natgillin/translations-raw huggingface dataset:
In a clinical trial of patients with LAM, the median whole blood sirolimus trough concentration after 3 weeks of receiving sirolimus tablets at a dose of 2 mg/day was 6.8 ng/mL (interquartile range 4.6 to 9.0 ng/mL; n=37). 
V kliničnem preskušanju pri bolnikih z LAM je mediana najmanjša koncentracija sirolimusa v stanju dinamičnega ravnovesja v polni krvi po 3 tednih prejemanja tablet sirolimusa v odmerku 2 mg/dan znašala 6,8 ng/ml (interkvartilni razmik od 4,6 do 9,0 ng/ml; n = 37).
Phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids and ascorbyl palmitate). 
Phosal 50 PG (fosfatidilholin, propilenglikol [E1520], mono- in digliceridi, etanol, maščobne kisline iz soje in askorbilpalmitat).
Stomach pain, diarrhoea, constipation, nausea 
Bolezni prebavil bolečine v trebuhu, zaprtje, diareja, navzea pankreatitis, stomatitis, ascites
Rapamune 0.5 mg coated tablets 2 years. 
Rapamune 0,5 mg obložene tablete 2 leti
What Rapamune contains 
Kaj vsebuje zdravilo Rapamune
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG 
Imetnik dovoljenja za promet z zdravilom: Izdelovalec: Pfizer Europe MA EEIG
Exposure to sunlight and UV light should be limited by covering your skin with clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer. 
Med zdravljenjem zaradi zvečanega tveganja za nastanek kožnega raka omejite neposredno izpostavljanje sončnim in UV žarkom, tako da si pokrijete kožo z oblačili in uporabljate kremo z visokim zaščitnim faktorjem.
Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis, have been associated with the administration of sirolimus (see section 4.8). 
Uporaba sirolimusa je bila povezana s preobčutljivostnimi reakcijami, med drugim anafilaktičnimi/anafilaktoidnimi reakcijami, angioedemom, eksfoliativnim dermatitisom in preobčutljivostnim vaskulitisom (glejte poglavje 4.8).
Grapefruit juice affects CYP3A4-mediated metabolism, and should therefore be avoided. 
Sok grenivke vpliva na presnovo sirolimusa preko CYP3A4, zato se mu je treba izogibati.
Each 60 mL bottle contains 60 mg sirolimus. 
Ena 60 ml steklenica vsebuje 60 mg sirolimusa.
Appropriate adjustment of the immunosuppression regimen should be considered in patients with elevated serum creatinine levels. 
Pri bolnikih z zvečanimi koncentracijami serumskega kreatinina je treba razmisliti o ustreznem prilagajanju imunosupresijske sheme.
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). 
Obloga tablete: makrogol, glicerolmonooleat, farmacevtska glazura, kalcijev sulfat, mikrokristalna celuloza, saharoza, titanov dioksid, poloksamer 188, -tokoferol, povidon, karnauba vosek, tiskarsko črnilo (šelak, rdeči železov oksid, propilenglikol [E1520], koncentrirana raztopina amonijaka, simetikon).
Rapamune contains 86.4 mg of lactose and up to 215.8 mg of sucrose. 
Zdravilo Rapamune vsebuje 86,4 mg laktoze in do 215,8 mg saharoze.
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, za vzdrževalno zdravljenje bolnikov s presadki ledvic, so 6 do 24 mesecev po prehodu na zdravilo Rapamune pogosto opazili zvečano izločanje beljakovin v urin (glejte poglavje 5.1).
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). 
V študiji varnosti in učinkovitosti prehoda zdravljenja z zaviralcev kalcinevrina na sirolimus (s ciljno koncentracijo 12-20 ng/ml) pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice so pri podskupini bolnikov (n = 90) z izhodiščno glomerulno filtracijo manj kot 40 ml/min vključevanje v študijo ustavili (glejte poglavje 5.1).
The bottle should remain in an upright position when withdrawing the solution. 
Steklenica naj bo med odvzemom postavljena pokonci.
