FrancophonIA/ELRC3.0 huggingface dataset:
English: In prospective published studies oral tacrolimus (given as Prograf capsules) 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 s-sigurtà ta' tacrolimus mogħti darbtejn kuljum fi trapjani ta' organi primarji oћra Fi studji prospettivi pubblikati, tacrolimus orali (mgћoti bћala Prograf) kien investigat bħala immunsuppressant primarju f'bejn wieħed u ieħor 175 pazjent wara trapjant tal-pulmun, f'475 pazjent wara trapjant tal-pankreas u f' 630 pazjent wara trapjant intestinali.
English: If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.
Maltese: Jekk jidhru xi sinjali kliniċi ta' riġezzjoni, għandha tintqies bidla fir-reġimen immunosuppressiv.
English: Race
Maltese: Ir-razza
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 doża infuża kontinwa fil-vini ta' minn 0.01 għal 0.03 mg/kg/kuljum u ngħata tacrolimus orali b'doża ta' minn 0.05 sa 0.3 mg/kg/kuljum.
English: Systemically available tacrolimus is metabolised by hepatic CYP3A4.
Maltese: Tacrolimus li hu disponibbli fis-sistema jimmetabolizza bil-CYP3A4 tal-fwied.
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: Granules for oral suspension.
Maltese: GĦAMLA FARMAĊEWTIKA Granijiet gћal suspensjoni orali.
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: Myasthenia
Maltese: mijastenija
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 rraportati (>10% tal-pazjenti) kienu rogћda, indeboliment renali, kondizzjonijiet ipergliċemiċi, dijabete, iperkalemija, infezzjonijiet, pressjoni gћolja u nuqqas ta' rqad.
English: Tel: +386 (0) 14011 400
Maltese: Astellas Pharma d.o.o. Tel: +386 (0) 14011 400
English: Uncommon side effects (may affect up to 1 in 100 people): - Changes in blood clotting, reduction in the number of all types of blood cells (seen in blood tests) - Dehydration, inability to urinate - Abnormal blood test results: reduced protein or sugar, increased phosphate, increase of the enzyme lactate dehydrogenase - Coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems - Clouding of the eye lens, impaired hearing - Irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal - Blood clot in a vein of a limb, shock - Difficulties in breathing, respiratory tract disorders, asthma
Maltese: Effetti mhux mixtieqa li mhumiex komuni (jistgħu jaffettwa sa 1 minn kull 100 persuni): - Bidla fl-għeqied tad-demm, tnaqqis fin-numru tat-tipi kollha ta'ċelluli tad-demm (li jidhru f'testijiet tad-demm) - Deidrazzjoni (nixfa), ma tistax tgħaddi l-awrina - Riżultati tad-demm li mhumiex normali: tnaqqis ta' proteini jew zokkor, żieda fl-enżima lactate dehydrogenase - Kôma, emoraġġija fil-moħħ, attakk, paraliżi, disturbi fil-moħħ, anormalitajiet fil-kliem u fil-lingwa, problemi ta' memorja - Lenti tal-għajn mżellġa/mhux ċara, smigħ mhux ċar - Taħbit irregolari tal-qalb, waqfien tat-taħbit tal-qalb, tinqis fil-ħidma tal-qalb, taqlib fil-muskolu talqalb, nefha tal-muskolu tal-qalb, taħbit aktar qawwi tal-qalb, ECG anormali, taħbit anormali tal-qalb u tal-polz - Għoqda demm f'vina ta' id jew ta' sieq, xokk - Diffikultajiet fin-nifs, taqlib fil-kanal respiratorju, ażma
English: Each sachet contains 0.2 mg tacrolimus (as monohydrate).
Maltese: Kull qartas fih 0.2 mg ta' tacrolimus (bħala monoidrat).
English: Astellas Ireland Co. Ltd. Killorglin
Maltese: Ireland Co., Ltd.
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 taqsima 4.2).
English: This approach was reserved for patients without organ dysfunction (e.g. renal dysfunction).
Maltese: Dan il-metodu kien irreżervat gћal pazjenti mingћajr disfunzjoni tal-organi (eż. disfunzjoni renali).
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: 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 nanogram/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 to 0.3 mg/kg/kuljum b'aġġustamenti wara fiddoża biex jilħqu l-inqas livelli ta' minn 12 sa 15 nanogram/ml.
