FrancophonIA/ELRC3.0 huggingface dataset:
English: Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Maltese: Tacrolimus jiġi metabolizzat malajr fil-fwied, primarjament biċ-ċitokromju P450-3A4.
English: Clinical efficacy and safety of Prograf capsules bid in primary organ transplantation In prospective studies oral Prograf was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Maltese: Effikaċja klinika u sigurtà tal-kapsuli Prograf fi trapjanti ta' organi primarji Fi studji prospettivi pubblikati, Prograf orali kien investigat bħala immunsuppressant primarju f'bejn wieħed u ieħor 175 pazjent wara trapjant tal-pulmun, f'f'475 pazjent wara trapjant tal-frixa u f'f'630 pazjent wara trapjant intestinali.
English: Lecithin (soya)
Maltese: Lecithin (soja) Simeticone
English: Each capsule contains less than 1 mmol sodium (23 mg).
Maltese: Kull kapsula fiha inqas minn 1 mmol sodium (23 mg).
English: A lower incidence of acute rejection episodes for tacrolimus- versus ciclosporin-treated patients (11.5% versus 22.6%) and a lower incidence of chronic rejection, the bronchiolitis obliterans syndrome (2.86% versus 8.57%), was reported within the first year after transplantation.
Maltese: Fl-ewwel sena wara t-trapjant kienu rappurtati inqas każi ta' episodji fejn kien hemm rifjut akut għal tacrolimus kontra pazjenti li ħadu ciclosporin (11.5% kontra t-22.6%) u inqas inċidenza ta' rifjut kroniku, is-sindrome bronkolite obliterans (2.86% kontra 8.57%).
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Red iron oxide (E 172) Sodium laurilsulfate Gelatin.
Maltese: Titanium dioxide (E 171) Yellow iron oxide (E 172) Red iron oxide (E 172) Sodium laurylsulphate Gelatin.
English: Advagraf contains the active substance tacrolimus.
Maltese: Advagraf fih is-sustanza attiva tacrolimus.
English: Another randomised study included 66 patients on tacrolimus versus 67 patients on ciclosporin.
Maltese: Studju ieħor randomizzat kien jinkludi 66 pazjent li ħadu tacrolimus kontra s-67 pazjent li ħadu ciclosporin.
English: to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Maltese: Fil-plażma, tacrolimus jaqbad sewwa (> 98.8%) mal-proteini tal-plażma, l-aktar mas-serum albumin u l-α-1-acid glycoprotein.
English: Excipients with known effect: Each capsule contains 306.52 mg lactose.
Maltese: Kull kapsula fiha 306.52 mg lactose.
English: Capsule shell: Titanium dioxide (E171), yellow iron oxide (E 172), red iron oxide (E 172), sodium laurilsulfate, gelatin.
Maltese: Il-qoxra tal-kapsula: titanium dioxide (E171), yellow iron oxide (E 172), red iron oxide (E 172), sodium laurylsulfate, gelatin.
English: The efficacy and safety of Advagraf and Prograf, both in combination with mycophenolate mofetil (MMF) and corticosteroids, was compared in 667 de novo kidney transplant recipients.
Maltese: L-effikaċja u s-sigurtà ta' Advagraf u Prograf, meta ngћataw flimkien ma' mycophenolate mofetil (MMF) u kortikosterojdi, tqabbel f'667 riċevitur de novo ta' trapjant tal-kliewi.
English: The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC 0-24) is similar between the two formulations Advagraf and Prograf.
Maltese: Ir-relazzjoni li hemm bejn l-inqas livelli ta' tacrolimus (C24) u l-espożizzjoni sistemika (AUC 0-24) huma simili bejn iż-żewġ formulazzjonijiet ta' Advagraf u ta' Prograf.
English: Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor.
Maltese: Tacrolimus jissopprimi l-attivazzjoni tat-T-cell u t-tixrid tal-B-cell li hu dipendenti fuq it-T-helper-cell, kif ukoll il-formazzjoni ta' limfokini (bħall-interlewkini 2, -3, u lγ-interferon) u l-espressjoni tar-reċettur interlewkin -2.
