FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no clinical data relating to the effect of cinacalcet on fertility.
Croatian: Nema kliničkih podataka vezano uz utjecaj cinakalceta na plodnost.
English: PTH levels should be assessed at least 12 hours after dosing with cinacalcet.
Croatian: Vrijednosti PTH-a treba odrediti najmanje 12 sati nakon uzimanja cinakalceta.
English: Cinacalcet Mylan reduces calcium levels.
Croatian: Cinacalcet Mylan snižava vrijednosti kalcija.
English: Reduce or withhold dose of cinacalcet.
Croatian: Smanjite ili privremeno prekinite dozu cinakalceta.
English: Testosterone levels are often below the normal range in patients with end-stage renal disease.
Croatian: Vrijednost testosterona često je ispod normalnog raspona u bolesnika sa završnim stadijem bolesti bubrega.
English: Warfarin: Multiple oral doses of cinacalcet did not affect the pharmacokinetics or pharmacodynamics (as measured by prothrombin time and clotting factor VII) of warfarin.
Croatian: Varfarin: Višekratne peroralne doze cinakalceta nisu utjecale na farmakokinetiku ili farmakodinamiku (mjerenu protrombinskim vremenom i faktorom koagulacije VII) varfarina.
English: Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Cinacalcet Mylan.
Croatian: Vaš liječnik će raspraviti s vama trebate li prestati dojiti ili prekinuti liječenje lijekom Cinacalcet Mylan.
English: Serum calcium
Croatian: Serumski kalcij
English: Based on in vitro data, cinacalcet is a strong inhibitor of CYP2D6, but is neither an inhibitor of other CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP3A4 nor an inducer of CYP1A2, CYP2C19 and CYP3A4.
Croatian: Na osnovi in vitro podataka, sinakalcet je snažan inhibitor CYP2D6, ali nije inhibitor drugih CYP enzima u koncentracijama koje se postižu kliničkom primjenom, uključujući CYP1A2, CYP2C8, CYP2C9, CYP2C19 i CYP3A4 niti je induktor CYP1A2, CYP2C19 i CYP3A4.
English: PTH levels in cinacalcet clinical trials were measured at the end of the dosing interval.
Croatian: Vrijednosti PTH-a u kliničkim ispitivanjima s sinakalcetom bile su mjerene na kraju intervala doziranja.
English: Please tell your doctor if you experience any of the following which may be signs of low calcium levels: spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, confusion or loss of consciousness while being treated with Cinacalcet Mylan.
Croatian: Obratite se svom liječniku ako se pojavi bilo što od sljedećeg, što može biti znak niskih vrijednosti kalcija: grčevi, trzanje mišića ili grčevi u mišićima, utrnulost ili trnci u prstima ruku, nogu ili oko ustiju, napadaji, smetenost ili gubitak svijesti tijekom liječenja Cinakalcetom Mylan.
English: • a medicine used to treat high blood pressure (metoprolol).
Croatian: • lijek koji se koristi za liječenje visokoga krvnog tlaka (metoprolol).
English: The non-teratogenic dose in rats was 4.4 times, on an AUC basis, the maximum dose for secondary HPT.
Croatian: Neteratogena doza u štakora bila je, na osnovi AUC, 4,4 puta veća od maksimalne doze za sekundarni HPT.
English: These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of medicines that are metabolized by CYP3A4 and CYP3A5, such as certain immunosuppressants, including ciclosporin and tacrolimus.
Croatian: Ti podaci ukazuju da sinakalcet ne bi utjecao na farmakokinetiku onih skupina lijekova koje se metaboliziraju putem CYP3A4 i CYP3A5, kao što su određeni imunosupresivi, uključujući ciklosporin i takrolimus.
English: • low blood pressure (hypotension)
Croatian: • snižen krvni tlak (hipotenzija)
English: No embryonal/foetal toxicities were seen in studies in pregnant rats and rabbits with the exception of decreased foetal body weights in rats at doses associated with maternal toxicities (see section 5.3).
Croatian: Nije opažena embrionalna ili fetalna toksičnost u ispitivanjima na skotnim štakorima i kunićima, uz iznimku smanjenja težine fetusa u štakora pri dozama toksičnim za majku (vidjeti dio 5.3).
English: The tablet coating contains hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132), iron oxide yellow (E172).
Croatian: Ovojnica tablete sadrži hipromelozu, titanijev dioksid (E171), triacetin, indigo carmine (E132), željezov oksid, žuti (E172).
English: Both primary and secondary hyperparathyroidism can cause loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.
Croatian: Oba, i primarni i sekundarni hiperparatireoidizam mogu uzrokovati gubitak kalcija iz kosti, što može biti uzrok bolova u kostima i prijeloma, poremećaja krvi i oštećenja srčanih krvnih žila, nastanka bubrežnih kamenaca, psihičkih poremećaja i kome.
English: Renal excretion of metabolites was the prevalent route of elimination of radioactivity.
Croatian: Bubrežno izlučivanje metabolita bilo je prevladavajući oblik eliminacije radioaktivno obilježene doze.
English: Manifestations of hypocalcaemia may include paraesthesias, myalgias, cramping, tetany and convulsions.
Croatian: Manifestacije hipokalcemije mogu uključivati parestezije, mijalgije, grčeve, tetaniju i konvulzije.
English: If you experience these side effects do not drive or operate machines.
Croatian: Ako ste imali navedene nuspojave, ne upravljajte vozilom ili strojevima.
English: The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion.
Croatian: Receptori kalcija na površini glavnih stanica paratireoidne žlijezde glavni su regulatori sekrecije PTH-a.
English: These may be signs that your calcium levels are too low (hypocalcaemia).
Croatian: Te nuspojave mogu biti znakovi da je vaša vrijednost kalcija preniska (hipokalcemija).
English: • heart failure.
Croatian: • zatajenje srca.
English: The pharmacokinetic profile of cinacalcet in patients with mild, moderate, and severe renal insufficiency, and those on haemodialysis or peritoneal dialysis is comparable to that in healthy volunteers.
Croatian: Farmakokinetički profil cinakalceta u bolesnika s blagom, umjerenom i teškom renalnom insuficijencijom, kao i u bolesnika na hemodijalizi ili peritonejskoj dijalizi, usporediv je s onim u zdravih dobrovoljaca.
English: The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).
Croatian: Paratireoide su četiri male žlijezde na vratu, pokraj štitnjače, koje proizvode paratireoidni hormon (PTH).
English: The mean reductions in serum Ca x P, calcium, and phosphorus were 14%, 7% and 8%, respectively.
Croatian: Prosječno sniženje serumskog umnoška kalcija i fosfora (Ca x P) te kalcija i fosfora, bilo je 14 %, 7 % odnosno 8 %.
English: Doses titrated up to 300 mg once daily have been administered to patients receiving dialysis without adverse outcome.
Croatian: Doze titrirane do 300 mg jednom dnevno bile su primijenjene kod bolesnika na dijalizi bez štetnih ishoda.
English: Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the contribution of CYP1A2 has not been characterised clinically).
Croatian: Sinakalcet se metabolizira putem više enzima, pretežno s CYP3A4 i CYP1A2 (doprinos CYP1A2 nije klinički okarakteriziran).
English: Decreased foetal weights were seen in rats at doses where dams had severe hypocalcaemia.
Croatian: Smanjena težina fetusa primijećena je u štakora pri dozama pri kojima su ženke štakora imale hipokalcemiju.
English: Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents, ATC code: H05BX01
Croatian: Farmakoterapijska skupina: Pripravci s utjecajem na mijenu kalcija, antiparatireoidni agensi, ATK oznaka: H05BX01.
English: Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): cinacalcet is a strong inhibitor of CYP2D6.
Croatian: Lijekovi koje metabolizira enzim P450 2D6 (CYP2D6): Sinakalcet je jak inhibitor enzima CYP2D6.
English: The mean half-life of cinacalcet is prolonged by 33% and 70% in patients with moderate and severe hepatic impairment, respectively.
Croatian: Prosječni poluvijek cinakalceta produljen je za 33 % i 70 % u bolesnika s umjerenim, odnosno teškim oštećenjem funkcije jetre.
English: Steady state levels of cinacalcet are achieved within 7 days with minimal accumulation.
Croatian: Razine cinakalceta u stanju dinamičke ravnoteže postižu se unutar 7 dana, uz minimalno nakupljanje lijeka.
English: Reference should be made to current treatment guidelines.
Croatian: Potrebno je pridržavati se važećih terapijskih smjernica.
English: Eighteen (18) of 29 patients (62%) with parathyroid carcinoma and 15 of 17 subjects (88%) with primary HPT achieved a reduction in serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).
Croatian: Od 29 bolesnika, 18 (62 %) s karcinomom paratireoidnih žlijezda i 15 od 17 bolesnika (88 %) s primarnim HPT-om postiglo je smanjenje serumskog kalcija od ≥ 1 mg/dl (≥ 0,25 mmol/l).
English: Other medicines and Cinacalcet Mylan
Croatian: Drugi lijekovi i Cinacalcet Mylan
English: The other ingredients are cellulose, microcrystalline; silica, colloidal anhydrous; povidone; crospovidone; magnesium stearate.
Croatian: Drugi sastojci su celuloza, mikrokristalična; silicijev dioksid, koloidni, bezvodni; povidon; krospovidon; magnezijev stearat.
English: The lack of effect of cinacalcet on the pharmacokinetics of R-and S-warfarin and the absence of autoinduction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, CYP1A2 or CYP2C9 in humans.
Croatian: Izostanak učinka cinakalceta na farmakokinetiku R- i S-varfarina i izostanak autoindukcije nakon višestrukih doza u bolesnika, ukazuje da sinakalcet nije induktor CYP3A4, CYP1A2 ili CYP2C9 kod ljudi.
English: The dose of cinacalcet should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.
Croatian: Dozu cinakalceta treba titrirati svaka 2 do 4 tjedna, u sekvencijalnim dozama od 30 mg dva puta dnevno, 60 mg dva puta dnevno, 90 mg dva puta dnevno, i 90 mg tri ili četiri puta dnevno, prema potrebi kako bi se snizile vrijednosti serumskog kalcija do gornje granice referentnih vrijednosti ili ispod nje.
English: In each of the studies, the primary endpoint (proportion of patients with an iPTH ≤ 250 pg/ml (≤ 26.5 pmol/l)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
Croatian: U svakom od ispitivanja mjera primarnog ishoda (udio bolesnika s iPTH ≤ 250 pg/ml (≤ 26,5 pmol/l)) postignuta je u 41 %, 46 % i 35 % bolesnika liječenih sinakalcetom, u usporedbi sa 4 %, 7 % i 6 % bolesnika koji su primili placebo.
English: The recommended starting dose for adults is 30 mg once per day.
Croatian: Preporučena početna doza za odrasle je 30 mg jedanput na dan.
English: Closely monitor serum calcium (see section 4.5).
Croatian: Pomno pratite serumski kalcij (vidjeti dio 4.5).
English: After steady state is reached, serum calcium concentrations remain constant over the dosing interval.
Croatian: Nakon što se uspostavi stanje dinamičke ravnoteže, serumska koncentracija kalcija ostaje stalna kroz interval doziranja.
English: Dizziness and seizures, which may have major influence on the ability to drive and use machines, have been reported by patients taking cinacalcet (see section 4.4).
Croatian: Omaglica i napadaji, koji mogu imati značajan utjecaj na sposobnost upravljanja vozilima i rada sa strojevima, zabilježeni su u bolesnika koji su uzimali cinakalcet (vidjeti dio 4.4).
English: • to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products
Croatian: • za liječenje sekundarnog hiperparatireoidizma u bolesnika s ozbiljnom bubrežnom bolesti koji trebaju dijalizu da bi se krv očistila od štetnih produkata
English: Patients receiving cinacalcet should not be given etelcalcetide (see section 4.4).
Croatian: Bolesnicima koji primaju cinakalcet ne smije se dati etelkalcetid (vidjeti dio 4.4).
English: What Cinacalcet Mylan is and what it is used for
Croatian: Što je Cinacalcet Mylan i za što se koristi
English: In toxicity studies in juvenile dogs, tremors secondary to decreased serum calcium, emesis, decreased body weight and body weight gain, decreased red cell mass, slight decreases in bone densitometry parameters, reversible widening of the growth plates of long bones, and histological lymphoid changes (restricted to the thoracic cavity and attributed to chronic emesis) were observed.
Croatian: U ispitivanjima toksičnosti na mladim psima opaženi su tremori kao posljedica smanjenog serumskog kalcija, emeza, gubitak tjelesne težine i dobivanje na tjelesnoj težini, smanjena masa eritrocita, blago smanjeni parametri gustoće kostiju, reverzibilno širenje epifizne ploče dugih kostiju, te histološke limfoidne promjene (ograničene na prsnu šupljinu i pripisane kroničnoj emezi).
English: Cinacalcet is metabolised in part by the enzyme CYP3A4.
Croatian: Sinakalcet se djelomično metabolizira pomoću enzima CYP3A4.
English: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) was a randomised, double-blind clinical study evaluating cinacalcet versus placebo for the reduction of the risk of allcause mortality and cardiovascular events in 3,883 patients with secondary HPT and CKD receiving dialysis.
Croatian: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events - Procjena terapije sinakalcetom za smanjenje kardiovaskularnih događaja) je bilo randomizirano, dvostruko slijepo, kliničko ispitivanje u kojem se procjenjivao sinakalcet naspram placeba u smanjenju rizika od mortaliteta svih uzroka i kardiovaskularnih događaja u 3883 bolesnika sa sekundarnim hiperparatireoidizmom i kroničnom bolešću bubrega na dijalizi.
English: In a clinical study of ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the cinacalcet-treated patients and by 16.3% in the placebo-treated patients after 6 months of treatment.
Croatian: U kliničkim ispitivanjima u bolesnika sa završnim stadijem bolesti bubrega na dijalizi, vrijednost slobodnog testosterona smanjila se za medijan od 31,3 % kod bolesnika koji su uzimali sinakalcet i za 16,3 % u placebo grupi nakon 6 mjeseci liječenja.
English: Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months.
Croatian: Kada se postigne doza održavanja, serumski kalcij treba mjeriti svaka 2 do 3 mjeseca.
English: Cinacalcet treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Croatian: Liječenje cinakalcetom ne smije se započeti u bolesnika s vrijednostima serumskog kalcija (korigiranima za albumin) ispod donje granice referentnih vrijednosti.
English: Midazolam: Co-administration of cinacalcet (90 mg) with orally administered midazolam (2 mg), a CYP3A4 and CYP3A5 substrate, did not alter the pharmacokinetics of midazolam.
Croatian: Midazolam: Istodobna primjena cinakalceta (90 mg) s peroralno primijenjenim midazolamom (2 mg), supstratom CYP3A4 i CYP3A5, nije promijenila farmakokinetiku midazolama.
English: In the event that corrected serum calcium levels fall below 8.4 mg/dl (2.1 mmol/l) and/or symptoms of hypocalcaemia occur the following management is recommended:
Croatian: U slučaju da korigirane vrijednosti serumskog kalcija padnu ispod 8,4 mg/dl (2,1 mmol/l) i/ili nastupe simptomi hipokalcemije, preporučuje se sljedeće liječenje:
English: Cinacalcet Mylan is not indicated for use in children and adolescents.
Croatian: Cinacalcet Mylan nije indiciran u djece i adolescenata.
English: Cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels (see section 4.8).
Croatian: Slučajevi hipotenzije i/ili pogoršanje zatajenja srca zabilježeni su u bolesnika s oštećenom funkcijom srca kod kojih nije bilo moguće u potpunosti isključiti uzročnu povezanost s cinakalcetom i može biti posredovana smanjenjem vrijednosti serumskog kalcija (vidjeti dio 4.8).
English: Cinacalcet should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in dialysis patients of between 150-300 pg/ml (15.9-31.8 pmol/l) in the intact PTH (iPTH) assay.
Croatian: Dozu cinakalceta treba titrirati svaka 2 do 4 tjedna, do maksimalne doze od 180 mg, primijenjene jednom dnevno da bi se u dijaliznih bolesnika postigla ciljna vrijednost paratireoidnog hormona (PTH) između 150 i 300 pg/ml (15,9-31,8 pmol/l), u testu intaktnog PTH (iPTH).
English: Reduction of hypercalcaemia in patients with:
Croatian: Smanjenje hiperkalcijemije u bolesnika s:
English: Approximately 60% of cinacalcet-treated patients achieved a ≥ 30% reduction in iPTH levels, and this effect was consistent across the spectrum of baseline iPTH levels.
Croatian: Oko 60 % bolesnika liječenih sinakalcetom postiglo je sniženje vrijednosti iPTH za ≥ 30 % i taj učinak bio je konzistentan, bez obzira na početnu vrijednost iPTH-a.
English: Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for overdose.
Croatian: Kako se sinakalcet u visokoj mjeri veže za proteine, hemodijaliza nije učinkovita u liječenju predoziranja.
English: Compared to subjects with normal liver function, average AUC of cinacalcet was approximately 2-fold higher in subjects with moderate impairment and approximately 4-fold higher in subjects with severe impairment.
Croatian: Uspoređujući s osobama s urednom jetrenom funkcijom, prosječni AUC cinakalceta bio je oko dva puta viši kod osoba s umjerenim oštećenjem funkcije jetre i oko četiri puta viši u osoba s teškim oštećenjem funkcije jetre.
English: 100 Film-coated tablets
Croatian: 100 filmom obloženih tableta
English: What Cinacalcet Mylan looks like and contents of the pack
Croatian: Kako Cinacalcet Mylan izgleda i sadržaj pakiranja
English: Administer cinacalcet with caution in patients receiving any other medicinal products known to lower serum calcium.
Croatian: Cinakalcet primijenite uz oprez u bolesnika koji primaju bilo koje druge lijekove za koje je poznato da snižavaju vrijednosti serumskog kalcija.
English: • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary hyperparathyroidism when removal of the parathyroid gland is not possible.
Croatian: • da bi se smanjila visoka razina kalcija u krvi (hiperkalcemija) u bolesnika s primarnim hiperparatireoidizmom kod kojih odstranjenje paratireoidne žlijezde nije moguće.
English: Co-administration of 200 mg, twice daily ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet levels.
Croatian: Istodobna primjena 200 mg ketokonazola dva puta dnevno, snažnog inhibitora CYP3A4, uzrokuje otprilike dvostruko povećanje razina cinakalceta.
English: Thereafter, as cinacalcet levels begin to decline, PTH levels increase until 12 hours post-dose, and then PTH suppression remains approximately constant to the end of the once-daily dosing interval.
Croatian: Nakon toga, kako razina cinakalceta počinje padati, razine PTH-a se povećavaju do 12 sati nakon primjene lijeka i supresija PTH-a ostaje stalna do kraja intervala doziranja jednom dnevno.
English: • If you experience swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).
Croatian: • Ako se pojavi oticanje lica, usnica, usta, jezika ili grla, što može uzrokovati teškoće s gutanjem ili disanjem (angioedem).
English: Because doses are titrated for each subject, no additional dose adjustment is necessary based on gender.
Croatian: Kako se doza titrira za svakog pojedinca, nije potrebno dodatno prilagođavanje doze prema spolu.
English: Based on between-study comparisons, the absolute bioavailability of cinacalcet in fasted subjects has been estimated to be about 20-25%.
