleg zaviralcev kalcinevrina, basiliksimaba in kortikosterodiov v polnih odmerkih dajali še zdravilo Rapamune v polnem odmerku (glejte poglavje 4.8).
English: Rapamune contains the active substance sirolimus, which belongs to a group of medicines called immunosuppressants.
Slovenian: Zdravilo Rapamune vsebuje učinkovino sirolimus, ki sodi med zdravila za zaviranje imunske odzivnosti.
English: Sirolimus concentrations, following the administration of Rapamune tablets (5 mg) to healthy subjects as single doses are dose proportional between 5 and 40 mg.
Slovenian: Pri zdravih prostovoljcih so koncentracije sirolimusa po enkratnem 5 mg odmerku zdravila Rapamune tablete odvisne od odmerka v razponu od 5 mg do 40 mg.
English: In a randomised, comparative evaluation of ramipril versus placebo for the prevention of proteinuria in kidney transplant patients converted from calcineurin inhibitors to sirolimus, a difference in the number of patients with BCAR through 52 weeks was observed [13 (9.5%) vs. 5 (3.2%), respectively; p=0.073].
Slovenian: V randomiziranem, primerjalnem vrednotenju ramiprila v primerjavi s placebom za preprečevanje proteinurije pri bolnikih s presajeno ledvico, ki so prešli z zaviralcev kalcinevrina na sirolimus, so po 52 tednih opazili razliko v številu bolnikov z BCAR [13 (9,5 %) v skupini, ki je prejemala ramipril, v primerjavi s 5 (3,2 %) v skupini, ki je prejemala placebo; p = 0,073].
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).
Slovenian: Varnost so ocenjevali v nadzorovani klinični študiji, v katero so bili vključeni bolniki po ledvični presaditvi, mlajši od 18 let in z velikim imunološkim tveganjem, kar pomeni z anamnezo ene ali več epizod akutne zavrnitve alogenega presadka in/ali prisotnostjo kronične nefropatije alogenega presadka ob ledvični biopsiji (glejte poglavje 5.1).
English: Multiple-dose administration of erythromycin and sirolimus oral solution significantly increased the rate and extent of absorption of both medicinal products.
Slovenian: Uporaba večkratnih odmerkov eritromicina in peroralne raztopine sirolimusa je pomembno zvečala razmerje in obseg absorpcije obeh zdravil.
English: New onset nephrosis (nephrotic syndrome) was also reported in 2% of the patients in the study (see section 4.8).
Slovenian: Pri 2 % bolnikov v študiji so poročali tudi o na novo nastali nefrozi (nefrotskem sindromu) (glejte poglavje 4.8).
English: There is insufficient experience to recommend the use of Rapamune in children and adolescents (see section 4.2).
Slovenian: Zaradi nezadostnih izkušenj pri otrocih in mladostnikih uporabe zdravila Rapamune pri tej starostni skupini ni mogoče priporočiti (glejte poglavje 4.2).
English: Sirolimus was not mutagenic in the in vitro bacterial reverse mutation assays, the Chinese Hamster Ovary cell chromosomal aberration assay, the mouse lymphoma cell forward mutation assay, or the in vivo mouse micronucleus assay.
Slovenian: Sirolimus se ni izkazal za mutagenega v in vitro bakterijskem testu reverznih mutacij, testu kromosomskih aberacij v ovarijskih celicah kitajskega hrčka, testu mutacije celic mišjega limfoma, in v in vivo mikronukleusnem testu pri miših.
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.
Slovenian: Pri bolnikih s hudo okvaro jeter (stopnja C po Child-Pugh-u) sta bili povprečni vrednosti AUC in t1/2 sirolimusa zvečani za 210 % oziroma 170 %, vrednost CL/F pa je bila zmanjšana za 67 % v primerjavi z normalnimi zdravimi preskušanci.
English: Liver function test abnormal (including alanine aminotransferase increased and aspartate aminotransferase increased)
Slovenian: Bolezni jeter, žolčnika in žolčevodov nenormalni izvidi testov jetrne funkcije (vključno z zvišanjem alaninaminotransferaze in zvišanjem aspartataminotransferaze)
English: In the stratum with baseline calculated GFR above 40 mL/min, the mean and median urinary protein to creatinine ratios were significantly higher in the Rapamune conversion group as compared to those of the calcineurin inhibitors continuation group at 24 months (see section 4.4).
