FrancophonIA/ELRC3.0 huggingface dataset:
English: In stable patients converted from Prograf capsules (twice daily) to Advagraf (once daily) on a 1:1 (mg:mg) total daily dose basis, the systemic exposure to tacrolimus (AUC0-24) for Advagraf was approximately 10% lower than that for Prograf.
Croatian: U stabilnih bolesnika koji su prešli s kapsula Prografa (dvaput na dan) na kapsule Advagrafa (jedanput na dan) u omjeru ukupne dnevne doze 1:1 (mg:mg), sistemska izloženost takrolimusu (AUC0-24) bila je oko 10% niža za Advagraf od one za Prograf.
English: Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea.
Croatian: Budući da se razine takrolimusa u krvi mogu značajno promijeniti tijekom epizoda proljeva, preporučuje se dodatno određivanje koncentracija takrolimusa tijekom takvih razdoblja.
English: Advagraf blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Advagraf, which may require interruption, an increase or a decrease in Advagraf dose.
Croatian: Razina Advagrafa u krvi može se promijeniti zbog utjecaja drugih lijekova koje uzimate, kao što se i razine drugih lijekova u krvi mogu promijeniti zbog utjecaja Advagrafa pa će možda biti potrebno prekinuti, povisiti ili sniziti dozu Advagrafa.
English: Most cases have been reversible, occurring with tacrolimus blood trough concentrations much higher than the recommended maximum levels.
Croatian: U većini su slučajeva bile reverzibilne i razvijale se kad je najniža koncentracija takrolimusa u krvi bila puno viša od preporučenih maksimalnih koncentracija.
English: Published clinical experience from a single centre on the use of oral Prograf 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.
Croatian: Objavljena klinička iskustva iz jednog centra s primjenom oralnog Prografa kao primarne terapije nakon presađivanja crijeva pokazala su da je aktuarska stopa preživljenja u 155 bolesnika (65 samo s presatkom crijeva, 75 s presatkom jetre i crijeva te 25 s presatcima više visceralnih organa) koji su primali takrolimus i prednizon bila 75% nakon jedne godine, 54% nakon 5 godina i 42% nakon 10 godina.
English: Dose reduction may be necessary in patients with severe liver impairment in order to maintain the tacrolimus blood trough levels within the recommended target range.
Croatian: Možda bude potrebno sniziti dozu u bolesnika s teškim oštećenjem jetre kako bi se najniže koncentracije takrolimusa u krvi održale unutar preporučenog ciljnog raspona.
English: headache, tremor common:
Croatian: glavobolja, tremor često:
English: The adverse reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medicinal products.
Croatian: Profil nuspojava povezanih s imunosupresivnim sredstvima često je teško utvrditi zbog osnovne bolesti i istodobne primjene više lijekova.
English: Stevens Johnson syndrome Musculoskeletal and connective tissue disorders common:
Croatian: Stevens Johnsonov sindrom Poremećaji mišićno-koštanog sustava i vezivnog tkiva često:
English: Tacrolimus is also considerably metabolised in the intestinal wall.
Croatian: Takrolimus se znatno metabolizira i u stijenci crijeva.
English: Freedom from acute rejection was higher in the tacrolimus group at 6 months (57.7% versus 45.8%) and at 1 year after lung transplantation (50% versus 33.3%).
Croatian: Izostanak akutnog odbacivanja bio je viši u skupini na takrolimusu nakon 6 mjeseci (57,7% nasuprot 45,8%) i jedne godine nakon presađivanja pluća (50% nasuprot 33,3%).
English: echocardiogram abnormal, electrocardiogram QT prolonged Injury, poisoning and procedural complications common:
Croatian: poremećen ehokardiografski nalaz, elektrokardiogram produženog QT-a Ozljede, trovanja i proceduralne komplikacije često:
English: Patients treated with tacrolimus have been reported to develop Epstein-Barr-Virus (EBV)-associated lymphoproliferative disorders (see section 4.8).
Croatian: Zabilježeno je da u bolesnika liječenih takrolimusom nastaju limfoproliferativni poremećaji povezani s Epstein-Barr virusom (EBV) (vidjeti dio 4.8).
English: fall, ulcer, chest tightness, thirst very rare:
Croatian: pad, ulkus, stezanje u prsištu, žeđ vrlo rijetko:
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).
Croatian: U slučaju izloženosti in utero, preporučuje se praćenje novorođenčeta zbog mogućih nuspojava takrolimusa (osobito utjecaja na bubrege).
English: A number of associated cases of transplant rejection have been reported (frequency cannot be estimated from available data).
Croatian: Zabilježeni su slučajevi odbacivanja presatka koji su bili povezani s takvim pogreškama (učestalost se ne može procijeniti na temelju dostupnih podataka).
English: The 1-year patient survival was 83% in the tacrolimus and 71% in the ciclosporin group, the 2-year survival rates were 76% and 66%, respectively.
Croatian: Jednogodišnje preživljenje bolesnika iznosilo je 83% u skupini na takrolimusu i 71% u skupini na ciklosporinu, dok su dvogodišnje stope preživljenja iznosile 76% za takrolimus i 66% za ciklosporin.
English: If clinically relevant changes are seen, adjustments of the immunosuppressive regimen should be considered.
Croatian: Ako se pokažu klinički važne promjene, treba razmotriti prilagodbu imunosupresivnog režima.
English: Reversible cardiotoxic effects were observed in rabbits following intravenous administration of tacrolimus.
Croatian: Reverzibilni kardiotoksični učinci bili su primijećeni u kunića nakon intravenske primjene takrolimusa.
English: Pharmacokinetics studies have indicated that the increase in blood levels is mainly a result of increase in oral bioavailability of tacrolimus owing to the inhibition of gastrointestinal metabolism.
Croatian: Farmakokinetička ispitivanja pokazala su da je povećanje koncentracije u krvi uglavnom posljedica povećane biološke raspoloživosti takrolimusa, zbog inhibicije metabolizma u probavnom sustavu.
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and antipyrine.
Croatian: Podaci iz ispitivanja na životinjama pokazuju da takrolimus može smanjiti klirens i produljiti poluvijek fenobarbitala i antipirina.
English: Embryofoetal toxicity was observed in rats and rabbits and was limited to doses that caused significant toxicity in maternal animals.
Croatian: Embriofetalna toksičnost bila je primijećena u štakora i kunića, no samo pri dozama koje su prouzročile značajnu toksičnost u skotnih ženki.
English: Each capsule contains less than 1 mmol sodium (23 mg).
Croatian: Jedna kapsula sadrži manje od 1 mmol natrija (23 mg).
English: This can lead to graft rejection or increased incidence of adverse reactions, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus.
Croatian: Ona može dovesti do odbacivanja presatka ili povećanja incidencije nuspojava, uključujući preslabu ili prejaku imunosupresiju, zbog klinički značajnih razlika u sistemskoj izloženosti takrolimusu.
English: In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3).
Croatian: Takrolimus je u štakora i kunića prouzročio embriofetalnu toksičnost u dozama koje su se pokazale toksične i za majku (vidjeti dio 5.3).
English: Metabolism and nutrition disorders very common:
Croatian: Poremećaji metabolizma i prehrane vrlo često:
English: There is limited experience in non-Caucasian patients and patients at elevated immunological risk (e.g. retransplantation, evidence of panel reactive antibodies, PRA).
Croatian: Iskustvo s bolesnicima koji nisu bjelačkog porijekla i bolesnicima u kojih postoji povećan imunološki rizik je ograničeno (npr. retransplantacija, dokaz panela reaktivnih protutijela, PRA)
English: In isolated patients with very high plasma levels, haemofiltration or -diafiltration have been effective in reducing toxic concentrations.
Croatian: U izoliranim slučajevima bolesnika s vrlo visokim razinama u plazmi pokazalo se da hemofiltracija ili dijafiltracija učinkovito smanjuju toksične koncentracije.
English: Advagraf doses are usually reduced in the post-transplant period.
Croatian: Doze Advagrafa u razdoblju nakon presađivanja obično se snižavaju.
English: The use of live attenuated vaccines should be avoided (see section 4.4).
Croatian: Potrebno je izbjegavati primjenu živog atenuiranog cjepiva (vidjeti dio 4.4).
English: In man tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract.
Croatian: Apsorpcija Pokazalo se da se takrolimus u ljudi apsorbira kroz cijeli gastrointestinalni trakt.
English: Obliterative bronchiolitis developed in 21.7% of patients in the tacrolimus group compared with 38.0% of patients in the ciclosporin group (p = 0.025).
Croatian: Bronhiolitis obliterans razvio se u 21,7% bolesnika u skupini koja je primala takrolimus i u 38,0% bolesnika u skupini koja je primala ciklosporin (p = 0,025).
English: Advagraf capsules contain lactose.
Croatian: Kapsule Advagrafa sadrže laktozu.
English: Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.
Croatian: Upotrijebiti sve kapsule unutar 1 godine nakon otvaranja aluminijskog omota i prije isteka roka valjanosti.
English: Following the initiation of your treatment with Advagraf, frequent blood tests will be taken by your doctor to define the correct dose.
Croatian: U početku liječenja Advagrafom, liječnik će Vam često raditi krvne pretrage kako bi odredio ispravnu dozu.
English: respiratory failures, respiratory tract disorders, asthma rare:
Croatian: respiratorno zatajenje, poremećaji dišnih puteva, astma rijetko:
English: How to take Advagraf
Croatian: Kako uzimati Advagraf
English: The treatment difference (AdvagrafPrograf) was 3.8% (95% confidence interval [-2.1%, 9.6%]).
Croatian: Razlika između liječenja (Advagraf-Prograf) iznosila je 3,8% (95% raspon pouzdanosti [-2,1%, 9,6%]).
English: Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) and febrile neutropenia (a decrease in the type of white blood cells which fight infection, accompanied by fever) have been reported.
Croatian: Zabilježeni su slučajevi izolirane aplazije crvene krvne loze (vrlo jako smanjenje broja crvenih krvnih stanica), agranulocitoze (jako smanjenje broja bijelih krvnih stanica), hemolitičke anemije (smanjenje broja crvenih krvnih stanica zbog abnormalnog raspadanja) i febrilne neutropenije (smanjenje vrste bijelih krvnih stanica koje se bore protiv infekcije, praćeno vrućicom).
English: It is recommended that the oral daily dose of Advagraf be administered once daily in the morning.
Croatian: Preporučuje se primjena dnevne oralne doze Advagrafa jedanput na dan, ujutro.
English: It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to Advagraf monotherapy.
Croatian: U nekim se slučajevima može obustaviti istodobna imunosupresivna terapija i ostaviti monoterapija Advagrafom.
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.
Croatian: Čini se da su učinci takrolimusa na molekularnoj razini posredovani njegovim vezanjem za protein citosola (FKBP12), koji je odgovoran za nakupljanje spoja u stanicama.
English: 12-month graft survival was 96.7% for Advagraf, 92.9% for Prograf and 95.7% for ciclosporin.
Croatian: Dvanaestomjesečno preživljenje presatka iznosilo je 96,7% za Advagraf, 92,9% za Prograf i 95,7% za ciklosporin.
English: Use all the prolonged-release hard capsules within 1 year of opening the aluminium wrapping.
Croatian: Sve tvrde kapsule s produljenim oslobađanjem moraju se potrošiti u roku od 1 godine po otvaranju aluminijskog omota.
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 bacterial infections) or antivirals (used to treat viral infections e.g. aciclovir).
Croatian: Obavijestite liječnika ako uzimate ili morate uzeti ibuprofen (koji se primjenjuje za liječenje vrućice, upale ili bola), amfotericin B (koji se primjenjuje za liječenje bakterijskih infekcija) ili antivirusne lijekove (koji se primjenjuju za liječenje virusnih infekcija npr. aciklovir).
English: Do not use Advagraf after the expiry date which is stated on the carton after “Exp”.
Croatian: Advagraf se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „Rok valjanosti“.
English: A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats.
Croatian: Negativni učinak takrolimusa na mušku plodnost u obliku smanjenja broja spermija i pokretljivosti primijećen je u štakora.
English: Posterior reversible encephalopathy syndrome (PRES) Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Croatian: U bolesnika liječenih takrolimusom zabilježen je razvoj sindroma posteriorne reverzibilne encefalopatije (PRES).
English: Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments.
Croatian: Takrolimus je visokopotentan imunosupresivni lijek, čije je djelovanje dokazano u ispitivanjima in vitro i in vivo.
English: All patients reported risk factors for PRCA such as parvovirus B19 infection, underlying disease or concomitant medications associated with PRCA.
Croatian: U svih su bolesnika zabilježeni čimbenici rizika za razvoj PRCA kao što je infekcija parvovirusom B19, osnovna bolest ili istodobno uzimanje lijekova koji su povezani s nastankom PRCA.
English: Capsule content: Hypromellose, ethylcellulose, lactose, magnesium stearate.
Croatian: Sadržaj kapsule: hipromeloza, etilceluloza, laktoza, magnezijev stearat.
English: Following your organ transplant (liver, kidney), your body's immune system will try to reject the new organ.
Croatian: (jetre, bubrega), Vaš imunološki sustav pokušat će odbaciti novi organ.
English: Factors such as low haematocrit and protein levels, which result in an increase in the unbound fraction of tacrolimus, or corticosteroid-induced increased metabolism, are considered to be responsible for the higher clearance rates observed following transplantation.
Croatian: Smatra se da su čimbenici poput niskog hematokrita i niske razine proteina, zbog čega je udio slobodnog takrolimusa veći, ili pojačanog metabolizma zbog kortikosteroida odgovorni za višu stopu klirensa primijećenu nakon presađivanja organa.
English: This has led to serious adverse reactions, including graft rejection, or other adverse reactions which could be a consequence of either under- or over-exposure to tacrolimus.
Croatian: Takve su pogreške dovele do ozbiljnih nuspojava, uključujući odbacivanje presatka, kao i drugih nuspojava koje su mogle biti posljedica premale ili prevelike izloženosti takrolimusu.
English: venoocclusive liver disease, hepatitic artery thrombosis very rare:
Croatian: venookluzivna bolest jetre, tromboza hepatičke arterije vrlo rijetko:
English: This effect may be enhanced if tacrolimus is administered in association with alcohol.
Croatian: Ti se učinci pojačavaju ako se takrolimus uzima zajedno s alkoholom.
English: - if you have or have had liver problems - if you have diarrhoea for more than one day
Croatian: - ako imate ili ste imali problema s jetrom
English: In an additional two-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 i 24 u skupinu koja je primala ciklosporin.
English: The most commonly reported adverse reactions (occurring in > 10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Croatian: Najčešće prijavljene nuspojave izazvane lijekom (javljaju se u > 10% bolesnika) uključuju tremor, oštećenje bubrega, hiperglikemička stanja, šećernu bolest, hiperkalijemiju, infekcije, hipertenziju i nesanicu.
English: As with other immunosuppressive agents, owing to the potential risk of malignant skin changes, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Croatian: Kao i tijekom uzimanja drugih imunosupresivnih lijekova, potrebno je ograničiti izlaganje sunčevom svjetlu i UV zrakama, nositi zaštitnu odjeću i koristiti preparate za kožu s visokim faktorom zaštite, zbog potencijalnog rizika od razvoja zloćudnih kožnih promjena.
English: A variety of innovations, such as techniques for early detection of Epstein-Barr (EBV) and CMV infections, bone marrow augmentation, the adjunct use of the interleukin-2 antagonist daclizumab, lower initial tacrolimus doses with target trough levels of 10 to 15 ng/ml, and most recently allograft irradiation were considered to have contributed to improved results in this indication over time.
Croatian: Smatra se da su razne inovacije, poput tehnika za rano otkrivanje infekcija Epstein-Barrovim virusom (EBV) i citomegalovirusom (CMV), povećanje koštane srži, dodatna primjena antagonista interleukina-2 daklizumaba, niže početne doze takrolimusa s najnižim ciljnim razinama od 10 do 15 ng/ml i od nedavno zračenje alografta pridonijele s vremenom sve boljim rezultatima liječenja u ovoj indikaciji.
English: Careful and frequent monitoring of tacrolimus trough levels is recommended in the first two weeks post-transplant with Advagraf to ensure adequate drug exposure in the immediate post-transplant period.
Croatian: Advagraf se tijekom prva dva tjedna nakon presađivanja organa preporučuje pažljivo i često određivanje najnižih koncentracija takrolimusa kako bi se osigurala odgovarajuća izloženost lijeku u razdoblju neposredno nakon presađivanja.
English: In patients unable to take oral medicinal products during the immediate post-transplant period, tacrolimus therapy can be initiated intravenously (see Summary of Product Characteristics for Prograf 5 mg/ml concentrate for solution for infusion) at a dose approximately 1/5th of the recommended oral dose for the corresponding indication.
Croatian: U bolesnika koji u ranom razdoblju nakon presađivanja organa ne mogu uzimati lijekove na usta, liječenje takrolimusom se može započeti intravenski (vidjeti Sažetak opisa svojstava lijeka za Prograf 5 mg/ml koncentrat za otopinu za infuziju) u dozi koja iznosi otprilike 1/5 preporučene oralne doze za tu indikaciju.
