FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are lactose monohydrate (see section 2 “Opsumit contains lactose, lecithin from soya and sodium"), microcrystalline cellulose (E460i), povidone, sodium starch glycolate Type A (see section 2 “Opsumit contains lactose, lecithin from soya and sodium”), magnesium stearate (E572), polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soya bean lecithin (E322) (see section 2 “Opsumit contains lactose, lecithin from soya and sodium") and xanthan gum (E415).
Danish: Øvrige indholdsstoffer: lactosemonohydrat (se afsnit 2 ”Opsumit indeholder lactose, lecithin udledt fra soja og natrium”), mikrokrystallinsk cellulose (E460i), povidon, natriumstivelsesglycolat type A (se afsnit 2 ”Opsumit indeholder lactose, lecithin udledt fra soja og natrium”), magnesiumstearat (E572), polysorbat 80 (E433), polyvinylalkohol (E1203), titandioxid (E171), talcum (E553b), sojalecithin (E322) (se afsnit 2 ”Opsumit indeholder lactose, lecithin udledt fra soja og natrium”) og xanthangummi (E415).
English: 2 Hypotension has been associated with the use of ERAs including macitentan.
Danish: 2 Hypotension er blevet forbundet med brug af ERA'er, herunder macitentan.
English: Reinitiation of Opsumit may be considered following the return of hepatic enzyme levels to within the normal range in patients who have not experienced clinical symptoms of liver injury.
Danish: Det kan overvejes at genoptage behandlingen med Opsumit, når leverenzymniveauerne igen ligger inden for normalområdet hos patienter, der ikke har haft kliniske symptomer på leverskade.
English: • if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception).
Danish: • hvis du er gravid, planlægger at blive gravid, eller kan blive gravid, fordi du ikke anvender en sikker præventionsmetode (kontraception).
English: There is limited clinical experience in patients over the age of 75 years.
Danish: Der er begrænset klinisk erfaring med patienter over 75 år.
English: The majority of adverse reactions are mild to moderate in intensity.
Danish: Størstedelen af bivirkningerne er af mild til moderat sværhedsgrad.
English: At baseline, the majority of enrolled patients (64%) were treated with a stable dose of specific therapy for PAH, either oral phosphodiesterase inhibitors (61%) and/or inhaled/oral prostanoids (6%).
Danish: Størstedelen af de inkluderede patienter (64 %) var ved udgangspunktet ('baseline') i behandling med en stabil dosis af en specifik PAH-behandling, enten orale phosphodiesterasehæmmere (61 %) og/eller inhalerede/orale prostanoider (6 %).
English: Aminotransferase elevations4
Danish: Øgede aminotransferaser4
English: Several members of the CYP2C family, namely CYP2C8, CYP2C9 and CYP2C19, as well as CYP3A4, are involved in the formation of these metabolites.
Danish: Adskillige medlemmer af CYP2C-familien, navnligt CYP2C8, CYP2C9 og CYP2C19, samt CYP3A4 er involveret i dannelsen af disse metabolitter.
English: Warfarin: Macitentan given as multiple doses of 10 mg once daily had no effect on exposure to S-warfarin (CYP2C9 substrate) or R-warfarin (CYP3A4 substrate) after a single dose of 25 mg warfarin.
Danish: Warfarin:Gentagne doser af 10 mg macitentan én gang dagligt havde ingen effektpå eksponeringen for S-warfarin (CYP2C9-substrat) eller R-warfarin (CYP3A4-substrat) efter en enkelt dosis af 25 mg warfarin.
English: What you need to know before you take Opsumit 3.
Danish: Det skal du vide, før du begynder at tage Opsumit 3.
English: The safety of macitentan in children and adolescents below 18 years has not yet been established.
Danish: Sikkerhed af macitentan hos børn og unge under 18 år er ikke klarlagt.
English: • if you are breastfeeding.
Danish: • hvis du ammer.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Opsumit and regularly (once a month) while you are taking Opsumit.
Danish: Hvis du er kvinde og i den fødedygtige alder vil lægen bede dig om at tage en graviditetstest, inden du starter med at tage Opsumit, og med jævne mellemrum (en gang om måneden) under behandlingen med Opsumit.
English: Efficacy in patients with pulmonary arterial hypertension
Danish: Virkning hos patienter med pulmonal arteriel hypertension
English: Macitentan was not genotoxic in a standard battery of in vitro and in vivo assays.
Danish: Macitentan var ikke genotoksisk i en række standardprøver in vitro og in vivo.
