natgillin/translations-raw huggingface dataset:
Based on the results of a single dose administration study of recommended doses of oral mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that co-administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Na podlagi rezultatov študije enkratnega odmerjanja priporočenih odmerkov peroralne oblike mofetilmikofenolata in intravenske oblike ganciklovirja in znanih učinkov ledvične okvare na farmakokinetiko mofetilmikofenolata (glejte poglavje 4.2) in ganciklovirja, je pričakovati, da bo sočasno dajanje obeh učinkovin, ki tekmujeta v mehanizmih renalne tubularne sekrecije, povzročilo povečanje koncentracij mikofenolglukuronida in ganciklovirja.
Patients should be advised that during treatment with Myclausen, vaccinations may be less effective, and the use of live attenuated vaccines should be avoided (see section 4.5).
Bolnike, ki prejemajo zdravilo Myclausen, moramo opozoriti, da so lahko cepiva manj učinkovita, uporabi živih cepiv pa se morajo izogibati (glejte poglavje 4.5).
• Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
V literaturnih poročilih so se malformacije pojavljale pri 23 do 27 % živorojenih otrok bolnic, ki so bile med nosečnostjo izpostavljene mofetilmikofenolatu, (v primerjavi z 2 do 3 % pri živorojenih otrocih v celokupni populaciji ter približno 4 do 5 % pri živorojenih otrocih bolnic s presajenim solidnim organom, zdravljenih z drugimi imunosupresivi razen mofetilmikofenolata).
Congenital disorders
Kongenitalne okvare
1 What Myclausen is and what it is used for 2 What you need to know before you take Myclausen 3 How to take Myclausen 4 Possible side effects
Kaj je zdravilo Myclausen in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Myclausen Kako jemati zdravilo Myclausen Možni neželeni učinki
As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are usually observed at approximately 6-12 hours post-dose.
Zaradi enterohepatičnega ponovnega obtoka se plazemske koncentracije mikofenolne kisline 6 do12 ur po odmerku ponovno zvečajo.
PHARMACEUTICAL FORM AND CONTENTS 100 hard capsules
FARMACEVTSKA OBLIKA IN VSEBINA 100 trdih kapsul
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately.
Če med zdravljenjem z mofetilmikofenolatom zanosite, morate nemudoma obvestiti zdravnika.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
V študijah plodnosti in reproduktivnosti so peroralni odmerki po 4,5 mg/kg/dan pri podganjih samicah povzročili malformacije (vključno z anoftalmijo, agnatijo in hidrocefalijo) pri prvi generaciji potomcev, pri materah pa škodljivih učinkov ni bilo.
When comparing rates of transplant rejection, rates of graft loss or adverse event profiles between mycophenolate mofetil patients with and without concomitant telmisartan medication, no clinical consequences of the pharmacokinetic medicinal product-medicinal product interaction were seen.
Ko so primerjali deleže zavrnitve presadka, deleže izgube presadka ali profile neželenih učinkov med bolniki, zdravljenimi z mofetilmikofenolatom v kombinaciji s telmisartanom ali brez njega, niso opazili nobenih kliničnih posledic farmakokinetičnega medsebojnega delovanja med zdraviloma.
PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 50 filmsko obloženih tablet
No substantial alteration of MPA pharmacokinetics is anticipated and Myclausen dose adjustment is not required.
Znatnih sprememb v farmakokinetiki mikofenolne kisline ni pričakovati, zato prilagajanje odmerkov zdravila Myclausen ni potrebno.
Capsule shells: gelatine, titanium dioxide (E 171)
Obloga kapsul: želatina, titanov dioksid (E 171).
Titanium dioxide (E 171)
Obloga kapsul želatina titanov dioksid (E 171)
Gingival hyperplasia (≥ 1/100 to < 1/10), colitis including cytomegalovirus colitis, (≥ 1/100 to < 1/10), pancreatitis (≥ 1/100 to < 1/10) and intestinal villous atrophy.
Gingivalna hiperplazija (≥ 1/100 do < 1/10), kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (≥ 1/100 do < 1/10), pankreatitis (≥ 1/100 do < 1/10) in atrofija črevesne sluznice.
PHARMACEUTICAL FORM AND CONTENTS 150 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 150 filmsko obloženih tablet
There are no data on mycophenolate mofetil with phosphate binders other than sevelamer.
Ni podatkov o dajanju mofetilmikofenolata z drugimi vezalci fosfatov, razen sevelamerjem.
As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking Myclausen.
Kot previdnostni ukrep je za vas ali vašo partnerko priporočljivo, da med zdravljenjem in 90 dni po končanem zdravljenju uporabljate/uporablja zanesljivo obliko kontracepcije.
AcMPAG is pharmacologically active and is suspected to be responsible for some of mycophenolate mofetil´s side effects (diarrhoea, leucopenia).
Ta je farmakološko aktiven in verjetno odgovoren za nekaj neželenih učinkov mofetilmikofenolata (diareja, levkopenija).
Pharmacokinetic behaviour of mycophenolate mofetil in the elderly ( 65 years) has not been formally evaluated.
Farmakokinetičnih parametrov mofetilmikofenolata pri starejših bolnikih (starih 65 let ali več) niso proučevali.
Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Myclausen is contraindicated in nursing mothers (see section 4.3).
Zaradi možnih resnih škodljivih vplivov mofetilmikofenolata na dojenčke, je zdravilo Myclausen pri doječih materah kontraindicirano (glejte poglavje 4.3).
As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
V tej starostni skupini se v primerjavi z odraslimi bolniki nekateri neželeni učinki pojavljajo pogosteje (glejte poglavje 4.8), zato bo morda treba začasno zmanjšati odmerek ali prekiniti zdravljenje.
No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
Pri samicah in nadaljnjih generacijah potomcev niso opazili učinkov na reproduktivnost ali plodnost.
5 How to store Myclausen 6 Contents of the pack and other information
Shranjevanje zdravila Myclausen Vsebina pakiranja in dodatne informacije
• Counselling of patients: This section will emphasise the importance of a thorough, informative and ongoing dialogue between patient and healthcare professional about the pregnancy risks associated with mycophenolate mofetil and the relevant minimisation strategies including alternative treatment choices, if applicable.
To poglavje bo poudarilo pomembnost temeljitega, poučnega in stalnega pogovora med bolnikom in zdravstvenim delavcem o tveganju uporabe mofetilmikofenolata med nosečnostjo in ustreznih strategijah za njegovo zmanjševanje, vključno z drugimi možnostmi zdravljenja, če so primerne.
Myclausen capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Myclausen v odmerku 750 mg dvakrat dnevno (dnevni odmerek 1,5 g).
This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.
Pogostejše so okužbe možganov, kože, ust, želodca in črevesja, pljuč ter sečil.
Very common Common Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased Note: 501 (2 g mycophenolate mofetil daily), 289 (3 g mycophenolate mofetil daily) and 277 (2 g intravenous / 3 g oral mycophenolate mofetil daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Preiskave zelo pogosti pogosti zvišani jetrni encimi, zvišan kreatinin v krvi, zvišana laktat-dehidrogenaza v krvi, zvišana sečnina v krvi, zvišana alkalna fosfataza v krvi, zmanjšana telesna teža Opomba: 501 (2 g mofetilmikofenolata dnevno), 289 (3 g mofetilmikofenolata dnevno) in 277 (2 g intravenozno / 3 g mofetilmikofenolata peroralno dnevno) bolnikov je bilo zdravljenih v III. fazi kliničnih preiskušanj za preprečitev zavrnitve ledvičnega, srčnega oziroma jetrnega presadka.
• Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
Pri nosečnicah, izpostavljenih mofetilmikofenolatu, so poročali o spontanih splavih pri 45 do 49 % bolnic v primerjavi z med 12 in 33 % pri bolnicah s presajenim solidnim organom, zdravljenih z drugimi imunosupresivi razen mofetilmikofenolata.
• The first dose will be given within 3 days after the transplant operation.
• Prvi odmerek prejmete v 3 dneh po presaditvenem posegu.