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 tvari koje mogu ući u interakciju (vidjeti dio 4.5) - osobito jaki inhibitori CYP3A4 (poput telaprevira, boceprevira, ritonavira, ketokonazola, vorikonazola, itrakonazola, telitromicina ili klaritromicina) ili induktori CYP3A4 (poput rifampicina i rifabutina) - kombiniraju s takrolimusom, potrebno je pratiti razinu takrolimusa u krvi kako bi se doza takrolimusa mogla primjereno prilagoditi i tako održati slična izloženost takrolimusu.
English: The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC0-24) for Advagraf is similar to that of Prograf.
Croatian: Odnos između najnižih izmjerenih doza takrolimusa (C24) i sistemske izloženosti (AUC0-24) kod Advagrafa sličan je onome kod Prografa.
English: Pure Red Cell Aplasia
Croatian: Izolirana aplazija crvene krvne loze
English: Both the rate and extent of absorption of Advagraf were reduced when administered with food.
Croatian: I brzina i opseg apsorpcije bile su smanjene kad se Advagraf primjenjivao uz obrok.
English: fat tissue increased not known:
Croatian: povećanje masnog tkiva nepoznato:
English: If abnormalities develop, dose reduction of Advagraf, or change of treatment to another immunosuppressive agent should be considered.
Croatian: Ako se razviju patološke promjene, potrebno je razmotriti smanjenje doze Advagrafa ili zamjenu terapije drugim imunosupresivom.
English: Results from clinical trials performed with once-daily tacrolimus Advagraf Liver transplantation
Croatian: Rezultati kliničkih ispitivanja provedenih s takrolimusom (Advagraf) koji se primjenjuje jedanput na dan
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 rijetko:
English: If PRES is diagnosed, adequate blood pressure and seizure control and immediate discontinuation of systemic tacrolimus is advised.
Croatian: U slučaju dijagnoze PRES-a, savjetuje se uvesti odgovarajuću kontrolu arterijskog tlaka i konvulzija te odmah prekinuti sistemsku primjenu takrolimusa.
English: thrombotic thrombocytopenic purpura, hypoprothrombinaemia, thrombotic microangiopathy not known:
Croatian: trombotička trombocitopenična purpura, hipoprotrombinemija, trombotska mikroangiopatija nepoznato:
English: Clinical efficacy and safety of Prograf capsules bid in primary organ transplantation In prospective studies oral Prograf was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Croatian: Peroralno primijenjen Prograf ispitivao se u prospektivnim ispitivanjima kao primarni imunosupresiv u oko 175 bolesnika s presatkom pluća, 475 bolesnika s presatkom gušterače i 630 bolesnika s presatkom crijeva.
English: 12-month graft survival was 85.3% for Advagraf and 85.6% for Prograf.
Croatian: Dvanaestomjesečno preživljenje presatka iznosilo je 85,3% za Advagraf i 85,6% za
English: Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective.
Croatian: Imunosupresivi mogu utjecati na odgovor na cijepljenje, a cijepljenje tijekom liječenja takrolimusom može biti manje djelotvorno.
English: A combination of immunosuppressives such as antilymphocytic antibodies (e.g. basiliximab, daclizumab) given concomitantly increases the risk of EBVassociated lymphoproliferative disorders.
Croatian: Kada se istodobno daje kombinacija imunosupresiva, kao što su antilimfocitna protutijela (npr. baziliksimab, daklizumab), povećava se rizik od razvoja limfoproliferativnih poremećaja povezanih s EBV.
English: The efficacy and safety of Advagraf and Prograf, both in combination with corticosteroids, was compared in 471 de novo liver transplant recipients.
Croatian: Djelotvornost i sigurnost primjene Advagrafa i Prografa, oba u kombinaciji s kortikosteroidima, uspoređivala se u 471 de novo primatelja presatka jetre.
English: heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations rare:
Croatian: zatajenje srca, ventrikularne aritmije i srčani arest, supraventrikularne aritmije, kardiomiopatije, ventrikularna hipertrofija, palpitacije rijetko:
English: Tell your doctor immediately if during treatment you suffer from:
Croatian: Obavijestite liječnika ako se sljedeći slučajevi odnose na Vas: