natgillin/translations-raw huggingface dataset:
This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart disease.
To vodi do hiperfosfatemije, ki lahko dolgoročno povzroči zaplete, na primer obolenje srca.
The active substance in Renagel, sevelamer, is a phosphate binder.
Zdravilna učinkovina zdravila Renagel je fosfatni vezalec sevelamer.
When taken with meals, sevelamer binds to phosphate from food within the gut, preventing it from being absorbed into the body.
Če se jemlje ob obrokih, se sevelamer v črevesju veže na fosfate iz hrane, s čimer preprečuje njihovo absorpcijo v telo.
This help to reduce the phosphate levels in the blood.
To pomaga pri zniževanju ravni fosfatov v krvi.
The effects of Renagel were first tested in experimental models before being studied in humans.
Učinki zdravila Renagel so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
In haemodialysis, Renagel has been studied in two short-term studies lasting eight weeks and one longer study lasting 44 weeks.
Pri hemodializi je bilo zdravilo Renagel preučevano v dveh kratkotrajnih študijah, ki sta trajali osem tednov in eni daljši študiji, trajajoči 44 tednov.
The first study compared Renagel with calcium acetate (another phosphate-lowering medicine) in 84 patients.
V prvi študiji so zdravilo Renagel pri 84 bolnikih primerjali s kalcijevim acetatom (drugim zdravilom za zniževanje koncentracije fosfatov).
The second, which did not compare Renagel with any
V drugi študiji, v kateri zdravila Renagel niso primerjali z nobenim drugim zdravilom, je sodelovalo 172 bolnikov.
In peritoneal dialysis, there has been one study of Renagel comparing its effectiveness with that of calcium acetate in 143 patients over 12 weeks.
Reproduction is authorised provided the source is acknowledged Pri peritonealni dializi so v eni študiji zdravila Renagel njegovo učinkovitost primerjali z učinkovitostjo kalcijevega acetata pri 143 bolnikih v obdobju 12 tednov.
In all studies, the main measure of effectiveness was the change in blood phosphate levels between the start and the end of treatment.
V vseh študijah je bilo glavno merilo učinkovitosti sprememba ravni fosfatov v krvi od začetka do konca zdravljenja.
What benefit has Renagel shown during the studies?
Kakšne koristi je zdravilo Renagel izkazalo med študijami?
Renagel produced a significant decrease in serum phosphate in all studies.
Zdravilo Renagel je v vseh študijah povzročilo bistveno znižanje koncentracije fosfatov v serumu.
In the comparative study of patients undergoing haemodialysis, there was an average fall of 0.65 mmol/ l over the eight weeks of Renagel treatment, compared with 0.68 mmol/ l when the patients were taking calcium acetate.
V primerjalni študiji bolnikov, ki so prejemali hemodializo, je bilo povprečno zmanjšanje v osmih tednih zdravljenja z zdravilom Renagel za 0, 65 mmol/ l, medtem ko je bilo zmanjšanje pri bolnikih, ki so prejemali kalcijev acetat, 0, 68 mmol/ l.
Patients taking Renagel had a similar fall in phosphate levels in the second study.
Pri bolnikih, ki so jemali zdravilo Renagel, je bilo v drugi študiji ugotovljeno podobno zmanjšanje koncentracije fosfatov.
In the third, there was an average fall of 0.71 mmol/ l over 44 weeks.
V tretji študiji je bilo v 44 tednih ugotovljeno povprečno zmanjšanje za 0, 71 mmol/ l.
In the study of patients undergoing peritoneal dialysis, the patients receiving Renagel had similar falls in phosphate to those receiving calcium acetate (0.52 and 0.58 mmol/ l, respectively).
V študiji z bolniki, ki so prejemali peritonealno dializo, je bilo pri bolnikih, ki so prejemali zdravilo Renagel, ugotovljeno podobno znižanje koncentracije fosfatov kot pri bolnikih, ki so prejemali kalcijev acetat (0, 52 oziroma 0, 58 mmol/ l).
The most common side effects with Renagel (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Najpogostejša neželena učinka zdravila Renagel (opažena pri več kot 1 bolniku od 10) sta navzeja (občutek slabosti) in bruhanje.
For the full list of all side effects reported with Renagel, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Renagel, glejte navodilo za uporabo.
Renagel should not be used in people who may be hypersensitive (allergic) to sevelamer or any of the other ingredients.
Zdravila Renagel ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) sevelamer ali katero koli drugo sestavino zdravila.
Renagel should also not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).
