FrancophonIA/ELRC3.0 huggingface dataset:
English: No specific antidote to tacrolimus therapy is available.
Maltese: Ma hemm l-ebda antidotu speċifiku għal terapija ta' tacrolimus.
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: Corresponding data based on whole blood averaged 47.6 l.
Maltese: Data li tikkorrispondi bbażata fuq id-demm sħiħ kellha medja ta'47.6 l.
English: haemolytic uraemic syndrome, anuria very rare:
Maltese: sindrome uremika emolitika, anurja rari ħafna:
English: The treatment difference was -3.0% (tacrolimus prolonged-release capsules - ciclosporin) (95.2% confidence interval [-9.9%, 4.0%]) for tacrolimus prolonged-release capsules vs. ciclosporin and1.9% (tacrolimus immediate release capsules - ciclosporin) (95.2% confidence interval [-8.9%, 5.2%]) for tacrolimus immediate release capsules vs. ciclosporin.
Maltese: [-9.9%, 4.0%]) gћal tacrolimus kapsuli li jerħu l-mediċina bil-mod vs ciclosporin u -1.9% (Tacrolimus kapsuli li jerħu l-mediċina b'mod immedjat-ciclosporin) (intervall ta' fiduċja ta' 95.2% [-8.9%, 5.2%]) gћal tacrolimus kapsuli li jerħu l-mediċina b'mod immedjat vs. ciclosporin.
English: The 1 - year patient survival rate was 80.8% in the tacrolimus and 83% in the ciclosporin group.
Maltese: 8% filgrupp ta' tacrolimus u 83% fil-grupp li ħadu ciclosporin.
English: It is an immunosuppressant.
Maltese: Huwa immunosoppressant.
English: Date of first authorisation: 8 December 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 8 ta' Diċembru 2017
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 taċ-ċellula T u lproliferazzjoni taċ-ċellula B li hi dipendenti fuq iċ-ċellula T-helper, kif ukoll il-formazzjoni ta' limfokini (bħall-interlewkini 2, 3, u l- γ-interferon) u l-espressjoni tar-reċettur tal-interlewkin 2.
English: How to take Tacforius
Maltese: Tiħux Tacforius
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: Tacforius 5 mg capsules contains ponceau 4R
Maltese: Kapsuli Tacforius 5 mg fihom ponceau 4R
English: Tacforius contains lactose (milk sugar).
Maltese: Tacforius fih lactose (zokkor tal-ћalib).
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 ta' pazjent kienu numerikament inqas f'dawk li ħadu tacrolimus (0.85 episodju) milli dawk tal-grupp li ħadu ciclosporin (1.09 episodji).
English: 0.10 - 0.30 mg per kg body weight per day depending on the transplanted organ.
Maltese: 0.10 - 0.30 mg kuljum għal kull kg tal-piż tal-ġisem skont l-organu trapjantat.
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: kondizzjonijiet gastrointestinali infjammatorji, emorraġiji gastrointestinali, ulċerazzjoni u perforazzjoni gastrointestinali, axxite, stomatite u ulċerazzjoni, stitikezza, sintomi u sinjali dispeptiċi, uġigħ ta' gass fl-istonku, nefħa u tkabbir, purgar maħlul mhux komuni:
English: Teva Operations Poland Sp. z o.o.
Maltese: Teva Operations Poland Sp. z o.o. Mogilska 80
English: Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments.
Maltese: Tacrolimus hu sustanza immunosoppressiva qawwija ħafna u wera attività f'esperimenti kemm in vitro kif ukoll in vivo.
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 irrappurtati li żviluppaw disturbi limfoproliferattiv marbutin mal-virus Epstein-Barr (EBV - Epstein-Barr-Virus) (ara sezzjoni 4.8).
English: In practice, tacrolimus-based therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Maltese: It-terapija bbażata fuq tacrolimus, fil-prattika tibda minn bejn 12-il siegħa sa 24 siegħa wara li jkun twaqqaf ciclosporin.
English: Other medicines and Tacforius
Maltese: Mediċini oħra u Tacforius
English: - Keep this leaflet.
Maltese: - Formazzjoni ta' ċesti fil-frixa
English: Only one of these has been shown in vitro to have immunosuppressive activity similar to that of tacrolimus.
Maltese: Wieħed minn dawn biss deher in vitro li għandu attività immunosoppressiva simili għal dik ta' tacrolimus.
