FrancophonIA/ELRC3.0 huggingface dataset:
English: The effects of Ameluz were examined in four main studies in patients with actinic keratosis, and in one main study in patients with basal cell carcinoma.
Danish: Virkningen af Ameluz var genstand for fire hovedstudier hos patienter med aktinisk keratose og ét hovedstudie hos patienter med basalcellekarcinom.
English: Actinic keratoses are skin growths caused by exposure to sunlight, which can lead to skin cancer.
Danish: Aktinisk keratose er vækster i huden, der opstår efter udsættelse for sollys, og som kan medføre hudkræft.
English: The main measure of effectiveness in all studies was the total number of patients whose actinic keratoses or cancer lesions had all cleared up three months after the last treatment.
Danish: I alle studierne blev virkningen hovedsagelig bedømt på det samlede antal patienter, hos hvem de aktiniske keratoser og kræftagtige forandringer helt var forsvundet tre måneder efter den sidste behandling.
English: Ameluz can also be used in adults to treat certain types of basal cell carcinoma (a type of skin cancer) when it cannot be treated by surgery.
Danish: Ameluz kan også anvendes til at behandle voksne for visse typer basalcellekarcinom (en form for hudkræft), når disse ikke kan behandles ved et kirurgisk indgreb.
English: Ameluz must not be given to people who are hypersensitive (allergic) to 5-aminolaevulinic acid, porphyrins, soybeans or peanuts, or any of the ingredients.
Danish: Ameluz må ikke anvendes hos personer, der er overfølsomme (allergiske) over for 5-aminolævulinsyre, porfyriner, sojabønner eller jordnødder eller andre af indholdsstofferne.
English: It must not be used in people who have porphyria (an inability to break down chemicals called porphyrins) or people who have certain skin diseases caused by exposure to light.
Danish: Ameluz må ikke anvendes hos personer med porfyri (manglende evne til at nedbryde en type kemiske stoffer, der kaldes porfyriner) eller hos personer med visse hudsygdomme, der skyldes udsættelse for lys.
English: When Ameluz is applied to the abnormal skin growths or lesions, the active substance in the medicine, 5-aminolaevulinic acid, is absorbed by cells where it acts as a photosensitising agent (a substance that changes when exposed to light of a certain wavelength).
Danish: Når Ameluz påføres på hudvæksterne eller -forandringerne, bliver det aktive stof i lægemidlet, 5aminolævulinsyre, optaget i cellerne, hvor det virker som et fotosensibiliserende middel (et stof, der ændrer sig, når det udsættes for lys af en bestemt bølgelængde).
English: A further study in 52 patients with actinic keratosis found that Ameluz was at least as effective as Metvix at clearing actinic keratosis when used in combination with daylight.
Danish: Et yderligere studie af 52 patienter med aktinisk keratose viste, at Ameluz var mindst lige så effektivt som Metvix til at fjerne aktinisk keratose ved anvendelse i kombination med dagslys.
English: Ameluz is applied directly to the skin growths or lesions or to the entire area affected and a red light source is then shone onto the skin.
Danish: Ameluz smøres direkte på hudvæksterne eller -forandringerne eller på hele det berørte område, og derefter belyses huden med rødt lys.
English: For basal cell carcinoma that cannot be treated surgically, Ameluz was investigated in a study involving 281 patients, in which it was compared with Metvix.
Danish: Som behandling for basalcellekarcinom, der ikke kan behandles ved et kirurgisk indgreb, var Ameluz genstand for et studie, der omfattede 281 patienter, og hvor det blev sammenlignet med Metvix.
English: Ameluz is a medicine used in adults to treat mild to moderate actinic keratoses on the face and scalp as well as the surrounding areas of the skin affected by the condition.
Danish: Ameluz er et lægemiddel, der anvendes hos voksne til behandling af let til moderat aktinisk keratose i ansigtet, hårbunden og de omgivende berørte hudområder.
English: Ameluz was at least as effective as Metvix in this study, with cancerous lesions clearing up in 93% (113 out of 121) of patients treated with Ameluz and 92% (101 out of 110) of those treated with the comparator medicine.
