FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that CellCept should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Croatian: Ne preporučuje se primjenjivati CellCept istodobno s azatioprinom jer njihova istodobna primjena nije ispitana.
English: In some of these cases switching CellCept to an alternative immunosuppressant resulted in serum IgG levels returning to normal.
Croatian: U nekima od tih slučajeva zamjena lijeka CellCept drugim imunosupresivom rezultirala je vraćanjem razine serumskog IgG-a na normalu.
English: Equivalence with oral dosage forms
Croatian: Ekvivalentnost s oblicima za peroralnu primjenu
English: If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see section 4.4).
Croatian: Ako se razvije neutropenija, potrebno je prekinuti primjenu lijeka CellCept ili smanjiti dozu (vidjeti dio 4.4).
English: Before starting CellCept treatment, women of childbearing potential should have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL in order to exclude unintended exposure of the embryo to mycophenolate.
Croatian: Prije početka liječenja lijekom CellCept, žene reproduktivne dobi moraju imati dva negativna nalaza testova na trudnoću provedenih na uzorku seruma ili mokraće, čija je osjetljivost najmanje 25 mIU/ml, kako bi se isključila mogućnost nehotičnog izlaganja embrija mikofenolatu.
English: The most serious infections were sepsis, peritonitis, meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Croatian: Najozbiljnije infekcije bile su sepsa, peritonitis, meningitis, endokarditis, tuberkuloza i atipična mikobakterijska infekcija.
English: Talk to a doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Croatian: Odmah se obratite svom liječniku ili medicinskoj sestri ako primijetite bilo koju od sljedećih ozbiljnih nuspojava - možda trebate hitno medicinsko liječenje:
English: Based on the results of a single dose administration study of recommended doses of oral mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics of CellCept (see section 4.2) and ganciclovir, it is anticipated that co-administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Croatian: Na temelju rezultata ispitivanja jednokratne primjene oralnog mikofenolata i intravenskog ganciklovira u preporučenoj dozi te poznatih učinaka oštećenja bubrega na farmakokinetiku lijeka CellCept (vidjeti dio 4.2) i ganciklovira, pretpostavilo se da će istodobna primjena tih lijekova (koji se natječu za mehanizam bubrežnog tubularnog izlučivanja) rezultirati povećanjem koncentracija MPAG-a i ganciklovira.
English: Contraception in women taking CellCept
Croatian: Kontracepcija u žena koje uzimaju CellCept
English: • CellCept tablets are lavender coloured and caplet shaped.
Croatian: • CellCept tablete su ovalnog oblika i boje lavande.
English: The recommended dose is 600 mg/ m2
Croatian: Preporučena doza je 600 mg/m2
English: If you take more CellCept than you should
Croatian: Ako uzmete više lijeka CellCept nego što ste trebali
English: In patients with renal impairment in whom CellCept and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered, the dose recommendations for ganciclovir should be observed and patients should be monitored carefully.
Croatian: Kod bolesnika s oštećenjem bubrega kod kojih se istodobno primjenjuju CellCept i ganciklovir ili njegovi prolijekovi, npr. valganciklovir, potrebno je razmotriti primjenu preporučene doze ganciklovira i pažljivo nadzirati bolesnika.
English: Add approximately half of the total amount of purified water to the bottle and shake the closed bottle well for about 1 minute.
Croatian: Dodajte otprilike polovicu ukupne količine pročišćene vode u bocu i snažno tresite zatvorenu bocu oko 1 minutu.
English: Dose adjustment of CellCept does not appear to be necessary.
Croatian: Prilagodba doze lijeka CellCept nije nužno potrebna.
English: As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking CellCept.
Croatian: Kao mjera opreza, preporučuje se da Vi ili Vaša partnerica koristite pouzdanu kontracepciju tijekom liječenja i još 90 dana nakon što prestanete uzimati CellCept.
English: (The shelf-life of the reconstituted suspension is two months.)
Croatian: (Rok valjanosti rekonstituirane suspenzije iznosi dva mjeseca.)
English: PHARMACEUTICAL FORM AND CONTENTS Multipack:150 (3 packs of 50) film-coated tablets
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje: 150 (3 pakiranja od 50) filmom-obloženih tableta
English: There is evidence of a higher frequency of certain types of infections (see section 4.4).
Croatian: Također je dokazana veća učestalost određenih vrsta infekcija (vidjeti dio 4.4).
