natgillin/translations-raw huggingface dataset:
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.
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.
METHOD AND ROUTE(S) OF ADMINISTRATION Tablets must be chewed or crushed and taken with meals.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Tablete je treba prežvečiti ali zdrobiti in jih jemati z obroki.
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).
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).
If you are not sure, talk to your doctor before taking this medicine.
Če niste prepričani, se pred jemanjem zdravila pogovorite s svojim zdravnikom.
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.
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.
The active moiety of Velphoro, pn-FeOOH, is practically insoluble and therefore not absorbed.
Aktivna sestavina zdravila Velphoro, pn­FeOOH, je praktično netopna in se zato ne absorbira.
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.
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.
What you need to know before you take Velphoro
Kaj morate vedeti, preden boste vzeli zdravilo Velphoro
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.
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.
INFORMATION IN BRAILLE velphoro
PODATKI V BRAILLOVI PISAVI velphoro
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.
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.
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%).
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 %).
In animal studies with rats and dogs administered 59Fe-Velphoro drug substance orally, radiolabelled iron was recovered in the faeces but not the urine.
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.
DO NOT swallow it whole.
pogoltnite je cele.
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.
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.
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).
Podatki kliničnih študij kažejo, da zdravilo Velphoro ne vpliva na znižanje lipidov zaviralcev HMG­ CoA reduktaze (npr. atorvastatin in simvastatin).
In animal studies, there were no adverse effects on mating performance, fertility, and litter parameters following treatment with Velphoro (see section 5.3).
V študijah na živalih ni bilo neželenih učinkov na uspešnost parjenja, plodnost in parametre legla po zdravljenju z zdravilom Velphoro (glejte poglavje 5.3).
What Velphoro is and what it is used for What you need to know before you take Velphoro How to take Velphoro
Kaj je zdravilo Velphoro in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Velphoro Kako jemati zdravilo Velphoro Možni neželeni učinki
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.
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.
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.
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.
Its degradation product, mononuclear iron species, can however be released from the surface of pnFeOOH and be absorbed.
Njegov razgradni produkt, mononuklearna vrsta železa, pa se lahko sprosti iz površine pn­FeOOH in se absorbira.
Velphoro should only be used in these patients following careful assessment of benefit/risk.
Pri takih bolnikih se zdravilo Velphoro lahko uporablja le po natančni oceni koristi/tveganja.
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.
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.
There are no data on the effect of Velphoro on fertility in humans.
Ni podatkov o vplivu zdravila Velphoro na plodnost pri ljudeh.
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.
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.
NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets
IME ZDRAVILA Velphoro 500 mg žvečljive tablete
Discoloured (black) stool may visually mask gastrointestinal bleeding (see section 4.5).
Spremenjena barva blata (črna) lahko vizualno prikrije morebitne krvavitve iz prebavil (glejte poglavje 4.5).
- The other ingredients are woodberry flavour, neohesperidin-dihydrochalcone, magnesium stearate, colloidal anhydrous silica.
- Druge sestavine zdravila so okus gozdne jagode, neohesperidin dihidrokalkon, magnezijev stearat, koloidni brezvodni silicijev dioksid.
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.
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.
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).
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).
Velphoro is available in packs containing 30 or 90 chewable tablets.
Zdravilo Velphoro je na voljo v pakiranjih po 30 ali 90 žvečljivih tablet.
Other medicines and Velphoro
Druga zdravila in zdravilo Velphoro
If you have accidentally taken too many tablets, do not take any more and talk to your doctor or pharmacist immediately.
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.
Velphoro should only be used by pregnant women if clearly needed following careful assessment of benefit/risk.
Pri nosečnicah se zdravilo Velphoro lahko uporablja le, če je nujno potrebno in po natančni oceni koristi/tveganja.
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.
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.
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.
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).
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.
Podatki, pridobljeni in vitro, kažejo, da se saharoza in škrob iz učinkovine lahko presnavljata v glukozo in fruktozo oziroma maltozo in glukozo.
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).
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).
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).
Če imate sladkorno bolezen, morate upoštevati, da ena tableta zdravila Velphoro ustreza približno 1,4 g ogljikovih hidratov (enako kot 0,116 krušne enote).
Serum phosphorus levels and calcium-phosphorus product levels were reduced as a consequence of the reduced dietary phosphate absorption.
Raven fosforja in raven fosforjevih in kalcijevih produktov v serumu sta se zmanjšali kot posledica zmanjšane absorpcije fosfatov iz prehrane.
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.
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.
From week 12 to 24, dose titrations were allowed for both tolerability and efficacy reasons.
