FrancophonIA/ELRC3.0 huggingface dataset:
English: A majority of patients received 12 or 15 g/day of colestilan in the long-term studies.
Croatian: Većina bolesnika u ovim dugotrajnim ispitivanjima primala je 12 ili 15 g kolestilana na dan.
English: How to take BindRen
Croatian: Kako uzimati BindRen
English: Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia.
Croatian: Hipokalcemija/hiperkalcemija Bolesnici s bubrežnom insuficijencijom mogu razviti hipokalcemiju ili hiperkalcemiju.
English: (≥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) and not known (cannot be estimated from the available data).
Croatian: <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000) i nepoznato
English: Fax: +49 211 - 520 544 99
Croatian: Tel: +49 211 - 520 544 33 Fax: +49 211 - 520 544 99
English: In a double-blind, 12-week fixed-dose study with five colestilan groups (3, 6, 9, 12 and 15 g/day) and placebo, colestilan at 6 g/day and above demonstrated a dose-dependent reduction in serum phosphorus level.
Croatian: U dvostruko slijepom ispitivanju fiksne doze u trajanju od 12 tjedana s pet skupina koje su primale kolestilan (3, 6, 9, 12 i 15 g na dan) i placebo, pokazalo se da kolestilan u dozi od 6 g na dan i višoj smanjuje razine fosfora u serumu ovisno o dozi.
English: BindRen does not contain calcium, and has no effect on serum calcium concentrations on treatment for up to one year.
Croatian: BindRen ne sadrži kalcij i nema učinka na koncentracije kalcija u serumu tijekom liječenja u trajanju do godinu dana.
English: Patients who are constipated should be monitored carefully while being treated with BindRen.
Croatian: Bolesnike s konstipacijom treba pažljivo nadzirati za vrijeme liječenja BindRenom.
English: Folate deficiency, hypertriglyceridaemia, polydipsia
Croatian: manjak folata, hipertrigliceridemija, polidipsija
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava (vidjeti ispod).
English: Do not use this medicine after the expiry date stated on the box, the bottle label or the blister after the abbreviation “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, naljepnici bočice ili blisteru iza „Rok valjanosti”.
English: However, BindRen did not induce any clinically relevant change in chloride and bicarbonate on treatment for up to one year.
Croatian: Međutim, BindRen nije izazvao nikakvu klinički važnu promjenu klorida i bikarbonata tijekom liječenja u trajanju do godinu dana.
English: Patients with severe hepatic impairment were excluded from clinical studies.
Croatian: Bolesnici s teškim oštećenjem funkcije jetre bili su isključeni iz kliničkih ispitivanja.
English: Colestilan also binds bile acids, thereby lowering the serum LDL-cholesterol concentration.
Croatian: Kolestilan također veže žučne kiseline te tako snižava koncentraciju LDL-kolesterola u serumu.
English: Serum phosphorus concentrations should be monitored.
Croatian: Potrebno je pratiti koncentracije fosfora u serumu.
English: What you need to know before you take BindRen Do not take BindRen - if you are allergic to colestilan or any of the other ingredients of this medicine (listed in section 6) - if you have bowel obstruction (a blockage of your intestines)
Croatian: Nemojte uzimati BindRen - ako ste alergični na kolestilan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Vitamin K deficiency, calciphylaxis, electrolyte imbalance, fluid overload
Croatian: manjak vitamina K, kalcifilaksija, poremećaj elektrolita, preopterećenje tekućinom
English: Insomnia
Croatian: nesanica
English: Colestilan is a non-absorbed, non-calcium, non-metallic phosphate-binding polymer.
Croatian: Kolestilan je nemetalni polimer koji veže fosfate, ne apsorbira se i ne sadrži kalcij.
English: Caution should be exercised when prescribing BindRen to patients also taking anti-seizure medicinal products.
Croatian: Potreban je oprez kad se BindRen propisuje bolesnicima koji također uzimaju antiepileptike.
English: • Severe hepatic impairment (see also section 4.2)
Croatian: • teško oštećenje funkcije jetre (vidjeti također dio 4.2) • epileptički napadaji
English: High density polyethylene (HDPE) bottles, with a polypropylene cap and an induction seal.
Croatian: Boce od polietilena visoke gustoće (HDPE), s polipropilenskim zatvaračem i zaštitnom folijom.
English: Caution should be exercised when prescribing BindRen to patients receiving immunosuppressants.
Croatian: Potreban je oprez kad se BindRen propisuje bolesnicima koji primaju imunosupresive.
English: Your doctor may consider measuring blood levels of the other medicines you are taking.
Croatian: Liječnik može razmotriti i potrebu određivanja razine drugih lijekova u krvi.
English: Gastrointestinal haemorrhage
Croatian: Gastrointestinalno krvarenje
English: Tabulated list of adverse reactions A tabulated list of frequencies was defined using the following convention: very common (≥1/10); common
Croatian: Tablični popis učestalosti definiran je pomoću sljedećih kategorija: vrlo često (≥1/10); često (≥1/100 i
English: Uncommon (may affect up to 1 in 100 people) side effects: low blood pressure, weakness, thirst, headache, dizziness, shaking, dry mouth, swallowing difficulties, change in taste sensation, heartburn, hardening of the stool, inflammation or pain of the stomach or bowel, change in bowel habit, sleeplessness, itching, dry skin, rash, hives, itching red spots, collection of blood (haematoma) e.g. under the skin, joint pain, back pain, pain in limbs, muscle pain or spasms, increased blood levels of parathyroid hormone (a protein), certain blood fats and liver enzymes and a low level of folate (a vitamin).
Croatian: Manje česte (mogu se javiti u manje od 1 na 100 osoba) nuspojave: niski krvni tlak, slabost, žeđ, glavobolja, omaglica, drhtanje, suha usta, poteškoće pri gutanju, promjene osjeta okusa, žgaravica, tvrda stolica, upala ili bol u želucu ili crijevima, promjena crijevnih navika, nesanica, svrbež, suha koža, osip, koprivnjača, crvene točke koje svrbe, nakupine krvi (hematomi) npr. ispod kože, bol u zglobovima, bol u leđima, bol u udovima, mišićni bol ili grčevi, povišene razine paratiroidnog hormona (jedne bjelančevine) u krvi, određenih masnoća u krvi i enzima jetre te niska razina folata (vitamina).
English: 13.1 g. The rate of responders (either a reduction in serum phosphorus ≤ 1.78 mmol/L and/or a reduction from baseline ≥ 0.3 mmol/L) was 50.4 % and 43.8% in the two studies, respectively (placebo 30.8% and
Croatian: Brzina odgovora (smanjenje fosfora u serumu ≤ 1,78 mmol/l i/ili smanjenje u odnosu na početnu vrijednost ≥ 0,3 mmol/l) bila je 50,4 % odnosno 43,8% u ta dva ispitivanja (placebo 30,8% odnosno 26,3%).
English: BindRen did not induce a clinically relevant reduction in folate absorption during clinical studies of up to one year.
Croatian: BindRen nije izazvao klinički značajno smanjenje apsorpcije folata tijekom kliničkih ispitivanja u trajanju do godinu dana.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
English: After one year, the mean serum phosphorus level was 1.89 mmol/L with a significant reduction from baseline of 0.39 mmol/L and responder rate (phosphorus level <1.78 mmol/L) was 44%.
Croatian: Nakon jedne godine, srednja vrijednost fosfora u serumu bila je 1,89 mmol/l uz značajno sniženje u odnosu na početnu vrijednost za 0,39 mmol/l, a brzina odgovora (razina fosfora <1,78 mmol/l) bila je 44%.
English: Serum cholesterol
Croatian: Kolesterol u serumu
English: INFORMATION IN BRAILLE BindRen 1 g tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU BindRen 1 g tablete
English: • Serum albumin <30 g/L
Croatian: • nedavni peritonitis kod bolesnika na peritonejskoj dijalizi • serumski albumin <30 g/l
English: Serum calcium In clinical studies, colestilan had no effect on serum calcium levels over a period of up to one year.
Croatian: U kliničkim ispitivanjima, kolestilan nije imao učinka na razine kalcija u serumu u razdoblju do godinu dana.
English: BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
Croatian: BindRen je indiciran za liječenje hiperfosfatemije u odraslih bolesnika u 5. stadiju kroničnog bubrežnog zatajenja (KBZ) koji se liječe hemodijalizom ili peritonejskom dijalizom.
English: In subjects with baseline HbA1c ≥7.0%, colestilan showed a reduction of between 0.36 to 1.38% at week 12 in the fixed-dose study, and by 0.94 and 0.91% at week 12 in the two flexible-dose studies.
Croatian: U ispitanika s početnim HbA1c ≥7,0%, kolestilan je pokazao smanjenje za 0,36 do 1,38% u 12. tjednu u ispitivanju s fiksnom dozom te za 0,94 odosno 0,91% u 12. tjednu u dva ispitivanja s fleksibilnom dozom.
English: Acetic acid esters of mono- and diglycerides of fatty acids Polysorbate 80
Croatian: Film ovojnica hipromeloza esteri acetatne kiseline i mono- i diglicerida masnih kiselina polisorbat 80
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 3 G GRANULES IN SACHETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA - 3 G GRANULE U VREĆICAMA
English: Patients should be encouraged to adhere to their prescribed low phosphate diets.
Croatian: Bolesnike treba poticati da se pridržavaju propisane dijete s niskim sadržajem fosfata.
English: BindRen contains the active substance colestilan.
Croatian: BindRen sadrži djelatnu tvar kolestilan.
English: The Phase II and III clinical studies involving 1,410 patients with CKD Stage 5 on dialysis treated with BindRen for up to one year constituted the safety population.
Croatian: U kliničkim ispitivanjima faze II i III, sigurnost lijeka ispitana je na populaciji od 1410 bolesnika u 5. stadiju KBZ-a na dijalizi liječenih BindRenom u trajanju do godinu dana.
English: The colestilan-bound phosphorus is then excreted from your body in faeces.
Croatian: Fosfor vezan za kolestilan se potom izlučuje iz Vašeg tijela stolicom.
English: The other ingredients are purified water, hydroxypropylcellulose, colloidal, anhydrous silica, hydrogenated castor oil, hypromellose, acetic acid esters of mono- and diglycerides of fatty acids, polysorbate 80, shellac, indigo carmine aluminium lake (E132) and carnauba wax.
Croatian: Drugi sastojci su pročišćena voda, hidroksipropilceluloza, koloidni, bezvodni silicijev dioksid, hidrogenirano ricinusovo ulje, hipromeloza, esteri acetatne kiseline i mono- i diglicerida masnih kiselina, polisorbat 80, šelak, indigo carmine aluminium lake (E132) i karnauba vosak.
English: Muscle spasm, musculoskeletal pain, arthralgia, back pain, pain in extremities
Croatian: spazmi mišića, mišićno-koštani bol, artralgije, bol u leđima, bol u ekstremitetima
English: This includes medicines for irregular heart rhythm (such as digoxin), for treating high blood pressure (such as enalapril maleate), anti-seizure medicines (such as valproic acid, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, topiramate, gabapentin, vigabatrin, zonisamide and levetiracetam), levothyroxine (used to treat thyroid hormone deficiency), oral birth control medicines (oestrogen, progestogen or combination pills), immune system suppressing medicines (such as cyclosporine, mycophenolate mofetil, tacrolimus).
Croatian: To uključuje lijekove za nepravilan srčani ritam (kao što je digoksin), za liječenje povišenog krvnog tlaka (kao što je enalapril maleat), antiepilepsijske lijekove (kao što su valproična kiselina, fenitoin, karbamazepin, lamotrigin, okskarbazepin, topiramat, gabapentin, vigabatrin, zonisamid i levetiracetam),
English: Patients that become pregnant and where a benefit/risk assessment confirms continued treatment with BindRen, supplementation of vitamins may be required, see section 4.4.
Croatian: Bolesnicama koje zatrudne i kod kojih procjena omjera koristi i rizika potvrđuje korist od nastavka liječenja BindRenom može biti potrebna nadoknada vitamina, vidjeti dio 4.4.
English: Bottles
Croatian: Boce
English: Changes in the bile acid pool in the gastrointestinal tract have also been observed to lower serum glucose.
Croatian: Također je opaženo da promjene u količini žučnih kiselina u probavnom traktu snižavaju glukozu u serumu.
English: Hypothyroidism
Croatian: Hipotireoidizam
English: BindRen granules are white cylindrical granules.
Croatian: Kako BindRen izgleda i sadržaj pakovanja BindRen granule bijele, cilindrične granule.
English: The safety and efficacy of BindRen has not been studied in patients with:
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Sigurnost i djelotvornost BindRena nije ispitana u bolesnika s:
English: Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence, abdominal discomfort
Croatian: konstipacija, abdominalni bol, povraćanje, distenzija abdomena, mučnina, gastritis, dispepsija, proljev, flatulencija, abdominalna nelagoda
English: Granules.
Croatian: Granule.
English: Colestilan may also bind uric acid in the gastrointestinal tract.
Croatian: Kolestilan može vezati mokraćnu kiselinu u probavnom sustavu.
English: The other ingredients are: purified water, hydroxypropylcellulose, colloidal, anhydrous silica, hydrogenated castor oil, ethylcellulose, hypromellose, macrogol 8000, triethyl citrate, titanium dioxide, talc, cetanol and sodium laurilsulfate.
Croatian: Drugi sastojci su pročišćena voda, hidroksipropilceluloza, koloidni, bezvodni silicijev dioksid, hidrogenirano ricinusovo ulje, etilceluloza, hipromeloza, makrogol 8000, trietilcitrat, titanijev dioksid, talk, cetanol i natrijev laurilsulfat.
English: Talk to your doctor or pharmacist if during your treatment with BindRen, any of the following applies to you: - you experience constipation, since your doctor may wish to monitor your bowel function to detect potential side effects (see section 4).
Croatian: Obratite se svom liječniku ili ljekarniku ako tijekom liječenja BindRenom nešto od slijedećeg vrijedi za Vas: - imate zatvor, liječnik će možda htjeti pratiti funkciju Vaših crijeva kako bi prepoznao moguće nuspojave (vidjeti dio 4). - rečeno Vam je da imate poremećaj zbog kojeg je smanjena sposobnost crijeva da apsorbiraju hranjive sastojke (malapsorpcijski sindrom) ili ako se liječite takozvanim kumarinskim antikoagulansima (npr.
English: Calcium-phosphorus ion product was reduced by at least 0.48 mmol2/L2 at week 12 compared to placebo at doses ≥9 g/day in fixed-dose study and by 1.05 and 0.86 mmol2/L2 at week 12 in two flexible-dose studies.
Croatian: Umnožak kalcija i fosfora u serumu bio je smanjen za najmanje 0,48 mmol2/l2 u 12. tjednu u usporedbi s placebom u dozama od ≥9 g na dan u ispitivanju s fiksnom dozom i za 1,05 odnosno 0,86 mmol2/l2 u 12. tjednu u dva ispitivanja s fleksibilnom dozom.
English: Patients that breast-feed and where a benefit/risk assessment confirms continued treatment with BindRen, supplementation of vitamins may be required, see section 4.4.
Croatian: Bolesnicama koji doje i kod kojih procjena omjera koristi i rizika potvrđuje korist od nastavka liječenja BindRenom može biti potrebna nadoknada vitamina, vidjeti dio 4.4.
English: BindRen 1 g film-coated tablets colestilan
Croatian: BindRen 1 g filmom obložene tablete kolestilan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 g colestilan.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 1 g kolestilana.
English: No data on the use of BindRen in pre-dialysis patients are available.
Croatian: Nema dostupnih podataka o primjeni BindRena u bolesnika koji još nisu na dijalizi.
English: In these patients, monitoring of vitamin A, D and E concentrations or assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
Croatian: Kod tih se bolesnika preporučuje pratiti koncentracije vitamina A, D i E ili procijeniti status vitamina
English: Serum parathyroid hormone (PTH)
Croatian: Paratiroidni hormon (PTH) u serumu
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS - FILM-COATED TABLETS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI - FILMOM OBLOŽENE TABLETE
English: BindRen is indicated for use in patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
Croatian: BindRen je indiciran za primjenu u bolesnika u 5. stadiju kroničnog bubrežnog zatajenja (KBZ) na hemodijalizi ili peritonejskoj dijalizi.
English: Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence,
Croatian: konstipacija, abdominalni bol, povraćanje, distenzija abdomena, mučnina, gastritis, dispepsija, proljev,
English: However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption syndromes and patients treated with coumarin anticoagulants (e.g. warfarin).
Croatian: K ili vitamina topljivih u mastima, kao što su bolesnici sa sindromima malapsorpcije i bolesnici koji se liječe kumarinskim antikoagulansima (npr. varfarinom).
English: What BindRen is and what it is used for What you need to know before you take BindRen How to take BindRen
Croatian: Što morate znati prije nego počnete uzimati BindRen
English: Each film-coated tablet contains 1 g of colestilan.
Croatian: Jedna filmom obložena tableta sadrži 1 g kolestilana.
English: Hyperparathyroidism
Croatian: hiperparatireoidizam
English: The frequency of adverse reactions increased with dose.
Croatian: Učestalost nuspojava povećavala se s dozom.
English: These were considered to result from a deficiency of vitamin K following a reduction in the absorption of fat-soluble vitamins (see section 4.4).
Croatian: K nakon smanjenja apsorpcije vitamina topljivih u mastima (vidjeti dio 4.4).
English: Colestilan binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood.
Croatian: Kolestilan veže fosfor iz hrane u probavnom traktu i tako sprječava apsorpciju fosfora u krv.
English: Do not use this medicine after the expiry date stated on the box or the sachet after the abbreviation “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili vrećici iza „Rok valjanosti”.
English: Fixed-dose study:
Croatian: Ispitivanje fiksne doze:
English: Posology The recommended starting dose is 6-9 g per day (2-3 g three times daily).
Croatian: Doziranje Preporučena početna doza je 6-9 g na dan (2-3 g tri puta na dan).
English: BindRen is not absorbed from the gastrointestinal tract but may affect the bioavailability or absorption rate of other medicinal products.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija BindRen se ne apsorbira iz probavnog trakta, ali može utjecati na bioraspoloživost ili brzinu apsorpcije drugih lijekova.
English: Rare (may affect up to 1 in 1000 people) side effects: blockage of intestines, a low level of vitamin K, obstruction of the blood vessels that supply the heart muscle and swelling of the ankles or extremities.
Croatian: Rijetke (mogu se javiti u manje od 1 na 1000 osoba) nuspojave: blokada crijeva, niska razina vitamina K,
English: No data are available to assess the safety and efficacy in breast-feeding women.
Croatian: Nema dostupnih podataka da bi se mogla procijeniti sigurnost i djelotvornost u dojilja.
English: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with BindRen.
Croatian: Vrlo rijetko tijekom liječenja BindRenom opaženi su slučajevi intestinalne opstrukcije i ileus/subileus.
English: BindRen does not contain calcium and your doctor may prescribe additional calcium tablets.
Croatian: BindRen ne sadrži kalcij i liječnik Vam može dodatno propisati tablete kalcija. - imate nenormalno visoke razine kalcija u krvi zbog prejake aktivnosti paratiroidnih žlijezda.
English: - BindRen 2 g granules: each sachet contains 2 g of colestilan.
Croatian: BindRen 2 g granule: jedna vrećica sadrži 2 g kolestilana.
English: If you take more BindRen than you should If you take too much BindRen, tell your doctor or pharmacist.
Croatian: Ako uzmete previše BindRena, obavijestite svog liječnika ili ljekarnika.
English: About high blood phosphorus levels (hyperphosphataemia) If your kidneys no longer function properly you may undergo dialysis, which replaces many of the functions of your kidneys.
Croatian: Ako Vam bubrezi ne rade uredno, ići ćete na dijalizu koja zamjenjuje mnoge funkcije bubrega.
English: NAME OF THE MEDICINAL PRODUCT BindRen 1 g film-coated tablets
Croatian: NAZIV LIJEKA BindRen 1 g filmom obložene tablete
English: Infections and infestations Uncommon:
Croatian: Infekcije i infestacije
English: Sometimes, the dialysis and diet are not enough to stop the phosphorus in your blood rising to high levels, a condition referred to by your doctor as hyperphosphataemia.
Croatian: Ponekad, dijaliza i dijeta nisu dovoljne za sprječavanje porasta razine fosfora u krvi.
English: In these patients, monitoring serum folate status and supplementation with folic acid should be considered.
Croatian: U tih je bolesnika potrebno razmotriti praćenje koncentracije folata u serumu te nadoknadu folne kiseline.
English: Serum phosphorus
Croatian: Fosfor u serumu
English: • Severe gastrointestinal disorders such as chronic or severe constipation, intestinal stenosis, intestinal diverticulum, sigmoid colitis, gastrointestinal ulcers, or recent major gastrointestinal surgery
Croatian: divertikuloza crijeva, kolitis sigmoidnog kolona, gastrointestinalni ulkusi ili nedavni veliki kirurški zahvat na gastrointestinalnom traktu
English: Serum uric acid
Croatian: Mokraćna kiselina u serumu
English: BindRen did not induce any clinically relevant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year.
Croatian: Tijekom kliničkih ispitivanja u trajanju do godinu dana, BindRen nije izazvao nikakvo klinički značajno smanjenje apsorpcije vitamina A, D, E ili K.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g colestilan.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica sadrži 2 g kolestilana.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 3 g colestilan.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica sadrži 3 g kolestilana.
English: Gastrointestinal haemorrhage, oesophagitis, faecaloma, dysphagia, change in bowel habit, dry mouth
Croatian: gastrointestinalno krvarenje, ezofagitis, fekaliti (vrlo tvrda stolica), disfagija, promjene u pražnjenju crijeva, suha usta
English: Three Phase III studies and two long term follow-up studies have been performed in patients with CKD Stage 5 on dialysis, in order to investigate efficacy and safety in this population.
Croatian: Djelotvornost i sigurnost populacije bolesnika u 5. stadiju KBZ-a na dijalizi ispitana je u jednom ispitivanju faze III i dva ispitivanja s dugotrajnim praćenjem.
English: Elemental calcium should be given as a supplement in case of hypocalcaemia.
Croatian: U slučaju hipokalcemije potrebno je primijeniti nadomjesnu terapiju kalcijem.
English: In the first study, the mean serum phosphorus level was 2.33 mmol/L at baseline and 1.96 mmol/L (mean reduction by 0.36 mmol/L) at week 12 on a colestilan mean daily dose of 11.5 g. Similarly in the second study, the mean serum phosphorus level was 2.44 mmol/L at baseline and 1.94 mmol/L at week 12 (mean reduction by 0.50 mmol/L) on a colestilan mean daily dose of
Croatian: U prvom ispitivanju, srednja vrijednost fosfora u serumu bila je 2,33 mmol/l na početku i 1,96 mmol/l (smanjenje srednje vrijednosti za 0,36 mmol/l) u 12. tjednu, srednja vrijednost dnevne doze kolestilana iznosila je 11,5 g.