FrancophonIA/ELRC3.0 huggingface dataset:
English: The maximum total daily dose is 7.5 mg i.e., 2.5 mg 3 times daily.
Danish: Den maksimale totale daglige dosis er 7,5 mg, dvs. 2,5 mg 3 gange dagligt.
English: Highly active antiretroviral therapy (HAART)
Danish: Højaktiv antiretroviral behandling (HAART)
English: Riociguat is a type of medicine called a guanylate cyclase (sGC)-stimulator.
Danish: Riociguat er en type lægemiddel, der hedder guanylatcyklase (sGC)-stimulator.
English: Inadvertent overdosing with total daily doses of 9 to 25 mg riociguat between 2 to 32 days was reported.
Danish: Der er blevet rapporteret utilsigtede overdoseringer med samlede daglige doser på 9 til 25 mg riociguat mellem dag 2 og dag 32.
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of riociguat in paediatric patients.
Danish: Pædiatrisk population Der er ikke udført studier for at undersøge farmakokinetikken af riociguat hos pædiatriske patienter.
English: In juvenile rats, the changes consisted of thickening of trabecular bone and of hyperostosis and remodeling of metaphyseal and diaphyseal bone, whereas in adolescent rats an overall increase of bone mass was observed.
Danish: Hos juvenile rotter bestod ændringerne i fortykket spongiøs knogle og hyperostose og remodellering af metafyseal og diafyseal knogle, hvorimod der hos unge rotter blev observeret en samlet øget knoglemasse.
English: 95% CI, [p-value]
Danish: 95 % CI, [p-værdi]
English: More patients taking riociguat died (11% vs. 4%) and had serious adverse events (37% vs. 23%) during the main phase.
Danish: Flere patienter, der fik riociguat, døde (11 % versus 4 %) og oplevede alvorlige bivirkninger (37% versus 23 %) under den primære fase.
English: 15 to 56
Danish: 15 til 56
English: The safety of Adempas has been evaluated in phase III studies of 681 patients with CTEPH and PAH receiving at least one dose of riociguat (see section 5.1).
Danish: Sikkerheden af Adempas er blevet evalueret i fase III-studier med 681 patienter med CTEPH og PAH, der fik mindst én dosis riociguat (se pkt.
English: Antacids should be taken at least 2 hours before, or 1 hour after riociguat.
Danish: Antacida skal tages mindst to timer før eller én time efter riociguat.
English: Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of NO and insufficient stimulation of the NO-sGC-cGMP pathway.
Danish: Pulmonal hypertension er forbundet med endotel-dysfunktion, hæmmet syntese af NO og utilstrækkelig stimulering af NO-sGC-cGMP-pathway.
English: In addition, ritonavir showed inhibition of P-gp.
Danish: Derudover viste ritonavir hæmning af P-gp.
English: Before prescribing riociguat, physicians should carefully consider whether patients with certain underlying conditions, could be adversely affected by vasodilatory effects (e.g. patients on antihypertensive therapy or with resting hypotension, hypovolaemia, severe left ventricular outflow obstruction or autonomic dysfunction).
Danish: Før ordinationen af riociguat skal lægen nøje overveje, om patienter med visse underliggende sygdomme kan blive påvirket negativt af de vasodilatoriske virkninger (f.eks. patienter i antihypertensiv behandling eller med hypotension i hvile, hypovolæmi, svær obstruktion af udløbet fra venstre ventrikel eller autonom dysfunktion).
English: Riociguat should be avoided in patients with a history of serious haemoptysis or who have previously undergone bronchial arterial embolisation.
Danish: Riociguat bør undgås hos patienter med tidligere alvorlig hæmoptyse, eller som tidligere har gennemgået bronkial arterieembolisering.
English: CYP1A1 catalyses the formation of riociguat's main metabolite in liver and lungs and is known to be inducible by polycyclic aromatic hydrocarbons, which, for example, are present in cigarette smoke.
Danish: CYP1A1 katalyserer dannelsen af riociguats primære metabolit i lever og lunger og vides at kunne induceres af polycykliske aromatiske kulbrinter, som der f.eks. findes i cigaretrøg.
