FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class.
Slovenian: Najpogostejši neželeni učinki (≥ 5 % bolnikov) so bili vsi v organskem sistemu bolezni prebavil.
English: Efficacy and safety of Renagel has not been studied in patients with:
Slovenian: Učinkovitost in varnost zdravila Renagel nista bili preučevani pri bolnikih s/z:
English: Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative body surface area.
Slovenian: Študije na živalih so pokazale, da sevelamer ne vpliva na plodnost pri samcih in samičkah podgan pri izpostavljenosti primerjalnemu odmerku pri človeku, dvakrat večjemu od največjega odmerka v kliničnem preskušanju 13 g/dan, na osnovi relativne površine telesa.
English: Intestinal obstruction and ileus/subileus
Slovenian: Obstrukcija črevesj in ileus/subileus
English: Renagel does not contain calcium.
Slovenian: Zdravilo Renagel ne vsebuje kalcija.
English: If you forget to take Renagel
Slovenian: Če ste pozabili vzeti zdravilo Renagel
English: What Renagel is and what it is used for
Slovenian: Kaj je zdravilo Renagel in za kaj ga uporabljamo
English: Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with Renagel, a number of peritonitis cases were reported.
Slovenian: Peritonitis je znan zaplet pri bolnikih, ki prejemajo peritonealno dializo (PD), in v kliničnih študijah z zdravilom Renagel so poročali o številnih primerih peritonitisa.
English: • Renagel should not be taken at the same time as ciprofloxacin (an antibiotic).
Slovenian: • Zdravila Renagel ne smete jemati sočasno s ciprofloksacinom (antibiotik).
English: Other medicines and Renagel
Slovenian: Druga zdravila in zdravilo Renagel
English: In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted.
Slovenian: Narejene so bile vzporedne študije, ki so vključevale 244 bolnikov na hemodializi, pri katerih je trajalo zdravljenje do 54 tednov, ter 97 bolnikov s peritonelano dializo, pri katerih je zdravljenje trajalo 12 tednov.
English: In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Slovenian: Ko so preučevali medsebojno delovanje pri zdravih prostovoljcih, zdravilo Renagel ni imelo učinka na biološko uporabnost digoksina, varfarina, enalaprila ali metoprolola.
English: Renagel alone is not indicated for the control of hyperparathyroidism.
Slovenian: Zdravilo Renagel samo ni namenjeno za nadzorovanje hiperparatiroidizma.
English: • If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renagel.
Slovenian: • Če jemljete zdravila zaradi težav s srčnim ritmom ali zaradi epilepsije, se o jemanju zdravila Renagel posvetujte z zdravnikom.
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.
Slovenian: V študijah medsebojnega delovanja pri zdravih prostovoljcih je sevelamerijev klorid zmanjšal biološko uporabnost ciprofloksacina za približno 50 % pri sočasni uporabi z zdravilom Renagel v študiji z enim odmerkom.
English: Consequently, Renagel should not be taken simultaneously with ciprofloxacin.
Slovenian: Zato se zdravilo Renagel ne sme jemati istočasno s ciprofloksacinom.
English: In the clinical studies in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
Slovenian: Med kliničnimi študijami pri bolnikih, ki se zdravijo s hemodializo, sam sevelamer ni imel trajnega in klinično pomembnega učinka na intaktni paratiroidni hormon (iPTH).
English: However, in vitro and in vivo studies have indicated that Renagel does not have genotoxic potential.
Slovenian: Vendar pa so in vitro in in vivo raziskave pokazale, da zdravilo Renagel ni genotoksično.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki se po poročani pogostosti ocenjujejo kot zelo pogosti (≥1/10), pogosti ( (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do<1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
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.
Slovenian: • Če jemljete zdravila kot so omeprazol, pantoprazol ali lansoprazol za zdravljenje zgage, gastroezofagealne refluksne bolezni (GERB) ali želodčnih razjed, se o jemanju zdravila Renagel posvetujte s svojim zdravnikom.
English: The recommended starting dose of Renagel for adults and the elderly (>65 years) is one or two tablets with each meal 3 times a day.
Slovenian: Priporočljiv začetni odmerek zdravila Renagel za odrasle in starejše (> 65 let) je ena ali dve tableti pri vsakem glavnem obroku 3 krat dnevno.
English: Since constipation may be a preceding symptom in very rare cases of blockages in your intestine, it is important to inform your doctor or pharmacist of this symptom before or during the use of Renagel.
Slovenian: Ker je lahko zaprtost v zelo redkih primerih zgodnji simptom blokade v črevesju, je pomembno, da pred ali med uporabo zdravila Renagel o tem obvestite svojega zdravnika ali farmacevta.
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.
Slovenian: V predkliničnih raziskavah na podganah in psih je zdravilo Renagel v odmerku, ki je desetkrat večji od najvišjih odmerkov za ljudi, zmanjševalo absorpcijo v maščobi topnih vitaminov D, E in K ter folne fisline.
English: The dose range may vary between 1 and 10 tablets per meal.
Slovenian: Odmerek je lahko od 1 do 10 tablet pri enem obroku.
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.
Slovenian: Bolnikom, ki so prej jemali vezalce fosfata, je treba zdravilo Renagel dajati na osnovi gram po gram ter pri tem nadzirati ravni fosforja v serumu, da se zagotovijo optimalni dnevni odmerki.
English: When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Renagel, or the physician should consider monitoring blood levels.
Slovenian: Pri dajanju katerih koli zdravil, pri katerih ima lahko zmanjšanja biološka uporabnost klinično značilen vpliv na varnost ali učinkovitost, je treba zdravilo dati vsaj eno uro pred ali tri ure po uporabi zdravila Renagel, ali pa mora zdravnik razmisliti o nadzoru ravni v krvi.
English: What you need to know before you take Renagel 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Renagel
English: Sevelamer has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Sevelamer nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: The recommended starting dose of Renagel for adults and the elderly (>65 years) is two to four tablets with each meal 3 times a day.
Slovenian: Priporočljiv začetni odmerek zdravila Renagel za odrasle in starejše (> 65 let) sta dve do štiri tablete pri vsakem glavnem obroku 3 krat dnevno.
English: In some cases where Renagel should be taken at the same time as another medicine, your doctor may advise you to take this medicine 1 hour before or 3 hours after Renagel intake, or he/she may consider monitoring the blood levels of that medicine.
Slovenian: V nekaterih primerih, ko je treba zdravilo Renagel vzeti sočasno z drugim zdravilom, vam bo zdravnik morda svetoval, da vzamete drugo zdravilo 1 uro pred ali 3 ure po vnosu zdravila Renagel ali pa se bo odločil za nadziranje ravni tega zdravila v krvi.
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.
Slovenian: Pri prehodu z drugega fosfatnega vezalca na zdravilo Renagel je priporočljivo, da vaš zdravnik pazljiveje spremlja ravni hidrogenkarbonata v krvi, ker zdravilo Renagel te ravni lahko zniža.
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.
Slovenian: Zdravilo Renagel so dajali zdravim prostovoljcem v odmerkih do 14 gramov na dan, kar je enakovredno petintridesetim tabletam po 400 mg, osem dni zaporedoma brez neželenih učinkov.
English: These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystals deposit in your bowel.
Slovenian: Ti simptomi so lahko posledica resne vnetne bolezni črevesa zaradi odlaganja kristalov sevelamerja v črevesu.
English: The safety of Renagel has not been established in pregnant or breast-feeding women.
Slovenian: Varnosti zdravila Renagel pri nosečnicah ali doječih ženskah niso ugotavljali.
English: Uncommon (may affect up to 1 in 100 people): increased acidity of the blood.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): povečana kislost krvi
English: Renagel should only be given to pregnant or breast-feeding women if clearly needed.
Slovenian: Zdravilo Renagel se sme dajati nosečnicam ali doječim ženskam le, kadar je nujno potrebno.
English: • In certain people taking levothyroxine (a thyroid hormone) and Renagel, increased levels of thyroid stimulating hormone (TSH, a substance in your blood which helps control your body's chemical functions) may very rarely be observed.
Slovenian: • Pri nekaterih ljudeh, ki jemljejo levotiroksin (tiroidni hormon) in zdravilo Renagel, so zelo redko opazili zvišane ravni tiroideo stimulirajočega hormona (TSH, snov v krvi, ki pomaga nadzirati kemijske funkcije telesa).
English: Deficits in skeletal ossification were observed in several locations in fetuses of female rats dosed with sevelamer at 8-20 times the maximum human dose of 200 mg/kg.
Slovenian: Pomanjkanje okostenelosti skeleta je bilo opaziti pri več zarodkih podganjih samic, ki so dobivale odmerek sevelamera, ki je bil 8 do 20-krat večji od najvišjega odmerka za ljudi, ki znaša
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.
Slovenian: Vaš zdravnik bo na začetku zdravljenja na vsake 2-3 tedne preveril raven fosfatov v vaši krvi in bo morda odmerek zdravila Renagel spremenil, če bo potrebno (med 1 in 10 tabletami po 400 mg na obrok), da bi na ta način dosegel ustrezno raven fosfatov.
English: Renagel contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) polymer, free of metal and calcium.
Slovenian: Zdravilo Renagel vsebuje sevelamer, neabsorbiran polimer (alilaminijev klorid), ki veže fosfate, brez kovine in kalcija.
English: • patients with a history of major gastrointestinal surgery Therefore caution should be exercised when Renagel is used in patients with these disorders.
Slovenian: • pri bolnikih, ki so imeli v preteklosti obsežno gastrointestinalno operacijo Zato je treba biti pri teh bolnikih z uporabo zdravila Renagel zelo pazljiv.
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.
Slovenian: Vaš zdravnik bo na začetku zdravljenja na vsake 2-3 tedne preveril raven fosfatov v vaši krvi in bo morda odmerek zdravila Renagel spremenil, če bo potrebno (med 1 in 5 tabletami po 800 mg na obrok), da bi na ta način dosegel ustrezno raven fosfatov.
English: What Renagel looks like and contents of the pack
Slovenian: Izgled zdravila Renagel in vsebina pakiranja
English: The safety and efficacy of this product have not been established in patients below the age of 18 years.
Slovenian: Pediatrični bolniki Varnost in učinkovitost tega zdravila nista bili ugotovljeni pri bolnikih, ki so mlajši od 18 let.
English: uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated form the available data).
Slovenian: Neželeni učinki se po poročani pogostosti ocenjujejo kot zelo pogosti (1/10), pogosti (1/100 do <1/10), občasni (1/1.000 do <1/100), redki (1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: • gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis retention of gastric contents and abnormal or irregular bowel motion
Slovenian: • aktivnim vnetjem črevesa gastrointestinalnimi motnjami, vključno z nezdravljeno ali hudo gastroparezo, divertikulozo in zastajanjem hrane v želodcu in nenormalnim ali nepravilnim gibanjem črevesja
English: Do not crush, chew or break into pieces prior to swallowing.
Slovenian: Ne sme se jih zdrobiti, žvečiti ali zlomiti na koščke pred uporabo..
English: Uncommon reports of difficulty swallowing the Renagel tablet have been reported.
Slovenian: Občasno so poročali o težavah s požiranjem tablet Renagel.
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.
Slovenian: Priporočen začetni odmerek sevelamerijevega klorida je 2,4 g, 3,6 g ali 4,8 g na dan glede na klinične potrebe in ravni serumskega fosforja.
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Renagel.
Slovenian: • Učinke zdravil kot so ciklosporin, mofetilmikofenolat in takrolimus (zdravila, ki zavirajo odziv imunskega sistema), lahko zdravilo Renagel zmanjša.
English: The safety and efficacy in children (below the age of 18 years) has not been studied.
Slovenian: Varnost in učinkovitost tega zdravila pri otrocih, mlajših od 18 let, nista bili ugotovljeni.
English: • active inflammatory bowel disease
Slovenian: • aktivnim vnetjem črevesja
English: 100 film-coated tablets 180 film-coated tablets
Slovenian: 100 filmsko obloženih tablet 180 filmsko obloženih tablet
English: In a clinical trial of one-year duration, Renagel had no adverse effect on bone turnover or mineralisation compared to calcium carbonate.
Slovenian: V enoletnih kliničnih preskusih zdravilo Renagel na obnovo in mineralizacijo kosti v primerjavi s kalcijevim karbonatom ni imelo neugodnih učinkov.
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.
Slovenian: Zdravilo Renagel so dajali zdravim prostovoljcem v odmerkih do 14 gramov na dan, kar je enakovredno petintridesetim tabletam po 800 mg, osem dni zaporedoma brez neželenih učinkov.
English: Serum chloride may increase during Renagel treatment as chloride may be exchanged for phosphorus in the intestinal lumen.
Slovenian: Med zdravljenjem z zdravilom Renagel lahko pride do porasta koncentracije klorida v serumu, ker lahko fosfor zamenja klorid v črevesnem lumnu.
English: Patients taking Renagel should adhere to their prescribed diet and liquid intake.
Slovenian: Bolniki, ki jemljejo zdravilo Renagel, se morajo držati predpisane diete.
English: Hypromellose (E464) Diacetylated monoglycerides
Slovenian: Hipromeloza (E464), diacetilirani monogliceridi.
English: 1 bottle of 100 tablets
Slovenian: 1 plastenka s 100 tabletami
English: In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
Slovenian: V 12 tedenski študiji, ki je zajemala bolnike, ki so prejemali peritonealno dializo, pa se je pokazala primerljivost zmajšanja iPTHja z bolniki, ki so prejemali kalcijev acetat.
English: How to take Renagel
Slovenian: Kako jemati zdravilo Renagel
English: In clinical trials, sevelamer has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Slovenian: Klinične študije dokazujejo učinkovitost sevelamera pri zmanjševanju serumskega fosfata pri bolnikih, ki prejemajo hemodializo oziroma peritonealno dializo.
English: Serum phosphate level in patients not on phosphate binders
Slovenian: Raven fosfata v serumu pri bolnikih, ki ne jemljejo fosfatnih vezalcev
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.
Slovenian: Koncentracijo fosfata v serumu je treba skrbno spremljati in odmerek sevelamerijevega klorida titrirati z 0,4 do 0,8 g odmerkom trikrat na dan (1,2 g/dan ali 2,4 g/dan) glede na cilj znižanja fosfata v serumu na 1,76 mmol/l (5,5 mg/dl) ali manj.
English: Renagel 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 Renagel vplivalo na vašo sposobnost vožnje in upravljanja s stroji.
English: 180 film-coated tablets.
Slovenian: 180 filmsko obloženih tablet.
English: Common (may affect up to 1 in 10 people): diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): driska, slaba prebava, bolečine v trebuhu, zaprtost, nabiranje plinov v želodcu in črevesu
English: 360 film-coated tablets
Slovenian: 360 filmsko obloženih tablet
English: Multipack: 180 (6 bottles of 30) film-coated tablets
Slovenian: Skupno pakiranje: 180 (6 plastenk s 30 tabletami) filmsko obloženih tablet
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.
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): Poročali so o primerih srbečice, izpuščaja, bolečin v trebuhu, počasne gibljivosti (premikanja) črevesa, vnetja nenormalnih majhnih žepkov (imenovanih divertikli) v debelem črevesu, blokad v črevesu (znaki vključujejo: hudo napenjanje, bolečine v trebuhu, otekanje ali krče, hudo zaprtost), perforacije stene črevesa (znaki vključujejo: hude bolečine, mrzlico, zvišano telesno temperaturo, slabost v želodcu (siljenje na bruhanje), bruhanje ali občutljivost trebuha), resnem vnetju debelega črevesa (med simptomi so: hude bolečine v trebuhu, težave z želodcem ali črevesom ali kri v blatu [krvavitev v prebavila]) in kristalnih depozitih v črevesu
English: It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood.
Slovenian: Zdravilo Renagel veže fosfate iz hrane v prebavnem traktu in tako zniža koncentracijo serumskega fosfata v krvi.
English: Therefore Renagel is not recommended for use in this population.
Slovenian: Zato uporaba zdravila Renagel pri otrocih ni priporočljiva.
English: Starting dose of Renagel 400 mg tablets
Slovenian: Začetni odmerek zdravila Renagel 400 mg tablete
English: • if you have bowel obstruction.
Slovenian: • če imate zaporo črevesa,
English: Common Uncommon Very Rare
Slovenian: Neznana pogostnost
English: Patients should take Renagel with meals and adhere to their prescribed diets.
Slovenian: Bolniki morajo jemati zdravilo Renagel ob obroku in se držati predpisanih diet. Tablete je treba pogoltniti cele.
English: • if you have prolonged diarrhoea or pain in the abdomen (symptoms of active inflammatory bowel disease)
Slovenian: • imate podaljšano trajanje driske ali bolečine v trebuhu (simptomi vnetne črevesne bolezni) • ste prestali zahtevnejše operacije želodca ali črevesa
English: Talk to your doctor while taking Renagel:
Slovenian: Med jemanjem zdravila Renagel se posvetujte z zdravnikom:
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).
Slovenian: Zdravilo Renagel naj doječe ženske jemljejo le, če ga nujno potrebujejo in po skrbni analizi tveganja/koristi za mater in dojenčka (glejte poglavje 5.3.
English: Do not store above 25ºC.
Slovenian: Shranjujte pri temperaturi do 25 C.
English: Each tablet contains 800 mg sevelamer hydrochloride.
Slovenian: Ena tableta vsebuje 800 mg sevelamerijevega klorida.
English: Each tablet contains 400 mg sevelamer hydrochloride.
Slovenian: Ena tableta vsebuje 400 mg sevelamerijevega klorida.
English: Renagel contains sevelamer as the active ingredient.
Slovenian: Zdravilo Renagel vsebuje zdravilno učinkovino sevelamer.
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.
Slovenian: Pri bolnikih s sekundarnim hiperparatiroidizmom je treba zdravilo Renagel uporabljati v smislu večstranskega pristopa zdravljenja, ki lahko vključuje kalcijeve dodatke, 1,25 - dihidroksi vitamin D3 ali kakšen njegov analog, za znižanje koncentracijeiPTH.
English: 360 film-coated tablets.
Slovenian: 360 filmsko obloženih tablet.
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.
Slovenian: Pri bolnikih s sekundarnim hiperparatiroidizmom je treba zdravilo Renagel uporabljati v smislu večstranskega pristopa zdravljenja, ki lahko vključuje kalcijeve dodatke, 1,25 - dihidroksi vitamin D3 ali kakšen njegov analog, za znižanje koncentracije intaktnega paratiroidnega hormona (iPTH).
English: Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Slovenian: Zdravilo Renagel je namenjeno uravnavanju hiperfosfatemije pri zdravljenju odraslih bolnikov, ki prejemajo hemodializo oziroma peritonealno dializo.
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).
Slovenian: Zdravilo Renagel naj nosečnice jemljejo le, če ga nujno potrebujejo, in po skrbni analizi tveganja/koristi za mater in zarodek (glejte poglavje 5.3).