FrancophonIA/ELRC3.0 huggingface dataset:
English: Examination of serum iron storage parameters has shown that there is low systemic absorption of iron
Croatian: Istraživanje parametara skladištenja serumskog željeza pokazalo je postojanje niske sustavne apsorpcije željeza iz Fexerica od otprilike 1 %.
English: The symptoms of acute iron overdose include vomiting, diarrhoea, abdominal pain, irritability, and drowsiness.
Croatian: Simptomi akutnog predoziranja željezom uključuju povraćanje, proljev, bol u abdomenu, razdražljivost i omamljenost.
English: The safety of Fexeric for the treatment of hyperphosphataemia has been investigated in 18 clinical trials involving a total of 1388 CKD 5D patients with treatment duration of up to 2 years and 145 CKD ND patients with treatment duration of 12 weeks to 1 year.
Croatian: Sigurnost Fexerica u liječenju hiperfosfatemije ispitivana je u 18 kliničkih ispitivanja kojima je obuhvaćeno ukupno 1388 bolesnika s KBB 5D čije je liječenje trajalo najviše 2 godine i 145 bolesnika s KBB ND s trajanjem liječenja od 12 tjedana do 1 godine.
English: Reductions in intravenous iron and erythropoiesis-stimulating agent (ESA) use with this medicine have been observed.
Croatian: Opažena su smanjenja u upotrebi intravenskog željeza i lijekova za stimulaciju eritropoeze (LSE) kod primjene ovog lijeka.
English: Of the 557 patients receiving Fexeric in the pooled safety population, there were 67 (12%) patients with evidence of liver dysfunction at baseline.
Croatian: Od 557 bolesnika iz objedinjene populacije za ocjenu sigurnosti primjene koji su primali Fexeric, 67 (12 %) bolesnika imalo je dokazanu disfunkciju jetre na početku.ispitivanja
English: You may have been advised to follow a special diet to prevent the phosphorus in your blood rising to high levels.
Croatian: Možda ste dobili savjet da se držite posebne prehrane kako biste spriječili visoke razine fosfora u krvi.
English: No data are available regarding overdose of Fexeric in humans.
Croatian: Nema dostupnih podataka o predoziranju Fexericom u ljudi.
English: Phosphorus is contained in many foods.
Croatian: Mnoge prehrambene namirnice sadrže fosfor.
English: The safety and effectiveness of Fexeric have not been studied in this population.
Croatian: Fexerica nisu ispitane u toj populaciji.
English: Non-interventional post-authorisation safety study (PASS): prospective, observational, multicentre study in CKD patients treated with Fexeric in order to gain long-term (2 years) safety data (including iron overload events, infective and gastrointestinal events) particularly in EU patients, elderly and very elderly patients, dialysed (HD, PD) and non-dialysed patients, and in addition reflecting the specific risks in subgroups of serum ferritin levels > 500 ng/ml and in patients
Croatian: prospektivno, opservacijsko, multicentrično ispitivanje na bolesnicima s KBB-om koji se liječe Fexericom , kako bi se prikupili dugoročni (dvogodišnji) podaci o sigurnosti primjene (uključujući događaje preopterećenja željezom , infektivne i gastrointestinalne događaje) naročito u bolesnika na području EU-a, starijih i vrlo starih bolesnika, bolesnika na dijalizi (HD, PD) i bolesnika koji nisu na dijalizi, te koje dodatno odražava specifične rizike u podskupinama s razinama feritina u serumu > 500 ng/ml i kod bolesnika u rasponu od 200 do < 500 ng/ml.
English: In patients with CKD, the maximum dose studied was 12 g (12 tablets) of Fexeric per day.
Croatian: U bolesnika s KBB-om, maksimalna ispitivana doza iznosila je 12 g (12 tableta) Fexerica dnevno.
English: Table 1: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD 5D patients on haemodialysis or peritoneal dialysis.
Croatian: Tablica 1: Nuspojave opažene tijekom kliničkih ispitivanja u kojima je Fexeric primijenjen u bolesnika s KBB 5D na hemodijalizi ili peritonejskoj dijalizi.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: During the overall 52-week active-controlled period, the decrease in serum phosphorus (approximately 2.0 mg/dl following up to a 2 week washout period) and the percentage of patients who achieved and maintained serum phosphorus ≤ 5.5 mg/dl (approximately 62%) were comparable in both the Fexeric and the active control groups (Table 3).
