FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with immunosuppressants, including Advagraf 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: Infezzjonijiet li jinkludu wkoll infezzjonijiet opportunistiċi Pazjenti kkurati b'immunosuppressanti, inkluż Advagraf huma f'riskju akbar għal infezzjonijiet li jinkludu wkoll infezzjonijiet opportunistiċi (batterjali, fungali, virali u protożoali) bħal virus BK u lewkoenċefalopatija multifokali progressiva (PML) assoċjata mal-virus JC.
English: Astellas Pharma S.p.A. Tel: + 39 (0)2 921381
Maltese: Tel: + 39 (0)2 921381
English: The 12-month patient survival rates were 96.9% for Advagraf and 97.5% for Prograf; in the Advagraf arm 10 patients died (3 female, 7 male) and in the Prograf arm 8 patients died (3 female, 5 male).
Maltese: Wara 12-il xahar mit-trapjant, 96.9% tal-pazjenti li ћadu Advagraf u 97.5% tal-pazjenti li ћadu Prograf għexu; fil-grupp ta' Advagraf 10 pazjenti mietu (3 nisa, 7 irġiel) u fil-grupp ta' Prograf 8 pazjenti mietu (3 nisa, 5 irġiel).
English: 30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 60 prolonged-release hard capsules 60×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100×1 prolonged-release hard capsules
Maltese: 30 kapsula iebsa li jerћu l-mediċina bil-mod 30 ×1 kapsula iebsa li jerћu l-mediċina bil-mod 50 kapsula iebsa li jerћu l-mediċina bil-mod 50×1 kapsula iebsa li jerћu l-mediċina bil-mod 60 kapsula iebsa li jerћu l-mediċina bil-mod 60×1 kapsula iebsa li jerћu l-mediċina bil-mod 100 kapsula iebsa li jerћu l-mediċina bil-mod 100×1 kapsula iebsa li jerћu l-mediċina bil-mod
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 mdorrija fuq terapija bbażata fuq ciclosporin taqlibhom għall-kura bbażata fuq tacrolimus (ara sezzjonijiet 4.4 u 4.5).
English: In practice, tacrolimus-based therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Maltese: Il-kura bbażata fuq tacrolimus, filprattika tibda minn bejn 12-il siegħa sa 24 siegħa wara li jkun twaqqaf ciclosporin.
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) ġew irrapportati li żiedu r-riskju li jiżviluppaw dawn id-disturbi limfoproliferattiv.
English: The treatment difference was -3.0% (Advagrafciclosporin) (95.2% confidence interval [-9.9%, 4.0%]) for Advagraf vs. ciclosporin and -1.9% (Prografciclosporin) (95.2% confidence interval [-8.9%, 5.2%]) for Prograf vs. ciclosporin.
Maltese: [-9.9%, 4.0%]) gћal Advagraf vs ciclosporin u -1.9% (Prograf-ciclosporin) (95.
English: Administration should commence approximately 12-18 hours after the completion of surgery.
Maltese: Għandha tibda tingħata minn bejn 12-il siegħa sa 18-il siegħa mill-operazzjoni.
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 Kawkażi kif ukoll f'pazjenti li għandhom riskju immunoloġiku elevat (per. eż. ritrapjant, evidenza ta' panel reattiv ta' antikorpi,(PRA))
English: Advagraf 0.5 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “0.5 mg” on the light yellow capsule cap and “ 647” on the orange capsule body, containing white powder.
Maltese: Advagraf 0.5 mg kapsuli ibsin li jerћu l-mediċina bil-mod Kapsuli tal-ġelatina, b'“0.5 mg” miktuba bl-aħmar fuq l-għatu isfar ċar tal-kapsula u b'“ 647” fuq lgħatu oranġjo tal-kapsula, mimlija trab abjad.
English: EU/1/07/387/003 30 capsules EU/1/07/387/004 50 capsules EU/1/07/387/005 60 capsules EU/1/07/387/006 100 capsules EU/1/07/387/017 30×1 capsules EU/1/07/387/018 50×1 capsules EU/1/07/387/019 60×1 capsules EU/1/07/387/020 100×1 capsules
Maltese: EU/1/07/387/003 30 kapsula EU/1/07/387/004 50 kapsula EU/1/07/387/005 60 kapsula EU/1/07/387/006 100 kapsula EU/1/07/387/017 30×1 kapsula EU/1/07/387/018 50×1 kapsula EU/1/07/387/019 60×1 kapsula EU/1/07/387/020 100×1 kapsula
English: fall, ulcer, chest tightness, thirst very rare:
Maltese: uġigħ, ulċera, sider magħfus, għatx rari ħafna:
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Maltese: F'ċirkolazzjoni sistemika hemm waħda biss mill-metaboliti inattivi, b'konċentrazzjoni baxxa.
English: The initial oral per protocol dose of tacrolimus was 0.2 mg/kg/day with subsequent dose adjustments to target trough levels of 8 to 15 ng/ml by Day 5 and 5 to 10 ng/ml after Month 6.
Maltese: Id-doża orali fil-bidu ta' kull protokol ta' tacrolimus kienet ta' 0.2 mg/kg/kuljum b'aġġustamenti wara fid-doża biex ilaħħqu l-mira tal-livelli minimi ta' 8 sa 15 ng/ml sal-ħames jum u 5 to 10 ng/ml wara s-sitt xahar.
English: The incidence of efficacy failure at 12 months (defined as death, graft loss, biopsy-confirmed acute rejection, or lost to follow-up) was 14.0% in the Advagraf group (N=214), 15.1% in the Prograf group (N=212) and 17.0% in the ciclosporin group (N=212).
Maltese: 1% filfergħa ta' Prograf (N=212) u 17.0% fil-grupp ta' ciclosporin (N=212).
English: heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations rare:
Maltese: waqfien tal-qalb, arritmea ventrikolari u waqfien kardijaku, arritmea supraventrikolari, kardjomijopatite, ipertrofija ventrikolari, palpitazzjonijiet,
English: EU/1/07/387/011 30 capsules EU/1/07/387/012 50 capsules EU/1/07/387/013 100 capsules EU/1/07/387/021 30×1 capsules EU/1/07/387/022 50×1 capsules EU/1/07/387/023 100×1 capsules
Maltese: EU/1/07/387/011 30 kapsula EU/1/07/387/012 50 kapsula EU/1/07/387/013 100 kapsula EU/1/07/387/021 30×1 kapsula EU/1/07/387/022 50×1 kapsula EU/1/07/387/023 100×1 kapsula
English: The efficacy and safety of Advagraf and Prograf, both in combination with corticosteroids, was compared in 471 de novo liver transplant recipients.
Maltese: L-effikaċja u s-sigurtà ta' Advagraf u Prograf, meta ngћataw flimkien ma' kortikosterojdi, tqabbel f'f'471 riċevitur de novo ta' trapjant tal-fwied.
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' galattosi, defiċjenza ta' lattasi Lapp jew ma jassorbux tajjeb glukosju-galattosju ma' gћandhomx jieћdu dan il-prodott mediċinali.
English: Dose reduction may be necessary in patients with severe liver impairment (see section 4.2).
Maltese: F'pazjenti li jkollhom indeboliment sever tal-fwied jista' ikun li jiħtieġu tnaqqis tad-doża (ara sezzjoni 4.2).
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet suspettati avversi wara l-awtorizzazzjoni tal-prodott mediċinali.
English: coagulopathies, pancytopenia, neutropenia, coagulation and bleeding analyses, abnormal rare:
Maltese: koagulopatite, panċitopenija, newtropenija, analiżi tal-koagulazzjoni u tad-dmija anormali rari:
English: Corresponding data based on whole blood averaged 47.6 l.
Maltese: Tagħrif li għandu x'jaqsam ma' dan ibbażat fuq id-demm sħiħ kellu medja ta'47.6 l.
English: Advagraf 3 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “3 mg” on the orange capsule cap and “ 637” on the orange capsule body, containing white powder.
Maltese: Advagraf 3 mg kapsuli ibsin li jerћu l-mediċina bil-mod Kapsuli tal-ġelatina, b'“3 mg” miktuba bl-aħmar fuq l-għatu oranġjo tal-kapsula u b'“ 637” fuq lgħatu oranġjo tal-kapsula, mimlija trab abjad.
English: A multicentre study using oral Prograf 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 bl-użu ta' Prograf orali inkluda 205 pazjenti li għamlu f'daqqa trapjant tal-frixa u l-kliewi li ttieħdu bl-addoċċ għal (n = 103 pazjenti) bil-kura ta' tacrolimus jew għal (n = 102 pazjenti) bil-kura ta' ciclosporin.
