natgillin/translations-raw huggingface dataset:
blindness not known:
Vrlo rijetko: Nepoznato:
acute and chronic pancreatitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying rare:
akutni i kronični pankreatitis, paralitički ileus, gastrooezofagealna refluksna bolest, poremećeno želučano pražnjenje
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.
Kompleks FKBP12-takrolimus specifično se i kompetitivno veže za kalcineurin i inhibira ga što dovodi do inhibicije signalnih puteva
Blood trough levels of tacrolimus should be monitored during the post-transplantation period.
Najniže razine takrolimusa u krvi potrebno je pratiti tijekom poslijetransplantacijskog razdoblja.
fall, ulcer, chest tightness, thirst very rare:
pad, ulkus, stezanje u prsištu, žeđ
It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to tacrolimus monotherapy.
U nekim je slučajevima moguće ukinuti istovremenu imunosupresivnu terapiju što dovodi do monoterapije takrolimusom.
The suspension should be administered immediately after preparation.
Suspenzija se mora primijeniti neposredno nakon pripreme.
Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.
Potrebno je nastaviti pratiti razine ciklosporina u krvi nakon prebacivanja, jer to može utjecati na klirens ciklosporina.
Modigraf sachets must not be used partially.
Ne smije se primijeniti samo dio vrećice Modigrafa.
amylase increased, ECG investigations abnormal, heart rate and pulse investigations abnormal, weight decreased, blood lactate dehydrogenase increased very rare:
povišena razina amilaze, poremećen nalaz EKG-a, poremećena srčana frekvencija i puls, smanjenje tjelesne težine, povišena laktat dehidrogenaza u krvi vrlo rijetko:
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).
U bolesnika koji se liječe imunosupresivima, uključujući Modigraf, postoji povećan rizik od razvoja infekcija, uključujući oportunističke infekcije (bakterijske, gljivične, virusne i protozoalne) poput nefropatije povezane s BK virusom i progresivna multifokalna leukoencefalopatija (PML) povezana s
respiratory failures, respiratory tract disorders, asthma rare:
respiratorno zatajenje, poremećaji dišnih puteva, astma
Herbal preparations containing St. John's Wort (Hypericum perforatum) or other herbal preparations should be avoided when taking Modigraf 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).
Za vrijeme uzimanja Modigrafa potrebno je izbjegavati biljne pripravke koji sadrže gospinu travu (Hypericum perforatum) ili drugih biljnih pripravaka, zbog rizika od interakcija koje mogu ili sniziti koncentraciju takrolimusa u krvi i smanjiti klinički učinak takrolimusa ili povisiti koncentraciju takrolimusa u krvi i rizik od toksičnosti takrolimusa (vidjeti dio 4.5).
EBV-Viral Capsid Antigen (VCA)-negative patients have been reported to have an increased risk of developing lymphoproliferative disorders.
Zabilježeno je da bolesnici s negativnim nalazom EBVvirusnog kapsidnog antigena (VCA) imaju povećan rizik od razvoja limfoproliferativnih poremećaja.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I
In paediatric liver transplant patients the mean oral bioavailability of tacrolimus (investigated with the Modigraf granules) is 26%± 23% (individual range in paediatric liver transplant patients 4 - 80%).
U pedijatrijskih bolesnika s presatkom jetre srednja peroralna bioraspoloživost takrolimusa (ispitana pomoću Modigraf granula) je 26%± 23% (pojedinačni rasponi u pedijatrijskih bolesnika s presatkom jetre: 4 - 80%).
Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Prebacivanje bolesnika s terapije na bazi ciklosporina na terapiju na bazi takrolimusa treba pažljivo provesti (vidjeti dijelove 4.4 i 4.5).
In paediatric liver and kidney transplant patients, values for total body clearance of 2.3 ± 1.2 ml/min/kg and 2.1 ± 0.6 ml/min/kg, respectively, have been observed.
U pedijatrijskih bolesnika s presadcima jetre i bubrega opažene su vrijednosti ukupnog tjelesnog klirensa od 2,3 ± 1,2 ml/min/kg odnosno 2,1 ± 0,6 ml/min/kg.
Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient aided by whole blood tacrolimus trough level monitoring.
Doziranje prvenstveno treba temeljiti na kliničkoj procjeni reakcije odbacivanja i podnošljivosti terapije u svakog pojedinog bolesnika uz pomoć praćenja najnižih razina takrolimusa u punoj krvi.
cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Bolesnici koji primaju imunosupresivnu terapiju su pod povećanim rizikom od razvoja zloćudnih bolesti.
Modigraf contains the active substance tacrolimus.
Modigraf sadrži djelatnu tvar takrolimus.
blood alkaline phosphatase increased, weight increased uncommon:
povišena alkalna fosfataza u krvi, povećanje tjelesne težine manje često:
Other interactions which have led to clinically detrimental effects Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (e.g., aminoglycosides, gyrase inhibitors, vancomycin, sulfamethoxazole+trimethoprim, NSAIDs, ganciclovir or aciclovir).
Istodobna primjena takrolimusa s lijekovima za koje se zna da imaju nefrotoksične ili neurotoksične učinke može pojačati te učinke (npr. aminoglikozidi, inhibitori giraze, vankomicin, sulfametoksazol+trimetoprim, nesteroidni protuupalni lijekovi, ganciklovir ili aciklovir).
In some cases, it was necessary to switch to alternative immunosuppression.
U nekim je slučajevima bio potreban prelazak na drugu imunosupresivnu terapiju.
eye disorders, vision blurred, photophobia uncommon:
poremećaji oka, zamagljen vid, fotofobija
Increased clearance rates contribute to the shorter half-life observed in transplant recipients.
Povećana brzina klirensa pridonosi kraćem poluvijeku opaženom u bolesnika s presađenim organom.
influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance rare:
bolest slična influenci, osjećaj nemira, nenormalno osjećanje, višestruko zatajenje organa, osjećaj pritiska u prstištu, nepodnošenje temperature
Each sachet contains 473 mg lactose (as monohydrate).
Jedna vrećica sadrži 473 mg laktoze (u obliku hidrata).
Investigations very common:
Pretrage vrlo često :
Frequent trough level monitoring in the initial 2 weeks post transplantation is recommended, followed by periodic monitoring during maintenance therapy.
Preporučuje se često mjerenje najnižih razina u prva 2 tjedna nakon transplantacije, a nakon toga povremeno tijekom terapije održavanja.
Package leaflet: Information for the user Modigraf 0.2 mg, granules for oral suspension Modigraf 1 mg, granules for oral suspension
Uputa o lijeku: Informacija za korisnika Modigraf 0,2 mg, granule za oralnu suspenziju Modigraf 1 mg, granule za oralnu suspenziju takrolimus
In case of in utero exposure, monitoring of the newborn for the potential adverse events of tacrolimus is recommended (in particular effects on the kidneys).There is a risk for premature delivery (<37 week) (incidence of 66 of 123 births, i.e. 53.7%; however, data showed that the majority of the newborns had normal birth weight for their gestational age) as well as for hyperkalaemia in the newborn (incidence 8 of 111 neonates, i.e. 7.2%) which, however normalises spontaneously.
53,7%, međutim, podaci su pokazali da je većina novorođenčadi imala normalnu porođajnu tjelesnu težinu za svoju gestacijsku dob) kao i rizik od hiperkalijemije u novorođenčeta (incidencija od 8 na 111 novorođenčadi, tj. 7,2%), koja se, međutim, spontano normalizira.
primary graft dysfunction
poremećaj funkcije primarnog presatka
Each sachet contains 94.7 mg lactose (as monohydrate).
Jedna vrećica sadrži 94,7 mg laktoze (u obliku hidrata).
thrombotic thrombocytopenic purpura, hypoprothrombinaemia, thrombotic microangiopathy not known:
trombotička trombocitopenična purpura, hipoprotrombinemija, trombotska mikroangiopatija
EXP: After preparation, the suspension should be administered immediately.
Rok valjanosti: Nakon pripreme, suspenziju treba odmah primijeniti.
