natgillin/translations-raw huggingface dataset:
• 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.
Myclausen film-coated tablets should only be prescribed to patients with a body surface area greater than 1.5 m2, at a dose of 1 g twice daily (2 g daily dose). 
Filmsko obložene tablete Myclausen lahko predpišemo samo bolnikom, katerih telesna površina je večja od 1,5 m2, v odmerku 1 g dvakrat na dan (dnevni odmerek 2 g).
Therefore Myclausen is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection. 
Zato je zdravilo Myclausen med nosečnostjo kontraindicirano, razen če za preprečitev zavrnitve presadka ni na voljo primernih alternativnih zdravljenj.
• Take 3 tablets in the morning and then 3 tablets in the evening. 
• Vzemite 3 tablete zjutraj in 3 tablete zvečer.
• If you are pregnant or planning to become pregnant or think you may be pregnant If you are not using effective contraception (see Pregnancy, contraception and breast-feeding). 
• če ne uporabljate učinkovite kontracepcije (glejte Nosečnost, kontracepcija in dojenje),
Heart transplant 
Presaditev srca
Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG. 
Ni pričakovati, da bi s hemodializo odstranili klinično pomembne količine mikofenolne kisline ali mikofenolglukuronida.
Fighting infections 
Zaščita pred okužbami
Lymphoproliferative disease or lymphoma developed in 0.6 % of patients receiving mycophenolate mofetil (2 g or 3 g daily) in combination with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year. 
Limfoproliferativne bolezni ali limfomi so se pojavili pri 0,6 % bolnikov, ki so dobivali mofetilmikofenolat (2 g ali 3 g dnevno) skupaj z drugimi imunosupresivi v nadzorovanih kliničnih preskušanjih pri bolnikih z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, ki so trajala vsaj eno leto.
Patients with a body surface area greater than 1.5 m may be prescribed Myclausen capsules at a dose of 1 g twice daily (2 g daily dose). 
Pacientom, katerih telesna površina je večja od 1,5 m lahko predpišemo Myclausen kapsule v odmerku 1 g dvakrat na dan (dnevni odmerek 2 g).
Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil. 
Pri dajanju antacidov, kot so magnezijevi in aluminijevi hidroksidi, in zaviralcev protonske črpalke, vključno z lanzoprazolom in pantroprazolom, skupaj z zdravilom mofetilmikofenolata, so opazili zmanjšano izpostavljenost mikofenolni kislini.
Very common Common Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia 
Presnovne in prehranske motnje zelo pogosti pogosti acidoza, hiperkaliemija, hipokaliemija, hiperglikemija, hipomagnezemija, hipokalciemija, hiperholesterolemija, hiperlipidemija, hipofosfatemija, hiperurikemija, protin, anoreksija
These effects occurred at systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended dose of 2 g/day for renal transplant recipients. 
Učinki so se pojavili pri sistemski izpostavljenosti, ki je bila enaka ali manjša kot klinična izpostavljenost pri priporočenem odmerjanju 2 g na dan pri bolnikih z ledvičnim presadkom.
A negligible amount of substance is excreted as MPA (< 1 % of dose) in the urine. 
Zanemarljiva količina učinkovine (manj kot 1 % odmerka) se kot mikofenolna kislina izloča v urin.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28-75 % higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment. 
V študiji enkratnega odmerjanja (6 oseb/skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija < 25 ml/min/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 % večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
Hypogammaglobulinaemia has been reported in patients receiving mycophenolate mofetil in combination with other immunosuppressants (frequency not known). 
O hipogamaglobulinemiji so poročali pri bolnikih, ki so mofetilmikofenolat prejemali v kombinaciji z drugimi imunosupresivi (pogostnost ni poznana).
In order to assist patients in avoiding foetal exposure to mycophenolate and to provide additional important safety information, the Marketing Authorisation holder will provide educational materials to healthcare professionals. 
Imetnik dovoljenja za promet bo v pomoč bolnicam pri preprečevanju izpostavitve ploda mofetilmikofenolatu in za zagotovitev dodatnih pomembnih podatkov o varnosti zdravila zdravstvenim delavcem predal izobraževalno gradivo.
In patients with delayed renal graft function post-transplant, mean MPA AUC (0-12 h) was comparable to that seen in post-transplant patients without delayed graft function. 