INFORMATION IN BRAILLE Myclausen 500 mg
PODATKI V BRAILLOVI PISAVI Myclausen 500 mg
If you stop taking Myclausen
Če ste prenehali jemati zdravilo Myclausen
PHARMACEUTICAL FORM Film-coated tablet White round film-coated tablets.
FARMACEVTSKA OBLIKA Filmsko obložena tableta Bele okrogle filmsko obložene tablete
In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively unaffected by hepatic parenchymal disease.
Pri prostovoljcih z alkoholno jetrno cirozo procesi glukuronidacije mikofenolne kisline v jetrih niso bili pomembno spremenjeni zaradi bolezni jetrnega parenhima.
• you have a sign of infection such as a fever or sore throat
• imate znake okužbe, kot sta povišana telesna temperatura ali vneto grlo,
The following undesirable effects cover adverse reactions from clinical trials The principal adverse reactions associated with the administration of mycophenolate mofetil in combination with ciclosporin and corticosteroids include diarrhoea, leucopenia, sepsis and vomiting, and there is evidence of a higher frequency of certain types of infections (see section 4.4).
Sledeče neželene učinke so opazili pri kliničnih preskušanjih Glavni neželeni učinki, povezani z jemanjem mofetilmikofenolata v kombinaciji s ciklosporinom in kortikosteroidi, vključujejo drisko, levkopenijo, sepso in bruhanje, opisali pa so tudi višjo incidenco določenih tipov okužb (glejte poglavje 4.4).
Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.
Ker so pri ledvični okvari koncentracije mikofenolglukuronida in aciklovirja v plazmi povečane, obstaja možnost, da med mofetilmikofenolatom in aciklovirjem ali njegovim predzdravilom (npr. valaciklovirjem) prihaja do kompeticije pri tubularni sekreciji in dodatnega povečanja koncentracij obeh učinkovin.
• If you have a sign of infection such as a fever or sore throat
• če opazite znake okužbe, kot sta povišana telesna temperatura ali vneto grlo,
In the kidney MPA and its metabolites potently interact with renal organic anion transporters.
V ledvicah pride do močne interakcije mikofenolne kisline in njenih metabolitov z ledvičnimi organskimi anionskimi prenašalci.
• Take 4 capsules in the morning then 4 capsules in the evening.
• Vzemite 4 kapsule zjutraj in 4 kapsule zvečer.
Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA.
Mofetilmikofenolat je 2-morfolinoetilni ester mikofenolne kisline.
Digestive system and mouth problems such as: • swelling of the gums and mouth ulcers
Težave s prebavili in usti, kot so: • otekanje dlesni in razjede v ustih,
Thus, other substances known to undergo renal tubular secretion may compete with MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
Tako lahko druge učinkovine, za katere je znano, da so podvržene renalni tubularni sekreciji, tekmujejo z mikofenolglukuronidom in tako zvišajo koncentracije mikofenolglukuronida v plazmi ali drugih učinkovin, podvrženih renalni tubularni sekreciji.
INFORMATION IN BRAILLE Myclausen 250 mg
PODATKI V BRAILLOVI PISAVI Myclausen 250 mg
Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)).Your baby may be affected by one or more of these.
Okvare ob rojstvu, o katerih so poročali, vključujejo nepravilnosti ušes, oči, obraza (razcep ustnice ali neba), razvoja prstov, srca, požiralnika (cevi, ki povezuje žrelo z želodcem), ledvic in živčnega sistema (na primer spino bifido (kjer kosti hrbtenice niso pravilno razvite)).
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
PVC-aluminium blisters containing 10 film-coated tablets.
PVC-aluminijasti pretisni omot vsebuje 10 filmsko obloženih tablet.
The mechanism for mycophenolate mofetil induced PRCA is unknown.
Mehanizem z mofetilmikofenolatom sprožene PRCA ni znan.
• Take 2 tablets in the morning then 2 tablets in the evening.
• Vzemite 2 tableti zjutraj in 2 tableti zvečer.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myclausen film-coated tablets should not be broken or crushed.
Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, se Myclausen tablet ne ne sme zdrobiti.
