natgillin/translations-raw huggingface dataset:
Oral contraceptives: the pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of CellCept (see also section 5.2).
16 Peroralni kontraceptivi: sočasno jemanje zdravila CellCept ni vplivalo na farmakokinetiko in farmakodinamiko peroralnih kontraceptivov (glejte tudi poglavje 5. 2).
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%.
The use of CellCept is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
Uporaba zdravila CellCept med nosečnostjo ni priporočljiva, rezervirana je za primere, ko ustreznega nadomestnega zdravljenja ni na voljo.
However, congenital malformations including ear malformations, i. e. abnormally formed or absent external/ middle ear, have been reported in children of patients exposed
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.
Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats.
17 Študije na podganah so pokazale, da se mofetilmikofenolat izloča v mleko podgan v laktaciji.
The adverse reaction profile associated with the administration of CellCept 500 mg powder for concentrate for solution for infusion has been shown to be similar to that observed after oral administration.
Profil neželenih učinkov povezanih z dajanjem zdravila CellCept 500 mg prašek za koncentrat za raztopino za infundiranje je bil podoben tistim, ki so jih opazili pri peroralnem dajanju.
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 nadzorovanih 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.
Data in hepatic transplant patients are based on i. v. dosing of CellCept for up to 14 days followed by oral dosing.
Podatki za bolnike z jetrnim presadkom so vzeti iz preskušanja, kjer so bolniki zdravilo CellCept prejemali intravensko do 14 dni, temu pa je sledilo peroralno odmerjanje.
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) 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) in jetrnim presadkom, so našteti v spodnji preglednici.
18 Adverse Reactions, Probably or Possibly Related to CellCept, Reported in Patients Treated with CellCept in Renal and Hepatic Clinical Trials when Used in Combination with Ciclosporin and Corticosteroids
Neželeni učinki, verjetno ali možno povezani z zdravilom CellCept, ki so se pojavili pri bolnikih zdravljenih z zdravilom CellCept v kombinaciji s ciklosporinom in kortikosteroidi pri kliničnih preskušanjih bolnikov z ledvičnim ali jetrnim presadkom.
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).
18 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).
Blood and lymphatic system disorders Metabolism and nutrition disorders
- kožni rak, benigna neoplazma kože levkopenija, trombocitopenija, anemija pancitopenija, levkocitoza - acidoza, hiperkaliemija, hipokaliemija, hiperglikemija, hipomagnezemija, hipokalciemija, hiperholesterolemija, hiperlipidemija, hipofosfatemija, anoreksija
Very common Common Very common Common
Psihiatrične motnje
Psychiatric disorders
zelo pogosti
- Depression, thinking abnormal, insomnia
depresija, nenormalno mišljenje, nespečnost
- Convulsion, hypertonia, tremor, somnolence, headache, paraesthesia
- konvulzije, hipertonija, tremor, somnolenca, glavobol, parestezija
- Tachycardia
- tahikardija
- Hypotension, hypertension
- hipotenzija, hipertenzija
Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Bolezni prebavil
Very common Common Very common Common
zelo pogosti pogosti zelo pogosti pogosti
- Pleural effusion, dyspnoea, cough Vomiting, abdominal pain, diarrhoea, nausea Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence
- plevralni izliv, dispneja, kašelj bruhanje, bolečina v trebuhu, diareja, navzea krvavitev v prebavilih, peritonitis, ileus, kolitis, ulkus na želodcu, ulkus na dvanajstniku, gastritis, ezofagitis, stomatitis, zaprtje, dispepsija, flatulenca
Hepatobiliary disorders
zelo pogosti pogosti zelo pogosti pogosti
- Hepatitis
artralgija
Skin and subcutaneous tissue disorders Musculoskeletal and connective Tissue disorders Renal and urinary disorders
Bolezni sečil
Very common Common Very common Common Very common
zelo pogosti pogosti
- Rash, acne, alopecia, - Arthralgia -
Splošne težave in spremembe na
Renal impairment
mestu aplikacije
- Oedema, pyrexia, chills, pain, malaise, asthenia,
edem, pireksija, mrzlica, bolečina, občutek neugodja, astenija
- Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased, weight decreased
- zvišani jetrni encimi, zvišan kreatinin v krvi, zvišana laktat- dehidrogenaza v krvi, zvišana alkalna fosfataza v krvi, zmanjšana telesna masa
501 (2 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 and hepatic transplantation, respectively.
V III. fazi študij preprečevanja zavrnitve ledvičnega in jetrnega presadka so vključili 501 (2 g zdravila CellCept na dan) in 277 (2 g i. v. / 3 g peroralne oblike zdravila CellCept na dan) bolnikov.
Adverse reactions attributable to peripheral venous infusion were phlebitis and thrombosis, both observed at 4% in patients treated with CellCept 500 mg powder for concentrate for solution for infusion.
Oboje so opazili pri 4% bolnikov, zdravljenih z zdravilom CellCept 500 mg praškom za koncentrat za raztopino za infundiranje.
Additional adverse reactions reported during post- marketing experience with CellCept 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.
Disorders related to immunosuppression: serious life-threatening infections including meningitis, endocarditis tuberculosis and atypical mycobacterial infection.
Neželeni učinki, povezani z imunosupresijo: resne življenjsko nevarne okužbe vključno z meningitisom, endokarditisom, tuberkulozo in atipičnimi mikobakterijskimi okužbami.
Agranulocytosis (≥ 1/ 1000 to < 1/ 100) and neutropenia have been reported; therefore regular monitoring of patients taking CellCept is advised (see section 4.4).
Poročali so tudi o agranulocitozi (≥ 1/ 1. 000 do ≤ 1/ 100) in nevtropeniji, zato je priporočljivo bolnike, ki jemljejo zdravilo CellCept, redno spremljati (glejte poglavje 4. 4).
20 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.
Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic re- circulation of the drug (see section 5.2).
Adsorbenti žolčnih kislin, kot je holestiramin, lahko odstranijo mikofenolno kislino z zmanjšanjem enterohepatičnega ponovnega obtoka zdravila (glejte poglavje 5. 2).
The parent substance mycophenolate mofetil can be measured systemically during intravenous infusion; however, after oral administration it is below the limit of quantitation (0.4 μ g/ ml).
Po peroralni uporabi pa je njena koncentracija pod mejo merljivosti (0, 4 μg/ ml).
Orally administered radiolabelled mycophenolate mofetil results in complete recovery of the administered dose, with 93% of the administered dose recovered in the urine and 6% recovered in faeces.
Peroralno zaužit in radioaktivno označen mofetilmikofenolat se je skoraj popolnoma izločil, od tega 93% s sečem in 6% z blatom.
MPA AUC values obtained following administration of 1 g BID intravenous CellCept to renal transplant patients in the early post- transplant phase are comparable to those observed following 1 g BID oral CellCept.
AUC vrednosti za mikofenolno kislino, ki so jih pri bolnikih z ledvičnim presadkom opazili pri intravenskem jemanju 1 g zdravila CellCept dvakrat na dan v zgodnjem obdobju po presaditvi, so primerljive z vrednostmi, ki so jih opazili pri jemanju 1 g zdravila CellCept peroralno.
In hepatic transplant patients, administration of 1 g BID intravenous CellCept followed by 1.5 g BID oral CellCept resulted in MPA AUC values similar to those found in renal transplant patients administered 1 g CellCept BID.
Pri bolnikih z jetrnim presadkom so se po 1 g intravenskih odmerkih zdravila CellCept dvakrat na dan, ki so jim sledili 1, 5 g peroralni odmerki zdravila CellCept dvakrat na dan, pojavile vrednosti AUC mikofenolne kisline podobne vrednostim, ki so jih našli pri bolnikih z ledvičnim presadkom, ki so jemali 1 g zdravila CellCept dvakrat na dan.
However, the mean single dose MPAG AUC was 3 – 6 fold higher in subjects with severe 21 renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
To se je ujemalo z znanim izločanjem mikofenolglukuronida skozi ledvice.
Delayed renal graft function:
21 Zapoznelo delovanje ledvičnega presadka:
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.
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.
The systemic exposure at this dose represents 2 – 3 times the clinical exposure at the recommended clinical dose of 2 g/ day.
Sistemska izpostavljenost pri tem odmerku predstavlja 2 - do 3- kratno klinično izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan.
The systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/ day.
Sistemska izpostavljenost pri tem odmerku je bila približno 0, 5- krat večja kot klinična izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan.
The systemic
V študijah teratogenosti pri podganah in kuncih so se pojavile malformacije in resorpcija zarodka pri odmerkih 6 mg• kg- 1• dan- 1 pri podganah (vključno z anoftalmijo, agnatijo in hidrocefalijo) ter pri odmerkih 90 mg• kg- 1• dan- 1 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.
22 exposure at these levels is approximately equivalent to or less than 0.5 times the clinical exposure at the recommended clinical dose of 2 g/ day.
Sistemska izpostavljenost pri tem odmerku je bila približno enaka ali manj kot 0, 5- krat večja kot klinična izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan.
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
22 Organi hematopoetskega in limfatičnega sistema so bili primarni organi, ki so bili prizadeti v toksikoloških študijah mofetilmikofenolata, ki so jih izvajali na podganah, miših, psih in opicah.
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.
Učinki so se pojavili pri sistemski izpostavljenosti, ki je bila enaka ali manjša kot klinična izpostavljenost pri priporočenem odmerjanju 2 g na dan.
CellCept 500 mg powder for concentrate for solution for infusion: polysorbate 80 citric acid hydrochloric acid sodium chloride.
CellCept 500 mg prašek za koncentrat za raztopino za infundiranje: polisorbat 80 citronska kislina klorovodikova kislina natrijev klorid
CellCept 500 mg powder for concentrate for solution for infusion solution should not be mixed or administered concurrently via the same catheter with other intravenous medicinal products or infusion admixtures.
Zdravila CellCept 500 mg praška za koncentrat za raztopino za infundiranje ne smemo mešati z drugimi infuzijskimi raztopinami ali ga dajati sočasno z istim katetrom z drugimi intravenskimi učinkovinami ali zmesmi infuzij.
Powder for concentrate for solution for infusion:
Prašek za koncentrat za raztopino za infundiranje:
If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.
Pripravljena raztopina in raztopina za infundiranje: če raztopine za infundiranje ne pripravite takoj pred dajanjem, mora biti začetek dajanja infuzije v 3 urah po rekonstituciji in razredčitvi zdravila.
Do not store above 30 °C.
Prašek za koncentrat za raztopino za infundiranje: shranjujte pri temperaturi do 30 °C.
Store at 15 – 30°C.
Pripravljena raztopina in raztopina za infundiranje: shranjujte pri temperaturi med 15 °C in 30 °C.
20 ml type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off caps.
20 ml viale iz bistrega stekla tipa I s sivim zamaškom iz butilne gume, hermetično zaprte z aluminijastim pokrovom s plastično zaporko, ki se odstrani.
23 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Preparation of Infusion Solution (6 mg/ ml)
Priprava infuzijske raztopine (6 mg/ ml)
CellCept 500 mg powder for concentrate for solution for infusion must be prepared in two steps: the first step is a reconstitution step with glucose intravenous infusion 5% and the second step is a dilution step with glucose intravenous infusion 5%.
23 Zdravilo CellCept 500 mg prašek za koncentrat za raztopino za infundiranje moramo pripraviti v dveh korakih: prvi korak je rekonstitucija z intravensko infuzijo 5% glukoze, drugi korak pa je razredčitev z intravensko infuzijo 5% glukoze.
Step 1 a.
Korak 1 a.
Reconstitute the content of each vial by injecting 14 ml of glucose intravenous infusion 5%.
Za pripravo 1 g odmerka uporabimo dve viali zdravila CellCept 500 mg praška za koncentrat za raztopino za infundiranje. Vsebino vsake viale raztopimo z injiciranjem 14 ml intravenske infuzije 5% glukoze v vialo.
2 x 15 ml) into 140 ml of glucose intravenous infusion 5%.
Po rekonstituciji vsebino dveh vial razredčite (približno 2 x 15 ml) na 140 ml z intravensko infuzijo 5% glukoze.
The final concentration of the solution is 6 mg/ ml mycophenolate mofetil.
Končna koncentracija mofetilmikofenolata v raztopini je 6 mg/ ml.
Keep solutions at 15 – 30° C.
Raztopine shranjujte pri temperaturi med 15 °C in 30 °C.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid direct contact of prepared solutions of CellCept 500 mg powder for concentrate for solution for infusion with skin or mucous membranes.
Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, se izogibajte neposrednemu stiku pripravljenih raztopin zdravila CellCept 500 mg praška za koncentrat za raztopino za infundiranje s kožo ali sluznicami.
If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Če pride do stika, dobro izperite z milom in vodo, oči pa izperite s čisto vodo.
EU/ 1/ 96/ 005/ 005 CellCept
EU/ 1/ 96/ 005/ 005 CellCept (4 viale)
25 1.
24 25 1.
CellCept 1 g/ 5 ml powder for oral suspension.
