FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not known whether Parsabiv can harm your unborn baby.
Danish: Det vides ikke, om Parsabiv kan skade et ufødt barn.
English: In clinical studies, 7.1% of patients with SHPT treated with Parsabiv for up to 6 months tested positive for binding antibodies.
Danish: I kliniske studier blev 7,1 % af patienter med SHPT, der blev behandlet med Parsabiv i op til 6 måneder, testet positive for bindende antistoffer.
English: • Reinitiate Parsabiv at a dose 5 mg lower than the last administered dose.
Danish: • Genstart Parsabiv i en dosis, der er 5 mg lavere end den seneste administrerede dosis.
English: • Numbness or tingling sensation
Danish: • Følelsesløshed eller prikkende fornemmelse
English: No special temperature storage requirements are needed.
Danish: Der er ingen særlige krav vedrørende opbevaringstemperaturer.
English: Other laboratory assays may have different cut-offs for the lower limit of the normal range.
Danish: Andre laboratorieanalyser kan have andre skæringspunkter for den nedre grænse for normalområdet.
English: consider reducing Parsabiv dose.
Danish: Overvej at reducere dosis af Parsabiv.
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.
Danish: Dit PTH-niveau vil blive kontrolleret under behandlingen med Parsabiv, og din dosis af Parsabiv vil muligvis blive reduceret, hvis dit PTH-niveau bliver meget lavt.
English: The inter-subject variability of the system clearance in the patient population is approximately
Danish: Den inter-individuelle variabilitet i den systemiske clearance i patientpopulationen er cirka 70 %.
English: Both studies demonstrated that Parsabiv reduced PTH, while lowering calcium, phosphate and Ca x P. Results of all primary and secondary endpoints were statistically significant and the results were consistent across both studies as shown in table 2.
Danish: Begge studier viste, at Parsabiv reducerede PTH og samtidig sænkede calcium, phosphat og Ca x P. Resultaterne af alle primære og sekundære endepunkter var statistisk signifikante, og som vist i tabel 2 var resultaterne konsekvente på tværs af de to studier.
English: Demographics and other baseline characteristics were similar to the placebo-controlled studies.
Danish: De demografiske data og andre baseline-karakteristika var de samme som i de placebokontrollerede studier.
English: The recommended starting dose for Parsabiv is 5 mg.
Danish: Den anbefalede startdosis af Parsabiv er 5 mg.
English: If formation of anti-etelcalcetide antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Danish: Hvis der er mistanke om dannelse af anti-etelcalcetid-antistoffer med en klinisk signifikant virkning, skal indehaveren af markedsføringstilladelsen kontaktes for at drøfte test af antistoffer.
English: They were mild to moderate in severity and transient in nature in the majority of patients.
Danish: De var lette til moderate og forbigående hos størstedelen af patienterne.
English: Before you are given Parsabiv, tell your doctor if you have or have ever had:
Danish: Fortæl det til din læge, inden du får Parsabiv, hvis du har eller nogensinde har haft:
English: • Low calcium levels in blood with no symptoms
Danish: • Lavt calciumniveau i blodet uden nogen symptomer
English: Do not use Parsabiv if you are allergic to etelcalcetide or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Parsabiv, hvis du er allergisk over for etelcalcetid eller et af de øvrige indholdsstoffer i Parsabiv (angivet i afsnit 6).
English: Concurrent administration may result in severe hypocalcaemia.
Danish: Samtidig administration kan medføre svær hypokalcæmi.
English: Keep in the original carton in order to protect from light.
Danish: Opbevares i den originale karton for at beskytte mod lys.
English: The expected pharmacological effect of decreased PTH and calcium in blood were observed in animal studies at clinical exposure levels.
Danish: Den forventede farmakologiske virkning af nedsat PTH og calcium i blodet blev observeret i dyrestudier ved kliniske eksponeringsniveauer.
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.
