FrancophonIA/ELRC3.0 huggingface dataset:
English: In these clinical trials, approximately 43% of patients experienced at least one adverse reaction during Velphoro treatment, which were reported as serious adverse reactions in 0.36%.
Slovenian: V teh kliničnih preskušanjih je med zdravljenjem z zdravilom Velphoro približno 43 % bolnikov doživelo najmanj en neželeni učinek, pri čemer je bilo 0,36 % resnih neželenih učinkov.
English: Concomitant administration of Velphoro did not affect the bioavailability of these medicinal products as measured by the area under the curve (AUC).
Slovenian: Sočasno jemanje zdravila Velphoro ni vplivalo na biološko uporabnost teh zdravil, kot je bilo izmerjeno v področju pod krivuljo (AUC).
English: If you have black stools and also have symptoms like increasing tiredness and breathlessness contact your doctor immediately (see section 4).
Slovenian: Če imate črno blato in tudi druge simptome, kot je povečana utrujenost in zadihanost, se nemudoma obrnite na svojega zdravnika (glejte poglavje 4).
English: This can result in stiffening of the blood vessels, making it harder for the blood to be pumped around the body.
Slovenian: Zaradi tega lahko pride do otrdelosti krvnih žil, kar otežuje pretok krvi po telesu.
English: Can't be sold separately.
Slovenian: Prodaja posameznega dela ni mogoča.
English: Your doctor may adjust the dose during the treatment course depending on the phosphorus level in your blood.
Slovenian: Med zdravljenjem lahko odmerek prilagodi, odvisno od ravni fosforja v vaši krvi.
English: Any instances of overdose of Velphoro (e.g. hypophosphataemia) should be treated by standard clinical practice.
Slovenian: Vse primere prevelikega odmerjanja zdravila Velphoro (npr. hipofosfatemijo) je treba zdraviti v skladu s standardno klinično prakso.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vifor Fresenius Medical Care Renal Pharma France
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Vifor Fresenius Medical Care Renal Pharma France
English: Non-clinical studies in several species (rats and dogs) showed that pn-FeOOH is distributed from the plasma to the liver, spleen and bone marrow, and utilized by incorporation into red blood cells.
Slovenian: Neklinične študije pri več vrstah (podganah in psih) so pokazale, da se zdravilo Velphoro porazdeli iz plazme v jetra, vranico in kostni mozeg ter porabi z vključitvijo v rdeče krvne celice.
English: Tablets have a 20 mm diameter and a thickness of 6.5 mm.
Slovenian: Tablete imajo premer 20 mm in debelino 6,5 mm.
English: They have been conducted in healthy human male and female subjects with losartan, furosemide, digoxin, warfarin, and omeprazole.
Slovenian: Izvedli so jih na zdravih moških in ženskah, ki so jemali losartan, furosemid, digoksin, varfarin in omeprazol.
English: Velphoro may be harmful to the teeth.
Slovenian: Zdravilo Velphoro lahko škodljivo vpliva na zobe.
English: 90 chewable tablets
Slovenian: 90 žvečljivih tablet
English: - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom - Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: This reduces the amount of phosphorus that can be absorbed into the bloodstream and thus lowers phosphorus levels in your blood.
Slovenian: Tako se zmanjšuje količina fosforja, ki se lahko absorbira v krvni obtok, zaradi česar se znižajo ravni fosforja v krvi.
English: Hypercalcaemia Hypocalcaemia
Slovenian: Hiperkalcemija Hipokalciemija
English: Reproductive and developmental toxicity studies in animals revealed no risk with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije vpliva na sposobnost razmnoževanja in razvoja na živalih niso pokazale škodljivih učinkov na nosečnost, razvoj zarodka/ploda, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: (rats and dogs) showed that systemic absorption was very low (≤1% of the administered dose).
Slovenian: Neklinične študije pri več vrstah (podganah in psih) so pokazale, da je bila sistemska absorpcija zelo nizka (≤ 1 % danega odmerka).
