FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Coagadex have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Coagadex.
English: How is Coagadex used?
Danish: Hvordan anvendes Coagadex?
English: How does Coagadex work?
Danish: Hvordan virker Coagadex?
English: What benefits of Coagadex have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Coagadex?
English: This summary was last updated in 06-2008.
Danish: Dette sammendrag blev sidst ajourført i 06-2008.
English: The study continued for over three years.
Danish: Undersøgelsen fortsatte i mere end tre år.
English: It is available as light green oval tablets (30, 60 or 90 mg).
Danish: Det fås som lysegrønne ovale tabletter (30, 60 eller 90 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Parareg on 22 October 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Parareg den 22. oktober 2004.
English: Parareg is used in adults and elderly patients:
Danish: Parareg anvendes hos voksne og ældre patienter:
English: The studies lasted for six months.
Danish: Undersøgelserne varede i seks måneder.
English: The marketing authorisation holder is Dompé Biotec S.p.A.
Danish: Indehaveren af markedsføringstilladelsen er Dompé Biotec S.p.A.
English: Parareg is taken with food or shortly after a meal.
Danish: Parareg indtages med føde eller kort efter et måltid.
English: Other information about Parareg:
Danish: Andre oplysninger om Parareg:
English: Parareg was compared with placebo (a dummy treatment).
Danish: Parareg blev sammenlignet med placebo (en uvirksom behandling).
English: It can lead to bone and joint pain and deformities of the arms and legs.
Danish: Dette kan føre til knogle- og ledsmerter og deformiteter af arme og ben.
English: Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Parareg over a total of almost six years.
Danish: Af disse fortsatte 45 i en fjerde, langsigtet undersøgelse, hvor der blev set nærmere på virkningen af Parareg over en periode på næsten seks år.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PARAREG EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PARAREG EPAR - sammendrag for offentligheden
English: The Committee recommended that Parareg be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Parareg.
English: This means that it mimics the action of calcium in the body.
Danish: Det betyder, at det efterligner virkningen af kalcium i kroppen.
English: It can be used as part of treatment including phosphate binders or vitamin D sterols.
Danish: Parareg kan anvendes som en del af en behandling, herunder med fosfatbindere eller D-vitamin-steroler,
English: The full EPAR for Parareg is available here.
Danish: Den fuldstændige EPAR for Parareg findes her.
English: • to treat secondary hyperparathyroidism.
Danish: • til behandling af sekundær hyperparatyreoidisme.
English: Parareg should not be used in people who may be hypersensitive (allergic) to cinacalcet or any of the other ingredients.
Danish: Parareg bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for cinacalcet eller andre af indholdsstofferne.
English: Parareg is a medicine containing the active substance cinacalcet.
Danish: Parareg er et lægemiddel, der indeholder det aktive stof cinacalcet.
English: Parareg is used in patients with serious kidney disease who need dialysis to clear their blood of waste products.
Danish: Parareg anvendes til patienter med svær nyresygdom, som har behov for dialyse for at rense blodet for affaldsstoffer.
English: A further three studies compared the effectiveness of Parareg and placebo in a total of 136 patients with primary hyperparathyroidism over up to a year.
Danish: Yderligere tre undersøgelser sammenlignede virkningen af Parareg og placebo hos i alt 136 patienter med primær hyperparatyreoidisme i op til et år.
English: What is the risk associated with Parareg?
Danish: Hvilken risiko er der forbundet med Parareg?
English: The main measure of effectiveness was the number of patients who had a reduction in blood calcium levels of more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study).
Danish: Den vigtigste målestok for virkningen var antallet af patienter, som havde et fald i kalciumindholdet i blodet på mere end 1 mg pr. deciliter på det tidspunkt, hvor der var fundet en vedligeholdelsesdosis (mellem to og 16 uger efter undersøgelsens start).
English: Parareg has been studied in three main studies involving 1,136 dialysis patients with serious kidney disease.
Danish: Parareg blev undersøgt i tre hovedundersøgelser, som omfattede 1 136 dialysepatienter med svær nyresygdom.
English: Parareg produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism(15 out of 17).