Prav tako se zdravilo Renagel ne sme uporabljati pri ljudeh s hipofosfatemijo (nizkimi ravnmi fosfatov v krvi) ali zaporo črevesa.
The Committee for Medicinal Products for Human Use (CHMP) decided that Renagel’ s benefits are greater than its risks for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Renagel pri nadzorovanju hiperfosfatemije pri odraslih bolnikih, ki prejemajo hemodializo ali peritonealno dializo, večje od z njim povezanih tveganj.
The Committee recommended that Renagel be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Renagel odobri dovoljenje za promet.
Renagel was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Renagel je bilo prvotno odobreno „ v izjemnih okoliščinah “, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 26 June 2006.
Ker je družba posredovala zahtevane dodatne informacije, so „ izjemne okoliščine “ dne 26. junija 2006 prenehale veljati.
Other information about Renagel:
Druge informacije o zdravilu Renagel:
The European Commission granted a marketing authorisation valid throughout the European Union for Renagel to Genzyme Europe B. V. on 28 January 2000.
Evropska komisija je dovoljenje za promet z zdravilom Renagel, veljavno po vsej Evropski uniji, odobrila družbi Genzyme Europe B. V. dne 28. januarja 2000.
The marketing authorisation was renewed on 28 January 2005.
Dovoljenje za promet je bilo podaljšano dne 28. januarja 2005.
The full EPAR for Renagel can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Renagel je na voljo tukaj.
EU Numbers EU/ 1/ 99/ 123/ 005
Številke EU EU/ 1/ 99/ 123/ 005
Invented name Renagel
Zaščiteno ime Renagel
Strengths 400 mg
Jakosti 400 mg
Pharmaceutical Forms Film-coated tablet
Farmacevtske oblike Filmsko obložena tableta
Route of Administration Oral use
Način uporabe Peroralna uporaba
Packaging Bottle (HDPE)
Ovojnina Steklenica (polietilen velike gostote)
Package sizes 1 bottle of 360 tablets with outer carton
Velikosti pakiranj 1 steklenica s 360 tabletami z zunanjo ovojnino
Each tablet contains 400 mg sevelamer.
Vsaka tableta vsebuje 400 mg sevelamera.
Film-coated tablet The off-white, oval tablets are imprinted with Renagel 400 on one side.
Filmsko obložene tablete Sivobele ovalne tablete imajo na eni strani natisnjeno oznako Renagel 400.
Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Renagel je namenjen uravnavanju hiperfosfatemije pri zdravljenju odraslih bolnikov, ki prejemajo hemodializo oziroma peritonealno dializo.
Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 – dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Renagel je treba uporabljati v smislu večstranskega pristopa zdravljenja, ki lahko vključuje kalcijeve dodatke, 1, 25 – dihidroksi vitamin D3 ali kakšen njegov analog, za nadziranje razvoja renalne osteodistrofije.
Children The safety and efficacy of this product has not been established in patients below the age of 18 years.
Otroci Varnost in učinkovitost tega zdravila nista ugotovljeni pri bolnikih, ki so mlajši od 18 let.
Adults and elderly (> 65 years) For patients who are not on phosphate binders, dosage is determined individually based on serum phosphate concentration as indicated in the table below:
Odrasli in starejši (> 65 let) Za bolnike, ki ne jemljejo fosfatnih vezalcev, se odmerek določa posamezno glede na koncentracijo fosfata v serumu, kot je navedeno v spodnji razpredelnici:
of Renagel 400 mg tablets
Raven fosfata v serumu pri bolnikih, Začetni odmerek Renagel 400 mg
1.76 – 2.42 mmol/ l (5.5-7.5 mg/ dl) 2.42 – 2.91 mmol/ l (7.5-9 mg/ dl) > 2.91 mmol/ l (> 9 mg/ dl)
2, 42 – 2, 91 mmol/ l (7, 5 – 9 mg/ dl) > 2, 91 mmol/ l (> 9 mg/ dl)
2 tablets, 3 times per day 3 tablets,3 times per day 4 tablets, 3 times per day
3- krat na dan po 3 tablete 3- krat na dan po 4 tablete
If Renagel is prescribed as an alternative phosphate binder, Renagel should be given in equivalent doses on a mg weight basis compared to the patient’ s previous calcium based phosphate binder.
Če zdravnik predpiše Renagel kot alternativni fosfatni vezalec, ga je treba dajati kot enakovreden odmerek v mg v primerjavi z bolnikovim predhodnim fosfatnim vezalcem na osnovi kalcija.
