FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may decide to monitor your blood pressure.
Danish: Din læge kan vælge at overvåge dit blodtryk.
English: Adempas can be taken alone or together with certain other medicines used to treat PAH.
Danish: Adempas kan tages alene eller sammen med visse andre lægemidler, der anvendes til at behandle PAH.
English: Moderate passage across the placental barrier was observed.
Danish: Der blev observeret en moderat passage over placentabarrieren.
English: If your blood pressure drops (which can make you feel dizzy) then you may need immediate medical attention.
Danish: Hvis dit blodtryk falder (hvilket kan gøre dig svimmel) kan du have behov for øjeblikkelig medicinsk behandling.
English: Elimination half-life is about 7 hours in healthy subjects and about 12 hours in patients.
Danish: Halveringstiden for elimination er ca. 7 timer hos raske personer, og ca. 12 timer hos patienter.
English: If this happens, contact your doctor immediately as you may need urgent medical treatment.
Danish: Hvis dette forekommer, skal du straks kontakte lægen, da du kan have behov for akut medicinsk behandling.
English: Terminal half-life increased from 7.3 to 9.2 hours and total body clearance decreased from 6.1 to 2.4 L/h.
Danish: Den terminale halveringstid steg fra 7,3 til 9,2 timer, og den totale kropsclearance faldt fra 6,1 til 2,4 l/time.
English: Riociguat has a dual mode of action.
Danish: Riociguat har en dobbelt virkningsmåde.
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), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres 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), meget sjælden ( <1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • inoperable CTEPH,
Danish: • inoperabel CTEPH,
English: In case of pronounced hypotension, active cardiovascular support may be required.
Danish: I tilfælde af udpræget hypotension kan det være nødvendigt med aktiv kardiovaskulær støtte.
English: Tablets can generally be taken with or without food.
Danish: Tabletterne kan generelt tages sammen med eller uden mad.
English: Six patients (10%) experienced at least one clinical worsening event, including 2 deaths unrelated to study drug.
Danish: 6 patienter (10 %) oplevede mindst en klinisk forværret bivirkning, herunder 2 dødsfald, der ikke var relateret til studiemedicinen.
English: Improved Stable Deteriorated p-value
Danish: Forbedret Stabil Forværret p-værdi
English: The volume of distribution is moderate with volume of distribution at steady state being approximately 30 L.
Danish: Fordelingsvoluminet er moderat med fordelingsvoluminet ved steady state på ca. 30 l.
English: If your treatment has to be stopped for 3 days or more, please tell your doctor before restarting your treatment.
Danish: Hvis din behandling skal stoppes i 3 dage eller længere, skal du fortælle det til lægen, før du genstarter din behandling.
English: Patients should be aware of how they react to this medicinal product, before driving or using machines.
Danish: Patienterne skal være opmærksomme på, hvordan de reagerer over for dette lægemiddel, før de fører motorkøretøj eller betjener maskiner.
English: With increased doses, over additive effects on systemic blood pressure were observed in some cases.
Danish: Med forhøjede doser blev der i nogle tilfælde observeret overadditive virkninger på det systemiske blodtryk.
English: Patients older than 65 years are at increased risk of hypotension.
Danish: Patienter over 65 år har en øget risiko for hypotension.
English: Do not stop taking this medicine without talking to your doctor first, because this medicine prevents the progression of the disease.
Danish: Du må ikke holde op med at tage dette lægemiddel uden først at tale med din læge, da medicinen forhindrer, at din sygdom fremskrider.
English: Adempas is available in different strengths and by checking your blood pressure regularly at the beginning of your treatment, your doctor will ensure that you are taking the appropriate dose.
Danish: Adempas findes i forskellige styrker, og ved at måle dit blodtryk regelmæssigt i begyndelsen af din behandling, vil lægen sikre, at du tager den korrekte dosis.
English: Patients with mild and moderate renal impairment were included in the pivotal studies.
Danish: Patienter med let og moderat nedsat nyrefunktion blev inkluderet i de pivotale studier.
English: A careful monitoring of patients taking anticoagulants according to common medical practice is recommended.
Danish: En nøje overvågning anbefales for de patienter, der tager antikoagulantia i henhold til almindelig medicinsk praksis.
English: A dose decrease may be required in patients who stop smoking.
Danish: Det kan være nødvendigt at reducere dosis hos patienter, som holder op med at ryge.
English: The established individual dose should be maintained unless signs and symptoms of hypotension occur.
