FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recommended that Entacapone Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Entacapone Teva.
English: Why has Entacapone Teva been approved?
Danish: Hvorfor blev Entacapone Teva godkendt?
English: What is Entacapone Teva?
Danish: Hvad er Entacapone Teva?
English: How has Entacapone Teva been studied?
Danish: Hvordan blev Entacapone Teva undersøgt?
English: How is Entacapone Teva used?
Danish: Hvordan anvendes Entacapone Teva?
English: What is Entacapone Teva used for?
Danish: Hvad anvendes Entacapone Teva til?
English: How does Entacapone Teva work?
Danish: Hvordan virker Entacapone Teva?
English: 20 October 2015 EMA/498568/2015
Danish: Den 20. oktober 2015 EMA/498568/2015
English: Caraway fruit medicines should only be used in adults and adolescents over the age of 12 years.
Danish: Lægemidler indeholdende kommen bør kun anvendes hos voksne og hos børn over 12 år.
English: Caraway fruit medicines must not be used in patients who are hypersensitive (allergic) to caraway fruit or other plants of the Apiaceae (Umbelliferae) family (fennel, anise, celery, coriander and dill), to mugwort or birch.
Danish: Lægemidler med kommen må ikke anvendes til patienter, der er allergiske (overfølsomme) overfor kommen eller andre planter fra skærmplantefamilien (f.eksfennikel, anis, selleri, koriander og dild), bynke eller birk.
English: Caraway fruit EMA/498568/2015
Danish: Kommen EMA/498568/2015
English: Caraway fruit is the common name for the fruit of the plant Carum carvi L. The plant is cultivated or gathered to obtain the fruit for medicinal use.
Danish: Kommen er fællesnavnet for frugter af planten Carum carvi L. Planten dyrkes eller indsamles for at anvende frugten til medicinsk brug.
English: Information on the use and licensing of caraway fruit medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder kommen, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: Any applications for the licensing of medicines containing caraway fruit have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder kommen, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Further information on the HMPC assessment of caraway fruit medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder kommen, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with caraway fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder kommen, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: How are caraway fruit medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder kommen, i EU?
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing caraway fruit.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder kommen.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of caraway fruit.
Danish: Dette er et sammendrag af Komiteen for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af kommen.
English: This summary is not intended to provide practical advice on how to use medicines containing caraway fruit.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder kommen, anvendes.
English: If symptoms last longer than two weeks during treatment, a doctor or a qualified healthcare practitioner should be consulted.
Danish: Hvis symptomerne varer længere end to ugerved samtidig brug af kommen, bør der søges råd hos en læge eller på apoteket.
English: Detailed instructions on how to take caraway fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler med kommen skal anvendes, og hvem der ka bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: The HMPC noted the lack of clinical studies on the effects of caraway fruit in patients, but took into account the well documented use of this herbal medicine for the above-mentioned use.
Danish: HMPC har i sin vurdering taget til efterretning, at der ikke foreligger tilstrækkelige kliniske data, men har derimod taget hensyn til den veldokumenterede og langvarige anvendelse af kommen til ovenstående formål.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The HMPC concluded that, on the basis of its long-standing use, caraway fruit medicines can be used for the relief of problems of the digestive system such as bloating and flatulence.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at kommen kan anvendes til at lindre symptomer fra fordøjelsessystemet såsom oppustethed og tarmluft.
English: Other information about caraway fruit medicines
Danish: Andre oplysninger om lægemidler, der indeholder kommen
English: What are the risks associated with caraway fruit medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder kommen?
English: For more information about treatment with caraway fruit medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder kommen, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What evidence supports the use of caraway fruit medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af lægemidler med kommen?
English: For practical information about using caraway fruit medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med kommen, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC conclusions on the use of caraway fruit medicines for the relief of digestive problems such as bloating and flatulence are based on their ‘traditional use' in this condition.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med kommen er baseret på lægemidlernes "traditionelle anvendelse" til ved behandling af oppustethed og tarmluft.
English: Herbal medicines containing whole or comminuted (reduced into tiny pieces) caraway fruit are usually available as a herbal tea to be drunk.
Danish: Plantelægemidler med kommen fås normalt som findelt materiale til fremstilling af urtete beregnet til at drikke.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is
Danish: Det betyder, at selvom der ikke foreligger tilstrækkelig dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (herunder mindst 15 år i EU).
English: Powder: 3 years.
Danish: Pulver: 3 år
English: If you have liver problems, this period might be longer.
Danish: Hvis De har leverproblemer, kan denne periode være længere.
English: If more than this is required, the system should be checked.
Danish: Hvis der kræves mere end dette, skal systemet kontrolleres.
English: You do not need to stay in a darkened room.
Danish: De behøver ikke at opholde Dem i et mørkelagt rum.
