FrancophonIA/ELRC3.0 huggingface dataset:
English: Other interactions potentially leading to increased tacrolimus blood levels Tacrolimus is extensively bound to plasma proteins.
Croatian: Druge interakcije koje mogu dovesti do povećanja koncentracije takrolimusa u krvi Takrolimus se u velikoj mjeri veže za proteine plazme.
English: Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
Croatian: Klinički podaci upućuju na to da istovremena primjena takrolimusa uglavnom ne mijenja farmakokinetiku statina.
English: Concomitant use of substances known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels.
Croatian: Istodobna primjena tvari za koje se zna da inhibiraju ili induciraju CYP3A4 može utjecati na metabolizam takrolimusa i tako povećati ili smanjiti njegovu koncentraciju u krvi.
English: The rate and extent of absorption of tacrolimus is greatest under fasted conditions.
Croatian: Brzina i opseg apsorpcije takrolimusa najveći su natašte.
English: In comparison to Caucasians, black patients may require higher tacrolimus doses to achieve similar trough levels.
Croatian: U usporedbi s bolesnicima bijele rase, bolesnici crne rase mogu zahtijevati više doze takrolimusa kako bi se postigle slične najniže razine.
English: A strong correlation exists between AUC and whole blood trough levels at steady-state for Modigraf.
Croatian: Postoji jaka korelacija između AUC-a i najnižih razina u punoj krvi u stanju ravnotežne koncentracije Modigrafa.
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.
Croatian: U kliničkoj praksi najniže razine u punoj krvi su općenito bile u rasponu od 5 do 20 nanogram/ml u bolesnika s presađenom jetrom i 10 do 20 nanogram/ml u bolesnika s presađenim bubregom i srcem u ranom poslijetransplantacijskom razdoblju.
English: Blood and lymphatic system disorders common:
Croatian: Poremećaji krvi i limfnog sustava Često:
English: Dosing should be delayed in the presence of elevated ciclosporin blood levels.
Croatian: Primjenu doze treba odgoditi u slučaju da su razine ciklosporina u krvi povišene.
English: pure red cell aplasia, agranulocytosis, haemolytic anaemia
Croatian: izolirana aplazija crvenih krvnih stanica, agranulocitoza, hemolitička anemija
English: Modigraf granules contain lactose.
Croatian: Modigraf granule sadrže laktozu.
English: Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole, nefazodone and (Chinese) herbal remedies containing extracts of Schisandra sphenanthera.
Croatian: Slabije interakcije opažene su s klotrimazolom, klaritromicinom, josamicinom, nifedipinom, nikardipinom, diltiazemom, verapamilom, amiodaronom, danazolom, etinilestradiolom, omeprazolom, nefazodonom i (kineskim) biljnim pripravcima koji sadrže ekstrakte biljke Schisandra sphenanthera.
English: In vitro the following substances have been shown to be potential inhibitors of tacrolimus metabolism: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethisterone, quinidine, tamoxifen, troleandomycin.
Croatian: In vitro se pokazalo da su sljedeće tvari potencijalni inhibitori metabolizma takrolimusa: bromokriptin, kortizon, dapson, ergotamin, gestoden, lidokain, mefenitoin, mikonazol, midazolam, nilvadipin, noretisteron, kinidin, tamoksifen, troleandomicin.
English: A lower incidence of acute rejection episodes for tacrolimus- versus ciclosporin-treated patients (11.5% versus 22.6%) and a lower incidence of chronic rejection, the bronchiolitis obliterans syndrome (2.86% versus 8.57%), was reported within the first year after transplantation.
Croatian: U prvoj godini nakon transplantacije zabilježena je niža incidencija epizoda akutnog odbacivanja u bolesnika liječenih takrolimusom u odnosu na one liječene ciklosporinom (11,5% nasuprot 22,6%) i niža incidencija kroničnog odbacivanja, sindrom obliterirajućeg bronhiolitisa (2,86% nasuprot 8,57%).
English: It is strongly recommended to closely monitor tacrolimus blood levels, as well as, QT prolongation (with ECG), renal function and other side effects, whenever substances which have the potential to alter CYP3A4 metabolism or otherwise influence tacrolimus blood levels are used concomitantly, and to interrupt or adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4).
Croatian: Strogo se preporučuje pomno nadzirati koncentracije takrolimusa u krvi, kao i produljenje QT-a (s EKG-om), bubrežnu funkciju i druge nuspojave, kad god se istodobno primjenjuju tvari koje imaju mogućnost promijeniti metabolizam CYP3A4 ili na neki drugi način utjecati na koncentracije takrolimusa u krvi te po potrebi prekinuti ili prilagoditi dozu takrolimusa kako bi se održala slična izloženost takrolimusu (vidjeti dijelove 4.2 i 4.4).
English: In an additional 2-centre study, 26 patients were randomised to the tacrolimus versus 24 patients to the ciclosporin group.
Croatian: U dodatnom ispitivanju u dva centra 26 je bolesnika bilo randomizirano u skupinu koja je primala takrolimus, a 24 bolesnika u skupinu koja je primala ciklosporin.
English: When substances with a potential for interaction (see section 4.5) - particularly strong inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampicin, rifabutin) - are being combined with tacrolimus, tacrolimus blood levels should be monitored to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure.
Croatian: Kad se s takrolimusom kombiniraju tvari koje mogu ući u interakciju (vidjeti dio 4.5) - osobito jaki inhibitori CYP3A4 (kao što je telaprevir, boceprevir, ritonavir, ketokonazol, vorikonazol, itrakonazol, telitromicin ili klaritromicin) ili induktori CYP3A4 (kao što su rifampicin i rifabutin) - potrebno je pratiti koncentracije takrolimusa u krvi da bi se doza takrolimusa mogla odgovarajuće prilagoditi kako bi se održala slična izloženost takrolimusu.
English: How to take Modigraf
Croatian: Kako uzimati Modigraf
English: The 1-year survival rates were 73.1% in the tacrolimus versus 79.2% in the ciclosporin group.
Croatian: Stopa preživljenja nakon jedne godine iznosila je 73,1% u skupini koja je primala takrolimus nasuprot 79,2% u skupini koja je primala ciklosporin.
English: After oral administration (0.30 mg/kg/day) to paediatric liver transplant patients, steady-state concentrations of tacrolimus were achieved within 3 days in the majority of patients.
Croatian: Nakon peroralne primjene (0,30 mg/kg na dan) u pedijatrijskih bolesnika s presatkom jetre ravnotežne koncentracije takrolimusa postigle su se u roku od 3 dana u većine bolesnika.
English: Psychiatric disorders very common:
Croatian: Psihijatrijski poremećaji Vrlo često:
English: dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia
Croatian: dehidracija, hipoglikemija, hipoproteinemija, hiperfosfatemija
English: The interim analysis of a recent multicentre study discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Croatian: Privremena analiza nedavnog multicentričnog ispitivanja istražila je 110 bolesnika koji su bili randomizirani u omjeru 1:1 u skupinu koja je primala takrolimus i onu koja je primala ciklosporin.
English: Mean oral bioavailability of tacrolimus (investigated with the Prograf capsules formulation) is in the range of 20 - 25% (individual range in adult patients 6 - 43%, in paediatric kidney transplant patients 3 - 77%).
Croatian: Srednja peroralna bioraspoloživost takrolimusa (ispitana pomoću formulacije Prograf kapsula) u rasponu je od 20 do 25% (pojedini rasponi u odraslih bolesnika 6 - 43%, u pedijatrijskih bolesnika s presatkom bubrega 3 - 77%).
English: It is recommended that the oral daily dose of Modigraf be administered in 2 divided doses (e.g. morning and evening).
Croatian: Preporučuje se primijeniti peroralnu dnevnu dozu Modigrafa u 2 odvojene doze (npr. ujutro i navečer).
English: encephalopathy, central nervous system haemorrhages and cerebrovascular accidents, coma, speech and language abnormalities, paralysis and paresis, amnesia rare:
Croatian: encefalopatija, krvarenja u središnji živčani sustav i cerebrovaskularni incidenti, koma, poremećaji govora i jezika, paraliza i pareza, amnezija
English: After preparation, the suspension should be taken immediately.
Croatian: Nakon pripreme, suspenzija se mora odmah primijeniti.
English: Modigraf contains lactose and sodium
Croatian: Modigraf sadrži laktozu i natrij
English: Therefore, you should not breast-feed whilst using Modigraf.
Croatian: Stoga ne smijete dojiti dok uzimate Modigraf.
English: Another randomised study included 66 patients on tacrolimus versus 67 patients on ciclosporin.
Croatian: Drugo randomizirano ispitivanje uključilo je 66 bolesnika koji su primali takrolimus i 67 bolesnika koji su primali ciklosporin.
English: gastrointestinal signs and symptoms, vomiting, gastrointestinal and abdominal pains, gastrointestinal inflammatory conditions, gastrointestinal haemorrhages, gastrointestinal ulceration and perforation, ascites, stomatitis and ulceration, constipation, dyspeptic signs and symptoms, flatulence, bloating and distension, loose stools uncommon:
Croatian: gastrointestinalni znakovi i simptomi, povraćanje, gastrointestinalni i abdominalni bolovi, gastrointestinalna upalna stanja, gastrointestinala krvarenja, gastrointestinalne ulceracije i perforacija, ascites, stomatitis i ulceracija, zatvor, znakovi i simptomi dispepsije, flatulencija, nadutost i distenzija, mekane stolice
English: High dose prednisolone or methylprednisolone administered for the treatment of acute rejection have the potential to increase or decrease tacrolimus blood levels.
Croatian: Visoke doze prednizolona ili metilprednizolona primijenjene zbog liječenja akutnog odbacivanja mogu povisiti ili sniziti razine takrolimusa u krvi.
English: Caution should also be exercised in patients diagnosed or suspected to have Congenital Long QT Syndrome or acquired QT prolongation or patients on concomitant medications known to prolong the QT interval, induce electrolyte abnormalities or known to increase tacrolimus exposure (see section 4.5).
Croatian: Potreban je također oprez u bolesnika s dijagnozom ili sumnjom na sindrom kongenitalno produljenog QT-a, stečenog produljenja QT-a ili u bolesnika na istovremenoj terapiji za koju se zna da produljuje QT interval, uzrokuje poremećaje elektrolita ili povećava izloženost takrolimusu (vidjeti dio 4.5).
English: Human data demonstrate that tacrolimus is excreted into breast milk.
Croatian: Podaci prikupljeni u ljudi pokazuju da se takrolimus izlučuje u majčino mlijeko.
English: blindness not known:
Croatian: Vrlo rijetko: Nepoznato:
English: acute and chronic pancreatitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying rare:
Croatian: akutni i kronični pankreatitis, paralitički ileus, gastrooezofagealna refluksna bolest, poremećeno želučano pražnjenje
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.
Croatian: Kompleks FKBP12-takrolimus specifično se i kompetitivno veže za kalcineurin i inhibira ga što dovodi do inhibicije signalnih puteva
English: Blood trough levels of tacrolimus should be monitored during the post-transplantation period.
Croatian: Najniže razine takrolimusa u krvi potrebno je pratiti tijekom poslijetransplantacijskog razdoblja.
English: fall, ulcer, chest tightness, thirst very rare:
Croatian: pad, ulkus, stezanje u prsištu, žeđ
English: It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to tacrolimus monotherapy.
Croatian: U nekim je slučajevima moguće ukinuti istovremenu imunosupresivnu terapiju što dovodi do monoterapije takrolimusom.
English: The suspension should be administered immediately after preparation.
Croatian: Suspenzija se mora primijeniti neposredno nakon pripreme.
English: Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.
Croatian: Potrebno je nastaviti pratiti razine ciklosporina u krvi nakon prebacivanja, jer to može utjecati na klirens ciklosporina.
English: Modigraf sachets must not be used partially.
Croatian: Ne smije se primijeniti samo dio vrećice Modigrafa.
English: amylase increased, ECG investigations abnormal, heart rate and pulse investigations abnormal, weight decreased, blood lactate dehydrogenase increased very rare:
Croatian: povišena razina amilaze, poremećen nalaz EKG-a, poremećena srčana frekvencija i puls, smanjenje tjelesne težine, povišena laktat dehidrogenaza u krvi vrlo rijetko:
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).
Croatian: 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
English: respiratory failures, respiratory tract disorders, asthma rare:
Croatian: respiratorno zatajenje, poremećaji dišnih puteva, astma
English: 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).
Croatian: 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).
English: EBV-Viral Capsid Antigen (VCA)-negative patients have been reported to have an increased risk of developing lymphoproliferative disorders.
Croatian: Zabilježeno je da bolesnici s negativnim nalazom EBVvirusnog kapsidnog antigena (VCA) imaju povećan rizik od razvoja limfoproliferativnih poremećaja.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I
English: 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%).
Croatian: 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%).
English: Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Croatian: Prebacivanje bolesnika s terapije na bazi ciklosporina na terapiju na bazi takrolimusa treba pažljivo provesti (vidjeti dijelove 4.4 i 4.5).
English: 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.
Croatian: 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.
English: Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient aided by whole blood tacrolimus trough level monitoring.
Croatian: 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.
English: cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Croatian: Bolesnici koji primaju imunosupresivnu terapiju su pod povećanim rizikom od razvoja zloćudnih bolesti.
English: Modigraf contains the active substance tacrolimus.
Croatian: Modigraf sadrži djelatnu tvar takrolimus.
English: blood alkaline phosphatase increased, weight increased uncommon:
Croatian: povišena alkalna fosfataza u krvi, povećanje tjelesne težine manje često:
English: 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).
Croatian: 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).
English: In some cases, it was necessary to switch to alternative immunosuppression.
Croatian: U nekim je slučajevima bio potreban prelazak na drugu imunosupresivnu terapiju.
English: eye disorders, vision blurred, photophobia uncommon:
Croatian: poremećaji oka, zamagljen vid, fotofobija
English: Increased clearance rates contribute to the shorter half-life observed in transplant recipients.
Croatian: Povećana brzina klirensa pridonosi kraćem poluvijeku opaženom u bolesnika s presađenim organom.
English: influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance rare:
Croatian: bolest slična influenci, osjećaj nemira, nenormalno osjećanje, višestruko zatajenje organa, osjećaj pritiska u prstištu, nepodnošenje temperature
English: Each sachet contains 473 mg lactose (as monohydrate).
Croatian: Jedna vrećica sadrži 473 mg laktoze (u obliku hidrata).
English: Investigations very common:
Croatian: Pretrage vrlo često :
English: Frequent trough level monitoring in the initial 2 weeks post transplantation is recommended, followed by periodic monitoring during maintenance therapy.
Croatian: Preporučuje se često mjerenje najnižih razina u prva 2 tjedna nakon transplantacije, a nakon toga povremeno tijekom terapije održavanja.
English: Package leaflet: Information for the user Modigraf 0.2 mg, granules for oral suspension Modigraf 1 mg, granules for oral suspension
Croatian: Uputa o lijeku: Informacija za korisnika Modigraf 0,2 mg, granule za oralnu suspenziju Modigraf 1 mg, granule za oralnu suspenziju takrolimus
English: 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.
Croatian: 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.
English: primary graft dysfunction
Croatian: poremećaj funkcije primarnog presatka
English: Each sachet contains 94.7 mg lactose (as monohydrate).
Croatian: Jedna vrećica sadrži 94,7 mg laktoze (u obliku hidrata).
English: thrombotic thrombocytopenic purpura, hypoprothrombinaemia, thrombotic microangiopathy not known:
Croatian: trombotička trombocitopenična purpura, hipoprotrombinemija, trombotska mikroangiopatija
English: EXP: After preparation, the suspension should be administered immediately.
Croatian: Rok valjanosti: Nakon pripreme, suspenziju treba odmah primijeniti.
English: A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats.
Croatian: U štakora je opažen negativni učinak takrolimusa na plodnost mužjaka u obliku smanjenog broja i pokretljivosti spermija.
English: Астелас Фарма ЕООД Teл.
Croatian: България Астелас Фарма ЕООД
English: 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).
Croatian: U štakora je opažen negativni učinak takrolimusa na plodnost mužjaka u obliku smanjenog broja i pokretljivosti spermija (vidjeti dio 5.3).
English: Paediatric data
Croatian: Pedijatrijski podaci
English: fever, nausea or vomiting - if you have an alteration of the electrical activity of your heart called “QT prolongation”.
Croatian: - ako imate promjenu električne aktivnosti srca zvane „produljenje QT-a“.
English: 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.
Croatian: 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.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET FOIL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
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).
Croatian: 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).
English: Neoplasms benign, malignant and unspecified (inl.
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)
English: 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.
Croatian: uključujući bolesnike koji u osobnoj ili obiteljskoj anamnezi imaju produljenje QT-a, kongestivno zatajenje srca, bradiaritmije i poremećaje elektrolita.
English: 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).
Croatian: 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).
English: Posterior reversible encephalopathy syndrome (PRES) Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Croatian: Zabilježeno je da bolesnici liječeni takrolimusom razvijaju sindrom posteriorne reverzibilne encefalopatije (engl.