FrancophonIA/ELRC3.0 huggingface dataset:
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 riġezzjoni akuta għal tacrolimus kontra pazjenti li ħadu ciclosporin (11.5% kontra t-22.6%) u inqas inċidenza ta' riġezzjoni kronika, is-sindrome bronkolite obliterans (2.86% versus 8.57%).
English: < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tal-effetti mhux mixtieqa hija definita kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 to < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieћed stima mid-data disponnibbli).
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Maltese: Bħal fil-każ ta' komponenti potenti immunosuppressivi oћra, mhux magħruf x'riskju jista' jkun hemm ta' kanċer sekondarju (ara taqsima 4.8).
English: renal impairment common:
Maltese: indeboliment renali komuni:
English: Only one of these has been shown in vitro to have immunosuppressive activity similar to that of tacrolimus.
Maltese: Waħda minn dawn biss dehret, in vitro, li għandha attività immunosuppressiva simili għal dik ta' tacrolimus.
English: The 1-year patient survival rate was 80.8% in the tacrolimus and 83% in the ciclosporin group.
Maltese: 8% tal-pazjenti li għexu wara li ħadu tacrolimus u 83% fil-grupp li ħadu ciclosporin.
English: Lymphoproliferative disorders and malignancies
Maltese: Disturbi limfoproliferattivi u malinji
English: Astellas Pharmaceuticals AEBE
Maltese: Astellas Pharmaceuticals AEBE Ελλάδα
English: Significantly more ciclosporin-treated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02).
Maltese: Sinifikattiv il-fatt li kien hemm aktar pazjenti li ħadu ciclosporin (n = 13) li kellhom jaqilbu għal tacrolimus milli pazjenti fuq tacrolimus li kellhom jaqilbu għal ciclosporin (n = 2) (p = 0.02).
English: The 1-year patient survival was 83% in the tacrolimus and 71% in the ciclosporin group, the 2-year survival rates were 76% and 66%, respectively.
Maltese: F'sena kien hemm 83% tal-pazjenti li għexu wara li ħadu tacrolimus u 71% fil-grupp li ħadu ciclosporin, fit-tieni sena kien hemm rispettivament 76% u 66% li għexu.
English: Tacrolimus may prolong the QT interval and may cause Torsades de Pointes.
Maltese: Tacrolimus jista' jtawwal l-intervall QT jista jikkaġuna Torsades de Pointes.
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' riġezzjoni akuta 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: Each sachet contains less than 1 mmol sodium (23 mg).
Maltese: Kull qartas fih inqas minn 1 mmol sodium (23 mg)
English: Batch:
Maltese: Eżempju:
English: acute respiratory distress syndrome Gastrointestinal disorders very common:
Maltese: sindrome ta' għeja respiratorja akuta Disturbi gastro-intestinali komuni ħafna:
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 talgrupp li ħadu tacrolimus meta mqabbla mat-38.0% tal-pazjenti li kienu fil-grupp ta' ciclosporin (p = 0.025).
English: psychotic disorder Nervous system disorders very common:
Maltese: disturbi psikotiċi Disturbi fis-sistema nervuża komuni ħafna:
English: Posterior reversible encephalopathy syndrome (PRES) Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Maltese: Saru rapporti li pazjenti ttrattati b'tacrolimus jiżviluppaw is-sindrome tal-enċefalopatija riversibbli posterjuri (posterior reversible encephalopathy syndrome - PRES).
English: Mean oral bioavailability of tacrolimus (investigated with the Prograf capsules formulation) is in the range of 20 - 25% (individual range in adult patients 6 - 43%, in paediatric kidney transplant patients 3 - 77%).
Maltese: Il-biodisponnibilta orali medja ta' tacrolimus (investigat bil-formulazzjoni tal-kapsuli Prograf) qiegħda filmedda ta' minn 20 sa 25% (il-medda individwali f'pazjenti adulti hija ta' bejn 6 u 43%), f'pazjenti pedjatrici ta' trapjant tal- kliewi 3-77%).
English: Published clinical experience from a single centre on the use of oral tacrolimus 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' tacrolimus 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 lfwied 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: In paediatric liver and kidney transplant patients, values for total body clearance of 2.3 ± 1.2 ml/min/kg and 2.1 ± 0.6 ml/min/kg, respectively, have been observed.
Maltese: F'pazjenti pedjatriċi ta' trapjant tal-fwied u tal-kliewi, valuri gћal tneћћija totali mill-ġisem ta' 2.3 ± 1.2 ml/min/kg and 2.1 ± 0.6 ml/min/kg, rispettivament, ġew osservati.
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 (bħal l-interlewkini 2, -3, u l- γinterferon) u l-espressjoni tar-reċettur interlewkin-2.
English: Another randomised study included 66 patients on tacrolimus versus 67 patients on ciclosporin.
Maltese: Studju ieħor ‘randomised' kien jinkludi 66 pazjent li ħadu tacrolimus kontra s-67 pazjent li ħadu ciclosporin.
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, riġettar, uġigħ gastrointestinali u addomenali, kondizzjonijiet gastrointestinali infjammatorji, emorraġiji gastrointestinali, ulċerazzjonijiet u perforazzjonijiet gastrointestinali, axxite, stomatite u ulċerazzjoni, kostipazzjoni, sintomi u sinjali dispeptiċi, uġigħ ta' gas fl-istonku, nefħa u tkabbir, purgar maħlul mhux komuni:
English: Modigraf is a granular formulation of tacrolimus, for twice-a-day administration.
Maltese: Modigraf, huwa formulazzjoni granulari ta' tacrolimus, li jittieħed darbtejn kuljum.
English: Then give a total daily dose of Modigraf 1.4 mg divided as 0.8 mg in the morning and 0.6 mg in the evening.
Maltese: Mela agħti doża totali tal-ġurnata ta' Modigraf 1.4 mg maqsuma bħala 0.8 mg filgħodu u 0.6 mg filgħaxija.
English: The use of live attenuated vaccines should be avoided (see section 4.4).
Maltese: Tilqim ħaj attenwat għandu jiġi evitat (ara taqsima 4.4).
English: Tacrolimus affected fertility in male rats (see section 5.3).
Maltese: Tacrolimus affetwa il-fertilita tal-firien irgiel (ara sezzjoni 5.3).
English: How to take Modigraf
Maltese: Mediċini oħra u Modigraf
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 Modigraf.
Maltese: Każijiet ta' nefropatija assoċjata ma' virus BK, kif ukoll każijiet ta' lewkoenċefalopatija multifokali progressiva (PML) assoċjata ma' virus JC, ġew irrapportati f'pazjenti kkurati b'immunosuppressanti, inkluż Modigraf.
English: thromboembolic and ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders uncommon:
Maltese: inċidenti trombemboliċi u iskemiċi, disturbi vaskolari ipotensivi, emorraġija, disturbi vaskolari periferiċi mhux komuni:
English: Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments.
Maltese: Tacrolimus hu aġent immunosuppressiv qawwi ħafna u wera attività fl-esperimenti kemm in vitro kif ukoll in vivo.
English: very rare:
Maltese: katarretti rari:
English: Clinically significant interactions have also been observed with phenobarbital.
Maltese: Interazzjonijiet kliniċi sinifikanti dehru wkoll ma' phenobarbital.
English: pancreatic pseudocyst, subileus Hepatobiliary disorders common:
Maltese: pseudoċista pankratika, subileus Disturbi fil-fwied u fil-marrara Komuni ћafna:
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 17 Feb 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazjoni: 15 ta` Mejju 2009
English: Pack size: carton box containing 50 sachets.
Maltese: Daqs tal-pakkett: pakkett ta' 50 qartas
English: Modigraf 0.2 mg granules for oral suspension EU/1/09/523/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Modigraf 0.2 mg granijiet gћal suspensjoni orali EU/1/09/523/001
English: Therefore, metabolites do not contribute to pharmacological activity of tacrolimus.
Maltese: Għaldaqstant, il-metaboliti ma jikkontribwixxux għall-attività farmakoloġika ta' tacrolimus.
English: Patients should be converted to oral therapy as soon as clinically practicable.
Maltese: Pazjenti gћandhom jinqalbu gћal terapija orali malli jkun klinikament possibbli.
English: In addition, synergistic/additive nephrotoxic effects can occur.
Maltese: Jistgħu wkoll jinħolqu effetti sinerġistiċi/addittivi nefrotossiċi.
English: headache, tremor common:
Maltese: dijarrea, dardir komuni:
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: Materials containing polyvinyl chloride (PVC) should not be used (see section 6.2).
Maltese: M'għandhomx jintużaw materjali bi polyvinyl chloride (PVC) (ara taqsima 6.2).
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 issigurtà għal dan il-prodott skont il-ħtiġijiet stabbiliti fil-lista ta' dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikata fuq il-portal elettroniku Ewropew tal-mediċini.
English: febrile neutropenia
Maltese: disturbi fil-ġogi
English: Torsades de Pointes
Maltese: DATA TA' SKADENZA
English: Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension
Maltese: Modigraf 0.2 mg granijiet gћal suspensjoni orali Modigraf 1 mg granijiet gћal suspensjoni orali
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and phenazone.
Maltese: Informazzjoni mill-annimali turi li tacrolimus jista' potenzjalment inaqqas din it-tneħħija u jżid il-half life ta' pentobarbital u phenazone.
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.
Maltese: Il-kura għar-riġezzjoni tal-allograft li tkun reżistenti għall-kura bi prodotti mediċinali immunosuppressivi oħra f'adulti u pazjenti pedjatrici.
English: When tacrolimus is administered intravenously as rapid infusion/bolus injection at a dose of 0.1 to 1.0 mg/kg, QTc prolongation has been observed in some animal species.
Maltese: Meta tacrolimus jingħata ġol-vina bħala infużjoni / injezzjoni bolus rapida f'doża ta 0.1-1.0 mg / kg, titwil tal-QTc kien osservat f'xi speċi ta' annimali.
English: Other interactions which have led 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, sulfamethoxazole+trimethoprim, 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, sulfamethoxazole+trimethoprim, NSAIDs, ganciclovir jew aciclovir).
English: Modigraf 0.2 mg granules for oral suspension tacrolimus
Maltese: Modigraf 0.2 mg granijiet gћal suspensjoni orali tacrolimus
English: Modigraf contains lactose (milk sugar).
Maltese: Modigraf fih lactose (zokkor tal-ћalib).
English: The relationship between tacrolimus trough levels (C12) and systemic exposure (AUC0-12) is similar between the 2 formulations Modigraf granules and Prograf capsules.
Maltese: Ir-relazzjoni li hemm bejn l-inqas livelli ta' tacrolimus (C24) u l-espożizzjoni sistemiku (AUC 0-24) huma simili bejn iż-żewġ formulazzjonijiet ta' u ta' granuli ta` Modigraf u kapsuli ta` Prograf.
English: In an additional 2-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 ‘randomised' biex jieħdu tacrolimus kontra 24 pazjent fil-grupp ta' ciclosporin.
English: primary graft dysfunction
Maltese: disfunzjoni tat-trapjant primarju
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li jkollhom problemi ereditarji rari ta' intolleranza ta' galactose, defiċjenza ta' lactase Lapp jew ma jassorbux tajjeb glucose - galactose ma' gћandhomx jieћdu dan il-prodott mediċinali.
English: In general, paediatric patients require doses 1½ - 2 times higher than the adult doses to achieve similar blood levels.
Maltese: Ġeneralment, pazjenti pedjatriċi jkollhom bżonn doża bejn 1½-2 aktar gћolja minn pazjenti adulti biex jintlaћqu livelli fid-demm simili.
English: In paediatric liver transplant patients the mean oral bioavailability of tacrolimus (investigated with the Modigraf granules) is 26%± 23% (individual range in paediatric liver transplant patients 4 - 80%).
Maltese: F'pazjenti pedjatriċi ta' trapjant tal-fwied, il-medjat ta' biodisponnibilta' orali ta' tacrolimus (investigat bilgranijiet Modigraf) hu 26%± 23% (il-medda individwali f'pazjenti pedjatriċi ta' trapjant tal-fwied hija ta' bejn 4% u 80%).
English: Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors, ATC code: L04AD02
Maltese: Immunosuppressanti, inibituri ta' calcineurin, Kodiċi ATC:
English: Croscarmellose sodium (E468)
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Lactose monohydrate Hypromellose (E464) Croscarmellose sodium (E468)
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 dehru li żviluppaw disturbi limfoproliferattiv marbutin mal-Epstein Barr Virus (EBV) (ara taqsima 4.8).
English: Increased tacrolimus doses, 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' anti-korpi mono-/poliklonali kollha ntużaw biex jikkontrollaw episodji ta' riġezzjoni.
English: In man, tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract.
Maltese: Fil-bniedem, tacrolimus deher li jista' jigi assorbit mill-kanal gastrointestinali.
English: EBV-Viral Capsid Antigen (VCA)-negative patients have been reported to have an increased risk of developing lymphoproliferative disorders.
Maltese: Pazjenti negattivi għall-EBV-Kapsida Antigena Virali (VCA) dehru li żiedu r-riskju li jiżviluppaw dawn id-disturbi limfoproliferattiv.
English: A multicentre study included 205 patients undergoing simultaneous pancreas-kidney transplantation who were randomised to tacrolimus (n = 103) or to ciclosporin (n = 102).
Maltese: Studju f'diversi ċentri inkluda 205 pazjent li għamlu f'daqqa trapjant tal-pankreas u l-kliewi li ttieħdu bladdoċċ għal (n = 103 pazjenti) bi-kura ta' tacrolimus jew għal (n = 102 pazjenti) bil-kura ta' ciclosporin.
English: Results of a single dose bioequivalence study with adult healthy volunteers showed that Modigraf granules were approximately 20% more bioavailable than the Prograf capsules.
Maltese: Ir-riżultati ta' studji bioekwivalenti ma' adulti b'saћћithom volontarji urew li il-granijiet ta' Modigraf kienu bejn wieћed u ieћor 20% iktar biodisponibbli mill-kapsuli ta' Prograf.
English: Other interactions potentially leading to increased tacrolimus blood levels Tacrolimus is extensively bound to plasma proteins.
Maltese: Interazzjonijiet oħra li jistgħu jżidu il-livelli fid-demm ta' tacrolimus Tacrolimus jingħaqqad estensivament mal-proteini tal-plażma.
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 fjakki b'clotrimazole, b'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 andġhom estratti ta Schisandra sphenanthera.
English: Following oral administration of Modigraf granules peak concentrations (Cmax) of tacrolimus in blood are on average achieved in approximately 2 to 2.5 hours.
Maltese: Wara amminsitrazzjoni orali tal-granijiet ta' Modigraf il-konċentrazzjoni massima fid-demm (Cmax) ta' tacrolimus hi ta' bejn wieћed u ieћor 2 sa 2.5 sieghat.
English: Modigraf 1 mg granules for oral suspension tacrolimus
Maltese: Modigraf 1 mg granijiet gћal suspensjoni orali tacrolimus
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 minn riġezzjoni akuta kien ikbar fil-grupp li ħadu tacrolimus wara sitt xhur (57.7% versus 45.8%) u wara sena li kienu għamlu t-trapjant talpulmun (50% kontra 33.3%).
English: CYP3A4 inhibitors potentially leading to increased tacrolimus blood levels Clinically the following substances have been shown to increase tacrolimus blood levels: 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 għasCMV, il-potenzjatur farmakokinetiku cobicistat, u l-inibituri ta' tyrosine kinase, nilotinib u imatinib.
English: Other potential interactions that may increase systemic exposure of tacrolimus include prokinetic agents (such as metoclopramide and cisapride), cimetidine and magnesium-aluminium-hydroxide.
Maltese: Interazzjonijiet oħra li jistgħu jżidu l-esponiment sistemiku ta' tacrolimus jinkludu aġenti prokinetiċi (bħalma huma metoclopramide u cisapride), cimetidine u magnesium-aluminum-hydroxide.
English: acute and chronic pancreatitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying rare:
Maltese: pankreatite akuta u kronika, peritonite, żieda tal-amylase fid-demm, ileus paralitiku, marda ta' rifluss gastroosofaġeali, dewmin fl-iżvojtar gastriku rari:
English: In some patients, tacrolimus appears to be continuously absorbed over a prolonged period yielding a relatively flat absorption profile.
Maltese: F'xi pazjenti, tacrolimus jidher li qed jigi kontinwametn assorbit fuq perjodu prolungat u jerhi profil relativament ċatt.
English: Approximately 2% of the radioactivity was eliminated in the urine.
Maltese: Bejn wieħed u ieħor 2% tar-radjoattività tneħħiet mal-awrina.
English: 2 ml of water (at room temperature) should be used per 1 mg tacrolimus to produce a suspension (up to a maximum of 50 ml, depending on body weight) in a cup.
Maltese: Għandhom jintużaw 2 ml ilma (temperatura tal-kamra) ma' kull 1 mg tacrolimus biex tipproduċi suspensjoni (sa massimu ta' 50 ml, skont il-piż tal-ġisem) f'tazza.
English: metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia uncommon:
Maltese: anoressija, aċidożi metabolika, anormalitajiet elektroliti oħra, iponatremija, fluwidu żejjed, iperuriċemija,ipomagnesemija, ipokalemija, ipokalċemija, nuqqas ta' aptit, iperkolesterolemija, iperlipidemija, ipertrigliċeridemija, ipofosfatemija mhux komuni:
English: The half-life of tacrolimus is long and variable.
Maltese: Il-half life ta' tacrolimus hi twila u varjabbli.
English: A combination of immunosuppressives such as antilymphocytic antibodies (e.g. basiliximab, daclizumab) given concomitantly increases the risk of EBV-associated lymphoproliferative disorders.
Maltese: Taħlita ta' immunosuppressivi bħalma huma antikorpori antilimfoċitiċi (eż. basiliximab, daclizumab), mogħtija flimkien ikabbru r-riskju tad-distrubi limfoproliferattivi marbutin malEBV.
English: Tacrolimus is a low-clearance substance.
Maltese: Tacrolimus hu imqassam estensivament mal-ġisem.
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 għallMediċini: http://www.ema.europa.eu/.
English: If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Modigraf may need to be reduced.
Maltese: Jekk jidhru sinjali ta' tossiċita' bћal reazzjonijiet avversi qawwija (ara taqsima 4.8) jista' jkun li d-doża ta' Modigraf jkollha titnaqqas.
English: NN:
Maltese: Sími:
English: This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull qartas, jiġifieri essenzjalment ‘ħielsa missodium'.