FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with CellCept.
Slovenian: Pri dajanju antacidov, kot so magnezijevi in aluminijevi hidroksidi, in zaviralcev protonske črpalke, vključno z lanzoprazolom in pantroprazolom, skupaj z zdravilom CellCept, so opazili zmanjšano izpostavljenost mikofenolni kislini.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign neoplasm of skin
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) benigna neoplazma kože limfom limfoproliferativna motnja neoplazma kožni rak
English: Then, tightly close the bottle with child safety bottle cap.
Slovenian: Nato steklenico tesno zaprite z za otroke varno zaporko.
English: If you stop taking CellCept
Slovenian: Če prenehate jemati zdravilo CellCept
English: Organic anion-transporting polypeptides (OATPs) and multidrug resistance-associated protein 2 (MRP2) are involved in MPA's disposition; OATP isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the glucuronides' biliary excretion.
Slovenian: Na razporeditev mikofenolne kisline vplivajo organski anionski prenašalni polipeptidi (OATP - Organic anion-transporting polypeptides) in protein za multiplo odpornost na zdravila 2 (MRP2 - Multidrug resistance-associated protein 2).
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.
Slovenian: Učinki so se pojavili pri sistemski izpostavljenosti, ki je bila enaka ali manjša kot klinična izpostavljenost pri priporočenem odmerjanju 2 g na dan.
English: • Do not use after the expiry date stated on the carton and bottle label (EXP).
Slovenian: • Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki steklenice (Uporabno do).
English: Further dilute the content of the two reconstituted vials (approx. 2 x 15 mL) into 140 mL of glucose intravenous infusion 5%.
Slovenian: Po rekonstituciji vsebino dveh vial razredčite (približno 2 x 15 ml) v 140 ml intravenske infuzije 5-% glukoze.
English: Powder for concentrate for solution for infusion.
Slovenian: prašek za koncentrat za raztopino za infundiranje
English: Mean plasma MPAG AUC0-12h was 2 - 3-fold higher than in post-transplant patients without delayed graft function.
Slovenian: Srednja AUC0-12 ur mikofenolglukuronida pa je bila 2- do 3-krat večja kot pri bolnikih brez zapoznelega delovanja ledvičnega presadka.
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.
Slovenian: Vsebino vial z zdravilom CellCept 500 mg prašek za koncentrat za raztopino za infundiranje je treba raztopiti s 14 ml intravenske infuzije 5-% glukoze.
English: Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Slovenian: • Nasvet, naj bolniki in bolnice ne darujejo krvi med zdravljenjem in še najmanj 6 tednov po zaključku zdravljenja z mofetilmikofenolatom.
English: Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory canal artesia (middle ear);
Slovenian: • nenormalna ušesa (npr. nenormalna oblika ali manjkajoče zunanje uho), atrezija zunanjega sluhovoda (srednjega ušesa),
English: • The shelf-life of the reconstituted suspension is two months.
Slovenian: • Rok uporabnosti pripravljene suspenzije je 2 meseca.
English: Do not break or crush them.
Slovenian: • Tablet ne smete lomiti ali drobiti.
English: Then shake the closed bottle well for about 1 minute.
Slovenian: • Nato zaprto steklenico temeljito stresajte približno 1 minuto.
English: • CellCept capsules are oblong shaped with one end blue and the other end brown.
Slovenian: • CellCept kapsule so ovalne oblike, en del kapsule je modre, drugi del pa rjave barve.
English: CellCept capsules pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate
Slovenian: CellCept kapsule: predgeliran koruzni škrob premrežen natrijev karmelozat povidon (K90) magnezijev stearat
English: 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.
Slovenian: Zdravila CellCept 500 mg prašek 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.
English: Powder for oral suspension and reconstituted suspension: Do not store above 30 °C.
Slovenian: Prašek za peroralno suspenzijo in pripravljena suspenzija: shranjujte pri temperaturi do 30 °C.
English: The most common gastrointestinal disorders, however, were diarrhea, nausea and vomiting.
Slovenian: Najpogostejše bolezni prebavil so bile driska, navzea in bruhanje.