English: Shelf-life after first opening the bottle: 90 days Opening date:
Slovenian: Rok uporabnosti po prvem odprtju plastenke: 90 dni Datum odprtja:
English: What Velphoro is and what it is used for
Slovenian: Kaj je zdravilo Velphoro in za kaj ga uporabljamo
English: The majority of the adverse reactions reported from trials were gastrointestinal disorders, with the most frequently reported adverse reactions being diarrhoea and discoloured faeces (very common).
Slovenian: Večina neželenih učinkov, o katerih so poročali v preskušanjih, so bile gastrointestinalne težave, najpogostejši neželeni učinek pa sta bila diareja in sprememba barve blata (zelo pogosta).
English: Velphoro is a chewable tablet that must be taken with meals.
Slovenian: Zdravilo Velphoro je žvečljiva tableta, ki jo je treba jemati s hrano.
English: Each tablet also contains 750 mg sucrose and 700 mg starches.
Slovenian: Ena tableta vsebuje tudi 750 mg saharoze in 700 mg škroba.
English: Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.
Slovenian: Zdravilo Velphoro je treba uporabljati v okviru večstranskega terapevtskega pristopa, ki lahko vključuje jemanje dodatnega kalcija, 1,25­dihidroksi vitamina D3 ali katerega od njegovih analogov, ali kalcimimetikov za nadzor razvoja ledvične osteodistrofije.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Tablets must be chewed or crushed and taken with meals.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Tablete je treba prežvečiti ali zdrobiti in jih jemati z obroki.
English: In clinical practice, treatment will be based on the need to control serum phosphorus levels, though patients who respond to Velphoro therapy usually achieve optimal serum phosphorus levels at doses of 1,500 - 2,000 mg iron per day (3 to 4 tablets).
Slovenian: V klinični praksi bo zdravljenje odvisno od potrebe po nadzoru ravni fosforja v serumu, čeprav bolniki, ki se odzivajo na terapijo z zdravilom Velphoro, običajno dosežejo optimalne ravni fosforja v serumu pri odmerkih od 1500 do 2000 mg železa na dan (3 do 4 tablete).
English: If you are not sure, talk to your doctor before taking this medicine.
Slovenian: Če niste prepričani, se pred jemanjem zdravila pogovorite s svojim zdravnikom.
English: Although the potential for interactions with medicinal products seems low, for concomitant treatment with medicinal products with a narrow therapeutic window, the clinical effect and adverse events should be monitored, on initiation or doseadjustment of either Velphoro or the concomitant medicinal product, or the physician should consider measuring blood levels.
Slovenian: Čeprav se zdi možnost za medsebojno delovanje z drugimi zdravili majhna, je treba pri sočasnem zdravljenju z zdravili z ozko terapevtsko širino ob začetku jemanja ali prilagoditvi odmerka zdravila Velphoro ali zdravila, ki se jemlje sočasno, spremljati klinični učinek in neželene dogodke ali pa mora zdravnik preučiti smiselnost merjenja ravni v krvi.
English: The active moiety of Velphoro, pn-FeOOH, is practically insoluble and therefore not absorbed.
Slovenian: Aktivna sestavina zdravila Velphoro, pn­FeOOH, je praktično netopna in se zato ne absorbira.
English: Peritonitis, gastric and hepatic disorders and gastrointestinal surgery Patients with a recent history of peritonitis (within the last 3 months), significant gastric or hepatic disorders and patients with major gastrointestinal surgery have not been included in clinical studies with Velphoro.
Slovenian: Peritonitis, težave želodca in jeter ter gastrointestinalni kirurški poseg Bolniki z nedavno anamnezo peritonitisa (v zadnjih 3 mesecih), večjimi težavami želodca ali jeter in bolniki po zahtevnejšem gastrointestinalnem kirurškem posegu niso bili vključeni v klinične študije uporabe zdravila Velphoro.
English: What you need to know before you take Velphoro
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Velphoro
English: Talk to your doctor or pharmacist before taking Velphoro: - if you have had peritonitis, an inflammation of the peritoneum (the thin tissue that lines the inner wall of the abdomen) within the last 3 months, - if you have significant stomach and/or liver problems, - if you have had major surgery on your stomach and/or intestines.