In some cases, the angioedema has resolved upon discontinuation or dose reduction of Rapamune. 
V nekaterih primerih je po prekinitvi zdravljenja z zdravilom Rapamune ali zmanjšanju njegovega odmerka angioedem izzvenel.
EU/1/01/171/013 30 tablets EU/1/01/171/014 100 tablets 
EU/1/01/171/013 30 tablet EU/1/01/171/014 100 tablet
Rapamune 1 mg coated tablets EU/1/01/171/007-8 
Rapamune 1 mg obložene tablete EU/1/01/171/007-008
Menstrual disorder (including amenorrhoea and menorrhagia) 
Motnje reprodukcije in dojk motnje menstrualnega cikla (vključno z amenorejo in menoragijo)
To minimise variability, Rapamune should consistently be taken either with or without food. 
Za zmanjšanje variabilnosti mora bolnik zdravilo Rapamune jemati vedno bodisi s hrano ali brez nje.
Each 60 mL bottle of Rapamune contains 60 mg sirolimus. 
Ena 60 ml steklenica zdravila Rapamune vsebuje 60 mg sirolimusa.
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). 
Imunosupresija lahko povzroči zvečano dovzetnost za okužbo in možen razvoj limfoma in drugih malignih bolezni, še zlasti kožnih (glejte poglavje 4.8).
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). 
Sledi odmerjanje po 2 mg enkrat na dan, dokler niso na voljo rezultati terapevtskega spremljanja zdravila (glejte Terapevtsko spremljanje koncentracije zdravila in prilagajanje odmerka).
Co-administration of sirolimus and rifampicin is not recommended (see section 4.4). 
Sočasna uporaba sirolimusa in rifampicina ni priporočljiva (glejte poglavje 4.4).
The incidence of biopsy confirmed acute rejection was higher (p=0.020*) for patients in the sirolimus group (11, 8.4%) compared to the tacrolimus group (2, 1.6%) through 2 years; most rejections were mild in severity (8 of 9 [89%] T-cell BCAR, 2 of 4 [50%] antibody mediated BCAR) in the sirolimus group. 
Incidenca z biopsijo potrjene akutne zavrnitve je bila v obdobju 2 let večja (p = 0,020*) pri bolnikih v skupini s sirolimusom (11; 8,4 %) v primerjavi s skupino s takrolimusom (2; 1,6 %).
Partly reversible reductions in sperm counts were reported in a 13-week rat study. 
Po 13-tedenski študiji na podganah so opazili delno reverzibilno zmanjšanje števila semenčic.
60 mL oral solution. 
60 ml peroralne raztopine
EU/1/01/171/009 30 tablets EU/1/01/171/010 100 tablets 
EU/1/01/171/009 30 tablet EU/1/01/171/010 100 tablet
Your dose will be adjusted depending on the level of Rapamune in your blood. 
Odmerek zdravila bo morda spremenil glede na koncentracijo zdravila v vaši krvi.
EU/1/01/171/007 30 tablets EU/1/01/171/008 100 tablets 
EU/1/01/171/007 30 tablet EU/1/01/171/008 100 tablet
Single-dose sirolimus did not affect the pharmacokinetics of ciclosporin (microemulsion) in healthy volunteers when administered simultaneously or 4 hours apart. 
Enkratni odmerek sirolimusa, dan zdravim prostovoljcem sočasno ali v razmaku 4 ur, ni spremenil farmakokinetike ciklosporina (mikroemulzije).
The rate and extent of sirolimus absorption was significantly increased by ciclosporin A (CsA). 
Ciklosporin A (CsA) je močno zvečal hitrost in obseg absorpcije sirolimusa.
Several assay methodologies have been used to measure the whole blood concentrations of sirolimus. 
Za merjenje koncentracij sirolimusa v polni krvi so uporabljali več metod.
See package leaflet for further information. 
Za nadaljnje informacije glejte priloženo navodilo za uporabo.
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).
