FrancophonIA/ELRC3.0 huggingface dataset:
English: Available tacrolimus is generally rapidly absorbed.
Croatian: Raspoloživi takrolimus se općenito brzo apsorbira.
English: In practice, tacrolimus-based therapy has been initiated 12 to 24 hours after discontinuation of ciclosporin.
Croatian: U praksi se liječenje takrolimusom započinje 12-24 sata nakon prekida primjene ciklosporina.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Envarsus.
Croatian: Budući da se ne mogu isključiti štetni učinci na novorođenče, žene ne smiju dojiti dok uzimaju Envarsus.
English: Ostenfelder Strasse 51-61 D-59320 Ennigerloh Germany
Croatian: Ostenfelder Strasse 51-61 D-59320 Ennigerloh
English: Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Croatian: Pozitivan nalaz PCR-a na EBV može potrajati mjesecima i sam po sebi ne upućuje na limfoproliferativnu bolest ili limfom.
English: After opening the aluminium foil wrapper: 45 days.
Croatian: Nakon otvaranja zaštitnog aluminijskog omota: 45 dana.
English: As gastrointestinal perforation is a medically important event that may lead to a life-threatening or serious condition, adequate treatments should be considered immediately after suspected symptoms or signs occur.
Croatian: S obzirom da je perforacija gastrointestinalnog trakta medicinski važan događaj koji može dovesti do stanja opasnog po život ili do ozbiljnog stanja, odgovarajuće liječenje treba uzeti u obzir odmah nakon što se pojave suspektni znaci ili simptomi.
English: A forgotten dose should be taken as soon as possible on the same day.
Croatian: Propuštena doza Zaboravljena doza mora se uzeti čim prije istog dana.
English: - The clinical risks associated with over- and under-dosing.
Croatian: - Klinički rizici vezani za premale ili prevelike doze.
English: However, cases of spontaneous abortion have been reported.
Croatian: Međutim, bilo je prijavljenih slučajeva spontanog pobačaja.
English: Posterior reversible encephalopathy syndrome (PRES)
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES)
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Croatian: Kao i kod drugih jakih imunosupresivnih lijekova, rizik od nastanka sekundarnog karcinoma nije poznat (vidjeti dio 4.8).
English: The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Croatian: Početnu dozu za sprječavanje odbacivanja presađenog organa odredit će liječnik tako što će je izračunati prema Vašoj tjelesnoj težini.
English: Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Croatian: Stoga praćenje najnižih razina u punoj krvi pruža dobru procjenu sustavne izloženosti.
English: Envarsus should generally be taken on an empty stomach to achieve maximal absorption (see section 5.2).
Croatian: Envarsus treba općenito uzimati na prazan želudac kako bi se postigla maksimalna apsorpcija (vidjeti dio 5.2).
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% nepromijenjenog takrolimusa otkriveno je u mokraći i stolici, što upućuje da se takrolimus gotovo u potpunosti metabolizira prije eliminacije: glavni put eliminacije je putem žuči
English: Tacrolimus reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Croatian: Takrolimus smanjuje obrambeni mehanizam tijela (imunološki sustav), koji neće biti tako učinkovit u obrani od infekcija kao obično.
English: Effect on hepatic clearance is less pronounced.
Croatian: Učinak na jetreni klirens manje je izražen.
English: It should be noted however, that there has been no direct experience with Envarsus in overdose.
Croatian: Međutim, treba naglasiti da ne postoji izravno iskustvo u predoziranju Envarsusom.
English: If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Croatian: U slučaju predoziranja, treba primjeniti opće potporne mjere i simptomatsko liječenje.
English: Your dose depends on your general condition and on which other immunosuppressive medicines you are taking.
Croatian: Doza koju ćete uzimati ovisit će o Vašem općem stanju i drugim imunosupresivnim lijekovima koje uzimate.
English: Your doctor may need to adjust your dose of Envarsus or will decide to stop treatment with tacrolimus.
