FrancophonIA/ELRC3.0 huggingface dataset:
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 sinakalcet, odnosno placebo skupinu.
English: Reductions in PTH were associated with non-significant reductions of bone metabolism markers (bone specific alkaline phosphatase, N-telopeptide, bone turnover and bone fibrosis).
Croatian: Sniženje PTH-a bilo je povezano sa statistički neznačajnim sniženjem biljega koštanog metabolizma (koštane alkalne fosfataze, N-telopeptida, koštane pregradnje i koštane fibroze).
English: Either the intact PTH (iPTH) or biointact PTH (biPTH) may be used to measure PTH levels; treatment with cinacalcet does not alter the relationship between iPTH and biPTH.
Croatian: Za određivanje vrijednosti PTH-a, treba odrediti ili intaktni PTH (iPTH) ili biointaktni PTH (biPTH); liječenje sinakalcetom ne mijenja odnos između iPTH-a i biPTH-a.
English: Cinacalcet Mylan may affect how medicines such as the following work:
Croatian: Cinacalcet Mylan može utjecati na djelovanje sljedećih lijekova:
English: Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia secondary to hypocalcaemia.
Croatian: Sniženje vrijednosti serumskog kalcija također može produljiti QT interval i dovesti do ventrikularne aritmije uzrokovane hipokalcemijom.
English: Patients receiving cinacalcet should not be given etelcalcetide.
Croatian: Bolesnicima koji primaju cinakalcet ne smije se dati etelkalcetid.
English: In Chronic Kidney Disease (CKD) patients receiving dialysis who were administered cinacalcet, approximately 30% of patients had at least one serum calcium value less than 7.5 mg/dl (1.9 mmol/l).
Croatian: U bolesnika s kroničnom bolesti bubrega na dijalizi koji su liječeni sinakalcetom, otprilike 30 % bolesnika imalo je najmanje jednu vrijednost serumskog kalcija manju od 7,5 mg/dl (1,9 mmol/l).
English: A fatal outcome was reported in a paediatric clinical trial patient with severe hypocalcaemia (see section 4.4).
Croatian: Smrtni ishod bio je zabilježen u kliničkom ispitivanju u jednog pedijatrijskog bolesnika s teškom hipokalcemijom (vidjeti dio 4.4).
English: Therefore, serum calcium levels should be closely monitored in patients receiving cinacalcet, particularly in patients with a history of a seizure disorder.
Croatian: Stoga je potrebno pomno praćenje vrijednosti serumskog kalcija u bolesnika koji se liječe cinakalcetom, osobito u bolesnika s napadajima u anamnezi.
English: Cinacalcet is a calcimimetic agent which directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium.
Croatian: Sinakalcet je kalcimimetik koji direktno smanjuje vrijednost PTH-a, povećavajući osjetljivost receptora za izvanstanični kalcij.
English: Cataracts are known to occur in rodents as a result of hypocalcaemia.
Croatian: Poznato je kako se katarakta javlja u glodavaca kao rezultat hipokalcemije.
English: In vitro data indicate that cinacalcet is in part metabolised by CYP1A2.
Croatian: In vitro rezultati pokazuju da se sinakalcet djelomično metabolizira pomoću CYP1A2.
English: What Cinacalcet Mylan contains
Croatian: Što Cinacalcet Mylan sadrži
English: Incidence of adverse reactions from controlled clinical studies and post-marketing experience are:
Croatian: Incidencija nuspojava u kontroliranim kliničkim ispitivanjima i nakon stavljanja lijeka u promet je sljedeća:
English: • medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine)
Croatian: • lijekova za liječenje depresije (amitriptilin, desipramin, nortriptilin i klomipramin);
English: Dose adjustments of concomitant medicinal products may be required when cinacalcet 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 konkomitantnih lijekova kada se sinakalcet 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: • reduced testosterone levels
Croatian: • snižene razine testosterona
English: Desipramine: Concurrent administration of 90 mg cinacalcet once daily with 50 mg desipramine, a tricyclic antidepressant metabolised primarily by CYP2D6, significantly increased desipramine exposure 3.6-fold (90% CI 3.0, 4.4) in CYP2D6 extensive metabolisers.
