natgillin/translations-raw huggingface dataset:
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Mycophenolate mofetil Teva, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8). The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
Bolniki, ki prejemajo kombinacije imunosupresivnih zdravil, vključno z zdravilom Mofetilmikofenolat Teva, so izpostavljeni povečanem tveganju nastanka limfomov in drugih malignih sprememb, zlasti kožnih (glejte poglavje 4. 8).
As general advice to
Zdi se, da je tveganje bolj odvisno od intenzivnosti in trajanja imunosupresije kot od specifičnosti učinkovin.
3 minimise the risk for skin cancer, exposure to sunlight and ultra violet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
3 Bolnikom, ki prejemajo zdravilo Mofetilmikofenolat Teva, naročimo, da morajo takoj poročati o kakršnemkoli znaku okužbe, nepričakovani modrici, krvavitvi ali drugih znakih depresije kostnega mozga.
Patients receiving Mycophenolate mofetil Teva should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Bolniki, ki se zdravijo z imunosupresivi, vključno z zdravilom Mofetilmikofenolat Teva, imajo povečano tveganje za oportunistične okužbe (bakterijske, glivične, virusne in protozojske), smrtne okužbe in sepso (glejte poglavje 4. 8).
Patients treated with immunosuppressants, including Mycophenolate mofetil Teva, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Oportunistične okužbe vključujejo nefropatijo, povezano z virusom BK in progresivno multifokalno levkoencefalopatijo (PML), povezano z virusom JC.
Among the opportunistic infections are BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Ti dve okužbi sta pogosto povezani z visokim imunosupresivnim bremenom in lahko vodita v resna ali smrtna stanja.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/ l) it may be appropriate to interrupt or discontinue Mycophenolate mofetil Teva.
Če se pojavi nevtropenija (absolutno število nevtrofilcev < 1, 3 x 103/ µl), moramo odmerke zdravila Mofetilmikofenolat Teva zmanjšati ali zdravljenje prekiniti.
Patients should be advised that during treatment with Mycophenolate mofetil Teva vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Bolnike, ki prejemajo zdravilo Mofetilmikofenolat Teva, moramo opozoriti, da so lahko cepiva manj učinkovita, uporabi živih cepiv pa se morajo izogibati (glejte poglavje 4. 5).
Because mycophenolate has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, Mycophenolate mofetil Teva should be administered with caution in patients with active serious digestive system disease.
Bolnikom s hujšimi boleznimi prebavil v aktivnih fazah zato dajemo zdravilo Mofetilmikofenolat Teva zelo previdno in pod skrbnim zdravniškim nadzorom.
Mycophenolate mofetil Teva is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Zdravilo Mofetilmikofenolat Teva je zaviralec inozin- monofosfat- dehidrogenaze (IMPDH).
On theoretical grounds, therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley- Seegmiller syndrome.
Na podlagi teoretičnih osnov zdravila Mofetilmikofenolat Teva ne dajemo bolnikom z redkim dednim pomanjkanjem hipoksantin- gvanin- fosforiboziltransferaze (HGPRT), kot sta Lesch- Nyhlanov in Kelley- Seegmillerjev sindrom.
It is recommended that Mycophenolate mofetil Teva should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Ne priporočamo sočasnega dajanja zdravila Mofetilmikofenolat Teva in azatioprina, ker kombiniranega jemanja teh zdravil niso proučevali.
In view of the significant reduction in the AUC (area under the curve) of MPA by cholestyramine, caution should be used in the concomitant administration of Mycophenolate mofetil Teva with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Mycophenolate mofetil Teva.
Ker holestiramin značilno zmanjša AUC (površino pod krivuljo) mikofenolne kisline, dajemo zdravilo Mofetilmikofenolat Teva previdno bolnikom, ki sočasno jemljejo druga zdravila, ki vplivajo na enterohepatični obtok zaradi možnosti zmanjšanja učinkovitosti zdravila Mofetilmikofenolat Teva.
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).
Aciclovir: higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
Aciklovir: pri sočasni uporabi aciklovirja in mofetilmikofenolata so opazili zvečane koncentracije mikofenolglukuronida in aciklovirja v plazmi v primerjavi s samostojnim jemanjem učinkovin.
The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
Spremembe v farmakokinetiki mikofenolglukuronida (ki ga je za 8% več) so bile minimalne in niso klinično pomembne.
Because MPAG plasma concentrations are increased in 4 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 do možnih nadaljnjih povečanj koncentracij obeh učinkovin.
Antacids with magnesium and aluminium hydroxides: absorption of mycophenolate mofetil was decreased when administered with antacids.
4 Antacidi z magnezijevimi in aluminijevimi hidroksidi: absorpcija mofetilmikofenolata se ob hkratnem dajanju antacidov zmanjša.
