natgillin/translations-raw huggingface dataset:
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. 
CellCept 1 g/5 ml, prašak za oralnu suspenziju, indiciran je u kombinaciji s ciklosporinom i kortikosteroidima za profilaksu akutnog odbacivanja presatka u primatelja alogenog bubrežnog, srčanog ili jetrenog presatka.
Hepatobiliary disorders Blood alkaline phosphatase increased 
Poremećaji jetre i žuči Povišene vrijednosti alkalne fosfataze u krvi
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. 
Nisu potrebne prilagodbe terapijske doze kod bolesnika s presađenim bubregom i teškom bolešću jetrenog parenhima.
The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to a maximum of 2 g daily). 
Preporučena doza mofetilmikofenolata iznosi 600 mg/m2, primijenjena oralno dvaput dnevno (najviše 2 g dnevno).
CellCept tablets microcrystalline cellulose polyvidone (K-90) croscarmellose sodium magnesium stearate 
CellCept tablete celuloza, mikrokristalična polividon (K-90) karmelozanatrij, umrežena magnezijev stearat
• The first dose is given within 3 days of the transplant operation. 
• Prva doza se daje unutar 3 dana nakon presađivanja.
values similar to those seen in adult renal transplant patients receiving CellCept at a dose of 1 g bid in the early and late post-transplant period. 
Uz tu su dozu postignute vrijednosti AUC-a MPA slične vrijednostima opaženima u odraslih bolesnika s presađenim bubregom koji su primali 1 g lijeka CellCept dvaput dnevno u ranom i kasnom razdoblju nakon presađivanja.
Drugs which interfere with MPA's enterohepatic cycle (e.g. cholesterolamine, antibiotics) should be used with caution due to their potential to reduce the plasma levels and efficacy of CellCept (see also section 4.5). 
Lijekove koji interferiraju s enterohepatičnom cirkulacijom MPA (npr. kolestiramin, antibiotici) treba primjenjivati uz oprez jer mogu sniziti plazmatske razine i djelotvornost lijeka CellCept (vidjeti također dio 4.5).
Hyperkalemia 
Hiperkalijemija
• Powder for oral suspension: do not store above 30°C. 
• Prašak za oralnu suspenziju: ne čuvati na temperaturi iznad 30°C.
Any unused product or waste material should be disposed of in accordance with local requirements 
Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima
Fungal infections 
Gljivične infekcije
CellCept 1 g/5 ml powder for oral suspension contains aspartame. 
Prašak za pripremu oralne suspenzije CellCept 1 g/5 ml sadrži aspartam.
CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. 
CellCept je indiciran u kombinaciji s ciklosporinom i kortikosteroidima za profilaksu akutnog odbacivanja presatka u primatelja alogenog bubrežnog, srčanog ili jetrenog presatka.
These effects occurred at systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended dose of 2 g/day for renal transplant recipients. 
Ti su se učinci pojavili pri razinama sistemske izloženosti ekvivalentnim ili manjim od kliničke izloženosti pri preporučenoj dozi od 2 g/dan za bolesnike s presađenim bubregom.
Convulsion 
Konvulzije
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 250 mg mycophenolate mofetil. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna kapsula sadrži 250 mg mofetilmikofenolata.
This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap. 
Na taj ćete način osigurati ispravan smještaj plastični nastavak za bočicu unutar bočice, kao i zaštitnu funkciju poklopca.
CellCept 500 mg film-coated tablets 
CellCept 500 mg filmom obložene tablete
No data are available for cardiac transplant patients with severe hepatic parenchymal disease. 
Nisu dostupni podaci za bolesnike s presađenim srcem i teškom bolešću jetrenog parenhima.
Vascular disorders Hypertension 
Krvožilni poremećaji Hipertenzija
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains the equivalent of 500 mg mycophenolate mofetil (as hydrochloride salt). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadržava 500 mg mofetilmikofenolata (u obliku mofetilmikofenolatklorida).
The adverse drug reactions (ADRs) from clinical trials and post marketing experience are listed in Table 1, by MedDRA system organ class (SOC) along with their frequencies. 
Tablici 1 navode se nuspojave prijavljene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet prema MedDRA klasifikaciji organskih sustava, zajedno s učestalošću njihova pojavljivanja.
