natgillin/translations-raw huggingface dataset:
Based on information from subsequent clinical trials, 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).
Na podlagi podatkov iz poznejših kliničnih preskušanj se ne priporoča uporabe zdravila Rapamune, mofetilijevega mikofenolata in kortikosteroidov v kombinaciji z indukcijo protiteles proti receptorjem IL- 2 (IL2R Ab) pri ledvičnem presadku de novo (glejte poglavje 5. 1).
In hepatically impaired patients, it is recommended that sirolimus whole blood trough levels be closely monitored.
Pri bolnikih z jetrno okvaro priporočamo skrbno spremljanje krvne koncentracije sirolimusa pred naslednjim odmerkom v stanju dinamičnega ravnovesja.
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).
Pri bolnikih s hudo jetrno okvaro priporočamo zmanjšanje vzdrževalnega odmerka za polovico, na podlagi zmanjšanja očistka (glejte poglavji 4. 2 in 5. 2).
Since half-life is prolonged in these patients, therapeutic drug monitoring after a loading dose or a change of dose should be performed for a prolonged period of time until stable concentrations are reached (see sections 4.2 and 5.2).
Ker je razpolovni čas pri teh bolnikih podaljšan, je po polnitvenem odmerku ali spremembi odmerka potrebno dolgotrajno spremljanje koncentracije zdravila, dokler se ne dosežejo stabilne koncentracije (glejte poglavji 4. 2 in 5. 2).
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).
Ne priporoča se sočasno dajanje sirolimusa in močnih zaviralcev CYP3A4 (kot so ketokonazol, vorikonazol, itrakonazol, telitromicin in klaritromicin) ali induktorjev CYP3A4 (kot so rifampicin, rifabutin) (glejte poglavje 4. 5).
4 Increased susceptibility to infection and the possible development of lymphoma and other malignancies, particularly of the skin, may result from immunosuppression (see section 4.8).
Premočno
Oversuppression of the immune system can also increase susceptibility to infection including opportunistic infections, fatal infections, and sepsis.
4 zaviranje imunskega sistema lahko tudi poveča sprejemljivost bolnika za okužbe, vključno z oportunističnimi okužbami, smrtnimi okužbami in sepso.
Patients treated with immunosuppressants, including Rapamune, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal).
Pri bolnikih, zdravljenih z imunosupresivi, med drugim tudi z zdravilom Rapamune, je večje tveganje oportunističnih okužb (bakterijskih, glivičnih, virusnih in protozojskih).
Among these conditions are BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Med temi boleznimi sta nefropatija, povezana z virusom BK, in progresivna multifokalna levkoencefalopatija (PML), povezana z virusom JC.
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Te okužbe so pogosto povezane z veliko skupno imunosupresivno obremenitvijo in lahko povzročijo resne ali smrtne bolezni, ki jih morajo zdravniki upoštevati v diferencialni diagnozi pri imunosuprimiranih bolnikih, ki se jim slabša delovanje ledvic ali imajo nevrološke simptome.
The safety and efficacy of Rapamune as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore, such use is not recommended.
Varnost in učinkovitost zdravila Rapamune za imunosupresivno terapijo nista bili ugotovljeni pri bolnikih s transplantacijo jeter ali pljuč, zato takšna uporaba ni priporočljiva.
In two clinical studies in de novo liver transplant patients the use of sirolimus plus ciclosporin or tacrolimus was associated with an increase in hepatic artery thrombosis, mostly leading to graft loss or death.
V dveh kliničnih študijah pri bolnikih z na novo presajenimi jetri so sočasno uporabo sirolimusa s ciklosporinom ali takrolimusom povezali s povečanjem pogostnosti tromboze jetrne arterije, kar je večinoma povzročilo izgubo presadka ali smrt bolnika.
Patients with a BMI greater than 30 kg/ m2 may be at increased risk of abnormal wound healing based on data from the medical literature.