Serum phosphate levels should be closely monitored and the dose of Renagel adjusted accordingly with the goal of lowering serum phosphate to 1.76 mmol/ l (5.5mg/ dl) or less.
Koncentracijo fosfata v serumu je treba skrbno spremljati in odmerek zdravila Renagel prilagoditi glede na cilj znižanja fosfata v serumu na 1, 76 mmol/ l (5, 5 mg/ dl) ali manj.
The dose range may vary between 1 and 10 capsules per meal.
Odmerek je lahko od 1 do 10 tablet po 400 mg pri enem obroku.
Patients should take Renagel with meals and adhere to their prescribed diets.
Bolniki morajo jemati Renagel ob obroku in se držati predpisanih diet.
The capsules must be swallowed whole.
Tablete je treba pogoltniti cele.
2 4.3 Contra-indications
2 4. 3 Kontraindikacije
• Hypersensitivity to sevelamer or to any of the excipients.. • Hypophosphataemia or bowel obstruction.
• Preobčutljivost za sevelamer ali katerokoli pomožno snov. • Hipofosfatemija ali zapora črevesa.
Efficacy and safety of Renagel has not been studied in children or in predialysis patients.
Učinkovitost in varnost zdravila Renagel pri otrocih ali bolnikih pred peritonealno dializo, nista bili proučevani.
The safety and efficacy of Renagel has not been studied in patients with swallowing disorders, untreated or severe gastroparesis, and retention of gastric contents.
Varnost in učinkovitost zdravila Renagel nista bili preučevani pri bolnikih s težavami pri požiranju, z nezdravljeno ali hudo gastroparezo in tistih, ki jim zastaja hrana v želodcu.
Renagel should only be used in these patients following careful assessment of benefit and risks.
Ti bolniki lahko jemljejo Renagel le po natančni oceni koristi in tveganj.
Efficacy and safety of Renagel has not been studied in patients with active inflammatory bowel disease, gastrointestinal motility disorders, abnormal or irregular bowel motion and patients with a history of major gastrointestinal surgery.
Učinkovitost in varnost zdravila Renagel nista bili preučevani pri bolnikih z aktivnim vnetjem črevesja, gastrointestinalnimi motnjami, nenormalnim ali nepravilnim gibanjem črevesja in pri bolnikih, ki so imeli v preteklosti obsežno gastrointestinalno operacijo.
Consequently, caution should be exercised when Renagel is used in patients with these disorders.
Zato je treba biti pri teh bolnikih z uporabo zdravila Renagel zelo pazljiv.
In very rare cases, intestinal obstruction and ileus/ subileus have been observed in patients during treatment with Renagel.
V zelo redkih primerih je bilo pri bolnikih med zdravljenjem z zdravilom Renagel opaziti črevesno zaporo in ileus/ subileus.
Patients who are constipated should be monitored carefully while being treated with Renagel.
Zaprte bolnike je potrebno med zdravljenjem z zdravilom Renagel skrbno spremljati.
Renagel treatment should be re- evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Pri bolnikih, ki imajo hudo zaprtje ali druge hude gastrointestinalne simptome, je treba ponovno pretehtati smiselnost zdravljenja z zdravilom Renagel.
Renagel alone is not indicated for the control of hyperparathyroidism.
Renagel sam ni namenjen za nadzorovanje hiperparatiroidizma.
In patients with secondary hyperparathyroidism Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Pri bolnikih s sekundarnim hiperparatiroidizmom je treba Renagel uporabljati v smislu večstranskega pristopa zdravljenja, ki lahko vključuje kalcijeve dodatke, 1, 25 – dihidroksi vitamin D3 ali kakšen njegov analog, za znižanje koncentracije intaktnega paratiroidnega hormona (iPTH).
Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia.
Pri bolnikih z ledvično odpovedjo lahko pride do hipokalcemije ali hiperkalcemije.
Renagel does not contain calcium.
Renagel ne vsebuje kalcija.
Serum calcium levels should be monitored as is done in normal follow-up of a dialysis patient.
Koncentracijo kalcija v serumu je treba spremljati kot pri običajnem postopku pri bolniku na dializi.
Elemental calcium should be given as a supplement in case of hypocalcaemia.
V primeru hipokalcemije mu je kot dopolnilo potrebno dajati elementaren kalcij.
Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels.
Odvisno od diete in vrste zadnje stopnje ledvične odpovedi lahko bolniki na dializi utrpijo pomanjkanje vitamina A, D, E in K.
Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and the vitamins should be supplemented if necessary.
