FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride.
Croatian: • Drugi sastojci su: polisorbat 80, citratna kiselina, kloridna kiselina, natrijev klorid.
English: The full name of your medicine is CellCept 250 mg capsules.
Croatian: Puno ime Vašeg lijeka je CellCept 250 mg kapsule
English: 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.
Croatian: Budući da se kod oštećenja funkcije bubrega koncentracije MPAG-a u plazmi povećavaju kao i koncentracije aciklovira, moguće je da se mofetilmikofenolat i aciklovir, ili njegovi predlijekovi, npr. valaciklovir, natječu za tubularno izlučivanje pa može doći do dodatnih povećanja koncentracija oba lijeka.
English: CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
Croatian: CellCept 500 mg prašak za koncentrat za otopinu za infuziju ne sadrži antibakterijske konzervanse te se stoga lijek mora rekonstituirati i razrijediti u aseptičnim uvjetima.
English: CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted and further diluted with glucose intravenous infusion 5% prior to administration to the patient (see section 6.6).
Croatian: CellCept 500 mg prašak za koncentrat za otopinu za infuziju mora se pripremiti i prije primjene u bolesnika dodatno razrijediti otopinom 5%-tne glukoze za intravensku infuziju (vidjeti dio 6.6).
English: Therefore, CellCept is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Croatian: Stoga je CellCept kontraindiciran tijekom trudnoće, osim ako ne postoje prikladni alternativni načini liječenja kojima bi se spriječilo odbacivanje presatka.
English: Further dilute the content of the two reconstituted vials (approx. 2 x 15 mL) into 140 mL of glucose intravenous infusion 5%.
Croatian: Dodatno razrijedite otopljeni sadržaj dviju bočica (otprilike 2 x 15 ml) sa 140 ml 5%-tne glukoze za intravensku infuziju.
English: PVC/aluminium foil blister strips
Croatian: Blister trake od PVC/aluminijske folije.
English: Caution should be used with medicinal products that interfere with enterohepatic recirculation because of their potential to reduce the efficacy of CellCept.
Croatian: Za lijekove koji interferiraju s enterohepatičnom recirkulacijom potreban je povećani oprez zbog mogućnosti smanjenja djelotvornosti lijeka CellCept.
English: Caution should be used during concomitant administration because of the potential to reduce efficacy of CellCept.
Croatian: Tijekom istodobne primjene potreban je povećan oprez zbog moguće smanjene djelotvornosti lijeka CellCept.
English: What CellCept is and what it is used for What you need to know before you have CellCept How you have CellCept
Croatian: Što je CellCept i za što se koristi Što morate znati prije nego počnete primati CellCept
English: Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA.
Croatian: Nakon peroralne primjene, mofetilmikofenolat se brzo i ekstenzivno apsorbira i prolazi cjelokupni metabolizam sve do aktivnog metabolita, MPA.
English: Hepatic transplant n = 277
Croatian: Jetreni presadak n = 277
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous infusion only Reconstitute and dilute before use Read the package leaflet before use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za infuziju u venu Prije uporabe pripremiti i razrijediti Prije uporabe pročitajte uputu o lijeku
English: Congenital malformations have been observed post-marketing in children of patients exposed to CellCept in combination with other immunosuppressants, see section 4.6.
Croatian: Nakon stavljanja lijeka u promet primijećene su kongenitalne malformacije u djece bolesnica izloženih lijeku CellCept u kombinaciji s drugim imunosupresivima (vidjeti dio 4.6).
English: Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
Croatian: Veće koncentracije aciklovira u plazmi primijećene su prilikom primjene mofetilmikofenolata s aciklovirom, u odnosu na primjenu aciklovira zasebno.
English: Take 6 capsules in the morning and then 6 capsules in the evening.
Croatian: • Uzmite 6 kapsula ujutro te 6 kapsula navečer.
English: The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of CellCept (see also section 5.2).
Croatian: Farmakokinetika i farmakodinamika oralnih kontraceptiva nije se izmijenila njihovom istodobnom primjenom s lijekom CellCept (vidjeti i dio 5.2).
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CellCept capsules.
Croatian: Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, CellCept kapsule ne smiju se otvarati ni drobiti, kako bi se izbjeglo udisanje ili izravan kontakt kože ili sluznica s praškom sadržanim u CellCept kapsulama.
English: No data are available for treatment of first or refractory rejection in paediatric transplant patients.
Croatian: Nema dostupnih podataka o liječenju prvog ili ponovnog odbacivanja presatka u pedijatrijskih bolesnika.
English: Of these, 991 were included in the three renal studies and 277 were included in one hepatic study.
Croatian: Među njima je 991 bolesnik bio uključen u tri ispitivanja primjene nakon presađivanja bubrega, a 277 bolesnika sudjelovalo je u jednom ispitivanju primjene nakon presađivanja jetre.
English: The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal, cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex.
Croatian: Najčešće oportunističke infekcije koje se pojavljuju kod bolesnika koji primaju CellCept (2 g ili 3 g dnevno) uz druge imunosupresive u kontroliranim kliničkim ispitivanjima u bolesnika s presađenim bubregom, srcem i jetrom, tijekom praćenja od barem godinu dana, bile su mukokutana kandidijaza, citomegalovirusna (CMV) viremija/sindrom i herpes simpleks.
English: During your entire treatment with CellCept
Croatian: • čitavo razdoblje liječenja lijekom CellCept
English: Viral infections
Croatian: Virusne infekcije
English: A bottle adapter and 2 oral dispensers are also provided.
Croatian: Također su priloženi plastični nastavak za bocu i 2 oralna dozatora.
English: Then shake the closed bottle well for about 1 minute.
Croatian: • Snažno tresite zatvorenu bocu približno 1 minutu.
English: Oral CellCept 1 g/5 ml powder for oral suspension should be initiated within 72 hours following transplantation.
Croatian: Prašak za oralnu suspenziju CellCept 1 g/5 ml mora se uzeti unutar 72 sata nakon presađivanja.
English: The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex.
Croatian: Najčešće oportunističke infekcije koje se pojavljuju kod bolesnika koji primaju CellCept (2 g ili 3 g dnevno) uz druge imunosupresive u kontroliranim kliničkim ispitivanjima u bolesnika s presađenim bubregom i jetrom, tijekom praćenja od barem godinu dana, bile su mukokutana kandidijaza, citomegalovirusna (CMV) viremija/sindrom i herpes simpleks.
English: • The other ingredients are sorbitol, colloidal anhydrous silica, sodium citrate, soybean lecithin, mixed fruit flavour, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), citric acid anhydrous.
Croatian: • Drugi sastojci su: sorbitol; silikon, koloidni bezvodni; natrijev citrat; sojin lecitin; okus miješanog voća; ksantanska guma; aspartam* (E951); metilparahidroksibenzoat (E218); citratna kiselina bezvodna *sadrži fenilalanin u vrijednosti 2,78 mg/5 ml suspenzije.
English: • Abnormalities of the ear (e.g. abnormally formed or absent externalear), external auditory canal atresia (middle ear);
Croatian: • abnormalnosti uha (npr. abnormalan oblik ili izostanak vanjskog uha), atrezija vanjskog zvukovoda (srednje uho);
English: • CellCept treatment should not be initiated in women of childbearing potential without providing a pregnancy test result to rule out unintended use in pregnancy (see section 4.6).
Croatian: • Liječenje lijekom CellCept ne smije se započeti kod žena reproduktivne dobi bez predočenja nalaza testa na trudnoću kako bi se isključila mogućnost nehotične primjene u trudnoći (vidjeti dio 4.6)
English: The systemic 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 (see section 4.6).
Croatian: Sistemska izloženost na tim razinama otprilike je ekvivalentna ili manja od 0,5 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan (vidjeti dio 4.6).
English: Endoscopic investigation of patients with CellCept-related diarrhea have revealed isolated cases of intestinal villous atrophy (see section 4.4).
Croatian: Endoskopske pretrage provedene u bolesnika s proljevom povezanim s lijekom CellCept ukazale su na izolirane slučajeve atrofije crijevnih resica (vidjeti dio 4.4).
English: • 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.
Croatian: • 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.
English: (MedDRA)
Croatian: Nuspojava (MedDRA)
English: Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Croatian: • Savjet o tome da bolesnici ne smiju darivati krv tijekom liječenja ili najmanje 6 tjedana nakon prekida primjene mikofenolata.
English: CellCept 500 mg powder for concentrate for solution for infusion must be given as an intravenous (IV) infusion.
Croatian: CellCept 500 mg prašak za koncentrat za otopinu za infuziju mora se primjenjivati u obliku intravenske (IV) infuzije.
English: Shake well before use Read the package leaflet before use
Croatian: Prije uporabe dobro protresti Prije uporabe pročitajte uputu o lijeku
English: 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.
Croatian: Vrste nuspojava prijavljenih nakon stavljanja lijeka CellCept u promet slične su onima opaženima u kontroliranim ispitivanjima primjene nakon presađivanja bubrega, srca i jetre.
English: The recommended dose is 600 mg/ m² taken twice a day.
Croatian: Preporučena doza je 600 mg/m2 i uzima se dvaput dnevno.
English: 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.
Croatian: Ti su se učinci pojavili pri razinama sistemske izloženosti ekvivalentnim ili manjim od kliničke izloženosti pri preporučenoj dozi od 2 g/dan.
English: It is recommended that CellCept 1 g/5 ml powder for oral suspension be reconstituted by the pharmacist prior to dispensing to the patient.
Croatian: Preporučuje se da prašak za pripremu oralne suspenzije CellCept 1 g/5 ml pripremi ljekarnik prije izdavanja bolesnicima.
English: Musculoskeletal pain such as myalgia, and neck and back pain were also very commonly reported.
Croatian: Osim toga, vrlo je često prijavljena i mišićno-koštana bol, poput mialgije te boli u vratu i leđima.
English: These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.
Croatian: To uključuje proljev, infekcije, smanjenje broja leukocita i eritrocita u krvi.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Do not take CellCept if you are breast-feeding.
Croatian: Nemojte uzimati CellCept ako dojite.
English: Keep the blister in the outer carton in order to protect from light.
Croatian: Čuvati blister u vanjskom pakiranju radi zaštite od svjetlosti.
English: Take off the child safety bottle cap and push the bottle adapter into the neck of the bottle.
Croatian: Uklonite sigurnosni zatvarač za djecu te plastični nastavak za bocu gurnite u vrat boce.
English: For instruction on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o rekonstituciji lijeka prije primjene vidjeti dio 6.6.
English: Turn the whole thing back round the right way.
Croatian: 7. Sve zajedno preokrenite u normalan položaj
English: 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.
Croatian: 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.
English: 20 mL type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off caps.
Croatian: Staklene bočice (bezbojno staklo tipa I) od 20 ml, sa sivim gumenim čepom (butil guma), aluminijskim prstenom i plastičnim „flip-off“ zatvaračem.
English: 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)
Croatian: 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)
English: 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.
Croatian: U bolesnica izloženih mofetilmikofenolatu prijavljeni su slučajevi spontanog pobačaja, prvenstveno u prvom tromjesečju trudnoće (vidjeti dio 4.6).
English: The full name of your medicine is CellCept 1 g/5 ml powder for oral suspension.
Croatian: Puno ime Vašeg lijeka je CellCept 1g/5 ml prašak za oralnu suspenziju.
English: Hypophosphatemia
Croatian: Hipofosfatemija
English: 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
Croatian: • ako imate rijedak nasljedni poremećaj metabolizma koji se zove „fenilketonurija“
English: 1 carton contains 100 capsules (in blister packs of 10) 1 carton contains 300 capsules (in blister packs of 10)
Croatian: 1 kutija sadrži 100 kapsula (u blister pakiranjima od 10 kapsula)
English: • Reconstituted suspension: do not store above 30°C.
Croatian: • Pripremljena suspenzija: ne čuvati na temperaturi iznad 30°C.
English: Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy.
Croatian: Nakon izlaganja mofetilmikofenolatu tijekom trudnoće prijavljeni su spontani pobačaj (stopa od 45% do 49%) i kongenitalne malformacije (procijenjena stopa od 23% do 27%).
English: • Do not use after the expiry date stated on the carton and bottle label (EXP).
Croatian: • Lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji (Rok valjanosti) i naljepnici bočice (EXP).
English: Reconstitute the content of each vial by injecting 14 mL of glucose intravenous infusion 5%.
Croatian: Sadržaj svake bočice rekonstituirajte ubrizgavanjem 14 ml otopine 5%-tne glukoze za intravensku infuziju.
English: Powder for oral suspension and reconstituted suspension: Do not store above 30 °C.
Croatian: Prašak za oralnu suspenziju i pripremljena suspenzija: Ne čuvati na temperaturi iznad 30°C.
English: • CellCept tablets: microcrystalline cellulose, polyvidone (K-90), croscarmellose sodium,
Croatian: • CellCept tablete: celuloza, mikrokristalična, polividon (K-90), karmelozanatrij, umrežen,
English: • fluid on the lungs or inside the chest,
Croatian: • tekućina u plućnoj ili prsnoj šupljini
English: Gastrointestinal disorders Abdominal distension
Croatian: Poremećaji probavnog sustava Distenzija abdomena
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna boca sadrži 35 g mofetilmikofenolat u 110 g praška za oralnu suspenziju.
English: Isavuconazole
Croatian: Izavukonazol
English: When reconstituted, the volume of the suspension is 175 mL, providing a usable volume of 160 - 165 mL.
Croatian: Nakon rekonstitucije, količina suspenzije iznosi 175 ml, što daje iskoristivu količinu od 160 - 165 ml. 5 ml rekonstituirane suspenzije sadrži 1 g mofetilmikofenolata.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: CONTENTS OF THE PACK AND OTHER INFORMATION
Croatian: Sadržaj pakiranja i druge informacije
English: Background information on mycophenolate mofetil teratogenicity and mutagenicity in humans.
Croatian: • Pozadinske informacije o teratogenosti i mutagenosti mofetilmikofenolata u ljudi.
English: 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.
Croatian: 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.
English: The full name of your medicine is CellCept 500 mg film-coated tablets.
Croatian: Puno ime Vašeg lijeka je CellCept 500 mg filmom obložene tablete
English: The types of adverse reactions reported during post-marketing with CellCept are similar to those seen in the controlled renal and hepatic transplant studies.
Croatian: Vrste nuspojava prijavljenih nakon stavljanja lijeka CellCept u promet slične su onima opaženima u kontroliranim ispitivanjima primjene nakon presađivanja bubrega i jetre.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOČICU
English: CellCept IV solution should never be administered by rapid or bolus intravenous injection.
Croatian: CellCept IV otopina ne smije se primjenjivati u obliku brzih injekcija u venu ili u obliku bolusa.
English: 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.
Croatian: Sadržaj bočica CellCept 500 mg praška za koncentrat za otopinu za infuziju mora se otopiti s 14 ml glukoze 5% za infuziju u venu.
English: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m2 mycophenolate mofetil orally twice daily.
Croatian: 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.
English: The first dose is given within 24 hours of the transplant operation.
Croatian: • Prva doza se daje unutar 24 sata nakon presađivanja.
English: Multipacks containing 150 (3 packs of 50) tablets
Croatian: Višestruko pakiranje sadrži 150 tableta (3 pakiranja od 50
English: Take care not to let the made-up medicine get onto your skin.
Croatian: Pazite da pripremljen lijek ne dođe u kontakt s Vašom kožom.
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see section 4.4).
Croatian: Pure Red Cell Aplasia, PRCA) kod bolesnika liječenih lijekom CellCept (vidjeti dio 4.4).
English: Renal and urinary disorders Blood creatinine increased
Croatian: Poremećaji bubrega i mokraćnog sustava Povišena razina kreatinina u krvi
English: METHOD OF ADMINISTRATION For intravenous infusion only Read the package leaflet before use
Croatian: NAČIN PRIMJENE LIJEKA Samo za infuziju u venu Prije uporabe pročitajte uputu o lijeku
English: If you have a rare problem with your metabolism called “phenylketonuria”, talk to your doctor before you start taking this medicine.
Croatian: „fenilketonurija“, obratite se svome liječniku prije nego uzmete ovaj lijek.
English: 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.
Croatian: 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.
English: • CellCept should not be given to women who are breastfeeding (see section 4.6).
Croatian: • CellCept se ne smije davati dojiljama (vidjeti dio 4.6).