FrancophonIA/ELRC3.0 huggingface dataset:
English: • You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner's syndrome or uterine agenesis
Croatian: • rođeni ste s jednim od sljedećih rijetkih urođenih stanja koja onemogućuju trudnoću: XY
English: Children may be more likely than adults to have some side effects.
Croatian: Veća je vjerojatnost da će se neke nuspojave pojaviti kod djece nego kod odraslih.
English: Patients treated with immunosuppressants, including Myclausen, 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 Myclausen, imaju povećani rizik za oportunističke infekcije (bakterijske, gljivične, virusne i protozoalne), infekcije sa smrtnim ishodom i sepse (vidjeti dio 4.8).
English: Patients should be advised that during treatment with Myclausen, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Croatian: Bolesnike treba upozoriti da će tijekom liječenja Myclausenom cijepljenje možda biti manje djelotvorno te da treba izbjegavati primjenu živog atenuiranog cjepiva (vidjeti dio 4.5).
English: The educational materials will reinforce the warnings about the teratogenicity of mycophenolate, provide advice on contraception before therapy is started and guidance on the need for pregnancy testing.
Croatian: U edukacijskim će se materijalima naglasiti upozorenje o teratogenosti mikofenolata, dati savjeti o kontracepciji prije početka liječenja te upozoriti na potrebu za provođenjem testova na trudnoću.
English: • tremor, muscle spasms, convulsions
Croatian: • nevoljno drhtanje, grčevi u mišićima, konvulzije
English: It is not known whether this substance is excreted in human milk.
Croatian: Nije poznato izlučuje li se ta tvar u majčino mlijeko.
English: The following undesirable effects cover adverse reactions from clinical trials The principal adverse reactions associated with the administration of mycophenolate mofetil in combination with ciclosporin and corticosteroids include diarrhoea, leucopenia, sepsis and vomiting, and there is evidence of a higher frequency of certain types of infections (see section 4.4).
Croatian: Sljedeći neželjeni učinci obuhvaćaju nuspojave prijavljene u kliničkim ispitivanjima Glavne nuspojave, vezane uz primjenu mofetilmikofenolata u kombinaciji s ciklosporinom i kortikosteroidima, su proljev, leukopenija, sepsa i povraćanje, a dokazana je veća učestalost određenih vrsta infekcija (vidjeti dio 4.4).
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
Croatian: U ispitivanju jedne doze (6 ispitanika/skupina), srednje vrijednosti AUC-a MPA u plazmi ispitanika s teškim kroničnim oštećenjem bubrega (brzina glomerularne filtracije < 25 ml•min
English: PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets
Croatian: OBLIK I SADRŽAJ 50 filmom obloženih tableta
English: General unwanted effects
Croatian: Opći neželjeni učinci
English: Medicinal products of other classes which interfere with MPA's enterohepatic cycle e.g. cholestyramine should be used with caution due to their potential to reduce the plasma levels and efficacy of Myclausen (see also section 4.5).
Croatian: Lijekove iz drugih skupina koji interferiraju s enterohepatičnom cirkulacijom MPA (npr. kolestiramin) treba primjenjivati uz oprez jer mogu sniziti plazmatske razine i djelotvornost lijeka Myclausen (vidjeti također dio 4.5).
English: PHARMACEUTICAL FORM AND CONTENTS 150 film-coated tablets
Croatian: OBLIK I SADRŽAJ 150 filmom obloženih tableta
English: • Myclausen should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1.
Croatian: • Myclausen se ne smije davati bolesnicima s preosjetljivošću na mofetilmikofenolat, mikofenolatnu kiselinu ili neku od pomoćnih tvari navedenih u dijelu 6.1.
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)).Your baby may be affected by one or more of these.
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: • The first dose will be given within 3 days after the transplant operation.
Croatian: • Prva doza se daje unutar 3 dana nakon presađivanja.
English: If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking Myclausen.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas (ili niste sigurni), prije uzimanja lijeka Myclausen odmah razgovarajte sa svojim liječnikom.
English: Digestive system and mouth problems such as:
Croatian: Poremećaje probavnog sustava i usta kao što su:
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/m mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g mycophenolate mofetil twice daily.
