FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who are constipated should be monitored carefully while being treated with Renvela.
Slovenian: Bolnike z zaprtjem je potrebno med zdravljenjem z zdravilom Renvela skrbno nadzorovati.
English: EU/1/09/521/002 180 (6 bottles of 30) film-coated tablets
Slovenian: EU/1/09/521/002 180 (6 vsebnikov po 30) filmsko obloženih tablet
English: SANOFI-AVENTIS Zrt Tel: +36 1 505 0050
Slovenian: Magyarország SANOFI-AVENTIS Zrt Tel: +36 1 505 0050
English: • problems with motility (movement) in your stomach and bowel
Slovenian: • težave z gibljivosti (motilnostjo) v trebuhu in črevesju
English: For paediatric patients the oral suspension should be administered, as tablet formulations are not appropriate for this population.
Slovenian: Pediatrični bolniki morajo zdravilo dobiti v peroralni suspenziji, ker tablete za to populacijo niso primerne.
English: If you stop taking Renvela
Slovenian: Če ste prenehali jemati zdravilo Renvela
English: The printing ink contains iron oxide black (E172), isopropyl alcohol and propylene glycol.
Slovenian: Tiskarsko črnilo vsebuje črn železov oksid (E172), izopropil alkohol in propilenglikol.
English: Do not heat Renvela powder (e.g. microwave) or add to heated foods or liquids.
Slovenian: Praška zdravila Renvela ne segrevajte (npr. mikrovalovna pečica) ali dodajte v ogreto hrano ali tekočino.
English: Discard sachets of powder that have been opened for more than 24 hours.
Slovenian: o Vrečice praška, ki so bile odprte več kot 24 ur, zavrzite.
English: Renvela 800 mg film-coated tablets
Slovenian: Renvela 800 mg filmsko obložene tablete
English: EU/1/09/521/001 30 film-coated tablets EU/1/09/521/003 180 film-coated tablets
Slovenian: EU/1/09/521/001 30 filmsko obloženih tablet EU/1/09/521/003 180 filmsko obloženih tablet
English: For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Renvela should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Slovenian: Bolnikom, ki so prej uživali vezalce fosforja (sevelamerijev klorid ali kalcijev sevelamerat) je treba zdravilo Renvela dajati na osnovi gram po gram ter pri tem nadzirati ravni fosforja v serumu, da se zagotovijo optimalni dnevni odmerki.
English: Microcrystalline cellulose Sodium chloride Zinc stearate
Slovenian: Jedro tablete: mikrokristalna celuloza natrijev klorid cinkov stearat
English: 30 film-coated tablets.
Slovenian: 30 filmsko obloženih tablet.
English: Closer monitoring of patients with hypothyroidism co-administered with sevelamer carbonate and levothyroxine is recommended (see section 4.5).
Slovenian: Priporoča se skrbno nadziranje bolnikov s hipotiroidizmom, ki dobivajo sevelamerijev karbonat sočasno z levotiroksinom (glejte poglavje 4.5).
English: Renvela treatment should be reevaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Slovenian: Zdravljenje z zdravilom Renvela je treba znova oceniti pri bolnikih, ki se jim pojavijo huda zaprtost ali kakšni drugi hudi gastrointestinalni simptomi.
English: There are no or limited amount of data from the use of sevelamer in pregnant women.
Slovenian: O uporabi sevelamera pri nosečnicah ni podatkov, ali pa so le ti omejeni.
English: The safety and efficacy of Renvela in children below the age of 6 years or in children with a BSA below 0.75 m2 have not been established.
Slovenian: Varnost in učinkovitost zdravila Renvela nista ugotovljeni pri otrocih, mlajših od 6 let, niti pri otrocih s telesno površino manj kot 0,75 m2.
English: Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become protonated in the stomach.
Slovenian: Sevelamer vsebuje številne amine, ki jih od polimerne verige ločuje le en ogljik, ki postanejo v želodcu protonirani.
English: Iron oxide black (E172) Propylene glycol Isopropyl alcohol Hypromellose (E464)
Slovenian: Črnilo: črn železov oksid (E172) propilenglikol izopropilalkohol hipromeloza (E464)
English: Bioavailability
Slovenian: Biološka uporabnost
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.
Slovenian: V zelo redkih primerih so opazili obstrukcijo črevesja in ileus/subileus pri bolnikih, zdravljenih s sevelamerijevim kloridom (kapsule/tablete), ki vsebuje enako učinkovino kot sevelamerijev karbonat.
