FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL WARNING(S), IF NECESSARY This product has corrosive properties.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Virker ætsende.
English: Labelling
Danish: Etikettering
English: Applicable to all products except those containing a polymethacrylate-triethylcitrate coating as modified-release mechanism.
Danish: Gælder alle produkter undtagen dem, som indeholder polymethacrylat-triethylcitrat-overtræk som mekanisme til modificeret udløsning.
English: Any existing warnings on the interaction with alcohol should be deleted.
Danish: Alle eksisterende advarsler om interaktion med alkohol bør slettes.
English: It is recommended not to drink alcohol while you're taking {product name}.
Danish: Det anbefales ikke at drikke alkohol, mens du tager {lægemidlets navn}.
English: Note: These amendments to the SPC, Package Leaflet and Labelling are valid at the time of the Commission Decision.
Danish: Bemærk: Disse ændringer af produktresumé, indlægsseddel og etikettering er gyldige på tidspunktet for Kommissionens afgørelse.
English: Summary of Product Characteristics 4.4 Special warnings and precautions for use
Danish: Produktresume 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Package Leaflet Section 2 - Before you take {product name}
Danish: Indlægsseddel Sektion 2 - Det skal du vide, før du begynder at tage {lægemidlets navn}
English: Drinking alcohol whilst taking {product name} may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness.
Danish: Hvis du drikker alkohol, mens du tager {lægemidlets navn}, kan du føle dig mere søvnig eller øge risikoen for alvorlige bivirkninger, såsom overfladisk vejrtrækning med risiko, for at åndedrættet ophører, eller bevidstløshed.
English: Alcohol may enhance the pharmacodynamic effects of {product name}; concomitant use should be avoided.
Danish: Alkohol kan forstærke de farmakodynamiske virkninger af {lægemidlets navn}; samtidig brug bør undgås.
English: For products not having warnings regarding the interaction with alcohol in the currently approved SPC and package leaflet, the below wording should be added.
Danish: For produkter uden advarsel om interaktion med alkohol i det nuværende godkendte produktresumé og den godkendte indlægsseddel, bør nedenstående ordlyd tilføjes.
English: For products having warnings regarding the interaction with alcohol, the existing wording in the SPC and package leaflet should be replaced by the wording below.
Danish: For produkter med advarsel om interaktion med alkohol bør den nuværende ordlyd i produktresuméet og indlægssedlen erstattes af nedenstående ordlyd.
English: Amendments to be included in the relevant sections of the Summary of Products Characteristics, Package Leaflet and labelling
Danish: Ændringer, som skal tilføjes de relevante punkter i produktresuméet, etiketteringen og indlægssedlen
English: Relevant Sections of the Summary of Product Characteristics, Package Leaflet and labelling
Danish: Relevante punkter i produktresuméet, etiketteringen og indlægssedlen
English: Concomitant use of alcohol and {product name} may increase the undesirable effects of {product name}; concomitant use should be avoided.
Danish: Hvis {produkt navn} tages sammen med alkohol, kan bivirkningerne af {lægemidlets navn} øges; samtidig brug bør undgås.
English: This is the maximum dose.
Danish: Dette er den maksimale dosis.
English: It is taken as one tablet a day, preferably at the same time of the day.
Danish: Der tages én tablet om dagen, helst på samme tidspunkt hver dag.
English: The marketing authorisation holder is Pfizer Limited.
Danish: Indehaveren af markedsføringstilladelsen er Pfizer Limited.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thelin on 10 August 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Thelin den 10. august 2006.
English: If after 12 weeks the patient's condition is getting worse, then the doctor should review the treatment.
Danish: Hvis patientens tilstand forværres efter 12 uger, skal lægen vurdere behandlingen igen.
English: The patient's liver should be monitored before and during the treatment.
Danish: Patientens leverfunktion skal overvåges før og under behandling.
English: Before treatment, the patients could walk around 366 metres in six minutes.
Danish: Inden behandlingen kunne patienterne gå ca. 366 meter på seks minutter.
