FrancophonIA/ELRC3.0 huggingface dataset:
English: In hepatically impaired patients, it is recommended that sirolimus whole blood trough levels be closely monitored.
Slovenian: Pri bolnikih z okvaro jeter je priporočljivo skrbno spremljanje najmanjše koncentracije sirolimusa v polni krvi.
English: If diltiazem is administered, sirolimus blood levels should be monitored and a dose adjustment may be necessary.
Slovenian: Pri sočasni uporabi sirolimusa in diltiazema je treba spremljati koncentracije sirolimusa v krvi in po potrebi prilagoditi odmerek.
English: Suggested ciclosporin trough concentration ranges for the first 2-3 months after transplantation are 150-400 ng/mL (monoclonal assay or equivalent technique) (see section 4.5).
Slovenian: Najmanjša koncentracija ciklosporina v stanju dinamičnega ravnovesja v prvih 2 do 3 mesecih po presaditvi naj bo med 150 in 400 ng/ml (monoklonska ali druga enakovredna metoda) (glejte poglavje 4.5).
English: Oral tablet
Slovenian: Peroralne tablete
English: How to take Rapamune
Slovenian: Kako jemati zdravilo Rapamune
English: If you have any liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Rapamune that you receive and may result in your having additional blood tests.
Slovenian: Pred začetkom jemanja zdravila Rapamune se posvetujte zzdravnikom ali farmacevtom: če imate ali ste imeli težave z jetri ali kakšno drugo bolezen, ki bi lahko prizadela vaša jetra.O tem obvestite zdravnika, ker bo morda prilagodil odmerek zdravila Rapamune, ki ga boste prejemali, in vas morda napotil na dodatne krvne preiskave.
English: When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts, with or without rash (thrombocytopaenic purpura/haemolytic uraemic syndrome).
Slovenian: Sočasno jemanje zdravila Rapamune z zdravili, imenovanimi zaviralci kalcinevrina (ciklosporin ali takrolimus), lahko zveča tveganje za okvaro ledvic z zmanjšanjem števila krvnih ploščic in rdečih krvničk, z izpuščajem ali brez njega (trombocitopenična purpura/hemolitično-uremični sindrom).
English: Patients receiving sirolimus should be monitored closely if taking ACE inhibitors concomitantly.
Slovenian: Bolnike, ki sočasno prejemajo sirolimus in zaviralce ACE, je treba skrbno spremljati.
English: Co-administration of sirolimus with strong inhibitors of CYP3A4 or inducers of CYP3A4 is not recommended (see section 4.4).
Slovenian: Sočasna uporaba sirolimusa in močnih zaviralcev ali induktorjev CYP3A4 ni priporočljiva (glejte poglavje 4.4).
English: Cases of interstitial lung disease (including pneumonitis and infrequently bronchiolitis obliterans organising pneumonia (BOOP) and pulmonary fibrosis), some fatal, with no identified infectious aetiology have occurred in patients receiving immunosuppressive regimens including Rapamune.
Slovenian: Pri bolnikih, zdravljenih po imunosupresivni shemi, vključno z zdravilom Rapamune, so se pojavili primeri intersticijske bolezni pljuč (vključno s pnevmonitisom, redko z bronhiolitis obliterans organizirano pljučnico (BOOP - Bronchiolitis Obliterans Organising Pneumonia) in pljučno fibrozo), nekateri s smrtnim izidom, brez identificirane infekcijske etiologije.
English: At present, there is minimal experience with overdose.
Slovenian: Dosedanje izkušnje s prevelikim odmerjanjem so skromne.
English: Kidney Transplant
Slovenian: Presaditev ledvic
English: The most commonly reported adverse reactions (occurring in 10% of patients) are thrombocytopaenia, 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).
Slovenian: Najpogosteje poročani neželeni učinki (pojavili so se pri  10 % bolnikov) so trombocitopenija, anemija, pireksija, hipertenzija, hipokaliemija, hipofosfatemija, okužba sečil, hiperholesterolemija, hiperglikemija, hipertrigliceridemija, bolečine v trebuhu, limfokela, periferni edemi, artralgija, akne, diareja, bolečina, zaprtje, navzea, glavobol, zvišanje kreatinina v krvi in zvišanje laktat-dehidrogenaze (LDH) v krvi.
English: Protein build-up in the air sacs of the lungs that may interfere with breathing Serious allergic reactions that can affect blood vessels (see above paragraph on allergic reactions)
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov kopičenje beljakovin v zračnih mehurčkih pljuč, kar lahko ovira dihanje, resne alergijske reakcije, ki lahko prizadenejo krvne žile (glejte zgornji odstavek o alergijskih reakcijah).