English: Like all medicines, CellCept can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, CellCept može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: These changes may suggest a ‘left shift' in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive CellCept.
Croatian: Te promjene kod krvnih pretraga mogu predstavljati „pomak u lijevo“ zrelosti neutrofila koji se, kod imunosuprimiranih bolesnika poput onih koji primaju CellCept, može pogrešno interpretirati kao znak infekcije.
English: Treatment with CellCept should be initiated and maintained by appropriately qualified transplant specialists.
Croatian: Liječenje lijekom CellCept smiju započeti i voditi liječnici specijalisti odgovarajuće kvalificirani u području transplantacijske medicine.
English: Other problems such as: weight loss, gout, high blood sugar, bleeding, bruising.
Croatian: Ostale poteškoće poput: • gubitka težine, gihta, visokog šećera u krvi, krvarenja, modrica
English: Metabolism and nutrition disorders Acidosis
Croatian: Poremećaji metabolizma i prehrane Acidoza
English: CellCept 500 mg film-coated tablets: 1 carton contains 50 tablets (in blister packs of 10)
Croatian: CellCept filmom obložene tablete 500 mg: Jedno pakiranje sadrži 50 tableta (u blister pakiranjima od 10 tableta)
English: Do not stop taking CellCept unless your doctor tells you to.
Croatian: Nemojte prestati uzimati CellCept, osim ako Vam to ne kaže Vaš liječnik.
English: However, keep taking CellCept until you see him or her.
Croatian: Međutim, nastavite uzimati CellCept sve dok ga ne posjetite.
English: Therapeutic drug monitoring of MPA may be appropriate when switching combination therapy (e.g. from ciclosporin to tacrolimus or vice versa) or to ensure adequate immunosuppression in patients with high immunological risk (e.g. risk of rejection, treatment with antibiotics, addition or removal of an interacting medication).
Croatian: Možda će biti primjereno provesti terapijsko praćenje koncentracije MPA kod prelaska na drugu kombiniranu terapiju (npr. s ciklosporina na takrolimus ili obrnuto) ili kako bi se osigurala odgovarajuća imunosupresija u bolesnika s visokim imunološkim rizikom (npr. rizik od odbacivanja presatka, liječenje antibioticima, dodavanje ili prekid primjene lijeka koji uzrokuje interakciju).
English: • isavuconazole - used to treat fungal infections
Croatian: • izavukonazol - koristi se za liječenje gljivičnih infekcija
English: Mycophenolate has been shown to be genotoxic in animal studies at concentrations exceeding the human therapeutic exposures only by small margins such that the risk of genotoxic effects on sperm cells cannot completely be excluded.
Croatian: U ispitivanjima na životinjama mikofenoklat se pokazao genotoksičnim pri koncentracijama koje tek neznatno premašuju terapijske razine izloženosti u ljudi, zbog čega se rizik od genotoksičnog učinka na stanice sperme ne može potpuno isključiti.
English: Contraception in men taking CellCept
Croatian: Kontracepcija u muškaraca koji uzimaju CellCept
English: This needs mixing with purified water before using.
Croatian: Prije primjene treba ga pomiješati s pročišćenom vodom.
English: Precautions to be taken before handling or administering the medicinal product.
Croatian: Mjere opreza koje treba poduzeti prije rukovanja lijekom ili njegove primjene
English: PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets.
Croatian: OBLIK I SADRŽAJ 50 filmom-obloženih tableta.
English: Adverse reactions attributable to peripheral venous infusion were phlebitis and thrombosis, both observed at 4% in patients treated with CellCept 500 mg powder for concentrate for solution for infusion.
Croatian: Nuspojave koje su se mogle pripisati infuziji u perifernu venu bile su flebitis i tromboza, koje su obje opažene u 4% bolesnika liječenih CellCept 500 mg praškom za koncentrat za otopinu za infuziju.
English: Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed).
Croatian: Prijavljene prirođene mane uključuju anomalije ušiju, očiju, lica (rascjep usne/nepca), razvoja prstiju, srca, jednjaka (cijevi koja povezuje grlo sa želucem), bubrega i živčanog sustava (npr. spina bifida [kod koje se kosti kralježnice nisu pravilno razvile]).
