FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportion of subjects with average serum potassium < 5.1 mmol/L was 88%, the average serum potassium level was 4.66 mmol/L and the proportion of serum potassium measurements below 3.5 mmol/L was less than 1%; between 3.5 and 5.1 mmol/L was 77%; or between 3.5 and 5.5 mmol/L was 93%, irrespective of other factors that might influence the serum potassium.
Croatian: Udio ispitanika s prosječnom serumskom vrijednošću kalija < 5,1 mmol/l iznosio je 88%, a prosječna serumska vrijednost kalija 4,66 mmol/l; udio izmjerenih vrijednosti kalija u serumu ispod 3,5 mmol/l bio je manji od 1%, udio vrijednosti između 3,5 i 5,1 mmol/l iznosio je 77%, dok je udio vrijednosti između 3,5 i 5,5 mmol/l bio 93%, neovisno o drugim faktorima koji bi mogli utjecati na kalij u serumu.
English: No events of intestinal perforation have been reported with Lokelma.
Croatian: Nije prijavljen niti jedan događaj intestinalne perforacije kod primjene lijeka Lokelma.
English: Patients were randomised to receive escalating doses of Lokelma (0.3 g, 3 g and 10 g) or placebo, administered three times a day with meals for two to four days.
Croatian: Bolesnici su bili randomizirani za primanje lijeka Lokelma u dozama koje su se postupno povećavale (0,3 g, 3 g i 10 g) ili placeba, triput na dan uz obroke, tijekom 2 do 4 dana.
English: In addition, mean reductions in blood urea nitrogen (BUN) were observed in the 5 g (1.1 mg/dL) and 10 g (2.0 mg/dL) three times daily groups compared with small mean increases in the placebo (0.8 mg/dL) and low dose sodium zirconium cyclosilicate (0.3 mg/dL) groups.
Croatian: Nadalje, primijećena su srednja smanjenja ureje u krvi (BUN, engl. blood urea nitrogen) u skupini liječenoj dozom od 5 g (1,1 mg/dl) i onoj liječenoj dozom od 10 g (2,0 mg/dl) triput na dan, u odnosu na mala srednja povećanja u skupini koja je primala placebo (0,8 mg/dl) i onoj liječenoj niskom dozom natrijevog cirkonijevog ciklosilikata (0,3 mg/dl).
English: If the patient is having abdominal X-rays, radiographers should keep this in mind.
Croatian: Radiolozi moraju to imati na umu ako se bolesnika podvrgava rendgenskom snimanju abdomena.
English: If you forget to take Lokelma
Croatian: Ako ste zaboravili uzeti lijek Lokelma
English: An in vivo mass balance study in rats showed that sodium zirconium cyclosilicate was recovered in the faeces with no evidence of systemic absorption.
Croatian: U ispitivanju masene bilance in vivo provedenom u štakora, natrijev cirkonijev ciklosilikat pronađen je u fecesu, bez dokaza sistemske apsorpcije.
English: Twenty-four hour urine collections showed that Lokelma decreased urinary potassium excretion from baseline by 15.8 mmol/24 h compared to placebo increase by 8.9 mmol/24 h (p < 0.001).
Croatian: Prikupljanje uzoraka mokraće tijekom 24 sata pokazalo je da je Lokelma smanjila izlučivanje kalija mokraćom za 15,8 mmol/24 sata u odnosu na početnu vrijednost, dok je uz placebo zabilježeno povećanje za 8,9 mmol/24 sata (p < 0,001).
English: During the correction phase, patients were randomised to receive Lokelma (1.25 g, 2.5 g, 5 g or 10 g) or placebo, administered three times daily for the initial 48 hours (Table 2).
