natgillin/translations-raw huggingface dataset:
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.
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.
Derfor anbefales riociguat ikke til disse patienter.
Therefore, administration of riociguat to such patients is not recommended.
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.
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).
-843,0 til -45,0 [< 0,0001]
-843.0 to -45.0 [<0.0001]
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.
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.
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.
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.
Køn Farmakokinetiske data afdækker ingen relevante kønsforskelle ved eksponering for riociguat.
Gender Pharmacokinetic data reveal no relevant differences due to gender in the exposure to riociguat.
Patienter på en stabil dosis af stærke multipathway CYP/P-glykoprotein (P-gp) og brystcancerresistensprotein (BCRP)-hæmmere.
Patients on stable doses of strong multi pathway CYP / P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) inhibitors
Derfor bør Adempas ikke anvendes til disse patienter (se pkt.
Therefore use of Adempas is not recommended in these patients (see section 4.4).
Virkning er påvist i en PAH-population, herunder ætiologier med idiopatisk eller arvelig PAH, eller PAH forbundet med en bindevævssygdom (se pkt.
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).
Placebojusteret forskel (m)
Placebo-adjusted difference (m)
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.
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.
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.
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.
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.
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.
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.
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.
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,
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%).
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.
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).
Farmakokinetiske data afdækker ingen relevante forskelle hvad angår vægten ved eksponering for riociguat.
Different weight categories Pharmacokinetic data reveal no relevant differences due to weight in the exposure to riociguat.
-303,3 til -189,5 [< 0,0001]
-303.3 to -189.5 [<0.0001]
Alvorlig blødning omfattede også to patienter med vaginalblødning, to med blødning ved kateterstedet og hver én med subduralt hæmatom, hæmatemese og intraabdominal blødning.
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.
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.
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.
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 %).
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%).
-281,4 til -170,1[< 0,0001]
-281.4 to -170.1[<0.0001]
• 90 tabletter: fem gennemsigtige kalender-blisters med 18 tabletter i hver
• 90 tablets: five transparent blisters of 18 tablets each.
- 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).
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).
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.
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.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Bayer AG 51368 Leverkusen Tyskland
MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Adempas 1 mg og 1,5 mg tabletter indeholder også jernoxid, gul (E 172).
Adempas 1 mg, 1.5 mg tablets also contains iron oxide yellow (E 172).
Der foreligger ingen data om anvendelsen af riociguat til ammende kvinder.
No data on the use of riociguat in breast-feeding women are available.
- Svært nedsat leverfunktion (Child Pugh C).
- Severe hepatic impairment (Child Pugh C).
Adempas er kontraindiceret under graviditet (se pkt.
Adempas is contraindicated during pregnancy (see section 4.3).
Mave-tarm- og abdominalsmerter Forstoppelse Udspilet abdomen
Gastrointestinal and abdominal pains, Constipation, Abdominal distension
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.
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.
Behandlingsnaiv patientpopulation
Treatment-naïve patient population
• kronisk tromboembolisk pulmonal hypertension (CTEPH).
• chronic thromboembolic pulmonary hypertension (CTEPH).
- Aktivt stof: Riociguat.
- The active substance is riociguat.
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.
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).
Samtidig anvendelse af andre CYP og P-gp/BCRP-hæmmere
Concomitant use with other CYP and P-gp/BCRP inhibitors
Tabletkerne: Cellulose, mikrokrystallinsk, crospovidon (type B), hypromellose 5 cP, lactosemonohydrat, magnesiumstearat og natriumlaurilsulfat (se sidst i pkt.
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).
Adempas 2 mg og 2,5 mg tabletter indeholder også jernoxid, gul (E 172) og jernoxid, rød (E 172).
Adempas 2 mg and 2.5 mg tablets also contains iron oxide yellow (E172) and iron oxide red (E 172).
Data for patienter med kreatininclearance < 30 ml/min er begrænsede, og der er ingen data for dialysepatienter.
Data in patients with creatinine clearance <30 mL/min are limited and there are no data for patients on dialysis.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 March 2014
Forbehandlet patientpopulation
Pre-treated patient population
• 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.
• 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).
Hvis du har taget for mange tabletter, og du får bivirkninger (se pkt.
If you have taken more tablets than you should and experience any side effects (see section 4), please contact your doctor.
Samtidig anvendelse af riociguat og PDE5-hæmmere (såsom sildenafil, tadalafil, vardenafil) er kontraindiceret (se pkt.
Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is contraindicated (see sections 4.2 and 4.3).
Adempas indeholder lactose
Adempas contains lactose
Kronisk tromboembolisk pulmonal hypertension (CTEPH)
Chronic thromboembolic pulmonary hypertension (CTEPH)
Virkning og anvendelse 2.
What Adempas is and what it is used for 2.
Særlig forsigtighed bør udvises under individuel dosistitrering.
Particular care should be exercised during individual dose titration.
• 42 tabletter: to gennemsigtige kalender-blisters med 21 tabletter i hver
• 42 tablets: two transparent calendar blisters of 21 tablets each.
Samtidig anvendelse af stærke multipathway CYP og P-gp/BCRP-hæmmere
Concomitant use with strong multi pathway CYP and P-gp/BCRP inhibitors
Funktionsklasse III patientpopulation
FC III patient population
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).
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.
- Patienter med pulmonal hypertension associeret med idiopatisk interstitiel pneumonitis (PH-IIP)
- Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH
• Samtidig anvendelse af riociguat og stærke multipathway cytokrom P450 (CYP)- og P-glykoprotein (P-gp)/brystcancer-resistensprotein (BCRP)-hæmmere, såsom azol-antimykotika (f.eks. ketoconazol, posaconazol, itraconazol) eller hiv-proteasehæmmere (f.eks. ritonavir) resulterer i en udtalt forhøjelse i riociguat-eksponeringen (se pkt.
• The concomitant use of riociguat with strong multi pathway cytochrome P450 (CYP) and Pglycoprotein (P-gp) / breast cancer resistance protein (BCRP) inhibitors such as azole antimycotics (e.g. ketoconazole, posaconazole, itraconazole) or HIV protease inhibitors (e.g. ritonavir) results in a pronounced increase in riociguat exposure (see sections 4.5 and 5.2).
Derfor opstilles bivirkninger identificeret fra placebokontrollerede 12- og 16-ugers kliniske studier med den samlede hyppighed i den nedenstående tabel (se tabel 1).
The safety profile of Adempas in patients with CTEPH and PAH appeared to be similar, therefore adverse reactions identified from placebo controlled 12 and 16 weeks clinical studies are presented as pooled frequency in the table listed below (see table 1).
Funktionsklasse II patientpopulation
FC II patient population
• 84 tabletter: fire gennemsigtige kalender-blisters med 21 tabletter i hver
• 84 tablets: four transparent calendar blisters of 21 tablets each.
Data for patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) er begrænsede, og der er ingen data for dialysepatienter.
Data in patients with severe renal impairment (creatinine clearance <30 mL/min) are limited and there are no data for patients on dialysis.
Placebojusteret forskel (ng/l) 95 % CI, [p-værdi]
Placebo-adjusted difference (ng/L) 95% CI, [p-value]
Riociguat stimulerer også sGC direkte, uafhængigt af NO. Riociguat genetablerer NO-sGC-cGMP-pathway og fører til en øget dannelse af cGMP.
Riociguat restores the NO-sGC-cGMP pathway and leads to increased generation of cGMP.
- Samtidig administration af PDE5-hæmmere (såsom sildenafil, tadalafil, vardenafil) (se pkt.
- Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see sections 4.2 and 4.5).
Følg anbefalingen om dosistitrering ved samtidig administration af bosentan (se pkt.
For co-administration with bosentan follow the recommendation on dose titration (see section 4.2).
Følg anbefalingen om dosistitrering ved samtidig administration af disse stoffer (se pkt.
For co-administration with these substances follow the recommendation on dose titration (see section 4.2).
Det anbefales at monitorere for tegn og symptomer på hypotension efter ethvert skift af lægemiddel (se pkt.
It is recommended to monitor for signs and symptoms of hypotension after any transition (see sections 4.3, 4.5 and 5.1).
Tabletkerne:
Crushed tablets:
Det anbefales, at overvåge patienter for tegn og symptomer på hypotension (se pkt.
It is recommended to monitor these patients for signs and symptoms of hypotension (see sections 4.2 and 4.4).
Placebojusteret forskel (m) 95 % CI, [p-værdi]
Placebo-adjusted difference (m) 95% CI, [p-value]
Placebojusteret forskel (m) 95 % CI
Placebo-adjusted difference (m) 95% CI
Gastroøsofageal reflukssygdom Dysfagi
Gastro-oesophageal reflux disease,
Pulmonal hypertension er en tilstand, hvor disse blodkar bliver forsnævrede, og dermed gør det sværere for hjertet at pumpe blod gennem dem.
Adempas can be used to treat adults with certain forms of pulmonary hypertension, a condition in which these blood vessels become narrowed, making it harder for the heart to pump blood through them and leading to high blood pressure in the vessels.
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, f.eks. ketoconazol,
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. ketoconazole, posaconazole or itraconazole consider a reduced starting dose.
- Graviditet (se pkt.
- if you are pregnant.
Sådan skal du tage Adempas
How to take Adempas
Baseline (dyn·s·cm-5)
Baseline (dyn·s·cm-5) [SD]
Adempas 2 mg filmovertrukne tabletter Adempas 2,5 mg filmovertrukne tabletter riociguat
Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets riociguat
Hver filmovertrukket tablet indeholder 1 mg riociguat.
Each film-coated tablet contains 1 mg of riociguat.
Følg anbefalingen om dosistitrering ved samtidig administration af kraftige CYP3A4-induktorer (se pkt.
For coadministration with strong CYP3A4 inducers follow the recommendation on dose titration (see section
Udseende og pakningsstørrelser
What Adempas looks like and contents of the pack
4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Adempas påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
4.7 Effects on ability to drive and use machines
Hver filmovertrukket tablet indeholder 2 mg riociguat.
Each film-coated tablet contains 2 mg of riociguat.
hydroxypropylcellulose hypromellose 3 cP propylenglycol (E 1520) titandioxid (E 171) * jernoxid gul (E 172) (kun i 1 mg, 1,5 mg, 2 mg og 2,5 mg tabletter) * jernoxid rød (E 172) (kun i 2 mg og 2,5 mg tabletter)
hydroxypropylcellulose hypromellose 3 cP propylene glycol (E 1520) titanium dioxide (E 171) iron oxide yellow (E 172)
Gennemsnitlig ændring fra baseline (m) [SD]
Mean change from baseline (m) [SD]
Adempas 1,5 mg - pakning med 294 filmovertrukne tabletter - EU/1/13/907/018 Adempas 2 mg - pakning med 42 filmovertrukne tabletter - EU/1/13/907/010
Adempas 1.5 mg - pack of 294 film-coated tablets - EU/1/13/907/018 Adempas 2 mg - pack of 42 film-coated tablets - EU/1/13/907/010
Adempas 0,5 mg - pakning med 294 filmovertrukne tabletter - EU/1/13/907/016 Adempas 1 mg - pakning med 42 filmovertrukne tabletter - EU/1/13/907/004
Adempas 0.5 mg - pack of 294 film-coated tablets - EU/1/13/907/016 Adempas 1 mg - pack of 42 film-coated tablets - EU/1/13/907/004
Adempas 0,5 mg tabletter Adempas 1 mg tabletter Adempas 1,5 mg tabletter Adempas 2 mg tabletter Adempas 2,5 mg tabletter riociguatum
Adempas 0.5 mg tablets Adempas 1 mg tablets Adempas 1.5 mg tablets Adempas 2 mg tablets Adempas 2.5 mg tablets riociguat
• 294 tabletter: fjorten gennemsigtige kalender-blisters med 21 tabletter i hver Ikke alle pakningsstørrelser er nødvendigvis markedsført.