Posterior reversible encephalopathy syndrome (PRES), a serious nervous system syndrome that has the following symptoms: headache, nausea, vomiting, confusion, seizures, and visual loss. 
Neznano: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti sindrom posteriorne reverzibilne encefalopatije (PRES), resen sindrom živčnega sistema, ki se kaže z naslednjimi simptomi: glavobol, slabost (navzea), bruhanje, zmedenost, epileptični krči in izguba vida.
The Rapamune dose should then be individualised to obtain whole blood trough levels of 4 to 12 ng/mL (chromatographic assay). 
Odmerek zdravila Rapamune je treba nato individualno prilagoditi tako, da so najmanjše koncentracije učinkovine v stanju dinamičnega ravnovesja v polni krvi med 4 in 12 ng/ml (kromatografska metoda).
Cases of Pneumocystis carinii pneumonia have been reported in renal transplant patients not receiving antimicrobial prophylaxis. 
Pri bolnikih s presadki ledvic, ki niso prejemali protimikrobne profilakse, so poročali o primerih pljučnice, povzročene s Pneumocystis carinii.
Each coated tablet contains 0.5 mg sirolimus. 
Ena obložena tableta vsebuje 0,5 mg sirolimusa.
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. 
Bolnike z majhnim do zmernim imunološkim tveganjem, vključno z bolniki z alogenim ledvičnim presadkom umrlega ali živega darovalca, so vključili v študijo III. faze ukinitve ciklosporina vzdrževalnega zdravljenja z zdravilom Rapamune.
Reporting of side effects 
Poročanje oneželenih učinkih
The incidence of any adverse reaction(s) may increase as the trough sirolimus level increases. 
Incidenca kateregakoli neželenega učinka se lahko zveča z zvečanjem najnižje koncentracije sirolimusa.
Co-administration of sirolimus and ketoconazole is not recommended (see section 4.4). 
Sočasna uporaba sirolimusa in ketokonazola ni priporočljiva (glejte poglavje 4.4).
Lung and liver transplant populations 
Populacija s presadki pljuč in jeter
Polysorbate 80 (E433) and phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids, and ascorbyl palmitate). 
Druge sestavine zdravila so: polisorbat 80 (E433) in phosal 50 PG (fosfatidilholin, propilenglikol [E1520], mono- in digliceridi, etanol, maščobne kisline iz soje in askorbilpalmitat).
The Cmax, tmax, and AUC of plasma erythromycin base were increased 1.6-fold, 1.3-fold, and 1.7-fold, respectively. 
Vrednosti Cmax, tmax in AUC eritromicina v plazmi so se povečale za 1,6-krat, 1,3-krat in 1,7-krat.
In some cases, ovarian cysts and these menstrual disorders have resolved upon discontinuation of Rapamune. 
V nekaterih primerih so po prenehanju jemanja zdravila Rapamune ovarijske ciste in motnje menstrualnega cikla izzvenele.
Rapamune 1 mg coated tablets 3 years. 
Rapamune 1 mg obložene tablete 3 leta
Reductions in testicular weights and/or histological lesions (e.g. tubular atrophy and tubular giant cells) were observed in rats and in a monkey study. 
Pri podganah in v študiji na opicah so opazili zmanjšanje mase testisov in/ali histološke spremembe (npr. tubularna atrofija in pojav tubularnih celic velikank).
Rapamune should be taken consistently, either with or without food. 
Zdravilo Rapamune vedno jemljite enako, bodisi s hrano bodisi brez nje.
Then place the capped dosing syringe in the carrying case provided. 
Zaščiteno napolnjeno brizgo nato položite v priloženo škatlo za hranjenje odmerne brizge.
Very common: may affect more than 1 in 10 people 
Pogosti:pojavijo se lahko pri največ 1 od 10 bolnikov okužbe (vključno z življenjsko ogrožajočimiokužbami),
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. 
Pri bolnikih, zdravljenih z imunosupresivi, vključno z zdravilom Rapamune, so poročali o primerih nefropatije, povezane z virusom BK, in o primerih progresivne multifokalne levkoencefalopatije (PML), povezane z virusom JC.
