FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean change from baseline for the overall population (N=237) was 57 m at 6 months (n=218), 51 m at 9 months (n=219), 52 m at 12 months (n=209) and 48 m at 24 months (n=193).
Danish: Gennemsnitlig ændring fra baseline for den samlede population (N=237) var 57 m ved 6 måneder (n=218), 51 m ved 9 måneder (n=219), 52 m ved 12 måneder (n=209) og 48 m ved 24 måneder (n=193).
English: In PATENT-2, all patients received an individualised riociguat dose up to 2.5 mg three times daily.
Danish: I PATENT-2 fik alle patienter en individualiseret dosis af riociguat op til 2,5 mg tre gange dagligt.
English: The impact of HAART (including different combinations of abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, lamivudine, rilpivirine, ritonavir, and tenofovir) on riociguat exposure was investigated in a dedicated study in HIV patients.
Danish: Påvirkningen af HAART (herunder forskellige kombinationer af abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabin, lamivudin, rilpivirin, ritonavir og tenofovir) på riociguat-eksponering blev undersøgt i et specifikt studie hos hiv-patienter.
English: PK data show that higher riociguat exposure was observed in patients with moderate hepatic impairment (Child Pugh B) (see section 5.2).
Danish: Farmakokinetiske data viser, at en højere eksponering for riociguat blev observeret hos patienter med moderat nedsat leverfunktion (Child Pugh B) (se pkt.
English: Therefore co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form, including recreational drugs called ‘poppers', is contraindicated (see section 4.3).
Danish: Derfor er samtidig administration af Adempas og nitrater eller nitrogenoxiddonorer (såsom amylnitrit) i enhver form, inklusive de såkaldte poppers) kontraindiceret (se pkt.
English: -10 to 61
Danish: -10 til 61
English: Overall, mean dose- and weight- normalised exposure values for riociguat were higher in subjects with renal impairment compared to subjects with normal renal function.
Danish: Samlet set var de gennemsnitlige dosis- og vægt-normaliserede eksponeringsværdier for riociguat højere hos personer med nedsat nyrefunktion, sammenlignet med personer med normal nyrefunktion.
English: Table 2: Effects of riociguat on 6MWD in CHEST-1 at last visit Entire patient population
Danish: Tabel 2: Virkninger af riociguat på den 6-minutters gangtest for CHEST-1 ved sidste besøg Hele patientpopulationen
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 0.5 mg, 1 mg, 1.5 mg, 2 mg or 2.5 mg riociguat.
Danish: ANGIVELSE AF AKTIVT STOF Hver filmovertrukket tablet indeholder 0,5 mg, 1 mg, 1,5 mg, 2 mg eller 2,5 mg riociguat.
English: Patients with moderate hepatic impairment (Child Pugh B) showed a higher exposure to this medicinal product (see section 5.2).
Danish: Patienter med moderat nedsat leverfunktion (Child Pugh B) viste en højere eksponering for dette lægemiddel (se pkt.
English: Very common: may affect more than 1 in 10 people - headache - dizziness - indigestion (dyspepsia) - swelling of limbs (oedema peripheral) - diarrhoea - feeling or being sick (nausea and vomiting)
Danish: Meget almindelig: kan forekomme hos flere end 1 ud af 10 personer - hovedpine - svimmelhed - fordøjelsesbesvær (dyspepsi) - hævede arme og ben (perifert ødem) - diaré - kvalme eller opkastning
English: Mean change from baseline for the overall population (N=396) was 53 m at 6 months (n=366), 52 m at 9 months (n=354), 50 m at 12 months (n=351) and 46 m at 24 months (n=316).
Danish: Gennemsnitlig ændring fra baseline for den samlede population (N=396) var 53 m ved 6 måneder (n=366), 52 m ved 9 måender (n=354), 50 m ved 12 måneder (n=351) og 46 m ved 24 måneder (n=316).
English: Due to the potential for serious adverse reactions in breast-fed infants Adempas should not be used during breast-feeding.
Danish: Da der er risiko for alvorlige bivirkninger hos ammede spædbørn, må Adempas ikke anvendes under amning.
English: Table 5: Effects of riociguat in PATENT-1 on PVR and NT-proBNP at last visit PVR
Danish: Tabel 5: Virkninger af riociguat for PATENT-1 på PVR og NT-proBNP ved sidste besøg
English: Patients with any clinical worsening Death
Danish: Klinisk forværrende hændelser
English: In vitro, abacavir, rilpivirine, efavirenz, ritonavir, cobicistat and elvitegravir inhibited CYP1A1 and the metabolism of riociguat in the order listed with abacavir as the strongest inhibitor.
Danish: Abacavir, rilpivirin, efavirenz, ritonavir, cobicistat og elvitegravir hæmmede in vitro CYP1A1 og metabolismen af riociguat i den nævnte rækkefølge med abacavir, som den stærkeste hæmmer.
English: Placebo-adjusted difference (dyn·s·cm-5)
Danish: Placebojusteret forskel (dyn·s·cm-5)
English: Consider a dose reduction for patients on Adempas doses higher than or equal to 1.0 mg if the patient develops signs or symptoms of hypotension (see sections 4.4 and 4.5).
Danish: Dosisreduktion kan overvejes hos patienter, der tager Adempas med dosis på 1,0 mg eller højere, hvis patienten udvikler tegn eller symptomer på hypotension (se pkt.
English: A 12 week combination study in 18 patients with PAH on stable sildenafil treatment (20 mg three times daily) and riociguat (1.0 mg to 2.5 mg three times daily) compared to sildenafil alone was performed.
Danish: Der blev udført et 12-ugers kombinationsstudie med 18 patienter med PAH i stabil behandling med sildenafil (20 mg tre gange dagligt) og riociguat (1,0 mg til 2,5 mg tre gange dagligt), sammenlignet med sildenafil alene.
English: In CHEST-2, all patients received an individualised riociguat dose up to 2.5 mg three times daily.
Danish: I CHEST-2 fik alle patienter en individualiseret dosis af riociguat op til 2,5 mg tre gange dagligt.
English: How to store Adempas 6.
Danish: Sådan skal du tage Adempas 4.
English: - if you have low blood pressure (systolic blood pressure less than 95 mmHg) before starting first treatment with this medicine.
Danish: Dette omfatter også de såkaldte "poppers" - hvis du har lavt blodtryk (systolisk blodtryk under 95 mmHg), før du starter den første behandling med dette lægemiddel.
English: Riociguat is cleared mainly via cytochrome P450-mediated (CYP1A1, CYP3A4, CYP3A5, CYP2J2) oxidative metabolism, direct biliary/faecal excretion of unchanged riociguat and renal excretion of unchanged riociguat via glomerular filtration.
Danish: Riociguat udskilles primært via CYP-medieret (CYP1A1, CYP3A4, CYP3A5, CYP2J2) oxidativ metabolisme, direkte biliær/fækal udskillelse af uomdannet riociguat og renal udskillelse af uomdannet riociguat via glomerulær filtration.
English: Medicinal products strongly inhibiting P-gp/BCRP such as the immuno-suppressive cyclosporine A, should be used with caution (see sections 4.4 and 5.2).
Danish: Lægemidler, der er potente hæmmere af P-gp/BCRP, såsom det immunsupprimerende ciclosporin, bør anvendes med forsigtighed (se pkt.
English: Therefore, Adempas is contraindicated during pregnancy (see section 4.3).
Danish: Adempas er derfor kontraindiceret under graviditeten (se pkt.
English: In an exploratory interaction study in 7 patients with PAH on stable sildenafil treatment (20 mg three times daily) single doses of riociguat (0.5 mg and 1 mg sequentially) showed additive haemodynamic effects.
Danish: I et eksplorativt interaktionsstudie med 7 patienter med PAH i stabil behandling med sildenafil (20 mg tre gange dagligt) viste enkeltdoser af riociguat (0,5 mg og 1 mg i rækkefølge) additive hæmodynamiske virkninger.
English: Co-administration of the antacid aluminium hydroxide / magnesium hydroxide reduced riociguat mean AUC by 34% and mean Cmax by 56% (see section 4.2).
Danish: Samtidig administration af syreneutraliserende aluminiumhydroxid/magnesiumhydroxid reducerede gennemsnitlig AUC for riociguat med 34 %, og gennemsnitlig Cmax med 56 % (se pkt.
English: For patients prone to hypotension, as a precautionary measure, switches between fed and fasted Adempas intake are not recommended because of increased peak plasma levels of riociguat in the fasting compared to the fed state (see section 5.2).
Danish: Som en sikkerhedsforanstaltning for patienter med tendens til hypotension anbefales det at undlade at skifte mellem at indtage Adempas sammen med og uden mad på grund af øgede maksimale plasmakoncentrationer af riociguat i fastende tilstand sammenlignet med samtidig indtagelse af mad (se pkt.
English: - Pregnancy (see sections 4.4; 4.5 and 4.6).
Danish: 4.4, 4.5 og 4.6).
English: cellulose microcrystalline crospovidone (type B) hypromellose 5 cP magnesium stearate lactose monohydrate sodium laurilsulfate
Danish: cellulose, mikrokrystallinsk crospovidon (type B) hypromellose 5 cP magnesiumstearat lactosemonohydrat natriumlaurilsulfat
English: N-demethylation, catalysed by CYP1A1, CYP3A4, CYP3A5 and CYP2J2 is the major biotransformation pathway of riociguat leading to its major circulating active metabolite M-1 (pharmacological activity: 1/10th to 1/3rd of riociguat) which is further metabolised to the pharmacologically inactive N-glucuronide.
Danish: N-demethylering, katalyseret af CYP1A1, CYP3A4, CYP3A5 og CYP2J2, er den primære biotransformationsvej for riociguat, og fører til den primære cirkulerende aktive metabolit M-1 (farmakologisk aktivitet: 1/10 til 1/3 af riociguat), som metaboliseres videre til det farmakologisk inaktive N-glukuronid.
English: Therefore, administration of riociguat to such patients is not recommended.
Danish: Derfor anbefales riociguat ikke til disse patienter.
English: For patients who are unable to swallow whole tablets, Adempas tablets may be crushed and mixed with water or soft foods, such as apple sauce, immediately prior to use and administered orally (see section 5.2).
Danish: Patienter, der ikke kan sluge Adempas-tabletterne hele, kan knuse dem og blande dem med vand eller bløde madvarer, som f.eks. æblemos, umiddelbart før indtagelse (se pkt.
English: -843.0 to -45.0 [<0.0001]
Danish: -843,0 til -45,0 [< 0,0001]
English: The concomitant use of riociguat with strong CYP3A4 inducers (e.g. phenytoin, carbamazepine, phenobarbitone or St. John's Wort) may also lead to decreased riociguat plasma concentration.
Danish: Den samtidige anvendelse af riociguat og kraftige CYP3A4-induktorer (f.eks. phenytoin, carbamazepin, phenobarbiton eller prikbladet perikon) kan også føre til nedsatte plasmakoncentrationer af riociguat.
English: Other medicines and Adempas Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular, medicines used for: - high blood pressure or heart disease (such as nitrates and amyl nitrite) in any form, as you must not take those medicines together with Adempas.
Danish: Brug af anden medicin sammen med Adempas Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig, især lægemidler, der anvendes til: - højt blodtryk eller hjertesygdom (såsom nitrater og amylnitrit) af enhver slags, da du ikke må tage disse lægemidler sammen med Adempas - højt blodtryk i lungekarrene (lungearterier), da du ikke må tage visse lægemidler (sildenafil og tadalafil) sammen med Adempas.
English: Gender Pharmacokinetic data reveal no relevant differences due to gender in the exposure to riociguat.
Danish: Køn Farmakokinetiske data afdækker ingen relevante kønsforskelle ved eksponering for riociguat.
English: Patients on stable doses of strong multi pathway CYP / P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) inhibitors
Danish: Patienter på en stabil dosis af stærke multipathway CYP/P-glykoprotein (P-gp) og brystcancerresistensprotein (BCRP)-hæmmere.
English: Therefore use of Adempas is not recommended in these patients (see section 4.4).
Danish: Derfor bør Adempas ikke anvendes til disse patienter (se pkt.
English: Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1).
Danish: Virkning er påvist i en PAH-population, herunder ætiologier med idiopatisk eller arvelig PAH, eller PAH forbundet med en bindevævssygdom (se pkt.