The risk/benefit ratio of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
Razmerja med tveganjem in koristnostjo mofetilmikofenolata v kombinaciji s takrolimusom ali sirolimusom še niso raziskali (glejte tudi poglavje 4.5).
Contraception in men taking Myclausen
Kontracepcija pri bolnicah, ki jemljejo zdravilo Myclausen
However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.
Vendar pa je med jemanjem te kombinacije zdravil in kratek čas po prenehanju jemanja antibiotikov potreben pazljiv klinični nadzor.
Pharmacotherapeutic group: immunosuppressants, selective immunosuppressants, ATC code: L04AA06
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, oznaka ATC: L04AA06
MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive phenolic glucuronide of MPA (MPAG).
Mikofenolna kislina se večinoma presnovi z glukuronilno transferazo (izoencim UGT1A9) v neaktivni fenolni glukuronid mikofenolne kisline (mikofenolglukuronid).
• This belongs to a group of medicines called “immunosuppressants”.
• Spada v skupino zdravil za zaviranje imunske odzivnosti.
Medicinal products of other classes which interfere with MPA's enterohepatic cycle e.g. cholestyramine should be used with caution due to their potential to reduce the plasma levels and efficacy of Myclausen (see also section 4.5).
Zdravila drugih razredov, ki vplivajo na enterohepatični obtok mikofenolne kisline, npr. holestiramin, je treba uporabljati previdno, saj lahko zmanjšajo plazemske koncentracije in učinkovitost zdravila Myclausen (glejte tudi poglavje 4.5).
• If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
• če ste bolnica, ki bi lahko bila noseča, in pred prvim predpisanim receptom nimate potrjenega negativnega testa nosečnosti, saj lahko mofetilmikofenolat povzroči prirojene okvare in spontani splav,
Polyvinyl alcohol (partially hydrolysed) Titanium dioxide (E 171) Macrogol 3000
Obloga tablet polivinilalkohol (delno hidroliziran) titanov dioksid (E 171) makrogol 3000 smukec
Patients should be instructed to consult their physician immediately should pregnancy occur.
Bolnicam je treba svetovati, naj v primeru zanositve nemudoma obvestijo zdravnika.
Patients on Myclausen who develop recurrent infections should have their serum immunoglobulins measured.
Bolnikom, ki jemljejo zdravilo Mofetilmikofenolata in se jim okužbe ponavljajo, je treba določiti raven imunoglobulinov v serumu.
MPA is a powerful teratogen.
Mofetilmikofenolat je močan teratogen.
In patients with renal impairment in whom Myclausen and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered, the dose recommendations for ganciclovir should be observed and patients should be monitored carefully.
Bolnike z ledvično okvaro, ki sočasno dobivajo zdravilo Myclausen in ganciklovir oziroma njegova predzdravila (npr. valganciklovir), je treba skrbno nadzorovati in proučiti odmerjanje ganciklovirja.
Myclausen is indicated in adults, and children and adolescents aged 2 to 18 years in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Zdravilo Myclausen je indicirano pri odraslih, otrocih in mladostnikih, starih 2 do 18 let v kombinaciji s ciklosporinom in kortikosteroidi za preprečevanje akutnih zavrnitvenih reakcij pri bolnikih z alogenim ledvičnim, srčnim ali jetrnim presadkom.
It is recommended that Myclausen should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Ne priporočamo sočasnega dajanja zdravila Myclausen in azatioprina, ker kombiniranega jemanja teh zdravil niso proučevali.
MPA's disposition depends on several transporters.
Razporeditev mikofenolne kisline je odvisna od različnih prenašalcev.
Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in ≥ 1/10 and in ≥ 1/100 to < 1/10 of patients treated with mycophenolate mofetil in the controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients are listed in the following table.
Neželeni učinki, ki so verjetno ali možno povezani z mofetilmikofenolatom in so se pojavili pri ≥ 1/10 in pri ≥ 1/100 do < 1/10 bolnikov, zdravljenih z mofetilmikofenolatom v nadziranih kliničnih preskušanjih bolnikov z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, so našteti v spodnji preglednici.
