FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other excipients are hypromellose, lactose monohydrate, macrogol 6000, poloxamer 188, magnesium stearate, tartaric acid (E334), butylated hydroxytoluene (E321), dimethicone 350.
Slovenian: - Druge sestavine zdravila so hipromeloza, laktoza monohidrat, makrogol 6000, poloksamer 188, magnezijev stearat, vinska kislina (E334), butilirani hidroksitoluen (E321), dimetikon 350.
English: Tacrolimus is extensively distributed in the body.
Slovenian: Takrolimus se izdatno porazdeli po telesu.
English: Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed in tacrolimus treated patients on rare occasions.
Slovenian: Srčne bolezni Ventrikularno hipertrofijo ali hipertrofijo septuma, opisani kot kardiomiopatije, so opazili v redkih primerih zdravljenja bolnikov s takrolimusom.
English: Conversion from ciclosporin to tacrolimus
Slovenian: Prehod s ciklosporina na takrolimus
English: How to store Envarsus 6.
Slovenian: Shranjevanje zdravila Envarsus 6.
English: Envarsus contains lactose (milk sugar).
Slovenian: Zdravilo Envarsus vsebuje laktozo (mlečni sladkor).
English: Patients should be advised not to swallow the desiccant.
Slovenian: Bolnike je treba opozoriti, da morajo biti pozorni, da ne bi pomotoma pogoltnili sušilnega sredstva.
English: • Summary of Product Characteristics and Patient Information Leaflet
Slovenian: • Povzetek glavnih značilnosti zdravila in Navodilo za uporabo
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.
Slovenian: V primeru pojava toksičnosti, npr. izrazitejših neželenih učinkov (glejte poglavje 4.8) bo odmerek zdravila Envarsus morda treba zmanjšati.
English: Envarsus 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 Envarsus mora temeljiti predvsem na klinični oceni zavrnitve in prenašanja pri vsakem bolniku posebej s pomočjo spremljanja koncentracije v krvi (glejte spodaj »Terapevtsko nadziranje zdravila«).
English: The treatment difference (Envarsus-Prograf) was -1.35% (95% confidence interval [-7.94%, 5.27%]).
Slovenian: Razlika v zdravljenju (zdravilo Envarsus - zdravilo Prograf) je bila -1,35 % (95-odstotni interval zaupanja [-7,94 %; 5,27 %]).
English: Dose reduction may be necessary in patients with severe liver impairment (see section 4.2).
Slovenian: Pri bolnikih s hudo okvaro jeter bo morda potrebno zmanjšanje odmerka (glejte poglavje 4.2).
English: Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea.
Slovenian: Ker se lahko koncentracija takrolimusa v krvi med obdobji driske značilno spremeni, je v času driske priporočljivo dodatno nadziranje koncentracije takrolimusa.
English: EBV-Viral Capsid Antigen (VCA)-negative patients have been reported to have an increased risk of developing lymphoproliferative disorders.
Slovenian: Poročali so, da pri EBV-VCA (antigen virusne kapside) negativnih bolnikih obstaja večje tveganje za razvoj limfoproliferativnih bolezni.
English: Tacrolimus is a known CYP3A4 inhibitor; thus, concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.
Slovenian: Takrolimus je znan zaviralec CYP3A4, zato lahko njegova sočasna uporaba z zdravili, ki se presnavljajo s CYP3A4, vpliva na presnovo takšnih zdravil.
English: In rats, female reproductive function including birth was impaired at toxic doses and the offspring showed reduced birth weights, viability and growth.
Slovenian: Pri podganah je bila reprodukcijska funkcija samic, vključno s kotenjem, okvarjena pri toksičnih odmerkih, pri mladičih pa so ugotovili manjšo telesno maso ob skotitvi, manjšo viabilnost in počasnejšo rast.
English: The event rate of biopsy-confirmed acute rejection within the 360-day study period was not significantly different between the Envarsus group and the tacrolimus immediate-release group.
Slovenian: Stopnja dogodkov akutne zavrnitve, potrjene z biopsijo, v 360-dnevnem obdobju trajanja študije, se med skupino z zdravilom Envarsus in s skupino s takrolimusom s takojšnjim sproščanjem ni značilno razlikovala.
English: Lymphoproliferative disorders and malignancies
Slovenian: Limfoproliferativnie bolezni in malignosti
English: Treatment of allograft rejection after kidney or liver transplantation For conversion from other immunosuppressants to once daily tacrolimus, treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for prophylaxis of transplant rejection.