English: Placebo-adjusted difference (m)
Danish: Placebojusteret forskel (m)
English: At the last visit, the increase in 6MWD in patients treated with riociguat was 46 m (95% confidence interval (CI): 25 m to 67 m; p<0.0001), compared to placebo.
Danish: Ved det sidste besøg var forhøjelsen i den 6-minutters gangtest hos patienter i behandling med riociguat 46 m (95 % konfidensinterval (CI): 25 m til 67 m; p< 0,0001), sammenlignet med placebo.
English: During the first 8 weeks riociguat was titrated every 2-weeks based on the patient's systolic blood pressure and signs or symptoms of hypotension to the optimal individual dose (range 0.5 mg to 2.5 mg three times daily), which was then maintained for a further 4 weeks.
Danish: I løbet af de første 8 uger blev riociguat titreret hver 2. uge baseret på patientens systoliske blodtryk samt tegn eller symptomer på hypotension til den optimale individuelle dosis (interval 0,5 mg til 2,5 mg tre gange dagligt), som dernæst blev vedligeholdt i yderligere 4 uger.
English: At the last visit the increase in 6MWD with riociguat individual dose titration (IDT) was 36 m (95% CI: 20 m to 52 m; p0.0001) compared to placebo.
Danish: Ved det sidste besøg var forhøjelsen i den 6-minutters gangtest med individuel dosistitrering (IDT) af riociguat 36 m (95 % CI: 20 m til 52 m, p0,0001) sammenlignet med placebo.
English: The mean change in 6MWD from baseline to week 12 (last observation until week 12) in CHEST-2 (28 weeks on-study for CHEST-1 + CHEST-2) was 57 m in the former 1.0-2.5 mg riociguat group and 43 m in the former placebo group.
Danish: Den gennemsnitlige ændring i 6-minutters gangtesten fra baseline til uge 12 (sidste observation indtil uge 12) i CHEST-2 (28 uger i studiet for CHEST-1 + CHEST-2) var 57 m i gruppen, der tidligere fik 1,0-2,5 mg riociguat, og 43 m i gruppen, der tidligere fik placebo.
English: Adverse Events leading to discontinuation occurred less frequently in both riociguat treatment groups than in the placebo group (riociguat IDT 1.0-2.5 mg, 3.1%; riociguat CT 1.6%; placebo, 7.1%).
Danish: Bivirkninger, der førte til seponering, forekom mindre hyppigt i de 2 grupper med riociguatbehandling end i placebogruppen (riociguat IDT 1,0-2,5 mg, 3,1 %, riociguat CT 1,6 %; placebo,
English: Talk to your doctor or pharmacist before taking Adempas if: you have recently experienced serious bleeding from the lung, or if you have undergone treatment to stop coughing up blood (bronchial arterial embolisation).
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Adempas, hvis: - du for nyligt har oplevet alvorlig blødning fra lungen, eller hvis du har gennemgået behandling for at holde op med at hoste blod op (bronkial arterieembolisering) - du tager blodfortyndende lægemidler (antikoagulantia), da de kan forårsage blødning fra lungerne.
English: Different weight categories Pharmacokinetic data reveal no relevant differences due to weight in the exposure to riociguat.
Danish: Farmakokinetiske data afdækker ingen relevante forskelle hvad angår vægten ved eksponering for riociguat.
English: -303.3 to -189.5 [<0.0001]
Danish: -303,3 til -189,5 [< 0,0001]
English: Serious haemorrhagic events also included 2 patients with vaginal haemorrhage, 2 with catheter site haemorrhage, and 1 each with subdural haematoma, haematemesis, and intra-abdominal haemorrhage.
Danish: Alvorlig blødning omfattede også to patienter med vaginalblødning, to med blødning ved kateterstedet og hver én med subduralt hæmatom, hæmatemese og intraabdominal blødning.
English: The mean change in 6MWD from baseline to week 12 (last observation until week 12) in PATENT-2 (24 weeks on-study for PATENT-1 + PATENT-2) was 52 m in the former 1.0-2.5 mg riociguat group,45 m in the former placebo group and 52 m in the former 1.0-1.5 mg riociguat group.
