FrancophonIA/ELRC3.0 huggingface dataset:
English: Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
Croatian: Parsabiv je indiciran za liječenje sekundarnog hiperparatireoidizma (SHPT) u odraslih bolesnika s kroničnom bolesti bubrega (KBB) na terapiji hemodijalizom.
English: A 6-month, double-blind, active-controlled study compared the efficacy and safety of Parsabiv with cinacalcet in 683 SHPT patients with CKD on haemodialysis.
Croatian: Dvostruko-slijepo, aktivno kontrolirano ispitivanje u trajanju od 6 mjeseci usporedilo je djelotvornost i sigurnost lijeka Parsabiv sa cinakalcetom u 683 bolesnika sa SHPT-om i KBB-om na hemodijalizi.
English: The median average weekly dose of Parsabiv during the efficacy assessment period (EAP) was 20.4 mg (6.8 mg per administration).
Croatian: Medijan prosječne tjedne doze lijeka Parsabiv tijekom razdoblja procjene djelotvornosti iznosio je 20,4 mg (6,8 mg po primjeni).
English: All subjects received Parsabiv at a starting dose of 5 mg 3 times a week.
Croatian: Svi ispitanici primali su Parsabiv u početnoj dozi od 5 mg 3 puta tjedno.
English: The pharmacokinetics of etelcalcetide is linear and does not change over time following single (5 to 60 mg) and multiple intravenous doses (2.5 to 20 mg) in CKD patients with secondary HPT receiving haemodialysis.
Croatian: Farmakokinetika etelkalcetida je linearna i ne mijenja se tijekom vremena nakon intravenske primjene jednokratne doze (5 do 60 mg ) i višekratnih doza (2,5 do 20 mg ) u bolesnika s KBB-om i sekundarnim HPT-om koji su na hemodijalizi.
English: The recommended initial dose of etelcalcetide is 5 mg administered by bolus injection 3 times per week.
Croatian: Preporučena početna doza etelkalcetida je 5 mg primijenjeno bolus injekcijom 3 puta tjedno.
English: - The other ingredients are sodium chloride, succinic acid, water for injections, hydrochloric acid, and sodium hydroxide.
Croatian: - Drugi sastojci su: natrijev klorid, sukcinatna kiselina, voda za injekcije, kloridna kiselina i natrijev hidroksid.
English: Serum calcium levels should be closely monitored in patients with congenital long QT syndrome, previous history of QT prolongation, family history of long QT syndrome or sudden cardiac death and other conditions that predispose to QT prolongation and ventricular arrhythmia while being treated with Parsabiv.
Croatian: Razine kalcija u serumu treba pomno pratiti u bolesnika s urođenim sindromom dugog QT intervala, s produljenjem QT intervala u anamnezi, sa sindromom dugog QT intervala ili iznenadnom srčanom smrti u obiteljskoj anamnezi i drugim predisponirajućim stanjima za produljenje QT intervala i ventrikularnu aritmiju tijekom liječenja lijekom Parsabiv.
English: The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks to a maximum dose of 15 mg 3 times per week to achieve the desired parathyroid hormone (PTH) target.
Croatian: Doza se može povećavati postepeno po 2,5 mg ili 5 mg, ne češće od jedanput svaka 4 tjedna, do maksimalne doze od 15 mg 3 puta tjedno, kako bi se postigla željena ciljna vrijednost paratireoidnog hormona (PTH).
English: In mouse and rat carcinogenicity studies, there were no etelcalcetide-related tumours up to exposure of 0.4-fold clinical exposure levels.
Croatian: U ispitivanjima kancerogenosti u miševa i štakora, nije bilo tumora povezanih s etelkalcetidom do izloženosti koje su iznosile 0,4 puta od razina kliničke izloženosti.
English: Parsabiv should be titrated so that doses are individualised between 2.5 mg and 15 mg.
Croatian: Parsabiv treba titrirati tako da su doze prilagođene pojedinom bolesniku između 2,5 mg i 15 mg.
English: Parenteral medicinal products should be inspected visually for particulate matter and change in colour prior to administration.
Croatian: Parenteralne lijekove treba prije primjene vizualno pregledati zbog prisutnosti čestica i promjene boje.
English: • Numbness or tingling sensation
Croatian: • Osjećaj utrnulosti ili trnaca
English: It is not known whether Parsabiv can pass into breast milk.
