FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not give this medicine to children and adolescents below 18 years because Opsumit has not been tested in children.
Danish: Børn og unge Giv ikke dette lægemiddel til børn og unge under 18 år, da Opsumit ikke er blevet undersøgt hos børn.
English: 4.6 Fertility, pregnancy, and lactation
Danish: 4.6 Fertilitet, graviditet og amning
English: Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of effects such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation.
Danish: Endothelin (ET)-1 og dets receptorer (ETA og ETB) medierer en række virkninger, såsom vasokonstriktion, fibrose, proliferation, hypertrofi og inflammation.
English: PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries).
Danish: PAH er højt blodtryk i de blodkar, der transporterer blodet fra hjertet til lungerne (lungearterierne).
English: The Healthcare Professionals brochure should contain the following key elements:
Danish: Brochuren til sundhedspersonale skal indeholde følgende nøgleelementer:
English: This lowers the blood pressure, relieves the symptoms and improves the course of the disease.
Danish: Det får blodtrykket til at falde, lindrer symptomerne og forbedrer sygdomsforløbet.
English: In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage.
Danish: Ved sygdomstilstande såsom PAH er det lokale ET-system opreguleret og involveret i vaskulær hypertrofi og organbeskadigelse.
English: Your doctor may perform additional tests, and will determine what treatment regimen is most suitable for you.
Danish: Din læge vil eventuelt foretage yderligere test og bestemme, hvilken behandling der er bedst for dig.
English: Worsening of PAH n (%) i.v./s.c.
Danish: Forværring af PAH n (%) indledning af i.v./s.c.
English: The safety of macitentan has been evaluated in a long-term placebo-controlled trial of 742 patients with symptomatic PAH.
Danish: Sikkerheden af macitentan er blevet vurderet i et langvarigt placebokontrolleret forsøg med 742 patienter med symptomatisk PAH.
English: • That patients should be capable of complying with the requirements for the safe use of Opsumit;
Danish: • Patienterne skal være i stand til at overholde kravene til sikker brug af Opsumit;
English: • Healthcare Professional brochure containing information about Opsumit;
Danish: • Brochure til sundhedspersonale indeholdende information om Opsumit;
English: It is unknown whether macitentan is excreted in human milk.
Danish: Det er ukendt, om macitentan udskilles i human mælk.
English: • whether your liver is working properly
Danish: • Om din lever fungerer korrekt
English: How to take Opsumit 4.
Danish: Sådan skal du tage Opsumit 4.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 ℃.
English: After repeated administration, the pharmacokinetics of macitentan are dose-proportional up to and including 30 mg.
Danish: Efter gentagen administration er farmakokinetikken af macitentan dosisproportionel til og med 30 mg.
English: • The need for regular monitoring of liver function because Opsumit has hepatotoxic potential.
Danish: • Behovet for regelmæssig monitorering af leverfunktionen, fordi Opsumit har hepatotoksisk potentiale.
English: White, opaque PVC/PE/PVdC/Aluminium blisters in cartons containing 15 or 30 film-coated tablets.
Danish: Hvide, uigennemsigtige PVC-/PE-/PVdC-/alublister i kartoner indeholdende 15 eller 30 filmovertrukne tabletter.
English: Leukopenia6
Danish: Leukopeni6
English: It is not known if Opsumit is transferred to breast milk.
Danish: Det vides ikke, om Opsumit overføres til modermælken.
English: Opsumit is a registered trademark of Actelion Pharmaceuticals Ltd
Danish: Opsumit er et registreret varemærke, der tilhører Actelion Pharmaceuticals Ltd
English: • dark-coloured urine
Danish: • Mørkfarvet urin
English: Your doctor will take blood test before you start treatment with Opsumit and during treatment to test:
Danish: Lægen vil tage nogle blodprøver, før du starter behandlingen med Opsumit og under behandlingen, for at kontrollere:
English: No testicular findings were noted in mice after treatment up to 2 years.
Danish: Der blev ikke noteret testikulære påvirkninger hos mus efter behandling af op til 2 års varighed.
English: The Prescribing Checklist should remind prescribers of the contraindications, warnings and precautions as well as the following key elements:
Danish: Ordinationstjeklisten skal minde ordinerende læger om kontraindikationer, advarsler og forsigtighedsregler samt følgende nøgleelementer:
English: If you are allergic to soya, do not use this medicine (see section 2 ‘Do not take Opsumit').
Danish: Hvis du er allergisk over for soja, må du ikke bruge dette lægemiddel (se afsnit 2 'Tag ikke Opsumit').
English: Patients with renal impairment may run a higher risk of experiencing hypotension and anaemia during treatment with macitentan.
Danish: Patienter med nyreinsufficiens kan have større risiko for at opleve hypotension og anæmi under behandlingen med macitentan.
English: • The need for regular blood tests because Opsumit causes a decrease in haemoglobin;
Danish: • Behovet for regelmæssige blodprøver, fordi Opsumit forårsager et fald i hæmoglobin;
English: • To provide patients with appropriate information regarding the safe use of the product;
Danish: • At give patienterne tilstrækkelig information vedrørende sikker brug af lægemidlet;
English: a = based on Cox's Proportional Hazards Model b = % of patients with an event at 36 months = 100 × (1 - KM estimate) c= all cause death up to EOT regardless of prior worsening
Danish: a = baseret på Cox' proportionelle risikomodel b = % af patienter med en hændelse efter 36 måneder = 100 × (1 - KM-estimat) c= dødsfald af enhver årsag indtil behandlingens afslutning uanset tidligere forværring
English: The predicted increase was approximately 3fold in the presence of ketoconazole 200 mg twice daily using physiologically based pharmacokinetic (PBPK) modelling.
Danish: Den forventede stigning var cirka tre gange højere ved administration af ketoconazol 200 mg to gange dagligt ved brug af en fysiologisk baseret farmakokinetisk (PBPK) model.
English: Like other medicines of this class, Opsumit can induce anaemia (a reduced number of red blood cells) and can have effects on the liver.
Danish: Ligesom andre lægemidler i denne klasse kan Opsumit forårsage blodmangel (nedsat antal røde blodlegemer) og virkninger på leveren.
English: Oxidative depropylation of the sulfamide yields a pharmacologically active metabolite.
Danish: Oxidativ depropylering af sulfamidet frembringer en farmakologisk aktiv metabolit.
English: • Patients with severe hepatic impairment (with or without cirrhosis) (see section 4.2).
Danish: • Patienter med svær leverinsufficiens (med eller uden cirrose) (se pkt.
English: Pharmacotherapeutic group: anti-hypertensives, anti-hypertensives for pulmonary arterial hypertension.
Danish: Farmakoterapeutisk klassifikation: antihypertensiva, antihypertensiva til pulmonal arteriel hypertension.
English: whether your liver is working properly
Danish: om din lever fungerer korrekt
English: In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them.
Danish: Hos personer, der har PAH, bliver disse arterier smallere, så hjertet skal arbejde hårdere for at pumpe blod igennem dem.
English: See section ‘Pregnancy and breastfeeding'.
Danish: Se afsnittet 'Graviditet og amning'.
English: Opsumit contains the active substance macitentan, which belongs to the class of medicines called “endothelin receptor antagonists”.
Danish: Opsumit indeholder det aktive stof macitentan, der tilhører en gruppe af lægemidler, der kaldes ”endothelinreceptorantagonister”.
English: Due to the high degree of protein binding of macitentan, dialysis is unlikely to be effective.
Danish: Da macitentan har en høj proteinbindingsgrad er dialyse sandsynligvis uden virkning.
English: You should have a pregnancy test before initiation of Opsumit and every month during treatment even if you think that you are not pregnant.
Danish: Du skal have taget en graviditetstest, inden du begynder at tage Opsumit, og hver måned under behandlingen, også selvom du ikke mener, at du er gravid.
English: • fatigue/malaise/weakness
Danish: • Træthed/utilpashed/svaghed
English: • ketoconazole (except shampoo), itraconazole, voriconazole (medicines used against fungal infections)
Danish: • ketoconazol (undtagen shampoo), itraconazol, voriconazol (lægemidler, der anvendes mod svampeinfektioner)
English: Intimal thickening of coronary arteries was observed at 17-fold the human exposure after 4 to 39 weeks of treatment.
Danish: Der blev set intimafortykkelse af koronararterierne ved eksponeringer, der var 17 gange højere end eksponeringen hos mennesker, efter 4 til 39 ugers behandling.
English: The most commonly reported adverse reactions are nasopharyngitis (14%), headache (13.6%) and anaemia (13.2%, see section 4.4).
Danish: De hyppigst indberettede bivirkninger er nasofaryngitis (14 %), hovedpine (13,6 %) og anæmi (13,2 %, se pkt.
English: Patients should be monitored for signs of hepatic injury and monthly monitoring of ALT and AST is recommended.
Danish: Patienter bør monitoreres for tegn på leverskade, og det anbefales at kontrollere ALAT og ASAT en gang om måneden.
English: Treatment of juvenile rats from postnatal Day 4 to Day 114 caused reduced body weight gain leading to secondary effects on development (slight delay of descensus testis, reversible reduction of long-bone length, prolonged estrous cycle).
Danish: Behandling af unge rotter fra dag 4 til dag 114 efter fødslen forårsagede nedsat legemsvægtøgning, der medførte sekundære virkninger på udviklingen (let forsinket descensus testium, reversibel reduktion af længden af os longum, forlænget østruscyklus).
English: Opsumit should only be prescribed by a doctor experienced in the treatment of pulmonary arterial hypertension.
Danish: Opsumit bør kun ordineres af en læge med erfaring i behandling af pulmonal arteriel hypertension.
English: Macitentan was teratogenic in rabbits and rats at all doses tested.
Danish: Macitentan var teratogent hos kaniner og rotter i alle afprøvede doser.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: • To provide patients with the patient card;
Danish: • At udlevere patientkortet til patienterne;
English: INFORMATION IN BRAILLE Opsumit 10 mg
Danish: INFORMATION I BRAILLESKRIFT Opsumit 10 mg
English: The mean treatment duration was 103.9 weeks in the macitentan 10 mg group, and 85.3 weeks in the placebo group.
Danish: Den gennemsnitlige behandlingsvarighed var 103,9 uger i den gruppe, der fik macitentan 10 mg, og 85,3 uger i placebogruppen.
English: In dogs, macitentan decreased blood pressure at exposures similar to the therapeutic human exposure.
Danish: Hos hunde sænkede macitentan blodtrykket ved eksponeringer, der svarede til den terapeutiske eksponering hos mennesker.
English: You can take Opsumit with or without food.
Danish: Du kan tage Opsumit sammen med eller uden mad.
English: Liver enzyme tests should be obtained prior to initiation of Opsumit.
Danish: Der skal indhentes leverenzymprøver inden indledning af Opsumit.
English: Macitentan was not phototoxic in vivo after single dose at exposures of up to 24-fold the human exposure.
Danish: Macitentan var ikke fototoksisk in vivo efter enkeltdosering ved eksponeringer, der var op til 24 gange højere end eksponeringen hos mennesker.
English: If you have anaemia (a reduced number of red blood cells), you may have the following signs:
Danish: Hvis du har blodmangel (nedsat antal røde blodlegemer), kan du have følgende tegn:
English: However, undesirable effects may occur (e.g., headache, hypotension) that may influence the ability to drive and use machines (see section
Danish: Der kan imidlertid forekomme bivirkninger (f.eks. hovedpine og hypotension), som kan påvirke evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: The mean age of all patients was 46 years (range 12-85 years of age, including 20 patients below 18, 706 patients between 18-74 years, and 16 patients aged 75 and older) with the majority of subjects being Caucasian (55%) and female (77%).
Danish: Den gennemsnitlige alder af samtlige patienter var 46 år (aldersområde: 12-85 år, herunder 20 patienter under 18 år, 706 patienter i alderen 18-74 år og 16 patienter på 75 år eller derover), og størstedelen af forsøgsdeltagerne var kaukasere (55 %) og kvinder (77 %).
English: Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean lecithin (E322).
Danish: Hver filmovertrukken tablet indeholder cirka 37 mg lactose (som monohydrat) og cirka 0,06 mg sojalecithin (E322).
English: In patients with pulmonary veno-occlusive disease (obstruction of the lung veins), the use of medicines for treatment of PAH, including Opsumit, may lead to pulmonary oedema.
Danish: Hos patienter med pulmonal venookklusiv sygdom (tilstopning af lungevenerne) kan brug af lægemidler til behandling af PAH, herunder Opsumit, medføre lungeødem.
English: At 36 months, 44.6% of patients on placebo and 29.4% of patients on macitentan 10 mg (Absolute Risk Reduction = 15.2%) had been hospitalised for PAH or died from a PAH-related cause.
Danish: Efter 36 måneder havde 44,6 % af patienterne på placebo og 29,4 % af patienterne på macitentan 10 mg (absolut risikoreduktion = 15,2 %) været indlagt for PAH eller var døde af PAH-relateret årsag.
English: The pharmacodynamic effect of warfarin on International Normalised Ratio (INR) was not affected by macitentan.
Danish: Den farmakodynamiske effektaf warfarin på INR (international normaliseret ratio) blev ikke påvirket af macitentan.
English: If sustained, unexplained, clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin > 2 × ULN, or by clinical symptoms of liver injury (e.g., jaundice), Opsumit treatment should be discontinued.
Danish: Hvis der opstår vedvarende, uforklarlige, klinisk relevante stigninger i aminotransferaseniveauerne, eller hvis stigninger er ledsaget af en stigning i bilirubin > 2 x ULN eller af kliniske symptomer på leverskade (f.eks. ikterus), skal behandlingen med Opsumit seponeres.
English: Sildenafil: At steady-state, the exposure to sildenafil 20 mg three times a day was increased by 15% during concomitant administration of macitentan 10 mg once daily.
Danish: Sildenafil: Ved steady-state var eksponeringen for sildenafil 20 mg tre gange dagligt øget med 15 % ved samtidig administration af macitentan 10 mg én gang dagligt.
English: This reaction is dependent on the cytochrome P450 system, mainly CYP3A4 (approximately 99%) with minor contributions of CYP2C8, CYP2C9 and CYP2C19.
Danish: Denne reaktion er afhængig af cytochrom P450-systemet, hovedsageligt CYP3A4 (ca. 99 %) med mindre bidrag fra CYP2C8, CYP2C9 og CYP2C19.
English: They may be taken with or without food.
Danish: De kan tages sammen med eller uden føde.
English: No dose adjustment is required in patients over the age of 65 years (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter over 65 år (se pkt.
English: This prevents endothelin-mediated activation of second messenger systems that result in vasoconstriction and smooth muscle cell proliferation.
Danish: Dette forhindrer endothelinmedieret aktivering af sekundære beskedsystemer, der resulterer i vasokonstriktion og proliferation af glatte muskelceller.
English: Opsumit is supplied as 10 mg film-coated tablets in blister packs of 15 or 30 tablets, or in bottles of 30 tablets.
Danish: Opsumit leveres som 10 mg filmovertrukne tabletter i blisterpakninger med 15eller 30 tabletter eller i beholder med 30 tabletter.
English: Increased liver weight and hepatocellular hypertrophy were observed in mice, rats and dogs after treatment with macitentan.
Danish: Der blev set øget levervægt og hepatocellulær hypertrofi hos mus, rotter og hunde efter behandling med macitentan.
English: Idiopathic or heritable PAH was the most common aetiology in the study population (57%), followed by PAH due to connective tissue disorders (31%), PAH associated with corrected simple congenital heart disease (8%), and PAH associated with other aetiologies (medicinal products and toxins [3%] and HIV [1%]).
Danish: Idiopatisk eller hereditær PAH var den mest almindelige ætiologi i studiepopulationen (57 %) efterfulgt af PAH på grund af bindevævssygdom (31 %), PAH forbundet med korrigeret simpel kongenit hjertesygdom (8 %) og PAH forbundet med andre ætiologier (lægemidler og toksiner [3 %] og hiv [1 %]).
English: • regular monitoring of liver function;
Danish: • regelmæssig monitorering af leverfunktion;
English: Macitentan is only excreted after extensive metabolism.
Danish: Macitentan udskilles først efter omfattende metabolisering.
English: The effect of macitentan on human male fertility is not known (section 4.6).
Danish: Effekten af macitentan på den mandlige fertilitet hos mennesker kendes ikke (pkt.
English: A multicenter, double-blind, placebo-controlled, parallel-group, event-driven, Phase 3 outcome study (AC-055-302/SERAPHIN) was conducted in 742 patients with symptomatic PAH, who were randomised to three treatment groups (placebo [N = 250], 3 mg [N = 250] or 10 mg [N = 242] of macitentan once daily), to assess the long-term effect on morbidity or mortality.
Danish: Et dobbeltblindet, placebokontrolleret, hændelsesstyret, udfaldsstudie i fase III udført på flere centre ('multicenter') og med parallelgrupper (AC-055-302/SERAPHIN) inkluderede i alt 742 patienter med symptomatisk PAH, der blev randomiseret til tre behandlingsgrupper (placebo [N = 250], 3 mg [N = 250] eller 10 mg [N = 242] macitentan én gang dagligt), med henblik på at vurdere den langsigtede virkning på morbiditet og mortalitet.
English: Hormonal contraceptives: Macitentan 10 mg once daily did not affect the pharmacokinetics of an oral contraceptive (norethisterone 1 mg and ethinyl estradiol 35 µg).
Danish: Hormonelle antikonceptiva: Macitentan 10 mg én gang dagligt påvirkede ikke farmakokinetikken af et oralt antikonceptivum (norethisteron 1 mg og ethinylestradiol 35 µg).
English: Macitentan is an orally active potent endothelin receptor antagonist, active on both ETA and ETB receptors and approximately 100-fold more selective for ETA as compared to ETB in vitro.
Danish: Macitentan er en oralt aktiv, potent endothelinreceptorantagonist med virkning på både ETA- og ETB-receptorer og cirka 100 gange mere selektiv over for ETA end over for ETBin vitro.
English: Macitentan and its active metabolite are highly bound to plasma proteins (> 99%), primarily to albumin and to a lesser extent to alpha1-acid glycoprotein.
Danish: Macitentan og dets aktive metabolit bindes i høj grad til plasmaproteiner (99 %), primært til albumin og i mindre omfang til alfa1-surt glykoprotein.
English: In both species there were cardiovascular and mandibular arch fusion abnormalities.
Danish: Hos begge arter blev der set kardiovaskulære abnormiteter og fusion af arcus mandibularis.
English: All patients were followed up to end-of-study (EOS) for vital status.
Danish: Alle patienter blev fulgt med henblik på vital status indtil studiets afslutning.
English: The safety and efficacy of macitentan in children and adolescents below 18 years have not yet been established.
Danish: Sikkerhed og effektaf macitentan hos børn og unge under 18 år er endnu ikke klarlagt.
English: Talk to your doctor or pharmacist before taking Opsumit.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Opsumit.
English: Other worsening of PAH was defined as the presence of all of the three following components: a sustained decrease in 6-minute walk distance (6MWD) of at least 15% from baseline; worsening of PAH symptoms (worsening of WHO FC or right heart failure); and need for new treatment for PAH.
Danish: Anden forværring af PAH var defineret som forekomst af alle tre af følgende komponenter: et vedvarende fald i 6-minutters gangdistance (6MWD) på mindst 15 % i forhold til udgangsværdien, forværring af PAH-symptomer (forværring af WHO-funktionsklasse eller højresidigt hjertesvigt) og behov for ny behandling mod PAH.
English: Macitentan inhibits the breast cancer resistance protein (BCRP) at clinically relevant intestinal concentrations.
Danish: Macitentan hæmmer det brystcancerresistente protein (BCRP) ved klinisk relevante intestinale koncentrationer.
English: • If you become pregnant or think that you may be pregnant while you are taking Opsumit, or shortly after stopping Opsumit (up to 1 month), see your doctor immediately.
Danish: • Hvis du bliver gravid, eller får mistanke om, at du er gravid, mens du er i behandling med Opsumit, eller kort tid efter du er stoppet med at tage Opsumit (op til 1 måned), skal du straks kontakte lægen.
English: Macitentan and its active metabolite ACT-132577 are well distributed into tissues as indicated by an apparent volume of distribution (Vss/F) of approximately 50 L and 40 L for macitentan and ACT-132577, respectively.
Danish: Macitentan og dets aktive metabolit, ACT-132577, fordeles godt til vævene, hvilket viser sig ved et tilsyneladende fordelingsvolumen (Fss/F) af macitentan og ACT-132577 på hhv. cirka 50 l og 40 l.
English: Treatment comparison: macitentan 10 mg vs placebo
Danish: Behandlingssammenligning: macitentan 10 mg vs. placebo
English: The European Medicines Agency has deferred the obligation to submit the results of studies with macitentan in all subsets of the paediatric population for PAH (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med macitentani alle undergrupper af den pædiatriske population med PAH (se pkt.
English: If a patient is hypersensitive to soya, Opsumit must not be used (see section 4.3).
Danish: Hvis en patient er overfølsom over for soja, må Opsumit ikke anvendes (se pkt.
English: It is recommended that haemoglobin concentrations be measured prior to initiation of treatment and tests repeated during treatment as clinically indicated.
Danish: Det anbefales at måle hæmoglobinkoncentrationerne før indledning af behandlingen og at gentage sådanne målinger efter klinisk behov under behandlingen.
English: Adverse reactions associated with macitentan obtained from this clinical study are tabulated below.
Danish: Bivirkninger forbundet med macitentan i dette kliniske studie er angivet i tabellen nedenfor.
English: In a placebo-controlled trial in patients with PAH, the efficacy and safety of macitentan in combination with sildenafil were demonstrated.
Danish: I et placebokontrolleret forsøg med patienter med PAH blev der påvist effektog sikkerhed af macitentan i kombination med sildenafil.
English: • The need for baseline and monthly pregnancy tests and monitoring of haemoglobin levels and liver function.
Danish: • Behovet for graviditetstest inden behandlingen og månedligt under behandlingen og for monitorering af hæmoglobinniveauer og leverfunktion.
English: Haemodynamic parameters were assessed in a subset of patients (placebo [N = 67], macitentan 10 mg [N = 57]) after 6 months of treatment.
Danish: Der blev foretaget en vurdering af hæmodynamiske parametre i en undergruppe af patienter (placebo [N = 67], macitentan 10 mg [N = 57] efter 6 måneders behandling.
English: Opsumit widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Danish: Opsumit udvider lungearterierne, så det bliver nemmere for hjertet at pumpe blod igennem dem.