Croatian: Tijekom korekcijske faze, bolesnici su bili randomizirani za primanje lijeka Lokelma (1,25 g, 2,5 g, 5 g ili 10 g) ili placeba, triput na dan tijekom prvih 48 sati (Tablica 2)
English: 3 sachets
Croatian: 3 vrećice
English: Correction phase (Study 4): proportion of subjects with serum potassium concentrations between 3.5 and 5.0 mmol/L, inclusive, or between 3.5 and 5.5 mmol/L, inclusive, by correction phase study dayITT population
Croatian: Tablica 4. Korekcijska faza (4. ispitivanje): udio ispitanika s koncentracijom kalija u serumu od 3,5 do 5,0 mmol/l (uključujući navedene vrijednosti) ili od 3,5 do 5,5 mmol/l (uključujući navedene vrijednosti), navedeno prema danu korekcijske faze ispitivanja - populacija predviđena za liječenje (engl. intent-to-treat, ITT)
English: Sodium zirconium cyclosilicate can transiently increase gastric pH by absorbing hydrogen ions and can lead to changes in solubility and absorption kinetics for co-administered medicinal products with pH-dependent bioavailability.
Croatian: Natrijev cirkonijev ciklosilikat može privremeno povisiti želučani pH apsorbiranjem iona vodika te može izmijeniti topljivost i apsorpcijsku kinetiku istodobno primijenjenih lijekova čija bioraspoloživost ovisi o vrijednosti pH.
English: Patients who achieved normokalaemia (potassium levels between 3.5 and 5 mmol/L) were randomised in a double-blind fashion to one of three doses of Lokelma [5 g (n=45), 10 g (n=51), or 15 g (n=56)] or placebo (n=85) administered once daily for 28 days (the double-blind randomised withdrawal phase).
Croatian: Bolesnici koji su postigli normokalijemiju (vrijednosti kalija između 3,5 i 5 mmol/l) bili su randomizirani na dvostruko slijep način za primanje jedne od triju doza lijeka Lokelma (5 g [n = 45], 10 g [n = 51], 15 g [n = 56]) ili placeba (n = 85) jedanput na dan tijekom 28 dana (dvostruko slijepa, randomizirana faza prekida primjene lijeka).
English: Figure 2: Correction and maintenance phases in 12-month open-label study (Study 4) - mean serum potassium over time with 95% CI
Croatian: Slika 2: Korekcijska faza i faza održavanja u 12-mjesečnom otvorenom ispitivanju (4. ispitivanje) - srednja vrijednost kalija u serumu tijekom vremena uz 95% CI
English: During the correction phase, 10 g of Lokelma was administered three times daily for at least 24 hours and up to 72 hours.
Croatian: Izlazak Kraj ispitivanja primjenjivala u dozi od 10 g triput na dan tijekom najmanje 24 sata, a najviše 72 sata.
English: The proportion of subjects with average serum potassium < 5.1 mmol/L from Study Day 8 to 29 (three-week period) was greater at the 5 g, 10 g and 15 g once daily doses of Lokelma (80%, 90% and 94%, respectively), compared with placebo (46%).
Croatian: Udio ispitanika s prosječnom serumskom vrijednošću kalija < 5,1 mmol/l od 8. do 29. dana ispitivanja (trotjedno razdoblje) bio je veći među bolesnicima liječenima lijekom Lokelma u dozi od 5 g, 10 g i 15 g jedanput na dan (80%, 90% odnosno 94%) u odnosu na one koji su primali placebo (46%).
English: P-value vs. placebo
Croatian: Lokelma p-vrijednost naspram placeba
English: Use of diuretics and RAAS inhibitors was reported by 51 and 70% of subjects, respectively.
Croatian: Primjenu diuretika prijavilo je 51% ispitanika, a primjenu RAAS inhibitora njih 70%.
English: There is a reduction in urinary potassium excretion which is a consequence of a reduction in serum potassium concentration.
Croatian: Izlučivanje kalija mokraćom je smanjeno, što je posljedica snižene koncentracije kalija u serumu.
English: Sodium zirconium cyclosilicate may be opaque to X-rays.
Croatian: Natrijev cirkonijev ciklosilikat može biti neproziran za rendgenske zrake.
English: Patients with pre-treatment potassium levels in excess of 5.5 mmol/L (average baseline 5.8 mmol/L) saw an average decrease of 1.1 mmol/L at 48 hours while those with starting potassium levels at or below 5.3 mmol/L had an average decrease of 0.6 mmol/L at the highest dose.
Croatian: Bolesnici kojima su vrijednosti kalija prije liječenja bile iznad 5,5 mmol/l (prosječna početna vrijednost: 5,8 mmol/l) ostvarili su prosječno smanjenje za 1,1 mmol/l nakon 48 sati, dok su oni s početnim vrijednostima kalija od 5,3 mmol/l ili manje ostvarili prosječno smanjenje za 0,6 mmol/l pri najvišoj dozi.
English: Normokalaemia was maintained while patients remained on drug and the mean serum potassium increased following discontinuation.
Croatian: Normokalijemija se održala dok su bolesnici primali lijek, a nakon prekida njegove primjene srednja se vrijednost kalija u serumu povećala.
English: Sodium zirconium cyclosilicate has also been shown to bind ammonium in vitro and in vivo, thereby removing ammonium and increasing serum bicarbonate levels.
Croatian: Pokazalo se da natrijev cirkonijev ciklosilikat vezuje amonijak in vitro i in vivo te tako uklanja amonijak i povisuje serumske razine bikarbonata.
English: Serum Potassium with 95% CI (mmol/L)
Croatian: Vrijednost kalija u serumu uz 95% CI (mmol/l)
English: Serum potassium should be checked and potassium supplemented as needed.
Croatian: Treba provjeriti serumsku razinu kalija i po potrebi nadomjestiti kalij.
English: Maintenance fixed dose (day)
Croatian: Korekcija (sat) Održavanje fiksnom dozom (dan) Održavanje titriranom dozom (dan)
English: In patients with severe hypokalaemia, Lokelma should be discontinued and the patient re-evaluated.
Croatian: Kod bolesnika s teškom hipokalijemijom potrebno je prekinuti primjenu lijeka Lokelma i ponovno ocijeniti bolesnikovo stanje.
English: One hundred and twenty-six patients had a baseline serum potassium ≥ 6.0 mmol/L (mean baseline potassium 6.28 mmol/L).
Croatian: Stotinu dvadeset i šest bolesnika imalo je početnu vrijednost kalija u serumu ≥ 6,0 mmol/l (srednja vrijednost kalija na početku ispitivanja: 6,28 mmol/l).
English: A two-phase, placebo-controlled correction and maintenance use study A two-part, double-blind, randomised, placebo-controlled clinical trial of 753 patients (mean age of 66 years, range 22 to 93 years) with hyperkalaemia (5 to ≤ 6.5 mmol/L, baseline potassium average 5.3 mmol/L), and included patients with chronic kidney disease, heart failure, diabetes mellitus and those on RAAS inhibitor therapy.
Croatian: Dvofazno placebom kontrolirano ispitivanje primjene radi korekcije i održavanja Dvostruko slijepo, randomizirano, placebom kontrolirano ispitivanje provedeno u dva razdoblja uključivalo je 753 bolesnika (srednja dob: 66 godina; raspon: 22 do 93 godine) s hiperkalijemijom (5 do ≤ 6,5 mmol/l; prosječna početna vrijednost kalija: 5,3 mmol/l), među kojima su bili bolesnici s kroničnom bubrežnom bolešću, zatajivanjem srca, šećernom bolešću te oni liječeni RAAS inhibitorima.
English: Limitations of the clinical data
Croatian: Ograničenja kliničkih podataka Bolesnici na dijalizi
English: Responses were larger in patients with more severe hyperkalaemia; serum potassium fell 0.8, 1.2 and 1.5 mmol/L in patients with baseline serum potassium < 5.5, 5.5-5.9 and ≥ 6 mmol/L, respectively.
Croatian: Odgovor na lijek bio je jači kod bolesnika s težom hiperkalijemijom; vrijednosti kalija u serumu smanjile su se za 0,8, 1,2 i 1,5 mmol/l kod bolesnika kojima je početna serumska vrijednost kalija iznosila < 5,5, od 5,5 do 5,9 odnosno ≥ 6 mmol/l.
English: EU/1/17/1173/003 3 sachets EU/1/17/1173/006 28 sachets EU/1/17/1173/004 30 sachets EU/1/17/1173/010 3 sachets EU/1/17/1173/011 28 sachets EU/1/17/1173/012 30 sachets
Croatian: EU/1/17/1173/003 3 vrećice EU/1/17/1173/006 28 vrećica EU/1/17/1173/004 30 vrećica EU/1/17/1173/010 3 vrećice EU/1/17/1173/011 28 vrećica EU/1/17/1173/012 30 vrećica
English: Effect of other medicinal products on sodium zirconium cyclosilicate As sodium zirconium cyclosilicate is not absorbed or metabolised by the body, there are no expected effects of other medicinal products on the pharmacologic action of sodium zirconium cyclosilicate.
Croatian: Budući da se natrijev cirkonijev ciklosilikat ne apsorbira i ne metabolizira u tijelu, ne očekuje se da će drugi lijekovi utjecati na farmakološku aktivnost natrijevog cirkonijevog ciklosilikata.
English: 10g Titrated dose Off treatment
Croatian: 10g Titrirana doza
English: The events were observed in the maintenance phase only and were more commonly seen in patients treated with 15 g. Up to 53% were managed by initiating a diuretic or adjusting a diuretic dose; the remainder did not require treatment.
Croatian: Kod do 53% bolesnika ti su događaji zbrinuti uvođenjem diuretika ili prilagođavanjem doze diuretika; ostalima nije bilo potrebno liječenje.
English: If severe hypokalaemia should occur, Lokelma should be discontinued and the patient re-evaluated.
Croatian: U slučaju teške hipokalijemije potrebno je prekinuti primjenu lijeka Lokelma i ponovno ocijeniti bolesnikovo stanje.
English: A study in chronic kidney disease patients with hyperkalaemia This study was a double-blind placebo-controlled dose-escalating study in 90 patients (60 Lokelma patients; 30 controls) with baseline eGFR between 30-60 ml/min/1.73m2 and hyperkalaemia (baseline serum potassium 5.2 mmol/L, range 4.6-6 mmol/L).
Croatian: Ispitivanje kod bolesnika s kroničnom bubrežnom bolešću i hiperkalijemijom Ovo je ispitivanje bilo dvostruko slijepo, placebom kontrolirano ispitivanje uz postupno povećavanje doze, provedeno kod 90 bolesnika (60 bolesnika liječenih lijekom Lokelma; 30 kontrolnih ispitanika) s početnom vrijednošću eGFR-a od 30 do 60 ml/min/1,73 m2 i hiperkalijemijom (početna serumska vrijednost kalija: 5,2 mmol/l; raspon: 4,6 - 6 mmol/l).
English: A multi-phase, placebo-controlled maintenance study with an additional open-label phase In the correction phase of the study, 258 patients with hyperkalaemia (baseline average 5.6, range 4.1 - 7.2 mmol/L) received 10 g of Lokelma administered three times daily for 48 hours.
Croatian: Višefazno placebom kontrolirano ispitivanje terapije održavanja s dodatnom otvorenom fazom U korekcijskoj fazi ispitivanja, 258 bolesnika s hiperkalijemijom (prosječna početna vrijednost: 5,6; raspon: 4,1 - 7,2 mmol/l) primalo je 10 g lijeka Lokelma triput na dan tijekom 48 sati.
English: Figure 1 illustrates the mean serum potassium over the correction and maintenance phases of the study.
Croatian: Slika 1 prikazuje srednje vrijednosti kalija u serumu tijekom korekcijske faze i faze održavanja u ispitivanju.
