FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of sevelamer carbonate have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l.
Croatian: Nisu ustanovljene sigurnost primjene i djelotvornost sevelamerkarbonata u odraslih bolesnika s kroničnom bubrežnom bolešću koji nisu na dijalizi, a koji imaju razinu fosfora u serumu < 1,78 mmol/l.
English: *Plus subsequent titrating, see section “Titration and maintenance” Children/adolescents (>6 years of age and a BSA of >0.75m2) The recommended starting dose of sevelamer carbonate for children is between 2.4 g and 4.8 g per day based on the patient's BSA category.
Croatian: Djeca/adolescenti (>6 godina starosti i površine tijela >0,75 m Preporučena početna doza sevelamerkarbonata za djecu je između 2,4 g i 4,8 g dnevno ovisno o kategoriji kojoj bolesnik pripada prema površini tijela.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 TABLETS (WITH OUTER CARTON) LABEL with Blue box - BOTTLE OF 180 TABLETS (WITHOUT OUTER CARTON)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA - BOČICA S 30 TABLETA (S VANJSKOM KUTIJOM) NALJEPNICA s plavim okvirom - BOČICA SA 180 TABLETA (BEZ VANJSKE KUTIJE)
English: The treatment response during the 2-week FDP was not affected by BSA, in contrast however, no treatment response was observed in paediatric patients with qualifying phosphorus levels <7.0 mg/dL.
Croatian: Površina tijela nije utjecala na odgovor na liječenje tijekom 2 tjedna razdoblja fiksne doze, te je nasuprot tome, izostanak odgovora na liječenje zabilježen u pedijatrijskih bolesnika s početnom vrijednosti fosfora <7,0 mg/dL.
English: How to take Renvela
Croatian: Kako uzimati lijek Renvela
English: In case of constipation, please inform your doctor or pharmacist.
Croatian: U slučaju zatvora obavijestite o tome svog liječnika ili ljekarnika.
English: Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Croatian: Renvela je indicirana i za kontrolu hiperfosfatemije u odraslih bolesnika s kroničnom bubrežnom bolešću koji nisu na dijalizi, a koji imaju razinu fosfora u serumu > 1,78 mmol/l.
English: Iron oxide black (E172) Propylene glycol Isopropyl alcohol Hypromellose (E464)
Croatian: Tinta za označavanje: željezov oksid, crni (E172) propilenglikol izopropilni alkohol hipromeloza (E464)
English: • adult patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.
Croatian: • odraslih bolesnika s kroničnom (dugotrajnom) bubrežnom bolesti koji nisu na dijalizi i imaju razinu fosfora u serumu (krvi) jednaku ili višu od 1,78 mmol/L.
English: Renvela treatment should be reevaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Croatian: Liječenje lijekom Renvela se treba ponovo procijeniti u bolesnika koji razviju tešku konstipaciju ili druge teške gastrointestinalne simptome.
English: Packs of 1 bottle of 30 or 180 tablets (without outer carton) and a multipack containing 180 (6 bottles of 30) tablets.
Croatian: Pakiranje od jedne bočice sa 30 ili 180 tableta (bez vanjske kutije) i višestruko pakiranje koje sadrži 180 (6 bočica sa 30) tableta.
English: The treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Croatian: Treba ponovno procijeniti nastavak liječenja u bolesnika koji razviju tešku konstipaciju ili im se jave drugi teški gastrointestinalni simptomi.
English: • patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.
Croatian: • bolesnika s kroničnom (dugotrajnom) bubrežnom bolesti koji nisu na dijalizi i imaju razinu fosfora u serumu (krvi) jednaku ili višu od 1,78 mmol/l.
English: In this case the 0.4 g dose of Renvela powder must be measured using the dosing spoon provided in the carton.
Croatian: U tom slučaju doza od 0,4 g Renvela praška mora se odmjeriti uporabom dozirne žličice koja je priložena u kutiji.
English: How to store Renvela
Croatian: Kako čuvati lijek Renvela
English: • swallowing problems.
Croatian: • imate problema s gutanjem.
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Renvela.
Croatian: • Renvela može umanjiti učinke lijekova kao što su ciklosporin, mofetilmikofenolat i takrolimus (lijekovi koji se primjenjuju za potiskivanje imunološkog sustava).
English: Caution should be exercised when prescribing PPI to patients concomitantly treated with Renvela.
Croatian: Potreban je oprez pri propisivanju inhibitora protonske pumpe bolesnicima koji su istovremeno liječeni lijekom Renvela.