CellCept 250 mg capsules: 
CellCept kapsule 250 mg:
• If you are pregnant or planning to become pregnant or think you may be pregnant 
• ako ste trudni, planirate zatrudnjeti ili mislite da biste mogli biti trudni
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. 
Kod bolesnika s presađenom jetrom primjena intravenskog lijeka CellCept u dozi od 1 g dvaput dnevno, nakon koje je slijedila primjena oralnog lijeka CellCept u dozi od 1,5 g dvaput dnevno, rezultirala je vrijednostima AUC MPA sličnima onima primijećenima kod bolesnika s presađenim bubregom u kojih je primijenjen CellCept od 1 g dvaput dnevno.
How to take CellCept 
Kako uzimati CellCept
No pharmacokinetic data with CellCept for infusion are available for paediatric renal transplant patients. 
Za djecu s presađenim bubregom nisu dostupni farmakokinetički podaci o lijeku CellCept za infuziju.
Hypercholesterolemia 
Hiperkolesterolemija
LIST OF EXCIPIENTS Also contains polysorbate 80, citric acid, hydrochloric acid and sodium chloride. 
POPIS POMOĆNIH TVARI Pomoćne tvari: polisorbat 80, citratna kiselina, kloridna kiselina i natrijev klorid
Hypocalcemia 
Hipokalcijemija
• Each bottle of 110 g powder for oral suspension contains 35 g of mycophenolate mofetil. Reconstitute with 94 mL of purified water. 
• Jedna boca od 110 g praška za oralnu suspenziju sadrži 35 g mofetilmikofenolata.
(mycophenolate mofetil) 
(mofetilmikofenolat)
Powder for concentrate for solution for infusion: Do not store above 30 °C. 
Prašak za koncentrat za otopinu za infuziju: Ne čuvati na temperaturi iznad 30°C.
The first dose is given within 5 days of the transplant operation. 
• Prva doza se daje unutar 5 dana od presađivanja.
Trimethoprim/sulfamethoxazole No effect on the bioavailability of MPA was observed. 
Nije opažen učinak na bioraspoloživost MPA.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) 
Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension. 
NAZIV LIJEKA CellCept 1 g/5 ml prašak za oralnu suspenziju.
Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid direct contact of the dry powder or prepared solutions of CellCept 500 mg powder for concentrate for solution for infusion with skin or mucous membranes. 
Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, treba izbjegavati izravan kontakt suhog praška ili pripremljenih otopina CellCept 500 mg praška za koncentrat za otopinu za infuziju s kožom ili sluznicama.
Uncommon Very Rare 
Hipogamaglobulinemija manje često vrlo rijetko vrlo rijetko
NAME OF THE MEDICINAL PRODUCT CellCept 250 mg capsules mycophenolate mofetil 
NAZIV LIJEKA CellCept 250 mg kapsule mofetilmikofenolat
Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension. 
Jedna boca sadrži 35 g mofetilmikofenolata u 110 g praška za oralnu suspenziju.
5 mL of the reconstituted suspension contains 1 g of mycophenolate mofetil. 
5 ml rekonstituirane suspenzije sadrži 1 g mofetilmikofenolata.
The shelf-life of the reconstituted suspension is 2 months. 
Rok valjanosti pripremljene suspenzije je 2 mjeseca.
Oral administration. 
Peroralna primjena.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA CellCept 500 mg prašak za koncentrat za otopinu za infuziju mofetilmikofenolat
In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of CellCept (1.5 g BID) were administered to hepatic transplant patients taking tacrolimus. 
Nasuprot tome, kod bolesnika s presađenom jetrom koji su uzimali takrolimus, došlo je do povećanja AUC-a takrolimusa za otprilike 20% pri uzimanju višestrukih doza lijeka CellCept (1,5 g dvaput dnevno).
Do not use solvent-containing wipes for cleaning. 
Nemojte ga čistiti maramicama koje sadrže otapala.
Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including CellCept. 
U bolesnika liječenih imunosupresivima, uključujući CellCept, prijavljeni su slučajevi nefropatije povezane s BK virusom, kao i slučajevi progresivne multifokalne leukoencefalopatije (PML) povezane s JC virusom.
Hyperlipidemia 
Hiperlipidemija
Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal, hepatic and cardiac transplant patients. 
Zbog opaženih velikih razlika u učestalosti određenih nuspojava lijeka kod primjene u različitim indikacijama, učestalost je navedena zasebno za bolesnike s bubrežnim, jetrenim odnosno srčanim presatkom.
