FrancophonIA/ELRC3.0 huggingface dataset:
English: What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Danish: Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2875 på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg tabletter irbesartan/hydrochlorthiazid
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg were 100%.
Danish: Forholdet mellem den laveste og den maksimale effekt af Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg var 100%, når blodtrykket blev monitoreret ambulant.
English: What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Danish: Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2876 på den anden side.
English: Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
Danish: Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg kan gives til patienter, hvis blodtryk ikke kan reguleres tilstrækkeligt med hydrochlorthiazid eller irbesartan 150 mg alene; Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg kan gives til patienter, der er utilstrækkeligt regulerede med irbesartan 300 mg eller med Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg.
English: What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Danish: Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2775 på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Danish: Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2776 på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: Lactose monohydrate Hypromellose
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Hypromellose Silikondioxid
English: This medicine has been prescribed for you.
Danish: Lægemidlet må kun udleveres efter recept.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets.
Danish: LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tabletter
English: WHAT IRBESARTAN HYDROCHLOROTHIAZIDE BMS IS AND WHAT IT IS USED FOR
Danish: Irbesartan Hydrochlorothiazide BMS indeholder:
English: Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide BMS hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Danish: Omvendt kan der opstå hyperkaliæmi på grund af irbesartankomponenten i Irbesartan Hydrochlorothiazide BMS.
English: The European Commission granted a marketing authorisation valid throughout the EU for Biograstim to CT Arzneimittel GmbH on 15 September 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Biograstim til CT Arzneimittel GmbH den 15. september 2008.
English: Other information about Biograstim:
Danish: Andre oplysninger om Biograstim:
English: This means that Biograstim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Danish: Det betyder, at Biograstim svarer til et biologisk lægemiddel, som allerede er godkendt i Den Europæiske Union (EU), og som indeholder det samme aktive stof (også kendt som "referencelægemidlet").
English: The Committee recommended that Biograstim be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Biograstim.
English: Biograstim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Danish: Biograstim kan også anvendes til patienter, der skal donere blodstamceller til transplantation, for at bidrage til at frigøre disse celler fra knoglemarven.
English: Biograstim is used to stimulate the production of white blood cells in the following situations:
Danish: Biograstim anvendes til at stimulere dannelsen af hvide blodlegemer i følgende tilfælde:
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Biograstim is being used for.
Danish: Andre bivirkninger kan optræde hos flere end 1 ud af 10 patienter, afhængig af den tilstand, som Biograstim anvendes til behandling af.
English: The active substance in Biograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Danish: Det aktive stof i Biograstim, filgrastim, svarer i høj grad til et humant protein kaldet granulocyt kolonistimulerende faktor (G-CSF).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BIOGRASTIM EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) BIOGRASTIM EPAR - Sammendrag for offentligheden
English: The most common side effect with Biograstim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Danish: Den hyppigste bivirkning ved Biograstim (som ses hos mere end 1 ud af hver 10 patienter) er muskelsmerter (smerter i muskler og knogler).
English: The full EPAR for Biograstim can be found here.
Danish: Den fuldstændige EPAR for Biograstim findes her.
English: Biograstim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Danish: Biograstim bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for filgrastim eller andre af indholdsstofferne.
English: Biograstim is a ‘biosimilar' medicine.
Danish: Biograstim er et ‘biosimilært' lægemiddel.
English: Biograstim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Danish: Biograstim blev sammenlignet med Neupogen og placebo (en virkningsløs behandling) i en hovedundersøgelse af 348 patienter med brystcancer.
English: To study the safety of Biograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
Danish: For at undersøge sikkerheden af Biograstim blev der gennemført to undersøgelser af patienter med lungecancer og non-Hodgkin's lymfom (en form for lymfekræft).
English: During the first 21-day chemotherapy cycle, patients treated with either Biograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Danish: I løbet af deres første kemoterapicyklus på 21 dage havde patienter behandlet med Biograstim eller Neupogen svær neutropeni i gennemsnitligt 1,1 dag sammenlignet med 3,8 dage hos dem, der fik placebo.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Biograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at Biograstim i overensstemmelse med EU's krav har en profil med hensyn til kvalitet, sikkerhed og virkning, som svarer til Neupogen.
