FrancophonIA/ELRC3.0 huggingface dataset:
English: However, efficacy, safety, optimal doses and treatment targets have not been established in treatment of predialytic renal failure patients.
Slovenian: Vendar učinkovitost, varnost, optimalni odmerki in terapevtski cilji za zdravljenje predializnih bolnikov z ledvično odpovedjo niso ugotovljeni.
English: All of these effects were seen at a systemic exposure, on an AUC basis, approximately equivalent to the exposure in patients at the maximum dose for secondary HPT.
Slovenian: Vse te učinke so opazili pri sistemski izpostavljenosti na osnovi AUC, približno enakovredne izpostavljenosti pri bolnikih z največjim odmerkom pri sekundarnem HPT.
English: Caution is advised in patients with other risk factors for QT prolongation such as patients with known congenital long QT syndrome or patients receiving medicinal products known to cause QT prolongation.
Slovenian: Potrebna je previdnost pri bolnikih, ki imajo druge dejavnike tveganja za podaljšanje intervala QT, kot so bolniki z znanim prirojenim sindromom dolgega intervala QT ali bolniki, ki prejemajo zdravila, za katera je znano, da povzročajo podaljšanje intervala QT.
English: • parathyroid carcinoma.
Slovenian: • paratiroidnim karcinomom.
English: Before you start taking Cinacalcet Mylan, tell your doctor if you have or have ever had:
Slovenian: Pred začetkom jemanja zdravila Cinakalcet Mylan, morate zdravniku povedati, če imate ali ste kdaj v preteklosti imeli:
English: After administration of a 75 mg radiolabelled dose to healthy volunteers, cinacalcet was rapidly and extensively metabolised by oxidation followed by conjugation.
Slovenian: Po aplikaciji 75 mg radioaktivno označenega odmerka zdravim prostovoljcem se je cinakalcet hitro in izdatno presnovil z oksidacijo, ki ji je sledila konjugacija.
English: There were no effects on fertility in animal studies.
Slovenian: Pri študijah na živalih učinkov na plodnost ni bilo.
English: If a patient stops or starts smoking, cinacalcet plasma levels may change and dose adjustment may be necessary.
Slovenian: Če bolnik preneha ali začne kaditi, se koncentracija cinakalceta v plazmi lahko spremeni in lahko je potrebna prilagoditev odmerka.
English: In case of pregnancy, your doctor may decide to modify your treatment, as cinacalcet might harm the unborn baby.
Slovenian: Če zanosite, se bo zdravnik morda odločil, da vam zdravljenje prilagodi, ker lahko cinakalcet škoduje vašemu nerojenemu otroku.
English: • allergic reactions (hypersensitivity)
Slovenian: • alergijske reakcije (preobčutljivost),
English: Your doctor will tell you how much Cinacalcet Mylan you must take.
Slovenian: Zdravnik vam bo povedal, koliko zdravila Cinakalcet Mylan morate jemati.
English: Tablets should be taken whole and should not be chewed, crushed or divided.
Slovenian: Tablete je treba vzeti cele in se jih ne sme zgristi, zdrobiti ali deliti.
English: Do not take Cinacalcet Mylan if you have low levels of calcium in your blood.
Slovenian: Ne jemljite zdravila Cinakalcet Mylan, če imate nizke koncentracije kalcija v krvi.
English: An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in cinacalcet-treated patients.
Slovenian: Odprto podaljšanje te študije med 3-letnim obdobjem ni pokazalo dodatnega znižanja koncentracije prostega in celotnega testosterona pri bolnikih, ki so dobivali cinakalcet.
English: Cinacalcet is approximately 97% bound to plasma proteins and distributes minimally into red blood cells.
Slovenian: Cinakalcet je približno 97 % vezan na beljakovine v plazmi in se minimalno porazdeli v eritrocite.
English: Safety margins from the toxicology studies are small due to the dose-limiting hypocalcaemia observed in the animal models.
Slovenian: Varnostne meje, ugotovljene v toksikoloških študijah, so nizke zaradi hipokalciemije, ki omejuje odmerek in so jo opažali v živalskih modelih.
English: Dose adjustment may be necessary if a patient starts or stops smoking or when concomitant treatment with strong CYP1A2 inhibitors is initiated or discontinued.
Slovenian: Prilagoditve odmerka so lahko potrebne, če bolnik začne kaditi ali opusti kajenje; enako velja po uvedbi ali prekinitvi sočasnega zdravljenja z močnimi zaviralci CYP1A2.
English: PTH should be monitored approximately every 1-3 months during maintenance.
Slovenian: Med vzdrževalnim zdravljenjem je treba PTH kontrolirati približno na 1-3 mesece.
English: Cinacalcet has not been tested in pregnant women.
Slovenian: Cinakalcet ni preizkušen pri nosečnicah.
English: Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate (see section 5.1).
Slovenian: Zdravilo Cinakalcet Mylan je mogoče uporabiti v terapevtski shemi, ki vključuje vezalce fosfatov in/ali sterole vitamina D, kot je primerno (glejte poglavje 5.1).
English: Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2mediated metabolism.
Slovenian: Očistek cinakalceta je pri kadilcih večji kot pri nekadilcih, verjetno zaradi indukcije presnove s CYP1A2.
English: The pharmacokinetics of cinacalcet does not change over time.
Slovenian: Farmakokinetika cinakalceta se s časom ne spreminja.
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.
Slovenian: Za merjenje koncentracije PTH je mogoče uporabiti intaktni PTH (iPTH) ali biointaktni PTH (biPTH); zdravljenje s cinakalcetom ne spremeni razmerja med iPTH in biPTH.
English: The study did not meet its primary objective of demonstrating a reduction in risk of all-cause mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112).
Slovenian: Študija ni dosegla primarnega cilja in sicer dokazanega zmanjšanja tveganja za umrljivost zaradi vseh vzrokov ali kardiovaskularnih dogodkov, vključno z miokardnim infarktom, hospitalizacijo zaradi nestabilne angine pektoris, srčnim popuščanjem ali perifernim žilnim dogodkom (razmerje ogroženosti 0,93, 95 % interval zaupanja: 0,85, 1,02, p = 0,112).
English: Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): cinacalcet is a strong inhibitor of CYP2D6.
Slovenian: Zdravila, ki se presnavljajo z encimom P450 2D6 (CYP2D6): cinakalcet je močan zaviralec CYP2D6.
English: Testosterone levels
Slovenian: Koncentracija testosterona
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.
Slovenian: Farmakokinetični profil cinakalceta pri bolnikih z blago, zmerno in hudo insuficienco ledvic ter pri bolnikih na hemodializi ali peritonealni dializi je primerljiv kot pri zdravih prostovoljcih.
English: Serum calcium
Slovenian: Kalcij v serumu
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.
Slovenian: Ti podatki nakazujejo, da naj cinakalcet ne bi vplival na farmakokinetiko tistih skupin zdravil, ki se presnavljajo s CYP3A4 in CYP3A5, kot so nekateri imunosupresivi, vključno s ciklosporinom in takrolimusom.
English: After single and multiple once daily oral doses of cinacalcet, plasma cinacalcet concentrations (Cmax and AUC values after normalisation by dose and weight) were similar to those observed in adult patients.
Slovenian: Po enkratnem in večkratnih peroralnih odmerkih cinakalceta enkrat na dan je bila koncentracija cinakalceta v plazmi (vrednosti Cmax in AUC po normalizaciji za odmerek in telesno maso) podobna kot pri odraslih bolnikih.
English: Demographic and baseline characteristics were representative of the dialysis patient population with secondary HPT.
Slovenian: Demografske in izhodiščne značilnosti so bile reprezentativne za populacijo dializnih bolnikov s sekundarnim hiperparatiroidizmom.
English: There are no clinical data relating to the effect of cinacalcet on fertility.
Slovenian: Kliničnih podatkov v zvezi z učinkom cinakalceta na plodnost ni.
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.
Slovenian: Približno 60 % s cinakalcetom zdravljenih bolnikov je doseglo ≥ 30 % znižanje koncentracije iPTH; tak učinek je bil dosleden prek spektra različnih izhodiščnih koncentracij iPTH.
English: Medicines such as these can affect how Cinacalcet Mylan works:
Slovenian: Zdravila, kot so naslednja, lahko vplivajo na delovanje zdravila Cinakalcet Mylan:
English: What Cinacalcet Mylan is and what it is used for What you need to know before you take Cinacalcet Mylan How to take Cinacalcet Mylan Possible side effects
Slovenian: Kaj je zdravilo Cinakalcet Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Cinakalcet Mylan Kako jemati zdravilo Cinakalcet Mylan Možni neželeni učinki
English: It is recommended that Cinacalcet Mylan be taken with food or shortly after a meal, as studies have shown that bioavailability of cinacalcet is increased when taken with food (see section 5.2).