• 294 tablets: fourteen transparent calendar blisters of 21 tablets each.
Adempas 1 mg filmovertrukne tabletter Adempas 1,5 mg filmovertrukne tabletter
Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets
Dosisreduktion kan overvejes, og patienterne overvåges for tegn og symptomer på hypotension for at mindske risikoen for hypotension (se pkt.
To mitigate the risk of hypotension, consider dose reduction and monitoring for signs and symptoms of hypotension (see sections 4.2 and 4.5).
Gennemsnitlig ændring fra baseline (ng/l) [SD]
Mean change from baseline (ng/L) [SD]
Adempas 1 mg filmovertrukne tabletter
Adempas 1 mg film-coated tablets
Disse lægemidler mod for meget mavesyre skal tages mindst to timer før eller én time efter du tager Adempas - kvalme, opkastning (såsom granisetron).
These antacid medicines should be taken at least two hours before or one hour after taking
Adempas 2 mg filmovertrukne tabletter
Adempas 2 mg film-coated tablets
Mave-tarm-kanalen Dyspepsi Diaré
Gastrointestinal disorders Dyspepsia, Diarrhoea,
Adempas 1 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 1 mg riociguat.
Adempas 1 mg film-coated tablets Each film-coated tablet contains 1 mg riociguat.
20 m til 52 m [< 0,0001]
20 to 52 [<0.0001]
Patienter i funktionsklasse III
FC III patients
Tilfælde med dødelig udgang er observeret (ikke almindelig bivirkning, kan forekomme hos op til 1 ud af 100 personer).
• acute bleeding from the lungs (pulmonary haemorrhage) may result in coughing up blood, cases with fatal outcomes were observed (uncommon side effect, may affect up to 1 in 100 people).
Adempas 2 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 2 mg riociguat.
Adempas 2 mg film-coated tablets Each film-coated tablet contains 2 mg riociguat.
Adempas 1,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 1,5 mg riociguat.
Adempas 1.5 mg film-coated tablets Each film-coated tablet contains 1.5 mg riociguat.
Kontakt lægen, før du tager dette lægemiddel, hvis din læge har fortalt dig, at du ikke tåler visse sukkerarter.
If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Adempas 0,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 0,5 mg riociguat.
Adempas 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg riociguat.
Adempas 2,5 mg filmovertrukne tabletter
Adempas 2.5 mg film-coated tablets
Gennemsnitlig ændring fra baseline (dyn·s·cm-5)
Mean change from baseline (dyn·s·cm-5) [SD]
Hver 1 mg filmovertrukket tablet indeholder 37,2 mg lactose (som monohydrat).
Each 1 mg film-coated tablet contains 37.2 mg lactose (as monohydrate).
Adempas 1,5 mg filmovertrukne tabletter
Adempas 1.5 mg film-coated tablets
Data for patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) er begrænsede, og der er ingen data for patienter, som er i dialyse.
Data in patients with severe renal impairment (creatinine clearance < 30 mL/min) are limited and there are no data for patients on dialysis, therefore riociguat is not recommended in these patients.
Hver 2 mg filmovertrukket tablet indeholder 36,3 mg lactose (som monohydrat).
Each 2 mg film-coated tablet contains 36.3 mg lactose (as monohydrate).
Adempas 0,5 mg filmovertrukne tabletter
Adempas 0.5 mg film-coated tablets
Din læge vil overvåge dig regelmæssigt - du føler dig stakåndet under behandlingen med dette lægemiddel.
Your doctor will regularly monitor you.