natgillin/translations-raw huggingface dataset:
Take the tablets whole, with one glass of water, with or immediately after meals.
Tablete zaužijte cele, s kozarcem vode, ob obrokih ali takoj po njih.
The non clinical programme was based on 7 repeat dose toxicology studies in rats and dogs.
Predklinični program je temeljil na sedmih študijah toksičnosti večkratnega odmerjanja na podganah in psih.
Phosphorus is contained in many foods.
Mnogo živil vsebuje fosfor.
Experience from clinical studies in patients with hepatic impairment is limited.
Izkušnje iz kliničnih študij pri bolnikih z okvaro jeter so omejene.
Patients with kidneys that do not work properly are not able to eliminate phosphorus from their body adequately.
Bolniki s poslabšanim delovanjem ledvic niso zmožni zadostno izločati fosforja iz telesa.
Significantly elevated ferritin levels were observed particularly when concomitant intravenous iron was used.
Opazili so pomembno zvišane ravni feritina, predvsem pri sočasni uporabi intravenskega železa.
As a secondary endpoint in dialysis patients, and a co-primary endpoint in non-dialysis patients, the ability of Fexeric to increase iron stores was also evaluated.
Kot sekundarni opazovani dogodek pri bolnikih na dializi in sočasni primarni opazovani dogodek pri bolnikih, ki niso na dializi, so prav tako ocenili zmožnost zdravila Fexeric za povečanje zalog železa.
Pharmacotherapeutic group: Drugs for treatment of hyperkalemia and hyperphosphatemia
Farmakoterapevtska skupina: zdravila za zdravljenje hiperkaliemije in hiperfosfatemije
No data are available on the potential influence of Fexeric on fertility.
Podatkov o morebitnem vplivu zdravila Fexeric na plodnost ni.
Active severe gastrointestinal disorders (e.g. gastrointestinal bleeding) Haemochromatosis or laboratory tests indicating possible haemochromatosis Other iron overload (primary or secondary) syndromes
aktivne hude bolezni prebavil (npr. krvavitev v prebavilih), hemokromatoza ali laboratorijske preiskave, ki kažejo na morebitno hemokromatozo, drugi (primarni in sekundarni) sindromi preobremenitve z železom.
Frequencies of adverse reactions are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Pogostnost neželenih učinkov je opredeljena na naslednji način: zelo pogosti(≥ 1/10), pogosti (≥ 1/100 do < 1/10),
Patients with elevated ferritin levels receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy.
Pri bolnikih s povišanimi ravnmi feritina, ki prejemajo intravensko železo, bo morda treba zmanjšati odmerek ali prekiniti intravensko zdravljenje
Effects of other medicinal products on Fexeric
Vpliv drugih zdravil na zdravilo Fexeric
These patients were treated according to the recommended dosing regimen without any safety concerns.
Te bolnike so zdravili skladno s priporočenim režimom odmerjanja in niso odkrili nobenih težav z varnostjo.
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%.
V študijah medsebojnega delovanja med zdravili pri zdravih moških in ženskah je zdravilo Fexeric zmanjšalo biološko uporabnost sočasno apliciranega ciprofloksacina (izmerjeno s površino pod krivuljo (AUC)) za približno 45 %.
Although the potential for interactions with medicinal products seems low, for concomitant treatment with products with a narrow therapeutic window, the clinical effect/adverse events should be monitored on initiation or dose adjustment of Fexeric or the concomitant product.
Čeprav je možnost za medsebojno delovanje z zdravili majhna, je treba pri sočasnem zdravljenju z zdravili z ozkim terapevtskim oknom spremljati klinični učinek/neželene učinke pri uvedbi ali prilagajanju odmerka zdravila Fexeric ali sočasno vzetega zdravila.
The starting dose of active control was the patient's dose prior to the washout period.
Začetni odmerek pri aktivni kontrolni skupini je bil bolnikov odmerek pred
The elderly patients were treated according to the recommended dosing regimen without any safety concerns.
Starejše bolnike so zdravili skladno s priporočenim režimom odmerjanja in niso odkrili nobenih težav z varnostjo.
There are no data regarding the use of ferric citrate coordination complex in pregnant women.
Podatkov o uporabi koordinacijskega kompleksa železovega citrata pri nosečnicah ni.
In patients with CKD, the maximum dose studied was 12 g (12 tablets) of Fexeric per day.
Pri bolnikih s KLB je bil največji preučevani odmerek 12 g (12 tablet) zdravila Fexeric na dan.
If you are able to become pregnant, you must use birth control during treatment.
Če ste ženska v rodni dobi, morate med zdravljenjem uporabljati kontracepcijo.
Of the 557 patients receiving Fexeric in the pooled safety population, there were 67 (12%) patients with evidence of liver dysfunction at baseline.
Od 557 bolnikov, ki so prejemali zdravilo Fexeric in so bili vključeni v zbrano populacijo za oceno varnosti, jih je imelo 67 (12 %) ob izhodišču dokaze jetrne disfunkcije.
Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney
Zdravilo Fexeric je indicirano za nadzorovanje hiperfosfatemije pri odraslih bolnikih s kronično
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.
Pri bolnikih s KLB ND je primarna ocena varnosti temeljila na podatkih iz ključne študije (študije 204), v kateri so 75 bolnikov 12 tednov zdravili z zdravilom Fexeric.
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.
Odmerek je mogoče povečati ali zmanjšati za 1 do 2 g (1 do 2 tableti) na dan v 2- do 4-tedenskih presledkih, kot je potrebno za vzdrževanje priporočenih ciljnih ravni fosforja v serumu, do največ 12 g
Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Ob sočasni uporabi zdravilo Fexeric ni spremenilo biološke uporabnosti naslednjih zdravil: klopidogrela, digoksina, diltiazema, glimepirida, losartana.
Abnormal breath sounds, increased serum ferritin, increased transferrin saturation, increased weight
nenormalni zvoki pri dihanju, povišana raven feritina v serumu, povečana saturacija transferina, povečana telesna masa
No data are available regarding overdose of Fexeric in humans.
Podatki o prevelikem odmerjanju zdravila Fexeric pri človeku niso na voljo.
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.
Preglednica z neželenimi učinki Varnost zdravila Fexeric pri zdravljenju hiperfosfatemije so preučevali v 18 kliničnih preskušanjih, ki so vključila skupno 1.388 bolnikov s KLB 5D, pri katerih je zdravljenje trajalo do dve leti, in 145 bolnikov s KLB ND, pri katerih je zdravljenje trajalo od 12 tednov do enega leta.
If you become pregnant during treatment, you must ask your doctor for advice.
Če med zdravljenjem zanosite, se morate posvetovati z zdravnikom.
Shelf-life after first opening of the bottle: 60 days
Rok uporabnosti po prvem odprtju plastenke: 60 dni
Patients must take Fexeric with or immediately after meals.
Bolniki morajo zdravilo Fexeric jemati z obroki ali takoj po njih.
Package leaflet: Information for the patient Fexeric 1 g film-coated tablets ferric citrate coordination complex This medicine is subject to additional monitoring.
Navodilo za uporabo Fexeric 1 g filmsko obložene tablete koordinacijski kompleks železovega citrata Za to zdravilo se izvaja dodatno spremljanje varnosti.
Therefore, patients may need reduction in, or discontinuation of, intravenous iron
Bolniki bodo torej morda potrebovali zmanjšanje ali prekinitev vnosa intravenskega železa in/ali ESA.
If this is the case, you must continue to follow the special diet even if you are taking
V tem primeru se morate še naprej držati te posebne diete, tudi če jemljete zdravilo Fexeric.
It is not known whether ferric citrate coordination complex/metabolites are excreted in human milk.
Ni znano, ali se koordinacijski kompleks železovega citrata/njegovi presnovki izločajo v materino mleko pri človeku.
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
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): prospektivna, opazovalna, multicentrična študija pri bolnikih s KLB, zdravljenih z zdravilom Fexeric, da bi pridobili podatke o dolgoročni (dve leti) varnosti (vključno z dogodki preobremenitve z železom, infekcijskimi in gastrointestinalnimi dogodki), in sicer zlasti pri bolnikih v EU, starejših in zelo starih bolnikih, bolnikih na dializi (HD, PD)
The tablets are packed in plastic bottles with child-resistant caps.
Tablete so pakirane v plastenkah, ki imajo za otroke varno zaporko.
Treatment with Fexeric may lead to elevations in iron stores, particularly in patients receiving concomitant intravenous iron therapy.
Zdravljenje z zdravilo Fexeric lahko povzroči povečanje zalog železa, predvsem pri bolnikih, ki sočasno prejemajo intravensko zdravljenje z železom.
The symptoms of acute iron overdose include vomiting, diarrhoea, abdominal pain, irritability, and drowsiness.
Simptomi akutnega prevelikega odmerjanja železa vključujejo bruhanje, diarejo, bolečino v trebuhu, iritabilnost in dremavost.
This compound is insoluble and is excreted in the stool, reducing the amount of phosphate that is absorbed from the GI tract.
Ta spojina ni topna in se izloči z blatom, kar zmanjša količino fosfata, ki se absorbira iz prebavil.
The following side effects have been reported with Fexeric in dialysis patients: Very common side effects (may affect more than 1 in 10 people):
Pri zdravilu Fexeric in bolnikih na dializi so poročali o naslednjih neželenih učinkih: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
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).
Med skupnim 52-tedenskim obdobjem z aktivno kontrolo sta bila znižanje ravni fosforja v serumu (približno 2,0 mg/dl po največ 2-tedenskem obdobju izplavljanja) in odstotek bolnikov, ki so dosegli in vzdrževali ravni fosforja v serumu ≤ 5,5 mg/dl (približno 62 %), primerljiva v skupini z zdravilom Fexeric in aktivni kontrolni skupini (preglednica 3).
Fexeric film-coated tablets are peach-coloured, oval-shaped tablets embossed with “KX52” on one side.
Filmsko obložene tablete zdravila Fexeric so ovalne tablete breskove barve z oznako „KX52“ na eni strani.
Do not take a double dose to make up for a forgotten
Ne vzemite dvojnega odmerka, če ste
Fexeric N=281
zdravilo Fexeric N = 281
You may have been advised to follow a special diet to prevent the phosphorus in your blood rising to high levels.
Morda vam je zdravnik svetoval posebno dieto za preprečevanje zvišanja ravni fosforja v krvi.
Ferric citrate was neither mutagenic in the bacterial reverse mutation assay (Ames test) nor clastogenic in the chromosomal aberration test in Chinese hamster fibroblasts.
Železov citrat ni bil mutagen pri preiskavi bakterijskih reverznih mutacij (preiskavi Ames) in ni bil klastogen pri preiskavi kromosomskih aberacij na rdeče barvilo AC (E129)
These adverse reactions are characteristic of iron-containing medicinal products and abated with time with continued dosing.
Ta neželena učinka sta značilna za zdravila, ki vsebujejo železo, in sta se med nadaljevanjem odmerjanja sčasoma ublažila.
Fexeric binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood.
Zdravilo Fexeric se v prebavilih veže na fosfor v hrani, s čimer prepreči njegovo absorpcijo v kri.
Fexeric N=72
zdravilo Fexeric N = 72
The dose of phosphate binder was titrated as needed to maintain serum phosphorus levels between 3.5 and 5.5 mg/dl, to a maximum of 12 g/day.
Odmerek zdravila, ki veže fosfate, je bil titriran, kot je bilo potrebno za vzdrževanje ravni fosforja v serumu med 3,5 in 5,5 mg/dl, do največjega odmerka 12 g/dan.
Reductions in intravenous iron and erythropoiesis-stimulating agent (ESA) use with this medicine have been observed.
Pri uporabi tega zdravila so opazili zmanjšano uporabo intravenskega železa in eritropoezo stimulirajočih snovi (ESA- erythropoiesis-stimulating agent).
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.
Priporočeni odmerek je: - začetni odmerek pri odraslih: od 3 do 6 tablet na dan, v ločenih odmerkih, ob glavnih obrokih ali takoj po njih.
The European Medicines Agency has deferred the obligation to submit the results of studies with Fexeric in in one or more subsets of the paediatric population in the treatment of hyperphosphataemia related to chronic kidney disease (see section 4.2 for information on paediatric use).
Fexeric za eno ali več podskupin pediatrične populacije pri zdravljenju hiperfosfatemije, povezane s kronično ledvično boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
By binding phosphate in the GI tract and decreasing absorption, Fexeric lowers the levels of serum phosphorus.
Z vezavo fosfata v prebavilih in zmanjšanjem absorpcije zdravilo Fexeric zniža ravni fosforja v serumu.
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)
Po koncu 52-tedenskega obdobja z aktivno kontrolo so se lahko bolniki vključili v 4-tedensko, s placebom nadzorovano obdobje, v katerem so bili ponovno naključno razporejeni v skupino, ki je prejemala zdravilo Fexeric (n = 96), ali skupino s placebom (n = 96).
§ Primary endpoint in Study 304; Co-primary endpoint in Study 204.
§ Primarni opazovani dogodek v študiji 304; sočasni primerni opazovani dogodek v študiji 204.
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.
Zmožnost zdravila Fexeric za nadzorovanje ravni fosforja v serumu pri bolnikih s KLB so prvotno ocenili v enem dolgotrajnem ključnem preskušanju faze III (študija 304) pri bolnikih s KLB 5D in enem ključnem, 12-tedenskem, s placebom nadzorovanem preskušanju Faze II (študija 204) pri bolnikih s KLB ND ter anemijo.
Long term safety data are limited in non-dialysis and peritoneal dialysis (PD) patients (see section
Podatki o dolgoročni varnosti pri bolnikih, ki niso na dializi ali so na peritonealni dializi (PD), so
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.
V ključni dializni študiji 304 so imeli bolniki s KLB 5D, zdravljeni z zdravilom Fexeric, v primerjavi z bolniki, zdravljenimi z aktivno kontrolo, pomembno večje zvišanje ravni feritina in TSAT po 52 tednih zdravljenja (preglednica 4) ter pomembno manjšo uporabo kumulativnega intravenskega železa (96 v primerjavi s 149 mg/mesec) in ESA (7.713 v primerjavi z 9.183 i.e./teden) v istem obdobju.
What Fexeric looks like and contents of the pack
Izgled zdravila Fexeric in vsebina pakiranja
The starting dose of Fexeric was 6 tablets/day (6 g/day), in divided doses with meals.
Začetni odmerek zdravila Fexeric je bil 6 tablet/dan (6 g/dan) v ločenih odmerkih, ki so se jemali ob obrokih.
In the pivotal non-dialysis study 204, a total of 148 CKD ND patients with hyperphosphatemia and iron deficiency anaemia received treatment with study drug; there were 141 patients in the intent-totreat population (Fexeric: 72 patients; Placebo: 69 patients).
V ključni nedializni študiji 204 je skupno 148 bolnikov s KLB ND, hiperfosfatemijo in anemijo zaradi pomanjkanja železa prejemalo zdravljenje s preiskovanim zdravilom; v populaciji, ki so jo nameravali zdraviti (ITT- intent-to-treat) je bilo 141 bolnikov (zdravilo Fexeric: 72 bolnikov, placebo:
CKD patients who are not on dialysis require the lower starting dose, 3 g (3 tablets) per day.
Bolniki s KLB, ki niso na dializi, potrebujejo manjši začetni odmerek 3 g (3 tablete) na dan.
- maximum dose: 12 tablets daily, in separated doses, with or immediately after meals of the
- največji odmerek: 12 tablet na dan, v ločenih odmerkih, ob obrokih ali takoj po njih.
The recommended starting dose of Fexeric is 3 to 6 g (3 to 6 tablets) per day based on serum
Priporočeni začetni odmerek zdravila Fexeric je od 3 do 6 g (od 3 do 6 tablet) na dan, kar je odvisno
Fexeric should be temporarily discontinued if serum ferritin exceeds 800 ng/ml.
Uporabo zdravila Fexeric je treba začasno prekiniti, če raven feritina v serumu preseže 800 ng/ml (glejte poglavje 4.4).
All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhoea, gastritis, gastritis erosive, and haematemesis).
Vsi resni neželeni učinki so bili prebavni (bolečina v trebuhu, zaprtost, diareja, gastritis, erozijski gastritis in hematemeza).
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.
Začetni odmerek zdravila Fexeric je bil tri tablete na dan (3 g/dan) v ločenih odmerkih, ki se dajejo ob obrokih, in se je prilagodil do največ 12 g/dan, kot je bilo potrebno za vzdrževanje ravni fosforja v serumu med 3,0 in 3,5 mg/dl.
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)
Preglednica 4: Povzetek rezultatov glede homeostaze železa v 12. in 52. tednu študije 304 (KLB 5D) ter 12. tednu študije 204 (KLB ND)
Patients treated with Fexeric should not receive concomitant treatment with other oral iron
Bolniki, zdravljeni z zdravilom Fexeric, se ne smejo sočasno zdraviti z drugimi peroralnimi pripravki
Talk to your doctor or pharmacist before taking Fexeric if you have: too much iron in your body bowel inflammation
Pred začetkom jemanja zdravila Fexeric se posvetujte z zdravnikom ali farmacevtom, če imate: - preveč železa v telesu,
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.
Ena filmsko obložena tableta vsebuje oranžno barvilo FCF (E110) (0,99 mg) in rdeče barvilo AC (E129) (0,70 mg), ki lahko sprožita alergijsko reakcijo.
Patients previously on other phosphate binders who are switched to Fexeric should start taking 3 to 6 g
Bolniki, ki so predhodno jemali druga zdravila, ki vežejo fosfate, in preidejo na zdravilo Fexeric, morajo začeti jemati od 3 do 6 g (od 3 do 6 tablet) na dan.
It is unknown whether Fexeric
Ni znano, ali ima zdravilo Fexeric
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.
Fexeric, so prav tako ugotovili pomembno zmanjšanje izločanja fosforja z urinom in FGF-23 glede na izhodišče v primerjavi z bolniki, zdravljenimi s placebom.
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.
Če je raven fosforja v serumu < 3 mg/dl, začasno prekinite uporabo zdravila Fexeric in jo ponovno uvedite, ko je raven fosforja v serumu znova znotraj ciljnega razpona.
During the subsequent 4-week placebo-controlled period, the serum phosphorus levels remained stable in patients receiving Fexeric (mean decrease of 0.24 mg/dl), whereas patients receiving placebo had a mean increase of 1.79 mg/dl (p < 0.0001 for treatment difference).
Med poznejšim 4-tedenskim s placebom nadzorovanim obdobjem so ravni fosforja v serumu pri bolnikih, ki so prejemali zdravilo Fexeric, ostale stabilne (povprečno zmanjšanje za 0,24 mg/dl), medtem ko so se pri bolnikih, ki so prejemali placebo, povprečno povišale za 1,79 mg/dl (p < 0,0001 za razliko med oblikama zdravljenja).
During the 52-week treatment period, haemoglobin remained relatively stable in the Fexeric group compared to
V 52-tedenskem obdobju zdravljenja je raven hemoglobina v skupini z zdravilom Fexeric ostala relativno stabilna v primerjavi z aktivno kontrolno skupino (preglednica 4).
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
Zdravilo Fexeric vsebuje železo, zato bo morda zdravnik moral prilagoditi odmerek drugih
Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of ferric iron).
Ena filmsko obložena tableta vsebuje 1 g koordinacijskega kompleksa železovega citrata (kar je enako 210 mg železa).
severe abdominal pain or constipation (uncommon)
hudo bolečino v trebuhu ali zaprtost (občasno),
The most common side effects (affecting more than 1 in 10 people) in patients not on dialysis also
Najpogostejši neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) pri bolnikih, ki niso na dializi, prav tako prizadenejo želodec ali črevesje:
Examination of serum iron storage parameters has shown that there is low systemic absorption of iron
Raziskava parametra zalog železa v serumu je pokazala, da je sistemska absorpcija železa iz zdravila Fexeric majhna (približno 1-odstotna).
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)
Preglednica 3: Povzetek parametrov učinkovitosti glede homeostaze fosforja v 12. in 52. tednu študije 304 (KLB 5D) ter 12. tednu študije 204 (KLB ND) Študija 304 (KLB 5D)
Patients not on dialysis require the lower starting dose: 3 tablets daily, in separated doses, with or
Bolniki, ki niso na dializi, potrebujejo manjši začetni odmerek: 3 tablete na dan, v ločenih odmerkih, ob obrokih ali takoj po njih.
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).
V preostalih študijah pri bolnikih, ki niso na dializi, so poročali o skupno treh resnih neželenih učinkih pri dveh bolnikih, ti pa so prizadeli prebavila (ulkus na prebavilih, želodčni polipi in polipi v kolonu).
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.
V ključni dializni študiji 304 so 441 bolnikov s KLB 5D in hiperfosfatemijo po 2-tedenskem obdobju izplavljanja naključno razporedili v skupino, ki je prejemala zdravilo Fexeric (n = 292), ali aktivno kontrolno skupino (sevelamerijev karbonat in/ali kalcijev acetat, n = 149).