FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine should only be prescribed to you by a doctor with experience in the treatment of transplant patients.
Croatian: Ovaj lijek Vam treba propisati liječnik s iskustvom u liječenju transplantiranih bolesnika.
English: In practice, tacrolimus-based therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Croatian: U praksi se liječenje takrolimusom započinjalo 12-24 sata nakon prekida liječenja ciklosporinom.
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Croatian: Kao i kod drugih jakih imunosupresiva, rizik od nastanka sekundarnog karcinoma nije poznat (vidjeti dio 4.8).
English: Advagraf therapy requires careful monitoring by adequately qualified and equipped personnel.
Croatian: Liječenje Advagrafom mora biti pod strogim nadzorom odgovarajuće obučenih i opremljenih zdravstvenih radnika.
English: Overall, the safety profile of oral Prograf in these published studies appeared to be similar to what was reported in the large studies, where Prograf was used as primary treatment in liver, kidney and heart transplantation.
Croatian: Čini se da je općenito profil sigurnosti peroralno primijenjenog Prografa u tim objavljenim ispitivanjima bio sličan onome navedenom u velikim ispitivanjima, u kojima se Prograf koristio kao primarna terapija nakon presađivanja jetre, bubrega i srca.
English: In healthy subjects, the mean half-life in whole blood is approximately 43 hours.
Croatian: U zdravih je ispitanika prosječni poluvijek u punoj krvi otprilike 43 sata.
English: Your dose depends on your general condition and on which other immunosuppressive medication you are taking.
Croatian: Doza koju ćete uzimati ovisit će o Vašem općem stanju i drugom imunosupresivnom lijeku koji uzimate.
English: To suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.
Croatian: Da bi se suprimiralo odbacivanje presatka, mora se održati imunosupresija; posljedično tome, ne može se dati ograničenje trajanja oralne terapije.
English: Tacrolimus treatment can be considered in pregnant women, when there is no safer alternative and when the perceived benefit justifies the potential risk to the foetus.
Croatian: Primjena takrolimusa u trudnica može se razmotriti kad nema sigurnije alternative i kada očekivana korist od liječenja opravdava izlaganje fetusa potencijalnom riziku.
English: Do not stop your treatment unless your doctor tells you to do so.
Croatian: Nemojte prestati uzimati lijek osim ako Vam to nije savjetovao liječnik.
English: Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Croatian: PCR-a na EBV može trajati mjesecima i nije sam po sebi indikativan za limfoproliferativnu bolest ili limfom.
English: Limited data are available but no recommendation on a posology can be made.
Croatian: Dostupni su ograničeni podaci stoga se ne mogu dati preporuke za doziranje.
English: If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Advagraf may need to be reduced.
Croatian: U slučaju da se primijete znakovi toksičnosti, kao što su teške nuspojave (vidjeti dio 4.8), možda će biti potrebno smanjiti dozu Advagrafa.
English: In rats, tacrolimus caused toxic effects to the nervous system and the eyes.
Croatian: U štakora je takrolimus prouzročio toksične učinke u živčanom sustavu i očima.
English: - if you feel strong abdominal pain accompanied or not with other symptoms, such as chills, fever,
Croatian: - ako osjećate jaku bol u trbuhu s drugim simptomima ili bez njih, kao što su zimica, vrućica,
English: The use of Advagraf is not recommended in children and adolescents under 18 years.
Croatian: Ne preporučuje se primjena Advagrafa u djece i adolescenata mlađih od 18 godina.
English: The half-life of tacrolimus is long and variable.
Croatian: Takrolimus ima dug i varijabilan poluvijek.
English: Certain combinations of tacrolimus with drugs known to have nephrotoxic or neurotoxic effects may increase the risk of these effects (see section 4.5).
Croatian: Određene kombinacije takrolimusa i lijekova koji imaju nefrotoksične ili neurotoksične učinke mogu povisiti rizik od takvih učinaka (vidjeti dio 4.5).
English: Stopping your treatment with Advagraf may increase the risk of rejection of your transplanted organ.
Croatian: Prestanak liječenja Advagrafom može povisiti rizik od odbacivanja presađenog organa.
English: If you are, think you might be or are planning to become pregnant, ask your doctor for advice before using Advagraf.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: In patients who are hypersensitive to peanut or soya, the risk and severity of hypersensitivity should be weighed against the benefit of using Advagraf.
Croatian: U bolesnika koji su preosjetljivi na kikiriki ili soju potrebno je odvagnuti rizik i težinu reakcije preosjetljivosti u odnosu na korist od uzimanja Advagrafa.
English: Advagraf should be administered in the morning.
Croatian: Advagraf je potrebno uzimati ujutro.
English: If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Croatian: U slučaju predoziranja, potrebno je uvesti opće potporne mjere i simptomatsko liječenje.
English: Effect on hepatic clearance is less pronounced.
Croatian: Utjecaj na jetreni klirens manje je izražen.
English: Results continuously improved with increasing experience over the course of 11 years.
Croatian: S povećanjem iskustva tijekom 11 godina poboljšavali su se i rezultati liječenja.
English: The oral bioavailability of Advagraf was reduced when it was administered after a meal.
Croatian: Oralna biološka raspoloživost Advagrafa bila je smanjena kad se primjenjivao nakon obroka.
English: The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects).
Croatian: Volumen distribucije pri stanju dinamičke ravnoteže određen na temelju koncentracija u plazmi iznosi oko 1300 l (zdravi ispitanici).
English: This is because Advagraf capsules allow for a prolonged release (more slow release over a longer period) of tacrolimus.
Croatian: Razlog tome je taj što kapsule Advagrafa omogućuju produljeno oslobađanje takrolimusa (sporije oslobađanje tijekom duljeg razdoblja).
English: Take Advagraf on an empty stomach or 2 to 3 hours after a meal.
Croatian: Uzmite Advagraf na prazan želudac ili 2 do
English: Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Croatian: Stoga praćenje najnižih koncentracija u punoj krvi omogućuje dobru procjenu sistemske izloženosti.
English: In total 34 patients switched treatment from ciclosporin to tacrolimus, whereas only 6 tacrolimus patients required alternative therapy.
Croatian: U ukupno 34 bolesnika liječenje ciklosporinom zamijenjeno je takrolimusom, dok je samo 6 bolesnika na takrolimusu trebalo alternativno liječenje.
English: As the pharmacokinetics of tacrolimus are unaffected by renal function (see section 5.2), no dose adjustment is required.
Croatian: Budući da na farmakokinetiku takrolimusa ne utječe bubrežna funkcija (vidjeti dio 5.2), dozu nije potrebno prilagođavati.
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Croatian: U sistemskom je krvotoku samo jedan od nedjelatnih metabolita prisutan u niskim koncentracijama.
English: Tacrolimus may cause visual and neurological disturbances.
Croatian: Takrolimus može prouzročiti poremećaje vida i neurološke poremećaje.
English: Concomitant use of these substances may require decreased tacrolimus doses in nearly all patients.
Croatian: Istodobna primjena ovih tvari zahtijeva smanjenje doze takrolimusa u gotovo svih bolesnika.
English: You should keep in regular contact with your doctor.
Croatian: Morate se redovito javljati liječniku.
English: Printing ink (Opacode S-1-15083): Shellac
Croatian: Tinta za označavanje (Opacode S-1-15083):
English: Data from clinical studies suggest that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 ng/ml.
Croatian: Podaci iz kliničkih ispitivanja ukazuju na to da se većina bolesnika može uspješno zbrinuti ako se najniže koncentracije takrolimusa u krvi održavaju ispod 20 ng/ml.
English: Advagraf is used to control your body's immune response, enabling your body to accept the transplanted organ.
Croatian: Advagraf se primjenjuje za obuzdavanje imunološkog odgovora tijela, čime mu se omogućuje da prihvati presađeni organ.
English: Initial daily doses just after transplantation will generally be in the range of
Croatian: Početne dnevne doze neposredno nakon presađivanja općenito se kreću u rasponu od
English: Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine.
Croatian: Pazite da Vam svaki put kad podižete lijek na recept daju istu vrstu lijeka s takrolimusom, osim ako Vaš liječnik specijalist transplantacijske medicine nije odlučio da morate promijeniti oblik takrolimusa koji uzimate.
English: In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
Croatian: U ljudi se dostupnost takrolimusa nakon intravenske primjene može opisati kao bifazična.
English: These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating hepatic or renal function or neurological symptoms.
Croatian: Te su infekcije često povezane s visokim ukupnim opterećenjem imunosupresivima i mogu dovesti do ozbiljnih stanja, pa i smrtnog ishoda, što liječnici moraju uzeti u obzir pri postavljanju diferencijalne dijagnoze u imunosupresiranih bolesnika sa sve slabijom funkcijom jetre ili bubrega ili neurološkim simptomima.
English: Peak blood concentrations achieved with these doses were above 150 ng/mL which is more than 6-fold higher than mean peak concentrations observed with Advagraf in clinical transplantation.
Croatian: Vršna koncentracija u krvi postignuta s ovim dozama je bila viša od 150 ng/ml što je više nego 6 puta veće od srednjih vršnih koncentracija koje su uočene s Advagrafom u kliničkoj transplantaciji.
English: If you stop taking Advagraf
Croatian: Ako prestanete uzimati Advagraf
English: However, owing to the nephrotoxic potential of tacrolimus careful monitoring of renal function is recommended (including serial serum creatinine concentrations, calculation of creatinine clearance and monitoring of urine output).
