FrancophonIA/ELRC3.0 huggingface dataset:
English: Tacrolimus is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Croatian: Takrolimus se rutinski primjenjuje zajedno s drugim imunosupresivnim lijekovima u ranom postoperativnom razdoblju.
English: The combined administration of ciclosporin and tacrolimus is not recommended.
Croatian: Ne preporučuje se kombinirana primjena ciklosporina i takrolimusa.
English: See leaflet for further information.
Croatian: Pročitajte uputu o lijeku za dodatne informacije.
English: Only one of these has been shown in vitro to have immunosuppressive activity similar to that of tacrolimus.
Croatian: Samo jedan od njih pokazuje in vitro imunosupresivno djelovanje slično takrolimusu.
English: PVC blisters containing 10 prolonged-release tablets.
Croatian: PVC blister sadrži 10 tableta s produljenim oslobađanjem.
English: In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection.
Croatian: Takrolimus posebno inhibira stvaranje citotoksičnih limfocita, koji su uglavnom odgovorni za odbacivanje presatka.
English: Drugs which interfere with mycophenolic acid's enterohepatic cycle have potential to reduce the plasma level and efficacy of mycophenolic acid.
Croatian: Lijekovi koji utječu na enterohepatični ciklus mikofenolatne kiseline mogu smanjiti plazmatsku razinu i djelotvornost mikofenolatne kiseline.
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 cytokine genes.
Croatian: Kompleks FKBP12 i takrolimusa specifično i kompetitivno se veže za kalcineurin te ga inhibira, što uzrokuje inhibiciju puteva transdukcije signala T-stanica ovisnih o kalciju, čime se sprječava transkripcija posebne skupine gena za citokine.
English: There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall.
Croatian: Postoje dokazi i o gastrointestinalnom metabolizmu putem CYP3A4 u stjenci crijeva.
English: If clinically relevant changes are seen, adjustments of the immunosuppressive regimen should be considered.
Croatian: Ako se primijete klinički značajne promjene, treba razmotriti prilagodbu imunosupresivnog režima.
English: Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor.
Croatian: Takrolimus suprimira aktivaciju T-stanica i proliferaciju B-stanica ovisnu o pomoćničkim T-stanicama, kao i stvaranje limfokina (poput interleukina-2, -3 i γ-interferona) i ekspresiju receptora interleukina-2.
English: Mean values for Cmax, percentage degree of fluctuation and percentage degree of swing were significantly lower with administration of Envarsus tablets.
Croatian: Srednje vrijednosti za Cmax, postotak stupnja fluktuacije i postotak stupnja oscilacije bili su znatno niži uz primjenu tableta Envarsus.
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 razine u krvi uglavnom posljedica povećane bioraspoloživosti peroralno uzetog takrolimusa, zbog inhibicije gastrointestinalnog metabolizma.
English: Tacrolimus is a known CYP3A4 inhibitor; thus, concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.
Croatian: Takrolimus je poznati inhibitor CYP3A4, stoga istodobno uzimanje takrolimusa s lijekovima za koje je poznato da se metaboliziraju pomoću CYP3A4 može utjecati na metabolizam tih lijekova.
English: - The role of the patient card in ensuring that patients are aware of the product they are taking and the recommendations for safe and effective use in particular once daily dose and the importance of avoiding switching between other tacrolimus containing products except under the advice and supervision of your doctor
Croatian: - Uloga kartice za bolesnika kako bi se osiguralo da su bolesnici upoznati s lijekom kojega uzimaju i preporukama za sigurnu i djelotvornu primjenu jedne doze dnevno, te važnost da se izbjegne prebacivanje između lijekova koji sadrže takrolimus osim ako je to u skladu sa savjetima i pod nadzorom vašeg liječnika
English: Grapefruit juice has been reported to increase the blood level of tacrolimus and should, therefore, be avoided.
Croatian: Zabilježeno je da sok od grejpfruta povećava koncentraciju takrolimusa u krvi pa ga stoga treba izbjegavati.
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 epizoda proljeva.