English: CellCept has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Slovenian: Pri bolnikih, ki so prejemali zdravilo CellCept, so opazili povišano incidenco neželenih dogodkov v prebavilih, vključno z redkimi primeri razjed v prebavnem traktu, krvavitvami in perforacijami črevesa.
English: Take care not to let the made-up medicine get onto your skin.
Slovenian: Bodite previdni, da pripravljeno zdravilo ne pride v stik s kožo.
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.
Slovenian: Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, kapsul CellCept ne smemo odpreti ali drobiti, da se izognemo vdihavanju ali neposrednemu stiku praška v CellCept kapsulah s kožo ali sluznico.
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).
Slovenian: • Zdravljenja z zdravilom Cellcept ne smemo uvesti pri bolnicah v rodni dobi, ki ne zagotovijo izvida testa nosečnosti, da izključimo nenamerno uporabo zdravila med nosečnostjo (glejte poglavje 4.6).
English: 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.
Slovenian: 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.
English: • CellCept should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Slovenian: • Zdravila CellCept ne smemo uporabljati pri bolnicah v rodni dobi, ki ne uporabljajo zelo učinkovitih kontracepcijskih metod (glejte poglavje 4.6).
English: The first dose is given within 24 hours of the transplant operation.
Slovenian: Odrasli • Prvi odmerek prejmete v 24 urah po presaditvenem posegu.
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).
Slovenian: Tablete CellCept lahko predpišemo samo bolnikom, katerih telesna površina je večja od 1,5 m2, v odmerku 1 g dvakrat na dan (dnevni odmerek 2 g).
English: 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.
Slovenian: Zdravilo CellCept je indicirano skupaj s ciklosporinom in kortikosteroidi za preprečevanje akutnih zavrnitvenih reakcij pri bolnikih z alogenim ledvičnim, srčnim ali jetrnim presadkom.
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 medicines.
Slovenian: • Prvi peroralni odmerek zdravila CellCept boste prejeli vsaj 4 dni po presaditvenem posegu in takoj, ko boste lahko jemali zdravila peroralno.
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 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.
Slovenian: 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, in 1,3- do 2-krat večjo sistemsko izpostavljenost (AUC ali Cmax) kot pri bolnikih s srčnim presadkom, ki so prejemali priporočeni klinični odmerek 3 g na dan.
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.
Slovenian: Najpogostejše oportunistične okužbe pri bolnikih z ledvičnim 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.
English: Do not take CellCept if you are breast-feeding.
Slovenian: Dojenje Ne jemljite zdravila CellCept, če dojite.
English: You need to use the dispenser and bottle adapter supplied with the medicine to measure the dose.
Slovenian: Za pripravo ustreznega odmerka potrebujete peroralni razdelilnik in nastavek za steklenico, ki ju dobite skupaj z zdravilom.
English: There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving CellCept in combination with other immunosuppressants.
Slovenian: Poročali so o primerih hipogamaglobulinemije v povezavi s ponavljajočimi se okužbami pri bolnikih, ki so prejemali zdravilo CellCept v kombinaciji z drugimi imunosupresivi.
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.
Slovenian: Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, se je treba izogibati vdihavanju ali neposrednemu stiku praška s kožo ali sluznico kot tudi neposrednemu stiku rekonstituirane raztopine s kožo.
English: CellCept 250 mg capsules:
Slovenian: CellCept 250 mg kapsule:
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).
Slovenian: Sistemska izpostavljenost pri tem odmerku je bila približno enaka ali manj kot 0,5-krat tolikšna kot klinična izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan (glejte poglavje 4.6).
English: • CellCept should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Slovenian: • Zdravila Cellcept ne smemo uporabljati med nosečnostjo, razen če ni na voljo primernega alternativnega zdravljenja za preprečitev zavrnitve presadka (glejte poglavje 4.6).
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.
Slovenian: Če kar koli izmed naštetega velja za vas (ali ste negotovi), se nemudoma pogovorite z zdravnikom ali medicinsko sestro, preden se začnete zdraviti z zdravilom CellCept.
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.
Slovenian: Najpogostejše oportunistične okužbe pri bolnikih z ledvičnim, 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.