English: EU/1/17/1244/025 100 capsules EU/1/17/1244/026 100x1 capsules
Maltese: EU/1/17/1244/026 100x1 kapsula
English: To date, no other relevant epidemiological data are available.
Maltese: Sa llum, m'hemmx disponibbli l-ebda data epidemjoloġiku rilevanti oħra.
English: Tacforius 5 mg capsules contain ponceau 4R.
Maltese: Kapsuli Tacforius 5 mg fihom ponceau 4R.
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% tal pazjenti li kienu fil-grupp ta' ciclosporin (p = 0.025).
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 rifjut akut kien ikbar fil-grupp li ħadu tacrolimus wara sitt xhur (57.7% kontra 45.8%) u wara sena wara trapjant tal-pulmun (50% kontra 33.3%).
English: If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Tacforius 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' Tacforius jkollha titnaqqas.
English: pericardial effusion very rare:
Maltese: indeboliment fl-iżvojtar gastriku rari:
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' immunosoppressivi bħalma huma antikorpi antilimfoċitiċi (eż. basiliximab, daclizumab), mogħtija flimkien ikabbru r riskju ta' disturbi limfoproliferattivi marbutin mal-EBV.
English: Systemically available tacrolimus is metabolised by hepatic CYP3A4.
Maltese: Tacrolimus li hu disponibbli fis-sistema jiġi metabolizzat minn CYP3A4 tal-fwied.
English: Published clinical experience from a single centre on the use of oral tacrolimus immediate release capsules 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 ppubblikata minn ċentru wieħed dwar l-użu ta' tacrolimus kapsuli li jerħu l mediċina b'mod immedjat 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 il-fwied u l-intestini, u 25 multivixxerali), f'dawk li ħadu tacrolimus u prednisone kienet ta' 75% wara sena, 54% wara 5 snin, u 42% wara 10 snin.
English: joint disorders rare:
Maltese: disturbi fil-ġogi rari:
English: 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 magħrufa li għandhom effetti nefrotossiċi jew newrotossiċi jista' jżid dawn l-effetti (eż., aminoglycosides, inibituri ta' gyrase, vancomycin, cotrimoxazole, NSAIDs, ganciclovir jew aciclovir).
English: nervous system disorders, seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired uncommon:
Maltese: disturbi fis-sistema nervuża, aċċessjonijiet, disturbi fl-istat ta' koxjenza, newropatiji periferali, sturdamenti, parestesiji u disestesiji, indeboliment fil-kitba mhux komuni:
English: hirsutism
Maltese: Pożoloġija
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the halflife of pentobarbital and antipyrine.
Maltese: Data mill-annimali turi li tacrolimus jista' potenzjalment inaqqas din it-tneħħija u jżid il-half life ta' pentobarbital u antipyrine.
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 fl-embrijuni u l-feti b'dożi li wrew tossiċità materna (ara sezzjoni 5.3).
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Maltese: Bħal fil-każ ta' komposti immunosoppressivi qawwijin oћrajn, mhux magħruf x'riskju jista' jkun hemm ta' kanċer sekondarju (ara sezzjoni 4.8).
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 tacrolimus prolonged-release capsules.
Maltese: Każijiet ta' nefropatija assoċjata mal-virus BK, kif ukoll każijiet ta' lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy) assoċjata mal-virus JC, ġew irrappurtati f'pazjenti kkurati b'immunosoppressanti, inkluż tacrolimus kapsuli li jerħu l-mediċina bil mod.
English: There is limited experience in non-Caucasian patients and patients at elevated immunological risk (e.g. retransplantation, evidence of panel reactive antibodies, PRA).
Maltese: Hemm esperjenza limitata f'pazjenti mhux Kawkasi kif ukoll f'pazjenti li għandhom riskju immunoloġiku elevat (eż. trapjant mill-ġdid, evidenza ta' panel reactive antibodies, PRA)
English: Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Maltese: Għandha tingħata attenzjoni meta pazjenti jinqalbu minn terapija bbażata fuq ciclosporin għal terapija bbażata fuq tacrolimus (ara sezzjonijiet 4.4 u 4.5).
English: The most commonly reported adverse reactions (occurring in >10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni (>10 % tal-pazjenti) huma rogћda, indeboliment renali, kondizzjonijiet ipergliċemiċi, dijabete mellitus, iperkalimja, infezzjonijiet,
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.01 to 0.03 mg/kg/day and oral tacrolimus was administered at a dose of 0.05 to 0.3 mg/kg/day.