Danish: Den gennemsnitlige ændring i 6-minutters gangtesten fra baseline til uge 12 (sidste observation indtil uge 12) i PATENT-2 (24 uger i studiet for PATENT-1 + PATENT-2) var 52 m i gruppen, der tidligere fik 1,0-2,5 mg riociguat, 45 m i gruppen, der tidligere fik placebo, og 52 m i gruppen, der tidligere fik 1,0-1,5 mg riociguat.
English: Adverse Events leading to discontinuation occurred at a similar frequency in both treatment groups (riociguat individual dose titration (IDT) 1.0-2.5 mg, 2.9%; placebo, 2.3%).
Danish: Bivirkninger, der førte til seponering, forekom med en sammenlignelig hyppighed i de 2 behandlingsgrupper (individuel dosistitrering (IDT) af riociguat 1,0-2,5 mg, 2,9 %; placebo, 2,3 %).
English: -281.4 to -170.1[<0.0001]
Danish: -281,4 til -170,1[< 0,0001]
English: • 90 tablets: five transparent blisters of 18 tablets each.
Danish: • 90 tabletter: fem gennemsigtige kalender-blisters med 18 tabletter i hver
English: you take medicines used to treat fungal infections (e.g. ketoconazole, posaconazole, itraconazole) or medicines for the treatment of HIV infection (e.g. abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, lamivudine, rilpivirine, ritonavir, and tenofovir).
Danish: - du tager lægemidler, som anvendes til at behandle svampeinfektioner (f.eks. ketoconazol, posaconazol, itraconazol) og lægemidler, som anvendes til at behandle hiv-infektion (f.eks. abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabin, lamivudin, rilpivirin, ritonavir og tenofovir).
English: To mitigate the risk of hypotension when Adempas is initiated in patients on stable doses of strong multi pathway CYP (especially CYP1A1 and CYP3A4) and P-gp/BCRP inhibitors, e.g. as contained in HAART, consider a reduced starting dose.
Danish: For at mindske risikoen for hypotension, når Adempas initieres hos patienter på stabil dosis af stærke multipathway CYP- (især CYP1A1 og CYP3A4) og P-gp/BCRP-hæmmere, som f.eks. HAART indeholder, kan det overvejes at reducere startdosis.
English: MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Bayer AG 51368 Leverkusen Tyskland
English: Adempas 1 mg, 1.5 mg tablets also contains iron oxide yellow (E 172).
Danish: Adempas 1 mg og 1,5 mg tabletter indeholder også jernoxid, gul (E 172).
English: No data on the use of riociguat in breast-feeding women are available.
Danish: Der foreligger ingen data om anvendelsen af riociguat til ammende kvinder.
English: - Severe hepatic impairment (Child Pugh C).
Danish: - Svært nedsat leverfunktion (Child Pugh C).
English: Adempas is contraindicated during pregnancy (see section 4.3).
Danish: Adempas er kontraindiceret under graviditet (se pkt.
English: Gastrointestinal and abdominal pains, Constipation, Abdominal distension
Danish: Mave-tarm- og abdominalsmerter Forstoppelse Udspilet abdomen
English: When initiating Adempas in patients on stable doses of strong multi pathway CYP and P-gp/BCRP inhibitors, such as azole antimycotics (e.g. ketoconazole, posaconazole, itraconazole) or HIV protease inhibitors (e.g. ritonavir), consider a starting dose of 0.5 mg, three times a day to mitigate the risk of hypotension.
Danish: Når patienter starter på en stabil dosis af stærke multipathway CYP og P-gp/BCRP-hæmmere, såsom azol-antimykotika (f.eks. ketoconazol, posaconazol, itraconazol) eller hiv-proteasehæmmere (f.eks. ritonavir) kan en startdosis på 0,5 mg tre gange dagligt anbefales for at mindske risikoen for hypotension.
English: Treatment-naïve patient population
Danish: Behandlingsnaiv patientpopulation
English: • chronic thromboembolic pulmonary hypertension (CTEPH).
Danish: • kronisk tromboembolisk pulmonal hypertension (CTEPH).
English: - The active substance is riociguat.
Danish: - Aktivt stof: Riociguat.
English: In vitro, ketoconazole, classified as a strong CYP3A4 and P-glycoprotein (P-gp) inhibitor, has been shown to be a multi-pathway CYP and P-gp/breast cancer resistance protein (BCRP) inhibitor for riociguat metabolism and excretion (see section 5.2).