English: Pack size: 90 sachets per carton
Croatian: Veličina pakiranja: 90 vrećica u kutiji
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with Blue box - BOTTLE OF 30 TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA s plavim okvirom- BOČICA S 30 TABLETA
English: In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
Croatian: U 12-tjednom ispitivanju koje je uključivalo bolesnike na peritonealnoj dijalizi, uočena su slična smanjenja vrijednosti iPTH-a kao u bolesnika koji su primali kalcijev acetat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with Blue Box - MULTIPACK OF 180 (6 BOTTLES OF 30) TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA s plavim okvirom - VIŠESTRUKO PAKIRANJE OD 180 (6 BOČICA S 30) TABLETA
English: The second study demonstrated that sevelamer carbonate powder dosed three times per day was equivalent to sevelamer hydrochloride tablets dosed three times per day in 31 hyperphosphataemic (defined as serum phosphorus levels ≥ 1.78 mmol/l) haemodialysis patients over two randomised 4 week treatment periods (mean serum phosphorus time-weighted averages were 1.6 ± 0.5 mmol/l for sevelamer carbonate powder and 1.7 ± 0.4 mmol/l for sevelamer hydrochloride tablets).
Croatian: Drugo je ispitivanje pokazalo da je sevelamerkarbonat u obliku praška primijenjen tri puta na dan bio jednako učinkovit kao tablete sevelamerklorida primijenjene tri puta na dan u 31 hemodijaliziranog bolesnika s hiperfosfatemijom (definiranom razinom fosfora u serumu ≥ 1,78 mmol/l) tijekom dva nasumična 4-tjedna razdoblja liječenja (srednje vrijednosti serumskog fosfora, uzimajući u obzir vrijeme liječenja, bile su 1,6 ± 0,5 mmol/l kod primjene praška sevelamerkarbonata, odnosno 1,7 ± 0,4 mmol/l kod primjene tableta sevelamerklorida).
English: The anti-arrhythmic medicinal product should be taken at least one hour before or three hours after Renvela and blood monitoring can be considered.
Croatian: Lijekove protiv aritmije je potrebno uzeti barem jedan sat prije ili tri sata nakon uzimanja lijeka Renvela te se može razmotriti praćenje koncentracije u krvi.
English: Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.
Croatian: Stoga će liječnik možda pažljivije pratiti razine hormona koji stimulira štitnjaču u krvi.
English: Renvela 800 mg film-coated tablets
Croatian: NAZIV LIJEKA Renvela 800 mg filmom obložene tablete
English: • if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool (gastrointestinal bleeding).
Croatian: • razvijete jaku bol u trbuhu, poremećaje u želucu ili crijevima ili krv u stolici (gastrointestinalno krvarenje).
English: Each sachet of 0.8 g of powder is to be dispersed in 30 mL of water prior to administration (see section 6.6).
Croatian: Svaka vrećica s 0,8 g praška mora se prije primjene rastopiti u 30 ml vode (vidjeti dio 6.6).
English: Sanofi Oy Puh/Tel: + 358 201 200 300
Croatian: Puh/Tel: + 358 201 200 300
English: There was an increased incidence of urinary bladder transitional cell papilloma in male rats of the high dose group (human equivalent dose twice the maximum clinical trial dose of 14.4 g).
Croatian: Uočena je povećana incidencija papiloma tranzicijskih stanica mokraćnog mjehura kod mužjaka štakora u skupini koja je primala visoku dozu (koja je odgovarala dvostrukoj najvišoj dozi za ljude u kliničkim ispitivanjima od 14,4 g).
English: Powder for oral suspension 0.8 g powder
Croatian: Prašak za oralnu suspenziju 0,8 g praška
English: The suspension should be ingested within 30 minutes after being prepared.
Croatian: Pripremljena suspenzija se mora primijeniti unutar 30 minuta od pripreme za primjenu.
English: In patients not taking supplemental folic acid but on sevelamer, folate level should be assessed regularly.
Croatian: Ako bolesnici ne uzimaju nadomjestke folne kiseline, a liječe se sevelamerom, potrebno je redovno pratiti razinu folata.
English: In pregnant rabbits given oral doses of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose).
Croatian: U skotnih ženki kunića kojima je sevelamerklorid primijenjen peroralno kroz sondu tijekom organogeneze, došlo je do povećanja rane resorpcije u skupini koja je dobila visoku dozu (odgovarajuća doza za ljude dvostruko je veća od maksimalne doze iz kliničkog ispitivanja).
English: For 0.4 g doses, the powder in the sachet may be divided.
Croatian: Za doze od 0,4 g prašak u vrećici može se podijeliti.
English: Talk to you doctor before taking Renvela if any of the following applies to you:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego što uzmete lijek Renvela ako se nešto od navedenog odnosi na Vas:
English: Renvela contains sevelamer carbonate as the active substance.
Croatian: Renvela sadrži djelatnu tvar sevelamerkarbonat.
English: Powder for oral suspension 1.6 g powder
Croatian: Prašak za oralnu suspenziju 1,6 g praška
English: The 0.4 g dose of Renvela powder must be measured using the dosing spoon provided in the carton.
Croatian: Doza od 0,4 g Renvela praška mora se odmjeriti uporabom dozirne žličice koja je priložena u kutiji
English: Renvela 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 to control the development of renal bone disease.
Croatian: Renvela se 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: Powder for oral suspension 2.4 g powder
Croatian: Prašak za oralnu suspenziju 2,4 g praška
English: What you need to know before you take Renvela Do not take Renvela if:
Croatian: Što morate znati prije nego što počnete uzimati lijek Renvela
English: Each sachet of 1.6 g of powder is to be dispersed in 40 mL of water prior to administration (see section 6.6).
Croatian: Svaka vrećica s 1,6 g praška mora se prije primjene rastopiti u 40 ml vode (vidjeti dio 6.6).
English: These also demonstrated that sevelamer carbonate in both tablet and powder formulations are therapeutically equivalent to sevelamer hydrochloride.
Croatian: U tim je ispitivanjima također dokazano da je sevelamerkarbonat i u obliku tableta i u obliku praška terapijski ekvivalentan sevelamerkloridu.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 TABLETS (MULTIPACK PRESENTATION)
Croatian: NALJEPNICA - BOČICA S 30 TABLETA (VIŠESTRUKO PAKIRANJE)
English: Each sachet of 2.4 g of powder is to be dispersed in 60 mL of water prior to administration (see section 6.6).
Croatian: Svaka vrećica od 2,4 g praška mora se prije primjene rastopiti u 60 ml vode (vidjeti dio 6.6).
English: • Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Renvela.
Croatian: • U nekih osoba koje uzimaju levotiroksin (koji se koristi za liječenje niskih razina hormona štitnjače) i lijek Renvela manje često može doći do nedostatka hormona štitnjače.
English: Each tablet contains 800 mg sevelamer carbonate.
Croatian: Jedna filmom obložena tableta sadrži 800 mg sevelamerkarbonata.
English: In two randomised, cross over clinical trials, sevelamer carbonate in both tablet and powder formulations when administered three times per day has been shown to be therapeutically equivalent to sevelamer hydrochloride and therefore effective in controlling serum phosphorus in CKD patients on haemodialysis.
Croatian: U dva randomizirana ukrižena klinička ispitivanja dokazano je da je sevelamerkarbonat i u obliku tableta i u obliku praška za oralnu suspenziju, kada se primjenjuje tri puta na dan, terapijski ekvivalentan sevelamerkloridu, što znači da učinkovito kontrolira koncentracije fosfora u serumu u bolesnika s kroničnom bubrežnom bolešću koji su na hemodijalizi.
English: (Instructions for presentation with dosing spoon) The sachet has to be discarded after 24 hours of opening.
Croatian: (Upute za pakiranje s dozirnom žličicom) Vrećica se mora baciti nakon 24 sata od otvaranja.
English: Sanofi Belgium Tél/Tel: + 32 2 710 54 00
Croatian: België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 2 710 54 00
English: Hyperparathyroidism
Croatian: Hiperparatireoza
English: (Instructions for presentation with dosing spoon)
Croatian: (Upute za pakiranje SA dozirnom žličicom)
English: Each sachet contains 1.6 g sevelamer carbonate.
Croatian: Jedna vrećica sadrži 1,6 g sevelamerkarbonata.
English: Bioavailability
Croatian: Bioraspoloživost
English: The first study demonstrated that sevelamer carbonate tablets dosed three times per day was equivalent to sevelamer hydrochloride tablets dosed three times per day in 79 haemodialysis patients treated over two randomised 8 week treatment periods (mean serum phosphorus time-weighted averages were 1.5 ± 0.3 mmol/l for both sevelamer carbonate and sevelamer hydrochloride).
Croatian: U prvom je ispitivanju dokazano da je primjena tableta sevelamerkarbonata tri puta na dan bila jednako učinkovita kao primjena tableta sevelamerklorida tri puta na dan u 79 bolesnika na hemodijalizi liječenih tijekom dva nasumična 8-tjedna razdoblja liječenja (prosjek srednjih vrijednosti serumskog fosfora, uzimajući u obzir vrijeme liječenja bio je 1,5 ± 0,3 mmol/l i kod primjene sevelamerkarbonata i kod primjene sevelamerklorida).
English: (Instructions for presentation with dosing spoon) Each carton contains 90 sachets and a dosing spoon to measure the 0.4 g dose of powder.
Croatian: Jedna kutija sadrži 90 vrećica i dozirnu žličicu za odmjeravanje doze od 0,4 g praška.
English: Crystal deposit intestine*1
Croatian: Pretrage kristalne naslage u crijevu*
English: EU/1/09/521/008 90 sachets EU/1/09/521/009 90 sachets (with a dosing spoon)
Croatian: EU/1/09/521/009 90 vrećica (sa dozirnom žličicom)
English: - The other ingredients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride,
Croatian: - Drugi sastojci su propilenglikolalginat (E405), aroma kreme od citrusa, natrijev klorid, sukraloza i žuti željezov oksid (E172).
English: For a 0.8 g dose, the powder for oral suspension should be dispersed in 30 mL of water per sachet.
Croatian: Doza od 0,8 g praška za oralnu suspenziju iz jedne vrećice se prije primjene mora rastopiti u 30 ml vode.
English: Titration increases/decreases
Croatian: Titracija na veću/manju dozu
English: Renvela 2.4 g
Croatian: 2,4 g
English: 30 film-coated tablets.
Croatian: OBLIK I SADRŽAJ 30 filmom obloženih tableta.
English: In two randomised, cross over clinical trials, sevelamer carbonate has been shown to be therapeutically equivalent to sevelamer hydrochloride and therefore effective in controlling serum phosphorus in CKD patients on haemodialysis.
Croatian: U dva randomizirana ukrižena klinička ispitivanja dokazano je da je sevelamerkarbonat terapijski ekvivalentan sevelamerkloridu, što znači da učinkovito kontrolira koncentracije fosfora u serumu u bolesnika s kroničnom bubrežnom bolesti koji su na hemodijalizi.
English: Each sachet contains 0.8 g sevelamer carbonate.
Croatian: Jedna vrećica sadrži 0,8 g sevelamerkarbonata.
English: 30 film-coated tablets
Croatian: OBLIK I SADRŽAJ 30 filmom obloženih tableta
English: EU/1/09/521/002 180 (6 bottles of 30) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/521/002 180 (6 bočica od 30) filmom obloženih tableta
English: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride (capsules/tablets), which contains the same active moiety as sevelamer carbonate.
Croatian: U vrlo rijetkim slučajevima su tijekom liječenja sevelamerkloridom (kapsule/tablete), koji sadrži istu djelatnu tvar kao sevelamerkarbonat, u bolesnika opaženi opstrukcija crijeva i ileus/subileus.
English: 60 sachets per carton 90 sachets per carton
Croatian: Veličine pakiranja: 60 vrećica u kutiji 90 vrećica u kutiji
English: HDPE bottles with a polypropylene cap and a foil induction seal.
Croatian: Bočice od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem i zalijepljenom zaštitnom folijom.
English: Hepatic impairment No studies have been performed in patients with hepatic impairment.
Croatian: Bolesnici s oštećenjem funkcije jetre Nisu provedena ispitivanja u bolesnika s oštećenjem funkcije jetre.
English: Each sachet contains 2.4 g sevelamer carbonate.
Croatian: Jedna vrećica sadrži 2,4 g sevelamerkarbonata.
English: For a 1.6 g dose, the powder for oral suspension should be dispersed in 40 mL of water per sachet.
Croatian: Doza od 1,6 g praška za oralnu suspenziju iz jedne vrećice se prije primjene mora rastopiti u 40 mL vode.
English: - 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: - Ozbiljna upala debelog crijeva (simptomi uključuju: jaku bol u trbuhu, poremećaje u želucu ili crijevima ili krv u stolici [gastrointestionalno krvarenje]) i nakupljanje kristala u crijevima su zabilježeni.
English: Renvela 1.6 g powder for oral suspension sevelamer carbonate
Croatian: Renvela 1,6 g prašak za oralnu suspenziju sevelamerkarbonat
English: The safety and efficacy of Renvela in children over 6 year of age and a BSA >0.75 m2 have been established.
Croatian: Sigurnost i djelotvornost lijeka Renvela u djece starije od 6 godina i s površinom tijela iznad 0,75 m su ustanovljene.
English: Only for bottle label of 180 tablets: PC:
Croatian: Samo na naljepnici od bočice sa 180 tableta.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Only for bottle label of 180 tablets: 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Samo na naljepnici od bočice sa 180 tableta.
English: For a 2.4 g dose, the powder for oral suspension should be dispersed in 60 mL of water per sachet.
Croatian: Doza od 2,4 g praška za oralnu suspenziju iz jedne vrećice se prije primjene mora rastopiti u 60 ml vode.
English: Renvela 2.4 g powder for oral suspension sevelamer carbonate
Croatian: Renvela 2,4 g prašak za oralnu suspenziju sevelamerkarbonat
English: o Ensure the dosing spoon is dry o Hold the dosing spoon horizontally and pour the powder out of the sachet into the dosing spoon.
Croatian: o Držite dozirnu žličicu horizontalno i istresite prašak iz vrećice u dozirnu žličicu o Isipajte prašak u dozirnu žličicu kako biste ispunili žličicu do vrha (do ruba žličice).
English: Renvela 0.8 g powder for oral suspension sevelamer carbonate
Croatian: Renvela 0,8 g prašak za oralnu suspenziju sevelamerkarbonat
English: • dysphagia
Croatian: • disfagijom
English: Renvela 0.8 g powder for oral suspension
Croatian: NAZIV LIJEKA Renvela 0,8 g prašak za oralnu suspenziju
English: BSA (m2)
Croatian: Površina tijela (m
English: For adult patients, serum phosphorus must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Croatian: Za odrasle bolesnike, razine fosfora u serumu moraju se pratiti i doza sevelamerkarbonata titrirati u koracima od 0,8 g tri puta na dan (2,4 g/dan) svaka 2 do 4 tjedna dok se ne postigne prihvatljiva razina fosfora u serumu, s redovitim praćenjem nakon toga.
English: Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Croatian: Razine fosfora u serumu moraju se pratiti i doza sevelamerkarbonata titrirati u koracima od 0,8 g tri puta na dan (2,4 g/dan) svaka 2 do 4 tjedna dok se ne postigne prihvatljiva razina fosfora u serumu te redovito nakon toga.
English: Tел: +359 2 9705300
Croatian: SANOFI BULGARIA EOOD Tел: +359 2 9705300
English: The powder should be dispersed in 40 mL of water per sachet prior to administration.
Croatian: Prašak iz jedne vrećice mora se prije primjene rastopiti u 40 ml vode.
English: Film-coating:
Croatian: Doziranje:
English: intestinal mass*1
Croatian: 1, masa u crijevima*
English: Your doctor may advise you to take this medicine 1 hour before or 3 hours after Renvela intake.
Croatian: U slučajevima kada lijek Renvela morate uzimati istodobno s drugim lijekom liječnik Vam može preporučiti da taj lijek uzmete 1 sat prije ili 3 sata nakon uzimanja lijeka Renvela.
English: (Instructions for presentation WITHOUT dosing spoon) To achieve the correct dose when the sachet has to be divided, please use the dedicated presentation of 0.8 g powder with dosing spoon.
Croatian: Kako bi se postigla ispravna doza kada se vrećica s praškom mora podijeliti, koristiti za to predviđeno pakiranje s vrećicama od 0,8 g praška s priloženom dozirnom žličicom.
English: Renvela 2.4 g powder for oral suspension
Croatian: NAZIV LIJEKA Renvela 2,4 g prašak za oralnu suspenziju
English: Renvela 1.6 g powder for oral suspension
Croatian: NAZIV LIJEKA Renvela 1,6 g prašak za oralnu suspenziju
English: Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
Croatian: Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 1600
English: If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon.
Croatian: Ako se mora primijeniti doza od 0,4 g, treba koristiti za to predviđeno pakiranje s vrećicama od 0,8 g praška s priloženom dozirnom žličicom.
English: Propylene glycol alginate (E405) Citrus Cream flavour Sodium chloride Sucralose
Croatian: Propilenglikolalginat (E405) aroma kreme od citrusa natrijev klorid sukraloza željezov oksid, žuti (E172)
English: • active inflammation of the bowel
Croatian: • Opstrukcija crijeva
English: - Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation) has been reported.
Croatian: - blokada crijeva (znakovi uključuju jaku nadutost, bol u trbuhu, oticanje ili grčeve, teški zatvor) je zabilježena.
English: Nausea, vomiting, upper abdominal pain, constipation
Croatian: Često: proljev, bol u trbuhu, probavne tegobe, vjetrovi
English: In patients with secondary hyperparathyroidism sevelamer carbonate should be used within the context of a multiple therapeutic approach, which could include calcium as 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 sevelamerkarbonat u sklopu multiterapijskog pristupa koji može uključivati nadomjestke kalcija te 1,25-dihidroksi vitamin D3 ili neki od njegovih analoga, kako bi se snizila razina intaktnog paratiroidnog hormona (iPTH).