Zaradi prenašanja zdravila in učinkovitosti so bile od 12. do 24. tedna dovoljene titracije odmerkov.
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.
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.
Velphoro works by binding phosphate in the gastrointestinal tract and thus the serum concentration is not relevant for its efficacy.
Zdravilo Velphoro veže fosfate v prebavnem traktu, tako da njegova koncentracija v serumu ni pomembna za učinkovitost zdravila.
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).
Bolniki z diabetesom morajo upoštevati, da ena tableta zdravila Velphoro ustreza približno 1,4 g ogljikovih hidratov (enako kot 0,116 krušne enote).
The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches (potato starch and pregelatinised maize starch) per tablet.
Učinkovina železov(III) oksihidroksid saharozni kompleks vsebuje 750 mg saharoze in 700 mg škroba (krompirjev škrob in predgelatinizirani koruzni škrob) na tableto.
However, the degradation product of Velphoro, mononuclear iron species, can be released from the surface of polynuclear iron(III)oxyhydroxide and be absorbed.
Razgradni produkt zdravila Velphoro, mononuklearna vrsta železa, pa se lahko sprosti iz površine polinuklearnega železovega(III) oksihidroksida in se absorbira.
The chewable tablets are brown, circular, and embossed with PA500 on one side.
Žvečljive tablete so rjave barve, okrogle in imajo na eni strani vtisnjeno oznako PA500.
In addition, post-hoc analyses from clinical studies demonstrated no impact of Velphoro on iPTH lowering effect of oral Vitamin D analogues.
Poleg tega post hoc analize kliničnih študij niso pokazale vpliva zdravila Velphoro na učinek analogov vitamina D na zmanjševanje PTHi.
Product taste abnormal
Neprijeten okus zdravila
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
Če niste prepričani, ali katera od zgornjih trditev velja za vaš primer, se pred uporabo tega zdravila pogovorite s svojim zdravnikom ali farmacevtom.
Patients with severe hepatic impairment were excluded from participating in clinical studies with Velphoro.
Bolniki s hudo okvaro jeter niso sodelovali v kliničnih študijah uporabe zdravila Velphoro.
Velphoro is indicated for the control of serum phosphorus levels in adult CKD patients on HD or PD.
Zdravilo Velphoro je indicirano za nadzor ravni fosforja v serumu pri odraslih bolnikih s KLB ali tistih na HD ali PD.
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.
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.
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).
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): driska (običajno se pojavi na začetku zdravljenja, stanje pa se sčasoma izboljšuje).
Abdominal distension Gastritis Abdominal discomfort Dysphagia Gastro-oesophageal reflux disease (GORD) Tongue discolouration
Napihnjenost trebuha Gastritis Nelagodje v trebuhu Disfagija Gastroezofagealni refluks (GERB) Sprememba barve jezika
Velphoro has been administered to over 248 seniors (≥65 years of age) according to the approved dosing regimen.
V skladu z odobrenim režimom odmerjanja so zdravilo Velphoro dajali več kot 248 starostnikom (≥ 65 let).
See section 2 for further information on sucrose and starches.
Za več informacij o saharozi in škrobu glejte poglavje 2.
Velphoro does not affect guaiac based (Haemoccult) or immunological based (iColo Rectal and Hexagon Obti) faecal occult blood tests.
Zdravilo Velphoro ne vpliva na teste gvajak (Haemoccult) ali imunološke (iColo Rectal in Hexagon Obti) teste krvi v blatu.
Child-resistant aluminium/aluminium perforated unit-dose blister, each blister containing 6 chewable tablets.
Aluminijasti pretisni omot/aluminijasti perforiran pretisni omot za enkratni odmerek z otroško zaščito, pri čemer en omot vsebuje 6 žvečljivih tablet.
Brown, circular tablets embossed with PA500 on one side.
Rjave, okrogle tablete, ki imajo na eni strani vtisnjeno oznako PA500.
If you forget to take Velphoro
Če ste pozabili vzeti zdravilo Velphoro
Adult patients with hyperphosphataemia (serum phosphorus levels ≥1.94 mmol/L) were treated with Velphoro at a starting dose of 1,000 mg iron/day followed by an 8-week dose titration period.
Odrasle bolnike s hiperfosfatemijo (raven fosforja v serumu ≥ 1,94 mmol/l) so zdravili z zdravilom Velphoro z začetnim odmerkom 1.000 mg železa/dan, čemur je sledilo 8­tedensko obdobje titriranja odmerka.
Pack sizes of 30 or 90 chewable tablets.
Velikost pakiranj: 30 ali 90 žvečljivih tablet.