Croatian: Na osnovi usporedbe između ispitivanja, apsolutna bioraspoloživost cinakalceta u osoba koje su na tašte procijenjena je na oko 20 do 25 %.
English: Cinacalcet has been shown to cross the placental barrier in rabbits.
Croatian: Dokazano je da sinakalcet prolazi placentarnu barijeru u kunića.
English: Three, 6 month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients with uncontrolled secondary HPT receiving dialysis (n=1,136).
Croatian: Tri šestomjesečna, dvostruko slijepa, placebom kontrolirana ispitivanja provedena su u bolesnika sa završnim stadijem bolesti bubrega i nekontroliranim sekundarnim HPT-om na dijalizi (n=1136).
English: If you take more Cinacalcet Mylan than you should If you take more Cinacalcet Mylan than you should you must contact your doctor immediately.
Croatian: Ako uzmete više lijeka Cinacalcet Mylan nego što ste trebali, morate odmah kontaktirati liječnika.
English: Dose adjustment of cinacalcet may be required if a patient receiving cinacalcet initiates or discontinues therapy with a strong inhibitor (e.g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (e.g. rifampicin) of this enzyme.
Croatian: Prilagodba doze cinakalceta može biti potrebna kod bolesnika liječenih sinakalcetom u kojih se počinje ili prekida terapija snažnim inhibitorom (npr. ketokonazol, itrakonazol, telitromicin, vorikonazol, ritonavir), ili induktorom (npr. rifampicin) navedenog enzima.
English: • medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin)
Croatian: • lijekovi za liječenje bakterijskih infekcija (telitromicin, rifampicin i ciprofloksacin)
English: In post-hoc analyses of pooled data from 6 and 12 months clinical studies, Kaplan-Meier estimates of bone fracture and parathyroidectomy were lower in the cinacalcet group compared with the control group.
Croatian: U post-hoc analizi objedinjenih rezultata iz 6-mjesečnih i 12-mjesečnih kliničkih ispitivanja, Kaplan-Meierovom metodom procijenjeno je manje koštanih prijeloma i paratireoidektomija u sinakalcet grupi u usporedbi s kontrolnom grupom.
English: Soon after dosing, PTH begins to decrease until a nadir at approximately 2 to 6 hours post dose, corresponding with cinacalcet Cmax.
Croatian: Ubrzo nakon doziranja, vrijednost PTH-a počinje opadati do najnižih krajnjih vrijednosti nakon 2 do 6 sati od primjene lijeka, što odgovara Cmax cinakalceta.
English: Cinacalcet is excreted in the milk of lactating rats with a high milk to plasma ratio.
Croatian: Sinakalcet se izlučuje u mlijeku ženke štakora u laktaciji uz visok omjer između mlijeka i plazme.
English: Hypersensitivity reactions*
Croatian: • reakcije preosjetljivosti*
English: Hypersensitivity reactions including angioedema and urticaria have been identified during postmarketing use of cinacalcet.
Croatian: Reakcije preosjetljivosti uključujući angioedem i urtikariju identificirane su tijekom primjene cinakalceta nakon stavljanja tog lijeka u promet.
English: The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg once daily.
Croatian: AUC (površina ispod krivulje) i Cmax (vršna koncentracija) cinakalceta raste linearno u rasponu doza od 30 do 180 mg jednom dnevno.
English: After oral administration of cinacalcet, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours.
Croatian: Nakon peroralne primjene cinakalceta, maksimalna koncentracija cinakalceta u plazmi postiže se nakon otprilike 2 do 6 sati.
English: Cinacalcet was not teratogenic in rabbits when given at a dose of 0.4 times, on an AUC basis, the maximum human dose for secondary HPT (180 mg daily).
Croatian: Sinakalcet nije imao teratogeno djelovanje kod kunića kojima je dana doza od 0,4 puta maksimalne humane doze za sekundarni HPT (180 mg dnevno) na osnovi AUC.
English: Cinacalcet has not been tested in pregnant women.
Croatian: Sinakalcet nije ispitivan u trudnica.