Cholestyramine: following single dose administration 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g three times a day (TID) of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2).
Holestiramin: če dajemo holestiramin 4 dni v odmerku 4 g trikrat na dan, ta zmanjša AUC mikofenolne kisline po enkratnem peroralnem vnosu 1, 5 g mofetilmikofenolata za približno 40% (glejte poglavje 4. 4 in poglavje 5. 2).
Medicinal products that interfere with enterohepatic circulation: caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of mycophenolate mofetil.
Zdravila, ki vplivajo na enterohepatični obtok: pri uporabi zdravil, ki vplivajo na enterohepatični obtok, je potrebna previdnost, saj lahko zmanjšajo učinkovitost mofetilmikofenolata.
Ciclosporin A: ciclosporin A (CsA) pharmacokinetics were unaffected by mycophenolate mofetil.
Ciklosporin A: mofetilmikofenolat ne vpliva na farmakokinetiko ciklosporina A.
Ganciclovir; based on the results of a single dose administration study of recommended doses of oral mycophenolate and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate (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 No substantial alteration of MPA pharmacokinetics is anticipated and mycophenolate mofetil dose adjustment is not required.
Znatnih sprememb v farmakokinetiki mikofenolne kisline ni pričakovati, zato prilagajanje odmerkov zdravila Mofetilmikofenolat Teva ni potrebno.
In patients with renal impairment in which Mycophenolate mofetil Teva and ganciclovir or its prodrugs, e. g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
Bolnike z ledvično okvaro, ki sočasno dobivajo zdravilo mofetilmikofenolat in ganciklovir oziroma njegova predzdravila, npr. valganciklovir, je treba skrbno nadzorovati in proučiti odmerjanje ganciklovirja.
Oral contraceptives: the pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co-administration of mycophenolate (see also section 5.2).
Peroralni kontraceptivi: sočasno jemanje mofetilmikofenolata ni vplivalo na farmakokinetiko in farmakodinamiko peroralnih kontraceptivov (glejte poglavje 5. 2).
Rifampicin: in patients not also taking ciclosporin, concomitant administration of Mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC 0-12h) of 18% to 70%. It is recommended to monitor MPA exposure levels and to adjust Mycophenolate mofetil Teva doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Priporočljivo je spremljanje ravni izpostavljenosti mikofenolni kislini in prilagoditev odmerkov zdravila Mofetilmikofenolat Teva za ohranitev klinične učinkovitosti, kadar sočasno dajemo rifampicin.
Sirolimus: in renal transplant patients, concomitant administration of mycophenolate mofetil and CsA resulted in reduced MPA exposures by 30-50% compared with patients receiving the combination of sirolimus and similar doses of mycophenolate mofetil (see also section 4.4).
Sirolimus: pri bolnikih z ledvičnim presadkom je sočasno dajanje mofetilmikofenolata in ciklosporina A povzročilo manjšo izpostavljenost mikofenolni kislini za 30 do 50% v primerjavi z bolniki, ki so prejeli kombinacijo sirolimusa in podobnih odmerkov zdravila Mofetilmikofenolat Teva (glejte tudi poglavje 4. 4).
Sevelamer: decrease in MPA C max and AUC 0-12 by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection). It is recommended, however, to administer Mycophenolate mofetil Teva at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Vseeno je priporočljivo, da dajemo zdravilo Mofetilmikofenolat Teva vsaj eno uro pred ali tri po dajanju sevelamerja, zato da zmanjšamo vpliv na absorpcijo mikofenolne kisline.
There is no data on mycophenolate mofetil with phosphate binders other than sevelamer.
Ni podatkov o dajanju mofetilmikofenolata z drugimi vezalci fosfatov, razen sevelamerjem.
Norfloxacin and metronidazole: in healthy volunteers, no significant interaction was observed when mycophenolate mofetil was concomitantly administered with norfloxacin and metronidazole separately.
Norfloksacin in metronidazol: pri dajanju mofetilmikofenolata skupaj z norfloksacinom ali metronidazolom zdravim prostovoljcem pomembnega medsebojnega delovanja niso opazili.
However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of mycophenolate mofetil.
Kombinacija norfloksacina in metronidazola pa zmanjša izpostavljenost mikofenolni kislini za približno 30% po enkratnem odmerku mofetilmikofenolata.
5 Tacrolimus: in liver transplant recipients initiated on mycophenolate mofetil and tacrolimus, the AUC and C max of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by trough tacrolimus level.
5 dajanja takrolimusa ni bila pomembna.
In renal transplant patients, the tacrolimus concentration did not appear to be altered by mycophenolate mofetil.
Pri bolnikih z ledvičnim presadkom mofetilmikofenolat ni spremenil koncentracije takrolimusa.
