natgillin/translations-raw huggingface dataset:
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Zdravniki naj pomislijo nanju pri ugotavljanju diagnoze pri imunosuprimiranih bolnikih, pri katerih se slabša delovanje ledvic ali so prisotni nevrološki simptomi.
3 Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept itself, concomitant medications, viral infections, or some combination of these causes.
3 Bolnike, ki prejemajo zdravilo CellCept, je treba skrbno nadzorovati zaradi nevtropenije, ki je lahko posledica jemanja zdravila CellCept, sočasno uporabljenih zdravil, virusnih okužb ali nekaterih kombinacij teh vzrokov.
If neutropenia develops 3 (absolute neutrophil count < 1.3 x 10 / µl), it may be appropriate to interrupt or discontinue CellCept.
Če se pojavi nevtropenija (absolutno število nevtrofilcev < 1, 3 x 103/ μl), moramo odmerke zdravila CellCept zmanjšati ali zdravljenje prekiniti.
Patients should be advised that during treatment with CellCept, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Bolnike, ki prejemajo zdravilo CellCept, moramo opozoriti, da so lahko cepiva manj učinkovita, uporabi živih cepiv pa se morajo izogibati (glejte poglavje 4. 5).
Because CellCept has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, CellCept should be administered with caution in patients with active serious digestive system disease.
Bolnikom s hujšimi boleznimi prebavil v aktivnih fazah zato dajemo zdravilo CellCept zelo previdno in pod skrbnim zdravniškim nadzorom.
CellCept is an IMPDH (inosine monophosphate dehydrogenase) inhibitor.
Zdravilo CellCept 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 CellCept ne dajemo bolnikom z redkim dednim pomanjkanjem hipoksantin- gvanin - fosforibozil- transferaze (HGPRT), kot sta Lesch- Nyhlanov in Kelley- Seegmillerjev sindrom.
In view of the significant reduction in the AUC of MPA by cholestyramine, caution should be used in the concomitant administration of CellCept with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of CellCept.
Ker holestiramin značilno zmanjša AUC mikofenolne kisline, dajemo zdravilo CellCept previdno bolnikom, ki sočasno jemljejo druga zdravila, ki vplivajo na enterohepatični obtok zaradi možnosti zmanjšanja učinkovitosti zdravila CellCept.
The risk: benefit 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 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 aciklovirja v plazmi v primerjavi s samostojnim jemanjem aciklovirja.
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 (fenolnega glukuronida mikofenolne kisline) (ki ga je bilo za 8% več) so bile minimalne in jih ne smatramo za klinično pomembne.
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.
Antacids with magnesium and aluminium hydroxides: absorption of mycophenolate mofetil was decreased when administered with antacids.
Antacidi z magnezijevimi in aluminijevimi hidroksidi: absorpcija mofetilmikofenolata se ob hkratnem dajanju antacidov zmanjša.
Cholestyramine: following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g 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 CellCept.
Zdravila, ki vplivajo na enterohepatični obtok: pri uporabi zdravil, ki vplivajo na enterohepatični obtok, je potrebna previdnost, saj lahko zmanjšajo učinkovitost zdravila CellCept.
4 Ciclosporin A: ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Ciklosporin A: mofetilmikofenolat ne vpliva na farmakokinetiko ciklosporina A.
In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30% should be expected.
Če pa sočasno zdravljenje s ciklosporinom prekinemo, lahko pričakujemo povečanje AUC mikofenolne kisline za približno 30%.
Ganciclovir: 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 CellCept (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.
4 Ganciklovir: na podlagi rezultatov študije enkratnega odmerjanja priporočenih odmerkov peroralne oblike mofetilmikofenolata in intravenske oblike ganciklovirja in znanih učinkov ledvične okvare na farmakokinetiko zdravila CellCept (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.
In patients with renal impairment in which CellCept 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 CellCept 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 coadministration of CellCept (see also section 5.2).
Peroralni kontraceptivi: sočasno jemanje zdravila CellCept ni vplivalo na farmakokinetiko in farmakodinamiko peroralnih kontraceptivov (glejte tudi poglavje 5. 2).
Rifampicin: in patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Rifampicin: pri bolnikih, ki ne jemljejo tudi ciklosporina, je sočasno dajanje zdravila CellCept in rifampicina povzročilo zmanjšanje izpostavljenosti mikofenolni kislini (AUC0- 12h) za 18 do 70%.
Sirolimus: in renal transplant patients, concomitant administration of CellCept and CsA resulted in reduced MPA exposures by 30-50% compared with patients receiving the combination of sirolimus and similar doses of CellCept (see also section 4.4).
Sirolimus: pri bolnikih z ledvičnim presadkom je sočasno dajanje zdravila CellCept 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 CellCept (glejte tudi poglavje 4. 4).
Sevelamer: decrease in MPA Cmax and AUC0-12 by 30% and 25%, respectively, were observed when CellCept was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
Sevelamer: pri sočasnem dajanju zdravila CellCept in sevelamerja so opazili zmanjšanje Cmax mikofenolne kisline za 30% in AUC0- 12h mikofenolne kisline za 25%, kliničnih posledic (zavrnitve presadka) pa ni bilo.