English: confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare uncommon:
Maltese: konfużjoni u diżorjentament, depressjoni, sintomi ta' ansjetà, alluċinazzjonijiet, disturbi mentali, burdata depressiva, disturbi u taqlib fil-burdata, ħmar il-lejl mhux komuni:
English: Astellas Pharma Ltd. Tel: + 44 (0) 203 379 8700
Maltese: Tel: + 44 (0) 203 379 8700
English: Stopping your treatment with Modigraf may increase the risk of rejection of your transplanted organ.
Maltese: Jekk twaqqaf il-kura ta' Modigraf tista' tkabbar ir-riskju ta' riġezzjoni tal-organu trapjantat.
English: In practice, tacrolimus-based therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Maltese: Il-kura bażata fuq tacrolimus, fil-prattika tibda minn bejn 12-il siegħa sa 24 siegħa wara li jkun twaqqaf ciclosporin.
English: Example: Total daily dose Prograf capsules given as 1 mg in the morning and 0.5 mg in the evening.
Maltese: Id doża totali tal-ġurnata tal-kapsuli Prograf mgħotija bħala 1mg filgħodu u 0.5 mg filgħaxija.
English: In patients without antibody induction, if tacrolimus therapy is initiated intravenously, the recommended starting dose is 0.03 - 0.05 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) as a continuous 24-hour infusion targeted to achieve tacrolimus whole blood concentrations of 15 - 25 nanogram/ml.
Maltese: 03-0.05 mg/kg/kuljum (b'Prograf 5mg/ml konċentrat għal soluzzjoni għallinfużjoni) bћala infużjoni kontinwa ta' 24 siegћa biex wieћed jilћaq konċentrazzjoni fid-demm ta' tacrolimus ta' 15-25 nanogram/ml.
English: venous thrombosis deep limb, shock, infarction Respiratory, thoracic and mediastinal disorders common:
Maltese: trombożi fonda ġol-vini fir-riġel, xokk, infart Disturbi respiratorji, toraċiċi u medjastinali komuni:
English: Patients treated with immunosuppressants, including Modigraf, 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 Modigraf 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 ma' virus JC.
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: coagulopathies, pancytopenia, neutropenia, coagulation and bleeding analyses abnormal rare:
Maltese: koagulopatite, panċitopenija, newtropenija, analiżi tal-koagulazzjoni u tad-dmija anormali rari:
English: You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Modigraf.
Maltese: Illimita kemm toqgħod fix-xemx u fid-dawl UV(ultraviolet) meta tkun fuq il-kura ta' Modigraf.
English: The first dose of oral therapy should be 0.30 mg/kg/day starting 8 to 12 hours after discontinuing intravenous therapy.
Maltese: Lewwel doża ta' terapija orali gћanda tkun 0.30 mg/kg/kuljum u gћanda tinbeda 8 sa 12-il siegћa wara li jitwaqqaf it-trattament ta' ġol-vini.
English: Modigraf 0.2 mg granules for oral suspension Each sachet contains 0.2 mg tacrolimus (as monohydrate).
Maltese: Modigraf 0.2 mg granijiet gћal suspensjoni orali Kull qartas fih 0.2 mg tacrolimus (bћala monoidrat).
English: Administration should commence within 24 hours after the completion of surgery.
Maltese: Għandha tibda tingħata fi żmien 24 siegħa mill-operazzjoni.
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 nanogram/ml by Day 5 and 5 to 10 nanogram/ml after Month 6.
Maltese: Iddoża 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-inqas livelli ta' 8 sa 15 nanogram/ml sal-ħames jum u 5 to 10 nanogram/ml wara s-sitt xahar.
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: Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Maltese: Għandha tittieħed prekawzjoni partikolari meta pazjenti mdorrija fuq terapija mibnija fuq ciclosporin taqlibhom għall-kura mibnija fuq tacrolimus (ara taqsimiet 4.4 u 4.5).
