natgillin/translations-raw huggingface dataset:
Endoscopic investigation of patients with CellCept-related diarrhea have revealed isolated cases of intestinal villous atrophy (see section 4.4). 
Endoskopske pretrage provedene u bolesnika s proljevom povezanim s lijekom CellCept ukazale su na izolirane slučajeve atrofije crijevnih resica (vidjeti dio 4.4).
• The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications. 
• Prvu dozu lijeka CellCept za primjenu kroz usta primit ćete najmanje 4 dana nakon presađivanja, kad budete mogli gutati lijekove koji se primjenjuju kroz usta.
(MedDRA) 
Nuspojava (MedDRA)
Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate. 
• Savjet o tome da bolesnici ne smiju darivati krv tijekom liječenja ili najmanje 6 tjedana nakon prekida primjene mikofenolata.
CellCept 500 mg powder for concentrate for solution for infusion must be given as an intravenous (IV) infusion. 
CellCept 500 mg prašak za koncentrat za otopinu za infuziju mora se primjenjivati u obliku intravenske (IV) infuzije.
Shake well before use Read the package leaflet before use 
Prije uporabe dobro protresti Prije uporabe pročitajte uputu o lijeku
The types of adverse reactions reported during post-marketing with CellCept are similar to those seen in the controlled renal, cardiac and hepatic transplant studies. 
Vrste nuspojava prijavljenih nakon stavljanja lijeka CellCept u promet slične su onima opaženima u kontroliranim ispitivanjima primjene nakon presađivanja bubrega, srca i jetre.
The recommended dose is 600 mg/ m² taken twice a day. 
Preporučena doza je 600 mg/m2 i uzima se dvaput dnevno.
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. 
Ti su se učinci pojavili pri razinama sistemske izloženosti ekvivalentnim ili manjim od kliničke izloženosti pri preporučenoj dozi od 2 g/dan.
It is recommended that CellCept 1 g/5 ml powder for oral suspension be reconstituted by the pharmacist prior to dispensing to the patient. 
Preporučuje se da prašak za pripremu oralne suspenzije CellCept 1 g/5 ml pripremi ljekarnik prije izdavanja bolesnicima.
Musculoskeletal pain such as myalgia, and neck and back pain were also very commonly reported. 
Osim toga, vrlo je često prijavljena i mišićno-koštana bol, poput mialgije te boli u vratu i leđima.
These include diarrhoea, infections, fewer white cells and fewer red cells in the blood. 
To uključuje proljev, infekcije, smanjenje broja leukocita i eritrocita u krvi.
Female patients of reproductive potential must be made aware of the increased risk of pregnancy loss and congenital malformations at the beginning of the treatment and must be counseled regarding pregnancy prevention and planning. 
Žene reproduktivne dobi mora se na početku liječenja upozoriti na povećan rizik od gubitka ploda i kongenitalnih malformacija te ih se mora savjetovati o sprječavanju i planiranju trudnoće.
The mean single dose MPAG AUC was 3 - 6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG. 
Srednja vrijednost AUC MPAG-a jedne doze bila je 3-6 puta veća kod ispitanika s teškim oštećenjem bubrežne funkcije nego kod ispitanika s blagim oštećenjem bubrežne funkcije ili normalnih zdravih ispitanika u skladu s poznatom bubrežnom eliminacijom MPAG-a.
Do not take CellCept if you are breast-feeding. 
Nemojte uzimati CellCept ako dojite.
Keep the blister in the outer carton in order to protect from light. 
Čuvati blister u vanjskom pakiranju radi zaštite od svjetlosti.
Take off the child safety bottle cap and push the bottle adapter into the neck of the bottle. 
Uklonite sigurnosni zatvarač za djecu te plastični nastavak za bocu gurnite u vrat boce.
For instruction on reconstitution of the medicinal product before administration, see section 6.6. 
Za uputu o rekonstituciji lijeka prije primjene vidjeti dio 6.6.
Turn the whole thing back round the right way. 
7. Sve zajedno preokrenite u normalan položaj
If any of the above apply to you (or you are not sure), talk to your doctor or nurse straight away starting treatment with CellCept. 
Ako se bilo što od gore navedenog odnosi na Vas (ili niste sigurni), odmah razgovarajte sa svojim liječnikom ili medicinskom sestrom prije nego što započnete liječenje lijekom CellCept.
20 mL type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off caps. 
Staklene bočice (bezbojno staklo tipa I) od 20 ml, sa sivim gumenim čepom (butil guma), aluminijskim prstenom i plastičnim „flip-off“ zatvaračem.
Table 1 Summary of adverse drug reactions occurring in patients treated with CellCept reported from clinical trials and post marketing experience Adverse drug reaction (MedDRA) 
Tablica 1 Sažetak nuspojava lijeka koje su se javile u bolesnika liječenih lijekom CellCept u kliničkim ispitivanjima i nakon stavljanja lijeka u promet Nuspojava (MedDRA)
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. 
U bolesnica izloženih mofetilmikofenolatu prijavljeni su slučajevi spontanog pobačaja, prvenstveno u prvom tromjesečju trudnoće (vidjeti dio 4.6).
The full name of your medicine is CellCept 1 g/5 ml powder for oral suspension. 
Puno ime Vašeg lijeka je CellCept 1g/5 ml prašak za oralnu suspenziju.
Hypophosphatemia 
Hipofosfatemija
If you have ever had a problem with your digestive system such as a stomach ulcer If you have a rare problem with your metabolism called “phenylketonuria” which runs in families 
• ako imate rijedak nasljedni poremećaj metabolizma koji se zove „fenilketonurija“
1 carton contains 100 capsules (in blister packs of 10) 1 carton contains 300 capsules (in blister packs of 10) 
1 kutija sadrži 100 kapsula (u blister pakiranjima od 10 kapsula)
• Reconstituted suspension: do not store above 30°C. 
• Pripremljena suspenzija: ne čuvati na temperaturi iznad 30°C.
Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy. 
Nakon izlaganja mofetilmikofenolatu tijekom trudnoće prijavljeni su spontani pobačaj (stopa od 45% do 49%) i kongenitalne malformacije (procijenjena stopa od 23% do 27%).
• Do not use after the expiry date stated on the carton and bottle label (EXP). 
• Lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji (Rok valjanosti) i naljepnici bočice (EXP).
Reconstitute the content of each vial by injecting 14 mL of glucose intravenous infusion 5%. 
Sadržaj svake bočice rekonstituirajte ubrizgavanjem 14 ml otopine 5%-tne glukoze za intravensku infuziju.
Powder for oral suspension and reconstituted suspension: Do not store above 30 °C. 
Prašak za oralnu suspenziju i pripremljena suspenzija: Ne čuvati na temperaturi iznad 30°C.
• CellCept tablets: microcrystalline cellulose, polyvidone (K-90), croscarmellose sodium, 
• CellCept tablete: celuloza, mikrokristalična, polividon (K-90), karmelozanatrij, umrežen,
• fluid on the lungs or inside the chest, 
• tekućina u plućnoj ili prsnoj šupljini
Gastrointestinal disorders Abdominal distension 
Poremećaji probavnog sustava Distenzija abdomena
QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna boca sadrži 35 g mofetilmikofenolat u 110 g praška za oralnu suspenziju.
Isavuconazole 
Izavukonazol
When reconstituted, the volume of the suspension is 175 mL, providing a usable volume of 160 - 165 mL. 
Nakon rekonstitucije, količina suspenzije iznosi 175 ml, što daje iskoristivu količinu od 160 - 165 ml. 5 ml rekonstituirane suspenzije sadrži 1 g mofetilmikofenolata.
Patients with a body surface area greater than 1.5 m2 may be prescribed CellCept capsules at a dose of 1 g twice daily (2 g daily dose). 
Bolesnicima tjelesne površine veće od 1,5 m2 mogu se propisivati CellCept kapsule u dozi od 1 g dvaput dnevno (dnevna doza od 2 g).
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid inhalation or direct contact with skin or mucous membranes of the dry powder as well as direct contact of the reconstituted suspension with the skin. 
Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, treba izbjegavati udisanje ili izravan kontakt kože ili sluznica sa suhim praškom, kao i izravan kontakt rekonstituirane otopine s kožom.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
CONTENTS OF THE PACK AND OTHER INFORMATION 
Sadržaj pakiranja i druge informacije
Background information on mycophenolate mofetil teratogenicity and mutagenicity in humans. 
• Pozadinske informacije o teratogenosti i mutagenosti mofetilmikofenolata u ljudi.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity. 
U ispitivanju plodnosti i reprodukcije ženki, provedenom na štakorima, peroralne doze od 4,5 mg/kg/dan uzrokovale su malformacije (uključujući anoftalmiju, agnatiju i hidrocefalus) u prvom naraštaju potomaka, dok toksičnost za majku nije primijećena.
The full name of your medicine is CellCept 500 mg film-coated tablets. 
Puno ime Vašeg lijeka je CellCept 500 mg filmom obložene tablete
The types of adverse reactions reported during post-marketing with CellCept are similar to those seen in the controlled renal and hepatic transplant studies. 
Vrste nuspojava prijavljenih nakon stavljanja lijeka CellCept u promet slične su onima opaženima u kontroliranim ispitivanjima primjene nakon presađivanja bubrega i jetre.
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. 
Najveća doza primijenjena u ispitivanjima karcinogenosti na životinjama rezultirala je 2 - 3 puta većom sistemskom izloženošću (AUC ili Cmax) od primijećene kod bolesnika s presađenim bubregom pri preporučenoj kliničkoj dozi od 2 g/dan.
CellCept 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). 
CellCept tablete smiju se propisivati samo bolesnicima tjelesne površine veće od 1,5 m2 u dozi od 1 g dvaput dnevno (dnevna doza od 2 g).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOČICU
CellCept IV solution should never be administered by rapid or bolus intravenous injection. 
CellCept IV otopina ne smije se primjenjivati u obliku brzih injekcija u venu ili u obliku bolusa.
The contents of CellCept 500 mg powder for concentrate for solution for infusion vials must be reconstituted with 14 mL of glucose intravenous infusion 5% each. 
Sadržaj bočica CellCept 500 mg praška za koncentrat za otopinu za infuziju mora se otopiti s 14 ml glukoze 5% za infuziju u venu.
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m2 mycophenolate mofetil orally twice daily. 
Farmakokinetički parametri ocijenjeni su kod 49 pedijatrijskih bolesnika s bubrežnim presatkom (u dobi od 2 do 18 godina) koji su dvaput dnevno peroralno primali 600 mg/m2 mofetilmikofenolata.
The first dose is given within 24 hours of the transplant operation. 
• Prva doza se daje unutar 24 sata nakon presađivanja.
Multipacks containing 150 (3 packs of 50) tablets 
Višestruko pakiranje sadrži 150 tableta (3 pakiranja od 50
Take care not to let the made-up medicine get onto your skin. 
Pazite da pripremljen lijek ne dođe u kontakt s Vašom kožom.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see section 4.4). 
Pure Red Cell Aplasia, PRCA) kod bolesnika liječenih lijekom CellCept (vidjeti dio 4.4).
Renal and urinary disorders Blood creatinine increased 
Poremećaji bubrega i mokraćnog sustava Povišena razina kreatinina u krvi
METHOD OF ADMINISTRATION For intravenous infusion only Read the package leaflet before use 
NAČIN PRIMJENE LIJEKA Samo za infuziju u venu Prije uporabe pročitajte uputu o lijeku
If you have a rare problem with your metabolism called “phenylketonuria”, talk to your doctor before you start taking this medicine. 
„fenilketonurija“, obratite se svome liječniku prije nego uzmete ovaj lijek.
CellCept 500 mg powder for concentrate for solution for infusion is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal or hepatic transplants. 
CellCept 500 mg prašak za koncentrat za otopinu za infuziju indiciran je u kombinaciji s ciklosporinom i kortikosteroidima za profilaksu akutnog odbacivanja presatka kod bolesnika koji primaju alogene bubrežne ili jetrene presatke.
• CellCept should not be given to women who are breastfeeding (see section 4.6). 
• CellCept se ne smije davati dojiljama (vidjeti dio 4.6).
OTHER SPECIAL WARNING(S), IF NECESSARY Do not breathe the powder before constitution or allow it to touch your skin Avoid skin contact with the reconstituted suspension 
Ne udišite prašak prije pripreme i ne dozvolite doticaj praška s kožom Izbjegavajte doticaj kože s pripremljenom suspenzijom
Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to CellCept in combination with other immunosuppressants during pregnancy. 
Nakon stavljanja lijeka u promet prijavljene su kongenitalne malformacije, uključujući višestruke malformacije, kod djece bolesnica koje su bile izložene lijeku CellCept u kombinaciji s drugim imunosupresivima tijekom trudnoće.
CellCept should be used together with other medicines: Ciclosporin and corticosteroids. 
CellCept se mora koristiti zajedno s drugim lijekovima:
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 4.8). 
Bolesnici koji primaju imunosupresivnu terapiju koja obuhvaća kombinaciju lijekova, uključujući CellCept, izloženi su povećanom riziku od nastajanja limfoma i drugih zloćudnih bolesti, osobito kože (vidjeti dio 4.8).
diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence. 
• proljev, zatvor, mučnina, loša probava, gubitak apetita, vjetrovi
CellCept 500 mg powder for concentrate for solution for infusion is available in packs containing 4 vials. 
CellCept 500 mg prašak za koncentrat za otopinu za infuziju dostupan je u pakiranjima od 4 bočice.
• 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. 
• ako ste žena koja bi mogla zatrudnjeti, a niste predočili negativan nalaz testa na trudnoću prije nego što
In patients with delayed renal graft function post-transplant, mean MPA AUC0-12h was comparable to that seen in post-transplant patients without delayed graft function. 
Kod bolesnika kod kojih nakon presađivanja dolazi do odgođene funkcije presađenog bubrega srednja vrijednost AUC0-12 sati MPA mogla se usporediti s AUC-om MPA bolesnika kod kojih nakon presađivanja nije došlo do odgođene funkcije presađenog bubrega.
Tablet coating hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132) red iron oxide (E172) 
Ovojnica tablete hipromeloza hidroksipropilceluloza titanijev dioksid (E171) polietilenglikol 400 indigo carmine aluminium lake (E132) željezov oksid, crveni (E172)
Then shake the closed bottle well for about another minute. 
• Snažno tresite zatvorenu bočicu još 1 minutu.
Contents of the pack and other information 
SADRŽAJ PAKIRANJA I OSTALE INFORMACIJE
Any unused product or waste material should be disposed of in accordance with local requirements. 
Neiskorišten lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
Paediatric population 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). 
Preporučena doza praška za oralnu suspenziju CellCept 1 g/5 ml iznosi 600 mg/m2 dvaput dnevno (do najviše 2 g/10 ml oralne suspenzije dnevno).
Capsule shells gelatin indigo carmine (E132) yellow iron oxide (E172) red iron oxide (E172) titanium dioxide (E171) black iron oxide (E172) potassium hydroxide shellac. 
Ovojnica kapsula želatina indigo karmin (E132) željezov oksid, žuti (E172) željezov oksid, crveni (E172) titanijev dioksid (E171) željezov oksid, crni (E172) kalijev hidroksid šelak.
• CellCept should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6). 
• CellCept se ne smije koristiti u trudnoći, osim ako ne postoji prikladno alternativno liječenje kojim bi se spriječilo odbacivanje presatka (vidjeti dio 4.6).
CellCept capsules pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate 
CellCept kapsule kukuruzni škrob, prethodno geliran karmelozanatrij, umrežena polividon (K-90) magnezijev stearat
Package leaflet: Information for the user CellCept 1 g/5 ml powder for oral suspension (mycophenolate mofetil) 
Uputa o lijeku: Informacije za korisnika CellCept 1 g/5 ml prašak za oralnu suspenziju (mofetilmikofenolat)
Do not use cloths or wipes for drying. 
Dozator nemojte brisati krpom ili maramicom.
• Do not use the capsules after the expiry date stated on the carton (EXP). 
• Kapsule se ne smiju upotrijebiti nakon isteka roka valjanosti navedenog na kutiji (Rok valjanosti).
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/006 CellCept (1 bottle 110g) 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/006 CellCept (1 bočica 110 g)
The full name of your medicine is CellCept 500 mg powder for concentrate for solution for infusion. 
Puno ime Vašeg lijeka je CellCept 500 mg prašak za koncentrat za otopinu za infuziju.
Oral CellCept should be initiated within 5 days following transplantation. 
CellCept u oralnom obliku mora se primijeniti unutar 5 dana nakon presađivanja.
CellCept 500 mg powder for concentrate for solution for infusion 
CellCept 500 mg prašak za koncentrat za otopinu za infuziju
The pharmacokinetics of oral contraceptives were unaffected by co-administration of CellCept (see also section 4.5). 
Istodobna primjena lijeka CellCept nije utjecala na farmakokinetiku oralnih kontraceptiva (vidjeti i dio 4.5).
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. 
Vrijednosti AUC MPA primijećene nakon primjene intravenskog lijeka CellCept u dozi od 1 g dvaput dnevno kod bolesnika s presađenim bubregom u ranom razdoblju nakon presađivanja mogu se usporediti s onima primijećenima nakon primjene oralnog lijeka CellCept u dozi od 1 g dvaput dnevno.
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 co-administration with tacrolimus. 
Kod bolesnika s presađenom jetrom kod kojih je započeto liječenje lijekom CellCept i takrolimusom, istodobna primjena takrolimusa nije značajno utjecala na AUC i Cmax aktivnog metabolita lijeka CellCept, MPA.
• The shelf-life of the reconstituted suspension is two months. 
• Rok valjanosti pripremljene suspenzije je dva mjeseca.
The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose), i.e. 5 mL oral suspension twice daily. 
Preporučena doza za bolesnike s presađenim bubregom iznosi 1 g dvaput dnevno (dnevna doza od 2 g), tj. 5 ml oralne suspenzije dvaput dnevno.
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). 
Bolesnici koji primaju imunosupresivnu terapiju koja obuhvaća kombinaciju lijekova, uz ostalo i CellCept, izloženi su povećanom riziku od nastajanja limfoma i drugih zloćudnih bolesti, osobito kože (vidjeti dio 4.4).
Then put the tip of the dispenser firmly into the opening of the bottle adapter. 
Čvrsto umetnite vrh dozatora u otvor plastičnog nastavka za bocu.
Oral CellCept should be initiated within 72 hours following transplantation. 
Odrasli CellCept kapsule moraju se uzeti unutar 72 sata nakon presađivanja.
The systemic exposure at this dose represents 2 - 3 times the clinical exposure at the recommended clinical dose of 2 g/day. 
Sistemska izloženost pri tim dozama je 2 - 3 puta veća od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan.
1 bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension. 
1 boca sadrži 35 g mofetilmikofenolata u 110 g praška za oralnu suspenziju.
CellCept 250 mg capsules 
CellCept 250 mg kapsule
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. 
Starije osobe koje primaju CellCept kao dio kombiniranog imunosupresivnog liječenja mogu u odnosu na mlađe pojedince biti izložene povećanom riziku od određenih infekcija (uključujući invazivnu citomegalovirusnu bolest tkiva), a vjerojatno i gastrointestinalnih krvarenja te plućnog edema.
Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1 
Emil-Barell-Strasse 1
The systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day. 
Sistemska izloženost pri ovoj dozi iznosila je otprilike 0,5 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan.
Mean plasma MPAG AUC0-12h was 2 - 3-fold higher than in post-transplant patients without delayed graft function. 
Srednja vrijednost AUC0-12 h MPAG-a u plazmi bila je 2-3 puta veća nego kod bolesnika kod kojih nakon presađivanja nije došlo do odgođene funkcije presatka.
Manufacturing Authorisation holder responsible for batch release: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany. 
Proizvođač odgovoran za puštanje serije lijeka u promet: Roche Pharma AG, Emil-Barell-Str.
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. 
Najveća doza primijenjena u ispitivanjima karcinogenosti na životinjama rezultirala je 2 - 3 puta većom sistemskom izloženošću (AUC ili Cmax) od primijećene kod bolesnika s presađenim bubregom pri preporučenoj kliničkoj dozi od 2 g/dan te 1,3 - 2 puta većom sistemskom izloženošću (AUC ili Cmax) od primijećene kod bolesnika s presađenim srcem pri preporučenoj kliničkoj dozi od 3 g/dan.
It is recommended that the suspension be reconstituted by the pharmacist prior to dispensing to the patient 
Preporučuje se da ljekarnik pripremi CellCept oralnu suspenziju neposredno prije izdavanja bolesniku