Danish: Parareg medførte et fald i kalciumindholdet i blodet på mere end 1 mg/dl hos 62 % af kræftpatienterne (18 ud af 29) og hos 88 % af patienterne med primær hyperparatyreoidisme (15 ud af 17).
English: Parareg brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.
Danish: Parareg medførte et fald på 42 % i PTH-niveauerne sammenlignet med en stigning på 8 % hos de patienter, der fik placebo.
English: The dose of Parareg should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Danish: Doseringen af Parareg bør øges hver anden til fjerde uge op til 90 mg tre eller fire gange daglig efter behov for at reducere kalciumindholdet i blodet til normale niveauer.
English: Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Parareg.
Danish: Blodkalciumniveauet bør måles ofte og inden for en uge efter hver justering af dosis med Parareg.
English: The active substance in Parareg, cinacalcet, is a calcimimetic agent.
Danish: Det aktive stof i Parareg, cinacalcet, er et kalciummimetisk stof.
English: Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.
Danish: Når der er fastsat en vedligeholdelsesdosis, bør kalciumniveauet måles en gang om måneden, og PHT-niveauerne bør måles med en til tre måneders mellemrum.
English: Why has Parareg been approved?
Danish: Hvorfor blev Parareg godkendt?
English: The dose is adjusted every two to four weeks, according the patient's PTH levels, up to a maximum of 180 mg once a day.
Danish: Dosis justeres hver anden til fjerde uge i overensstemmelse med patientens PTH-niveauer med op til maksimalt 180 mg en gang daglig.
English: The results of the additional studies supported the use of Parareg for hypercalcaemia in patients with primary hyperparathyroidism.
Danish: Resultaterne af de supplerende undersøgelser underbyggede anvendelsen af Parareg til hypercalcæmi hos patienter med primær hyperparatyreoidisme.
English: In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day.
Danish: Ved sekundær hyperparatyreoidisme er den anbefalede startdosis for voksne 30 mg en gang daglig.
English: In dialysis patients with serious kidney disease, about 40% of the patients taking Parareg had PTH levels below 250 micrograms/l at the end of the study, compared with about 6% of those taking placebo.
Danish: Hos dialysepatienter med svær nyresygdom havde ca. 40 % af patienterne, som fik Parareg, PTHniveauer under 250 mikrogram/l ved slutningen af undersøgelsen sammenlignet med ca. 6 % hos de patienter, der fik placebo.
English: Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate PTH secretion.
Danish: Cinacalcet virker ved at øge følsomheden i de kalciumsensitive receptorer på biskjoldbruskkirtlerne, som regulerer PTH-sekretionen.
English: For the full list of all side effects reported with Parareg, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Parareg fremgår af indlægssedlen.
English: What is Parareg?
Danish: Hvad er Parareg?
English: The most common side effects with Parareg in secondary hyperparathyroidism (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Danish: De hyppigste bivirkninger af Parareg ved sekundær hyperparatyreoidisme (som ses hos flere end 1 ud af 10 patienter) er kvalme og opkastninger.
English: PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Parareg.
Danish: PTH-niveauerne bør vurderes mindst 12 timer efter dosering og en til fire uger efter justering af dosis med Parareg.
English: The main measure of effectiveness was the number of patients who had a PTH level below 250 micrograms per litre at the end of the study.
Danish: Den vigtigste målestok for virkningen var antallet af patienter, som ved slutningen af undersøgelsen havde et PTH-niveau på under 250 mikrogram pr. liter.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Parareg's benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Parareg opvejer risiciene til behandling af sekundær hyperparatyreoidisme hos dialysepatienter med nyresygdom i terminalstadiet og til reduktion af hypercalcæmi hos patienter med kræft i biskjoldbruskkirtlerne eller primær hyperparatyreoidisme, hvor der ville være indikation for parathyreoidektomi på basis af serumkalciumniveauet, men hvor parathyreoidektomi ikke er klinisk hensigtsmæssigt eller er kontraindiceret.
English: ‘Secondary' means that the hyperparathyroidism is caused by another condition.