Slovenian: Pred začetkom jemanja zdravila Velphoro se posvetujte z zdravnikom ali farmacevtom: - če ste imeli v zadnjih 3 mesecih peritonitis, vnetje peritoneja (mehko tkivo, ki pokriva notranjo steno trebuha); - če imate hujše težave z želodcem in/ali jetri; - če ste imeli večji kirurški poseg na želodcu in/ali črevesju.
English: INFORMATION IN BRAILLE velphoro
Slovenian: PODATKI V BRAILLOVI PISAVI velphoro
English: Uncommon (may affect up to 1 in 100 people): bloating (abdominal distension), inflammation of the stomach, abdominal discomfort, difficulty swallowing, acid coming back up from the stomach (gastrooesophageal reflux disease), tongue discolouration, low or high calcium levels in the blood seen in tests, tiredness, itch, rash, headache, shortness of breath.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): napihovanje (napenjanje), vnetje želodca, nelagodje v trebuhu, težave pri požiranju, kislina, ki se dviguje nazaj iz želodca (gastroezofagealna refluksna bolezen), razbarvanje jezika, nizka ali visoka raven kalcija v krvi, vidna na testih, utrujenost, srbečica, izpuščaj, glavobol, zasoplost.
English: In healthy subjects, the median uptake of radiolabelled iron in the blood was estimated to be 0.43% (range 0.16 - 1.25%) on Day 21, in pre-dialysis patients 0.06% (range 0.008 - 0.44%) and in haemodialysis patients 0.02% (range 0 - 0.04%).
Slovenian: Pri zdravih preiskovancih je bil na 21. dan povprečen sprejem radioaktivno označenega železa v krvi ocenjen na 0,43 % (razpon 0,16 - 1,25 %), pri bolnikih pred dializo na 0,06 % (razpon 0,008 - 0,44 %) in pri bolnikih na hemodializi na 0,02 % (razpon 0 - 0,04 %).
English: In animal studies with rats and dogs administered 59Fe-Velphoro drug substance orally, radiolabelled iron was recovered in the faeces but not the urine.
Slovenian: V študijah na živalih, kjer so podgane in psi peroralno dobivali učinkovino 59Fe­Velphoro, so odkrili radioaktivno označeno železo v blatu, ne pa tudi v urinu.
English: DO NOT swallow it whole.
Slovenian: pogoltnite je cele.
English: The mean daily dose of Velphoro over 55 weeks of treatment was 1,650 mg iron and the mean daily dose of sevelamer carbonate was 6,960 mg.
Slovenian: Povprečni dnevni odmerek zdravila Velphoro v 55 tednih zdravljenja je bil 1.650 mg železa in povprečni dnevni odmerek sevelamerijevega karbonata je bil 6.960 mg.
English: Data from clinical studies have shown that Velphoro does not affect the lipid lowering effects of HMG-CoA reductase inhibitors (e.g., atorvastatin and simvastatin).
Slovenian: Podatki kliničnih študij kažejo, da zdravilo Velphoro ne vpliva na znižanje lipidov zaviralcev HMG­ CoA reduktaze (npr. atorvastatin in simvastatin).
English: In animal studies, there were no adverse effects on mating performance, fertility, and litter parameters following treatment with Velphoro (see section 5.3).
Slovenian: V študijah na živalih ni bilo neželenih učinkov na uspešnost parjenja, plodnost in parametre legla po zdravljenju z zdravilom Velphoro (glejte poglavje 5.3).
English: What Velphoro is and what it is used for What you need to know before you take Velphoro How to take Velphoro
Slovenian: Kaj je zdravilo Velphoro in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Velphoro Kako jemati zdravilo Velphoro Možni neželeni učinki
English: Adverse reactions reported from the use of Velphoro at doses from 250 mg iron/day to 3,000 mg iron/day in these patients (n=835) are listed in Table 1.
Slovenian: Neželeni učinki, o katerih so poročali pri uporabi zdravila Velphoro v odmerkih od 250 mg železa/dan do 3.000 mg železa/dan pri teh bolnikih (n = 835), so navedeni v tabeli 1.