A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats.
U štakora je opažen negativni učinak takrolimusa na plodnost mužjaka u obliku smanjenog broja i pokretljivosti spermija.
A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats (see section 5.3).
U štakora je opažen negativni učinak takrolimusa na plodnost mužjaka u obliku smanjenog broja i pokretljivosti spermija (vidjeti dio 5.3).
Paediatric data
Pedijatrijski podaci
fever, nausea or vomiting - if you have an alteration of the electrical activity of your heart called “QT prolongation”.
- ako imate promjenu električne aktivnosti srca zvane „produljenje QT-a“.
Your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease, (e.g. amiloride, triamterene, or spironolactone), non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes, while you take Modigraf.
Vaš liječnik također mora znati uzimate li za vrijeme liječenja Modigrafom dodatke kalija ili određene diuretike koji se primjenjuju kod zatajenja srca, povišenog krvnog tlaka i bubrežne bolesti, (npr. amilorid, triamteren ili spironolakton), nesteroidne protuupalne lijekove (npr. ibuprofen) koji se primjenjuju kod vrućice, upale i bola, antikoagulanse (za razrjeđivanje krvi) ili lijekove za šećernu bolest koji se uzimaju na usta.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET FOIL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
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).
Potrebno je izbjegavati kombiniranu primjenu ciklosporina i takrolimusa i pažljivo pristupati kada se takrolimus daje bolesnicima koji su prethodno primali ciklosporin (vidjeti dijelove 4.2 i 4.5).
Neoplasms benign, malignant and unspecified (inl.
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)
Caution should be exercised in patients with risk factors for QT prolongation, including patients with a personal or family history of QT prolongation, congestive heart failure, bradyarrhythmias and electrolyte abnormalities.
uključujući bolesnike koji u osobnoj ili obiteljskoj anamnezi imaju produljenje QT-a, kongestivno zatajenje srca, bradiaritmije i poremećaje elektrolita.
For these reasons, the combined administration of ciclosporin and tacrolimus is not recommended and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.4).
Zbog toga se ne preporučuje kombinirana primjena ciklosporina i takrolimusa te je potreban oprez kad se takrolimus primjenjuje u bolesnika koji su prethodno primali ciklosporin (vidjeti dijelove 4.2 i 4.4).
Posterior reversible encephalopathy syndrome (PRES) Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Zabilježeno je da bolesnici liječeni takrolimusom razvijaju sindrom posteriorne reverzibilne encefalopatije (engl.
Tacrolimus is a low-clearance substance.
Izlučivanje Takrolimus je tvar s niskim klirensom.
hirsutism Metabolism and nutrition disorders very common:
Poremećaji metabolizma i prehrane Vrlo često:
High potassium intake or potassium-sparing diuretics should be avoided (see section 4.5).
Treba izbjegavati uzimanje velikih količina kalija ili diuretika koji štede kalij (vidjeti dio 4.5).
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.
0,2 mg/kg na dan s naknadnim prilagodbama doze do ciljnih najnižih razina od 8 do 15 nanogram/ml do 5. dana i 5 do 10 nanogram/ml nakon 6 mjeseci.
Increased tacrolimus doses, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.
Za liječenje epizoda odbacivanja koristile su se više doze takrolimusa, nadomjesna kortikosteroidna terapija i kratkotrajne terapije monoklonalnim ili poliklonalnim protutijelima.
Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.
Profilaksa odbacivanja alogenog presatka u odraslih i pedijatrijskih bolesnika kojima su presađeni bubreg, jetra ili srce.
