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.
Croatian: Primijećeno je smanjenje izloženosti MPA-u u slučajevima kada su antacidi, poput magnezijevog i aluminijevog hidroksida te IPP, uključujući lanzoprazol i pantoprazol bili primjenjivani zajedno s lijekom CellCept.
English: CellCept contains mycophenolate mofetil.
Croatian: CellCept sadrži mofetilmikofenolat.
English: Take care not to let the made-up medicine get into your eyes.
Croatian: Pazite da pripremljen lijek ne dospije u Vaše oči.
English: Reconstituted solution and infusion solution: If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.
Croatian: Rekonstituirani koncentrat i infuzijska otopina: ako infuzijska otopina nije priređena neposredno prije primjene, primjenu infuzijske otopine treba započeti najkasnije 3 sata od rekonstitucije i razrjeđivanja lijeka.
English: Caution should be exercised when switching combination therapy from regimens containing immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure.
Croatian: Potreban je oprez kada se kombinirana terapija prebacuje s protokola koji sadrže imunosupresive koji interferiraju s enterohepatičnom recirkulacijom MPA (npr. ciklosporin), na druge lijekove koji nemaju takav učinak (npr. takrolimus, sirolimus, belatacept) ili obratno, jer to može dovesti do promjena u izloženosti MPA u.
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept tablets should not be crushed.
Croatian: Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, CellCept tablete ne smiju se drobiti.
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).
Croatian: Smanjenje Cmax i AUC0 - 12 h MPA za 30% odnosno 25% primijećeno je pri istodobnoj primjeni lijeka CellCept i sevelamera bez ikakvih kliničkih posljedica (tj. odbacivanja presatka).
English: Write the expiry date of the made-up medicine on the bottle label.
Croatian: Zapišite datum isteka roka valjanosti pripremljenog lijeka na naljepnicu boce.
English: CellCept 500 mg powder for concentrate for solution for infusion is contraindicated in patients who are allergic to polysorbate 80.
Croatian: CellCept 500 mg prašak za koncentrat za otopinu za infuziju kontraindiciran je kod bolesnika koji su alergični na polisorbat 80.
English: Holding onto the body of the dispenser, carefully pull the dispenser out of the bottle adapter.
Croatian: • Držeći tijelo dozatora, pažljivo izvucite dozator iz plastičnog nastavka za bocu.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o rekonstituciji i razrjeđivanju lijeka prije primjene, vidjeti dio 6.6.
English: In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 - 6 months post-transplant).
Croatian: U ranom razdoblju nakon presađivanja (< 40 dana nakon presađivanja), srednja vrijednost AUC-a MPA kod bolesnika s presađenim bubregom, srcem ili jetrom bila je otprilike 30% niža, dok je Cmax bio otprilike 40% niži u odnosu na kasnije razdoblje nakon presađivanja (3 - 6 mjeseci nakon presađivanja).
English: • CellCept should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Croatian: • CellCept se ne smije davati ženama reproduktivne dobi koje ne koriste visoko učinkovite metode kontracepcije (vidjeti dio 4.6).
English: If this happens, rinse your eyes with plain water.
Croatian: • Ako do toga dođe, isperite oči s običnom vodom.
English: Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Croatian: Bolesnici liječeni imunosupresivima, uključujući i CellCept, imaju povećani rizik za oportunističke infekcije (bakterijske, gljivične, virusne i protozoalne), infekcije koje mogu imati smrtni ishod i sepse (vidjeti dio 4.8).
English: A kidney or liver.
Croatian: • Bubreg ili jetru.
English: The health professional educational material should contain: · The Summary of Product Characteristics · Guide for healthcare professionals
Croatian: Edukacijski materijali za zdravstvene radnike moraju sadržavati: · Sažetak opisa svojstava lijeka
English: Patients should be advised that during treatment with CellCept, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Croatian: Bolesnike je potrebno upozoriti da će tijekom liječenja lijekom CellCept cijepljenje možda biti manje učinkovito te da moraju izbjegavati primjenu živog atenuiranog cjepiva (vidjeti dio 4.5).
English: Agranulocytosis and neutropenia have been reported; therefore, regular monitoring of patients taking CellCept is advised (see section 4.4).
Croatian: Budući da su prijavljene agranulocitoza i neutropenija, preporučuje se redovito praćenje bolesnika koji uzimaju CellCept (vidjeti dio 4.4).
English: Cytopenias, including leucopenia, anemia, thrombocytopenia and pancytopenia, are known risks associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and hemorrhages (see section 4.4).
Croatian: Citopenije, uključujući leukopeniju, anemiju, trombocitopeniju i pancitopeniju, poznat su rizik povezan s mofetilmikofenolatom i mogu dovesti do infekcija i krvarenja ili pridonijeti njihovu razvoju (vidjeti dio 4.4).
English: Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA enterohepatic recirculation thus leading to reduced systemic MPA exposure.
Croatian: Antibiotici koji uništavaju bakterije koje proizvode ß-glukuronidaze u crijevima (npr. aminoglikozidi, cefalosporini, fluorokinoloni i penicilinske skupine antibiotika) mogu interferirati s enterohepatičnom recirkulacijom MPAG-a/MPA i tako dovesti do smanjene sistemske izloženost MPA.
English: Hepatic enzyme increased
Croatian: Povišene vrijednosti jetrenih enzima
English: The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who were given 600 mg/m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g CellCept twice daily.
Croatian: Vrsta i učestalost nuspojava zabilježenih u kliničkom ispitivanju s 92 pedijatrijska bolesnika u dobi od 2 do 18 godina, koji su peroralno primali 600 mg/m2 mofetilmikofenolata dvaput dnevno, bila je uglavnom slična onima uočenima kod odraslih bolesnika koji su uzimali 1 g lijeka CellCept dvaput dnevno.
English: CellCept has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Croatian: Primjena lijeka CellCept povezuje se s povećanom incidencijom štetnih događaja vezanih uz probavni sustav, uključujući manje česte pojave ulkusa gastrointestinalnog trakta, krvarenja i perforacije.
English: What you need to know before you take CellCept
Croatian: Što morate znati prije nego počnete uzimati CellCept
English: Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML).
Croatian: Takve infekcije uključuju reaktivaciju latentnih virusa, poput reaktivacije hepatitisa B ili hepatitisa C i infekcije uzrokovane polioma virusima (nefropatija povezana s BK virusom, progresivna multifokalna leukoencefalopatija (PML) povezana s JC virusom).
English: Renal transplant n = 991
Croatian: Bubrežni presadak n = 991
English: CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30-50% in renal transplant patients treated with CellCept and CsA compared with patients receiving sirolimus or belatacept and similar doses of CellCept (see also section 4.4).
Croatian: A smanjuje izloženost MPA-u za 30-50% u usporedbi s bolesnicima koji primaju sirolimus ili belatacept i slične doze lijeka CellCept (vidjeti i dio 4.4).
English: The initial dose of CellCept 500 mg powder for concentrate for solution for infusion should be given within 24 hours following transplantation.
Croatian: Inicijalna doza CellCept 500 mg praška za koncentrat za otopinu za infuziju mora se primijeniti u roku od 24 sata nakon presađivanja.
English: There are no data on CellCept with phosphate binders other than sevelamer.
Croatian: Ne postoje podaci o primjeni lijeka CellCept s lijekovima koji vežu fosfate, osim sevelamera.
English: In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28 - 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Croatian: U ispitivanju primjene jedne doze (6 ispitanika/skupina), srednje vrijednosti AUC-a MPA u plazmi ispitanika s teškim kroničnim oštećenjem bubrežne funkcije (brzina glomerularne filtracije < 25 ml/min/1,73 m2) bile su 28 - 75% više u odnosu na srednje vrijednosti koje su primijećene kod normalnih, zdravih ispitanika ili ispitanika s blažim stupnjevima oštećenja bubrežne funkcije.
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
Croatian: CellCept 1 g/5 ml prašak za oralnu suspenziju sorbitol silikon, koloidni bezvodni natrijev citrat sojin lecitin okus miješanog voća ksantanska guma aspartam* (E951) metilparahidroksibenzoat (E218) citratna kiselina bezvodna
English: • They are available as packs of 50 (in blister packs of 10) or Multipacks containing 150 (3 packs of 50) tablets.
Croatian: • Nalaze se u pakiranju od 50 tableta (u blister pakiranjima od po 10 tableta) ili višestrukom pakiranju od 150 tableta (3 pakiranja od po 50 tableta)
English: When comparing rates of transplant rejection, rates of graft loss or adverse event profiles between CellCept patients with and without concomitant telmisartan medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen.
Croatian: Kada su se uspoređivale stope odbacivanja transplantata, stope gubitka presatka ili profili nuspojava između bolesnika liječenih lijekom CellCept koji su istodobno primali telmisartan i onih koji nisu primali telmisartan, nisu primijećene kliničke posljedice farmakokinetičke interakcije između tih dvaju lijekova.
English: If you forget to take CellCept
Croatian: Ako ste zaboravili uzeti CellCept
English: Sodium less than 1 mmol (23 mg) per dose
Croatian: Natrij: manje od 1 mmol (23 mg) po dozi.
English: Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) Concomitant administration of drugs affecting glucuronidation of MPA may change MPA exposure.
Croatian: Lijekovi koji utječu na glukuronidaciju (npr. izavukonazol, telmisartan) Istodobna primjena lijekova koji utječu na glukuronidaciju MPA može promijeniti izloženost MPA-u.
English: Take the dispenser and push the plunger completely down toward the tip of the dispenser.
Croatian: Uzmite dozator i potisnite cijeli klip prema vrhu dozatora.
English: • phosphate binders - used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood
Croatian: • lijekove koji vežu fosfate - primjenjuju se kod bolesnika s kroničnim zatajenjem bubrega kako bi se smanjila apsorpcija fosfata u krv
English: Thus, other substances known to undergo renal tubular secretion may compete with MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
Croatian: Na taj se način druge tvari koje se izlučuju putem bubrežnih tubula mogu natjecati s MPAG-om i tako povećavati plazmatske koncentracije MPAG-a ili drugih tvari koje se izlučuju tubularnom sekrecijom.
English: If you stop taking CellCept
Croatian: Ako prestanete uzimati CellCept
English: Gently shake the vial to dissolve the medicinal product yielding a slightly yellow solution.
Croatian: Lagano protresite bočicu da se lijek otopi i stvori žućkasta otopina.
English: CellCept capsules: oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and "Roche" name on the capsule body.
Croatian: CellCept kapsule: duguljasta, plavosmeđa kapsula s crnim natpisom "CellCept 250" na kapici kapsule i imenom „Roche“ na tijelu kapsule.
English: Cardiac disorders Tachycardia
Croatian: Srčani poremećaji Tahikardija
English: They have “CellCept 250” printed in black on the capsule cap and “Roche” printed in black on the capsule body.
Croatian: "CellCept 250" na kapici kapsule i crni natpis „Roche“ na tijelu kapsule.
English: Oral administration of radiolabelled mycophenolate mofetil results in complete recovery of the administered dose, with 93% of the administered dose recovered in the urine and 6% recovered in faeces.
Croatian: Peroralna primjena radioizotopom označenog mofetilmikofenolata rezultira potpunom ponovnom detekcijom primijenjene doze, od čega se 93% primijenjene doze ponovno detektira u urinu, a 6% u fecesu.
English: CellCept tablets: lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and "ROCHE" name on the other.
Croatian: CellCept tablete: ovalna tableta boje lavande s utisnutim "CellCept 500" s jedne strane i imenom
English: When comparing rates of transplant rejection or rates of graft loss between CellCept patients taking PPIs vs. CellCept patients not taking PPIs, no significant differences were seen.
Croatian: Uspoređujući stope odbacivanja transplantata ili stope gubitka presatka između bolesnika koji su uzimali CellCept i IPP naspram bolesnika koji s lijekom CellCept nisu uzimali IPP, nisu primijećene značajne razlike.
English: • Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
Croatian: • Prema izvješćima iz literature, malformacije su se pojavile u 23 - 27% živorođene djece čije su majke bile izložene mofetilmikofenolatu tijekom trudnoće (u usporedbi sa stopom od 2 - 3% kod živorođene djece u cjelokupnoj populaciji te približno 4 - 5% kod živorođene djece bolesnica s presatkom solidnog organa liječenih drugim imunosupresivima osim mofetilmikofenolata).
English: There have been published reports of bronchiectasis in adults and children who received CellCept in combination with other immunosuppressants.
Croatian: Objavljeni su izvještaji o bronhiektazijama u odraslih i djece koji su primili CellCept u kombinaciji s drugim imunosupresivima.
English: Hernia
Croatian: Hernija
English: Urinary problems such as: blood in the urine.
Croatian: Poteškoće s mokrenjem kao što su: krv u mokraći
English: Then, tightly close the bottle with child safety bottle cap.
Croatian: Čvrsto zatvorite bocu sigurnosnim zatvaračem za djecu.
English: Contents of the pack and other information Making-up the medicine
Croatian: Sadržaj pakiranja i druge informacije Priprema lijeka
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.
Croatian: CellCept 500 mg prašak za koncentrat za otopinu za infuziju ne smije se miješati ni zajednički primjenjivati putem istog katetera s drugim intravenskim lijekovima ili infuzijskim smjesama.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CellCept capsules should be handled with care
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO CellCept kapsulama rukujte oprezno
English: There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with CellCept in combination with other immunosuppressants, some of which have been fatal.
Croatian: Zabilježeni su izolirani slučajevi intersticijske plućne bolesti i plućne fibroze kod bolesnika liječenih lijekom CellCept u kombinaciji s drugim imunosupresivima, od kojih su neki bili sa smrtnim ishodom.
English: If you are not sure, talk to your doctor or nurse before having CellCept.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom ili medicinskom sestrom prije primanja lijeka CellCept.
English: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Croatian: Kod bolesnika s presađenim bubregom i teškim kroničnim oštećenjem bubrežne funkcije (brzina glomerularne filtracije < 25 ml/min/1,73 m2) izvan neposrednog postoperativnog razdoblja, moraju se izbjegavati doze veće od 1 g primijenjene dvaput dnevno.
English: Heart and blood vessel problems such as: change in blood pressure, accelerated heartbeat, widening of blood vessels.
Croatian: Poteškoće sa srcem i krvnim žilama kao što su: • promjena krvnog tlaka, ubrzani otkucaji srca i proširenje krvnih žila
English: CellCept 500 mg powder for concentrate for solution for infusion polysorbate 80 citric acid hydrochloric acid sodium chloride
Croatian: CellCept 500 mg prašak za koncentrat za otopinu za infuziju polisorbat 80 citratna kiselina kloridna kiselina natrijev klorid
English: Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing mothers (see section 4.3).
Croatian: Zbog mogućih ozbiljnih nuspojava mofetilmikofenolata kod dojenčadi CellCept je kontraindiciran u dojilja (vidjeti dio 4.3).
English: Following intravenous administration, mycophenolate mofetil undergoes rapid and complete metabolism to the active metabolite, MPA.
Croatian: Nakon intravenske primjene, mofetilmikofenolat brzo se i potpuno metabolizira do aktivnog metabolita, MPA.
English: This leaflet was last revised on {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG} Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.
Croatian: Ako infuzijska otopina nije priređena neposredno prije primjene, primjenu infuzijske otopine treba započeti najkasnije 3 sata od otapanja i razrjeđivanja lijeka.