Predklinične študije za sevelamer v odmerku, 10- krat večjem od odmerka za ljudi, so pokazale, da zmanjšuje absorpcijo vitaminov D, E in K ter folne kisline (glejte tudi 5. 3 Predklinični podatki o varnosti). Potemtakem je pri bolnikih, ki ne uživajo vitaminov, treba upoštevati spremljanje koncentracije vitaminov A, D in E in ocenitev stanja vitamina K s pomočjo meritev tromboplastinskega časa, vitamine pa je treba dodati, če je potrebno.
Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical study, vitamin A, D, E and K levels were not measured in these patients.
Dodatno spremljanje vitaminov in folne kisline se priporoča pri bolnikih, ki prejemajo peritonealno dializo, ker v kliničnih študijah vrednosti vitamina A, D, E in K niso bile izmerjene pri teh bolnikih.
One gram of Renagel contains approximately 180 mg (5.1mEq) chloride.
En gram zdravila Renagel vsebuje približno 180 mg (5, 1 mEq) klorida.
Worsening of acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated with calcium-based binders were observed.
V številnih študijah, kjer so pri bolnikih, zdravljenih s sevelamerom, v primerjavi z bolniki, zdravljenimi z vezalci na osnovi kalcija, opazili nižje ravni bikarbonata, so zabeležili poslabšanje acidoze pri prehodu z drugih fosfatnih vezalcev na sevelamer.
Closer monitoring of serum bicarbonate levels is therefore recommended.
Zato je priporočljivo pozornejše spremljanje ravni bikarbonata v serumu.
3 Very rare cases of hypothyroidism have been reported in patients co-administered Renagel and Levothyroxine.
3 Poročali so o redkih primerih hipotiroidizma pri bolnikih, ki so sočasno dobivali Renagel in levotiroksin.
Closer monitoring of TSH levels is therefore recommended in patients receiving both medicinal products.
Zaradi tega se pri bolnikih, ki istočasno prejemajo obe zdravili, priporoča natančnejše spremljanje ravni TSH.
Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from clinical trials.
Bolniki, ki so jemali antiaritmična zdravila za zdravljenje motenj srčnega ritma in antiepileptična zdravila za zdravljenje epilepsije, so bili iz kliničnih preskušanj izključeni.
Caution should be exercised when prescribing Renagel to patients also taking these medications.
Pri predpisovanju zdravila Renagel bolnikom, ki prejemajo ta zdravila, je potrebna previdnost.
Patients receiving dialysis are subject to certain risks for infection specific to the dialysis modality.
Bolniki, ki prejemajo dializo, so podvrženi določenim tveganjem, specifičnim za način dialize.
Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with Renagel, a number of peritonitis cases were reported.
Pri bolnikih, ki prejemajo peritonealno dializo (PD), pogosto pride do peritonitisa in v kliničnih študijah z zdravilom Renagel poročajo o številnih takih primerih.
Therefore, patients on PD should be closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.
Zato je treba bolnike na PD skrbno spremljati, da se zagotovi zanesljiva uporaba ustrezne aseptične tehnike s hitrim prepoznanjem in reagiranjem na kakršne koli znake in simptome, povezane s peritonitisom.
As data on the chronic use of sevelamer for over one year are not yet available, potential absorption and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded (see section 5.2 Pharmacokinetics).
Farmakokinetične lastnosti).
In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Ko so preučevali medsebojno delovanje pri zdravih prostovoljcih, Renagel ni imel učinka na biološko uporabnost digoksina, varfarina, enalaprila ali metoprolola.
However, the bioavailability of ciprofloxacin was decreased by approximately 50% when co-administered with Renagel in a single dose study.
Vendar pa se je biološka uporabnost ciprofloksacina zmanjšala za 50%, ko so ga uporabili z zdravilom Renagel ob preučevanju enega samega odmerka.
Consequently, Renagel should not be taken simultaneously with ciprofloxacin.
Zato se Renagel ne sme jemati istočasno s ciprofloksacinom.
Renagel may affect the bioavailability of other medicinal products.
Renagel utegne vplivati tudi na biološko uporabnost drugih zdravil.
Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when coadministered with Renagel without any clinical consequences (i. e graft rejection).
Pri bolnikih po presaditvi, ki so sočasno prejemali zdravilo Renagel, so poročali o zmanjšanih koncentracijah ciklosporina, mikofenolat mofetila in takrolimusa, vendar brez kakršnihkoli kliničnih posledic (npr. zavrnitev presadka).
When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Renagel, or the physician should consider monitoring blood levels.
