FrancophonIA/ELRC3.0 huggingface dataset:
English: (> 98.8%) to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Slovenian: V plazmi je takrolimus v veliki meri (> 98,8 %) vezan na plazemske beljakovine, predvsem na serumski albumin in α-1-kisli glikoprotein.
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.
Slovenian: Po peroralnem jemanju zrnc Modigraf je najvišja koncentracija v krvi v povprečju dosežena po približno 2 do 2,5 urah.
English: The total daily dose of Modigraf granules should be administered in 2 equal doses.
Slovenian: Skupni dnevni odmerek zrnc Modigraf je potrebno vzeti v dveh enakih odmerkih.
English: If you have accidentally taken too much Modigraf, contact your doctor or nearest hospital emergency department immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Modigraf, kot bi smeli Če ste po nesreči vzeli preveč zdravila Modigraf, se takoj obrnite na svojega zdravnika ali oddelek za nujno pomoč v najbližji bolnišnici.
English: Modigraf is taken orally twice daily, usually in the morning and evening.
Slovenian: Zdravilo Modigraf jemljite peroralno dvakrat na dan, in sicer zjutraj in zvečer.
English: Granules for oral suspension.
Slovenian: Zrnca za peroralno suspenzijo.
English: Treatment of allograft rejection after transplantation of other allografts The dose recommendations for lung, pancreas and intestinal transplantation are based on limited prospective clinical trial data with the Prograf formulation.
Slovenian: Zdravljenje zavrnitve alogenskega presadka po presaditvi drugih alogenskih presadkov Priporočila o odmerjanju po presaditvah pljuč, trebušne slinavke in črevesa temeljijo na majhnem številu podatkov prospektivnih kliničnih preskušanj z zdravilom Prograf.
English: Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with tacrolimus.
Slovenian: Večjo nefrotoksičnost so opazili po uporabi amfotericina B in ibuprofena v kombinaciji s takrolimusom.
English: Most cases have been reversible, occurring with tacrolimus blood trough concentrations much higher than the recommended maximum levels.
Slovenian: Večina primerov je bila reverzibilna in se je pojavila v primerih, ko je bila najnižja koncentracija takrolimusa v krvi veliko višja, kot je priporočena najvišja raven.
English: If equal doses are not possible, then the higher dose should be administered in the morning and the lower dose in the evening.
Slovenian: Če ni mogoče doseči enakih odmerkov, je treba večji odmerek vzeti zjutraj in manjšega zvečer.
English: Administration should commence within 24 hours after the completion of surgery.
Slovenian: Začeti se mora v roku 24 ur po koncu operacije.
English: If abnormalities develop, dose reduction of Modigraf, or change of treatment to another immunosuppressive agent should be considered.
Slovenian: Če se pojavijo nenormalnosti, je treba razmisliti o zmanjšanju odmerka zdravila Modigraf ali o prehodu na drugo imunosupresivno zdravilo.
English: The syndrome may respond to tacrolimus dose reduction.
Slovenian: Sindrom se lahko odzove na zmanjšanje odmerka takrolimusa.
English: Take Modigraf on an empty stomach or 2 to 3 hours after a meal.
Slovenian: Zdravilo Modigraf vzemite na prazen želodec ali 2 do 3 ure po jedi.
English: Treatment of allograft rejection after kidney or liver transplantation - adults and paediatric patients For conversion from other immunosuppressants to twice daily Modigraf, treatment should begin with the initial oral dose recommended for primary immunosuppression.
Slovenian: Zdravljenje zavrnitve alogenskega presadka po presaditvi ledvic ali jeter - odrasli in pediatrični bolniki Pri prehodu z zdravljenja z drugimi imunosupresivi na zdravljenje z zdravilom Modigraf dvakrat na dan, je treba zdravljenje uvesti v začetnem peroralnem odmerku, ki je priporočen za primarno imunosupresijo.
English: 50 sachets containing granules for oral suspension.
Slovenian: 50 vrečk z zrnci za peroralno suspenzijo
English: Modigraf is used to control your body's immune response enabling your body to accept the transplanted organ.
Slovenian: Zdravilo Modigraf uporabljamo za obvladovanje telesnega imunskega odziva, kar omogoči, da telo sprejme presajeni organ.
English: Other potential interactions that may increase systemic exposure of tacrolimus include prokinetic agents (such as metoclopramide and cisapride), cimetidine and magnesium-aluminium-hydroxide.
Slovenian: Druge možne interakcije, ki lahko povečajo sistemsko izpostavljenost takrolimusa, vključujejo interakcije s propulzivi (kot sta metoklopramid in cisaprid), cimetidinom in magnezijevim/aluminijevim hidroksidom.
English: Therefore, you may be more prone to infections while you are taking Modigraf.
Slovenian: Tako ste lahko med jemanjem zdravila Modigraf bolj nagnjeni k okužbam.
English: It is not advised to use any liquids or utensils to empty the sachets.
Slovenian: Uporaba kakršnihkoli tekočin ali pripomočkov za praznjenje vrečk ni priporočljiva.
English: The suspension can be drawn up with a syringe or swallowed directly by the patient.
Slovenian: Suspenzijo se lahko izsesa z injekcijsko brizgo ali jo bolnik zaužije neposredno.
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.
Slovenian: Zdravljenje zavrnitve alogenskega presadka, odporne na zdravljenje z drugimi imunosupresivi pri odraslih bolnikih in otrocih.
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.
Slovenian: Ko greste z receptom v lekarno, se vedno prepričajte, da ste dobili enako zdravilo s takrolimusom, razen če se je zdravnik, strokovnjak za presaditve organov, strinjal z zamenjavo z drugim zdravilom s takrolimusom.
English: Hold the opened sachet between thumb and index finger above the cup with the open side of the sachet facing downwards.
Slovenian: Odprto vrečko nad posodico primite s palcem in kazalcem ter odprto stran vrečke obrnite navzdol.
English: In general, paediatric patients require doses 1½ - 2 times higher than the adult doses to achieve similar blood levels.
Slovenian: Na splošno potrebujejo pediatrični bolniki za dosego podobnih koncentracij v krvi od 1,5 do 2-krat večje odmerke kot odrasli.
English: In stable liver transplant patients, the oral bioavailability of tacrolimus was reduced when it was administered after a meal of moderate fat (34% of calories) content.
Slovenian: Pri stabilnih bolnikih s presajenimi jetri je bila pri peroralni uporabi takrolimusa biološka uporabnost zmanjšana, ko je bil zaužit po obroku z zmerno vsebnostjo maščob (34 % kalorij).
English: Modigraf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Slovenian: Zdravilo Modigraf se v začetnem pooperacijskem obdobju uporablja rutinsko skupaj z drugimi imunosupresivi.
English: A multicentre study included 205 patients undergoing simultaneous pancreas-kidney transplantation who were randomised to tacrolimus (n = 103) or to ciclosporin (n = 102).
Slovenian: Multicentrična študija je zajela 205 bolnikov, pri katerih je bila hkrati narejena presaditev pankreasa in ledvice; bolnike so randomizirali na takrolimus (n = 103) ali na ciklosporin (n = 102).
English: If you forget to take Modigraf
Slovenian: Če ste pozabili vzeti zdravilo Modigraf
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.
Slovenian: Pri tem so se pojavili resni neželeni učinki, vključno z zavrnitvijo presadka, ali drugi neželeni učinki, ki bi lahko bili posledica premajhne ali prevelike izpostavljenosti takrolimusu.
English: In the systemic circulation, tacrolimus binds strongly to erythrocytes resulting in an approximate 20:1 distribution ratio of whole blood/plasma concentrations.
Slovenian: V sistemskem obtoku se takrolimus močno veže na eritrocite, zato je porazdelitveno razmerje med koncentracijo v polni krvi in plazmi približno 20 : 1.
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.
Slovenian: Druga zdravila, ki jih jemljete, lahko vplivajo na koncentracijo zdravila Modigraf v krvi, pa tudi jemanje zdravila Modigraf lahko vpliva na koncentracijo drugih zdravil v krvi, zato utegne biti potrebna prekinitev, povečanje ali zmanjšanje odmerka zdravila Modigraf.
English: As the pharmacokinetics of tacrolimus are unaffected by renal function (see section 5.2), no dose adjustment is required.
Slovenian: Delovanje ledvic ne vpliva na farmakokinetiko takrolimusa (glejte poglavje 5.2), zato prilagoditev odmerka ni potrebna.
English: Dose reduction may be necessary in patients with severe liver impairment (See section 4.2).
Slovenian: Pri bolnikih s hudo okvaro jeter utegne biti potrebno zmanjšanje odmerka (glejte poglavje 4.2).
English: dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia
Slovenian: dehidracija, hipoglikemija, hipoproteinemija, hiperfosfatemija
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET FOIL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH FOLIJA VREČKE
English: Paediatric data
Slovenian: Pediatrični podatki
English: Each sachet contains less than 1 mmol sodium (23 mg).
Slovenian: Ena vrečka vsebuje manj kot 1 mmol natrija (23 mg).
English: Modigraf granules are an immediate-release formulation of tacrolimus for twice daily dosing.
Slovenian: Zrnca Modigraf so farmacevtska oblika takrolimusa s takojšnjim sproščanjem, ki se odmerja dvakrat dnevno.
English: Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), amphotericin B (used to treat bacterial infections) or antivirals (used to treat viral infections e.g. aciclovir).
Slovenian: Povejte zdravniku, če ste jemali ali morate jemati ibuprofen (uporablja se za zdravljenje vročine, vnetja in bolečine), amfotericin B (uporablja se za zdravljenje bakterijskih okužb) ali protivirusna zdravila (uporabljajo se za zdravljenje virusnih okužb, npr. aciklovir).
English: Modigraf should be prescribed by doctors trained to treat transplant patients and experienced in the use of medicines that control the body's immune system (immunosuppressants).
Slovenian: Zdravilo Modigraf smejo predpisovati samo zdravniki, usposobljeni v zdravljenju bolnikov s presadki in izkušeni v uporabi zdravil, ki nadzorujejo imunski sistem telesa (imunosupresivi).
English: Lymphoproliferative disorders and malignancies
Slovenian: Limfoproliferativna in maligna obolenja
English: Materials used to prepare and administer the suspension, e.g. drinking vessels, cups, or tubing, must not contain PVC.
Slovenian: Materiali, ki se jih uporablja za pripravo in jemanje suspenzije, kot so skodelice, lončki ali cevke, ne smejo vsebovati PVC-ja. 6.3 Rok uporabnosti
English: If you stop taking Modigraf
Slovenian: Če ste prenehali jemati zdravilo Modigraf
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.
Slovenian: Farmakokinetične študije so pokazale, da je povišanje koncentracije v krvi v glavnem posledica večje biološke uporabnosti peroralnega takrolimusa zaradi zaviranja presnove v prebavilih.
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.
Slovenian: Profil neželenih učinkov zdravila je pri imunosupresivih pogosto težko ugotoviti zaradi osnovne bolezni in sočasne uporabe več zdravil.
English: Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.
Slovenian: Koncentracijo ciklosporina v krvi je treba nadzirati tudi po prehodu, ker se očistek ciklosporina lahko spremeni.
English: The 1-year patient survival rate was 80.8% in the tacrolimus and 83% in the ciclosporin group.
Slovenian: Enoletno preživetje bolnikov je bilo v skupini s takrolimusom 80,8 % in v skupini s ciklosporinom 83 %.
English: Modigraf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below under “Therapeutic drug monitoring”).
Slovenian: Odmerjanje zdravila Modigraf mora temeljiti predvsem na klinični oceni zavrnitve in prenašanja pri vsakem bolniku posebej s pomočjo spremljanja koncentracije v krvi (glejte spodaj “Spremljanje koncentracije zdravila”).
English: Tacrolimus has been used with or without antibody induction in paediatric heart transplantation.
Slovenian: Takrolimus se pri presaditvah srca pediatričnih bolnikov uporablja z ali brez indukcije protiteles.
English: Example: Total daily dose Prograf capsules given as 1 mg in the morning and 0.5 mg in the evening.
Slovenian: Za primer: Skupni dnevni odmerek kapsul Prograf je razdeljen na 1 mg zjutraj in 0,5 mg zvečer.
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.
Slovenian: Za pripravo suspenzije v kozarcu je treba uporabiti 2 ml vode (pri sobni temperaturi) na 1 mg takrolimusa (skupno največ do 50 ml, odvisno od bolnikove telesne mase).
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.
Slovenian: Če ni mogoče doseči enakih odmerkov, je potrebno dnevni odmerek kapsul Prograf zaokrožiti navzgor na najbližjo možno vrednost in večji odmerek vzeti zjutraj ter manjšega zvečer.
English: In healthy subjects, the average total body clearance estimated from whole blood concentrations was 2.25 l/h.
Slovenian: Pri zdravih preiskovancih je iz koncentracije v polni krvi ocenjeni povprečni celotni telesni očistek 2,25 l/uro.
English: The first dose of oral therapy should be 0.30 mg/kg/day starting 8 to 12 hours after discontinuing intravenous therapy.
Slovenian: Priporočen prvi peroralni odmerek je 0,30 mg/kg/dan, 8 do 12 ur po ukinitvi intravenskega zdravljenja.
English: This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodiumfree'.
Slovenian: Zdravilo Modigraf vsebuje manj kot 1 mmol (23 mg) natrija na eno vrečko, kar v bistvu pomeni »brez natrija«.
English: Therefore, you should not breast-feed whilst using Modigraf.
Slovenian: Zato med jemanjem zdravila Modigraf ne smete dojiti.
English: If conversion on the basis of equal quantities is not possible, the total daily dose of Modigraf should be rounded down to the nearest total daily dose possible with sachets 0.2 mg and 1 mg.
Slovenian: Če zamenjava po principu enakih količin ni možna, je potrebno skupni dnevni odmerek zrnc Modigraf zaokrožiti navzdol le toliko, da je skupni dnevni odmerek dosegljiv z uporabo vrečk po 0,2 mg in 1 mg.
English: There is limited experience in non-Caucasian patients and patients at elevated immunological risk (e.g. retransplantation, evidence of panel reactive antibodies, PRA).
Slovenian: Pri bolnikih nekavkazijskega porekla in bolnikih z večjim imunološkim tveganjem (npr. retransplantacija, dokaz panelnih reaktivnih protiteles (PRA)) je izkušenj malo.
English: Within each frequency groupingadverse reactions are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: The rate and extent of absorption of tacrolimus is greatest under fasted conditions.
Slovenian: Hitrost in obseg absorpcije takrolimusa sta največja na tešče.
English: Caution should be exercised in patients with risk factors for QT prolongation, including patients with a personal or family history of QT prolongation, congestive heart failure, bradyarrhythmias and electrolyte abnormalities.
Slovenian: Previdnost je potrebna pri bolnikih z dejavniki tveganja za podaljšan interval QT, vključno z bolniki, ki imajo podaljšani QT interval v anamnezi ali družinski anamnezi, kongestivno srčno popuščanje, bradiaritmije in elektrolitsko neravnovesje.
English: In case of in utero exposure, monitoring of the newborn for the potential adverse events of tacrolimus is recommended (in particular effects on the kidneys).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.
Slovenian: Obstaja tveganje za prezgoden porod (< 37 tednov) (pri 66 od 123 rojstev, tj. pojavnost 53,7 %; vendar podatki kažejo, da je imela večina novorojenčkov normalno telesno maso za njihovo gestacijsko starost) in za hiperkaliemijo pri novorojenčku (pri 8 od 111 novorojenčkov; pojavnost 7,2 %), ki pa se normalizira sama od sebe.
English: Only one of these has been shown in vitro to have immunosuppressive activity similar to that of tacrolimus.
Slovenian: Le za enega od njih so in vitro ugotovili, da deluje podobno imunosupresivno kot takrolimus.
English: It is not recommended that Modigraf is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Slovenian: Jemanje zdravila Modigraf skupaj s ciklosporinom (drugo zdravilo, ki se uporablja za preprečevanje zavrnitve organa po presaditvi) ni proporočljivo.
English: Modigraf passes into breast milk.
Slovenian: Zdravilo Modigraf prehaja v materino mleko.
English: This can lead to graft rejection or increased incidence of undesirable effects, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus.
Slovenian: Takšna zamenjava lahko povzroči zavrnitev presadka ali vodi do povečanega tveganja za neželene učinke, vključno s premajhno ali preveliko imunosupresijo, zaradi klinično pomembnih razlik v sistemski izpostavljenosti takrolimusu.
English: A strong correlation exists between AUC and whole blood trough levels at steady-state for Modigraf.
Slovenian: Obstaja močna korelacija med AUC in najnižjo koncentracijo v polni krvi v stanju dinamičnega ravnovesja za zdravilo Modigraf.
English: In some cases, it was necessary to switch to alternative immunosuppression.
Slovenian: V nekaterih primerih je bil potreben prehod na drugo imunosupresivno zdravljenje.
English: Other interactions potentially leading to increased tacrolimus blood levels Tacrolimus is extensively bound to plasma proteins.
Slovenian: Druge interakcije, ki lahko vodijo do povišanih vrednosti takrolimusa v krvi Takrolimus se izdatno veže na beljakovine v plazmi.
English: Lansoprazole and ciclosporin may potentially inhibit CYP3A4-mediated metabolism of tacrolimus and thereby increase tacrolimus whole blood concentrations.
Slovenian: Lansoprazol in ciklosporin lahko potencialno zavirata presnovo takrolimusa s CYP3A4 in tako povišata koncentracije takrolimusa v polni krvi.
English: In general, inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe.
Slovenian: Na splošno, nepazljiva, nenamerna ali nenadzorovana zamenjeva zdravil s takrolimusom v farmacevtskih oblikah, s takojšnjim ali podaljšanim sproščanjem, ni varna.
English: confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare uncommon:
Slovenian: zmedenost in dezorientiranost, depresija, simptomi anksioznosti, halucinacije, duševne motnje, potrtost, motnje razpoloženja, nočne more občasni:
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.
Slovenian: Začetni dnevni odmerki tik po presaditvi so praviloma od 0,075 do 0,30 mg na kg telesne mase na dan, odvisno od presajenega organa.
English: A combination of immunosuppressives such as antilymphocytic antibodies (e.g. basiliximab, daclizumab) given concomitantly increases the risk of EBV-associated lymphoproliferative disorders.
Slovenian: Pri kombiniranem zdravljenju z imunosupresivi, npr. sočasna uporaba antilimfocitnih protiteles (npr. baziliksimab, daclizumab), se tveganje za pojav z EBV povezanih limfoproliferativnih bolezni poveča.
English: How to take Modigraf
Slovenian: Kako jemati zdravilo Modigraf
English: Then give a total daily dose of Modigraf 1.4 mg divided as 0.8 mg in the morning and 0.6 mg in the evening.
Slovenian: V tem primeru se predpiše skupni dnevni odmerek zdravila Modigraf v količini 1,4 mg in se ga razdeli v 0,8 mg zjutraj in 0,6 mg zvečer.
English: Grapefruit and grapefruit juice should be avoided while taking Modigraf, since it can affect its levels in the blood.
Slovenian: Med jemanjem zdravila Modigraf se morate izogibati uživanju grenivk in grenivkinega soka, ker lahko vplivajo na njegove vrednosti v krvi.
English: The relationship between tacrolimus trough levels (C12) and systemic exposure (AUC0-12) is similar between the 2 formulations Modigraf granules and Prograf capsules.
Slovenian: Razmerje med najnižjimi koncentracijami takrolimusa (C12) in sistemsko izpostavljenostjo (AUC 0-12) je pri obeh farmacevtskih oblikah, pri zrncih Modigraf in kapsulah Prograf, podobno.
English: Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) and febrile neutropenia (a decrease in the type of white blood cells which fight infection, accompanied by fever) have been reported.
Slovenian: Poročali so o primerih čiste aplazije rdečih krvnih celic (hudo zmanjšanje števila rdečih krvnih celic), agranulocitozi (hudo zmanjšanje števila belih krvnih celic), hemolitični anemiji (zmanjšano število rdečih krvnih celic zaradi nenormalnega razpada) in vročinski nevtropeniji (zmanjšano število tistih belih krvnih celic, ki se bojujejo proti okužbi, ki ga spremlja povišana telesna temperatura).
English: Modigraf should not be switched with the prolonged-release capsules (Advagraf) as a clinically relevant difference in bioavailability between the two formulations cannot be excluded.
Slovenian: Zdravila Modigraf ne smemo zamenjati s kapsulami s podaljšanim sproščanjem (zdravilo Advagraf), ker ne moremo izključiti klinično pomembne razlike v biološki uporabnosti med zdraviloma.
English: Significantly more ciclosporin-treated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02).
Slovenian: S ciklosporina na takrolimus je moralo preiti statistično značilno več bolnikov (n = 13) kot s takrolimusa na ciklosporin (n = 2) (p = 0,02).
English: Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.
Slovenian: Po prehodu na katerokoli drugo farmacevtsko obliko je treba spremljati koncentracijo zdravila v telesu ter prilagoditi odmerek, da bi tako zagotovili ustrezno sistemsko izpostavljenost takrolimusu.
English: Modigraf contains lactose (milk sugar).
Slovenian: Zdravilo Modigraf vsebuje laktozo (mlečni sladkor).