English: Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin
Croatian: Kapsule ne otvarajte niti ne lomite te ne udišite prašak koji se nalazi unutar kapsule i izbjegavajte doticaj praška s kožom
English: A negligible amount of substance is excreted as MPA (< 1% of dose) in the urine.
Croatian: Zanemariva količina lijeka izlučuje se u urin u obliku MPA (< 1% doze).
English: The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered in the elderly patients (≥ 65 years) when compared to younger patients.
Croatian: Nije utvrđena izmijenjena farmakokinetika mofetilmikofenolata ni njegovih metabolita u starijih bolesnika (≥ 65 godina) u odnosu na mlađe bolesnike s presatkom.
English: Gastrointestinal hemorrhage
Croatian: Gastrointestinalno krvarenje
English: The dose given will vary depending on the size of the child.
Croatian: • Primijenjena će se doza razlikovati ovisno o veličini djeteta.
English: This data support extrapolation of this finding to all antacids because the reduction in exposure when CellCept was coadministered with magnesium and aluminium hydroxides is considerably less than when CellCept was co-administered with PPIs.
Croatian: Ti podaci podržavaju ekstrapolaciju ovih zaključaka na sve antacide jer je smanjenje izloženosti u slučaju kada je CellCept istodobno primjenjivan s magnezijevim i aluminijevim hidroksidom značajno manje, nego kada je CellCept istodobno primjenjivan s IPP.
English: Patients on CellCept who develop recurrent infections should have their serum immunoglobulins measured.
Croatian: Bolesnicima koji uzimaju CellCept i razviju rekurentne infekcije moraju se izmjeriti vrijednosti serumskih imunoglobulina.
English: Counselling of patients: This section will emphasise the importance of a thorough, informative and ongoing dialogue between patient and healthcare professional about the pregnancy risks associated with mycophenolate mofetil and the relevant minimisation strategies including alternative treatment choices, if applicable.
Croatian: U ovom će se dijelu naglasiti važnost iscrpnog, informativnog i neprekidnog dijaloga između bolesnika i zdravstvenog radnika o riziku od trudnoće kod primjene mofetilmikofenolata te značajnim strategijama za minimizaciju tog rizika, uključujući druge terapijske opcije, ako one postoje.
English: A further dilution with glucose intravenous infusion 5% is required to a final concentration of 6 mg/mL.
Croatian: Daljnje razrjeđivanje glukozom 5% za infuziju u venu potrebno je do konačne koncentracije od 6 mg/ml.
English: The made-up medicine can be used for 2 months.
Croatian: • Pripremljeni se lijek mora iskoristiti unutar dva mjeseca.
English: Hematuria
Croatian: Hematurija
English: Take 7.5 mL suspension in the morning and then 7.5 mL suspension in the evening.
Croatian: • Uzmite 7,5 ml suspenzije ujutro i 7,5 ml suspenzije navečer.
English: Changes to CellCept therapy should only be undertaken under appropriate supervision in transplant recipients in order to minimise the risk of graft rejection (see section 4.8).
Croatian: U transplantiranih primatelja promjene u liječenju lijekom CellCept smiju se poduzeti samo pod odgovarajućim nadzorom kako bi se smanjio rizik od odbacivanja presatka (vidjeti dio 4.8).
English: Multiple dosing of mycophenolate mofetil in patients with severe chronic renal impairment has not been studied.
Croatian: Višestruko doziranje mofetilmikofenolata kod bolesnika s teškim kroničnim oštećenjem bubrežne funkcije nije ispitano.
English: Following reconstitution to a concentration of 6 mg/mL, CellCept 500 mg powder for concentrate for solution for infusion must be administered by slow intravenous infusion over a period of 2 hours by either a peripheral or a central vein (see section 6.6).
Croatian: Nakon rekonstitucije do koncentracije od 6 mg/ml, CellCept 500 mg prašak za koncentrat za otopinu za infuziju mora se primijeniti u perifernu ili središnju venu kao polagana intravenska infuzija u trajanju od 2 sata (vidjeti dio 6.6).
English: These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle), headache, flu symptoms and swelling.
Croatian: To uključuje ozbiljne alergijske reakcije (kao što su anafilaksija, angioedem), vrućicu, osjećaj teškog umora, poteškoće sa spavanjem, bolove (primjerice u trbuhu, prsima, zglobovima ili mišićima), glavobolju, simptome gripe i oticanje.
English: Take 2 tablets in the morning and then 2 tablets in the evening.