English: Advagraf 0.5 mg prolonged-release hard capsules Advagraf 1 mg prolonged-release hard capsules Advagraf 3 mg prolonged-release hard capsules Advagraf 5 mg prolonged-release hard capsules
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI FOLJA Advagraf 0.5 mg kapsuli ibsin li jerћu l-mediċina bil-mod
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: influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance rare:
Maltese: , mard bħal tal-influwenza, fid-demm, tħossok abnormali, diversi organi ma jaħdmux, sensazzjoni ta' pressjoni fuq is-sider, intolleranza tat-temperatura rari:
English: Advagraf 5 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “5 mg” on the greyish red capsule cap and “ 687” on the orange capsule body, containing white powder.
Maltese: Advagraf 5 mg kapsuli ibsin li jerћu l-mediċina bil-mod Kapsuli tal-ġelatina, b'“5 mg” miktuba bl-aħmar fuq l-għatu aħmar fil griż tal-kapsula u b'“ 687” fuq l-għatu oranġjo tal-kapsula, mimlija trab abjad.
English: Advagraf contains lactose, sodium and lecithin (soya)
Maltese: Advagraf fih il-lattosju, is-sodium u l-lecithin (soja) Advagraf fih lattosju (zokkor tal-ћalib).
English: Lansoprazole and ciclosporin may potentially inhibit CYP3A4-mediated metabolism of tacrolimus and thereby increase tacrolimus whole blood concentrations.
Maltese: Lansoprazole u ciclosporin jista' jkun li potenzjalment jinibixxu l-metaboliżmu bil-CYP3A4 ta' tacrolimus u b'hekk iżid il-konċentrazzjonijiet ta' tacrolimus fid-demm sħiħ.
English: Each capsule of Advagraf 5 mg contains 5 mg of tacrolimus (as monohydrate).
Maltese: Kull kapsula Advagraf 5 mg fiha 5 mg ta' tacrolimus (bħala monoidrat).
English: Advagraf 0.5 mg prolonged-release hard capsules Tacrolimus
Maltese: Advagraf 0.5 mg kapsuli ibsin li jerћu l-mediċina bil-mod Tacrolimus
English: Severe effects may occur, including allergic and anaphylactic reactions.
Maltese: Jista' jkun hemm xi effetti serji, inkluż reazzjonijiet allerġiċi u anafilattiċi.
English: The FKBP12tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calciumdependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of cytokine genes.
Maltese: Il-kumpless FKBP12tacrolimus speċifikament u kompetittivament jingħaqqad ma' u jinibixxi l-kalċinewrina, li jwassal għall-inibizzjoni tal-mogħdijiet trans duktali tas-sinjal tat-T-cell, u li hi dipendenti fuq il-kalċjum.
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 rrapportati (>10% tal-pazjenti) huma rogћda, indeboliment renali, kondizzjonijiet ipergliċemiċi, dijabete mellitus, iperkalemija, infezzjonijiet, pressjoni gћolja u nuqqas ta' rqad.
English: Each capsule of Advagraf 1 mg contains 1 mg of tacrolimus (as monohydrate).
Maltese: Kull kapsula Advagraf 1 mg fiha 1 mg ta' tacrolimus (bħala monoidrat).
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.025 mg/kg/day and oral tacrolimus was administered at a dose of 0.15 mg/kg/day with subsequent dose adjustments to target trough levels of 10 to 20 ng/ml.
Maltese: Tacrolimus inbeda bħala infużjoni kontinwa ġol-vini b'doża ta' 0.025 mg/kg/kuljum u tacrolimus orali ingħata f'doża ta' 0.15 mg/kg/kuljum b'aġġustamenti wara fid-doża biex jilħqu llivelli minimi ta' minn 10 sa 20 ng/ml.
English: Advagraf 1 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “1 mg” on the white capsule cap and “ 677” on the orange capsule body, containing white powder.
Maltese: Advagraf 1 mg kapsuli ibsin li jerћu l-mediċina bil-mod Kapsuli tal-ġelatina, b'“1 mg” miktuba bl-aħmar fuq l-għatu abjad tal-kapsula u b'“ 677” fuq l-għatu oranġjo tal-kapsula, mimlija trab abjad.