Pri bolnikih z zapoznelim delovanjem ledvičnega presadka je bila srednja AUC (0-12 ur) mikofenolne kisline primerljiva s tisto pri bolnikih brez zapoznelega delovanja ledvičnega presadka.
In addition, a pregnancy follow-up questionnaire including details of exposure during pregnancy, including timing and dose; duration of therapy, before and during pregnancy; concomitant drugs; known teratogenic risks and full details of congenital malformations should be agreed to with the national competent authorities and implemented within four months after completion of this procedure. 
Dodatno se je treba z nacionalnim organom, pristojnim za zdravila, dogovoriti o vprašalniku o spremljanju nosečnosti, ki bo vseboval podrobnosti o izpostavitvi med nosečnostjo, času in odmerku, trajanju zdravljenja pred in med nosečnostjo, sočasno uporabljenih zdravilih, znanih tveganjih za teratogenost in vsemi podrobnostmi o kongenitalnih malformacijah.
Use in cardiac transplant 
Uporaba pri presaditvi srca
• The first dose is given within 5 days of the transplant operation. 
• Prvi odmerek prejmete v 5 dneh po presaditvenem posegu.
Myclausen contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
Zdravilo Myclausen vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30 50 % in renal transplant patients treated with mycophenolate mofetil and CsA compared with patients receiving sirolimus or belatacept and similar doses of mycophenolate mofetil (see also section 4.4). 
Ciklosporin A vpliva na enterohepatični obtok mikofenolne kisline in s tem zmanjša izpostavljenost mikofenolni kislini za 30-50 % pri bolnikih z ledvičnim presadkom, ki so bili zdravljeni z mofetilmikofenolatom in ciklosporinom A, v primerjavi z bolniki, ki so prejemali sirolimus ali belatacept in podobne odmerke mofetilmikofenolata (glejte tudi poglavje 4.4).
Lymph and skin cancer 
Rak limfatičnega sistema in kožni rak
PHARMACEUTICAL FORM Capsule, hard. 
FARMACEVTSKA OBLIKA kapsula, trda podolgovate, bele kapsule
The most common opportunistic infections in patients receiving mycophenolate mofetil (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex. 
Najpogostejše oportunistične okužbe pri bolnikih z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, ki so v nadzorovanih kliničnih preskušanjih prejemali mofetilmikofenolat (2 g ali 3 g na dan) z drugimi imunosupresivi vsaj eno leto, so bile okužbe z glivicami (Candida mucocutaneus), sindrom CMV/viremija in okužbe z virusom herpesa simpleksa.
Before starting Myclausen treatment, women of child bearing potential should have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL in order to exclude unintended exposure of the embryo to mycophenolate. 
Da izključimo nenamerno izpostavljenost zarodka mofetilmikofenolatu, morajo bolnice v rodni dobi pred začetkom zdravljenja z zdravilom Myclausen opraviti dva serumska ali urinska testa nosečnosti, z občutljivostjo najmanj 25 mi.e./ml, ki morata biti negativna.
Children • There is no information for the use of Myclausen in children with a liver transplant. 
Otroci • Podatki o uporabi zdravila Myclausen pri otrocih z jetrnim presadkom niso na voljo.
The highest dose tested in the animal carcinogenicity studies resulted in approximately 2-3 times the systemic exposure (AUC or Cmax) observed in renal transplant patients at the recommended clinical dose of 2 g/day and 1.3-2 times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended clinical dose of 3 g/day. 
Najvišji preizkušani odmerek v živalskih študijah karcinogenosti je povzročil približno 2- do 3-krat večjo sistemsko izpostavljenost (AUC ali Cmax) kot pri bolnikih z ledvičnim presadkom, ki so prejemali priporočeni klinični odmerek 2 g na dan, in 1,3- do 2-krat večjo sistemsko izpostavljenost (AUC ali Cmax) kot pri bolnikih s srčnim presadkom, ki so prejemali priporočeni klinični odmerek 3 g na dan.
Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for mycophenolate mofetil, mycophenolic acid the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mycophenolate mofetil, mycophenolic acid is unchanged subject to the proposed changes to the product information 
Na podlagi znanstvenih zaključkov za mofetilmikofenolat in mikofenolno kislino odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) mofetilmikofenolat in mikofenolno kislino, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.