FrancophonIA/ELRC3.0 huggingface dataset:
English: • That women of childbearing potential must use reliable contraception;
Danish: • Kvinder i den fødedygtige alder skal anvende sikker kontraception;
English: Absolute risk reduction
Danish: Absol ut risikoreduktion
English: In the presence of strong CYP3A4 inducers reduced efficacy of macitentan could occur.
Danish: Stærke CYP3A4-induktorer kan nedsætte effekten af macitentan.
English: The primary endpoint was the time to first occurrence of a morbidity or mortality event, up to the end of double-blind treatment, defined as death, or atrial septostomy, or lung transplantation, or initiation of intravenous (i.v.)
Danish: Det primære endepunkt var tid til første forekomst af en morbiditets- eller mortalitetshændelse indtil afslutningen af dobbeltblindet behandling.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Testicular tubular atrophy, and minimal effects on reproductive variables and sperm morphology were recorded at exposures 3.8-fold the human exposure.
Danish: Der blev registreret testikulær tubulær atrofi og minimale virkninger på reproduktionsvariabler og sædmorfologi ved eksponeringer, der var 3,8 gange højere end den humane eksponering.
English: Cyclosporine A: Concomitant treatment with cyclosporine A 100 mg twice daily, a combined CYP3A4 and OATP inhibitor, did not alter the steady-state exposure to macitentan and its active metabolite to a clinically relevant extent.
Danish: Ciclosporin A: Samtidig behandling med ciclosporin A (kombineret CYP3A4- og OATP-hæmmer) 100 mg to gange dagligt ændrede ikke steady-state-eksponeringen for macitentan og dets aktive metabolit i klinisk relevant omfang.
English: Reduced efficacy of macitentan in the presence of a potent inducer of CYP3A4 such as rifampicin should be considered.
Danish: Der skal tages højde for nedsat effekt af macitentan ved samtidig brug af en stærk CYP3A4-induktor, såsom rifampicin.
English: • Urinary tract infection (bladder infection)
Danish: • Urinvejsinfektion (blærebetændelse)
English: • The Summary of Product Characteristics for Opsumit;
Danish: • Produktresuméet for Opsumit;
English: The safety margins for fertility were 18 for male and 44 for female rats.
Danish: Sikkerhedsmarginerne vedrørende fertiliteten var18 hos hanrotter og 44 hos hunrotter.
English: • Anaemia (low number of red blood cells) or reduced haemoglobin
Danish: • Blodmangel (lavt antal røde blodlegemer) eller nedsat hæmoglobin
English: Based on PK data, no dose adjustment is required in patients with renal impairment.
Danish: Baseret på farmakokinetiske data er det ikke nødvendigt at justere dosis hos patienter med nyreinsufficiens.
English: In a long-term doubleblind study in patients with PAH, hypotension was reported for 7.0% and 4.4% of patients on macitentan 10 mg and placebo, respectively.
Danish: I et langvarigt dobbeltblindet studie hos patienter med PAH blev der rapporteret om hypotension hos 7,0 % og 4,4 % af de patienter, der fik hhv. macitentan 10 mg og placebo.
English: • Allergic reactions (swelling around the eyes, face, lips, tongue or throat, itching and/or rash) If you notice any of these signs, tell your doctor immediately.
Danish: • Allergiske reaktioner (hævde øjenomgivelser, hævelser i ansigt, læber, tunge eller svælg, kløe og/eller udslæt).
English: If you take Opsumit together with other medicines including those listed below, the effects of Opsumit or the other medicines might be altered.
Danish: Hvis du tager Opsumit sammen med andre lægemidler, herunder nedennævnte lægemidler, kan virkningen af Opsumit eller de andre lægemidler blive ændret.Kontakt lægen eller apotekspersonalet, hvis du tager et eller flere af følgende lægemidler:
English: Opsumit is contraindicated during pregnancy and in women of childbearing potential who are not using reliable contraception (see section 4.3).
Danish: Opsumit er kontraindiceret under graviditeten og hos fertile kvinder, der ikke anvender sikker kontraception (se pkt.
English: • Leukopenia (decreased white blood cell counts)
Danish: • Leukopeni (nedsat antal hvide blodlegemer)
English: • nefazodone (used to treat depression),
Danish: • nefazodon (anvendes til behandling af depression),
English: Initiation of Opsumit is not recommended in patients with severe anaemia.
Danish: Det frarådes at påbegynde behandling med Opsumit hos patienter med svær anæmi.
English: Macitentan and its active metabolite are not inhibitors of hepatic or renal uptake transporters at clinically relevant concentrations, including the organic anion transporting polypeptides (OATP1B1 and OATP1B3).
Danish: Macitentan og dets aktive metabolit er ikke hæmmere af hepatiske eller renale optagstransportører i klinisk relevante koncentrationer, herunder de organiske aniontransporterende polypeptider (OATP1B1 og OATP1B3).
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 brugere)
English: Adverse reactions of headache, nausea, and vomiting were observed.
Danish: Der blev set bivirkninger i form af hovedpine, kvalme og opkastning.
English: Do not breastfeed while you are taking Opsumit.
Danish: Du må ikke amme, mens du er i behandling med Opsumit.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger(kan påvirke op til 1 ud af 10 brugere)
English: Elevations > 5 × ULN occurred in 2.5% of patients on macitentan 10 mg versus 2% of patients on placebo.
Danish: Øgninger > 5 x ULN optrådte hos 2,5 % af de patienter, der fik macitentan 10 mg, og hos 2 % af de patienter, der fik placebo.
English: What Opsumit looks like and contents of the pack Opsumit 10 mg tablets are white to off-white, biconvex, round, film-coated tablets with “10” on both sides.
Danish: Opsumit 10 mg tabletter er hvide til råhvide, bikonvekse, runde, filmovertrukne tabletter, der er præget med ”10” på begge sider.
English: Opsumit is contraindicated during breastfeeding (see section 4.3).
Danish: Opsumit er kontraindiceret under amning (se pkt.
English: The combination of macitentan with strong CYP3A4 inducers (e.g., rifampicin, St. John's wort, carbamazepine, and phenytoin) should be avoided (see section 4.5).
Danish: Kombination af macitentanog stærke CYP3A4-induktorer (f.eks. rifampicin, hypericum perforatum, carbamazepin og phenytoin) bør undgås (se pkt.
English: In two double-blind clinical studies in patients with digital ulcers associated with systemic sclerosis, the incidences of peripheral oedema AEs ranged from 13.4% to 16.1% in the macitentan 10 mg groups and from 6.2% to 4.5% in the placebo groups.
Danish: I to dobbeltblindede kliniske studier hos patienter med fingersåri forbindelse med systemisk sklerose var forekomsten af bivirkninger i form af perifere ødemer fra 13,4 % til 16,1 % i de grupper, der fik macitentan 10 mg, og fra 6,2 % til 4,5 % i placebogrupperne.
English: If you have signs of pulmonary oedema when using Opsumit, such as a sudden, important increase in breathlessness and low oxygen, tell your doctor immediately.
Danish: Kontakt omgående lægen, hvis du får tegn på lungeødem, såsom en pludselig, markant forværring af stakåndethed og lavt iltniveau, mens du bruger Opsumit.
English: White high-density polyethylene (HDPE) bottles with child-resistant closure and a silica gel desiccant.
Danish: Beholder af hvid højdensitetspolyethylen (HDPE) med børnesikret låg og et tørremiddel (silicagel).
English: The combination of macitentan with strong CYP3A4 inducers should be avoided (see section 4.4).
Danish: Kombination af macitentan og stærke CYP3A4-induktorer bør undgås (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/893/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/893/001
English: Macitentan and its active metabolite are not inhibitors of hepatic or renal efflux pumps at clinically relevant concentrations, including the multi-drug resistance protein (P-gp, MDR-1) and multidrug and toxin extrusion transporters (MATE1 and MATE2-K).