Danish: Det er vist, at ketoconazol, klassificeret som en stærk CYP3A4- og P-glykoprotein (P-gp)-hæmmer, in vitro er en multipathway CYP og P-gp/brystcancer-resistensprotein (BCRP)-hæmmer af riociguatmetabolisme og -udskillelse (se pkt.
English: Concomitant use with other CYP and P-gp/BCRP inhibitors
Danish: Samtidig anvendelse af andre CYP og P-gp/BCRP-hæmmere
English: Tablet core: cellulose microcrystalline, crospovidone (type B), hypromellose 5 cP, lactose monohydrate, magnesium stearate and sodium laurilsulfate (see end of section 2 for further information on lactose).
Danish: Tabletkerne: Cellulose, mikrokrystallinsk, crospovidon (type B), hypromellose 5 cP, lactosemonohydrat, magnesiumstearat og natriumlaurilsulfat (se sidst i pkt.
English: Adempas 2 mg and 2.5 mg tablets also contains iron oxide yellow (E172) and iron oxide red (E 172).
Danish: Adempas 2 mg og 2,5 mg tabletter indeholder også jernoxid, gul (E 172) og jernoxid, rød (E 172).
English: Data in patients with creatinine clearance <30 mL/min are limited and there are no data for patients on dialysis.
Danish: Data for patienter med kreatininclearance < 30 ml/min er begrænsede, og der er ingen data for dialysepatienter.
English: Luxembourg / Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Danish: Luxembourg / Luxemburg MSD Belgium BVBA/SPRL Tel/Tél: +32(0)27766211 dpoc_belux@merck.com
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 March 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Pre-treated patient population
Danish: Forbehandlet patientpopulation
English: • The concomitant use of riociguat with strong CYP1A1 inhibitors, such as the tyrosine kinase inhibitor erlotinib, and strong P-glycoprotein (P-gp) / breast cancer resistance protein (BCRP) inhibitors, such as the immuno-suppressive agent cyclosporine A, may increase riociguat exposure (see sections 4.5 and 5.2).
Danish: • Den samtidige anvendelse af riociguat og kraftige CYP1A1-hæmmere, såsom tyrosinkinasehæmmeren erlotinib, og kraftige P-glykoprotein (P-gp)/brystcancerresistensprotein (BCRP)-hæmmere, såsom det immunosupprimerende stof ciklosporin A, kan forhøje eksponeringen for riociguat (se pkt.
English: If you have taken more tablets than you should and experience any side effects (see section 4), please contact your doctor.
Danish: Hvis du har taget for mange tabletter, og du får bivirkninger (se pkt.
English: Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is contraindicated (see sections 4.2 and 4.3).
Danish: Samtidig anvendelse af riociguat og PDE5-hæmmere (såsom sildenafil, tadalafil, vardenafil) er kontraindiceret (se pkt.
English: Adempas contains lactose
Danish: Adempas indeholder lactose
English: Chronic thromboembolic pulmonary hypertension (CTEPH)
Danish: Kronisk tromboembolisk pulmonal hypertension (CTEPH)
English: What Adempas is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Particular care should be exercised during individual dose titration.
Danish: Særlig forsigtighed bør udvises under individuel dosistitrering.
English: • 42 tablets: two transparent calendar blisters of 21 tablets each.
Danish: • 42 tabletter: to gennemsigtige kalender-blisters med 21 tabletter i hver
English: Concomitant use with strong multi pathway CYP and P-gp/BCRP inhibitors
Danish: Samtidig anvendelse af stærke multipathway CYP og P-gp/BCRP-hæmmere
English: FC III patient population
Danish: Funktionsklasse III patientpopulation
English: In rabbits, starting at systemic exposure of about 3-fold of human exposure (2.5 mg three times daily) abortion and foetal toxicity were seen.
Danish: Hos kaniner blev der observeret abort og føtal toksicitet startende ved systemisk eksponering af ca. 3 gange den humane eksponering (2,5 mg tre gange dagligt).
English: - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH
Danish: - Patienter med pulmonal hypertension associeret med idiopatisk interstitiel pneumonitis (PH-IIP)