Croatian: Liječnik će možda morati prilagoditi Vašu dozu lijeka Envarsus ili će odlučiti prekinuti liječenje takrolimusom.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to
Croatian: Učestalost nuspojava definirana je na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 i
English: This medicine should only be prescribed for you by a doctor with experience in the treatment of transplant patients.
Croatian: Ovaj lijek Vam treba propisivati samo liječnik s iskustvom u liječenju transplantiranih bolesnika.
English: Therefore, metabolites do not contribute to the pharmacological activity of tacrolimus.
Croatian: Stoga, metaboliti ne pridonose farmakološkom djelovanju takrolimusa.
English: Your doctor will usually reduce your Envarsus dose once your condition has stabilised.
Croatian: Liječnik će obično smanjiti dozu Envarsusa kad Vam se stanje stabilizira.
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: Ove infekcije često su povezane s visokim ukupnim opterećenjem imunosupresivima i mogu dovesti do ozbiljnih ili smrtonosnih stanja, što liječnici moraju uzeti u obzir pri postavljanju diferencijalne dijagnoze u imunosupresivnih bolesnika s pogoršanjem funkcije jetre ili bubrega ili s neurološkim simptomima.
English: In rats, tacrolimus caused toxic effects to the nervous system and the eyes.
Croatian: U štakora je takrolimus uzrokovao toksične učinke u živčanom sustavu i na očima.
English: From time to time, your doctor may need to do blood, urine, heart, or eye tests, to set the right dose of Envarsus.
Croatian: Liječnik će Vam s vremena na vrijeme napraviti pretrage krvi, mokraće, srca ili očiju, kako bi odredio pravu dozu Envarsusa.
English: Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors, ATC code: L04AD02
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori kalcineurina, ATK oznaka: L04AD02
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, nije moguće navesti ograničenje trajanja peroralne terapije.
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 kod drugih imunosupresivnih lijekova, zbog potencijalnog rizika od nastanka malignih promjena na koži, savjetuje se ograničeno izlaganje sunčevoj svjetlosti i UV zrakama, nošenje zaštitne odjeće i korištenje preparata za zaštitu od sunca s visokim zaštitnim faktorom.
English: Comparisons of concentrations from the published literature to individual values in clinical practice should be assessed with care and knowledge of the assay methods employed.
Croatian: Usporedbe koncentracija objavljenih u literaturi s pojedinim vrijednostima u kliničkoj praksi moraju se procijenjivati s oprezom, uz poznavanje primjenjenih metoda testiranja.
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: Stoga, visokorizične bolesnike koji primaju značajnu imunosupresiju treba pratiti uz primjenu postupaka ehokardiografije ili EKG-a prije i poslije transplantacije (npr. prvo nakon 3 mjeseca, a potom nakon 9-12 mjeseci).
English: The Marketing Authorisation Holder should ensure that, at launch, all Healthcare Professionals who are expected to prescribe or dispense Envarsus are provided with an Educational pack.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet trebao bi osigurati, da pri stavljanju lijeka u promet svi zdravstveni djelatnici za koje se očekuje da će propisivati ili izdavati Envarsus, dobiju edukacijski paket.
English: No specific antidote to tacrolimus therapy is available.
Croatian: Ne postoji specifični antidot za terapiju takrolimusom.
English: 59320 Ennigerloh Germany or
Croatian: 59320 Ennigerloh
English: If the appearance of this medicine is not the same as usual, or if doe 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 promijenjene, odmah se obratite liječniku ili ljekarniku kako biste provjerili jeste li dobili ispravan lijek.
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Envarsus.
Croatian: Stoga se u ovoj grupi bolesnika treba obaviti serološko ispitivanje EBV-VCA prije početka liječenja Envarsusom.
English: - The need for specialist supervision and monitoring if there is a clinical decision to switch a patient to another tacrolimus containing products.
Croatian: - Potreba za nadzorom i praćenjem od strane specijalista ako je donesena klinička odluka da se bolesnika prebaci na drugi lijek koji sadrži takrolimus.
English: In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
Croatian: U ljudi se dostupnost takrolimusa nakon intravenske infuzije može opisati kao bifazična.