Croatian: Tijekom cjelokupnog 52-tjednog razdoblja aktivne kontrole smanjenje razine fosfora u serumu (otprilike 2,0 mg/dl nakon 2tjednog razdbolja ispiranja) i postotak bolesnika koji su postigli i održali razinu fosfora u serumu ≤ 5,5 mg/dl (otprilike 62 %) bili su usporedivi u skupini koja je uzimala Fexeric i onoj koja je uzimala aktivnu kontrolu (Tablica 3).
English: Experience from clinical studies in patients with hepatic impairment is limited.
Croatian: Iskustvo iz kliničkih ispitivanja za bolesnike s oštećenjem jetre je ograničeno.
English: During the 52-week treatment period, haemoglobin remained relatively stable in the Fexeric group compared to
Croatian: Tijekom razdoblja liječenja od 52 tjedna, razina hemoglobina ostala je relativno stabilna u skupini liječenoj Fexericom u usporedbi sa skupinom liječenom aktivnom
English: Patients previously on other phosphate binders who are switched to Fexeric should start taking 3 to 6 g
Croatian: Bolesnici koji su prethodno uzimali druge vezače fosfata, a prebačeni su na Fexeric trebaju početi uzimati 3 do 6 g dnevno (3 do 6 tableta).
English: By binding phosphate in the GI tract and decreasing absorption, Fexeric lowers the levels of serum phosphorus.
Croatian: Vezivanjem fosfata u gastrointestinalnom traktu i smanjenjem apsorpcije, Fexeric smanjuje razine fosfora u serumu.
English: Fexeric must be taken in divided doses with or immediately after meals of the day.
Croatian: Fexeric se mora uzimati u podijeljenim dozama uz dnevne obroke ili neposredno nakon njih.
English: In CKD ND patients, the primary evaluation of safety is based on data from the pivotal study (Study 204), where 75 patients were treated with Fexeric for 12 weeks.
Croatian: U bolesnika s KBB ND primarna procjena sigurnosti temelji se na analizi podataka iz pivotalnog ispitivanja (Ispitivanje 204) kojim je obuhvaćeno 75 bolesnika koji su liječeni Fexericom tijekom 12 tjedana.
English: Increases in ferritin and transferrin saturation (TSAT) are observed with Fexeric use.
Croatian: Opažena su povećanja feritina i saturacije transferina (TSAT) prilikom primjene Fexerica.
English: Therefore, patients may need reduction in, or discontinuation of, intravenous iron
Croatian: Stoga, bolesnicima može biti potrebno smanjenje ili prekid primjene intravenskog željeza i/ili LSE.
English: The starting dose of Fexeric was 6 tablets/day (6 g/day), in divided doses with meals.
Croatian: Početna doza Fexerica bila je 6 tableta dnevno (6 g dnevno) u podijeljenim dozama uz obroke.
English: Fexeric binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood.
Croatian: Fexeric veže fosfor iz hrane u Vašem probavnom traktu radi sprječavanja njegove apsorpcije u krv.
English: The other ingredients are pregelatinised starch, calcium stearate, hypromellose, titanium dioxide, triacetin, sunset yellow FCF (E110), allura red AC (E129), indigo carmine.
Croatian: Ostali sastojci su prethodno geliran škrob, kalcijev stearat, hipromeloza, titanijev dioksid, triacetin i boje sunset yellow FCF (E110), allura red AC (E129) i indigo carmine.
English: Following completion of the 52-week active-controlled period, patients were eligible to enter a 4-week placebo-controlled period in which they were re-randomized to receive Fexeric (n=96)
Croatian: Nakon što je završilo razdoblje aktivne kontrole u trajanju od 52 tjedna, bolesnici su mogli početi s 4-tjednim placebom kontroliranim razdobljem u kojem su ponovno randomizirani za primanje Fexerica (n=96) ili placeba (n=96).
English: Fexeric should not be taken at the same time as aluminium containing medicines.
Croatian: • lijekovi koji sadrže aluminij Fexeric se ne smije uzimati istodobno s lijekovima koji sadrže aluminij.