Croatian: Međutim, zbog nefrotoksičnog potencijala takrolimusa, preporučuje se pažljivo praćenje bubrežne funkcije (uključujući serijsko određivanje koncentracije kreatinina u serumu, izračun klirensa kreatinina i praćenje diureze).
English: A double dose should not be taken on the next morning.
Croatian: Ne smije se uzeti dvostruka doza sljedećeg jutra.
English: Advagraf is a prolonged-release formulation of tacrolimus resulting in an extended oral absorption profile with an average time to maximum blood concentration (Cmax) of approximately 2 hours (tmax).
Croatian: Advagraf je formulacija takrolimusa s produljenim oslobađanjem što rezultira produljenim apsorpcijskim profilom nakon peroralne primjene uz srednje vrijeme do postizanja maksimalne koncentracije u krvi (Cmax) od otprilike 2 sata (tmax).
English: Severe effects may occur, including allergic and anaphylactic reactions.
Croatian: Mogu nastupiti izraziti učinci, uključujući alergijske i anafilaktičke reakcije.
English: If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Croatian: Ako lijek nema uobičajeni izgled ili su upute o doziranju drugačije, odmah se obratite liječniku ili ljekarniku kako biste provjerili jeste li dobili ispravan lijek.
English: The incidences of acute rejection were numerically lower with tacrolimus in all three studies and one of the studies reported a significantly lower incidence of bronchiolitis obliterans syndrome with tacrolimus.
Croatian: Incidencije akutnog odbacivanja bile su numerički niže za takrolimus u sva tri ispitivanja, a u jednom se od ispitivanja zabilježila značajno niža incidencija sindroma obliterirajućeg bronhiolitisa uz takrolimus.
English: Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
Croatian: Nakon intravenske i peroralne primjene takrolimusa označenog izotopom 14C, većina je radioaktivnosti bila eliminirana stolicom.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Less than 1% of unchanged tacrolimus was detected in the urine and faeces, indicating that tacrolimus is almost completely metabolised prior to elimination: bile being the principal route of elimination.
Croatian: Manje od 1% neizmijenjenog takrolimusa pronađeno je u mokraći i stolici, što ukazuje na to da se takrolimus gotovo potpuno metabolizira prije izlučivanja i da je žuč glavni put izlučivanja.
English: Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors, ATC code: L04AD02
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori kalcineurina, ATK oznaka: L04AD02 Mehanizam djelovanja
English: From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Advagraf.
Croatian: Liječnik će Vam s vremena na vrijeme napraviti pretrage krvi, mokraće, srca i očiju, kako bi odredio pravu dozu Advagrafa.
English: If you are allergic to peanut or soya, talk to your doctor to determine whether you should use this medicine.
Croatian: Ako ste alergični na kikiriki ili soju, potražite savjet liječnika kako biste mogli procijeniti smijete li uzimati ovaj lijek.
English: Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed in Prograf treated patients on rare occasions and may also occur with Advagraf.
Croatian: Ventrikularna hipertrofija i hipertrofija septuma, prijavljene kao kardiomiopatije, bile su primijećene u rijetkim prilikama u bolesnika liječenih Prografom, a mogu nastati i s Advagrafom.
English: hypertonia very rare:
Croatian: hipertonija vrlo rijetko:
English: Tacrolimus may prolong the QT interval and may cause Torsades de Pointes.
Croatian: Takrolimus može produžiti QT interval i može prouzročiti Torsades de Pointes.
English: If you forget to take Advagraf
Croatian: Ako ste zaboravili uzeti Advagraf
English: The use of live attenuated vaccines should be avoided.
Croatian: Potrebno je izbjegavati primjenu živog atenuiranog cjepiva.
English: Advagraf therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Croatian: Liječenje Advagrafom treba započeti nakon razmatranja koncentracije ciklosporina u krvi i kliničkog stanja bolesnika.
English: Neoplasms benign, malignant and unspecified Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine Bolesnici koji primaju imunosupresivnu terapiju pod povećanim su rizikom od razvoja zloćudnih bolesti.
English: primary graft dysfunction
Croatian: primarna disfunkcija presatka
English: An updated RMP should be submitted: - At the request of the European Medicines Agency, - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Ažurirani RMP treba dostaviti: - na zahtjev Europske agencije za lijekove - prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Avoid grapefruit (also as juice) while on treatment with Advagraf, since it can affect its levels in the blood.
Croatian: Izbjegavajte grejpfrut (i sok od grejpfruta) dok uzimate Advagraf, jer može utjecati na razinu lijeka u krvi.
English: As tacrolimus may reduce the clearance of steroid-based contraceptives leading to increased hormone exposure, particular care should be exercised when deciding upon contraceptive measures.
Croatian: Budući da takrolimus može smanjiti klirens steroidnih kontraceptiva i tako dovesti do povećane izloženosti hormonima, potreban je osobit oprez pri odabiru kontracepcijske metode.
English: Efficacy results of the largest studies in each indication are summarised below.
Croatian: U sljedećim su poglavljima prikazani sažeti rezultati najvećih ispitivanja o djelotvornosti za svaku pojedinu indikaciju.
English: Also contains lactose and traces of soya lecithin.
Croatian: Također sadrži laktozu i sojin lecitin u tragovima.
English: The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).
Croatian: Tinta za označavanje kojom je otisnuta oznaka na kapsuli sadrži sojin lecitin u tragovima (0,48% ukupnog sastava tinte za označavanje).
English: The capsules should be swallowed whole with fluid (preferably water).
Croatian: Kapsule se moraju progutati cijele s tekućinom (po mogućnosti vodom).
English: You may also be given Advagraf 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: Advagraf možete primiti i kad već imate reakciju odbacivanja presatka jetre, bubrega, srca ili nekog drugog organa, kada se terapijom koju ste prethodno uzimali nije mogao obuzdati imunološki odgovor nakon presađivanja.
English: Accordingly, high-risk patients receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9 -12 months).
Croatian: Sukladno tome, visokorizični bolesnici pod jakom imunosupresijom moraju se pratiti pomoću ehokardiografskih i elektrokardiografskih metoda prije i poslije presađivanja organa (npr. prvo nakon 3 mjeseca, a potom nakon 9-12 mjeseci).
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
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 sistemsku izloženost takrolimusu uključuju prokinetička sredstva (poput metoklopramida i cisaprida), cimetidin i magnezij-aluminij-hidroksid.
English: Limited data from organ transplant recipients show no evidence of an increased risk of adverse reactions on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Croatian: Na temelju ograničenih podataka prikupljenih u primatelja presađenih organa, nema dokaza o povećanom riziku od nuspojava koje bi mogle utjecati na tijek i ishod trudnoće za vrijeme liječenja takrolimusom u usporedbi s drugim imunosupresivnim lijekovima.
English: Advagraf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Croatian: Advagraf se rutinski primjenjuje zajedno s drugim imunosupresivnim lijekovima u ranom poslijeoperacijskom razdoblju.
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 potiskuje 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: Therefore, metabolites do not contribute to the pharmacological activity of tacrolimus.
Croatian: Iz toga se zaključuje da metaboliti ne pridonose farmakološkoj aktivnosti takrolimusa.
English: blindness not known:
Croatian: sljepoća nepoznato:
English: Advagraf contains lactose (milk sugar).
Croatian: Advagraf sadrži laktozu (mliječni šećer).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar pojedine skupine po učestalosti, nuspojave su navedene slijedom prema sve manjoj ozbiljnosti.
English: These effects are more frequent if you also drink alcohol.
Croatian: Takvi se učinci češće javljaju ako se Advagraf uzima s alkoholom.
English: However, Advagraf is taken once daily, whereas Prograf is taken twice daily.
Croatian: dok se Prograf uzima dvaput na dan.
English: Carbamazepine, metamizole and isoniazid have the potential to decrease tacrolimus concentrations.
Croatian: Karbamazepin, metamizol i izonijazid mogu smanjiti koncentraciju takrolimusa.
English: 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: tjedana) (incidencija je 66 na 123 novorođenih, tj. 53,7%; međutim, podaci su pokazali da je većina novorođenčadi imala normalnu porođajnu težinu za gestacijsku dob), kao i od hiperkalijemije u novorođenčadi (incidencija je 8 na 111 novorođene djece, tj. 7,2 %), koja se spontano normalizira.
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 se stoga mora izbjegavati.
English: If patients taking tacrolimus present with symptoms indicating PRES such as headache, altered mental status, seizures, and visual disturbances, a radiological procedure (e.g. MRI) should be performed.
Croatian: Ako se u bolesnika koji uzimaju takrolimus pojave simptomi koji ukazuju na PRES, kao što su glavobolja, promjena mentalnog stanja, konvulzije i poremećaji vida, potrebno je napraviti radiološki pregled (npr. MRI).
English: Endocrine disorders rare:
Croatian: Endokrini poremećaji rijetko:
English: The FKBP12tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calciumdependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of cytokine genes.
Croatian: Kompleks FKBP12 i takrolimusa specifično se i kompetitivno veže za kalcineurin i inhibira ga, što dovodi do inhibicije signalnih puteva T-stanica ovisne o kalciju i sprječava prepisivanje diskretne skupine gena za citokine.
English: Dose reduction may be necessary in patients with severe liver impairment (see section 4.2).
Croatian: Sniženje doze može se pokazati neophodnim u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
English: In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection.
Croatian: Konkretno, takrolimus inhibira stvaranje citotoksičnih limfocita, koji su najvećim dijelom odgovorni za odbacivanje presatka.