Croatian: Nije poznato prelazi li Parsabiv u majčino mlijeko.
English: 2 Hyperkalaemia includes preferred terms of hyperkalaemia and blood potassium increased.
Croatian: 2 Hiperkalijemija uključuje preporučene pojmove: hiperkalijemija i povišena razina kalija u krvi.
English: In the studies total serum calcium was measured using Roche modular analysers.
Croatian: U ispitivanjima, ukupni kalcij u serumu bio je mjeren pomoću Roche modularnog analizatora.
English: Decreased myocardial performance, hypotension, and congestive heart failure (CHF) may be associated with significant reductions in serum calcium levels.
Croatian: Smanjena funkcionalnost miokarda, hipotenzija i kongestivno zatajenje srca mogu biti povezani sa značajnim sniženjima razina kalcija u serumu.
English: There were no effects on embryo-foetal development in rats and rabbits when exposed to up to 1.8 to 4.3 times clinical exposure levels during organogenesis.
Croatian: Nije bilo učinaka na embrio-fetalni razvoj u štakora i kunića koji su bili izloženi dozama od 1,8 do 4,3 puta većima od razina kliničke izloženosti tijekom organogeneze.
English: Parsabiv was associated with reductions in bone metabolism markers (bone specific alkaline phosphatase and type I collagen c-telopeptide) and fibroblast growth factor 23 (exploratory endpoints) at the end of the study (week 27), compared with placebo.
Croatian: U usporedbi s placebom, Parsabiv je bio povezan sa smanjenjem markera koštanog metabolizma (alkalna fosfataza specifična za kosti i c-telopeptid kolagena tipa 1) i faktora rasta fibroblasta 23 (eksploratorne mjere ishoda) na kraju ispitivanja (27. tjedan).
English: How to use Parsabiv
Croatian: Kako primjenjivati Parsabiv
English: The ratio of blood-to-plasma [14C]-etelcalcetide concentrations is approximately 0.6.
Croatian: Omjer koncentracija [14C]-etelkalcetida u krvi i plazmi je približno 0,6.
English: When given during rinse-back at least 150 mL of rinse-back volume should be administered after injection.
Croatian: Kada se primjenjuje tijekom ispiranja, nakon injiciranja treba primijeniti najmanje 150 ml volumena za ispiranje.
English: Parsabiv is used to treat secondary hyperparathyroidism in patients with serious kidney disease who need haemodialysis to clear their blood of waste products.
Croatian: Parsabiv se koristi u liječenju sekundarnog hiperparatireoidizma u bolesnika s ozbiljnom bolesti bubrega koji trebaju hemodijalizu da bi pročistili krv od otpadnih produkata.
English: Discontinuation of therapy as a result of undesirable effects was mainly due to low blood calcium, nausea, and vomiting.
Croatian: Prekid terapije kao rezultat nuspojava uglavnom je bio posljedica niske razine kalcija u krvi, mučnine i povraćanja.
English: It will be given by a doctor or nurse at the end of your haemodialysis treatment through the tube (bloodline) that connects you to the haemodialysis machine. Parsabiv will be given 3 times per week.
Croatian: Primijenit će je liječnik ili medicinska sestra na kraju Vaše hemodijalize kroz cjevčicu (krvnu liniju) koja Vas povezuje s aparatom za hemodijalizu.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake 'Rok valjanosti'.
English: The inter-subject variability of the system clearance in the patient population is approximately
Croatian: Varijabilnost sistemskog klirensa između ispitanika u populaciji bolesnika bila je približno 70%.
English: A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Parsabiv therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se odlučiti o prekidu dojenja ili prekidu/privremenom prekidu terapije lijekom Parsabiv, uzevši u obzir koristi dojenja za dijete i koristi terapije za majku.
English: The effect of reducing PTH levels was maintained throughout the 6-month dosing period when etelcalcetide was administered by intravenous bolus 3 times a week.
Croatian: Učinak sniženja razina PTH bio je održan tijekom razdoblja doziranja od 6 mjeseci, kada je etelkalcetid primjenjivan intravenski kao bolus injekcija 3 puta tjedno.
English: • If clinically indicated: start or increase calcium supplements, calciumcontaining phosphate binders, and/or vitamin D sterols.
Croatian: • Ako je klinički indicirano: započeti ili povećati primjenu nadomjestaka kalcija, vezača fosfata koji sadrže kalcij i/ili sterola vitamina D. povećati koncentraciju kalcija u dijalizatu.