English: Such inhibitors include certain antifungals (e.g. clotrimazole, fluconazole, itraconazole, voriconazole), certain antibiotics (e.g. troleandomycin, telithromycin, clarithromycin), certain protease inhibitors (e.g. ritonavir, indinavir, boceprevir, and telaprevir), nicardipine, bromocriptine, cimetidine, and danazol.
Slovenian: Taki zaviralci so nekateri antimikotiki (npr. klotrimazol, flukonazol, itrakonazol, vorikonazol), nekateri antibiotiki (npr. troleandomicin, telitromicin, klaritromicin), nekateri zaviralci proteaz (npr. ritonavir, indinavir, boceprevir in telaprevir), nikardipin, bromokriptin, cimetidin in danazol.
English: Inform your doctor if you have difficulty taking the oral solution.
Slovenian: Obvestite zdravnika, če imate težave pri jemanju peroralne raztopine.
English: Sirolimus is also a substrate for the multidrug efflux pump, P-glycoprotein (P-gp) located in the small intestine.
Slovenian: Sirolimus je tudi substrat za P-glikoprotein (P-gp), iztočno črpalko za več zdravil, ki se nahaja v tankem črevesu.
English: 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).
Slovenian: 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).
English: The risk/benefit should be considered in patients with established hyperlipidaemia before initiating an immunosuppressive regimen, including Rapamune.
Slovenian: Pri bolnikih z ugotovljeno hiperlipidemijo je treba pred začetkom zdravljenja z zaviralci imunske odzivnosti, vključno z zdravilom Rapamune, pretehtati razmerje med koristjo in tveganjem.
English: In renal transplant patients with delayed graft function, sirolimus may delay recovery of renal function.
Slovenian: Pri bolnikih s presadki ledvic z zakasnelim delovanjem presadka lahko sirolimus zapozni okrevanje ledvičnega delovanja.
English: BOTTLE LABEL: 60 mL BOTTLE
Slovenian: NALEPKA ZA STEKLENICO: 60 ml STEKLENICA
English: The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, serum lipid abnormalities (including, but not limited to, increased serum triglycerides and total cholesterol), and urinary tract infections (see section 4.8).
Slovenian: 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).
English: 4.4 Special warnings and precautions for use Rapamune has not been adequately studied in renal transplant patients at high immunological risk, therefore use is not recommended in this group of patients (see section 5.1).
Slovenian: 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).
English: Decreased sperm count has been associated with the use of Rapamune and usually returns to normal once treatment is stopped.
Slovenian: Z jemanjem zdravila Rapamune je bilo povezano zmanjšanje števila semenčic, ki se po prekinitvi jemanja zdravila običajno popravi.
English: Bioavailability has not been determined for tablets after they have been crushed, chewed or split, and therefore this cannot be recommended.
Slovenian: Za zdrobljene, prežvečene ali razdeljene tablete biološke uporabnosti niso ugotavljali, zato tablet ni priporočljivo jemati na tak način.
English: Following the discontinuation of ciclosporin therapy, a target trough range of 12 to 20 ng/mL (chromatographic assay) is recommended.
Slovenian: Po ukinitvi zdravljenja s ciklosporinom je priporočeni ciljni razpon najmanjših koncentracij v stanju dinamičnega ravnovesja od 12 do 20 ng/ml (kromatografska metoda).
English: The risk may be increased as the trough sirolimus level increases.
Slovenian: Tveganje se lahko poveča z zvečanjem najmanjše koncentracije sirolimusa.
English: Whole blood trough sirolimus concentrations, as measured by LC/MS/MS, were significantly correlated (r2=0.85) with AUC,ss.
Slovenian: Korelacija med najmanjšimi koncentracijami sirolimusa v polni krvi (merjenimi z LC/MS/MS) in AUC,ss je bila statistično pomembna (r
English: 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.
Slovenian: 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.
English: Do not store above 25˚C.
Slovenian: Shranjujte pri temperaturi do 25°C.
English: Sporadic Lymphangioleiomyomatosis (S-LAM)
Slovenian: Sporadična limfangioleiomiomatoza (S-LAM)
English: Rapamune 2 mg coated tablets EU/1/01/171/009-010
Slovenian: Rapamune 2 mg obložene tablete EU/1/01/171/009-010
English: 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
Slovenian: 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).
English: Similarly the risk/benefit of continued Rapamune therapy should be re-evaluated in patients with severe refractory hyperlipidaemia.
Slovenian: Podobno je treba pri bolnikih s hudo trdovratno hiperlipidemijo ponovno pretehtati razmerje med koristjo in tveganjem nadaljnjega zdravljenja z zdravilom Rapamune.
English: Patients with sporadic lymphangioleiomyomatosis (S-LAM)
Slovenian: Bolniki s sporadično limfangioleiomiomatozo (S-LAM)
English: The rate at which the dose of sirolimus is increased should correspond to the rate of ciclosporin elimination.
Slovenian: Hitrost zvečevanja odmerka sirolimusa naj ustreza hitrosti zmanjševanja odmerka oziroma ukinitve ciklosporina.
English: Impaired healing following transplant surgery has been reported, including fascial dehiscence, incisional hernia, and anastomotic disruption (e.g., wound, vascular, airway, ureteral, biliary).
Slovenian: Poročali so o slabšem celjenju po presaditveni operaciji, vključno z dehiscenco fascije, postoperativno hernijo in uničenjem anastomoze (npr. rane, žilne, dihalne, ureterne, biliarne).
English: EXP Date opened
Slovenian: Datum odprtja
English: Patients can be switched from Rapamune oral solution to the tablet formulation on a mg per mg basis.
Slovenian: Bolniki lahko prehajajo s peroralne raztopine zdravila Rapamune na tablete na podlagi enakega odmerka v miligramih.
English: INTERMEDIATE CARTON: 60 mL BOTTLE
Slovenian: VMESNA ŠKATLA: 60 ml STEKLENICA
English: The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, serum lipid abnormalities (including, but not limited to, increased serum triglycerides and cholesterol), and urinary tract infections.
Slovenian: 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.
English: Maintenance therapy
Slovenian: Vzdrževalno zdravljenje
English: You must use an effective method of contraception during treatment with Rapamune and for 12 weeks after treatment has stopped.
Slovenian: Med zdravljenjem z zdravilom Rapamune in do 12 tednov po koncu zdravljenja je treba uporabljati učinkovito metodo kontracepcije.
English: 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).
Slovenian: 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).
English: Phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids and ascorbyl palmitate).
Slovenian: Phosal 50 PG (fosfatidilholin, propilenglikol [E1520], mono- in digliceridi, etanol, maščobne kisline iz soje in askorbilpalmitat).
English: Stomach pain, diarrhoea, constipation, nausea
Slovenian: Bolezni prebavil bolečine v trebuhu, zaprtje, diareja, navzea pankreatitis, stomatitis, ascites
English: Rapamune 0.5 mg coated tablets 2 years.
Slovenian: Rapamune 0,5 mg obložene tablete 2 leti
English: What Rapamune contains
Slovenian: Kaj vsebuje zdravilo Rapamune
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Slovenian: Imetnik dovoljenja za promet z zdravilom: Izdelovalec: Pfizer Europe MA EEIG
English: 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.
Slovenian: 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.
English: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis, have been associated with the administration of sirolimus (see section 4.8).
Slovenian: Uporaba sirolimusa je bila povezana s preobčutljivostnimi reakcijami, med drugim anafilaktičnimi/anafilaktoidnimi reakcijami, angioedemom, eksfoliativnim dermatitisom in preobčutljivostnim vaskulitisom (glejte poglavje 4.8).
English: Grapefruit juice affects CYP3A4-mediated metabolism, and should therefore be avoided.
Slovenian: Sok grenivke vpliva na presnovo sirolimusa preko CYP3A4, zato se mu je treba izogibati.
English: Each 60 mL bottle contains 60 mg sirolimus.
Slovenian: Ena 60 ml steklenica vsebuje 60 mg sirolimusa.
English: Appropriate adjustment of the immunosuppression regimen should be considered in patients with elevated serum creatinine levels.
Slovenian: Pri bolnikih z zvečanimi koncentracijami serumskega kreatinina je treba razmisliti o ustreznem prilagajanju imunosupresijske sheme.
English: Tablet core: lactose monohydrate, macrogol, magnesium stearate, talc Tablet coating: macrogol, glycerol monooleate, pharmaceutical glaze, calcium sulfate, microcrystalline cellulose, sucrose, titanium dioxide, poloxamer 188, -tocopherol, povidone, carnauba wax, Printing ink (Shellac, Iron Oxide Red, Propylene Glycol [E1520], Concentrated Ammonia Solution, Simethicone).
Slovenian: 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).
English: Rapamune contains 86.4 mg of lactose and up to 215.8 mg of sucrose.
Slovenian: Zdravilo Rapamune vsebuje 86,4 mg laktoze in do 215,8 mg saharoze.
English: 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).
Slovenian: 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).
English: In a study evaluating the safety and efficacy of conversion from calcineurin inhibitors to sirolimus (target levels of 12 - 20 ng/mL in maintenance renal transplant patients, enrollment was stopped in the subset of patients (n=90) with a baseline glomerular filtration rate of less than 40 mL/min (see section 5.1).
Slovenian: 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).
English: The bottle should remain in an upright position when withdrawing the solution.
Slovenian: Steklenica naj bo med odvzemom postavljena pokonci.
English: In some cases, the angioedema has resolved upon discontinuation or dose reduction of Rapamune.