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,
Osobito trebate obavijestiti svog liječnika ako uzimate ili ste nedavno uzimali lijekove kao što su: - antimikotici i antibiotici, osobito takozvani makrolidni antibiotici, koji se primjenjuju za liječenje infekcija, npr. ketokonazol, flukonazol, itrakonazol, vorikonazol, klotrimazol i izavukonazol, eritromicin, klaritromicin, josamicin i rifampicin
Prophylaxis of heart transplant rejection
Profilaksa odbacivanja presatka srca
metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia uncommon:
preopterećenje tekućinom, hiperuricemija, hipomagnezijemija, hipokalijemija, hipokalcijemija, smanjeni apetit, hiperkolesterolemija, hiperlipidemija, hipertrigliceridemija, hipofosfatemija
How to store Modigraf
Kako čuvati Modigraf
During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations.
elektrokardiogram, neurološki status i status vida, razinu glukoze u krvi natašte, elektrolite (osobito kalij), testove jetrene i bubrežne funkcije, hematološke parametre, koagulacijske vrijednosti i proteine u plazmi.
The frequency of blood level monitoring should be based on clinical needs.
Razinu u krvi treba određivati onoliko često koliko je to klinički potrebno.
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.
Prograf se primjenjivao u bolesnika s presađenim plućima u početnoj peroralnoj dozi od 0,10 do 0,15 mg/kg na dan, u bolesnika s presađenom gušteračom u početnoj peroralnoj dozi od 0,2 mg/kg na dan i u bolesnika s presađenim crijevima u početnoj peroralnoj dozi od 0,3 mg/kg na dan.
Systemically available tacrolimus is metabolised by hepatic CYP3A4.
Sistemski dostupan takrolimus se metabolizira putem CYP3A4 u jetri.
This medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
4.2 Doziranje i način primjene Ovaj lijek smiju propisivati i započetu imunosupresivnu terapiju mijenjati samo liječnici s iskustvom u primjeni imunosupresivne terapije i liječenju bolesnika s presađenim organom.
Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.
Zabilježene su dobroćudne kao i zloćudne novotvorine uključujući limfoproliferativne poremećaje povezane s EBV virusom i kožne zloćudne promjene povezane s liječenjem takrolimusom.
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.
Takrolimus je započet kao kontinuirana intravenska infuzija u dozi od 0,01 do 0,03 mg/kg na dan, a peroralni takrolimus je primjenjen u dozi od 0,05 do 0,3 mg/kg na dan.
Intestinal transplantation
Transplantacija pluća
hypertension, renal or hepatic dysfunction, infections, fluid overload, and oedema.
uzimanje kortikosteroida, hipertenziju, poremećaj funkcije bubrega ili jetre, infekcije, preopterećenje tekućinom i edeme.
Tell your doctor immediately if during treatment you suffer from: problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
probleme s vidom kao što su zamagljen vid, promjene vida u boji, otežano uočavanje detalja, ili ako
Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.
Liječenje odbacivanja alogenog presatka u odraslih i pedijatrijskih bolesnika u slučaju rezistencije na liječenje drugim imunosupresivnim lijekovima.
Tacrolimus has been shown to increase the blood level of phenytoin.
Pokazalo se da takrolimus povećava razinu fenitoina u krvi.
These may worsen kidney or nervous system problems when taken together with Modigraf.
Kad se ti lijekovi uzimaju zajedno s Modigrafom mogu pogoršati tegobe s bubrezima ili živčanim sustavom.
Treatment of allograft rejection after kidney or liver transplantation - adults and paediatric patients For conversion from other immunosuppressants to twice daily Modigraf, treatment should begin with the initial oral dose recommended for primary immunosuppression.
Za prebacivanje s drugih imunosupresiva na Modigraf dvaput na dan, liječenje treba započeti početnom peroralnom dozom koja se preporučuje za primarnu imunosupresiju.
Modigraf is a granular formulation of tacrolimus, for twice-a-day administration.
Modigraf je granularni oblik takrolimusa za primjenu dvaput na dan.
Similarly, for conversion of patients from Prograf capsules to Modigraf granules, the total daily Modigraf dose should preferably be equal to the total daily Prograf dose.
Slično tome, za prebacivanje bolesnika s Prograf kapsula na Modigraf granule ukupna dnevna doza
hepatic failure Skin and subcutaneous tissue disorders common:
Poremećaji kože i potkožnog tkiva Često:
febrile disorders, pain and discomfort, asthenic conditions, oedema, body temperature perception disturbed uncommon:
febrilni poremećaji, bol i nelagoda, astenijska stanja, edemi, poremećen doživljaj tjelesne temperature
Patients treated with tacrolimus have been reported to develop Epstein-Barr Virus (EBV)-associated lymphoproliferative disorders (see section 4.8).
Epstein-Barrovim virusom (EBV) (vidjeti dio 4.8).
ischaemic coronary artery disorders, tachycardia uncommon:
ishemijski poremećaji koronarnih arterija, tahikardija
venoocclusive liver disease, hepatic artery thrombosis very rare:
venookluzivna bolest jetre, tromboza jetrene arterije
Patients should be maintained on a single formulation of tacrolimus with the corresponding dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8).
Promjene u formulacijama ili režimu davanja smiju se provesti samo pod strogim nadzorom specijalista transplantacijske medicine (vidjeti dijelove 4.4 i 4.8).
Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension
Modigraf 0,2 mg granule za oralnu suspenziju Modigraf 1 mg granule za oralnu suspenziju
pancreatic pseudocyst, subileus Hepatobiliary disorders common:
pseudocista gušterače, subileus
Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulations or regimen should only take place under the close supervision of a transplant specialist (see sections 4.2 and 4.8).
Promjene u formulacijama ili režimu davanja smiju se provesti samo pod strogim nadzorom specijalista za transplantacijsku medicinu (vidjeti dijelove 4.2 i 4.8).
heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations rare:
zatajenje srca, ventrikularne aritmije i srčani arest, supraventrikularne aritmije,
Following antibody induction, if Modigraf therapy is initiated orally, the recommended starting dose is 0.10 - 0.30 mg/kg/day administered as 2 divided doses (e.g. morning and evening).
Ako se nakon indukcije protutijela terapija Modigrafom započne peroralno, preporučena početna doza je 0,10 do 0,30 mg/kg na dan podijeljena u 2 odvojene doze (npr. ujutro i navečer).
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.
Takrolimus je započet kao kontinuirana intravenska infuzija u dozi od 0,05 mg/kg na dan, a peroralni takrolimus je primijenjen u dozi od 0,1 do 0,3 mg/kg na dan s naknadnim prilagodbama doze do ciljnih najnižih razina od 12 do 15 nanogram/ml.
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).
Nakon indukcije protutijela, peroralnu terapiju Modigrafom treba započeti dozom od 0,075 mg/kg na dan podijeljenom u 2 odvojene doze (npr. ujutro i navečer).
Endocrine disorders rare:
Endokrini poremećaji
In adult liver, kidney and heart transplant patients, values of 4.1 l/h, 6.7 l/h and 3.9 l/h, respectively, have been observed.
Opaženo je da je taj klirens iznosio 4,1 l/sat u odraslih bolesnika s presatkom jetre, s presatkom bubrega 6,7 l/h i s presatkom srca 3,9 l/sat.
Published clinical experience from a single centre on the use of oral tacrolimus for primary treatment following intestinal transplantation showed that the actuarial survival rate of 155 patients (65 intestine alone, 75 liver and intestine, and 25 multivisceral) receiving tacrolimus and prednisone was 75% at 1 year, 54% at 5 years, and 42% at 10 years.
(65 samo s presađenim crijevima, 75 s presađenom jetrom i crijevima i 25 s multivisceralnim presatcima) koji su primali takrolimus i prednizon iznosila 75% nakon 1 godine, 54% nakon 5 godina i
rash, pruritus, alopecias, acne, sweating increased uncommon:
osip, svrbež, alopecija, akne, pojačano znojenje
bile duct disorders, hepatocellular damage and hepatitis, cholestasis and jaundice rare:
poremećaji žučovoda, hepatocelularno oštećenje i hepatitis, kolestaza i žutica
Therapeutic drug monitoring
Terapijsko praćenje koncentracije lijeka
Patients are also at an increased risk of infections with viral hepatitis (for example, hepatitis B and C reactivation and de novo infection, as well as hepatitis E, which may become chronic).
(primjerice, reaktivacija i de novo infekcija virusom hepatitisa B i C, kao i infekcija virusom hepatitisa