English: Patients with > 30% reduction in PTH during the EAP, n (%)
Croatian: Bolesnici sa sniženjem PTH > 30% tijekom razdoblja procjene djelotvornosti, n (%)
English: The starting dose of cinacalcet was 30 mg daily, titrated every 4 weeks in 30 mg increments or 60 mg for the last uptitration to a maximum dose of 180 mg daily following the cinacalcet prescribing information.
Croatian: Početna doza cinakalceta bila je 30 mg dnevno, titrirano svaka 4 tjedna u povećanjima od 30 mg ili povećanju od 60 mg za zadnju titraciju, do maksimalne doze od 180 mg dnevno, u skladu s uputama za propisivanje cinakalceta.
English: Parsabiv is a solution for injection in a vial.
Croatian: Parsabiv je otopina za injekciju u bočici.
English: LIST OF EXCIPIENTS Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide.
Croatian: POPIS POMOĆNIH TVARI Natrijev klorid, sukcinatna kiselina, voda za injekcije, kloridna kiselina, natrijev hidroksid.
English: The reduction in PTH is associated with a concomitant decrease in serum calcium and phosphate levels.
Croatian: Sniženje razine PTH povezano je s istodobnim sniženjem razina kalcija i fosfata u serumu.
English: The threshold for seizures may be lowered by significant reductions in serum calcium levels.
Croatian: Prag za pojavu napadaja može biti snižen značajnim sniženjima razina kalcija u serumu.
English: Most events of asymptomatic blood calcium decreased and symptomatic hypocalcaemia were mild or moderate in severity.
Croatian: Većina događaja asimptomatskog sniženja kalcija u krvi i simptomatske hipokalcijemije bili su blage do umjerene težine.
English: Patients receiving Parsabiv should not be given cinacalcet (see section 4.4).
Croatian: Parsabiv ne smije se davati cinakalcet (vidjeti dio 4.4).
English: In addition, Parsabiv decreased pre-dialysis PTH to ≤ 300 pg/mL in more than 50% of patients and decreased mean PTH, cCa, cCa x P, and phosphate from baseline.
Croatian: Dodatno, Parsabiv je smanjio razinu PTH prije dijalize na ≤ 300 pg/ml u više od 50% bolesnika te je smanjio srednje razine PTH, cCa, cCa x P i fosfata u odnosu na početnu vrijednost.
English: Key secondary endpoints were the proportion of patients who achieved > 50% and > 30% reductions from baseline in mean PTH during the EAP and the mean number of days of vomiting or nausea per week in the first 8 weeks, sequentially tested for superiority.
Croatian: Ključne sekundarne mjere ishoda bile su udio bolesnika koji su postigli sniženja srednje vrijednosti PTH od > 50% i > 30% u odnosu na početnu vrijednost tijekom razdoblja procjene djelotvornosti i srednja vrijednost broja dana povraćanja ili mučnine u tjednu tijekom prvih 8 tjedana, sekvencionalno testirani za superiornost.
English: • Low calcium levels in blood with symptoms such as tingling around the mouth or in the extremities, muscle aches or cramps and seizures (fits)
Croatian: • Niska razina kalcija u krvi sa simptomima poput utrnulosti oko usta ili u udovima, bolova u mišićima ili grčeva i napadaja
English: In the combined placebo-controlled studies, the subject incidence of adjudicated CHF events requiring hospitalisation was 2.2% in the Parsabiv treatment group compared to 1.2% in the placebo group.
Croatian: U kombiniranim placebom kontroliranim ispitivanjima, incidencija ispitanika s procijenjenim događajima kongestivnog zatajenja srca koji su zahtijevali hospitalizaciju bila je 2,2% u skupini koja je primala Parsabiv, u usporedbi s 1,2% u skupini na placebu.
English: The dosing regimen for Parsabiv was similar to that in the placebo-controlled studies (starting dose of 5 mg titrated every 4 weeks with 2.5 mg to 5 mg increments to a maximum of 15 mg 3 times a week).
Croatian: Režim doziranja lijeka Parsabiv bio je sličan onom u placebom kontroliranim ispitivanjima (početna doza od 5 mg titrirana je svaka 4 tjedna u povećanjima od 2,5 mg do 5 mg, do maksimalne doze od 15 mg 3 puta tjedno).
English: Closely monitor serum calcium (see section 4.5).
Croatian: Potrebno je pomno pratiti razinu kalcija u serumu (vidjeti dio 4.5).
English: Since etelcalcetide lowers serum calcium, patients should be advised to seek medical attention if they experience symptoms of hypocalcaemia and should be monitored for the occurrence of hypocalcaemia (see section 4.2).
Croatian: S obzirom da etelkalcetid snižava razinu kalcija u serumu, bolesnike treba savjetovati da potraže liječničku pomoć ako im se jave simptomi hipokalcijemije i treba ih pratiti zbog pojave hipokalcijemije (vidjeti dio 4.2).
English: How to store Parsabiv
Croatian: Kako čuvati Parsabiv
English: For further information regarding potential manifestations of hypocalcaemia and serum calcium monitoring please see sections 4.4 and 4.2 respectively.
Croatian: Za daljnje informacije o mogućim manifestacijama hipokalcijemije i praćenju razine kalcija u serumu vidjeti dio 4.4, odnosno 4.2.
English: If clinically meaningful decreases in corrected serum calcium levels occur, steps should be taken to increase serum calcium levels (see section 4.2).
Croatian: U slučaju pojave klinički značajnih sniženja razina korigiranog kalcija u serumu, treba poduzeti mjere za povećanje razina kalcija u serumu (vidjeti dio 4.2).
English: Please tell your doctor if you have 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 Parsabiv.
Croatian: Molimo, obavijestite svog liječnika ako tijekom liječenja lijekom Parsabiv imate grčeve ili trzaje mišića, utrnulost ili trnce u prstima ruku i nogu ili oko usta, ili napadaje, smetenost ili gubitak svijesti.
English: Patients with lower screening PTH levels typically required lower doses (median average weekly doses of 15.0 mg, 21.4 mg, 27.1 mg, respectively, for patients with screening PTH levels < 600 pg/mL, 600 to ≤ 1,000 pg/mL, and > 1,000 pg/mL).
Croatian: Bolesnicima s nižim razinama PTH prilikom probira obično su bile potrebne niže doze (medijan prosječne tjedne doze bio je 15,0 mg za bolesnike s razinama PTH prilikom probira < 600 pg/ml, 21,4 mg za bolesnike s razinama PTH prilikom probira od 600 do ≤ 1000 pg/ml i 27,1 mg za bolesnike s razinama PTH prilikom probira > 1000 pg/ml).
English: Worsening heart failure
Croatian: Pogoršanje zatajenja srca
English: Two 6-month, double-blind, placebo-controlled clinical studies were conducted in SHPT patients with CKD receiving haemodialysis 3 times per week (n = 1,023).
Croatian: Dva dvostruko-slijepa, placebom kontrolirana ispitivanja u trajanju od 6 mjeseci provedena su u bolesnika sa SHPT-om i KBB-om koji su primali hemodijalizu 3 puta tjedno (n = 1023).
English: A 52-week, single arm extension study to the placebo-controlled and “switch” studies described above was conducted to characterise the long term safety and efficacy of Parsabiv in 891 SHPT patients with CKD on haemodialysis.
Croatian: Nastavci ispitivanja s jednom skupinom, u trajanju od 52 tjedna provedeni su za gore opisano placebom kontrolirano ispitivanje i ispitivanje prebacivanja, kako bi se okarakterizirale dugotrajna sigurnost i djelotvornost lijeka Parsabiv u 891 bolesnika sa SHPT-om i KBB-om na hemodijalizi.
English: In the combined placebo-controlled studies, a higher proportion of patients in the Parsabiv group compared with patients in the placebo group developed at least one serum cCa value < 7.0 mg/dL (1.75 mmol/L) (7.6% Parsabiv; 3.1% placebo), < 7.5 mg/dL (1.88 mmol/L) (27.1% Parsabiv; 5.5% placebo), and < 8.3 mg/dL (2.08 mmol/L) (78.6% Parsabiv; 19.4% placebo).
Croatian: U kombiniranim placebom kontroliranim ispitivanjima, u usporedbi sa skupinom na placebu, u skupini koja je primala Parsabiv bio je viši udio bolesnika u kojih je razina cCa najmanje jedanput bila < 7,0 mg /dl (1,75 mmol/l) (7,6% Parsabiv ; 3,1% placebo), < 7,5 mg /dl (1,88 mmol/l) (27,1% Parsabiv ; 5,5% placebo), te < 8,3 mg /dl (2,08 mmol/l) (78,6% Parsabiv ; 19,4% placebo).
English: Parsabiv is administered into the venous line of the dialysis circuit at the end of the haemodialysis treatment during rinse-back or intravenously after rinse-back.
Croatian: Parsabiv se primjenjuje u vensku liniju dijaliznog sustava na kraju dijaliznog liječenja, tijekom faze ispiranja ili intravenski nakon ispiranja.
English: If rinse-back is completed and Parsabiv was not administered, then it may be administered intravenously followed by at least 10 mL saline flush volume.
Croatian: Ako se ispiranje dovrši bez primjene lijeka Parsabiv, tada se može primijeniti intravenski, nakon čega se primjenjuje najmanje 10 ml fiziološke otopine za ispiranje.
English: Phosphate
Croatian: Fosfat
English: Parsabiv should not be initiated in patients until 7 days after the last dose of cinacalcet and the corrected serum calcium is at or above the lower limit of the normal range (see section 5.1).
Croatian: Parsabiv se ne smije započeti primjenjivati u bolesnika do 7. dana od zadnje doze cinakalceta i dok razina korigiranog kalcija u serumu ne bude na ili iznad donje granice normalnog raspona (vidjeti dio 5.1).
English: Etelcalcetide is rapidly cleared in subjects with normal renal function, whilst in CKD patients requiring haemodialysis, etelcalcetide was predominantly eliminated by haemodialysis.
Croatian: Etelklacetid se brzo eliminira u ispitanika s normalnom funkcijom bubrega, dok se u bolesnika s KBB-om kojima je potrebna hemodijaliza najveći dio etelkalcetida eliminira hemodijalizom.
English: • High potassium levels in blood
Croatian: • Visoka razina kalija u krvi
English: “Switch study”
Croatian: “Ispitivanje prebacivanja”
English: Parsabiv was non-inferior to cinacalcet for the primary endpoint, and was superior to cinacalcet for the secondary endpoints of proportion of patients achieving > 30% reduction from baseline in mean PTH during the EAP (68.2% Parsabiv versus 57.7% cinacalcet; p = 0.004); and proportion of patients achieving > 50% reduction from baseline in mean PTH during the EAP (52.4% Parsabiv versus 40.2% cinacalcet; p = 0.001).
Croatian: Parsabiv je bio neinferioran u odnosu na cinakalcet s obzirom na primarnu mjeru ishoda, te je bio superioran u odnosu na cinakalcet s obzirom na sekundarne mjere ishoda udjela bolesnika koji su postigli sniženje srednje razine PTH > 30% u odnosu na početnu vrijednost tijekom razdoblja procjene djelotvornosti (68,2% Parsabiv naspram 57,7% cinakalcet; p = 0,004); i udjela bolesnika koji su postigli sniženje srednje razine PTH > 50% u odnosu na početnu vrijednost tijekom razdoblja procjene djelotvornosti (52,4% Parsabiv naspram 40,2% cinakalcet; p = 0,001).
English: Patients with ≤ 300 pg/mL in PTH during the EAP, n (%)
Croatian: Bolesnici s PTH ≤ 300 pg/ml tijekom razdoblja procjene djelotvornosti, n (%)
English: Serum calcium levels should be monitored in patients with a history of congestive heart failure while being treated with Parsabiv (see section 4.2), which may be associated with reductions in serum calcium levels.
Croatian: Razine kalcija u serumu treba pratiti tijekom liječenja lijekom Parsabiv u bolesnika s kongestivnim zatajenjem srca u anamnezi (vidjeti dio 4.2), koje može biti povezano sa sniženjima razina kalcija u serumu.
English: Serum calcium levels should be measured prior to initiating treatment, within 1 week of initiation or dose adjustment of Parsabiv and every 4 weeks during treatment.
Croatian: Razine kalcija u serumu treba izmjeriti prije početka liječenja, unutar 1 tjedna od početka liječenja ili prilagodbe doze lijeka Parsabiv i svaka 4 tjedna tijekom liječenja.
English: No specific pharmacokinetic studies of etelcalcetide have been conducted in patients with mild to severe kidney impairment.
Croatian: Nisu provedena specifična ispitivanja farmakokinetike etelkalcetida u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
English: Patients were administered Parsabiv or placebo at a starting dose of 5 mg 3 times per week at the end of haemodialysis and titrated every 4 weeks through week 17 to a maximum dose of 15 mg 3 times per week to achieve target PTH level ≤ 300 pg/mL.
Croatian: Bolesnicima je primijenjen Parsabiv ili placebo u početnoj dozi od 5 mg 3 puta tjedno na kraju hemodijalize, a doza je titrirana svaka 4 tjedna tijekom 17 tjedana do maksimalne doze od 15 mg 3 puta tjedno, kako bi se postigla ciljna razina PTH od ≤ 300 pg/ ml.
English: Ventricular arrhythmia and QT prolongation secondary to hypocalcaemia
Croatian: Ventrikularna aritmija i produljenje QT intervala kao posljedica hipokalcijemije
English: Hypersensitivity reactions1 (including anaphylaxis)
Croatian: Kategorija učestalosti Nuspojave Poremećaji imunološkog sustava Nepoznato reakcije preosjetljivosti1 (uključujući anafilaksiju)
English: Reduction in PTH levels correlated with plasma etelcalcetide concentrations in haemodialysis patients.
Croatian: Sniženje razine PTH u korelaciji je s koncentracijom etelkalcetida u plazmi u bolesnika na hemodijalizi.
English: 4 Asymptomatic reductions in calcium below 7.5 mg/dL (1.88 mmol/L) or clinically significant asymptomatic reductions in serum cCa between 7.5 and < 8.3 mg/dL (1.88 and < 2.08 mmol/L) (that required medical management).
Croatian: 4 Asimptomatska sniženja razine kalcija ispod 7,5 mg/dl (1,88 mmol/l) ili klinički značajna asimptomatska sniženja razine korigiranog kalcija u serumu između 7,5 i < 8,3 mg/dl (1,88 mmol/l i < 2,08 mmol/l) (koja su zahtijevala liječničko zbrinjavanje).
English: Results from a study which evaluated changes in corrected serum calcium levels when switching patients from cinacalcet to Parsabiv showed that treatment with Parsabiv, at a starting dose of 5 mg, could be safely initiated after a 7-day discontinuation of cinacalcet, provided that the corrected serum calcium was ≥ 8.3 mg/dL (2.08 mmol/L).
Croatian: Rezultati ispitivanja koje je procijenilo promjene razina korigiranog kalcija u serumu prilikom prebacivanja bolesnika sa cinakalceta na Parsabiv pokazalo je da se liječenje lijekom Parsabiv pri početnoj dozi od 5 mg može sigurno započeti nakon 7-dnevnog razdoblja prekida liječenja cinakalcetom, uz uvjet da je razina korigiranog kalcija u serumu bila ≥ 8,3 mg /dl (2,08 mmol/l).
English: In the event of overdose, serum calcium should be checked and patients should be monitored for symptoms of hypocalcaemia (see section 4.4) and appropriate measures should be taken (see section 4.2).
Croatian: U slučaju predoziranja treba provjeriti razinu kalcija u serumu i pratiti bolesnike zbog moguće pojave simptoma hipokalcijemije (vidjeti dio 4.4) te je potrebno poduzeti odgovarajuće mjere (vidjeti dio 4.2).
English: Serum calcium should be measured within 1 week of initiation or dose adjustment of Parsabiv.
Croatian: Razina kalcija u serumu treba se mjeriti unutar jednog tjedna od početka liječenja ili od prilagodbe doze lijeka Parsabiv.
English: The lower limit of the normal range for corrected serum calcium was 8.3 mg/dL (2.08 mmol/L).
Croatian: Donja granica normalnog raspona za korigirani kalcij u serumu bila je 8,3 mg /dl (2,08 mmol/l).
English: Very common side effects with Parsabiv are blood calcium decreased, muscle spasms, diarrhoea, nausea, and vomiting.
Croatian: Vrlo česte nuspojave lijeka Parsabiv su snižena razina kalcija u krvi, mišićni spazam, proljev, mučnina i povraćanje.
English: Contact details are provided in section 6 of the package leaflet.
Croatian: Kontakt podaci nalaze se u dijelu 6 upute o lijeku.
English: No specific study in patients with hepatic impairment was performed.
Croatian: Nisu provedena specifična ispitivanja u bolesnika s oštećenjem funkcije jetre.