FrancophonIA/ELRC3.0 huggingface dataset:
English: In preclinical studies in rats and dogs, Renagel at a dose of 10 times the maximum human doses reduced absorption of fat soluble vitamins D, E and K, and folic acid.
Croatian: U pretkliničkim ispitivanjima na štakorima i psima Renagel u dozi 10 puta većoj od maksimalne doze za ljude smanjio je apsorpciju vitamina D, E i K topivih u mastima i folne kiseline.
English: Very rare (may affect up to 1 in 10000 people): hypersensitivity.
Croatian: Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba): preosjetljivost.
English: Uncommon reports of difficulty swallowing the Renagel tablet have been reported.
Croatian: Manje često su prijavljene poteškoće s gutanjem Renagel tableta.
English: How to take Renagel
Croatian: Kako uzimati Renagel
English: • gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis retention of gastric contents and abnormal or irregular bowel motion
Croatian: • s poremećajima motiliteta gastrointestinalnog trakta uključujući i neliječenu ili tešku gastroparezu, divertikulozu, retenciju želučanog sadržaja te neuobičajenu ili nepravilnu peristaltiku crijeva
English: If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental vitamins as necessary.
Croatian: Ako ne uzimate multivitaminske dodatke prehrani, mogu se sniziti vrijednosti vitamina A, E i K te folne kiseline u krvi, te će ih stoga liječnik možda pratiti i po potrebi Vam propisati vitaminsku dopunu.
English: It cannot be excluded that Renagel can bind fat-soluble vitamins contained in ingested food.
Croatian: Ne može se isključiti mogućnost da Renagel veže vitamine topive u mastima iz konzumirane hrane.
English: Renagel should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus (see section 5.3).
Croatian: Renagel se smije davati trudnicama samo ako je to prijeko potrebno i nakon pažljive analize rizika i koristi kako za majku tako i za fetus (vidjeti dio 5.3).
English: For patients previously on phosphate binders, Renagel should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Croatian: Bolesnicima koji su prethodno uzimali vezače fosfata Renagel se mora davati gram po gram uz praćenje razina fosfora u serumu kako bi se osigurala primjena optimalnih dnevnih doza.
English: nausea and/or vomiting
Croatian: mučnina i/ili povraćanje
English: Very Common
Croatian: Vrlo rijetko
English: Renagel has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of thirty five 400 mg tablets per day for eight days with no undesirable effects.
Croatian: Renagel se davao normalnim, zdravim dobrovoljcima u dozama do 14 grama na dan, što odgovara količini od 35 tableta od 400 mg na dan, tijekom osam dana bez neželjenih učinaka.
English: Uncommon (may affect up to 1 in 100 people): increased acidity of the blood.
Croatian: Manje često (mogu se javiti u manje od 1 na 100 osoba): povećana kiselost krvi.
English: Renagel should only be given to breast-feeding women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the infant (see section 5.3).
Croatian: Renagel se smije davati dojiljama samo ako je to prijeko potrebno i nakon pažljive analize rizika i koristi kako za majku tako i za dojenče (vidjeti dio 5.3).
English: Renagel has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of seventeen 800 mg tablets per day for eight days with no undesirable effects.
Croatian: Renagel se davao normalnim, zdravim dobrovoljcima u dozama do 14 grama na dan, što odgovara količini od 17 tableta od 800 mg na dan, tijekom osam dana bez neželjenih učinaka.
English: Initially your doctor will check the levels of phosphate in your blood every 2-3 weeks and may adjust the dose of Renagel when necessary (between 1 and 10 tablets of 400 mg per meal) to reach an adequate phosphate level.
Croatian: U početku će liječnik provjeravati razine fosfata u krvi svakih 2-3 tjedna te će po potrebi prilagoditi dozu lijeka Renagel (između 1 i 10 tableta od 400 mg po obroku) kako bi se postigla odgovarajuća razina fosfata.
English: Patients should take Renagel with meals and adhere to their prescribed diets.
Croatian: Bolesnici moraju uzimati Renagel uz obroke i pridržavati se propisane dijete.
English: Renagel should only be given to pregnant or breast-feeding women if clearly needed.
Croatian: Renagel se smije davati trudnicama i dojiljama samo kada je to prijeko potrebno.
English: Renagel contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) polymer, free of metal and calcium.
Croatian: Renagel sadrži sevelamer, neapsorbirajući poli (alilamin klorid) polimer koji veže fosfate, a ne sadrži metale ni kalcij.