English: Concomitant use with medicinal products increasing gastric pH
Danish: Samtidig anvendelse af lægemidler, som øger gastrisk pH
English: Therefore, patients are advised to stop smoking (see section 4.2).
Danish: Derfor rådes patienterne til at holde op med at ryge (se pkt.
English: The tablets should be taken 3 times a day, approximately 6 to 8 hours apart.
Danish: Tabletterne skal tages 3 gange om dagen, med ca. 6-8 timers mellemrum.
English: Improvements in 6MWD persisted at 2 years in CHEST-2.
Danish: Forbedringer i 6-minutters gangtesten varede ved i 2 år i CHEST-2.
English: Total riociguat (parent compound and metabolites) is excreted via both renal (33-45%) and biliary/faecal routes (48-59%).
Danish: Totalt riociguat (udgangsstof og metabolitter) udskilles via både nyrer (33-45 %) og galde/fæces (48-59 %).
English: In cigarette smokers riociguat exposure is reduced by 50-60% (see section 5.2).
Danish: Hos cigaretrygere er eksponeringen for riociguat reduceret med 50-60 % (se pkt.
English: If you stop taking Adempas
Danish: Hvis du holder op med at tage Adempas
English: In pulmonary hypertension patients there is increased likelihood for respiratory tract bleeding, particularly among patients receiving anticoagulation therapy.
Danish: Hos patienter med pulmonal hypertension er der en øget sandsynlighed for blødning i luftvejene, især hos patienter, der får antikoagulantia.
English: Therefore, caution should be exercised when administering riociguat in these patients.
Danish: Derfor bør der udvises forsigtighed, når riociguat administreres til disse patienter.
English: Non-clinical data show undesirable effects on growing bone (see section 5.3).
Danish: Prækliniske data viser uønskede virkninger på voksende knogler (se pkt.
English: The tablet may be crushed and mixed with water or a soft food, such as apple sauce, immediately before you take it.
Danish: Tabletten kan knuses og blandes med vand eller bløde madvarer, som æblemos, umiddelbart før du tager den.
English: The most commonly reported adverse reactions, occurring in ≥10% of patients under Adempas treatment (up to 2.5 mg three times daily), were headache, dizziness, dyspepsia, peripheral oedema, nausea, diarrhoea and vomiting.
Danish: De mest almindeligt rapporterede bivirkninger, der forekommer hos ≥ 10 % af patienter i behandling med Adempas (op til 2,5 mg tre gange dagligt), var hovedpine, svimmelhed, dyspepsi, perifert ødem, kvalme, diaré og opkastning.
English: Approximately 4-19% of the administered dose was excreted as unchanged riociguat via the kidneys.
Danish: Ca. 4-19 % af den administrerede dosis blev udskilt som uændret riociguat via nyrerne.
English: If you forget to take Adempas
Danish: Hvis du har glemt at tage Adempas
English: Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of riociguat (haemodynamic and smooth muscle relaxing effects).
Danish: Virkninger observeret i toksicitetsstudier med gentagne doser skyldtes primært en overdreven farmakodynamisk aktivitet af riociguat (hæmodynamiske virkninger og afslappende virkninger på den glatte muskulatur).
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteret og kartonen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: 35 to 81
Danish: 35 til 81
English: Therefore, clinically relevant drug-drug interactions with co-treatment which are significantly cleared by CYP1A1-mediated biotransformation, such as erlotinib or granisetron cannot be ruled out.
Danish: Derfor kan klinisk relevante lægemiddelinteraktioner med samtidig behandling, der i signifikant grad udskilles via CYP1A1-medieret biotransformation, såsom erlotinib eller granisetron, ikke udelukkes.
English: If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine because it might harm your baby.
Danish: Hvis du ammer eller planlægger at amme, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel, da det kan skade din baby.
English: Improvements in 6MWD persisted at 2 years in PATENT-2.
Danish: Forbedringer i 6-minutters gangtesten varede ved i 2 år i PATENT-2.