Slovenian: Zdravilo Cinakalcet Mylan je priporočljivo vzeti s hrano ali kmalu po jedi, kajti študije so pokazale, da je biološka uporabnost cinakalceta večja, če ga vzamemo skupaj s hrano (glejte poglavje 5.2).
English: The effect of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) on cinacalcet plasma levels has not been studied.
Slovenian: Učinek zaviralcev CYP1A2 (npr. fluvoksamina, ciprofloksacina) na koncentracijo cinakalceta v plazmi ni raziskan.
English: Your doctor will monitor your blood calcium levels.
Slovenian: Zdravnik vam bo kontroliral koncentracijo kalcija v krvi.
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).
Slovenian: • nenavadno hiter ali razbijajoč srčni utrip, ki je lahko povezan z nizkimi vrednostmi kalcija v krvi (podaljšanje intervala QT in ventrikularna aritmija zaradi hipokalciemije).
English: Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia secondary to hypocalcaemia.
Slovenian: Znižanja kalcija v serumu lahko tudi podaljšajo interval QT, to pa lahko povzroči ventrikularno aritmijo zaradi hipokalciemije.
English: It is important that you take your dose of Cinacalcet Mylan as advised by your doctor.
Slovenian: Pomembno je, da vzamete odmerek zdravil Cinakalcet Mylan, kot vam je naročil zdravnik.
English: • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Slovenian: • primarnim hiperparatiroidizmom, pri katerih bi bila glede na koncentracijo kalcija v serumu indicirana paratiroidektomija (kot je opredeljeno v ustreznih smernicah za zdravljenje), a ta pri njih ni klinično primerna ali je kontraindicirana.
English: Based on between-study comparisons, the absolute bioavailability of cinacalcet in fasted subjects has been estimated to be about 20-25%.
Slovenian: Na podlagi primerjav med študijami ocenjujejo, da je absolutna biološka uporabnost cinakalceta pri preiskovancih na tešče okrog 20 - 25 %.
English: Following careful benefit/risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Cinacalcet Mylan.
Slovenian: Po natančni oceni koristi in tveganj se je treba odločiti bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Cinakalcet Mylan.
English: Effect of cinacalcet on other medicines
Slovenian: Vpliv cinakalceta na druga zdravila
English: The safety and efficacy of cinacalcet in children for the treatment of parathyroid carcinoma and primary hyperparathyroidism have not been established.
Slovenian: Varnost in učinkovitost cinakalceta za zdravljenje paratiroidnega karcinoma in primarnega hiperparatiroidizma pri otrocih nista dokazani.
English: Parathyroid carcinoma and primary hyperparathyroidism:
Slovenian: Paratiroidni karcinom in primarni hiperparatiroidizem:
English: If you have forgotten a dose of Cinacalcet Mylan, you should take your next dose as normal.
Slovenian: Če ste pozabili odmerek zdravila Cinakalcet Mylan, vzemite naslednji odmerek kot običajno.
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.
Slovenian: Varfarin: Večkratni peroralni odmerki cinakalceta niso vplivali na farmakokinetiko ali farmakodinamiko varfarina (merjeno s protrombinskim časom in faktorjem strjevanja VII).
English: Cinacalcet is metabolised in part by the enzyme CYP3A4.
Slovenian: Cinakalcet se deloma presnovi z encimom CYP3A4.
English: Effect of other medicines on cinacalcet
Slovenian: Vpliv drugih zdravil na cinakalcet
English: Because doses are titrated for each subject, no additional dose adjustment is necessary based on gender.
Slovenian: Ker je odmerek titriran za vsakega bolnika posebej, dodatno prilagajanje odmerka glede na spol ni potrebno.
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.
Slovenian: V študijah toksičnosti pri mladih psih so opazili tremorje, ki so bili posledica zmanjšanega kalcija v serumu, bruhanje, zmanjšanje telesne mase in zvečanje telesne mase, zmanjšano maso rdečih krvnih celic, rahlo zmanjšanje pri parametrih kostne denzitometrije, reverzibilno širjenje rastnih ploščic dolgih kosti in histološke spremembe limfatičnih tkiv (omejeno na prsno votlino in pripisana kroničnemu bruhanju).
English: Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents, ATC code: H05BX01
Slovenian: Farmakoterapevtska skupina: Zdravila za uravnavanje homeostaze kalcija; zdravila, ki zavirajo paratiroideo, oznaka ATC: H05BX01.
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.
Slovenian: V post-hoc analizah kumulativnih podatkov iz 6- in 12-mesečnih kliničnih študij so bile Kaplan-Meierjeve ocene za zlome kosti in paratiroidektomije v skupini s cinakalcetom nižje kot v kontrolni skupini.
English: After adjusting for baseline characteristics in a secondary analysis, the HR for the primary composite endpoint was 0.88; 95% CI: 0.79, 0.97.
Slovenian: Po korekciji za izhodiščne značilnosti v sekundarni analizi je bilo razmerje ogroženosti za primarni sestavljeni opazovani dogodek 0,88, 95 % interval zaupanja: 0,79, 0,97.
English: Cinacalcet treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Slovenian: Zdravljenja s cinakalcetom se ne sme začeti pri bolnikih, ki imajo kalcij v serumu (korigiran za albumin) pod spodnjo mejo normalnega območja.
English: You should not take Cinacalcet Mylan together with etelcalcetide.
Slovenian: Zdravila Cinakalcet Mylan ne smete jemati skupaj z etelkalcetidom.
English: After taking cinacalcet a very small number of patients with heart failure had worsening of their condition and/or low blood pressure (hypotension).
Slovenian: Pri zelo majhnem številu bolnikov s srčnim popuščanjem so po uporabi cinakalceta zabeležili poslabšanje njihovega stanja in/ali nizek krvni tlak (hipotenzijo).
English: • to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products
Slovenian: • za zdravljenje sekundarnega hiperparatiroidizma pri bolnikih z resno boleznijo ledvic, ki za odstranjevanje odpadnih snovi iz krvi potrebujejo dializo,
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.
Slovenian: V študijah in vitro so za transporter serotonina ugotovili 7-krat večje vrednosti IC50 in za KATP-kanale 12-krat večje vrednosti IC50 kot je bila EC50 za kalcij-zaznavajoče receptorje pod enakimi eksperimentalnimi pogoji.
English: Corrected Serum calcium level or clinical symptoms of hypocalcaemia
Slovenian: Koncentracija korigiranega kalcija v serumu ali klinični simptomi hipokalciemije
English: Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the contribution of CYP1A2 has not been characterised clinically).
Slovenian: Presnova cinakalceta poteka z več encimi, pretežno s CYP3A4 in CYP1A2 (prispevek CYP1A2 klinično ni opredeljen).
English: There were no effects on fertility in males or females at exposures up to 4 times a human dose of 180 mg/day (safety margins in the small population of patients administered a maximum clinical dose of 360 mg daily would be approximately half those given above).
Slovenian: Ob izpostavljenosti, ki je bila do 4-krat tolikšna kot pri humanem odmerku 180 mg/dan, zdravilo ni vplivalo na plodnost samcev ali samic (varnostne meje pri majhni populaciji bolnikov, ki so dobivali največji klinični odmerek 360 mg na dan, bi bile približno polovične glede na zgoraj navedene).
English: Overdose of cinacalcet may lead to hypocalcaemia.
Slovenian: Prevelik odmerek cinakalceta lahko povzroči hipokalciemijo.
English: The mean reductions in serum Ca x P, calcium, and phosphorus were 14%, 7% and 8%, respectively.
Slovenian: Povprečno znižanje serumskega Ca x P je bilo 14 %, kalcija 7 % in fosforja 8 %.
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).
Slovenian: V študijah na brejih podganah in kunkah niso opazili embrionalnih/fetalnih toksičnih učinkov, razen zmanjšane telesne mase plodov pri podganah ob odmerkih, ki so jih spremljali toksični učinki pri samicah-materah (glejte poglavje 5.3).
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.
Slovenian: Če ste vzeli večji odmerek zdravila Cinakalcet Mylan, kot bi smeli Če ste vzeli večji odmerek zdravila Cinakalcet Mylan, kot bi smeli, se morate takoj posvetovati z zdravnikom.
