FrancophonIA/ELRC3.0 huggingface dataset:
English: • Opadry clear (containing hypromellose, macrogol)
Danish: • Opadry klar (indeholder hypromellose, macrogol).
English: Do not initiate cinacalcet or increase the dose if non-compliance is suspected.
Danish: Cinacalcet må ikke initieres eller dosis forhøjes, hvis der er mistanke om manglende komplians.
English: If you take more Mimpara than you should you must contact your doctor immediately.
Danish: Hvis De har taget for meget Mimpara, skal De straks kontakte Deres læge.
English: Mimpara is used in children aged 3 years to less than 18 years of age:
Danish: Mimpara bruges til børn fra 3 år og op til 18 år til:
English: The study consisted of a 24-week dose titration period followed by a 6-week efficacy assessment phase (EAP), and a 30-week openlabel extension.
Danish: Studiet bestod af en 24-ugers periode med dosistitrering efterfulgt af en 6-ugers fase med vurdering af effekten (EAP) og en 30-ugers åben udvidelse.
English: The mean half-life of cinacalcet is prolonged by 33% and 70% in patients with moderate and severe hepatic impairment, respectively.
Danish: Den gennemsnitlige halveringstid for cinacalcet forlænges med henholdsvis 33 % og 70 % hos patienter med moderat og svær leversvækkelse.
English: If 1-3 capsules are used per day use at least 15 mL food; if 4-6 capsules are used per day use at least 30 mL food.
Danish: Hvis der bruges 1-3 kapsler om dagen, bruges mindst 15 ml mad; hvis der bruges 4-6 kapsler om dagen, bruges mindst 30 ml mad.
English: Treatment should be reinitiated using the next lowest dose of Mimpara.
Danish: Behandling bør reinitieres ved den næste laveste Mimpara-dosis.
English: 66% of patients were receiving vitamin D sterols at study entry, and > 90% were receiving phosphate binders.
Danish: 66 % af patienterne fik administreret D-vitamin-steroler ved studiets start, og >90 % fik administreret fosfatbindere.
English: Take all food or liquid immediately.
Danish: Spis eller drik al maden eller al væsken med det samme.
English: Demographic and baseline characteristics were representative of the dialysis patient population with secondary HPT.
Danish: Demografi- og baseline karakteristika var repræsentative for dialysepatientgruppen med sekundær HPT.
English: This medicinal product does not require any special storage conditions.
Danish: Denne medicin kræver ingen særlige forholdsregler ved opbevaring.
English: • allergic reactions (hypersensitivity)
Danish: • allergiske reaktioner (overfølsomhed),
English: Pack sizes of 1 blister (14 tablets), 2 blisters (28 tablets), 6 blisters (84 tablets) per carton.
Danish: Pakningsstørrelser på 1 blisterpakning (14 tabletter), 2 blisterpakninger (28 tabletter), 6 blisterpakninger (84 tabletter) pr. æske.
English: It is recommended that Mimpara be taken with food or shortly after a meal, as studies have shown that bioavailability of cinacalcet is increased when taken with food (see section 5.2).
Danish: Det anbefales, at Mimpara tages sammen med mad eller kort tid efter et måltid, da studier har vist, at biotilgængeligheden af cinacalcet forøges, når præparatet indtages sammen med mad (se pkt.
English: Testosterone levels are often below the normal range in patients with end-stage renal disease.
Danish: Testosteronniveauet ligger ofte under normalområdet hos patienter med nyresygdom i slutstadiet.
English: For additional information see section 4.
Danish: Punkt 4 nedenfor indeholder mere information.
English: Doses titrated up to 300 mg once daily have been administered to adult patients receiving dialysis without adverse outcome.
Danish: Doser titreret op til 300 mg én gang dagligt er blevet administreret til voksne dialysepatienter uden utilsigtede udfald.
English: The mean reductions in serum Ca x P, calcium, and phosphorus were 14%, 7% and 8%, respectively.
Danish: De gennemsnitlige reduktioner i serum-Ca x P, -calcium og -fosfor var henholdsvis 14 %, 7 % og 8 %.
English: Patients receiving concomitant medications known to prolong the corrected QT interval were excluded from the study.
Danish: Patienter, der fik samtidige medicinske behandlinger, som vides at forlænge det korrigerede QT-interval, blev udelukket fra studiet.
English: Mimpara is used in adults:
Danish: Mimpara bruges til voksne til:
English: Using water is not recommended as it may make the medicine taste bitter.