At the end of week 24, 93 patients on hemodialysis whose serum phosphorus levels were controlled (<1.78 mmol/L) with Velphoro in the first part of the study, were re-randomized to continue treatment with either their week 24 maintenance dose (N=44 or a non-effective low dose control 250 mg iron/day, N=49) of Velphoro for a further 3 weeks.
Na koncu 24. tedna so 93 bolnikov na hemodializi, ki so jim v prvem delu študije nadzirali ravni fosforja v serumu (< 1,78 mmol/l) z zdravilom Velphoro, ponovno randomizirali, da so nadaljevali zdravljenje bodisi z vzdrževalnim odmerkom 24. tedna (N = 44) bodisi z neučinkovitim nizkim odmerkom kontrole 250 mg železa/dan, (N = 49) zdravila Velphoro še nadaljnje 3 tedne.
4.7 Effects on ability to drive and use machines Velphoro has no or negligible influence on the ability to drive and use machines.
Zdravilo Velphoro nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and a foil induction seal, or in child resistant aluminium blister.
Tablete so pakirane v plastenkah iz polietilena visoke gostote, ki imajo za otroke varen polipropilenski pokrovček in zaporko z indukcijsko zatesnjeno folijo, ali v aluminijastih pretisnih omotih z otroško zaščito.
The usual recommended starting dose is the equivalent of 1,500 mg iron per day (3 tablets).
Običajni priporočeni začetni odmerek zdravila je enak 1.500 mg železa na dan (3 tablete).
Multipacks are available for the blister packs with 90 chewable tablets (containing 3 individual packs of 30 × 1 chewable tablets each).
Večja pakiranja so na voljo za pakiranja s pretisnimi omoti z 90 žvečljivimi tabletami (vsebujejo 3 posamezna pakiranja po 30 × 1 žvečljivo tableto).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS), PART OF MULTIPACK (WITHOUT BLUE BOX)
ZUNANJOST ŠKATLE - 30 ŽVEČLJIVIH TABLET (5 PRETISNIH OMOTOV S PO 6 ŽVEČLJIVIMI TABLETAMI), DEL VEČJEGA PAKIRANJA (BREZ MODREGA OKENCA)
What Velphoro looks like and contents of the pack
Izgled zdravila Velphoro in vsebina pakiranja
PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) chewable tablets.
FARMACEVTSKA OBLIKA IN VSEBINA Večje pakiranje: 90 (3 pakiranja po 30) žvečljivih tablet.
The maximum recommended dose is 3,000 mg iron (6 tablets) per day.
Največji priporočeni odmerek je 3000 mg železa (6 tablet) na dan.
When administering any medicinal product that is already known to interact with iron (like alendronate and doxycycline) or has the potential to interact with Velphoro based only on in vitro studies like levothyroxine, the medicinal product should be administered at least one hour before or two hours after Velphoro.
Pri jemanju katerega koli zdravila, za katerega je znano, da vpliva na železo (kot sta alendronat in doksiciklin), ali pa se je pri študijah in vitro pokazala možnost, da bi zdravilo, kot je levotiroksin, lahko vplivalo na zdravilo Velphoro, je treba to zdravilo jemati vsaj eno uro pred jemanjem zdravila Velphoro ali dve uri po tem.
If you stop taking Velphoro
Če ste prenehali jemati zdravilo Velphoro
In Study-05A, 1,055 patients on hemodialysis (N=968) or peritoneal dialysis (N=87) with serum phosphorus ≥1.94 mmol/L following a 2 - 4-week phosphate binder washout period, were randomized and treated with either Velphoro, at a starting dose of 1,000 mg iron/day (N=707), or active-control (sevelamer carbonate, N=348) for 24 weeks.
V študiji­05A so 1.055 bolnikov na hemodializi (N = 968) ali peritonealni dializi (N = 87) s fosforjem v serumu ≥ 1,94 mmol/l, ki je sledila 2­ do 4­tedenskemu obdobju brez fosfatnih vezalcev, naključno porazdelili in jih 24 tednov zdravili z zdravilom Velphoro z začetnim odmerkom 1.000 mg železa/dan (N = 707) ali s kontrolo z učinkovino (sevelamerijev karbonat, N = 348).
High density polyethylene (HDPE) bottle with child-resistant polypropylene closure and foil induction seal, containing a molecular sieve desiccant and cotton.
Plastenka iz polietilena visoke gostote (HDPE) z za otroke varnim polipropilenskim pokrovčkom in zaporko z indukcijsko zatesnjeno folijo ter sušilnim molekularnim sitom in bombažem.