Note: 991 (2 g / 3 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. 
Napomena: U ispitivanjima faze III 991 bolesnik primao je CellCept u dozi od 2 g / 3 g na dan za sprječavanje odbacivanja bubrežnog presatka, 289 bolesnika primalo je CellCept u dozi od 3 g na dan za sprječavanje odbacivanja srčanog presatka, a 277 bolesnika primalo je CellCept u dozi od 2 g i.v. / 3 g peroralno na dan za sprječavanje odbacivanja jetrenog presatka.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacture(s) responsible for batch release CellCept 500 mg powder for concentrate for solution for infusion CellCept 1 g/5 ml powder for oral suspension: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany. 
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet - CellCept 500 mg prašak za koncentrat za otopinu za infuziju - CellCept 1 g/5 ml prašak za pripremu oralne suspenzije:
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. 
Pri peroralnim dozama do 20 mg/kg/dan, mofetilmikofenolat nije imao učinka na plodnost mužjaka štakora.
Keep the blister in outer carton in order to protect from light 
• Čuvati u vanjskom pakiranju radi zaštite od svjetlosti
Measure 94 mL of purified water in a measuring cylinder. 
Izmjerite 94 ml pročišćene vode u menzuri.
An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole. 
Kod istodobne primjene izavukonazola primijećen je porast AUC0-∞ MPA za 35%.
Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal and hepatic transplant patients. 
Zbog opaženih velikih razlika u učestalosti određenih nuspojava lijeka kod primjene u različitim indikacijama, učestalost je navedena zasebno za bolesnike s bubrežnim presatkom i bolesnike s jetrenim presatkom.
Mouth, esophageal, gastric, duodenal, and intestinal ulcers often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis and colitis were commonly reported during the pivotal clinical trials. 
U pivotalnim su kliničkim ispitivanjima često prijavljeni ulkusi u ustima, jednjaku, želucu, dvanaesniku i crijevima, često praćeni krvarenjem kao komplikacijom, kao i hematemeza, melena te hemoragijski oblici gastritisa i kolitisa.
Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed CellCept capsules at a dose of 750 mg twice daily (1.5 g daily dose). 
CellCept kapsule smiju se propisivati samo bolesnicima tjelesne površine od najmanje 1,25 m2. Bolesnicima tjelesne površine od 1,25 do 1,5 m2 mogu se propisivati CellCept kapsule u dozi od 750 mg dvaput dnevno (dnevna doza od 1,5 g).
There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving CellCept in combination with other immunosuppressants. 
Prijavljeni su slučajevi hipogamaglobulinemije povezani s rekurentnim infekcijama kod bolesnika koji su primali CellCept u kombinaciji s drugim imunosupresivima.
Hypogammaglobulinaemia has been reported in patients receiving CellCept in combination with other immunosuppressants. 
Prijavljena je hipogamaglobulinemija kod bolesnika koji primaju CellCept u kombinaciji s drugim imunosupresivima.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start CellCept: 
Naročito, prije nego što počnete uzimati CellCept, recite svom liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova:
In particular, tell your doctor or nurse if you are taking any of the following medicines before you start CellCept: 
Naročito, prije nego što počnete primati CellCept, recite svom liječniku ili medicinskoj sestri ako uzimate neki od sljedećih lijekova:
The daily dose is 10 mL suspension (2 g of the medicine) taken as 2 separate doses. 
• Dnevna doza je 10 ml suspenzije (2 g lijeka), koja se uzima u 2 odvojene doze.
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey. 
U toksikološkim ispitivanjima provedenima s mofetilmikofenolatom na štakorima, miševima, psima i majmunima bili su primarno pogođeni organi hematopoetskog i limfoidnog sustava.
• The daily dose is 15 mL suspension (3 g of the medicine) taken as 2 separate doses. 
• Dnevna doza je 15 ml suspenzije (3 g lijeka), koja se uzima u 2 odvojene doze.
If you have any further questions on the use of this product, ask your doctor or nurse. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili medicinskoj sestri.
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. 
Intravenski oblik lijeka CellCept mora se primjenjivati prva 4 dana nakon presađivanja jetre, a s primjenom oralnog lijeka CellCept treba započeti čim to dozvoljava bolesnikovo stanje.
Skin problems such as: acne, cold sores, shingles, skin growth, hair loss, rash, itching. 
Probleme s kožom kao što su: akne, groznice, herpes zoster, kožne izrasline, gubitak kose, osip praćen svrbežom
Therefore, a change in the dose of CellCept should not normally be necessary in the absence of clinical evidence of graft dysfunction. 
Stoga, ako nema kliničkih dokaza disfunkcije presatka, promjena doze lijeka CellCept obično nije potrebna.
Therefore, women of childbearing potential must use at least one form of reliable contraception (see section 4.3) before starting CellCept therapy, during therapy, and for six weeks after stopping the therapy, unless abstinence is the chosen method of contraception. 
Stoga žene reproduktivne dobi moraju prije započinjanja liječenja, tijekom liječenja i još šest tjedana nakon prekida liječenja lijekom CellCept koristiti najmanje jedan pouzdan oblika kontracepcije (vidjeti dio 4.3), osim ako je kao metoda kontracepcije odabrana apstinencija.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION CellCept 1 g/5 ml powder for oral suspension mycophenolate mofetil 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA CellCept 1 g/5 ml prašak za oralnu suspenziju mofetilmikofenolat
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressants. 
Prijavljeni su slučajevi izolirane aplazije eritrocita (engl.Pure Red Cell Aplasia, PRCA) kod bolesnika liječenih lijekom CellCept u kombinaciji s drugim imunosupresivima.
Powder for concentrate for solution for infusion: do not store above 30°C. 
• Prašak za koncentrat za otopinu za infuziju: ne čuvati na temperaturi iznad 30°C.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 500 mg mycophenolate mofetil. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 500 mg mofetilmikofenolata.
Ecchymosis 
Ekhimoza
NAME OF THE MEDICINAL PRODUCT CellCept 500 mg powder for concentrate for solution for infusion. 
NAZIV LIJEKA CellCept 500 mg prašak za koncentrat za otopinu za infuziju.
The recommended dose of 1 g administered twice a day for renal or hepatic transplant patients is appropriate for the elderly. 
Preporučena doza od 1 g primijenjena dvaput dnevno prikladna je za starije osobe s presađenim bubregom ili jetrom.
The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses. 
• Dnevna doza je 4 tablete (2 g lijeka), koje se uzimaju u 2 odvojene doze.
The recommended dose of CellCept for infusion in hepatic transplant patients is 1 g administered twice daily (2 g daily dose). 
Preporučena doza infuzije lijeka CellCept za bolesnike s presađenom jetrom iznosi 1 g dvaput dnevno (dnevna doza od 2 g).
No pharmacokinetic data are available during hepatic transplant rejection. 
Farmakokinetički podaci za slučaj odbacivanja presađene jetre nisu dostupni.
Esophagitis 
Ezofagitis
You need to use the dispenser and bottle adapter supplied with the medicine to measure the dose. 
Za odmjeravanje doze morate upotrijebiti dozator i plastični nastavak za bocu.
Reconstituted solution and the diluted solution: store between 15°C and 30°C. 
• Pripremljenu otopinu i razrijeđenu otopinu čuvati na temperaturi od 15 do 30ºC
• tablet coating: hydroxypropyl methycellulose, hydroxypropyl cellulose, titanium dioxide 
• ovojnica tablete: hipromeloza, hidroksipropilceluloza, titanijev dioksid (E171), polietilenglikol
Hyperglycemia 
Hiperglikemija
Blood lactate dehydrogenase increased 
Povišene vrijednosti laktat dehidrogenaze u krvi često manje često
The infusion flow rate should be controlled to equate to a 2-hour period of administration. 
Brzinu infuzije treba namjestiti tako da primjena lijeka traje 2 sata.
Making up the medicine 
Priprema lijeka
There is no information for the use of CellCept in children with a heart transplant. 
• Nema podataka o primjeni lijeka CellCept u djece s presađenim srcem.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOCU
Note: 991 (2 g / 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 and hepatic transplantation, respectively 
Napomena: U ispitivanjima faze III 991 bolesnik primao je CellCept u dozi od 2 g / 3 g na dan za sprječavanje odbacivanja bubrežnog presatka, dok je 277 bolesnika primalo CellCept u dozi od 2 g i.v. / 3 g peroralno na dan za sprječavanje odbacivanja jetrenog presatka.
• Do not mix the medicine with any other liquid when you swallow it. Close the bottle with the child safety bottle cap after each use. 
Bocu zatvorite sigurnosnim zatvaračem za djecu nakon svake uporabe.
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/005 CellCept (4 vials) 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/005 CellCept (4 bočice)
• CellCept capsules: pregelatinised maize starch, croscarmellose sodium, polyvidone (K-90), 
• CellCept kapsule: kukuruzni škrob, prethodno geliran, karmelozanatrij, umrežen, polividon (K90), magnezijev stearat
IV CellCept should continue for the first 4 days following hepatic transplant, with oral CellCept initiated as soon after this as it can be tolerated. 
Tijekom prva 4 dana nakon presađivanja jetre treba nastaviti s intravenskom primjenom lijeka CellCept, a peroralna primjena lijeka CellCept treba započeti čim to dozvoljava bolesnikovo stanje.
NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension mycophenolate mofetil 
CellCept 1 g/5 ml prašak za oralnu suspenziju mofetilmikofenolat
The systemic exposure at this dose represents 2 - 3 times the clinical exposure at the recommended clinical dose of 2 g/day in renal transplant patients and 1.3 - 2 times the clinical exposure at the recommended clinical dose of 3 g/day in cardiac transplant patients. 
Sistemska izloženost pri tim dozama je 2 - 3 puta veća od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan kod bolesnika s presađenim bubregom i 1,3 - 2 puta veća od kliničke izloženosti pri preporučenoj kliničkoj dozi od 3 g/dan kod bolesnika s presađenim srcem.
There have been reports of aplastic anaemia and bone marrow failure in patients treated with CellCept, some of which have been fatal. 
U bolesnika liječenih lijekom CellCept prijavljeni su slučajevi aplastične anemije i zatajivanja koštane srži, od kojih su neki imali smrtni ishod.
METHOD AND ROUTE(S) OF ADMINISTRATION For oral administration 
NAČIN I PUT(EVI) PRIMJENE LIJEKA
Azathioprine was the comparator used in the hepatic and cardiac studies and in two of the renal studies whilst the other renal study was placebocontrolled. 
U ispitivanjima primjene nakon presađivanja jetre i srca i dvama ispitivanjima primjene nakon presađivanja bubrega usporedni je lijek bio azatioprin, dok je treće ispitivanje primjene nakon presađivanja bubrega bilo kontrolirano placebom.
• There is no information for the use of CellCept in children with a liver transplant. 
• Nema podataka o primjeni lijeka CellCept u djece s presađenom jetrom.
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/002 CellCept 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/002 CellCept
The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses. 
• Dnevna doza je 6 tableta (3 g lijeka) koje se uzimaju u 2 odvojene doze.
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/001 CellCept 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/001 CellCept
Edema 
Edem
Do not use the tablets after the expiry date stated on the carton (EXP). 
• Tablete se ne smiju upotrijebiti nakon isteka roka valjanosti navedenog na kutiji (Rok valjanosti).
Two vials of CellCept 500 mg powder for concentrate for solution for infusion are used for preparing each 1 g dose. 
Za pripremu svake doze od 1 g upotrebljavaju se dvije bočice CellCept 500 mg praška za koncentrat za otopinu za infuziju.
CellCept should be administered with caution in patients with active serious digestive system disease. 
Kod bolesnika s aktivnom ozbiljnom bolešću probavnog sustava CellCept se mora primjenjivati s oprezom.
• Capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), red iron oxide (E172), 
• ovojnica kapsule: želatina, boja indigo karmin crvena (E132), željezov oksid, žuti (E172), željezov oksid, crveni (E172), titanijev dioksid (E171), željezov oksid, crni (E172), kalijev hidroksid, šelak
• Cellcept is provided in a 20 mL type I clear glass vial with a grey butyl rubber stopper and aluminium seal with a plastic flip-off cap. 
• CellCept se nalazi u staklenim bočicama od 20 ml bezbojnog stakla tipa
However, in renal transplant patients, tacrolimus concentration did not appear to be altered by CellCept (see also section 4.4). 
Čini se da CellCept nije promijenio koncentraciju takrolimusa kod bolesnika s presađenim bubregom (vidjeti i dio 4.4).
The daily dose is 2 g of the medicine taken as 2 separate doses. 
• Dnevna doza je 2 g lijeka, u dvije odvojene doze.