Ob uporabi zdravila, kjer ima zmanjšanje biološke uporabnosti lahko klinično pomembne vplive na varnost ali učinkovitost, je potrebno zdravilo vzeti vsaj eno uro pred ali tri ure po zaužitju zdravila Renagel ali pa mora zdravnik spremljati koncentracije v krvi.
The safety of Renagel has not been established in pregnant or lactating women.
Varnost zdravila Renagel pri nosečnicah ali doječih ženskah ni ugotovljena.
In animal studies there was no evidence that sevelamer induced embryo-foetal toxicity.
Pri živalih ni bilo dokazov, da bi sevelamer povzročal embriofetalno toksičnost.
Renagel should only be given to pregnant or lactating women if clearly needed and after a careful risk/ benefit analysis has been conducted for both the mother and the foetus or infant (See 5.3 Preclinical safety data).
Predklinični podatki o varnosti).
No studies on the effects on ability to drive and use machines have been performed.
Študije o vplivu zdravila na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks, the most frequently occurring (≥ 5% of patients) undesirable effects possibly or probably related to Renagel were all in the gastrointestinal disorders system organ class.
V vzporednih študijah, ki so vključevale 244 hemodializna bolnika, pri katerih je trajalo zdravljenje do 54 tednov ter 97 bolnikov s peritonelano dializo, pri katerih je zdravljenje trajalo 12 tednov, je šlo pri vseh najpogostejših (≥ 5% bolnikov) neželenih učinkih, ki so mogoče ali verjetno povezani z uporabo zdravila Renagel, za bolezni prebavil glede na sistem klasifikacije organov.
Data possibly or probably related to Renagel from these studies (299 patients) and from uncontrolled clinical trials (384 patients) are listed by frequency in the table below.
Podatki, ki so verjetno povezani z zdravilom Renagel iz teh študij (299 bolnikov) in iz nekontroliranih kliničnih preskušanj (384 bolnikov), so glede na pogostost našteti v spodnji preglednici.
The reporting rate is classified as very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10),
Neželeni učinki se po poročani
4 uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000), including isolated reports.
4 pogostosti ocenjujejo kot zelo pogosti (≥1/ 10), pogosti ((≥1/ 100, < 1/ 10), občasni (≥1/ 1, 000, < 1/ 100), redki (≥1/ 10, 000, < 1/ 1, 000), zelo redki (< 1/ 10, 000), vključno s posameznimi poročanji.
Diarrhoea, dyspepsia, flatulence, upper abdominal pain, constipation
Bolezni prebavil zelo pogosti (≥1/ 10): slabost, bruhanje pogosti (≥1/ 100, < 1/ 10): driska, dispepsija, flatulenca, bolečine v zgornjem delu trebuha, zaprtje
Most of these events are commonly observed in patients Stage 5 Chronic Kidney Disease and are not necessarily attributable to Renagel.
Večina teh učinkov je na splošno značilnih za bolnike s 5. stopnjo kronične bolezni ledvic in niso nujno posledica zdravila Renagel.
Post-marketing experience:
Izkušnje z uporabo:
Renagel has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of thirty- five 403 mg capsules (equivalent to thirty-five 400 mg tablets), per day for eight days with no undesirable effects.
Renagel so dajali zdravim prostovoljcem v odmerkih do 14 gramov na dan, kar je enakovredno petintridesetim 403 mg kapsulam (enakovredno 35 tabletam po 400 mg), osem dni zaporedoma brez neželenih učinkov.
Treatment of hyperphosphatemia.
Zdravljenje hiperfosfatemije.
Renagel contains sevelamer, a non-absorbed phosphate binding poly(allylamine hydrochloride) polymer, free of metal and calcium.
Renagel vsebuje sevelamer, neabsorbiran polimer (alilaminijev klorid), ki veže fosfate, brez kovine in kalcija.
In clinical trials, selevamer has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Klinične študije dokazujejo učinkovitost sevelamera pri zmanjševanju serumskega fosfata pri bolnikih, ki prejemajo hemodializo oziroma peritonealno dializo.
In clinical trials mean total and LDL cholesterol declined by 15-31%.
Pri kliničnih preskušanjih je povprečna vrednost skupnega holesterola in holesterola LDL upadla za 15 - 31%.
In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
V 12 tedenski študiji, ki je zajemala bolnike, ki so prejemali peritonealno dializo, pa se je pokazala primerljivost zmajšanja iPTH - ja z bolniki, ki so prejemali kalcijev acetat.