Danish: I dette studie var Ameluz mindst lige så effektivt som Metvix, idet de kræftagtige forandringer forsvandt hos 93 % (113 ud af 121) af de patienter, der blev behandlet med Ameluz, og hos 92 % (101 ud af 110) af de patienter, der blev behandlet med sammenligningslægemidlet.
English: It may also be used to treat an area of sun-induced skin damage with multiple actinic keratosis growths (field cancerisation).
Danish: Ameluz kan også anvendes til at behandle solbeskadigede hudområder med multiple aktiniske keratosevækster (områdeforandringer).
English: How is Ameluz used?
Danish: Hvordan anvendes Ameluz?
English: For the full list of side effects reported with Ameluz, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ameluz fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ameluz have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ameluz.
English: What benefits of Ameluz have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ameluz?
English: The condition cleared up in 91% (50 out of 55) of patients given Ameluz, compared with 22% (7 out of 32) given placebo.
Danish: Sygdommen forsvandt hos 91 % (50 ud af 55) af de patienter, der fik Ameluz, sammenholdt med 22 % (7 ud af 32) af de patienter, der fik placebo.
English: In the first main study involving 571 patients, Ameluz was compared with placebo and Metvix, a product containing methylaminolaevulinate, used together with a red light for one or two treatment sessions.
Danish: I det første hovedstudie, der omfattede 571 patienter, blev Ameluz sammenlignet med placebo og Metvix, der er et lægemiddel, som indeholder methylaminolævulinat, i kombination med rødt lys over én eller to behandlinger.
English: Actinic keratosis cleared up in 78% (194 out of 248) of patients treated with Ameluz, compared with 64% (158 out of 246) of patients treated with Metvix and 17% (13 out of 76) of patients treated with placebo.
Danish: Den aktiniske keratose forsvandt hos 78 % (194 ud af 248) af de patienter, der blev behandlet med Ameluz, sammenholdt med 64 % (158 ud af to 246) af de patienter, der blev behandlet med Metvix, og 17 % (13 ud af 76) af de patienter, der blev behandlet med placebo.
English: In the second main study involving 122 patients, Ameluz was compared with placebo used together with a red light for one or two treatment sessions.
Danish: I den anden hovedundersøgelse, der omfattede 122 patienter, blev Ameluz sammenlignet med placebo i kombination med rødt lys over én eller to behandlinger.
English: In the third study involving 87 patients with field cancerisation (an area of sun damage with several actinic keratosis growths), Ameluz was compared with placebo used for one together with a red light or two treatment sessions.
Danish: I det tredje studie, der omfattede 87 patienter med områdeforandringer (et solbeskadiget område med flere aktiniske keratosevækster), blev Ameluz sammenlignet med placebo i kombination med rødt lys over én eller to behandlinger.
English: How does Ameluz work?
Danish: Hvordan virker Ameluz?
English: Actinic keratosis cleared up in 66% (53 out of 80) of patients treated with Ameluz, compared with 13% (5 out of 40) of patients treated with placebo.
Danish: Den aktiniske keratose forsvandt hos 66 % (53 ud af 80) af de patienter, der blev behandlet med Ameluz, sammenholdt med 13 % (5 ud af 40) af de patienter, der blev behandlet med placebo.
English: When treating actinic keratosis growths, Ameluz can also be activated by exposure to full daylight.
Danish: Når lægemidlet anvendes til behandling af vækster, der skyldes aktinisk keratose, kan det også aktiveres af eksponering for dagslys.
English: When the affected skin is exposed to light,
Danish: Når det berørte hudområde eksponeres for lys, bliver det fotosensibiliserende middel aktiveret og reagerer med ilten i cellerne, så
English: Elebrato Ellipta receiveda marketing authorisation valid throughout the EU on 15 November 2017.
Danish: Elebrato Ellipta fik en markedsføringstilladelse med gyldighed i hele EU den 15. november 2017.
English: Further information on Elebrato Ellipta can be found on the Agency's website: ema.europa.eu/ medicines/human/EPAR/elebrato-ellipta.