English: SANOFI BULGARIA EOOD Tел: +359 2 9705300
Croatian: SANOFI BULGARIA Tел: +359 2 9705300
English: The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of mycophenolate mofetil, ciclosporin and tacrolimus should be considered during the use of combination and after its withdrawal.
Croatian: Ne može se isključiti mogućnost interakcije te treba razmotriti pozorno praćenje koncentracija mikofenolat mofetila, ciklosporina i takrolimusa u krvi tijekom i nakon kombinirane primjene s lijekom Renagel.
English: Initially your doctor will check the levels of phosphate in your blood every 2-3 weeks and may adjust the dose of Renagel when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an adequate phosphate level.
Croatian: U početku će liječnik provjeravati razine fosfata u krvi svakih 2-3 tjedna te će po potrebi prilagoditi dozu lijeka Renagel (između 1 i 5 tableta od 800 mg po obroku) kako bi se postigla odgovarajuća razina fosfata.
English: When you switch from another phosphate binder to Renagel, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Renagel may decrease the levels of bicarbonate.
Croatian: Kada prelazite s liječenja nekim drugim vezačem fosfata na Renagel, liječnik može razmisliti o tome da pozornije prati razine bikarbonata u krvi jer Renagel može smanjiti razine bikarbonata.
English: The safety of Renagel has not been established in pregnant or breast-feeding women.
Croatian: Sigurnost primjene lijeka Renagel u trudnica i dojilja nije ustanovljena.
English: Renagel contains sevelamer as the active ingredient.
Croatian: Renagel sadrži djelatnu tvar sevelamer.
English: Common (may affect up to 1 in 10 people): diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Croatian: Često (mogu se javiti u manje od 1 na 10 osoba): proljev, probavne tegobe, bol u trbuhu, zatvor, vjetrovi.
English: • if you have undergone major surgery on your stomach or bowel.
Croatian: • ako ste imali veliku operaciju želuca ili crijeva
English: • If you are taking medicine such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease (GERD), or gastric ulcers, you should consult your doctor when taking Renagel.
Croatian: • Ako uzimate lijekove za liječenje žgaravice, gastroezofagealne refluksne bolesti (GERB) ili čira na želucu, kao što su omeprazol, pantoprazol ili lanzoprazol, morate se savjetovati sa svojim liječnikom kad uzimate Renagel.
English: Serum phosphate levels should be closely monitored and the dose of sevelamer hydrochloride titrated by 0.4 g or 0.8 g three times per day (1.2 g/day or 2.4 g/day) increments with the goal of lowering serum phosphate to 1.76 mmol/L (5.5mg/dl) or less.
Croatian: Neophodno je pozorno pratiti razine fosfata u serumu i titrirati dozu sevelamerklorida u koracima po 0,4 g ili 0,8 g tri puta dnevno (1,2 g/dan ili 2,4 g/dan) s ciljem smanjenja koncentracije fosfata u serumu na 1,76 mmol/l (5,5 mg/dl) ili manje.
English: The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and an induction seal.
Croatian: Tablete su pakirane u bočice od polietilena visoke gustoće s polipropilenskim sigurnosnim čepom za djecu i zalijepljenom zaštitnom folijom.
English: 1 See inflammatory gastrointestinal disorders warning in section 4.4
Croatian: *iskustvo nakon stavljanja lijeka u promet Vidjeti upozorenja o gastrointestinalnim upalnim poremećajima u dijelu 4.4
English: The recommended starting dose of sevelamer hydrochloride is 2.4 g, 3.6 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Croatian: Preporučena početna doza sevelamerklorida je 2,4 g, 3,6 g ili 4,8 g na dan, ovisno o kliničkim potrebama i razini fosfora u serumu.
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Renagel.
Croatian: • Renagel može umanjiti učinke lijekova kao što su ciklosporin, mikofenolat mofetil i takrolimus (lijekova koji se primjenjuju u bolesnika s presatkom organa).
English: Caution should be exercised when Renagel is used in patients with difficulty swallowing.
Croatian: Potreban je oprez kad se Renagel primjenjuje u bolesnika koji otežano gutaju.
English: In clinical trials, sevelamer has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Croatian: Kliničkim je ispitivanjima dokazano da sevelamer djelotvorno smanjuje koncentracije fosfora u serumu u bolesnika koji su na hemodijalizi ili peritonealnoj dijalizi.
English: Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Croatian: Renagel je indiciran za kontrolu hiperfosfatemije u odraslih bolesnika koji su na hemodijalizi ili peritonealnoj dijalizi.
English: Renagel treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Croatian: Treba ponovno procijeniti nastavak liječenja lijekom Renagel u bolesnika u kojih dođe do teške konstipacije ili se jave drugi teški gastrointestinalni simptomi.