CellCept 1 g/ 5 ml prašek za peroralno suspenzijo
Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Vsaka steklenica vsebuje 35 g mofetilmikofenolata v 110 g praška za peroralno suspenzijo.
5 ml of the reconstituted suspension contains 1 g of mycophenolate mofetil.
5 ml pripravljene suspenzije vsebuje 1 g mofetilmikofenolata.
Powder for oral suspension.
Prašek za peroralno suspenzijo
CellCept 1 g/ 5 ml powder for oral suspension is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Zdravilo CellCept 1 g/ 5 ml prašek za peroralno suspenzijo je indicirano skupaj s ciklosporinom in kortikosteroidi za preprečevanje akutnih zavrnitvenih reakcij pri bolnikih z alogenim ledvičnim, srčnim ali jetrnim presadkom.
Adults: oral CellCept 1 g/ 5 ml powder for oral suspension should be initiated within 72 hours following transplantation.
Odrasli: peroralno dajanje zdravila CellCept 1 g/ 5 ml prašek za peroralno suspenzijo je treba uvesti v 72 urah po presaditvi.
5 ml oral suspension twice daily.
Priporočeni odmerek pri bolnikih z ledvičnim presadkom je 1 g dvakrat na dan (dnevni odmerek 2 g), to je 5 ml peroralne suspenzije dvakrat na dan.
Children and adolescents (aged 2 to 18 years): the recommended dose of CellCept 1 g/ 5 ml powder for oral suspension is 600 mg/ m2 administered twice daily (up to a maximum of 2 g/ 10 ml oral suspension daily).
Otroci in mladostniki (stari od 2 do 18 let): priporočeni odmerek zdravila CellCept 1 g/ 5 ml prašek za peroralno suspenzijo je 600 mg/ m2, dvakrat na dan (do največ 2 g/ 10 ml peroralne suspenzije na dan).
26 Use in hepatic transplant:
Uporaba pri presaditvi jeter:
IV CellCept should be administered for the first 4 days following hepatic transplant, with oral CellCept initiated as soon after this as it can be tolerated.
26 Odrasli: prve 4 dni po presaditvi jeter je treba dajati zdravilo CellCept intravensko, takoj ko je bolnik sposoben požirati, pa nadaljujemo s peroralno obliko zdravila CellCept.
(see section 5.2).
Bolnikom, pri katerih se je po operaciji ledvično delovanje presadka vzpostavilo z zakasnitvijo, prilagajanje odmerkov ni potrebno (glejte poglavje 5. 2).
Note If required, CellCept 1 g/ 5 ml powder for oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
Opomba Če je treba, lahko zdravilo CellCept 1 g/ 5 ml prašek za peroralno suspenzijo bolniku damo z nazogastrično sondo z velikostjo najmanj 8 French (najmanj 1, 7 mm notranjega premera).
Among the opportunistic infections are BK virus associated nephropathy and JC virus associated progressive
Oportunistične okužbe vključujejo nefropatijo, povezano z virusom BK in progresivno multifokalno levkoencefalopatijo (PML), povezano z virusom JC.
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.
27 pomislijo nanju pri ugotavljanju diagnoze pri imunosuprimiranih bolnikih, pri katerih se slabša delovanje ledvic ali so prisotni nevrološki simptomi.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/ 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).
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 CellCepta ne dajemo bolnikom z redkim dednim pomanjkanjem hipoksantin- gvanin - fosforibozil- transferaze (HGPRT), kot sta Lesch- Nyhlanov in Kelley- Seegmillerjev sindrom.
CellCept 1 g/ 5 ml powder for oral suspension contains aspartame.
Zdravilo CellCept 1 g/ 5 ml prašek za peroralno suspenzijo vsebuje aspartam.
Therefore, care should be taken if CellCept 1 g/ 5 ml powder for oral suspension is administered to patients with phenylketonuria (see section 6.1)
Pri dajanju zdravila CellCept 1 g/ 5 ml praška za peroralno suspenzijo bolnikom s fenilketonurijo je zato potrebna previdnost (glejte 6. 1).
28 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.
28 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).
Thus, other substances known to undergo renal tubular secretion 29 may compete with MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
29 koncentracije mikofenolglukuronida v plazmi ali drugih učinkovin, podvrženih renalni tubularni sekreciji.
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).
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
Najpogostejše oportunistične okužbe pri bolnikih z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, ki so v nadzorovanih 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.
Children and adolescents (aged 2 to 18 years):
30 Otroci in mladostniki (stari od 2 do 18 let):