Slovenian: V nekaterih primerih je po prekinitvi zdravljenja z zdravilom Rapamune ali zmanjšanju njegovega odmerka angioedem izzvenel.
English: EU/1/01/171/013 30 tablets EU/1/01/171/014 100 tablets
Slovenian: EU/1/01/171/013 30 tablet EU/1/01/171/014 100 tablet
English: Rapamune 1 mg coated tablets EU/1/01/171/007-8
Slovenian: Rapamune 1 mg obložene tablete EU/1/01/171/007-008
English: Menstrual disorder (including amenorrhoea and menorrhagia)
Slovenian: Motnje reprodukcije in dojk motnje menstrualnega cikla (vključno z amenorejo in menoragijo)
English: To minimise variability, Rapamune should consistently be taken either with or without food.
Slovenian: Za zmanjšanje variabilnosti mora bolnik zdravilo Rapamune jemati vedno bodisi s hrano ali brez nje.
English: Each 60 mL bottle of Rapamune contains 60 mg sirolimus.
Slovenian: Ena 60 ml steklenica zdravila Rapamune vsebuje 60 mg sirolimusa.
English: 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).
Slovenian: Imunosupresija lahko povzroči zvečano dovzetnost za okužbo in možen razvoj limfoma in drugih malignih bolezni, še zlasti kožnih (glejte poglavje 4.8).
English: 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).
Slovenian: Sledi odmerjanje po 2 mg enkrat na dan, dokler niso na voljo rezultati terapevtskega spremljanja zdravila (glejte Terapevtsko spremljanje koncentracije zdravila in prilagajanje odmerka).
English: Co-administration of sirolimus and rifampicin is not recommended (see section 4.4).
Slovenian: Sočasna uporaba sirolimusa in rifampicina ni priporočljiva (glejte poglavje 4.4).
English: 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.
Slovenian: 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 %).
English: Partly reversible reductions in sperm counts were reported in a 13-week rat study.
Slovenian: Po 13-tedenski študiji na podganah so opazili delno reverzibilno zmanjšanje števila semenčic.
English: 60 mL oral solution.
Slovenian: 60 ml peroralne raztopine
English: EU/1/01/171/009 30 tablets EU/1/01/171/010 100 tablets
Slovenian: EU/1/01/171/009 30 tablet EU/1/01/171/010 100 tablet
English: Your dose will be adjusted depending on the level of Rapamune in your blood.
Slovenian: Odmerek zdravila bo morda spremenil glede na koncentracijo zdravila v vaši krvi.
English: EU/1/01/171/007 30 tablets EU/1/01/171/008 100 tablets
Slovenian: EU/1/01/171/007 30 tablet EU/1/01/171/008 100 tablet
English: Single-dose sirolimus did not affect the pharmacokinetics of ciclosporin (microemulsion) in healthy volunteers when administered simultaneously or 4 hours apart.
Slovenian: Enkratni odmerek sirolimusa, dan zdravim prostovoljcem sočasno ali v razmaku 4 ur, ni spremenil farmakokinetike ciklosporina (mikroemulzije).
English: The rate and extent of sirolimus absorption was significantly increased by ciclosporin A (CsA).
Slovenian: Ciklosporin A (CsA) je močno zvečal hitrost in obseg absorpcije sirolimusa.
English: Several assay methodologies have been used to measure the whole blood concentrations of sirolimus.
Slovenian: Za merjenje koncentracij sirolimusa v polni krvi so uporabljali več metod.
English: See package leaflet for further information.
Slovenian: Za nadaljnje informacije glejte priloženo navodilo za uporabo.
English: INFORMATION IN BRAILLE Rapamune 1 mg/mL
Slovenian: Rapamune 1 mg/ml
English: There have also been reports of fluid accumulation, including peripheral oedema, lymphoedema, pleural effusion and pericardial effusions (including haemodynamically significant effusions in children and adults) in patients receiving Rapamune.
Slovenian: 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).
English: Posterior reversible encephalopathy syndrome (PRES), a serious nervous system syndrome that has the following symptoms: headache, nausea, vomiting, confusion, seizures, and visual loss.
Slovenian: 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.
English: The Rapamune dose should then be individualised to obtain whole blood trough levels of 4 to 12 ng/mL (chromatographic assay).
Slovenian: 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).
English: Cases of Pneumocystis carinii pneumonia have been reported in renal transplant patients not receiving antimicrobial prophylaxis.
Slovenian: Pri bolnikih s presadki ledvic, ki niso prejemali protimikrobne profilakse, so poročali o primerih pljučnice, povzročene s Pneumocystis carinii.
English: Each coated tablet contains 0.5 mg sirolimus.
Slovenian: Ena obložena tableta vsebuje 0,5 mg sirolimusa.