After dilution (see section 6.6), the preparation should be used immediately. 
Po redčenju je treba zdravilo uporabiti takoj (glejte poglavje 6.6).
(1) in patients with hepatic impairment (2) when inducers or inhibitors of CYP3A4 are concurrently administered and after their discontinuation (see section 4.5) and/or (3) if ciclosporin dosing is markedly reduced or discontinued, as these populations are most likely to have special dosing requirements. 
in/ali (3) če odmerjanje ciklosporina znatno zmanjšamo ali prekinemo, ker so pri teh bolnikih posebne zahteve glede odmerjanja najverjetnejše.
Seven major metabolites, including hydroxyl, demethyl, and hydroxydemethyl, are identifiable in whole blood. 
V krvi so opredelili sedem pomembnejših presnovkov, med njimi hidroksilno, demetilno in hidroksidemetilno obliko.
Each coated tablet contains 2 mg sirolimus. 
Ena obložena tableta vsebuje 2 mg sirolimusa.
Rapamune 2 mg coated tablets 3 years. 
Rapamune 2 mg obložene tablete 3 leta
Grapefruit juice affects CYP3A4-mediated metabolism and must, therefore, be avoided. 
Sok grenivke vpliva na presnovo, povezano z izoencimom CYP3A4, zato se je treba njegovi uporabi med zdravljenjem izogibati.
Pericardial effusion 
peroralna raztopina
Each coated tablet contains 1 mg sirolimus. 
Ena obložena tableta vsebuje 1 mg sirolimusa.
Rapamune 1 mg/mL oral solution sirolimus 
Rapamune 1 mg/ml peroralna raztopina sirolimus
It helps to control your body's immune system after you have received a kidney transplant. 
Po presaditvi ledvice pomaga nadzorovati vaš imunski sistem.
Each Rapamune 0.5 mg coated tablet contains 0.5 mg of sirolimus. 
Rapamune 0,5 mg: ena obložena tableta vsebuje 0,5 mg sirolimusa.
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 zaviralcem kalcinevrina lahko poveča tveganje za hemolitičnouremični sindrom/trombotično trombocitopenično purpuro/trombotično mikroangiopatijo (HUS/TTP/TMA), izzvanimi z zaviralcem kalcinevrina.
Impairments of sperm parameters have been observed among some patients treated with Rapamune. 
Pri nekaterih bolnikih, zdravljenih z zdravilom Rapamune, so ugotovili poslabšanje parametrov semenčic.
Whole blood sirolimus Cmax, tmax, and AUC were increased 4.4-fold, 1.4-fold, and 4.2-fold, respectively. 
Vrednosti Cmax, tmax in AUC sirolimusa v polni krvi so se povečale za 4,4-krat, 1,4-krat oziroma 4,2-krat.
Each Rapamune 2 mg coated tablet contains 2 mg of sirolimus. 
Rapamune 2 mg: ena obložena tableta vsebuje 2 mg sirolimusa.
Verapamil (CYP3A4 inhibitor) 
Verapamil (zaviralec CYP3A4)
Increased rates of biopsy confirmed acute rejection (BCAR) in renal transplant patients have been observed with concomitant use of sirolimus with ACE inhibitors (see section 5.1). 
Pri sočasni uporabi sirolimusa in zaviralcev ACE so pri bolnikih s presadki ledvic opazili večji delež z biopsijo potrjene akutne zavrnitve (BCAR - Biopsy Confirmed Acute Rejection) (glejte poglavje 5.1).
Hepatic impairment 
Maligne bolezni
Blood creatinine increased *See section below. 
Preiskave zvišanje laktatdehidrogenaze v krvi, zvišanje kreatinina v krvi *Glejte nadaljevanje.
Rapamune 1 mg/mL oral solution: 
Rapamune 1 mg/ml peroralna raztopina:
The Rapamune group failed to demonstrate superiority to the control group in terms of the first occurrence of biopsy confirmed acute rejection, graft loss, or death. 