Podatki iz medicinske literature kažejo, da utegne biti pri bolnikih, ki imajo BMI večji od 30 kg/ m2, tveganje nenormalnega celjenja ran večje.
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.
Pri bolnikih, ki so prejemali zdravilo Rapamune, so poročali tudi o kopičenju tekočine, vključno s perifernimi edemi, limfedemom, plevralnim izlivom in perikardialnimi izlivi (vključno s hemodinamsko pomembnimi izlivi pri otrocih in odraslih).
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.
Poročali so o primerih dehiscence bronhialnih anastomoz, večinoma smrtnih, pri pacientih z novo transplantiranimi pljuči, ki so uporabljali sirolimus kot del imunosupresivnega zdravljenja.
Hypersensitivity reactions, including anaphylactic/ anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis, have been associated with the administration of sirolimus (see section 4.8).
Ob uporabi sirolimusa so se pojavile preobčutljivostne reakcije tudi anafilaktične/ anafilaktoidne, angioedem, eksfoliativni dermatitis in hipersenzitivni vaskulitis – (glejte poglavje 4. 8.).
In rare cases, the concomitant administration of sirolimus and ACE inhibitors has resulted in angioneurotic oedema-type reactions.
V redkih primerih je sočasna uporaba sirolimusa in zaviralcev ACE povzročila reakcije tipa angionevrotičnega edema.
As usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Kot ponavadi pri bolnikih s povečano nevarnostjo za pojav kožnega raka, se priporoča zaščita pred sončno in UV svetlobo z obleko in zaščitnimi kremami z visokim zaščitnim faktorjem.
Cases of Pneumocystis carinii pneumonia have been reported in patients not receiving antimicrobial prophylaxis.
Pri bolnikih, ki niso prejemali profilaktičnega zdravljenja z antibiotiki, so poročali o primerih pljučnice, povzročene s Pneumocystis carinii.
Therefore, antimicrobial prophylaxis for Pneumocystis carinii pneumonia should be administered for the first 12 months following transplantation.
Zato mora bolnik prvih 12 mesecev po presaditvi profilaktično jemati antibiotik proti Pneumocystis carinii.
Cytomegalovirus (CMV) prophylaxis is recommended for 3 months after transplantation, particularly for patients at increased risk for CMV disease.
Priporočena je tudi profilaksa proti citomegalovirusni (CMV) okužbi, ki naj traja 3 mesece po presaditvi, še posebej pri bolnikih, pri katerih je tveganje za CMV okužbo večje.
Patients administered Rapamune should be monitored for hyperlipidemia using laboratory tests and if hyperlipidemia is detected, subsequent interventions such as diet, exercise, and lipid-lowering agents should be initiated.
Če se ugotovi hiperlipidemija, je treba bolniku uvesti dieto, telesno dejavnost in hipolipemike po potrebi.
The risk/ benefit should be considered in patients with established hyperlipidemia before initiating an immunosuppressive regimen including
Pri bolnikih z ugotovljeno hiperlipidemijo je treba pred začetkom zdravljenja z zaviralci imunske odzivnosti, vključno z zdravilom Rapamune, pretehtati pričakovano korist in tveganje.
Similarly the risk/ benefit of continued Rapamune therapy should be re-evaluated in patients with severe refractory hyperlipidemia.
5 lahko pride do pojava rabdomiolize in morebitnih drugih neželenih učinkov, ki so opisani v Povzetkih glavnih značilnosti zdravila za omenjena zdravila.
Renal function should be monitored during concomitant administration of Rapamune and ciclosporin.
Pri sočasnem zdravljenju z zdravilom Rapamune in ciklosporinom je treba spremljati delovanje ledvic.
Appropriate adjustment of the immunosuppression regimen should be considered in patients with elevated serum creatinine levels.
Pri bolnikih z zvišano vrednostjo serumskega kreatinina se po potrebi ustrezno prilagodi odmerjanje zaviralca imunske odzivnosti.
Caution should be exercised when co-administering other agents that are known to have a deleterious effect on renal function.