English: Therefore, Envarsus should generally be taken on an empty stomach to achieve maximal absorption.
Croatian: Prema tome, Envarsus treba općenito uzimati na prazan želudac kako bi se postigla maksimalna apsorpcija.
English: In healthy subjects, the mean half-life in whole blood is approximately 30 hours.
Croatian: U zdravih je ispitanika srednji poluvijek u punoj krvi približno 30 sati.
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 prilagođivati.
English: Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel.
Croatian: Liječenje takrolimusom mora biti pod pažljivim nadzorom odgovarajuće obučenih i opremljenih zdravstvenih djelatnika.
English: The use of live attenuated vaccines should be avoided.
Croatian: Potrebno je izbjegavati primjenu živih atenuiranih cjepiva.
English: The oral bioavailability of Envarsus was decreased when the medicinal product was administered after a meal; the extent of absorption was decreased by 55% and the maximum plasma concentration was decreased by 22% when taken directly after a high-fat meal.
Croatian: Envarsusa smanjila se kada je lijek bio davan nakon obroka, apsorpcija se smanjila za 55% a maksimalna koncentracija u plazmi smanjila se za 22% kada se uzimao odmah nakon obroka s visokim udjelom masti.
English: Tacrolimus is extensively distributed in the body.
Croatian: Takrolimus se opsežno raspodjeljuje u tijelu.
English: Tacrolimus blood trough levels should be determined approximately 24 hours post-dosing of Envarsus, just prior to the next dose.
Croatian: Najniže razine takrolimusa u krvi treba odrediti približno 24 sata nakon primjene Envarsusa, neposredno prije sljedeće doze.
English: Severe effects may occur, including allergic and anaphylactic reactions.
Croatian: Mogu nastupiti teške nuspojave, uključujući alergijske i anafilaktičke reakcije.
English: Concomitant use of these substances may require decreased tacrolimus doses in nearly all patients.
Croatian: Istovremena primjena ovih tvari može zahtijevati smanjenje doze takrolimusa u gotovo svih bolesnika.
English: During treatment, careful monitoring with EBV-PCR (Polymerase-Chain-Reaction) is recommended.
Croatian: Tijekom liječenja preporučuje se pažljivo praćenje EBV-a metodom lančane reakcije polimerazom (engl.
English: Caution should be exercised in patients with diagnosed or suspected Congenital Long QT Syndrome.
Croatian: Oprez je potreban u bolesnika s dijagnosticiranim ili suspektnim sindromom kongenitalnog produljenog QT intervala.
English: Certain combinations of tacrolimus with substances known to have nephrotoxic or neurotoxic effects may increase the risk of these effects (see section 4.5).
Croatian: Određene kombinacije takrolimusa i tvari s poznatim nefrotoksičnim ili neurotoksičnim učincima mogu povisiti rizik od takvih učinaka (vidjeti dio 4.5).
English: Envarsus is supplied in PVC blisters containing 10 tablets.
Croatian: Envarsus se isporučuje u PVC blisterima koji sadrže 10 tableta.
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Croatian: U sustavnom krvotoku prisutan je u maloj koncetraciji samo jedan od inaktivnih metabolita.
English: It is recommended that the oral daily dose of Envarsus is administered once daily in the morning.
Croatian: Preporučuje se primjena dnevne peroralne doze Envarsusa jedanput na dan, ujutro.
English: The tablets should be swallowed whole with fluid (preferably water) immediately following removal from the blister.
Croatian: Tablete treba progutati cijele s tekućinom (po mogućnosti s vodom) neposredno nakon vađenja iz blistera.
English: You will need to take Envarsus every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Croatian: Envarsus ćete morati uzimati svakodnevno, sve dok Vam je potrebna imunosupresija, kako bi se spriječilo odbacivanje presađenog organa.
English: In clinical practice, whole blood trough levels have generally been in the range of 5-20 ng/mL in kidney transplant patients in the early post-transplant period, and 5-15 ng/mL during subsequent maintenance therapy.