English: Renagel 800 mg
Croatian: 800 mg
English: Serum phosphate level in patients not on phosphate binders
Croatian: Razina fosfata u serumu u bolesnika koji ne uzimaju vezače fosfata
English: Renagel 400 mg
Croatian: 400 mg
English: In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with Renagel in a single dose study.
Croatian: U ispitivanjima interakcija u zdravih dobrovoljaca, prilikom istodobne primjene sevelamerklorida i ciprofloksacina u ispitivanju s primjenom jedne doze, Renagel je smanjio bioraspoloživost ciprofloksacina za približno 50%.
English: 180 film-coated tablets.
Croatian: 180 filmom obloženih tableta
English: You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Croatian: Posebna napomena za pacijente na peritonealnoj dijalizi Možete razviti peritonitis (infekcija tekućine u trbuhu) povezan s peritonealnom dijalizom.
English: What you need to know before you take Renagel Do not take Renagel:
Croatian: Što morate znati prije nego što počnete uzimati Renagel
English: Acidosis, increased serum chloride levels
Croatian: Poremećaji metabolizma i prehrane acidoza, povećane razine klorida u serumu
English: How to store Renagel
Croatian: Kako čuvati Renagel
English: Not known (frequency cannot be estimated from the available data): cases of itching, rash, abdominal pain, slow intestine motility (movement), inflammation of abnormal small pouches (called diverticula) in the large intestine, blockages in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation), rupture in the intestine wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen),serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have been reported.
Croatian: prijavljeni su slučajevi svrbeža, osipa, boli u trbuhu, sporog motiliteta (pokretljivost) crijeva, upale malih vrećica (koje se nazivaju divertikuli) u debelom crijevu, blokade crijeva (znakovi uključuju: jaku nadutost, bol u trbuhu, oticanje ili grčeve, teški zatvor), puknuća stijenke crijeva (znakovi uključuju: jaku bol u trbuhu, zimicu, vrućicu, mučninu, povraćanje i osjetljivost trbuha), ozbiljne upale debelog crijeva (simptomi uključuju: jaku bol u trbuhu, poremećaje u želucu ili crijevima ili krv u stolici [gastrointestinalno krvarenje]) i nakupljanja kristala u crijevima.
English: Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Croatian: Renagel se koristi za reguliranje razina fosfata u krvi u odraslih bolesnika sa zatajenjem bubrega koji su na hemodijalizi ili peritonealnoj dijalizi.
English: LABEL - BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON LABEL with Blue Box - 1 BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON
Croatian: OD 800 mg NALJEPNICA - BOČICA SA 180 TABLETA OD 800 mg S KUTIJOM NALJEPNICA s plavim okvirom - 1 BOČICA SA 180 TABLETA OD 800 mg BEZ KUTIJE
English: Starting dose of Renagel 400 mg tablets
Croatian: Početna doza Renagel tableta od 400 mg
English: 360 film-coated tablets.
Croatian: OBLIK I SADRŽAJ 360 filmom obloženih tableta.
English: Each tablet contains 400 mg sevelamer hydrochloride.
Croatian: Jedna tableta sadrži 400 mg sevelamerklorida.
English: 360 film-coated tablets
Croatian: OBLIK I SADRŽAJ 360 filmom obloženih tableta
English: Renagel tablets are film coated, off white, oval tablets with Renagel 400 imprinted on one side.
Croatian: Renagel tablete su filmom obložene, bjelkaste, ovalne tablete, s otisnutom oznakom Renagel 400 na jednoj strani.
English: Starting dose of Renagel 800 mg tablets
Croatian: Početna doza Renagel tableta od 800 mg
English: Renagel tablets are film coated, off white, oval tablets with Renagel 800 imprinted on one side.
Croatian: Renagel tablete su filmom obložene, bjelkaste, ovalne tablete, s otisnutom oznakom Renagel 800 na jednoj strani.
English: Nederland sanofi-aventis Netherlands B.V. Tel: +31 20 245 4000
Croatian: Nederland Genzyme Europe B.V.Tel: +31 20 245
English: OUTER CARTON with the Blue Box - MULTIPACK OF 720 (2 BOTTLES OF 360) TABLETS 400 mg
Croatian: KUTIJA s plavim okvirom - VIŠESTRUKO PAKIRANJE SA 720 (2 BOČICE S 360) TABLETA OD 400 mg
English: HDPE bottles, with a child resistant polypropylene closure and a foil induction seal.
Croatian: Bočice od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim čepom za djecu i zalijepljenom zaštitnom folijom.
English: 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.
Croatian: Renagel treba primjenjivati u sklopu multiterapijskog pristupa, koji može uključivati nadomjestke kalcija i 1,25-dihidroksi vitamin D3 ili neki od njegovih analoga, kako bi se kontrolirao razvoj bubrežne osteodistrofije.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL without Blue Box - BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON (MULTIPACK PRESENTATION)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA bez plavog okvira - BOČICA SA 180 TABLETA OD 800 mg S KUTIJOM (VIŠESTRUKO PAKIRANJE)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with Blue Box - MULTIPACK OF 180 (6 BOTTLES OF 30) TABLETS 800 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA s plavim okvirom - VIŠESTRUKO PAKIRANJE SA 180 (6 BOČICA S 30) TABLETA OD 800 mg
English: EU/1/99/123/008 1 bottle of 180 film-coated tablets EU/1/99/123/009 multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) EU/1/99/123/010 multipacks containing 540 film-coated tablets (3 bottles of 180 tablets) EU/1/99/123/011 1 bottle of 100 film-coated tablets EU/1/99/123/012 1 bottle of 180 film-coated tablets without outer carton EU/1/99/123/013 multipacks containing 180 film-coated tablets (6 bottles of 30 tablets)
Croatian: EU/1/99/123/008 1 bočica sa 180 filmom obloženih tableta EU/1/99/123/009 višestruka pakiranja od 360 filmom obloženih tableta (2 bočice sa 180 tableta) EU/1/99/123/010 višestruka pakiranja od 540 filmom obloženih tableta (3 bočice sa 180 tableta) EU/1/99/123/011 1 bočica sa 100 filmom obloženih tableta EU/1/99/123/012 1 bočica sa 180 filmom obloženih tableta bez kutije EU/1/99/123/013 višestruka pakiranja od 180 filmom obloženih tableta (6 bočica s 30 tableta)
English: Do not store this medicine above 25 °C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25°C.
English: 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 iPTH levels.
Croatian: Bolesnici sa sekundarnom hiperparatireozom trebaju uzimati Renagel u sklopu multiterapijskog pristupa, koji može uključivati nadomjestke kalcija te primjenu 1,25-dihidroksi vitamina D3 ili nekog od njegovih analoga kako bi se snizila razina iPTH-a.
English: 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.
Croatian: Bolesnici sa sekundarnom hiperparatireozom trebaju uzimati Renagel u sklopu multiterapijskog pristupa koji može uključivati nadomjestke kalcija te primjenu 1,25-dihidroksi vitamina D3 ili nekog od njegovih analoga kako bi se snizila razina intaktnog paratiroidnog hormona (iPTH).
English: OUTER CARTON with Blue Box - MULTIPACK OF 540 (3 BOTTLES OF 180) TABLETS 800 mg
Croatian: KUTIJA s plavim okvirom - VIŠESTRUKO PAKIRANJE S 540 (3 BOČICE SA 180) TABLETA OD 800 mg
English: 1 bottle of 180 film-coated tablets multipacks containing 180 film-coated tablets (6 bottles of 30 tablets) multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) multipacks containing 540 film-coated tablets (3 bottles of 180 tablets)
Croatian: 1 bočica sa 100 filmom obloženih tableta 1 bočica sa 180 filmom obloženih tableta višestruka pakiranja od 180 filmom obloženih tableta (6 bočica s 30 tableta) višestruka pakiranja od 360 filmom obloženih tableta (2 bočice sa 180 tableta) višestruka pakiranja od 540 filmom obloženih tableta (3 bočice sa 180 tableta)
English: 1 bottle of 180 tablets multipacks containing 180 tablets (6 bottles of 30 tablets) multipacks containing 360 tablets (2 bottles of 180 tablets) multipacks containing 540 tablets (3 bottles of 180 tablets)
Croatian: 1 bočica sa 180 tableta višestruka pakiranja od 180 tableta (6 bočica s 30 tableta) višestruka pakiranja od 360 tableta (2 bočice sa 180 tableta) višestruka pakiranja od 540 tableta (3 bočice sa 180 tableta)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 BOTTLE OF 360 TABLETS 400 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 1 BOČICA S 360 TABLETA
English: 1 bottle of 360 tablets multipacks containing 720 tablets (2 bottles of 360 tablets) multipacks containing 1080 tablets (3 bottles of 360 tablets)
Croatian: 1 bočica s 360 tableta višestruka pakiranja od 720 tableta (2 bočice s 360 tableta) višestruka pakiranja od 1080 tableta (3 bočice s 360 tableta)
English: EU/1/99/123/013
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/123/013
English: Multipack: 180 (6 bottles of 30) film-coated tablets
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje: 180 (6 bočica s 30) filmom obloženih tableta
English: 1 bottle of 360 film-coated tablets multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)
Croatian: 1 bočica s 360 filmom obloženih tableta višestruka pakiranja od 720 filmom obloženih tableta (2 bočice s 360 tableta) višestruka pakiranja od 1080 filmom obloženih tableta (3 bočice s 360 tableta)
English: Patients taking Renagel should adhere to their prescribed diet and liquid intake.
Croatian: Renagel se moraju pridržavati propisane dijete i unosa tekućine.
English: OUTER CARTON with Blue Box - MULTIPACK OF 360 (2 BOTTLES OF 180) TABLETS 800 mg
Croatian: KUTIJA s plavim okvirom - VIŠESTRUKO PAKIRANJE S 360 (2 BOČICE SA 180) TABLETA OD 800 mg
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 360 TABLETS 400 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA - BOČICA S 360 TABLETA
English: Abdominal pain, intestinal obstruction, ileus/subileus, diverticulitis, intestinal perforation1, gastrointestinal hemorrhage*1, intestinal ulceration*1, gastrointestinal necrosis*1, colitis*1, intestinal mass*1
Croatian: Poremećaji probavnog sustava mučnina, povraćanje proljev, dispepsija, flatulencija, bol u gornjem dijelu abdomena, konstipacija bol u abdomenu, opstrukcija crijeva, ileus/subileus, divertikulitis, perforacija crijeva gastrointestinalna hemoragija* ulceracija crijeva* gastrointestinalna nekroza* kolitis*
English: 1 tablet, 3 times per day
Croatian: 1 tableta, 3 puta na dan
English: Renagel 800 mg film-coated tablets
Croatian: Renagel 800 mg filmom obložene tablete sevelamerklorid
English: OUTER CARTON with the Blue Box - MULTIPACK OF 1080 (3 BOTTLES OF 360) TABLETS 400 mg
Croatian: KUTIJA s plavim okvirom-VIŠESTRUKO PAKIRANJE S 1080 (3 BOČICE S 360) TABLETA OD 400 mg
English: 4 tablets, 3 times per day
Croatian: 4 tablete, 3 puta na dan
English: 2 tablets, 3 times per day
Croatian: 2 tablete, 3 puta na dan
English: EU/1/99/123/011 1 bottle of 100 film-coated tablets EU/1/99/123/008 1 bottle of 180 film-coated tablets
Croatian: EU/1/99/123/008 1 bočica sa 180 filmom obloženih tableta
English: Renagel 400 mg film-coated tablets
Croatian: Renagel 400 mg filmom obložene tablete sevelamerklorid
English: EU/1/99/123/009 multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) EU/1/99/123/010 multipacks containing 540 film-coated tablets (3 bottles of 180 tablets)
Croatian: EU/1/99/123/009 višestruko pakiranje s 360 filmom obloženih tableta (2 bočice sa 180 tableta) EU/1/99/123/010 višestruko pakiranje s 540 filmom obloženih tableta (3 bočice sa 180 tableta)
English: EU/1/99/123/011 1 bottle of 100 film-coated tablets EU/1/99/123/008 1 bottle of 180 film-coated tablets with outer carton EU/1/99/123/012 1 bottle of 180 film-coated tablets without outer carton
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/123/011 1 bočica sa 100 filmom obloženih tableta EU/1/99/123/008 1 bočica sa 180 filmom obloženih tableta s kutijom EU/1/99/123/012 1 bočica sa 180 filmom obloženih tableta bez kutije
English: Renagel is not absorbed from the gastrointestinal tract according to a single dose pharmacokinetic study in healthy volunteers.
Croatian: Prema farmakokinetičkom ispitivanju jedne doze u zdravih dobrovoljaca, Renagel se ne apsorbira iz gastrointestinalnog trakta.
English: Renagel may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease.
Croatian: Renagel se može primjeniti uz druge lijekove koji uključuju nadomjestke kalcija ili vitamina
English: EU/1/99/123/006 multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) EU/1/99/123/007 multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)
Croatian: EU/1/99/123/006 višestruka pakiranja sa 720 filmom obloženih tableta (2 bočice s 360 tableta) EU/1/99/123/007 višestruka pakiranja s 1080 filmom obloženih tableta (3 bočice s 360 tableta)
English: EU/1/99/123/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/123/005