Slovenian: V skupini z izhodiščno izračunano GFR nad 40 ml/min sta bili po 24 mesecih razmerji povprečnih in medianih vrednosti beljakovin v urinu v primerjavi z vrednostmi kreatinina v skupini po prehodu na zdravilo Rapamune pomembno večji kot v skupini, ki je zdravljenje nadaljevala z zaviralci kalcinevrina (glejte poglavje 4.4).
English: One patient experienced an episode of atrial fibrillation after ingestion of 150 mg of Rapamune.
Slovenian: Pri enem bolniku je po zaužitju 150 mg zdravila Rapamune prišlo do atrijske fibrilacije.
English: In particular, you should inform your doctor or pharmacist if you are taking any of the following:
Slovenian: Opozorite zdravnika ali farmacevta, če jemljete katerokoli drugo zdravilo, še posebno pa:
English: The longer half-lives observed in hepatically impaired patients delay reaching steady state.
Slovenian: Daljši razpolovni čas, opažen pri bolnikih z okvaro jeter, zakasni dosego stanja dinamičnega ravnovesja.
English: Do not attempt to remove the syringe adapter from the bottle once inserted.
Slovenian: Nastavka za odmerno brizgo po vstavitvi ne poskušajte več sneti s steklenice.
English: There have been reports of impaired or delayed wound healing in patients receiving Rapamune, including lymphocele in renal transplant patients and wound dehiscence.
Slovenian: Pri bolnikih, ki so dobivali zdravilo Rapamune, so poročali o slabšem ali zapoznelem celjenju ran, vključno z limfokelo pri bolnikih s presadki ledvic in dehiscenco rane.
English: In patients with delayed graft function, sirolimus may delay recovery of renal function.
Slovenian: Pri bolnikih z zakasnelim delovanjem presadka lahko sirolimus zapozni okrevanje ledvičnega delovanja.
English: Concomitant immunosuppressive agents included mycophenolate mofetil, azathioprine, and corticosteroids.
Slovenian: Sočasno dana imunosupresivna zdravila so vključevala mofetilijev mikofenolat, azatioprin in kortikosteroide.
English: Common (≥1/100 to
Slovenian: Pogosti (≥ 1/100 do < 1/10)
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).
Slovenian: Sočasno zdravljenje s sirolimusom in močnimi zaviralci CYP3A4 (na primer ketokonazolom, vorikonazolom, itrakonazolom, telitromicinom ali klaritromicinom) ali induktorji CYP3A4 (na primer rifampicinom, rifabutinom) ni priporočljivo (glejte poglavje 4.5).
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.
Slovenian: Sočasna uporaba sirolimusa (2 mg v enkratnem odmerku) z večkratnimi, peroralnimi odmerki vorikonazola (1 dan 400 mg na 12 ur, nato 8 dni 100 mg na 12 ur) je pri zdravih osebah povzročila povečanje vrednosti Cmax in AUC sirolimusa v povprečju za 7- oziroma 11-krat.
English: In mild and moderate hepatically impaired patients (Child-Pugh classification A or B), mean values for sirolimus AUC and t1/2 were increased 61% and 43%, respectively, and CL/F was decreased 33% compared to normal healthy subjects.
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter (stopnje A ali B po Child-Pugh-u) sta bili srednji vrednosti AUC in t1/2 povečani za 61 % oziroma 43 %, medtem ko je bila vrednost CL/F zmanjšana za 33 % v primerjavi z vrednostmi pri normalnih zdravih preskušancih.
English: The use of live vaccines should be avoided during treatment with Rapamune.
Slovenian: Med zdravljenjem z zdravilom Rapamune se je treba izogibati uporabi živih cepiv.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija osteonekroza
English: Kidney damage with low blood cell counts (thrombocytopaenic purpura/haemolytic uraemic syndrome)
Slovenian: Okvara ledvic z zmanjšanim številom krvnih celic (trombocitopenična purpura/hemolitičnouremični sindrom)
English: There were more adverse events (99.2% vs. 91.1%, p=0.002*) and more discontinuations from the treatment due to adverse events (26.7% vs. 4.1%, p<0.001*) in the group converted to sirolimus compared to the tacrolimus group.
Slovenian: V skupini, ki je prešla na sirolimus, je bilo v primerjavi s skupino na takrolimusu več neželenih učinkov (99,2 % v primerjavi z 91,1 %, p = 0,002*) in več prekinitev zdravljenja zaradi neželenih učinkov (26,7 % v primerjavi s 4,1 %, p < 0,001*).