English: Patients must take Fexeric with or immediately after meals.
Croatian: Bolesnici moraju uzeti Fexeric tijekom obroka ili neposredno nakon njih.
English: Proportion with ferritin > 500 ng/ml at baseline Proportion with ferritin > 500 ng/ml at Week 12 174 (61.9%)
Croatian: > 500 ng/ml u 12. tjednu 174 (61,9%) > 500 ng/ml u 52. tjednu 160 (56,9%)
English: This compound is insoluble and is excreted in the stool, reducing the amount of phosphate that is absorbed from the GI tract.
Croatian: Taj je spoj netopljiv i izlučuje se stolicom, smanjujući količinu fosfata koja se apsorbira iz gastrointestinalnog trakta.
English: The starting dose of Fexeric was 3 tablets a day (3 g/day) in divided doses with meals and was adjusted as needed to a maximum of 12 g/day in order to maintain serum phosphorus levels between 3.0 and 3.5 mg/dl.
Croatian: Početna doza Fexerica bila je 3 tablete dnevno (3 g dnevno) u podijeljenim dozama uz obroke i po potrebi je prilagođena do najviše 12 g dnevno kako bi se razine fosfora u serumu održale između 3,0 i 3,5 mg/dl.
English: The target organ for primary toxicity of ferric citrate is the GI tract, with evidence of mucosal erosion and acute to sub-acute inflammation of the GI tract in dogs at elevated doses.
Croatian: Ciljni organ za primanu toksičnost željezovog citrata je gastrointestinalni trakt uz dokazanu pojavu erozije sluznice i akutne do subakutne upale gastrointestinalnog trakta u pasa pri povišenim dozama.
English: After 12 weeks of treatment, the mean (± SD) change in serum phosphorus from baseline was −2.02 ± 2.0 mg/dl for Fexeric and −2.21 ± 2.18 mg/dl for sevelamer carbonate, demonstrating non-inferiority of Fexeric to sevelamer.
Croatian: Nakon 12 tjedana liječenja srednja vrijednost promjene (± SD) razine fosfora u serumu u odnosu na početnu vrijednost iznosila je −2,02 ± 2,0 mg/dl za Fexeric i −2,21 ± 2,18 mg/dl za sevelamerkarbonat, što dokazuje neinferiornost Fexerica u odnosu na sevelamer.
English: Long term safety data are limited in non-dialysis and peritoneal dialysis (PD) patients (see section
Croatian: Podaci o dugoročnoj sigurnosti u bolesnika koji se ne liječe dijalizom i peritonejskom dijalizom (PD)
English: In drug-drug interaction studies in healthy male and female subjects, Fexeric decreased the bioavailability of concomitantly administered ciprofloxacin (as measured by the area under the curve [AUC]) by approximately 45%.
Croatian: U ispitivanjima interakcija lijekova u zdravih muških i ženskih ispitanika, Fexeric je smanjio bioraspoloživost istodobno primijenjenog ciprofloksacina (mjereno površinom ispod krivulje [AUC])
English: It is not known whether ferric citrate coordination complex/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se kompleksni spoj željezovog citrata/metaboliti u majčino mlijeko u ljudi.
English: In adults with impaired kidney function it is used to lower high blood phosphorus levels.
Croatian: Upotrebljava se u odraslih osoba s oštećenjem bubrežne funkcije za snižavanje visokih razina fosfora u krvi.
English: The most commonly reported adverse reactions in non-dialysis dependent CKD (CKD ND) patients during treatment were discoloured faeces, constipation and diarrhoea occurring in 27%, 13% and 11% of patients, respectively.
Croatian: Najčešće prijavljene nuspojave tijekom liječenja bolesnika s kroničnom bolesti bubrega koji se ne liječe dijalizom (KBB ND) bile su promjena boje fecesa, konstipacija i proljev koji su se javili u 27 %, 13 %, odnosno 11 % bolesnika.
English: Non-inferiority to sevelamer carbonate was determined at Week 12.
Croatian: U 12. tjednu utvrđena je neinferiornost u odnosu na sevelamerkarbonat.
English: Patients treated with Fexeric should not receive concomitant treatment with other oral iron
Croatian: Bolesnici koji se liječe Fexericom ne smiju istodobno primati liječenje drugim oralnim pripravcima
English: In the pivotal dialysis study 304, following a 2-week washout period, 441 CKD 5D patients with hyperphosphatemia were randomised to receive Fexeric (n=292) or active control (sevelamer carbonate and/or calcium acetate; n=149) open-label for 52 weeks.
Croatian: U pivotalnom ispitivanju 304 na bolesnicima liječenim dijalizom, nakon 2-tjednog razdoblja ispiranja, 441 bolesnik s KBB 5D i hiperfosfatemijom randomiziran je za primanje Fexerica (n=292) ili aktivne kontrole (sevelamerkarbonat i/ili kalcijev acetat; n=149) tijekom otvorenog ispitivanja u trajanju od 52 tjedna.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: Uncommon side effects (may affect up to 1 in 100 people): changes in iron blood test results decreased or increased appetite indigestion, flatulence inflammation of stomach lining, ulcer of mucosal lining of the stomach or the first part of the bowel reflux of stomach juices in the oesophagus abnormal stools, irregularity in bowel movement shortness of breath, wheezing, abnormal breath sounds
Croatian: Manje česte nuspojave (mogu se javiti kod do 1 na 100 osoba): promjene u rezultatima krvnih pretraga za željezo smanjen ili povećan apetit probavne smetnje, vjetrovi upala želučane sluznice, čir na sluznici želuca ili prvom dijelu crijeva povrat (refluks) želučane kiseline u jednjak neuobičajene stolice, nepravilnost pražnjenja crijeva niske razine fosfora u serumu suha usta poremećaj okusa niske razine kalija u serumu nedostatak zraka, piskanje, neuobičajeni zvukovi disanja
English: In the pivotal dialysis study 304, CKD 5D patients treated with Fexeric, compared with patients treated with active control, had significantly higher increases in ferritin and TSAT levels after 52 weeks of treatment (Table 4), and significantly lower cumulative intravenous iron (96 versus 149 mg/month) and ESA use (7,713 versus 9,183 IU/week) during the same period.
Croatian: U pivotalnom ispitivanju 304 na bolesnicima liječenim dijalizom, bolesnici s KBB 5D liječeni Fexericom imali su, u usporedbi s bolesnicima liječenim aktivnom kontrolom, značajno viša povećanja razina feritina i TSAT-a nakon 52 tjedna liječenja (Tablica 4) te značajno nižu kumulativnu primjenu intravenskog željeza (96 naspram 149 mg mjesečno) i LSE (7713 naspram 9183 IU tjedno) tijekom istog razdoblja.
English: Therefore, patients may need a reduction in
Croatian: Stoga, bolesnicima može biti potrebno smanjenje doze LSE .
English: The dose can be increased or decreased by 1 to 2 g (1 to 2 tablets) per day at 2- to 4-week intervals as needed to maintain serum phosphorus at recommended target levels up to a maximum of 12 g (12 tablets) per day.
Croatian: Po potrebi se doza može povećati ili smanjiti za 1 do 2 g dnevno (1 do 2 tablete) u intervalima od 2 do 4 tjedna do najviše 12 g dnevno (12 tableta)
English: Each 1 g film-coated tablet contains sunset yellow FCF (E110) (0.99 mg) and Allura Red AC (E129) (0.70 mg) which may cause allergic reaction.
Croatian: Svaka filmom obložena tableta od 1 g sadrži boje Sunset Yellow FCF (E110) (0,99 mg) i Allura Red AC (E129) (0,70 mg) koje mogu uzrokovati alergijsku reakciju.
English: The iron component reacts with dietary phosphate in the gastrointestinal (GI) tract and precipitates phosphate as ferric phosphate.
Croatian: Željezo reagira s fosfatom iz prehrane u gastrointestinalnom traktu i taloži fosfat u obliku željezovog fosfata.
English: These adverse reactions are characteristic of iron-containing medicinal products and abated with time with continued dosing.
Croatian: Te nuspojave karakteristične su za lijekove koji sadrže željezo i s vremenom se smanjuju s nastavkom doziranja.
English: The ability of Fexeric to control serum phosphorus in CKD patients was principally evaluated in one long-term, pivotal Phase III trial (Study 304) in CKD 5D patients, and in one pivotal Phase II, 12 week, placebo-controlled trial (Study 204) in CKD ND patients with anaemia.
Croatian: Sposobnost Fexerica da kontrolira razinu fosfora u serumu bolesnika s KBB-om prvotno je ocijenjena u jednom dugotrajnom pivotalnom ispitivanju faze III (Ispitivanje 304) u bolesnika s KBB 5D i u jednom pivotalnom, placebom kontroliranom ispitivanju faze II u trajanju od 12 tjedana (Ispitivanje 204) u bolesnika s KBB ND i anemijom.
English: The following medicines can affect or be affected by Fexeric: Fexeric contains iron and your doctor may need to adjust the dose of your other iron-containing
Croatian: Fexeric sadrži željezo te će Vaš liječnik možda trebati prilagoditi dozu Vaših drugih lijekova koji
English: Common side effects (may affect up to 1 in 10 people): abdominal distension or bloating nausea, vomiting
Croatian: Česte nuspojave (mogu se javiti kod do 1 na 10 osoba): bol/nelagoda u trbuhu nadimanje ili nadutost u trbuhu mučnina, povraćanje
English: Reductions in ESA use with Fexeric have been observed.
Croatian: Opaženo je smanjenje primjene LSE s Fexericom.
English: During the 12-week treatment period, patients treated with Fexeric had a significant decrease in serum phosphorus, compared to the placebo group (p < 0.001 for treatment difference) (Table 3).
Croatian: Tijekom 12-tjednog razdoblja liječenja, bolesnici koji su liječeni Fexericom imali su značajno smanjenje razine fosfora u serumu u usporedbi sa skupinom koja je uzimala placebo (p< 0,001 za razliku u liječenju) (Tablica 3).
English: Adverse reactions reported in CKD 5D and CKD ND patients are presented in Tables 1 and 2, respectively.
Croatian: Nuspojave prijavljene u bolesnika s KBB 5D i KBB ND prikazane su u Tablici 1.,
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: The Fexeric-bound phosphorus is then excreted from your body in faeces.
Croatian: Fosfor vezan na Fexeric tada se izlučuje iz Vašeg tijela stolicom.
English: Table 2: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD ND patients.
Croatian: Tablica 2.: Nuspojave opažene tijekom kliničkih ispitivanja u kojima je Fexeric primijenjen u
English: System Organ Class by MedDRA
Croatian: Klasifikacija organskih sustava prema
English: Temporarily discontinue Fexeric if the serum phosphorus is < 3 mg/dl and resume at a lower dose once the serum phosphorus has returned to the target range.
Croatian: Ako je razina fosfora u serumu < 3 mg/dl potrebno je privremeno prekinuti primjenu Fexerica i nastaviti s primjenom manje doze nakon što se vrijednost fosfora u serumu vrati unutar ciljnog
English: The recommended starting dose of Fexeric is 3 to 6 g (3 to 6 tablets) per day based on serum
Croatian: Preporučena početna doza Fexerica je 3 do 6 g dnevno (3 do 6 tableta), ovisno o razini fosfora u
English: In the pivotal non-dialysis study 204 CKD ND patients treated with Fexeric had a significant increase in serum TSAT, ferritin and haemoglobin levels compared to the placebo group after 12 weeks of treatment (p< 0.001 for treatment difference for each parameter) (Table 4).
Croatian: U pivotalnom ispitivanju 204 na bolesnicima koji nisu na dijalizi, bolesnici s KBB ND liječeni Fexericom imali su značajno povećanje razina TSAT-a, feritina i hemoglobina u serumu u usporedbi sa skupinom liječenom placebom nakon 12 tjedana liječenja (p< 0,001 za razliku u liječenju za svaki parametar) (Tablica 4).
English: Urinary phosphorus excretion and FGF-23 were also significantly decreased relative to baseline in the CKD ND patients treated with Fexeric compared to patients treated with placebo.
Croatian: Izlučivanje fosfora urinom i FGF-23 (engl. fibroblast growth factor 23) također su znatno smanjeni u odnosu na početnu vrijednost u bolesnika s KBB ND koji su liječeni
English: § Primary endpoint in Study 304; Co-primary endpoint in Study 204.
Croatian: § Koprimarni ishod u Ispitivanju 204.
English: Serum phosphorus concentrations should be monitored within 2 to 4 weeks of starting or changing the dose of Fexeric, and approximately every 2-3 months when stable.
Croatian: Titracija doze Koncentracije fosfora u serumu trebaju se nadzirati unutar 2 do 4 tjedna od početka ili promjene doze
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih dodatnih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili
English: Table 4: Summary of results on iron homeostasis at Week 12 and Week 52 in Study 304 (CKD 5D) and at Week 12 in Study 204 (CKD ND)
Croatian: Tablica 4: Sažetak rezultata homeostaze željeza u 12. i 52. tjednu Ispitivanja 304 (KBB 5D) te u 12. tjednu Ispitivanja 204 (KBB ND)
English: Fexeric contains sunset yellow FCF (E110) and Allura Red AC (E129)
Croatian: Fexeric sadrži boje Sunset Yellow FCF (E110) i Allura Red AC (E129)
English: Patients not on dialysis require the lower starting dose: 3 tablets daily, in separated doses, with or
Croatian: Bolesnicima koji nisu na dijalizi potrebna je niža početna doza: 3 tablete dnevno u podijeljenim dozama uz glavne dnevne obroke ili odmah nakon njih.
English: Table 3: Summary of efficacy parameters on phosphorus homeostasis at Week 12 and Week 52 in Study 304 (CKD 5D) and at Week 12 in Study 204 (CKD ND)
Croatian: Tablica 3: Sažetak parametara djelotvornosti za homeostazu fosfora u 12. i 52. tjednu Ispitivanja 304 (KBB 5D) te u 12. tjednu Ispitivanja 204 (KBB ND)
English: Diarrhoea, discoloured faeces Abdominal pain/discomfort/distension, constipation, nausea, vomiting Abnormal faeces, bowel movement irregularity, dry mouth, dysgeusia, dyspepsia, flatulence, frequent bowel movements, gastritis, gastritis erosive, gastrooesophageal reflux disease, haematemesis, peptic ulcer
Croatian: mučnina, povraćanje neuobičajeni feces, neredovito pražnjenje crijeva, suha usta, disgeuzija, dispepsija, flatulencija, česta pražnjenja crijeva, gastritis, erozivni gastritis, gastroezofagealna refluksna bolest, hematemeza, peptički ulkus
English: After first opening of the bottle, use within 60 days.
Croatian: Upotrijebiti unutar 60 dana od prvog otvaranja boce.
English: The most common side effects (affecting more than 1 in 10 people) in patients not on dialysis also
Croatian: Najčešće nuspojave (javljaju se kod više od 1 na 10 osoba) u bolesnika koji nisu na dijalizi također su povezane sa želucem ili crijevima:
English: The recommended dose is: - starting dose for adults: 3 to 6 tablets daily, in separated doses, with or immediately after main meals of the day.
Croatian: - početna doza za odrasle: 3 do 6 tableta dnevno u podijeljenim dozama uz glavne dnevne obroke ili odmah nakon njih.
English: In the remaining non-dialysis studies, a total of 3 serious adverse reactions reported in 2 patients were gastrointestinal in nature (gastrointestinal ulcer, gastric polyps and colonic polyps).
Croatian: U preostalim ispitivanjima bolesnika koji se ne liječe dijalizom prijavljene su ukupno 3 ozbiljne nuspojave u 2 bolesnika i one su bile gastrointestinalnog karaktera
English: Following absorption, citrate is converted
Croatian: Nakon apsorpcije, tkiva pretvaraju citrat u bikarbonat.
English: Peach-coloured, oval shaped, film-coated tablet, embossed with “KX52”.
Croatian: Ovalna filmom obložena tableta boje breskve s utisnutom oznakom „KX52”.
English: If you are able to become pregnant, you must use birth control during treatment.
Croatian: Ako ste žena reproduktivne dobi, za vrijeme liječenja morate upotrebljavati zaštitu od začeća.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva Manje često:
English: - maximum dose: 12 tablets daily, in separated doses, with or immediately after meals of the
Croatian: - maksimalna doza: 12 tableta dnevno u podijeljenim dozama uz glavne dnevne obroke ili