FrancophonIA/ELRC3.0 huggingface dataset:
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 - psychotic behaviour, such as delusions, hallucinations, and confusion - 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, partial or total inability to hear - 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 - acute or chronic inflammation of the pancreas, inflammation of the lining of the inner wall of the abdomen, obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach contents in your throat, delayed emptying of the stomach - inflammation of the skin, burning sensation in the sunlight - joint disorders - painful menstruation and abnormal menstrual bleeding - multiple organ failure, flu-like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, weight loss
Maltese: - Riżultati tat-testijiet tad-demm mhux normali: proteina jew zokkor imnaqqsa, żieda ta' phosphate, żieda fl-enzima lactate dehydrogenase - Koma, fsada fil-moħħ, puplesija, paralisi, disturb fil-moħħ, anormalitajiet fid-diskors u fillingwa, problemi ta' memorja - Lenti tal-għajn tiċċajpar, nuqqas ta' smigħ parzjali jew totali - Taħbit irregolari tal-qalb, waqfien tat-taħbit tal-qalb, prestazzjoni mnaqqsa ta' qalbek, disturb fil-muskolu tal-qalb, tkabbir tal-muskolu tal-qalb, taħbit tal-qalb aktar f'saħħtu, ECG mhux normali, rata tal-qalb u polz mhux normali
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'
English: Oval, white to off-white uncoated tablet, debossed with “0.75” on one side and “TCS” on the other side.
Maltese: mhux miksija, imnaqqxa b'“0.75” fuq naħa waħda u “TCS” fuq in-naħa l-oħra.
English: During treatment, careful monitoring with EBV-PCR (Polymerase-Chain-Reaction) is recommended.
Maltese: Waqt il-kura, huwa rakkomandat monitoraġġ b'EBV-PCR (Polymerase-Chain-Reaction).
English: The use of Envarsus is not recommended in children and adolescents under 18 years.
Maltese: L-użu ta' Envarsus mhux rakkomandat fi tfal u adolexxenti b'età inqas minn 18- il sena.
English: The event rate for locally read BPAR during the 360-day study was 1.2% in the Envarsus group (N=162) post conversion from Prograf at a dose ratio of 1:0.7 (mg:mg) and 1.2% in the group maintained on Prograf (N=162).
Maltese: Ir-rata ta' avveniment ta' BPAR interpretat lokalment matul l-istudju ta' 360 ġurnata kienet ta' 1.2% fil-grupp ta' Envarsus (N=162) wara bidla minn Prograf f'proporzjon ta' doża ta' 1:0.
English: In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3).
Maltese: Fil-firien u fniek, tacrolimus ikkawża tossiċità fl-embrijuni u l-feti b'dożaġġi li wrew tossiċità fl-omm (ara sezzjoni 5.3).
English: Envarsus 1 mg prolonged-release tablets tacrolimus
Maltese: Envarsus 1 mg pilloli li jerħu l-mediċina bil-mod tacrolimus
English: Take the tablet as soon as possible on the same day.
Maltese: Ħu l-pillola mill-aktar fis possibbli fl-istess jum.
English: Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section 4.4).
Maltese: Disturbi fis-sistema immuni Reazzjonijiet allerġiċi u anafilaktojdi kienu osservati f'pazjenti li jirċievu tacrolimus (ara sezzjoni 4.4).
English: Dosing should be delayed in the presence of elevated ciclosporin blood levels.
Maltese: L-iddozar għandu jiġi ttardjat fil-preżenza ta' livelli elevati ta' ciclosporin fid-demm.
English: Psychiatric disorders insomnia confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare psychotic disorder
Maltese: Disturbi psikjatriċi nuqqas ta' rqad konfużjoni u disorjentazzjoni, depressjoni, sintomi ta' ansjetà,
English: The most commonly reported adverse reactions for tacrolimus (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 għal tacrolimus (iseħħu f'>10% tal-pazjenti) huma rogħda, indeboliment tal-kliewi, kondizzjonijiet ipergliċemiċi, dijabete mellitus, iperkalimja,
English: Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.
Maltese: Neoplażmi beninni kif ukoll malinni inkluż disturbi limfoproliferattivi assoċjati ma' EBV u tumuri malinn fil-ġilda kienu rrappurtati f'assoċjazzjoni ma' kura b'tacrolimus.
