FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Sammenlignet med placebo var Parsabiv forbundet med fald i markører for knoglemetabolisme (knoglespecifik alkalisk fosfatase og type I-kollagen c-telopeptid) samt fibroblast-vækstfaktor 23 (eksploratoriske endepunkter) i slutningen af studiet (uge 27).
English: Although Parsabiv is cleared by dialysis, haemodialysis has not been studied as a treatment for overdose.
Danish: Selvom Parsabiv fjernes ved dialyse, er hæmodialyse til behandling af overdosering ikke undersøgt.
English: However certain symptoms of low calcium levels (such as fits or convulsions) can affect your ability to drive or operate machinery.
Danish: Visse symptomer på lavt calciumniveau (for eksempel kramper) kan dog påvirke evnen til at køre motorkøretøj og betjene maskiner.
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.
Danish: Serum-calcium monitoreres nøje hos patienter med kongenit langt QT-syndrom, QT-forlængelse i anamnesen, langt QT-syndrom eller pludselig hjertedød i familieanamnesen samt andre tilstande, som prædisponerer for QT-forlængelse og ventrikulær arytmi.
English: Parsabiv should be administered at the next haemodialysis treatment at the same dose.
Danish: Parsabiv skal administreres ved næste hæmodialyse i samme dosis.
English: What Parsabiv looks like and contents of the pack Parsabiv is a clear and colourless liquid.
Danish: Udseende og pakningsstørrelser Parsabiv er en klar og farveløs væske.
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.
Danish: Der var ingen indvirkning på han- eller hundyrs fertilitet, når etelcalcetid blev administreret til rotter i eksponeringsniveauer, der var op til 1,8 gange højere end det kliniske eksponeringsniveau, der opnås hos patienter, som får etelcalcetid 15 mg tre gange om ugen.
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.
Danish: I et 6-måneders dobbeltblindt studie med aktiv kontrol blev Parsabivs virkning og sikkerhed sammenlignet med cinacalcet hos 683 SHPT-patienter med CKD, der var i hæmodialyse.
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.
Danish: Hvis blodet er returneret til patienten, og Parsabiv ikke er blevet administreret, kan det administreres intravenøst efterfulgt af mindst 10 ml 0,9 % natriumchlorid.
English: It is not known whether Parsabiv can pass into breast milk.
Danish: Det vides ikke, om Parsabiv kan blive udskilt i mælken hos mennesker.
English: Switch from cinacalcet to Parsabiv
Danish: Studie med skift fra cinacalcet til Parsabiv
English: Open-label extension study
Danish: Åbent studieforlængelse
English: Studies in rats showed [14C]-etelcalcetide was excreted in the milk at concentrations similar to plasma.
Danish: Rottestudier viste, at [14C]-etelcalcetid blev udskilt i mælken i koncentrationer svarende til plasmakoncentrationen.
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.
Danish: I de kombinerede placebokontrollerede studier var forekomsten af CHF-hændelser, hvor indlæggelse var påkrævet, 2,2 % i Parsabiv-gruppen sammenlignet med 1,2 % i placebogruppen.
English: The recommended initial dose of etelcalcetide is 5 mg administered by bolus injection 3 times per week.
Danish: Den anbefalede initialdosis af etelcalcetid er 5 mg, der administreres som en bolusinjektion 3 gange om ugen.
English: Ventricular arrhythmia and QT prolongation secondary to hypocalcaemia
Danish: Ventrikulær arytmi og QT-forlængelse sekundært til hypokalcæmi
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.
Danish: Efter intravenøs dosering til CKD-patienter 3 gange om ugen i slutningen af hver 3-4 timers hæmodialysesession nåede plasmaniveauet af etelcalcetid næsten steady state 4 uger efter dosering med en observeret akkumuleringsratio på 2-3 gange.
English: • heart problems, such as heart failure or arrhythmias (abnormal heart rhythm);
Danish: • problemer med hjertet, for eksempel hjertesvigt eller unormal hjerterytme (arytmier),
English: Available data in rats have shown that etelcalcetide is excreted in milk (see section 5.3).
Danish: Tilgængelige data fra rotter har vist, at etelcalcetid udskilles i mælk (se pkt.