English: Other information about Thelin:
Danish: Andre oplysninger om Thelin:
English: This document is a summary of the European public assessment report (EPAR) for Thelin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Thelin.
English: The study measured the improvement in exercise capacity by looking at the change in how far the patients could walk in six minutes after 12 to 18 weeks of treatment.
Danish: Undersøgelsen målte forbedringen i fysisk kapacitet ved at se på ændringen i den afstand, patienterne kunne gå på seks minutter efter 12 til 18 ugers behandling.
English: Thelin was more effective than placebo at improving exercise capacity.
Danish: Thelin var mere effektivt end placebo til at forbedre den fysiske kapacitet.
English: It is available as yellow-toorange, capsule-shaped tablets (100 mg).
Danish: Det fås som gulorange, kapselformede tabletter (100 mg).
English: In the patients with class III disease, this was around 46 metres.
Danish: Hos patienter med klasse III-sygdom var dette ca. 46 meter.
English: After 12 to 18 weeks, this distance had increased by 33 metres more in the patients taking 100 mg Thelin than in the patients taking placebo.
Danish: Efter 12 til 18 uger var denne distance øget med 33 meter mere hos patienter, som tog 100 mg Thelin, end hos patienter, som tog placebo.
English: Because the number of patients with pulmonary arterial hypertension is low, the disease is considered ‘rare', and Thelin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 October 2004.
Danish: Da antallet af patienter med pulmonal arteriel hypertension er lavt, betragtes sygdommen som ”sjælden”, og Thelin blev udpeget som ”lægemiddel til sjældne sygdomme” den 21. oktober 2004.
English: Three doses of Thelin (50, 100 and 300 mg) have been compared with placebo (a dummy treatment) in three main studies involving a total of 523 patients with PAH, most of whom had class II or III disease.
Danish: Tre doser Thelin (50, 100 og 300 mg) er blevet sammenlignet med placebo (en virkningsløs behandling) i tre hovedundersøgelser af i alt 523 patienter med PAH, hvoraf de fleste havde klasse IIeller III-sygdom.
English: The ‘class' reflects the seriousness of the disease: ‘class III' involves marked limitation of physical activity.
Danish: Klassen afspejler sygdommens sværhedsgrad: Klasse III betyder således, at den fysiske aktivitet er markant begrænset.
English: The most common side effect with Thelin (seen in more than 1 patient in 10) is headache.
Danish: Den hyppigste bivirkning ved Thelin (som ses hos flere end 1 ud af 10 patienter) er hovedpine.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Thelin.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Thelin.
English: Thelin should only be started and monitored by a doctor who has experience in the treatment of PAH.
Danish: Behandling med Thelin bør kun indledes og overvåges af en læge med erfaring i behandling af PAH.
English: For more information about treatment with Thelin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Thelin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Thelin is a medicine that contains the active substance sitaxentan sodium.
Danish: Thelin er et lægemiddel, der indeholder det aktive stof sitaxentannatrium.
English: Thelin is used to treat adults (aged 18 years or over) with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Danish: Thelin anvendes til behandling af voksne (18 år og derover) med pulmonal arteriel hypertension (PAH) for at forbedre den fysiske kapacitet (evnen til at udføre fysisk aktivitet).
English: The CHMP concluded that Thelin had shown an effectiveness that was as expected for this class of medicines.
Danish: CHMP konkluderede, at Thelin har vist sig at være virksomt, og at virkningen var som forventet for denne klasse af lægemidler.
English: The company will also set up a system to monitor Thelin's side effects, suspected interactions with other medicines and the outcome of any pregnancies that may happen in women using the medicine.
Danish: Virksomheden skal også iværksætte et system til overvågning af bivirkninger ved Thelin, formodede bivirkninger ved indtagelse sammen med andre lægemidler og resultatet af enhver graviditet hos kvinder, der anvender lægemidlet.
English: Therefore, the Committee decided that Thelin's benefits are greater than its risks for patients with class III disease and recommended that it be given marketing authorisation.
