FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant immunosuppressive agents included mycophenolate mofetil, azathioprine, and corticosteroids.
Maltese: Sustanzi immunosoppressivi konkomitanti kienu jinkludu mycophenolate mofetil, azathioprine u kortikosterojdi.
English: Also contains: ethanol, propylene glycol (E1520), soya fatty acids.
Maltese: Fih ukoll: ethanol, propylene glycol (E1520), soya fatty acids.
English: Rapamune oral solution contains soya oil.
Maltese: Rapamune soluzzjoni orali fih iż-żejt tas-sojja.
English: Rapamune 1 mg/mL oral solution:
Maltese: Rapamune 1 mg/mL soluzzjoni orali:
English: Pyelonephritis; Cytomegalovirus infection; Herpes zoster caused by the varicella zoster virus
Maltese: Infezzjoni b'ċitomegaloviru s; Herpes zoster ikkawżat millvirus tal-varicella zoster
English: Sirolimus in combination with other immunosuppressive agents has not been extensively investigated.
Maltese: Sirolimus flimkien ma' mediċini immunosoppressivi oħra ma ġiex investigat estensivament.
English: Maintenance therapy
Maltese: Terapija ta' manteniment
English: Ovarian cysts and menstrual disorders (including amenorrhoea and menorrhagia) have been reported.
Maltese: Ġew irrapportati ċesti fl-ovarji u disturbi fil-mestruwazzjoni (inkluż amenorrea u menorraġija).
English: Sirolimus is a substrate for both cytochrome P450 IIIA4 (CYP3A4) and P-glycoprotein.
Maltese: Sirolimus huwa substrat kemm għaċ-ċitokromu P450 IIIA4 (CYP3A4) kif ukoll għall-glikoproteina-P.
English: antibiotics or antifungal medicines used to treat infection e.g. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole.
Maltese: xi mediċini immunosoppressanti oħra. antibijotiċi jew mediċini antifungali użati biex jikkuraw infezzjonijiet eż. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole.
English: The pharmacokinetics of sirolimus were similar in various populations, with renal function ranging from normal to absent (dialysis patients).
Maltese: Il-farmakokinetika ta' sirolimus kienet simili f'popolazzjonijiet diversi b'funzjoni renali li tvarja minn normali sa assenti (pazjenti tad-dijalisi).
English: Rapamune should not be taken with grapefruit juice.
Maltese: Tiħux Rapamune mal-meraq tal-grejpfrut.
English: INFORMATION IN BRAILLE Rapamune 1 mg/mL
Maltese: Rapamune 1 mg/mL
English: With concentration-control (target concentrations 5 to 15 ng/mL), the median sirolimus concentration at the end of 12 months of treatment was 6.8 ng/mL (interquartile range 5.9 to 8.9 ng/mL; n=37).
Maltese: B'kontroll tal-konċentrazzjoni (konċentrazzjonijiet filmira 5 sa 15 ng/mL), il-konċentrazzjoni medjana ta' sirolimus fl-aħħar tal-kura ta' 12-il xahar kienet ta' 6.8 ng/mL (medda interkwartili 5.9 sa 8.9 ng/mL; n=37).
English: Rapamune 1 mg coated tablets EU/1/01/171/007-8
Maltese: Rapamune 1 mg pilloli miksija EU/1/01/171/007-8
English: Focal segmental glomerulosclerosis has been reported.
Maltese: Glomerulosklero żi segmentali fokali*
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: INFORMATION IN BRAILLE Rapamune 0.5 mg
Maltese: Rapamune 0.5 mg
English: In 24 healthy volunteers receiving Rapamune tablets with a high-fat meal, Cmax, tmax and AUC showed increases of 65%, 32%, and 23%, respectively.
Maltese: F'24 volontier b'saħħtu li ħadu l-pilloli ta' Rapamune ma' ikla b'kontenut għoli ta' xaħam, Cmax, tmax u AUC urew żidiet ta 65%, 32% u 23% rispettivament.
English: Rapamune oral solution contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Maltese: Rapamune soluzzjoni orali fih polysorbate-80, li hu magħruf li jgħolli r-rata ta' estrazzjoni di-(2ethylhexyl)phthalate (DEHP) minn polyvinyl chloride (PVC).
English: A lower incidence of squamous cell carcinoma of the skin was observed in the sirolimus group (0% vs. 4.9%).