English: Take the tablets immediately following removal from the blister.
Croatian: Tablete popijte odmah čim ste ih izvadili iz blistera.
English: In vitro test results indicate that there is no risk of in vivo dose dumping related to alcohol intake.
Croatian: Rezultati testova in vitro ukazuju da nema rizika od in vivo naglog otpuštanja doze koje je povezano s unosom alkohola.
English: Envarsus contains lactose (milk sugar).
Croatian: Envarsus sadrži laktozu (mliječni šećer).
English: Carbamazepine, metamizole and isoniazid have the potential to decrease tacrolimus concentrations.
Croatian: Karbamazepin, metamizol i izoniazid mogu smanjiti koncentracije takrolimusa.
English: Other potential interactions that may increase systemic exposure of tacrolimus include prokinetic agents (such as metoclopramide and cisapride), cimetidine and magnesium-aluminium-hydroxide.
Croatian: Druge potencijalne interakcije koje mogu povećati sustavnu izloženost takrolimusu uključuju prokinetičke lijekove (poput metoklopramida i cisaprida), cimetidin i magnezij-aluminijhidroksid.
English: 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, gljivičnih i protozoalnih).
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 vezanjem na protein citosola (FKBP12), koji je odgovoran za intracelularnu kumulaciju spoja.
English: Do not use this medicine after the expiry date which is stated on the carton, blister and wrapper after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru i omotu iza oznake „Rok valjanosti“ ili „EXP“.
English: Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed in tacrolimus treated patients on rare occasions.
Croatian: Ventrikularna hipertrofija ili hipertrofija septuma, prijavljene kao kardiomiopatije, bile su primijećene u rijetkim slučajevima u bolesnika liječenih takrolimusom.
English: If you take more Envarsus than you should
Croatian: Ako uzmete više lijeka Envarsus nego što ste trebali
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, a aktivnost mu je dokazana u ispitivanjima in vitro i in vivo.
English: If you stop taking Envarsus
Croatian: Ako prestanete uzimati Envarsus
English: Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with tacrolimus.
Croatian: Pojačana nefrotoksičnost primijećena je nakon primjene amfotericina B i ibuprofena zajedno s takrolimusom.
English: The use of live attenuated vaccines should be avoided (see section 4.4).
Croatian: Treba izbjegavati primjenu živih atenuiranih cjepiva (vidjeti dio 4.4).
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 će biti potrebno sniziti dozu u bolesnika s teškim oštećenjem jetre kako bi se najniže koncentracije takrolimusa u krvi održale unutar preporučenog ciljnog raspona.
English: Most cases have been reversible, occurring with tacrolimus blood trough concentrations much higher than the recommended maximum levels.
Croatian: U većini slučajeva bile su reverzibilne i pojavile su se kad su najniže koncentracije takrolimusa u krvi bile puno više od preporučenih maksimalnih koncentracija.
English: The frequency of blood level monitoring should be based on clinical needs.
Croatian: Učestalost određivanja razine takrolimusa u krvi mora se temeljiti na kliničkim potrebama.
English: You should keep in regular contact with your doctor.
Croatian: Morate se redovito javljati na liječnički pregled.
English: If you need to have any vaccinations, please tell your doctor before.
Croatian: Ako se morate cijepiti, prethodno obavijestite o tome svog liječnika.
English: In cases of oral intoxication, gastric lavage and/or the use of adsorbents (such as activated charcoal) may be helpful if used shortly after intake.
Croatian: U slučaju peroralne intoksikacije, može pomoći ispiranje želuca i/ili primjena adsorbensa (poput aktivnog ugljena) ukoliko se primijene neposredno nakon uzimanja takrolimusa.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI I OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Several cases of accidental overdose have been reported with tacrolimus.
Croatian: Prijavljeno je nekoliko slučajeva slučajnog predoziranja s takrolimusom.
English: If abnormalities develop, dose reduction of tacrolimus or change of treatment to another immunosuppressive agent should be considered.
Croatian: Ako se razviju poremećaji, treba razmotriti smanjenje doze takrolimusa ili zamjenu liječenja drugim imunosupresivom.
English: Higher Cavg (~50%), reduced peak trough fluctuation (Cmax/Cmin) and a longer Tmax were seen for Envarsus when compared with both, tacrolimus immediate-release formulation (Prograf) and a tacrolimus once daily formulation (Advagraf).
Croatian: Viša Cavg (~50%), smanjena fluktuacija vršne i najniže koncentracije (Cmax/Cmin) te dulji Tmax uočeni su za Envarsus u usporedbi s oba takrolimusa: s trenutnim oslobađanjem (Prograf) i takrolimusom koji se uzima jedanput na dan (Advagraf).
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and antipyrine.
Croatian: Podaci iz istraživanja na životinjama pokazali su da takrolimus može smanjiti klirens i produljiti poluvijek fentobarbitala i antipirina.
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: Envarsus blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Envarsus, which may require interruption, an increase or a decrease in Envarsus dose.
Croatian: Razina Envarsusa u krvi može se promijeniti zbog utjecaja drugih lijekova koje uzimate, kao što se i razine drugih lijekova u krvi mogu promijeniti zbog uzimanja Envarsusa pa će možda biti potrebno prekinuti, povisiti ili sniziti dozu Envarsusa.
English: - The importance of avoiding inadvertent switching between tacrolimus containing products and the risk of under and overdosing if monitoring is inadequate.
Croatian: - Važnost da se izbjegne nenamjerno prebacivanje između lijekova koji sadrže takrolimus te opasnost od premale ili prevelike doze ako nadzor nije odgovarajući.
English: In current clinical practice, whole blood levels are monitored using immunoassay methods.
Croatian: U današnjoj kliničkoj praksi koncentracije u punoj krvi određuju se pomoću imunoloških testova.
English: A combination of immunosuppressives, such as antilymphocytic antibodies (e.g. basiliximab, daclizumab), given concomitantly increases the risk of EBV-associated lymphoproliferative disorders.
Croatian: Kombinacija imunosupresiva, kao što su antilimfocitna protutijela (npr. baziliksimab, daklizumab), danih istodobno, povećava rizik od razvoja limfoproliferativnih poremećaja povezanih s EBV.
English: Reversible cardiotoxic effects were observed in rabbits following intravenous administration of tacrolimus.
Croatian: Reverzibilni kardiotoksični učinci su primijećeni u kunića nakon intravenske primjene takrolimusa.
English: It is necessary to consider the clinical condition of the patient when interpreting whole blood levels.
Croatian: Nužno je uzeti u obzir kliničko stanje bolesnika prilikom tumačenja razina takrolimusa u punoj krvi.
English: If PRES is diagnosed, adequate blood pressure and seizure control and immediate discontinuation of systemic tacrolimus is advised.
Croatian: Ako se dijagnosticira PRES, savjetuje se praćenje krvnog tlaka i kontrola konvulzija te trenutni prekid sustavne primjene takrolimusa.
English: • Envarsus 4 mg tablets:
Croatian: • Envarsus 4 mg tablete:
English: Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Croatian: Takrolimus se najvećim dijelom metabolizira u jetri, primarno putem citokroma P450-3A4.
English: The overall incidence of fatal treatment emergent adverse events for the combined de novo and stable liver transplant population was not significantly different between the Envarsus group and the tacrolimus immediate-release group.
Croatian: Ukupna incidencija štetnih događaja sa smrtnim ishodom tijekom liječenja za kombiniranu de novo i stabilnu populaciju bolesnika s transplantiranom jetrom nije se znatno razlikovala između skupine liječene Envarsusom i skupine koja je primala takrolimus s trenutnim oslobađanjem.
English: You may also be given Envarsus for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation.
Croatian: Envarsus možete dobiti i kad je odbacivanje presatka jetre, bubrega, srca ili nekog drugog organa već započelo, a kada se liječenjem koje ste do tada primali ne može kontrolirati imunološki odgovor nakon presađivanja.
English: Embryofoetal toxicity was observed in rats and rabbits and was limited to doses that caused significant toxicity in maternal animals.
Croatian: Embriofetalna toksičnost primijećena je u štakora i kunića, no samo u dozama izrazito toksičnim u skotnih ženki.
English: Effect of other medicinal products on the metabolism of tacrolimus
Croatian: Učinak drugih lijekova na metabolizam takrolimusa
English: EBV-Viral Capsid Antigen (VCA)-negative patients have been reported to have an increased risk of developing lymphoproliferative disorders.
Croatian: EBV-viral capsid antigen, EBV-VCA) zabilježen je povećani rizik od razvoja limfoproliferativnih poremećaja.
English: It should be noted that black patients may require a higher dose to achieve the targeted trough levels.
Croatian: Treba imati na umu da bolesnicima crne rase može biti potrebna viša doza da bi se postigle željene razine.
English: Maintenance doses of corticosteroids have been shown to reduce tacrolimus blood levels.
Croatian: Pokazalo se da doze održavanja kortikosteroida također smanjuju razinu takrolimusa u krvi.
English: If you forget to take Envarsus
Croatian: Ako ste zaboravili uzeti Envarsus
English: In healthy subjects, the average total body clearance estimated from whole blood concentrations was 2.25 L/h.
Croatian: U zdravih je ispitanika prosječni klirens takrolimusa iz cijelog tijela procijenjen iz koncentracija u punoj krvi iznosio 2,25 l/sat.
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 za koje je poznato da inhibiraju ili induciraju CYP3A4 može utjecati na metabolizam takrolimusa i tako povećati ili smanjiti razine takrolimusa u krvi.
English: The pharmacokinetics, efficacy and safety of Envarsus and tacrolimus immediate-release capsules, both in combination with corticosteroids were compared in 117 liver transplant recipients, of whom 88 received treatment with Envarsus.
Croatian: Farmakokinetika, djelotvornost i sigurnost Envarsusa i kapsula takrolimusa s trenutnim oslobađanjem, oba u kombinaciji s kortikosteroidima, uspoređene su u 117 primatelja presatka jetre od kojih je 88 liječeno Envarsusom.
English: In man tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract.
Croatian: Za takrolimus je dokazano se u ljudi apsorbira iz cijelog gastrointestinalnog 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 toksične doze uzrokovale su poremećaj reprodukcijske funkcije, uključujući okot, a među potomstvom je zapaženo smanjenje porođajne težine, smanjeno preživljavanje i usporen rast.
English: In case of in utero exposure, monitoring of the newborn for 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 učinci na bubrege).
English: Gastrointestinal perforation has been reported in patients treated with tacrolimus.
Croatian: Prijavljena je perforacija gastrointestinalnog trakta kod bolesnika liječenih takrolimusom.
English: Pack sizes of 30, 60 and 90 prolonged-release tablets.
Croatian: Veličine pakiranja od 30, 60 i 90 tableta s produljenim oslobađanjem.
English: Italy or
Croatian: Italija ili
English: As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) should be avoided (see section 4.4).
Croatian: Budući da liječenje takrolimusom može biti praćeno hiperkalijemijom ili može povećati već postojeću hiperkalijemiju, treba izbjegavati povećan unos kalija ili diuretike koji štede kalij (npr. amilorid, triamteren ili spironolakton) (vidjeti dio 4.4).
English: Reproductive system and breast disorders dysmenorrhoea and uterine bleeding
Croatian: Poremećaji reproduktivnog sustava i dojki dismenoreja i krvarenje iz uterusa
English: Envarsus is taken once daily and is not interchangeable with other existing medicines containing tacrolimus (immediate release or prolonged release) on an equal dose by dose basis.
Croatian: Envarsus se uzima jedanput na dan i ne može se zamjenjivati s drugim postojećim lijekovima koji sadrže takrolimus (s trenutnim ili produljenim oslobađanjem) na osnovi jednakih doza.
English: The treatment difference (Envarsus-Prograf) was -1.35% (95% confidence interval [-7.94%, 5.27%]).
Croatian: Prograf) bila je -1,35% (95%-tni interval pouzdanosti [-7,94%;5,27%]).
English: Elderly patients (> 65 years) There is no evidence currently available to indicate that dose should be adjusted in elderly patients.
Croatian: Trenutno nema dostupnih dokaza koji bi ukazivali na to da se u starijih bolesnika mora prilagoditi doza.
English: Conversion from ciclosporin to tacrolimus
Croatian: Prelazak s ciklosporina na takrolimus
English: Possible interactions with other active substances known to have high affinity for plasma proteins should be considered (e.g. NSAIDs, oral anticoagulants or oral antidiabetics).
Croatian: Treba uzeti u obzir moguće interakcije s drugim djelatnim tvarima koje imaju visok afinitet za proteine plazme (npr. nesteroidni protuupalni lijekovi NSAIL, oralni antikoagulansi ili oralni antidijabetici).
English: In the systemic circulation, tacrolimus binds strongly to erythrocytes resulting in an approximate 20:1 distribution ratio of whole blood/plasma concentrations.
Croatian: U sustavnom krvotoku takrolimus se snažno veže na eritrocite, pa omjer distribucije koncentracije u punoj krvi / plazmi iznosi približno 20:1.
English: Endocrine disorders hirsutism
Croatian: Endokrini poremećaji hirzutizam
English: Limited knowledge of interactions between tacrolimus and statins is available.
Croatian: Poznavanje interakcija između takrolimusa i statina je ograničeno.
English: Envarsus therapy should commence at a dose of 0.17 mg/kg/day administered once daily in the morning.
Croatian: Liječenje Envarsusom treba započeti dozom od 0,17 mg/kg/dan koja se primjenjuje jedanput na dan, ujutro.
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 imunosupresivnog režima.
English: - The other excipients are hypromellose, lactose monohydrate, macrogol 6000, poloxamer 188, magnesium stearate, tartaric acid (E334), butylated hydroxytoluene (E321), dimethicone 350.
Croatian: - Drugi sastojci su hipromeloza, laktoza hidrat, makrogol 6000, poloksamer 188, magnezijev stearat, tartaratna kiselina, butilhidroksitoluen (E321), dimetikon 350.
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: Vam morati redovito raditi krvne pretrage kako bi utvrdio ispravnu dozu i po potrebi je prilagodio.
English: In clinical studies patients converted from twice daily Prograf were converted to Envarsus at 1:0.85 (mg:mg).
Croatian: U kliničkim ispitivanjima, bolesnici su prešli s Prografa, dva puta dnevno, na Envarsus u omjeru 1: 0,85 (mg:mg).
English: Liver transplantation
Croatian: Presađivanje jetre
English: In stable patients converted from tacrolimus immediate-release products (twice daily) to Envarsus (once daily) on a 1:0.7 (mg:mg) total daily dose basis, the mean systemic exposure to tacrolimus (AUC0-24) was similar to that of immediate-release tacrolimus.
Croatian: U stabilnih bolesnika koji su prešli s lijekova koji sadrže takrolimus s trenutnim oslobađanjem (dvaput na dan) na Envarsus (jedanput na dan) u omjeru ukupne dnevne doze 1: 0,7 (mg:mg), srednja sustavna izloženost takrolimusu (AUC0-24) bila je slična onoj takrolimusa s trenutnim oslobađanjem.
English: Lymphoproliferative disorders and malignancies
Croatian: Limfoproliferativni poremećaji i zloćudne bolesti
English: A negative effect of tacrolimus on male fertility in the form of reduced sperm count and motility was observed in rats (see section 5.3).
Croatian: Primijećen je negativni učinak takrolimusa na plodnost mužjaka štakora u obliku smanjenog broja i motiliteta spermija (vidjeti dio 5.3).
English: Pure red cell aplasia
Croatian: Izolirana aplazija crvene krvne loze
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 farmakokinetika statina uglavnom nije promijenjena pri istvremenoj primjeni s takrolimusom.
English: Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Croatian: U bolesnika liječenih takrolimusom prijavljena je pojava sindroma posteriorne reverzibilne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES).