FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with parathyroid carcinoma, mean serum calcium declined from 14.1 mg/dL to 12.4 mg/dL (3.5 mmol/L to 3.1 mmol/L), while in patients with primary HPT, serum calcium levels declined from 12.7 mg/dL to 10.4 mg/dL (3.2 mmol/L to 2.6 mmol/L).
Croatian: U bolesnika s karcinomom paratireoidnih žlijezda srednja vrijednost serumskog kalcija smanjila se sa 14,1 mg/dl na 12,4 mg/dl (3,5 mmol/l na 3,1 mmol/l), a u bolesnika s primarnim HPT-om vrijednost serumskog kalcija smanjila se s 12,7 mg/dl na 10,4 mg/dl (3,2 mmol/l na 2,6 mmol/l).
English: • Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blue (E132), iron oxide yellow (E172))
Croatian: • Opadry green (sadrži laktozu hidrat, hipromelozu, titanijev dioksid (E171), gliceroltriacetat, FD&C Blue (E132), željezov oksid, žuti (E172))
English: Capsule Printing ink: iron oxide black, shellac, propylene glycol
Croatian: Kapsula tinta za označavanje: željezov oksid, crni, šelak, propilenglikol
English: • Iron oxide yellow (E172) (1 mg and 2.5 mg capsules)
Croatian: • željezov oksid, žuti (E172) (1 mg i 2,5 mg kapsule)
English: 60 mg tablets are approximately 12.2 mm long and 7.6 mm wide.
Croatian: 60 mg tablete su otprilike 12,2 mm duge i 7,6 mm široke.
English: Each bottle contains 30 tablets.
Croatian: Svaka boca sadrži 30 tableta.
English: ≥ 36 to < 50
Croatian: ≥ 36 do < 50
English: Serum calcium levels in paediatric patients should be maintained within the normal range.
Croatian: Vrijednost serumskog kalcija u pedijatrijskih bolesnika potrebno je održavati unutar raspona referentnih vrijednosti.
English: • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Croatian: • oticanje lica, usnica, usta, jezika ili grla, što može uzrokovati teškoće s gutanjem ili disanjem
English: The percentage of patients who achieved the primary endpoint (≥ 30% reduction from baseline in mean plasma iPTH during the EAP; weeks 25 to 30) was 55% in the cinacalcet group and 19.0% in the placebo group (p = 0.02).
Croatian: Postotak bolesnika koji su postigli primarnu mjeru ishoda (smanjenje srednje vrijednosti iPTH-a u plazmi od ≥ 30 % u udnosu na početnu tijekom faze ocjene djelotovrnosti; 25. do 30. tjedan) iznosio je 55 % u skupini koja je primala cinakalcet i 19,0 % u skupini koja je primala placebo (p = 0,02).
English: High Density Polyethylene (HDPE) bottle with a cotton coil, and a child-resistant polypropylene cap with an induction seal, packed into a carton.
Croatian: Boca od polietilena visoke gustoće (HDPE) s pamučnom vatom, i polipropilenskim sigurnosnim zatvaračem za djecu, sa zaštitnom folijom, pakirana u kutiju.
English: • parathyroid carcinoma.
Croatian: • karcinomom paratireoidnih žlijezda.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER
English: Because doses are titrated for each subject based on safety and efficacy parameters, no additional dose adjustment is necessary for subjects with hepatic impairment (see sections 4.2 and 4.4).
Croatian: Kako se doza titrira za svakog pojedinca na osnovi sigurnosnog profila i djelotvornosti, nije potrebno dodatno prilagođavanje doze u osoba s oštećenjem funckije jetre (vidjeti dijelove 4.2 i 4.4).
English: Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Croatian: Liječenje sekundarnog hiperparatireoidizma (HPT) u odraslih bolesnika sa završnim stadijem bolesti bubrega na terapiji održavanja dijalizom.
English: Corrected serum calcium is at or below age-specified lower limit of normal or if symptoms of hypocalcaemia occur, regardless of calcium level.
Croatian: Korigirana vrijednost serumskog kalcija je u razini ili ispod donje granice referentnih vrijednosti specifičnih za dob ili ako nastupe simptomi hipokalcemije, neovisno o vrijednosti kalcija.
English: Administration of Mimpara with food results in an approximate 50-80% increase in cinacalcet bioavailability.
Croatian: Uzimanje lijeka Mimpara s hranom povećava bioraspoloživost cinakalceta za oko 50 do 80 %.
English: * Administer calcium supplements, calcium-containing phosphate binders and/or vitamin D sterols, as clinically indicated.
Croatian: Prekinite liječenje lijekom Mimpara.* Primijenite nadomjestke kalcija, vezače fosfata koji sadrže kalcij i/ili sterole vitamina D, kako je klinički indicirano.
English: Each 30 mg tablet contains 2.74 mg of lactose.
Croatian: Jedna tableta od 30 mg sadrži 2,74 mg laktoze.
English: The mean serum calcium levels during the EAP were within the normal range for the cinacalcet treatment group.
Croatian: Srednja vrijednost razina serumskog kalcija tijekom faze ocjene djelotvornosti bila je unutar referentnih vrijednosti za skupinu liječenu cinakalcetom.
English: Dose adjustments of concomitant medicinal products may be required when Mimpara is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e.g. flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine).
Croatian: Možda će biti potrebna prilagodba doze konkominantnih lijekova kada se lijek Mimpara primjenjuje s lijekovima koji se individualno titriraju, imaju uski terapijski raspon i pretežno se metaboliziraju enzimom CYP2D6 (npr. flekainid, propafenon, metoprolol, desipramin, nortriptilin, klomipramin).
English: Mimpara is available in bottles of 1 mg, 2.5 mg or 5 mg capsules, inside a carton.
Croatian: Mimpara je dostupna u bocama s kapsulama od 1 mg, 2,5 mg ili 5 mg, u kutiji.
English: • Hold the capsule upright over the soft food or liquid.
Croatian: • Držite kapsulu uspravno iznad mekane hrane ii tekućine.
English: Mimpara granules can be administered orally or through nasogastric or gastrostomy tubes.
Croatian: Mimpara granule se mogu primijeniti kroz usta ili nazogastričnu sondu ili gastrostomu.
English: Paediatric population: The pharmacokinetics of cinacalcet was studied in paediatric patients with ESRD receiving dialysis aged 3 to 17 years of age.
Croatian: Pedijatrijska populacija: Farmakokinetika cinakalceta ispitana je u pedijatrijskih bolesnika sa završnim stadijem bolesti bubrega u dobi od 3 do 17 godina.
English: • muscle pain (myalgia)
Croatian: • mišićna bol (mijalgija)
English: Once the maintenance dose has been established, weekly measurement of serum calcium is recommended.
Croatian: Kada je postignuta doza održavanja, preporučuje se tjedno kontrolirati vrijednost serumskog kalcija.
English: • to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with primary hyperparathyroidism when removal of the gland is not possible.
Croatian: • da bi se smanjila visoka razina kalcija u krvi (hiperkalcemija) u odraslih bolesnika s primarnim hiperparatireoidizmom kod kojih odstranjenje žlijezde nije moguće.
English: Study 2 was an open-label study in which 55 patients aged 6 to < 18 years (mean 13 years) were randomised to receive either cinacalcet in addition to standard of care (SOC, n = 27) or SOC alone (n = 28).
Croatian: Ispitivanje 2 bilo je otvoreno ispitivanje s 55 bolesnika u dobi od 6 do < 18 godina (srednja dob 13 godina) randomiziranih u skupinu koja je primala cinakalcet uz standardno liječenje (n = 27) ili samo standardno liječenje (n = 28).
English: LIST OF EXCIPIENTS Lactose monohydrate.
Croatian: POPIS POMOĆNIH TVARI Laktoza hidrat.
English: Dizziness and seizures have been reported by patients taking Mimpara.
Croatian: Omaglica i napadaji prijavljeni su od bolesnika liječenih lijekom Mimpara.
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Croatian: OBLIK I SADRŽAJ 30 tableta.
English: Switch from etelcalcetide to Mimpara
Croatian: Prelazak s etelkalcetida na lijek Mimpara
English: • Gelatin
Croatian: • želatina
English: Withhold administration of Mimpara until serum calcium levels reach 8.0 mg/dL (2.0 mmol/L) and/or symptoms of hypocalcaemia have resolved.
Croatian: Privremeno prekinite primjenu lijeka Mimpara sve dok vrijednosti serumskog kalcija ne dosegnu 8,0 mg/dl (2,0 mmol/l) i/ili se simptomi hipokalcemije ne povuku.
English: • to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products, whose condition is not controlled with other treatments.
Croatian: • za liječenje sekundarnog hiperparatireoidizma u bolesnika s ozbiljnom bubrežnom bolesti koji trebaju dijalizu da bi se krv očistila od štetnih produkata, u kojih se bolest ne kontrolira drugim terapijama.
English: Patients should drink fluids after oral administration to make sure all of the mixture is swallowed.
Croatian: Bolesnici nakon primjene kroz usta trebaju popiti tekućinu kako bi se osiguralo da je lijek progutan u cijelosti.
English: Dextromethorphan: Multiple doses of 50 mg cinacalcet increased the AUC of 30 mg dextromethorphan (metabolised primarily by CYP2D6) by 11-fold in CYP2D6 extensive metabolisers.
Croatian: Dekstrometorfan: Višekratne doze od 50 mg cinakalceta povećavale AUC 30 mg dekstrometorfana (pretežno se metabolizira enzimom CYP2D6) za 11 puta u brzih CYP2D6 metabolizatora.
English: Pantoprazole: Co-administration of pantoprazole (80 mg od) did not alter the pharmacokinetics of cinacalcet.
Croatian: Pantoprazol: Istodobna primjena pantoprazola (80 mg dnevno) nije promijenila farmakokinetiku cinakalceta.
English: ≥ 50 to < 75
Croatian: ≥ 50 do < 75
English: Since cinacalcet lowers serum calcium, patients should be monitored carefully for the occurrence of hypocalcaemia (see section 4.2).
Croatian: Kako cinakalcet smanjuje serumski kalcij, treba pomno pratiti bolesnike zbog moguće hipokalcemije (vidjeti dio 4.2).
English: “Primary” means that the hyperparathyroidism is not caused by any other condition and “secondary” means that the hyperparathyroidism is caused by another condition, e.g. kidney disease.
Croatian: U primarnom i sekundarnom hiperparatireoidizmu paratireoidne žlijezde proizvode previše PTH-a. „Primarni“ znači da hiperparatireoidizam nije posljedica nekog drugog poremećaja, a „sekundarni“ da je hiperparatireoidizam uzrokovan drugim poremećajem, npr. bolesti bubrega.
English: 5, 10, 15, 30, 60, and 90
Croatian: 5, 10, 15, 30, 60 i 90
English: • Printing ink: iron oxide black, shellac, propylene glycol
Croatian: • tinta za označavanje: željezov oksid, crni, šelak, propilenglikol
English: 5, 10, 15, 30, and 60
Croatian: 5, 10, 15, 30 i 60
English: ≥ 25 to < 36
Croatian: ≥ 25 do < 36
English: INFORMATION IN BRAILLE mimpara 2.5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mimpara 2,5 mg
English: Investigational studies in patients with CKD and secondary HPT not undergoing dialysis indicated that cinacalcet reduced PTH levels to a similar extent as in patients with ESRD and secondary HPT receiving dialysis.
Croatian: Ispitivanja bolesnika s kroničnom bolesti bubrega i sekundarnim hiperparatiroidizmom koji nisu na dijalizi, pokazala su da cinakalcet smanjuje vrijednosti PTH-a do sličnih granica kao i u bolesnika s završnim stadijem bolesti bubrega i sekundarnim hiperparatireoidizmom koji su na dijalizi.
English: In a 28 week placebo-controlled study, 67 adult patients with primary HPT who met criteria for parathyroidectomy on the basis of corrected total serum calcium (> 11.3 mg/dL (2.82 mmol/L) but ≤ 12.5 mg/dL (3.12 mmol/L), but who were unable to undergo parathyroidectomy were included.
Croatian: U placebom kontrolirano ispitivanje, trajanja 28 tjedana, bilo je uključeno 67 odraslih bolesnika s primarnim hiperparatireoidizmom koji su ispunjavali uvjete za paratireoidektomiju na temelju korigiranog ukupnog kalcija u serumu (> 11,3 mg/dl (2,82 mmol/l) ali ≤ 12,5 mg/dl (3,12 mmol/l), ali koji nisu mogli biti podvrgnuti paratireoidektomiji.