English: How to store Envarsus
Maltese: X'fih Envarsus
English: Each prolonged-release tablet contains 4 mg tacrolimus (as monohydrate).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 4 mg tacrolimus (bħala monohydrate).
English: Each prolonged-release tablet contains 1 mg tacrolimus (as monohydrate).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 1 mg tacrolimus (bħala monohydrate).
English: Vascular disorders hypertension thromboembolic and ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders venous thrombosis deep limb, shock, infarction
Maltese: Disturbi vaskulari pressjoni għolja avvenimenti tromboemboliċi u iskemiċi, disturbi vaskulari ipotensivi,
English: Pregnancy and breast-feeding
Maltese: Indeboliment fis-smigħ
English: Administration should commence within 24 hours after the completion of surgery.
Maltese: L-għoti għandu jinbeda' fi żmien 24 siegħa wara li tintemm l-operazzjoni.
English: Tacrolimus may prolong the QT interval but at this time lacks substantial evidence for causing Torsades de Pointes.
Maltese: Tacrolimus jista' jtawwal l-intervall QT iżda għalissa m'hemmx evidenza sostanzjali li jikkawża Torsades de Pointes.
English: Herbal preparations containing St. John's Wort (Hypericum perforatum) should be avoided when taking tacrolimus due to the risk of interactions that lead to a decrease in both blood concentrations and the therapeutic effect of tacrolimus (see section 4.5).
Maltese: Preparazzjonijiet mill-ħxejjex li fihom St John's Wort (Hypericum perforatum) għandhom ikun evitati meta jittieħed tacrolimus minħabba r-riskju ta' interazzjoni li twassal għal tnaqqis kemm filkonċentrazzjoni fid-demm kif ukoll fl-effett terapewtiku ta' tacrolimus (ara sezzjoni 4.5).
English: Respiratory, thoracic and mediastinal disorders parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammations respiratory failures, respiratory tract disorders, asthma acute respiratory distress syndrome
Maltese: insuffiċjenza akuta tal-kliewi, nefropatija tossika, nekrosi tat-tubi tal-kliewi, anormalitajiet flawrina, oligurja, sintomi tal bużżieqa tal awrina u tal-uretra sindrome emolitika uremika, anurja nefropatija, ċistite emorraġika
English: Envarsus 4 mg prolonged-release tablets Each prolonged-release tablet contains 4 mg tacrolimus (as monohydrate).
Maltese: Envarsus 4 mg pilloli li jerħu l-mediċina bil-mod Kull pillola li terħi l-mediċina bil-mod fiha 4 mg tacrolimus (bħala monohydrate).
English: Envarsus 0.75 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “0.75” on one side and “TCS” on the other side.
Maltese: Envarsus 0.75 mg pilloli li jerħu l-mediċina bil-mod Pillola ovali ta' lewn abjad sa abjad maħmuġ, mhux miksija, imnaqqxa b'“0.75” fuq naħa waħda u
English: - if you are allergic to sirolimus or to any macrolide-antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Maltese: - jekk inti allerġiku għal sirolimus jew għal xi antibijotiku macrolide (eż. erythromycin,
English: Prolonged-release tablet.
Maltese: Mhux applikabbli.
English: In clinical studies in kidney transplant patients receiving Envarsus, the most frequent adverse reactions (at least in 2% of patients) were tremor, diabetes mellitus, blood creatinine increased, urinary tract infection, hypertension, BK virus infection, renal impairment, diarrhoea, toxicity to various agents, and toxic nephropathy all of which are known to occur in the respective patient population under immunosuppressive treatment.
Maltese: Fi studji kliniċi f'pazjenti bi trapjanti tal-kliewi li kienu qed jirċievu Envarsus, ir-reazzjonijiet avversi l-aktar frekwenti (mill-inqas f'2% tal-pazjenti) kienu rogħda, dijabete mellitus, żieda ta' krejatinina fid-demm, infezzjoni fl-apparat tal-awrina, pressjoni għolja, infezzjoni mill-virus BK, indeboliment tal-kliewi, dijarea, tossiċità għal diversi sustanzi, u nefropatija tossika li kollha huma magħrufa li jseħħu fil-popolazzjoni ta' pazjenti rispettiva taħt kura immunosoppressiva.
