natgillin/translations-raw huggingface dataset:
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.
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.
Demographic and baseline characteristics were representative of the dialysis patient population with secondary HPT.
Demografske in izhodiščne značilnosti so bile reprezentativne za populacijo dializnih bolnikov s sekundarnim hiperparatiroidizmom.
There are no clinical data relating to the effect of cinacalcet on fertility.
Kliničnih podatkov v zvezi z učinkom cinakalceta na plodnost ni.
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.
Približno 60 % s cinakalcetom zdravljenih bolnikov je doseglo ≥ 30 % znižanje koncentracije iPTH; tak učinek je bil dosleden prek spektra različnih izhodiščnih koncentracij iPTH.
Medicines such as these can affect how Cinacalcet Mylan works:
Zdravila, kot so naslednja, lahko vplivajo na delovanje zdravila Cinakalcet Mylan:
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
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
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).
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).
The effect of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) on cinacalcet plasma levels has not been studied.
Učinek zaviralcev CYP1A2 (npr. fluvoksamina, ciprofloksacina) na koncentracijo cinakalceta v plazmi ni raziskan.
Your doctor will monitor your blood calcium levels.
Zdravnik vam bo kontroliral koncentracijo kalcija v krvi.
• 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).
• nenavadno hiter ali razbijajoč srčni utrip, ki je lahko povezan z nizkimi vrednostmi kalcija v krvi (podaljšanje intervala QT in ventrikularna aritmija zaradi hipokalciemije).
Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia secondary to hypocalcaemia.
Znižanja kalcija v serumu lahko tudi podaljšajo interval QT, to pa lahko povzroči ventrikularno aritmijo zaradi hipokalciemije.
It is important that you take your dose of Cinacalcet Mylan as advised by your doctor.
Pomembno je, da vzamete odmerek zdravil Cinakalcet Mylan, kot vam je naročil zdravnik.
• 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.
• 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.
Based on between-study comparisons, the absolute bioavailability of cinacalcet in fasted subjects has been estimated to be about 20-25%.
Na podlagi primerjav med študijami ocenjujejo, da je absolutna biološka uporabnost cinakalceta pri preiskovancih na tešče okrog 20 - 25 %.
Following careful benefit/risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Cinacalcet Mylan.
Po natančni oceni koristi in tveganj se je treba odločiti bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Cinakalcet Mylan.
Effect of cinacalcet on other medicines
Vpliv cinakalceta na druga zdravila
The safety and efficacy of cinacalcet in children for the treatment of parathyroid carcinoma and primary hyperparathyroidism have not been established.
Varnost in učinkovitost cinakalceta za zdravljenje paratiroidnega karcinoma in primarnega hiperparatiroidizma pri otrocih nista dokazani.
Parathyroid carcinoma and primary hyperparathyroidism:
Paratiroidni karcinom in primarni hiperparatiroidizem:
If you have forgotten a dose of Cinacalcet Mylan, you should take your next dose as normal.
Če ste pozabili odmerek zdravila Cinakalcet Mylan, vzemite naslednji odmerek kot običajno.
Warfarin: Multiple oral doses of cinacalcet did not affect the pharmacokinetics or pharmacodynamics (as measured by prothrombin time and clotting factor VII) of warfarin.
Varfarin: Večkratni peroralni odmerki cinakalceta niso vplivali na farmakokinetiko ali farmakodinamiko varfarina (merjeno s protrombinskim časom in faktorjem strjevanja VII).
Cinacalcet is metabolised in part by the enzyme CYP3A4.
Cinakalcet se deloma presnovi z encimom CYP3A4.
Effect of other medicines on cinacalcet
Vpliv drugih zdravil na cinakalcet
Because doses are titrated for each subject, no additional dose adjustment is necessary based on gender.
Ker je odmerek titriran za vsakega bolnika posebej, dodatno prilagajanje odmerka glede na spol ni potrebno.
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.
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).
Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents, ATC code: H05BX01
Farmakoterapevtska skupina: Zdravila za uravnavanje homeostaze kalcija; zdravila, ki zavirajo paratiroideo, oznaka ATC: H05BX01.
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.
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.
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.
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.
Cinacalcet treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Zdravljenja s cinakalcetom se ne sme začeti pri bolnikih, ki imajo kalcij v serumu (korigiran za albumin) pod spodnjo mejo normalnega območja.
You should not take Cinacalcet Mylan together with etelcalcetide.
Zdravila Cinakalcet Mylan ne smete jemati skupaj z etelkalcetidom.
After taking cinacalcet a very small number of patients with heart failure had worsening of their condition and/or low blood pressure (hypotension).
Pri zelo majhnem številu bolnikov s srčnim popuščanjem so po uporabi cinakalceta zabeležili poslabšanje njihovega stanja in/ali nizek krvni tlak (hipotenzijo).
• to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products
• za zdravljenje sekundarnega hiperparatiroidizma pri bolnikih z resno boleznijo ledvic, ki za odstranjevanje odpadnih snovi iz krvi potrebujejo dializo,
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.
