FrancophonIA/ELRC3.0 huggingface dataset:
English: The 3 studies demonstrated similar survival rates.
Croatian: Stope preživljenja bile su slične u ova 3 ispitivanja.
English: Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Croatian: Poboljšanje stanja bolesnika nakon transplantacije može promijeniti farmakokinetiku takrolimusa i može zahtijevati daljnje prilagodbe doze.
English: As the pharmacokinetics of tacrolimus are unaffected by renal function (see section 5.2), no dose adjustment is required.
Croatian: Budući da funkcija bubrega ne utječe na farmakokinetiku takrolimusa (vidjeti dio 5.2), nije potrebna prilagodba doze.
English: Modigraf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Croatian: Modigraf se rutinski propisuje zajedno s drugim imunosupresivnim lijekovima u ranom poslijeoperacijskom razdoblju.
English: Gently tap on the closed end of the sachet and pour the contents of each sachet into the glass or cup containing the water.
Croatian: Nježno udarajte po zatvorenom kraju vrećice i istresite sadržaj svake vrećice u čašu ili šalicu s vodom.
English: Other factors observed to increase the risk of these clinical conditions included pre-existing heart disease, corticosteroid usage,
Croatian: Drugi čimbenici za koje je opaženo da povećavaju rizik od tih kliničkih stanja uključivali su već postojeću srčanu bolest,
English: Following oral administration of Modigraf granules peak concentrations (Cmax) of tacrolimus in blood are on average achieved in approximately 2 to 2.5 hours.
Croatian: Nakon peroralne primjene Modigraf granula vršne se koncentracije (Cmax) takrolimusa u krvi u prosjeku postižu za otprilike 2 do 2,5 sata.
English: From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Modigraf.
Croatian: S vremena na vrijeme, liječnik će Vam morati napraviti pretrage krvi, mokraće, srca i očiju, kako bi točno prilagodio dozu Modigrafa.
English: - If you are allergic to sirolimus (another substance used to prevent rejection of your transplanted organ) or to any macrolide antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Croatian: - ako ste alergični na sirolimus (druga tvar koja se primjenjuje za sprječavanje odbacivanja presađenog organa) ili neki makrolidni antibiotik (npr. eritromicin, klaritromicin, josamicin).
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 opažena u štakora i kunića i bila je ograničena na doze koje su uzrokovale značajnu toksičnost u skotnih ženki.
English: The syndrome may respond to tacrolimus dose reduction.
Croatian: Sindrom može odgovoriti na smanjenje doze takrolimusa.
English: Within each frequency groupingadverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su navedene slijedom prema sve manjoj ozbiljnosti.
English: - if you feel strong abdominal pain accompanied or not with other symptoms, such as chills,
Croatian: - ako osjećate jaku bol u trbuhu s drugim simptomima ili bez njih, kao što su zimica, vrućica,
English: In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
Croatian: U čovjeka se raspoloživost takrolimusa nakon intravenske primjene može opisati kao bifazična.
English: Results of a single dose bioequivalence study with adult healthy volunteers showed that Modigraf granules were approximately 20% more bioavailable than the Prograf capsules.
Croatian: Rezultati ispitivanja bioekvivalencije s jednom dozom u odraslih zdravih dobrovoljaca pokazali su da Modigraf granule imaju približno 20% veću bioraspoloživost nego Prograf kapsule.
English: The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly.
Croatian: Poluvijek ciklosporina produljen je kad se istovremeno daje takrolimus.
English: Decreases in AUC (2 to 12%) and Cmax (15 to 38%), and an increase in tmax (38 to 80%) in whole blood were evident.
Croatian: Smanjenje AUC (2 do 12%) i Cmax (15 do 38%) te povećanje tmax (38 do 80%) u punoj krvi bili su očiti.
English: Stopping your treatment with Modigraf may increase the risk of rejection of your transplanted organ.
Croatian: Prestanak liječenja Modigrafom može povećati rizik od odbacivanja presađenog organa.
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 mogućeg rizika od zloćudnih promjena na koži potrebno je ograničiti izlaganje sunčevom svjetlu ili ultraljubičastim zrakama noseći zaštitnu odjeću te koristeći sredstva s visokim faktorom zaštite od sunca.
English: Absorption of tacrolimus is variable.
Croatian: Apsorpcija takrolimusa varira.
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 imunosuprimiranih bolesnika sa sve slabijom funkcijom jetre ili bubrega ili neurološkim simptomima.
English: The incidences of acute rejection were numerically lower with tacrolimus in all 3 studies and one of the studies reported a significantly lower incidence of bronchiolitis obliterans syndrome with tacrolimus.
Croatian: Incidencije akutnog odbacivanja bile su brojčano niže uz takrolimus u sva 3 ispitivanja, a u jednom je ispitivanju zabilježena značajno niža incidencija sindroma obliterirajućeg bronhiolitisa uz takrolimus.