Croatian: Vrsta i učestalost nuspojava uočenih u kliničkom ispitivanju s 92 pedijatrijska bolesnika u dobi od 2 do 18 godina, koji su peroralno primali 600 mg/m mofetilmikofenolata dvaput dnevno, bila je uglavnom slična onima uočenima kod odraslih bolesnika koji su uzimali 1 g mofetilmikofenolata dvaput dnevno.
English: Myclausen contains sodium
Croatian: Myclausen sadrži natrij
English: Myclausen 500 mg film-coated tablets are available in PVC-aluminium blisters containing 10 tablets.
Croatian: Myclausen 500 mg filmom obložene tablete dostupne su u PVC-aluminij blisterima koji sadrže po 10 tableta.
English: • Myclausen should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Croatian: • Myclausen se ne smije davati ženama reproduktivne dobi koje ne koriste visoko učinkovite metode kontracepcije (vidjeti dio 4.6).
English: • Do not break or crush them.
Croatian: • Nemojte ih lomiti ili drobiti.
English: Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil.
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 Myclausen.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency 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: This is to stop you rejecting your transplant.
Croatian: To je iz razloga da se spriječi odbacivanje Vašeg presađenog organa.
English: Lymph and skin cancer
Croatian: Rak limfoidnog tkiva i kože
English: Do not take Myclausen if you are breast-feeding.
Croatian: Nemojte uzimati Myclausen ako dojite.
English: Very common Common Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased
Croatian: Pretrage vrlo čestočesto povišene razine jetrenih enzima, povišena razina kreatinina u krvi, povišena razina laktatdehidrogenaze u krvi, povišena razina ureje u krvi, povišena razina alkalne fosfataze u krvi, smanjenje tjelesne mase
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: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: INFORMATION IN BRAILLE Myclausen 250 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Myclausen 250 mg
English: Ganciclovir
Croatian: Ganciklovir
English: However, 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: Srednji AUC MPAG-a jedne doze bio je 3-6 puta veći kod ispitanika s teškim oštećenjem bubrega nego kod ispitanika s blagim bubrežnim oštećenjem ili normalnih zdravih ispitanika u skladu s poznatom bubrežnom eliminacijom MPAG-a.
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 counselled 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: Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience.
Croatian: Izvješća o predoziranju mofetilmikofenolatom zabilježena su tijekom kliničkih ispitivanja te nakon stavljanja lijeka u promet.
English: There are no data on mycophenolate mofetil with phosphate binders other than sevelamer.
Croatian: Ne postoje podaci o primjeni mofetilmikofenolata s lijekovima koji vežu fosfate, osim sevelamera.
English: Myclausen contains mycophenolate mofetil.
Croatian: Myclausen sadrži mofetilmikofenolat.
English: Caution should be used during concomitant administration because of the potential to reduce efficacy of Myclausen.
Croatian: Tijekom istodobne primjene potreban je povećani oprez zbog moguće smanjene djelotvornosti Myclausena.
English: Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats.
Croatian: Pokazalo se da se mofetilmikofenolat izlučuje u mlijeko ženki štakora u laktacijskom razdoblju.
English: How to take Myclausen
Croatian: Kako uzimati Myclausen
English: INFORMATION IN BRAILLE Myclausen 500 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Myclausen 500 mg
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 prolaze bubrežno tubularno izlučivanje, mogu natjecati s MPAG-om i tako povećavati koncentracije MPAG-a u plazmi ili druge tvari koja će se tubularno izlučiti.
English: Paediatric population aged 2 to 18 years The recommended dose of mycophenolate mofetil is 600 mg/m administered orally twice daily (up to a maximum of 2 g daily).
Croatian: Pedijatrijska populacija u dobi od 2 do 18 godina Preporučena doza mofetilmikofenolata iznosi 600 mg/m2, primijenjena peroralno dvaput dnevno (najviše 2 g dnevno).
English: • The first dose is given within 5 days of the transplant operation.
Croatian: • Prva doza se daje unutar 5 dana od presađivanja.
English: This includes 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: Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA.
Croatian: Mofetilmikofenolat je 2-morfolinoetil ester MPA.
English: Medicinal products that interfere with enterohepatic circulation Caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of Myclausen.
Croatian: Lijekovi koji se uključuju u enterohepatičnu cirkulaciju Za lijekove koji interferiraju s enterohepatičnom cirkulacijom potreban je povećani oprez zbog mogućnosti smanjenja djelotvornosti Myclausena.
English: • Take 2 tablets in the morning then 2 tablets in the evening.
Croatian: • Uzmite 2 tablete ujutro te 2 tablete navečer.
English: Fighting infections
Croatian: Svladavanje infekcija
English: It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 4.4).
Croatian: Očekuje se da bi predoziranje mofetilmikofenolatom možda moglo rezultirati prekomjernim potiskivanjem funkcije imunološkog sustava i povećanjem podložnosti infekcijama, kao i supresijom koštane srži (vidjeti dio 4.4).
English: Results of all pregnancy tests should be discussed with the patient.
Croatian: Liječnik mora s bolesnicom razgovarati o nalazu svakog testa na trudnoću.
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 23% kod živorođene djece u cjelokupnoj populaciji te približno 4 - 5% kod živorođene djece bolesnica s presatkom solidnog organa liječenih drugim imunosupresivima osim mofetilmikofenolata).
English: Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and congenital malformations in case of exposure during pregnancy;
Croatian: Mikofenolat ima snažan teratogen učinak u ljudi, pa izlaganje tijekom trudnoće povećava rizik od spontanog pobačaja i kongenitalnih malformacija;
English: Patients on Myclausen who develop recurrent infections should have their serum immunoglobulins measured.
Croatian: Bolesnicima koji uzimaju Mofetilmikofenolata i razviju rekurentne infekcije moraju se izmjeriti vrijednosti serumskih imunoglobulina.
English: Very common Common Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
Croatian: Poremećaji metabolizma i prehrane vrlo čestočesto acidoza, hiperkalijemija, hipokalijemija, hiperglikemija, hipomagnezijemija, hipokalcijemija, hiperkolesterolemija, hiperlipidemija, hipofosfatemija, hiperuricemija, giht, anoreksija
English: The most common opportunistic infections in patients receiving mycophenolate mofetil (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), 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 mofetilmikofenolat (2 g ili 3 g dnevno) uz druge imunosupresive u kontroliranim kliničkim ispitivanjima bolesnika s presađenim bubregom (podaci o dozi od 2 g), srcem i jetrom, tijekom praćenja od barem godinu dana, bile su mukokutana kandidijaza, citomegalovirusna (CMV) viremija/sindrom i herpes simpleks.
English: The full name of your medicine is Myclausen 250 mg hard capsules.
Croatian: Puno ime Vašeg lijeka je Myclausen 250 mg kapsule.
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 samog aciklovira.
English: • Take 4 capsules in the morning then 4 capsules in the evening.
Croatian: • Uzmite 4 kapsule ujutro te 4 kapsule navečer.
English: Pregnancy whilst taking mycophenolate must be avoided.
Croatian: Tijekom primjene mikofenolata mora se izbjegavati trudnoća.
English: Co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold.
Croatian: Istodobna primjena probenecida i mofetilmikofenolata kod majmuna trostruko podiže AUC MPAG-a u plazmi.
English: There have been published reports of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants.
Croatian: Objavljeni su izvještaji o bronhiektazijama u odraslih i djece koji su primili Mofetilmikofenolata u kombinaciji s drugim imunosupresivima.
English: Hypersensitivity reactions to mycophenolate mofetil have been observed (see section 4.8).
Croatian: Primijećene su reakcije preosjetljivosti na Myclausen (vidjeti dio 4.8).
English: Myclausen is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Croatian: Myclausen je kontraindiciran tijekom trudnoće, osim ako ne postoji prikladno alternativno liječenje kojim bi se spriječilo odbacivanje presatka.
English: Lung problems such as:
Croatian: Plućne tegobe kao što su:
English: Therefore Myclausen is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Croatian: Stoga je Myclausen kontraindiciran tijekom trudnoće, osim ako ne postoje prikladni alternativni načini liječenja kojima bi se spriječilo odbacivanje presatka.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“.
English: Adverse reactions, reported in patients treated with mycophenolate mofetil in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
Croatian: Nuspojave prijavljene u ispitivanjima bolesnika s presađenim bubregom, srcem i jetrom liječenih mofetilmikofenolatom u kombinaciji s ciklosporinom i kortikosteroidima
English: When comparing rates of transplant rejection, rates of graft loss or adverse event profiles between mycophenolate mofetil patients with and without concomitant telmisartan medication, no clinical consequences of the pharmacokinetic medicinal product-medicinal product interaction were seen.
Croatian: Kada su se uspoređivale stope odbacivanja transplantata, stope gubitka presatka ili profili nuspojava između bolesnika liječenih mofetilmikofenolatom koji su istodobno primali telmisartan i onih koji nisu primali telmisartan, nisu primijećene kliničke posljedice farmakokinetičke interakcije između tih dvaju lijekova.
English: Heart transplant
Croatian: Presađivanje srca
English: This dose achieved MPA AUC values similar to those seen in adult renal transplant patients receiving mycophenolate mofetil at a dose of 1 g bid in the early and late posttransplant period.
Croatian: Uz tu su dozu postignute vrijednosti AUC-a MPA slične vrijednostima opaženima u odraslih bolesnika s presađenim bubregom koji su primali 1 g mofetilmikofenolata dvaput dnevno u ranom i kasnom razdoblju nakon presađivanja.
English: • If you are pregnant or planning to become pregnant or think you may be pregnant If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Croatian: • ako ne koristite učinkovitu kontracepciju (pogledajte dio 'Trudnoća, kontracepcija i dojenje')
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 and implemented within four months after completion of this procedure.
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: In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start Myclausen:
Croatian: Naročito, prije nego što počnete uzimati Myclausen, recite svom liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova:
English: Blood and immune system
Croatian: Poremećaji krvi i imunološkog sustava
English: Patients with a body surface area greater than 1.5 m may be prescribed Myclausen capsules at a dose of 1 g twice daily (2 g daily dose).
Croatian: Bolesnicima tjelesne površine veće od 1,5 m mogu se propisivati Myclausen kapsule u dozi od 1 g dvaput dnevno (dnevna doza 2 g).
English: By interfering with enterohepatic circulation of the medicinal product, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9).
Croatian: Interferencijom s enterohepatičnom cirkulacijom lijeka, lijekovi za snižavanje razine žučnih kiselina, poput kolestiramina, snizuju AUC MPA (vidjeti dio 4.9).
English: • Take 3 tablets in the morning then 3 tablets in the evening.
Croatian: • Uzmite 3 tablete ujutro te 3 tablete navečer.
English: • constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Croatian: • zatvor, mučnina, loša probava, gubitak apetita, vjetrovi.
English: • Myclausen treatment should not be initiated in women of child bearing potential without providing a pregnancy test result to rule out unintended use in pregnancy (see section 4.6).
Croatian: • Liječenje lijekom Myclausen 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: Oral Myclausen should be initiated within 5 days following transplantation.
Croatian: Peroralni Myclausen treba primijeniti u roku od 5 dana nakon presađivanja.
English: Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Myclausen is contraindicated in nursing mothers (see section 4.3).
Croatian: Zbog mogućih teških nuspojava mofetilmikofenolata kod dojenčadi Myclausen je kontraindiciran u dojilja (vidjeti dio 4.3).
English: Congenital malformations have been observed post-marketing in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants, see section 4.6.
Croatian: Nakon stavljanja lijeka u promet primijećene su kongenitalne malformacije u djece bolesnica izloženih lijeku Myclausen u kombinaciji s drugim imunosupresivima (vidjeti dio 4.6).
English: • Myclausen should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Croatian: • Myclausen se ne smije koristiti u trudnoći, osim ako ne postoji prikladno alternativno liječenje kojim bi se spriječilo odbacivanje presatka (vidjeti dio 4.6).
English: There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with mycophenolate mofetil in combination with other immunosuppressants, some of which have been fatal.
Croatian: Zabilježeni su izolirani slučajevi intestinalne plućne bolesti i pulmonarne fibroze kod bolesnika liječenih mofetilmikofenolatom u kombinaciji s drugim imunosupresivima, od kojih su neki bili sa smrtnim ishodom.
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 for renal transplant recipients.
Croatian: Ti su se učinci pojavili na razinama sistemske izloženosti ekvivalentnim ili manjim od kliničke izloženosti pri preporučenoj dozi od 2 g/dan za bolesnike s presađenim bubregom.
English: Paediatric population No data are available for paediatric hepatic transplant patients.
Croatian: Pedijatrijska populacija Nisu dostupni podaci za pedijatrijske bolesnike s presađenom jetrom.