English: INFORMATION IN BRAILLE mimpara 1 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mimpara 1 mg
English: PTH levels should be assessed at least 12 hours after dosing with Mimpara and iPTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
Croatian: Vrijednosti PTH-a treba odrediti najmanje 12 sati nakon uzimanja lijeka Mimpara, a iPTH treba izmjeriti 1 do 4 tjedna nakon započete terapije ili prilagodbe doze lijeka Mimpara.
English: Hepatic Insufficiency: Mild hepatic impairment did not notably affect the pharmacokinetics of cinacalcet.
Croatian: Jetrena insuficijencija: Blago oštećenje funkcija jetre ne utječe značajno na farmakokinetiku cinakalceta.
English: Investigational studies have shown that adult CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum calcium levels < 8.4 mg/dL [2.1 mmol/L]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Croatian: Ispitivanja su pokazala da odrasli bolesnici s kroničnom bolesti bubrega koji nisu na dijalizi, a liječeni su cinakalcetom, imaju povećan rizik za hipokalcemiju (vrijednost serumskog kalcija < 8,4 mg/dl [2,1 mmol/l]) u usporedbi sa cinakalcetom liječenim bolesnicima s kroničnom bolesti bubrega koji su na dijalizi, što može biti posljedica manje početne vrijednosti kalcija i/ili postojeće ostatne funkcije bubrega.
English: The study did not meet its primary endpoint (≥ 30% reduction from baseline in mean plasma iPTH during the EAP; weeks 17 to 20).
Croatian: Ispitivanje nije postiglo primarnu mjeru ishoda (smanjenje srednje vrijednosti iPTH-a u plazmi od ≥ 30 % u odnosu na početnu tijekom faze ocjene djelotvornosti; 17. do 20. tjedan).
English: Corrected serum calcium should be in the upper range of, or above, the age-specified reference interval prior to administration of first dose of Mimpara, and closely monitored (see section 4.4).
Croatian: Korigirana vrijednost serumskog kalcija treba biti u gornjem rasponu ili iznad referentnog intervala specifičnog za dob prije primjene prve doze lijeka Mimpara, i treba se pomno pratiti (vidjeti dio 4.4).
English: Mimpara is available in bottles of 30 mg, 60 mg or 90 mg film-coated tablets, inside a carton.
Croatian: Mimpara je dostupna u bocama od 30 mg, 60 mg ili 90 mg filmom obloženim tabletama, u kutiji.
English: Mimpara should be used with caution in patients with moderate to severe hepatic impairment and treatment should be closely monitored during dose titration and continued treatment (see sections 4.4 and 5.2).
Croatian: Potreban je oprez kod primjene lijeka Mimpara u bolesnika s umjerenim do teškim oštećenjem funkcije jetre te je potrebno pomno praćenje tijekom titracije doze i nastavka liječenja (vidjeti dijelove 4.4 i 5.2).
English: ATC code: H05BX01.
Croatian: Farmakoterapijska skupina: Pripravci s utjecajem na mijenu kalcija, antiparatireoidne tvari, ATK oznaka: H05BX01.
English: • to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with parathyroid cancer.
Croatian: • da bi se smanjila visoka razina kalcija u krvi (hiperkalcemija) u odraslih bolesnika s rakom paratireoidnih žlijezda.
English: • Pre-gelatinised maize starch
Croatian: • kukuruzni škrob prethodno geliran
English: • If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures.
Croatian: • Ako osjetite utrnulost ili trnce oko usta, bolove u mišićima ili grčeve i napadaje.
English: The efficacy and safety of cinacalcet for the treatment of secondary HPT in paediatric patients with ESRD receiving dialysis was evaluated in two randomised controlled studies and one single-arm study.
Croatian: Djelotvornost i sigurnost cinakalceta za liječenje sekundarnog HPT-a u pedijatrijskih bolesnika sa završnim stadijem bolesti bubrega koji primaju dijalizu ocjenjivana je u dva randomizirana kontrolirana ispitivanja i jednom ispitivanju na jednoj skupini.
English: Mean baseline iPTH concentrations across the 3 studies were 733 and 683 pg/mL (77.8 and 72.4 pmol/L) for the cinacalcet and placebo groups, respectively.
Croatian: Srednja početna vrijednost iPTH-a u tri ispitivanja bila je 733 pg/ml i 683 pg/ml (77,8 i 72,4 pmol/l) za cinakalcet i placebo skupinu.
English: The recommended starting dose of Mimpara for adults is 30 mg twice per day.
Croatian: Preporučena početna doza lijeka Mimpara za odrasle je 30 mg dva puta dnevno.
English: There have been reports of idiosyncratic cases of hypotension and/or worsening heart failure in cinacalcet-treated patients with impaired cardiac function in post-marketing safety surveillance, the frequencies of which cannot be estimated from available data.
Croatian: Tijekom praćenja sigurnosti lijeka nakon stavljanja u promet zabilježeni su idiosinkrazijski slučajevi hipotenzije i/ili pogoršanja zatajenja srca u bolesnika liječenih cinakalcetom s oštećenom srčanom funkcijom, čija se učestalost ne može procijeniti iz dostupnih podataka.
English: • to treat secondary hyperparathyroidism in adults with serious kidney disease who need dialysis to clear their blood of waste products.
Croatian: • za liječenje sekundarnog hiperparatireoidizma u odraslih s ozbiljnom bubrežnom bolesti koji trebaju dijalizu da bi se krv očistila od štetnih produkata.
English: The majority of patients (75%) were using vitamin D sterols at baseline.
Croatian: Većina bolesnika (75 %) je koristila sterole vitamina
English: Administration using nasogastric or gastrostomy tubes
Croatian: Primjena kroz nazogastričnu sondu ili gastrostomu
English: Mimpara must be taken orally, with or shortly after food.
Croatian: Mimpara se mora uzeti kroz usta, s jelom ili neposredno nakon obroka.
English: Children who require doses of 30 mg or more and who are able to swallow tablets may receive appropriate doses of Mimpara tablets.
Croatian: Kod djece koja trebaju primijeniti doze od 30 mg ili više i koja mogu progutati tablete, mogu se primijeniti odgovarajuće doze Mimpara tableta.
English: Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: MedDRA system organ class
Croatian: Incidencija nuspojava u kontroliranim kliničkim ispitivanjima i nakon stavljanja lijeka u promet je sljedeća:
English: • Unusually fast or pounding heart beat which may be associated with low levels of calcium in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).
Croatian: • neobično ubrzano ili jako lupanje srca, koje može biti povezano s niskim razinama kalcija u krvi
English: In one study, 46 adult patients (29 with parathyroid carcinoma and 17 with primary HPT and severe hypercalcaemia who had failed or had contraindications to parathyroidectomy) received cinacalcet for up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for patients with primary HPT).
Croatian: U jednom ispitivanja 46 bolesnika (29 s karcinomom paratireoidnih žlijezda i 17 s primarnim hiperparatireoidizmom i teškom hiperkalcemijom kod kojih paratireoidektomija nije uspjela ili je bila kontraindicirana) liječeno je cinakalcetom do tri godine (prosječno 328 dana bolesnici s karcinomom paratireoidnih žlijezda i prosječno 347 dana bolesnici s primarnim HPTom).
English: These studies show that CKD patients not undergoing dialysis treated with cinacalcet have an increased risk for hypocalcaemia compared with cinacalcet-treated ESRD patients receiving dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Croatian: Ova ispitivanja su pokazala da kod bolesnika s kroničnom bolesti bubrega koji nisu na dijalizi, a liječeni su cinakalcetom, postoji povećan rizik hipokalcemije, u usporedbi s bolesnicima sa završnim stadijem bolesti bubrega liječenih cinakalcetom koji su na dijalizi, što može biti zbog niže početne vrijednosti kalcija i/ili postojeće ostatne bubrežne funkcije.
English: What Mimpara looks like and contents of the pack Mimpara granules are white to off-white in appearance and are presented in capsules for opening.
Croatian: Mimpara granule su bijelog do bjelkastog izgleda sadržane u kapsulama za otvaranje.