English: In a fertility study in rats, decreased testes weights occurred at systemic exposure of about 7-fold of human exposure, whereas no effects on male and female fertility were seen.
Danish: I et fertilitetsstudie hos rotter forekom der reduceret testikelvægt ved systemisk eksponering af ca. 7 gange den humane eksponering, hvorimod der ikke blev set nogen virkninger på fertiliteten hos mænd og kvinder.
English: Please tell your doctor if you smoke or if you stop smoking during treatment.
Danish: Fortæl det til lægen hvis du ryger, eller hvis du holder op med at ryge under behandlingen.
English: Improvement in exercise capacity was accompanied by consistent improvement in multiple clinicallyrelevant secondary endpoints.
Danish: Forbedring af fysisk arbejdsevne var ledsaget af en konsistent forbedring af flere klinisk relevante sekundære endepunkter.
English: Efficacy in patients with CTEPH
Danish: Virkning hos patienter med CTEPH
English: • coughing up blood (haemoptysis) (common side effect, may affect up to 1 in 10 people),
Danish: • ophostning af blod (hæmoptyse) (almindelig bivirkning, kan forekomme hos op til 1 ud af 10 personer)
English: - Patients with systolic blood pressure < 95 mm Hg at treatment initiation.
Danish: - Patienter med systolisk blodtryk < 95 mmHg ved behandlingens påbegyndelse.
English: Approximately 9-44% of the administered dose was found as unchanged riociguat in faeces.
Danish: Ca. 9-44 % af den administrerede dosis blev fundet som uændret riociguat i fæces.
English: PVR= pulmonary vascular resistance
Danish: PVR = pulmonal vaskulær modstand
English: Your doctor will increase the dose every 2 weeks to a maximum of 2.5 mg 3 times a day (maximum daily dose of 7.5 mg) unless you experience any side effects or very low blood pressure.
Danish: Din læge vil øge dosis hver 2. uge til et maksimum på 2,5 mg 3 gange dagligt (maksimal daglig dosis på 7,5 mg), medmindre du oplever bivirkninger eller meget lavt blodtryk.
English: In chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy is the treatment of choice as it is a potentially curative option.
Danish: Ved kronisk tromboemolisk pulmonal hypertension, er pulmonal endarterektomi første behandlingsvalg, da det er et potentielt kurativt alternativ.
English: Patients with ALT > 3 x ULN and bilirubin > 2 x ULN were not studied (see section 4.4).
Danish: Patienter med ALAT > 3 x ULN og bilirubin > 2 x ULN blev ikke undersøgt (se pkt.
English: Co-treatment of medicinal products increasing the upper gastro intestinal pH may lead to lower oral bioavailability.
Danish: Samtidig behandling med lægemidler, der øger pH-værdien i den øvre del af mave-tarm-kanalen, kan føre til en lavere oral biotilgængelighed.
English: You should tell your doctor if you start or stop smoking during treatment with this medicine.
Danish: Du skal fortælle det til din læge, hvis du starter eller stopper med at ryge under behandlingen med dette lægemiddel.
English: Therefore, drug-drug interactions by inhibition of CYP1A1 could result in increased riociguat exposure, especially in smokers (see section 5.2).
Danish: Derfor kunne lægemiddelinteraktionen ved hæmning af CYP1A1 føre til en øget eksponering for riociguat, især hos rygere (se pkt.
English: These findings were in accordance with improvements in additional haemodynamic parameters (see table 5).
Danish: Disse fund var i overensstemmelse med forbedringer af yderligere hæmodynamiske parametre (se tabel 5).
English: Pack sizes: 42, 84, 90 or 294 film-coated tablets.
Danish: Pakningsstørrelser: 42, 84, 90 eller 294 filmovertrukne tabletter.
English: When NO binds to sGC, the enzyme catalyses synthesis of the signalling molecule cyclic guanosine monophosphate (cGMP).
Danish: Når NO bindes til sGC katalyserer enzymet syntesen af signalmolekylet cyklisk guanosinmonophosphat (cGMP).