• fluid on the lungs or inside the chest
• tekočina v pljučih ali prsih,
There have been published reports of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants.
Objavljeni so bili primeri bronhiektazije pri odraslih in otrocih, ki so prejeli zdravilo Mofetilmikofenolata v kombinaciji z drugimi imunosupresivi.
How to take Myclausen
Kako jemati zdravilo Myclausen
Children • There is no information for the use of Myclausen in children with a heart transplant.
Otroci • Podatki o uporabi zdravila Myclausen pri otrocih s srčnim presadkom niso na voljo.
No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section 5.2).
Bolnikom, pri katerih se je po operaciji primerno ledvično delovanje presadka vzpostavilo z zakasnitvijo, prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
Pregnancy, puerperium and perinatal conditions Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil, mainly in the first trimester, see section 4.6.
Motnje v času nosečnosti, puerperija in perinatalnem obdobju Poročali so o primerih spontanih splavov pri bolnicah, izpostavljenih mofetilmikofenolatu, pretežno v prvem trimesečju, glejte poglavje 4.6.
Caution should be exercised when switching combination therapy from regimens containing immunosuppressants, which interfere with MPA enterohepatic recirculation e.g. ciclosporin to others devoid of this effect e.g. sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure.
Pri prehodu iz kombiniranega zdravljenja s shemo z imunosupresivi, ki ovirajo enterohepatični obtok mikofenolne kisline (npr. ciklosporin) na druge, ki nimajo takega učinka (npr. sirolimus, belatacept), ali obratno, je potrebna previdnost, saj to lahko vodi k spremembam izpostavljenosti mikofenolni kislini.
Paediatric population
Pediatrični bolniki
Also do this if someone else accidentally takes your medicine.
Če nekdo drug po nesreči zaužije vaše zdravilo, naj stori enako.
Use in special populations
Uporaba pri posebnih bolnikih
Pharmacotherapeutic group: immunosuppressants, selective immunosuppressants, ATC code L04AA06
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, selektivna zdravila za zaviranje imunske odzivnosti, oznaka ATC: L04AA06
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
V študijah teratogenosti pri podganah in kuncih so se pojavile malformacije in resorpcija zarodka pri odmerkih 6 mg/kg/dan pri podganah (vključno z anoftalmijo, agnatijo in hidrocefalijo) ter pri odmerkih 90 mg/kg/dan pri kuncih (vključno s kardiovaskularnimi motnjami in motnjami delovanja ledvic, kot so ektopija srca in ledvic ter preponska in popkovna kila), pri materah pa škodljivih učinkov ni bilo.
Taking into account the PRAC Assessment Report on the PSUR(s) for mycophenolate mofetil, mycophenolic acid, the scientific conclusions of CHMP are as follows: Following a review of all available information regarding pregnancies following paternal exposure to mycophenolate mofetil or mycophenolic acid, including a review of all nonclinical data and information on transmission of mycophenolic acid via the semen, the PRAC concluded that the data does not highlight any patterns or an increase in congenital malformations or spontaneous abortions.
Po pregledu vseh razpoložljivih podatkov o nosečnostih, kjer je bil mofetilmikofenolatu ali mikofenolni kislini izpostavljen oče, vključno s pregledom vseh nekliničnih podatkov in informacij o prenosu mikofenolne kisline s semenom, je PRAC ugotovil, da podatki ne nakazujejo na vzorec povečanih prirojenih malformacij ali spontanih splavov.
Each carton contains either 100 or 300 hard capsules.
Vsaka škatla vsebuje 100 ali 300 trdih kapsul.
In hepatic transplant patients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by coadministration with tacrolimus.
Pri bolnikih z jetrnim presadkom, pri katerih so uvedli mofetilmikofenolat in takrolimus, sprememba AUC in Cmax mikofenolne kisline, aktivnega presnovka mofetilmikofenolata, zaradi sočasnega dajanja takrolimusa ni bila pomembna.
Myclausen is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Zdravilo Myclausen je med nosečnostjo kontraindicirano, razen če za preprečitev zavrnitve presadka ni na voljo primernega alternativnega zdravljenja.