English: The response rates, defined as the proportion of subjects achieving serum phosphorus levels within the KDOQI (Kidney Disease Outcomes Quality Initiative) recommended range were 45.3% and 59.1% at week 12 and 51.9% and 55.2% at week 52, for Velphoro and sevelamer carbonate, respectively.
Slovenian: Stopnje odziva, definirane kot delež preiskovancev, ki dosegajo ravni fosforja v serumu znotraj priporočenega razpona KDOQI (Iniciativa za kvalitetno obravnavo ledvične bolezni), so bile 45,3 % za Velphoro in 59,1 % za sevelamerijev karbonat v 12. tednu ter 51,9 % za Velphoro in 55,2 % za sevelamerijev karbonat v 52. tednu.
English: Its degradation product, mononuclear iron species, can however be released from the surface of pnFeOOH and be absorbed.
Slovenian: Njegov razgradni produkt, mononuklearna vrsta železa, pa se lahko sprosti iz površine pn­FeOOH in se absorbira.
English: Velphoro should only be used in these patients following careful assessment of benefit/risk.
Slovenian: Pri takih bolnikih se zdravilo Velphoro lahko uporablja le po natančni oceni koristi/tveganja.
English: If you are taking any other medicine that is known to be affected by iron (for example medicines containing the active substance alendronate (used to treat certain bone disorders) or doxycycline (an antibiotic)) or has the potential to be affected by iron (for example medicines containing the active substance levothyroxine (used to treat thyroid function disorder)), make sure that you take this medicine at least one hour before taking Velphoro or at least two hours after taking Velphoro.
Slovenian: Če jemljete katero koli zdravilo, za katerega je znano, da nanj vpliva železo (na primer zdravila, ki vsebujejo učinkovino alendronat (za zdravljenje nekaterih bolezni kosti) ali doksiciklin (antibiotik)) ali nanj lahko vpliva železo (na primer zdravila, ki vsebujejo učinkovino levotiroksin (za zdravljenje motenj delovanja ščitnice)), je treba to zdravilo jemati vsaj eno uro pred jemanjem zdravila Velphoro ali dve uri po tem.
English: There are no data on the effect of Velphoro on fertility in humans.
Slovenian: Ni podatkov o vplivu zdravila Velphoro na plodnost pri ljudeh.
English: Mucosal hyperplasia, with diverticulum/cyst formation was observed in the colon and caecum of mice after 2-years treatment, but this was considered a species-specific effect with no diverticula/cysts seen in long term studies in rats or dogs.
Slovenian: Po 2­letnem zdravljenju so pri miših opazili hiperplazijo sluznice z nastajanjem divertikla/ciste v kolonu in slepem črevesu, a se je to štelo za učinek, specifičen za živalsko vrsto, saj pri dolgoročnih študijah na podganah in psih ni bilo opaziti divertiklov/cist.
English: NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets
Slovenian: IME ZDRAVILA Velphoro 500 mg žvečljive tablete
English: Discoloured (black) stool may visually mask gastrointestinal bleeding (see section 4.5).
Slovenian: Spremenjena barva blata (črna) lahko vizualno prikrije morebitne krvavitve iz prebavil (glejte poglavje 4.5).
English: - The other ingredients are woodberry flavour, neohesperidin-dihydrochalcone, magnesium stearate, colloidal anhydrous silica.
Slovenian: - Druge sestavine zdravila so okus gozdne jagode, neohesperidin dihidrokalkon, magnezijev stearat, koloidni brezvodni silicijev dioksid.
English: Common (may affect up to 1 in 10 people): feeling sick (nausea), constipation, vomiting, indigestion, pain in stomach and gut, gas, tooth discolouration, change in taste.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): občutek siljenja na bruhanje (navzea), zaprtje, bruhanje, slaba prebava, bolečine v trebuhu in črevesju, vetrovi, obarvanost zob, spremenjen okus.
English: The iron uptake from radiolabelled Velphoro drug substance, 2,000 mg iron in 1 day was investigated in 16 CKD patients (8 pre-dialysis and 8 haemodialysis patients) and 8 healthy volunteers with low iron stores (serum ferritin <100 mcg/L).