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 - 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) - 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,
Maltese: - inibituri tal-protease tal-HIV (eż. ritonavir, nelfinavir, saquinavir), il-mediċina booster cobicistat, u pilloli ta'kombinazzjoni, użati għall-kura ta' infezzjoni tal-HIV - inibituri tal-protease tal-HCV (eż. telaprevir, boceprevir, u l-kombinazzjoni ombitasvir/paritaprevir/ritonavir bi jew mingħajr dasabuvir), użati għall-kura tal-epatite Ċ - nilotinib u imatinib (użati għat-trattament ta' ċerti kanċers) - mycophenolic acid, użat għas-soppressjoni tas-sistema immuni biex pprevjeni r-rifjut tattrapjant
English: Other interactions potentially leading to increased tacrolimus blood levels Tacrolimus is extensively bound to plasma proteins.
Maltese: Tacrolimus tintrabat b'mod estensiv mal-proteini tal-plażma.
English: Eye disorders eye disorders, vision blurred, photophobia cataract blindness optic neuropathy
Maltese: fotofobija katarretti telf tal-vista newropatija ottika
English: The percentage of patients with one or greater than one episode of clinically-suspected and treated rejections during the 360-day study was 13.8% for the Envarsus group (N=268) and 15.6% for the Prograf group (N=275).
Maltese: Il-perċentwali ta' pazjenti b'espisodju wieħed jew aktar ta' rifjut suspettat klinikament u kkurat matul l-istudju ta' 360 ġurnata kien ta' 13.8% għall-grupp ta' Envarsus (N=268) u 15.
English: Tacrolimus is a low-clearance substance.
Maltese: Tacrolimus huwa sustanza bi tneħħija baxxa.
English: Tacrolimus may cause visual and neurological disturbances.
Maltese: Tacrolimus jista' jikkawża disturbi fil-vista u newroloġiċi.
English: Treatment emergent fatal adverse events occurred in 1.2% of Envarsus patients and 0.6% of Prograf patients.
Maltese: Avvenimenti avversi fatali li dehru mal-kura seħħew f'1.2% tal-pazjenti fuq Envarsus u f'0.6% tal-pazjenti fuq Prograf.
English: Symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine and alanine aminotransferase levels.
Maltese: urtikarja, letarġija u żiediet fin-nitroġenu mill-urea fid-demm, fil-krejatinina fis-serum, u fil-livelli ta' alanine aminotransferase.
English: The efficacy failure rate as measured by the composite endpoint of death, graft loss, locally read BPAR and loss to follow-up was 2.5% in both the Envarsus and Prograf groups.
Maltese: Ir-rata ta' falliment tal-effikaċja kif imkejjel mill-punt finali kompost ta' mewt, telf tat-trapjant, BPAR interpretat lokalment u telf ta' segwitu kienet ta' 2.5% kemm fil-grupp ta' Envarsus kif ukoll f'dak ta' Prograf.
English: Envarsus 1 mg prolonged-release tablets Each prolonged-release tablet contains 1 mg tacrolimus (as monohydrate).
Maltese: Envarsus 1 mg pilloli li jerħu l-mediċina bil-mod Kull pillola li terħi l-mediċina bil-mod fiha 1 mg tacrolimus (bħala monohydrate).
English: - medicines known as “statins”, used to treat elevated cholesterol and triglycerides - phenytoin or phenobarbital, used to treat epilepsy - prednisolone and methylprednisolone, belonging to the class of corticosteroids and used to treat inflammations or suppress the immune system (e.g. in transplant rejection) - carbamazepine, used to prevent and control seizures - metamizole, used to treat pain and high fever - nefazodone, used to treat depression - herbal preparations containing St. John's Wort (Hypericum perforatum)
Maltese: - phenytoin jew phenobarbital, użati għall-kura tal-epilessija - prednisolone u methylprednisolone, li jappartjenu għall-klassi ta' kortikosterojdi u wżati għall kura ta' infjammazzjonijiet jew biex irażżnu s-sistema immuni (eż. f'rifjut ta' trapjant) - carbamazepine, użat biex jipprevjeni u jikkontrolla l-aċċessjonijiet
English: Therapeutic drug monitoring
Maltese: Kategorija farmakoterapewtika:
English: Envarsus therapy should commence at a dose of 0.17 mg/kg/day administered once daily in the morning.
Maltese: Terapija ta' Envarsus għandha tinbeda b'doża ta' 0.17 mg/kg/kuljum mogħtija darba kuljum filgħodu.