Tudi pri sočasnem predpisovanju drugih zdravil, za katere je znano, da škodljivo delujejo na ledvice, je potrebna previdnost.
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.
Pri bolnikih, ki so bili zdravljeni z zdravilom Rapamune in ciklosporinom več kot 3 mesece, so bile vrednosti serumskega kreatinina višje, izračunana vrednost glomerulne filtracije pa nižja kot pri tistih v kontrolni skupini, ki so prejemali ciklosporin in placebo ali azatioprin.
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.
Bolniki so po uspešni ukinitvi ciklosporina imeli nižje vrednosti serumskega kreatinina in višje izračunane vrednosti glomerulne filtracije, kot tudi nižjo pogostnost malignosti v primerjavi s tistimi, ki so se še vedno zdravili s ciklosporinom.
The continued co-administration of ciclosporin and Rapamune as maintenance therapy cannot be recommended.
Nadaljnja sočasna uporaba ciklosporina in zdravila Rapamune v okviru vzdrževalne terapije ni priporočena.
Periodic quantitative monitoring of urinary protein excretion is recommended.
Priporočeno je periodično kvantitativno spremljanje izločanja beljakovin z urinom.
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).
V študiji, v kateri so ocenjevali prehod z zaviralcev kalcinevrina na zdravilo Rapamune pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice, so pogosto opažali zvečano izločanje beljakovin z urinom 6 do 24 mesecev po prehodu na zdravilo Rapamune (glejte poglavje 5. 1).
New onset nephrosis (nephrotic syndrome) was also reported in 2% of the patients in the study (see section 4.8).
Pri 2% bolnikov v študiji so poročali tudi o novo nastali nefrozi (nefrotičnem sindromu) (glejte poglavje 4. 8).
The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients have not been established.
Varnosti in učinkovitosti prehoda z zaviralcev kalcinevrina na zdravilo Rapamune pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice niso ugotovili.
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).
Sočasna uporaba zdravila Rapamune z zaviralci kalcinevrina lahko poveča tveganje za nastanek hemolitično uremičnega sindroma/ trombotične trombocitopenične purpure/ trombotične mikroangiopatije( HUS/ TTP/ TMA), induciranih z zaviralci kalcinevrina.
Sirolimus is also a substrate for the multidrug efflux pump, P-glycoprotein (P-gp) located in the small intestine.
Je tudi substrat za P- glikoprotein (P- gp), iztočno črpalko za več zdravil, ki se nahaja v tankem črevesu.
Inhibitors of CYP3A4 (such as ketoconazole, voriconazole, itraconazole, telithromycin, or clarithromycin) decrease the metabolism of sirolimus and increase sirolimus levels.
Zaviralci CYP3A4 (kot so ketokonazol, vorikonazol, itrakonazol, telitromicin in klaritromicin) zmanjšajo presnovo sirolimusa in tako zvišajo njegov nivo.
Inducers of CYP3A4 (such as rifampin or rifabutin) increase the metabolism of sirolimus and decrease sirolimus levels.
Induktorji CYP3A4 (kot so rifampicin in rifabutin) zvišajo presnovo sirolimusa in tako znižajo njegov nivo.
Co-administration of sirolimus with strong inhibitors of CYP3A4 or inducers of CYP3A4 is not recommended (see section 4.4).
Sočasna uporaba sirolimusa in močnih zaviralcev CYP3A4 ali spodbujevalcev CYP3A4 ni priporočena (glejte poglavje 4. 4).
Ciclosporin (CYP3A4 substrate):
Ciklosporin (substrat za CYP3A4):
The rate and extent of sirolimus absorption was significantly increased by ciclosporin A (CsA).
Ciklosporin A močno zviša hitrost in obseg absorpcije sirolimusa.
Sirolimus administered concomitantly (5 mg), and at 2h (5 mg) and 4h (10 mg) after CsA (300 mg) resulted in increased sirolimus AUC by approximately 183%, 141% and 80% respectively.