English: EU/1/17/1173/001 3 sachets EU/1/17/1173/005 28 sachets EU/1/17/1173/002 30 sachets EU/1/17/1173/007 3 sachets EU/1/17/1173/008 28 sachets EU/1/17/1173/009 30 sachets
Croatian: EU/1/17/1173/001 3 vrećice EU/1/17/1173/005 28 vrećica EU/1/17/1173/002 30 vrećica EU/1/17/1173/007 3 vrećice EU/1/17/1173/008 28 vrećica EU/1/17/1173/009 30 vrećica
English: Titrated dose Off treatment
Croatian: Titrirana doza Bez liječenja
English: A starting dose of 5 g once daily is recommended, with possible titration up to 10 g once daily, or down to 5 g once every other day, as needed, to maintain a normal potassium level.
Croatian: Za održavanje normalne razine kalija preporučuje se početna doza od 5 g jedanput na dan, uz moguće povećanje na 10 g jedanput na dan ili smanjenje na 5 g jedanput svaki drugi dan, prema potrebi.
English: Figure 2 illustrates the mean serum potassium over the correction and maintenance phases of the study.
Croatian: Slika 2 prikazuje srednje vrijednosti kalija u serumu tijekom korekcijske faze i faze održavanja.
English: Lokelma contains the active substance sodium zirconium cyclosilicate.
Croatian: Lokelma sadrži djelatnu tvar natrijev cirkonijev ciklosilikat.
English: Exit EOS
Croatian: Izlazak Kraj ispitivanja
English: Patients with renal/hepatic impairment No changes from the normal doses are required for patients with renal or hepatic impairment.
Croatian: Nije potrebno mijenjati uobičajenu dozu kod bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Maintenance phase (12 days, Study 1): Mean number of normokalaemic days Maintenance phase treatment (once daily)
Croatian: Tablica 3. Faza održavanja (12 dana, 1. ispitivanje): Srednja vrijednost broja dana s normokalijemijom
English: Correction and maintenance phases (Study 2): mean serum potassium over time with 95% CI
Croatian: Slika 1: Korekcijska faza i faza održavanja (2. ispitivanje): srednje vrijednosti kalija u serumu tijekom vremena uz 95% CI
English: Study 1
Croatian: 1. ispitivanje
English: CP at 72 hours/CP Last
Croatian: KF nakon 24 sata KF nakon 48 sati KF nakon 72 sata/KF nakon posljednje doze
English: Lokelma-treated patients experienced an increase of 1.1 mmol/L at 5 g once daily, 2.3 mmol/L at 10 g once daily and 2.6 mmol/L at 15 g once daily in bicarbonate compared with a mean increase of 0.6 mmol/L for those receiving placebo.
Croatian: Kod bolesnika liječenih lijekom Lokelma vrijednost bikarbonata porasla je za 1,1 mmol/l uz dozu od 5 g jedanput na dan, 2,3 mmol/l uz dozu od 10 g jedanput na dan te 2,6 mmol/l uz dozu od 15 g jedanput na dan, dok je srednja vrijednost porasta razine bikarbonata kod bolesnika koji su primali placebo iznosila 0,6 mmol/l.
English: Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension
Croatian: Lokelma 5 g prašak za oralnu suspenziju Lokelma 10 g prašak za oralnu suspenziju
English: The active substance is sodium zirconium cyclosilicate.
Croatian: Djelatna tvar je natrijev cirkonijev ciklosilikat.
English: Study 2
Croatian: 2. ispitivanje
English: No more than 10 g once daily should be used for maintenance therapy.
Croatian: Za terapiju održavanja ne smije se primjenjivati doza veća od 10 g jedanput na dan.
English: Baseline serum potassium, mmol/L 5.3 Normokalaemic at 48 hours, % 48 p-value vs. placebo
Croatian: Normokalijemija nakon 48 sati, % 48 p-vrijednost naspram placeba
English: These subjects had a mean reduction of 1.37 mmol/L at the end of the correction phase.
Croatian: Kod tih je ispitanika na kraju korekcijske faze zabilježena srednja vrijednost smanjenja za 1,37 mmol/l.
English: How to take Lokelma
Croatian: Kako uzimati lijek Lokelma
English: There was a mean decrease in serum potassium of 0.77 mmol/L, 1.10 mmol/L, 1.19 mmol/L and 0.44 mmol/L, respectively, and the proportion of subjects who remained normokalaemic was 71%, 76%, 85% and 48% in the 5 g, 10 g, 15 g once daily doses of Lokelma and placebo groups, respectively.
Croatian: Srednje vrijednosti sniženja serumske razine kalija uz doze lijeka Lokelma od 5 g, 10 g i 15 g jedanput na dan odnosno uz placebo iznosile su 0,77 mmol/l, 1,10 mmol/l, 1,19 mmol/l odnosno 0,44 mmol/l, dok je udio bolesnika u kojih je održana normokalijemija iznosio 71%, 76%, 85% odnosno 48%.
English: Study 4
Croatian: 4. ispitivanje
English: NS
Croatian: A.
English: Serum potassium 3.5 to 5.0 mmol/L, inclusive
Croatian: Kalij u serumu 3,5 - 5,0 mmol/l (uključujući navedene vrijednosti)
English: A two-phase, multicenter, multi-dose, open-label safety and efficacy study The long term (up to 12 months) effects of Lokelma were assessed in this study in 751 subjects with hyperkalaemia (baseline average 5.59 mmol/L; range 4.3-7.6 mmol/L).
Croatian: U ovom su se ispitivanju ocjenjivali dugoročni (do 12 mjeseci) učinci lijeka Lokelma kod 751 ispitanika s hiperkalijemijom (prosječna početna vrijednost kalija u serumu: 5,59 mmol/l; raspon: 4,3 - 7,6 mmol/l).
English: How to store Lokelma
Croatian: Kako čuvati lijek Lokelma
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Study 3
Croatian: 3. ispitivanje
English: Each sachet contains 5 g of sodium zirconium cyclosilicate.
Croatian: Jedna vrećica sadrži 5 g natrijevog cirkonijevog ciklosilikata.
English: Each sachet contains 10 g of sodium zirconium cyclosilicate.
Croatian: Jedna vrećica sadrži 10 g natrijevog cirkonijevog ciklosilikata.
English: Lokelma 10 g powder for oral suspension Each sachet contains 10 g of powder.
Croatian: Lokelma 10 g prašak za oralnu suspenziju Jedna vrećica sadrži 10 grama praška.
English: Lokelma 5 g powder for oral suspension Each sachet contains 5 g of powder.
Croatian: Lokelma 5 g prašak za oralnu suspenziju Jedna vrećica sadrži 5 grama praška.
English: Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Croatian: Lokelma 5 g prašak za oralnu suspenziju Lokelma 10 g prašak za oralnu suspenziju natrijev cirkonijev ciklosilikat
English: What Lokelma looks like and contents of the pack The powder for oral suspension is a white, free flowing powder, essentially free of debris and particulates.
Croatian: Prašak za oralnu suspenziju je bijeli, sipki prašak praktički bez fragmenata i čestica, koji dolazi u vrećici.
English: Correction phase Lokelma dose N Days n
Croatian: Doza lijeka Lokelma u korekcijskoj fazi
English: Days
Croatian: Dani
English: Sodium zirconium cyclosilicate can be co-administered without spacing of dosing times with oral medications that do not exhibit pH-dependent bioavailability.
Croatian: Nije potreban razmak između primjene doza natrijevog cirkonijevog ciklosilikata i oralnih lijekova čija bioraspoloživost ne ovisi o pH-vrijednosti.