Danish: Yderligere information om Elebrato Ellipta findes på agenturets websted under: ema.europa.eu/ medicines/human/EPAR/elebrato-ellipta.
English: Elebrato Ellipta is used for maintenance (regular) treatment on a daily basis.
Danish: Elebrato Ellipta anvendes til vedligeholdelsesbehandling (regelmæssig behandling) på daglig basis.
English: This compares with an average reduction of 29 ml seen in patients taking the combination of budesonide and formoterol over the same period.
Danish: Dette skal sammenlignes med en gennemsnitlig reduktion på 29 ml observeret hos patienter, der tog en kombination af budesonid og formoterol over det samme tidsrum.
English: For more information about using Elebrato Ellipta, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Elebrato Ellipta, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: As for all medicines, data on the use of Elebrato Ellipta are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Elebrato Ellipta løbende overvåget.
English: Fluticasone furoate is a corticosteroid.
Danish: Fluticasonfuroat er et kortikosteroid.
English: In this study, Elebrato Ellipta reduced the rate of moderate and severe exacerbations over one year by 15% compared with treatment with vilanterol and fluticasone furoate, and by 25% compared with treatment with vilanterol and umeclidinium bromide.
Danish: I dette studie reducerede Elebrato Ellipta andelen af moderate og alvorlige forværringer over ét år med 15 % sammenlignet med behandling med vilanterol og fluticasonfuroat og med 25 % sammenlignet med behandling med vilanterol og umeclidiniumbromid.
English: Vilanterol is a long-acting beta-2 agonist.
Danish: Vilanterol er en såkaldt langtidsvirkende beta-2-agonist.
English: Patients treated with Elebrato Ellipta also reported improved health compared with those treated with the comparator treatment.
Danish: Patienter, der blev behandlet med Elebrato Ellipta, rapporterede også et forbedret helbred sammenholdt med dem, der blev behandlet med sammenligningspræparatet.
English: Regarding the safety profile of the medicine, the most frequent side effects reported with Elebrato Ellipta were similar to those with the individual active substances of the medicine and are well known.
Danish: Hvad angår lægemidlets sikkerhedsprofil, var de hyppigste bivirkninger ved Elebrato Ellipta de samme som med de enkelte aktive stoffer i lægemidlet, og de er velkendte.
English: Elebrato Ellipta (fluticasone furoate / umeclidinium bromide / vilanterol)
Danish: Elebrato Ellipta (fluticasonfuroat/umeclidiniumbromid/vilanterol)
English: Other information about Elebrato Ellipta
Danish: Andre oplysninger om Elebrato Ellipta
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors (targets) in various types of immune cells.
Danish: Det virker ligesom naturlige kortikosteroider, idet det dæmper immunsystemets aktivitet ved at binde sig til receptorer (mål) i forskellige typer af immunceller.
English: The European Medicines Agency therefore decided that Elebrato Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Elebrato Ellipta opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: Side effects reported with Elebrato Ellipta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Elebrato Ellipta vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Elebrato Ellipta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Elebrato Ellipta?
English: Elebrato Ellipta contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.
Danish: Elebrato Ellipta indeholder tre aktive stoffer, der på forskellig vis udvider luftvejene og forbedrer vejrtrækningen ved KOL.
English: Umeclidinium bromide is a muscarinic receptor antagonist.
Danish: Umeclidiniumbromid er en såkaldt muskarin receptorantagonist.
English: Long-acting beta-2 agonists widen the airways; corticosteroids reduce inflammation in the airways and lungs; and muscarinic receptor antagonists cause the muscles of the airways to relax.
Danish: Langtidsvirkende beta-2-agonister udvider luftvejene, kortikosteroider mindsker betændelse i luftvejene og lungerne, og muskarine receptor-antagonister får musklerne i luftvejene til at slappe af.
English: It works by attaching to beta-2 receptors in some types of muscle cells.
Danish: Det virker ved at binde sig til beta-2receptorerne i nogle typer af muskelceller.
English: The most common side effects with Elebrato Ellipta (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache and upper respiratory tract infection (nose and throat infection).
