FrancophonIA/ELRC3.0 huggingface dataset:
English: may affect up to 1 in 1,000 users - Inflammation of the eyes (conjunctivitis) - Allergic reaction - Anxiety - Fainting - Amnesia - Seizure - Increased pressure in the eye (glaucoma), lacrimation increased - Effects on the heart (such as heart attack, altered heart beat or angina) - High or low blood pressure - Nose bleed - Effect on results of blood tests to check liver function - Sensitivity of the skin to sun light - Painful erections - Chest pain - Temporarily decreased blood flow to parts of the brain
Danish: Påvirkning af hjertet (f.eks. hjerteanfald, ændret hjerterytme eller hjertekramper (angina) Højt eller lavt blodtryk
English: What Levitra is and what it is used for What you need to know before you take Levitra How to take Levitra
Danish: Det skal De vide, før De begynder at tage Levitra Sådan skal De tage Levitra Bivirkninger
English: In vivo studies
Danish: In vivo-undersøgelser
English: With other alpha-blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.4).
Danish: Et doseringsinterval bør overvejes, hvis vardenafil ordineres samtidigt med andre alfa-blokkere (se pkt.
English: may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data - Blood in the urine (Haematuria) - Penile bleeding (Penile Haemorrhage) - Presence of blood in the semen (Haematospermia) - Sudden death - Bleeding in the brain
Danish: forekommer hos færre end 1 ud af 10.000 behandlede Blod i urinen (hæmaturi)
English: Gastritis
Danish: Dosering
English: Ear and
Danish: Almindelig e
English: Levitra 10 mg orodispersible tablets should not be taken as starting dose in patients treated with alpha-blockers (see section 4.4).
Danish: Patienter, der bliver behandlet med alfa-blokker, må ikke tage Levira 10 mg smeltetabletter som startdosis (se pkt.
English: Dyspepsia Gastro-oesopha geal reflux disease
Danish: Gastroøsofagea l reflukssygdom Gastritis Gastointestinale smerter og abdominalsmert er
English: 4 These types of reactions can also be related to the underlying disease.
Danish: 4 Disse typer reaktioner kan også relateres til den underliggende sygdom.
English: Efficacy has been shown in:
Danish: Effektivitet er blevet påvist ved:
English: No If Yes, write the names of these here:
Danish: Nej Hvis ja, så skriv her hvilke metoder:
English: The potential risk for humans is still unknown.
Danish: Den potentielle risiko for mennesker kendes stadig ikke.
English: Date of first authorisation: 24 June 2013 Date of latest renewal: 8 January 2018
Danish: Dato for første markedsføringstilladelse: 24. juni 2013 Dato for seneste fornyelse: 08. januar 2018
English: • primary (with no identified cause or familial);
Danish: • primær (uden nogen kendt årsag eller familiær);
English: It is especially important to tell your doctor if you are taking:
Danish: Det er især vigtigt at informere lægen, hvis De tager:
English: There was no decrease to below 8 g/dL.
Danish: Der var ingen fald til under 8 g/dl.
English: He recovered completely within 24 hours with blood pressure support.
Danish: Han kom sig fuldstændig inden for 24 timer, hvor blodtrykket blev understøttet.
English: Signs that your liver may not be working properly include:
Danish: Tegn på, at Deres lever ikke fungerer korrekt, omfatter:
English: If you are a woman of childbearing age read this page carefully
Danish: Hvis De er en kvinde i den fødedygtige alder, skal De læse denne side grundigt
English: The table below illustrates the pre-specified protocol analyses.
Danish: Tabellen nedenfor viser den forud specificerede protokolanalyse.
English: Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about STAYVEER ask your doctor.
Danish: Deres Navn: _____________________________________________ Ordinerende læge: ______________________________________ Spørg Deres læge, hvis De har nogen spørgsmål vedrørende STAYVEER.
English: This patient recovered within the 60-day follow-up period.
Danish: Denne patient kom sig i løbet af opfølgningsperioden på 60 dage.
English: Date of first monthly test: _________________________________
Danish: Dato for første månedlige prøve: _________________________________
English: Appropriate monitoring of the HIV therapy is recommended.
Danish: Passende monitorering af hiv-behandling anbefales.
English: The mean treatment duration was 45 weeks.
Danish: Den gennemsnitlige behandlingsvarighed var 45 uger.
English: Intensified monitoring is recommended during the discontinuation period.
Danish: Intensiveret monitorering anbefales i seponeringsperioden.
English: Steady-state conditions are reached within 3-5 days.
Danish: Steady-state tilstande opnås inden for 3-5 dage.
English: There are no data on the safety and efficacy in patients under the age of 18 years.
Danish: Der foreligger ingen data vedrørende sikkerhed og virkning hos patienter under 18 år.
English: Do you currently use or take contraceptives?
Danish: Anvender De i øjeblikket nogen form for prævention?
English: This card contains important information about STAYVEER.
Danish: Dette kort indeholder vigtige oplysninger om STAYVEER.
English: Animal models
Danish: Dyremodeller
English: 6-Minute Walk Distance (m)
Danish: Tilbagelagt afstand i 6 minutters gangdistance (m)
English: ‘Class II' involves slight limitation of physical activity.
Danish: ‘Klasse II' medfører en let begrænsning af den fysiske aktivitet.
English: Important Safety Alerts for Patients taking STAYVEER (bosentan)
Danish: Vigtige sikkerhedsadvarsler for patienter, der tager STAYVEER (bosentan)
English: The maximum plasma concentrations are attained within 3-5 hours.
Danish: Den maksimale plasmakoncentration opnås inden for 3-5 timer.
English: The patient's response to treatment and need for continued therapy should be re-evaluated on a regular basis.
Danish: Patientens respons på behandling og behov for fortsat behandling bør revurderes regelmæssigt.
English: It is important that you have these regular blood tests as long as you are taking STAYVEER.
Danish: Det er vigtigt, at De får foretaget disse blodundersøgelser regelmæssigt, så længe De tager STAYVEER.
English: The PAH for which STAYVEER is indicated can be:
Danish: Den PAH, som STAYVEER er indiceret for, kan være:
English: lips, tongue or throat)
Danish: læber, tunge eller svælg)
English: This interaction is unlikely to be of clinical relevance.
Danish: Det er usandsynligt, at denne interaktion er klinisk relevant.
English: The estimates may have been influenced by the initiation of epoprostenol treatment in 43/235 patients.
Danish: Estimaterne kan have været påvirket af initieringen af epoprostenol behandling hos 43/235 patienter.
English: Monitoring of cholesterol levels and subsequent dosage adjustment should be considered.
Danish: Monitorering af kolesterolniveauer og efterfølgende dosisjustering bør overvejes.
English: PVR (dyn.sec/cm5)
Danish: PVR (dyn.sek/cm5)
English: The primary objective was to show that bosentan did not worsen hypoxaemia.
Danish: Det primære formål var at vise, at bosentan ikke forværrede hypoxæmi.
English: The safety profile of the combination was not different from the one expected with each component and the combination therapy was well tolerated in children and adults.
Danish: Kombinationens sikkerhedsprofil var ikke forskellig fra den, der forventedes fra hver enkelt komponent, og kombinationsbehandlingen var veltålt hos børn og voksne.
English: A clinically significant reduction of efficacy cannot be excluded.
Danish: En klinisk signifikant reduktion i virkning kan ikke udelukkes.
English: The most serious side effects with STAYVEER are
Danish: De alvorligste bivirkninger ved STAYVEER er
English: The results did not indicate an additional benefit of bosentan in this population:
Danish: Resultaterne viste ingen yderligere gavnlig virkning af bosentan i denne population:
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter ”EXP”.
English: Open date:
Danish: Åbnet dato:
English: Haupt Pharma Wülfing GmbH Bethelner Landstraße 18 31028 Gronau/Leine Germany
Danish: Haupt Pharma Wülfing GmbH Bethelner Landstraße 18 31028 Gronau/Leine Tyskland
English: 9 patients were newly initiated on PAH-specific medication during the study.
Danish: 9 patienter blev nyopstartet på PAH-specifik medicinering under studiet.
English: Management in the event of clinical deterioration of PAH
Danish: Behandling i tilfælde af klinisk forværring af PAH
English: The plasma concentrations of bosentan were also decreased by 29%.
Danish: Plasmakoncentrationen af bosentan faldt ligeledes med 29%.
English: Bosentan was negative in tests for genotoxicity.
Danish: Bosentan var negativ i tests for genotoksicitet.
English: Bosentan forms three metabolites and only one of these is pharmacologically active.
Danish: Bosentan danner tre metabolitter, og kun en af disse er farmakologisk aktiv.
English: Monitoring of aminotransferase levels should be continued at least every 2 weeks.
Danish: Monitorering af aminotransferaseniveauer skal fortsættes mindst hver anden uge.
English: This combination should not be used.
Danish: Denne kombination bør ikke bruges.
English: However, decreases in exposure were as much as 56% and 66%, respectively, in individual subjects.
Danish: Reduktionen i eksponering var imidlertid op til henholdsvis 56% og 66% hos enkelte individer.
English: The mechanism for this interaction may be induction of P-glycoprotein.
Danish: Mekanismen for denne interaktion kan være induktion af P-glykoprotein.
English: No evidence for acute rebound has been observed.
Danish: Der er ikke blevet observeret noget bevis for akut rebound.
English: The advice of a hepatologist is recommended.
Danish: Det anbefales, at der søges rådgivning fra en hepatolog.
English: This lowers the blood pressure and relieves the symptoms.
Danish: Dette nedsætter blodtrykket og lindrer symptomerne.
English: ULN = upper limit of normal
Danish: ULN = upper limit of normal (øvre grænse for normalt område)
English: Combination with epoprostenol
Danish: Kombination med epoprostenol
English: The ‘class' reflects the seriousness of the disease: ‘class III' involves marked limitation of physical activity.
Danish: 'Klassen' siger noget om, hvor alvorlig sygdommen er: ‘Klasse III' medfører en udtalt begrænsning af den fysiske aktivitet.
English: However, some patients who show no response after 8 weeks of treatment with STAYVEER may respond favourably after an additional 4 to 8 weeks of treatment.
Danish: Nogle af disse patienter, som ikke udviser nogen reaktion efter 8 ugers behandling med STAYVEER, kan dog reagere positivt efter yderligere 4 til 8 ugers behandling.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking STAYVEER, and regularly while you are taking STAYVEER.
Danish: Hvis De er en kvinde, som kan blive gravid, vil Deres læge bede Dem om at tage en graviditetstest, før De begynder at tage STAYVEER, og regelmæssigt mens De tager STAYVEER.
English: The requirements for submission of periodic safety update reports including liver reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Less than 3% of an administered oral dose is recovered in urine.
Danish: Mindre end 3% af en indgiven peroral dosis genfindes i urinen.
English: STAYVEER should only be initiated if the systemic systolic blood pressure is higher than 85 mmHg.
Danish: STAYVEER behandling bør kun påbegyndes, hvis det systemiske systoliske blodtryk er over 85 mmHg.
English: Do not take a double dose to make up for forgotten tablets.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • if you are allergic to bosentan or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis De er allergisk over for bosentan eller et af de øvrige indholdsstoffer i denne medicin (angivet i punkt 6)
English: Only one death occurred in each treatment group during the 6-month double-blind study period, therefore no conclusion can be drawn on survival.
Danish: Kun et dødsfald forekom i hver behandlingsgruppe i de 6 måneder det dobbeltblinde forsøg varede, og derfor kan der ikke drages konklusioner med hensyn til overlevelse.
English: However, to avoid the possible occurrence of harmful clinical deterioration due to potential rebound effect, gradual dose reduction (halving the dose for 3 to 7 days) should be considered.
Danish: For at undgå mulig forekomst af skadelig, klinisk forværring, der skyldes potentiel rebound-effekt, bør gradvis nedsættelse af dosis (halvering af dosis i 3 til 7 dage) dog overvejes.
English: STAYVEER is used to treat:
Danish: STAYVEER anvendes til at behandle:
English: Bosentan is highly bound (> 98%) to plasma proteins, mainly albumin.
Danish: Bosentan har en høj bindingsgrad (> 98%) til plasmaproteiner, især albumin.
English: It is important that you have these tests as ordered by your doctor.
Danish: Det er vigtigt, at De får foretaget disse test efter Deres læges anvisning.
English: The combination is not recommended.
Danish: Denne kombination anbefales ikke.
English: A volume of distribution (Vss) of about 18 litres was determined after an intravenous dose of 250 mg.
Danish: Et distributionsvolumen (Vss) på ca. 18 liter blev konstateret efter en intravenøs dosis på 250 mg.
English: The film-coated tablets are to be swallowed with water.
Danish: De filmovertrukne tabletter skal synkes med vand.
English: Anaemia may occasionally require blood transfusion
Danish: Anæmi kræver sommetider blodtransfusion
English: The primary endpoint for each study was change in 6-minute walk distance at 12 weeks for the first study and 16 weeks for the second study.
Danish: Det primære slutpunkt for hver undersøgelse var en ændring i 6-minutters gangdistance ved 12 uger for den første undersøgelse og 16 uger for den anden undersøgelse.
English: Warnings and precautions Tests your doctor will do before treatment
Danish: Advarsler og forsigtighedsregler Prøver, som Deres læge vil udføre før behandling
English: The side effects that have been reported in children treated with STAYVEER are the same as those in adults.
Danish: De bivirkninger, der er indberettet for børn og unge, der er blevet behandlet med STAYVEER, er de samme som for voksne.
English: EXP {MM/YYYY} Use within 30 days after the first opening
Danish: EXP {MM/ÅÅÅÅ} Anvendes inden for 30 dage efter anbrud
English: Re-introduction of treatment
Danish: Reintroduktion af behandlingen
English: Your monthly liver blood test schedule:
Danish: Deres månedlige leverblodprøve-plan:
English: Based on these findings and preclinical data, it cannot be excluded that bosentan may have a detrimental effect on spermatogenesis in men.
Danish: Baseret på disse resultater og prækliniske data kan det ikke udelukkes, at bosentan kan have en skadelig indvirkning på spermatogenesen hos mænd.
English: The consequences of these findings regarding hepatotoxicity are unknown.
Danish: Konsekvenserne af disse resultater med hensyn til hepatotoksicitet er ukendte.
English: There was evidence of a mild thyroid hormonal imbalance induced by bosentan in rats.
Danish: Der fandtes bevis på en let tyroid hormonel ubalance, som blev fremkaldt af bosentan hos rotter.
English: It is not known whether bosentan is excreted into human breast milk.
Danish: Det vides ikke, om bosentan udskilles i human mælk.
English: Uncontrolled clinical studies in paediatric patients
Danish: Ikke-kontrollerede kliniske studier med pædiatriske patienter
English: Control was placebo plus current therapy.
Danish: Kontrollen bestod af placebo plus aktuel behandling.
English: In both studies, treatment with bosentan resulted in significant increases in exercise capacity.
Danish: I begge studier resulterede behandlingen med bosentan i en signifikant forbedring af arbejdskapaciteten.
English: The majority of patients were diagnosed with idiopathic or heritable PAH (61%).
Danish: Størstedelen af patienterne havde diagnosen idiopatisk eller arvelig PAH (61%).
English: Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.
Danish: Tadalafil påvirkede ikke eksponeringen (AUC og Cmax) af bosentan eller dets metabolitter.
English: Therefore, you must not take STAYVEER if you are pregnant and you must also not become pregnant while taking STAYVEER.
Danish: Derfor må De ikke tage STAYVEER, hvis De er gravid, og De må heller ikke blive gravid, mens De tager STAYVEER.
English: Tell your doctor immediately if you become pregnant while you are taking STAYVEER, or plan to become pregnant in the near future.
Danish: Fortæl det omgående til Deres læge, hvis De bliver gravid, mens De tager STAYVEER, eller planlægger at blive gravid i nærmeste fremtid.
English: In the event of late clinical deterioration despite treatment with STAYVEER (i.e., after several months of treatment), the treatment should be re-assessed.
Danish: I tilfælde af sen klinisk forværring på trods af behandling med STAYVEER (dvs. efter flere måneders behandling) skal behandlingen revurderes.
English: Invasive haemodynamic parameters were assessed in the first study only.
Danish: Invasive hæmodynamiske parametre blev kun vurderet i den første undersøgelse.
English: • other medicines for the treatment of HIV infection, which may require special monitoring if used together with STAYVEER.
Danish: • andre lægemidler til behandling af hiv-infektion, da disse kan kræve speciel overvågning, hvis de tages sammen med STAYVEER.
English: Some improvements have also been shown in patients with class II PAH.
Danish: Der er også vist visse forbedringer hos patienter med klasse II-PAH.
English: The dose recommendation in children is only for PAH.
Danish: Doseringsanbefalingerne til børn gælder kun for PAH.
English: CL = confidence limit; PVR = pulmonary vascular resistance; SD = standard deviation.
Danish: CL = konfidensgrænse; PVR = pulmonal vaskulær modstand; SD = standardafvigelse
English: • inform patients of the need to avoid pregnancy and to ensure effective contraceptive measures are used.
Danish: • At informere patienterne om nødvendigheden af at undgå graviditet og sikre, at de anvender effektive præventionsmetoder.
English: No drug-drug interaction data are available with the other sulfonylureas.
Danish: Der foreligger ingen lægemiddelinteraktionsdata for de andre sulfonylurinstoffer.
English: Based on the investigated range of each variable, it is not expected that the pharmacokinetics of bosentan will be influenced by gender, body weight, race, or age in the adult population to any relevant extent.
Danish: Baseret på det undersøgte område for hver variabel forventes bosentans farmakokinetik ikke at blive påvirket af køn, legemsvægt, race eller alder i den voksne population i væsentlig grad.
English: If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with STAYVEER and to perform further tests to investigate the cause.
Danish: Hvis disse resultater er unormale, kan Deres læge beslutte at nedsætte Deres dosis eller stoppe behandlingen med STAYVEER og foretage yderligere prøver for at undersøge årsagen.
English: If you suspect you may be pregnant, tell your doctor or gynaecologist.
Danish: Hvis De tror, at De kan være gravid, skal De fortælle det til lægen eller gynækologen.
English: Due to limited data in children below 2 years of age, pharmacokinetics remain not well characterised in this age category.
Danish: På grund af begrænsede data fra børn under 2 år er farmakokinetikken endnu ikke tilstrækkeligt klarlagt i denne alderskategori.
English: Patients should be advised not to swallow the desiccant found in the white high-density polyethylene bottles.
Danish: Patienten skal rådes til ikke at sluge tørremidlet i de hvide polyethylenflasker af høj densitet.
English: Increasing the dose or the dosing frequency will likely not result in additional clinical benefit.
Danish: Øgning af dosis eller doseringshyppighed vil sandsynligvis ikke medføre yderligere klinisk gavnlig virkning.
English: The mechanism of this adverse effect is unclear.
Danish: Mekanismen for denne bivirkning er uklar.
English: • facilitate patients' awareness of the need for regular blood tests for liver function.
Danish: • At fremme patienternes opmærksomhed på nødvendigheden af regelmæssige blodprøver til undersøgelse af leverfunktion.
English: In healthy subjects, the absolute bioavailability of bosentan is approximately 50% and is not affected by food.
Danish: Hos raske individer er bosentans absolutte biotilgængelighed omkring 50% og påvirkes ikke af føde.
English: No dose adjustment is required in patients over the age of 65 years.
Danish: Der kræves ingen dosisjustering til patienter over 65 år.
English: Oral use Read the package leaflet before use
Danish: Oral anvendelse Læs indlægssedlen inden brug
English: Pharmacotherapeutic group: other antihypertensives, ATC code: C02KX01
Danish: Farmakoterapeutisk klassifikation: Andre antihypertensiva, ATC-kode: C02KX01
English: Massive overdose may result in pronounced hypotension requiring active cardiovascular support.
Danish: Massiv overdosering kan muligvis medføre udtalt hypotension, som kræver aktiv støtte af hjerte-kar-systemet.
English: Eisenmenger's physiology
Danish: Eisenmengers fysiologi
English: No dose adjustment of STAYVEER is considered necessary.
Danish: En justering af STAYVEER-dosis anses ikke for at være nødvendig.
English: This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Danish: Det høje tryk nedsætter den mængde ilt, der kan komme over i blodet i lungerne, og gør fysisk aktivitet vanskeligere.
English: Film-coated tablet (tablets):
Danish: Filmovertrukket tablet (tabletter):
English: The number of new digital ulcers from baseline to study endpoint was a primary endpoint in both studies.
Danish: Antallet af nye fingersår fra basalniveau til afslutningen af studiet var det primære mål i begge studier.
English: If you are a man taking STAYVEER, it is possible that this medicine may lower your sperm count.
Danish: Hvis du er en mand og tager STAYVEER, er det muligt, at dette lægemiddel kan nedsætte dit sædtal.
English: If a clinically relevant decrease in haemoglobin concentration occurs, further evaluation and investigation should be undertaken to determine the cause and need for specific treatment.
Danish: Hvis der sker et klinisk relevant fald i hæmoglobinkoncentrationen, skal der foretages en yderligere evaluering og undersøgelser bør iværksættes for at fastlægge årsagen og behovet for specifik behandling.
English: STAYVEER widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Danish: STAYVEER udvider de pulmonale arterier, hvilket gør det lettere for hjertet at pumpe blod igennem dem.
English: Neutropenia, leukopenia1
Danish: Neutropeni, leukopeni1
English: We suggest you write the date of your most recent test and also of your next test (ask your doctor for the date) on the Patient Alert Card, to help you remember when your next test is due.
Danish: Vi foreslår, at De noterer datoen for Deres sidste undersøgelse og ligeledes for Deres næste undersøgelse (spørg Deres læge angående datoen) på Deres patientadvarselskort.
English: Clearance and volume of distribution decrease with increased intravenous doses and increase with time.
Danish: Clearance og distributionsvolumen falder med forøgede intravenøse doser og forøges med tiden.