English: Hypocalcaemia Hyperkalaemia Reduced testosterone levels†
Slovenian: Preiskave hipokalciemija hiperkaliemija znižane koncentracije testosterona
English: If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with Cinacalcet Mylan and during treatment with Cinacalcet Mylan.
Slovenian: Če se zdravite zaradi sekundarnega hiperparatiroidizma, vam mora zdravnik kontrolirati koncentracijo kalcija pred začetkom zdravljenja z zdravilom Cinakalcet Mylan in med zdravljenjem s tem zdravilom.
English: Adynamic bone disease may develop if PTH levels are chronically suppressed below approximately 1.5 times the upper limit of normal with the iPTH assay.
Slovenian: Adinamična bolezen kosti se lahko pojavi, če je koncentracija PTH kronično zavrta pod približno 1,5kratno zgornjo mejo normalnega območja (merjeno s testom iPTH).
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.
Slovenian: Midazolam: Sočasna uporaba cinakalceta (90 mg) s peroralnim midazolamom (2 mg), ki je substrat CYP3A4 in CYP3A5, ni spremenila farmakokinetike midazolama.
English: Italia Mylan Italia S.r.l.
Slovenian: Mylan Italia S.r.l.
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).
Slovenian: Osemnajstim (18) od 29 bolnikov (62 %) s paratiroidnim karcinomom in 15 od 17 preiskovancev (88 %) s primarnim hiperparatiroidizmom se je kalcij v serumu znižal za ≥ 1 mg/dl (≥ 0,25 mmol/l).
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).
Slovenian: Znižanje iPTH je bilo povezano z neznačilnimi znižanji označevalcev presnove kosti (za kosti specifične alkalne fosfataze, N-telopeptida, kostne premene in fibroze kosti).
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
Slovenian: Ker so odmerki titrirani za vsakega bolnika posebej glede na parameter varnosti in učinkovitosti, pri bolnikih z okvaro jeter ni potrebno dodatno prilagajanje odmerka (glejte poglavji 4.2 in 4.4).
English: • low blood pressure (hypotension)
Slovenian: • nizek krvni tlak (hipotenzija),
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.
Slovenian: Dejstvo, da cinakalcet ne vpliva na farmakokinetiko R- in S-varfarina in da večkratno odmerjanje pri bolnikih ne povzroči avtoindukcije, kaže, da cinakalcet pri človeku ne inducira CYP3A4, CYP1A2 ali CYP2C9.
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.
Slovenian: V posameznih študijah je primarni cilj (delež bolnikov z iPTH ≤ 250 pg/ml (≤ 26,5 pmol/l)) doseglo 41 %, 46 % oz. 35 % bolnikov, ki so dobivali cinakalcet, in 4 %, 7 % oz. 6 % bolnikov, ki so prejemali placebo.
English: Closely monitor serum calcium (see section 4.5).
Slovenian: Natančno kontrolirajte kalcij v serumu (glejte poglavje 4.5).
English: • upper respiratory infection
Slovenian: • okužba zgornjih dihal,
English: • reduced testosterone levels
Slovenian: • zmanjšanje vrednosti testosterona,
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).
Slovenian: Paratiroidni karcinom in primarni hiperparatiroidizem V eni študiji je 46 odraslih bolnikov (29 s paratiroidnim karcinomom in 17 s primarnim hiperparatiroidizmom in hudo hiperkalciemijo, pri katerih paratiroidektomija ni bila uspešna ali je bila kontraindicirana) dobivalo cinakalcet do 3 let (povprečje pri bolnikih s paratiroidnim karcinomom je bilo 328 dni, pri bolnikih s primarnim hiperparatiroidizmom pa 347 dni).
English: Patients receiving cinacalcet should not be given etelcalcetide (see section 4.4).
Slovenian: Bolniki, ki prejemajo cinakalcet, ne smejo dobiti etelkalcetida (glejte poglavje 4.4).
English: Cinacalcet Mylan is not indicated for use in children and adolescents.
Slovenian: Zdravilo Cinakalcet Mylan ni indicirano za uporabo pri otrocih in mladostnikih.
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).
Slovenian: Cinakalcet za kunce ni bil teratogen v odmerku, ki je bil (na podlagi AUC) 0,4-krat tolikšen kot največji človeški odmerek za sekundarni hiperparatiroidizem (180 mg/dan).