English: Riociguat-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0046; Stratified log-rank test) (see table 6).
Danish: Riociguat-behandlede patienter oplevede en signifikant udskydelse i tiden til klinisk forværring versus placebo-behandlede patienter (p = 0,0046; stratificeret log-rank-test) (se tabel 6).
English: If a dose is missed, treatment should be continued with the next dose as planned.
Danish: Hvis patienten glemmer en dosis, skal behandlingen fortsætte med den næste dosis som planlagt.
English: Improvement in exercise capacity was accompanied by improvement in multiple clinically relevant secondary endpoints.
Danish: Forbedring af fysisk arbejdsevne var ledsaget af en forbedring af flere klinisk relevante sekundære endepunkter.
English: The recommended starting dose is 1 mg three times daily for 2 weeks.
Danish: Den anbefalede startdosis er 1 mg tre gange dagligt i 2 uger.
English: A randomised, double blind, placebo-controlled phase II study (RISE-IIP) to evaluate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) was terminated early due to an increased risk of mortality and serious adverse events in patients treated with riociguat and a lack of efficacy.
Danish: Et randomiseret, dobbeltblindt placebo-kontrolleret fase II-studie (RISE-IPP) til evaluering af riociguats virkning og sikkerhed hos patienter med symptomatisk pulmonal hypertension associeret med idiopatisk interstitiel pneumonitis (PH-IIP) blev afsluttet tidligt på grund af en øget risiko for død og alvorlige bivirkninger hos patienter behandlet med riociguat og manglende virkning.
English: Studies in animals have shown reproductive toxicity and placental transfer (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet samt placental overførsel (se pkt.
English: Hospitalisations due to PH Decrease in 6MWD due to PH Persistent worsening of Functional Class due to PH
Danish: Patienter med alle kliniske forværringer Død Indlæggelser på grund af PH Reduktion af den 6-minutters gangtest på grund af PH Vedvarende forværring af funktionsklasse på grund af PH Start af ny PH-behandling
English: You should be aware of the side effects of this medicine before driving or using machines (see section 4).
Danish: Du bør være klar over bivirkninger ved dette lægemiddel, før du fører motorkøretøj eller betjener maskiner (se pkt.
English: In pulmonary arterial hypertension, studies with riociguat have been mainly performed in forms related to idiopathic or heritable PAH and PAH associated with connective tissue disease.
Danish: Ved pulmonal arteriel hypertension er studier med riociguat primært blevet udført ved former i forbindelse med idiopatisk eller arvelig PAH og PAH forbundet med bindevævssygdom.
English: Women of childbearing potential must use effective contraception during treatment with Adempas.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med Adempas.
English: In elderly patients (65 years or older) there is a higher risk of hypotension and therefore particular care should be exercised during individual dose titration (see section 5.2).
Danish: Hos ældre patienter (65 år eller derover) er der en højere risiko for hypotension, og derfor bør der udvises særligt hensyn ved individuel dosistitrering (se pkt.
English: In a reproduction toxicity study in rats, decreased testes weights were seen, but there were no effects on fertility (see section 5.3).
Danish: I et toksicitetsstudie af reproduktion hos rotter, blev der observeret nedsat testikelvægt, men der sås ingen virkning på fertiliteten (se pkt.
English: A dose increase to the maximum daily dose of 2.5 mg three times daily may be required in patients who are smoking or start smoking during treatment (see sections 4.5 and 5.2).
Danish: En dosisforhøjelse til den maksimale daglige dosis på 2.5 mg tre gange dagligt kan være nødvendigt hos patienter, som ryger eller som begynder at ryge under behandlingen (se pkt.
English: Intake with food reduced riociguat AUC slightly, Cmax was reduced by 35%.
Danish: Indtagelse sammen med mad reducerede riociguat-AUC i mindre grad. Cmax blev reduceret med 35 %.
English: -11 to 31
Danish: -11 til 31
English: In rats, an increased rate of cardiac malformation was observed as well as a reduced gestation rate due to early resorption at maternal systemic exposure of about 7-fold of human exposure (2.5 mg three times daily).