80%.
The effect of CsA was also reflected by increases in sirolimus Cmax and tmax.
Učinek CsA se je pokazal tudi v zvišanju Cmax in tmax sirolimusa.
Single-dose sirolimus did not affect the pharmacokinetics of ciclosporin (microemulsion) in healthy volunteers when administered simultaneously or 4 hours apart.
Enkratni odmerek sirolimusa, ki so ga dajali zdravim prostovoljcem istočasno ali v razmaku 4 ur ni spremenil farmakokinetike ciklosporina (mikroemulzije).
6 Rifampicin (CYP3A4 inducer):
Rifampicin (induktor CYP3A4):
Administration of multiple doses of rifampicin decreased sirolimus whole blood concentrations following a single 10 mg dose of Rapamune oral solution.
Dajanje večkratnih odmerkov rifampicina zniža krvne koncentracije sirolimusa po enkratnem 10 mg odmerku peroralne raztopine zdravila Rapamune.
Rifampicin increased the clearance of sirolimus by approximately 5.5-fold and decreased AUC and Cmax by approximately 82% and 71%, respectively.
Rifampicin poveča izločanje sirolimusa za približno 5, 5- krat ter zmanjša AUC za približno 82% in Cmax za približno 71%.
Co-administration of sirolimus and rifampicin is not recommended (see section 4.4).
Sočasna uporaba sirolimusa in rifampicina ni priporočena (glejte poglavje 4. 4).
Ketoconazole (CYP3A4 inhibitor):
6 Ketokonazol (zaviralec CYP3A4):
Multiple-dose ketoconazole administration significantly affected the rate and extent of absorption and sirolimus exposure as reflected by increases in sirolimus Cmax, tmax, and AUC of 4.4-fold, 1.4-fold, and 10.9-fold, respectively.
Dajanje večkratnih odmerkov ketokonazola znatno spremeni hitrost in obseg absorpcije sirolimusa ter izpostavljenost sirolimusu, kar je vidno iz povečanja vrednosti sirolimusa - Cmax za 4, 4- krat, t max za 1, 4- krat in AUC za 10, 9- krat.
Co-administration of sirolimus and ketoconazole is not recommended (see section 4.4).
Sočasna uporaba sirolimusa in ketokonazola ni priporočena (glejte poglavje 4. 4).
Voriconazole (CYP3A4 inhibitor):
Vorikonazol (zaviralec CYP3A4):
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.
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 zvišanje Cmax in AUC sirolimusa v poprečju za 7 oz. 11- krat.
Co-administration of sirolimus and voriconazole is not recommended (see section 4.4).
Sočasna uporaba sirolimusa in vorikonazola ni priporočena (glejte poglavje 4. 4).
Diltiazem (CYP3A4 inhibitor):
Diltiazem (zaviralec CYP3A4):
Sirolimus Cmax, tmax, and AUC were increased 1.4-fold, 1.3-fold, and 1.6-fold, respectively.
Cmax za 1, 4- krat, tmax za 1, 3- krat in AUC za 1, 6- krat.
Verapamil (CYP3A4 inhibitor):
Verapamil (zaviralec CYP3A4):
Multiple-dose administration of verapamil and sirolimus oral solution significantly affected the rate and extent of absorption of both drugs.
Uporaba večkratnih odmerkov verapamila in peroralne raztopine sirolimusa pomembno vpliva na razmerje in obseg absorpcije obeh učinkovin.
Whole blood sirolimus Cmax, tmax, and AUC were increased 2.3-fold, 1.1-fold, and 2.2-fold, respectively.
2, 2- krat.
Plasma S-(-) verapamil Cmax and AUC were both increased 1.5-fold, and tmax was decreased 24%.
Cmax in AUC S - (-) verapamila v plazmi se zvišata za 1, 5- krat, tmax se zniža za 24%.
Sirolimus levels should be monitored and appropriate dose reductions of both medications should be considered.