Danish: ”Sekundær” hyperparatyreoidisme betyder, at lidelsen er forårsaget af en anden tilstand.
English: • to reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands), or in patients with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that removal of the parathyroid glands is not appropriate.
Danish: • til reduktion af hypercalcæmi (høje kalciumniveauer i blodet) hos patienter med cancer i paratyroidea (kræft i biskjoldbruskkirtlerne) eller hos patienter med primær hyperparatyreoidisme, som ikke kan få biskjoldbruskkirtlerne fjernet, eller når lægen vurderer, at det ikke er hensigtsmæssigt at fjerne biskjoldbruskkirtlerne.
English: In patients with parathyroid carcinoma or primary hyperparathyroidism, the side effects are similar to those seen in patients with long-standing kidney disease - the most frequent side effects are nausea and vomiting.
Danish: Hos patienter med kræft i biskjoldbruskkirtlerne eller primær hyperparatyreoidisme svarer bivirkningerne til dem, der kan iagttages hos patienter med langvarig nyresygdom - de hyppigste bivirkninger er kvalme og opkastninger.
English: Parareg has also been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid carcinoma and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective.
Danish: Parareg blev også undersøgt hos 46 patienter med hypercalcæmi, heraf 29 med kræft i biskjoldbruskkirtlerne og 17 med primær hyperparatyreoidisme, som ikke kunne få biskjoldbruskkirtlerne fjernet, eller hvor kirurgisk fjernelse af biskjoldbruskkirtlerne ikke var effektiv.
English: This is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH).
Danish: Hyperparatyreoidisme er en lidelse, hvor biskjoldbruskkirtlerne på halsen producerer for meget paratyroideahormon (PTH).
English: What is Parareg used for?
Danish: Hvad anvendes Parareg til?
English: In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Parareg for adults is 30 mg twice a day.
Danish: Hos patienter med kræft i biskjoldbruskkirtlerne er den anbefalede startdosis Parareg for voksne 30 mg to gange daglig.
English: How has Parareg been studied?
Danish: Hvordan blev Parareg undersøgt?
English: What benefit has Parareg shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Parareg?
English: ‘Primary' means that the hyperparathyroidism is not caused by any
Danish: ”Primær” hyperparatyreoidisme betyder, at lidelsen ikke skyldes nogen anden sygdomstilstand.
English: How is Parareg used?
Danish: Hvordan anvendes Parareg?
English: By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands.
Danish: Ved at øge de kalciumsensitive receptorers følsomhed medfører cinacalcet, at biskjoldbruskkirtlerne producerer mindre PTH. Reduktionen af PTH-niveauerne medfører ligeledes et fald i kalciumindholdet i blodet.
English: How does Parareg work?
Danish: Hvordan virker Parareg?
English: *NRI: None responder imputation.
Danish: *NRI: Non-responder imputation.
English: *At least one of these adverse reactions was reported as serious
Danish: *Mindst én af disse bivirkninger blev rapporteret som værende alvorlig
English: In some cases, patients were hospitalised.
Danish: I nogle tilfælde blev patienterne indlagt.
English: • if you are pregnant or think you may be pregnant.
Danish: • hvis du er gravid eller tror du kan være gravid.
English: How much to take
Danish: Hvor meget skal der tages?
English: This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before.
Danish: Dette betyder, at den påvirkning, din sygdom har på daglige aktiviteter, forhold og andre faktorer bør være mindre end før.
English: Apremilast is not genotoxic.
Danish: Apremilast er ikke genotoksisk.
English: Do not take a dose
Danish: Du må ikke tage en dosis
English: • Swallow the tablets whole, preferably with water.
Danish: • Slug tabletterne hele, helst med vand.
English: Not known side effects (frequency cannot be estimated from the available data):
Danish: Ikke kendte bivirkninger (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: • You should continue taking Otezla until your doctor tells you to stop.
Danish: • Du bør fortsætte med at tage Otezla, indtil lægen fortæller dig, at du skal stoppe.
English: These improvements were maintained at week 24.
Danish: Disse forbedringer blev opretholdt efter uge 24.
English: No fertility data is available in humans.
Danish: Der foreligger ingen fertilitetsdata hos mennesker.
English: Poly(vinyl alcohol)
Danish: Poly(vinylalkohol)
English: • You can take the tablets either with or without food.
Danish: • Du kan tage tabletterne sammen med eller uden mad.
English: Human plasma protein binding of apremilast is approximately 68%.
Danish: Den humane plasmaproteinbinding af apremilast er ca. 68 %.
English: • Take Otezla at about the same time each day, one tablet in the morning and one tablet in the evening.
Danish: • Tag Otezla på omtrent det samme tidspunkt hver dag, én tablet om morgenen, og en tablet om aftenen.
English: Most events occurred within the first few weeks of treatment.
Danish: De fleste hændelser skete inden for de første uger af behandlingen.
English: Pregnancy should be excluded before treatment can be initiated.
Danish: Graviditet skal udelukkes, før behandlingen kan påbegyndes.
English: • This is a total daily dose of 60 mg. By the end of day 6 you will have reached this recommended dose.
Danish: • Dette er en daglig dosis på i alt 60 mg. Ved slutningen af dag 6 vil du have nået til denne anbefalede dosis.
English: The median duration of PsA disease was 5 years.
Danish: Den mediane varighed af PsA-sygdom var 5 år.
English: The patient's response to treatment should be evaluated on a regular basis.
Danish: Patientens respons på behandlingen bør evalueres regelmæssigt.
English: Patients in these studies had a diagnosis of PsA for at least 6 months.
Danish: Patienterne i disse studier havde en diagnose på PsA i mindst 6 måneder.
English: • Your treatment will start at a lower dose and will gradually be increased over the first 6 days of treatment.
Danish: • Din behandling vil starte med en lavere dosis, og den vil øges gradvist i løbet af de første 6 dages behandling.
English: One qualifying psoriatic skin lesion (at least 2 cm in diameter) was also required in PALACE 3.
Danish: En kvalificerende psoriatiske hudlæsion (mindst 2 cm i diameter) var også påkrævet i PALACE 3.
English: Physical function and health-related quality of life
Danish: Fysisk funktion og helbredsrelateret livskvalitet
English: • The ‘treatment initiation pack' is clearly labelled to make sure you take the correct tablet at the correct time.
Danish: • 'Pakningen med indledende behandling' er tydeligt etiketteret for at sikre, at du tager den korrekte tablet på det korrekte tidspunkt
English: Concomitant treatment with biologic DMARDs, including TNF blockers, was not allowed.
Danish: Samtidig behandling med biologisk DMARDs, herunder TNF-blokkere, var ikke tilladt.
English: • rifampicin - an antibiotic used for tuberculosis
Danish: • rifampicin - et antibiotikum, der anvendes mod tuberkulose
English: This is because Otezla can affect the way some other medicines work.
Danish: Dette skyldes, at Otezla kan påvirke den måde, nogle andre lægemidler virker på.
English: Apremilast is the major circulating component following oral administration.
Danish: Apremilast er den primære cirkulerende komponent efter oral administration.
English: Patient weight was measured routinely in clinical studies.
Danish: Patientens vægt blev målt rutinemæssigt i kliniske studier.
English: Take the next dose at your regular time.
Danish: Tag den næste dosis til normal tid.
English: • Do not stop taking Otezla without talking to your doctor first.
Danish: • Du må ikke holde op med at tage Otezla, uden først at kontakte din læge.
English: Subjects who discontinued early prior to the time point and subjects who did not have sufficient data for a definitive determination of response status at the time point are counted as non-responders.
Danish: Personer, der afbrød tidligt før tidspunktet, og personer, som ikke havde tilstrækkelige data til en definitiv bestemmelse af responsstatus på tidspunktet, tælles som non-responders.
English: Pre- and post-natal development
Danish: Præ- og postnatal udvikling
English: • The ‘treatment initiation pack' will also contain enough tablets for another 8 days at the recommended dose (days 7 to 14).
Danish: • 'Pakningen med indledende behandling' vil også indeholde nok tabletter til endnu 8 dage med den anbefalede dosis (dag 7 til 14).
English: The mean apparent volume of distribution (Vd) is 87 L, indicative of extravascular distribution.
Danish: Det gennemsnitlige tilsyneladende fordelingsvolumen (Vd) er 87 l, hvilket indikerer ekstravaskulær fordeling.
English: Due to the study design the duration of re-treatment was variable, and ranged from 2.6 to 22.1 weeks.
Danish: På grund af studiedesignet var varigheden af den gentagne behandling variabel, og varede fra 2,6 til 22,1 uger.
English: You will only ever need to go through this stage of gradually increasing your dose once even if you re-start treatment.
Danish: Du vil kun behøve at gå igennem dette trin med en gradvis dosisøgning én gang, selv hvis du genstarter behandlingen.
English: Your doctor will talk to you about how to increase your dose when you first start taking Otezla.
Danish: Din læge vil tale med dig om hvordan din dosis skal øges, når du først begynder med at tage Otezla.
English: Similar response rates were observed across all weight ranges.
Danish: Sammenlignelige responsrater blev observeret i alle vægtintervaller.
English: The film-coated tablets should be swallowed whole, and can be taken either with or without food.
Danish: De filmovertrukne tabletter skal sluges hele, og de kan tages enten sammen med eller uden mad.
English: Fertility and early embryonic development
Danish: Fertilitet og tidlig embryonal udvikling
English: Apremilast was studied in young and elderly healthy subjects.
Danish: Apremilast blev undersøgt hos unge og ældre raske personer.
English: No re-titration is required after initial titration.
Danish: Ingen gentitrering er nødvendig efter den indledende titrering.
English: There is limited pharmacokinetic data in subjects over 75 years of age in clinical trials.
Danish: Der er begrænsende farmakokinetiske data hos personer over 75 år i kliniske studier.
English: Apremilast is associated with an increased risk of psychiatric disorders such as insomnia and depression.
Danish: Apremilast er forbundet med en øget risiko for psykiske forstyrrelser såsom insomni og depression.
English: What Otezla is used for Otezla is used to treat adults with the following conditions:
Danish: Anvendelse Otezla anvendes til at behandle voksne med de følgende sygdomme:
English: There is no evidence of immunotoxic, dermal irritation, or phototoxic potential.
Danish: Der er ikke bevis for immunotoksisk potentiale, hudirritation eller fototoksisk potentiale.
English: If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment should be reconsidered.
Danish: Hvis en patient ikke viser nogen tegn på terapeutisk virkning efter 24 uger, bør behandlingen revurderes.
English: Frequencies are defined as: 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); not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret som: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • When you first start taking Otezla, you will receive a ‘treatment initiation pack' which contains all the doses as listed in the table below.
Danish: • Når du først begynder at tage Otezla, vil du modtage en 'pakning med indledende behandling', som indeholder alle de doser, der er opgivet i tabellen nedenfor.
English: Sun as symbol for morning dose Moon as symbol for evening dose Refer to the wallet card for daily dose
Danish: Sol som symbol for morgen dosering Måne som symbol for aften dosering Se doseringskortet for oplysning om daglig dosis
English: • If you miss a dose of Otezla, take it as soon as you remember.
Danish: • Hvis du har glemt en dosis af Otezla, skal du tage den så snart du husker på det.
English: If patients miss a dose, the next dose should be taken as soon as possible.
Danish: Hvis patienten glemmer en dosis, skal den næste dosis tages så snart som muligt.
English: An initial titration schedule is required as shown below in Table 1.
Danish: Et indledende titreringsskema påkræves som vist nedenfor i tabel 1.
English: These studies had a similar design through week 32.
Danish: Disse studier havde et sammenligneligt design til og med uge 32.
English: QR code to be included www.otezla-eu-pil.com
Danish: QR-koden skal indsættes www.otezla-eu-pil.com
English: The safety and efficacy of apremilast in children aged 0 to 17 years have not been established.
Danish: Apremilasts sikkerhed og virkning hos børn i alderen 0 til 17 år er ikke klarlagt.
English: Carcinogenicity studies
Danish: Studier af karcinogenicitet