English: For the full list of all side effects reported with Biograstim, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Biograstim fremgår af indlægssedlen.
English: What is the risk associated with Biograstim?
Danish: Hvilken risiko er der forbundet med Biograstim?
English: The reference medicine for Biograstim is Neupogen.
Danish: Referencelægemidlet for Biograstim er Neupogen.
English: Biograstim is given by injection under the skin or infusion into a vein.
Danish: Biograstim gives ved injektion under huden eller ved infusion i en vene.
English: Biograstim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Danish: Biograstim gives sædvanligvis på et specialiseret behandlingscenter, selvom de patienter, der får lægemidlet gennem injektion under huden,
English: Biograstim is a solution for injection or for infusion (drip into a vein).
Danish: Biograstim er en opløsning til injektion eller infusion (drop i en vene).
English: Biograstim was studied to show that it is comparable to the reference medicine, Neupogen.
Danish: Biograstim blev undersøgt for at påvise, at det er sammenligneligt med referencelægemidlet Neupogen.
English: Why has Biograstim been approved?
Danish: Hvorfor blev Biograstim godkendt?
English: Therefore, the effectiveness of Biograstim was shown to be equivalent to that of Neupogen.
Danish: Virkningen af Biograstim viste sig derfor at svare til virkningen af Neupogen.
English: Treatment with Biograstim and Neupogen brought about similar reductions in duration of severe neutropenia.
Danish: Behandling med Biograstim mindskede varigheden af svær neutropeni på tilsvarende måde som Neupogen.
English: What is Biograstim used for?
Danish: Hvad anvendes Biograstim til?
English: What benefit has Biograstim shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Biograstim?
English: How has Biograstim been studied?
Danish: Hvordan blev Biograstim undersøgt?
English: What is Biograstim?
Danish: Hvad er Biograstim?
English: How is Biograstim used?
Danish: Hvordan anvendes Biograstim?
English: How does Biograstim work?
Danish: Hvordan virker Biograstim?
English: Date of first authorisation: 15 May 2002 Date of latest renewal: 20 April 2012
Danish: Dato for første markedsføringstilladelse: 15. maj 2002 Dato for seneste fornyelse: 20. april 2012
English: Comparison between formulations
Danish: Sammenligning af formuleringer
English: Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about Tracleer ask your doctor.
Danish: Deres Navn: _____________________________________________ Ordinerende læge: ______________________________________ Spørg Deres læge, hvis De har nogen spørgsmål vedrørende Tracleer.
English: Use enough water to cover the whole tablet.
Danish: Brug nok vand til at dække hele tabletten.
English: Push the pharmaceutical product through the foil.
Danish: Tryk lægemidlet gennem folien.
English: Important Safety Alerts for Patients taking Tracleer (bosentan)
Danish: Vigtige sikkerhedsadvarsler for patienter, der tager Tracleer (bosentan)
English: The PAH for which Tracleer is indicated can be:
Danish: Den PAH, som Tracleer er indiceret for, kan være:
English: 56 dispersible tablets (14 x 4)
Danish: 56 dispergible tabletter (14 x 4)
English: Tracleer should only be initiated if the systemic systolic blood pressure is higher than 85 mmHg.
Danish: Tracleer behandling bør kun påbegyndes, hvis det systemiske systoliske blodtryk er over 85 mmHg.
English: However, some patients who show no response after 8 weeks of treatment with Tracleer 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 Tracleer, kan dog reagere positivt efter yderligere 4 til 8 ugers behandling.
English: This card contains important information about Tracleer.
Danish: Dette kort indeholder vigtige oplysninger om Tracleer.
English: Tracleer is used to treat:
Danish: Tracleer anvendes til at behandle:
English: It is important that you have these regular blood tests as long as you are taking Tracleer.
Danish: Det er vigtigt, at De får foretaget disse blodundersøgelser regelmæssigt, så længe De tager Tracleer.
English: The side effects that have been reported in children treated with Tracleer are the same as those in adults.
Danish: De bivirkninger, der er indberettet for børn og unge, der er blevet behandlet med Tracleer, er de samme som for voksne.
English: CL = confidence limit; PVR = pulmonary vascular resistance; SD = standard deviation.
Danish: CL = konfidensgrænse; PVR = pulmonal vaskulær modstand; SD = standardafvigelse.
English: • other medications for the treatment of pulmonary hypertension: sildenafil and tadalafil;
Danish: • andre lægemidler til behandling af pulmonal hypertension: sildenafil og tadalafil;
English: This medicine contains 3.7 mg of aspartame in each dispersible tablet.
Danish: Dette lægemiddel indeholder 3,7 mg aspartam i hver dispergibel tablet.
English: Leave for about one minute, until the tablet has fully dissolved, and then swallow all of the liquid.
Danish: Vent i cirka ét minut indtil tabletten er fuldstændig opløst og synk derefter al væsken.
English: The most serious side effects with Tracleer are
Danish: De alvorligste bivirkninger ved Tracleer er
English: In the event of late clinical deterioration despite treatment with Tracleer (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 Tracleer (dvs. efter flere måneders behandling) skal behandlingen revurderes.
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-karsystemet.
English: Thus its use in adults should be reserved for patients who cannot take the film-coated tablet.
Danish: Anvendelsen heraf hos voksne bør derfor begrænses til patienter, som ikke kan indtage de filmovertrukne tabletter.
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 og dets metabolitter.
English: Aspartame is a source of phenylalanine.
Danish: Aspartam er en fenylalaninkilde.
English: If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with Tracleer 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 Tracleer og foretage yderligere prøver for at undersøge årsagen.
English: • warfarin (an anticoagulant agent);
Danish: • warfarin (et antikoagulerende middel);
English: When the tablet has fully dissolved, give the liquid to the patient.
Danish: Når tabletten er helt opløst, gives væsken til patienten.
English: Tracleer widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Danish: Tracleer udvider de pulmonale arterier, hvilket gør det lettere for hjertet at pumpe blod igennem dem.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Tracleer, and regularly while you are taking Tracleer.
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 Tracleer, og regelmæssigt mens De tager Tracleer.
English: Tracleer with food and drink
Danish: Brug af Tracleer sammen med mad og drikke
English: Aspartame (E951), see the package leaflet for further information Aspartame (E951) may be harmful for people with phenylketonuria
Danish: Aspartam (E951), se indlægssedlen for yderligere information Aspartam (E951) kan være skadelig for personer med fenylketonuri
English: Tell your doctor immediately if you become pregnant while you are taking Tracleer, or plan to become pregnant in the near future.
Danish: Fortæl det omgående til Deres læge, hvis De bliver gravid, mens De tager Tracleer, eller planlægger at blive gravid i nærmeste fremtid.
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Danish: Det kan være skadeligt, hvis De har fenylketonuri (PKU), som er en sjælden genetisk lidelse, hvor fenylalanin ophobes, fordi kroppen ikke kan fjerne det ordentligt.
English: No dose adjustment of Tracleer is considered necessary.
Danish: En justering af Tracleer-dosis anses ikke for at være nødvendig.
English: Long-term data were generated from all 173 patients who were treated with bosentan in the controlled phase and/or were switched from placebo to bosentan in the open-label extension phase of the EARLY study.
Danish: Langtidsdata blev genereret fra alle 173 patienter, som blev behandlet med bosentan i den kontrollerede fase, og/eller som skiftede fra placebo til bosentan i den åbne udvidede fase af EARLYstudiet.
English: Suddenly stopping your treatment with Tracleer may lead to your symptoms getting worse.
Danish: Hvis De pludselig stopper behandlingen med Tracleer, kan det medføre, at Deres symptomer forværres.
English: If you have the impression that the effect of Tracleer is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed.