English: Published clinical experience from a single centre on the use of oral Prograf for primary treatment following intestinal transplantation showed that the actuarial survival rate of 155 patients (65 intestine alone, 75 liver and intestine, and 25 multivisceral) receiving tacrolimus and prednisone was 75% at 1 year, 54% at 5 years, and 42% at 10 years.
Maltese: Esperjenza klinika pubblikata minn ċentru wieħed dwar l-użu ta' Prograf orali bħala l-ewwel kura wara trapjant intestinali wriet li r-rata attwarja ta' dawk li għexu kienet ta' 155 pazjent (65 l-intestini biss, 75 l-fwied u l-intestini, u 25 multivixxerali) jieħdu tacrolimus u prednisone kienet ta' 75% f'sena, 54% f'5 snin, u 42% f'10 snin.
English: 12-month graft survival was 96.7% for Advagraf, 92.9% for Prograf and 95.7% for ciclosporin.
Maltese: Ma' 12-il xahar mit-trapjant, kien hemm sopravivenza tat-trapjant ta' 96.7% gћal Advagraf, 92.9% gћal Prograf u 95.7% gћal ciclosporin.
English: Branch Belgique/Belgien Tél/Tel: + 32 (0)2 5580710
Maltese: België/Belgique/Belgien Astellas Pharma B.V. Branch Tél/Tel: + 32 (0)2 5580710
English: The 1-year survival rates were 73.1% in the tacrolimus versus 79.2% in the ciclosporin group.
Maltese: F'sena kien hemm 73.1% tal pazjenti li għexu wara li ħadu tacrolimus kontra 79.2% fil-grupp li ħadu ciclosporin.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni gћat-tqegћid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott skont il-ħtiġiet stabbiliti fil-lista ta' dati ta' referenza tal-Unjoni (lista EURD) prevista fl-Artikolu 107c (7) tad-Direttiva 2001/83/KE u ppubblikata fuq il-portal elettroniku Ewropew tal-Mediċini.
English: In stable patients converted from Prograf capsules (twice daily) to Advagraf (once daily) on a 1:1 (mg:mg) total daily dose basis, the systemic exposure to tacrolimus (AUC0-24) for Advagraf was approximately 10% lower than that for Prograf.
Maltese: F'pazjenti stabbli li qalbu minn kapsuli Prograf (darbtejn kuljum) għal Advagraf (darba kuljum) fuq bażi ta' doża totali kuljum ta' 1:1 (mg:mg), l-esponiment sistemiku għal tacrolimus (AUC0-24) għal Advagraf kien bejn wieħed u ieħor 10% inqas minn dak għal Prograf.
English: gastrointestinal signs and symptoms, vomiting, gastrointestinal and abdominal pains, gastrointestinal inflammatory conditions, gastrointestinal haemorrhages, gastrointestinal ulceration and perforation, ascites, stomatitis and ulceration, constipation, dyspeptic signs and symptoms, flatulence, bloating and distension, loose stools uncommon:
Maltese: sintomi u sinjali gastrointestinali, rifjut, uġigħ gastrointestinali u addominali, kondizzjonijiet gastrointestinali infjammatorji, emorraġiji gastrointestinali, ulċerazzjonijiet u perforazzjonijiet gastrointestinali, axxite, stomatite u ulċerazzjoni, stitikezza, sintomi u sinjali dispeptiċi, uġigħ ta' gass fl-istonku, nefħa u tkabbir, purgar maħlul mhux komuni:
English: Obliterative bronchiolitis developed in 21.7% of patients in the tacrolimus group compared with 38.0% of patients in the ciclosporin group (p = 0.025).
Maltese: Bronkjolite obliterattiva żviluppat f'21.7% tal-pazjenti tal-grupp li ħadu tacrolimus meta mqabbla mat-38.0% talpazjenti li kienu fil-grupp ta' ciclosporin (p = 0.025).
English: Excipients with known effect: Each capsule contains 102.17 mg lactose.
Maltese: Kull kapsula fiha 102.17 mg lactose.
English: Acute rejection episodes per 100 patient-days were numerically fewer in the tacrolimus (0.85 episodes) than in the ciclosporin group (1.09 episodes).
Maltese: Episodji ta' rifjut akut għal kull 100 jum-pazjent kienu numerikament inqas f'dawk li ħadu tacrolimus (0.85 episodji) milli dawk tal-grupp li ħadu ciclosporin (1.09 episodji).
English: Strong interactions have been observed with antifungal agents such as ketoconazole, fluconazole, itraconazole, voriconazole and isavuconazole, the macrolide antibiotic erythromycin, HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), HCV protease inhibitors (e.g. telaprevir, boceprevir, and the combination of ombitasvir and paritaprevir with ritonavir, when used with and without dasabuvir), or the CMV antiviral letermovir, the pharmacokinetic enhancer cobicistat, and the tyrosine kinase inhibitors nilotinib and imatinib.
Maltese: Interazzjonijiet qawwija kienu osservati ma' aġenti antifungali bħalma huma ketoconazole, fluconazole, itraconazole, voriconazole u isavuconazole, l-antibijotiku macrolide erythromycin, HIV protease inhibitors (eż. ritonavir nelfinavir, saquinavir), inibituri ta' protease HCV (eż. telaprevir, boceprevir, u ombitasvir u paritaprevir flimkien ma' ritonavir, meta użati ma' jew mingħajr dasabuvir), jew l-antivirali letermovir għas-CMV, il-potenzjatur farmakokinetiku cobicistat, u linibituri ta' tyrosine kinase, nilotinib u imatinib.
English: Tacrolimus may prolong the QT interval and may cause Torsades de Pointes.
Maltese: Tacrolimus jista' jtawwal l-intervall QT u jista jikkaġuna Torsades de Pointes.
English: Excipients with known effect: Each capsule contains 51.09 mg lactose.
Maltese: Kull kapsula fiha 51.09 mg lactose.
English: Advagraf is used in adults.
Maltese: Advagraf jingħata lil persuni adulti.
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 Advagraf.
Maltese: Każijiet ta' nefropatija assoċjata mal-virus BK, kif ukoll każijiet ta' lewkoenċefalopatija multifokali progressiva (PML) assoċjata mal-virus JC, ġew irrapportati f'pazjenti kkurati b'immunosuppressanti, inkluż Advagraf.
English: Transparent PVC/PVDC aluminium blister or unit-dose perforated blister wrapped in an aluminium wrapper with a desiccant containing 10 capsules per blister.
Maltese: Folja trasparenti PVC/PVDC tal-aluminju jew kapsuli mifrudin minn ma' xulxin fuq l-istess folja mgeżwrin f'qoxra tal-aluminju b'desikkant u li fiha 10 kapsuli kull folja.
English: Posterior reversible encephalopathy syndrome (PRES) Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Maltese: Sindrome ta' enċefalopatija riversibbli ta' wara (PRES, Posterior reversible encephalopathy syndrome) Saru rapporti li pazjenti ttrattati b'tacrolimus jiżviluppaw is-sindrome tal-enċefalopatija riversibbli posterjuri (posterior reversible encephalopathy syndrome - PRES).
English: acute and chronic pancreatitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying rare:
Maltese: pankreatite akuta u kronika, , ileus paralitiku, marda ta' rifluss gastroosofaġeali, dewmin fl-iżvojtar gastriku rari:
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and antipyrine.
Maltese: Informazzjoni mill-annimali turi li tacrolimus jista' potenzjalment inaqqas din it-tneħħija u jżid il-half life ta' pentobarbital u antipyrine.
English: Other interactions potentially leading to increased tacrolimus blood levels Tacrolimus is extensively bound to plasma proteins.
Maltese: Interazzjonijiet oħra li jistgħu jżidu l-livelli fid-demm ta' tacrolimus Tacrolimus jingħaqqad estensivament mal-proteini tal-plażma.
English: - if you are allergic to sirolimus or to any macrolide-antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Maltese: - jekk int allerġiku/a gћal sirolimus jew gћal kwalunkwe antibijotiku-makrolidi (eż. erythromycin, clarithromycin, josamycin).
English: How to store Advagraf
Maltese: Mediċini oħra u Advagraf
English: Therefore, metabolites do not contribute to the pharmacological activity of tacrolimus.
Maltese: Għaldaqstant, il-metaboliti ma jikkontribwixxux għall-attività farmakoloġika ta' tacrolimus.
English: Systemically available tacrolimus is metabolised by hepatic CYP3A4.
Maltese: Tacrolimus li hu disponibbli fis-sistema jiġi metabolizzat bil-CYP3A4 tal-fwied.
English: Absorption is variable and the mean oral bioavailability of tacrolimus (investigated with the Prograf formulation) is in the range of 20% - 25% (individual range in adult patients 6% - 43%).
Maltese: L-assorbiment ivarja u l-medja biodisponibbli orali ta' tacrolimus (investigat bil-formulazzjoni ta' Prograf) qiegħda fil-medda ta' minn 20% sa 25% (il-medda individwali f'pazjenti adulti hija ta' bejn 6% u 43%).
English: Patients treated with tacrolimus have been reported to develop Epstein-Barr-Virus (EBV)-associated lymphoproliferative disorders (see section 4.8).
Maltese: Pazjenti li qed jieħdu tacrolimus ġew irrapportati li żviluppaw disturbi limfoproliferattiv marbutin mal-virus Epstein-Barr (EBV) (ara sezzjoni 4.8).
English: If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Advagraf may need to be reduced.
Maltese: Jekk jidhru sinjali ta' tossiċità bћal reazzjonijiet avversi serji (ara sezzjoni 4.8) jista' jkun li d-doża ta' Advagraf jkollha titnaqqas.
English: 12-month graft survival was 91.5% for Advagraf and 92.8% for Prograf.
Maltese: Wara 12-il xahar mittrapjant, kien hemm sopravivenza tat-trapjant ta' 91.5% gћal Advagraf u 92.8% gћal Prograf.
English: Other interactions leading to clinically detrimental effects Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (e.g., aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir or aciclovir).
Maltese: L-użu ta' tacrolimus flimkien ma' prodotti mediċinali oħra magħrufa li għandhom effetti nefrotossiċi jew newrotossiċi jista' jżid dawn l-effetti (eż. aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir jew aciclovir).
English: Excipients with known effect: Each capsule contains 510.9 mg lactose.
Maltese: Kull kapsula fiha 510.9 mg lactose.
English: The event rate of biopsy confirmed acute rejection within the first 24 weeks after transplantation was 32.6% in the Advagraf group (N=237) and 29.3% in the Prograf group (N=234).
Maltese: Ir-rata ta' rifjut akut ikkonfermat b'bijopsija fl-ewwel 24 ġimgħa wara t-trapjant kien 32.6% fil-grupp ta' Advagraf (N=237) u 29.3% fil-grupp ta' Prograf (N=234).
English: A combination of immunosuppressives such as antilymphocytic antibodies (e.g. basiliximab, daclizumab) given concomitantly increases the risk of EBVassociated lymphoproliferative disorders.
Maltese: Taħlita ta' immunosuppressivi bħalma huma antikorpori antilimfoċitiċi (eż. basiliximab, daclizumab), mogħtija flimkien ikabbru r-riskju tad distrubi limfoproliferattivi marbutin mal-EBV.
English: The event rate for biopsy-confirmed acute rejection within the first 24 weeks after transplantation was 18.6% in the Advagraf group (N=331) and 14.9% in the Prograf group (N=336).
Maltese: Ir-rata ta' rifjut akut ikkonfermat b'bijopsija fl-ewwel 24 ġimgħa wara t-trapjant kien 18.6% fil-grupp ta' Advagraf (N=331) u 14.9% fil-grupp ta' Prograf (N=336).
English: The use of live attenuated vaccines should be avoided (see section 4.4).
Maltese: Tilqim ħaj attenwat għandu jiġi evitat (ara sezzjoni 4.4).
English: In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3).
Maltese: Fil-firien u l-fniek, tacrolimus ikkawża tossiċità embrijofetali f'dożaġġ li wera t-tossiċità materna (ara sezzjoni 5.3).
English: A number of associated cases of transplant rejection have been reported (frequency cannot be estimated from available data).
Maltese: Numru ta' każijiet assoċjati ta' rifjut ta' trapjanti kien irrapportat (stima tal-frekwenza ma tistax tittieћed mill-informazzjoni disponibbli).
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull kapsula, jiġifieri essenzjalment ‘ħielsa mis-sodium'
English: Pancreas survival at 1 year was significantly superior with tacrolimus: 91.3% versus 74.5% with ciclosporin (p < 0.0005), whereas renal graft survival was similar in both groups.
Maltese: 91.3% kontra 74.5% b'ciclosporin (p < 0.0005), filwaqt li dawk li għexu wara trapjant tal-kliewi kien simili fiż-żewġ gruppi.
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Maltese: Bħal fil-każ ta' komponenti immunosuppressivi qawwijin oћrajn, mhux magħruf x'riskju jista' jkun hemm ta' kanċer sekondarju (ara sezzjoni 4.8).
English: In man tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract.
Maltese: Fil-bniedem, tacrolimus deher li jista' jiġi assorbit mill-kanal gastrointestinali.
English: Pain in extremity has been described in a number of published case reports as part of CalcineurinInhibitor Induced Pain Syndrome (CIPS).
Maltese: L-uġigħ fl-estremitajiet ġie deskritt f'numru ta' rapporti ta' każijiet ippubblikati bħala parti misSindrome ta' Uġigħ Ikkaġunat minn Calcineurin-Inhibitor (CIPS, Calcineurin-Inhibitor Induced Pain Syndrome).
English: renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptoms uncommon:
Maltese: insuffiċjenza renali, insuffiċjenza renali akuta, nefropatija tossika, nekrożi tubulari tal-kliewi, anormalitajiet urinarji, oligurija, sintomi tal-bużżieqa u tal-kanal talawrina mhux komuni:
English: Prograf and Advagraf both contain the active substance, tacrolimus.
Maltese: Prograf u Advagraf, it-tnejn gћandhom is-sustanza attiva tacrolimus.
English: Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors, ATC code: L04AD02
Maltese: Immunosuppressanti, Inibituri ta' calcineurin, Kodiċi ATC:
English: The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC0-24) for Advagraf is similar to that of Prograf.
Maltese: Ir-relazzjoni bejn l-inqas livelli ta' tacrolimus (C24) u l-espożizzjoni sistemika (AUC0-24) għal Advagraf tixbaћ ħafna lil dik ta' Prograf.
English: CYP3A4 inhibitors potentially leading to increased tacrolimus blood levels Clinically the following substances have been shown to increase tacrolimus blood levels:
Maltese: Indutturi ta' CYP3A4 li jistgħu jnaqqsu l-livelli fid-demm ta' tacrolimus Klinikament is-sustanzi li ġejjin urew li jnaqqsu l-livelli ta' tacrolimus fid-demm:
English: It is not recommended that Advagraf is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Maltese: Mhux rakkomandat li tieћu Advagraf flimkien ma' ciclosporin (mediċina oħra li tintuża biex tevita rifjut tal-organu trapjantat).
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Maltese: Il-kura għar-rifjut tal-allograft li tkun reżistenti għall-kura bi prodotti mediċinali immunosuppressivi oħra f'pazjenti adulti.
English: Capsule shell:
Maltese: Il-qoxra tal-kapsula:
English: In an additional two-centre study, 26 patients were randomised to the tacrolimus versus 24 patients to the ciclosporin group.
Maltese: Fi studju ieħor f'żewġ ċentri, 26 pazjent intgħażlu b'mod randomizzat biex jieħdu tacrolimus kontra 24 pazjent fil-grupp ta' ciclosporin.
English: Freedom from acute rejection was higher in the tacrolimus group at 6 months (57.7% versus 45.8%) and at 1 year after lung transplantation (50% versus 33.3%).
Maltese: Ħelsien minnrifjut akut kien ikbar fil-grupp li ħadu tacrolimus wara sitt xhur (57.7% kontra 45.8%) u wara sena li kienu għamlu t-trapjant tal-pulmun (50% kontra 33.3%).
English: hirsutism
Maltese: irsutiżmu
English: Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole, nefazodone and (Chinese) herbal remedies containing extracts of Schisandra sphenanthera.