Danish: Macitentan og dets aktive metabolit i klinisk relevante koncentrationer hæmmer ikke hepatiske eller renale efflukspumper, herunder det multilægemiddelresistente protein (P-gp, MDR-1) og multilægemiddel- og toksinekstrusiontransportørerne (MATE1 og MATE2-K).
English: Exposure to macitentan was decreased by 21%, 34%, and 6% and, for the active metabolite by 20%, 25%, and 25% in subjects with mild, moderate or severe hepatic impairment, respectively.
Danish: Hos patienter med mild, moderat eller svær leverinsufficiens var eksponeringen for macitentan nedsat med hhv. 21 %, 34 % og 6 %, og eksponeringen for den aktive metabolit var nedsat med hhv. 20 %, 25 % og 25 %.
English: The risk of PAH related death or hospitalisation for PAH up to EOT was reduced by 50% (HR 0.50; 97.5% CI: 0.34 to 0.75; logrank p < 0.0001) in patients receiving macitentan 10 mg (50 events) compared to placebo (84 events).
Danish: Risikoen for PAH-relateret dødsfald eller hospitalisering på grund af PAH frem til behandlingens afslutning var nedsat med 50 %(risikoforhold 0,50; 97,5 % CI: 0,34 til 0,75; logrank p < 0,0001) hos de patienter, der fik macitentan 10 mg (50 hændelser), sammenlignet med placebo (84 hændelser).
English: There is limited clinical experience with macitentan in patients over the age of 75 years, therefore Opsumit should be used with caution in this population (see section 4.2).
Danish: Der er begrænset erfaring med Opsumit hos patienter over 75 år.Opsumit skal anvendes med forsigtighed i denne aldersgruppe.
English: In placebo-controlled studies, macitentan-related decreases in haemoglobin concentration were not progressive, stabilised after the first 4-12 weeks of treatment and remained stable during chronic treatment.
Danish: De var stabiliseret efter de første 4 til 12 ugers behandling og forblev stabile under kronisk behandling.
English: Do not take a double dose to make up for a forgotten tablet.
Danish: Herefter skal du fortsætte med at tage tabletterne på det sædvanlige tidspunkt.Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: However, there is no clinical experience with the use of macitentan in PAH patients with moderate or severe hepatic impairment.
Danish: Der er imidlertid ingen klinisk erfaring med brug af macitentanhos PAH-patienter med moderat eller svær leverinsufficiens.
English: Page 5 (inside right)
Danish: Side 5 (indvendig højre side)
English: • phenytoin (a medicine used to treat seizures),
Danish: • phenytoin (et lægemiddel, der anvendes til behandling af krampeanfald),
English: If you forget to take Opsumit, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Danish: Hvis du glemmer at tage Opsumit, skal du tage en dosis, så snart du kommer i tanker om det.
English: In a double-blind study in patients with idiopathic pulmonary fibrosis, the incidence of peripheral oedema AEs in the macitentan and placebo treatment groups was 11.8% and 6.8%, respectively.
Danish: I et dobbeltblindet studie hos patienter med idiopatisk lungefibrose var forekomsten af bivirkninger i form af perifere ødemer i macitentangruppen og placebogruppen henholdsvis 11,8 % og 6,8 %.
English: Treatment with macitentan 10 mg resulted in a 45% risk reduction (hazard ratio [HR] 0.55; 97.5% CI: 0.39 to 0.76; logrank p < 0.0001) of the composite morbidity-mortality endpoint up to EOT when compared to placebo [Figure 1 and Table 1].
Danish: Behandling med macitentan 10 mg resulterede i en risikoreduktion på 45 % (risikoforhold [HR] 0,55; 97,5 % CI: 0,39 til 0,76; logrank p < 0,0001) i det sammensatte endepunkt bestående afmorbiditetmortalitet indtil behandlingens afslutning sammenlignet med placebo [Figur 1 og Tabel 1].
English: Opsumit contains lactose.
Danish: Opsumit indeholder lactose.
English: At clinically relevant concentrations, macitentan and its active metabolite do not interact with proteins involved in hepatic bile salt transport, i.e., the bile salt export pump (BSEP) and the sodium-dependent taurocholate co-transporting polypeptide (NTCP).