Danish: Hos rotter blev der observeret en øget hyppighed af hjertemisdannelser, samt en reduceret gestationshyppighed på grund af tidlig resorption ved maternel systemisk eksponering på ca. 7 gange den humane eksponering (2,5 mg tre gange dagligt).
English: Adempas is only prescribed for certain forms of PAH, i.e. idiopathic PAH (the cause of PAH is unknown), heritable PAH and PAH caused by connective tissue disease.
Danish: Adempas udskrives kun til visse former for PAH, dvs. idiopatisk PAH (årsagen til PAH er ikke kendt), arvelig PAH og PAH på grund af sygdom i bindevævet.
English: Do not take Adempas: - if you are taking certain medicines called PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil).
Danish: Tag ikke Adempas: - hvis du tager visse lægemidler, der kaldes PDE5-hæmmere (f.eks. sildenafil, tadalafil, vardenafil).
English: Transitioning between phosphodiesterase-5 (PDE5) inhibitors and riociguat Sildenafil must be discontinued at least 24 hours prior to administration of riociguat.
Danish: Skift mellem phosphodiesterase-5 (PDE5)-hæmmere og riociguat Behandlingen med sildenafil skal afbrydes mindst 24 timer før administration af riociguat.
English: Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.
Danish: Adempas er, som monoterapi eller i kombination med endothelin-receptorantagonister, indiceret til behandling af voksne patienter med pulmonal arteriel hypertension (PAH) med WHO-funktionsklasse (FC) II til III for at forbedre deres fysiske arbejdsevne.
English: Corresponding values for the main metabolite were higher in subjects with renal impairment compared to healthy subjects.
Danish: Tilhørende værdier for den primære metabolit var højere hos personer med nedsat nyrefunktion, sammenlignet med raske personer.
English: From the recombinant CYP isoforms investigated in vitro CYP1A1 catalysed formation of riociguat's main metabolite most effectively.
Danish: Fra de rekombinante CYP-isoformer, der blev undersøgt, katalyserede in vitro-CYP1A1 dannelsen af riociguats primære metabolit mest effektivt.
English: Serious bleeding occurred in 2.4% (12/490) of patients taking riociguat compared to 0/214 of placebo patients.
Danish: Der opstod alvorlig blødning hos 2,4 % (12/490) af de patienter, der tog riociguat, sammenlignet med 0/214 af placebopatienterne.
English: Riociguat and its main metabolite are strong inhibitors of CYP1A1 in vitro.
Danish: Riociguat og dets primære metabolit er kraftige hæmmere af CYP1A1 in vitro.
English: RESPITE was a 24-week, uncontrolled study to investigate switching from PDE5 inhibitors to riociguat, in 61 adult PAH patients on stable PDE5 inhibitors.
Danish: RESPITE var et 24-ugers ukontrolleret studie, der undersøgte skift fra PDE5-hæmmere til riociguat hos 61 voksne PAH-patienter, der fik en stabil dosis af PDE5-hæmmere.
English: Lack of pharmacokinetic interactions between riociguat and the CYP2C9 substrate warfarin was demonstrated in vivo.
Danish: Der blev ikke påvist farmakokinetiske interaktioner mellem riociguat og CYP2C9-substratet warfarin in vivo.
English: Patients were either treatment-naïve (50%) or pre-treated with ERA (43%) or a prostacyclin analogue (inhaled (iloprost), oral (beraprost) or subcutaneous (treprostinil); 7%) and had been diagnosed with idiopathic or heritable PAH (63.4%), PAH associated with connective tissue disease (25.1%) and congenital heart disease (7.9%).
Danish: Patienterne var enten behandlingsnaive (50 %) eller forbehandlede med ERA (43 %) eller en prostacyklinanalog (inhaleret (iloprost), oral (beraprost) eller subkutan (treprostinil) 7 %), og er blevet diagnosticeret med idiopatisk eller arvelig PAH (63,4 %), PAH forbundet med bindevævssygdom (25,1 %) og medfødt hjertesygdom (7,9 %).
English: Monitor for signs and symptoms of hypotension on initiation and on treatment.
Danish: Patienterne skal overvåges for tegn og symptomer på hypotension ved initieringen og under behandlingen.
English: Riociguat must not be used in patients with a systolic blood pressure below 95 mmHg (see section 4.3).
Danish: Riociguat må ikke anvendes til patienter med et systolisk blodtryk under 95 mmHg (se pkt.
English: In CTEPH, the blood vessels of the lung are blocked or narrowed with blood clots.
Danish: Ved CTEPH er lungernes blodkar blokerede eller forsnævrede af blodpropper.
English: 14 to 62
Danish: 14 til 62
English: In case of respiratory tract bleeding, the prescriber should regularly assess the benefitrisk of treatment continuation.
Danish: Hvis der opstår blødning i luftvejene, skal den ordinerende læge regelmæssigt vurdere benefit/riskforholdet for den videre behandling.
English: Treatment-naïve patients (n=189) improved by 38 m, and pre-treated patients (n=191) by 36 m (ITT analysis, see table 4).
Danish: Behandlingsnaive patienter (n=189) blev forbedret med 38 m, og forbehandlede patienter (n=191) med 36 m (ITT-analyse, se tabel 4).
English: Tablets should be taken three times daily approximately 6 to 8 hours apart (see section 5.2).
Danish: Tabletterne skal tages tre gange dagligt med ca. 6 til 8 timers mellemrum (se pkt.
English: • In patients on stable doses of Adempas, the initiation of strong multi pathway CYP and P-gp/BCRP inhibitors is not recommended as no dosage recommendation can be given due to limited data.
Danish: • Hos patienter på en stabil dosis af Adempas frarådes en initiering af stærke multipathway CYP og P-gp/BCRP-hæmmere, da dosisanbefaling ikke kan gives på grund af begrænsede data.
English: Most of the adverse reactions are caused by relaxation of smooth muscle cells in vasculature or the gastrointestinal tract.
Danish: De fleste bivirkninger forårsages af afslapning af de glatte muskelceller i vaskulaturen eller mavetarm-kanalen.
English: Changes from baseline suggested beneficial effects in selected patients, e.g. improvement in 6MWD (+31m), N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels (-347 pg/mL) and WHO FC I/II/III/IV,% (2/52/46/0), cardiac index (+0.3 L/min/m2).
Danish: Ændringer fra baseline indikerede en gavnlig virkning hos udvalgte patienter, f.eks. forbedring i 6MWD (+31m), N-terminal pro B-type natriuretisk peptid (NT-proBNP) niveauer (-347 pg/ml) og WHO FC I/II/III/IV (2/52/46/0 %) og hjerteindeks (+0,3 l/min/m2).
English: The concomitant use of riociguat with other cumarin-derivatives (e.g. phenprocoumon) is also not expected to alter prothrombin time.
Danish: Den samtidige anvendelse af riociguat og andre coumarin-derivater (f.eks. phenprocoumon) forventes heller ikke at ændre protrombintiden.
English: If systolic blood pressure falls below 95 mmHg, the dose should be maintained provided the patient does not show any signs or symptoms of hypotension.
Danish: Hvis det systoliske blodtryk falder til under 95 mmHg, bør dosis opretholdes under forudsætning af, at patienten ikke viser tegn eller symptomer på hypotension.
English: Patients with mild and moderate renal impairment (creatinine clearance <80 - 30 mL/min) showed a higher exposure to this medicinal product (see section 5.2).
Danish: Patienter med let og moderat nedsat nyrefunktion (kreatininclearance < 80 - 30 ml/min) viste en højere eksponering over for dette lægemiddel (se pkt.
English: Dose adjustment may be necessary in patients who start or stop smoking during treatment with riociguat (see sections 4.2 and 5.2).
Danish: Dosisjustering kan være nødvendig hos patienter, der starter eller stopper med at ryge under behandlingen med riociguat (se pkt.