Glede prvega pojava z biopsijo potrjene akutne zavrnitve presadka, izgube presadka ali smrti za skupino z zdravilom Rapamune niso uspeli dokazati superiornosti v primerjavi s kontrolno skupino.
Ciclosporin (CYP3A4 substrate) 
Ciklosporin (substrat za CYP3A4)
Sirolimus Cmax, tmax, and AUC were increased 1.4-fold, 1.3-fold, and 1.6-fold, respectively. 
Vrednosti Cmax, tmax in AUC sirolimusa so se povečale za 1,4-krat, 1,3-krat oziroma 1,6-krat.
Each mL of Rapamune contains 1 mg sirolimus. 
1 ml zdravila Rapamune vsebuje 1 mg sirolimusa.
Oral solution 60 mL bottle 
peroralna raztopina 60 ml steklenica
Each Rapamune 1 mg coated tablet contains 1 mg of sirolimus. 
Rapamune 1 mg: ena obložena tableta vsebuje 1 mg sirolimusa.
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. 
V 13 raziskovalnih centrih v Združenih državah, Kanadi in na Japonskem so v študijo vključili 89 bolnikov, od katerih jih je S-LAM imelo 81, ki so jih randomizirali tako, da je 39 bolnikov s SLAM prejemalo placebo in 42 bolnikov zdravilo Rapamune.
Diltiazem (CYP3A4 inhibitor) 
Diltiazem (zaviralec CYP3A4)
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. 
Bolnike, ki prejemajo zdravilo Rapamune, je treba z laboratorijskimi testi spremljati glede pojava hiperlipidemije.
Rare reports of fatal hepatic necrosis have been reported with elevated trough sirolimus levels. 
Ob zvečani najmanjši koncentraciji sirolimusa so poročali o redkih primerih nekroze jeter s smrtnim izidom.
Infectious diarrhoea with Clostridium difficile 
Srčne bolezni tahikardija perikardialni izliv
MARKETING AUTHORISATION NUMBER(S) Rapamune 0.5 mg coated tablets EU/1/01/171/013-14 
Rapamune 0,5 mg obložene tablete EU/1/01/171/013-014
Renal function should be monitored during concomitant administration of Rapamune and ciclosporin. 
Med sočasno uporabo zdravila Rapamune in ciklosporina je treba spremljati delovanje ledvic.
Whole blood sirolimus Cmax, tmax, and AUC were increased 2.3-fold, 1.1-fold, and 2.2-fold, respectively. 
Vrednosti Cmax, tmax in AUC sirolimusa v polni krvi so se povečale za 2,3-krat, 1,1-krat oziroma 2,2-krat.
Co-administration of sirolimus and voriconazole is not recommended (see section 4.4). 
Sočasna uporaba sirolimusa in vorikonazola ni priporočljiva (glejte poglavje 4.4).
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. 
Podatki iz medicinske literature kažejo, da je lahko tveganje za nenormalno celjenje ran večje pri bolnikih, ki imajo indeks telesne mase (ITM) večji od 30 kg/m
Cancer of the lymph tissue (lymphoma/post-transplant lympho-proliferative disorder), combined lowering of red blood cells, white blood cells and blood platelets Bleeding from the lung 
nemelanomski kožni rak* limfom*, maligni melanom*, potransplantacijska limfoproliferativ na motnja nevroendokrini karcinom kože*
Voriconazole (CYP3A4 inhibitor) 
Vorikonazol (zaviralec CYP3A4)
Rapamune 0.5 mg is supplied to you as tan-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 0.5 mg” on one side. 
Zdravilo Rapamune 0,5 mg so rumenorjave trikotne obložene tablete, ki so na eni strani označene z "RAPAMUNE 0,5 mg".
Venous thrombosis (including deep vein thrombosis) 
Žilne bolezni hipertenzija, limfokela venska tromboza (vključno z globoko vensko trombozo)
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. 
