FrancophonIA/ELRC3.0 huggingface dataset:
English: A 2-year carcinogenicity study in mice showed an increased combined incidence of hepatocellular adenomas and carcinomas in males, but not in females, at plasma concentrations about 2 to 4 times the plasma concentrations achieved at the therapeutic dose in humans.
Danish: En 2-årig karcinogenicitetsundersøgelse med mus viste en øget kombineret forekomst af hepatocellulære adenomer og karcinomer hos hanmus, men ikke hos hunmus, ved plasmakoncentrationer på ca. 2 til 4 gange de plasmakoncentrationer, der blev opnået ved den terapeutiske dosis hos mennesker.
English: In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
Danish: I et randomiseret, placebokontrolleret studie udført hos PPHN-patienter (FUTURE-4) blev i alt 13 nyfødte behandlet med bosentan dispergible tabletter i en dosis på 2 mg/kg to gange dagligt (8 patienter fik placebo).
English: In this open-label randomised study with the bosentan 32 mg dispersible tablet formulation, 64 children with stable PAH from 3 months to 11 years of age were randomised to 24 weeks' bosentan treatment 2 mg/kg twice daily (n = 33) or 2 mg/kg three times daily (n = 31).
Danish: I dette åbne, randomiserede studie med bosentan 32 mg dispergible tabletter blev 64 børn med stabil PAH i alderen 3 måneder til 11 år randomiseret til 24 ugers behandling med bosentan 2 mg/kg to gange dagligt (n=33) eller 2 mg/kg tre gange dagligt (n=31).
English: Lopinavir+ritonavir (and other ritonavir-boosted protease inhibitors): Co-administration of bosentan 125 mg twice daily and lopinavir+ritonavir 400+100 mg twice daily for 9.5 days in healthy volunteers resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after bosentan administered alone.
Danish: Lopinavir+ritonavir (og andre ritonavir-boostede proteaseinhibitorer): Samtidig administration af bosentan 125 mg to gange dagligt og lopinavir+ritonavir 400 +100 mg to gange dagligt i 9,5 dage til raske forsøgspersoner medførte initiale dalkoncentrationer af bosentan, som var omtrent 48 gange højere end de koncentrationer, der blev målt efter administration af bosentan alene.
English: In the 20 integrated placebo-controlled studies, elevations in liver aminotransferases ≥ 3 ×ULN were observed in 11.2% of the bosentan-treated patients as compared to 2.4% of the placebo-treated patients.
Danish: I de 20 integrerede placebokontrollerede undersøgelser blev der iagttaget stigninger i leveraminotransferaser > 3 x ULN hos 11,2% af de patienter, der fik bosentan mod 2,4% af de patienter, der fik placebo.
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance dose studied in both these studies was 125 mg twice daily.
Danish: Efter 4 ugers behandling med bosentan 62,5 mg to gange dagligt var vedligeholdelsesdosis i begge studier 125 mg to gange dagligt.
English: Inside your pack of STAYVEER tablets you will find a Patient Alert Card. You should complete this card and take it to your doctor at your next visit so that your doctor or gynaecologist can assess whether you need additional or alternative reliable contraceptive methods.
Danish: De skal udfylde dette kort og medbringe det ved Deres næste konsultation, således at lægen eller gynækologen kan vurdere, om De har brug for en supplerende eller anden form for pålidelig prævention.
English: No dose adjustment is required in patients with renal impairment.
Danish: Der kræves ingen dosisjustering hos patienter med nedsat nyrefunktion.
English: Treatment and monitoring recommendations
Danish: ALAT/ASAT-niveauer Behandlings- og monitoreringsrekommandationer
English: Study AC-052-356 (BREATHE-3) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with PAH who were dosed on the basis of body weight with 2 mg/kg twice daily.
Danish: I studie AC-052-356 (BREATHE-3) blev farmakokinetikken af oral enkeltdosis og gentagne doser bosentan som filmovertrukne tabletter undersøgt hos 19 børn i alderen fra 3 til 15 år med PAH, som fik en vægtbaseret dosis på 2 mg/kg to gange dagligt.
English: STAYVEER 125 mg film-coated tablets EU/1/13/832/002
Danish: STAYVEER 125 mg filmovertrukne tabletter EU/1/02/220/002
English: No clinically relevant differences in adverse reactions were observed between the overall dataset and the approved indications.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er. Der blev ikke observeret klinisk relevante forskelle i bivirkningerne i de samlede data i forhold til de godkendte indikationer.
English: Therefore, hormonebased contraceptives alone, regardless of the route of administration (i.e., oral, injectable, transdermal or implantable forms), are not considered as reliable methods of contraception (see sections 4.4 and
Danish: Derfor er hormonelle præventionsmetoder alene, uanset administrationsmetoden (dvs. orale, injicérbare, transkutane eller implantable former), ikke anvendelige som pålidelige præventionsmetoder (se pkt.
English: Some patients taking STAYVEER were found to have abnormal liver function tests.
Danish: Nogle patienter, der er i behandling med STAYVEER, har unormale leverfunktions-værdier.
English: 56 film-coated tablets 112 film-coated tablets
Danish: 56 filmovertrukne tabletter 112 filmovertrukne tabletter
English: Of the 22 patients stable at week 8, 6 improved at week 12/16 and 4 deteriorated compared with baseline.
Danish: Ud af de 22 patienter, der var stabiliseret i uge 8, viste 6 forbedringer i uge 12/16, og 4 havde dårligere resultater sammenlignet med udgangspunktet.
English: After an increase in dose, an additional test will be done after 2 weeks.
Danish: Hvis dosis øges, skal De yderligere have foretaget en prøve efter 14 dage.
English: STAYVEER is contraindicated in patients with moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 4.3).
Danish: STAYVEER er kontraindiceret til patienter med moderat til svær leverinsufficiens, dvs. Child-Pugh klasse B eller C (se pkt.
English: Package leaflet: Information for the user STAYVEER 62.5 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren STAYVEER 62,5 mg filmovertrukne tabletter
English: In a prospective, multi-centre, randomised, double-blind, placebo-controlled study (AC-052-405 [BREATHE-5]), patients with PAH WHO functional class III and Eisenmenger physiology associated with congenital heart disease received bosentan 62.5 mg twice daily for 4 weeks, then 125 mg twice daily for a further 12 weeks (n = 37, of whom 31 had a predominantly right to left, bidirectional shunt).
Danish: I et prospektivt multicenter, randomiseret, dobbelblindt, placebokontrolleret studie (AC-052-405 [BREATHE-5]) fik patienter med PAH WHO funktionsklasse III og Eisenmenger fysiologi associeret med kongenit hjertesygdom bosentan 62,5 mg to gange dagligt i 4 uger, herefter 125 mg to gange dagligt i yderligere 12 uger (n = 37, af hvilke 31 havde en overvejende højre mod venstre tovejs-shunt).
English: Package leaflet: Information for the user STAYVEER 125 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren STAYVEER 125 mg filmovertrukne tabletter
English: STAYVEER is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease.
Danish: STAYVEER anbefales ikke til pædiatriske patienter med systemisk sklerose og aktiv finger/tå-sårssygdom.
English: Warfarin: Co-administration of bosentan 500 mg twice daily for 6 days decreased the plasma concentrations of both S-warfarin (a CYP2C9 substrate) and R-warfarin (a CYP3A4 substrate) by 29% and 38%, respectively.
Danish: Warfarin: Ved samtidig administration af bosentan 500 mg to gange dagligt i 6 dage faldt plasmakoncentrationen af både S-warfarin (et CYP2C9-substrat) og R-warfarin (et CYP3A4-substrat) med henholdsvis 29% og 38%.
English: How to take STAYVEER.
Danish: Sådan skal De tage STAYVEER.
English: Patients were treated with bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily for a further 12 weeks.
Danish: Patienterne blev behandlet med bosentan 62,5 mg to gange dagligt i 4 uger efterfulgt af 125 mg to gange dagligt i yderligere 12 uger.
English: A Patient Alert Card providing important safety information that patients need to be aware of before and during treatment with STAYVEER is included in the pack.
Danish: Pakningen indeholder et patientadvarselskort med vigtig sikkerhedsinformation, som patienten skal være opmærksom på før og under behandlingen med STAYVEER.
English: PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Danish: PVC/PE/PVDC/aluminium-blistre indeholdende 14 filmovertrukne tabletter.
English: OUTER CARTON/BLISTERS
Danish: UDVENDIG ÆSKE/BLISTRE
English: • Hypersensitivity reactions (including skin inflammation, itching and rash)
Danish: • Overfølsomhedsreaktioner (herunder hudirritation, kløe og udslæt)
English: In a randomised, double-blind, multi-centre, placebo-controlled study (AC-052-364 [EARLY]), 185 PAH patients in WHO functional class II (mean baseline 6-minute walk distance of 435 metres) received bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily (n = 93), or placebo (n = 92) for 6 months.
Danish: I et randomiseret, dobbeltblindt, multi-center, placebokontrolleret studie (AC-052-364 [EARLY]), 185 PAH fik patienter i WHO funktionsklasse II (gennemsnitlig baseline 435 meter i 6 minutters gangdistance) 62,5 mg bosentan to gange dagligt i 4 uger efterfulgt af 125 mg to gange dagligt (n = 93) eller placebo (n = 92) i 6 måneder.
English: Sildenafil: Co-administration of bosentan 125 mg twice daily (steady state) with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease in the sildenafil AUC and a 50% increase in the bosentan AUC.
Danish: Sildenafil: Samtidig administration af bosentan 125 mg to gange dagligt (steady-state) og sildenafil 80 mg tre gange dagligt (ved steady-state) i 6 dage til raske forsøgspersoner resulterede i en reduktion i sildenafils AUC på 63% og en stigning i bosentans AUC på 50%.
English: Pulmonary arterial hypertension patients with concomitant left ventricular failure
Danish: Patienter med pulmonal arteriel hypertension med samtidig dysfunktion af venstre ventrikel
English: 3 Headache was reported in 11.5% of patients on bosentan and 9.8% of patients on placebo.
Danish: 3 Hovedpine blev rapporteret hos 11,5% af patienterne behandlet med bosentan og 9,8% af patienterne behandlet med placebo.
English: Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 122 (study AC-052-401 [RAPIDS-1]) and 190 (study AC-052-331 [RAPIDS-2]) adult patients with systemic sclerosis and digital ulcer disease (either ongoing digital ulcers or a history of digital ulcers within the previous year).
Danish: Der er udført to randomiserede, dobbeltblinde, multicenter, placebokontrollerede studier med henholdsvis 122 (studie AC-052-401 [RAPIDS-1]) og 190 (studie AC-052-331 [RAPIDS-2]) voksne patienter med systemisk sklerose og fingersårssygdom (enten akutte fingersår eller fingersår i anamnesen inden for det foregående år).
English: Concomitant use of STAYVEER and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Danish: Samtidig anvendelse af STAYVEER og ciclosporin A er kontraindiceret (se pkt.
English: In the patients above 2 years (n = 22) the daily exposure was 8,820 ng·h/mL; AUCτ was 4,410 ng·h/mL (CV: 58%).
Danish: Hos patienterne over 2 år (n=22) var den daglige eksponering 8.820 ng·t/ml; AUCτ var 4.410 ng·t/ml (CV 58%).
English: Abnormal liver function test (see section 4.4)
Danish: Unormal leverfunktionstest (se pkt.
English: For white high-density polyethylene bottles, use within 30 days after the first opening.
Danish: For hvide polyethylenflasker af høj densitet, skal det anvendes inden for 30 dage efter anbrud.
English: 4 years For white high-density polyethylene bottles, use within 30 days after the first opening.
Danish: 4 år For hvide polyethylenflasker af høj densitet skal indholdet anvendes inden for 30 dage efter anbrud.
English: A pooled analysis of uncontrolled paediatric studies conducted in PAH with the bosentan 32 mg dispersible tablet formulation (FUTURE 1/2, FUTURE 3/Extension) included a total of 100 children treated with bosentan 2 mg/kg twice daily (n = 33), 2 mg/kg three times daily (n = 31), or 4 mg/kg twice daily (n = 36).
Danish: En samlet analyse af ikke-kontrollerede pædiatriske studier udført hos PAH-patienter med bosentan 32 mg dispergible tabletter (FUTURE 1/2, FUTURE 3/forlængelse) omfattede i alt 100 børn, der blev behandlet med bosentan 2 mg/kg to gange dagligt (n=33), 2 mg/kg tre gange dagligt (n=31) eller 4 mg/kg to gange dagligt (n=36).
English: Your doctor may tell you to reduce the dose over a few days before stopping completely.
Danish: De skal ikke holde op med at tage STAYVEER, medmindre Deres læge har bedt Dem om det. Deres læge kan bede Dem reducere dosis over nogle få dage, før De stopper helt med behandlingen.
English: In patients between 3 months and 2 years the daily exposure was 7,879 ng·h/mL; AUCτ was 3,939 ng·h/mL (CV: 72%).
Danish: Hos patienter i alderen mellem 3 måneder og 2 år var den daglige eksponering 7.879 ng·t/m; AUCτ var 3.939 ng·t/ml; (CV 72%).
English: Skin and subcutaneous disorders Common
Danish: Hud og subkutane væv
English: In study AC-052-401, during 16 weeks of double-blind therapy, patients in the bosentan group developed a mean of 1.4 new digital ulcers vs 2.7 new digital ulcers in the placebo group (p = 0.0042).
Danish: I studie AC-052-401udviklede patienter i bosentan-gruppen i løbet af de 16 uger dobbeltblind behandling gennemsnitligt 1,4 nye fingersår vs. 2,7 nye fingersår i placebogruppen (p= 0,0042).
English: Cyclosporine A: Co-administration of STAYVEER and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Danish: Ciclosporin: Samtidig administration af STAYVEER og ciclosporin (en calcineurinhæmmer) er kontraindiceret (se pkt.
English: 2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo.
Danish: 2 Der har været rapporteret overfølsomhedsreaktioner hos 9,9% af patienterne behandlet med bosentan og hos 9,1% af patienterne behandlet med placebo.
English: Glibenclamide: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of glibenclamide (a CYP3A4 substrate) by 40%, with potential significant decrease of the hypoglycaemic effect.
Danish: Glibenclamid: Samtidig administration af bosentan 125 mg to gange dagligt i 5 dage reducerede plasmakoncentrationen af glibenclamid (et CYP3A4-substrat) med 40% med potentiel betydelig reduktion af den hypoglykæmiske virkning.
English: No dose adjustment is required in patients undergoing dialysis (see section 5.2).
Danish: Dosisjustering er ikke nødvendig til patienter, der er i dialysebehandling (se pkt.
English: Bosentan is eliminated by biliary excretion following metabolism in the liver by the cytochrome P450 isoenzymes, CYP2C9 and CYP3A4.
Danish: Bosentan elimineres gennem galden efter metabolisering i leveren via cytochrom P450-isoenzymer CYP2C9 og CYP3A4.
English: Headache3
Danish: Hovedpine3
English: Bosentan is metabolised by CYP2C9 and CYP3A4.
Danish: Bosentan metaboliseres ved hjælp af CYP2C9 og CYP3A4.
English: Treatment with bosentan has been associated with dose-dependent elevations in liver aminotransferases and decreases in haemoglobin concentration (see section 4.4).
Danish: Behandling med bosentan har været associeret med dosisafhængig stigning i leveraminotransferaser og fald i hæmoglobinkoncentration (se pkt.
English: Treatment with STAYVEER should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Danish: Behandling bør kun påbegyndes og ledes af en læge, som har erfaring inden for behandling af PAH eller systemisk sklerose.
English: Treatment with bosentan has been associated with dose-related decreases in haemoglobin concentration (see section 4.8).
Danish: Behandling med bosentan har været forbundet med dosisrelateret fald i hæmoglobinkoncentrationen (se pkt.
English: In the FUTURE-4 study including 13 neonates with PPHN treated with bosentan 2 mg/kg twice daily for less than 10 days (range 0.5-10.0 days), there were no cases of liver aminotransferases ≥ 3 × ULN
Danish: I FUTURE-4-studiet, der omfattede 13 nyfødte med PPHN, der blev behandlet med bosentan 2 mg/kg to gange dagligt i under 10 dage (interval 0,5-10,0 dage), var der ingen tilfælde af leveraminotransferaser ≥ 3 × ULN under behandlingen, men der indtrådte ét tilfælde af hepatitis 3 dage efter, bosentanbehandlingen var afsluttet.
English: STAYVEER may harm the development of the foetus.
Danish: STAYVEER kan skade det ufødte barn.
English: Breast-feeding is not recommended during treatment with STAYVEER.
Danish: Amning frarådes under behandling med STAYVEER.
English: If the aminotransferase levels return to pre-treatment values reintroducing STAYVEER according to the conditions described below should be considered.
Danish: Hvis aminotransferaseniveauer retableres til de samme niveauer som inden behandlingen, skal det overvejes at reintroducere STAYVEER i henhold til nedenstående betingelser.
English: STAYVEER 62.5 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Danish: STAYVEER 62,5 mg filmovertrukne tabletter PVC/PE/PVDC/aluminium-blisterpakninger, der indeholder 14 filmovertrukne tabletter.
English: If the aminotransferase levels return to pre-treatment values continuing or re-introducing STAYVEER according to the conditions described below should be considered.
Danish: Hvis aminotransferaseniveauer retableres til de samme niveauer som inden behandlingen, skal det overvejes at fortsætte eller reintroducere STAYVEER i henhold til nedenstående betingelser.
English: Simvastatin: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate) and its active β-hydroxy acid metabolite by 34% and 46%, respectively.
Danish: Simvastatin: Samtidig administration af bosentan 125 mg to gange dagligt i 5 dage medførte en reduktion af plasmakoncentrationen af simvastatin (et CYP3A4-substrat) og dets aktive β-hydroxysyremetabolit med henholdsvis 34% og 46%.
English: 5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo.
Danish: 5 Ødem eller væskeretention blev rapporteret hos 13,2% af patienterne behandlet med bosentan og 10,9% af patienterne behandlet med placebo.
English: - STAYVEER 125 mg film-coated tablets: The active substance is bosentan as monohydrate.
Danish: - STAYVEER 125 mg filmovertrukne tabletter: Aktivt stof: bosentan som monohydrat.
English: A careful benefit/risk assessment should be made, taking into consideration that the liver toxicity is dose dependent (see sections 4.4 and 5.1).
Danish: Omhyggelig afvejning af fordele/risici bør foretages under hensyntagen til, at levertoksiciteten er dosisafhængig (se pkt.
English: Rifampicin: Co-administration in 9 healthy subjects for 7 days of bosentan 125 mg twice daily with rifampicin, a potent inducer of CYP2C9 and CYP3A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case.
Danish: Rifampicin: Samtidig administration af bosentan 125 mg 2 gange dagligt og rifampicin, en potent inducer af CYP2C9 og CYP3A4, til 9 raske forsøgspersoner i 7 dage reducerede plasmakoncentrationen af bosentan med 58%; i et enkelt tilfælde op til næsten 90%.
English: STAYVEER 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Danish: STAYVEER 125 mg filmovertrukne tabletter PVC/PE/PVDC/aluminium-blisterpakninger, der indeholder 14 filmovertrukne tabletter.
English: Blood tests for liver function
Danish: Blodprøver for leverfunktion
English: You need to use a barrier form of birth control - like a condom, diaphragm or vaginal sponge - in addition to any of these kinds of hormonal birth control.
Danish: De skal anvende en barrieremetode - f.eks. kondom, pessar eller svangerskabsforebyggende svamp i skeden - sammen med den hormonelle prævention.
English: Rare (may affect up to one in 1000 people):
Danish: Sjældne (kan forekomme hos op til 1 og 1.000 personer):
English: Due to the potential for interactions related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection.
Danish: 4.5), som vil kunne påvirke virkningen af antiretroviral behandling, bør disse patienter også monitoreres omhyggeligt med hensyn til deres hiv-infektion.
English: • Women of childbearing potential who are not using reliable methods of contraception (see sections 4.4, 4.5 and 4.6)
Danish: • Kvinder i den fertile alder, som ikke benytter pålidelige præventionsmetoder (se pkt.
English: Inhibition by ritonavir of transport protein-mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction.
Danish: Denne interaktion skyldes med stor sandsynlighed ritonavirs hæmning af transportprotein-medieret optagelse i hepatocytter og af CYP3A4, idet bosentans clearance reduceres herved.
English: Very common (may affect more than one in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer):
English: STAYVEER treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Danish: STAYVEER-behandling bør initieres med en dosis på 62,5 mg 2 gange dagligt i 4 uger og derefter øges til vedligeholdelsesdosis 125 mg 2 gange dagligt.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteket, hvis der er noget, De er i tvivl om eller føler Dem usikker på.
English: A careful benefit/risk assessment should be made, taking into consideration the liver toxicity of bosentan (see sections 4.4 and 4.8).
Danish: Omhyggelig afvejning af fordele/risici bør foretages under hensyntagen til bosentans levertoksicitet (se pkt.
English: For all these tests please refer also to the Patient Alert Card (inside your pack of STAYVEER tablets).
Danish: Se patientadvarselskortet (i pakken med STAYVEER-tabletter) for mere information om alle disse prøver.
English: Systemic sclerosis with ongoing digital ulcer disease
Danish: Systemisk sklerose med eksisterende fingersår
English: Systemic sclerosis with digital ulcer disease
Danish: Systemisk sklerose med fingersårssygdom
English: STAYVEER 62.5 mg film-coated tablets STAYVEER 125 mg film-coated tablets
Danish: STAYVEER 62,5 mg filmovertrukne tabletter STAYVEER 125 mg filmovertrukne tabletter
English: Cartons contain, 56 or 112 film-coated tablets.
Danish: Æsker med 56 eller 112 filmovertrukne tabletter.
English: - STAYVEER 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate.
Danish: - STAYVEER 62, 5 mg filmovertrukne tabletter: Aktivt stof: bosentan som monohydrat.
English: For further details please refer to section 4.5.
Danish: For yderligere oplysninger se pkt.
English: STAYVEER therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
Danish: Det tilhører gruppen af lægemidler, der kaldes ”endothelinreceptor-antagonister”.
English: STAYVEER 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Danish: STAYVEER 62,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 62,5 mg bosentan (som monohydrat).
English: STAYVEER has not been shown to have a beneficial effect on the healing of existing digital ulcers.
Danish: Der er ikke påvist en fordelagtig virkning af STAYVEER på opheling af eksisterende fingersår.