FrancophonIA/ELRC3.0 huggingface dataset:
English: Etelcalcetide was efficiently removed with a haemodialysis clearance value of 7.66 L/hour.
Croatian: Etelkalcetid se učinkovito eliminirao s vrijednosti hemodijaliznog klirensa od 7,66 l/sat.
English: Convulsions6
Croatian: Konvulzije6
English: Parsabiv has no or negligible influence on the ability to drive and use machines.
Croatian: Parsabiv ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i strojevima.
English: • heart problems, such as heart failure or arrhythmias (abnormal heart rhythm);
Croatian: • probleme sa srcem, poput zatajenja srca ili aritmija (poremećen srčani ritam);
English: Once the maintenance phase has been established for a patient, corrected serum calcium should be measured approximately every 4 weeks.
Croatian: Jednom kada se uspostavi faza održavanja za bolesnika, korigirani kalcij u serumu treba mjeriti približno svaka 4 tjedna.
English: • Disturbances in the heart's electrical activity seen as QT prolongation on electrocardiogram
Croatian: • Poremećaj električne aktivnosti srca, što je vidljivo kao produljenje QT intervala na elektrokardiogramu
English: What Parsabiv looks like and contents of the pack Parsabiv is a clear and colourless liquid.
Croatian: Kako Parsabiv izgleda i sadržaj pakiranja Parsabiv je bistra i bezbojna tekućina.
English: What Parsabiv is and what it is used for What you need to know before you use Parsabiv How to use Parsabiv
Croatian: Što je Parsabiv i za što se koristi Što morate znati prije nego počnete primjenjivati Parsabiv Kako primjenjivati Parsabiv
English: Etelcalcetide was mutagenic in some strains of bacteria (Ames), however was not genotoxic in in vitro and in vivo mammalian genotoxicity assays and therefore is considered non-genotoxic in humans.
Croatian: Etelkalcetid je bio mutagen u nekim bakterijskim sojevima (Ames), međutim nije bio genotoksičan u in vitro i in vivo ispitivanjima genotoksičnosti u sisavaca i stoga se ne smatra genotoksičnim u ljudi.
English: For additional information see section 4.
Croatian: Za dodatne informacije, pogledajte dio 4.
English: • Parsabiv is stable for a maximum of 7 cumulative days if stored in the original carton.
Croatian: • Parsabiv je stabilan najdulje 7 uzastopnih dana ako se čuva u originalnoj kutiji.
English: No statistically significant difference between the two groups was observed for the secondary endpoint evaluating the mean number of days of vomiting or nausea per week in the first 8 weeks.
Croatian: Nije opažena statistički značajna razlika između dvije skupine za sekundarnu mjeru ishoda procjene srednje vrijednosti broja dana povraćanja ili mučnine u tjednu tijekom prvih 8 tjedana.
English: Additional recommendations related to the management of low calcium are provided in the table below.
Croatian: Dodatne preporuke povezane sa zbrinjavanjem niske razine kalcija nalaze se u tablici niže.
English: No evidence of altered pharmacokinetic profile, clinical response or safety profile was associated with pre-existing or developing anti-etelcalcetide antibodies.
Croatian: Nije bilo dokaza o promijenjenom farmakokinetičkom profilu, kliničkom odgovoru ili sigurnosnom profilu povezanima s prethodno postojećim ili novonastalim antitijelima na etelkalcetid.
English: Uncommon: may affect up to 1 in 100 people • Seizures (fits or convulsions); for additional information see section 2
Croatian: Manje često: mogu se javiti u manje od 1 na 100 osoba • Epileptički napadaji (napadaji ili konvulzije); za dodatne informacije, pogledajte dio 2
English: Parsabiv should not be diluted.
Croatian: Parsabiv se ne smije razrjeđivati.
English: By controlling the levels of PTH, Parsabiv helps to control calcium and phosphate in your body.
Croatian: Kontroliranjem razine PTH, Parsabiv pomaže kontrolirati razinu kalcija i fosfata u Vašem tijelu.
English: Your PTH levels will be monitored during treatment with Parsabiv and your dose of Parsabiv may be reduced if your PTH levels become very low.
Croatian: Vaša razina PTH pratit će se tijekom liječenja lijekom Parsabiv, a Vaša doza lijeka Parsabiv može biti smanjena ako razina PTH postane vrlo niska.
English: There is no known risk of pharmacokinetic interaction with etelcalcetide.
Croatian: Nema poznatog rizika od farmakokinetičkih interakcija s etelkalcetidom.
English: For albumin levels < 4.0 g/dL cCa (mg/dL) = Total Ca (mg/dL) + (4 - albumin[g/dL])*0.8.
Croatian: Za razine albumina < 4,0 g/dl cCa (mg/dl) = ukupni Ca (mg/dl) + (4 - albumin[g/dl])*0,8.
English: In clinical studies, 7.1% of patients with SHPT treated with Parsabiv for up to 6 months tested positive for binding antibodies.
Croatian: U kliničkim ispitivanjima, 7,1% bolesnika sa SHPT-om liječenih lijekom Parsabiv do 6 mjeseci bilo je pozitivno na vezujuća antitijela.
English: Parsabiv may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate (see section 5.1).
Croatian: Parsabiv se može primjenjivati kao dio terapijskog režima koji uključuje vezače fosfata i/ili sterole vitamina D, kako je primjenjivo (vidjeti dio 5.1).
English: Etelcalcetide is not metabolised by CYP450 enzymes.
Croatian: Etelkalcetid se ne metabolizira preko CYP450 enzima.
English: Available data in rats have shown that etelcalcetide is excreted in milk (see section 5.3).
Croatian: Dostupni podaci na štakorima pokazali su da se etelkalcetid izlučuje u mlijeko (vidjeti dio 5.3).
English: If a regularly scheduled haemodialysis treatment is missed, do not administer any missed doses.
Croatian: Ako se propusti predviđena redovita hemodijaliza, nemojte primjenjivati nijednu propuštenu dozu.
English: 1 See section on description of selected adverse reactions.
Croatian: 1 Vidjeti dio Opis odabranih nuspojava.
English: The recommended starting dose for Parsabiv is 5 mg.
Croatian: Preporučena početna doza lijeka Parsabiv je 5 mg.
English: • Low calcium levels in blood with no symptoms
Croatian: • Niska razina kalcija u krvi bez simptoma
English: • Reinitiate Parsabiv at a dose 5 mg lower than the last administered dose.
Croatian: • Ponovno uvesti lijek Parsabiv u dozi 5 mg nižoj od zadnje primijenjene doze.
English: The expected pharmacological effect of decreased PTH and calcium in blood were observed in animal studies at clinical exposure levels.
Croatian: Očekivani farmakološki učinak snižene razine PTH i kalcija u krvi opažen je u ispitivanjima na životinjama pri razinama kliničke izloženosti.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Parsabiv in one or more subsets of the paediatric population in the treatment of hyperparathyroidism (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Parsabiv u jednoj ili više podskupina pedijatrijske populacije u liječenju hiperparatireoidizma (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Active-controlled study
Croatian: Aktivno kontrolirano ispitivanje
English: If PTH does not return to > 100 pg/mL following dose reduction, the dose should be stopped.
Croatian: Ako se PTH ne vrati na razinu > 100 pg/ml nakon smanjenja doze, doziranje treba prekinuti.
English: However, certain potential manifestations of hypocalcaemia may affect the ability to drive and use machines (see section 4.4).
Croatian: Međutim, određene moguće manifestacije hipokalcijemije mogu utjecati na sposobnost upravljanja vozilima i strojevima (vidjeti dio 4.4).
English: Noncovalent binding of etelcalcetide to plasma proteins is low with a fraction unbound ratio of 0.53.
Croatian: Nekovalentno vezanje etelkalcetida na proteine u plazmi je nisko, s omjerom nevezane frakcije od 0,53.
English: The plasma exposure of biotransformation products was approximately 5-fold higher than that of etelcalcetide and their concentration-time course parallels that of etelcalcetide.
Croatian: Izloženost u plazmi za produkte biotransformacije bila je približno 5 puta veća od izloženosti etelkalcetidu, a njihov tijek koncentracije-vremena odgovara onom etelkalcetida.
English: Patients were maintained on dialysate calcium concentration ≥ 2.25 meq/L.
Croatian: Bolesnici su održavani na koncentraciji kalcija u dijalizatu ≥ 2,25 meq/l.
English: Secondary hyperparathyroidism can cause the loss of calcium from the bones, which can lead to bone pain and fractures and problems with blood and heart vessels.
Croatian: Sekundarni hiperparatireoidizam može uzrokovati gubitak kalcija iz kostiju, što može dovesti do bolova u kostima i prijeloma te probleme s krvnim i srčanim žilama.
English: What you need to know before you use Parsabiv
Croatian: Što morate znati prije nego počnete primjenjivati Parsabiv
English: • If removed from the original carton Parsabiv is stable for a maximum of 4 hours if protected from direct sunlight.
Croatian: • Ako se izvadi iz originalne kutije, Parsabiv je stabilan najdulje 4 sata, ako je zaštićen od izravne sunčeve svjetlosti.
English: If formation of anti-etelcalcetide antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Croatian: Ako se sumnja na stvaranje antitijela na etelkalcetid s klinički značajnim učinkom, potrebno je obratiti se nositelju odobrenja za stavljanje lijeka u promet radi dogovora za testiranje na antitijela.
English: No data are available on the effect of etelcalcetide on human fertility.
Croatian: Nema dostupnih podataka o učinku etelkalcetida na plodnost u ljudi.
English: * Total calcium was measured using Roche modular analyser.
Croatian: * Ukupni kalcij izmjeren je koristeći Roche modularni analizator.
English: Low calcium levels can cause abnormal heart rhythm.
Croatian: Niska razina kalcija može uzrokovati poremećaj srčanog ritma.
English: Worsening heart failure1 QT prolongation1
Croatian: Često pogoršanje zatajenja srca1 produljenje QT intervala1
English: What Parsabiv contains - The active substance is etelcalcetide.
Croatian: Što Parsabiv sadrži - Djelatna tvar je etelkalcetid.
English: If PTH is below 100 pg/mL (10.6 pmol/L), the dose should be reduced or temporarily stopped.
Croatian: Ako je razina PTH niža od 100 pg/ml (10,6 pmol/l), treba smanjiti dozu ili privremeno prekinuti liječenje.
English: In the event that clinically meaningful decreases in corrected serum calcium levels below the lower limit of the normal range occur and/or symptoms of hypocalcaemia occur, the following management is recommended:
Croatian: U slučaju da dođe do klinički značajnih smanjenja razine korigiranog kalcija u serumu ispod donje granice normalnog raspona i/ili da se pojave simptomi hipokalcijemije, preporučuje se sljedeće zbrinjavanje:
English: Parsabiv reduces calcium levels.
Croatian: Parsabiv snižava razine kalcija.
English: At the end of 52 weeks, Parsabiv was not associated with any new safety findings and demonstrated maintenance of treatment effect as evidenced by a decrease in pre-dialysis PTH by > 30% from baseline in 2/3rd of patients.
Croatian: Na kraju razdoblja od 52 tjedna, Parsabiv nije bio povezan s nikakvim novim sigurnosnim nalazima i pokazao je održivost učinka liječenja, dokazano sniženjem razine PTH prije dijalize za > 30% u odnosu na početnu vrijednost u dvije trećine bolesnika.
English: 6.6 Special precautions for disposal and other handling For single use only.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Samo za jednokratnu primjenu.
English: Corrected serum calcium value or clinical symptoms of hypocalcaemia*:
Croatian: Vrijednost korigiranog kalcija u serumu ili klinički simptomi hipokalcijemije*:
English: Intravenous administration 3 times per week at the end of a haemodialysis session resulted in an effective half-life of 3 to 5 days.
Croatian: Intravenska primjena 3 puta tjedno na kraju hemodijalize rezultirala je efektivnim poluvijekom od 3 do 5 dana.
English: In vitro, etelcalcetide did not inhibit or induce CYP450 enzymes and was itself not a substrate for metabolism by CYP450 enzymes.
Croatian: In vitro, etelkalcetid nije inhibirao ili inducirao CYP450 enzime i nije bio supstrat za metabolizam putem CYP450 enzima.
English: In a pre- and post-natal development study in rats there was a minimal increase in perinatal pup mortality, delay in parturition and transient reductions in post-natal growth associated with maternal toxicities of hypocalcaemia, tremoring, and reductions in body weight and food consumption at 1.8 times clinical exposure levels.
Croatian: U ispitivanju pre- i postnatalnog razvoja u štakora postojalo je minimalno povećanje perinatalne smrtnosti mladunčadi, odgođenog okota i prolazne redukcije postnatalnog rasta povezanog s majčinskom toksičnosti hipokalcijemije, tremora te smanjenja tjelesne težine i unosa hrane pri razinama izloženosti 1,8 puta većima od razina kliničke izloženosti.
English: In vitro, etelcalcetide was not a substrate of efflux and uptake transporter proteins; and etelcalcetide was not an inhibitor of common transporter proteins.
Croatian: In vitro, etelkalcetid nije bio supstrat proteinskih prijenosnika za unos i izbacivanje iz stanice; te etelkalcetid nije bio inhibitor uobičajenih proteinskih prijenosnika.
English: It is unknown whether etelcalcetide is present in human milk.
Croatian: Nije poznato je li etelkalcetid prisutan u majčinom mlijeku.
English: < 7.5 mg/dL (1.88 mmol/L) or symptoms of hypocalcaemia
Croatian: < 7,5 mg /dl (1,88 mmol/l) ili simptomi hipokalcijemije
English: Headache Paraesthesia3
Croatian: Često glavobolja parestezija3
English: Concurrent administration may result in severe hypocalcaemia.
Croatian: Istodobna primjena može dovesti do teške hipokalcijemije.
English: Etelcalcetide is biotransformed in blood by reversible disulphide exchange with endogenous thiols to predominantly form conjugate with serum albumin.
Croatian: Biotransformacija etelkalcetida odvija se u krv putem reverzibilne izmjene disulfida s endogenim tiolima pri čemu pretežno nastaje konjugat sa serumskim albuminom.
English: Important information about some of the ingredients of Parsabiv This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Croatian: Važne informacije o nekim sastojcima lijeka Parsabiv Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
English: Adverse reactions from controlled clinical studies and post-marketing experience
Croatian: Nuspojave iz kontroliranih kliničkih ispitivanja i razdoblja nakon stavljanja lijeka u promet
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu ukazala na izravne ili neizravne štetne učinke s obzirom na plodnost (vidjeti dio 5.3).
English: Following a single radiolabelled dose of etelcalcetide in CKD patients with secondary HPT receiving haemodialysis, approximately 60% of dosed [14C]-etelcalcetide was recovered in dialysate and approximately 7% recovered in urine and faeces combined over 175 days of collection period.
Croatian: Nakon primjene jednokratne doze radioaktivno obilježenog etelkalcetida u bolesnika s KBB-om i sekundarnim HPT-om koji su na hemodijalizi, približno je 60% primijenjenog [14C]-etelkalcetida nađeno u dijalizatu i približno 7% u urinu i fecesu zajedno tijekom 175 dana razdoblja prikupljanja.
English: Tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems or heart failure or if you take medicines that can cause heart rhythm problems, while receiving Parsabiv.
Croatian: Obavijestite svog liječnika ako tijekom liječenja lijekom Parsabiv osjetite neuobičajeno brze otkucaje ili lupanje srca, ako imate probleme sa srčanim ritmom ili zatajenje srca ili ako uzimate lijekove koji mogu uzrokovati probleme srčanog ritma.
English: Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminium seal with flip-off dust cover.
Croatian: Bočica (staklo tipa I) za jednokratnu primjenu s čepom (elastomer, s laminiranim fluoropolimerom) i aluminijskim zatvaračem s flip-off poklopcem.
English: Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia (see section 4.8).
Croatian: Smanjenja razine kalcija u serumu mogu produljiti QT interval, što može rezultirati ventrikularnom aritmijom (vidjeti dio 4.8).
English: Potential manifestations of hypocalcaemia include paraesthesias, myalgias, muscle spasm and seizures.
Croatian: Moguće manifestacije hipokalcijemije uključuju paresteziju, mijalgiju, mišićni spazam i napadaje.
English: Parsabiv should be administered at the next haemodialysis treatment at the same dose.
Croatian: Parsabiv treba primijeniti prilikom sljedeće hemodijalize pri istoj dozi.
English: The dose of Parsabiv could be titrated at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve target PTH levels ≤ 300 pg/mL while maintaining serum cCa concentrations.
Croatian: Doza lijeka Parsabiv mogla se titrirati u 5., 9., 17., 25., 33., 41. i 49. tjednu, do maksimalne doze od 15 mg, kako bi se postigle ciljne razine PTH od ≤ 300 pg/ml uz održavanje koncentracija cCa u serumu.
English: Although Parsabiv is cleared by dialysis, haemodialysis has not been studied as a treatment for overdose.
Croatian: Iako se Parsabiv eliminira dijalizom, hemodijaliza nije ispitivana kao metoda liječenja predoziranja.
English: 3 Paraesthesia includes preferred terms of paraesthesia and hypoaesthesia.
Croatian: 3 Parestezija uključuje preporučene pojmove: parestezija i hipoestezija.
English: Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Parsabiv, considering the benefit of breast-feeding to the baby and the benefit of Parsabiv to the mother.
Croatian: Vaš liječnik će Vam pomoći odlučiti hoćete li prekinuti dojenje ili liječenje lijekom Parsabiv, uzimajući u obzir korist dojenja za dijete i korist liječenja lijekom Parsabiv za majku.
English: • Worsening heart failure
Croatian: • Pogoršanje zatajenja srca
English: After discontinuation, therapy can be resumed at a lower dose to maintain PTH in the target range (see section 4.2).
Croatian: Nakon privremenog prekida liječenja, terapija se može ponovno započeti pri nižoj dozi kako bi se razina PTH održala unutar ciljnog raspona (vidjeti dio 4.2).
English: Parsabiv contains the active substance etelcalcetide, which reduces parathyroid hormone known as PTH.
Croatian: Parsabiv sadrži aktivnu tvar etelkalcetid, koji snižava razinu paratireoidnog hormona poznatog kao PTH.
English: Effects of Parsabiv on PTH, corrected serum calcium, phosphate and Ca x P in 6 month placebo-controlled studies
Croatian: Učinci lijeka Parsabiv na PTH, korigirani kalcij u serumu, fosfate i Ca x P tijekom 6-mjesečnih, placebom kontroliranih ispitivanja
English: Cases of seizures have been reported in patients treated with Parsabiv (see section 4.8).
Croatian: Prijavljeni su slučajevi (epileptičkih) napadaja u bolesnika liječenih lijekom Parsabiv (vidjeti dio 4.8).
English: Switch from cinacalcet to Parsabiv
Croatian: Prebacivanje sa cinakalceta na Parsabiv
English: Keep in the original carton in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: You should not receive Parsabiv together with cinacalcet.
Croatian: Ne smijete primati Parsabiv istodobno sa cinakalcetom.
English: If doses are missed for more than 2 weeks, then Parsabiv should be administered at 5 mg, (or 2.5 mg if that was the patient's last administered dose), and titrated to achieve the desired PTH.
Croatian: Ako se doze propuste tijekom više od dva tjedna, onda Parsabiv treba primijeniti pri dozi od 5 mg, (ili 2,5 mg ako je to bila zadnja primijenjena doza u bolesnika), i titrirati kako bi se postigla željena razina PTH.
English: < 8.3 mg/dL (2.08 mmol/L) and ≥ 7.5 mg/dL (1.88 mmol/L)
Croatian: < 8,3 mg /dl (2,08 mmol/l) i ≥ 7,5 mg /dl (1,88 mmol/l)
English: Succinic acid
Croatian: Sukcinatna kiselina
English: There was no effect on male or female fertility when etelcalcetide was administered to rats at exposure levels up to 1.8-fold higher than clinical exposures levels achieved in patients receiving etelcalcetide at 15 mg three times per week.
Croatian: Nije bilo učinka na mušku ili žensku plodnost kada je etelkalcetid primjenjivan u štakora pri razinama izloženosti do 1,8 puta većima od razina kliničke izloženosti postignutih u bolesnika koji su primali etelkalcetid pri dozi od 15 mg tri puta tjedno.
English: In these studies 1% of patients in the Parsabiv group and 0% of patients in the placebo group discontinued treatment due to the adverse event of low serum calcium.
Croatian: U ovim ispitivanjima, 1% bolesnika u skupini koja je primala Parsabiv te 0% bolesnika u skupini na placebu prekinuli su liječenje zbog nuspojave niske razine kalcija u serumu.
English: Dose adjustments based on serum calcium levels
Croatian: Prilagodbe doze na temelju razine kalcija u serumu
English: PTH should be measured after 4 weeks from initiation or dose adjustment of Parsabiv, and approximately every 1-3 months during maintenance.
Croatian: PTH treba izmjeriti 4 tjedna nakon početka primjene ili prilagodbe doze lijeka Parsabiv, te otprilike svakih 1 - 3 mjeseca tijekom faze održavanja.
English: Following 3 times a week intravenous dosing at the end of each 3 to 4 hour haemodialysis session in CKD patients, etelcalcetide plasma levels reached near steady-state 4 weeks after dosing with an observed accumulation ratio of 2- to 3-fold.
Croatian: Nakon intravenske primjene 3 puta tjedno, na kraju svake 3- do 4-satne hemodijalize u bolesnika s KBB-om, razine etelkalcetida u plazmi približno su dostigle stanje dinamičke ravnoteže 4 tjedna nakon doziranja, uz opaženi omjer akumulacije od 2 do 3 puta.
English: No body weight, gender, age, or race-related pharmacokinetic differences have been observed in adult patients studied.
Croatian: Nisu opažene razlike u farmakokinetici s obzirom na tjelesnu težinu, spol, dob ili rasu u ispitivanih odraslih bolesnika.
English: The average duration of haemodialysis prior to study entry was 5.4 years and 68% of patients were receiving vitamin D sterols at study entry, with 83% receiving phosphate binders.
Croatian: Prosječno trajanje hemodijalize prije uključivanja u ispitivanje bilo je 5,4 godina, a 68% bolesnika uzimalo je sterole vitamina
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 osjetljivi na kalcij na površini glavnih stanica paratireoidne žlijezde glavni su regulatori sekrecije PTH.
English: Each mL contains 5 mg etelcalcetide.
Croatian: Svaki ml sadrži 5 mg etelkalcetida.
English: Following a single intravenous bolus administration of 5 mg etelcalcetide, PTH levels decreased rapidly within 30 minutes post-dose and were maximally decreased for 1 hour, before returning to baseline.
Croatian: Nakon jednokratne intravenske bolus primjene etelkalcetida u dozi od 5 mg, razine PTH brzo su se smanjile unutar 30 minuta nakon primjene i bile najniže tijekom 1 sata, prije nego su se vratile na početnu vrijednost.
English: • Low phosphate levels in blood
Croatian: • Niska razina fosfata u krvi
English: Parsabiv decreased PTH regardless of baseline PTH, duration of dialysis, and whether or not patients were receiving vitamin D sterols.
Croatian: Parsabiv je smanjio razinu PTH neovisno o početnoj razini PTH, trajanju dijalize i o tome jesu li, ili nisu bolesnici primali sterole vitamina D.
English: Studies in rats showed [14C]-etelcalcetide was excreted in the milk at concentrations similar to plasma.
Croatian: Ispitivanja na štakorima pokazala su da se [14C]-etelkalcetid izlučuje u mlijeko u koncentracijama sličnima onoj u plazmi.
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Croatian: Kloridna kiselina (za prilagođavanje pH)
English: Etelcalcetide is a synthetic peptide calcimimetic agent which reduces PTH secretion through binding and activation of the calcium-sensing receptor.
Croatian: Etelkalcetid je sintetski kalcimimetički peptid koji snižava sekreciju PTH putem vezanja i aktivacije receptora osjetljivih na kalcij.