Danish: Det anbefales ikke at bruge vand, da det kan give medicinen en bitter smag.
English: Available sequential dose levels (mg)
Danish: Tilgængelige fortløbende dosisniveauer (mg)
English: Discontinuation of therapy as a result of undesirable effects was mainly due to nausea and vomiting.
Danish: Seponering af behandlingen som følge af bivirkninger skyldtes fortrinsvis nausea og opkastning.
English: Approximately 60% of cinacalcet-treated patients achieved a ≥ 30% reduction in iPTH levels, and this effect was consistent across the spectrum of baseline iPTH levels.
Danish: Cirka 60 % af de patienter, der blev behandlet med cinacalcet, opnåede en reduktion på ≥30 % i iPTH-niveauet, og denne virkning var konsekvent for hele spektret af baseline-iPTH-niveauer.
English: After oral administration of Mimpara, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours.
Danish: Efter oral administration af Mimpara opnås den maksimale plasma-cinacalcetkoncentration efter ca. 2-6 timer.
English: Your doctor will monitor your blood calcium levels.
Danish: Deres læge vil kontrollere Deres calciumniveauer i blodet.
English: The granules are not compatible with tubes made of polyurethane and silicone.
Danish: Granulatet er ikke kompatibelt med slanger af polyurethan og silikone.
English: Mimpara works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Danish: Mimpara virker ved at kontrollere niveauerne af paratyroideahormon (PTH), calcium og fosfor i kroppen.
English: After adjusting for baseline characteristics in a secondary analysis, the HR for the primary composite endpoint was 0.88; 95% CI: 0.79, 0.97.
Danish: Efter justering for baseline-karakteristika i en sekundær analyse var HR for det primære sammensatte endepunkt 0,88; 95 % CI: 0,79-0,97.
English: After administration of a 75 mg radiolabelled dose to healthy volunteers, cinacalcet was rapidly and extensively metabolised by oxidation followed by conjugation.
Danish: Efter administration af en 75 mg radioaktivt mærket dosis til raske, frivillige forsøgspersoner blev cinacalcet metaboliseret hurtigt og i stort omfang ved oxidation efterfulgt af konjugation.
English: Common*
Danish: Almindelig*
English: Caution is advised in patients with other risk factors for QT prolongation such as patients with known congenital long QT syndrome or patients receiving medicinal products known to cause QT prolongation.
Danish: Der tilrådes forsigtighed hos patienter, som har andre risikofaktorer for QT-forlængelse, for eksempel patienter med kongenit langt QT-syndrom eller patienter, der får lægemidler, som vides at forårsage QT-forlængelse.
English: What Mimpara contains
Danish: Mimpara indeholder
English: If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with Mimpara and during treatment with Mimpara.
Danish: Hvis De behandles for sekundær hyperparatyroidisme, skal Deres læge kontrollere Deres calciumniveauer, inden behandlingen med Mimpara starter og under behandlingen med Mimpara.
English: The study did not meet its primary objective of demonstrating a reduction in risk of all-cause mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112).
Danish: Studiet opfyldte ikke det primære formål med påvisning af en reduktion af risikoen for all-cause-mortalitet eller kardiovaskulære hændelser, herunder myokardieinfarkt, hospitalsindlæggelse på grund af ustabil angina, hjerteinsufficiens eller perifer vaskulær hændelse (HR 0,93; 95 % CI: 0,85; 1,02; p = 0,112).
English: There were no effects on fertility in males or females at exposures up to 4 times a human dose of 180 mg/day (safety margins in the small population of patients administered a maximum clinical dose of 360 mg daily would be approximately half those given above).
Danish: Der var ingen påvirkning af fertiliteten hos hanner og hunner ved eksponeringer på op til 4 gange en human dosis på 180 mg/dag (sikkerhedsmarginerne i den lille patientpopulation, der fik administreret en maksimal klinisk dosis på 360 mg dagligt, ville være ca. det halve af det ovenfor oplyste).
English: It is important that you take your dose of Mimpara as advised by your doctor.
Danish: Det er vigtigt, at De tager deres Mimpara-dosis efter lægens anvisninger.
English: Overdose of Mimpara may lead to hypocalcaemia.
Danish: Overdosering af Mimpara kan medføre hypokalcæmi.
English: Mimpara should be used in paediatric patients only if the potential benefit justifies the potential risk.
Danish: Mimpara bør kun bruges til pædiatriske patienter, hvis den potentielle fordel opvejer den potentielle risiko.
English: Mimpara should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Mimpara må kun bruges under graviditet, hvis den potentielle nyttevirkning berettiger den potentielle risiko for fosteret.
English: Testosterone levels
Danish: Testosteronniveau
English: Anorexia Decreased appetite
Danish: Anoreksi Nedsat appetit
English: Each bottle contains 30 capsules.
Danish: Hver flaske indeholder 30 kapsler.
English: Adverse reactions, considered at least possibly attributable to cinacalcet treatment in the placebo-controlled studies and single-arm studies based on best-evidence assessment of causality are listed below using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: De bivirkninger, der på grundlag af en vurdering af kausaliteten med rimelighed kan henføres til cinacalcet-behandling i placebo-kontrollerede forsøg og enkeltarms-studier, er vist i nedenstående tabel under anvendelse af følgende konvention: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden
English: There are no clinical data relating to the effect of cinacalcet on fertility.
Danish: Der findes ingen kliniske data vedrørende cinacalcets effekt på fertiliteten.
English: Mimpara treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Danish: Mimpara-behandling må ikke påbegyndes hos patienter med et serumcalcium (justeret for albumin), der ligger under den nedre grænse af normalområdet.
English: It is not known whether Mimpara is excreted in human milk.
Danish: Det vides ikke, om Mimpara udskilles i mælken hos mennesker.
English: Tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking Mimpara.
Danish: Fortæl det til Deres læge, hvis De får unormalt hurtige eller bankende hjerteslag, hvis De får hjerterytmeproblemer, eller hvis De tager medicin, der vides at forårsage hjerterytmeproblemer, mens De tager Mimpara.
English: After single and multiple once daily oral doses of cinacalcet, plasma cinacalcet concentrations (Cmax and AUC values after normalisation by dose and weight) were similar to those observed in adult patients.
Danish: Efter enkelte og flere orale doser cinacalcet én gang dagligt var plasmakoncentrationerne af cinacalcet (Cmax og AUC-værdier efter normalisering efter dosis og vægt) de samme som dem, der er observeret hos voksne patienter.
English: Mimpara is also available as tablets.
Danish: Mimpara fås også som tabletter.
English: A daily dose of 3.9 mg/kg was prescribed to a paediatric patient receiving dialysis in a clinical study with subsequent mild stomach ache, nausea and vomiting.
Danish: En daglig dosis på 3,9 mg/kg blev i et klinisk studie ordineret til en pædiatrisk patient, der fik dialysebehandling, med efterfølgende let mavepine, kvalme og opkastning.
English: Starting dose (mg)
Danish: Initialdosis (mg)
English: Smoking: Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2-mediated metabolism.
Danish: Rygning: Clearance af cinacalcet er større hos rygere end hos ikke-rygere, hvilket sandsynligvis skyldes induktion af CYP1A2-fremmet metabolisme.
English: The primary endpoint of the study was a reduction of serum calcium of ≥ 1 mg/dL (≥ 0.25 mmol/L).
Danish: Det primære endepunkt for studiet var en reduktion af serumcalcium på ≥ 1 mg/dl (≥ 0,25 mmol/l).
English: If PTH levels decrease below the recommended target range in patients treated with Mimpara, the dose of Mimpara and/or vitamin D sterols should be reduced or therapy discontinued.
Danish: Hvis PTH-niveauet falder til under det anbefalede målområde hos patienter, der behandles med Mimpara, skal dosen af Mimpara og/eller D-vitamin-steroler reduceres, eller behandlingen skal afbrydes.
English: Capsules should be opened by gently squeezing and twisting the coloured top from the white body of the capsule, having first tapped the capsule gently so the contents settle in the bottom of the capsule (white part of the capsule).
Danish: Kapslen åbnes ved, at den farvede top forsigtigt trykkes sammen og drejes af kapslens hvide kerne, efter at man først har banket forsigtigt på kapslen, så indholdet falder ned i bunden af kapslen (den hvide del af kapslen).
English: Administration of Mimpara with food results in an approximate 50-80% increase in cinacalcet bioavailability.
Danish: Administration af Mimpara sammen med mad giver en stigning på ca. 50-80 % i biotilgængeligheden for cinacalcet.
English: In in vitro studies, IC50 values for the serotonin transporter and KATP channels were found to be 7 and 12-fold greater, respectively, than the EC50 for the calcium-sensing receptor obtained under the same experimental conditions.
Danish: I in vitro-studier var IC50-værdierne for serotonin-transportør- og KATP-kanaler 7 respektive 12 gange højere end EC50 for calciumreceptoren ved samme forsøgsbetingelser.
English: Recommendations
Danish: Anbefalinger
English: Elderly: There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet.
Danish: Ældre personer: Der er ingen klinisk relevante forskelle forårsaget af alder i de farmakokinetiske egenskaber for cinacalcet.
English: Low calcium levels can have an effect on your heart rhythm.
Danish: Lave calciumniveauer kan påvirke Deres hjerterytme.
English: Based on between-study comparisons, the absolute bioavailability of cinacalcet in fasted subjects has been estimated to be about 20-25%.
Danish: På grundlag af sammenligninger mellem studier er den absolutte biotilgængelighed for cinacalcet hos fastende forsøgspersoner blevet anslået til ca. 20-25 %.
English: The recommended starting dose for children aged ≥ 3 years to < 18 years is ≤ 0.20 mg/kg once daily based on the patient's dry weight (see table 1).
Danish: Den anbefalede initialdosis for børn i alderen ≥ 3 år til < 18 år er ≤ 0,20 mg/kg én gang dagligt baseret på patientens tørvægt (se tabel 1).
English: Cinacalcet is a calcimimetic agent which directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium.
Danish: Cinacalcet er et calciummimetisk stof, der sænker PTH-niveauet direkte ved at øge den calciumfølende receptors følsomhed over for ekstracellulært calcium.
English: Reduce or withhold dose of Mimpara.
Danish: Nedsæt eller seponer Mimpara-dosen.
English: Reductions in PTH levels correlate with cinacalcet concentration.
Danish: Reduktioner i PTH-niveauet stemmer overens med cinacalcet-koncentrationen.
English: The study did not meet its primary endpoint (≥ 30% reduction from baseline in mean plasma iPTH during the EAP; weeks 17 to 20).
Danish: Studiet opfyldte ikke det primære endepunkt (≥ 30 % fald i forhold til baseline i gennemsnitlig plasma-iPTH under EAP; uge 17 til 20).
English: • Unusually fast or pounding heart beat which may be associated with low levels of calcium in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).
Danish: • unormalt hurtige eller bankende hjerteslag, der kan være forbundet med lave niveauer af calcium i Deres blod (QT-forlængelse og ventrikulær arytmi sekundært til hypokalcæmi).
English: Serum calcium levels in paediatric patients should be maintained within the normal range.
Danish: Serumcalciumniveauerne hos pædiatriske patienter skal holdes inden for normalområdet.
English: To open the capsule:
Danish: Åbning af kapslen:
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter og indgreb (ifølge aftalen i RMP, modul 1.8.2. i markedsføringstilladelsen) og enhver aftalt efterfølgende opdatering af RMP.
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 calciumfølende receptor på overfladen af paratyroideas hovedcelle er den primære regulator af PTH-udskillelsen.
English: Mimpara may affect how medicines such as the following work:
Danish: Mimpara kan have betydning for, hvordan følgende medicin virker:
English: Mimpara granules can be administered orally or through nasogastric or gastrostomy tubes.
Danish: Mimpara granulat kan indgives oralt eller gennem nasogastriske sonder eller gastrostomisonder.
English: The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg once daily.
Danish: AUC og Cmax for cinacalcet stiger omtrent lineært over dosisintervallet på 30 til 180 mg én gang dagligt.
English: There were no effects on fertility in animal studies.
Danish: I dyrestudier var der ingen virkninger på fertiliteten.
English: Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: MedDRA system organ class
Danish: Forekomsten af bivirkninger i kontrollerede kliniske forsøg og efter markedsføring: Systemorganklasse i henhold til
English: Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for overdose.
Danish: Da cinacalcet er meget proteinbundet, er hæmodialyse ikke en effektiv form for behandling i forbindelse med overdosering.
English: Inform paediatric patients and/or their caregivers about the symptoms of hypocalcaemia and about the importance of adherence to instructions about serum calcium monitoring, and posology and method of administration.
Danish: Pædiatriske patienter og/eller deres omsorgspersoner skal informeres om symptomerne på hypocalcæmi og om vigtigheden af at følge anvisningerne vedrørende monitorering af serumcalcium samt dosering og administration.
English: Concurrent administration may result in severe hypocalcaemia.
Danish: Samtidig administration kan medføre svær hypocalcæmi.
English: • Over a clean work surface remove from the bottle the number of capsules your doctor or pharmacist told you to use.
Danish: • Tag det antal kapsler, som lægen eller apoteket har sagt, De skal bruge, ud af beholder.
English: Cinacalcet was initiated at a dose of 30 mg twice daily and titrated to maintain a corrected total serum calcium concentration within the normal range.
Danish: Cinacalcet blev initieret med en dosis på 30 mg to gange dagligt og titreret til at opretholde et korrigeret serumcalcium inden for normal området.
English: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) was a randomised, double-blind clinical study evaluating cinacalcet versus placebo for the reduction of the risk of all-cause mortality and cardiovascular events in 3,883 patients with secondary HPT and CKD receiving dialysis.
Danish: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) var et randomiseret, dobbeltblindet klinisk studie til undersøgelse af cinacalcet vs. placebo til reduktion af risikoen for allcause-mortalitet og kardiovaskulære hændelser hos 3.883 patienter med sekundær HPT og CKD, der var i dialyse.
English: - The capsule shell contains:
Danish: - Kapslens skal indeholder:
English: After absorption, cinacalcet concentrations decline in a biphasic fashion with an initial half-life of approximately 6 hours and a terminal half-life of 30 to 40 hours.
Danish: Efter absorption falder cinacalcet-koncentrationerne tofaset med en indledende halveringstid på ca. 6 timer og en terminal halveringstid på 30 til 40 timer.
English: You must open the capsules and administer the entire content of granules.
Danish: De skal åbne kapslerne og indgive hele granulatet.
English: None had corrected serum calcium < 8.4 mg/dL (2.1 mmol/L) for ages 2-5 years.
Danish: Ingen havde korrigeret serumcalcium på < 8,4 mg/dl (2,1 mmol/l) for alderen 2-5 år.
English: In toxicity studies in juvenile dogs, tremors secondary to decreased serum calcium, emesis, decreased body weight and body weight gain, decreased red cell mass, slight decreases in bone densitometry parameters, reversible widening of the growth plates of long bones, and histological lymphoid changes (restricted to the thoracic cavity and attributed to chronic emesis) were observed.
Danish: I toksicitetsstudier af unge hunde blev der observeret tremor sekundært til nedsat serumcalcium, emesis, reduceret legemsvægt og nedsat vægtstigning, nedsat antal røde blodlegemer, lette fald i parametrene for knogledensitrometri, reversibel udvidelse af lange knoglers vækstplader samt histologiske lymfoide forandringer (begrænset til brysthulen og tilskrevet kronisk emesis).
English: In a clinical study of adult ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the Mimpara-treated patients and by 16.3% in the placebo-treated patients after 6 months of treatment.
Danish: I et klinisk studie af voksne ESRD-patienter (end-stage renal disease) i dialyse faldt det fri testosteronniveau i gennemsnit med 31,3 % hos de patienter, der blev behandlet med Mimpara, og med 16,3 % hos patienterne i placebogruppen efter 6 måneders behandling.
English: Adynamic bone disease may develop if PTH levels are chronically suppressed below approximately 1.5 times the upper limit of normal with the iPTH assay.
Danish: Adynamisk knoglesygdom kan opstå, hvis PTH-niveauet konstant undertrykkes til under ca. 1,5 gange den øvre grænse for normalområdet i analysen af iPTH.
English: What you need to know before you take Mimpara Do not take Mimpara if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal De vide, før De begynder at tage Mimpara Tag ikke Mimpara, hvis De er allergisk over for cinacalcet eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: You should not receive Mimpara together with etelcalcetide.
Danish: De må ikke få Mimpara samtidig med etelcalcetid.
English: Mimpara contains lactose
Danish: Mimpara indeholder lactose
English: • For patients who have nasogastric or gastrostomy tubes, the granules can be administered with a small amount (at least 5 mL) of water using PVC tubing.
Danish: • Til patienter, der har en nasogastrisk sonde eller gastrostomisonde, kan granulatet indgives med en lille mængde (mindst 5 ml) vand ved hjælp af PVC-slanger.
English: The capsule must be opened and the entire contents of a capsule should be sprinkled in food or liquid and administered.
Danish: Kapslen skal åbnes, og hele indholdet af kapslen skal drysses oven på mad eller væske og gives.
English: Manifestations of hypocalcaemia may include paraesthesias, myalgias, cramping, tetany and convulsions.
Danish: Manifestationer af hypokalcæmi kan omfatte paræstesier, myalgier, kramper, tetani og konvulsioner.