Maltese: Tacrolimus inbeda bħala infużjoni kontinwa fil-vini b'doża ta' 0.01 sa 0.03 mg/kg/jum u tacrolimus orali ngħata b'doża ta' 0.05 sa 0.3 mg/kg/jum.
English: Absorption is variable and the mean oral bioavailability of tacrolimus (immediate release capsules formulation) is in the range of 20% - 25% (individual range in adult patients 6% - 43%).
Maltese: L-assorbiment ivarja u l-medja tal-bijodisponibilità orali ta' tacrolimus (formulazzjoni ta' kapsuli li jerħu l-mediċina b'mod immedjat) qiegħda fil-medda ta' 20% - 25% (il-medda individwali f'pazjenti adulti hija 6% - 43%).
English: In prospective studies oral tacrolimus immediate release capsules was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Maltese: Fi studji prospettivi, tacrolimus kapsuli li jerħu l-mediċina b'mod immedjat orali kien investigat bħala immunosoppressant primarju f'bejn wieħed u ieħor 175 pazjent wara trapjant tal-pulmun, f'475 pazjent wara trapjant tal-frixa u f'630 pazjent wara trapjant intestinali.
English: A multicentre study using oral tacrolimus immediate release capsules included 205 patients undergoing simultaneous pancreas-kidney transplantation who were randomised to tacrolimus (n = 103) or to ciclosporin (n = 102).
Maltese: 205 pazjenti li għamlu f'daqqa trapjant tal-frixa u l-kliewi li kienu randomised għal tacrolimus (n = 103 pazjenti) jew għal ciclosporin (n = 102).
English: heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations rare:
Maltese: insuffiċjenza tal-qalb, arritmiji ventrikolari u waqfien kardijaku, arritmiji supraventrikolari, kardjomijopatiji, ipertrofija ventrikolari, palpitazzjonijiet rari:
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 immunosoppressivi oħra f'pazjenti adulti.
English: The event rate for biopsy-confirmed acute rejection within the first 24 weeks after transplantation was 18.6% in the tacrolimus prolonged-release capsules group (N=331) and 14.9% in the tacrolimus immediate release capsules group (N=336).
Maltese: Ir-rata ta' rifjut akut ikkonfermat b'bijopsija fl-ewwel 24 ġimgħa wara t-trapjant kienet ta' 18.6% fil-grupp ta' tacrolimus kapsuli li jerħu l-mediċina bil-mod (N=331) u 14.9% fil-grupp ta' tacrolimus kapsuli li jerħu l-mediċina b'mod immedjat (N=336).
English: Tacrolimus is also considerably metabolised in the intestinal wall.
Maltese: Tacrolimus jiġi wkoll metabolizzat b'mod konsiderevoli fil-ħajt intestinali.
English: Absorption 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: 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 potenzjali oħra li jistgħu jżidu l-esponiment sistemiku għal tacrolimus jinkludu sustanzi prokinetiċi (bħalma huma metoclopramide u cisapride), cimetidine u magnesium-aluminum-hydroxide.
English: Administration should commence approximately 12 - 18 hours after the completion of surgery.
Maltese: Għandha tibda tingħata bejn wieħed u ieħor 12-il siegħa sa 18-il siegħa mill-operazzjoni.
English: 5 mg Contains lactose and ponceau 4R.
Maltese: Fih lactose u ponceau 4R.
English: EU/1/17/1244/018 EU/1/17/1244/019 EU/1/17/1244/020
Maltese: EU/1/17/1244/021 EU/1/17/1244/022 EU/1/17/1244/023 EU/1/17/1244/024
English: EBV-Viral Capsid Antigen (VCA)-negative patients have been reported to have an increased risk of developing lymphoproliferative disorders.
Maltese: Pazjenti negattivi għall-antiġen tal-Kapsida Virali (VCA - Viral Capsid Antigen) ta' EBV ġew irrappurtati li għandhom żieda fir-riskju li jiżviluppaw dawn id-disturbi limfoproliferattivi.
English: Tacrolimus immediate release capsules (e.g, Tacni) and Tacforius prolonged-release capsules both contain the active substance, tacrolimus.
Maltese: Tacrolimus kapsuli li jerћu l-mediċina b'mod immedjat (eż., Tacni) u Tacforius kapsuli li jerћu l mediċina bil-mod, it-tnejn fihom is-sustanza attiva tacrolimus.
English: The 12 - month patient survival rates were 98.6% for tacrolimus prolonged-release capsules, 95.7% for tacrolimus immediate release capsules and 97.6% for ciclosporin; in the tacrolimus prolonged-release capsules arm 3 patients died (all male), in the tacrolimus immediate release capsules 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 tacrolimus kapsuli li jerħu l-mediċina bil-mod, 95.7% tal-pazjenti li ћadu tacrolimus kapsuli li jerħu l-mediċina b'mod immedjat u 97.6% tal-pazjenti li ћadu ciclosporin għexu; fil-fergħa ta' tacrolimus kapsuli li jerħu l-mediċina bil-mod 3 pazjenti mietu (kollha rġiel), fil-fergħa ta' tacrolimus kapsuli li jerħu l-mediċina b'mod immedjat 10 pazjenti mietu (3 nisa, 7 irġiel) u fil fergħa ta' ciclosporin 6 pazjenti mietu (3 nisa, 3 irġiel).
English: Transparent PVC/PVDC aluminium blister or perforated unit-dose blister wrapped in an aluminium pouch with a desiccant containing 10 capsules per blister.
Maltese: Folja trasparenti tal-PVC/PVDC aluminju jew folja perforata b'doża waħda mgeżwra f'borża talaluminju b'desikkant li fiha 10 kapsuli f'kull folja.
English: Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Maltese: Saru rapporti li pazjenti ttrattati b'tacrolimus żviluppaw is-sindrome tal-enċefalopatija riversibbli posterjuri (PRES - posterior reversible encephalopathy syndrome).
English: Titanium dioxide (E171)
Maltese: Iron oxide isfar (E172) Titanium dioxide (E171) Gelatin
English: The event rate of biopsy confirmed acute rejection within the first 24 weeks after transplantation was 32.6% in the tacrolimus prolonged-release capsules group (N=237) and 29.3% in the tacrolimus immediate release capsules group (N=234).
Maltese: Ir-rata ta' rifjut akut ikkonfermat b'bijopsija fl-ewwel 24 ġimgħa wara t-trapjant kienet ta' 32.6% fil-grupp ta' tacrolimus kapsuli li jerħu l-mediċina bil-mod (N=237) u 29.3% fil grupp ta' tacrolimus kapsuli li jerħu l-mediċina b'mod immedjat (N=234).
English: 12 - month graft survival was 96.7% for tacrolimus prolonged-release capsules, 92.9% for tacrolimus immediate release capsules and 95.7% for ciclosporin.
Maltese: Ma' 12-il xahar mit-trapjant, kien hemm sopravivenza tat-trapjant ta' 96.7% gћal tacrolimus kapsuli li jerħu l-mediċina bil-mod, 92.9% gћal tacrolimus kapsuli li jerħu l-mediċina b'mod immedjat u 95.7% gћal ciclosporin.
English: Herbal preparations containing St. John's Wort (Hypericum perforatum) or other herbal preparations should be avoided when taking tacrolimus due to the risk of interactions that lead to either a decrease in blood concentrations of tacrolimus and reduced clinical effect of tacrolimus, or an increase in blood concentrations of tacrolimus and risk of tacrolimus toxicity (see section 4.5).
Maltese: interazzjonijiet li jwasslu għal tnaqqis kemm fil-konċentrazzjoni fid-demm kif ukoll fl-effett kliniku ta' tacrolimus, jew żieda fil-konċentrazzjonijiet ta' tacrolimus fid-demm u riskju ta' tossiċità ta' tacrolimus (ara sezzjoni 4.5).
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 għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'gћandhomx jieћdu dan il-prodott mediċinali.
English: Patients treated with immunosuppressants, including tacrolimus are at increased risk for infections including opportunistic infections (bacterial, fungal, viral and protozoal) such as BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Maltese: Pazjenti kkurati b'immunosoppressanti, inkluż tacrolimus huma f'riskju akbar għal infezzjonijiet inklużi infezzjonijiet opportunistiċi (batterjali, fungali, virali u protożoali) bħal vajrus BK assoċjat man-nefropatija u l-vajrus JC assoċjat mal-lewkoenċefalopatija multifokali progressiva (PML
English: Approximately 2% of the radioactivity was eliminated in the urine.
Maltese: Bejn wieħed u ieħor 2% tar-radjuattività tneħħiet mal-awrina.
English: The incidence of efficacy failure at 12 months (defined as death, graft loss, biopsy-confirmed acute rejection, or lost to followup) was 14.0% in the tacrolimus prolonged-release capsules group (N=214), 15.1% in the tacrolimus immediate release capsules group (N=212) and 17.0% in the ciclosporin group (N=212).
Maltese: inċidenza ta' nuqqas ta' effikaċja wara 12-il xahar (definit bћala mewt, telf tat-trapjant, rifjut akut ikkonfermat b'bijopsija jew ma ġiex segwit) kienet 14.0% fil-fergħa ta' tacrolimus kapsuli li jerħu l mediċina bil-mod (N=214), 15.
English: metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia uncommon:
Maltese: aċidożi metabolika, anormalitajiet fl-elettroliti oħra, iponatremija, fluwidu żejjed, iperuriċemija,ipomanjesimja, ipokalimja, ipokalċemija, nuqqas ta' aptit, iperkolesterolemija, iperlipidemija, ipertrigliċeridemija, ipofosfatemija mhux komuni:
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 fl-estremitajiet t'isfel u jista' jkun assoċjat ma' livelli supra-terapewtiċi ta' tacrolimus.
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 b'żewġ ċentri, 26 pazjent kienu randomised biex jieħdu tacrolimus kontra 24 pazjent għall-grupp ta' ciclosporin.
English: Each capsule of Tacforius 0.5 mg contains 0.5 mg of tacrolimus (as monohydrate).
Maltese: Kull kapsula Tacforius 0.5 mg fiha 0.5 mg ta' tacrolimus (bħala monohydrate ).
English: Each capsule of Tacforius 3 mg contains 3 mg of tacrolimus (as monohydrate).
Maltese: Kull kapsula Tacforius 3 mg fiha 3 mg ta' tacrolimus (bħala monohydrate ).
English: Tacforius 5 mg prolonged-release hard capsules Red iron oxide (E172)
Maltese: Tacforius 5 mg kapsuli ibsin li jerћu l-mediċina bil-mod Iron oxide aħmar (E172)
English: Pack sizes: 30, 50, 60 and 100 prolonged-release hard capsules in blisters or 30x1, 50x1, 60x1 and 100x1 prolonged-release hard capsules in perforated unit-dose blisters.
Maltese: Daqsijiet tal-pakkett ta': 30, 50, 60 u 100 kapsula iebsa li terћi l-mediċina bil-mod f'folji jew 30x1, 50x1, 60x1 u 100x1 kapsuli iebsin li jerħu l-mediċina bil-mod f'folji perforati b'doża waħda.
English: In stable patients converted from tacrolimus immediate release capsules (twice daily) to tacrolimus prolonged-release capsules (once daily) on a 1:1 (mg:mg) total daily dose basis, the systemic exposure to tacrolimus (AUC0-24) for tacrolimus prolonged-release capsules was approximately 10% lower than that for tacrolimus immediate release capsules.
Maltese: F'pazjenti stabbli li qalbu minn tacrolimus kapsuli li jerћu l-mediċina b'mod immedjat (darbtejn kuljum) għal tacrolimus kapsuli li jerћu l-mediċina bil-mod (darba kuljum) fuq bażi ta' doża totali kuljum ta' 1:1 (mg:mg), l-esponiment sistemiku għal tacrolimus (AUC0-24) għal tacrolimus kapsuli li jerћu l-mediċina bil-mod kien bejn wieħed u ieħor 10% inqas minn dak għal tacrolimus kapsuli li jerћu l-mediċina b'mod immedjat.
English: Not known (frequency cannot be estimated from the available data) - Abnormality of the optic nerve (optic neuropathy)
Maltese: - Anormalità tan-nerv ottiku (newropatija ottika)
English: psychotic disorder Nervous system disorders very common: headache, tremor common:
Maltese: disturbi psikotiċi Disturbi fis-sistema nervuża komuni ħafna:
English: In addition, synergistic/additive nephrotoxic effects can occur.
Maltese: Barra dan jistgħu jseħħu wkoll effetti sinerġistiċi/addittivi nefrotossiċi.