Danish: De hyppigste bivirkninger ved Elebrato Ellipta (som kan forekomme hos op til 1 ud af 10 patienter) er betændelse i næse og svælg, hovedpine og infektion i næse og svælg.
English: An overview of Elebrato Ellipta and why it is authorised in the EU
Danish: En oversigt over Elebrato Ellipta, og hvorfor det er godkendt i EU
English: Elebrato Ellipta can only be obtained with a prescription.
Danish: Elebrato Ellipta udleveres kun efter recept.
English: After 24 weeks, patients taking Elebrato Ellipta had their FEV1 (the maximum volume of air they could breathe out in one second) improve by 142 ml.
Danish: Efter 24 uger var FEV1 (den maksimale luftmængde, som en person kan udånde på et sekund) hos de patienter, der fik Elebrato Ellipta, forbedret med 142 ml.
English: This reduces the release of substances involved in the inflammation process, such as histamine, thereby reducing inflammation and helping to keep the airways clear and allowing the patient to breathe more easily.
Danish: Dette mindsker frigivelsen af stoffer, der medvirker i betændelsesprocessen, som f.eks. histamin, hvorved betændelsen reduceres og luftvejene bedre kan holdes frie, så patienten får lettere ved at trække vejret.
English: It works by blocking muscarinic receptors, which are involved in the contraction of muscles.
Danish: Det virker ved at blokere de muskarine receptorer, der er involverede i muskulaturens sammentrækning.
English: What is Elebrato Ellipta and what is it used for?
Danish: Hvad er Elebrato Ellipta, og hvad anvendes det til?
English: Elebrato Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Danish: Elebrato Ellipta er et lægemiddel, der anvendes til at lindre symptomerne på moderat til svær kronisk obstruktiv lungesygdom (KOL).
English: Why is Elebrato Ellipta authorised in the EU?
Danish: Hvorfor blev Elebrato Ellipta godkendt i EU?
English: Elebrato Ellipta is used in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a longacting muscarinic antagonist.
Danish: Elebrato Ellipta anvendes til voksne, hvis sygdom ikke er tilstrækkeligt reguleret med en kombination af inhalerede lægemidler, der består af en langtidsvirkende beta-2-agonist, plus enten et kortikosteroid eller en langtidsvirkende muskarin antagonist.
English: Elebrato Ellipta improves lung function as well as the quality of life of patients with moderate to severe COPD.
Danish: Elebrato Ellipta forbedrer lungefunktionen samt livskvaliteten hos patienter med moderat til svær KOL.
English: What are the risks associated with Elebrato Ellipta?
Danish: Hvilke risici er der forbundet med Elebrato Ellipta?
English: A study compared Elebrato Ellipta with either vilanterol given with fluticasone furoate or vilanterol with umeclidinium bromide, in 10,355 patients with advanced COPD who were at risk of exacerbations and whose disease was not satisfactorily controlled with a daily maintenance treatment.
Danish: Elebrato Ellipta blev i et studie sammenlignet med enten vilanterol givet med fluticasonfuroat eller vilanterol givet med umeclidiniumbromid, hos 10 355 KOL-patienter, hvis sygdom var i fare for at forværres og ikke var tilstrækkeligt reguleret med daglig vedligeholdelsesbehandling.
English: Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Elebrato Ellipta more effective at improving patients' breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.
Danish: Af et andet hovedstudie med 1 810 patienter, hvis KOL ikke var tilstrækkeligt reguleret med en daglig vedligeholdelsesbehandling, fremgik det, at Elebrato Ellipta var mere effektivt til at forbedre patienternes vejrtrækning end en inhaleret kombination af budesonid, et kortikosteroid, og formoterol, en langtidsvirkende beta-2-agonist.
English: For the full list of side effects and restrictions with Elebrato Ellipta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Elebrato Ellipta fremgår af indlægssedlen.
English: Elebrato Ellipta was shown to improve patients' breathing and reduce exacerbations (flare-ups) of the disease in 2 main studies.
Danish: Elebrato Ellipta blev i to hovedstudier påvist at forbedre patienternes vejrtrækning og reducere forværringer (opblussen) af sygdommen.
English: It is available as an inhalation powder, which the patient inhales through the mouth using a portable inhaler device; the patient should inhale the medicine once a day at around the same time each day.
Danish: Det fås som et inhalationspulver, som patienten inhalerer gennem munden ved hjælp af en bærbar inhalator.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elebrato Ellipta have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Elebrato Ellipta.
English: How is Elebrato Ellipta used?
Danish: Hvordan anvendes Elebrato Ellipta?
English: What benefits of Elebrato Ellipta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Elebrato Ellipta?
English: How does Elebrato Ellipta work?
Danish: Hvordan virker Elebrato Ellipta?
English: Other information about Senstend
Danish: Andre oplysninger om Senstend
English: Further information on Senstend can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/senstend.
Danish: Yderligere information om Senstend findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/senstend.
English: Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.
Danish: En række patienter blev fulgt i op til 9 måneder i en forlængelse af de indledende studier, og de fortsatte med at opleve en lignende fordel.
English: What is Senstend and what is it used for?
Danish: Hvad er Senstend, og hvad anvendes det til?
English: Why is Senstend authorised in the EU?
Danish: Hvorfor er Senstend godkendt i EU?
English: This medicine is the same as Fortacin, which is already authorised in the EU.
Danish: Lægemidlet er identisk med Fortacin, som allerede er godkendt i EU.
English: Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours.
Danish: Påføringen bør højst foretages hver 4. time, og der bør ikke anvendes mere end højst tre doser pr. 24 timer.
English: As for all medicines, data on the use of Senstend are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Senstend løbende overvåget.
English: Senstend (lidocaine / prilocaine)
Danish: Senstend (lidocain/prilocain)
English: Senstend must also not be used in patients whose partners are hypersensitive to these substances.
Danish: Senstend må heller ikke anvendes hos patienter, hvis partnere er overfølsomme over for disse stoffer.
English: The company that makes Fortacin has agreed that its scientific data can be used for Senstend (‘informed consent').
Danish: Den virksomhed, der fremstiller Fortacin, er indforstået med, at dens videnskabelige data anvendes i forbindelse med Senstend ("informeret samtykke").
English: An overview of Senstend and why it is authorised in the EU
Danish: En oversigt over Senstend, og hvorfor det er godkendt i EU
English: There were also positive psychological benefits to patients and their partners, and side effects were local and generally manageable.
Danish: Der er også positive psykiske fordele for patienterne og deres partnere, og bivirkningerne er lokale og håndterbare.
English: It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).
Danish: Det anvendes til at behandle mænd med primær (varig) præmatur sædafgang (når sædafgangen regelmæssigt sker før penetration eller for tidligt under penetration).
English: What measures are being taken to ensure the safe and effective use of Senstend?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Senstend?
English: The Agency therefore decided that Senstend's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Senstend opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: This reduces sensitivity to stimulation, and when applied onto the head of the penis this will help to increase the time taken to ejaculate.
Danish: Dette nedsætter følsomheden for stimulation, og når sprayen anvendes på penishovedet, vil det medvirke til at øge tiden til sædafgang.
English: For more information about using Senstend, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Senstend, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The European Medicines Agency considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at de aktive stoffer er en kombination af velkendte lokalbedøvende midler, og at brugen af en lokal spray minimerer mængden af absorberet aktivt stof og dermed risikoen for bivirkninger, der påvirker kroppen som helhed.
English: Senstend (lidocaine / prilocaine) EMA/519240/2019
Danish: Senstend (lidocain/prilocain) EMA/519240/2019
English: What are the risks associated with Senstend?
Danish: Hvilke risici er der forbundet med Senstend?
English: Senstend can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray.
Danish: Senstend fås kun på recept og leveres som en spray, der afgiver 7,5 mg lidocain og 2,5 mg prilocain pr. sprayaktivering.
English: Senstend is a medicine containing the active substances lidocaine and prilocaine.
Danish: Senstend er et lægemiddel, der indeholder de aktive stoffer lidocain og prilocain.