English: Efficacy of macitentan 10 mg on the primary endpoint was consistent across subgroups of age, sex, ethnic origin, geographical region, aetiology, by monotherapy or in combination with another PAH therapy and by WHO FC (I/II and III/IV).
Danish: Effektenaf macitentan 10 mg på det primære endepunkt var konsekvent på tværs af undergrupper af alder, køn, etnisk oprindelse, geografisk region, ætiologi og WHO-funktionsklasse (I/II og III/IV), både som monoterapi og i kombination med anden PAH-behandling.
English: • unusual tiredness or exhaustion (lethargy or fatigue)
Danish: • Usædvanlig træthed eller udmattelse (letargi eller træthed)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 December 2013
Danish: Dato for første markedsføringstilladelse: 20. december 2013.
English: Macitentan and its active metabolite are not relevant substrates of OATP1B1 and OATP1B3, but enter the liver by passive diffusion.
Danish: Macitentan og dets aktive metabolit er ikke relevante substrater af OATP1B1og OATP1B3 men overføres til leveren via passiv diffusion.
English: • regular monitoring of haemoglobin levels;
Danish: • regelmæssig monitorering af hæmoglobinniveauer;
English: Death c n (%)
Danish: Dødsfaldc n (%)
English: • yellowing of your skin or the whites of your eyes (jaundice)
Danish: • Gulfarvning af huden og det hvide i øjnene (gulsot)
English: • To ensure females of childbearing potential are not pregnant and are on reliable contraception prior to starting Opsumit;
Danish: • At sikre, at kvinder i den fødedygtige alder, ikke er gravide og anvender sikker kontraception, inden behandlingen med Opsumit startes.
English: OUTER CARTON/BOTTLE
Danish: YDRE KARTON/BEHOLDER
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: Macitentan may lead to more reduction of blood pressure and decrease in haemoglobin in patients with kidney problems.
Danish: Macitentan kan medføre yderligere fald i blodtrykket og fald i hæmoglobin hos patienter med nyreproblemer.
English: 5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with “10” on both sides.
Danish: 5,5 mm, rund, bikonveks, hvid til råhvid, filmovertrukken tablet, der er præget med ”10” på begge sider.
English: Cases of anaemia requiring blood cell transfusion have been reported with macitentan and other ERAs.
Danish: Der er rapporteret om tilfælde af anæmi, der krævede transfusion af blodceller, med macitentanog andre ERA'er.
English: Administration of macitentan to female rats from late pregnancy through lactation at maternal exposures 5-fold the human exposure, caused reduced pup survival and impairment of the reproductive capability of the offspring, which was exposed to macitentan during late intrauterine life and via the milk during the suckling period.
Danish: Administration af macitentan til hunrotter i maternelle eksponeringer, der var fem gange højere end den humane eksponering, fra den sene drægtighedsperiode til og med den diegivende periode forårsagede nedsat overlevelse hos afkommet og nedsat reproduktionsevne hos afkom, der blev eksponeret for macitentan sent i fostertilværelsen og via mælken i dieperioden.
English: • Oedema (swelling), especially of the ankles and feet
Danish: • Ødem (hævelse), særligt på ankler og fødder
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, eller apoteket.
English: Sildenafil, a CYP3A4 substrate, did not affect the pharmacokinetics of macitentan, while there was a 15% reduction in the exposure to the active metabolite of macitentan.
Danish: Sildenafil, der er et CYP3A4-substrat, påvirkede ikke farmakokinetikken af macitentan, men der blev set en reduktion på 15 % i eksponeringen for den aktive metabolit af macitentan.
English: Opsumit can cause side effects such as headaches and hypotension (listed in section 4), and the symptoms of your condition can also make you less fit to drive.
Danish: Opsumit kan forårsage bivirkninger, såsom hovedpine og lavt blodtryk (anført i punkt 4), og de symptomer, du har i forbindelse med din sygdom, kan også nedsætte din evne til at føre motorkøretøj.
English: • carbamazepine (used to treat depression and epilepsy),
Danish: • carbamazepin (anvendes til behandling af depression og epilepsi),
English: Therefore Opsumit should be used with caution in this population (see section 4.4).
Danish: Opsumit bør derfor anvendes med forsigtighed i denne population (se pkt.
English: Page 6 (back)
Danish: Side 6 (bagside)
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger(kan påvirke mere end 1 ud af 10 brugere)
English: The pharmacokinetics of macitentan and its active metabolite have mainly been documented in healthy subjects.
Danish: Farmakokinetikken af macitentan og dets aktive metabolit er primært blevet dokumenteret hos raske forsøgsdeltagere.
English: Hypospermatogenesis was observed in the life-long carcinogenicity study in rats and in the repeatdose toxicity studies in dogs at exposures that provide safety margins of 9.7 in rats and 23 in dogs.
Danish: Der blev set hypospermatogenese i det livslange karcinogenicitetsstudie med rotter og i studiet af toksicitet efter gentagen administration hos hunde ved eksponeringer, der giver sikkerhedsmarginer på 9,7 hos rotter og 23 hos hunde.
English: • monthly pregnancy tests;
Danish: • månedlige graviditetstest:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg macitentan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 10 mg macitentan.
English: • rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
Danish: • rifampicin, clarithromycin, telithromycin (antibiotika, der anvendes til behandling af infektioner),
English: Morbiditymortality event b
Danish: Morbiditetsmortalitetshændelseb
English: Slightly increased pre- and post-implantation loss, decreased mean number of pups, and decreased testis and epididymis weights, were observed at exposures 7-fold the human exposure.
Danish: Der blev set et let forøget præ- og postimplantationstab, fald i gennemsnitligt antal unger og nedsat vægt af testis og epididymis ved eksponeringer, der var 7 gange højere end den humane eksponering.
English: The MAH shall ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Opsumit are provided with a Prescriber Kit containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle sundhedsfaglige personer, der skal ordinere og/eller udlevere Opsumit, har fået udleveret et ordinationssæt, der indeholder følgende, inden de ordinerer Opsumit:
English: Opsumit contains lecithin derived from soya.
Danish: Opsumit indeholder lecithin, der er udledt fra soja.
English: Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Danish: Der er rapporteret om tilfælde af lungeødemer i forbindelse med brug af vasodilatatorer (hovedsageligt prostacykliner) hos patienter med pulmonal veno-okklusiv sygdom.
English: This causes people to feel tired, dizzy, and short of breath.
Danish: Dette forårsager træthed, svimmelhed og åndenød.
English: For the treatment of pulmonary arterial hypertension
Danish: Til behandling af pulmonal arteriel hypertension
English: If you forget to take Opsumit
Danish: Hvis du har glemt at tage Opsumit
English: Macitentan induced minimal to slight mucosal hyperplasia and inflammatory infiltration in the submucosa of the nasal cavity in the mouse carcinogenicity study at all doses.
Danish: Macitentan forårsagede minimal til let slimhindehyperplasi og inflammatorisk infiltration i submucosa i næsehulen i alle doser i karcinogenicitetsstudierne med mus.
English: Cartons containing 1 bottle of 30 film-coated tablets.
Danish: Kartoner indeholdende 1 beholder med 30 filmovertrukne tabletter.
English: Logrank p-value
Danish: Logrankp-værdi
English: • Thrombocytopenia (decreased blood platelet counts)
Danish: • Trombocytopeni (nedsat antal blodplader)
English: A risk to the breastfeeding child cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko hos ammede børn.
English: Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells.
Danish: Macitentan udviser høj affinitet til og vedvarende okkupation af ET-receptorerne i cellerne i den glatte muskulatur i lungearterierne hos mennesker.
English: Nasal congestion1
Danish: Nasal obstruktion1
English: • Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 × ULN) (see sections 4.2 and 4.4).
Danish: • Leveraminotransferaseniveauer ved baseline (aspartataminotransferaser (ASAT) og/eller alaninaminotransferaser (ALAT) > 3 x ULN) (se pkt.
English: It is important that you report immediately to your prescribing doctor pregnancy or any side effects that may occur during treatment with Opsumit.
Danish: Det er vigtigt, at du omgående fortæller det til din læge, hvis du bliver gravid eller får bivirkninger under behandlingen med Opsumit
English: Elevations of liver aminotransferases (AST, ALT) have been associated with PAH and with endothelin receptor antagonists (ERAs).
Danish: Stigninger i leveraminotransferaser (ASAT, ALAT) er blevet forbundet med PAH og med endothelinreceptorantagonister (ERA'er).
English: Other medicines and Opsumit
Danish: Brug af anden medicin sammen med Opsumit
English: Exposure to macitentan in patients with PAH was approximately 1.2-fold greater than in healthy subjects.
Danish: Eksponeringen for macitentan hos patienter med PAH var cirka 1,2 gange højere end hos raske forsøgsdeltagere.
English: Opsumit must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (> 3 × ULN); see sections 4.3 and
Danish: Opsumit må ikke påbegyndes hos patienter med svær leverinsufficiens eller klinisk signifikant forhøjede leveraminotransferaser (over 3 gange den øvre normalgrænse (> 3 x ULN); se pkt.
English: Macitentan and its active metabolite do not have clinically relevant inhibitory or inducing effects on cytochrome P450 enzymes.
Danish: Macitentan og dets aktive metabolit har ingen klinisk relevante hæmmende eller inducerende effekterpå cytochrom P450-enzymer.
English: • itching of your skin
Danish: • Kløe i huden
English: prostanoid initiation n (%)
Danish: prostanoid n (%)
English: There is no clinically relevant effect of age, sex or ethnic origin on the pharmacokinetics of macitentan and its active metabolite.
Danish: Alder, køn og etnisk oprindelse har ingen klinisk relevant indvirkning på farmakokinetikken af macitentan og dets aktive metabolit.
English: • Nasal congestion (blocked nose)
Danish: • Nasal obstruktion (tilstoppet næse)
English: The pharmacokinetics of macitentan and its active metabolite were not affected by warfarin.
Danish: Farmakokinetikken af macitentan og dets aktive metabolit blev ikke påvirket af warfarin.
English: Do not use Opsumit after the expiry date which is stated on the carton, bottle and blister after “EXP”.
Danish: Brug ikke Opsumit efter den udløbsdato, der står på kartonen, beholdernog blisteren efter Exp.Udløbsdatoen er den sidste dag i den nævnte måned.
English: • ritonavir, saquinavir (used to treat HIV infections),
Danish: • ritonavir, saquinavir (anvendes til behandling af hiv-infektioner),
English: If you stop taking Opsumit
Danish: Hvis du holder om med at tage Opsumit
English: • Hypersensitivity to the active substance, soya or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof, soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON til BLISTER
English: The Patient Reminder Card for patients prescribed Opsumit should include the following key elements:
Danish: Patienthuskekortet til patienter, der får ordineret Opsumit, skal indeholde følgende nøgleelementer:
English: The benefit/risk balance of macitentan has not been established in patients with WHO class I functional status of pulmonary arterial hypertension.
Danish: Benefit/risk-forholdet af macitentan er ikke klarlagt hos patienter med pulmonal arteriel hypertension i WHO-funktionsklasse I.
English: LIST OF EXCIPIENTS Also contains lactose and soya bean lecithin (E322).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også lactose og sojalecithin (E322).
English: What you need to know before you take Opsumit
Danish: Det skal du vide, før du begynder at tage Opsumit
English: NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag Int
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Janssen-Cilag Int
English: Carcinogenicity studies of 2 years' duration did not reveal a carcinogenic potential at exposures 18fold and 116-fold the human exposure in rats and mice, respectively.
Danish: Karcinogenicitetsstudier af 2 års varighed viste intet karcinogent potentiale ved eksponeringer hos rotter og mus, der var hhv. 18 gange og 116 gange højere end eksponeringen hos mennesker.
English: The incidence of aminotransferase elevations (ALT/AST) > 3 × ULN was 3.4% on macitentan 10 mg and 4.5% on placebo in a double-blind study in patients with PAH.
Danish: Forekomsten af øgede aminotransferaser (ALAT/ASAT) > 3 x ULN var 3,4 % med macitentan 10 mg og 4,5 % med placebo i et dobbeltblindet studie med PAH-patienter.
English: Hypersensitivity reactions (e.g., angioedema, pruritus, rash)1
Danish: Overfølsomhedsreaktioner (f.eks. angioødem, pruritus, udslæt)
English: • fast heart rate, palpitations
Danish: • Hurtig puls, hjertebanken
English: In rats, macitentan and its metabolites are excreted into milk during lactation (see section 5.3).
Danish: Hos rotter udskilles macitentan og dets metabolitter i mælken under diegivning (se pkt.
English: Monthly pregnancy tests during treatment with Opsumit are recommended to allow the early detection of pregnancy.
Danish: Det anbefales at foretage månedlige graviditetstest under behandlingen med Opsumit, så eventuel graviditet kan konstateres så hurtigt som muligt.
English: Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Baseret på farmakokinetiske data er det ikke nødvendigt at justere dosis hos patienter med mild, moderat eller svær leverinsufficiens (se pkt.
English: No nasal cavity findings were noted in the 3-month mouse toxicity study or in rat and dog studies.
Danish: Der blev ikke set nogen effekter i næsehulen i musetoksicitetsstudiet af tre måneders varighed eller i rotte- og hundestudier.
English: 5 Haemoglobin
Danish: 5 Hæmoglobin
English: In vivo studies
Danish: In vivo-studier
English: Testicular tubular dilatation was observed in chronic toxicity studies with male rats and dogs with safety margins of 11.6 and 5.8, respectively.
Danish: Der blev set testikulær tubulær dilatation i kroniske toksicitetsstudier med hanrotter og -hunde med sikkerhedsmarginer på hhv. 11,6 og 5,8.
English: Use in women of childbearing potential
Danish: Brug hos kvinder i den fertile alder
English: Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Danish: Opsumit er indiceret som monoterapi eller i kombination med andre lægemidler til langvarig behandling af pulmonal arteriel hypertension (PAH) hos voksne patienter i WHO-funktionsklasse II eller III.
English: Caution should be exercised when macitentan is administered concomitantly with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir) (see section 4.5).
Danish: Der skal udvises forsigtighed ved samtidig administration af macitentan og stærke CYP3A4-hæmere (f.eks. itraconazol, ketoconazol, voriconazol, clarithromycin, telithromycin, nefazodon, ritonavir og saquinavir) (se pkt.
English: Exposure to macitentan and its active metabolite was increased by 1.3- and 1.6-fold, respectively, in patients with severe renal impairment.
Danish: Eksponeringen for macitentan og dets aktive metabolit var hhv. 1,3 og 1,6 gange højere hos patienter med svær nyreinsufficiens.
English: • flu-like syndrome (joint and muscle pain with fever)
Danish: • Influenzalignende syndrom (led- og muskelsmerter med feber)
English: In the period between end-of-treatment (EOT) and EOS, patients could receive open-label macitentan 10 mg or alternative PAH therapy.
Danish: I den periode, der lå imellem behandlingens afslutning og studiets afslutning, kunne patienterne få åben macitentan 10 mg eller anden PAH-behandling.
English: The exposure to the active metabolite in patients, which is approximately 5-fold less potent than macitentan, was approximately 1.3-fold higher than in healthy subjects.
Danish: Eksponeringen for den aktive metabolit, der er cirka 5 gange mindre potent end macitentan, var cirka 1,3 gange højere hos patienter end hos raske forsøgsdeltagere.
English: After 2 years of treatment, testicular tubular atrophy was seen in rats at 4-fold the human exposure.
Danish: Efter to års behandling blev der set testikulær tubulær atrofi hos rotter ved eksponeringer, der var 4 gange højere end eksponeringen hos mennesker.
English: Page 4 (inside centre)
Danish: Side 4 (indvendig midterside)
English: Polysorbate 80 (E433)
Danish: Magnesiumstearat (E572) Polysorbat 80 (E433)
English: • Bronchitis (inflammation of the airways)
Danish: • Bronkitis (betændelse i luftvejene)
English: Keep this leaflet.
Danish: Læs den nøje.
English: Outcome endpoints
Danish: Udfaldsrelaterede endepunkter
English: Ketoconazole: In the presence of ketoconazole 400 mg once daily, a strong CYP3A4 inhibitor, exposure to macitentan increased approximately 2-fold.
Danish: Ketoconazol: Ved brug af 400 mg ketoconazol, der er en stærk CYP3A4-hæmmer, én gang dagligt steg eksponeringen for macitentan ca. to gange.
English: You need to use a reliable form of birth control (contraception) while you are taking Opsumit.
Danish: Du skal anvende en sikker præventionsmetode (kontraception), så længe du tager Opsumit.
English: Strong CYP3A4 inducers: Concomitant treatment with rifampicin 600 mg daily, a potent inducer of CYP3A4, reduced the steady-state exposure to macitentan by 79% but did not affect the exposure to the active metabolite.
Danish: Stærke CYP3A4-induktorer: Samtidig behandling med rifampicin (potent CYP3A4-induktor) 600 mg dagligt reducerede steady-state-eksponeringen for macitentan med 79 % men påvirkede ikke eksponeringen for den aktive metabolit.
English: Macitentan 10 mg (N = 242)
Danish: Placebo (N = 250) Macitentan1 0 mg (N = 242)
English: The cytochrome P450 enzymes CYP3A4, CYP2C8, CYP2C9, and CYP2C19 are involved in the metabolism of macitentan and formation of its metabolites (see section 5.2).
Danish: Cytochrom P450-enzymerne CYP3A4, CYP2C8, CYP2C9 og CYP2C19 er involveret i metabolismen af macitentan og dannelsen af dets metabolitter (se pkt.
English: The development of testicular tubular atrophy in male animals was observed after treatment with macitentan (see section 5.3).
Danish: Der er set udvikling af testikulær tubulær atrofi hos handyr efter behandling med macitentan (se pkt.