Maltese: Inċidenza iktar baxxa ta' karċinoma ta' ċelloli skwamużi tal-ġilda ġiet osservata fil-grupp ta' sirolimus (0% vs. 4.9%).
English: Sirolimus Cmax, tmax, and AUC were increased 1.4-fold, 1.3-fold, and 1.6-fold, respectively.
Maltese: Sirolimus Cmax, tmax, u AUC żdiedu b'1.4 darbiet, 1.3 darbiet, u 1.6 darbiet, rispettivament.
English: Rare 0 to
Maltese: [VAS-QOL]: -0.
English: EU/1/01/171/013 30 tablets EU/1/01/171/014 100 tablets
Maltese: EU/1/01/171/013 30 pillola EU/1/01/171/014 100 pillola
English: Other medicines and Rapamune
Maltese: Mediċini oħra u Rapamune
English: Pharmacokinetic interactions may be observed with gastrointestinal prokinetic agents, such as cisapride and metoclopramide.
Maltese: Interazzjonijiet farmakokinetiċi jistgħu jiġu osservati b'sustanzi prokinetiċi gastrointestinali, bħal cisapride u metoclopramide.
English: Sirolimus pharmacokinetic parameters following daily doses of 2 mg Rapamune tablets administered in combination with ciclosporin microemulsion (4 hours prior to Rapamune tablets) and corticosteroids in 13 renal transplant patients, based on data collected at months 1 and 3 after transplantation, were: Cmin,ss 7.39  2.18 ng/mL; Cmax,ss 15.0  4.9 ng/mL; tmax,ss 3.46  2.40 hours; AUC,ss 230  67 ng.h/mL; CL/F/WT, 139  63 mL/h/kg (parameters calculated from LC-MS/MS assay results).
Maltese: Il-parametri farmakokinetiċi ta' sirolimus b'dożi ta' 2 mg kuljum ta' pilloli ta' Rapamune li ttieħdu ma' mikroemulsjoni ta' ciclosporin (4 sigħat qabel il-pilloli ta' Rapamune) u kortikosterojdi fi 13-il pazjent li kellhom trapjant renali, bbażata fuq dejta miġbura xahar u tliet xhur wara t-trapjant kienu: Cmin,ss, 7.39 ± 2.18 ng/mL; Cmax,ss, 15.0 ± 4.9 ng/mL; tmax,ss, 3.46 ± 2.40 sigħat; AUCτ,ss, 230 ± 67 ng·siegħa/mL; CL/F/W, 139 ± 63 mL/siegħa/kg (parametri kkalkulati minn riżultati ta' testijiet LC-MS/MS).
English: Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections, and sepsis.
Maltese: Soppressjoni żejda tas-sistema immuni tista' wkoll iżżid is-suxxettibbilità għal infezzjoni, li tinkludi infezzjonijiet opportunistiċi (batterjali, fungali, virali u protozoali), infezzjonijiet fatali, u sepsis.
English: Haemolytic uraemic syndrome;
Maltese: Sindromu uremiku emolitiku;
English: It is recommended that Rapamune be administered 4 hours after ciclosporin (microemulsion).
Maltese: Hu rakkomandat li Rapamune jingħata 4 sigħat wara ciclosporin (mikroemulsjoni).
English: Liver function test abnormal (including alanine aminotransferase increased and aspartate aminotransferase increased)
Maltese: Test tal-funzjoni tal-fwied mhux normali (li jinkludi żieda f'alanine aminotransferase u żieda f'aspartate amino transferase)
English: The rate and extent of sirolimus absorption was significantly increased by ciclosporin A (CsA).
Maltese: Ir-rata u l-grad ta' assorbiment ta' sirolimus żdiedu b'mod sinifikanti minn ciclosporin A (CsA).
English: Cytochrome P450 isozymes
Maltese: Isożimi ta' ċitokrom P450
English: Sporadic Lymphangioleiomyomatosis (S-LAM)
Maltese: Limfanġjolejomijomatożi Sporadika (S-LAM)
English: EU/1/01/171/009 30 tablets EU/1/01/171/010 100 tablets
Maltese: EU/1/01/171/009 30 pillola EU/1/01/171/010 100 pillola
English: The target for trough concentrations was 10-20 ng/mL.
Maltese: Ilmira għall-konċentrazzjonijiet l-aktar baxxi kienet ta' 10-20 ng/mL.
English: EU/1/01/171/007 30 tablets EU/1/01/171/008 100 tablets
Maltese: EU/1/01/171/007 30 pillola EU/1/01/171/008 100 pillola
English: There is limited experience on the use of Rapamune in children and adolescents less than 18 years of age.
Maltese: Hemm esperjenza limitata dwar l-użu ta' Rapamune fi tfal u adolexxenti ta' inqas minn 18-il sena.
English: Rapamune therapy should be optimised with a tapering regimen of steroids and ciclosporin microemulsion.
Maltese: It-terapija ta' Rapamune għandha tilħaq laħjar kundizzjoni bi tnaqqis skont skeda programmata ta' sterojdi u mikroemulsjoni ta' ciclosporin.
English: Hyperlipidaemia (including hypercholesterolaemia);
Maltese: Iperlipidemija (li tinkludi iperkolesterolemi ja);
English: Ciclosporin (CYP3A4 substrate)
Maltese: Ciclosporin (substrat ta' CYP3A4)
English: After dilution (see section 6.6), the preparation should be used immediately.
Maltese: Wara t-taħlita (ara sezzjoni 6.6), il-preparazzjoni għandha tiġi użata minnufih.
English: Each mL contains up to 25 mg of ethanol, approximately 350 mg of propylene glycol (E1520), and 20 mg of soya oil.
Maltese: Kull mL fih sa 25 mg ta' ethanol, madwar 350 mg ta' propylene glycol (E1520), u 20 mg ta' żejt tassojja.
English: No clinically significant pharmacokinetic interaction was observed between sirolimus and any of the following substances: acyclovir, atorvastatin, digoxin, glibenclamide, methylprednisolone, nifedipine, prednisolone, and trimethoprim/sulfamethoxazole.
Maltese: acyclovir, atorvastatin, digoxin, glibenclamide, methlprednisolone, nifedipine, prednisolone, u trimethoprim/sulfamethoxazole.
English: Clear polyvinyl chloride (PVC)/polyethylene (PE)/polychlorotrifluoroethylene (Aclar) aluminium blister packages of 30 and 100 tablets.
Maltese: Pakketti ta' 30 u 100 pillola fil-folji tal-aluminju magħmulin minn polyvinyl chloride ċara (PVC)/polyethylene (PE)/polychlorotrifluoroethylene (Aclar).
English: Seven major metabolites, including hydroxyl, demethyl, and hydroxydemethyl, are identifiable in whole blood.
Maltese: Seba' metaboliti ewlenin, li jinkludu hydroxyl, demethyl, u hydroxydemethyl, ġew identifikati fid-demm sħiħ.
English: See section 4.
Maltese: L04AA10.
English: Oral solution 60 mL bottle
Maltese: Soluzzjoni orali Flixkun ta' 60 mL
English: Abnormal tests of liver function, elevated AST and/or ALT liver enzymes Rash
Maltese: Testijiet tal-funzjoni tal-fwied b'riżultat anormali, livelli għoljin ta' enzimiAST u/jew ALT tal-fwied
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
Maltese: Fis-sistema tal-klassifika tal-organi, ir-reazzjonijiet avversi huma elenkati taħt titli ta' frekwenza (numru ta' pazjenti mistennija li jkollhom ir-reazzjoni), bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Rifampicin increased the clearance of sirolimus by approximately 5.5-fold and decreased AUC and Cmax by approximately 82% and 71%, respectively.
Maltese: Rifampicin żied it-tneħħija ta' sirolimus b'madwar 5.5 darbiet u naqqas AUC u Cmax b'madwar 82% u 71%, rispettivament.
English: Impaired healing*
Maltese: Insuffiċjenza talfwied*
English: The corresponding results for the oral solution in the same clinical study were Cmin,ss 5.40  2.50 ng/mL, Cmax,ss 14.4  5.3 ng/mL, tmax,ss 2.12  0.84 hours, AUC,ss 194  78 ng.h/mL, CL/F/W 173  50 mL/h/kg.
Maltese: Ir-riżultati korrispondenti għal mediċina meħuda bħala soluzzjoni orali fl-istess studju kliniku kienu: Cmin,ss, 5.40 ± 2.50 ng/mL; Cmax,ss, 14.4 ± 5.3 ng/mL; tmax,ss, 2.12 ± 0.84 sigħat;
English: Inducers of CYP3A4 (such as rifampin or rifabutin) increase the metabolism of sirolimus and decrease sirolimus levels.