Slovenian: Prejemanje železa iz radioaktivno označene učinkovine zdravila Velphoro, to je 2000 mg železa v 1 dnevu, so raziskali pri 16 bolnikih s KLB (8 bolnikov pred dializo in 8 na hemodializi) in 8 zdravih prostovoljcih z nizkimi zalogami železa (feritin v serumu < 100 mcg/l).
English: Velphoro is available in packs containing 30 or 90 chewable tablets.
Slovenian: Zdravilo Velphoro je na voljo v pakiranjih po 30 ali 90 žvečljivih tablet.
English: Other medicines and Velphoro
Slovenian: Druga zdravila in zdravilo Velphoro
English: If you have accidentally taken too many tablets, do not take any more and talk to your doctor or pharmacist immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Velphoro, kot bi smeli Če ste pomotoma vzeli preveč tablet, ne vzemite nobene več in se takoj posvetujte s svojim zdravnikom ali farmacevtom.
English: Velphoro should only be used by pregnant women if clearly needed following careful assessment of benefit/risk.
Slovenian: Pri nosečnicah se zdravilo Velphoro lahko uporablja le, če je nujno potrebno in po natančni oceni koristi/tveganja.
English: A decision on whether to continue breast-feeding or to continue therapy with Velphoro should be made taking into account the benefit of breast-feeding to the child and the benefit of Velphoro therapy to the mother.
Slovenian: Odločitev o nadaljevanju dojenja ali nadaljevanju zdravljenja z zdravilom Velphoro je treba sprejeti ob upoštevanju koristi dojenja za otroka in koristi zdravljenja z zdravilom Velphoro za mater.
English: Corresponding levels for sevelamer carbonate at baseline were 2.4 mmol/L and 1.7 mmol/L at week 12 (reduction by 0.7 mmol/L), respectively.
Slovenian: Ustrezne ravni za sevelamerijev karbonat v izhodišču so bile 2,4 mmol/l in 1,7 mmol/l v 12. tednu (zmanjšanje za 0,7 mmol/l).
English: In vitro data suggest that the sucrose and starch components of the drug substance can be digested to glucose and fructose, and maltose and glucose, respectively.
Slovenian: Podatki, pridobljeni in vitro, kažejo, da se saharoza in škrob iz učinkovine lahko presnavljata v glukozo in fruktozo oziroma maltozo in glukozo.
English: Velphoro is for use by adult patients who undergo haemodialysis or peritoneal dialysis (procedures to eliminate toxic substances from the blood) because of chronic kidney disease; it is used in order to help control the phosphorus level in their blood when it is too high (hyperphosphataemia).
Slovenian: Zdravilo Velphoro se uporablja za odrasle bolnike s kronično ledvično boleznijo, ki prejemajo hemodializo ali peritonealno dializo (postopka za odstranjevanje toksičnih snovi iz krvi), za pomoč pri nadzorovanju ravni fosforja v krvi, kadar je ta previsoka (hiperfosfatemija).
English: If you have diabetes you should take notice that one tablet of Velphoro is equivalent to approximately 1.4 g of carbohydrates (equivalent to 0.116 bread units).
Slovenian: Če imate sladkorno bolezen, morate upoštevati, da ena tableta zdravila Velphoro ustreza približno 1,4 g ogljikovih hidratov (enako kot 0,116 krušne enote).
English: Serum phosphorus levels and calcium-phosphorus product levels were reduced as a consequence of the reduced dietary phosphate absorption.
Slovenian: Raven fosforja in raven fosforjevih in kalcijevih produktov v serumu sta se zmanjšali kot posledica zmanjšane absorpcije fosfatov iz prehrane.
English: Treatment of patient sub-populations from week 24 to week 27 with maintenance dose of Velphoro (1,000 to 3,000 mg iron/day) or low dose (250 mg iron/day) of Velphoro demonstrated superiority of the maintenance dose.
Slovenian: Zdravljenje podskupin bolnikov od 24. do 27. tedna z vzdrževalnim odmerkom zdravila Velphoro (1.000 do 3.000 mg železa/dan) ali nizkim odmerkom (250 mg železa/dan) zdravila Velphoro je dokazalo premoč vzdrževalnega odmerka.
English: From week 12 to 24, dose titrations were allowed for both tolerability and efficacy reasons.