Danish: Den opnåede individuelle dosis skal opretholdes, medmindre der opstår tegn og symptomer på hypotension.
English: All patients were WHO Functional Class III and 82% received background therapy with an endothelin receptor antagonist (ERA).
Danish: Alle patienter var WHOfunktionsklasse III og 82 % fik baggrundsbehandling med en endothelin-receptorantagonist (ERA).
English: With a systemic clearance of about 3-6 L/h, riociguat can be classified as a low-clearance drug.
Danish: Med en systemisk clearance på ca. 3-6 l/t kan riociguat klassificeres som et lægemiddel med lav clearance.
English: Based on this study and as riociguat is not an inducer of any of the relevant metabolic enzymes, also no pharmacokinetic interaction is expected with other hormonal contraceptives.
Danish: Baseret på dette studie og eftersom riociguat ikke er en induktor af nogen relevante metaboliske enzymer, forventes der ikke nogen farmakokinetisk interaktion med andre hormonelle kontraceptionsmidler.
English: Date of latest renewal: 18 January 2019
Danish: Dato for første markedsføringstilladelse: 27. marts 2014 Dato for seneste fornyelse: 18. januar 2019
English: Plasma concentrations of riociguat in smokers are reduced compared to non-smokers.
Danish: Plasmakoncentrationen af riociguat hos rygere er reduceret i forhold til hos ikke-rygere.
English: Intra-cellular cGMP plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis, and inflammation.
Danish: Intracellulær cGMP spiller en vigtig rolle i regulerende processer, der påvirker vaskulær tonus, proliferation, fibrose og inflammation.
English: If any of these applies to you, talk to your doctor first and do not take Adempas.
Danish: Hvis noget af dette gælder for dig, skal du først tale med din læge, og ikke tage Adempas.
English: Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems.
Danish: Særlige hensyn for patienter med nyre- eller leverproblemer Du bør fortælle det til din læge, hvis du har nyre- eller leverproblemer.
English: Deteriorated p-value
Danish: Forværret p-værdi
English: The safety and efficacy of riociguat in children and adolescents below 18 years have not been established.
Danish: Riociguats sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Effects of other substances on riociguat
Danish: Virkninger af andre stoffer på riociguat
English: During the first weeks of treatment your doctor will need to measure your blood pressure at regular intervals.
Danish: I løbet af de første ugers behandling skal lægen måle dit blodtryk med regelmæssige mellemrum.
English: If not tolerated, dose reduction should be considered at any time.
Danish: Hvis dosis ikke tåles, skal det på ethvert tidspunkt overvejes at reducere dosis.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Adempas in one or more subsets of the paediatric population in the treatment of pulmonary hypertension.
Danish: Det Europæiske Lægemiddelagentur (EMA) har udsat forpligtelsen til at fremlægge resultaterne af studier med Adempas i en eller flere undergrupper af den pædiatriske population til behandling af pulmonal hypertension.
English: Adempas is used in either of two types of pulmonary hypertension:
Danish: Adempas anvendes til to typer pulmonal hypertension:
English: Stable
Danish: Stabil
English: Non-clinical data revealed no specific hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, phototoxicity, genotoxicity and carcinogenicity.
Danish: De prækliniske data viste ingen specifik risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter enkeltdoser, fototoksicitet, genotoksicitet og karcinogenicitet.
English: Individual dose titration at treatment initiation allows adjustment of the dose to the patient´s needs.
Danish: Individuel dosistitrering ved behandlingens start gør der muligt at justere dosis efter patientens behov.
English: Effects of riociguat on other substances
Danish: Virkning af riociguat på andre stoffer
English: Riociguat has vasodilatory properties which may result in lowering of blood pressure.
Danish: Riociguat har vasodilatoriske egenskaber, der kan forårsage en reduktion af blodtrykket.
English: Because the heart must work harder than normal, people with pulmonary hypertension feel tired, dizzy and short of breath.
Danish: Da hjertet må arbejde hårdere end normalt, føler et menneske med pulmonal hypertension sig træt, svimmel og stakåndet.
English: No specific studies with riociguat in humans have been conducted to evaluate effects on fertility.
Danish: Der er ikke udført specifikke studier med riociguat hos mennesker for at evaluere virkningerne på fertilitet.
English: It may cause side effects such as dizziness.
Danish: Det kan forårsage bivirkninger, såsom svimmelhed.
English: In case of overdose, standard supportive measures should be adopted as required.
Danish: I tilfælde af overdosering skal der opstartes standard støttebehandling efter behov.
English: Riociguat is rapidly absorbed with maximum concentrations (Cmax) appearing 1-1.5 hours after tablet intake.
Danish: Riociguat absorberes hurtigt, og maksimale koncentrationer (Cmax) opnås 1-1,5 timer efter tabletindtagelsen.
English: Improved
Danish: Forbedret
English: What you need to know before you take Adempas 3.
Danish: Det skal du vide, før du begynder at tage Adempas 3.
English: Adempas can be used for patients with CTEPH who cannot be operated on, or after surgery for patients in whom increased blood pressure in the lungs remains or returns.
Danish: Adempas kan anvendes til patienter med CTEPH, som ikke kan opereres, eller efter operationen hos patienter, som stadig har et forhøjet blodtryk i lungerne, eller hvor det vender tilbage.
English: If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Adempas.
Danish: Hvis du har problemer med at sluge tabletten hel, kan du tale med lægen om andre måder at tage Adempas på.
English: If there is a chance you could become pregnant, use reliable forms of contraception while you are taking these tablets.
Danish: Hvis der er en risiko for, at du kan blive gravid, skal du anvende en pålidelig præventionsmetode, mens du tager disse tabletter.
English: Results were consistent in the main sub-groups evaluated (ITT analysis, see table 2).
Danish: Resultaterne var konsistente i de primære undergrupper, der blev evalueret (ITT-analyse, se tabel 2).
English: An open-label extension study (CHEST-2) included 237 patients who had completed CHEST-1.
Danish: Et åbent forlængelsesstudie (CHEST-2) inkluderede 237 patienter, som havde gennemført CHEST-1.
English: Pregnancy/contraception
Danish: Graviditet/ kontraception
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: An open-label extension study (PATENT-2) included 396 patients who had completed PATENT-1 at the cut-off-date.
Danish: Et åbent forlængelsesstudie (PATENT-2) inkluderede 396 patienter, som havde gennemført PATENT-1 ved afskæringsdatoen.
English: Therefore, female patients at potential risk of pregnancy must use an effective method of contraception.
Danish: Derfor skal kvindelige patienter, der har en potentiel risiko for at blive gravide, anvende sikker kontraception.
English: In case treatment has to be interrupted for 3 days or more, treatment should be restarted with 1 mg three times daily for 2 weeks, and continued with the dose titration regimen as described above.
Danish: Hvis behandlingen skal afbrydes i 3 dage eller mere, bør behandlingen genstartes med 1 mg tre gange dagligt i 2 uger, og fortsættes med det dosistitreringsprogram, der er beskrevet ovenfor.
English: If you are older than 65 years, you have an increased risk of developing low blood pressure.
Danish: Hvis du er over 65 år, har du en øget risiko for at få lavt blodtryk.
English: You are also advised to take monthly pregnancy tests.
Danish: Det anbefales også at du tager en månedlig graviditetstest.
English: Your dose may need to be adjusted.
Danish: Din dosis skal muligvis justeres.
English: In this case, your doctor will prescribe you Adempas at the highest dose you are comfortable on. For some patients lower doses three times a day might be sufficient, the optimal dose will be selected by your doctor.
Danish: I dette tilfælde vil lægen ordinere Adempas til dig ved den højeste dosis, du har det godt med. For nogle patienter kan en lavere dosis tre gange dagligt være tilstrækkelig.
English: Patient population with CTEPH post-PEA
Danish: Patientpopulation med CTEPH post-PEA
English: Blood pressure should be monitored and dose reduction of riociguat be considered.
Danish: Blodtrykket bør overvåges, og en dosisreduktion af riociguat bør overvejes.
English: Treatment should only be started and monitored by a doctor experienced in the treatment of CTEPH or PAH.
Danish: Behandlingen bør kun påbegyndes og overvåges af en læge med erfaring i behandling af CTEPH eller PAH.
English: Change in WHO Functional Class
Danish: Ændring i WHO-funktionsklasse
English: Developmental toxicity studies in rats and rabbits have shown reproductive toxicity of riociguat.
Danish: Toksicitetsstudier af udviklingen hos rotter og kaniner har vist reproduktionstoksicitet af riociguat.
English: The adverse reactions reported with Adempas are listed in the table below by MedDRA system organ class and by frequency.
Danish: Bivirkningerne rapporteret med Adempas er opstillet i den nedenstående tabel i henhold til MedDRA systemorganklasse og hyppighed.