Slovenian: Zdravljenje zavrnitve alogenskega presadka ledvic ali jeter Pri prehodu z zdravljenja z drugimi imunosupresivi na zdravljenje s takrolimusom enkrat na dan je treba zdravljenje uvesti v začetnem peroralnem odmerku, ki je priporočen za preprečevanje zavrnitve presadka po presaditvi ledvic oziroma jeter.
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 načeloma ni potrebna.
English: The efficacy failure rate as measured by the composite endpoint of death, graft loss, locally read BPAR and loss to follow-up was 2.5% in both the Envarsus and Prograf groups.
Slovenian: Stopnja izgube učinkovitosti, izmerjena kot opazovani dogodek, sestavljen iz smrti, izgube presadka, lokalno določena BPAR in bolnikov, izgubljenih za spremljanje, je bila 2,5 % za skupino z zdravilom Envarsus in za skupino z zdravilom Prograf.
English: In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
Slovenian: Porazdelitev takrolimusa po intravenski infuziji pri človeku je mogoče opisati kot dvofazno.
English: Liver transplantation
Slovenian: Presaditev jeter
English: The overall incidence of fatal treatment emergent adverse events for the combined de novo and stable liver transplant population was not significantly different between the Envarsus group and the tacrolimus immediate-release group.
Slovenian: Celokupna incidenca smrti, povezanih z zdravljenjem, pri kombinirani populaciji z novo in stabilno presaditvijo jeter se med skupino z zdravilom Envarsus in s skupino s takrolimusom s takojšnjim sproščanjem ni značilno razlikovala.
English: Several cases of accidental overdose have been reported with tacrolimus.
Slovenian: Poročali so o več primerih naključnega prevelikega odmerjanja takrolimusa.
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 še po prehodu, ker se očistek ciklosporina lahko spremeni.
English: Drugs which interfere with mycophenolic acid's enterohepatic cycle have potential to reduce the plasma level and efficacy of mycophenolic acid.
Slovenian: Zdravila, ki ovirajo enterohepatično kroženje mikofenolne kisline, lahko zmanjšajo plazemsko koncentracijo in učinkovitost mikofenolne kisline.
English: In stable patients converted from tacrolimus immediate-release products (twice daily) to Envarsus (once daily) on a 1:0.7 (mg:mg) total daily dose basis, the mean systemic exposure to tacrolimus (AUC0-24) was similar to that of immediate-release tacrolimus.
Slovenian: Pri stabilnih bolnikih, ki s takrolimusa s takojšnjim sproščanjem (dvakrat na dan) preidejo na zdravilo Envarsus (enkrat na dan) na osnovi skupnega dnevnega odmerka v razmerju 1:0,7 (mg:mg), je bila sistemska izpostavljenost takrolimusu (AUC0-24) podobna kot pri takrolimosu s takojšnjim sproščanjem.
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.
Slovenian: absorpcija se je zmanjšala za 55 % in največja koncentracija v plazmi se je zmanjšala za 22 % po uporabi neposredno po obroku z visoko vsebnostjo maščobe.
English: What Envarsus looks like and contents of the pack
Slovenian: Izgled zdravila Envarsus in vsebina pakiranja
English: Via San Leonardo 96 43122 Parma Italy
Slovenian: Via San Leonardo 96 43122 Parma Italija
English: Effect of tacrolimus on the metabolism of other medicinal products
Slovenian: Vpliv takrolimusa na presnovo drugih zdravil
English: Envarsus is taken once daily and is not interchangeable with other existing medicines containing tacrolimus (immediate release or prolonged release) on an equal dose by dose basis.
Slovenian: Zdravilo Envarsus se jemlje enkrat na dan in ni zamenljivo z drugimi obstoječimi zdravili, ki vsebujejo takrolimus (takojšnje sproščanje ali podaljšano sproščanje) na osnovi enakega odmerka.
English: The efficacy and safety of Envarsus and Prograf, both in combination with mycophenolate mofetil (MMF), corticosteroids and IL-2 receptor antagonist as per the standard of care were compared in a randomised, double-blind, double-dummy study, in 543 de novo kidney transplant recipients.
Slovenian: Učinkovitost in varnost zdravila Envarsus in zdravila Prograf, oba v kombinaciji z mofetilmikofenolatom (MMF), kortikosteroidi, in antagonistom receptorja IL-2, kot pri standardni negi, so primerjali v randomizirani, dvojno slepi, dvojno zakriti študiji, pri 543 bolnikih po novi presaditvi ledvice.
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%).
Slovenian: 20 % do 25 % (individualni razpon pri odraslih bolnikih 6 % do 43 %).
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Slovenian: Zdravljenje zavrnitve alogenskega presadka, odporne na zdravljenje z drugimi imunosupresivi, pri odraslih bolnikih.
English: Treatment of allograft rejection
Slovenian: Zdravljenje zavrnitve alogenskega presadka
English: Packs of 30, 60 and 90 prolonged-release tablets are available.
Slovenian: Na voljo so pakiranja po 30, 60 in 90 tablet s podaljšanim sproščanjem.
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. sočasni uporabi antilimfocitnih protiteles (npr. baziliksimab, daklizumab), se tveganje za pojav z EBV povezanih limfoproliferativnih bolezni poveča.
English: In vitro the following substances have been shown to be potential inhibitors of tacrolimus metabolism: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen and (triacetyl)oleandomycin.
Slovenian: In vitro so se kot možni zaviralci presnove takrolimusa izkazale naslednje snovi: bromokriptin, kortizon, dapson, ergotamin, gestoden, lidokain, mefenitoin, mikonazol, midazolam, nilvadipin, noretindron, kinidin, tamoksifen in (triacetil)oleandomicin.
English: Each tablet contains 104 mg lactose monohydrate.
Slovenian: Ena tableta vsebuje 104 mg laktoze monohidrata.
English: The efficacy and safety of Envarsus and Prograf, both in combination with mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) and corticosteroids, were compared in 324 stable kidney transplant recipients.
Slovenian: Učinkovitost in varnost zdravila Envarsus in zdravila Prograf, oba v kombinaciji z mofetilmikofenolatom (MMF) ali natrijevim mikofenolatom (MPS) in kortikosteroidi, so primerjali pri 324 stabilnih bolnikih po presaditvi ledvice.
English: The percentage of patients with one or greater than one episode of clinically-suspected and treated rejections during the 360-day study was 13.8% for the Envarsus group (N=268) and 15.6% for the Prograf group (N=275).
Slovenian: Odstotek bolnikov z eno ali več kot eno epizodo s kliničnim sumom na zavrnitev in zdravljenjem zavrnitve v 360-dnevni študiji je bila 13,8 % za skupino z zdravilom Envarsus (N = 268) in 15,6 % za skupino z zdravilom Prograf (N = 275).
English: The most commonly reported adverse reactions for tacrolimus (occurring in >10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali za takrolimus (pojavili so se pri > 10 % bolnikov), so tremor, ledvična okvara, hiperglikemična stanja, sladkorna bolezen, hiperkaliemija, okužbe, hipertenzija in nespečnost.
English: The event rate for locally read BPAR during the 360-day study was 1.2% in the Envarsus group (N=162) post conversion from Prograf at a dose ratio of 1:0.7 (mg:mg) and 1.2% in the group maintained on Prograf (N=162).
Slovenian: Stopnja dogodkov za lokalno določeno BPAR med 360-dnevno študijo je bila 1,2 % v skupini z zdravilom Envarsus (N = 162) po prehodu z zdravila Prograf z razmerjem odmerkov 1:0,7 (mg:mg) in 1,2 % v skupini, ki je ostala na zdravilu Prograf
English: When substances with a potential for interaction (see section 4.5), particularly strong inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin, or clarithromycin) or inducers of CYP3A4 (such as rifampicin or rifabutin), are being combined with tacrolimus, tacrolimus blood levels should be monitored to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure.
Slovenian: Pri kombinirani uporabi učinkovin, pri katerih obstaja možnost za medsebojno delovanje (glejte poglavje 4.5), zlasti močnih zaviralcev CYP3A4 (kot so telaprevir, bokeprevir, ritonavir, ketokonazol, vorikonazol, itrakonazol, telitromicin ali klaritromicin) ali induktorji CYP3A4 (kot sta rifampicin ali rifabutin) skupaj s takrolimusom, je treba nadzirati ravni takrolimusa v krvi in ustrezno prilagajati odmerek takrolimusa, da se vzdržuje podobna izpostavljenost takrolimusu.
English: - if you have diarrhoea for more than one day.
Slovenian: - če imate ali ste kdaj prej imeli težave z jetri, - če imate več kot en dan drisko,
English: Lansoprazol 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 zvišata koncentracije takrolimusa v polni krvi.
English: Each tablet contains 41.7 mg lactose monohydrate.
Slovenian: Ena tableta vsebuje 41,7 mg laktoze monohidrata.
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8).
Slovenian: Bolniki naj ves čas ohranjajo eno farmacevtsko obliko takrolimusa z ustreznim dnevnim režimom odmerjanja; spremembe v farmacevtski obliki ali režimu naj se izvajajo le pod skrbnim nadzorom specialista za presaditve (glejte poglavji 4.4 in 4.8).
English: Reproductive system and breast disorders dysmenorrhoea and uterine bleeding
Slovenian: Motnje reprodukcije in dojk dismenoreja in krvavitev iz maternice
English: Effect of other medicinal products on the metabolism of tacrolimus
Slovenian: Vpliv drugih zdravil na presnovo takrolimusa
English: The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC0-24) for Envarsus is similar to that of immediate-release tacrolimus.
Slovenian: Razmerje med najnižjimi vrednostmi takrolimusa (C24) in povprečni sistemski izpostavljenosti (AUC0-24) za zdravilo Envarsus je podobno kot pri takrolimusu s takojšnjim sproščanjem.
English: It is strongly recommended to closely monitor tacrolimus blood levels, as well as renal function and other undesirable effects, whenever substances which have the potential to alter CYP3A4 metabolism or otherwise influence tacrolimus blood levels are used concomitantly, and to interrupt or adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and
Slovenian: Zato je koncentracijo takrolimusa v krvi ter delovanje ledvic in ostalih neželenih učinkov priporočljivo nadzirati, kadar koli sočasno uporabljate učinkovine, ki lahko spremenijo presnovo CYP3A ali kako drugače vplivajo na koncentracijo takrolimusa v krvi in odmerek takrolimusa ustrezno prilagoditi, da bi izpostavljenost takrolimusu ohranili približno enako (glejte poglavji 4.2 in 4.4).
English: Psychiatric disorders insomnia confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare psychotic disorder
Slovenian: Psihiatrične motnje nespečnost zmedenost in dezorientiranost, depresija, simptomi anksioznosti, halucinacije, duševne motnje, potrtost, motnje razpoloženja, nočne more psihotična motnja
English: Pack sizes of 30, 60 and 90 prolonged-release tablets.
Slovenian: Velikosti pakiranja po 30, 60 in 90 tablet s podaljšanim sproščanjem.
English: Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
Slovenian: Klinični podatki kažejo, da sočasna uporaba takrolimusa v glavnem ne spremeni farmakokinetike statinov.
English: Patients treated with immunosuppressants, including Envarsus, are at increased risk for infections including opportunistic infections (bacterial, fungal, viral and protozoal) such as BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Slovenian: Pri bolnikih, zdravljenih z imunosupresivi, vključno z zdravilom Envarsus, je večje tveganje za okužbe, vključno z oportunističnimi okužbami (bakterijske, glivične, virusne in protozojske), kot sta nefropatija, povezana z virusom BK, in progresivna multifokalna levkoencefalopatija (PML),
English: Chiesi S.A.S Tél: + 33 1 47688899
Slovenian: Tél: + 33 1 47688899
English: Herbal preparations containing St. John's Wort (Hypericum perforatum) should be avoided when taking tacrolimus due to the risk of interactions that lead to a decrease in both blood concentrations and the therapeutic effect of tacrolimus (see section 4.5).
Slovenian: Med jemanjem takrolimusa bolniki ne smejo uporabljati zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum) zaradi nevarnosti za medsebojno delovanje, ki zmanjša koncentracijo takrolimusa v krvi in oslabi njegov klinični učinek (glejte poglavje 4.5).
English: Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.
Slovenian: Za obvladanje zavrnitvenih epizod so uporabljali večje odmerke takrolimusa, dodatno zdravljenje s kortikosteroidi in uvedbo kratkih ciklusov mono-/poliklonskih protiteles.
English: 30 prolonged-release tablets 60 prolonged-release tablets 90 prolonged-release tablets
Slovenian: 30 tablet s podaljšanim sproščanjem 60 tablet s podaljšanim sproščanjem 90 tablet s podaljšanim sproščanjem
English: For treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients clinical studies are not yet available for the prolonged-release formulation Envarsus.
Slovenian: Za zdravljenje zavrnitve alogenskega presadka, odporne na zdravljenje z drugimi imunosupresivi, pri odraslih bolnikih klinične študije za farmacevtsko obliko s podaljšanim sproščanjem Envarsus še niso na voljo.
English: • Envarsus 0.75 mg tablets: 41.7 mg
Slovenian: • Envarsus 0,75 mg tablete: 41,7 mg • Envarsus 1 mg tablete:
English: In current clinical practice, whole blood levels are monitored using immunoassay methods.
Slovenian: V klinični praksi se za nadziranje koncentracije v polni krvi trenutno uporabljajo metode imunskega preskusa.
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.2 and 4.8).
Slovenian: Bolniki naj ves čas ohranjajo eno farmacevtsko obliko takrolimusa z ustreznim dnevnim režimom odmerjanja; spremembe v farmacevtski obliki ali režimu odmerjanja naj se izvajajo le pod skrbnim nadzorom specialista za presaditve (glejte poglavji 4.2 in 4.8).
English: You will need to take Envarsus every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Slovenian: Kako dolgo moram jemati tablete zdravila Envarsus Zdravilo Envarsus boste morali jemati vsak dan, dokler potrebujete imunosupresijo zaradi preprečevanja zavrnitve presajenega organa.
English: The educational material for Healthcare Professionals should include information on the following key elements: - The authorised indications - The need for prescribing and dispensing with attention to pharmaceutical form (prolonged-release) and posology (once daily administration).
Slovenian: Izobraževalno gradivo za zdravstvene delavce mora vsebovati informacije o naslednjih ključnih elementih: - odobrene indikacije - Pri predpisovanju in izdajanju zdravila je potrebna pozornost zaradi farmacevtske oblike
English: Caution should be exercised in patients with diagnosed or suspected Congenital Long QT Syndrome.
Slovenian: Previdnost je potrebna pri bolnikih, ki imajo ugotovljen prirojeni sindrom podaljšanega QT intervala, ali pa obstaja sum, da imajo ta sindrom.
English: Possible interactions with other active substances known to have high affinity for plasma proteins should be considered (e.g. NSAIDs, oral anticoagulants or oral antidiabetics).
Slovenian: Upoštevati je treba možnost medsebojnega delovanja z učinkovinami, ki imajo veliko afiniteto za beljakovine v plazmi (npr. nesteroidna protivnetna zdravila, peroralni antikoagulanti ali peroralni antidiabetiki).
English: Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Slovenian: Pri prehodu bolnikov z zdravljenja na osnovi ciklosporina na zdravljenje na osnovi takrolimusa je potrebna previdnost (glejte poglavji 4.4 in 4.5).
English: In all, there appears to be no significant difference in the pattern of adverse events suspected to be causally related to study drug between once daily Envarsus and tacrolimus immediate-release capsules (Prograf).
Slovenian: Kaže, da ni značilne razlike v vzorcu neželenih učinkov, ki so domnevno povezane s študijskim zdravilom, med zdravilom Envarsus enkrat na dan in kapsulami takrolimusa s takojšnjim sproščanjem (zdravilo Prograf).
English: The event rate for centrally read, biopsy-confirmed acute rejection (BPAR) during the 360-day study was 13.1% in the Envarsus group (N=268) and 13.5% in the Prograf group (N=275).
Slovenian: Stopnja dogodkov za centralno določeno, z biopsijo potrjeno akutno zavrnitvijo (BPAR - biopsy-confirmed acute rejection) med 360-dnevno študijo je bila 13,1 % za skupino z zdravilom Envarsus (N = 268) in 13,5 % za skupino z zdravilom Prograf (N = 275).
English: The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly.
Slovenian: Pri sočasni uporabi takrolimusa se razpolovni čas ciklosporina podaljša.
English: In healthy subjects, the average total body clearance estimated from whole blood concentrations was 2.25 L/h.
Slovenian: ocenjen iz koncentracij polne krvi, 2,25 l/h.
English: For prophylaxis of transplant rejection in adult heart, lung, pancreas, or intestine allograft recipients clinical data are not yet available for Envarsus.
Slovenian: Za preprečevanje zavrnitve presadka pri odraslih po alogenski presaditvi srca, pljuč, trebušne slinavke ali črevesja klinični podatki za farmacevtsko obliko s podaljšanim sproščanjem Envarsus še niso na voljo.