English: Treatment of allograft rejection after transplantation of other allografts Although there is no clinical experience with Advagraf in lung-, pancreas- or intestine-transplanted patients, Prograf has been used in lung-transplanted patients at an initial oral dose of 0.10 - 0.15 mg/kg/day, in pancreas-transplanted patients at an initial oral dose of 0.2 mg/kg/day and in intestinal transplantation at an initial oral dose of 0.3 mg/kg/day.
Maltese: Trattament tar-rifjut ta' allograft wara trapjanti ta' allografts oћra Għalkemm ma hemm ebda esperjenza klinika b'Advagraf f'pazjenti li għamlu trapjant tal-pulmun, talfrixa jew tal-intestini (msaren), Prograf intuża f'pazjenti li kellhom trapjant tal-pulmun b'doża millħalq li bdiet bi 0.10 - 0.15 mg/kg/kuljum, f'pazjenti bi trapjant tal-pancreas b'doża mill-ħalq li bdiet bi 0.2 mg/kg/kuljum u f'pazjenti bi trapjant intestinali b'doża mill-ħalq li bdiet bi 0.3 mg/kg/kuljum.
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.05 mg/kg/day and oral tacrolimus was administered at a dose of 0.1 to 0.3 mg/kg/day with subsequent dose adjustments to target trough levels of 12 to 15 ng/ml.
Maltese: Tacrolimus inbeda bħala infużjoni kontinwa intravenali b'doża ta' 0.05 mg/kg/kuljum u tacrolimus orali ingħata f'doża ta' 0.1 għal 0.3 mg/kg/kuljum b'aġġustamenti wara fid-doża biex jilħqu l-livelli minimi ta' minn 12 sa 15 ng/ml.
English: myasthenia
Maltese: mijastenija
English: At the molecular level, the effects of tacrolimus appear to be mediated by binding to a cytosolic protein (FKBP12) which is responsible for the intracellular accumulation of the compound.
Maltese: Fil-livell molekulari, l-effetti ta' tacrolimus jidhru li jibdew billi jingħaqdu ma' proteina ċistolika (FKBP12) li hi responsabbli għall-akkumulazzjoni intraċellulari tat-taħlita.
English: Possible interactions with other active substances known to have high affinity for plasma proteins should be considered (e.g., NSAIDs, oral anticoagulants, or oral antidiabetics).
Maltese: Għalhekk iridu jitqiesu linterazzjonijiet possibbli ma' sustanzi attivi oħra magħrufa li għandhom affinità kbira għall-proteini tal-plażma (eż. NSAIDs, antikoagulanti jew antidijabetiċi orali).
English: Skin and subcutaneous tissue disorders common:
Maltese: Disturbi muskolu-skeltrali u tat-tessuti konnettivi komuni:
English: Itching, rash, hair loss, acne, increased sweating
Maltese: IL-KONTENUT SKONT IL-PIŻ, VOLUM, JEW PARTI
English: Pregnancy and breast-feeding
Maltese: Trapjant tal-Frixa
English: Available tacrolimus is generally rapidly absorbed.
Maltese: Tacrolimus li hawn ġeneralment jiġi assorbit malajr.
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 imma dan jiddependi mill-organu trapjantat.
English: - medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine) - antiemetics, used to treat nausea and vomiting (e.g. metoclopramide) - cisapride or the antacid magnesium-aluminium-hydroxide, used to treat heartburn - the contraceptive pill or other hormone treatments with ethinylestradiol, hormone treatments with danazol - medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine, diltiazem and verapamil) - anti-arrhythmic drugs (amiodarone) used to control arrhythmia (uneven beating of the heart) - medicines known as “statins” used to treat elevated cholesterol and triglycerides - phenytoin or phenobarbital, used to treat epilepsy - the corticosteroids prednisolone and methylprednisolone, belonging to the class of corticosteroids used to treat inflammations or suppress the immune system (e.g. in transplant rejection) - nefazodone, used to treat depression
Maltese: HIV (eż. ritonavir nelfinavir, saquinavir), il-mediċina booster cobicistat, u pilloli ta' kombinazzjoni, li jintużaw gћat-trattament tal-infezzjoni HIV - inibituri ta' protease HCV (eż. telaprevir, boceprevir, u l-kombinazzjoni ombitasvir/paritaprevir/ritonavir bi jew mingħajr dasabuvir) li jintuzaw biex jikkuraw infezzjoni tal-Epatite Ċ. - nilotinib u imatinib (użati għat-trattament ta' ċerti kanċers) - mycophenolic acid, użat għas-soppressjoni tas-sistema immuni biex jipprevjeni r-rifjut tat trapjant - mediċini gћall-ulċeri fl-istonku u rifluss tal-aċidu (eż. omeprazole, lansoprazole jew cimetidine) - antiemetiċi, li jintużaw għall-kura tad-dardir u r-rimettar (eż. metoclopramide) - cisapride jew l-antiaċidu magnesium-aluminium-hydroxide, li jintuża għall-ħruq ta' stonku - il-pillola kontraċettiva jew xi kura oħra ormonali b'ethinylestradiol, kura ormonali b'danazol - mediċini gћall-kura tal-pressjoni għolja jew problemi fil-qalb (eż. nifedipine, nicardipine,
English: Advagraf 3 mg prolonged-release hard capsules EU/1/07/387/011
Maltese: Advagraf 3 mg kapsuli ibsin li jerћu l-mediċina bil-mod EU/1/07/387/011
English: Advagraf 5 mg prolonged-release hard capsules EU/1/07/387/007
Maltese: Advagraf 5 mg kapsuli ibsin li jerћu l-mediċina bil-mod EU/1/07/387/007
English: Results from clinical trials performed with once-daily tacrolimus Advagraf Liver transplantation
Maltese: Riżultati minn provi kliniċi li saru b'tacrolimus darba kuljum Advagraf Trapjant tal-fwied
English: Each capsule contains 1 mg tacrolimus (as monohydrate).
Maltese: Kull kapsula fiha 1 mg ta' tacrolimus (bħala monoidrat)
English: pancreatic pseudocyst, subileus
Maltese: pseudoċista pankratika, subileus Disturbi fil-fwied u fil-marrara komuni:
English: The treatment difference (Advagraf - Prograf) was 3.3% (95% confidence interval [5.7%, 12.3%]).The 12-month patient survival rates were 89.2% for Advagraf and 90.8% for Prograf; in the Advagraf arm 25 patients died (14 female, 11 male) and in the Prograf arm 24 patients died (5 female, 19 male).
Maltese: Wara 12-il xahar mit-trapjant, 89.2% tal-pazjenti li ћadu Advagraf u 90.8% tal-pazjenti li ћadu Prograf għexu; fil-fergћa ta' Advagraf 25 pazjent mietu (14 nisa, 11 irġiel) u fil-fergħa ta'
English: Each capsule contains 5 mg tacrolimus (as monohydrate).
Maltese: Kull kapsula fiha 5 mg ta' tacrolimus (bħala monoidrat)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 1 mg prolonged-release hard capsules (30, 50, 60, 100 Aluminium Wrapper)
Maltese: Ż-ŻGĦAR EWLENIN QARTAS TAL-ALUMINJU Advagraf 1 mg kapsuli ibsin li jerћu l-mediċina bil-mod (30, 50, 60, 100 f'Qartas tal-Aluminju)
English: Hypersensitivity to tacrolimus, or to any of the excipients listed in section 6.1 Hypersensitivity to other macrolides
Maltese: Sensittività eċċessiva għal tacrolimus, jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1
English: Advagraf 1 mg prolonged-release hard capsules Tacrolimus
Maltese: Advagraf 1 mg kapsuli ibsin li jerћu l-mediċina bil-mod Tacrolimus
English: 30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100×1 prolonged-release hard capsules
Maltese: 30 kapsula iebsa li jerћu l-mediċina bil-mod 30×1 kapsula iebsa li jerћu l-mediċina bil-mod 50 kapsula iebsa li jerћu l-mediċina bil-mod 50×1 kapsula iebsa li jerћu l-mediċina bil-mod 100 kapsula iebsa li jerћu l-mediċina bil-mod 100×1 kapsula iebsa li jerћu l-mediċina bil-mod
English: Astellas Pharma Kft. Tel.: +36 1 577 8200
Maltese: Tel.: + 36 1 577 8200
English: The interim analysis of a recent multicentre study using oral Prograf discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Maltese: L-analiżi interim ta' studju reċenti minn diversi ċentri li użaw Prograf orali kien dwar 110 pazjenti li bl-addoċċ ta' 1:1 ingħataw jew tacrolimus jew ciclosporin.
English: Advagraf is a once-a-day oral formulation of tacrolimus.
Maltese: Advagraf huwa formolazzjoni orali ta' tacrolimus li tittieћed darba kuljum.
English: This can lead to graft rejection or increased incidence of adverse reactions, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus.
Maltese: Dan jista' jwassal gћal rifjut tal-graft jew gћal żieda fl-inċidenza tar-reazzjonijiet avversi, inklużi nuqqas jew żieda flimmunosuppressjoni, minћabba differenzi klinikament relevanti fl-espożizzjoni sistemika gћal tacrolimus.
English: Advagraf 0.5 mg prolonged-release hard capsules EU/1/07/387/001
Maltese: Advagraf 0.5 mg kapsuli ibsin li jerћu l-mediċina bil-mod EU/1/07/387/001
English: The combined administration of ciclosporin and tacrolimus is not recommended.
Maltese: Mhuwiex rakkomandat li ciclosporin u tacrolimus jingħataw flimkien.
English: Advagraf 3 mg prolonged-release hard capsules Tacrolimus
Maltese: Advagraf 3 mg kapsuli ibsin li jerћu l-mediċina bil-mod Tacrolimus
English: Advagraf 5 mg prolonged-release hard capsules Tacrolimus
Maltese: Advagraf 5 mg kapsuli ibsin li jerћu l-mediċina bil-mod Tacrolimus
English: Advagraf 3 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 3 mg tacrolimus (as monohydrate).
Maltese: Advagraf 3 mg kapsuli ibsin li jerћu l-mediċina bil-mod Kull kapsula iebsa li terћi l-mediċina bil-mod fiha 3 mg tacrolimus (bћala monoidrat).
English: Tacrolimus is also considerably metabolised in the intestinal wall.
Maltese: Tacrolimus jiġi wkoll immetabolizzat b'mod konsiderevoli fil-ħajt intestinali.
English: Advagraf therapy requires careful monitoring by adequately qualified and equipped personnel.
Maltese: Terapija b'Advagraf teħtieġ monitoraġġ bir-reqqa minn persunal adegwatament ikkwalifikat u attrezzat.
English: Prolonged-release hard capsule.
Maltese: Kapsula iebsa li terћi l-mediċina bil-mod.
English: Advagraf 0.5 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as monohydrate).
Maltese: Advagraf 0.5 mg kapsuli ibsin li jerћu l-mediċina bil-mod Kull kapsula iebsa li terћi l-mediċina bil-mod fiha 0.5 mg tacrolimus (bћala monoidrat).
English: Advagraf 1 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 1 mg tacrolimus (as monohydrate).
Maltese: Advagraf 1 mg kapsuli ibsin li jerћu l-mediċina bil-mod Kull kapsula iebsa li terћi l-mediċina bil-mod fiha 1 mg tacrolimus (bћala monoidrat).
English: As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) should be avoided (see section 4.4).
Maltese: Billi l-kura ta' tacrolimus tista' tkun assoċjata mal-iperkalemija, jew tista' żżid iperkalemija prieżistenti, għandu jiġi evitat it-teħid ta' ammont kbir ta' potassju, jew dijuretiċi potassju-sparing (eż. amiloride, triamterene, jew spironolactone) (ara sezzjoni 4.4).
English: Advagraf 1 mg prolonged-release hard capsules EU/1/07/387/003
Maltese: Advagraf 1 mg kapsuli ibsin li jerћu l-mediċina bil-mod EU/1/07/387/003
English: Effect of tacrolimus on the metabolism of other medicinal products Tacrolimus is a known CYP3A4 inhibitor; thus concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.
Maltese: L-effett ta' tacrolimus fuq il-metaboliżmu ta' prodotti mediċinali oħra Tacrolimus hu inibitur magħruf ta' CYP3A4; għaldaqstant l-użu ta' tacrolimus flimkien ma' prodotti mediċinali magħrufa li jiġu metabolizzati b'CYP3A4 jista' jeffettwa l-metaboliżmu ta' dawn ilprodotti mediċinali.