English: The use of live attenuated vaccines should be avoided (see section 4.4).
Maltese: L-użu ta' tilqim ħaj attenwat għandu jiġi evitat (ara sezzjoni 4.4).
English: Therefore, metabolites do not contribute to the pharmacological activity of tacrolimus.
Maltese: Għalhekk, il-metaboliti ma jikkontribwixxux għall-attività farmakoloġika ta' tacrolimus.
English: It is not recommended that Envarsus is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Maltese: Mhux rakkomandat li Envarsus jittieħed flimkien ma' ciclosporin (mediċina oħra użata għall prevenzjoni ta' rifjut ta' organi trapjantati).
English: As the pharmacokinetics of tacrolimus are unaffected by renal function (see section 5.2), no dose adjustment is required.
Maltese: Peress li l-farmakokinetika ta' tacrolimus mhux affettwata mill-funzjoni tal-kliewi (ara sezzjoni 5.2),
English: Cardiac disorders ischaemic coronary artery disorders, tachycardia heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations pericardial effusion
Maltese: ipertrigliċeridemij a, ipofosfatemija deidratazzjoni, ipogliċemija, ipoproteinimja, ipofosfatimija
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: (FKBP12) li hi responsabbli għall-akkumulazzjoni intraċellulari tas-sustanza.
English: The safety and efficacy of Envarsus in children below 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Envarsus fit-tfal taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Envarsus 4 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “4” on one side and “TCS” on the other side.
Maltese: Envarsus 4 mg pilloli li jerħu l-mediċina bil-mod huma ovali, ta' lewn abjad sa abjad maħmuġ, mhux miksija, imnaqqxa b'“4” fuq naħa waħda u “TCS” fuq in-naħa l-oħra.
English: Envarsus 1 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “1” on one side and “TCS” on the other side
Maltese: Envarsus 1 mg pilloli li jerħu l-mediċina bil-mod huma ovali, ta' lewn abjad sa abjad maħmuġ, mhux miksija, imnaqqxa b'“1” fuq naħa waħda u “TCS” fuq in-naħa l-oħra.
English: What you need to know before you take Envarsus 3.
Maltese: X'għandek tkun taf qabel ma tieħu Envarsus 3.
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 or back, muscle cramps - 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: - Funzjoni tal-kliewi insuffiċjenti, tnaqqis fil-produzzjoni tal-awrina, indeboliment biex tgħaddi l awrina jew uġigħ biex tgħaddi l-awrina - Dgħufija ġenerali, deni, akkumulazzjoni ta' fluwidu f'ġismek, uġigħ u skonfort, żieda fl-enzima alkaline phosphatase fid-demm tiegħek, żieda fil-piż, sensazzjoni ta' disturb fit-temperatura
English: Tacrolimus therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Maltese: Terapija ta' tacrolimus għandha tinbeda wara li jiġu kkunsidrati lkonċentrazzjoni ta' ciclosporin fid-demm u l-kondizzjoni klinika tal-pazjent.
English: Renal and urinary disorders renal impairment renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptoms haemolytic uraemic syndrome, anuria nephropathy , cystitis haemorrhag ic
Maltese: triamterene, jew spironolactone), sustanzi anti-infjammatorji mhux sterojdi (NSAIDs, eż. ibuprofen) użati għad-deni, infjammazzjoni u uġigħ, sustanzi kontra il-koagulazzjoni tad-demm (irraqqu d demm), jew mediċini orali għad-dijabete.
English: High potassium intake or potassium-sparing diuretics should be avoided (see section 4.5).
Maltese: Konsum għoli ta' potassium jew dijuretiċi li ma jnaqqsux il-potassium għandu jiġi evitat (ara sezzjoni 4.5).
English: Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), amphotericin B (used to treat fungal infections), antibiotics (used to treat bacterial infections, e.g. aminoglycosides, vancomycin or clotrimazole) or antivirals (used to treat viral infections, e.g. aciclovir).
Maltese: antibijotiċi (użati għat-trattament ta' infezzjonijiet ikkawżati minn batterja, eż., aminoglycosides, vancomycin jew clotrimazole) jew sustanzi kontra l-virusis (użati għall-kura ta' infezzjonijiet virali, eż aciclovir).
English: Lansoprazol and ciclosporin may potentially inhibit CYP3A4-mediated metabolism of tacrolimus and, thereby, increase tacrolimus whole blood concentrations.
Maltese: Lansoprazol u ciclosporin potenzjalment jistgħu jinibixxu l-metaboliżmu medjat minn CYP3A4 ta' tacrolimus u, b'hekk, iżidu l-konentrazzjonijiet ta' tacrolimus fid-demm sħiħ.
English: Limited data from organ transplant recipients show no evidence of an increased risk of adverse events on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Maltese: Dejta limitata minn riċevituri ta' trapjanti ta' organi ma turi l-ebda evidenza ta' żieda fir-riskju ta' avvenimenti avversi fuq il-kors u r-riżultat tat tqala taħt kura b'tacrolimus meta mqabbel ma' prodotti mediċinali immunosoppressivi oħra.
English: hallucination, mental disorders - fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders - blurred vision, increased sensitivity to light, eye disorders - ringing sound in your ears - reduced blood flow in the heart vessels, faster heartbeat - bleeding, partial or complete blocking of blood vessels, reduced blood pressure - shortness in breath, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms - stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting,
Maltese: - Fluss ta' demm imnaqqas fil-kanali tal-qalb, taħbit tal-qalb aktar mgħaġġel - Fsada, imblokk parzjali jew komplut tal-kanali tad-demm, pressjoni mnaqqsa - Qtugħ ta' nifs, disturbi fit-tessuti respiratorji fil-pulmun, akkumulazzjoni ta' likwidu madwar il pulmun, infjammazzjoni tal-farinġi, sogħla, sintomi li jixbħu l-influwenza
English: Ear and labyrinth disorders tinnitus hypoacusis deafness neurosensory hearing impaired
Maltese: Fil-livell molekulari, l-effetti ta' tacrolimus jidhru li huma medjati minn irbit mal-proteina ċitosolika
English: Cardiac disorders
Maltese: Disturbi respiratorji,
English: 3 blisters are packed together within a protective aluminium foil wrapper, including a desiccant.
Maltese: Envarsus huwa fornut f'folji tal-PVC li fihom 10 pilloli. 3 folji huma ppakkjati flimkien f'ippakkjar protettiv b'fojl tal-aluminju, inkluż dessikant.
English: Envarsus should generally be taken on an empty stomach to achieve maximal absorption (see section 5.2).
Maltese: Envarsus ġeneralment għandu jittieħed fuq stonku vojt biex jintlaħaq assorbiment massimu (ara sezzjoni 5.2).
English: The oral bioavailability is approximately 40% higher for Envarsus as compared to the same dose of tacrolimus immediate-release formulation (Prograf) in kidney transplant patients.
Maltese: Il-bijodisponibiltà orali hija madwar 40% ogħla għal Envarsus meta mqabbel mal-istess doża ta' formulazzjoni ta' tacrolimus li terħi l-mediċina b'mod immedjat (Prograf) f'pazjenti bi trapjanti tal-kliewi.
English: 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: Tacrolimus huwa inibitur magħruf ta' CYP3A4; għalhekk, l-użu ta' tacrolimus flimkien ma' prodotti mediċinali magħrufa li huma metabolizzati minn CYP3A4 jista' jaffettwa l-metaboliżmu ta' prodotti mediċinali bħal dawn.
English: Envarsus 0.75 mg prolonged-release tablets
Maltese: IL-PRODOTT MEDIĊINALI Envarsus 0.75 mg pilloli li jerħu l-mediċina bil-mod tacrolimus
English: Initial daily doses just after transplantation will generally be in the range of: 0.11 - 0.17 mg per kg body weight per day depending on the transplanted organ.
Maltese: Dożi inizjali ta' kuljum eżatt wara t-trapjant ġeneralment ikunu fil-firxa ta': 0.11- 0.17 mg għal kull kg ta' piż tal-ġisem kuljum, skont l-organu trapjantat.
English: Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
Maltese: Data klinika tissuġġerixxi li l-farmakokinetika ta' statins ġeneralment ma tinbidilx bl-għoti fl-istess waqt 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: L-għoti flimkien ta' ciclosporin u tacrolimus għandu jiġi evitat u għandu jkun hemm attenzjoni meta tacrolimus jingħata lill-pazjenti li qabel kienu jirċievu ciclosporin (ara sezzjonijiet 4.2 u 4.5).