Pri bolnikih z de novo presajenimi pljuči, ki so uporabljali sirolimus kot del imunosupresivnega zdravljenja so poročali o primerih dehiscence bronhialnih anastomoz, ki so bili večinoma smrtni.
Neutropaenia 
Odmerjanje
Rapamune 2 mg is supplied to you as yellow to beige-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 2 mg” on one side. 
Zdravilo Rapamune 2 mg so rumene do bež trikotne obložene tablete, ki so na eni strani označene z "RAPAMUNE 2 mg".
Protein in the urine, occasionally severe and associated with side effects, such as swelling Scarring in the kidney that may reduce kidney function Too much fluid collecting in the tissues due to irregular lymph function Low blood platelets, with or without rash (thrombocytopaenic purpura) Serious allergic reactions that can cause peeling of the skin Tuberculosis 
Občasni:pojavijo se lahko pri največ 1 od 100 bolnikov rak limfnega tkiva (limfom/popresaditveni limfoproliferativni sindrom), kombinirano zmanjšanještevilardečih inbelih krvničk terkrvnihploščic, krvavitev iz pljuč, beljakovine v urinu,ki jih je včasih veliko, kar je povezanoz neželenimi učinki, na primer otekanjem, brazgotinjenjeledvic, ki lahko zmanjšadelovanje ledvic, prekomerno zastajanje tekočine v tkivih zaradi motenega odtoka limfe, nizka raven krvnih ploščicz izpuščajem ali brez njega(trombocitopenična purpura), resne alergijske reakcije, ki lahko povzročijo luščenje kože, tuberkuloza, okužba z virusom Epstein-Barr, infekcijska driska zaradi bakterije Clostridium difficile, resna okvara jeter.
Each tablet contains 86.4 mg of lactose monohydrate and 214.4 mg of sucrose. 
Rapamune 2 mg obložene tablete Ena tableta vsebuje 86,4 mg laktoze monohidrata in 214,4 mg saharoze.
Erythromycin (CYP3A4 inhibitor) 
Eritromicin (zaviralec CYP3A4)
Rapamune 1 mg is supplied to you as white-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 1 mg” on one side. 
Rapamune 1 mg obložene tablete bela trikotna obložena tableta, na eni strani označena z “RAPAMUNE 1 mg”
Also, when switching between different tablet strengths, verification of trough concentrations is recommended. 
Preverjanje najmanjše koncentracije sirolimusa v krvi je priporočljivo tudi ob prehodu na drugo jakost tablet.
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja izpuščaj, akne eksfoliativni dermatitis preobčutljivostni vaskulitis
How to store Rapamune 
Shranjevanje zdravila Rapamune
Each tablet contains 86.4 mg of lactose monohydrate and 215.7 mg of sucrose. 
Rapamune 0,5 mg obložene tablete Ena tableta vsebuje 86,4 mg laktoze monohidrata in 215,7 mg saharoze.
Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of sucrose. 
Rapamune 1 mg obložene tablete Ena tableta vsebuje 86,4 mg laktoze monohidrata in 215,8 mg saharoze.
Your doctor will need to perform blood tests to measure Rapamune concentrations. 
Za določitev koncentracije zdravila Rapamune vas bo zdravnik napotil na krvne preiskave.
With the plunger fully depressed, insert one of the dosing syringes into the opening in the adapter. 
Vzemite odmerno brizgo in jo namestite v odprtino nastavka.
4.1 ng/mL (14 to 24 ng/mL) and 8.2  4.2 mg (3.6 to 13.6 mg), respectively (see section 4.2). 
Vzdrževalno zdravljenje: Od 3. do 12. meseca po ukinitvi ciklosporina so bile pri bolnikih srednje vrednosti (10., 90. percentil) najmanjših koncentracij sirolimusa (izražene kot vrednosti kromatogafskega preskusa) 19 ± 4,1 ng/ml (od 14 do 24 ng/ml), dnevnih odmerkov pa 8,2 ± 4,2 mg (od 3,6 do 13,6 mg) (glejte poglavje 4.2).