FrancophonIA/ELRC3.0 huggingface dataset:
English: • Reinitiate Parsabiv at a dose 5 mg lower than the last administered dose.
Slovenian: • Ponovno uvedite zdravilo Parsabiv v odmerku, ki je 5 mg manjši od zadnjega uporabljenega odmerka.
English: Tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant when taking Parsabiv.
Slovenian: Zdravniku morate povedati, če ste noseči, če menite, da ste noseči, ali če med zdravljenjem z zdravilom Parsabiv načrtujete zanositev.
English: For albumin levels < 4.0 g/dL cCa (mg/dL) = Total Ca (mg/dL) + (4 - albumin[g/dL])*0.8.
Slovenian: Pri koncentraciji albumina < 4,0 g/dl je cCa (mg/dl) = celotni Ca (mg/dl) + (4 - albumin [g/dl])*0,8.
English: You and your doctor should decide if you should use Parsabiv.
Slovenian: Skupaj z zdravnikom bosta presodila, ali naj uporabljate zdravilo Parsabiv.
English: If PTH is below 100 pg/mL (10.6 pmol/L), the dose should be reduced or temporarily stopped.
Slovenian: Če je PTH pod 100 pg/ml (10,6 pmol/l), je treba odmerek zmanjšati ali uporabo zdravila začasno prekiniti.
English: What Parsabiv looks like and contents of the pack Parsabiv is a clear and colourless liquid.
Slovenian: Izgled zdravila Parsabiv in vsebina pakiranja Zdravilo Parsabiv je bistra in brezbarvna tekočina.
English: Uncommon: may affect up to 1 in 100 people • Seizures (fits or convulsions); for additional information see section 2
Slovenian: Občasni: pojavijo se lahko pri do 1 od 100 bolnikov • Konvulzije (napadi krčev, podobni epileptičnim); za dodatne informacije glejte poglavje 2
English: Parsabiv has not been tested in pregnant women.
Slovenian: Zdravilo Parsabiv ni preizkušeno pri nosečnicah.
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.
Slovenian: V študiji pre- in postnatalnega razvoja na podganah so ugotovili minimalno povečanje perinatalne umrljivosti mladičev, zapoznelo parturicijo in prehodno upočasnitev postnatalne rasti v povezavi z maternalnimi toksičnimi učinki hipokalciemije, tremorja in zmanjšanja telesne mase in uživanja hrane ob 1,8-kratniku klinične izpostavljenosti.
English: It is not known whether Parsabiv can pass into breast milk.
Slovenian: Ni znano, ali lahko zdravilo Parsabiv prehaja v materino mleko.
English: • Low calcium levels in blood with no symptoms
Slovenian: • Nizka koncentracija kalcija v krvi brez simptomov
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.
Slovenian: Etelkalcetid je bil mutagen pri nekaterih sevih bakterij (Ames), niti in vitro niti in vivo pa ni bil genotoksičen v preskusih genotoksičnosti pri sesalcih, zato ne velja za genotoksičnega za človeka.
English: Convulsions6
Slovenian: Občasni konvulzije6
English: The recommended starting dose for Parsabiv is 5 mg.
Slovenian: Priporočeni začetni odmerek zdravila Parsabiv je 5 mg.
English: What you need to know before you use Parsabiv
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Parsabiv
English: For further information regarding potential manifestations of hypocalcaemia and serum calcium monitoring please see sections 4.4 and 4.2 respectively.
Slovenian: Za dodatne informacije o možnih manifestacijah hipokalciemije in o kontrolah kalcija v serumu glejte poglavji 4.4 in 4.2.
English: Patients were maintained on dialysate calcium concentration ≥ 2.25 meq/L.
Slovenian: Bolnike so vzdrževali na koncentraciji kalcija v dializatu ≥ 2,25 meq/l.
English: Available data in rats have shown that etelcalcetide is excreted in milk (see section 5.3).
Slovenian: Razpoložljivi podatki pri podganah kažejo na izločanje etelkalcetida v mleko (glejte poglavje 5.3).
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.
Slovenian: Sekundarni hiperparatiroidizem lahko povzroči izgubljanje kalcija iz kosti, posledice pa so lahko bolečine v kosteh in zlomi kosti ter težave s krvjo in srčnimi žilami.
English: If PTH levels decrease below the recommended target range, the dose of vitamin D sterols and/or Parsabiv should be reduced or therapy discontinued.
Slovenian: Če se koncentracija PTH zniža pod priporočeno ciljno območje, je treba odmerek sterolov vitamina D in/ali zdravila Parsabiv zmanjšati ali zdravljenje prekiniti.
English: Studies in rats showed [14C]-etelcalcetide was excreted in the milk at concentrations similar to plasma.
Slovenian: Študije na podganah so pokazale, da se [14C]-etelkalcetid izloča v mleku v koncentraciji, podobni koncentraciji v plazmi.
English: Etelcalcetide is not metabolised by CYP450 enzymes.
Slovenian: Etelkalcetid se ne presnavlja z encimi CYP450.
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.
Slovenian: Izpostavljenost biotransformiranim produktom v plazmi je bila približno 5-krat večja od izpostavljenosti etelkalcetidu in njihov koncentracijsko-časovni potek je bil vzporeden tistemu pri etelkalcetidu.
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.
Slovenian: Po enkratnem intravenskem bolusu 5 mg etelkalcetida se je koncentracija PTH hitro znižala v 30 minutah po odmerku in je bila maksimalno zmanjšana 1 uro, preden se je vrnila na izhodiščno raven.
English: Patients with > 30% reduction in PTH during the EAP, n (%)
Slovenian: Bolniki z > 30 % znižanjem PTH med OOU, n (%)
English: < 7.5 mg/dL (1.88 mmol/L) or symptoms of hypocalcaemia
Slovenian: < 7,5 mg/dl (1,88 mmol/l) ali simptomi hipokalciemije
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.
Slovenian: Zdravniku morate povedati, če se vam pojavi nenavadno hitro ali močno bitje srca, če imate motnje srčnega ritma ali srčno popuščanje, ali če med zdravljenjem z zdravilom Parsabiv jemljete kakšna zdravila, ki lahko povzročijo težave s srčnim ritmom.
English: The median average weekly dose of Parsabiv during the efficacy assessment period (EAP) was 20.4 mg (6.8 mg per administration).
Slovenian: Mediani povprečni tedenski odmerek zdravila Parsabiv med obdobjem ocenjevanja učinkovitosti (OOU) je bil 20,4 mg (6,8 mg na eno uporabo).
English: You should not receive Parsabiv together with cinacalcet.
Slovenian: Zdravila Parsabiv ne smete dobiti skupaj s cinakalcetom.
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.
Slovenian: Odmerek zdravila Parsabiv so lahko titrirali 5., 9., 17., 25., 33., 41. in 49. teden do največjega odmerka 15 mg, da so dosegli ciljno koncentracijo PTH ≤ 300 pg/ml ob hkratnem vzdrževanju koncentracije cCa v serumu.
English: Most events of asymptomatic blood calcium decreased and symptomatic hypocalcaemia were mild or moderate in severity.
Slovenian: Večina dogodkov z asimptomatskim znižanjem kalcija v krvi in simptomatska hipokalciemija so bili blagi ali zmerni.
English: After discontinuation, therapy can be resumed at a lower dose to maintain PTH in the target range (see section 4.2).
Slovenian: Po prekinitvi je mogoče zdravljenje znova uvesti v manjšem odmerku, da se ohrani koncentracija PTH v ciljnem območju (glejte poglavje 4.2).
English: In vitro, etelcalcetide did not inhibit or induce CYP450 enzymes and was itself not a substrate for metabolism by CYP450 enzymes.
Slovenian: Etelkalcetid in vitro ni zavrl ali induciral encimov CYP450 in sam ni bil substrat presnove z encimi CYP450.
English: Parsabiv should be administered at the next haemodialysis treatment at the same dose.
Slovenian: Zdravilo Parsabiv je treba uporabiti pri naslednjem hemodializem zdravljenju v enakem odmerku.
English: Very low levels of PTH over long periods can result in a type of abnormal bone structure known as adynamic bone which can only be diagnosed by biopsy.
Slovenian: Zelo nizka koncentracija PTH, ki traja dolgo časa, lahko povzroči posebno vrsto nenormalne zgradbe kosti; to motnjo imenujemo adinamična kostna bolezen, diagnosticirati pa jo je mogoče le z biopsijo.
English: PTH should be measured after 4 weeks from initiation or dose adjustment of Parsabiv, and approximately every 1-3 months during maintenance.
Slovenian: PTH je treba izmeriti 4 tedne po uvedbi ali prilagoditvi odmerka zdravila Parsabiv ter približno na vsake 1-3 mesece med obdobjem vzdrževalnega zdravljenja.
English: Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia (see section 4.8).
Slovenian: Znižanje kalcija v serumu lahko podaljša interval QT in povzroči ventrikularne aritmije (glejte poglavje 4.8).
English: “Switch study”
Slovenian: "Študija prehoda"
English: No data are available on the effect of etelcalcetide on human fertility.
Slovenian: Podatkov o vplivu etelkalcetida na plodnost pri človeku ni.
English: 2 Hyperkalaemia includes preferred terms of hyperkalaemia and blood potassium increased.
Slovenian: 2 Hiperkaliemija vključuje prednostna izraza hiperkaliemija in zvišanje kalija v krvi.
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Slovenian: Natrijev hidroksid (za prilagoditev pH)
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.
Slovenian: Vpliv znižanja koncentracije PTH se je ohranil med celotnim 6-mesečnim obdobjem uporabe, če je bil etelkalcetid uporabljan v intravenskem bolusu 3-krat na teden.
English: Active-controlled study
Slovenian: Z učinkovino kontrolirana študija
English: Low calcium levels can cause abnormal heart rhythm.
Slovenian: Nizka koncentracija kalcija lahko povzroči motnje srčnega ritma.
English: Discontinuation of therapy as a result of undesirable effects was mainly due to low blood calcium, nausea, and vomiting.
Slovenian: Vzroki za prenehanje zdravljenja zaradi neželenih učinkov so bili v glavnem nizka koncentracija kalcija v krvi, navzea in bruhanje.
English: There is no known risk of pharmacokinetic interaction with etelcalcetide.
Slovenian: Ni znano, da bi obstajalo tveganje za farmakokinetično medsebojno delovanje z etelkalcetidom.
English: If PTH does not return to > 100 pg/mL following dose reduction, the dose should be stopped.
Slovenian: Če se PTH po zmanjšanju odmerka ne vrne na > 100 pg/ml, je treba uporabo prekiniti.
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'.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Parsabiv To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo; kar v bistvu pomeni, da je praktično "brez natrija".
English: Patients with ≤ 300 pg/mL in PTH during the EAP, n (%)
Slovenian: Bolniki z ≤ 300 pg/ml PTH med OOU, n (%)
English: The ratio of blood-to-plasma [14C]-etelcalcetide concentrations is approximately 0.6.
Slovenian: Razmerje koncentracije [14C]-etelkalcetida med krvjo in plazmo je približno 0,6.
English: • heart problems, such as heart failure or arrhythmias (abnormal heart rhythm);
Slovenian: • težave s srcem, na primer srčno popuščanje ali motnje srčnega ritma (aritmije),
English: Noncovalent binding of etelcalcetide to plasma proteins is low with a fraction unbound ratio of 0.53.
Slovenian: Nekovalentna vezava etelkalcetida na beljakovine v plazmi je majhna, frakcijsko nevezano razmerje je 0,53.
English: Adynamic bone may develop if PTH levels are chronically suppressed below 100 pg/mL.
Slovenian: Adinamična kostna bolezen se lahko pojavi, če je koncentracija PTH kronično zavrta pod 100 pg/ml.
English: consider reducing Parsabiv dose.
Slovenian: - razmislite o zmanjšanju odmerka zdravila Parsabiv.
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.
Slovenian: V 6-mesečni, dvojno slepi, z učinkovino kontrolirani študiji so primerjali učinkovitost in varnost zdravila Parsabiv s cinakalcetom pri 683 bolnikih s KLB in SHPT, zdravljenih s hemodializo.
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prekinitvijo/prenehanjem zdravljenja z zdravilom Parsabiv, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Contact details are provided in section 6 of the package leaflet.
Slovenian: Kontaktni podatki so navedeni v poglavju 6 navodila za uporabo.
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.
Slovenian: Med zdravljenjem z zdravilom Parsabiv je treba koncentracijo kalcija v serumu skrbno kontrolirati pri bolnikih s sindromom prirojenega dolgega intervala QT, anamnezo predhodnega podaljšanja intervala QT, družinsko anamnezo sindroma dolgega intervala QT ali nenadne srčne smrti ter z drugimi motnjami, ki povečujejo nagnjenost k podaljšanju intervala QT in ventrikularnim aritmijam.
English: By controlling the levels of PTH, Parsabiv helps to control calcium and phosphate in your body.
Slovenian: Z uravnavanjem ravni PTH, zdravilo Parsabiv pomaga uravnavati raven kalcija in fosfata v telesu.
English: Effects of Parsabiv on PTH, corrected serum calcium, phosphate and Ca x P in 6 month placebo-controlled studies
Slovenian: Preglednica 2: Vpliv zdravila Parsabiv na PTH, korigirani kalcij v serumu, fosfat in Ca x P v 6-mesečnih, s placebom kontroliranih študijah
English: 1 See section on description of selected adverse reactions.
Slovenian: 1 Glejte podpoglavje Opis izbranih neželenih učinkov.
English: Parsabiv should not be diluted.
Slovenian: Zdravila Parsabiv se ne sme redčiti.
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.
Slovenian: Po koncu 52 tednov ni bilo pri zdravilu Parsabiv nobenih novih izsledkov o varnosti in dokazano je bilo ohranjanje terapevtskega učinka, kot je razvidno iz znižanja PTH pred dializo za > 30 % v primerjavi z izhodiščem pri 2/3 bolnikov.
English: Each mL contains 5 mg etelcalcetide.
Slovenian: 1 ml vsebuje 5 mg etelkalcetida.
English: • If clinically indicated: start or increase calcium supplements, calciumcontaining phosphate binders, and/or vitamin D sterols.
Slovenian: • Če je klinično indicirano: - uvedite ali povečajte odmerek dodatkov kalcija, vezalcev fosfatov, ki vsebujejo kalcij, in/ali sterolov vitamina D. - povečajte koncentracijo kalcija v dializatu.
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.
Slovenian: Zdravnik vam bo pomagal pri odločitvi, ali naj nehate dojiti ali naj nehate uporabljati zdravilo Parsabiv, ob upoštevanju prednosti dojenja za otroka in prednosti zdravljenja z zdravilom Parsabiv za vas.
English: In the studies total serum calcium was measured using Roche modular analysers.
Slovenian: V študijah so celotni kalcij v serumu merili z modularnimi analizatorji družbe Roche.
English: These may be signs that your calcium levels are too low (hypocalcaemia).
Slovenian: Ti znaki lahko pomenijo, da imate prenizko koncentracijo kalcija v krvi (hipokalciemijo).
English: What Parsabiv is and what it is used for What you need to know before you use Parsabiv How to use Parsabiv
Slovenian: Kaj je zdravilo Parsabiv in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Parsabiv Kako uporabljati zdravilo Parsabiv Možni neželeni učinki
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:
Slovenian: Če se koncentracija korigiranega kalcija v serumu klinično pomembno zniža pod spodnjo mejo normalnega območja in/ali se pojavijo simptomi hipokalciemije, je priporočljivo ukrepati takole:
English: < 8.3 mg/dL (2.08 mmol/L) and ≥ 7.5 mg/dL (1.88 mmol/L)
Slovenian: < 8,3 mg/dl (2,08 mmol/l) in ≥ 7,5 mg/dl (1,88 mmol/l)
English: Etelcalcetide is biotransformed in blood by reversible disulphide exchange with endogenous thiols to predominantly form conjugate with serum albumin.
Slovenian: V krvi se transformira z reverzibilno disulfidno izmenjavo z endogenimi tioli, tako da pretežno nastane konjugat z albuminom v serumu.
English: If formation of anti-etelcalcetide antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Slovenian: V primeru suma na nastajanje protiteles proti etelkalcetidu s klinično pomembnim učinkom se obrnite na imetnika dovoljenja za promet z zdravilom za dogovor o testiranju protiteles.
English: There are no or limited amount of data from the use of etelcalcetide in pregnant women.
Slovenian: Podatkov o uporabi etelkalcetida pri nosečnicah ni oziroma so omejeni.
English: - The other ingredients are sodium chloride, succinic acid, water for injections, hydrochloric acid, and sodium hydroxide.
Slovenian: - Druge sestavine zdravila so natrijev klorid, jantarna kislina, voda za injekcije, klorovodikova kislina in natrijev hidroksid.
English: • Low phosphate levels in blood
Slovenian: • Nizka koncentracija fosfata v krvi
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.
Slovenian: Začetni odmerek cinakalceta je bil 30 mg na dan, titriran na 4 tedne v korakih po 30 mg, ali 60 mg za zadnje večanje odmerka do največjega odmerka 180 mg na dan v skladu z navodili za predpisovanje cinakalceta.
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.
Slovenian: Po intravenski uporabi ob koncu hemodialize 3-krat na teden je bil efektivni razpolovni čas od 3 do 5 dni.
English: The recommended initial dose of etelcalcetide is 5 mg administered by bolus injection 3 times per week.
Slovenian: Priporočeni začetni odmerek etelkalcetida je 5 mg v bolusni injekciji 3-krat na teden.
English: If a regularly scheduled haemodialysis treatment is missed, do not administer any missed doses.
Slovenian: V primeru izpuščenega redno načrtovanega hemodializnega zdravljenja morebitnih izpuščenih odmerkov ne nadomeščajte.
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).
Slovenian: V primeru prevelikega odmerjanja je treba kontrolirati kalcij v serumu, bolnike je treba nadzorovati glede simptomov hipokalciemije (glejte poglavje 4.4) in treba je ustrezno ukrepati (glejte poglavje 4.2).
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.
Slovenian: Po uporabi enkratnega odmerka radioaktivno označenega etelkalcetida pri bolnikih s KLB in SHPT, zdravljenih s hemodializo, se je v 175 dneh zbiranja približno 60 % uporabljenega [14C]-etelkalcetida pojavilo v dializatu in približno 7 % v urinu in blatu skupaj.
English: QTc prolongation secondary to hypocalcaemia
Slovenian: Podaljšanje intervala QTc zaradi hipokalciemije
English: Patients receiving Parsabiv should not be given cinacalcet.
Slovenian: Bolniki, ki prejemajo zdravilo Parsabiv, ne smejo dobiti cinakalceta.
English: What Parsabiv contains - The active substance is etelcalcetide.
Slovenian: Kaj vsebuje zdravilo Parsabiv - Učinkovina je etelkalcetid.
English: Concurrent administration may result in severe hypocalcaemia.
Slovenian: Njuna sočasna uporaba lahko povzroči hudo hipokalciemijo.
English: Potential manifestations of hypocalcaemia include paraesthesias, myalgias, muscle spasm and seizures.
Slovenian: Med možnimi znaki hipokalciemije so parestezije, mialgije, spazmi mišic in konvulzije.
English: Serum calcium should be measured within 1 week of initiation or dose adjustment of Parsabiv.
Slovenian: Kalcij v serumu je treba izmeriti v 1. tednu po uvedbi ali prilagoditvi odmerka zdravila Parsabiv.
English: Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminium seal with flip-off dust cover.
Slovenian: Viala (iz stekla tipa I) za enkratno uporabo z zamaškom (elastomeren, laminiran s fluoropolimerom) in aluminijskim tesnilom s snemnim zaščitnim pokrovčkom.
English: Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
Slovenian: Zdravilo Parsabiv je indicirano za zdravljenja sekundarnega hiperparatiroidizma (SHPT) pri odraslih bolnikih s kronično ledvično boleznijo (KLB) na hemodializnem zdravljenju.
English: Although Parsabiv is cleared by dialysis, haemodialysis has not been studied as a treatment for overdose.
Slovenian: Zdravilo Parsabiv se sicer odstrani z dializo, vendar hemodialize niso raziskali kot načina za zdravljenje prevelikega odmerjanja.
English: Worsening heart failure1 QT prolongation1
Slovenian: Pogosti poslabšanje srčnega popuščanja1 podaljšanje intervala QT1
English: In mouse and rat carcinogenicity studies, there were no etelcalcetide-related tumours up to exposure of 0.4-fold clinical exposure levels.
Slovenian: V študijah kancerogenosti na miših in podganah ni bilo z etelkalcetidom povezanih tumorjev pri odmerkih do 0,4-kratnika klinične izpostavljenosti.
English: LIST OF EXCIPIENTS Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide.
Slovenian: SEZNAM POMOŽNIH SNOVI Natrijev klorid, jantarna kislina, voda za injekcije, klorovodikova kislina, natrijev hidroksid.
English: Cases of seizures have been reported in patients treated with Parsabiv (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Parsabiv, so poročali o primerih konvulzij (glejte poglavje 4.8).
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.
Slovenian: Zdravilo Parsabiv se daje v vensko linijo dializnega obtoka na koncu hemodializnega zdravljenja med izpiranjem ali intravensko po izpiranju.
English: Patients receiving Parsabiv should not be given cinacalcet (see section 4.4).
Slovenian: Bolniki, ki prejemajo zdravilo Parsabiv, ne smejo dobiti cinakalceta (glejte poglavje 4.4).
English: Parsabiv is used to treat secondary hyperparathyroidism in patients with serious kidney disease who need haemodialysis to clear their blood of waste products.
Slovenian: Zdravilo Parsabiv uporabljamo za zdravljenje sekundarnega hiperparatiroidizma pri bolnikih z resno boleznijo ledvic, ki potrebujejo hemodializo za odstranjevanje odpadnih snovi iz krvi.