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.
Corrected Serum calcium level or clinical symptoms of hypocalcaemia
Koncentracija korigiranega kalcija v serumu ali klinični simptomi hipokalciemije
Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the contribution of CYP1A2 has not been characterised clinically).
Presnova cinakalceta poteka z več encimi, pretežno s CYP3A4 in CYP1A2 (prispevek CYP1A2 klinično ni opredeljen).
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).
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).
Overdose of cinacalcet may lead to hypocalcaemia.
Prevelik odmerek cinakalceta lahko povzroči hipokalciemijo.
The mean reductions in serum Ca x P, calcium, and phosphorus were 14%, 7% and 8%, respectively.
Povprečno znižanje serumskega Ca x P je bilo 14 %, kalcija 7 % in fosforja 8 %.
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).
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).
If you take more Cinacalcet Mylan than you should If you take more Cinacalcet Mylan than you should you must contact your doctor immediately.
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.
Hypocalcaemia Hyperkalaemia Reduced testosterone levels†
Preiskave hipokalciemija hiperkaliemija znižane koncentracije testosterona
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.
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.
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.
Adinamična bolezen kosti se lahko pojavi, če je koncentracija PTH kronično zavrta pod približno 1,5kratno zgornjo mejo normalnega območja (merjeno s testom iPTH).
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.
Midazolam: Sočasna uporaba cinakalceta (90 mg) s peroralnim midazolamom (2 mg), ki je substrat CYP3A4 in CYP3A5, ni spremenila farmakokinetike midazolama.
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).
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).
Reductions in PTH were associated with non-significant reductions of bone metabolism markers (bone specific alkaline phosphatase, N-telopeptide, bone turnover and bone fibrosis).
Znižanje iPTH je bilo povezano z neznačilnimi znižanji označevalcev presnove kosti (za kosti specifične alkalne fosfataze, N-telopeptida, kostne premene in fibroze kosti).
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
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).
• low blood pressure (hypotension)
• nizek krvni tlak (hipotenzija),
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.
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.
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.
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.
Closely monitor serum calcium (see section 4.5).
Natančno kontrolirajte kalcij v serumu (glejte poglavje 4.5).
• upper respiratory infection
• okužba zgornjih dihal,
• reduced testosterone levels
• zmanjšanje vrednosti testosterona,
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).
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).
Patients receiving cinacalcet should not be given etelcalcetide (see section 4.4).
Bolniki, ki prejemajo cinakalcet, ne smejo dobiti etelkalcetida (glejte poglavje 4.4).
Cinacalcet Mylan is not indicated for use in children and adolescents.
Zdravilo Cinakalcet Mylan ni indicirano za uporabo pri otrocih in mladostnikih.
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).
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).
• medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin)
• zdravila za zdravljenje bakterijskih okužb (telitromicin, rifampicin in ciprofloksacin),
Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Zdravljenje sekundarnega hiperparatiroidizma (HPT) pri bolnikih s končno odpovedjo ledvic (ESRD) na vzdrževalnem dializnem zdravljenju.
Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months.
Ko je vzdrževalni odmerek določen, je treba kalcij v serumu meriti na 2 do 3 mesece.
After absorption, cinacalcet concentrations decline in a biphasic fashion with an initial half-life of approximately 6 hours and a terminal half-life of 30 to 40 hours.
Po absorpciji je upadanje koncentracije cinakalceta dvofazno, z uvodnim razpolovnim časom približno 6 ur in končnim razpolovnim časom od 30 do 40 ur.
Manifestations of hypocalcaemia may include paraesthesias, myalgias, cramping, tetany and convulsions.
Med znaki hipokalciemije so lahko parestezije, mialgije, krči, tetanija in konvulzije.
• liver problems;
• težave z jetri;
Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for overdose.
Cinakalcet je močno vezan na beljakovine, zato hemodializa za zdravljenje prevelikega odmerka ni učinkovita.
The non-teratogenic dose in rats was 4.4 times, on an AUC basis, the maximum dose for secondary HPT.
Neteratogeni odmerek pri podganah je bil (na podlagi AUC) 4,4-krat tolikšen kot največji odmerek za sekundarni hiperparatiroidizem.
Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism Based on available data from patients receiving cinacalcet in placebo controlled studies and single-arm studies the most commonly reported adverse reactions were nausea and vomiting.
Sekundarni hiperparatiroidizem, paratiroidni karcinom in primarni hiperparatiroidizem Na osnovi razpoložljivih podatkov o bolnikih, ki so cinakalcet prejemali v študijah, nadzorovanih s placebom, in študijah z enim krakom, sta bila najpogosteje poročana neželena učinka navzea in bruhanje.
Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
V študijah toksičnosti pri ponavljajočih se odmerkih in študijah kancerogenega potenciala pri glodalcih so ugotavljali katarakte in motnjave leč; takšnih sprememb niso ugotovili pri psih in opicah in tudi ne v kliničnih študijah, v katerih so spremljali nastajanje katarakt.
• a medicine used to treat HIV infection and AIDS (ritonavir)
• zdravilo za zdravljenje okužbe s HIV in AIDS-a (ritonavir),
What Cinacalcet Mylan is and what it is used for
Kaj je zdravilo Cinakalcet Mylan in za kaj ga uporabljamo
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.
Cinakalcet je znižal ravni iPTH, Ca x P, kalcij in fosfor ne glede na izhodiščno raven iPTH ali Ca x P, način dialize (peritonealna dializa ali hemodializa), trajanje dialize in uporabo ali neuporabo sterolov vitamina D.
After titration to the maximum dose of cinacalcet, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of cinacalcet therapy should be considered (see section 5.1).
Po titriranju do največjega odmerka cinakalceta kalcij v serumu redno kontrolirajte; če zdravilo ne ohranja klinično pomembnega znižanja kalcija v serumu, pride v poštev prenehanje zdravljenja s cinakalcetom (glejte poglavje 5.1).
What you need to know before you take Cinacalcet Mylan
Kaj morate vedeti, preden boste vzeli zdravilo Cinakalcet Mylan
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.
Cinakalcet so jim uvedli v odmerku 30 mg dvakrat na dan, nato pa so odmerek prilagajali, da so vzdrževali korigirano celotno koncentracijo kalcija v normalnem območju.
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).
Pri bolnikih s kronično boleznijo ledvic, ki so se zdravili z dializo in so prejemali cinakalcet, je imelo približno 30 % bolnikov vsaj eno vrednost kalcija v serumu manj kot 7,5 mg/dl (1,9 mmol/l).
The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).
Obščitnice so štiri majhne žleze, ki ležijo v vratu blizu žleze ščitnice in izločajo paratiroidni hormon (PTH).
Cinacalcet Mylan reduces calcium levels.
Zdravilo Cinakalcet Mylan znižuje koncentracije kalcija.
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.
Študija EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) je bila randomizirana, dvojno slepa klinična študija, v kateri so ocenjevali cinakalcet v primerjavi s placebom za zmanjšanje tveganja za umrljivost zaradi vseh vzrokov in za kardiovaskularne dogodke pri 3.883 bolnikih s sekundarnim hiperparatiroidizmom in kronično boleznijo ledvic, ki so na dializi.
Cinacalcet Mylan contains the active ingredient cinacalcet, which works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Zdravilo Cinakalcet Mylan vsebuja zdravilno učinkovino cinakalcet, ki deluje tako, da v telesu uravnava koncentracijo paratiroidnega hormona (PTH), kalcija in fosforja.
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.
V primerjavi s preiskovanci z normalnim delovanjem jeter je povprečna AUC cinakalceta pri preiskovancih z zmerno okvaro približno 2-krat večja, pri preiskovancih s hudo okvaro pa približno 4-krat večja.
Cinacalcet is a calcimimetic agent which directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium.
Cinakalcet je kalcimimetično zdravilo, ki neposredno zniža koncentracijo PTH tako, da poveča občutljivost teh receptorjev na zunajcelični kalcij.
Cinacalcet is excreted in the milk of lactating rats with a high milk to plasma ratio.
V mleko doječih podgan se cinakalcet izloča z velikim razmerjem med mlekom in plazmo.
The tablet coating contains hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132), iron oxide yellow (E172).
Filmska obloga vsebuje: hipromelozo, titanov dioksid (E171), triacetin, indigotin (E132) in rumeni železov oksid (E172).
Cataracts are known to occur in rodents as a result of hypocalcaemia.
Znano je, da se pri glodalcih zaradi hipokalciemije pojavijo katarakte.
• a medicine used to treat depression (fluvoxamine).
• zdravilo za zdravljenje depresije (fluvoksamin).
Sevelamer: Co-administration of sevelamer (2,400 mg, three times a day) did not affect the pharmacokinetics of cinacalcet.
Sevelamer: Sočasna uporaba sevelamera (2400 mg trikrat na dan) ni vplivala na farmakokinetiko cinakalceta.
Do not use this medicine after the expiry date which is stated on the blister, carton or bottle after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu, škatli ali plastenki poleg oznake EXP. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
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:
V primeru, da se koncentracija korigiranega kalcija v serumu zniža pod 8,4 mg/dl (2,1 mmol/l) in/ali se pojavijo simptomi hipokalciemije, je priporočljivo sledeče ukrepanje:
In vitro data indicate that cinacalcet is in part metabolised by CYP1A2.
Podatki in vitro kažejo, da se cinakalcet deloma presnavlja s CYP1A2.
Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
Ko je vzdrževalni odmerek določen, je treba koncentracijo kalcija v serumu izmeriti približno enkrat na mesec.
• low calcium levels in the blood (hypocalcaemia).
• nizke vrednosti kalcija v krvi (hipokalciemija).