There is no data on CellCept with phosphate binders other than sevelamer.
Ni podatkov o dajanju zdravila CellCept z drugimi vezalci fosfatov, razen sevelamerjem.
Trimethoprim/ sulfamethoxazole: no effect on the bioavailability of MPA was observed.
Trimetoprim/ sulfametoksazol: vplivov na biološko uporabnost mikofenolne kisline niso opazili.
Norfloxacin and metronidazole: in healthy volunteers, no significant interaction was observed when CellCept was concomitantly administered with norfloxacin and metronidazole separately.
Norfloksacin in metronidazol: pri dajanju zdravila CellCept 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 CellCept.
Kombinacija norfloksacina in metronidazola pa je zmanjšala izpostavljenost mikofenolni kislini za približno 30% po enkratnem odmerku zdravila CellCept.
Tacrolimus: in hepatic transplant patients initiated on CellCept and tacrolimus, the AUC and Cmax of MPA, the active metabolite of CellCept, were not significantly affected by coadministration with tacrolimus.
Takrolimus: pri bolnikih z jetrnim presadkom, pri katerih so uvedli zdravilo CellCept in takrolimus, sprememba AUC in Cmax mikofenolne kisline, aktivnega presnovka zdravila CellCept, zaradi sočasnega dajanja takrolimusa ni bila pomembna.
In, contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of CellCept (1.5 g BID) were administered to patients taking tacrolimus.
Nasprotno, po dajanju večkratnih odmerkov zdravila CellCept (1, 5 g dvakrat na dan) bolnikom, ki so jemali takrolimus, se je AUC takrolimusa povečala za približno 20%.
However, in renal transplant patients, tacrolimus concentration did not appear to be altered by CellCept (see also section 4.4).
Pri bolnikih z ledvičnim presadkom pa zdravilo CellCept ni spremenilo koncentracije takrolimusa (glejte tudi poglavje 4. 4).
Other interactions: co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold.
Druge interakcije: sočasno jemanje probenecida in mofetilmikofenolata je pri opicah povzročilo zvišanje AUC mikofenolglukuronida v plazmi za trikrat.
Live vaccines: live vaccines should not be given to patients with an impaired immune response.
Živa cepiva: živih cepiv ne smemo dajati bolnikom z oslabelim imunskim odzivom.
The antibody response to other vaccines may be diminished (see also section 4.4).
Tudi odziv protiteles na druga cepiva je lahko zmanjšan (glejte tudi poglavje 4. 4).
5 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
It is recommended that CellCept therapy should not be initiated until a negative pregnancy test has been obtained.
Pred začetkom zdravljenja z zdravilom CellCept je treba izključiti nosečnost.
Effective contraception must be used before beginning CellCept therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5).
Pred in med zdravljenjem ter najmanj šest tednov po končani terapiji z zdravilom CellCept, morajo bolnice uporabljati učinkovito kontracepcijo (glejte poglavje 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 CellCept is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
5 Uporaba zdravila CellCept med nosečnostjo ni priporočljiva, rezervirana je za primere, ko ustreznega nadomestnega zdravljenja ni na voljo.
CellCept should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus.
Zdravilo CellCept dajemo nosečnicam le v primeru, kadar pričakovana korist za mater prevlada nad tveganjem za plod.
There is limited data from the use of CellCept in pregnant women.
Na voljo so omejeni podatki o uporabi zdravila CellCept pri nosečnicah.
However, congenital malformations including ear malformations, i. e. abnormally formed or absent external/ middle ear, have been reported in children of patients exposed to CellCept in combination with other immunosuppressants during pregnancy.
Pri otrocih bolnic, ki so se v času nosečnosti zdravile z zdravilom CellCept 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 CellCept.
Pri bolnicah, ki so se zdravile z zdravilom CellCept, so poročali o primerih spontanih splavov.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije pri živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing mothers (see section 4.3).
Zaradi možnih resnih škodljivih vplivov mofetilmikofenolata na dojenčke, je zdravilo CellCept pri doječih materah kontraindicirano (glejte poglavje 4. 3).
The principal adverse reactions associated with the administration of CellCept 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 zdravila CellCept 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).
Malignancies:
Malignosti:
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including CellCept, 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 zdravilom CellCept, 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 CellCept (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 zdravilo CellCept (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.
Non-melanoma skin carcinomas occurred in 3.6% of patients; other types of malignancy occurred in 1.1% of patients.
Pri 3, 6% bolnikov so opazili nemelanomski kožni rak, druge vrste malignosti pa so se pojavile pri 1, 1% bolnikov.
Opportunistic infections:
Oportunistične okužbe:
All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4).
Pri vseh bolnikih s presadki je povečana nevarnost oportunističnih okužb, nevarnost narašča z zvečano stopnjo imunosupresije (glejte poglavje 4. 4).
The most common opportunistic infections in patients receiving CellCept (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 nadziranih kliničnih preskušanjih prejemali zdravilo CellCept (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 proportion of patients with CMV viraemia/ syndrome was 13.5%.