English: Tell your doctor immediately:
Danish: Tal øjeblikkeligt med lægen:
English: Use Before or After Radiotherapy
Danish: Brug før eller efter stråleterapi
English: frequency cannot be estimated from the available data.
Danish: hyppighed kan ikke estimeres ud fra forhåndenværende data.
English: Your doctor will decide how to proceed with the treatment.
Danish: Deres læge vil beslutte, hvordan behandlingen skal fortsættes.
English: The treatment regimen is summarized in Table 4.
Danish: Behandlingsregimenet er opsummeret i Tabel 4.
English: The objective is to expose and treat all areas of HGD and the entire length of BO.
Danish: Målet er at eksponere og behandle alle områder af HGD og hele længden af BO.
English: Available treatment and surveillance guidelines should be considered.
Danish: Tilgængelige retningslinjer for behandling og overvågning bør tages i betragtning.
English: In addition, an updated RMP should be submitted:
Danish: Desuden skal en opdateret RMP fremsendes
English: if you notice a change in your eyesight.
Danish: hvis De bemærker forandringer i Deres syn.
English: Data on the long-term effect of PhotoBarr (beyond two years) are not available at the moment.
Danish: Data om langtidseffekten af PhotoBarr (udover to år) er ikke tilgængelige i øjeblikket.
English: It is important to avoid contact with the eyes and skin during preparation and/or administration.
Danish: Det er vigtigt at undgå kontakt med øjne og hud under klargøringen og/eller administrationen.
English: − There are a number of potential side effects that patients should be aware of.
Danish: − Der er en række mulige bivirkninger, som patienterne skal være opmærksomme på.
English: If you realise that you have missed your appointment for the laser treatment, contact your doctor immediately.
Danish: Hvis De opdager, at De har glemt Deres aftale om laserbehandling, skal De kontakte Deres læge med det samme.
English: The tissue around the eyes may be more sensitive, and therefore, it is not recommended that the face be used for testing.
Danish: Vævet omkring øjnene kan være mere følsomt, hvorfor det ikke anbefales, at ansigtet bruges til testning.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at 23°C.
Danish: Kemisk og fysisk holdbarhed i brug er påvist i 3 timer ved 23 °C.
English: Eight percent were severe, requiring multiple (6 - >10) dilatations.
Danish: Otte procent var alvorlige og krævede multiple (6 - >10) dilatationer.
English: Frequencies are defined as: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); not known (cannot be estimated from the available data).
Danish: Hyppigheder er defineret som: meget almindelig (>1/10); almindelig (>1/100 til <1/10); ikke almindelig (>1/1.000 til <1/100); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The necrotic reaction and associated inflammatory response evolve over several days.
Danish: Den nekrotiserende reaktion og det tilhørende inflammatoriske respons strækker sig over adskillige dage.
English: Research in animals and in cell culture has suggested that many active substances could influence the effects of PDT, possible examples of which are described below.
Danish: Forsøg på dyr og i cellekultur har antydet, at mange aktive substanser kan have indflydelse på effekten af PDT, hvoraf mulige eksempler er beskrevet nedenfor.
English: Therefore, you should take liquid food only for a few days (in some cases up to 4 weeks).
Danish: Derfor bør De udelukkende indtage flydende føde i nogle få dage (i visse tilfælde indtil 4 uger).
English: All incidences of strictures were considered associated with treatment of which 1% was considered serious.
Danish: Alle tilfælde af strikturer betragtedes som associeret med behandling, hvoraf 1% blev betragtet som alvorlig.
English: Physicians should be trained in the use of PDT.
Danish: Læger skal uddannes i brugen af PDT.
English: Therefore, care should be taken to prevent extravasation at the injection site.
Danish: Der skal derfor udvises omhu for at undgå ekstravasation på injektionsstedet.
English: The majority of these was mild to moderate in intensity and could be managed through 1-2 dilatations.
Danish: Hovedparten af disse var milde til moderate i intensitet og kunne behandles ved hjælp af 1-2 dilatationer.
English: There is no known benefit from injecting the extravasation site with another substance.
Danish: Der er ingen kendte fordele ved at injicere ekstravasationsstedet med en anden substans.
English: Therefore, adequate and rigorous surveillance should be continued despite possible endoscopic partial or complete restitution of the normal squamous mucosa.
Danish: Derfor bør adækvat og streng overvågning fortsættes trods mulig endoskopisk delvis eller fuldstændig restitution af den normale pladeepitelmucosa.
English: The more active lifestyle of the healthy and relatively younger subjects compared with cancer patients may have been a contributing factor to these photosensitivity reactions.
Danish: De sunde og forholdsvis yngre personers mere aktive livsstil sammenlignet med cancerpatienternes kan have været en medvirkende faktor ved disse lysfølsomhedsreaktioner.