Slovenian: Zaradi prenašanja zdravila in učinkovitosti so bile od 12. do 24. tedna dovoljene titracije odmerkov.
English: If you are breastfeeding, your doctor will discuss with you whether to continue breastfeeding or to continue therapy with Velphoro, taking into account the benefit of Velphoro therapy to you and the benefit of breastfeeding to your child.
Slovenian: Če dojite, se boste s svojim zdravnikom pogovorili o tem, ali boste nadaljevali z dojenjem ali pa z jemanjem zdravila Velphoro, pri čemer je treba upoštevati vaše koristi zdravljenja z zdravilom Velphoro in koristi dojenja za vašega otroka.
English: Velphoro works by binding phosphate in the gastrointestinal tract and thus the serum concentration is not relevant for its efficacy.
Slovenian: Zdravilo Velphoro veže fosfate v prebavnem traktu, tako da njegova koncentracija v serumu ni pomembna za učinkovitost zdravila.
English: Patients with diabetes should take notice that one tablet of Velphoro is equivalent to approximately 1.4 g of carbohydrates (equivalent to 0.116 bread units).
Slovenian: Bolniki z diabetesom morajo upoštevati, da ena tableta zdravila Velphoro ustreza približno 1,4 g ogljikovih hidratov (enako kot 0,116 krušne enote).
English: The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches (potato starch and pregelatinised maize starch) per tablet.
Slovenian: Učinkovina železov(III) oksihidroksid saharozni kompleks vsebuje 750 mg saharoze in 700 mg škroba (krompirjev škrob in predgelatinizirani koruzni škrob) na tableto.
English: However, the degradation product of Velphoro, mononuclear iron species, can be released from the surface of polynuclear iron(III)oxyhydroxide and be absorbed.
Slovenian: Razgradni produkt zdravila Velphoro, mononuklearna vrsta železa, pa se lahko sprosti iz površine polinuklearnega železovega(III) oksihidroksida in se absorbira.
English: The chewable tablets are brown, circular, and embossed with PA500 on one side.
Slovenian: Žvečljive tablete so rjave barve, okrogle in imajo na eni strani vtisnjeno oznako PA500.
English: In addition, post-hoc analyses from clinical studies demonstrated no impact of Velphoro on iPTH lowering effect of oral Vitamin D analogues.
Slovenian: Poleg tega post hoc analize kliničnih študij niso pokazale vpliva zdravila Velphoro na učinek analogov vitamina D na zmanjševanje PTHi.
English: Product taste abnormal
Slovenian: Neprijeten okus zdravila
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
Slovenian: Če niste prepričani, ali katera od zgornjih trditev velja za vaš primer, se pred uporabo tega zdravila pogovorite s svojim zdravnikom ali farmacevtom.
English: Patients with severe hepatic impairment were excluded from participating in clinical studies with Velphoro.
Slovenian: Bolniki s hudo okvaro jeter niso sodelovali v kliničnih študijah uporabe zdravila Velphoro.
English: Velphoro is indicated for the control of serum phosphorus levels in adult CKD patients on HD or PD.
Slovenian: Zdravilo Velphoro je indicirano za nadzor ravni fosforja v serumu pri odraslih bolnikih s KLB ali tistih na HD ali PD.
English: Following completion of Study-05A, 658 patients (597 on hemodialysis and 61 on peritoneal dialysis) were treated in the 28-week extension study (Study-05B) with either Velphoro (N=391) or sevelamer carbonate (N=267) according to their original randomization.
Slovenian: Po zaključku študije­05A so 658 bolnikov (597 na hemodializi in 61 na peritonealni dializi) zdravili v 28­tedenski podaljšani študiji (študija­05B) bodisi z zdravilom Velphoro (N = 391) bodisi s sevelamerijevim karbonatom (N = 267) glede na njihovo prvotno naključno porazdelitev.
English: The following side effects have also been reported in patients taking this medicine: Very common (may affect more than 1 in 10 people): diarrhoea (generally occurring early on in the treatment, and improving over time).
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): driska (običajno se pojavi na začetku zdravljenja, stanje pa se sčasoma izboljšuje).