English: Talk to your doctor if you develop a persistent cough or breathlessness.
Croatian: Razgovarajte sa svojim liječnikom u slučaju pojave trajnog kašlja ili nedostatka zraka.
English: This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 mL) must be further diluted into 140 mL glucose intravenous infusion 5% solution.
Croatian: To znači da je za pripremu doze od 1 g mofetilmikofenolata otopljeni sadržaj dvije bočice (otprilike 2 x 15 ml) potrebno dalje razrijediti sa 140 ml otopine 5% glukoze za infuziju u venu.
English: The final concentration of the solution is 6 mg/mL mycophenolate mofetil.
Croatian: Krajnja je koncentracija otopine 6 mg/ml mofetilmikofenolata.
English: • Take 4 capsules in the morning and then 4 capsules in the evening.
Croatian: • Uzmite 4 kapsule ujutro te 4 kapsule navečer.
English: Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with CellCept.
Croatian: Zapaženi su izolirani slučajevi patološke morfologije neutrofila, uključujući i stečenu Pelger-Huet anomaliju kod bolesnika liječenih lijekom CellCept.
English: Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2).
Croatian: Nakon primjene jedne doze od 1,5 g mofetilmikofenolata u normalnih zdravih ispitanika koji su prethodno liječeni dozom od 4 g kolestiramina triput dnevno tijekom četiri dana, došlo je do smanjenja AUC-a (površina ispod krivulje) MPA za 40% (vidjeti dijelove 4.4 i 5.2).
English: • They are available as a carton of 100 or 300 capsules (both in blister packs of 10).
Croatian: • Nalaze se u pakiranju od 100 ili 300 kapsula ( u blister pakiranjima od po 10 kapsula)
English: Concomitant administration of telmisartan and CellCept resulted in an approximately 30% decrease of MPA concentrations.
Croatian: Istodobna primjena telmisartana i lijeka CellCept snizila je koncentracije MPA za približno 30%.
English: Blood and lymphatic system disorders Anemia
Croatian: Poremećaji krvi i limfnog sustava Anemija
English: Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.
Croatian: Muškarci ne smiju donirati spermu tijekom liječenja lijekom CellCept i najmanje 90 dana nakon prestanka liječenja.
English: By interfering with enterohepatic recirculation of the drug, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9).
Croatian: Interferencijom s enterohepatičnom recirkulacijom lijeka, lijekovi za snižavanje razine žučnih kiselina, poput kolestiramina, snizuju AUC MPA (vidjeti dio 4.9).
English: CellCept is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Croatian: CellCept je kontraindiciran tijekom trudnoće, osim ako ne postoji prikladno alternativno liječenje kojim bi se spriječilo odbacivanje presatka.
English: 1 bottle adapter and 2 oral dispensers are provided
Croatian: Priloženi su 1 plastični nastavak za bocu i 2 oralna dozatora
English: If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting treatment with CellCept.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas (ili niste sigurni), odmah razgovarajte sa svojim liječnikom prije nego što započnete liječenje lijekom CellCept.
English: Of these, 991 were included in the three renal studies, 277 were included in one hepatic study, and 289 were included in one cardiac study.
Croatian: Među njima je 991 bolesnik bio uključen u tri ispitivanja primjene nakon presađivanja bubrega, 277 bolesnika sudjelovalo je u jednom ispitivanju primjene nakon presađivanja jetre, a 289 bolesnika bilo je uključeno u jedno ispitivanje primjene nakon presađivanja srca.
English: If you need to have a vaccine (a live vaccine) while taking CellCept, talk to your doctor or pharmacist first.
Croatian: Ako se tijekom uzimanja lijeka CellCept trebate cijepiti (živim cjepivom), prvo razgovarajte sa svojim liječnikom ili ljekarnikom.
English: What CellCept is and what it is used for What you need to know before you take CellCept How to take CellCept
Croatian: Što je CellCept i za što se koristi Što morate znati prije nego počnete uzimati CellCept