English: Only one of these has been shown in vitro to have immunosuppressive activity similar to that of tacrolimus.
Croatian: Samo jedan od njih je pokazao in vitro da ima imunosupresivno djelovanje slično djelovanju takrolimusa.
English: 2 ml of water (at room temperature) should be used per 1 mg tacrolimus to produce a suspension (up to a maximum of 50 ml, depending on body weight) in a cup.
Croatian: Trebalo bi uzeti 2 ml vode (sobne temperature) po 1 mg takrolimusa kako biste napravili suspenziju u čaši (do najviše 50 ml, ovisno o tjelesnoj težini).
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 nevezane frakcije takrolimusa, ili pojačanje metabolizma izazvano kortikosteroidima, smatraju se odgovornima za veći postotak klirensa opažen nakon transplantacije.
English: It is not advised to use any liquids or utensils to empty the sachets.
Croatian: Ne savjetuje se koristiti tekućinu ili posuđe za pražnjenje vrećica.
English: Packs containing 50 sachets are available.
Croatian: Dostupne su veličine pakiranja od 50 vrećica.
English: Accordingly, high-risk patients, particularly young children and those 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, potrebno je nadzirati visokorizične bolesnike, osobito malu djecu i one koji primaju znatnu imunosupresijsku terapiju pomoću postupaka kao što je ehokardiografija ili elektrokardiografija prije i poslije transplantacije (npr. u početku nakon 3 mjeseca, a zatim nakon 912 mjeseci).
English: Patients should be converted to oral therapy as soon as clinically practicable.
Croatian: Bolesnike treba prebaciti na peroralnu terapiju čim to klinički bude izvedivo.
English: Mycophenolic acid.
Croatian: Mikofenolatna kiselina.
English: Concomitant use of these substances may require decreased tacrolimus doses in nearly all patients.
Croatian: Istodobna primjena ovih tvari može zahtijevati smanjenje doze takrolimusa u gotovo svih bolesnika.
English: Dose reduction may be necessary in patients with severe liver impairment (See section 4.2).
Croatian: Smanjivanje doze može biti potrebno u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
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 odgovarajuća kontrola krvnog tlaka i napadaja te hitni prekid sistemske primjene takrolimusa.
English: Following the initiation of your treatment with Modigraf, frequent blood tests will be taken by your doctor to define the correct dose and to adjust the dose from time to time.
Croatian: Nakon početka Vašeg liječenja Modigrafom liječnik će Vam često raditi krvne pretrage kako bi utvrdio ispravnu dozu i povremeno je prilagodio.
English: Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments.
Croatian: Takrolimus je visokopotentno imunosupresivno sredstvo s dokazanim djelovanjem i u in vitro i u in vivo pokusima.
English: Modigraf can be used with antibody induction (allowing for delayed start of tacrolimus therapy) or alternatively in clinically stable patients without antibody induction.
Croatian: Modigraf se može primjenjivati uz indukciju protutijela (što omogućuje odgađanje početka terapije takrolimusom) ili, alternativno, bez indukcije protutijela u klinički stabilnih bolesnika.
English: Tacrolimus therapy is generally initiated by the oral route.
Croatian: Terapija takrolimusom obično se započinje peroralnim putem.
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 uglavnom odgovorni za odbacivanje presatka.
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 pomagačkim T stanicama, kao i stvaranje limfokina (kao što su interleukini-2, -3 i γ-interferon) i ekspresiju interleukin-2 receptora.
English: Peak blood concentrations achieved with these doses were above 150 nanogram/mL which is more than 6-fold higher than mean peak concentrations observed with Modigraf in clinical transplantation.
Croatian: Vršna koncentracija u krvi postignuta s ovim dozama je bila viša od 150 nanogram/ml što je više nego 6 puta veće od srednjih vršnih koncentracija koje su uočene s Modigrafom u kliničkoj transplantaciji.
English: - The other ingredients are: lactose monohydrate, hypromellose (E464) and croscarmellose sodium (E468).
Croatian: - Ostali sastojci su: laktoza hidrat, hipromeloza (E464) i umrežena karmelozanatrij (E468).
English: Benign and malignant tumours have been reported following Modigraf treatment.
Croatian: Dobroćudni i zloćudni tumori su zabilježeni nakon liječenja Modigrafom.
English: In total 34 patients switched treatment from ciclosporin to tacrolimus, whereas only 6 tacrolimus patients required alternative therapy.
Croatian: Ukupno je 34 bolesnika prebačeno s ciklosporina na takrolimus, dok je samo 6 bolesnika liječenih takrolimusom trebalo drugu terapiju.
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: Prema ograničenim podacima prikupljenima od primatelja presađenih organa nema dokaza da je rizik od nuspojava na tijek i ishod trudnoće povećan tijekom liječenja takrolimusom u usporedbi s drugim imunosupresivnim lijekovima.
English: Modigraf blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Modigraf, which may require interruption, an increase or a decrease in Modigraf dose.
Croatian: Na razine Modigrafa u krvi mogu utjecati i drugi lijekovi koje uzimate, kao što i uzimanje Modigrafa može utjecati na razine drugih lijekova u krvi zbog čega može biti potrebno prekinuti, povisiti ili sniziti dozu Modigrafa.
English: As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal).
Croatian: Kao što je dobro poznato za druga potentna imunosupresivna sredstva, bolesnici koji primaju takrolimus često imaju povećan rizik od infekcija (virusnih, bakterijskih, gljivičnih, protozoalnih).
English: Grapefruit juice has been reported to increase the blood level of tacrolimus and should therefore be avoided.
Croatian: Zabilježeno je da sok od grejpa povećava razine takrolimusa u krvi pa ga stoga treba izbjegavati.
English: This effect may be enhanced if tacrolimus is administered in association with alcohol.
Croatian: Ovaj učinak može biti pojačan ako se takrolimus primjenjuje zajedno s alkoholom.
English: The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Croatian: Bubrezi i gušterača bili su primarno zahvaćeni organi u ispitivanjima toksičnosti provedenima u štakora i babuna.
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: Ispitivanja farmakokinetike pokazala su da je povišenje razine takrolimusa u krvi uglavnom rezultat povećanja njegove peroralne bioraspoloživosti zbog inhibicije gastrointestinalnog metabolizma.
English: The presence of food decreases both the rate and extent of absorption of tacrolimus, the effect being most pronounced after a high-fat meal.
Croatian: Prisutnost hrane smanjuje kako brzinu, tako i opseg apsorpcije takrolimusa, pri čemu je učinak najizraženiji nakon obroka bogatog mastima.
English: In a study of stable renal transplant patients who were administered tacrolimus immediately after a standard continental breakfast the effect on oral bioavailability was less pronounced.
Croatian: U ispitivanju u stabilnih bolesnika s presatkom bubrega kojima je takrolimus bio primijenjen odmah nakon standardnog kontinentalnog doručka učinak na peroralnu bioraspoloživost bio je manje izražen.
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Modigraf.
Croatian: Stoga je u toj skupini bolesnika potrebno utvrditi serološki status EBV-VCA prije početka liječenja
English: Administration should commence approximately 12 hours after the completion of surgery.
Croatian: S primjenom treba započeti približno 12 sati nakon završetka operacije.
English: The first dose of oral therapy should be 0.30 mg/kg/day starting 8 to 12 hours after discontinuing intravenous therapy.
Croatian: Prva doza peroralne terapije treba iznositi 0,30 mg/kg na dan i početi 8 do 12 sati nakon prekida intravenske terapije.
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 drugih nuspojava koje su mogle biti posljedica preslabe ili prejake izloženosti takrolimusu.
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 veći dio radioaktivnosti pronašao se eliminiran u stolici.
English: There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall.
Croatian: Također postoji dokaz gastrointestinalnog metabolizma putem CYP3A4 u stijenci crijeva.
English: Example: Total daily dose Prograf capsules given as 1 mg in the morning and 0.5 mg in the evening.
Croatian: Primjer: ukupna dnevna doza Prograf kapsula daje se kao 1 mg ujutro i 0,5 mg navečer.
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 takrolimusa u plazmi, hemofiltracija ili hemodijafiltracija su bili učinkoviti u smanjenju toksičnih koncentracija.
English: Do not use any utensils or liquids to empty the sachet.
Croatian: Nemojte koristiti nikakav pribor niti tekućinu da biste ispraznili vrećicu.
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 tijekom takvih epizoda dodatno nadzirati 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 moguće interakcije koje mogu povećati sistemsku izloženost takrolimusu uključuju prokinetičke lijekove (kao što su metoklopramid i cisaprid), cimetidin i magnezij-aluminij-hidroksid.
English: The relationship between tacrolimus trough levels (C12) and systemic exposure (AUC0-12) is similar between the 2 formulations Modigraf granules and Prograf capsules.
Croatian: Odnos između najnižih razina takrolimusa (C12) i sistemske izloženosti (AUC0-12) sličan je za obje formulacije takrolimusa, Modigraf granule i Prograf kapsule.
English: The total daily dose of Modigraf granules should be administered in 2 equal doses.
Croatian: Ukupnu dnevnu dozu Modigraf granula treba primijeniti u 2 jednake doze.
English: Based on its high molecular weight, poor aqueous solubility, and extensive erythrocyte and plasma protein binding, it is anticipated that tacrolimus will not be dialysable.
Croatian: Na temelju njegove velike molekularne težine, slabe topljivosti u vodi i opsežnog vezivanja za eritrocite i proteine plazme očekuje se da se takrolimus ne može ukloniti dijalizom.
English: You should generally take Modigraf on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal.
Croatian: U pravilu biste trebali uzimati Modigraf na prazan želudac ili najmanje 1 sat prije ili 2 do 3 sata nakon obroka.
English: Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed.
Croatian: Zabilježene su medikacijske pogreške, uključujući nesmotrenu, nenamjernu ili nenadziranu zamjenu formulacija takrolimusa s trenutnim ili produljenim oslobađanjem.
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: nepromijenjenog takrolimusa otkriveno je u mokraći i stolici što pokazuje da se takrolimus gotovo u potpunosti metabolizira prije eliminacije, s time da je žuč glavni put eliminacije.
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 povezan s imunosupresivnim sredstvima često je teško utvrditi zbog osnovne bolesti i istodobne primjene većeg broja lijekova.
English: What you need to know before you take Modigraf Do not take Modigraf
Croatian: Što trebate znati prije nego počnete uzimati Modigraf
English: (> 98.8%) to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Croatian: U plazmi je takrolimus u visokom postotku vezan (> 98,8%) za proteine plazme, uglavnom za serumski albumin i α-1-kiseli glikoprotein.
English: Effect of tacrolimus on the metabolism of other medicinal products Tacrolimus is a known CYP3A4 inhibitor; thus concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.
Croatian: Učinak takrolimusa na metabolizam drugih lijekova Takrolimus je poznati inhibitor CYP3A4, stoga istovremena primjena takrolimusa s lijekovima za koje se zna da se metaboliziraju putem CYP3A4 može utjecati na metabolizam tih lijekova.
English: Human data show that tacrolimus crosses the placenta.
Croatian: Podaci prikupljeni u ljudi pokazuju da takrolimus prelazi placentu.
English: Modigraf 1 mg granules for oral suspension EU/1/09/523/002
Croatian: Modigraf 1 mg granule za oralnu suspenziju EU/1/09/523/002
English: This typically presents as a bilateral and symmetrical, severe, ascending pain in the lower extremities and may be associated with supra-therapeutic levels of tacrolimus.
Croatian: Obično se manifestira kao obostrana i simetrična, teška, uzlazna bol u donjim ekstremitetima, a može biti povezana s koncentracijama takrolimusa većima od terapijskih.
English: Pancreas survival at 1 year was significantly superior with tacrolimus: 91.3% versus 74.5% with ciclosporin (p < 0.0005), whereas renal graft survival was similar in both groups.
Croatian: Preživljenje gušterače nakon 1 godine bilo je značajno više uz takrolimus: 91,3% nasuprot 74,5% uz ciklosporin (p < 0,0005), dok je preživljenje bubrežnog presatka bilo slično u obje skupine.
English: The half-life in paediatric transplant patients averages approximately 12 hours.
Croatian: Poluvijek u pedijatrijskih bolesnika s presađenim organom prosječno iznosi 12 sati.
English: Stevens Johnson syndrome Musculoskeletal and connective tissue disorders common:
Croatian: Stevens Johnsonov sindrom Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: If equal doses are not possible, the total daily dose of Prograf should be rounded-up to the nearest amount possible, with the higher dose given in the morning and the lower dose in the evening.
Croatian: Ako nisu moguće jednake doze, potrebno je zaokružiti ukupnu dnevnu dozu Prografa na najbližu moguću veličinu, s time da se viša doza daje ujutro, a niža navečer.
English: Initial doses just after transplantation will generally be in the range of 0.075 - 0.30 mg per kg body weight per day depending on the transplanted organ.
Croatian: Početne doze neposredno nakon presađivanja obično će biti u rasponu od 0,075 do 0,30 mg po kg tjelesne težine na dan, ovisno o presađenom organu.
English: dermatitis, photosensitivity rare:
Croatian: dermatitis, fotoosjetljivost
English: If abnormalities develop, dose reduction of Modigraf, or change of treatment to another immunosuppressive agent should be considered.
Croatian: Ako se razviju abnormalnosti, potrebno je razmotriti smanjenje doze Modigrafa ili promijeniti liječenje i dati drugi imunosupresivni lijek.
English: Significantly more ciclosporin-treated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02).
Croatian: Značajno je više bolesnika liječenih ciklosporinom (n = 13) trebalo prebaciti na takrolimus nego bolesnika liječenih takrolimusom na ciklosporin (n = 2) (p = 0,02).
English: If you stop taking Modigraf
Croatian: Ako prestanete uzimati Modigraf
English: Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Croatian: Takrolimus se opsežno metabolizira u jetri, primarno putem citokroma P450-3A4.