English: The sachet has to be discarded after 24 hours of opening.
Slovenian: Vrečico je treba zavreči v roku 24 ur po odpiranju.
English: 1 See inflammatory gastrointestinal disorders warning in section 4.4
Slovenian: *izkušnje po začetku trženja Glejte opozorilo o vnetnih gastrointestinalnih motnjah v poglavju 4.4
English: The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Slovenian: Priporočen začetni odmerek sevelamerijevega karbonata je 2,4 g ali 4,8 g na dan glede na klinične potrebe in ravni fosforja v serumu.
English: Paediatric dose based on BSA (m2)
Slovenian: Pediatrično odmerjanje na podlagi telesne površine (m
English: By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer lowers the phosphorus concentration in the serum.
Slovenian: Z vezavo fosfata v prebavnem traktu in zmanjšanjem absorpcije, sevelamer znižuje koncentracijo fosfata v serumu.
English: The recommended starting dose of sevelamer carbonate for adults is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Slovenian: Priporočen začetni odmerek sevelamerijevega karbonata pri odraslih je 2,4 g ali 4,8 g na dan glede na klinične potrebe in ravni serumskega fosforja.
English: The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.
Slovenian: Obloga tablete vsebuje hipromelozo (E464) in diacetilirane monogliceride.
English: Your doctor may also consider monitoring the levels of that medicine in your blood.
Slovenian: Zdravnik se lahko odloči tudi za spremljanje koncentracije tega zdravila v krvi.
English: Other side effects have been reported in patients taking Renvela: Very common: vomiting, upper abdominal pain, nausea Common (may affect up to 1 in 10 people): diarrhoea, stomach ache, indigestion, flatulence Not known: cases of itching, rash, slow intestine motility (movement)
Slovenian: Pri bolnikih, ki jemljejo zdravilo Renvela, so poročali o drugih neželenih učinkih: Zelo pogosti: bruhanje, bolečine v zgornjem delu trebuha, slabost Pogosti (pojavijo se lahko pri največ 1 od 10 oseb): driska, bolečine v trebuhu, prebavne motnje, napenjanje Neznana pogostnost: primeri srbečice, izpuščaja, počasne gibljivosti (premikanja) črevesja
English: The tablets are packed in high density polyethylene bottles with a polypropylene cap and an induction seal.
Slovenian: Tablete so pakirane v vsebnike iz polietilena visoke gostote s polipropilenskim pokrovom in induktivno zvarjeno zaporko.
English: • swallowing problems.
Slovenian: • težave s požiranjem.
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).
Slovenian: Pri brejih kunčjih samicah, ki so dobivale peroralne odmerke sevelamerijevega klorida z gavažo v času organogeneze, je prišlo do zgodnje resorpcije v skupini, ki je dobivala visoke odmerke (pri človeku primerljivo z odmerkom, dvakrat večjim od največjega odmerka v kliničnem preskušanju).
English: o Mix the powder from the dosing spoon in 30 mL of water.
Slovenian: o Zmešajte prašek iz odmerne žličke v 30 ml vode.
English: Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop Renvela treatment.
Slovenian: Posvetujte se s svojim zdravnikom, ki bo presodil, ali otroka lahko dojite in ali morate prenehati zdravljenje z zdravilom Renvela.
English: There was no increased incidence of tumours observed in mice (human equivalent dose 3 times the maximum clinical trial dose).
Slovenian: Pri miših niso opazili povečanja pojavnosti tumorjev (pri človeku primerljivo z odmerkom, 3-krat večjim od največjega odmerka v kliničnem preskušanju).
English: These also demonstrated that sevelamer carbonate in both tablet and powder formulations are therapeutically equivalent to sevelamer hydrochloride.
Slovenian: To je tudi pokazalo, da je sevelamerijev karbonat v obliki tablete in praška, terapevtsko enakovreden s sevelamerijevim kloridom.
English: Proper swallowing ability should be carefully monitored in patients with co-morbid conditions.
Slovenian: Pri bolnikih s takšnimi sočasnimi boleznimi je treba skrbno kontrolirati sposobnost za ustrezno požiranje.
English: The study met its primary endpoint, meaning Sevelamer carbonate reduced serum phosphorus by an LS mean difference of 0.90 mg/dL compared to placebo, and secondary efficacy endpoints.
Slovenian: Študija je dosegla svoj primarni opazovani dogodek: to pomeni, da je sevelamerijev karbonat v primerjavi s placebom znižal koncentracijo fosforja v serumu za povprečno 0,90 mg/dl (po metodi najmanjših kvadratov); dosegla je tudi sekundarne opazovane dogodke učinkovitosti.
English: o Do not tap the dosing spoon to compact the powder.
Slovenian: o Ne tapkajte po odmerni žlički, da bi stisnili prašek.
English: The reconstituted suspension must be administered within 30 minutes of reconstitution.
Slovenian: Rekonstituirano suspenzijo je treba odmeriti v 30 minutah po rekonstituciji.
English: In patients not taking supplemental folic acid but on sevelamer, folate level should be assessed regularly.
Slovenian: Bolnikom, ki prejemajo sevelamer, a ne jemljejo dodatkov folne kisline, je treba redno kontrolirati koncentracijo folata.
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).
Slovenian: Druga študija je pokazala, da so bili trije dnevni odmerki praška sevelamerijevega karbonata enakovredni trem dnevnim odmerkom tablet sevelamerijevega klorida pri 31 bolnikih s hiperfosfatemijo na hemodializi (opredeljeno kot ravni fosforja v serumu ≥ 1,78 mmol/l), zdravljenih v dveh naključnih 4-tedenskih obdobjih (srednje časovno uteženo povprečje fosforja v serumu je bilo 1,6 ± 0,5 mmol/l za prašek sevelamerijevega karbonata in 1,7 ± 0,4 mmol/l za tablete sevelamerijevega klorida).
English: Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study in which the females were treated from 14 days prior to mating through gestation and the males were treated for 28 days prior to mating.
Slovenian: Sevelamerijev klorid ni okvaril sposobnosti razmnoževanja podganjih samcev ali samic v študiji z dietnim odmerjanjem, v kateri so samice prejemale zdravilo 14 dni pred parjenjem in ves čas brejosti, samci pa 28 dni pred parjenjem.
English: Powder for oral suspension 90 sachets
Slovenian: prašek za peroralno suspenzijo 90 vrečic
English: The anti-arrhythmic medical product should be taken at least one hour before or three hours after Renvela, and blood monitoring can be considered.
Slovenian: Antiaritmik mora bolnik vzeti vsaj eno uro pred zdravilom Renvela ali tri ure po njem; razmisliti je treba o pregledih krvi.
English: Stir the suspension and drink it within 30 minutes of being prepared.
Slovenian: Premešajte suspenzijo in jo popijte v 30
English: The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Slovenian: Varnost sevelamera (tako karbonata kot kloridne soli) je bila raziskana v številnih kliničnih preskušanjih, ki so zajela skupaj 969 bolnikov na hemodializi, pri katerih je zdravljenje trajalo med 4 do 50 tednov (724 bolnikov, zdravljenih s sevelamerijevim kloridom in 245 s sevelamerijevim karbonatom), 97 bolnikov na peritonealni dializi, pri katerih je zdravljenje trajalo 12 tednov (vsi zdravljeni s sevelamerijevim kloridom) in 128 bolnikih s KBL, ki niso na dializi, pri katerih je zdravljenje trajalo med 8 do 12 tednov (79 bolnikov, zdravljenih s sevelamerijevim kloridom, in 49 s sevelamerijevim karbonatom).
English: Thereafter all patients received sevelamer carbonate for the 26-week DTP.
Slovenian: Potem so med 26-tedenskim OTO vsi bolniki prejemali sevelamerijev karbonat.
English: To achieve the correct dose, the dosing spoon provided in the carton must be used to measure 0.4 g of Renvela Powder.
Slovenian: Za dosego ustreznega odmerka je treba uporabiti odmerno žličko, ki se nahaja v škatli in s katero odmerimo 0,4 g praška zdravila Renvela.
English: Bile acid binding by ion exchange resins is a well-established method of lowering blood cholesterol.
Slovenian: Vezava žolčne kisline s smolami ionske izmenjave je uveljavljena metoda zniževanja holesterola v krvi.
English: In case of constipation, please inform your doctor or pharmacist.
Slovenian: V primeru zaprtosti o tem obvestite svojega zdravnika ali farmacevta.
English: How to take Renvela
Slovenian: Kako jemati zdravilo Renvela
English: The safety and efficacy of Renvela in children over 6 year of age and a BSA >0.75 m2 have been established.
Slovenian: Varnost in učinkovitost zdravila Renvela sta ugotovljeni pri otrocih, starejših od 6 let in s telesno površino > 0,75 m2.
English: Renvela contains sevelamer, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium.
Slovenian: Zdravilo Renvela vsebuje sevelamer, neabsorptiven premrežen polimer, ki veže fosfate in ne vsebuje kovin ali kalcija.
English: In this case the 0.4 g dose of Renvela powder must be measured using the dosing spoon provided in the carton.
Slovenian: V tem primeru je treba 0,4 g odmerek zdravila Renvela odmeriti z odmerno žličko, ki se nahaja v škatli.
English: Crystal deposit intestine*1
Slovenian: Preiskave kristalen depozit v črevesu*
English: • Bowel obstruction.
Slovenian: • obstrukcija črevesja
English: • if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool (gastrointestinal bleeding).
Slovenian: • če se vam pojavijo hude bolečine v trebuhu, težave z želodcem ali črevesom ali kri v blatu (krvavitev v prebavila).
English: This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Slovenian: To zdravilo se uporablja sočasno z drugimi zdravili za preprečevanje razvoja bolezni kosti kot so dodatki kalcija in vitamin D.
English: The white to off-white tablets are imprinted with “RENVELA 800” on one side.
Slovenian: filmsko obložena tableta (tableta) Bele do sivo-bele tablete z natisom „RENVELA 800“ na eni strani.
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.
Slovenian: Zato utegne zdravnik nadzirati koncentracijo vitamina D v krvi in vam po potrebi predpisati dodatek vitamina D. Če ne jemljete multivitaminskih dodatkov, vam lahko pade tudi koncentracija vitaminov A, E, K in folne kisline v krvi, zato utegne zdravnik nadzirati tudi te koncentracije in vam po potrebi predpisati dodatne vitamine.
English: HDPE bottles with a polypropylene cap and a foil induction seal.
Slovenian: Vsebniki iz HDPE s polipropilenskim pokrovom in induktivno zvarjeno zaporko iz folije.
English: Pack size: 90 sachets per carton
Slovenian: Velikosti pakiranja: 90 vrečic na škatlo
English: If you get any side effects, talk to your doctor.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
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.
Slovenian: • bolnikih s kroničnim (dolgotrajnim) obolenjem ledvic, ki niso na dializi in imajo serumske (krvne) ravni fosforja enake ali višje kot 1,78 mmol/l.
English: In paediatric patients with hyperphosphatemia secondary to CKD, sevelamer carbonate significantly reduced serum phosphorus levels compared to placebo during a 2-week FDP.
Slovenian: Pediatričnim bolnikom, ki so imeli hiperfosfatemijo zaradi KBL, je sevelamerijev karbonat v primerjavi s placebom med 2-tedenskim UFO značilno znižal koncentracijo fosforja v serumu.
English: **Children and adolescents (>6 years of age and a BSA of >0.75m2) For paediatric patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated in increments based on patient's BSA, three times per day every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Slovenian: **Otroci in mladostniki (stari > 6 let in s telesno površino > 0,75 m Pri pediatričnih bolnikih je treba koncentracijo fosforja v serumu kontrolirati in odmerek sevelamerijevega karbonata titrirati v povečanjih glede na bolnikovo telesno površino trikrat na dan vsaka 2 do 4 tedne, dokler ni dosežena sprejemljiva koncentracija fosforja v serumu; potem je treba koncentracijo redno kontrolirati.
English: Powder for oral suspension 60 sachets
Slovenian: prašek za peroralno suspenzijo 60 vrečic
English: The suspension powder is pale yellow and has a citrus flavour.
Slovenian: Prašek za suspenzijo je svetlorumen in ima okus po citrusu.
English: • have undergone major surgery on your stomach or bowel
Slovenian: • imeli ste veliko operacijo trebuha ali črevesja.
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.
Slovenian: Varnosti in učinkovitosti sevelamerijevega karbonata pri odraslih s kronično boleznijo ledvic, ki niso na dializi, z ravnjo fosforja v serumu < 1,78 mmol/l, niso ugotavljali.
English: Renvela 800 mg film-coated tablets sevelamer carbonate
Slovenian: Renvela 800 mg filmsko obložene tablete sevelamerijev karbonat
English: Your doctor may monitor the phosphate level in your blood.
Slovenian: Zdravnik vam bo morda kontroliral koncentracijo fosfata v krvi.
English: Anti-arrhythmics and anti-seizure medicinal products
Slovenian: Antiaritmiki in zdravila za nadzor epileptičnih napado
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).
Slovenian: Prva študija je pokazala, da so bili trije dnevni odmerki tablet sevelamerijevega karbonata enakovredni trem dnevnim odmerkom tablet sevelamerijevega klorida pri 79 bolnikih na hemodializi, zdravljenih v dveh naključnih 8-tedenskih obdobjih (srednje časovno uteženo povprečje fosforja v serumu je bilo 1,5 ± 0,3 mmol/l za sevelamerijev karbonat kot tudi za sevelamerijev klorid).
English: • being sick frequently
Slovenian: • pogoste slabosti
English: (Instructions for presentation with dosing spoon) A 0.4 g dosing spoon is provided in the carton.
Slovenian: (Navodila za obliko z odmerno žličko) 0,4 g odmerna žlička se nahaja v škatli.
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.
Slovenian: • odraslih bolnikih s kroničnim (dolgotrajnim) obolenjem ledvic, ki niso na dializi in imajo serumske (krvne) ravni fosforja enake ali višje kot 1,78 mmol/l;
English: For 0.4 g doses, the powder in the sachet may be divided.
Slovenian: Za odmerek 0,4 g je mogoče prašek v vrečici razdeliti.
English: The 0.4 g dose of Renvela powder must be measured using the dosing spoon provided in the carton.
Slovenian: 0,4 g odmerek praška zdravila Renvela je treba odmeriti z odmerno žličko, ki se nahaja v škatli.
English: Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.
Slovenian: Zato se lahko vaš zdravnik odloči za skrbno nadziranje ravni ščitnico stimulirajočega hormona v vaši krvi.
English: Check with your doctor, pharmacist or nurse if you are not sure.
Slovenian: Če niste prepričani, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: • Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Renvela.
Slovenian: • Pri nekaterih ljudeh, ki jemljejo levotiroksin (uporablja se za zdravljenje nizkih ravni tiroidnega hormona) in zdravilo Renvela, so redko opazili pomanjkanje tiroidnega hormona.
English: Each tablet contains 800 mg sevelamer carbonate.
Slovenian: Ena tableta vsebuje 800 mg sevelamerijevega karbonata.
English: You must take Renvela as prescribed by your doctor.
Slovenian: Pri jemanju zdravila Renvela natančno upoštevajte navodila svojega zdravnika.
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.
Slovenian: Zdravilo Renvela je indicirano tudi za nadzor hiperfosfatemije pri odraslih bolnikih s kronično boleznijo ledvic (KBL; CKD - Chronic Kidney Disease), ki niso na dializi, in imajo raven fosforja v serumu ≥ 1,78 mmol/l.
English: The oral suspension must be administered within 30 minutes.
Slovenian: Po rekonstituciji Peroralno suspenzijo je treba uporabiti v 30 minutah.
English: Your doctor should monitor the level of bicarbonate in your blood.
Slovenian: Zdravnik vam mora kontrolirati koncentracijo bikarbonata v krvi.
English: The medicinal product does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila.
English: Powder for oral suspension 0.8 g powder
Slovenian: prašek za peroralno suspenzijo 0,8 g praška
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).
Slovenian: Vsako vrečico po 0,8 g praška je treba pred uporabo raztopiti v 30 ml vode (glejte poglavje 6.6).
English: Sevelamer has been shown to bind bile acids in vitro and in vivo in experimental animal models.
Slovenian: Pri živalskih modelih se je pokazalo, da sevelamer veže žolčne kisline in vitro in in vivo.
English: Hepatic impairment No studies have been performed in patients with hepatic impairment.
Slovenian: Okvara jeter Študij pri bolnikih z okvaro jeter niso izvedli.
English: 60 sachets per carton 90 sachets per carton
Slovenian: Velikosti pakiranja: 60 vrečic na škatlo 90 vrečic na škatlo
English: Packs of 1 bottle of 30 or 180 tablets (without outer carton) and a multipack containing 180 (6 bottles of 30) tablets.
Slovenian: Pakiranja z 1 vsebnikom, ki vsebuje 30 ali 180 tablet (brez zunanje škatle), in skupno pakiranje s 180 (6 vsebnikov po 30 tablet) tabletami.
English: Powder for oral suspension 1.6 g powder
Slovenian: prašek za peroralno suspenzijo 1,6 g praška
English: Renvela is unlikely to affect your ability to drive or to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Renvela vplivalo na vašo sposobnost vožnje in upravljanja strojev.