Danish: Macitentan og dets aktive metabolit i klinisk relevante koncentrationer interagerer ikke med de proteiner, der er involveret i den hepatiske galdesalttransport, dvs. Galdesalteksportpumpen (BSEP) og det natriumafhængige taurocholat-co-transporterende polypeptid (NTCP).
English: Treatment with macitentan 10 mg at Month 6 led to a 74% higher chance of WHO FC improvement relative to placebo (risk ratio 1.74; 97.5% CI: 1.10 to 2.74; p = 0.0063).
Danish: Behandling med macitentan 10 mg i seks måneder medførte 74 % større chance for forbedring i WHO-funktionsklasse i forhold til placebo (risikoforhold 1,74; 97,5 % CI: 1,10 til 2,74; p = 0,0063).
English: Concomitant use with strong CYP3A4 inducers
Danish: Samtidig brug af stærke CYP3A4-induktorer
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/893/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/893/003
English: • Women of childbearing potential who are not using reliable contraception (see sections 4.4 and
Danish: • Kvinder i den fertile alder, der ikke anvender sikker kontraception (se pkt.
English: 4.7 Effects on ability to drive and use machines Macitentan has minor influence on the ability to drive and use machines.
Danish: Macitentan påvirker i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: • if you have liver disease or if you have very high levels of liver enzymes in your blood.
Danish: • hvis du har en leversygdom, eller hvis du har meget høje niveauer af leverenzymer i dit blod.Kontakt lægen, som vil vurdere, hvorvidt dette lægemiddel er egnet til dig.
English: A decrease from baseline in haemoglobin concentration to below 10 g/dL was reported in 8.7% of patients treated with macitentan 10 mg and 3.4% of placebo-treated patients.
Danish: Der blev rapporteret om et fald i hæmoglobinkoncentration i forhold til udgangsvurderingen til under 6.2 mmol/l hos 8,7 % af de patienter, der blev behandlet med macitentan 10 mg, og hos 3,4 % af de patienter, der blev behandlet med placebo.
English: PHARMACEUTICAL FORM AND CONTENTS 15 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 15 filmovertrukne tabletter
English: • The need for baseline and:
Danish: • Behovet for undersøgelserinden behandlingsstart og:
English: This decrease is not considered clinically relevant (see sections 4.2 and 4.4).
Danish: Dette fald anses ikke for at være klinisk relevant (se pkt.
English: Package leaflet: information for the user Opsumit 10 mg film-coated tablets macitentan
Danish: Indlægsseddel:Information til brugeren Opsumit 10 mg filmovertrukne tabletter macitentan
English: This increase is not considered clinically relevant (see sections 4.2 and 4.4).
Danish: Denne stigning anses ikke for at være klinisk relevant (se pkt.
English: Page 3 (inside left)
Danish: Side 3 (indvendig venstre side)
English: The use of Opsumit is not recommended in patients undergoing dialysis (see sections 4.4 and 5.2).
Danish: Det frarådes at bruge Opsumit hos patienter, der er i dialyse (se pkt.
English: Evaluation of 6MWD by functional class resulted in a placebo-corrected mean increase from baseline to Month 6 in FC III/IV patients of 37 meters (97.5% CI: 5 to 69) and in FC I/II of 12 meters (97.5% CI: −8 to 33).
Danish: Evaluering af 6MWD i henhold til funktionsklasse resulterede i en placebokorrigeret gennemsnitlig stigning fra udgangsvurderingen til måned 6 på 37 meter hos patienter i funktionsklasse III/IV (97,5 % CI: 5 til 69) og på 12 meter hos patienter i funktionsklasse I/II (97,5 % CI: -8 til 33).
English: 3 Oedema/fluid retention has been associated with the use of ERAs including macitentan.
Danish: Ødem/væskeretention er blevet forbundet med brug af ERA'er, herunder macitentan.
English: In a longterm double-blind study in patients with PAH, the incidence of oedema AEs in the macitentan 10 mg and placebo treatment groups was 21.9% and 20.5%, respectively.