Danish: Der blev ikke observeret nogen statistisk signifikant forskel mellem de to grupper for så vidt angår det sekundære endepunkt: gennemsnitligt antal dage om ugen med opkastning eller kvalme i de første 8 uger.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk
English: The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion.
Danish: Den calciumfølsomme receptor på overfladen af glandula paratyreoideas hovedcelle er den vigtigste regulator af PTH-sekretion.
English: In the population pharmacokinetics model, volume of distribution at steady-state was approximately 796 L. Etelcalcetide is predominately bound to plasma albumin by reversible covalent binding.
Danish: I den farmakokinetiske populationsmodel var distributionsvolumenet ved steady state cirka 796 l. Etelcalcetid bindes fortrinsvis til plasmaalbumin ved reversibel kovalent binding.
English: There are no or limited amount of data from the use of etelcalcetide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af etelcalcetid til gravide kvinder.
English: Etelcalcetide was efficiently removed with a haemodialysis clearance value of 7.66 L/hour.
Danish: Etelcalcetid blev elimineret effektivt med en clearance ved hæmodialyse på 7,66 l/time.
English: Low calcium levels can cause abnormal heart rhythm.
Danish: Lavt calciumniveau kan forårsage unormal hjerterytme.
English: • Parsabiv is stable for a maximum of 7 cumulative days if stored in the original carton.
Danish: • Parsabiv er stabilt i maksimalt 7 dage i træk, når det opbevares i den originale karton.
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.
Danish: Den gennemsnitlige varighed af hæmodialyse inden studiestart var 5,4 år, 68 % af patienterne fik vitamin D-steroler ved studiestart, og 83 % fik phosphatbinder.
English: No evidence of altered pharmacokinetic profile, clinical response or safety profile was associated with pre-existing or developing anti-etelcalcetide antibodies.
Danish: Der var ingen tegn på ændringer i farmakokinetisk profil, klinisk respons eller sikkerhedsprofil forbundet med eksisterende eller udvikling af anti-etelcalcetid-antistoffer.
English: You may need to take calcium and vitamin D supplements while being treated with Parsabiv.
Danish: Du vil muligvis få behov for tilskud af calcium og vitamin D, mens du er i behandling med Parsabiv.
English: Uncommon: may affect up to 1 in 100 people • Seizures (fits or convulsions); for additional information see section 2
Danish: Ikke almindelig: kan ramme op til 1 ud af 100 personer • Krampeanfald; afsnit 2 indeholder mere information
English: The dose may be increased up to 15 mg or lowered down to 2.5 mg depending on your response.
Danish: Dosis kan øges til op til 15 mg eller nedsættes til 2,5 mg afhængigt af, hvordan du reagererpå behandlingen.
English: For albumin levels < 4.0 g/dL cCa (mg/dL) = Total Ca (mg/dL) + (4 - albumin[g/dL])*0.8.
Danish: Ved albumin < 4,0 g/dl er cCa (mg/dl) = total Ca (mg/dl) + (4 - albumin[g/dl])*0,8.
English: Dose adjustments based on PTH levels
Danish: Dosisjustering baseret på PTH-niveau
English: QTc prolongation secondary to hypocalcaemia
Danish: QTc-forlængelse sekundært til hypokalcæmi
English: * Total calcium was measured using Roche modular analyser.
Danish: * Total-calcium blev målt med anvendelse af Roches modulære analysesystem.
English: Parsabiv has no or negligible influence on the ability to drive and use machines.
Danish: Parsabiv påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Noncovalent binding of etelcalcetide to plasma proteins is low with a fraction unbound ratio of 0.53.
Danish: Den ikke-kovalente binding af etelcalcetid til plasmaproteiner er lav med en ubundet fraktionsratio på 0,53.
English: Demographic and baseline characteristics between the two groups in each study were similar.
Danish: De demografiske data og baseline-karakteristika var sammenlignelige mellem de to grupper i begge studier.
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.