Maltese: Kien hemm interazzjonijiet aktar ħfief bi clotrimazole, bi clarithromycin, b'josamycin, b'nifedipine, b'nicardipine, b'diltiazem, b'verapamil, b'amiodarone, b'danazol, b'ethinylestradiol, b'omeprazole u b'nefazodone u mediċini tal-ħxejjex (Ċiniżi) li għandhom estratti ta' Schisandra sphenanthera.
English: Each capsule of Advagraf 0.5 mg contains 0.5 mg of tacrolimus (as monohydrate).
Maltese: Kull kapsula Advagraf 0.5 mg fiha 0.5 mg ta' tacrolimus (bħala monoidrat).
English: Also contains lactose and traces of soya lecithin.
Maltese: Fih ukoll: lactose u traċċi ta' soja lecithin.
English: Each capsule of Advagraf 3 mg contains 3 mg of tacrolimus (as monohydrate).
Maltese: Kull kapsula Advagraf 3 mg fiha 3 mg ta' tacrolimus (bħala monoidrat).
English: The printing ink used on Advagraf capsules contains soya lecithin.
Maltese: Il-linka użata fuq il-kapsuli ta' Advagraf fiha soja lecithin.
English: nervous system disorders seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired uncommon:
Maltese: disturbi fis-sistema nervuża attakk ta' puplesija, disturbi meta f'sensik, newropatiji periferali, sturdamenti, parestesija u disestesija, nuqqas ta' ħila fil-kitba mhux komuni:
English: Advagraf capsules contain lactose.
Maltese: Il-kapsuli ta' Advagraf, fihom lactose.
English: Stopping your treatment with Advagraf may increase the risk of rejection of your transplanted organ.
Maltese: Jekk twaqqaf il-kura ta' Advagraf tista' tkabbar ir-riskju ta' rifjut tal-organu trapjantat.
English: metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia uncommon:
Maltese: , aċidożi metabolika, anormalitajiet elektroliti oħra, iponatremija, fluwidu żejjed, iperuriċemija,ipomagnesemija, ipokalemija, ipokalċemija, nuqqas ta' aptit, iperkolesterolemija, iperlipidemija, ipertrigliċeridemija, ipofosfatemija mhux komuni:
English: The 12-month patient survival rates were 98.6% for Advagraf, 95.7% for Prograf and 97.6% for ciclosporin; in the Advagraf arm 3 patients died (all male), in the Prograf arm 10 patients died (3 female, 7 male) and in the ciclosporin arm 6 patients died (3 female, 3 male).
Maltese: Wara 12-il xahar mit-trapjant, 98.6% tal-pazjenti li ћadu Advagraf, 95.7% tal-pazjenti li ћadu Prograf u 97.6% tal-pazjenti li ћadu ciclosporin għexu; fil-fergħa ta' -Advagraf 3 pazjenti mietu (kollha rġiel), fil-fergħa ta' Prograf 10 pazjenti mietu (3 nisa, 7 irġiel) u fil-fergħa ta' ciclosporin 6 pazjenti mietu (3 nisa, 3 irġiel).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.
Maltese: Jekk jidhru xi sinjali kliniċi ta' rifjut, għandha titqies bidla fir-reġimen immunosuppressiv.
English: 12-month graft survival was 85.3% for Advagraf and 85.6% for Prograf.
Maltese: 3% gћal Advagraf u 85.
English: This typically presents as a bilateral and symmetrical, severe, ascending pain in the lower extremities and may be associated with supra-therapeutic levels of tacrolimus.
Maltese: Dan normalment jinħass ruħu bħala wġigħ bilaterali u simmetriku, sever u axxendenti flestremitajiet t'isfel u jista' jkun assoċjat ma' livelli supra-terapewtiċi ta' tacrolimus.
English: Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.
Maltese: Żidiet fid-dożi ta' tacrolimus, terapija supplementari kortikosterojdika, kif ukoll l-introduzzjoni ta' korsijiet qosra ta' antikorpi mono-/poliklonali kollha ntużaw biex jikkontrollaw episodji ta' rifjut.