Nivo sirolimusa je treba spremljati in po potrebi ustrezno znižati odmerka obeh zdravil.
Erythromycin (CYP3A4 inhibitor):
Eritromicin (zaviralec CYP3A4):
Multiple-dose administration of erythromycin and sirolimus oral solution significantly increased the rate and extent of absorption of both drugs.
Uporaba večkratnih odmerkov eritromicina in peroralne raztopine sirolimusa pomembno zviša razmerje in obseg absorpcije obeh učinkovin.
Whole blood sirolimus Cmax, tmax, and AUC were increased 4.4-fold, 1.4-fold, and 4.2-fold, respectively.
4, 2- krat.
The Cmax, tmax, and AUC of plasma erythromycin base were increased 1.6-fold, 1.3-fold, and 1.7-fold, respectively.
Cmax, tmax in AUC eritromicina v plazmi v izhodišču se posledično zvišajo za 1, 6- krat, 1, 3- krat in 1, 7- krat.
No clinically significant pharmacokinetic interaction was observed between sirolimus and 0.3 mg norgestrel/ 0.03 mg ethinyl estradiol.
Pri sočasni uporabi sirolimusa in kombinacije 0, 3 mg norgestrela in 0, 03 mg etinilestradiola niso opazili klinično pomembnega farmakokinetičnega medsebojnega delovanja.
Although the results of a single dose drug interaction study with an oral contraceptive suggest the lack of a pharmacokinetic interaction, the results cannot exclude the possibility of changes in the pharmacokinetics that might affect the efficacy of the oral contraceptive during long term treatment with Rapamune.
Čeprav izsledki študije s peroralnim kontraceptivom v enkratnem odmerku ne kažejo farmakokinetičnega medsebojnega delovanja, ni izključena možnost sprememb farmakokinetike, ki bi lahko vplivale na učinkovitost zaščite pred zanositvijo pri dolgotrajnem zdravljenju z zdravilom Rapamune.
Other possible interactions Moderate and weak inhibitors of CYP3A4 may decrease the metabolism of sirolimus and increase sirolimus blood levels (e. g. calcium channel blockers: nicardipine; antifungal agents: clotrimazole, fluconazole; antibiotics: troleandomycin; other substances: bromocriptine, cimetidine, danazol, protease inhibitors).
Tako zmerni kot šibki zaviralci izoencima CYP3A4 lahko zmanjšajo presnovo sirolimusa in povečajo njegove krvne koncentracije (npr. zaviralci kalcijevih kanalčkov: nikardipin; protiglivična zdravila: klotrimazol, flukonazol; antibiotiki: troleandomicin; druga zdravila: bromokriptin, cimetidin, danazol, zaviralci proteaz).
John's wort (Hypericum perforatum), anticonvulsants: carbamazepine, phenobarbital, phenytoin).
Induktorji CYP3A4 lahko povečajo presnovo sirolimusa in znižajo njegove krvne koncentracije (npr. šentjanževka (Hypericum perforatum), antikonvulzivi: karbamazepin, fenobarbital, fenitoin).
Although sirolimus inhibits human liver microsomal cytochrome P450 CYP2C9, CYP2C19, CYP2D6, and CYP3A4/ 5 in vitro, the active substance is not expected to inhibit the activity of these isozymes in vivo since the sirolimus concentrations necessary to produce inhibition are much higher than those observed in
V in vitro poskusih sirolimus zavira humani jetrni mikrosomski citokrom P450 CYP2C9, CYP2C19, CYP2D6 in CYP3A4/ 5, vendar ni pričakovati, da bi zaviral aktivnost teh encimov tudi in vivo, saj so koncentracije sirolimusa, ki so potrebne za inhibicijo, mnogo višje od tistih, ki jih izmerijo pri bolnikih, ki jemljejo terapevtske odmerke zdravila Rapamune.
Inhibitors of P-gp may decrease the efflux of sirolimus from intestinal cells and increase sirolimus levels.