Danish: Derfor besluttede udvalget, at fordelene ved Thelin er større end risiciene for patienter med klasse III-sygdom, og anbefalede udstedelse af markedsføringstilladelse for Thelin.
English: However, the effectiveness was only considered sufficient in patients with class III disease.
Danish: Virkningen blev dog kun anset som tilstrækkelig hos patienter med klasse III-sygdom.
English: This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Danish: Et sådant blodtryk reducerer den mængde ilt, der kan komme ind i blodet i lungerne, og gør fysisk aktivitet vanskeligere.
English: See the package leaflet for full details.
Danish: Se indlægssedlen for at få mere detaljerede oplysninger.
English: The full EPAR for Thelin can be found here.
Danish: Den fuldstændige EPAR for Thelin findes her.
English: Thelin is used in patients with class III disease.
Danish: Thelin anvendes til patienter med klasse III-sygdom.
English: What measures are being taken to ensure the safe use of Thelin?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Thelin?
English: Caution is needed when Thelin is taken at the same time as some other medicines.
Danish: Der skal udvises forsigtighed, når Thelin tages sammen med visse andre lægemidler.
English: The active substance in Thelin, sitaxentan sodium, blocks the receptors for a hormone called endothelin-1 (ET-1), which causes blood vessels to constrict.
Danish: Det aktive stof i Thelin, sitaxentannatrium, blokerer receptorerne for et hormon kaldet endothelin-1 (ET-1), som forårsager forsnævring af blodkarrene.
English: Thelin has been shown to be effective in PAH with no identified cause and PAH caused by connective tissue disease.
Danish: Thelin har vist sig at være effektivt til behandling af PAH uden påviselig årsag og PAH forårsaget af bindevævssygdom.
English: Thelin must not be used in women who are breastfeeding.
Danish: Thelin må ikke anvendes til kvinder, som ammer.
English: What is the risk associated with Thelin?
Danish: Hvilken risiko er der forbundet med Thelin?
English: The company that makes Thelin will provide doctors and patients with educational material about the medicine.
Danish: Den virksomhed, som fremstiller Thelin, skal fremlægge oplysningsmateriale til læger og patienter vedrørende lægemidlet.
English: Thelin must not be taken with ciclosporin A (a medicine used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver and kidney transplants).
Danish: Thelin må ikke indtages sammen med ciclosporin A (et lægemiddel, som anvendes til behandling af psoriasis og leddegigt og til at forebygge afstødning af lever- og nyretransplantater).
English: By blocking the effect of ET-1, Thelin allows the vessels to dilate (expand), helping to lower the blood pressure and improving symptoms.
Danish: Ved at blokere virkningen af ET-1 gør Thelin det muligt for karrene at udvide sig (dilatere), og dette medvirker til at sænke blodtrykket og forbedre symptomerne.
English: It must not be used in patients who have mild to severe problems with their liver or raised levels of some liver enzymes.
Danish: Det må ikke anvendes af patienter, der har milde til alvorlige leverproblemer eller forhøjede niveauer af visse leverenzymer.
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Danish: PAH er et unormalt højt blodtryk i lungernes arterier.
English: Thelin should not be used in people who may be hypersensitive (allergic) to sitaxentan sodium or any of the other ingredients.
Danish: Thelin må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for sitaxentannatrium eller et eller flere af de øvrige indholdsstoffer.
English: It causes high blood pressure in the vessels taking blood from the heart to the lungs.
Danish: Den medfører højt blodtryk i de blodkar, der fører blodet fra hjertet til lungerne.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Thelin is available here.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Thelin findes her.
English: What is Thelin?
Danish: Hvad er Thelin?
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Danish: PAH er en invaliderende sygdom, der består i svær konstriktion (forsnævring) af blodkarrene i lungerne.
English: Why has Thelin been approved?
Danish: Hvorfor blev Thelin godkendt?
English: For the full list of all side effects reported with Thelin, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Thelin fremgår af indlægssedlen.
English: Thelin sitaxentan sodium
Danish: Thelin sitaxentannatrium
English: What is Thelin used for?
Danish: Hvad anvendes Thelin til?
English: How has Thelin been studied?
Danish: Hvordan blev Thelin undersøgt?
English: What benefit has Thelin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Thelin?
English: How is Thelin used?
Danish: Hvordan anvendes Thelin?
English: How does Thelin work?
Danish: Hvordan virker Thelin?
English: This can cause damage to the affected areas.
Danish: Det kan giver skader i de berørte områder.
English: Reabsorption is not complete.
Danish: Reabsorptionen er ikke fuldstændig.
English: Liver function should also be monitored.
Danish: Leverfunktionen skal også monitoreres.
English: The suspension is stable for up to 7 days.
Danish: Suspensionen er stabil i op til 7 dage.
English: If you stop taking this medicine your symptoms may worsen.
Danish: Hvis du holder op med at tage lægemidlet, kan dine symptomer blive værre.
English: Date of first authorisation: 10/04/2017
Danish: Dato for første markedsføringstilladelse: 10/04/2017
English: The capsules can be taken with or without food.
Danish: Kapslerne kan tages sammen med eller uden mad.
English: Data exists only in the adult population.
Danish: Der foreligger kun data for den voksne population.
English: Efficacy and safety was studied in two retrospective trials in two centres in Europe.
Danish: Virkning og sikkerhed er undersøgt i 2 retrospektive studier på 2 centre i Europa.
English: Side effects of unknown frequency (cannot be estimated from the available data)
Danish: Bivirkninger med ukendt hyppighed (kan ikke vurderes ud fra tilgængelige data)
English: Take your next dose when you would normally take it. Do not take a double dose to make up for a forgotten dose.
Danish: Tag den næste dosis, når det er tid til at tage den. Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Divided dose*
Danish: Opdelt dosis*
English: The three adverse reactions were all nonserious.
Danish: De 3 bivirkninger var alle ikke-alvorlige.
English: However, these patients should be carefully monitored and the dose titrated individually.
Danish: Disse patienter skal monitoreres omhyggeligt og dosis titreres individuelt.
English: Germany e-mail: info@leadiantbiosciences.com
Danish: Tyskland e-mail: info@leadiantbiosciences.com
English: *number of divided doses dependant on advice from doctor.
Danish: *antal delte doser afhængigt af lægens anbefaling.
English: Telephone: +49 (0)89 5506675 - 0 Fax: +49 (0) 89 55 066 75 25 e-mail: info@leadiantbiosciences.com
Danish: Telefon: +49 (0)89 5506675 - 0 Fax: +49 (0) 89 55 066 75 25 e-mail: info@leadiantbiosciences.com
English: Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Danish: Lægen vil fortælle dig, hvor mange kapsler du skal tage, og hvornår du skal tage kapslerne.
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er inddelt i henhold til systemorganklasse og efter følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Take care to scrape any powder from the side of the bowl into the mixture and stir (for about 5 minutes) to make sure that there are no lumps.
Danish: Sørg for at skrabe pulver af skålens sider og ned i blandingen, og omrør (i ca. 5 minutter) for at sikre, at der ikke er nogen klumper.
English: In babies and children the dose will be calculated from the child's weight.
Danish: Hos spædbørn og børn beregnes dosis ud fra barnets vægt.
English: Study resultsPSUR and annual reassessments
Danish: StudieresultaterPSUR og årlige revurderinger
English: Paediatric population (1 month -18 years)
Danish: Pædiatrisk population (1 måned-18 år)
English: The requirements for submission of periodic safety update 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 webportal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-reference-datoer (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: You should contact your doctor for advice if you or your child has taken more than the amount prescribed.
Danish: Du skal kontakte lægen, hvis du eller dit barn har taget mere end den ordinerede mængde.
English: This substance is normally produced by the liver from cholesterol.
Danish: Dette stof produceres normalt af leveren ud fra kolesterol.
English: Do not use this medicine after the expiry date which is stated on the carton and blister pack after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterpakningen efter ”anv.
English: Limited safety data are available (see section 4.8).
Danish: Der foreligger begrænsede sikkerhedsdata (se pkt.
English: MedDRA System Organ Class Preferred term
Danish: Systemorganklasse i henhold til MedDRA Foretrukken betegnelse
English: Please speak to your doctor if you are taking any of these medicines.
Danish: Tal med lægen, hvis du tager et af disse lægemidler.
English: (aluminium oxide)
Danish: (aluminiumoxid)
English: Reabsorption of chenodeoxycholic acid is variable (29 - 84%).
Danish: Reabsorption af chenodeoxycholsyre varierer (29-84 %).
English: The suspension produced contains 22.9 mg of sodium per mL, which needs to be taken into consideration by patients on a controlled sodium diet.
Danish: Suspension indeholder 22,9 mg natrium pr. ml, hvilket skal tages i betragtning hos patienter på en natriumkontrolleret diæt.
English: This medicine is for long-term use.
Danish: Dette lægemiddel skal anvendes i lang tid.
English: Patients who are unable to swallow capsules
Danish: Patienter, som ikke kan synke kapsler
English: Stir the mixture until all the powder is in suspension.
Danish: Blandingen omrøres, indtil alt pulver er opslæmmet.
English: Developmental toxicity studies in rats, hamsters and primates showed an absence of teratogenic effects.
Danish: Udviklingsstudier hos rotter, hamstere og primater viste fravær af teratogene virkninger.
English: Use in children (aged one month to 18 years)
Danish: Børn (i alderen 1 måned til 18 år)
English: However, parkinsonian symptoms, a rare disease manifestation/association that occurred in only 2 patients during the course of the study, did not respond.
Danish: Parkinsonlignende symptomer, der er en sjælden sygdomsmanifestation/-association og kun forekom hos 2 patienter under studiet, responderede ikke.
English: Epilepsy resolved in 100% (3/3 patients) and polyneuropathy stabilised or improved in 100% (11/11).
Danish: Epilepsi forsvandt hos 100 % (3/3 patienter), og polyneuropati blev stabiliseret eller forbedret hos 100 % (11/11).
English: The presented safety information for hepatic adverse reactions is derived from paediatric patients.
Danish: De fremlagte sikkerhedsoplysninger for leverbivirkninger stammer fra pædiatriske patienter.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at rapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: There was a statistically significant (p = 0.04) improvement (decrease) of -0.31 ± 0.48 in the mean Rankin score for the < 21 years of age subgroup.
Danish: Der var en statistisk signifikant (p = 0,04) forbedring (fald) på0,31 ±0,48 i den gennemsnitlige Rankin-score for undergruppen <21 år.
English: The safety and efficacy in neonates less than one month of age has not been established.
Danish: Sikkerhed og virkning hos nyfødte under 1 måned er ikke klarlagt.
English: Ciclosporin and sirolimus
Danish: Ciclosporin og sirolimus
English: • ciclosporin and sirolimus (medicines used to suppress the immune system)
Danish: • ciclosporin og sirolimus (lægemidler, der bruges til at undertrykke immunsystemet)
English: A pharmacy label should be placed on the bottle and include the patient's name, dosing instructions, use by date, name of medicinal product and any other required information to be in compliance with local pharmacy regulations.
Danish: Der skal anbringes en apotekslabel på glasflasken med patientens navn, doseringsvejledning, udløbsdato, lægemidlets navn og eventuelle andre oplysninger, som er nødvendige for at overholde gældende farmaceutisk lovgivning.
English: 100 hard capsules
Danish: 100 hårde kapsler
English: Diarrhoea disappeared in 100% (23/23 patients) of the patients who had this symptom at baseline.
Danish: Diarré forsvandt hos 100 % (23/23 patienter) af de patienter, som havde dette symptom ved baseline.
English: - if you are allergic to chenodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6)
Danish: - hvis du er allergisk over for chenodeoxycholsyre eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Signs and symptoms of the disease remained stable in most of the patients.
Danish: Sygdomssymptomerne var stabile hos de fleste patienter.