natgillin/translations-raw huggingface dataset:
Ligheden mellem det mønster for misdannelser, der er iagttaget i forbindelse med andre ET-receptorantagonister og hos ET-knockoutmus, indikerer, at der er tale om en klasseeffekt.
The similarities of the pattern of malformations observed with other ET receptor antagonists and in ET knock-out mice indicate a class effect.
Plasmakoncentrationen af bosentan påvirkedes ikke ved samtidig indgift af simvastatin.
The plasma concentrations of bosentan were not affected by concomitant simvastatin.
Data fra andre CYP3A4-inducere f.eks. carbamazepin, phenobarbital, phenytoin og perikon mangler, men samtidig administration forventes at medføre reduceret systemisk eksponering for bosentan.
Data on other CYP3A4 inducers, e.g., carbamazepine, phenobarbital, phenytoin and St. John's wort are lacking, but their concomitant administration is expected to lead to reduced systemic exposure to bosentan.
De hyppigste bivirkninger var infektioner i øvre luftveje (25%), pulmonal (arteriel) hypertension (20%), nasopharyngitis (17%), pyreksi (15%), opkastning (13%), bronchitis (10%), abdominalsmerter (10%) og diarré (10%).
The most frequent adverse events were upper respiratory tract infections (25%), pulmonary (arterial) hypertension (20%), nasopharyngitis (17%), pyrexia (15%), vomiting (13%), bronchitis (10%), abdominal pain (10%), and diarrhoea (10%).
Anbefalinger i tilfælde af forøgelse af ALAT/ASAT
Recommendations in the event of ALT/AST elevations ALT/AST levels
• gulsot (gulfarvning af Deres hud eller af det hvide i øjnene)
• jaundice (yellowing of your skin or the whites of your eyes)
• sirolimus eller tacrolimus (lægemidler, der anvendes efter transplantationer), da det ikke anbefales at bruge disse sammen med STAYVEER.
• sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with STAYVEER.
> 3 og ≤ 5 × ULN Resultatet skal bekræftes med en ekstra leverfunktionstest; hvis bekræftet, skal der tages en beslutning på individuel basis om at fortsætte med STAYVEER, eventuelt med reduceret dosis, eller seponere STAYVEER (se pkt.
> 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue STAYVEER, possibly at a reduced dose, or to stop STAYVEER administration (see section 4.2).
Mekanismen for denne interaktion er højst sandsynlig ciclosporins hæmning af transportprotein-medieret optagelse af bosentan i hepatocytter.
The mechanism of this interaction is most likely inhibition of transport protein-mediated uptake of bosentan into hepatocytes by cyclosporine.
Bosentans sikkerhed og tolerabilitet blev undersøgt i et eksplorativt, ukontrolleret 12-ugers studie hos 11 patienter med pulmonal hypertension sekundært til alvorlig KOL (GOLD klassifikation grad III).
Safety and tolerability of bosentan was investigated in an exploratory, uncontrolled 12-week study in 11 patients with pulmonary hypertension secondary to severe COPD (stage III of GOLD classification).
Hvis De har glemt at tage STAYVEER, skal De gøre det, så snart De kommer i tanke om det og derefter på de normale tidspunkter.
If you forget to take STAYVEER, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Anæmi eller nedsat hæmoglobin, der kræver transfusion af røde blodlegemer1
Anaemia or haemoglobin decreases requiring red blood cell transfusion1
Patienter, der har behov for kombinationen, skal overvåges nøje med hensyn til bivirkninger, der er relateret til STAYVEER samt plasmakoncentrationer af tacrolimus og sirolimus.
Patients in need of the combination should be closely monitored for adverse events related to STAYVEER and for tacrolimus and sirolimus blood concentrations.
• Pulmonal arteriel hypertension sekundært til sklerodermi uden signifikant interstitiel pulmonal sygdom
• Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
Hvis De kan blive gravid, skal De anvende en pålidelig svangerskabsforebyggende metode (prævention), mens De tager STAYVEER.
If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking STAYVEER.
Der er begrænset erfaring med pludselig seponering af STAYVEER hos patienter med PAH.
There is limited experience with abrupt discontinuation of STAYVEER in patients with PAH.
Prægelatineret stivelse Natriumstivelsesglycolat (type A) Povidon
Pregelatinised starch Sodium starch glycolate (Type A) Povidone
Desuden skal leveraminotransferaseniveauerne måles 2 uger efter enhver dosisforhøjelse.
In addition, liver aminotransferase levels must be measured 2 weeks after any dose increase.
Han havde symptomer som kvalme, opkastning, svimmelhed, svedtendens og sløret syn.
He had symptoms of nausea, vomiting, hypotension, dizziness, sweating and blurred vision.
Af samme årsag kan samtidig administration af både en stærk CYP3A4-inhibitor (som f.eks. ketoconazol, itraconazol eller ritonavir) og en CYP2C9-inhibitor (som f.eks. voriconazol) sammen med STAYVEER ikke anbefales.
For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with STAYVEER is not recommended.
• hvis De bliver behandlet med ciclosporin (et lægemiddel, som anvendes efter en transplantation eller til behandling af psoriasis) Fortæl det til Deres læge, hvis noget af dette gælder for Dem.
• if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis) If any of these apply to you, tell your doctor.
Hvis De har pulmonal arteriel hypertension kan en graviditet endvidere forårsage en alvorlig forværring i symptomerne på Deres sygdom.
Moreover, if you are suffering from pulmonary hypertension disease, the occurrence of a pregnancy can severely deteriorate the symptoms of your disease.
Da hormonel prævention muligvis ikke er effektiv under behandling med STAYVEER, og også på grund af risikoen for at pulmonal hypertension forværres alvorligt under graviditet, anbefales det, at der udføres månedlige graviditetsprøver under STAYVEER-behandlingen for at opdage en graviditet tidligst muligt.
Because of possible hormonal contraception failure during STAYVEER treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with STAYVEER are recommended to allow early detection of pregnancy.
I denne samlede population var Kaplan-Meier estimater vedrørende overlevelse henholdsvis 93% og 84% henholdsvis 1 og 2 år efter behandlingsstart med bosentan.
In this total population, Kaplan-Meier estimates of survival were 93% and 84% 1 and 2 years after the start of treatment with bosentan, respectively.
Virkningen af bosentan på mitokondriefunktionen er ikke kendt.
The effect of bosentan on mitochondrial function is unknown.
Balancen mellem fordele/risici for bosentan er ikke undersøgt hos patienter med WHO klasse I funktionsstatus ved PAH.
The benefit/risk balance of bosentan has not been established in patients with WHO class I functional status of PAH.
STAYVEER kan imidlertid medføre hypotension (for lavt blodtryk), som kan gøre Dem svimmel, påvirke Deres syn og påvirke Deres evne til at fore motorkøretøj og betjene maskiner.
However, STAYVEER can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines.
Et interaktionsstudie med bosentan og lopinavir+ritonavir hos raske individer viste øgede plasmakoncentrationer af bosentan med maksimalt niveau i løbet af de første 4 dages behandling (se pkt.
An interaction study between bosentan and lopinavir+ritonavir in healthy subjects showed increased plasma concentrations of bosentan, with the maximum level during the first 4 days of treatment (see section 4.5).
• en graviditetstest, hvis De er en kvinde i den fødedygtige alder Hos nogle patienter, som tager STAYVEER, har man fundet unormale leverfunktionsprøver og blodmangel (lavt hæmoglobin).
• a pregnancy test if you are a woman of childbearing potential Some patients taking STAYVEER have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Hyppigheder er baseret på statistisk modellering af data fra placebokontrollerede kliniske forsøg.
1 Data derived from post-marketing experience, frequencies based on statistical modelling of placebo-controlled clinical trial data.
Bosentan nedsætter både den pulmonale og systemiske vaskulære modstand, hvilket forøger hjertets minutvolumen, uden at hjertefrekvensen øges.
Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate.
Ved studiestarten fik under halvdelen af de inkluderede patienter (45,3% [29/64]) behandling med bosentan alene uden anden PAH-medicin.
At study start, less than half of the patients included (45.3% [29/64]) had bosentan treatment alone not combined with other PAH medication.
Der skal udvises forsigtighed ved brug af denne kombination.
The combination should be used with caution.
• Det anbefales at udføre månedlige graviditetsprøver med henblik på tidlig konstatering af graviditet.
• Monthly pregnancy tests are recommended during treatment to allow early detection of pregnancy
PAH-ætiologien i henhold til Dana-pointklassifikation omfattede idiopatisk PAH (46%), arvelig PAH (3%), PAH relateret til korrigerende hjertekirurgi (38%) og PAH relateret til kongenit hjertesygdom forbundet med systemiske-til-pulmonale shunts, herunder Eisenmengers syndrom (13%).
The aetiology of PAH, according to Dana Point classification, included idiopathic PAH (46%), heritable PAH (3%), associated PAH after corrective cardiac surgery (38%), and PAH related to congenital heart disease associated with systemic-topulmonary shunts, including Eisenmenger syndrome (13%).
I post-marketingperioden blev der rapporteret om sjældne tilfælde af levercirrose og leversvigt.
In the post-marketing period rare cases of liver cirrhosis and liver failure have been reported.
Plasmakoncentrationer af bosentanmetaboliter steg til omkring det dobbelte hos disse patienter i sammenligning med personer med normal nyrefunktion.
Plasma concentrations of bosentan metabolites increased about 2-fold in these patients as compared with subjects with normal renal function.
De samme anbefalinger gør sig gældende ved reintroduktion af STAYVEER efter behandlingsafbrydelse (se pkt.
The same recommendations apply to reintroduction of STAYVEER after treatment interruption (see section 4.4).
Pulmonal arteriel hypertension associeret med hiv-infektion
Pulmonary arterial hypertension associated with HIV infection
• en blodprøve for at kontrollere Deres leverfunktion
• a blood test to check your liver function
Behandling med bosentan var associeret med en reduktion i hastigheden af klinisk forværring defineret som en kombination af symptomatisk progression, hospitalsindlæggelse for PAH og død sammenlignet med placebo (proportional reduktion i risiko på 77%, 95% konfidensinterval [CI] 2094%, p = 0,0114).
Treatment with bosentan was associated with a reduction in the rate of clinical worsening, defined as a composite of symptomatic progression, hospitalisation for PAH and death, compared with placebo (proportional risk reduction 77%, 95% confidence interval [CI] 20-94%, p = 0.0114).
Der blev observeret en øget minutventilation og et fald i iltmætning; den hyppigste bivirkning var dyspnø, som forsvandt efter seponering af bosentan.
An increase in minute ventilation and a decrease in oxygen saturation were observed, and the most frequent adverse event was dyspnoea, which resolved with discontinuation of bosentan.
De hyppigste bivirkninger hos de bosentan- og placebobehandlede patienter var henholdsvis anæmi eller hæmoglobinreduktion (7 og 2 patienter), generaliseret ødem (3 og 0 patienter) og opkastning (2 og 0 patienter).
The most frequent adverse events in the bosentan- and placebo-treated patients were, respectively, anaemia or haemoglobin decrease (7 and 2 patients), generalised oedema (3 and 0 patients), and vomiting (2 and 0 patients).
Dette var et dobbeltblindet, placebokontrolleret, randomiseret studie udført hos præmature og fuldbårne nyfødte (gestationsalder 36-42 uger) med PPHN.
This was a double-blind, placebo-controlled, randomised study in pre-term or term neonates (gestational age 36-42 weeks) with PPHN.
Bivirkninger i form af leverabnormiteter og anæmi/hæmoglobinreduktion indtrådte hos henholdsvis 9% og 5% af patienterne.
Adverse events of liver abnormalities and anaemia/haemoglobin decrease occurred in 9% and 5% of patients, respectively.
Denne metabolit udskilles hovedsagelig uomdannet via galden.
This metabolite is mainly excreted unchanged via the bile.
Patienterne var i WHO-funktionsklasse I (n=19, 29%), II (n=27, 42%) eller III (n=18, 28%) ved opstart af studiebehandlingen.
Patients were in WHO functional class I (n = 19, 29 %), class II (n = 27, 42%) or class III (n = 18, 28%) at start of study treatment.
Virkningen af bosentan på reduktion af antallet af nye fingersår var mere udtalt hos patienter med mange fingersår.
The effect of bosentan on reduction of the number of new digital ulcers was more pronounced in patients with multiple digital ulcers.
Bosentan har vist sig at være teratogent hos rotter ved plasmakoncentrationer, der er mere end 1,5 gange højere end de plasmakoncentrationer, der blev opnået ved terapeutiske doser hos mennesker.
Bosentan has been shown to be teratogenic in rats at plasma levels higher than 1.5 times the plasma concentrations achieved at the therapeutic dose in humans.
Nogle patienter, der ikke responderer godt på 125 mg STAYVEER to gange dagligt, kan forbedre deres arbejdskapacitet lidt, hvis dosis øges til 250 mg to gange dagligt.
Some patients not responding well to 125 mg twice daily of STAYVEER may slightly improve their exercise capacity when the dose is increased to 250 mg twice daily.
Hos børn i alderen 1 år og derover starter behandlingen med STAYVEER sædvanligvis med 2 mg pr. kg legemsvægt to gange dagligt (morgen og aften).
For children aged 1 year and older, treatment with STAYVEER is usually started with 2 mg per kg bodyweight twice daily (morning and evening).
Efter 16 uger var den gennemsnitlige placebokorrigerede øgning i 6 minutters gangdistance, 53 meter (p = 0,0079), hvilket afspejler forbedring i arbejdskapaciteten.
After 16 weeks, the mean placebo-corrected increase in 6-minute walk distance was 53 metres (p = 0.0079), reflecting improvement in exercise capacity.
Der var ingen evidens for nogen klinisk fordel ved 2 mg/kg tre gange dagligt i forhold til 2 mg/kg to gange dagligt.
There was no evidence of any clinical benefit with 2 mg/kg three times daily as compared to 2 mg/kg twice daily dosing.
Hvis De har glemt at tage STAYVEER
If you forget to take STAYVEER
• STAYVEER behandling må ikke påbegyndes hos kvinder i den fertile alder, medmindre de bruger pålidelig prævention, og en graviditetsprøve inden behandlingens start er negativ
• STAYVEER treatment must not be initiated in women of childbearing potential unless they practise reliable contraception and the result of the pre-treatment pregnancy test is negative
Tilfælde af pulmonært ødem har været rapporteret i forbindelse med vasodilatatorer (især prostacykliner), når de anvendes til patienter med pulmonær veno-okklusiv sygdom.
Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Bosentans farmakokinetik er ikke undersøgt hos patienter med Child-Pugh klasse C nedsat leverfunktion.
The pharmacokinetics of bosentan have not been studied in patients with Child-Pugh class C hepatic impairment.
Kaplan-Meier-estimatet (hændelsesfri) for forværring af PAH (død, lungetransplantation eller hospitalsindlæggelse på grund af PAH-forværring) efter 2 år var 78,9%.
The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 2 years was 78.9%.
STAYVEER nedsætter antallet af forekomsten af nye finger- og tåsår.
STAYVEER reduces the number of new finger and toe ulcers that appear.
De skal læse det grundigt, inden De starter behandling med STAYVEER.
Please read this card carefully before starting your treatment with STAYVEER.
Samtidig brug af Rifampicin og STAYVEER frarådes.
Concomitant use of rifampicin and STAYVEER is not recommended.
Dette fald skyldes sandsynligvis en autoinduktion af metaboliserende leverenzymer.
This decrease is probably due to auto-induction of metabolising liver enzymes.
I AC-052-352 studiet blev 92% af de 213 patienter klassificeret ud fra initialværdier som WHO funktionsklasse III og 8% som funktionsklasse IV.
In the AC-052-352 study, 92% of the 213 patients were classified at baseline as WHO functional class III and 8% as class IV.
Hvis De anvender et hormonelt præventionsmiddel, skal De derfor også anvende en barrieremetode (f.eks. femidom, pessar eller svangerskabsforebyggende svamp, eller Deres partner skal også anvende kondom).
Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge, or your partner must also use a condom).
Ved baseline havde patienterne idiopatisk (31 patienter [86%]) eller familiær (5 patienter [14%]) PAH og var i WHO-funktionsklasse II (n=23, 64%) eller III (n=13, 36%).
At baseline, patients had idiopathic (31 patients [86%]) or familial (5 patients [14%]) PAH, and were in WHO functional class II (n = 23, 64%) or class III (n = 13, 36%).
Hos drengebørn kan det ikke udelukkes, at der på langt sigt er en indvirkning på fertiliteten efter behandling med bosentan.
In male children, a long-term impact on fertility after treatment with bosentan cannot be excluded.
Gastroøsofageal reflukssygdom Diarré
Gastrooesophageal reflux disease Diarrhoea
Middelstigningen fra basalniveau ved hjerteindeks var 0,5 l/min/m2, gennemsnitligt fald i gennemsnitligt pulmonalt arterielt tryk var 8 mmHg, og gennemsnitligt fald i PVR var 389 dyn·sec·cm-5.
The mean increase from baseline in cardiac index was 0.5 L/min/m2, the mean decrease in mean pulmonary arterial pressure was 8 mmHg, and the mean decrease in PVR was 389 dyn·sec·cm-5.
Nogen bedring er ligeledes vist hos patienter med pulmonal arteriel hypertension WHO funktionsklasse II (se pkt.
Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II (see section 5.1).
Stigninger i aminotransferaser blev associeret med forhøjet bilirubin (> 2 x ULN) uden tegn på biliær obstruktion hos 0,2% (5) af patienterne på bosentan og hos 0,3% (6) af patienterne på placebo.
Elevations in aminotransferases were associated with elevated bilirubin (≥ 2 × ULN) without evidence of biliary obstruction in 0.2% (5 patients) on bosentan and 0.3% (6 patients) on placebo.
Bosentan filmovertrukne tabletter blev evalueret i et åbent ikke-kontrolleret studie med 19 pædiatriske patienter i alderen 3 til15 år med PAH.
Bosentan film-coated tablets were evaluated in an open-label uncontrolled study in 19 paediatric patients with PAH aged 3 to 15 years.
I FUTURE-4-studiet oplevede 6 ud af 13 bosentanbehandlede nyfødte med PPHN et fald i hæmoglobin fra en værdi inden for referenceområdet ved baseline til et niveau under den nedre normalgrænse under behandlingen.
In the FUTURE-4 study, 6 out of 13 bosentan-treated neonates with PPHN experienced a decrease in haemoglobin from within the reference range at baseline to below the lower limit of normal during the treatment.
Studie udført hos nyfødte med persisterende pulmonal hypertension hos nyfødte (PPHN)
Study performed in neonates with persistent pulmonary hypertension of the newborn (PPHN):
STAYVEER indeholder natrium
STAYVEER contains sodium
Samtidig anvendelse af andre lægemidler:
Concomitant use with other medicinal products
STAYVEER påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
STAYVEER has no or negligible influence on the ability to drive and use machines.
Vitalstatus over længere tid for alle 235 patienter, som blev behandlet med bosentan, blev imidlertid noteret, i de to pivotale placebo-kontrollerede studier (AC-052-351 og AC-052-352) og/eller deres to ukontrollerede, open-label forlængelser.
However, long-term vital status was recorded for all 235 patients who were treated with bosentan in the two pivotal placebo-controlled studies (AC-052-351 and AC-052-352) and/or their two uncontrolled, open-label extensions.
Den gennemsnitlige varighed for eksponering for bosentan var 1,9 år ± 0,7 år; (min: 0,1 år; max: 3,3 år) og patienterne blev observeret i gennemsnitligt 2,0 ± 0,6 år.
The mean duration of exposure to bosentan was 1.9 years ± 0.7 years (min: 0.1 years; max: 3.3 years) and patients were observed for a mean of 2.0 ± 0.6 years.
Ved kombination med en CYP3A4 inhibitor risikerer patienter med dårlig omsætning af CYP2C9 dog forøgede plasmakoncentrationer af bosentan, som kan være endnu højere og dermed føre til potentielt skadelige bivirkninger.
However, when combined with a CYP3A4 inhibitor, patients who are poor metabolisers of CYP2C9 are at risk of increases in bosentan plasma concentrations that may be of higher magnitude, thus leading to potential harmful adverse events.
Brug af anden medicin sammen med STAYVEER
Other medicines and STAYVEER
I FUTURE 1 fik 9 patienter epoprostenol ved baseline.
At baseline in FUTURE 1, 9 patients were taking epoprostenol.
Kvinder i den fertile alder må derfor ikke anvende hormonale præventionsmetoder (inklusive orale, injicerbare, transkutane eller implantable former) som den eneste form for prævention, men skal anvende en supplerende eller en alternativ pålidelig form for prævention.
Therefore, women of childbearing potential must not use hormonal contraceptives (including oral, injectable, transdermal or implantable forms) as the sole method of contraception but must use an additional or an alternative reliable method of contraception.
Titandioxid (E171) Jernoxid, gult (E172) Jernoxid, rødt (E172) Ethylcellulose
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
For PVC/PE/PVDC/aluminium-blisterpakninger: Må ikke opbevares ved temperaturer over 30 °C.
For PVC/PE/PVDC/aluminium-blisters: Do not store above 30 °C.
Samtidig anvendelse af STAYVEER og glibenclamid, fluconazol og rifampicin anbefales ikke.
Concomitant use of STAYVEER with glibenclamide, fluconazole and rifampicin is not recommended.
I BREATHE-3 var de hyppigste bivirkninger ansigtsrødme (21%), hovedpine og unormal leverfunktionstest (begge 16%).
In BREATHE-3, the most frequent adverse reactions were flushing (21%), headache, and abnormal liver function test (each 16%).
Leverenzymændringer forekommer typisk inden for de første 26 uger af behandlingen, men kan også forekomme senere under behandlingen (se pkt.
Liver enzyme changes typically occur within the first 26 weeks of treatment but may also occur late in treatment (see section 4.8).
Behandling med bosentan førte til en signifikant forøgelse af hjerteindeks som var forbundet med en signifikant nedsættelse af det pulmonale arterielle tryk, pulmonal vaskulær modstand og gennemsnitligt tryk i højre atrium.
Treatment with bosentan led to a significant increase in cardiac index associated with a significant reduction in pulmonary artery pressure, pulmonary vascular resistance and mean right atrial pressure.
I studie AC-052-365 (FUTURE 1) blev der administreret dispergible tabletter til 36 PAH-børn i alderen fra 2 til 11 år.
In study AC-052-365 (FUTURE 1), dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
Ved voksenalderen (dag 69 post partum) blev der ikke set nogen virkninger af bosentan ved en eksponering, der var 1,3 (hanner) og 2,6 (hunner) gange højere end den terapeutiske eksponering hos børn med PAH.
At adult age (Day 69 post partum), no effects of bosentan were detected at 1.3 (males) and 2.6 (females) times the therapeutic exposure in children with PAH.