English: PTH should be measured after 4 weeks from initiation or dose adjustment of Parsabiv, and approximately every 1-3 months during maintenance.
Danish: PTH skal måles efter 4 uger, beregnet fra initiering af Parsabiv eller dosisjustering, og cirka hver 1.-3. måned i vedligeholdelsesfasen.
English: Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents.
Danish: Farmakoterapeutisk klassifikation: Calciumhomeostase, anti-paratyreoide midler.
English: increase dialysate calcium concentration.
Danish: Forhøj koncentrationen af calcium i dialysat.
English: < 8.3 mg/dL (2.08 mmol/L) and ≥ 7.5 mg/dL (1.88 mmol/L)
Danish: < 8,3 mg/dl (2,08 mmol/l) og ≥ 7,5 mg/dl (1,88 mmol/l)
English: It is unknown whether etelcalcetide is present in human milk.
Danish: Det er ukendt, om etelcalcetid udskilles i human mælk.
English: Hypocalcaemia1, 5
Danish: Hypokalcæmi1, 5 Hyperkaliæmi2
English: In mouse and rat carcinogenicity studies, there were no etelcalcetide-related tumours up to exposure of 0.4-fold clinical exposure levels.
Danish: I karcinogenicitetsstudier med mus og rotter var der ingen etelcalcetid-relaterede tumorer ved eksponering indtil 0,4 gange det kliniske eksponeringsniveau.
English: No specific study in patients with hepatic impairment was performed.
Danish: Der er ikke udført specifikke studier hos patienter med nedsat leverfunktion.
English: Potential manifestations of hypocalcaemia include paraesthesias, myalgias, muscle spasm and seizures.
Danish: De potentielle manifestationer af hypokalcæmi omfatter paræstesier, myalgier, muskelspasmer og krampeanfald.
English: The reduction in PTH is associated with a concomitant decrease in serum calcium and phosphate levels.
Danish: Faldet i PTH er forbundet med et samtidigt fald i serum-calcium og serumphosphat.
English: Your doctor will monitor your blood calcium levels.
Danish: Din læge vil løbende kontrollere indholdet af calcium i dit blod.
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.
Danish: Fortæl det til din læge, hvis du får spasmer, muskelspjæt eller kramper i dine muskler eller følelsesløshed eller prikken i dine fingre eller tæer eller omkring munden, eller hvis du får krampeanfald, bliver forvirret eller mister bevidstheden, mens du er i behandling med Parsabiv.
English: Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminium seal with flip-off dust cover.
Danish: Engangshætteglas (type I-glas) med prop (fluorpolymer-belagt elastomer) og aluminiumsforsegling med vippeskive.
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.
Danish: Desuden reducerede Parsabiv PTH inden dialyse til ≤ 300 picog/ml hos mere end 50 % af patienterne og reducerede gennemsnitlig PTH, cCa, cCa x P og phosphat i forhold til baseline.
English: What you need to know before you use Parsabiv
Danish: Det skal du vide, før du begynder at bruge Parsabiv
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.
Danish: Vigtige sekundære endepunkter var andelen af patienter, der opnåede fald på > 50 % og > 30 % i gennemsnitlig PTH i forhold til baseline i EAP og det gennemsnitlige antal dage om ugen med opkastning eller kvalme i de første 8 uger, sekventielt testet for superioritet.
English: Patients with ≤ 300 pg/mL in PTH during the EAP, n (%)
Danish: Patienter med ≤ 300 picog/ml i PTH under EAP, n (%)
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.
Danish: Det vil blive givet af en læge eller sygeplejerske i afslutningen af din hæmodialyse gennem det rør (blodslange), der forbinder dig til dialysemaskinen.
English: Administer Parsabiv with caution in patients receiving any other medicinal products known to lower serum calcium.
Danish: Parsabiv skal administreres med forsigtighed hos patienter, som får andre lægemidler, der vides at sænke serum-calcium.
English: Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia (see section 4.8).
Danish: Fald i serum-calcium kan forlænge QT-intervallet og potentielt medføre ventrikulær arytmi (se pkt.
English: If clinically meaningful decreases in corrected serum calcium levels occur, steps should be taken to increase serum calcium levels (see section 4.2).
Danish: Hvis der opstår klinisk relevante fald i korrigeret serum-calcium, skal der træffes foranstaltninger til at øge serum-calcium (se pkt.
English: Corrected serum calcium should be at or above the lower limit of the normal range prior to administration of first dose of Parsabiv, a dose increase, or reinitiation after a dose stop (see also dose adjustments based on serum calcium levels).
Danish: Korrigeret serum-calcium skal være ≥ den nedre grænse for normalområdet inden administration af den første dosis Parsabiv, ved dosisøgning og ved reinitiering efter doseringsafbrydelse (se også afsnittet om dosisjustering baseret på serum-calcium).
English: The median average weekly dose of Parsabiv during the EAP was 15.0 mg (5.0 mg per administration) and of cinacalcet was 360.0 mg (51.4 mg per administration).
Danish: Den mediane ugentlige gennemsnitsdosis af Parsabiv i EAP var 15,0 mg (5,0 mg pr. administration), og den mediane ugentlige gennemsnitsdosis af cinacalcet var 360,0 mg (51,4 mg pr. administration).
English: In vitro, etelcalcetide was not a substrate of efflux and uptake transporter proteins; and etelcalcetide was not an inhibitor of common transporter proteins.
Danish: Etelcalcetid var ikke substrat for efflux- eller optagelsestransportproteiner in vitro, og etelcalcetid hæmmede ikke almindelige transportproteiner.
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.
Danish: Det skal besluttes, om amning eller behandling med Parsabiv skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Corrected serum calcium Mean percent change during the EAP, % (SE)
Danish: Korrigeret serum-calcium Gennemsnitlig procentvis ændring under EAP, % (SE)
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).
Danish: Parsabiv var noninferiort til cinacalcet hvad angår det primære endepunkt og superiort til cinacalcet hvad angår de 2 sekundære endepunkter: andelen af patienter, der opnåede et fald på > 30 % i gennemsnitlig PTH i forhold til baseline i EAP (68,2 % for Parsabiv vs. 57,7 % for cinacalcet; p = 0,004), og andelen af patienter, der opnåede et fald på > 50 % i gennemsnitlig PTH i forhold til baseline i EAP (52,4 % for Parsabiv vs. 40,2 % for cinacalcet; p = 0,001).
English: • Worsening heart failure
Danish: • Forværring af hjertesvigt
English: What Parsabiv contains - The active substance is etelcalcetide.
Danish: Parsabiv indeholder: - Aktivt stof: etelcalcetid.
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.
Danish: Der var ingen virkninger på embryoets/fosterets udvikling hos rotter og kaniner ved eksponeringer under organogenesen, som var 1,8 til 4,3 gange det kliniske eksponeringsniveau.
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.
Danish: Fortæl det til din læge, hvis du mærker en usædvanligt hurtig eller bankende hjerterytme (puls), mens du er i behandling med Parsabiv, eller hvis du har problemer med hjerterytmen eller har haft hjertesvigt, eller hvis du får medicin, som kan give problemer med hjerterytmen.
English: 2 Hyperkalaemia includes preferred terms of hyperkalaemia and blood potassium increased.
Danish: 2 Hyperkaliæmi omfatter de foretrukne termer hyperkaliæmi og forhøjet serumkalium.
English: The lower limit of the normal range for corrected serum calcium was 8.3 mg/dL (2.08 mmol/L).
Danish: Den nedre grænse for normalområdet for korrigeret serum-calcium var 8,3 mg/dl (2,08 mmol/l).
English: Parsabiv is used to treat secondary hyperparathyroidism in patients with serious kidney disease who need haemodialysis to clear their blood of waste products.
Danish: Parsabiv bruges til behandling af sekundær hyperparatyreoidisme hos patienter med alvorlig nyresygdom, der har behov for hæmodialyse for at rense blodet for affaldsstoffer.
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.
Danish: Initialdosis af cinacalcet var 30 mg dagligt, der blev titreret hver 4. uge i trin på 30 mg eller på 60 mg for den sidste optitrering til en maksimumdosis på 180 mg dagligt i henhold til ordinationsoplysningerne for cinacalcet.
English: Patients receiving Parsabiv should not be given cinacalcet.
Danish: Patienter, der behandles med Parsabiv, må ikke få cinacalcet.
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)
Danish: • Lavt calciumniveau i blodet med symptomer såsom prikken omkring munden eller i arme og ben, muskelsmerter eller muskelkramper og krampeanfald.
English: Other medicines and Parsabiv
Danish: Brug af anden medicin sammen med Parsabiv
English: The secondary endpoints were the proportion of patients with a mean PTH ≤ 300 pg/mL during the EAP, and percent change from baseline during the EAP for PTH, serum cCa, phosphate and calcium phosphate product (Ca x P).
Danish: De sekundære endepunkter var andelen af patienter med et gennemsnitligt PTH-niveau ≤ 300 picog/ml i EAP og den procentvise ændring i PTH i forhold til baseline i EAP, serum-cCa, serumphosphat og calcium-phosphat-produktet (Ca x P).
English: In the combined placebo-controlled studies, a higher percentage of patients in the Parsabiv group compared with the placebo group had a maximum increase from baseline of > 60 msec in the QTcF interval (1.2% Parsabiv; 0% placebo).
Danish: I de kombinerede placebokontrollerede studier havde en større procentdel af patienterne i Parsabivgruppen end i placebogruppen en maksimal stigning på > 60 ms i QTcF-intervallet (1,2 % Parsabiv; 0 % placebo) i forhold til baseline.
English: Serum calcium should be measured within 1 week of initiation or dose adjustment of Parsabiv.
Danish: Serum-calcium skal måles inden for 1 uge efter initiering af Parsabiv eller dosisjustering.
English: The patient incidence of maximum post-baseline pre-dialysis QTcF > 500 msec in the Parsabiv and placebo groups was 4.8% and 1.9%, respectively.
Danish: Forekomsten af en maksimal QTcF på > 500 ms efter baseline og inden dialyse i Parsabiv-gruppen og placebogruppen var henholdsvis 4,8 % og 1,9 %.
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.
Danish: Der blev gennemført en 52-ugers studieforlængelse med en enkelt behandlingsarm til det placebokontrollerede studie og til studiet med skift fra cinacalcet til Parsabiv, der beskrives ovenfor, for at beskrive Parsabivs langsigtede virkning og sikkerhed hos 891 SHPT-patienter med CKD, der er i hæmodialyse.
English: Concurrent administration of other medicinal products known to reduce serum calcium and Parsabiv may result in an increased risk of hypocalcaemia (see section 4.4).
Danish: Samtidig administration af Parsabiv og andre lægemidler, der vides at reducere serum-calcium, kan medføre øget risiko for hypokalcæmi (se pkt.
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).
Danish: I de kombinerede placebokontrollerede studier udviklede en større andel af patienterne i Parsabiv-gruppen end i placebogruppen mindst én serum-cCa-værdi < 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) og < 8,3 mg/dl (2,08 mmol/l) (78,6 % Parsabiv; 19,4 % placebo).
English: Mean (SE) baseline PTH concentrations were 1,092.12 (33.8) and 1,138.71 (38.2) pg/mL for the Parsabiv and cinacalcet groups respectively.
Danish: De gennemsnitlige (SE) PTH-koncentrationer ved baseline var 1.092,12 (33,8) og 1.138,71 (38,2) picog/ml for henholdsvis Parsabiv-gruppen og cinacalcet-gruppen.
English: Parsabiv is a solution for injection in a vial.
Danish: Parsabiv er en injektionsvæske i et hætteglas.
English: Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
Danish: Parsabiv er indiceret til behandling af sekundær hyperparatyreoidisme (SHPT) hos voksne patienter med kronisk nyresygdom (CKD), der er i hæmodialyse.
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).
Danish: 4 Asymptomatiske fald i calcium under 7,5 mg/dl (1,88 mmol/l) eller klinisk signifikante asymptomatiske fald i serum-cCa mellem 7,5 og < 8,3 mg/dl (1,88 og < 2,08 mmol/l) (hvor medicinsk behandling var påkrævet).
English: Tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant when taking Parsabiv.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du fortælle det til din læge, før du bruger Parsabiv.
English: Parsabiv 2.5 mg solution for injection EU/1/16/1142/001 - 1 vial EU/1/16/1142/002 - 6 vials EU/1/16/1142/003 - 12 vials EU/1/16/1142/004 - 42 vials Parsabiv 5 mg solution for injection EU/1/16/1142/005 - 1 vial EU/1/16/1142/006 - 6 vials EU/1/16/1142/007 - 12 vials EU/1/16/1142/008 - 42 vials Parsabiv 10 mg solution for injection EU/1/16/1142/009 - 1 vial EU/1/16/1142/010 - 6 vials EU/1/16/1142/011 - 12 vials EU/1/16/1142/012 - 42 vials
Danish: Parsabiv 2,5 mg injektionsvæske, opløsning EU/1/16/1142/001 - 1 hætteglas EU/1/16/1142/002 - 6 hætteglas EU/1/16/1142/003 - 12 hætteglas EU/1/16/1142/004 - 42 hætteglas Parsabiv 5 mg injektionsvæske, opløsning EU/1/16/1142/005 - 1 hætteglas EU/1/16/1142/006 - 6 hætteglas EU/1/16/1142/007 - 12 hætteglas EU/1/16/1142/008 - 42 hætteglas Parsabiv 10 mg injektionsvæske, opløsning EU/1/16/1142/009 - 1 hætteglas EU/1/16/1142/010 - 6 hætteglas EU/1/16/1142/011 - 12 hætteglas EU/1/16/1142/012 - 42 hætteglas
English: Contact details are provided in section 6 of the package leaflet.
Danish: Indlægssedlens afsnit 6 indeholder kontaktoplysninger.
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).
Danish: Resultaterne fra et studie, hvor man undersøgte ændringer i korrigeret serum-calcium efter skift fra cinacalcet til Parsabiv, viste, at det var sikkert at initiere behandling med Parsabiv med en initialdosis på 5 mg 7 dage efter seponering af cinacalcet, forudsat at korrigeret serum-calcium var ≥ 8,3 mg/dl (2,08 mmol/l).
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).
Danish: Parsabiv bør ikke initieres hos patienter før 7 dage efter den sidste dosis cinacalcet, og før korrigeret serum-calcium er inden for eller over den nedre grænse for normalområdet (se pkt.
English: Very common side effects with Parsabiv are blood calcium decreased, muscle spasms, diarrhoea, nausea, and vomiting.
Danish: Meget almindelige bivirkninger af Parsabiv er fald i serum-calcium, muskelspasmer, diaré, kvalme og opkastning.
English: LIST OF EXCIPIENTS Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide.
Danish: LISTE OVER HJÆLPESTOFFER Natriumchlorid, ravsyre, vand til injektionsvæsker, saltsyre, natriumhydroxid.
English: All subjects received Parsabiv at a starting dose of 5 mg 3 times a week.
Danish: Alle patienter fik Parsabiv i en initialdosis på 5 mg 3 gange om ugen.
English: No specific pharmacokinetic studies of etelcalcetide have been conducted in patients with mild to severe kidney impairment.
Danish: Der er ikke udført specifikke farmakokinetiske studier af etelcalcetid hos patienter med let til svær nyreinsufficiens.
English: - The other ingredients are sodium chloride, succinic acid, water for injections, hydrochloric acid, and sodium hydroxide.
Danish: - Øvrige indholdsstoffer: natriumchlorid, ravsyre, vand til injektionsvæsker, saltsyre og natriumhydroxid.
English: 5 Symptomatic reductions in serum cCa < 8.3 mg/dL (2.08 mmol/L).
Danish: 5 Symptomatiske fald i serum-cCa < 8,3 mg/dl (2,08 mmol/l).
English: When given during rinse-back at least 150 mL of rinse-back volume should be administered after injection.
Danish: Når præparatet gives, mens blodet returneres til patienten, skal mindst 150 ml af blodet gives tilbage efter injektionen.
English: The primary endpoint was non-inferiority for the proportion of patients who achieved > 30% reduction from baseline in mean PTH during the EAP (weeks 20 to 27).
Danish: Det primære endepunkt var noninferioritet for den andel af patienterne, der opnåede et fald på > 30 % i gennemsnitlig PTH i forhold til baseline i EAP (uge 20 til 27).