Delež bolnikov s sindromom CMV/ viremijo je znašal 13, 5%.
Children and adolescents (aged 2 to 18 years):
Otroci in mladostniki (stari od 2 do 18 let):
However, the
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 zdravila CellCept dvakrat na dan.
6 following treatment-related adverse events were more frequent in the paediatric population, particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Naslednji neželeni učinki povezani z zdravljenjem pa so bili v primerjavi z odraslimi pogostejši pri otrocih in mladostnikih, zlasti pri otrocih, mlajših od 6 let: driska, sepsa, levkopenija, anemija in okužba.
Elderly patients (≥ 65 years):
Starejši bolniki (stari 65 let ali več):
Elderly patients receiving CellCept as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
6 imunosupresivnega režima, je v primerjavi z mlajšimi tveganje za pojav določenih okužb (vključno s citomegalovirusno tkivno invazivno boleznijo), krvavitev v prebavilih in pljučnega edema lahko večje.
Other adverse reactions:
Drugi neželeni učinki:
Adverse reactions, probably or possibly related to CellCept, reported in ≥ 1/ 10 and in ≥ 1/ 100 to < 1/ 10 of patients treated with CellCept 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 zdravilom CellCept in so se pojavili pri ≥ 1/ 10 in pri ≥ 1/ 100 do < 1/ 10 bolnikov, zdravljenih z zdravilom CellCept 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 form the available data).
Neželeni učinki so znotraj organskih sistemov razvrščeni po pogostnosti v naslednje skupine: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000), z neznano pogostnostjo (iz podatkov, ki so na voljo določitev ni mogoča).
Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster
sepsa, gastrointestinalna kandidoza, okužba urinarnega trakta, herpes simpleks, herpes zoster
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benigne in maligne neoplazme (vključno s cistami in polipi) Bolezni krvi in limfatičnega sistema Presnovne in prehranske motnje
Very common Common
zelo pogosti pogosti zelo pogosti pogosti zelo pogosti pogosti
- Skin cancer, benign neoplasm of skin
Psihiatrične motnje
Blood and lymphatic system disorders Metabolism and nutrition disorders
zelo pogosti pogosti
Very common Common Very common Common
zelo pogosti pogosti
Leucopenia, thrombocytopenia, anaemia Pancytopenia, leucocytosis - Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
- konvulzije, hipertonija, tremor, somnolenca, miastenijski sindrom, omotica, glavobol, parestezija, sprememba okusa
Psychiatric disorders
Srčne bolezni
- Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
- tahikardija
- Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
- hipotenzija, hipertenzija, vazodilatacija
Cardiac disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Bolezni prebavil
Very common
zelo pogosti pogosti zelo pogosti
-
- plevralni izliv, dispneja, kašelj bruhanje, bolečina v trebuhu, diareja, navzea
- Pleural effusion, dyspnoea, cough Vomiting, abdominal pain, diarrhoea, nausea Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
krvavitev v prebavilih, peritonitis, ileus, kolitis, ulkus na želodcu, ulkus na dvanajstniku, gastritis, ezofagitis, stomatitis, zaprtje, dispepsija, flatulenca, kolcanje
Hepatobiliary disorders
Bolezni jeter, žolčnika in žolčevodov Bolezni kože in podkožja
Very common Common
zelo pogosti pogosti zelo pogosti pogosti
- Hepatitis, jaundice, hyperbilirubinaemia
- hepatitis, zlatenica, hiperbilirubinemija - hipertrofija kože, izpuščaj, akne, alopecija
Skin and subcutaneous tissue disorders Musculoskeletal and connective Tissue disorders Renal and urinary disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva Bolezni sečil
Very common Common Very common Common Very common Common
zelo pogosti pogosti zelo pogosti pogosti
- Skin hypertrophy, rash, acne, alopecia, - Arthralgia - Renal impairment
- artralgija - ledvična okvara
- Oedema, pyrexia, chills, pain, malaise, asthenia,
- edem, pireksija, mrzlica, bolečina, občutek neugodja, astenija
- Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased
- zvišani jetrni encimi, zvišan kreatinin v krvi, zvišana laktat- dehidrogenaza v krvi, zvišana sečnina v krvi, zvišana alkalna fosfataza v krvi, zmanjšana telesna masa
501 (2 g CellCept daily), 289 (3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept 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 zdravila CellCept na dan), 289 (3 g zdravila CellCept na dan) in 277 (2 g i. v. / 3 g peroralne oblike zdravila CellCept na dan) bolnikov.
The following undesirable effects cover adverse reactions from post-marketing experience:
Neželeni učinki, opaženi med trženjem zdravila:
Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
V oklepajih je navedena njihova pogostnost, če je znana.
Gastrointestinal: colitis including cytomegalovirus colitis, (≥ 1/ 100 to < 1/ 10), pancreatitis, (≥ 1/ 100 to < 1/ 10) and intestinal villous atrophy.
Prebavila: kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (≥ 1/ 100 do < 1/ 10), pankreatitis (≥ 1/ 100 do < 1/ 10) in atrofija črevesne sluznice.