natgillin/translations-raw huggingface dataset:
It is important to follow the instructions to drink Rapamune oral solution at once when a plastic container is used for the dilution and/or administration (see section 6.6).
Kadar za redčenje in/ali dajanje uporabljamo plastični vsebnik, je treba celotno vsebino popiti takoj, skladno z navodilom za uporabo zdravila Rapamune peroralne raztopine (glejte poglavje 6.6).
The risk/benefit should be considered in patients with established hyperlipidaemia before initiating an immunosuppressive regimen, including Rapamune.
Pri bolnikih z ugotovljeno hiperlipidemijo je treba pred začetkom zdravljenja z zaviralci imunske odzivnosti, vključno z zdravilom Rapamune, pretehtati razmerje med koristjo in tveganjem.
In renal transplant patients with delayed graft function, sirolimus may delay recovery of renal function.
Pri bolnikih s presadki ledvic z zakasnelim delovanjem presadka lahko sirolimus zapozni okrevanje ledvičnega delovanja.
BOTTLE LABEL: 60 mL BOTTLE
NALEPKA ZA STEKLENICO: 60 ml STEKLENICA
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 total cholesterol), and urinary tract infections (see section 4.8).
Uporaba zdravila Rapamune sočasno z zaviralci kalcinevrina in kortikosteroidi je bila povezana z zvečanim tveganjem za poslabšanje ledvične funkcije, nenormalne izvide serumskih lipidov (med drugim zvišane trigliceride in celotni holesterol) in okužbe sečil (glejte poglavje 4.8).
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).
Pri bolnikih s presadki ledvic z velikim imunološkim tveganjem zdravila Rapamune niso zadostno proučili, zato uporaba pri tej skupini bolnikov ni priporočljiva (glejte poglavje 5.1).
Decreased sperm count has been associated with the use of Rapamune and usually returns to normal once treatment is stopped.
Z jemanjem zdravila Rapamune je bilo povezano zmanjšanje števila semenčic, ki se po prekinitvi jemanja zdravila običajno popravi.
Bioavailability has not been determined for tablets after they have been crushed, chewed or split, and therefore this cannot be recommended.
Za zdrobljene, prežvečene ali razdeljene tablete biološke uporabnosti niso ugotavljali, zato tablet ni priporočljivo jemati na tak način.
Following the discontinuation of ciclosporin therapy, a target trough range of 12 to 20 ng/mL (chromatographic assay) is recommended.
Po ukinitvi zdravljenja s ciklosporinom je priporočeni ciljni razpon najmanjših koncentracij v stanju dinamičnega ravnovesja od 12 do 20 ng/ml (kromatografska metoda).
The risk may be increased as the trough sirolimus level increases.
Tveganje se lahko poveča z zvečanjem najmanjše koncentracije sirolimusa.
Whole blood trough sirolimus concentrations, as measured by LC/MS/MS, were significantly correlated (r2=0.85) with AUC,ss.
Korelacija med najmanjšimi koncentracijami sirolimusa v polni krvi (merjenimi z LC/MS/MS) in AUC,ss je bila statistično pomembna (r
In patients with severe hepatic impairment, monitoring should be performed every 5 to 7 days until 3 consecutive trough levels have shown stable concentrations of sirolimus after dose adjustment or after loading dose due to the delay in reaching steady-state because of the prolonged half-life.
Pri bolnikih s hudo okvaro jeter je treba zaradi podaljšanega razpolovnega časa in posledično zakasnjenega dosega stanja dinamičnega ravnovesja, po prilagoditvi odmerka ali polnilnem odmerku pregled opraviti vsakih 5 do 7 dni, dokler 3 zaporedne najmanjše koncentracije ne pokažejo stabilnih koncentracij sirolimusa.
Do not store above 25˚C.
Shranjujte pri temperaturi do 25°C.
Sporadic Lymphangioleiomyomatosis (S-LAM)
Sporadična limfangioleiomiomatoza (S-LAM)
Ciclosporin should be progressively discontinued over 4 to 8 weeks, and the Rapamune dose should be adjusted to obtain whole blood trough levels of 12 to 20 ng/mL (chromatographic assay; see
Ciklosporin je treba ukiniti postopoma v času od 4 do 8 tednov, odmerke zdravila Rapamune pa prilagajati tako, da je najmanjša koncentracija v stanju dinamičnega ravnovesja v polni krvi med 12 in 20 ng/ml (kromatografska metoda, glejte poglavje Terapevtsko spremljanje koncentracije zdravila in prilagajanje odmerka).
Similarly the risk/benefit of continued Rapamune therapy should be re-evaluated in patients with severe refractory hyperlipidaemia.
Podobno je treba pri bolnikih s hudo trdovratno hiperlipidemijo ponovno pretehtati razmerje med koristjo in tveganjem nadaljnjega zdravljenja z zdravilom Rapamune.
Patients with sporadic lymphangioleiomyomatosis (S-LAM)
Bolniki s sporadično limfangioleiomiomatozo (S-LAM)
The rate at which the dose of sirolimus is increased should correspond to the rate of ciclosporin elimination.
Hitrost zvečevanja odmerka sirolimusa naj ustreza hitrosti zmanjševanja odmerka oziroma ukinitve ciklosporina.
Impaired healing following transplant surgery has been reported, including fascial dehiscence, incisional hernia, and anastomotic disruption (e.g., wound, vascular, airway, ureteral, biliary).
Poročali so o slabšem celjenju po presaditveni operaciji, vključno z dehiscenco fascije, postoperativno hernijo in uničenjem anastomoze (npr. rane, žilne, dihalne, ureterne, biliarne).
EXP Date opened
Datum odprtja
Patients can be switched from Rapamune oral solution to the tablet formulation on a mg per mg basis.
Bolniki lahko prehajajo s peroralne raztopine zdravila Rapamune na tablete na podlagi enakega odmerka v miligramih.
INTERMEDIATE CARTON: 60 mL BOTTLE
VMESNA ŠKATLA: 60 ml STEKLENICA
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.
Uporaba zdravila Rapamune sočasno z zaviralci kalcinevrina in kortikosteroidi je bila povezana z zvečanim tveganjem za poslabšanje ledvične funkcije, nenormalne izvide serumskih lipidov (med drugim z zvišanimi trigliceridi in holesterolom) in okužbe sečil.
Maintenance therapy
Vzdrževalno zdravljenje
You must use an effective method of contraception during treatment with Rapamune and for 12 weeks after treatment has stopped.
Med zdravljenjem z zdravilom Rapamune in do 12 tednov po koncu zdravljenja je treba uporabljati učinkovito metodo kontracepcije.
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.