Croatian: • Uzmite 2 tablete ujutro te 2 tablete navečer.
English: Skin hypertrophy
Croatian: Hipertrofija kože
English: Advice on action if a pregnancy occurs or is suspected during or shortly after being treated with mycophenolate mofetil.
Croatian: • Savjet o koracima koje treba poduzeti ako dođe do trudnoće ili ako se na nju posumnja tijekom liječenja mofetilmikofenolatom ili ubrzo nakon njega.
English: The need to avoid foetal exposure: Contraceptive requirements for patients of reproductive potential prior to, during and after treatment with mycophenolate mofetil.
Croatian: • Potreba za izbjegavanjem izlaganja fetusa lijeku: Zahtjevi za primjenom kontracepcije kod bolesnika i bolesnica reproduktivne dobi prije, tijekom i nakon liječenja mofetilmikofenolatom.
English: An estimated total of 1557 patients received CellCept during five clinical trials in the prevention of acute organ rejection.
Croatian: Procjenjuje se da je u pet kliničkih ispitivanja ukupno 1557 bolesnika primilo CellCept za sprječavanje akutnog odbacivanja presatka.
English: Safety and efficacy of CellCept for infusion in paediatric patients have not been established.
Croatian: Sigurnost i djelotvornost infuzije lijeka CellCept kod djece nije ustanovljena.
English: LIST OF EXCIPIENTS Also contains aspartame (E951) and methyl parahydroxybenzoate (E218).
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: aspartam (E951) i metilparahidroksibenzoat (E218)
English: • septum pellucidum agenesis;
Croatian: • ageneze septuma pellucidum
English: Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept itself, concomitant medications, viral infections, or some combination of these causes.
Croatian: Bolesnike koji primaju CellCept potrebno je pažljivo nadzirati kako bi se opazili znakovi neutropenije, koju može izazvati sam CellCept, lijekovi koji se istodobno primjenjuju, virusne infekcije ili kombinacija tih uzroka.
English: If this happens, rinse with plenty of plain water.
Croatian: • Ako se to dogodi, isperite s puno obične vode.
English: Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.
Croatian: Gastrointestinalni učinci primijećeni su kod pasa pri razinama sistemske izloženosti ekvivalentnim ili manjim od kliničke izloženosti pri preporučenim dozama.
English: The change in predose level may not accurately represent changes in overall MPA exposure.
Croatian: Promjene koncentracije lijeka neposredno prije sljedeće doze možda nisu točan pokazatelj promjene ukupne izloženosti MPA.
English: An estimated total of 1268 patients received CellCept during four clinical trials in the prevention of acute organ rejection.
Croatian: Procjenjuje se da je u četiri klinička ispitivanja ukupno 1268 bolesnika primilo CellCept za sprječavanje akutnog odbacivanja presatka.
English: Male patients of reproductive potential should be made aware of and discuss with a qualified health-care professional the potential risks of fathering a child.
Croatian: Muške bolesnike reproduktivne dobi kvalificirani zdravstveni radnik treba upoznati i s njima razgovarati o mogućim rizicima povezanima sa začećem djeteta.
English: CellCept has a moderate influence on the ability to drive and use machines.
Croatian: CellCept umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Therefore, care should be taken if CellCept 1 g/5 ml powder for oral suspension is administered to patients with phenylketonuria (see section 6.1)
Croatian: Stoga treba paziti ako se prašak za pripremu oralne suspenzije CellCept 1 g/5 ml daje bolesnicima s fenilketonurijom (pogledajte odjeljak 6.1).
English: Diarrhoea, leucopenia, sepsis and vomiting were among the most common and/or serious adverse drug reactions associated with the administration of CellCept in combination with ciclosporin and corticosteroids.
Croatian: Proljev, leukopenija, sepsa i povraćanje bile su neke od najčešćih i/ili najozbiljnijih nuspojava primjene lijeka CellCept u kombinaciji s ciklosporinom i kortikosteroidima.
English: Venous thrombosis
Croatian: Venska tromboza
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON FOR BLISTER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA ZA BLISTER
English: In addition, a pregnancy follow-up questionnaire including details of exposure during pregnancy, including timing and dose; duration of therapy, before and during pregnancy; concomitant drugs; known teratogenic risks and full details of congenital malformations should be agreed to with the national competent authorities.
Croatian: Osim toga, s nacionalnim nadležnim tijelom treba dogovoriti i upitnik za praćenje trudnoće koji će obuhvatiti pojedinosti o izlaganju lijeku tijekom trudnoće, uključujući vrijeme primjene i dozu; trajanje liječenja prije i tijekom trudnoće; istodobno primijenjene lijekove; poznate teratogene rizike i sve pojedinosti o prirođenim malformacijama.
English: Reconstituted solution and infusion solution: Store at 15 - 30°C.
Croatian: Rekonstituirani koncentrat i infuzijska otopina: čuvati na temperaturi od 15-30°C.
English: If you are not sure, talk to your doctor or pharmacist before taking CellCept.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka CellCept.
English: Shake the closed bottle well for about 5 seconds before each use.
Croatian: Prije svake uporabe dobro protresite zatvorenu bocu tijekom 5 sekundi.
English: Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.
Croatian: Budući da su T- i B-limfociti izuzetno ovisni o de novo sintezi purina u svojoj proliferaciji, dok druge vrste stanica mogu iskoristiti pomoćne puteve, citostatski učinci MPA izraženiji su na limfocite nego na druge stanice.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CellCept film-coated tablets should be handled with care Do not crush the tablets
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO CellCept filmom obloženim tabletama rukujte oprezno Tablete ne lomite
English: Cardiac transplant n = 289
Croatian: Srčani presadak n = 289
English: Do this by: wearing protective clothing which also covers your head, neck, arms and legs using a sunscreen with a high protection factor.
Croatian: • nosite zaštitnu odjeću koja također pokriva Vašu glavu, vrat, ruke i noge
English: Take 3 tablets in the morning and then 3 tablets in the evening.
Croatian: • Uzmite 3 tablete ujutro te 3 tablete navečer.
English: Add the remainder of water and shake the closed bottle well for about 1 minute.
Croatian: Dodajte preostalu vodu i snažno protresite zatvorenu bočicu oko 1 minutu.
English: • If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in Section 6)
Croatian: • ako ste alergični (preosjetljivi) na mofetilmikofenolat, mikofenolatnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Your doctor will decide the most appropriate dose based on your child's height and weight (body surface area - measured as square metres or “m²”).
Croatian: • Liječnik će odrediti odgovarajuću dozu na temelju visine i težine Vašeg djeteta (tjelesna površina djeteta mjerena u metrima kvadratnim ili „m²“).
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.
Croatian: Smanjenje AUC-a MPA od otprilike 40% vezano je uz istodobnu primjenu kolestiramina (4 g triput dnevno), što ukazuje na značajnu količinu enterohepatične recirkulacije.
English: There is no basis for CellCept dose adjustment following cardiac transplant rejection.
Croatian: Ne postoji osnova za promjenu terapijske doze lijeka CellCept nakon odbacivanja presađenog srca.
English: CellCept 500 mg powder for concentrate for solution for infusion must be prepared in two steps: the first step is a reconstitution step with glucose intravenous infusion 5% and the second step is a dilution step with glucose intravenous infusion 5%.
Croatian: CellCept 500 mg prašak za koncentrat za otopinu za infuziju priprema se u dva koraka: prvi je korak rekonstitucija otopinom 5%-tne glukoze za intravensku infuziju, a drugi korak razrjeđivanje otopinom 5%-tne glukoze za intravensku infuziju.
English: If this happens, wash the area thoroughly with soap and water.
Croatian: • Ako do toga dođe, temeljito isperite područje sapunom i vodom.
English: Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (2327 %) in the unborn baby.
Croatian: Mikofenolat vrlo često uzrokuje spontani pobačaj (50%) i teške prirođene mane (23 - 27%) kod nerođena djeteta.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Avoid skin contact with infusion solution
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Izbjegavajte doticaj kože s otopinom za infuziju
English: The most common gastrointestinal disorders, however, were diarrhea, nausea and vomiting.
Croatian: Međutim, najčešći poremećaji probavnog sustava bili su proljev, mučnina i povraćanje.
English: In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively unaffected by hepatic parenchymal disease.
Croatian: Kod dobrovoljnih ispitanika s alkoholnom cirozom, procesi glukuronidacije MPA u jetri bili su relativno nepromijenjeni bolešću jetrenog parenhima.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign neoplasm of skin
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Dobroćudna kožna novotvorina