FrancophonIA/ELRC3.0 huggingface dataset:
English: New onset nephrosis (nephrotic syndrome) was also reported in 2% of the patients in the study (see section 4.8).
Maltese: Il-bidu mill-ġdid ta' nefrosi (sindrome nefrotiku) kien irrappurtat ukoll fi 2% tal-pazjenti fl-istudju (ara sezzjoni 4.8).
English: Rapamune 2 mg coated tablets 3 years.
Maltese: Rapamune 2 mg pilloli miksija 3 snin.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, ta' defiċjenza tal-Lapp lactase jew ta' malassorbiment ta' glucose-galactose, m'għandhomx jieħdu din il-mediċina.
English: In two multi-centre clinical studies, de novo renal transplant patients treated with sirolimus, mycophenolate mofetil (MMF), corticosteroids, and an IL-2 receptor antagonist had significantly higher acute rejection rates and numerically higher death rates compared to patients treated with a calcineurin inhibitor, MMF, corticosteroids, and an IL-2 receptor antagonist (see section 4.4).
Maltese: F'żewġ studji kliniċi multiċentri, pazjenti ta' trapjanti renali de novo kkurati b'sirolimus, mycophenolate mofetil (MMF), kortikosterojdi, u antagonista tar-riċettur IL-2 kellhom rati ta' rifjut akut sinifikament ogħla u rati ta' mwiet numerikament ogħla meta mqabbla ma' pazjenti kkurati b'inibitur ta' calcineurin, MMF, kortikosterojdi u antagonista tar-riċettur IL-2 (ara sezzjoni 4.4).
English: As compared with the placebo group, the sirolimus group had improvement from baseline to 12 months in measures of forced vital capacity (-12±3 vs. 7±3 mL per month, respectively, p<0.001), serum vascular endothelial growth factor D (VEGF-D; -8.6±15.2 vs. -85.3±14.2 pg/mL per month, respectively, p<0.001), and quality of life (Visual Analogue Scale - Quality of Life [VAS-QOL] score: -0.3±0.2 vs. 0.4±0.2 per month, respectively, p=0.022) and functional performance (-0.009±0.005 vs. 0.004±0.004 per month, respectively, p=0.044) in patients with S-LAM.
Maltese: Meta mqabbel mal-grupp tal-plaċebo, il-grupp ta' sirolimus kellu titjib mil-linja bażi għal 12-il xahar f'kejl ta' kapaċità vitali furzata (-12±3 vs. 7±3 mL kull xahar, rispettivament, p<0.001), fattur ta' tkabbir D endoteljati vaskulari fis-seru (VEGF-D; -8.6±15.2 vs. -85.3±14.2 pg/mL kull xahar, rispettivament, p<0.001), u kwalità tal-ħajja (punteġġ ta' Skala Analoga Viżwali - Kwalità tal-Ħajja
English: Hypokalaemia; Hypophosphataemia;
Maltese: Ipofosfatimija;
English: The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients (6-120 months after transplantation) was assessed in a randomised, multicentre, controlled trial, stratified by calculated GFR at baseline (20-40 mL/min vs. above 40 mL/min).
Maltese: Is-sigurtà u l-effikaċja tal-bidla minn inibituri ta' calcineurin għal Rapamune f'pazjenti bi trapjanti renali mantenuti (6-120 xahar wara t-trapjant) kienu assessjati fi prova kkontrollata, każwali, multiċentri, stratifikata skont il-GFR ikkalkulat fil-linja bażi (20-40 mL/min kontra iktar minn 40 mL/min).
English: Initial therapy (2 to 3 months post-transplantation)
Maltese: Terapija inizjali (2 sa 3 xhur wara t-trapjant):
English: Sirolimus trough concentration data in 35 renal transplant patients above 65 years of age were similar to those in the adult population (n=822) from 18 to 65 years of age.
Maltese: It-tagħrif dwar l-aktar konċentrazzjoni baxxa ta' sirolimus minn 35 pazjent bi trapjant renali li għandhom iżjed minn 65 sena kien simili għal dak fil-popolazzjoni adulta (n=822) ta' bejn 18 sa 65 sena.
English: Urinary tract infection
Maltese: Tromboċitopenija Anemija
English: Although sirolimus inhibits human liver microsomal cytochrome P450 CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 in vitro, the active substance is not expected to inhibit the activity of these isozymes in vivo since the sirolimus concentrations necessary to produce inhibition are much higher than those observed in patients receiving therapeutic doses of Rapamune.
Maltese: Għalkemm sirolimus in vitro jinibixxi ċ-ċitokromu mikrosomali tal-fwied uman P450 CYP2C9, CYP2C19, CYP2D6, u CYP3A4/5, madankollu s-sustanza attiva mhix mistennija li tfixkel l-attività ta' dawn l-isoenzimi in vivo, għax il-konċentrazzjonijiet ta' sirolimus neċessarji biex jikkawżaw inibizzjoni huma ħafna aktar għoljin minn dawk osservati f'pazjenti li jirċievu dożi terapewtiċi ta' Rapamune.
English: The blood to plasma ratio (B/P) of 36 indicates that sirolimus is extensively partitioned into formed blood elements.
Maltese: Il-proporzjon fid-demm mal-plażma (B/P) ta' 36 jindika li sirolimus huwa mqassam estensivament ġol-elementi ffurmati tad-demm.
English: In rat, testicular interstitial cell adenomas were likely indicative of a species-dependent response to lutenising hormone levels and are usually considered of limited clinical relevance.
Maltese: Fil-firien, adenomi fiċ-ċelluli interstizjali testikolari kienu probabbilment indikattivi ta' reazzjoni dipendenti fuq l-ispeċi għal-livelli ta' ormon lewtenizzanti.
English: 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).
Maltese: L-użu fl-istess ħin ta' Rapamune ma' inibitur ta' calcineurin jista' jżid ir-riskju ta' sindrome uremiku emolitiku/purpura tromboċitopenika trombotika/mikroanġjopatija trombotika (HUS/TTP/TMA) kkawżati minn inibituri ta' calcineurin.
English: Verapamil (CYP3A4 inhibitor)
Maltese: Verapamil (inibitur ta' CYP3A4)
English: 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.
Maltese: Każijiet ta' nefropatija assoċjata ma' virus BK, kif ukoll każijiet ta' lewkoenċefalopatija multifokali progressiva (PML) assoċjata ma' virus JC, ġew irrappurtati f'pazjenti kkurati b'immunosoppressanti, li jinkludu Rapamune.
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).
Maltese: Fi prova klinika ta' pazjenti b'LAM, il-konċentrazzjoni minima ta' sirolimus fid-demm sħiħ medjana wara 3 ġimgħat ta' riċeviment ta' pilloli ta' sirolimus b'doża ta' 2 mg/jum kienet ta' 6.8 ng/mL (medda interkwartili 4.6 sa 9.0 ng/mL; n=37).
English: Ketoconazole (CYP3A4 inhibitor)
Maltese: Ketoconazole (inibitur ta' CYP3A4)
English: Lymphoma*; Malignant melanoma*;
Maltese: Kanċer tal-ġilda mhux melanoma*
English: Other possible interactions
Maltese: Interazzjonijiet oħra possibbli
English: Enrollment in the patient stratum with baseline calculated GFR below 40 mL/min was discontinued due to an imbalance in safety events (see section 4.8).
Maltese: Ir-reġistrazzjoni fl-istratum tal-pazjenti bil-GFR ikkalkulat fil-linja bażi taħt 40 mL/min ġiet imwaqqfa minħabba żbilanċ f'okkorrenzi ta' sigurtà (ara sezzjoni 4.8).
English: Erythromycin (CYP3A4 inhibitor)
Maltese: Erythromycin (inibitur ta' CYP3A4)
English: 30 coated tablets 100 coated tablets
Maltese: 30 pillola miksija 100 pillola miksija
English: Cases of Pneumocystis carinii pneumonia have been reported in renal transplant patients not receiving antimicrobial prophylaxis.
Maltese: Każijiet ta' pnewmonja Pneumocystis carinii kienu rrappurtati f'pazjenti li għamlu trapjant tal-kliewi li ma kinux qed jirċievu profilassi antimikrobjali.
English: The key inclusion criteria was post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤70% of predicted during the baseline visit.
Maltese: Il-kriterji ta' inklużjoni ewlenin kienu volum espiratorju furzat wara l-bronkodilatur f'sekonda (FEV1) ≤70% ta' dak imbassar waqt il-vista fil-linja bażi.
English: One patient experienced an episode of atrial fibrillation after ingestion of 150 mg of Rapamune.
Maltese: Pazjent wieħed kellu esperjenza ta' episodju ta' fibrillazzjoni atrijali wara li ħa doża ta' 150 mg ta' Rapamune.
English: Safety was assessed in a controlled study involving 89 patients with LAM, of which 81 patients had S-LAM and 42 of whom were treated with Rapamune (see section 5.1).
Maltese: Is-sigurtà ġiet ivvalutata fi studju kkontrollat li involva 89 pazjent b'LAM, li minnhom 81 pazjent kellhom S-LAM u li 42 minnhom ġew ikkurati b'Rapamune (ara sezzjoni 5.1).
English: Voriconazole (CYP3A4 inhibitor)
Maltese: Voriconazole (inibitur ta' CYP3A4)
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.
Maltese: L-inċidenza ta' rifjut akut ikkonfermat b'bijopsija kienet ferm ogħla (p=0.020*) għal pazjenti fil-grupp ta' sirolimus (11, 8.4%) meta mqabbel mal-grupp ta' tacrolimus (2, 1.6%) wara sentejn; il-parti l-kbira tar-rifjuti kienu ħfief fis-severità tagħhom (8 minn 9 [89%] ċellola-T BCAR, 2 minn 4 [50%] BCAR medjat b'antikorpi) fil-grupp ta' sirolimus.
English: Hepatic impairment
Maltese: Stomatite Axxite
English: Patients initiated on ramipril 10 mg had a higher rate of BCAR (15%) compared to patients initiated on ramipril 5 mg (5%).
Maltese: Il-pazjenti mibdija fuq ramipril 10 mg kellhom rata ogħla ta' BCAR (15%) meta mqabbla mal-pazjenti mibdija fuq ramipril 5 mg (5%).
English: 24 hours in the dosing syringe (at room temperature, but not to exceed 25C).
Maltese: 24 siegħa fis-siringa tad-dożaġġ (f'temperatura tal-kamra, li ma taqbiżx 25C).
English: Hypersensitivity (including angioedema, anaphylactic reaction, and anaphylactoid reaction)
Maltese: Sensittività eċċessiva (li tinkludi anġjoedema, reazzjoni anafilattika, u reazzjoni anafilattojde)
English: Diltiazem (CYP3A4 inhibitor)
Maltese: Diltiazem (inibitur ta' CYP3A4)
English: The younger children had a higher weight-normalised CL/F (214 mL/h/kg) compared with the adolescents (136 mL/h/kg).
Maltese: It-tfal iżgħar kellhom CL/F normalizzat ogħla meta mqabbel mal-piż (214 mL/siegħa/kg) meta mqabbel mal-adolexxenti (136 mL/siegħa/kg).
English: Nephrotic syndrome (see section 4.4); Focal segmental glomerulosclerosis*
Maltese: Sindromu nefrotiku (ara sezzjoni 4.4);
English: The tablets are supplied in blister packs of 30 and 100 tablets.
Maltese: Il-pilloli jiġu f'pakketti ta' folji ta' 30 u 100 pillola.
English: Menstrual disorder (including amenorrhoea and menorrhagia)
Maltese: Disturb filmestrwazzjoni (li jinkludi amenorrea u menorraġija)
English: In general, the adverse effects of overdose are consistent with those listed in section 4.8.
Maltese: Ġeneralment l-effetti avversi ta' doża eċċessiva huma konsistenti ma' dawk elenkati f'sezzjoni 4.8.
English: The risk/benefit should be considered in patients with established hyperlipidaemia before initiating an immunosuppressive regimen, including Rapamune.
Maltese: Irriskju/benefiċċju għandu jkun ikkunsidrat f'pazjenti li jbatu regolarment minn iperlipidimja, qabel tinbeda kura immunosoppressiva, inkluż Rapamune.
English: Co-administration of sirolimus (2 mg single dose) with multiple-dose administration of oral voriconazole (400 mg every 12 hours for 1 day, then 100 mg every 12 hours for 8 days) in healthy subjects has been reported to increase sirolimus Cmax and AUC by an average of 7-fold and 11-fold, respectively.
Maltese: Sirolimus (2 mg f'doża waħdanija) meħud ma' doża multipla ta' voriconazole orali (400 mg kull 12-il siegħa għal jum wieħed biss, u 100 mg kull 12-il siegħa għal 8 ijiem), f'individwi b'saħħithom, kien irrappurtat li jżid is-Cmax u l-AUC ta' sirolimus, b'medja ta' 7 darbiet u 11-il darba, rispettivament.
English: This medicine contains approximately 350 mg propylene glycol (E1520) in each mL.
Maltese: Din il-mediċina fiha madwar 350 mg propylene glycol (E1520) f'kull mL.
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).
Maltese: L-użu ta' Rapamune li ngħata flimkien ma' impedituri ta' calcineurin u kortikosterojdi kien assoċjat ma' riskju ogħla ta' deterjorament tal-funzjoni renali, abnormalitajiet tal-lipidi fis-serum (li jinkludu, imma mhumiex limitati għal, żieda ta' trigliċeridi u kolesterol totali fis-serum), u infezzjonijiet fis-sistema urinarja (ara sezzjoni 4.8).
English: Co-administration of sirolimus with strong inhibitors of CYP3A4 or inducers of CYP3A4 is not recommended (see section 4.4).
Maltese: inibituri qawwija ta' CYP3A4 jew mediċini li jistimulaw CYP3A4 mhuwiex rakkomandat (ara sezzjoni 4.4).
English: In paediatric patients on dialysis (30% to 50% reduction in glomerular filtration rate) within age ranges of 5 to 11 years and 12 to 18 years, the mean weight-normalised CL/F was larger for younger paediatric patients (580 mL/h/kg) than for older paediatric patients (450 mL/h/kg) as compared with adults (287 mL/h/kg).
Maltese: F'pazjenti pedjatriċi fuq dijalisi (tnaqqis ta' bejn 30% sa 50% fir-rata ta' filtrazzjoni glomerulari) f'etajiet ta' bejn il-5 u l-11-il sena u t-12 u t-18-il sena, is-CL/F medju normalizzat għall-piż kien aktar f'pazjenti pedjatriċi iżgħar (580 mL/h/kg) milli għal pazjenti pedjatriċi akbar (450 mL/siegħa/kg) kif imqabbel ma' adulti (287 mL/siegħa/kg).
English: Rapamune 2 mg coated tablets
Maltese: Rapamune 2 mg pilloli miksija
English: The primary endpoint was the difference between the groups in the rate of change (slope) in FEV1.
Maltese: Il-punt aħħari primarju kien id-differenza bejn il-gruppi fir-rata ta' bidla (inklinazzjoni) f'FEV1.
English: Studies demonstrated that its effects are mediated by a mechanism that is different from that of ciclosporin, tacrolimus, and other immunosuppressive agents.
Maltese: Studji wrew li l-effetti tiegħu jsiru permezz ta' mekkaniżmu li hu differenti minn dak ta' cyclosprin, tacrolimus, u mediċini immunosoppressivi oħra.
English: By 60 months, the incidence of non-skin malignancies was significantly higher in the cohort who continued ciclosporin as compared with the cohort who had ciclosporin withdrawn (8.4% vs. 3.8%, respectively).
Maltese: Sa 60 xahar, linċidenza ta' tumuri malinni mhux tal-ġilda kienet sinifikament ogħla fil-grupp li kompla b'ciclosporin meta mqabbel mal-grupp li waqqaf ciclosporin (8.4% vs 3.8% rispettivament).
English: In another study enrolling renal transplant patients 20 years of age and below that was intended to assess the safety of progressive corticosteroid withdrawal (beginning at six months post-transplantation) from an immunosuppressive regimen initiated at transplantation that included full-dose immunosuppression with both Rapamune and a calcineurin inhibitor in combination with basiliximab induction, of the 274 patients enrolled, 19 (6.9%) were reported to have developed post-transplant lymphoproliferative disorder (PTLD).
Maltese: Fi studju ieħor li fih kienu rreġistrati pazjenti ta' 20 sena jew inqas li kellhom trapjant tal-kliewi li kien maħsub biex jevalwa s-sigurtà ta' twaqqif progressiv tal-kortikosterojdi (li beda sitt xhur wara ttrapjant) minn kors immunosoppressiv li nbeda mat-trapjant li kien jinkludi immunosoppressjoni b'doża sħiħa kemm b'Rapamune kif ukoll b'impeditur ta' calcineurin flimkien ma' induzzjoni ta' basiliximab, mill-274 pazjent li rreġistraw, 19 (6.9%) kienu rrappurtati li żviluppaw disturb limfoproliferattiv ta' wara t-trapjant (PTLD).
English: Instructions for use and handling:
Maltese: Terapija ta' manteniment:
English: Pyrexia;
Maltese: Ipokalimja;
English: The adverse drug reactions observed in patients with S-LAM were consistent with the known safety profile of the product for the indication prophylaxis of organ rejection in renal transplantation with the addition of weight decreased, which was reported in the study at a greater incidence with Rapamune when compared to that observed with placebo (common, 9.5% vs. common, 2.6%).
Maltese: Ir-reazzjonijiet avversi għal mediċina osservati f'pazjenti b'S-LAM kienu konsistenti mal-profil tas-sigurtà magħruf talprodott għall-indikazzjoni prevenzjoni ta' rifjut tal-organi fi trapjant tal-kliewi biż-żieda ta' tnaqqis filpiż, li ġie rrappurtat fl-istudju b'inċidenza akbar b'Rapamune meta mqabbel ma' dak osservat bilplaċebo (komuni ħafna, 9.5% kontra komuni, 2.6%).
English: New onset nephrosis (nephrotic syndrome) was also reported (see section 4.8).
Maltese: Kien irrappurtat ukoll ħruġ ta' nefrożi ġdida (sindromu nefrotiku) (ara sezzjoni 4.8).
English: Rapamune 1 mg coated tablets
Maltese: Rapamune 1 mg pilloli miksija
English: Co-administration of sirolimus and ketoconazole is not recommended (see section 4.4).
Maltese: Mhux rakkomandat li sirolimus u ketoconazole jingħataw flimkien (ara sezzjoni 4.4).
English: The difference in bioavailability was less marked upon steady-state administration to renal transplant recipients, and therapeutic equivalence has been demonstrated in a randomised study of 477 patients.
Maltese: Id-differenza fil-bijodisponibilità kienet anqas qawwija waqt l-għoti fi stat fiss lil riċevituri ta' trapjanti renali, u ekwivalenza terapewtika kienet murija fi studju każwali ta' 477 pazjent.
English: Each Rapamune 0.5 mg coated tablet contains 0.5 mg of sirolimus.
Maltese: Kull Rapamune 0.5 mg pillola miksija fiha 0.5 mg ta' sirolimus.
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).
Maltese: Reazzjonijiet minħabba sensittività eċċessiva, li jinkludu reazzjonijiet anafilattiċi/anafilattojdi, anġjoedema, dermatite bil-qxur, u vaskulite minħabba sensittività eċċessiva, kienu assoċjati mal-għoti ta' sirolimus (ara sezzjoni 4.8).
English: Rapamune 0.5 mg coated tablets
Maltese: Rapamune 0.5 mg pilloli miksija
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).
Maltese: Fi studju li jevalwa s-sigurtà u l-effikaċja ta' bidla minn inibituri ta' calcineurin għal sirolimus (livelli mmirati ta' 12-20 ng/mL f'pazjenti bi trapjant renali mantenut, ir-reġistrazzjoni twaqqfet fissottogrupp ta' pazjenti (n=90) b'rata ta' filtrazzjoni glomerulari fil-linja bażi ta' anqas minn 40 mL/min (ara sezzjoni 5.1).
English: 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.
Maltese: Pazjenti b'riskju immunologiku minn baxx sa moderat kienu mistħarrġa fi studju ta' fażi 3 dwar leliminazzjoni ta' ciclosporin-manteniment ta' Rapamune, li kien jinkludi pazjenti li ngħataw allograft renali minn donatur kadaveriku jew ħaj.
English: Rapamune was assessed in a 36-month controlled clinical study enrolling renal transplant patients below 18 years of age considered at high-immunologic risk, defined as having a history of one or more acute allograft rejection episodes and/or the presence of chronic allograft nephropathy on a renal biopsy.
Maltese: Rapamune kien evalwat fi studju kliniku kkontrollat li dam 36 xahar li għalih ġew irreġistrati pazjenti ta' inqas minn 18-il sena li kellhom trapjant tal-kliewi li kienu kkunsidrati li kienu f'riskju immunoloġiku għoli, imfisser bħala li pazjent ikollu storja medika ta' episodju wieħed jew aktar ta' rifjut ta' allograft akut u/jew il-preżenza ta' nefropatija ta' allograft kronika meta ssir bijopsija talkliewi.
English: Medicines known as “statins” and “fibrates” used to treat elevated cholesterol and triglycerides have been associated with an increased risk of muscle breakdown (rhabdomyolysis).
Maltese: Mediċini magħrufa bħala "statins” u “fibrates” użati biex jittrattaw kolesterol u trigliċeridi elevati ġew assoċjati ma' riskju ogħla ta' kollass muskolari (rabdomajoliżi).
English: Kidney Transplant
Maltese: Diabetes mellitus
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.
Maltese: L-użu ta' Rapamune flimkien ma' impedituri ta' calcineurin u kortikosterojdi kien assoċjat ma' risku ogħla ta' deterjorament tal-funzjoni renali, abnormalitajiet tal-lipidi fis-serum (li jinkludu imma mhumiex limitati għal, żieda fit-trigliċeridi u l-kolesterol fis-serum), u infezzjonijiet fl-apparat urinarju.
English: Inhibitors of CYP3A4 (such as ketoconazole, voriconazole, itraconazole, telithromycin, or clarithromycin) decrease the metabolism of sirolimus and increase sirolimus levels.
Maltese: (bħal ketoconazole, voriconazole, itraconazole, telithromycin jew clarithromycin) inaqqsu l-metaboliżmu ta' sirolimus u jżidu l-livelli ta' sirolimus.
English: At 48 months, there was a statistically significant difference in graft survival in favour of the Rapamune following ciclosporin elimination group compared to the Rapamune with ciclosporin therapy group (including and excluding loss to follow-up).
Maltese: Fit-48 xahar, kien hemm differenza statistikament sinifikattiva fis-sopravivenza tat-trapjant favur il-grupp li rċieva Rapamune wara l-eliminazzjoni ta' ciclosporin, meta mqabbel mal-grupp li rċieva Rapamune flimkien mat-terapija b'ciclosporin (li tinkludi u teskludi t-telf sal-follow up).
English: Rapamune 0.5 mg coated tablets, Rapamune 1 mg coated tablets, Rapamune 2 mg coated tablets:
Maltese: Rapamune 0.5 mg pilloli miksijin, Rapamune 1 mg pilloli miksijin, Rapamune 2 mg pilloli miksijin:
English: Most patients who received 2 mg of Rapamune 4 hours after ciclosporin had whole blood trough concentrations of sirolimus within the 4 to 12 ng/mL target range (expressed as chromatographic assay values).
Maltese: Il-biċċa l-kbira tal-pazjenti li rċivew 2 mg ta' Rapamune 4 sigħat wara ciclosporin, kellhom l-inqas konċentrazzjonijiet ta' sirolimus fid-demm sħiħ fil-medda mixtieqa ta' 4 sa 12 ng/mL (espressi bħala valuri ta' assaġġ kromatografiku).
English: Among these conditions in renal transplant patients are BK virus-associated nephropathy and JC virus-associated progressive multifocal leukoencephalopathy (PML).
Maltese: BK u lewkoenċefalopatija multifokali progressiva (PML) assoċjata mal-virus JC.
English: Sirolimus has been administered concurrently with the following agents in clinical studies: tacrolimus, ciclosporin, azathioprine, mycophenolate mofetil, corticosteroids and cytotoxic antibodies.
Maltese: Mediċini immunosoppressivi (Pazjenti li għamlu trapjant tal-kliewi biss) Fi studji kliniċi sirolimus ġie mogħti fl-istess waqt ma' dawn il-mediċini li ġejjin: tacrolimus, ciclosporin, azathioprine, mycophenolate mofetil, kortikosterojdi u antikorpi ċitotossiċi.
English: Grapefruit juice should be avoided (see section 4.5).
Maltese: Il-meraq tal-grejpfrut għandu jiġi evitat (ara sezzjoni 4.5).
English: How to take Rapamune
Maltese: X'fih Rapamune
English: At 2 years, the rate of non-melanoma skin malignancies was significantly lower in the Rapamune conversion group as compared to the calcineurin inhibitors continuation group (1.8% and 6.9%).
Maltese: Wara sentejn, ir-rata ta' tumuri malinni tal-ġilda li mhumiex melanoma, kienet sinifikament aktar baxxa fil-grupp li qaleb għal Rapamune meta mqabbla mal-grupp li kompla fuq inibituri ta' calcineurin (1.8% u 6.9%).
English: Hypersensitivity vasculitis
Maltese: Reazzjonijiet minħabba sensittività eċċessiva
English: Pain;
Maltese: Deni;