English: One patient experienced life-threatening dyspnoea and the others had no notable complications.
Danish: Én patient fik livstruende dyspnø, og de andre fik ingen betydende komplikationer.
English: Side effects may occur with certain frequencies, which are defined as follows: Very common:
Danish: Bivirkninger kan forekomme med visse hyppigheder, der defineres på følgende måde: Meget almindelig:
English: There are no human data available to support or rebut these possibilities.
Danish: Der er ingen tilgængelige data fra mennesker, der kan bekræfte eller afkræfte disse muligheder.
English: In the PDT + OM group, 133 patients were treated.
Danish: I PDT + OM gruppen blev 133 patienter behandlet.
English: Adverse reactions reported are listed below in Table 5 by organ class and frequency.
Danish: Rapporterede bivirkninger er listet nedenfor i Tabel 5 efter organklasse og hyppighed.
English: − It is important to follow exactly the correct steps for reconstitution and administration of porfimer.
Danish: − Det er vigtigt at følge de korrekte trin til rekonstitution og administration af porfimer med stor nøjagtighed.
English: Do not use other diluents.
Danish: Andre diluenter må ikke bruges.
English: Also, treating physicians should be aware of the possibility of squamous overgrowth and the risk of overlooking cancer.
Danish: Behandlende læger skal også være klar over muligheden for skvamøs overvækst og risikoen for at overse cancer.
English: The level of photosensitivity will vary for different areas of the body, depending on the extent of previous exposure to light.
Danish: Graden af lysfølsomhed vil variere for forskellige områder af kroppen afhængig af varigheden af tidligere eksponering for lys.
English: Gender had no effect on pharmacokinetic parameters except for tmax, which was approximately 1.5 hours in women and 0.17 hours in men.
Danish: Kønnet har ingen indvirkning på farmakokinetiske parametre undtagen tmax, som var cirka 1,5 timer for kvinder og 0,17 timer for mænd.
English: Porfimer sodium is not dialyzable.
Danish: Natriumporfimer er ikke dialysabelt.
English: Progression to cancer was related to the number of PDT courses administered.
Danish: Progression til cancer var relateret til antallet af administrerede PDT-kure.
English: If you go out during daylight hours (even on cloudy days and while travelling in a vehicle), you should take the following precautions:
Danish: Hvis De går ud om dagen (selv på overskyede dage og under rejse i et køretøj), skal De tage følgende forholdsregler:
English: For most patients (up to 75 kg) two vials of PhotoBarr 75 mg will suffice.
Danish: Til de fleste patienter (op til 75 kg) vil to hætteglas PhotoBarr 75 mg være tilstrækkeligt.
English: The formation of oesophageal stenosis cannot be reduced or eliminated by the use of steroids.
Danish: Dannelsen af øsofagusstenose kan ikke reduceres eller elimineres ved brug af steroider.
English: Photosensitivity reactions are very common side effects of PhotoBarr (affecting more than 2 users in 3).
Danish: Lysfølsomhedsreaktioner er meget almindelige bivirkninger for PhotoBarr (berører mere end 2 ud af 3 brugere).
English: How does photodynamic therapy (PDT) work?
Danish: Hvordan virker fotodynamisk terapi (PDT)?
English: Patients with pulmonary or cardiac medical illness or a history of such illness should be treated with caution.
Danish: Patienter med pulmonal eller kardial medicinsk sygdom eller en anamnese med en sådan sygdom skal behandles med forsigtighed.
English: Only a solution without particles should be used and without visible signs of deterioration.
Danish: Der bør kun anvendes en opløsning uden partikler og uden synlige tegn på nedbrydning.
English: Increased symptoms and damage to normal tissue might be expected following an overdose of light.
Danish: Forstærkede symptomer og beskadigelse af normalt væv kan forventes efter en overdosis af lys.
English: In case of an allergic reaction, appropriate measures (standard of care) should be taken and the PDT treatment should not be repeated.
Danish: I tilfælde af en overfølsomhedsreaktion skal der tages passende forholdsregler (standardbehandling), og PDTbehandling bør ikke gentages.
English: Like all medicines, PhotoBarr can cause side effects, although not everybody gets them.
Danish: PhotoBarr kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Weight decreased, body temperature increased
Danish: Nedsat vægt, forhøjet legemstemperatur
English: − It is important to have an appropriate light dose and a proper setting for the laser.
Danish: − Det er vigtigt at have en passende lysdosis og en korrekt indstillet laser.
English: Subsequent free radical reactions can form superoxide and hydroxyl radicals.
Danish: Efterfølgende kan frie radikal-reaktioner danne superoxid og hydroxylradikaler.
English: Tell your doctor immediately: if you notice a change in your eyesight.
Danish: Tal øjeblikkeligt med lægen: hvis De bemærker forandringer i Deres syn.
English: 4.8 Undesirable effects a. Summary of the safety profile
Danish: 4.8 Bivirkninger a. Opsummering af sikkerhedsprofilen
English: If extravasation does occur, the area should be protected from light for a minimum of 90 days.
Danish: Hvis der forekommer ekstravasation, skal området beskyttes mod lys i mindst 90 dage.
English: Do not mix PhotoBarr with other medicinal products in the same solution.
Danish: Undlad at blande PhotoBarr med andre lægemidler i den samme opløsning.
English: The photosensitivity is due to residual photoactive substances, which will be present in all parts of the skin.
Danish: Lysfølsomheden skyldes residuale fotoaktive substanser, som vil være til stede i alle dele af huden.
English: In this case, you should avoid any activity that requires mental alertness such as driving a car or using any machine.
Danish: I dette tilfælde skal De undgå enhver aktivitet, der kræver mental agtpågivenhed, såsom at køre bil eller betjene nogen maskine.
English: remember to take protective clothing and sunglasses with you to your appointment, as you will be photosensitive once the injection has been given.
Danish: Husk at tage beskyttende tøj og solbriller med til Deres aftale, da De vil være lysfølsom, så snart injektionen er givet.
English: The laser treatment induces a photochemical, not a thermal, effect.
Danish: Laserbehandlingen inducerer en fotokemisk, ikke en termisk effekt.
English: Note: No more than 1.5 times the required diffuser power output should be needed from the laser.
Danish: Bemærk: Ikke mere end 1,5 gange det nødvendige diffusoreffekt-output skal være påkrævet fra laseren.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel grundigt inden De begynder at bruge medicinen.
English: Both the medicine and laser light are necessary for the therapy to work.
Danish: Både medicinen og laserlyset er nødvendige, hvis terapien skal virke.
English: The majority of these reported adverse reactions were mild to moderate in intensity.
Danish: Hovedparten af disse rapporterede bivirkninger var af mild til moderat intensitet.
English: For the PDT procedure, sedation may be required, and consequently caution should be taken.
Danish: Til PDT- proceduren kan sedation være nødvendig, hvorfor der skal udvises forsigtighed.
English: In vitro binding of porfimer sodium to human serum protein is around 90% and independent of concentration between 20 and 100 μg/ml.
Danish: In vitro-binding af natriumporfimer til humant serumprotein er omkring 90% og uafhængig af koncentrationen mellem 20 og 100 μg/ml.
English: Photoactivation is controlled by the total light dose delivered.
Danish: Fotoaktivering kontrolleres af den totale afgivne lysmængde.
English: At the time of intended photoactivation 40-50 hours after injection, the pharmacokinetic profiles of porfimer sodium in men and women were very similar.
Danish: På tidspunktet for den tilsigtede fotoaktivering 40-50 timer efter injektion var de farmakokinetiske profiler for natriumporfimer hos mænd og kvinder meget ens.
English: Date of latest renewal: 4 March 2009
Danish: Dato for første markedsføringstilladelse: 25. marts 2004 Dato for seneste fornyelse: 4. marts 2009
English: Some other medicines may increase the risk for photosensitivity reactions for example antibiotics or antidiabetic medicines.
Danish: Visse andre lægemidler kan øge risikoen for lysfølsomhedsreaktioner som f.eks. antibiotika eller antidiabetika.
English: − Patients should be warned of the possibility of long term side effects, especially photosensitivity, and the need to seek medical assistance if they arise.
Danish: − Patienterne skal advares om muligheden for langvarige bivirkninger, især lysfølsomhed, og om nødvendigheden af at søge lægehjælp, hvis de skulle opstå.
English: Patients with mild to moderate hepatic impairment should be clearly instructed that the period requiring the precautionary measures described below may be longer than 90 days.
Danish: Patienter med let til moderat leverfunktionsnedsættelse skal tydeligt instrueres om, at perioden, som kræver de nedenfor beskrevne sikkerhedsforanstaltninger, kan vare længere end 90 dage.
English: An occurrence rate of 12% for oesophageal strictures was observed during the first course of treatment.
Danish: En forekomstfrekvens på 12% for øsofagusstrikturer sås under den første behandlingskur.
English: If you go on holiday to an area with more sunshine, remember to repeat the skin test, especially if some areas of skin have not been exposed to sunlight since your PhotoBarr treatment.
Danish: Hvis De tager på ferie et sted med mere solskin, skal De huske at gentage hudtesten, navnlig hvis nogle hudområder ikke har været udsat for sollys siden Deres PhotoBarr-behandling
English: o all patients should know that UV blocking is not effective in blocking visible light which activates porfimer.
Danish: o Alle patienter skal vide, at UV-blokering ikke effektivt blokerer synligt lys, som aktiverer porfimer.