English: Serum potassium 3.5 to 5.5 mmol/L, inclusive n/N Proportion 95% CI
Croatian: Kalij u serumu 3,5 - 5,5 mmol/l (uključujući navedene vrijednosti)
English: Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Croatian: Lokelma 10 g prašak za oralnu suspenziju natrijev cirkonijev ciklosilikat
English: Lokelma 5 g powder for oral suspension sodium zirconium cyclosilicate
Croatian: Lokelma 5 g prašak za oralnu suspenziju natrijev cirkonijev ciklosilikat
English: Lokelma 5 g powder for oral suspension Each sachet contains 5 g of sodium zirconium cyclosilicate.
Croatian: Lokelma 5 g prašak za oralnu suspenziju Jedna vrećica sadrži 5 g natrijevog cirkonijevog ciklosilikata.
English: Lokelma 10 g powder for oral suspension Each sachet contains 10 g of sodium zirconium cyclosilicate.
Croatian: Lokelma 10 g prašak za oralnu suspenziju Jedna vrećica sadrži 10 g natrijevog cirkonijevog ciklosilikata.
English: Serum potassium levels
Croatian: Razine kalija u serumu
English: Do not take Lokelma • If you are allergic to the active substance.
Croatian: • Ako ste alergični na djelatnu tvar
English: • The products can continue to be used as recommended.
Croatian: • Lijekovi se i dalje smiju koristiti u skladu s preporukama.
English: The marketing authorisation holder for both medicines is the same company, Bayer Pharma AG.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet za oba lijeka je ista tvrtka, Bayer Pharma AG.
English: Benefits continue to outweigh risks in previously untreated patients
Croatian: Koristi i dalje nadmašuju rizike u prethodno neliječenih bolesnika
English: 20 February 2014 EMA/108793/20144
Croatian: EMA/108793/2014
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all products.
Croatian: U ovom ispitivanju, incidencija razvoja inhibitora kretala se u rasponu od 28,2% do 37,7% za sve proizvode.
English: The octocog alfa in these products has the same structure as natural factor VIII (‘full-length').
Croatian: Oktokog alfa u ovih lijekova ima istu strukturu kao prirodni faktor VIII („pune dužine”).
English: Alternative products containing various forms of factor VIII are available and may be used similarly.
Croatian: Alternativni proizvodi koji sadrže različite oblike faktora VIII dostupni su i mogu se koristiti na sličan način.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Croatian: Preporuke PRAC-a dostavljene su Povjerenstvu za lijekove za primjenu kod ljudi (CHMP), koje je odgovorno za sva pitanja u vezi s lijekovima za ljudsku primjenu, koji su usvojeni u završnom mišljenju Agencije.
English: The CHMP considered the PRAC recommendations and agreed by consensus that they should be implemented.
Croatian: CHMP je razmotrio preporuke PRAC-a te je suglasan konsenzusom da preporuke treba primijeniti.
English: • However, when all the evidence was assessed, including that from this study, there was not enough to support a genuine difference between the products.
Croatian: • No, nakon ocijene svih dokaza, uključujući dokaza prikupljenih ovim ispitivanjem, utvrđeno je da nema dovoljno dokaza koji bi potvrdili stvarnu razliku između lijekova.
English: The frequency of inhibitor development in previously untreated patients has been amended in line with the current evidence to ‘very common'.
Croatian: Učestalost razvoja inhibitora u prethodno neliječenih bolesnika izmijenjena je u skladu s aktualnim dokazima na „vrlo često”.
English: In patients given Kogenate Bayer/Helixate NexGen, the incidence of inhibitor development was 64/183 (37.7%) when followed for up to 75 exposure days, of whom 40 had a high-titre inhibitor (25.2%).
Croatian: U bolesnika koji su primili Kogenate Bayer/Helixate NexGen, incidencija razvoja inhibitora iznosila je 64/183 (37.7%), u slučaju kada se pratilo do 75 dana izlaganja, od kojih je 40 imalo inhibitore velikog titara (25.2%).