Croatian: U kliničkoj praksi najniže razine u punoj krvi općenito su bile u rasponu od 5-20 ng/ml u bolesnika s transplantiranim bubregom u ranom razdoblju nakon transplantacije i 5-15 ng/ml tijekom naknadne terapije održavanja.
English: Therefore, you should not breast-feed whilst taking Envarsus.
Croatian: Stoga ne biste smjeli dojiti za vrijeme uzimanja
English: As an aid to optimise dosing, several immunoassays are available for determining tacrolimus concentrations in whole blood.
Croatian: Kao pomoć u optimizaciji doziranja dostupno je nekoliko imunoloških testova za određivanje koncentracije takrolimusa u punoj krvi.
English: Tacrolimus may cause visual and neurological disturbances.
Croatian: Takrolimus može uzrokovati poremećaje vida i neurološke poremećaje.
English: Use all the prolonged-release tablets within 45 days of opening the aluminium wrapping.
Croatian: Sve tablete s produljenim oslobađanjem moraju se upotrijebiti unutar 45 dana od otvaranja aluminijskog omota.
English: The other metabolites have only weak or no immunosuppressive activity.
Croatian: Ostali metaboliti imaju slabo imunosupresivno djelovanje ili ga uopće nemaju.
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 da se većina bolesnika može uspješno liječiti ako se najniže razine takrolimusa u krvi održe ispod 20 ng/ml.
English: Stopping your treatment with Envarsus may increase the risk of rejection of your transplanted organ.
Croatian: Prestanak liječenja Envarsusom može povisiti rizik od odbacivanja presađenog organa.
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 s 14C, većina radioaktivnosti je eliminirana stolicom.
English: In plasma, tacrolimus is highly bound (>98.8%) to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Croatian: U plazmi se takrolimus u velikoj mjeri veže (> 98,8%) na proteine plazme, uglavnom na serumski albumin i α-l-kiseli glikoprotein.
English: Absorption is variable and the mean oral bioavailability of tacrolimus is in the range of 20%-25% (individual range in adult patients 6%-43%).
Croatian: Apsorpcija varira i srednja oralna bioraspoloživost takrolimusa kreće se u rasponu od 20% do 25% (individualni raspon u odraslih bolesnika 6% - 43%).
English: A number of associated cases of transplant rejection have been reported.
Croatian: Prijavljeni su brojni slučajevi odbacivanja transplantata.
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: Envarsus may have a minor influence on the ability to drive and use machines.
Croatian: Envarsus malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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 što uzrokuje povećanu izloženost hormonima, potreban je poseban oprez prilikom odluke o primjeni kontracepcijskih mjera.
English: There is no evidence that male and female patients require different doses to achieve similar trough levels.
Croatian: Nema dokaza koji ukazuju da se u muškaraca i žena mora primijeniti različita doza kako bi se postigle slične vrijednosti najniže koncentracije.
English: What you need to know before you take Envarsus 3.
Croatian: Što morate znati prije nego počnete uzimati Envarsus
English: Limited data from organ transplant recipients show no evidence of an increased risk of adverse events on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Croatian: Ograničeni podaci u primatelja presađenih organa, ne pružaju dokaze o povećanom riziku od štetnih događaja koji bi mogli utjecati na tijek i ishod trudnoće za vrijeme liječenja takrolimusom u usporedbi s drugim imunosupresivnim lijekovima.
English: Initial daily doses just after transplantation will generally be in the range of: 0.11 - 0.17 mg per kg body weight per day depending on the transplanted organ.
Croatian: Početne dnevne doze odmah nakon transplantacije općenito se kreću u rasponu od: 0,110,17 mg po kg tjelesne težine na dan ovisno o tome koji je organ presađen.
English: Tacrolimus may prolong the QT interval but at this time lacks substantial evidence for causing Torsades de Pointes.
Croatian: Takrolimus može produljiti QT interval, ali zasada nema značajnih dokaza da uzrokuje Torsades de Pointes.
English: Store in the original aluminium foil wrapper in order to protect from light.
