FrancophonIA/ELRC3.0 huggingface dataset:
English: Rapamune 1 mg is supplied to you as white-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 1 mg” on one side.
Maltese: Rapamune 1 mg jasallek bħala pilloli miksija ta' lewn abjad, f'għamla trijangulari, u mmarkati “RAPAMUNE 1 mg” fuq naħa waħda.
English: Patients with a body mass index (BMI) greater than 30 kg/m2 may be at increased risk of abnormal wound healing based on data from the medical literature.
Maltese: Pazjenti li għandhom indiċi ta' piż tal-ġisem (BMI) ogħla minn 30 kg/m2 jistgħu jkunu f'riskju akbar ta' fejqan anormali tal-feriti bbażat fuq dejta miksuba minn letteratura medika.
English: Ciclosporin was not withdrawn in patients experiencing Banff Grade 3 acute rejection episodes, who were dialysis-dependent, who had a serum creatinine higher than 400 mol/L, or who had inadequate renal function to support ciclosporin withdrawal.
Maltese: Ciclosporin ma kienx imwaqqaf f'pazjenti li esperjenzaw episodji ta' rifjut akuta Banff Grad 3, li kienu dipendenti mid-dijalisi, li kellhom krejatinina fis-serum ogħla minn 400 μmol/L, jew li kellhom il-funzjoni renali inadegwata sabiex tiflaħ għat-twaqqif ta' ciclosporin.
English: 4.1 ng/mL (14 to 24 ng/mL) and 8.2  4.2 mg (3.6 to 13.6 mg), respectively (see section 4.2).
Maltese: Wara t-twaqqif ta' ciclosporin, minn xahar 3 sa xahar 12, ilkonċentrazzjonijiet l-aktar baxxi (espressi bħala valuri ta' assaġġi kromatografiċi) medji (10, 90 percentili) u dożi ta' kuljum kienu 19  4.1 ng/mL (14 sa 24 ng/mL) u 8.2  4.2 mg (3.6 sa 13.6 mg), rispettivament (ara sezzjoni 4.2).
English: Each tablet contains 86.4 mg of lactose monohydrate and 214.4 mg of sucrose.
Maltese: Rapamune 2 mg pilloli miksija Kull pillola fiha 86.4 mg ta' lactose monohydrate u 214.4 mg ta' sucrose.
English: This study compared Rapamune (dose adjusted to 5-15 ng/mL) with placebo for a 12-month treatment period, followed by a 12-month observation period in patients with TSC-LAM or S-LAM. Eighty-nine (89) patients were enrolled at 13 study sites in the United States, Canada, and Japan of which 81 patients had S-LAM; of these patients with S-LAM, 39 were randomised to receive placebo and 42 to receive Rapamune.
Maltese: Ġew irreġistrati disgħa u tmenin (89) pazjent fi 13il sit ta' studju fl-Istati Uniti, fil-Kanada u fil-Ġappun li minnhom 81 pazjent kellhom S-LAM; minn dawn il-pazjenti b'S-LAM, 39 ġew randomizzati biex jirċievu l-plaċebo u 42 biex jirċievu Rapamune.
English: NAME OF THE MEDICINAL PRODUCT Rapamune 1 mg tablets sirolimus
Maltese: Rapamune 1 mg pilloli sirolimus
English: Safety was assessed in a controlled clinical study enrolling renal transplant patients below 18 years of age considered of high immunologic risk, defined as a history of one or more acute allograft rejection episodes and/or the presence of chronic allograft nephropathy on a renal biopsy (see section 5.1).
Maltese: Is-sigurtà ġiet analizzata fi studju kliniku kkontrollat li fih kienu rreġistrati pazjenti ta' taħt it-18-il sena li kellhom trapjant tal-kliewi li kellhom u li kienu kkunsidrati bħala li għandhom riskju immunoloġiku għoli, definit bħala storja medika ta' episodju wieħed jew aktar ta' rifjut akut u/jew ilpreżenza ta' nefropatija ta' allograft kronika meta ssir bijopsija tal-kliewi (ara sezzjoni 5.1).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku talAġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Pneumonia;
Maltese: Pankreatite;
English: Rapamune contains the active substance sirolimus, which belongs to a group of medicines called immunosuppressants.
Maltese: Rapamune fih is-sustanza attiva sirolimus, li tappartjeni għal grupp ta' mediċini li jissejħu immunosoppressanti.
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.
Maltese: Kien hemm ukoll rapporti ta' akkumulazzjoni ta' fluwidu, li jinkludu edema periferali, limfoedema, effużjoni plewrali u effużjonijiet perikardjali (li jinkludu effużjonijiet emodinamikament sinifikanti fi tfal u adulti), f'pazjenti li jirċievu Rapamune.
English: Lot:
Maltese: SN:
English: Joint pain
Maltese: Komuni ħafna
English: Rapamune 2 mg is supplied to you as yellow to beige-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 2 mg” on one side.
Maltese: Rapamune 2 mg jasallek bħala pilloli miksija ta' lewn isfar fil-bex, f'għamla trijangulari, u mmarkati “RAPAMUNE 2 mg” fuq naħa waħda.
English: Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function (see sections 4.2 and 5.1).
Maltese: Rapamune huwa indikat għall-kura ta' pazjenti b'limfanġjolejomijomatożi sporadika b'marda talpulmun moderata jew b'funzjoni tal-pulmun li qed tonqos (ara sezzjonijiet 4.2 u 5.1).
English: The treatment regimen studied (continuous use of Rapamune in combination with calcineurin inhibitor) is not indicated for adult or paediatric patients (see section 4.1).
Maltese: Il-kors tal-kura studjat (l-użu kontinwu ta' Rapamune flimkien ma' impeditur ta' calcineurin) mhuwiex indikat għal pazjenti adulti jew pedjatriċi (ara sezzjoni 4.1).
English: Impaired healing following transplant surgery has been reported, including fascial dehiscence, incisional hernia, and anastomotic disruption (e.g., wound, vascular, airway, ureteral, biliary).
Maltese: Kien irrappurtat fejqan imdgħajjef wara kirurġija ta' trapjant, inklużi ftuħ tal-faxxa, ftuq inċiżjonali u sfaxxar tal-anastomożi (eż. ferita, vaskulari, passaġġi tal-arja, uretrali, biljari).
English: Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of sucrose.
Maltese: Rapamune 1 mg pilloli miksija Kull pillola fiha 86.4 mg ta' lactose monohydrate u 215.8 mg ta' sucrose.
English: White-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 1 mg” on one side.
Maltese: Pillola miksija ta' kulur abjad, f'għamla trijangulari, immarkata “RAPAMUNE 1 mg” fuq naħa waħda.
English: Pneumonitis*; Pleural effusion;
Maltese: Infezzjoni virali; Infezzjoni batterjali;
English: Rapamune 0.5 mg is supplied to you as tan-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 0.5 mg” on one side.
Maltese: Pillola miksija ta' kulur kannella jagħti fl-isfar, f'għamla trijangulari, u mmarkata “RAPAMUNE 0.5 mg” fuq naħa waħda.
English: Cytomegalovirus (CMV) prophylaxis is recommended for 3 months after renal transplantation, particularly for patients at increased risk for CMV disease.
Maltese: Profilassi għal cytomegalovirus (CMV) hi rakkomandata għal 3 xhur wara t-trapjant tal-kliewi, partikularment għal pazjenti li għandhom riskju akbar ta' mard b'CMV.
English: Rapamune tablets administered to 12 renal transplant patients above 65 years of age gave similar results to adult patients (n=167) 18 to 65 years of age.
Maltese: Ilpilloli Rapamune mogħtija lil 12-il pazjent li kellhom trapjant tal-kliewi u li kellhom iktar minn 65 sena, taw riżultati simili bħal dawk ta' pazjenti adulti (n = 167) li kellhom minn 18 sa 65 sena.
English: Each Rapamune 1 mg coated tablet contains 1 mg of sirolimus.
Maltese: Kull Rapamune 1 mg pillola miksija fiha 1 mg ta' sirolimus.
English: If you have a body mass index (BMI) greater than 30 kg/m2, you may be at increased risk of abnormal wound healing.
Maltese: Jekk għandek indiċi ta' piż tal-ġisem (BMI) ta' iżjed minn 30 kg/m2, tista' tkun f'riskju miżjud għal fejqan anormali ta' feriti.
English: LAM involves lung tissue infiltration with smooth muscle-like cells that harbour inactivating mutations of the tuberous sclerosis complex (TSC) gene (LAM cells).
Maltese: LAM tinvolvi infiltrazzjoni tat-tessut tal-pulmun b'ċelluli lixxi qishom muskoli li fihom mutazzjonijiet li ma jattivawx tal-ġene kumpless tal-isklerożi tuberuża (TSC) (ċelluli LAM).
English: The simultaneous oral administration of 10 mg of Rapamune oral solution and 120 mg of diltiazem significantly affected the bioavailability of sirolimus.
Maltese: L-għoti mill-ħalq fl-istess ħin ta' 10 mg ta' soluzzjoni orali ta' Rapamune flimkien ma' 120 mg ta' diltiazem affettwa b'mod sinifikanti l-bijodisponibilità ta' sirolimus.
English: Sirolimus is extensively metabolised by the CYP3A4 isozyme in the intestinal wall and liver.
Maltese: Sirolimus jiġi metabolizzat b'mod estensiv mill-isoenzimi CYP3A4 fil-ħajt tal-musrana u fil-fwied.
English: Each coated tablet contains 0.5 mg sirolimus.
Maltese: Kull pillola miksija fiha 0.5 mg sirolimus.
English: Neuroendoc rine carcinoma of the skin*
Maltese: Karċinoma newroendokrinali tal-ġilda*
English: Sporadic Lymphangioleiomyomatosis (S-LAM) Patients
Maltese: Pazjenti b'limfanġjolejomijomatożi sporadika (S-LAM)
English: NAME OF THE MEDICINAL PRODUCT Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets
Maltese: Rapamune 0.5 mg pilloli miksija Rapamune 1 mg pilloli miksija Rapamune 2 mg pilloli miksija
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose, malassorbiment ta' glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase, m'għandhomx jieħdu din il-mediċina.
English: Each Rapamune 2 mg coated tablet contains 2 mg of sirolimus.
Maltese: Kull Rapamune 2 mg pillola miksija fiha 2 mg ta' sirolimus.
English: Inhibitors of P-gp may decrease the efflux of sirolimus from intestinal cells and increase sirolimus levels.
Maltese: Inibituri tal-P-gp jistgħu jnaqqsu l-effluss ta' sirolimus miċ-ċelluli intestinali u jżidu llivelli ta' sirolimus.
English: In clinical studies, the concomitant administration of Rapamune and HMG-CoA reductase inhibitors and/or fibrates was well-tolerated.
Maltese: Fi studji kliniċi, l-għoti fl-istess ħin ta' Rapamune u inibituri ta' HMG-CoA reductase u/jew fibrates, kien ittollerat tajjeb.
English: An unacceptably high frequency of PTLD was seen in a paediatric clinical transplant study when full-dose Rapamune was administered to children and adolescents in addition to full-dose calcineurin inhibitors with basiliximab and corticosteroids (see section 4.8).
Maltese: Kienet osservata frekwenza għolja mhix aċċettabbli ta' PTLD fi studju kliniku dwar it-trapjanti fuq ittfal meta doża sħiħa ta' Rapamune ngħatat lil tfal u adolexxenti flimkien ma' doża sħiħa ta' impedituri ta' calcineurin flimkien ma' basiliximab u kortikosterojdi (ara sezzjoni 4.8).
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).
Maltese: Illivelli suġġeriti tal-konċentrazzjoni l-aktar baxxa ta' ciclosporin għall-ewwel xahrejn sa 3 xhur wara ttrapjant, huma bejn 150-400 ng/mL (analiżi monoklonali jew xi tip ta' analiżi simili) (ara sezzjoni 4.5).
English: If this occurs, simply bring your Rapamune oral solution to room temperature and shake gently.
Maltese: Jekk jiġri dan, ġib Rapamune soluzzjoni orali għat-temperatura tal-kamra u ċaqalqu bil-mod.
English: There was no significant between-group difference in this interval in the change in functional residual capacity, 6-minute walk distance, diffusing capacity of the lung for carbon monoxide, or general well-being score in patients with S-LAM.
Maltese: Ma kien hemm l-ebda differenza konsiderevoli bejn il-gruppi f'dan l-intervall fil-bidla fil-kapaċità residwali funzjonali, distanza bil-mixi ta' 6 minuti, li tifrex il-kapaċità tal-pulmun għall-monossidu tal-karbonju, jew il-punteġġ tal-benesseri ġenerali f'pazjenti b'S-LAM.
English: In a subset of the study patients with a baseline GFR above 40 mL/min and normal urinary protein excretion, calculated GFR was higher at 1 and 2 years in patients converted to Rapamune than for the corresponding subset of calcineurin inhibitor continuation patients.
Maltese: F'sottosett tal-pazjenti studjati b'linja bażi ta' GFR ta' iżjed minn 40 mL/min u eliminazzjoni normali ta' proteina urinarja, il-GFR ikkalkulat kien ogħla fl-ewwel sena u sentejn f'pazjenti li qalbu għal Rapamune milli għas-sottosett korrispondenti ta' pazjenti li komplew fuq inibitur ta' calcineurin.
English: Inhibitors of CYP3A4 may decrease the metabolism of sirolimus and increase sirolimus blood levels.
Maltese: Inibituri ta' CYP3A4 jistgħu jnaqqsu l-metaboliżmu ta' sirolimus u jżidu l-livell ta' sirolimus fiddemm.
English: Based on information from an open-label randomised study, conversion from the calcineurin inhibitor tacrolimus to Rapamune in maintenance renal transplant patients was associated with an unfavourable safety profile without efficacy benefit and can therefore not be recommended (see section 5.1).
Maltese: Abbażi ta' informazzjoni minn studju randomizzat bit-tikketta mikxufa, qlib mill-inibitur ta' calcineurin tacrolimus għal Rapamune f'pazjenti bi trapjant tal-kliewi ta' manteniment, kien assoċjat ma' profil tas-sigurtà mhux favorevoli mingħajr benefiċċju fir-rigward tal-effikaċja u għaldaqstant ma jistax jiġi rrakkomandat (ara sezzjoni 5.1).
English: NAME OF THE MEDICINAL PRODUCT Rapamune 2 mg tablets sirolimus
Maltese: Rapamune 2 mg pilloli sirolimus
English: In the stratum with baseline calculated GFR above 40 mL/min, the mean and median urinary protein to creatinine ratios were significantly higher in the Rapamune conversion group as compared to those of the calcineurin inhibitors continuation group at 24 months (see section 4.4).
Maltese: Fl-istratum bil-GFR ikkalkulat fil-linja bażi ta' iżjed minn 40 mL/min, ilproteina urinarja medja u medjana għal proporzjonijiet ta' krejatinina kienu sinifikament ogħla filgrupp ta' bidla ta' Rapamune meta mqabbel ma' dawk fil-grupp li kompla fuq l-inibituri ta' calcineurin għal 24 xahar (ara sezzjoni 4.4).
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: pancreatic islet cell vacuolation, testicular tubular degeneration, gastrointestinal ulceration, bone fractures and calluses, hepatic haematopoiesis, and pulmonary phospholipidosis.
Maltese: Ma dehrux effetti mhux mixtieqa waqt studji kliniċi, iżda dehru f'annimali li ġew esposti għal doża daqs dik klinika u jista' jkollhom rilevanza għall-użu kliniku, kif spjegat: vakwolazzjoni taċ-ċelluli talfrixa, tħassir tat-tubi testikolari, ulċerazzjoni gastrointestinali, ksur tal-għadam u kallijiet, ematopojesi epatika, u fosfolipidosi pulmonarja.
English: A loading dose should be considered in addition to a new maintenance dose when it is necessary to considerably increase sirolimus trough concentrations: Rapamune loading dose=3 x (new maintenance dose - current maintenance dose).
Maltese: Għandha tiġi kkunsidrata doża għolja tal-bidu flimkien ma' doża ġdida ta' manteniment meta jkun hemm bżonn li l-konċentrazzjonijiet minimi ta' sirolimus jiżdiedu b'mod konsiderevoli: doża għolja tal-bidu ta' Rapamune=3 x (doża ġdida ta' manteniment - doża kurrenti ta' manteniment).
English: Pancreatitis; Stomatitis; Ascites
Maltese: Uġigħ addominali, Dijarea Stitikezza Tqalligħ
English: Impairments of sperm parameters have been observed among some patients treated with Rapamune.
Maltese: Fost xi pazjenti kkurati b'Rapamune kienu osservati indebolimenti fil-parametri tal-isperma.
English: 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).
Maltese: Żieda fir-rati ta' rifjut akut ikkonfermat permezz ta' bijopsija (BCAR) f'pazjenti li għamlu trapjant talkliewi ġiet osservata bl-użu konkomitanti ta' sirolimus ma' inibituri ACE (ara sezzjoni 5.1).
English: (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.
