FrancophonIA/ELRC3.0 huggingface dataset:
English: These data support extrapolation of this finding to all antacids because the reduction in exposure when mycophenolate mofetil was co- administered with magnesium and aluminium hydroxides is considerably less than when mycophenolate mofetil was co-administered with PPIs.
Croatian: Ti podaci podržavaju ekstrapolaciju ovih zaključaka na sve antacide jer je smanjenje izloženosti u slučaju kada je mofetilmikofenolat istodobno primjenjivan s magnezijevim i aluminijevim hidroksidom značajno manje, nego kada je mofetilmikofenolat istodobno primjenjivan s IPP.
English: • serious disease of the central nervous system (JC virus associated progressive multifocal leucoencephalopathy)
Croatian: • ozbiljna bolest središnjeg živčanog sustava (progresivna multifokalna leukoencefalopatija povezana s JC virusom)
English: Cases of hepatitis due to reactivation of hepatitis B or hepatitis C have been reported in carrier patients treated with immunosuppressants.
Croatian: Prijavljeni su slučajevi hepatitisa kao posljedice reaktivacije hepatitisa B ili hepatitisa C u nositelja virusa liječenih imunosupresivima.
English: The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
Croatian: Promjene u farmakokinetici mikofenolglukuronida (MPAG-a) (fenolni glukuronid MPA) bile su minimalne (MPAG se povećao za 8 %) i nisu se smatrale klinički značajnima.
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), srednji AUC MPA kod bolesnika s presađenim bubregom, srcem ili jetrom bio je otprilike 30% niži, dok je Cmax bio otprilike 40% niži u odnosu na kasnije razdoblje nakon presađivanja (3 - 6 mjeseci nakon presađivanja).
English: It is not known whether this substance is excreted in human milk.
Croatian: Nije poznato izlučuje li se ta tvar u majčino mlijeko u ljudi.
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).
Croatian: Možda će biti primjereno provesti terapijsko praćenje koncentracije MPA-a 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).
English: • infection of the lung, flu, infection of the respiratory tract
Croatian: • infekcija pluća, gripa, infekcija dišnog sustava
English: If neutropenia develops, dosing with Myfenax should be interrupted or the dose reduced (see section 4.4).
Croatian: Ako se pojavi neutropenija, treba prekinuti primjenu Myfenaxa ili smanjiti dozu (vidjeti dio 4.4).
English: Treatment with Myfenax should be initiated and maintained by appropriately qualified transplant specialists.
Croatian: Liječenje Myfenaxom trebaju započeti i voditi liječnici specijalisti odgovarajuće kvalificirani u području transplantacijske medicine.
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 Myfenax.
Croatian: Te promjene kod krvnih pretraga mogu predstavljati „pomak u lijevo“ zrelosti neutrofila koji se, kod imunosuprimiranih bolesnika poput onih koji primaju Myfenax, može pogrešno interpretirati kao znak infekcije.
English: Myfenax contains sodium
Croatian: Myfenax sadrži natrij
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-a i tako dovesti do smanjene sistemske izloženosti MPA-u.
English: There is no basis for Myfenax dose adjustment following cardiac transplant rejection.
Croatian: Ne postoji osnova za promjenu terapijske doze Myfenaxa nakon odbacivanja presađenog srca.
English: Treatment should not be initiated without providing a negative pregnancy test result to rule out unintended use in pregnancy.
Croatian: Liječenje ne smije započeti prije nego što se predoči negativan nalaz testa na trudnoću kako bi se isključila mogućnost nehotične primjene u trudnoći.
English: Based on the results of a single dose administration study of recommended doses of oral mycophenolate mofetil and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that coadministration 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 mofetilmikofenolata i intravenskog ganciklovira u preporučenoj dozi te poznatih učinaka oštećenja bubrega na farmakokinetiku mofetilmikofenolata (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: Myfenax has not been shown to impair your ability to drive or operate machines.
Croatian: Myfenax nije pokazao učinak na smanjenje sposobnosti upravljanja motornim vozilima ili strojevima.
English: In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, agnathia and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
Croatian: U ispitivanju plodnosti ženki i reprodukcije provedenom na štakorima, oralne doze od 4,5 mg/kg/dan uzrokovale su malformacije (uključujući anoftalmiju, agnatiju i hidrocefalus) u prvom naraštaju potomaka, dok toksičnost za majku nije primijećena.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/
English: In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Croatian: Kod bolesnika koji ne uzimaju i ciklosporin, istodobna primjena mofetilmikofenolata i rifampicina rezultirala je smanjenjem izloženosti MPA-u (AUC0-12 h) od 18% do 70%.
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: Patients receiving Myfenax should be monitored for neutropenia, which may be related to Myfenax itself, concomitant medicinal products, viral infections, or some combination of these causes.
Croatian: Bolesnike koji primaju Myfenax treba pažljivo nadzirati kako bi se opazili znakovi neutropenije, koju može izazvati sam Myfenax, lijekovi koji se istodobno primjenjuju, virusne infekcije ili kombinacija tih uzroka.
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 Myfenax.
Croatian: Vi ili Vaša partnerica koristite pouzdanu kontracepciju tijekom liječenja i još 90 dana nakon što prestanete uzimati Myfenax.
English: • inflammation of the pancreas, which causes severe pain in the abdomen and back
Croatian: • upala gušterače što uzrokuje jaki bol u trbuhu i leđima
English: Patients should be advised that during treatment with Myfenax, 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 Myfenaxom cijepljenje možda biti manje djelotvorno te da treba izbjegavati primjenu živog atenuiranog cjepiva (vidjeti dio 4.5).
English: Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Croatian: Smanjenje Cmax i AUC0-12h MPA za 30% odnosno 25% primijećeno je pri istodobnoj primjeni mofetilmikofenolata i sevelamera bez ikakvih kliničkih posljedica (tj. odbacivanja presađenog organa).
English: The recommended dose is 600°mg/m2 taken twice a day.
Croatian: Preporučena doza je 600 mg/m2 i uzima se dvaput dnevno.
English: Myfenax is used to prevent your body rejecting a transplanted kidney, heart or liver.
Croatian: Myfenax se koristi za sprječavanje tijela da odbaci presađeni bubreg, srce ili jetru.
English: Ciprofloxacin or amoxicillin plus clavulanic acid
Croatian: Ciprofloksacin ili amoksicilin s klavulanskom kiselinom
English: • fungal infections (e.g. of the respiratory tract, skin and vagina)
Croatian: • gljivične infekcije (npr. dišnog sustava, kože i rodnice)
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: Following single dose administration of 1.5°g of mycophenolate mofetil to normal healthy subjects pre-treated with 4°g three times a day (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 osoba koje su prethodno liječene 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: If you answer yes to any of the following questions talk to your doctor before you start to take Myfenax:
Croatian: Ako odgovorite potvrdno na bilo koje od sljedećih pitanja, prije uzimanja Myfenaxa posavjetujte se sa svojim liječnikom:
English: Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.
Croatian: Blijedo ljubičasta, duguljasta filmom obložena tableta s utisnutom oznakom "M500" na jednoj strani i bez oznake na drugoj strani.
English: Before starting Myfenax treatment, women of childbearing potential must 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 Myfenax, 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: Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA.
Croatian: Nakon peroralne primjene, mofetilmikofenolat brzo se i ekstenzivno apsorbira i prolazi cjelokupni metabolizam sve do aktivnog metabolita, MPA.
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: • too much acid in the body
Croatian: • previsoka kiselost tijela
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom
Croatian: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG Velika Britanija
English: The active substance in this medicine is called mycophenolate mofetil.
Croatian: Djelatna tvar u ovom lijeku zove se mofetilmikofenolat.
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Croatian: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG Velika Britanija
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-u.
English: Myfenax 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: Myfenax se ne smije davati bolesnicima s preosjetljivošću na mofetilmikofenolat, mikofenolnu kiselinu ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Croatian: U teratološkim ispitivanjima provedenima na štakorima i zečevima, fetalne resorpcije i malformacije javljale su se u štakora pri dozi od 6 mg/kg/dan (uključujući anoftalmiju, agnatiju i hidrocefalus), a u zečeva pri dozama od 90 mg/kg/dan (uključujući kardiovaskularne i bubrežne anomalije, kao što su srčana ektopija i ektopični bubrezi te dijafragmalna i pupčana hernija), dok toksičnost za majku nije primijećena.
English: It is recommended that mycophenolate mofetil should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Croatian: Ne preporučuje se primjenjivati mofetilmikofenolat istodobno s azatioprinom jer njihova istodobna primjena nije ispitana.
English: See also further information in this section under “Warnings and precautions” and “Pregnancy, contraception and breast-feeding”.
Croatian: Za više informacija pogledajte i odlomke 'Upozorenja i mjere opreza' te 'Trudnoća i dojenje', koji se nalaze u ovome dijelu.
English: This means taking 3°tablets in the morning then 3°tablets in the evening.
Croatian: To znači da se 3 tablete uzimaju ujutro, a 3 tablete navečer.
English: • insufficient production of red blood cells
Croatian: • ozbiljne bolesti koštane srži • nedovoljna proizvodnja crvenih krvnih stanica
English: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA).
Croatian: Mofetilmikofenolat je 2-morfolinoetil ester mikofenolne kiseline (MPA).
English: Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
Croatian: Dodatne nuspojave prijavljene u sklopu stalnog praćenja sigurnosti primjene nakon stavljanja na tržište navedene su u nastavku s učestalošću navedenom u zagradama ako je ona poznata.
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.
Croatian: U raspoloživosti MPA sudjeluju organski anionski transportni polipeptidi (engl. organic anion-transporting polypeptide, OATP) i protein povezan s rezistencijom na više lijekova 2 (engl. multidrug resistance-associated protein 2, MRP2); izooblici OATP-a, MRP2 i protein koji uzrokuje rezistenciju raka dojke na lijekove (engl. breast cancer resistance protein, BCRP) prijenosnici su povezani s izlučivanjem tih glukuronida kroz žuč.
English: The first dose will be given within 72°hours after the transplant operation.
Croatian: Prvu dozu primit ćete najkasnije 72 sata nakon presađivanja.
English: • weight loss
Croatian: • smanjenje tjelesne težine
English: Agranulocytosis (≥1/1000 to <1/100) and neutropenia have been reported; therefore regular monitoring of patients taking Myfenax is advised (see section 4.4).
Croatian: Prijavljene su agranulocitoza (manje često) i neutropenija, stoga se preporučuje redovito praćenje bolesnika koji uzimaju Myfenax (vidjeti dio 4.4).
English: Patients treated with immunosuppressants, including Myfenax, 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 Myfenax, imaju povećani rizik za oportunističke infekcije (bakterijske, gljivične, virusne i protozoalne), infekcije koje mogu imati smrtni ishod i sepse (vidjeti dio 4.8).
English: • skin cancer, non-cancerous growth of the skin
Croatian: • rak kože izrasline na koži koje nisu povezane sa rakom
English: The mean single dose MPAG AUC was 3-6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Croatian: 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: The capsule body is caramel opaque, printed with ‘250' axially in black ink.
Croatian: Tijelo kapsule je neprozirno, boje karamela, s oznakom ‘250' uzdužno otisnutom crnom tintom.
English: MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive phenolic glucuronide of MPA (MPAG).
Croatian: Biotransformacija MPA se uglavnom metabolizira glukuronil transferazom (izooblik UGT1A9), stvarajući neaktivan fenolni glukuronid MPA (MPAG).
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 mofetilmikofenolatom.
English: Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Myfenax is contraindicated in breast-feeding mothers (see section 4.3).
Croatian: Zbog mogućih ozbiljnih nuspojava mofetilmikofenolata kod dojenčadi Myfenax je kontraindiciran u dojilja (vidjeti dio 4.3).
English: Paediatric population No data are available for paediatric cardiac transplant patients.
Croatian: Pedijatrijska populacija Nisu dostupni podaci za pedijatrijske bolesnike s presađenim srcem.
English: Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased
Croatian: Pretrage vrlo često često povišene razine jetrenih enzima, povišena razina kreatinina u krvi, povišena razina laktat-dehidrogenaze u krvi, povišena razina ureje u krvi, povišena razina alkalne fosfataze u krvi, smanjenje tjelesne težine
English: • severe reduction in the number of certain white blood cells (possible symptoms are fever, sore throat, frequent infections) (agranulocytosis)
Croatian: • veliko smanjenje broja određenih bijelih krvnih stanica (mogući simptomi su vrućica, upala grla,
English: Reductions in pre-dose (trough) MPA concentrations of about 50% have been reported in renal transplant recipients in the days immediately following commencement of oral ciprofloxacin or amoxicillin plus clavulanic acid.
Croatian: Kod primatelja bubrežnog presatka uočena su smanjenja najnižih koncentracija mikofenolatne kiseline (izmjerene neposredno prije primjene sljedeće doze) za oko 50% u prvim danima nakon početka primjene oralnog ciprofloksacina ili amoksicilina plus klavulanske kiseline.
English: Myfenax capsules should be handled with care.
Croatian: Myfenax kapsulama rukujte oprezno.
English: Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in patients treated with mycophenolate mofetil in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
Croatian: Nuspojave, vjerojatno ili moguće povezane sa mofetilmikofenolatom, prijavljene u ispitivanjima kod bolesnika s presađenim bubregom, srcem i jetrom liječenih mofetilmikofenolatom u kombinaciji s ciklosporinom i kortikosteroidima
English: • Background information on mycophenolate mofetil teratogenicity and mutagenicity in humans.
Croatian: • Pozadinske informacije o teratogenosti i mutagenosti mofetilmikofenolata u ljudi.
English: Patients on mycophenolate mofetil who develop recurrent infections should have their serum immunoglobulins measured.
Croatian: Bolesnicima koji uzimaju mofetilmikofenolat i razviju rekurentne infekcije moraju se izmjeriti vrijednosti serumskih imunoglobulina.
English: Serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH) and progesterone were not significantly affected.
Croatian: Istodobna primjena nije znatno utjecala na razine luteinizirajućeg hormona (LH), folikul stimulirajućeg hormona (FSH) i progesterona u serumu.
English: • Septum pellucidum agenesis;
Croatian: • ageneze septuma pellucidum
English: It is recommended that the second test should be performed 8-10 days after the first test. For transplants from deceased donors, if it is not possible to perform two tests 8-10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8-10 days later.
Croatian: Ako kod presađivanja organa preminulih davatelja nije moguće provesti dva testa u razmaku od 8 - 10 dana prije početka liječenja (zbog razdoblja dostupnosti presatka), jedan test na trudnoću mora se provesti neposredno prije početka liječenja, a drugi 8 - 10 dana nakon toga.
English: How to take Myfenax
Croatian: Kako uzimati Myfenax
English: Caution should be used during concomitant administration because of the potential to reduce efficacy of mycophenolate mofetil.
Croatian: Tijekom istodobne primjene potreban je povećani oprez zbog moguće smanjene djelotvornosti mofetilmikofenolata.
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 bubrega (brzina glomerularne filtracije < 25 ml/min/1,73 m2) izvan neposrednog postoperativnog razdoblja, treba izbjegavati doze veće od 1 g primjenjene dvaput dnevno.