Croatian: Čuvati u originalnom zaštitnom aluminijskom omotu radi zaštite od svjetlosti.
English: Gastrointestinal disorders
Croatian: Poremećaji gastrointestinalnog trakta
English: When treating rejection, the same doses may be used.
Croatian: Za liječenje odbacivanja presađenog organa, mogu se primijeniti iste doze.
English: Avoid grapefruit (also as juice) while on treatment with Envarsus, since it can affect its levels in the blood.
Croatian: Izbjegavajte grejpfrut (i sok od grejpfruta) dok se liječite Envarsusom, jer može utjecati na razinu lijeka u krvi.
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: Čimbenici poput niskog hematokrita i niske razine proteina, koji dovode do povećanja frakcije nevezanog takrolimusa ili povećanja metabolizma uzrokovanog kortikosteroidima, smatraju se odgovornim za veću brzinu klirensa primijećenu nakon presađivanja organa.
English: Caution should be exercised when switching combination therapy from ciclosporin, which interferes with enterohepatic recirculation of mycophenolic acid, to tacrolimus, which is devoid of this effect, as this might result in changes of mycophenolic acid exposure.
Croatian: Potreban je oprez kada se u kombiniranoj terapiji prelazi s ciklosporina, koji utječe na enterohepatičnu recirkulaciju mikofenolatne kiseline, na takrolimus, koji nema takav učinak, jer bi moglo doći do promjena u izloženosti mikofenolatnoj kiselini.
English: No studies have been conducted with conversion of patients from Advagraf to Envarsus; however, data from healthy volunteers would suggest that the same conversion rate is applicable as with the conversion from Prograf to Envarsus.
Croatian: Ispitivanja nisu bila provedena s prelaskom bolesnika sa Advagrafa na Envarsus, međutim podaci dobiveni kod zdravih dobrovoljaca ukazuju da se može primijeniti ista brzina prelaska kao i kod prelaska s Prografa na Envarsus.
English: Effect of tacrolimus on the metabolism of other medicinal products
Croatian: Učinak takrolimusa na metabolizam drugih lijekova
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: To je dovelo do ozbiljnih nuspojava, uključujući odbacivanje presatka, ili druge nuspojave koje mogu biti posljedica nedovoljne ili prekomjerne izloženosti takrolimusu.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar pojedine skupine učestalosti, nuspojave su navedene slijedom prema sve manjoj ozbiljnosti.
English: The steady-state volume of distribution based on plasma concentrations is approximately 1,300 L (healthy subjects).
Croatian: Volumen distribucije u stanju dinamičke ravnoteže određen na temelju koncentracija u plazmi iznosi oko 1300 l (zdravi ispitanici).
English: Tacrolimus therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Croatian: Liječenje takrolimusom treba započeti nakon što se provjere koncentracija ciklosporina u krvi i kliničko stanje bolesnika.
English: Tacrolimus is also considerably metabolised in the intestinal wall.
Croatian: Takrolimus se također znatno metabolizira u stijenci crijeva.
English: If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Envarsus may need to be reduced.
Croatian: slučaju znakova toksičnosti, kao što su teške nuspojave (vidjeti dio 4.8), možda će biti potrebno smanjiti dozu Envarsusa.
English: Envarsus doses are usually reduced in the post-transplant period.
Croatian: Doze Envarsusa u razdoblju nakon presađivanja obično se snižavaju.
English: The treatment difference (Envarsus-Prograf) was 0% (95% confidence interval [4.21%, 4.21%]).
Croatian: Razlika između liječenja (Envarsus-Prograf) iznosila je 0% (95% interval pouzdanosti [- 4,21%, 4,21%]).
English: Patients are also at an increased risk of infections with viral hepatitis (e.g. hepatitis B and C reactivation and de novo infection, as well as hepatitis E, which may become chronic).
Croatian: Bolesnici su također izloženi povećanom riziku od infekcija virusnim hepatitisom (primjerice, reaktivacija i de novo infekcija virusom hepatitisa B i C, kao i infekcija virusom hepatitisa E, koja može postati kronična).