Danish: Hvis De mener, at virkningen af Tracleer er for kraftig eller for svag, skal De tale med Deres læge om en eventuel justering af dosis.
English: If the decision to withdraw Tracleer is taken, it should be done gradually while an alternative therapy is introduced.
Danish: Hvis det besluttes at seponere Tracleer, skal dette gøres gradvist, mens en alternativ behandling indledes.
English: • other medicines for the treatment of HIV infection, which may require special monitoring if used together with Tracleer.
Danish: • andre lægemidler til behandling af hiv-infektion, da disse kan kræve speciel overvågning, hvis de tages sammen med Tracleer.
English: Pharmacotherapeutic group: other antihypertensives, ATC code: C02KX01
Danish: Farmakoterapeutisk klassifikation: Andre antihypertensiva, ATC-kode: C02KX01 Virkningsmekanisme
English: This may be harmful for people with phenylketonuria.
Danish: Kan være skadelig for patienter med fenylketonuri.
English: In the post-marketing period there was one reported overdose of 10,000 mg of Tracleer taken by an adolescent male patient.
Danish: I perioden efter markedsføring blev der rapporteret ét tilfælde med en overdosis på 10.000 mg Tracleer, som blev taget af en ung mandlig patient.
English: If you are a man taking Tracleer, it is possible that this medicine may lower your sperm count.
Danish: Hvis du er en mand og tager Tracleer, er det muligt, at dette lægemiddel kan nedsætte dit sædtal.
English: The dispersible tablet has been studied only in paediatric patients.
Danish: Den dispergible tablet er kun undersøgt hos pædiatriske patienter.
English: Tracleer may harm unborn babies conceived before starting or during treatment.
Danish: Tracleer kan skade ufødte børn, som er undfanget før eller under behandlingen.
English: Recommendations in the event of ALT/AST elevations
Danish: Anbefalinger i tilfælde af forøgelse af ALAT/ASAT
English: Therefore, you must not take Tracleer if you are pregnant and you must also not become pregnant while taking Tracleer.
Danish: Derfor må De ikke tage Tracleer, hvis De er gravid, og De må heller ikke blive gravid, mens De tager Tracleer.
English: Your liver and blood values will be monitored during treatment with Tracleer (see section 2).
Danish: Deres lever- og blodværdier vil blive overvåget under behandlingen med Tracleer (se pkt.
English: Tracleer can be taken with or without food.
Danish: Tracleer kan tages sammen med mad eller uden mad.
English: If you notice any of these signs tell your doctor immediately.
Danish: Hvis De opdager et eller flere af disse tegn, skal De omgående fortælle det til Deres læge.
English: Inside your pack of Tracleer tablets you will find a Patient Alert Card which you should read carefully.
Danish: Inden i pakningen med Tracleer-tabletter finder De et patientadvarselskort, som De skal læse omhyggeligt.
English: There are no studies to demonstrate beneficial effects of Tracleer treatment on survival.
Danish: Der foreligger ingen studier med formålet at vise fordelagtige virkninger af behandling med Tracleer på overlevelse.
English: These will be done every month for the duration of treatment with Tracleer.
Danish: Disse vil blive foretaget hver måned i behandlingsperioden med Tracleer.
English: In the event of clinical deterioration (e.g., decrease in 6-minute walk test distance by at least 10% compared with pre-treatment measurement) despite Tracleer treatment for at least 8 weeks (target dose for at least 4 weeks), alternative therapies should be considered.
Danish: I tilfælde af klinisk forværring (f.eks. mindst 10% reduktion i 6-minutters gangdistance i sammenligning med målinger inden behandlingens start) på trods af Tracleer behandling i mindst 8 uger (måldosis i mindst 4 uger), bør alternativ behandling overvejes.
English: - The active substance is bosentan as monohydrate.
Danish: - Aktivt stof: bosentan som monohydrat.
English: What you need to know before you take Tracleer Do not take Tracleer:
Danish: Det skal De vide, før De begynder at tage Tracleer Tag ikke Tracleer: