FrancophonIA/ELRC3.0 huggingface dataset:
English: pure red cell aplasia, agranulocytosis, haemolytic anaemia Immune system disorders
Croatian: izolirana aplazija crvene krvne loze, agranulocitoza, hemolitička anemija Poremećaji imunološkog sustava
English: In rats, female reproductive function including birth was impaired at toxic doses and the offspring showed reduced birth weights, viability and growth.
Croatian: U ženki štakora je pri toksičnim dozama bila narušena reproduktivna funkcija, uključujući okot, dok je mladunčad pokazala smanjenu porođajnu težinu,
English: For treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients clinical data are not yet available for the prolonged-release formulation Advagraf.
Croatian: Za liječenje odbacivanja alogenog presatka koje je rezistentno na liječenje drugim imunosupresivnim lijekovima u odraslih bolesnika još nema dostupnih kliničkih podataka za formulaciju Advagrafa s produljenim oslobađanjem.
English: Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Croatian: Potreban je oprez kada se bolesnicima zamjenjuje terapija koja se temelji na ciklosporinu terapijom koja se temelji na takrolimusu (vidjeti dio 4.4 i 4.5).
English: Bile flow does not influence the absorption of tacrolimus and therefore treatment with Advagraf may commence orally.
Croatian: Protok žuči ne utječe na apsorpciju takrolimusa pa se stoga liječenje može započeti peroralnom primjenom Advagrafa.
English: haemolytic uraemic syndrome, anuria very rare:
Croatian: hemolitičko uremijski sindrom, anurija vrlo rijetko:
English: Tacrolimus is a low-clearance substance.
Croatian: Takrolimus je tvar s niskim klirensom.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po kapsuli, tj. zanemarive količine natrija.
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: Primijećen je negativni utjecaj takrolimusa na plodnost mužjaka štakora u smislu smanjenog broja i motiliteta spermija (vidjeti dio 5.3).
English: In the early years the initial oral dose of tacrolimus was 0.3 mg/kg/day.
Croatian: prvim godinama liječenja, početna oralna doza takrolimusa iznosila je 0,3 mg/kg na dan.
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 kongenitalni sindrom produženog QT-a, stečenog produženja QT-a ili u bolesnika na istovremenoj terapiji za koju se zna da produžuje QT interval, uzrokuje poremećaje elektrolita ili povećava izloženost takrolimusu (vidjeti dio 4.5).
English: Tell your doctor if any of the following apply to you: - if you are taking any medicines mentioned below under ‘Other medicines and Advagraf'.
Croatian: - ako uzimate neke od lijekova navedene niže u dijelu „Drugi lijekovi i Advagraf”.
English: confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare uncommon:
Croatian: smetenost i dezorijentacija, depresija, anksiozni simptomi, halucinacije, duševni poremećaji, depresivno raspoloženje, poremećaji i smetnje raspoloženja, noćne more manje često: psihotički poremećaj
English: The treatment difference was -3.0% (Advagrafciclosporin) (95.2% confidence interval [-9.9%, 4.0%]) for Advagraf vs. ciclosporin and -1.9% (Prografciclosporin) (95.2% confidence interval [-8.9%, 5.2%]) for Prograf vs. ciclosporin.
Croatian: Razlika između liječenja iznosila je3,0% (Advagraf-ciklosporin) (95,2% raspon pouzdanosti [-9,9%, 4,0%]) za skupinu koja je primala Advagraf u usporedbi sa skupinom na ciklosporinu i -1,9% (Prograf-ciklosporin) (95,2% raspon pouzdanosti [-8,9%, 5,2%]) za skupinu koja je primala Prograf u usporedbi sa skupinom na ciklosporinu.
English: Effect of tacrolimus on the metabolism of other medicinal products Tacrolimus is a known CYP3A4 inhibitor; thus concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.
Croatian: Takrolimus je poznati inhibitor CYP3A4 pa istodobna primjena takrolimusa s lijekovima koji se metaboliziraju putem CYP3A4 može utjecati na metabolizam takvih lijekova.
English: How to store Advagraf
Croatian: Kako čuvati Advagraf
English: : +372 6 056 014 Fax: +372 6 056 011
Croatian: Biocodex OÜ Tel.: +372 6 056 014 Fax: +372 6 056 011
English: Astellas Ireland Co., Ltd. Killorglin, County Kerry Ireland
Croatian: Killorglin, County Kerry
English: Acute rejection episodes per 100 patient-days were numerically fewer in the tacrolimus (0.85 episodes) than in the ciclosporin group (1.09 episodes).
Croatian: Akutnih epizoda odbacivanja na 100 bolesnika-dana bilo je numerički manje u skupini na takrolimusu (0,85 epizoda)
English: Advagraf contains lactose, sodium and lecithin (soya)
Croatian: Advagraf sadrži laktozu, natrij i sojin lecitin
English: By Day 4, systemic exposure as measured by trough levels is similar for both kidney and liver transplant patients with both formulations.
Croatian: Do četvrtog dana, sistemska izloženost određena prema najnižoj izmjerenoj koncentraciji takrolimusa u bolesnika koji su primili presadak bubrega i onih koji su primili presadak jetre bila je slična za obje formulacije.
English: In current clinical practice, whole blood levels are monitored using immunoassay methods.
Croatian: Trenutno se u kliničkoj praksi koncentracije takrolimusa u punoj krvi određuju pomoću imunoloških testova.
English: Dose adjustments should be made to ensure that similar systemic exposure is maintained.
Croatian: Dozu je potrebno prilagoditi zato da bi se osigurala slična sistemska izloženost takrolimusu.
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.2 and 4.8).
Croatian: Bolesnike je potrebno održavati na jednoj formulaciji takrolimusa uz odgovarajući dnevni režim doziranja; promjena formulacije ili režima primjene smije se provesti samo pod strogim nadzorom specijaliste transplantacijske medicine (vidjeti dio 4.2 i 4.8).
English: hypertension common:
Croatian: hipertenzija često:
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, norethindrone, quinidine, tamoxifen, (triacetyl)oleandomycin.
Croatian: Sljedeće su se tvari in vitro pokazale potencijalnim inhibitorima metabolizma takrolimusa: bromokriptin, kortizol, dapson, ergotamin, gestoden, lidokain, mefenitoin, mikonazol, midazolam, nilvadipin, noretindron, kinidin, tamoksifen i (triacetil)oleandomicin.
English: Blood and lymphatic system disorders common:
Croatian: Poremećaj krvi i limfnog sustava često:
English: Lansoprazole and ciclosporin may potentially inhibit CYP3A4-mediated metabolism of tacrolimus and thereby increase tacrolimus whole blood concentrations.
Croatian: Lansoprazol i ciklosporin mogu potencijalno inhibirati metabolizam takrolimusa posredovan CYP3A4 i tako povećati koncentraciju takrolimusa u punoj krvi.
English: For prophylaxis of transplant rejection in adult heart allograft recipients clinical data are not yet available for Advagraf.
Croatian: Za sprječavanje odbacivanja presatka u odraslih primatelja alogenog presatka srca još nema dostupnih kliničkih podataka za Advagraf.
English: Take the capsules immediately following removal from the blister.
Croatian: Kapsule popijte čim ste ih izvadili iz blistera.
English: The interim analysis of a recent multicentre study using oral Prograf discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Croatian: Privremena analiza podataka iz nedavnog multicentričnog ispitivanja oralno primijenjenog Prografa uključila je 110 bolesnika koji su bili randomizirani 1:1 u skupinu koja prima takrolimus ili u skupinu koja prima ciklosporin.
English: Maintenance doses of corticosteroids have been shown to reduce tacrolimus blood levels.
Croatian: Pokazalo se da doze održavanja kortikosteroida također smanjuju koncentraciju takrolimusa u krvi.
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: Istodobno uzimanje tvari koje inhibiraju ili induciraju CYP3A4 može utjecati na metabolizam takrolimusa i tako povećati ili smanjiti koncentraciju takrolimusa u krvi.
English: Advagraf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below under “Therapeutic drug monitoring”).
Croatian: Doziranje Advagrafa mora se prvenstveno temeljiti na kliničkoj procjeni reakcije odbacivanja presatka i podnošljivosti lijeka u pojedinog bolesnika, dok određivanje koncentracije lijeka u krvi služi kao pomoć (vidjeti ispod pod „Terapijsko praćenje lijeka”).
English: hypoacusis rare:
Croatian: hipoakuzija rijetko:
English: In the systemic circulation, tacrolimus binds strongly to erythrocytes resulting in an approximate 20:1 distribution ratio of whole blood/plasma concentrations.
Croatian: Takrolimus se u sistemskom krvotoku u velikoj mjeri veže za eritrocite, zbog čega omjer raspodjele koncentracije u punoj krvi i plazmi iznosi otprilike 20:1.
English: The printing ink used on Advagraf capsules contains soya lecithin.
Croatian: Tinta kojom su otisnute oznake na kapsulama Advagrafa sadrži sojin lecitin.
English: Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Croatian: Nakon toga, liječnik će Vam morati redovito raditi krvne pretrage kako bi utvrdio ispravnu dozu i po potrebi je prilagodio.
English: Tacrolimus blood trough levels should be determined approximately 24 hours post-dosing of Advagraf, just prior to the next dose.
Croatian: Najniže koncentracije takrolimusa u krvi treba odrediti oko 24 sata nakon primjene Advagrafa,
English: cataract rare:
Croatian: katarakta rijetko:
English: Transparent PVC/PVDC aluminium blister or unit-dose perforated blister wrapped in an aluminium wrapper with a desiccant containing 10 capsules per blister.
Croatian: Prozirni PVC/PVDC aluminijski blister ili perforirani blister s jediničnim dozama u aluminijskom omotu sa sredstvom za sušenje; 10 kapsula po blisteru.
English: The event rate for biopsy-confirmed acute rejection within the first 24 weeks after transplantation was 18.6% in the Advagraf group (N=331) and 14.9% in the Prograf group (N=336).
Croatian: Stopa akutne reakcije odbacivanja potvrđena biopsijom u prvih 24 tjedana nakon presađivanja iznosila je 18,6% u skupini koja je primala Advagraf (N=331) i 14,9% u skupini koja je primala Prograf (N=336).
English: The 1-year patient survival rate was 80.8% in the tacrolimus and 83% in the ciclosporin group.
Croatian: Jednogodišnja stopa preživljenja bolesnika iznosila je 80,8% u skupini koja je primala takrolimus i 83% u skupini koja je primala ciklosporin.
English: Patients treated with immunosuppressants, including Advagraf are at increased risk for infections including opportunistic infections (bacterial, fungal, viral and protozoal) such as BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Croatian: U bolesnika koji se liječe imunosupresivima, uključujući Advagraf, 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: 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).
Croatian: (primjerice, reaktivacija i de novo infekcija virusom hepatitisa B i C, kao i infekcija virusom hepatitisa E, koja može postati kronična).
English: You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Advagraf.
Croatian: Za vrijeme liječenja Advagrafom potrebno je ograničiti izlaganje suncu i UV (ultraljubičastim) zrakama.
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 koje se primjenjuju u liječenju akutne reakcije odbacivanja mogu povećati ili smanjiti koncentraciju takrolimusa u krvi.
English: Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section
Croatian: Primijećene su alergijske i anafilaktoidne reakcije u bolesnika koji primaju takrolimus (vidjeti dio 4.4).
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I UPORABU LIJEKA
English: Conversion of Prograf-treated patients to Advagraf Allograft transplant patients maintained on twice daily Prograf capsules dosing requiring conversion to once daily Advagraf should be converted on a 1:1 (mg:mg) total daily dose basis.
Croatian: U bolesnika s alogenim presatkom koji uzimaju kapsule Prografa dvaput na dan, a moraju prijeći na liječenje Advagrafom koji uzimaju jedanput na dan, omjer ukupne dnevne doze mora ostati 1:1 (mg:mg).
English: When converting from Prograf capsules to Advagraf, trough levels should be measured prior to conversion and within two weeks after conversion.
Croatian: Kada se Prograf zamjenjuje Advagrafom, najniže koncentracije takrolimusa moraju se odrediti prije promjene terapije i u roku od dva tjedna nakon promjene terapije.
English: metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia uncommon:
Croatian: metabolička acidoza, drugi poremećaji elektrolita, hiponatremija, opterećenje tekućinom, hiperuricemija, hipomagnezemija, hipokalijemija, hipokalcemija, smanjen apetit, hiperkolesterolemija, hiperlipidemija, hipertrigliceridemija, hipofosfatemija manje često:
English: The efficacy and safety of Prograf, ciclosporin and Advagraf, all in combination with basiliximab antibody induction, MMF and corticosteroids, was compared in 638 de novo kidney transplant recipients.
Croatian: Djelotvornost i sigurnost primjene Prografa, ciklosporina i Advagrafa, svih u kombinaciji s indukcijom baziliksimab protutijelima, MMF-om i kortikosteroidima, uspoređivala se u 638 de novo primatelja presatka bubrega.
English: Skin and subcutaneous tissue disorders common:
Croatian: Poremećaji kože i potkožnog tkiva često:
English: Herbal preparations containing St. John's Wort (Hypericum perforatum) or other herbal preparations should be avoided when taking Advagraf 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 liječenja Advagrafom treba izbjegavati uzimanje biljnih pripravaka 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: Advagraf prolonged-release hard capsules should be taken immediately following removal from the blister.
Croatian: Advagraf tvrde kapsule s produljenim oslobađanjem moraju se uzeti odmah po otvaranju blistera.
English: hirsutism
Croatian: hirzutizam
English: The event rate of biopsy confirmed acute rejection within the first 24 weeks after transplantation was 32.6% in the Advagraf group (N=237) and 29.3% in the Prograf group (N=234).
Croatian: Stopa akutne reakcije odbacivanja potvrđene biopsijom u prva 24 tjedna nakon presađivanja iznosila je 32,6% u skupini koja je primala Advagraf (N=237) i 29,3% u skupini koja je primala Prograf (N=234).
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: Iz tih se razloga ne preporučuje kombinirana primjena ciklosporina i takrolimusa te je potreban oprez kada se takrolimus primjenjuje u bolesnika koji su prethodno uzimali ciklosporin (vidjeti dio 4.2 i 4.4).
English: Systemically available tacrolimus is metabolised by hepatic CYP3A4.
Croatian: Sistemski dostupan takrolimus metabolizira se putem jetrenog CYP3A4.
English: If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.
Croatian: Ako postoje jasni klinički znakovi odbacivanja presatka, potrebno je razmotriti mogućnost zamjene jednog imunosupresivnog režima drugim.
English: Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed.
Croatian: Primijećene su medikacijske pogreške, uključujući nepažljivu, nenamjernu ili nenadziranu međusobnu zamjenu formulacije takrolimusa s trenutnim i formulacije s produljenim oslobađanjem.
English: Investigations very common:
Croatian: Pretrage vrlo često:
English: It is an immunosuppressant.
Croatian: Advagraf je imunosupresivni lijek.
English: 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.
Croatian: Propisivati Advagraf i mijenjati imunosupresivne lijekove smiju samo liječnici s iskustvom u primjeni imunosupresivne terapije i liječenju transplantiranih bolesnika.
English: Other interactions leading 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, cotrimoxazole, NSAIDs, ganciclovir or aciclovir).
Croatian: Istodobna primjena takrolimusa i lijekova s nefrotoksičnim ili neurotoksičnim učincima može pojačati te učinke (npr. aminoglikozidi, inhibitori giraze, vankomicin, kotrimoksazol, nesteroidni protuupalni lijekovi, ganciklovir ili aciklovir).
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 nasuprot 67
English: eye disorders, vision blurred, photophobia uncommon:
Croatian: poremećaji oka, zamagljen vid, fotofobija manje često:
English: The efficacy and safety of Advagraf and Prograf, both in combination with mycophenolate mofetil (MMF) and corticosteroids, was compared in 667 de novo kidney transplant recipients.
Croatian: Djelotvornost i sigurnost primjene Advagrafa i Prografa, oba u kombinaciji s mikofenolat mofetilom (MMF) i kortikosteroidima, uspoređivala se u 667 de novo primatelja presatka bubrega.
English: 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.
Croatian: Tijekom ranog razdoblja nakon presađivanja organa rutinski se moraju pratiti sljedeći parametri: krvni tlak, EKG, neurološki i vidni status, koncentracija glukoze u krvi natašte, elektroliti (osobito kalij),
English: Strong interactions have been observed with antifungal agents such as ketoconazole, fluconazole, itraconazole, voriconazole and isavuconazole, the macrolide antibiotic erythromycin, HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), HCV protease inhibitors (e.g. telaprevir, boceprevir, and the combination of ombitasvir and paritaprevir with ritonavir, when used with and without dasabuvir), or the CMV antiviral letermovir, the pharmacokinetic enhancer cobicistat, and the tyrosine kinase inhibitors nilotinib and imatinib.
Croatian: Opažene su jake interakcije s antifungalnim lijekovima poput ketokonazola, flukonazola, itrakonazola, vorikonazola i izavukonazola, makrolidnim antibiotikom eritromicinom, inhibitorima proteaze HIV-a (npr. ritonavirom, nelfinavirom, sakvinavirom), inhibitorima proteaze HCV-a (npr. telaprevirom, boceprevirom i kombinacijom ombitasvira i paritaprevira s ritonavirom, primijenjenom s dasabuvirom ili bez njega), ili antivirotikom za liječenje CMV infekcija letermovirom, zatim farmakokinetičkim pojačivačem kobicistatom te inhibitorima tirozin kinaze nilotinibom i imatinibom.
English: to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Croatian: U plazmi je takrolimus uglavnom vezan (> 98,8%) za proteine plazme, uglavnom za serumski albumin i α-1-kiseli glikoprotein.
English: This medicine should be taken once a day.
Croatian: Advagraf se treba uzeti jedanput na dan.
English: influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance rare:
Croatian: bolest nalik gripi, osjećaj nervoze, osjećaj bolesti, multiorgansko zatajenje, osjećaj pritiska u prsištu, nepodnošenje temperature rijetko:
English: Following conversion, tacrolimus trough levels should be monitored and if necessary dose adjustments made to maintain similar systemic exposure.
Croatian: Nakon promjene terapije, potrebno je izmjeriti najniže koncentracije takrolimusa i po potrebi prilagoditi dozu kako bi se održala slična sistemska izloženost.
English: There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall.
Croatian: Ima dokaza i da se metabolizira u probavnom sustavu putem CYP3A4 u stijenci crijeva.
English: As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal).
Croatian: Bolesnici koji primaju takrolimus često su pod povećanim rizikom od infekcija (virusnih, bakterijskih,
English: Excipients with known effect: Each capsule contains 306.52 mg lactose.
Croatian: Jedna kapsula sadrži 306,52 mg laktoze.
English: In clinical practice, whole blood trough levels have generally been in the range 5 - 20 ng/ml in liver transplant recipients and 10 - 20 ng/ml in kidney and heart transplant patients in the early post-transplant period.
Croatian: U kliničkoj se praksi najniže razine takrolimusa u punoj krvi općenito kreću u rasponu od 5 do 20 ng/ml u primatelja presatka jetre te od 10 do 20 ng/ml u primatelja presatka bubrega i srca u ranom poslijetransplantacijskom razdoblju.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANAI UZ OPSKRBU I
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 u 10 000 ljudi):
English: acute and chronic pancreatitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying rare:
Croatian: akutni i kronični pankreatitis, paralitički ileus, gastroezofagealna refluksna bolest,
English: Advagraf contains the active substance tacrolimus.
Croatian: Advagraf sadrži djelatnu tvar takrolimus.