Croatian: Desipramin: Istodobna primjena 90 mg cinakalceta jednom dnevno s 50 mg desipramina, tricikličkog antidepresiva koji se metabolizira prvenstveno putem CYP2D6, značajno je povećala izloženost desipiraminu 3,6 puta (90 % CI 3,0, 4,4) u brzih CYP2D6 metabolizatora.
English: Significant reductions in iPTH, serum calcium-phosphorus product (Ca x P), calcium, and phosphorus were observed in the cinacalcet treated patients compared with placebo-treated patients receiving standard care, and the results were consistent across the 3 studies.
Croatian: Značajno smanjenje iPTH-a, umnoška serumskog kalcija i fosfora (Ca x P) te kalcija i fosfora, primijećena je u grupi liječenih sinakalcetom, u usporedbi s placebo grupom koja je liječena standardnim načinom i rezultati su bili konzistentni u sva tri ispitivanja.
English: ≤ 7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia and vitamin D cannot be increased
Croatian: ≤ 7,5 mg/dl (1,9 mmol/l) ili perzistirajući simptomi hipokalcemije i vitamin D se ne može povisiti
English: There are no clinical data from the use of cinacalcet in pregnant women.
Croatian: Nema kliničkih podataka o primjeni cinakalceta u trudnica.
English: • medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole)
Croatian: • lijekovi za liječenje kože i gljivičnih infekcija (ketokonazol, itrakonazol i vorikonazol)
English: QT prolongation and ventricular arrhythmia secondary to hypocalcaemia QT prolongation and ventricular arrhythmia secondary to hypocalcaemia have been identified during post-marketing use of cinacalcet, the frequencies of which cannot be estimated from available data (see section 4.4).
Croatian: Produljenje QT intervala i ventrikularna aritmija uzrokovana hipokalcemijom Produljenje QT intervala i ventrikularna aritmija uzrokovana hipokalcemijom identificirani su tijekom primjene cinakalceta nakon stavljanja u promet, s time da se njihova učestalost ne može procijeniti iz dostupnih podataka (vidjeti dio 4.4).
English: Life threatening events and fatal outcomes associated with hypocalcaemia have been reported in adult and paediatric patients treated with cinacalcet.
Croatian: Životno opasni događaji i smrtni ishodi povezani s hipokalcemijom zabilježeni su u odraslih i pedijatrijskih bolesnika liječenih sinakalcetom.
English: Overdose of cinacalcet may lead to hypocalcaemia.
Croatian: Predoziranje sinakalcetom može uzrokovati hipokalcemiju.
English: Elderly There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet.
Croatian: Stariji Nema klinički relevantnih razlika farmakokinetike cinakalceta zbog dobi.
English: Pantoprazole: Co-administration of pantoprazole (80 mg, once daily) did not alter the pharmacokinetics of cinacalcet.
Croatian: Pantoprazol: Istodobna primjena pantoprazola (80 mg, jedanput dnevno) nije promijenila farmakokinetiku cinakalceta.
English: • upper respiratory infection
Croatian: • infekcija gornjih dišnih puteva
English: • a medicine used to treat depression (fluvoxamine).
Croatian: • lijek kojim se liječi depresija (fluvoksamin).
English: • medicines used to treat changes in heart rate (flecainide and propafenone)
Croatian: • lijekova kojima se liječi poremećaj srčanog ritma (flecainid i propafenon);
English: The pharmacokinetics of cinacalcet was studied in paediatric patients with ESRD receiving dialysis aged 3 to 17 years of age.
Croatian: Farmakokinetika cinakalceta ispitana je u pedijatrijskih bolesnika sa završnim stadijem bolesti bubrega u dobi od 3 do 17 godina.
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
Croatian: Kako se doza titrira za svakog pojedinca na osnovi sigurnosnog profila i djelotvornosti, nije potrebno dodatno prilagođavanje doze u osoba s oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 4.4).
English: In in vitro studies, IC50 values for the serotonin transporter and KATP channels were found to be 7 and 12 fold greater, respectively, than the EC50 for the calcium-sensing receptor obtained under the same experimental conditions.
Croatian: U in vitro jspitivanjima, pod istim eksperimentalnim uvjetima, pronađeno je da su IC50 vrijednosti transportera serotonina i KATP kanala bile 7, odnosno 12 puta veće nego EC50 za receptore osjetljive na kalcij.
English: Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
Croatian: Kada je postignuta doza održavanja, vrijednost serumskog kalcija potrebno je kontrolirati otprilike mjesečno.
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 povećale su AUC 30 mg dekstrometorfana (pretežno se metabolizira enzimom CYP2D6) za 11 puta u brzih CYP2D6 metabolizatora.
English: Testosterone levels
Croatian: Vrijednost testosterona
English: Due to the potential for 2 to 4 fold higher plasma levels of cinacalcet in patients with moderate to severe hepatic impairment (Child-Pugh classification), cinacalcet should be used with caution in these patients and treatment should be closely monitored (see sections 4.2 and 5.2).
Croatian: Kako koncentracija cinakalceta u plazmi može biti 2 do 4 puta veća u bolesnika s umjerenim do teškim oštećenjem jetre (Child-Pugh klasifikacija), sinakalcet je potrebno primjenjivati s oprezom kod tih bolesnika i liječenje treba pažljivo pratiti (vidjeti dijelove 4.2 i 5.2).
English: The reduction in PTH is associated with a concomitant decrease in serum calcium levels.
Croatian: Sniženje PTH-a povezano je s istodobnim sniženjem serumske vrijednosti kalcija.
English: < 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL (1.9 mmol/L), or in the presence of clinical symptoms of hypocalcaemia
Croatian: < 8,4 mg/dl (2,1 mmol/l) i > 7,5 mg/dl (1,9 mmol/l), ili u prisutnosti kliničkih simptoma hipokalcemije
English: 4.8 Undesirable effects a)
Croatian: 4.8 Nuspojave a) Sažetak sigurnosnog profila
English: Cinacalcet was initiated at a dose of 30 mg twice daily and titrated to maintain a corrected total serum calcium concentration within the normal range.
Croatian: Sinakalcet je uveden u dozi od 30 mg dva puta dnevno i titriran tako da održava korigirani ukupni kalcij u serumu unutar normalnog raspona.
English: Cinacalcet Mylan is not indicated for use in paediatric patients.
Croatian: Cinacalcet Mylan nije indiciran za primjenu u pedijatrijskih bolesnika.
English: Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Croatian: Liječenje sekundarnog hiperparatireoidizma (HPT) u bolesnika sa završnim stadijem bolesti bubrega na terapiji održavanja dijalizom.
English: Indigo carmine aluminium lake (E132) Iron oxide yellow (E172)
Croatian: hipromeloza titanijev dioksid (E171) triacetin indigo carmine aluminium lake (E132) željezov oksid, žuti (E172),
English: Cinacalcet Mylan must be taken orally, with or shortly after food.
Croatian: Cinacalcet Mylan mora se uzeti kroz usta, s jelom ili neposredno nakon obroka.
English: Calcium carbonate: Co-administration of calcium carbonate (single 1,500 mg dose) did not alter the pharmacokinetics of cinacalcet.
Croatian: Kalcijev karbonat: Istodobna primjena kalcijeva karbonata (jednokratna doza od 1500 mg) nije promijenila farmakokinetiku cinakalceta.
English: It is used to treat problems with organs called parathyroid glands.
Croatian: Koristi se u liječenju tegoba povezanih s paratireoidnim žlijezdama.
English: A significantly higher percentage of cinacalcet treated patients achieved mean corrected total serum calcium concentration ≤ 10.3 mg/dl (2.57 mmol/l) and ≥ 1 mg/dl (0.25 mmol/l) decrease from baseline in mean corrected total serum calcium concentration, when compared with the placebo treated patients (75.8% versus 0% and 84.8% versus 5.9% respectively).
Croatian: Značajno viši postotak bolesnika liječenih sinakalcetom je dosegao srednju korigiranu ukupnu koncentraciju kalcija u serumu ≤ 10,3 mg/dl (2,57 mmol/l) i sniženje srednje korigirane ukupne koncentracije kalcija u serumu ≥ 1 mg/dl (0,25 mmol/l) od početne vrijednosti, u usporedbi s bolesnicima koji su primali placebo (75,8% naspram 0% odnosno 84,8% naspram 5,9%).
English: The threshold for seizures is lowered by significant reductions in serum calcium levels.
Croatian: Prag za pojavu napadaja smanjen je kod značajnih smanjenja razine serumskog kalcija.
English: Medicines such as these can affect how Cinacalcet Mylan works:
Croatian: Sljedeći lijekovi mogu utjecati na djelovanje lijeka Cinacalcet Mylan:
English: Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.
Croatian: Mogući znakovi predoziranja su utrnulost ili trnci oko usta, bolovi u mišićima ili grčevi i napadaji.
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: Parathyroid carcinoma and Primary Hyperparathyroidism 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 ispitivanju 46 odraslih 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 sinakalcetom do tri godine (prosječno 328 dana bolesnici s karcinomom paratireoidnih žlijezda i prosječno 347 dana bolesnici s primarnim HPTom).
English: Medicinal products known to reduce serum calcium Concurrent administration of other medicinal products known to reduce serum calcium and cinacalcet may result in an increased risk of hypocalcaemia (see section 4.4).
Croatian: Lijekovi s poznatim učinkom snižavanja serumskog kalcija Istodobna primjena drugih lijekova za koje je poznato da snižavaju vrijednosti serumskog kalcija i cinakalceta može rezultirati povećanim rizikom od hipokalcemije (vidjeti dio 4.4).
English: Cinacalcet decreased iPTH and Ca x P, calcium and phosphorus levels regardless of baseline iPTH or Ca x P level, dialysis modality (PD versus HD), duration of dialysis, and whether or not vitamin D sterols were administered.
Croatian: Sinakalcet je snizio iPTH i Ca x P, vrijednosti kalcija i fosfora bez obzira na početnu vrijednost iPTH-a ili Ca x P, tip dijalize (PD napram HD), trajanje dijalize i bez obzira na davanje sterola vitamina D.
English: Sevelamer: Co-administration of sevelamer (2,400 mg, three times a day) did not affect the pharmacokinetics of cinacalcet.
Croatian: Sevelamer: Istodobna primjena sevelamera (2400 mg, tri puta dnevno) nije promijenila farmakokinetiku cinakalceta.
English: 28 Film-coated tablets 28 x 1 Film-coated tablets 30 x 1 Film-coated tablets 84 x 1 Film-coated tablets
Croatian: 28 filmom obloženih tableta 28 x 1 filmom obložena tableta 30 x 1 filmom obložena tableta 84 x 1 filmom obložena tableta
English: If PTH levels decrease below the recommended target range in patients treated with cinacalcet, the dose of cinacalcet and/or vitamin D sterols should be reduced or therapy discontinued.
Croatian: Ako se vrijednost PTH-a smanji ispod preporučenoga ciljnog raspona u bolesnika liječenih sinakalcetom, dozu cinakalceta i/ili sterola vitamina
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).
English: • constipation
Croatian: • konstipacija
English: Cinacalcet Mylan 30 mg film-coated tablets are available in plastic bottles of 100 tablets.
Croatian: Cinacalcet Mylan 30 mg filmom obložene tablete dostupne su u plastičnim bocama od 100 tableta.
English: During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of cinacalcet.
Croatian: Tijekom titriranja doze,vrijednost serumskog kalcija treba se često kontrolirati, unutar tjedan dana od započete terapije ili prilagodbe doze cinakalceta.
English: < 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia despite attempts to increase serum calcium
Croatian: < 8,4 mg/dl (2,1 mmol/l) i > 7,5 mg/dl (1,9 mmol/l) ili perzistirajući simptomi hipokalcemije unatoč pokušajima da se povisi serumski kalcij
English: Administration of cinacalcet with food results in an approximate 50-80% increase in cinacalcet bioavailability.
Croatian: Uzimanje cinakalceta s hranom povećava bioraspoloživost cinakalceta za oko 50 do 80 %.
English: • dizziness
Croatian: • dispneja
English: Cases of seizures have been reported in patients treated with cinacalcet (see section 4.8).
Croatian: Slučajevi napadaja zabilježeni su u bolesnika liječenih cinakalcetom (vidjeti dio 4.8).
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: Marketing Authorisation Holder Mylan S.A.S.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: Mylan S.A.S.
English: • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with parathyroid cancer
Croatian: • da bi se smanjila visoka razina kalcija u krvi (hiperkalcemija) u bolesnika s rakom paratireoidnih žlijezda
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. bolešću bubrega.
English: If you have forgotten a dose of Cinacalcet Mylan, you should take your next dose as normal.
Croatian: Ako zaboravite uzeti dozu lijeka Cinacalcet Mylan, nastavite sa sljedećom redovnom dozom.
English: Cellulose, microcrystalline Silica, colloidal anhydrous Povidone
Croatian: celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni povidon krospovidon magnezijev stearat
English: Withhold administration of cinacalcet until serum calcium levels reach 8.0 mg/dL (2.0 mmol/L) and/or symptoms of hypocalcaemia have resolved.
Croatian: Privremeno prekinite primjenu cinakalceta sve dok vrijednosti serumskog kalcija ne dosegnu 8,0 mg/dl (2,0 mmol/l) i/ili se simptomi hipokalcemije ne povuku.
English: Corrected serum calcium should be measured and monitored and should be at or above the lower limit of the normal range prior to administration of first dose of cinacalcet (see section 4.4).
Croatian: Prilagodba doze na temelju vrijednosti serumskog kalcija Korigirana vrijednost serumskog kalcija treba se mjeriti i kontrolirati te treba biti u razini ili iznad donje granice referentnih vrijednosti prije primjene prve doze cinakalceta (vidjeti dio 4.4).
English: Anorexia Decreased appetite
Croatian: • anoreksija • smanjeni apetit
English: Cinacalcet 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 cinakalceta 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: 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 sinakalcet smanjuje vrijednosti PTH-a do sličnih granica kao i u bolesnika sa završnim stadijem bolesti bubrega i sekundarnim hiperparatireoidizmom koji su na dijalizi.
English: • numbness or tingling sensation (paraesthesia)
Croatian: • utrnulost ili osjećaj trnaca (parestezija)
English: Secondary Hyperparathyroidism
Croatian: Sekundarni hiperparatireoidizam
English: Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with cinacalcet (see section 4.8).
Croatian: Slučajevi produljenja QT intervala i ventrikularnih aritmija zabilježeni su u bolesnika liječenih sinakalcetom (vidjeti dio 4.8).
English: Concurrent administration may result in severe hypocalcaemia.
Croatian: Istodobna primjena može rezultirati teškom hipokalcemijom.
English: The recommended starting dose of Cinacalcet Mylan for adults is 30 mg twice per day.
Croatian: Preporučena početna doza lijeka Cinacalcet Mylan za odrasle je 30 mg dva puta dnevno.
English: Since cinacalcet lowers serum calcium, patients should be monitored carefully for the occurrence of hypocalcaemia (see section 4.2).
Croatian: Kako sinakalcet smanjuje serumski kalcij, treba pomno pratiti bolesnike zbog moguće hipokalcemije (vidjeti dio 4.2).
English: Effect of other medicines on cinacalcet
Croatian: Učinak drugih lijekova na sinakalcet
English: Cinacalcet Mylan 30 mg, 60 mg and 90 mg film-coated tablets PVC/PVdC/Alu blisters of 28 tablets and perforated unit dose blisters of 28 x 1, 30 x 1 and 84 x 1 tablets.
Croatian: Cinacalcet Mylan 30 mg, 60 mg i 90 mg filmom obložene tablete PVC/PVdC/Al blisteri s 28 tableta i perforirani blisteri djeljivi na jedinične doze s 28 x 1, 30 x 1 i 84 x 1 tabletom.
English: • high potassium levels in the blood (hyperkalaemia)
Croatian: • visoke razine kalija u krvi (hiperkalemija)
English: Mild hepatic impairment did not notably affect the pharmacokinetics of cinacalcet.
Croatian: Blago oštećenje funkcije jetre ne utječe značajno na farmakokinetiku cinakalceta.
English: Reductions in PTH levels correlate with cinacalcet concentration.
Croatian: Sniženje PTH-a korelira s koncentracijom cinakalceta.