Maltese: (1) f'pazjenti b'indeboliment tal-fwied (2) meta indutturi jew inibituri ta' CYP3A4 jingħataw fl-istess ħin u wara t-twaqqif tagħhom (ara sezzjoni 4.5) u/jew (3) jekk id-dożaġġ ta' ciclosporin jitnaqqas b'mod notevoli jew jitwaqqaf, għax dawn ilpopolazzjonijiet huma l-aktar li għandhom ċans li jkunu jeħtieġu dożaġġ speċjali.
English: Each tablet contains 86.4 mg of lactose monohydrate and 215.7 mg of sucrose.
Maltese: Rapamune 0.5 mg pilloli miksija Kull pillola fiha 86.4 mg ta' lactose monohydrate u 215.7 mg ta' sucrose.
English: In healthy subjects, the mean extent of bioavailability of sirolimus after single-dose administration of the tablet formulation is about 27% higher relative to the oral solution.
Maltese: F'individwi b'saħħithom, il-medda medja ta' bijodisponibilità ta' sirolimus wara għoti ta' doża waħda tal-formulazzjoni tal-pillola hija madwar 27% ogħla meta mqabbla mas-soluzzjoni orali.
English: Yellow to beige-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 2 mg” on one side.
Maltese: Pillola miksija ta' kulur isfar għal beige, f'għamla trijangulari, immarkata “RAPAMUNE 2 mg” fuq naħa waħda.
English: Co-administration of sirolimus and rifampicin is not recommended (see section 4.4).
Maltese: Mhux rakkomandat li sirolimus u rifampicin jittieħdu flimkien (ara sezzjoni 4.4)
English: Therefore, the sirolimus dose was approximately 4-fold higher to account for both the absence of the pharmacokinetic interaction with ciclosporin (2-fold increase) and the augmented immunosuppressive requirement in the absence of ciclosporin (2-fold increase).
Maltese: Għalhekk, id-doża ta' sirolimus kienet madwar 4 darbiet ogħla biex tagħti kont kemm tan-nuqqas ta' interazzjoni farmakokinetika (żieda doppja) u l-ħtieġa immunosoppressiva awmentata fin-nuqqas ta' ciclosporin (żieda doppja).
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
Maltese: Ciclosporin għandu jitwaqqaf gradwalment fuq perjodu ta' minn 4 sa 8 ġimgħat, u d-doża ta' Rapamune għandha tkun aġġustata biex tikseb l-inqas livell ta' 12 sa 20 ng/mL fid-demm (assaġġ kromatografiku; ara Monitoraġġ terapewtiku tal-prodott mediċinali u aġġustament fid-doża).
English: Each coated tablet contains 1 mg sirolimus.
Maltese: Kull pillola miksija fiha 1 mg sirolimus.
English: Ovarian cyst
Maltese: Popolazzjoni sewda
English: In rats, sirolimus caused embryo/foetotoxicity that was manifested as mortality and reduced foetal weights (with associated delays in skeletal ossification) (see section 4.6).
Maltese: Fil-firien, sirolimus ikkawża tossiċità flembriju/fetu li kienet tidher bħala mortalità u tnaqqis fil-piżijiet fetali (b'dewmien assoċjat flossifikazzjoni skeletrika) (ara sezzjoni 4.6).
English: Grapefruit juice affects CYP3A4-mediated metabolism, and should therefore be avoided.
Maltese: Il-meraq tal-grejpfrut jaffettwa l-metaboliżmu permezz ta' CYP3A4, u għalhekk għandu jiġi evitat.
English: Clinical studies with Rapamune oral solution did not include a sufficient number of patients above 65 years of age to determine whether they will respond differently than younger patients (see section 5.2).
Maltese: Fl-istudji kliniċi bis-soluzzjoni orali ta' Rapamune, ma kienx hemm numru suffiċjenti ta' pazjenti anzjani ta' iktar minn 65 sena, biex tkun tista' tgħid jekk jirrispondux b'mod differenti minn pazjenti ta' età iżgħar (ara sezzjoni 5.2).
English: If necessary, you may store the bottle at room temperature up to 25C for a short period of time, but no longer than 24 hours.
Maltese: Jekk ikun hemm bżonn, inti tista' żżomm il-flixkun f'temperatura tal-kamra sa 25C għal żmien qasir, iżda mhux aktar minn 24 siegħa.
English: Cases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when sirolimus has been used as part of an immunosuppressive regimen.