English: In particular, you should tell your doctor if you are taking or have recently taken medicines like: - antifungal medicines and antibiotics, particularly so-called macrolide antibiotics, used to treat infections e.g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, and isavuconazole, erythromycin, clarithromycin, josamycin, and rifampicin - letermovir, used to prevent illness caused by CMV (human cytomegalovirus) - HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), the booster medicine cobicistat,
Maltese: B'mod partikolari għandek tgħid lit-tabib tiegħek jekk tkunx qed tieħu jew jekk ħadtx reċentement xi mediċini bħal: - mediċini antifungali u antibijotiċi, partikolarment dawk imsejħa antibiotiċi makrolidi, li jintużaw kontra l-infezzjonijiet eż. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, u isavuconazole, erythromycin, clarithromycin, josamycin, u rifampicin - letermovir, użat biex jipprevjeni mard ikkawżat mis-CMV (human cytomegalovirus) - inibituri protesi HIV (eż. ritonavir, nelfinavir, saquinavir), il-mediċina booster cobicistat, u pilloli ta'
English: Pancreas transplantation
Maltese: Trapjant tal-Pankreas
English: encephalopathy, central nervous system haemorrhages and cerebrovascular accidents, coma, speech and language abnormalities, paralysis and paresis, amnesia rare:
Maltese: enċefalopatija, emorragiji fis-sistema nervuża ċentrali u aċċidenti ċerebrovaskolari, kôma, anormalitajiet fil-lingwa u d-diskors, paraliżi u pareżi, amneżija rari:
English: The FKBP12-tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calcium-dependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of lymphokine genes.
Maltese: Il-kumpless FKBP12-tacrolimus speċifikament u kompetittivament jingħaqqad ma' u jinibixxi l-kalċinewrina, li jwassal għall-inibizzjoni talmogħdijiet trans duktali tas-sinjal tat-T-cell, u li hi dipendenti fuq il-kalċjum.
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 nanogram/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 l- inqas livelli ta' minn 10 sa 20 nanogram/ml.
English: renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptoms uncommon:
Maltese: waqfien funzjonali tal-kliewi, waqfien funzjonali tal-kliewi akut, nefropatija tossika, nekrożi tubulari tal-kliewi, anormalitajiet urinarji, oligurija, sintomi tal-bużżieqa u talkanal tal-awrina mhux komuni:
English: Following antibody induction, oral Modigraf therapy should commence at a dose of 0.075 mg/kg/day administered as 2 divided doses (e.g. morning and evening).
Maltese: Wara induzzjoni tal-antikorpi, terapija orali ta' Modigraf gћanda tinbeda b'doża ta' 0.075 mg/kg/kuljum mogћtija f'żewġ dożi (eż. filgћodu u filgћaxija).
English: Therefore, you may be more prone to infections while you are taking Modigraf.
Maltese: Għaldaqstant ma għandekx tredda' waqt li qed tuża Modigraf.
English: Modigraf 1 mg granules for oral suspension Each sachet contains 1 mg tacrolimus (as monohydrate).
Maltese: Modigraf 1 mg granijiet gћal suspensjoni orali Kull qartas fih 1 mg tacrolimus (bћala monoidrat).
English: To date, no other relevant epidemiological data are available.
Maltese: Sa llum, m'hemm l-ebda tagћrif epidemjoloġiku rilevanti ieħor.
English: The interim analysis of a recent multicentre study discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Maltese: Sadattant l-analiżi ta' studju reċenti minn diversi ċentri kien dwar 110 pazjenti li bl-addoċċ ta' 1:1 ingħataw jew tacrolimus jew ciclosporin.
English: Do not use cups or spoons that are made of PVC (polyvinylchloride) to take Modigraf because the active substance in Modigraf may stick to PVC.
Maltese: Tużax tazzi jew imgћaref magћmulin mill-PVC (polyvinylchloride) biex tieћu Modigraf gћax is-sustanza attiva li tinstab f'Modigraf tista' teћel mal-PVC.
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 medjat bil-CYP3A4 ta' tacrolimus u b'hekk iżid il-konċentrazzjonijiet ta' tacrolimus fid-demm sħiħ.
English: Mechanism of action and pharmacodynamic effects 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: Administration should commence approximately 12 hours after the completion of surgery.
Maltese: Għandha tibda tingħata fi żmien 12-il siegħa mill-operazzjoni.
English: Investigations very common:
Maltese: tisfir mhux komuni:
English: rash, pruritus, alopecias, acne, sweating increased uncommon:
Maltese: raxx, ħakk, alopeċja, akne, żieda fl-għaraq mhux komuni:
English: Modigraf 1 mg granules for oral suspension tacrolimus oral use
Maltese: Modigraf 1 mg granijiet gћal suspensjoni orali tacrolimus użu orali
English: It is not recommended that Modigraf is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Maltese: Mhux rakkomandat li tieћu Modigraf flimkien ma' ciclosporin (mediċina oħra użata għall-prevenzjoni ta' rifjut ta' trapjanti).
English: and combination tablets, used to treat HIV infection - HCV protease inhibitors (e.g. telaprevir, boceprevir, and the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir), used to treat hepatitis C infection - nilotinib and imatinib (used to treat certain cancers) - mycophenolic acid, used to suppress the immune system to prevent transplant rejection - medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine) - anti-emetics, used to treat nausea and vomiting (e.g. metoclopramide) - cisapride or the antacid magnesium-aluminium-hydroxide, used to treat heartburn - the contraceptive pill, hormone treatments with ethinylestradiol, or hormone treatments with danazol - medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine,
Maltese: 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 gћal ulċeri fl-istonku u rifluss tal-aċidu (eż. omeprazole, lansoprazole jew cimetidine) - anti-emetiċi, li jintużaw għal-kura tad-dardir u r-rimettar (eż. metoclopramide) - cisapride jew l-antiaċidu magnesium-aluminium-hydroxide, li jintuża għal ħruq ta'stonku - il-pillola kontraċettiva jew xi kura oħra ormonali b' ethinylestradiol, jew kura ormonali b'danazol - mediċini gћall-kura tal-pressjoni għolja jew problemi fil-qalb (eż. nifedipine, nicardipine, diltiazem u verapamil) - mediċini kontra l-arritmja (amiodarone) li jintuzaw biex jikkontrollaw l-arritmja (taħbit irregolari tal qalb) - mediċini magħrufa bħala “statins” li jintużaw fil-kura ta' min għandu kolesterol għoli u trigliċeridi - phenytoin jew phenobarbital, biex jikkuraw l-epilessija - il-kortikosterojdi prednisolone u methylprednisolone, li jagħmlu mal-klassi tal-kortikosterojdi li jintużaw gћat-trattament ta' infjammazzjoni jew li jbaxxu s-sistema immunitarja (eż. F' riġettar tat trapjant) - nefazodone, li jintuża fil-kura tad-depressjoni - mediċini tal-ћxejjex li jkun fihom St.
English: Conversion between Modigraf and Prograf tacrolimus formulations In healthy subjects the systemic exposure to tacrolimus (AUC) for Modigraf was approximately 18% higher than that for Prograf capsules when administered as single doses.
Maltese: F'pazjenti b'saћћithom, l-espożizzjoni sistemika ta' tacrolimus (AUC) gћal Modigraf kien bejn wieћed u ieћor 18% gћola minn dak gћal kapsuli tal-Prograf meta ngћataw doża waћda.
English: Hypersensitivity to tacrolimus or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal tacrolimus jew għal kwalunkwe sustanza oħra mhux attiva elenkata fissezzjoni 6.1.
English: High potassium intake or potassium-sparing diuretics should be avoided (see section 4.5).
Maltese: Għandu jiġi evitat it-teħid ta' ammont kbir ta' potassju, jew dijuretiċi potassium-sparing (ara taqsima 4.5).
English: Therapeutic drug monitoring
Maltese: TAL-PRODOTT MEDIĊINALI
English: abdominal pain, indigestion, constipation, passing wind, bloating, loose stools - Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver - Itching, rash, hair loss, acne, increased sweating - Pain in joints, limbs, back and feet, muscle spasms - Insufficient function of the kidneys, reduced production of urine, impaired or painful urination - General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed - Insufficient function of your transplanted organ
Maltese: Effetti mhux mixtieqa li huma komuni (jistgħu jaffettwa sa 1 minn kull 10 persuni): - Tnaqqis fil-għadd taċ-ċelluli tad-demm (platelits, ċelluli ħomor jew bojod tad-demm), żieda fil-għadd taċ-ċelluli bojod tad-demm, tibdil fil-għadd taċ-ċelluli l-ħomor tad-demm (li jidhru f'testijiet taddemm) - Tnaqqis fid-demm ta' magnesju, fosfat, potassju, kalċju jew sodju, fluwidu żejjed, żieda fid-demm ta' aċidu uriku jew lipidi, nuqqas ta' aptit, żieda fl-aċidità tad-demm, bidliet oħra fil-melħ tad-demm (li jidhru f'testijiet tad-demm) - Sintomi ta' anzjetà, taħwid u diżorjentazzjoni, depressjoni, tibdil fil-burdati, ħmar-il-lejl, alluċinazzjonijiet, disturbi mentali - Aċċessjonijiet, tfixkil meta f'sensik, tnemnim u tirżiħ (nuqqas ta' ħass) (kultant li jwaġġa') fl-idejn u s-saqajn, sturdamenti, nuqqas ta' ħila fil-kitba, disturbi fis-sitema nervuża - Viżjoni mċajpra, sensittività akbar għad-dawl, disturbi fil-għajnejn - Ħsejjes ta' ċenċil fil-widnejn - Tnaqqis ta' ċirkolazzjoni ta' demm fil-vini tal-qalb, qalb tħabbat aktar malajr - Fsada, sadda parzjali jew sħiħa tal-vini, tnaqqis ta' pressjoni - Qtugħ ta' nifs, tibdil fit-tessut tal-pulmun, ġbir ta' likwidu madwar il-pulmun, infjammazzjoni talgriżmejn, sogħla, sintomi bħal tal-influwenza - Problemi tal-istonku bħal infjammazzjoni jew ulċera li tikkaġuna uġigħ addomenali jew dijarrea, fsada fl-istonku, infjammazzjoniji jew ulċera fil-ħalq, ġabra ta' fluwidu fiż-żaqq, riġettar, uġigħ addomenali, indiġistjoni, kostipazzjoni, tgћaddi il-gas, nefħa, purgar maħlul - Disturbi fil-kanal tal-marrara, sfura fil-ġilda minħabba problemi tal-fwied, ħsara fit-tessut tal-fwied u infjammazzjoni tal-fwied - Ħakk, raxx, telf ta' xagħar, akne, żieda fl-għaraq - Uġigħ fil-ġogi, dirgħajn, riġlejn jew dahar, krampi muskolari (bugħawieġ) - Nuqqas ta' ħidma tal-kliewi, tinqis fil-produzzjoni tal-awrina, urinazzjoni batuta jew bl-uġigħ - Debbulizza ġenerali, deni, ġabra ta' fluwidu fil-ġisem, uġigħ u skonfort, żieda ta' enżimi alkalini fosfati fid-demm, żieda fil-piż, ħass ta' disturbi fit-temperatura - Nuqqas ta' ħidma fl-organu trapjantat.
English: In clinical practice, whole blood trough levels have generally been in the range 5 - 20 nanogram/ml in liver transplant recipients and 10 - 20 nanogram/ml in kidney and heart transplant patients in the early post-transplant period.
Maltese: Fil-prattika klinika, l-inqas livelli fid-demm sħiħ kienu ġeneralment fil-medda ta' bejn il-5 u l-20 nanogram/ml f'dawk li rċevew trapjant tal-fwied u bejn l-10 u l20 nanogram/ml f'dawk li rċevew trapjant tal-kliewi u tal-qalb kmieni fl-ewwel żmien wara li jkun sar ittrapjant.
English: 6.3 Shelf life
Maltese: Vistor hf
English: anaemia, thrombocytopenia, leukopenia, red blood cell analyses abnormal, leukocytosis uncommon:
Maltese: anemija, tromboċitopenija, lewkopenija, analiżi anormali taċ-ċelluli ħomor tad-demm, lewkoċitożi,
English: Modigraf should not be switched with Advagraf as a clinically relevant difference in bioavailability between the two formulations cannot be excluded.
Maltese: Modigraf m'gћandux jinbidel ma kapsuli b'formulazzjoni ta' Advagraf li tirrilaxxa fit-tul gћax differenza klinika relevanti fil-bijodisponibilta' bejn iż-żewġ formulazzjonijiet ma tistax tiġi eskluża.
English: hypertension common:
Maltese: Kategorija farmakoterapewtika:
English: Vascular disorders very common:
Maltese: Disturbi vaskulari komuni ħafna:
English: Astellas Pharma Kft. Tel.: + 36 1 577 8200
Maltese: Tel.: + 36 1 577 8200
English: Carbamazepine, metamizole and isoniazid have the potential to decrease tacrolimus concentrations.
Maltese: Carbamazepine, metamizole u isoniazid għandhom il-potenzjal li jnaqqsu l-konċentrazzjonijiet ta' tacrolimus.
English: The combined administration of ciclosporin and tacrolimus should be avoided and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.5).
Maltese: Għal dawn ir-raġunijiet mhux rikkmandat li ciclosporin u tacrolimus jingħataw flimkien, u wieħed għandu joqgħod attent meta jingħata tacrolimus lill-pazjenti li qabel ikunu ħadu ciclosporin (ara taqsimiet 4.2 and 4.4).