English: • Microcrystalline cellulose
Croatian: • mikrokristalična celuloza
English: Parathyroid carcinoma and primary hyperparathyroidism in adults
Croatian: Karcinom paratireoidnih žlijezda i primarni hiperparatireoidizam u odraslih
English: Sevelamer: Co-administration of sevelamer (2,400 mg tid) did not affect the pharmacokinetics of cinacalcet.
Croatian: Sevelamer: Istodobna primjena sevelamera (2400 mg tri puta dnevno) nije promijenila farmakokinetiku cinakalceta.
English: The safety of Mimpara for the treatment of secondary HPT in paediatric patients with ESRD receiving dialysis was evaluated in two randomised controlled studies and one single-arm study (see section 5.1).
Croatian: Sigurnost lijeka Mimpara za liječenje sekundarnog HPT-a u pedijatrijskih bolesnika sa završnim stadijem bolesti bubrega koji primaju dijalizu ocjenjivana je u dva randomizirana kontrolirana ispitivanja i jednom ispitivanju na jednoj skupini (vidjeti dio 5.1).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1 mg, 2.5 mg or 5 mg cinacalcet (as hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 1 mg, 2,5 mg ili 5 mg cinakalceta (u obliku cinakalcetklorida).
English: During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Mimpara.
Croatian: Tijekom titriranja doze, vrijednost serumskog kalcija treba se često kontrolirati, unutar tjedan dana od započete terapije ili prilagodbe doze lijeka Mimpara.
English: None had corrected serum calcium < 8.4 mg/dL (2.1 mmol/L) for ages 2-5 years.
Croatian: Nijedan bolesnik u dobi od 2-5 godina nije imao korigiranu vrijednost serumskog kalcija < 8,4 mg/dl (2,1 mmol/l).
English: Pre-gelatinised starch (maize) Microcrystalline cellulose Povidone
Croatian: Granule škrob, prethodno geliran (kukuruzni) mikrokristalična celuloza povidon krospovidon amorfni silicijev dioksid
English: Mimpara 30 mg film-coated tablets Mimpara 60 mg film-coated tablets Mimpara 90 mg film-coated tablets
Croatian: Mimpara 30 mg filmom obložene tablete Mimpara 60 mg filmom obložene tablete Mimpara 90 mg filmom obložene tablete
English: Light green, oval (approximately 13.9 mm long and 8.7 mm wide), film-coated tablet marked “AMG” on one side and “90” on the other.
Croatian: Svijetlozelene, ovalne (otprilike 13,9 mm duge i 8,7 mm široke), filmom obložene tablete s oznakom „AMG“ na jednoj i „90“ na drugoj strani.
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava često*
English: The mean (SD) corrected total serum calcium concentrations at baseline were 9.9 (0.5) mg/dL for the cinacalcet group and 9.9 (0.6) mg/dL for the placebo group.
Croatian: Srednja vrijednost (SD) korigiranih koncentracija ukupnog serumskog kalcija na početku ispitivanja bila je 9,9 (0,5) mg/dl u skupini koja je primala cinakalcet i 9,9 (0,6) mg/dl u skupini koja je primala placebo.
English: b) Tabulated list of adverse reactions
Croatian: b) Tablični prikaz nuspojava
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 30 mg, 60 mg ili 90 mg cinakalceta (u obliku cinakalcetklorida).
English: Dosing recommendations
Croatian: Preporuke doziranja
English: Capsule consists of a dark green colour cap, marked “AMG” and white opaque body, marked “1 mg”.
Croatian: Kapsula se sastoji od tamnozelene kapice s oznakom „AMG“ i bijelog neprozirnog tijela s oznakom „1 mg“.
English: Opadry II green: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate,
Croatian: Opadry II green: (laktoza hidrat, hipromeloza, titanijev dioksid (E171), gliceroltriacetat, FD&C Blue
English: The mean (SD) iPTH concentrations at baseline were 757.1 (440.1) pg/mL for the cinacalcet group and 795.8 (537.9) pg/mL for the placebo group.
Croatian: Srednja vrijednost (SD) koncentracija iPTH-a na početku ispitivanja bila je 757,1 (440,1) pg/ml u skupinl koja je primala cinakalcet i 795,8 (537,9) pg/ml u skupini koja je primala placebo.