English: System Organ Class
Danish: MedDRA Systemorganklasse
English: However, if you are prone to having low blood pressure (hypotension), you should not switch from taking Adempas with food to taking Adempas without food because it may affect how you react to this medicine.
Danish: Men hvis du har en tendens til lavt blodtryk (hypotension), bør du ikke skifte fra at tage Adempas sammen med mad til at tage Adempas uden mad, da det kan påvirke hvordan du reagerer på Adempas.
English: If you already take one of these medicines and start treatment with Adempas, your doctor will monitor your health status and should consider a reduced starting dose for Adempas.
Danish: Hvis du allerede tager et af disse lægemidler og starter på behandling med Adempas, vil din læge overvåge din helbredstilstand og overveje, om du skal have en lavere startdosis af Adempas.
English: Preclinical studies in animal models showed additive systemic blood pressure lowering effect when riociguat was combined with either sildenafil or vardenafil.
Danish: Prækliniske studier af dyremodeller viste en additiv systemisk blodtrykssænkende virkning, når riociguat blev kombineret med enten sildenafil eller vardenafil.
English: Elderly patients (65 years or older) exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 40% higher in elderly, mainly due to reduced (apparent) total and renal clearance.
Danish: Ældre patienter (65 år eller derover) udviste højere plasmakoncentrationer end yngre patienter, med gennemsnitlige AUC-værdier, der var ca. 40 % højere hos ældre, primært på grund af en reduceret (tilsyneladende) total og renal clearance.
English: If you miss a dose, continue with the next dose as planned.
Danish: Hvis du springer en dosis over, skal du fortsætte med den næste dosis som planlagt.
English: PP/Aluminium foil blister.
Danish: PP/aluminiumsfolieblister.
English: • persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity (see section 5.1).
Danish: • persisterende eller tilbagevendende CTEPH efter kirurgisk behandling, for at forbedre deres fysiske arbejdsevne (se pkt.
English: Riociguat pharmacokinetics are linear from 0.5 to 2.5 mg. Inter-individual variability (CV) of riociguat exposure (AUC) across all doses is approximately 60%.
Danish: Farmakokinetikken for riociguat er lineær fra 0,5 til 2,5 mg. Interindividuel variabilitet (CV) af riociguat-eksponering (AUC) for alle doser er ca. 60 %.
English: Plasma protein binding in humans is high at approximately 95%, with serum albumin and alpha 1-acidic glycoprotein being the main binding components.
Danish: Plasmaproteinbindingen er høj hos mennesker, ca. 95 %, hvor serum-albumin og alfa 1-syre glykoprotein er de primære bindingskomponenter.
English: Your doctor will decide with you if you either should stop breast-feeding or stop treatment with Adempas.
Danish: Din læge vil sammen med dig afgøre, om du enten skal holde op med at amme eller stoppe behandlingen med Adempas.
English: The risk of serious and fatal respiratory tract bleeding may be further increased under treatment with riociguat, especially in the presence of risk factors, such as recent episodes of serious haemoptysis including those managed by bronchial arterial embolisation.
Danish: Risikoen for alvorlig og dødelig blødning i luftvejene kan yderligere øges under behandlingen med riociguat, især hvis der er risikofaktorer til stede, såsom nylige episoder af alvorlig hæmoptyse, herunder tilfælde, der behandles med bronkial arterieembolisering.
English: The safety profile observed in HIV patients taking a single dose of 0.5 mg riociguat together with different combinations of HIV drugs used in HAART was generally comparable to other patient populations.
Danish: Sikkerhedsprofilen observeret hos hivpatienter, som tog enkeltdosis af 0,5 mg riociguat sammen med forskellige kombinationer af hivlægemidler anvendt i HAART, var generelt sammenlignelig med andre patientpopulationer.
English: Adempas is a film-coated tablet:
Danish: Adempas er en filmovertrukket tablet:
English: In the long term extension part of this study (non controlled) the concomitant use of sildenafil and riociguat resulted in a high rate of discontinuation, predominately due to hypotension.
Danish: I langtidsforlængelsen af dette studie (ikke kontrolleret) førte den samtidige anvendelse af sildenafil og riociguat til en stor seponeringshyppighed, hovedsageligt på grund af hypotension.
English: Monthly pregnancy tests are recommended.
Danish: Det anbefales at foretage månedlige graviditetstests.
English: Your doctor will monitor your health status and should consider a reduced starting dose for Adempas.
Danish: Din læge vil overvåge din helbredsstilstand og bør overveje lavere startdosis af Adempas.
English: 65 years or older
Danish: 65 år og derover
English: Should signs of pulmonary oedema occur, the possibility of associated PVOD should be considered and treatment with riociguat should be discontinued.
Danish: Hvis der opstår tegn på lungeødem, skal muligheden for associeret PVOD overvejes, og behandlingen med riociguat bør seponeres.
English: If you are 65 years or older your doctor will take extra care in adjusting your dose of Adempas, because you may be at greater risk of low blood pressure.
Danish: Hvis du er 65 år eller derover, vil din læge omhyggeligt justere din dosis af Adempas, da du kan have en større risiko for lavt blodtryk.
English: You should not breast-feed while taking this medicine.
Danish: Du må ikke amme, når du tager dette lægemiddel.
English: The use of riociguat in other forms of PAH not studied is not recommended (see section 5.1).
Danish: Anvendelsen af riociguat til andre former for PAH, som ikke er undersøgt, anbefales ikke (se pkt.
English: There is no experience in the use of Adempas in other types of PAH.
Danish: Der er ingen erfaring om anvendelse af Adempas til andre former for PAH.
English: There is a direct relationship between riociguat plasma concentration and haemodynamic parameters such as systemic and pulmonary vascular resistance, systolic blood pressure and cardiac output.
Danish: Der er en direkte sammenhæng mellem riociguat-plasmakoncentration og hæmodynamiske parametre, såsom systemisk og pulmonal vaskulær modstand, systolisk blodtryk og hjerteminutvolumen.
English: Breast-feeding should be discontinued during treatment with this medicinal product.
Danish: Amning skal ophøre under behandling med dette lægemiddel.
English: It sensitises sGC to endogenous NO by stabilising the NO-sGC binding.
Danish: Det sensibiliserer sGC til endogen NO ved at stabilisere NO-sGC-bindingen.
English: According to standard medical practice, expert assessment of operability should be done prior to treatment with riociguat.
Danish: I henhold til gældende medicinsk praksis skal der forud for behandling med riociguat foretages en ekspertvurdering af operabilitet.
English: There are no data from the use of riociguat in pregnant women.
Danish: Der er ingen data fra anvendelse af riociguat til gravide kvinder.
English: Concomitant use with CYP3A4 inducers
Danish: Samtidig anvendelse af CYP3A4-induktorer
English: Inter-ethnic differences Pharmacokinetic data reveal no relevant inter-ethnic differences.
Danish: Interetniske forskelle Farmakokinetiske data afdækker ingen relevante interetniske forskelle.
English: In growing, juvenile and adolescent rats, effects on bone formation were seen.
Danish: Hos voksende, juvenile og unge rotter blev der observeret virkninger på knogledannelsen.
English: In the longterm extension, more patients who switched from the placebo group to riociguat (21%) died than those who continued in the riociguat group (3%).
Danish: I langtidsforlængelsen døde flere af de patienter, som skiftede fra placebogruppen til riociguat (21 %), end de patienter der fortsatte i riociguatgruppen (3 %)..
English: Concomitant treatment of riociguat and warfarin did not alter prothrombin time induced by the anticoagulant.
Danish: Samtidig behandling med riociguat og warfarin ændrede ikke protrombintiden, som blev induceret af det antikoagulerende lægemiddel.
English: It works by widening the pulmonary arteries (the blood vessels that connect the heart to the lungs), making it easier for the heart to pump blood through the lungs.
Danish: Det virker ved at udvide lungearterierne (de blodkar, der forbinder hjertet med lungerne), og derved gøre det nemmere for hjertet at pumpe blod gennem lungerne.
English: Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
Danish: Adempas er indiceret til behandling af voksne patienter med WHO-funktionsklasse (FC) II til III med
English: Pharmacotherapeutic group: Antihypertensives (antihypertensives for pulmonary arterial hypertension)
Danish: Farmakoterapeutisk klassifikation: Antihypertensiva (antihypertensitiva til pulmonal arteriel hypertension)
English: If you have severe liver problems (Child Pugh C), do not take Adempas.
Danish: Hvis du har alvorlige leverproblemer (Child Pugh C), må du ikke tage Adempas.
English: Table 1: Adverse reactions reported with Adempas in the phase III studies MedDRA
Danish: Tabel 1: Bivirkninger rapporteret med Adempas i fase III-studier
English: Data from animals indicate that riociguat is excreted into milk.
Danish: Data fra dyreforsøg indikerer, at riociguat udskilles i mælken.