Maltese: Mediċini li jistimulaw CYP3A4 (bħal rifampin jew rifabutin) iżidu l-metaboliżmu ta' sirolimus u jnaqqsu l-livelli ta' sirolimus.
English: Printing ink (Shellac, Iron Oxide Red, Propylene Glycol [E1520], Concentrated Ammonia Solution, Simethicone)
Maltese: Linka tal-istampar (Shellac, Iron Oxide Aħmar, Propylene Glycol [E1520], Soluzzjoni ta' Ammonja
English: Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued (see sections 4.2 and 5.1).
Maltese: Rapamune jista' jitkompla bħala terapija ta' manteniment flimkien ma' kortikosterojdi, dejjem jekk ilmikroemulsjoni ta' ciclosporin tista' tiġi progressivament imwaqqfa (ara sezzjonijiet 4.2 u 5.1).
English: Plasma S-(-) verapamil Cmax and AUC were both increased 1.5-fold, and tmax was decreased 24%.
Maltese: Cmax u AUC ta' S-(-) verapamil fil-plażma it-tnejn żdiedu b'1.5 darbiet, u tmax naqset b'24%.
English: The Cmax, tmax, and AUC of plasma erythromycin base were increased 1.6-fold, 1.3-fold, and 1.7-fold, respectively.
Maltese: Cmax, tmax u AUC ta' erythromycin fil-plażma żdiedu b'1.6 darbiet, b'1.3 darbiet, u b'1.7 darbiet rispettivament.
English: Not known: frequency cannot be estimated from the available data
Maltese: Mhux magħruf:il-frekwenza ma tistax tiġi stmata mid-data disponibbli
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, telaprevir), nicardipine, bromocriptine, cimetidine, and danazol.
Maltese: Inibituri bħal dawn jinkludu ċerti antifungali (eż. clotrimazole, fluconazole; itraconazole, voriconazole), ċerti antibijotiċi (eż. troleandomycin, telithromycin, clarithromycin), ċerti inibituri talprotease (eż. ritonavir, indinavir, boceprevir, telaprevir), nicardipine, bromocriptine, cimetidine, u danazol.
English: More patients converted to sirolimus developed new onset diabetes mellitus defined as 30 days or longer of continuous or at least 25 days non-stop (without gap) use of any diabetic treatment after randomisation, a fasting glucose ≥126 mg/dL or a non-fasting glucose ≥200 mg/dL after randomisation (18.3% vs. 5.6%, p=0.025*).
Maltese: Aktar pazjenti li nqelbu għal sirolimus żviluppaw diabetes mellitus b'feġġa ġdida, definita bħala 30 jum jew aktar ta' użu kontinwu jew għallinqas 25 jum bla waqfien (mingħajr interruzzjoni) ta' kwalunkwe kura kontra d-dijabete wara r-randomizzazzjoni, glucose ta' sawma ≥126 mg/dL jew glucose mhux ta' sawma ≥200 mg/dL wara randomizzazzjoni (18.3% vs. 5.6%, p=0.025*).
English: In severe hepatically impaired patients (Child-Pugh classification C), mean values for sirolimus AUC and t1/2 were increased 210% and 170%, respectively, and CL/F was decreased by 67% compared to normal healthy subjects.
Maltese: F'pazjenti b'indeboliment epatiku sever (klassifikazzjoni Child-Pugh C), il-valuri medji għal AUC u t1/2 għal sirolimus żdiedu b'210% u 170% rispettivament, u CL/F tnaqqas b'67% meta mqabbel ma' individwi b'saħħithom normali.
English: INFORMATION IN BRAILLE Rapamune 2 mg
Maltese: Rapamune 2 mg
English: 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
Maltese: Proteina fl-awrina, li kultant tkunsevera u assoċjata ma' effetti sekondarji, bħal nefħa Ċikatriċi fil-kliewi, li tista' tnaqqas il-funzjoni tal-kliewi Wisq fluwidu jakkumulafit-tessut minħabba funzjoni irregolari tal-limfa Livell baxx ta' plejtlits fid-demm, bi jew mingħajr raxx (pupura tromboċitopenika) Reazzjonijiet allerġiċi serji li jistgħu jikkawżaw tqaxxir tal-ġilda Tuberkulożi
English: Rapamune 1 mg coated tablets 3 years.
Maltese: Rapamune 1 mg pilloli miksija 3 snin.
English: There were more adverse events (99.2% vs. 91.1%, p=0.002*) and more discontinuations from the treatment due to adverse events (26.7% vs. 4.1%, p<0.001*) in the group converted to sirolimus compared to the tacrolimus group.
Maltese: 91.1%, p=0.002*) u aktar twaqqif mill-kura minħabba episodji avversi (26.7% vs. 4.1%, p<0.
English: Investigations Blood lactate dehydrogenase increased;
Maltese: Żieda fil-lactate dehydrogenase fid-demm;
English: Rifampicin (CYP3A4 inducer)
Maltese: Rifampicin (stimulatur ta' CYP3A4)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 March 2001
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' Marzu 2001
English: The mean calculated glomerular filtration rate (GFR) at 12, 24, 36, 48 and 60 months was significantly higher for patients receiving Rapamune following ciclosporin elimination than for those in the Rapamune with ciclosporin therapy group.
Maltese: Ir-rata medja kkalkulata ta' filtrazzjoni glomerulari (GFR) fi 12, 24, 36, 48 u 60 xahar kienet sinifikament ogħla għal pazjenti li jirċievu Rapamune wara l-eliminazzjoni ta' ciclosporin minn dawk fil-grupp tat-terapija ta' Rapamune ma' ciclosporin.
English: After a single dose of [14C] sirolimus in healthy volunteers, the majority (91.1%) of radioactivity was recovered from the faeces, and only a minor amount (2.2%) was excreted in urine.
Maltese: C] sirolimus f'voluntiera b'saħħithom, ilparti l-kbira (91.1%) ta' radjoattività ġiet irkuprata fl-ippurgar, u ammont minuri biss (2.2%) ġie eliminat fl-awrina.
English: Based on information from subsequent clinical studies, 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).
Maltese: Minn informazzjoni miġbura minn studji kliniċi sussegwenti, l-użu ta' Rapamune, mycophenolate mofetil u kortikosterojdi, flimkien mal-induzzjoni minn antikorpi ta' riċetturi IL-2 (IL2R Ab), mhuwiex rakkomandat fl-ambjent ta' trapjanti renali de novo (ara sezzjoni 5.1).
English: anti-epileptic medicines including carbamazepine, phenobarbital, phenytoin.
Maltese: John's Wort (Hypericum perforatum), antikonvulsivi: caramazepine, phenobarbital, phenytoin).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Sirolimus is also a substrate for the multidrug efflux pump, P-glycoprotein (P-gp) located in the small intestine.
Maltese: Sirolimus huwa wkoll substrat għall-pompa tal-effluss ta' mediċini differenti, P-glikoproteina (P-gp) li tinsab fil-musrana ż-żgħira.
English: The terminal half-life in stable renal transplant patients after multiple oral doses was 62  16 hours.
Maltese: Il-half life terminali wara dożi orali multipli f'pazjenti stabbli bi trapjant renali kienet ta' 6216-il siegħa.
English: Oedema;
Maltese: Edema;
English: A 6 mg loading dose contains up to 150 mg of alcohol which is equivalent to 3.80 mL beer or 1.58 mL wine.
Maltese: Doża għolja tal-bidu ta' 6 mg fiha sa 150 mg ta' alkoħol li hu ekwivalenti għal 3.80 mL ta' birra jew 1.58 mL ta' nbid.
English: Each 60 mL bottle contains 60 mg sirolimus.
Maltese: Kull flixkun ta' 60 mL fih 60 mg ta' sirolimus.
English: These effects have been reversible upon discontinuation of Rapamune in most cases (see section 5.3).
Maltese: F'ħafna każijiet dawn l-effetti kienu riversibbli malli twaqqaf Rapamune (ara sezzjoni 5.3).
English: MARKETING AUTHORISATION NUMBER(S) Rapamune 0.5 mg coated tablets EU/1/01/171/013-14
Maltese: Rapamune 0.5 mg pilloli miksija EU/1/01/171/013-14
English: In mild and moderate hepatically impaired patients (Child-Pugh classification A or B), mean values for sirolimus AUC and t1/2 were increased 61% and 43%, respectively, and CL/F was decreased 33% compared to normal healthy subjects.
Maltese: F'pazjenti b'indeboliment epatiku minn ħafif għal moderat (klassifikazzjoni Child-Pugh A jew B), ilvaluri medji għal AUC u t1/2 ta' sirolimus żdiedu b'61% u b'43% rispettivament, u CL/F kien imnaqqas b'33% meta mqabbel ma' individwi normali b'saħħithom.
English: Very common
Maltese: Rari sa
English: Rapamune contains 86.4 mg of lactose and up to 215.8 mg of sucrose.
Maltese: Rapamune fih 86.4 mg ta' lactose u sa 215.8 mg ta' sucrose.
English: In an open-label, randomised, comparative, multi-centre study where renal transplant patients were either converted from tacrolimus to sirolimus 3 to 5 months post-transplant or remained on tacrolimus, there was no significant difference in renal function at 2 years.
Maltese: Fi studju multiċentriku, bit-tikketta mikxufa, randomizzat, komparattiv fejn pazjenti bi trapjant talkliewi jew inqelbu minn tacrolimus għal sirolimus 3 sa 5 xhur wara t-trapjant jew baqgħu fuq tacrolimus, ma kien hemm ebda differenza sinifikanti fil-funzjoni renali wara sentejn.
English: EXPIRY DATE
Maltese: Data meta nfetaħ
English: Whole blood sirolimus levels should be closely monitored in the following populations:
Maltese: Istruzzjonijiet għall-użu u manipulazzjoni:
English: INFORMATION IN BRAILLE Rapamune 1 mg
Maltese: Rapamune 1 mg
English: Rapamune 0.5 mg coated tablets sirolimus
Maltese: Rapamune 0.5 mg pilloli sirolimus
English: Subjects were to receive Rapamune (sirolimus target concentrations of 5 to 15 ng/mL) in combination with a calcineurin inhibitor and corticosteroids or to receive calcineurin-inhibitor-based immunosuppression without Rapamune.
Maltese: L-individwi kellhom jirċievu Rapamune (konċentrazzjonijiet fil-mira ta' sirolimus ta' bejn 5 sa 15 ng/mL) flimkien ma' impeditur ta' calcineurin u kortikosterojdi jew inkella jirċievu immunosoppressjoni bbażata fuq impeditur ta' calcineurin mingħajr Rapamune.
English: The systemic availability of sirolimus in combination with simultaneously administered ciclosporin (Sandimune) is approximately 14%.
Maltese: Id-disponibilità sistemika ta' sirolimus f'kumbinazzjoni ma' ciclosporin (Sandimune) mogħti fl-istess ħin hija ta' madwar 14%.
English: Co-administration of sirolimus and voriconazole is not recommended (see section 4.4).
Maltese: Mhux rakkomandat li sirolimus u voriconazole jingħataw flimkien (ara sezzjoni 4.4).
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).
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati (li jiġru f'>10% tal-pazjenti) huma tromboċitopenija, anemija, deni, pressjoni għolja, ipokalimja, ipofosfatimija, infezzjoni tal-passaġġi urinarji, iperkolesterolemija, ipergliċemija, ipertrigliċeridemija, uġigħ addominali, limfoċele, edema periferali, artralġja, akne, dijarea, uġigħ, stitikezza, tqalligħ, uġigħ ta' ras, żieda ta' krejatinina fid-demm u żieda fil-lactate dehydrogenase (LDH) fid-demm.
English: In a randomised, comparative evaluation of ramipril versus placebo for the prevention of proteinuria in kidney transplant patients converted from calcineurin inhibitors to sirolimus, a difference in the number of patients with BCAR through 52 weeks was observed [13 (9.5%) vs. 5 (3.2%), respectively; p=0.073].
Maltese: F'evalwazzjoni każwali, komparattiva ta' ramipril kontra plaċebo għall-prevenzjoni ta' proteinurja f'pazjenti bi trapjant tal-kliewi li qalbu minn inibituri ta' calcineurin għal sirolimus, ġiet osservata differenza fin-numru ta' pazjenti bil-BCAR matul 52 ġimgħa [13 (9.5%) vs. 5 (3.2%), rispettivament; p=0.073].
English: Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets sirolimus
Maltese: Rapamune 0.5 mg pilloli miksija Rapamune 1 mg pilloli miksija Rapamune 2 mg pilloli miksija sirolimus