Danish: I et langvarigt dobbeltblindet studie hos patienter med PAH var forekomsten af ødemrelaterede bivirkninger i den gruppe, der fik macitentan 10 mg, og i placebogruppenhenholdsvis 21,9 % og 20,5 %.
English: • Patient reminder cards.
Danish: • Huskekort til patienter.
English: Consequently, if signs of pulmonary oedema occur when macitentan is administered in patients with PAH, the possibility of pulmonary veno-occlusive disease should be considered.
Danish: Som følge heraf skal der tages højde for muligheden for pulmonal veno-okklusiv sygdom, hvis der opstår tegn på lungeødemer, når macitentanadministreres til patienter med PAH.
English: There is no clinical experience with the use of macitentan in PAH patients with severe renal impairment.
Danish: Der er ingen klinisk erfaring med brug af macitentan hos PAH-patienter med svær nyreinsufficiens.
English: This corresponded to 3.5 events / 100 patient-years on macitentan 10 mg compared to 2.7 events / 100 patient-years on placebo.
Danish: Det svarede til 3,5 hændelser / 100 patientår med macitentan 10 mgvs.
English: Treatment with macitentan 10 mg at Month 6 resulted in a placebo-corrected mean increase in 6MWD of 22 meters (97.5% CI: 3 to 41; p = 0.0078).
Danish: Behandling med macitentan 10 mg i 6 måneder resulterede i en placebokorrigeret gennemsnitlig stigning i 6MWD på 22 meter (97,5 % CI: 3til 1; p = 0,0078).
English: • whether you have anaemia (a reduced number of red blood cells)
Danish: • Om du har blodmangel (nedsat antal røde blodlegemer).
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean platelet count of 17 × 109/L, versus a mean decrease of 11 × 109/L in placebo-treated patients.
Danish: I et dobbeltblindet studie hos patienter med PAH var macitentan 10 mg forbundet med et fald i det gennemsnitlige trombocyttal på 17 x 109/l vs. et gennemsnitligt fald på 11 x 109/l hos de patienter, der blev behandlet med placebo.
English: Patients treated with macitentan 10 mg achieved a median reduction of 36.5% (97.5% CI: 21.7 to 49.2%) in pulmonary vascular resistance and an increase of 0.58 L/min/m2 (97.5% CI: 0.28 to 0.93 L/min/m2) in cardiac index compared to placebo.
Danish: De patienter, der blev behandlet med macitentan 10 mg, opnåede en gennemsnitlig reduktion på 36,5 % (97,5 % CI: 21,7til 49,2 %) i den pulmonale vaskulære modstand og en stigning på 0,58 l/minut/m2 (97,5 % CI: 0,28 til
English: The recommended dose of Opsumit is one 10 mg tablet, once a day.
Danish: Den anbefalede dosis af Opsumit er én 10 mg tablet én gang dagligt.Tabletten skal synkes hel med et glas vand.
English: Opsumit treatment should only be initiated in women of childbearing potential when the absence of pregnancy has been verified, appropriate advice on contraception provided, and reliable contraception is practised (see sections 4.3 and 4.6).
Danish: Behandling med Opsumit bør først indledes hos kvinder i den fertile alder, når graviditet er blevet udelukket, når der er givet tilstrækkelig rådgivning om kontraception, og kvinden anvender sikker kontraception (se pkt.
English: • Elevated liver tests
Danish: • Forhøjede levertal
English: whether you have anaemia (a reduced number of red blood cells)
Danish: om du har blodmangel (nedsat antal røde blodlegemer)
English: Opsumit® 10 mg macitentan film-coated tablets
Danish: Opsumit 10 mg macitentan filmovertrukne tabletter
English: • Influenza (flu)
Danish: • Influenza
English: What Opsumit is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg macitentan
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 10 mg macitentan.
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Hvis du har nogen spørgsmål, så kontakt lægen.
English: Opsumit contains lactose, lecithin from soya and sodium Opsumit contains a sugar called lactose.
Danish: Opsumit indeholder en sukkerart, der kaldes for lactose.
English: The pharmacokinetics of macitentan in PAH patients were not influenced by the severity of the disease.
Danish: Sygdommens sværhedsgrad påvirkede ikke farmakokinetikken af macitentan hos PAH-patienter.
English: Microcrystalline cellulose (E460i)
Danish: Lactosemonohydrat Cellulose, mikrokrystallinsk (E460i) Natriumstivelsesglycolat Type A Povidon K-30
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean leucocyte count from baseline of 0.7 × 109/L versus no change in placebo-treated patients.
Danish: I et dobbeltblindet studie hos patienter med PAH var macitentan 10 mg forbundet med et fald i det gennemsnitlige leukocyttal i forhold til udgangsvurderingen på 0,7 x 109/l, hvorimod der ikke var nogen ændringer hos de patienter, der blev behandlet med placebo.
English: If you notice any of these signs, tell your doctor immediately.
Danish: Kontakt omgående lægen, hvis du bemærker nogen af disse tegn.
English: Opsumit is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults; it can be used on its own or with other medicines for PAH.
Danish: Opsumit anvendes til langvarig behandling af pulmonal arteriel hypertension (PAH) hos voksne.
English: • Breastfeeding (see section 4.6).
Danish: • Amning (se pkt.
English: Anaemia, haemoglobin decrease5
Danish: Anæmi, fald i hæmoglobin5
English: Poly(vinyl-alcohol) (E1203)
Danish: Poly(vinylalkohol) (E1203) Titandioxid (E171) Talcum (E553b) Sojalecithin (E322) Xanthangummi (E415)
English: Decrease in haemoglobin concentrations has been associated with endothelin receptor antagonists (ERAs) including macitentan (see section 4.8).
Danish: Endothelinreceptorantagonister (ERA'er), herunder macitentan, er blevet forbundet med fald i hæmoglobinkoncentrationen (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg tablets macitentan
Danish: LÆGEMIDLETS NAVN Opsumit 10 mg tabletter macitentan
English: If you notice any of these signs, tell your doctor.
Danish: Kontakt lægen, hvis du bemærker nogen af disse tegn.
English: ©2013 Actelion Pharmaceuticals Ltd
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.©2013 Actelion Pharmaceuticals Ltd
English: For more information on Opsumit, please read carefully the patient information leaflet.
Danish: Du kan finde yderligere oplysninger om Opsumit i indlægssedlen.
English: • St. John's Wort (an herbal preparation used to treat depression),
Danish: • prikbladet perikon (et urtepræparat, der anvendes til behandling af depression),
English: How to take Opsumit
Danish: Sådan skal du tage Opsumit
English: The number of deaths of all causes up to EOS on macitentan 10 mg was 35 versus 44 on placebo (HR 0.77; 97.5% CI: 0.46 to 1.28).
Danish: 44 med placebo (Risikoforhold 0,77; 97,5 % CI: 0,46 til 1,28).
English: NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Opsumit 10 mg filmovertrukne tabletter
English: Tabulated list of adverse reactions
Danish: Bivirkningsliste i tabelform
English: Tablet core
Danish: Hæmoglobinkoncentration
English: Opsumit is not to be initiated in patients with severe hepatic impairment or elevated aminotransferases (> 3 × ULN) (see sections 4.2 and 4.3), and is not recommended in patients with moderate hepatic impairment.
Danish: Opsumit må ikke initieres hos patienter, der har svær leverinsufficiens eller forhøjede aminotransferaseniveauer (> 3 x ULN) (se pkt.
English: If you have kidney problems, talk to your doctor before using Opsumit.
Danish: Kontakt lægen, før du begynder at bruge Opsumit, hvis du har nyreproblemer.
English: Opsumit contains soya bean lecithin.
Danish: Opsumit indeholder sojalecithin.
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a mean decrease in haemoglobin versus placebo of 1 g/dL.
Danish: I et dobbeltblindet studie hos patienter med PAH var macitentan 10 mg forbundet med et gennemsnitligt fald i hæmoglobin på 0.62 mmol/l i forhold til placebo.
English: • Pharyngitis (inflammation of the throat)
Danish: • Snue (betændelse i svælg og næse)