However, in hepatic transplant patients, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g taken twice a day [BID], morning and evening]) were administered to patients taking tacrolimus (see also section 4.4).
(glejte tudi poglavje 4. 4).
Other interactions: co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold. 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 druge učinkovine, za katere je znano, da so podvržene renalni tubularni sekreciji, lahko tekmujejo z mikofenolglukuronidom in tako zvišajo koncentracije mikofenolglukuronida v plazmi ali drugih učinkovin, podvrženih renalni tubularni sekreciji.
It is recommended that Mycophenolate mofetil Teva therapy should not be initiated until a negative pregnancy test has been obtained.
Pred začetkom zdravljenja z zdravilom Mofetilmikofenolat Teva je treba izključiti nosečnost.
Effective contraception must be used before beginning mycophenolate mofetil therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5). Patients should be instructed to consult their physician immediately should pregnancy occur.
Bolnicam svetujemo, naj v primeru zanositve takoj obvestijo svojega zdravnika.
The use of Mycophenolate mofetil Teva is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
Uporaba zdravila Mofetilmikofenolat Teva med nosečnostjo ni priporočljiva, rezervirana je za primere, ko ustreznega nadomestnega zdravljenja ni na voljo.
Mycophenolate mofetil Teva should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus.
Zdravilo Mofetilmikofenolat Teva dajemo nosečnicam le v primeru, kadar pričakovana korist za mater prevlada nad tveganjem za plod.
There is limited data from the use of mycophenolate mofetil in pregnant women.
Ustreznih podatkov o uporabi zdravila mofetilmikofenolata pri nosečnicah ni.
However, congenital malformations including ear malformations, i. e. abnormally formed or absent external/ middle ear have been reported in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy.
Pri otrocih bolnic, ki so se v času nosečnosti zdravile z mofetilmikofenolatom v kombinaciji z drugimi imunosupresivi, so poročali o kongenitalnih malformacijah, vključno z malformacijo ušesa, to je nenormalno oblikovanim ali manjkajočim zunanjim/ srednjim ušesom.
Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil.
Pri bolnicah, ki so se zdravile z mofetilmikofenolatom, so poročali o primerih spontanih splavov.
Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Mycophenolate mofetil Teva is contraindicated in breast-feeding mothers (see section 4.3).
Zaradi možnih resnih škodljivih vplivov mofetilmikofenolata na dojenčke, je zdravilo Mofetilmikofenolat Teva pri doječih materah kontraindicirano (glejte poglavje 4. 3).
The pharmacodynamics profile and the reported adverse reactions indicate that an effect is unlikely.
Farmakodinamični profil in neželeni učinki, o katerih so poročali, kažejo na to, da vpliv ni verjeten.
The principal adverse reactions associated with the administration of mycophenolate 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).
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).
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.4).
Bolniki, ki prejemajo imunosupresivna zdravila, obsegajoč kombinacije zdravil, vključno z mofetilmikofenolatom, imajo zvečano tveganje nastanka limfomov in drugih malignih sprememb, zlasti kožnih (glejte poglavje 4. 4).
Lymphoproliferative disease or lymphoma developed in 0.6% of patients receiving mycophenolate (2 g or 3 g daily) in combination with other immunosuppressants 6 in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year.
Pri 3, 6%
Non-melanoma skin carcinomas occurred in 3.6% of patients; other types of malignancy occurred in 1.1% of patients.
6 bolnikov so opazili nemelanomski kožni rak, druge vrste malignosti pa so se pojavile pri 1, 1% bolnikov.
The most common opportunistic infections in patients receiving mycophenolate (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, cytomegalovirus (CMV) viraemia/ syndrome and Herpes simplex.
Najpogostejše oportunistične okužbe pri bolnikih z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, ki so v nadziranih 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.
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who where given 600 mg/ m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g mycophenolate twice daily.
Vrsta in pogostnost neželenih učinkov v kliničnih študijah, ki so zajele 92 otrok in mladostnikov, starih od 2 do 18 let, ki so prejemali 600 mg/ m2 mofetilmikofenolata peroralno dvakrat na dan, sta bila podobna neželenim učinkom, opaženim pri odraslih bolnikih, ki so prejemali 1 g mofetilmikofenolata dvakrat na dan.
Elderly patients ( 65 years):
Starejši bolniki (stari 65 let ali več):
Adverse reactions, probably or possibly related to mycophenolate, reported in of patients treated with mycophenolate 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 bolnikih, zdravljenih z mofetilmikofenolatom v nadziranih kliničnih preskušanjih bolnikov z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, so našteti v spodnji preglednici.
Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common ( 1/ 10); common ( 1/ 100 to < 1/ 10); uncommon ( 1/ 1,000 to < 1/ 100); rare ( 1/ 10,000 to < 1/ 1,000); very rare ( 1/ 10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
7 Adverse reactions, probably or possibly related to Mycophenolate, reported in patients treated with Mycophenolate in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
7 Neželeni učinki, verjetno ali možno povezani z mofetilmikofenolatom, ki so se pojavili pri bolnikih zdravljenih z mofetilmikofenolatom v kombinaciji s ciklosporinom in kortikosteroidi pri kliničnih preskušanjih bolnikov z ledvičnim, srčnim ali jetrnim presadkom.
Frequency
Neželeni
Adverse drug reactions
učinki
Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea
zvišani jetrni encimi, zvišan kreatinin v krvi, zvišana laktat - dehidrogenaza v krvi, zvišana sečnina v krvi, zvišana alkalna fosfataza v krvi, zmanjšana telesna masa
Leukopenia, thrombocytopenia, anaemia Pancytopenia, leukocytosis
levkopenija, trombocitopenija, anemija
disorders
pancitopenija, levkocitoza
Respiratory,
Bolezni živčevja
Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis,
konvulzije, hipertonija, tremor, somnolenca, miastenijski sindrom, omotica, glavobol, parestezija, sprememba okusa
stomatitis, constipation, dyspepsia, flatulence, eructation
Bolezni dihal, prsnega koša in mediastinalnega prostora
Renal impairment
plevralni izliv, dispneja, kašelj
subcutaneous tissue disorders
bruhanje, bolečina v trebuhu, diareja, navzea
Skin hypertrophy, rash, acne, alopecia
krvavitev v prebavilih, peritonitis, ileus, kolitis, ulkus na želodcu, ulkus na dvanajstniku, gastritis, ezofagitis, stomatitis, zaprtje, dispepsija, flatulenca, kolcanje
Musculoskeletal
Bolezni sečil
Arthralgia
ledvična okvara
8
8 Organski sistem
System organ class
Neželeni učinki
Frequency
Bolezni kože in podkožja
Adverse drug reactions
zelo pogosti
Metabolism
pogosti
and nutrition
artralgija
Common
zelo pogosti
hypomagnesaemia, hypocalcaemia, hypercholesterolaemia,
acidoza, hiperkaliemija, hipokaliemija, hiperglikemija,
hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
hipomagnezemija, hipokalciemija, hiperholesterolemija, hiperlipidemija, hipofosfatemija, hiperurikemija, protin, anoreksija
Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
moniliaza, gastrointestinalna okužba, kandidoza, gastroenteritis, okužba, bronhitis, faringitis, sinuzitis, glivična okužba kože, kandidoza kože, vaginalna kandidoza, rinitis
Neoplasms
Benigne in maligne
benign,
neoplazme (vključno s cistami in polipi)
neoplasm of skin
kožni rak, benigna neoplazma kože
disorders and
spremembe na mestu aplikacije
administration site conditions
Bolezni jeter, žolčnika in
disorders Psychiatric
žolčevodov
Common Very common
pogosti
Hepatitis, jaundice,
hepatitis, zlatenica, hiperbilirubinemija
hyperbilirubinaemia -
Psihiatrične motnje
disorders
zelo pogosti
501 (2 g mycophenolate daily), 289 (3 g mycophenolate daily) and 277 (2 g intravenous / 3 g oral mycophenolate daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
V III. fazi študij preprečevanja zavrnitve ledvičnega, srčnega in jetrnega presadka so vključili 501 (2 g mofetilmikofenolata na dan), 289 (3 g mofetilmikofenolata na dan) in 277 (2 g i. v. / 3 g peroralne oblike mofetilmikofenolata na dan) bolnikov.
The following undesirable effects cover adverse reactions from post-marketing experience: the types of adverse reactions reported during post-marketing with mycophenolate are similar to those seen in the controlled renal, cardiac and hepatic transplant studies.
Neželeni učinki, ki so se pojavili v postmarketinških raziskavah zdravljenja z mofetilmikofenolatom, so podobni neželenim učinkom v nadzorovanih raziskavah bolnikov z ledvičnim, srčnim in jetrnim presadkom.
Gastrointestinal: colitis including cytomegalovirus colitis, (common), pancreatitis, (common) and intestinal villous atrophy.
9 Prebavila: kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (pogosti), pancreatitis (pogosti) in atrofija črevesne sluznice.
Agranulocytosis (uncommon) and neutropenia have been reported; therefore regular monitoring of patients taking Mycophenolate mofetil Teva is advised (see section 4.4). There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate, some of which have been fatal.
Pri bolnikih, ki so se zdravili z mofetilmikofenolatom, so poročali o primerih aplastične anemije in depresije kostnega mozga, nekateri od teh so bili smrtni.