Danish: I et studie af den præ- og postnatale udvikling hos rotter var der en minimal stigning i den perinatale mortalitet hos afkommet, forsinkelse i fødslen og forbigående fald i den postnatale vækst forbundet med maternel toksicitet i form af hypokalcæmi, tremor og fald i legemsvægt samt nedsat fødeindtagelse ved 1,8 gange det kliniske eksponeringsniveau.
English: After discontinuation, therapy can be resumed at a lower dose to maintain PTH in the target range (see section 4.2).
Danish: Efter afbrydelse kan behandlingen genoptages i en lavere dosis med henblik på at opretholde PTH-niveauet inden for målområdet (se pkt.
English: Parsabiv should not be diluted.
Danish: Parsabiv må ikke fortyndes.
English: Dose adjustments based on serum calcium levels
Danish: Dosisjustering baseret på serum-calcium
English: Patients were maintained on dialysate calcium concentration ≥ 2.25 meq/L.
Danish: Patienterne blev fastholdt på en calciumkoncentration i dialysatet på ≥ 2,25 meq/l.
English: Etelcalcetide is a synthetic peptide calcimimetic agent which reduces PTH secretion through binding and activation of the calcium-sensing receptor.
Danish: Etelcalcetid er et syntetisk peptid-calcimimetikum, der reducerer PTH-sekretionen gennem binding og aktivering af den calciumfølsomme receptor.
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.
Danish: I disse studier seponerede 1 % af patienterne i Parsabiv-gruppen og 0 % af patienterne i placebogruppen behandlingen som følge af bivirkningen lavt serum-calcium.
English: Parsabiv should be titrated so that doses are individualised between 2.5 mg and 15 mg.
Danish: Parsabiv skal titreres, så doserne tilpasses individuelt mellem 2,5 mg og 15 mg.
English: Once the maintenance phase has been established for a patient, corrected serum calcium should be measured approximately every 4 weeks.
Danish: Når vedligeholdelsesdosis er fastlagt for patienten, skal korrigeret serum-calcium måles cirka hver 4. uge.
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.
Danish: Hvis PTH-niveauerne falder til under det anbefalede målområde, skal dosis af vitamin D-steroler og/eller Parsabiv reduceres eller behandlingen afbrydes.
English: The median average weekly dose of Parsabiv during the efficacy assessment period (EAP) was 20.4 mg (6.8 mg per administration).
Danish: Den mediane ugentlige gennemsnitsdosis af Parsabiv i perioden til vurdering af effekt (EAP) var 20,4 mg (6,8 mg pr. administration).
English: Corrected serum calcium value or clinical symptoms of hypocalcaemia*:
Danish: Korrigeret serum-calcium eller kliniske symptomer på hypokalcæmi*:
English: 1 See section on description of selected adverse reactions.
Danish: 1 Se “Beskrivelse af udvalgte bivirkninger”.
English: Patients with > 30% reduction in PTH during the EAP, n (%)
Danish: Patienter med > 30 % reduktion i PTH under EAP, n (%)
English: Worsening heart failure1 QT prolongation1
Danish: Forværring af hjerteinsufficiens1 QT-forlængelse1
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger for så vidt angår fertilitet (se pkt.
English: There is no known risk of pharmacokinetic interaction with etelcalcetide.
Danish: Der er ingen kendt risiko for farmakokinetiske interaktioner med etelcalcetid.
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.
Danish: Efter en enkelt intravenøs bolusinjektion af 5 mg etelcalcetid faldt PTH-niveauet hurtigt inden for 30 minutter efter dosering og var maksimalt reduceret i 1 time, inden det vendte tilbage til baselineniveau.
English: No data are available on the effect of etelcalcetide on human fertility.
Danish: Der foreligger ingen data vedrørende etelcalcetids indvirkning på human fertilitet.
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.
Danish: Etelcalcetid var mutagent i nogle bakteriestammer (Ames' test), men var ikke genotoksisk i in vitro og in vivo genotoksicitetstest med pattedyrsceller og anses derfor for at være ikke-genotoksisk hos mennesker.
English: You should not receive Parsabiv together with cinacalcet.
Danish: Du må ikke få Parsabiv sammen med cinacalcet.
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.
Danish: Hvis man har et meget lavt PTH-niveau i lang tid, kan det medføre en unormal knoglestruktur, der kaldes for adynamisk knogle, og som kun kan diagnosticeres med en vævsprøve (biopsi).
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.
Danish: Virkningen af det reducerede PTH-niveau blev opretholdt i hele doseringsperioden på 6 måneder, når etelcalcetid blev administreret som en intravenøs bolus 3 gange om ugen.
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.
Danish: Intravenøs administration 3 gange om ugen sidst i hæmodialysen gav en effektiv halveringstid på 3-5 dage.
English: 3 Paraesthesia includes preferred terms of paraesthesia and hypoaesthesia.
Danish: 3 Paræstesi omfatter de foretrukne termer paræstesi og hypæstesi.
English: Etelcalcetide is biotransformed in blood by reversible disulphide exchange with endogenous thiols to predominantly form conjugate with serum albumin.
Danish: Etelcalcetid biotransformeres i blodet ved reversibel udveksling af disulfid og endogene tioler, så der primært dannes et konjugat med serumalbumin.
English: The extent and duration of the reduction in PTH increased with increasing dose.
Danish: Udstrækningen og varigheden af faldet i PTH steg i takt med dosen.
English: Effects of Parsabiv on PTH, corrected serum calcium, phosphate and Ca x P in 6 month placebo-controlled studies
Danish: Parsabivs virkning på PTH, korrigeret serum-calcium, serumphosphat og Ca x P i 2 6-måneders placebokontrollerede studier
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.
Danish: Hvis dosering mangler i mere end 2 uger, skal Parsabiv administreres med 5 mg (eller 2,5 mg, hvis dette var patientens seneste administrerede dosis) og titreres til at opnå det ønskede PTH.
English: As a precautionary measure, it is preferable to avoid the use of Parsabiv during pregnancy.
Danish: For en sikkerheds skyld bør Parsabiv undgås under graviditet.
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.
Danish: Efter 52 uger var Parsabiv ikke forbundet med nogen nye sikkerhedsmæssige fund, og behandlingseffekten var opretholdt, hvilket blev påvist ved et fald i PTH inden dialyse på > 30 % i forhold til baseline hos 2/3 af patienterne.
English: Parsabiv decreased PTH regardless of baseline PTH, duration of dialysis, and whether or not patients were receiving vitamin D sterols.
Danish: Parsabiv reducerede PTH uanset PTH ved baseline og dialysevarighed, og uanset om patienterne fik vitamin D-steroler eller ej.
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).
Danish: Der blev gennemført to 6-måneders dobbeltblinde, placebokontrollerede kliniske studier hos SHPT-patienter med CKD, der fik hæmodialyse 3 gange om ugen (n = 1.023).
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'.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Parsabiv Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. den er i det væsentlige natriumfri.
English: The ratio of blood-to-plasma [14C]-etelcalcetide concentrations is approximately 0.6.
Danish: Ratioen af blod-til-plasma [14C]-etelcalcetid-koncentrationer er cirka 0,6.
English: Decreased myocardial performance, hypotension, and congestive heart failure (CHF) may be associated with significant reductions in serum calcium levels.
Danish: Nedsat myokardiefunktion, hypotension og kongestiv hjerteinsufficiens (CHF) kan være forbundet med signifikante fald i serum-calcium.
English: However, certain potential manifestations of hypocalcaemia may affect the ability to drive and use machines (see section 4.4).
Danish: Visse potentielle manifestationer af hypokalcæmi kan dog påvirke evnen til at føre motorkøretøj og betjene maskiner (se pkt.
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.
Danish: Etelcalcetids farmakokinetik er lineær og ændres ikke med tiden efter en enkelt (5 til 60 mg) og flere intravenøse doser (2,5 til 20 mg) til CKD-patienter med sekundær HPT, der er i hæmodialyse.
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.
Danish: Sekundær hyperparatyreoidisme kan medføre tab af calcium (kalk) fra knoglerne, som kan medføre knoglesmerter og knoglebrud samt problemer med blod- og hjertekar.
English: Most events of asymptomatic blood calcium decreased and symptomatic hypocalcaemia were mild or moderate in severity.
Danish: De fleste tilfælde af asymptomatiske fald i serum-calcium og symptomatisk hypokalcæmi var lette eller moderate i sværhedsgrad.
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.
Danish: Dosis af Parsabiv kunne titreres i uge 5, 9, 17, 25, 33, 41 og 49 til en maksimumdosis på 15 mg for at opnå en målkoncentration af PTH på ≤ 300 picog/ml under samtidig opretholdelse af serum-cCa.
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).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Parsabiv i en eller flere undergrupper af den pædiatriske population med hyperparatyreoidisme (se pkt.
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.
Danish: Biotransformationsprodukternes plasmaeksponering var cirka 5 gange højere end etelcalcetids, og deres koncentration/tid-kurve svarer til etelcalcetids.
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.
Danish: Efter en enkelt radioaktivt mærket dosis etelcalcetid til CKD-patienter med sekundær HPT, der var i hæmodialyse, blev cirka 60 % af det doserede [14C]-etelcalcetid genfundet i dialysat og cirka 7 % urin og fæces samlet i løbet af en indsamlingsperiode på 175 dage.
English: < 7.5 mg/dL (1.88 mmol/L) or symptoms of hypocalcaemia
Danish: < 7,5 mg/dl (1,88 mmol/l) eller symptomer på hypokalcæmi
English: Active-controlled study
Danish: Studie med aktiv kontrol
English: • If clinically indicated: start or increase calcium supplements, calciumcontaining phosphate binders, and/or vitamin D sterols.
Danish: • Ved klinisk behov: Start eller forhøj calciumtilskud, phosphatbinder med calcium og/eller vitamin D-steroler.
English: Adynamic bone may develop if PTH levels are chronically suppressed below 100 pg/mL.
Danish: Der kan opstå adynamisk knoglesygdom, hvis PTH-niveauerne kronisk er under 100 picog/ml.
English: For additional information see section 4.
Danish: Afsnit 4 indeholder mere information.
English: Each mL contains 5 mg etelcalcetide.
Danish: Hver ml indeholder 5 mg etelcalcetid.
English: Patients with lower screening PTH levels were more likely to reach PTH ≤ 300 pg/mL during EAP.
Danish: Patienter med lavere PTH-niveau ved screening havde større sandsynlighed for at opnå PTH ≤ 300 picog/ml i EAP.
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).
Danish: Parsabiv kan anvendes som en del af et behandlingsregime, der omfatter phosphatbindere og/eller vitamin D-steroler efter behov (se pkt.
English: No body weight, gender, age, or race-related pharmacokinetic differences have been observed in adult patients studied.
Danish: Der er ikke observeret nogen farmakokinetiske forskelle på baggrund af legemsvægt, køn, alder eller race hos de undersøgte voksne patienter, der indgik i studierne.
English: In the studies total serum calcium was measured using Roche modular analysers.
Danish: I studierne blev total serum-calcium målt ved hjælp af Roches modulære analysesystem.
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:
Danish: Hvis der opstår klinisk relevante fald i korrigeret serum-calcium til under den nedre grænse for normalområdet og/eller symptomer på hypokalcæmi, anbefales følgende:
English: Etelcalcetide is not metabolised by CYP450 enzymes.
Danish: Etelcalcetid metaboliseres ikke af CYP-enzymer.
English: Worsening heart failure
Danish: Forværring af hjerteinsufficiens
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.
Danish: Din læge vil kunne hjælpe dig med at finde ud af, om du skal holde op med at amme eller holde op med at bruge Parsabiv under hensyntagen til fordelen ved at amme barnet og din fordel ved at bruge Parsabiv.
English: • Low phosphate levels in blood
Danish: • Lavt fosfatniveau i blodet