English: Shake bottle well before use
Slovenian: Za peroralno uporabo po pripravi Pred uporabo steklenico dobro pretresite
English: Metabolism and nutrition disorders Acidosis
Slovenian: Presnovne in prehranske motnje acidoza
English: The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride.
Slovenian: • Pomožne snovi so: polisorbat 80, citronska kislina, klorovodikova kislina, natrijev klorid.
English: Musculoskeletal and connective tissue disorders Arthralgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija
English: Cardiac disorders Tachycardia
Slovenian: Srčne bolezni tahikardija
English: Write the date of expiration of the reconstituted suspension on the bottle label.
Slovenian: Na nalepko steklenice napišite datum uporabnosti pripravljene suspenzije.
English: What CellCept contains
Slovenian: Kaj vsebuje zdravilo CellCept
English: Paediatric population No data are available for treatment of first or refractory rejection in pediatric transplant patients.
Slovenian: Pediatrični bolniki Za otroke s presadkom ni na voljo podatkov o zdravljenju prve ali ponovne zavrnitve.
English: METHOD OF ADMINISTRATION Oral use
Slovenian: Način uporabe peroralna uporaba
English: Paediatric population No data are available for paediatric cardiac transplant patients.
Slovenian: Pediatrični bolniki Za otroke s srčnim presadkom podatkov ni.
English: The first dose is given within 5 days of the transplant operation.
Slovenian: • Prvi odmerek prejmete v 5 dneh po presaditvenem posegu.
English: CellCept 500 mg film-coated tablets
Slovenian: CellCept 500 mg filmsko obložene tablete
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
Slovenian: • če imate redko dedno motnjo metabolizma, imenovano »fenilketonurija«,
English: Respiratory, thoracic and mediastinal disorders Bronchiectasis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora bronhiektazija kašelj
English: Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when CellCept was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Slovenian: Pri sočasnem dajanju zdravila CellCept in sevelamerja so opazili zmanjšanje Cmax mikofenolne kisline za 30 % in AUC0-12h mikofenolne kisline za 25 %, kliničnih posledic (zavrnitve presadka) pa ni bilo.
English: CellCept 500 mg powder for concentrate for solution for infusion is available in packs containing 4 vials.
Slovenian: Zdravilo CellCept 500 mg prašek za koncentrat za raztopino za infundiranje je na voljo v pakiranju po 4 viale.
English: 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).
Slovenian: 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).
English: Eructation
Slovenian: Kύπρος
English: 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.
Slovenian: 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.
English: Caution should be used during concomitant administration because of the potential to reduce efficacy of CellCept.
Slovenian: Pri sočasni uporabi holestiramina in zdravila CellCept je potrebna previdnost, saj je lahko učinkovitost zdravila CellCept zmanjšana.
English: diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Slovenian: • driska, zaprtje, slabost (navzea), dispepsija, izguba teka, napenjanje.
English: An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole.
Slovenian: Pri sočasni uporabi izavukonazola so opazili povečanje AUC0-∞ mikofenolne kisline za 35 %.
English: The systemic exposure at this dose represents 2 - 3 times the clinical exposure at the recommended clinical dose of 2 g/day.
Slovenian: Sistemska izpostavljenost pri tem odmerku predstavlja 2- do 3-kratno klinično izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan.
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Slovenian: Emil-Barell-Strasse 1
English: acne, cold sores, skin growth, shingles, hair loss, rash, itching.
Slovenian: • akne, herpes simpleks, pasasti izpuščaj, rast kože, izguba las, izpuščaj, srbenje.
English: Capsule shells gelatin indigo carmine (E132) yellow iron oxide (E172) red iron oxide (E172) titanium dioxide (E171) black iron oxide (E172) potassium hydroxide shellac.
Slovenian: Ovojnica kapsule: želatina indigotin (E132) rumeni železov oksid (E172) rdeči železov oksid (E172) titanov dioksid (E171) črni železov oksid (E172) kalijev hidroksid šelak
English: 5 mL of the reconstituted suspension contains 1 g of mycophenolate mofetil.
Slovenian: 5 ml pripravljene suspenzije vsebuje 1 g mofetilmikofenolata.
English: 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).
Slovenian: Bolniki, ki prejemajo kombinacije imunosupresivnih zdravil, vključno z zdravilom CellCept, so izpostavljeni povečanemu tveganju nastanka limfomov in drugih malignih sprememb, zlasti kožnih (glejte poglavje 4.8).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
English: If you take more CellCept than you should, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila CellCept, kot bi smeli Če ste zaužili več zdravila CellCept, kot bi smeli, takoj obvestite zdravnika ali pojdite v bolnišnico.
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.
Slovenian: Zdravilo CellCept 500 mg prašek za koncentrat za raztopino za infundiranje je indicirano skupaj s ciklosporinom in kortikosteroidi za preprečevanje akutnih zavrnitvenih reakcij pri bolnikih z alogenim ledvičnim ali jetrnim presadkom.
English: How to take CellCept
Slovenian: Kako jemati zdravilo CellCept
English: CellCept 250 mg capsules
Slovenian: CellCept 250 mg kapsule
English: The patient information pack should contain: · The Package Leaflet · Guide for patients
Slovenian: Gradivo za bolnike mora vsebovati:
English: 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).
Slovenian: Bolniki, ki prejemajo imunosupresivna zdravila, obsegajoč kombinacije zdravil, vključno z zdravilom CellCept, imajo zvečano tveganje nastanka limfomov in drugih malignih sprememb, zlasti kožnih (glejte poglavje 4.4).
English: A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating that there is a significant amount of enterohepatic recirculation.
Slovenian: Holestiramin v odmerku 4 g 3-krat na dan zmanjša AUC mikofenolne kisline za približno 40 %, kar potrjuje veliko stopnjo ponovnega enterohepatičnega obtoka.
English: Psychiatric disorders Confusional state
Slovenian: Psihiatrične motnje stanje zmedenosti depresija nespečnost
English: 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.
Slovenian: Pri starejših bolnikih, ki prejemajo zdravilo CellCept kot del kombinacije imunosupresivnega režima, je v primerjavi z mlajšimi tveganje za pojav določenih okužb (vključno s citomegalovirusno tkivno invazivno boleznijo), krvavitev v prebavilih in pljučnega edema lahko večje.
English: The infusion flow rate should be controlled to equate to a 2-hour period of administration.
Slovenian: Hitrost infuzije je treba uravnati tako, da boste infuzijo prejeli v 2 urah.
English: Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of CellCept is not required.
Slovenian: Zavrnitev ledvičnega presadka ne spremeni farmakokinetike mikofenolne kisline; zmanjšanje odmerkov ali prekinitev zdravljenja z zdravilom CellCept ni potrebna.
English: CellCept 1 g/5 ml powder for oral suspension sorbitol silica, colloidal anhydrous sodium citrate soybean lecithin mixed fruit flavour xanthan gum aspartame* (E951) methyl parahydroxybenzoate (E218) citric acid anhydrous
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi CellCept 1 g/5 ml prašek za peroralno suspenzijo sorbitol brezvoden koloidni silicijev dioksid natrijev citrat sojin lecitin mešana sadna aroma ksantanski gumi aspartam* (E951) metilparahidroksibenzoat (E218) brezvodna citronska kislina * vsebuje 2,78 mg fenilalanina v 5 ml suspenzije 6.2 Inkompatibilnosti
English: 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.
Slovenian: 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.
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).
Slovenian: Pred dajanjem zdravila CellCept 500 mg prašek za koncentrat za raztopino za infundiranje bolniku, je potrebna rekonstitucija in nadaljnja razredčitev zdravila z intravensko infuzijo 5 % glukoze (glejte poglavje 6.6).
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see section 4.4).
Slovenian: Pri zdravljenju z zdravilom CellCept so poročali o primerih čiste aplazije rdečih krvnih celic (PRCA) (glejte poglavje 4.4).
English: If you are a woman who could become pregnant you must use an effective method of contraception with CellCept.
Slovenian: Kontracepcija pri bolnicah, ki jemljejo zdravilo CellCept Če ste bolnica, ki bi lahko zanosila, morate med zdravljenjem z zdravilom CellCept uporabljati učinkovito kontracepcijsko zaščito, in sicer: