FrancophonIA/ELRC3.0 huggingface dataset:
English: If you touch the spike on the vial adapter germs from your fingers can be transferred.
Croatian: Ako dotaknete šiljak na nastavku za bočicu, može doći do prijenosa mikroorganizama s Vaših prstiju.
English: - 1 vial (12 ml) with white powder for solution for injection - 1 pre-filled syringe (10 ml) with solvent for reconstitution - 1 plunger rod - 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.
Croatian: - 1 bočicu (12 ml) s bijelim praškom za otopinu za injekciju - 1 napunjenu štrcaljku (10 ml) s otapalom za rekonstituciju - 1 potisni klip
English: If using a transfer needle, remove transfer needle from the packaging without taking it out of the protective cap. Screw the transfer needle tightly onto the syringe.
Croatian: Ako koristite iglu za prijenos, izvadite je iz pakiranja, ali je nemojte izvaditi iz zaštitnog omota.
English: • 1 vial with NovoSeven powder
Croatian: • 1 bočicu s NovoSeven praškom • 1 nastavak za bočicu
English: After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with solvent.
Croatian: Nakon rekonstitucije s otapalom, lijek sadrži 1 mg/ml eptakoga alfa (aktiviranog).
English: Eptacog alfa (activated) 8 mg/vial (400 KIU/vial), 1 mg/ml after reconstitution
Croatian: eptakog alfa (aktivirani) 8 mg/bočici (400 KIU/bočici), 1 mg/ml nakon pripreme otopine za primjenu
English: If you use a transfer needle, make sure to penetrate the centre of the rubber stopper.
Croatian: Ako koristite iglu za prijenos, pripazite da probijete sredinu gumenog čepa.
English: In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII is the only adverse drug reaction reported (frequency: common (≥ 1/100 to < 1/10)).
Croatian: FVII jedina je prijavljena nuspojava (učestalost: često (≥ 1/100 i < 1/10)).
English: In syringe (50 ml polypropylene) in hospital settings only Reconstitution must take place in controlled and validated aseptic conditions by adequately trained staff.
Croatian: U štrcaljki (50 ml, polipropilen), samo u bolničkom okruženju
English: Hold the syringe slightly tilted with the vial facing downwards.
Croatian: Držite štrcaljku lagano nagnutu s bočicom prema dolje.
English: Eptacog alfa (activated) 5 mg/vial (250 KIU/vial), 1 mg/ml after reconstitution
Croatian: eptakog alfa (aktivirani) 5 mg/bočici (250 KIU/bočici), 1 mg/ml nakon pripreme otopine za primjenu
English: If the caps are loose or missing, do not use the vials.
Croatian: Ukoliko zatvarači nisu pričvršćeni ili nedostaju, bočice nemojte koristiti.
English: - 1 vial (2 ml) with white powder for solution for injection - 1 pre-filled syringe (3 ml) with solvent for reconstitution - 1 plunger rod - 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.
Croatian: - 1 bočicu (2 ml) s bijelim praškom za otopinu za injekciju - 1 napunjenu štrcaljku (3 ml) s otapalom za rekonstituciju - 1 potisni klip
English: Factor VII deficiency
Croatian: Nedostatak faktora VII Distribucija i eliminacija
English: Gently swirl the vial until all the powder is dissolved.
Croatian: • Nježno vrtite bočicu dok se sav prašak ne otopi.
English: Turn the syringe with the vial upside down and withdraw the contents of the vial into the syringe.
Croatian: Okrenite štrcaljku s bočicom naopako i izvucite sadržaj bočice u štrcaljku.
English: • Screw the plunger rod clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Croatian: • Navijte potisni klip, okrećući ga u smjeru kazaljke na satu, na klip unutar napunjene štrcaljke dok ne osjetite otpor.
English: Do not take the vial adapter out of the protective cap.
Croatian: Nastavak za bočicu nemojte vaditi iz zaštitnog omota.
English: If you are using a transfer needle, make sure that the transfer needle tip is in the solvent.
Croatian: Ako koristite iglu za prijenos, provjerite da se vršak igle za prijenos nalazi u otopini.
English: Eptacog alfa (activated) 2 mg/vial (100 KIU/vial), 1 mg/ml after reconstitution
Croatian: eptakog alfa (aktivirani) 2 mg/bočici (100 KIU/bočici), 1 mg/ml nakon pripreme otopine za primjenu
English: • In case you only need part of the reconstituted solution, use the scale on the syringe to see how much of the solution you withdraw, as instructed by your doctor or nurse.
Croatian: pomoću skale na štrcaljki odredite koliko ćete otopine uvući, u skladu s uputama koje ste dobili od liječnika ili medicinske sestre.
English: Eptacog alfa (activated) 1 mg/vial (50 KIU/vial), 1 mg/ml after reconstitution
Croatian: eptakog alfa (aktivirani) 1 mg/bočici (50 KIU/bočici), 1 mg/ml nakon pripreme otopine za primjenu
English: Turn over the protective cap, and snap the vial adapter onto the vial.
Croatian: Okrenite zaštitni omot i pričvrstite nastavak za bočicu na bočicu.
English: NovoSeven 8 mg Powder for injection Eptacog alfa (activated) IV
Croatian: NovoSeven 8 mg Prašak za injekciju eptakog alfa (aktivirani)
English: EU/1/96/006/010
Croatian: EU/1/96/006/006 EU/1/96/006/010
English: Solvent vial
Croatian: Hallas Allé
English: Pull the plunger rod slightly downwards to draw the mixed solution into the syringe.
Croatian: Lagano povucite potisni klip prema dolje kako biste uvukli izmiješanu otopinu u štrcaljku.
English: Check the solution for visible particles and discolouration.
Croatian: Provjerite da u otopini nema vidljivih čestica i da nije promijenila boju.
English: NovoSeven 5 mg Powder for injection Eptacog alfa (activated) IV
Croatian: NovoSeven 5 mg Prašak za injekciju eptakog alfa (aktivirani)
English: If using a transfer needle, insert the transfer needle into the rubber stopper of the solvent vial.
Croatian: Ako koristite iglu za prijenos, umetnite iglu za prijenos u gumeni čep bočice s otapalom.
English: • Headache
Croatian: • Mučnina
English: Screw the syringe securely onto the vial adapter until resistance is felt.
Croatian: Čvrsto navijte štrcaljku na nastavak za bočicu dok ne osjetite otpor.
English: NovoSeven 2 mg Powder for injection Eptacog alfa (activated) IV
Croatian: NovoSeven 2 mg Prašak za injekciju eptakog alfa (aktivirani)
English: Store below 25°C Do not freeze Store protected from light
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 25°C.
English: NovoSeven 1 mg Powder for injection Eptacog alfa (activated) IV
Croatian: NovoSeven 1 mg Prašak za injekciju eptakog alfa (aktivirani)
English: EU/1/96/006/008
Croatian: EU/1/96/006/004 EU/1/96/006/008
English: If you use a transfer needle, make sure that the transfer needle tip is in the solution.
Croatian: Ako koristite iglu za prijenos, pazite da se vršak igle za prijenos nalazi u otapalu.
English: EU/1/96/006/011
Croatian: EU/1/96/006/007 EU/1/96/006/011
English: Contents
Croatian: Doziranje
English: Hold the prefilled syringe slightly tilted with the vial pointing downwards.
Croatian: Držite napunjenu štrcaljku lagano nagnutu s bočicom prema dolje.
English: NovoSeven reconstituted product is a clear, colourless solution.
Croatian: Pripremljena otopina lijeka NovoSeven bistra je i bezbojna.
English: EU/1/96/006/005
Croatian: EU/1/96/006/005 EU/1/96/006/009
English: • Turn over the protective cap, and snap the vial adapter onto the vial.
Croatian: • Okrenite zaštiti omot i pričvrstite nastavak za bočicu na bočicu.
English: NovoSeven is presented as powder and solvent for solution for injection containing 8 mg eptacog alfa (activated) per vial (corresponds to 400 KIU/vial).
Croatian: NovoSeven 8 mg (400 KIU) NovoSeven se sastoji od praška i otapala za otopinu za injekciju i sadrži 8 mg eptakoga alfa
English: NovoSeven is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/vial).
Croatian: NovoSeven 2 mg (100 KIU) NovoSeven se sastoji od praška i otapala za otopinu za injekciju i sadrži 2 mg eptakoga alfa
English: • Hold the syringe with the solvent vial upside down.
Croatian: • Držite štrcaljku s bočicom s otapalom okrenutom naopako.
English: • 1 pre-filled syringe with solvent for reconstitution
Croatian: • 1 bočicu s otapalom za pripremu otopine za primjenu.
English: If you use a vial adapter, unscrew the vial adapter with the empty vial.
Croatian: Ako koristite nastavak za bočicu, odvijte nastavak za bočicu s praznom bočicom.
English: Pre-filled syringe: Type I glass barrel with a polypropylene backstop and bromobutyl rubber plunger.
Croatian: I s polipropilenskim graničnikom i brombutilnim gumenim klipom.
English: NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/vial).
Croatian: NovoSeven 1 mg (50 KIU) NovoSeven se sastoji od praška i otapala za otopinu za injekciju i sadrži 1 mg eptakoga alfa
English: • If using a vial adapter, unscrew the vial adapter with the empty vial.
Croatian: • Ako koristite nastavak za bočicu, odvijte nastavak za bočicu s praznom bočicom.
English: The usual dose is 90 micrograms for every 1 kilogram you weigh; you can repeat the injection every 2-3 hours until bleeding is controlled.
Croatian: Ako imate hemofiliju: Uobičajena je doza 90 mikrograma po 1 kilogramu tjelesne težine: injiciranje možete ponoviti svaka
English: Solvent
Croatian: Metionin
English: • Screw the syringe tightly onto the vial adapter on the solvent vial.
Croatian: • Čvrsto navijte štrcaljku na nastavak za bočicu na bočici s otapalom.
English: 90 µg/kg (range 28 to 450 µg/kg).
Croatian: Medijan doze po infuziji za liječenje 333 epizoda krvarenja, bio je 90 µg/kg (raspon od 28 do 450 µg/kg).
English: Plastic cap
Croatian: KLINIČKI PODACI
English: NovoSeven is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/vial).
Croatian: NovoSeven 5 mg (250 KIU) NovoSeven se sastoji od praška i otapala za otopinu za injekciju i sadrži 5 mg eptakoga alfa
English: Renagel must be taken three times per day with meals.
Croatian: Renagel se mora uzimati triput na dan uz obrok.
English: Contact your doctor who will decide on continuing the treatment or not.
Croatian: Obratite se svome liječniku, koji će odlučiti hoćete li nastaviti s liječenjem ili ne.
English: Component of a multipack, can't be sold separately.
Croatian: Sastavnica višestrukog pakiranja, ne može se prodavati zasebno.
English: The safety and efficacy in children (below the age of 18 years) has not been studied.
Croatian: Sigurnost primjene i djelotvornost u djece (mlađe od 18 godina) nisu ispitivane.
English: The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer.
Croatian: Prosječna stvarna dnevna doza koja se primjenjivala u kroničnoj fazi jednogodišnjeg kliničkog ispitivanja bila je 7 grama sevelamera.
English: Package sizes are:
Croatian: Veličine pakiranja su:
English: • if you have symptoms of delayed emptying of stomach contents such as feeling of fullness,
Croatian: • ako imate simptome odgođenog pražnjenja želučanog sadržaja kao što su osjećaj punoće,
English: Other medicines and Renagel
Croatian: Drugi lijekovi i Renagel
English: As data on the chronic use of sevelamer for over one year are not yet available, potential absorption and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded (see section 5.2).
Croatian: Budući da još nisu dostupni podaci o kroničnoj primjeni sevelamera dulje od jedne godine, ne može se potpuno isključiti mogućnost apsorpcije i akumulacije sevelamera tijekom dugotrajnog kroničnog liječenja (vidjeti dio 5.2).
English: What you need to know before you take Renagel 3.
Croatian: Što morate znati prije nego što počnete uzimati Renagel 3.
English: If you take more Renagel than you should
Croatian: Ako uzmete više lijeka Renagel nego što ste trebali
English: What Renagel is and what it is used for 2.
Croatian: Što je Renagel i za što se koristi 2.
English: Your doctor will check for interactions between Renagel and other medicines on a regular basis.
Croatian: Liječnik će redovito provjeravati jesu li nastupile interakcije između lijeka Renagel i drugih lijekova.
English: Renagel does not contain calcium.
Croatian: Renagel ne sadrži kalcij.
English: One gram of Renagel contains approximately 180 mg (5.1 mEq) chloride.
Croatian: Jedan gram lijeka Renagel sadrži približno 180 mg (5,1 mEq) klorida.
English: Renagel is not absorbed and may affect the bioavailability of other medicinal products.
Croatian: Renagel se ne apsorbira i može utjecati na bioraspoloživost ostalih lijekova.
English: 1 bottle of 100 tablets
Croatian: 1 bočica sa 100 tableta
English: Date of first authorisation: 28 January 2000 Date of latest renewal: 28 January 2015
Croatian: Datum posljednje obnove odobrenja : 28. siječnja 2015.
English: What Renagel looks like and contents of the pack
Croatian: Kako Renagel izgleda i sadržaj pakiranja
English: Talk to your doctor before taking Renagel if any of the following applies to you:
Croatian: Obratite se svom liječniku prije nego što uzmete Renagel ako se nešto od navedenog odnosi na Vas:
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.
Croatian: S obzirom da zatvor može biti simptom koji u vrlo rijetkim slučajevima prethodi začepljenju crijeva, važno je da obavijestite svog liječnika ili ljekarnika o ovom simptomu prije ili tijekom korištenja lijeka Renagel.
English: There is at present insufficient data to exclude the possibility of folate deficiency during long term Renagel treatment.
Croatian: Trenutno nema dovoljno podataka da bi se mogla isključiti mogućnost manjka folata tijekom dugotrajnog liječenja lijekom Renagel.
English: If you forget to take Renagel
Croatian: Ako ste zaboravili uzeti Renagel
English: Adverse reactions from these studies (299 patients), from uncontrolled clinical trials (384 patients), and that were spontaneously reported from post-marketing experience are listed by frequency in the table below.
Croatian: Nuspojave iz tih ispitivanja (299 bolesnika), iz nekontroliranih kliničkih ispitivanja (384 bolesnika) i one spontano prijavljene nakon stavljanja lijeka u promet navedene su prema učestalosti u tablici u nastavku.
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).
Croatian: Stopa prijavljivanja definirana je kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The following side effects have been reported in patients taking Renagel: Very common (may affect more than 1 in 10 people): nausea, vomiting.
Croatian: U bolesnika koji su uzimali Renagel prijavljene su sljedeće nuspojave: Vrlo često (mogu se javiti u više od 1 na 10 osoba): mučnina, povraćanje.
English: Since Renagel does not contain calcium your doctor might prescribe additional calcium tablets.
Croatian: Budući da Renagel ne sadrži kalcij, liječnik Vam može propisati dodatno uzimanje tableta kalcija.
English: Efficacy and safety of Renagel has not been studied in patients with:
Croatian: Djelotvornost i sigurnost primjene lijeka Renagel nije ispitana u bolesnika:
English: Therefore Renagel is not recommended for use in this population.
Croatian: Stoga se ne preporučuje primjena lijeka Renagel u toj populaciji.
English: However, in vitro and in vivo studies have indicated that Renagel does not have genotoxic potential.
Croatian: Međutim, ispitivanja in vitro i in vivo indiciraju da Renagel nema genotoksičan potencijal.
English: What Renagel is and what it is used for
Croatian: Što je Renagel i za što se koristi
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti lijeka (PSUR-evi) Nositelj odobrenja će PSUR-eve za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: • Renagel should not be taken at the same time as ciprofloxacin (an antibiotic).
Croatian: • Renagel se ne bi smio uzimati istodobno s ciprofloksacinom (antibiotik).
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.
Croatian: • U nekih osoba koje uzimaju levotiroksin (hormon štitnjače) i Renagel vrlo rijetko može doći do povišenja razine hormona koji stimulira štitnjaču (TSH, tvari u krvi koja pomaže u regulaciji kemijskih funkcija Vašeg tijela).
English: The dose range may vary between 1 and 10 tablets per meal.
Croatian: Raspon doze može varirati između 1 i 10 tableta po obroku.
English: Renagel is unlikely to affect your ability to drive or to use machines.
Croatian: Nije vjerojatno da će Renagel utjecati na vašu sposobnost upravljanja vozilima i strojevima.
English: • If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renagel.
Croatian: • Ako uzimate lijekove za liječenje tegoba sa srčanim ritmom ili epilepsije, morate se savjetovati sa svojim liječnikom kad uzimate Renagel.
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.
Croatian: Peritonitis je poznata komplikacija u bolesnika koji su na peritonealnoj dijalizi (PD), a u kliničkom ispitivanju s lijekom Renagel prijavljen je određeni broj slučajeva peritonitisa.
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.
Croatian: Prilikom primjene bilo kojeg lijeka čija bi smanjena bioraspoloživost mogla imati klinički značajan učinak na sigurnost primjene ili djelotvornost, taj se lijek mora primijeniti najmanje jedan sat prije ili tri sata nakon lijeka Renagel, ili liječnik mora razmotriti praćenje razina u krvi.
English: These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystals deposit in your bowel.
Croatian: Ovi simptomi se mogu javiti zbog ozbiljne upalne bolesti crijeva uzrokovane nakupinama kristala sevelamera u Vašim crijevima.
English: Name and address of the manufacturer responsible for batch release Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Nazivi i adrese proizvođača odgovornog za puštanje serije lijeka u promet Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: Consequently, Renagel should not be taken simultaneously with ciprofloxacin.
Croatian: Stoga se Renagel ne bi smio uzimati istodobno s ciprofloksacinom.
English: Renagel alone is not indicated for the control of hyperparathyroidism.
Croatian: Renagel sam nije indiciran za kontrolu hiperparatireoze.
English: Talk to your doctor while taking Renagel:
Croatian: Obratite se svom liječniku ako tijekom uzimanja lijeka Renagel:
English: In a clinical trial of one-year duration, Renagel had no adverse effect on bone turnover or mineralisation compared to calcium carbonate.
Croatian: U kliničkom ispitivanju u trajanju od jedne godine Renagel nije imao štetne učinke na koštanu pregradnju ni mineralizaciju u usporedbi s kalcijevim karbonatom.
English: Do not use this medicine after the expiry date stated on the carton and bottle after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake “Rok valjanosti”.
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.
Croatian: Istraživanja na životinjama pokazala su da sevelamer nije štetno utjecao na plodnost mužjaka ni ženki štakora pri ekspoziciji dozama koje odgovaraju dvostrukoj maksimalnoj dozi za ljude iz kliničkih ispitivanja od 13 g/dan, temeljeno na usporedbi relativne površine tijela.
English: • if you have prolonged diarrhoea or pain in the abdomen (symptoms of active inflammatory bowel disease)
Croatian: • ako imate dugotrajni proljev ili bol u trbuhu (simptomi aktivne upalne bolesti crijeva)
English: In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Croatian: U ispitivanjima interakcija u zdravih dobrovoljaca, Renagel nije utjecao na bioraspoloživost digoksina, varfarina, enalaprila ili metoprolola.
English: He will base the dose on your serum phosphate level.
Croatian: On će odrediti Vašu dozu na temelju razine fosfata u serumu.
English: • active inflammatory bowel disease
Croatian: • s aktivnom upalnom bolešću crijeva
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.
Croatian: U nekim slučajevima kada Renagel morate uzimati istodobno s drugim lijekom, liječnik Vam može preporučiti da taj lijek uzmete 1 sat prije ili 3 sata nakon uzimanja lijeka Renagel ili može razmotriti praćenje razina tog lijeka u krvi.
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.
Croatian: Preporučena početna doza lijeka Renagel za odrasle i starije osobe (>65 godina) je jedna do dvije tablete uz svaki obrok 3 puta na dan.
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.
Croatian: Preporučena početna doza lijeka Renagel za odrasle i starije osobe (>65 godina) je dvije do četiri tablete uz svaki obrok 3 puta na dan.
English: Serum chloride may increase during Renagel treatment as chloride may be exchanged for phosphorus in the intestinal lumen.
Croatian: Količina klorida u serumu može se povećati tijekom liječenja lijekom Renagel jer se klorid može zamijeniti fosforom u crijevnom lumenu.
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska
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.
Croatian: Provedena su usporedna ispitivanja u kojima su sudjelovala 244 bolesnika na hemodijalizi čije je liječenje trajalo najdulje 54 tjedna i 97 bolesnika na peritonealnoj dijalizi čije je liječenje trajalo najdulje 12 tjedana.
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).
Croatian: U kliničkim ispitivanjima u bolesnika na hemodijalizi sevelamer sam nije imao konzistentan i klinički značajan učinak na razinu intaktnog paratiroidnog hormona (iPTH) u serumu.