Maltese: Każijiet ta' ftuħ anastomotiku tal-ferita kirurġika tal-bronki, il-biċċa l-kbira fatali, kienu rrappurtati f'pazjenti li kellhom trapjant tal-pulmun de novo meta sirolimus intuża bħala parti minn kors immunosoppressiv.
English: Multiple-dose ketoconazole administration significantly affected the rate and extent of absorption and sirolimus exposure from Rapamune oral solution as reflected by increases in sirolimus Cmax, tmax, and AUC of 4.4-fold, 1.4-fold, and 10.9-fold, respectively.
Maltese: L-għoti ta' dożi multipli ta' erythromycin u ta' soluzzjoni orali ta' sirolimus, żied b'mod sinifikanti rr-rata u l-grad ta' assorbiment taż-żewġ prodotti mediċinali. Cmax, tmax, u AUC ta' sirolimus fid-demm sħiħ żdiedu b'4.4 darbiet, b'1.4 darbiet, u 4.2 darbiet rispettivament.
English: The safety and efficacy of Rapamune in children and adolescents less than 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Rapamune fi tfal u adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: C.
Maltese: St.
English: Hyperglycaemia; Hypertriglyceridaemia; Diabetes mellitus
Maltese: Pnewmonite* Effużjoni plewrali Epistassi
English: Sirolimus was not mutagenic in the in vitro bacterial reverse mutation assays, the Chinese Hamster Ovary cell chromosomal aberration assay, the mouse lymphoma cell forward mutation assay, or the in vivo mouse micronucleus assay.
Maltese: Sirolimus ma kienx mutaġeniku fl-assaġġi in vitro ta' mutazzjonijiet batteriċi riversibbli, fl-assaġġ ta' aberrazzjoni kromosomali taċ-ċellula tal-ovarji tal-Ħamster Ċiniż, fl-assaġġ tal-mutazzjoni 'l quddiem taċ-ċellula tal-limfoma tal-ġurdien, jew fl-assaġġ in vivo tal-mikronukleju tal-ġurdien.
English: The clearance of sirolimus may be reduced in patients with impaired hepatic function (see section 5.2).
Maltese: It-tneħħija ta' sirolimus għandha mnejn tiġi mnaqqsa f'pazjenti li għandhom indeboliment fil-funzjoni tal-fwied (ara sezzjoni 5.2).
English: Rapamune must not be diluted in grapefruit juice or any other liquid other than water or orange juice (see section 6.6).
Maltese: Rapamune m'għandux jiġi dilwit fil-meraq tal-grejpfrut jew ma' xi likwidu ieħor għajr ilma jew meraq tal-laring (ara sezzjoni 6.6).
English: Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant.
Maltese: Rapamune hu indikat f'pazjenti adulti għall-prevenzjoni ta' rifjut tal-organi b'riskju immunoloġiku minn baxx sa moderat, li jirċievu trapjant renali.
English: Each mL of Rapamune contains 1 mg sirolimus.
Maltese: Kull mL għandu 1 mg sirolimus.
English: In the patient stratum with baseline calculated GFR above 40 mL/min, renal function was not improved overall.
Maltese: Fl-istratum tal-pazjenti bil-GFR ikkalkulat fil-linja bażi ta' iżjed minn 40 mL/min, il-funzjoni renali ma kinitx mtejba globalment.
English: All patients who developed PTLD were aged below 18 years.
Maltese: Ilpazjenti kollha li żviluppaw PTLD kellhom inqas minn 18-il sena.
English: There was a significantly higher rate of first biopsy-proven rejection in the ciclosporin elimination group compared to the ciclosporin maintenance group during the period post-randomisation to 12 months (9.8% vs. 4.2%, respectively).
Maltese: Kien hemm rata sinifikament ogħla tal-ewwel rifjut pprovat b'bijopsija fil-grupp tal-eliminazzjoni ta' ciclosporin meta mqabbel mal-grupp ta' manteniment ta' ciclosporin wara l-perjodu ta' wara meta l-pazjenti ntgħażlu b'mod każwali għal 12-il xahar (9.8% vs. 4.2% rispettivament).
English: The concomitant use of sirolimus with a calcineurin inhibitor may increase the risk of calcineurin inhibitor-induced HUS/TTP/TMA.
Maltese: L-użu ta' sirolimus flimkien ma' impeditur ta' calcineurin jista' jżid ir-riskju ta' HUS/TTP/TMA ikkaġunati minn impeditur ta' calcineurin.