Zaviralci P- gp lahko zmanjšajo izločanje sirolimusa iz črevesnih celic in povečajo koncentracije sirolimusa.
Grapefruit juice affects CYP3A4 mediated metabolism and should therefore be avoided.
Sok grenivke vpliva na presnovo z encimom CYP3A4, zato se je treba njegovi uporabi med zdravljenjem izogniti.
Pharmacokinetic interactions may be observed with gastrointestinal prokinetic agents such as cisapride and metoclopramide.
Farmakokinetično medsebojno delovanje lahko opazimo pri prokinetično delujočih učinkovinah z delovanjem na želodec in črevo, kot sta cisaprid in metoklopramid.
No clinically significant pharmacokinetic interaction was observed between sirolimus and any of the following substances: acyclovir, atorvastatin, digoxin, glibenclamide, methylprednisolone, nifedipine, prednisolone, and trimethoprim/ sulphamethoxazole.
7 Med sirolimusom in naslednjimi učinkovinami niso opazili klinično pomembnih farmakokinetičnih interakcij: aciklovirjem, atorvastatinom, digoksinom, glibenklamidom, metilprednizolonom, nifedipinom, prednizolonom in trimetoprimom/ sulfametoksazolom.
There are no adequate data from the use of sirolimus in pregnant women.
Ni zadostnih podatkov o uporabi sirolimusa pri nosečnicah.
Effective contraception must be used during Rapamune therapy and for 12 weeks after Rapamune has been stopped.
Med zdravljenjem z zdravilom Rapamune in še 12 tednov po prekinitvi zdravljenja mora ženska uporabljati učinkovito kontracepcijo.
It is not known whether sirolimus is excreted in human milk.
Ni znano, ali se sirolimus izloča tudi v materino mleko pri človeku.
Because of the potential for adverse reactions in nursing infants from sirolimus, nursing should be discontinued during therapy.
Zaradi možnosti pojava neželenih učinkov sirolimusa pri dojenčku se priporoča, da mati med zdravljenjem preneha z dojenjem.
These effects have been reversible upon discontinuation of Rapamune in most cases (see section 5.3).
Po prekinitvi zdravljenja z zdravilom Rapamune so bili ti učinki pri večini primerov reverzibilni (glejte poglavje 5. 3).
No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu sirolimusa na sposobnost vožnje in upravljanja s stroji niso izvedli.
The most commonly reported adverse drug reactions (occurring in  10% of patients) are thrombocytopenia, anaemia, pyrexia, hypertension, hypokalaemia, hypophosphataemia, urinary tract infection, hypercholesterolaemia, hyperglycaemia, hypertriglyceridaemia, abdominal pain, lymphocoele, peripheral oedema, arthralgia, acne, diarrhoea, pain, constipation, nausea, headache, increased blood creatinine, and increased blood lactate dehydrogenase (LDH).
Najpogosteje opisani neželeni učinki zdravila (pojavili so se pri > 10% bolnikov) so trombocitopenija, anemija, pireksija, zvišan krvni tlak, hipokaliemija, hipofosfatemija, okužba sečil, hiperholesterolemija, hiperglikemija, hipertrigliceridemija, bolečine v trebuhu, limfokela, periferni edemi, artralgija, akne, driska, bolečine, zaprtje, navzea, glavobol, zvišanje kreatinina v krvi in zvišanje laktat- dehidrogenaze (LDH) v krvi.
The incidence of any adverse event(s) may increase as the trough sirolimus level increases.
Incidenca kateregakoli neželenega pojava se lahko poveča z zvišanjem najnižje koncentracije sirolimusa.
Adverse reactions based on experience from clinical trials and postmarketing experience are presented in the following table by system organ class and frequency of occurrence.
Neželeni učinki na podlagi izkušenj iz kliničnih preskušanj in pomarketinških izkušenj so navedeni v naslednji tabeli po organskih sistemih in pogostnosti.