FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: By binding phosphate in the GI tract and decreasing absorption, Fexeric lowers the levels of serum phosphorus.
Slovenian: Z vezavo fosfata v prebavilih in zmanjšanjem absorpcije zdravilo Fexeric zniža ravni fosforja v serumu.
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)
Slovenian: 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).
English: § Primary endpoint in Study 304; Co-primary endpoint in Study 204.
Slovenian: § Primarni opazovani dogodek v študiji 304; sočasni primerni opazovani dogodek v študiji 204.
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.
Slovenian: 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.
English: Long term safety data are limited in non-dialysis and peritoneal dialysis (PD) patients (see section
Slovenian: Podatki o dolgoročni varnosti pri bolnikih, ki niso na dializi ali so na peritonealni dializi (PD), so
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.
Slovenian: 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.
English: What Fexeric looks like and contents of the pack
Slovenian: Izgled zdravila Fexeric in vsebina pakiranja
English: The starting dose of Fexeric was 6 tablets/day (6 g/day), in divided doses with meals.
Slovenian: Začetni odmerek zdravila Fexeric je bil 6 tablet/dan (6 g/dan) v ločenih odmerkih, ki so se jemali ob obrokih.
English: 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).
Slovenian: 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:
English: CKD patients who are not on dialysis require the lower starting dose, 3 g (3 tablets) per day.
Slovenian: Bolniki s KLB, ki niso na dializi, potrebujejo manjši začetni odmerek 3 g (3 tablete) na dan.
English: - maximum dose: 12 tablets daily, in separated doses, with or immediately after meals of the
Slovenian: - največji odmerek: 12 tablet na dan, v ločenih odmerkih, ob obrokih ali takoj po njih.
English: The recommended starting dose of Fexeric is 3 to 6 g (3 to 6 tablets) per day based on serum
Slovenian: Priporočeni začetni odmerek zdravila Fexeric je od 3 do 6 g (od 3 do 6 tablet) na dan, kar je odvisno
English: Fexeric should be temporarily discontinued if serum ferritin exceeds 800 ng/ml.
Slovenian: Uporabo zdravila Fexeric je treba začasno prekiniti, če raven feritina v serumu preseže 800 ng/ml (glejte poglavje 4.4).
English: All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhoea, gastritis, gastritis erosive, and haematemesis).
Slovenian: Vsi resni neželeni učinki so bili prebavni (bolečina v trebuhu, zaprtost, diareja, gastritis, erozijski gastritis in hematemeza).
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.
Slovenian: 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.
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)
Slovenian: Preglednica 4: Povzetek rezultatov glede homeostaze železa v 12. in 52. tednu študije 304 (KLB 5D) ter 12. tednu študije 204 (KLB ND)
English: Patients treated with Fexeric should not receive concomitant treatment with other oral iron
Slovenian: Bolniki, zdravljeni z zdravilom Fexeric, se ne smejo sočasno zdraviti z drugimi peroralnimi pripravki
English: Talk to your doctor or pharmacist before taking Fexeric if you have: too much iron in your body bowel inflammation
Slovenian: Pred začetkom jemanja zdravila Fexeric se posvetujte z zdravnikom ali farmacevtom, če imate: - preveč železa v telesu,
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.
Slovenian: 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.
English: Patients previously on other phosphate binders who are switched to Fexeric should start taking 3 to 6 g
Slovenian: 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.
English: It is unknown whether Fexeric
Slovenian: Ni znano, ali ima zdravilo Fexeric
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.
Slovenian: Fexeric, so prav tako ugotovili pomembno zmanjšanje izločanja fosforja z urinom in FGF-23 glede na izhodišče v primerjavi z bolniki, zdravljenimi s placebom.
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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: During the 52-week treatment period, haemoglobin remained relatively stable in the Fexeric group compared to
Slovenian: V 52-tedenskem obdobju zdravljenja je raven hemoglobina v skupini z zdravilom Fexeric ostala relativno stabilna v primerjavi z aktivno kontrolno skupino (preglednica 4).
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
Slovenian: Zdravilo Fexeric vsebuje železo, zato bo morda zdravnik moral prilagoditi odmerek drugih
English: Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of ferric iron).
Slovenian: Ena filmsko obložena tableta vsebuje 1 g koordinacijskega kompleksa železovega citrata (kar je enako 210 mg železa).
English: severe abdominal pain or constipation (uncommon)
Slovenian: hudo bolečino v trebuhu ali zaprtost (občasno),
English: The most common side effects (affecting more than 1 in 10 people) in patients not on dialysis also
Slovenian: 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:
English: Examination of serum iron storage parameters has shown that there is low systemic absorption of iron
Slovenian: Raziskava parametra zalog železa v serumu je pokazala, da je sistemska absorpcija železa iz zdravila Fexeric majhna (približno 1-odstotna).
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)
Slovenian: 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)
English: Patients not on dialysis require the lower starting dose: 3 tablets daily, in separated doses, with or
Slovenian: Bolniki, ki niso na dializi, potrebujejo manjši začetni odmerek: 3 tablete na dan, v ločenih odmerkih, ob obrokih ali takoj po 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).
Slovenian: 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).
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.
Slovenian: 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).
English: - if you are allergic to ferric citrate coordination complex or any of the other ingredients of this medicine (listed in section 6) - if you have low levels of phosphorus in your blood - if you have a severe stomach or bowel disease such as stomach or bowel bleeding
Slovenian: - če imate nizke ravni fosforja v krvi, - če imate hudo bolezen želodca ali črevesa, kot je krvavitev v želodcu ali črevesu,
English: This medicine should be used only in the absence of iron overload syndromes and with caution if serum ferritin rises above 500 ng/ml.
Slovenian: To zdravilo se ne sme uporabljati pri sindromih preobremenitve z železom; če se vrednost feritina v serumu poveča nad 500 ng/ml, pa ga je treba uporabljati previdno.
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).
Slovenian: Med 12-tedenskim obdobjem zdravljenja so pri bolnikih, zdravljenih z zdravilom Fexeric, opazili pomembno znižanje ravni fosforja v serumu v primerjavi s skupino, ki je prejemala placebo (p < 0,001 za razliko med oblikama zdravljenja) (preglednica 3).
English: and immunosuppressant (methotrexate) medications showed the potential to interact with Fexeric: any of these or other medicinal products that have the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
Slovenian: Katero koli od teh zdravil ali druga zdravila, ki lahko medsebojno delujejo z zdravilom Fexeric, je treba jemati vsaj 2 uri pred zdravilom Fexeric ali 2 uri po njem.
English: Monitoring blood levels of these medicines may also be considered: - ciprofloxacin, doxycycline, cefdinir: medicines to treat bacterial infections - valproic acid: a medicine to treat epilepsy and mental disorders - sertraline: a medicine to treat depression - methotrexate: a medicine to treat rheumatoid arthritis, cancer and the skin disease, psoriasis - alendronate: a medicine to treat decreased bone mass and density - levodopa: a medicine to treat Parkinson's disease - levothyroxine: a medicine to treat thyroid hormone deficiency
Slovenian: - ciprofloksacin, doksiciklin, cefdinir: zdravila za zdravljenje bakterijskih okužb, - valprojska kislina: zdravilo za zdravljenje epilepsije in duševnih motenj, - sertralin: zdravilo za zdravljenje depresije, - metotreksat: zdravilo za zdravljenje revmatoidnega artritisa, raka in kožne bolezni luskavice
English: Fexeric must be taken in divided doses with or immediately after meals of the day.
Slovenian: Zdravilo Fexeric je treba jemati v ločenih odmerkih skupaj z glavnimi obroki ali takoj po njih.
English: Muscle injury
Slovenian: - črevesno vnetje.
English: Data on primary and secondary pharmacodynamics, safety pharmacology and pharmacokinetics of Fexeric were derived from the repeat dose toxicology studies, and did not reveal safety concerns for humans.
Slovenian: Podatki o primarni in sekundarni farmakodinamiki, varnostni farmakologiji in farmakokinetiki zdravila Fexeric izhajajo iz študij toksičnosti večkratnega odmerjanja in niso pokazali težav z Podatki o genotoksičnosti, kancerogenem potencialu, vplivu železovega citrata na sposobnost razmnoževanja in razvoja so povzeti iz znanstvene literature.
English: Bronchitis
Slovenian: indigotin
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika
English: The iron component reacts with dietary phosphate in the gastrointestinal (GI) tract and precipitates phosphate as ferric phosphate.
Slovenian: Železova komponenta v prebavilih reagira s fosfatom v hrani in obori fosfat kot železov fosfat.
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.
Slovenian: Po 12 tednih zdravljenja je bila povprečna (± SD) sprememba ravni fosforja v serumu glede na izhodišče −2,02 ± 2,0 mg/dl pri zdravilu Fexeric in −2,21 ± 2,18 mg/dl pri sevelamerijevem karbonatu,
English: Very common:
Slovenian: Občasni:
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).
Slovenian: V ključni nedializni študiji 204 so imeli bolniki s KLB ND, zdravljeni z zdravilom Fexeric, po 12 tednih zdravljenja pomembno zvišanje ravni TSAT, feritina in hemoglobina v serumu v primerjavi s skupino s placebom (p < 0,001 za razliko med oblikama zdravljenja za posamezne parametre)
English: Each film-coated tablet contains sunset yellow FCF (E110) (0.99 mg) and Allura Red AC (E129) For the full list of excipients, see section 6.1.
Slovenian: Ena filmsko obložena tableta vsebuje oranžno barvilo FCF (E110) (0,99 mg) in rdeče barvilo AC Za celoten seznam pomožnih snovi glejte poglavje 6.1.
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
Slovenian: navzea, bruhanje nenormalno blato, neredno odvajanje blata, suha usta, disgevzija, dispepsija, flatulenca, pogosto odvajanje blata, gastritis, erozijski gastritis,
English: Peach-coloured, oval shaped, film-coated tablet, embossed with “KX52”.
Slovenian: Ovalna filmsko obložena tableta breskove barve z oznako „KX52“.
English: Since citrate is known to increase aluminium absorption, aluminium-based compounds should be avoided while patients receive Fexeric.
Slovenian: Učinki zdravila Fexeric na druga zdravila Ker je znano, da citrat poveča absorpcijo aluminija, se je treba med jemanjem zdravila Fexeric izogibati spojinam na osnovi aluminija.
English: OUTER CARTON AND BOTTLE LABEL
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN OZNAKA NA PLASTENKI
English: Adverse reactions reported in CKD 5D and CKD ND patients are presented in Tables 1 and 2, respectively.
Slovenian: Neželeni učinki, o katerih so poročali pri bolnikih s KLB 5D, so v preglednici 1, pri bolnikih s KLB ND pa v preglednici 2.
English: DATE OF REVISION OF THE TEXT
Slovenian: Sprememba vrednosti
English: After first opening of the bottle, use within 60 days.
Slovenian: Zdravilo porabite v 60 dneh po prvem odprtju plastenke.
English: In adults with impaired kidney function it is used to lower high blood phosphorus levels.
Slovenian: Uporablja se pri odraslih s poslabšanim delovanjem ledvic za zniževanje visokih ravni fosforja v serumu.
English: Increases in ferritin and transferrin saturation (TSAT) are observed with Fexeric use.
Slovenian: Pri uporabi zdravila Fexeric so opazili povečanje vrednosti feritina in saturacije transferina (TSATtransferrin saturation).
English: No dosage reduction is considered necessary but patients with hepatic impairment should initiate treatment with the lower starting dose, 3 g (3 tablets) per day (see section 5.1).
Slovenian: Zmanjšanje odmerka ni potrebno, vendar je treba pri bolnikih z okvaro jeter zdravljenje uvesti z manjšim začetnim odmerkom 3 g
English: From in vitro studies, certain antibiotic (doxycycline, cefdinir), anticonvulsant (valproate sodium), antidepressant (sertraline HCl), bisphosphonate (alendronate sodium), anti-parkinsonian (levodopa)
Slovenian: V študijah in vitro so pokazali, da lahko nekateri antibiotiki (doksiciklin, cefdinir), antikonvulzivi (natrijev valproat), antidepresivi (sertralinijev klorid), bifosfonati (natrijev alendronat), antiparkinsoniki (levodopa) in imunosupresivi (metotreksat) medsebojno delujejo z zdravilom Fexeric.
English: In CKD 5D patients, the primary evaluation of safety is based on the integrated analysis of data from 4 studies involving 557 CKD 5D patients treated with Fexeric for up to 1 year.
Slovenian: Pri bolnikih s KLB 5D je primarna ocena varnosti temeljila na integrirani analizi podatkov iz 4 študij,
English: Table 1: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD 5D patients on haemodialysis or peritoneal dialysis.
Slovenian: Fexeric uporabljalo pri bolnikih s KLB 5D na hemodializi ali peritonealni dializi
English: Fexeric has been administered to over 400 patients ≥ 65 years of age in studies where the dose was titrated to achieve target serum phosphorus levels.
Slovenian: Fexeric uporabili pri več kot 400 bolnikih ≥ 65 let.
English: Contact a doctor or poison control centre immediately if a child accidentally takes Fexeric.
Slovenian: Če zdravilo Fexeric nenamerno zaužije otrok, se takoj obrnite na zdravnika ali center za zastrupitve.
English: There was no evidence of hepatic impairment or significant alteration of hepatic enzymes across the clinical studies with Fexeric, including the long-term studies.
Slovenian: V kliničnih študijah z zdravilom Fexeric, vključno z dolgotrajnimi študijami, ni bilo dokazov o poslabšanem jetrnem delovanju ali pomembni spremembi vrednosti jetrnih encimov.
English: The Fexeric-bound phosphorus is then excreted from your body in faeces.
Slovenian: Fosfor, ki se veže na zdravilo Fexeric, se potem iz telesa izloči z blatom.
English: Increases in ferritin and TSAT above safety thresholds are observed with Fexeric use.
Slovenian: Pri uporabi zdravila Fexeric so opazili povečanje ravni feritina in TSAT nad varnostnimi mejnimi vrednostmi.
English: HDPE bottles with child-resistant closure with desiccant.
Slovenian: Plastenke iz HDPE, ki imajo za otroke varno zaporko in vsebujejo sušilno sredstvo.
English: Results from subgroup analyses in the pivotal clinical study in dialysis patients show that the concomitant use of frequently co-prescribed medications in CKD patients (fluoroquinolones, tetracyclines, proton pump inhibitors, thyroid hormones, sertraline, Vitamin D, warfarin, acetylsalicylic acid) do not affect the efficacy of Fexeric with respect to its ability to lower serum
Slovenian: zaviralcev protonske črpalke, ščitničnih hormonov, sertralina, vitamina D, varfarina, acetilsalicilne kisline) ne vplivajo na učinkovitost zdravila Fexeric glede njegove sposobnosti zniževanja ravni
English: Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of
Slovenian: Ena filmsko obložena tableta vsebuje 1 g koordinacijskega kompleksa železovega citrata (kar je enako
English: General disorders and administration site
Slovenian: Splošne težave in spremembe na mestu aplikacije
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OTHER CONDITIONS AND REQUIREMENTS OF THE CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: They are supplied in one pack size of
Slovenian: Na voljo so v eni velikosti pakiranja po 200 tablet na plastenko.
English: If you take too much Fexeric, tell your doctor of pharmacist.
Slovenian: Če ste vzeli večji odmerek zdravila Fexeric, kot bi smeli Če ste vzeli prevelik odmerek zdravila Fexeric, se posvetujte z zdravnikom ali farmacevtom.
English: abdominal pain/discomfort, nausea, vomiting, haemorrhoids, haematochezia, mucous stools, dyspepsia, flatulence, dry mouth
Slovenian: hemoroidi, hematohezija, sluzasto blato, dispepsija, flatulenca, suha usta
English: Also contains sunset yellow FCF (E110), Allura Red AC (E129), see the package leaflet for futher
Slovenian: Vsebuje tudi oranžno barvilo FCF (E110) in rdeče barvilo AC (E129); za dodatne informacije glejte
English: The most commonly reported adverse reactions in dialysis-dependent chronic kidney disease (CKD 5D) patients during treatment were discoloured faeces and diarrhoea occurring in 18% and 13% of patients, respectively.
Slovenian: (KLB 5D), odvisno od dialize, sta bila obarvano blato in diareja, ki sta se pojavila pri 18 % oziroma
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: *Proportion of patients achieving serum phosphorus ≤ 5.5 mg/dl in CKD 5D patients; **Proportion of patients achieving serum phosphorus ≤ 4.0 mg/dl in CKD ND patients NAP: not applicable; SD: standard deviation
Slovenian: * Delež bolnikov, ki so dosegli raven fosforja v serumu ≤ 5,5 mg/dl pri bolnikih s KLB 5D.
English: Table 2: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD ND patients.
Slovenian: Preglednica 1: Neželeni učinki, ki so jih opazili v kliničnih študijah, v katerih se je zdravilo