FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation Number: EU/1/97/045/001
Danish: Må ikke opbevares over 25°C Receptpligtigt lægemiddel Markedsføringstilladelsesnummer: EU/1/97/045/001
English: • The patient must continue to breathe through the straw while removing it from the breath sample container, and then immediately seal the breath sample container with its stopper.
Danish: • Mens patienten fortsætter med at ånde ud gennem røret, trækkes det ud og testbeholderen til udånding forsegles med det samme med proppen.
English: Marketing Authorisation Number: EU/1/97/045/005
Danish: Må ikke opbevares over 25°C Receptpligtigt lægemiddel Markedsføringstilladelsesnummer: EU/1/97/045/005
English: 50 Package leaflet
Danish: 5 Indlægsseddel
English: • Periodic Safety Update Reports
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Endemic areas are areas where the disease occurs regularly throughout the year.
Danish: Endemiske områder er områder, hvor sygdommen forekommer regelmæssigt i løbet af året.
English: The injection is given under the skin, preferably in the upper arm.
Danish: Indsprøjtningen gives under huden, fortrinsvis i overarmen.
English: Three studies were carried out in Asia and Latin America involving over 35,000 children aged 2 to 16 years.
Danish: Der blev i Asien og Latinamerika gennemført tre studier, som omfattede over 35.000 børn i alderen 2 til 16 år.
English: Additional studies showed that the vaccine is also effective in people aged 16 to 45 years.
Danish: Yderligere studier viste, at vaccinen også var effektiv hos personer i alderen 16 til 45 år.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend the body against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod en sygdom.
English: Further information on Dengvaxia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Dengvaxia.
Danish: Yderligere information om Dengvaxia findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Dengvaxia.
English: The risk of severe disease is higher in people who have been infected a second time.
Danish: Risikoen for alvorlig sygdom er større hos personer, som får infektionen for anden gang.
English: Cases of dengue disease were recorded for one year after the last injection.
Danish: Tilfælde af denguefeber blev registreret i et år efter den sidste indsprøjtning.
English: However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage.
Danish: Nogle få patienter udvikler dog alvorlige tilfælde af sygdommen med potentielt livstruende blødning og organskade.
English: There is no other vaccine for dengue disease and neither is there a specific treatment.
Danish: Der findes ingen anden vaccine mod denguefeber og heller ingen specifik behandling.
English: The vaccine is given as 3 doses, 6 months apart.
Danish: Vaccinen gives i tre doser med seks måneders mellemrum.
English: ‘foreign' and makes antibodies against them.
Danish: og danner antistoffer mod dem.
English: Allergic reactions, which may be severe, are a very rare side effect of Dengvaxia.
Danish: Allergiske reaktioner, som kan være alvorlige, er en meget sjælden bivirkning ved Dengvaxia.
English: As for all medicines, data on the use of Dengvaxia are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Dengvaxia løbende overvåget.
English: Dengvaxia's side effects are usually mild or moderate and do not last longer than three days.
Danish: Dengvaxias bivirkninger er normalt lette eller moderate og varer ikke mere end tre dage.
English: For more information about using Dengvaxia, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Dengvaxia, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Dengvaxia must not be given to people with weakened immune systems, including people whose immune system has been weakened by HIV infection or medicines such as cancer medicines or high doses of corticosteroids.
Danish: Dengvaxia må ikke gives til personer med svækket immunsystem, herunder personer, hvis immunsystem er svækket af hivinfektion eller lægemidler såsom kræftlægemidler eller høje doser kortikosteroider.
English: What measures are being taken to ensure the safe and effective use of Dengvaxia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dengvaxia?
English: Other information about Dengvaxia
Danish: Andre oplysninger om Dengvaxia
English: Dengvaxia can only be obtained with a prescription and should be used according to official recommendations.
Danish: Dengvaxia udleveres kun efter recept og bør anvendes i henhold til de officielle anbefalinger.
English: Dengvaxia (dengue tetravalent vaccine [live, attenuated])
Danish: Dengvaxia (tetravalent denguevaccine [levende, svækket])
English: In the future, when the person comes into contact with dengue virus, these antibodies together with other components of the immune system will be able to kill the virus and help protect against the disease.
Danish: Hvis personen senere kommer i kontakt med denguevirus, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe virusset og hjælpe med at beskytte mod sygdommen.
English: The European Medicines Agency therefore decided that Dengvaxia's benefits are greater than its risks and it can be authorised for use in the EU in areas where dengue disease is endemic.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Dengvaxia opvejer risiciene, og at det kan godkendes til anvendelse i EU i områder, hvor denguefeber er endemisk.
English: Side effects reported with Dengvaxia are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Dengvaxia vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The most common side effects with Dengvaxia (which may affect more than 1 in 10 people) are headache, injection site pain, malaise (feeling unwell), muscle pain, weakness and fever.
Danish: De hyppigste bivirkninger ved Dengvaxia (som optræder hos mere end 1 ud af 10 patienter) er hovedpine, smerter på injektionsstedet, utilpashed, muskelsmerter, svaghed og feber.
English: An overview of Dengvaxia and why it is authorised in the EU
Danish: En oversigt over Dengvaxia, og hvorfor det er godkendt i EU
English: Children were given either 3 injections of Dengvaxia or 3 injections of placebo (a dummy vaccine) with 6 months between each injection.
Danish: Børnene fik enten tre indsprøjtninger Dengvaxia eller tre indsprøjtninger placebo (en virkningsløs behandling) med seks måneders mellemrum mellem hver indsprøjtning.
English: There are several varieties (called serotypes) of dengue virus and Dengvaxia protects against serotypes 1, 2, 3 and 4.
Danish: Denguevirus findes i flere varianter (kaldet serotyper), og Dengvaxia beskytter mod serotype 1, 2, 3 og 4.
English: Dengvaxia contains weakened viruses that do not cause disease.
Danish: Dengvaxia indeholder svækkede virus, som ikke forårsager sygdom.
English: Dengvaxia must also not be given to women who are pregnant or breastfeeding.
Danish: Dengvaxia må heller ikke gives til gravide eller ammende.
English: Why is Dengvaxia authorised in the EU?
Danish: Hvorfor blev Dengvaxia godkendt i EU?
English: What is Dengvaxia and what is it used for?
Danish: Hvad er Dengvaxia, og hvad anvendes det til?
English: The company that markets Dengvaxia will provide educational material for healthcare professionals with information on the use of Dengvaxia including the need to test for previous dengue infection and how to detect early dengue disease.
Danish: Virksomheden, der markedsfører Dengvaxia, skal sørge for, at sundhedspersonale er udstyret med uddannelsesmateriale med information om anvendelsen af Dengvaxia, herunder behovet for at teste for tidligere dengueinfektion, og hvordan denguefeber opdages tidligt.
English: Therefore, the vaccine should only be given to people who have had a previous dengue infection, as confirmed by laboratory testing.
Danish: Derfor bør vaccinen udelukkende gives til personer med tidligere dengueinfektion, bekræftet ved laboratorieprøve.
English: For the full list of side effects and restrictions with Dengvaxia, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Dengvaxia fremgår af indlægssedlen.
English: Dengvaxia is effective at reducing the number of cases of dengue disease in people aged between 9 and 45 years who have had the infection in the past.
Danish: Dengvaxia er effektivt til at mindske antallet af denguefebertilfælde blandt personer i alderen 9 til 45 år, som har haft infektionen tidligere.
English: Overall, among children aged between 9 and 16 years and who had previous dengue infection, there were around 79% fewer cases of dengue disease in children vaccinated with 3 doses of Dengvaxia compared with placebo.
Danish: Blandt børn i alderen 9 til 16 år, som tidligere havde haft dengueinfektion, var der ca. 79 % færre tilfælde af denguefeber hos børn, der var blevet vaccineret med tre doser Dengvaxia, sammenholdt med placebo.
English: When a person is given the vaccine, the immune system recognises the dengue proteins in the weakened viruses as
Danish: Når en person vaccineres, opfatter immunsystemet dengueproteinerne i de svækkede virus som "fremmede"
English: What are the risks associated with Dengvaxia?
Danish: Hvilke risici er der forbundet med Dengvaxia?
English: However, people who have not had dengue infection in the past may have a higher risk of severe dengue disease if they become infected with the virus after vaccination with Dengvaxia.
Danish: Personer, som ikke tidligere har haft dengueinfektion, kan være i større risiko for at få alvorlig denguefeber, hvis de bliver smittet med virusset efter at være blevet vaccineret med Dengvaxia.
English: However, among children aged between 9 and 16 years who had not had previous dengue infection, the risk of severe dengue disease if they later became infected with the virus was higher in people vaccinated compared with those given placebo (estimated at 2 additional cases per 1000 people vaccinated over 5 years).
Danish: Blandt børn i alderen 9 til 16 år, som ikke tidligere havde haft dengueinfektion, var risikoen for alvorlig denguefeber, hvis de senere blev smittet med virusset, imidlertid større hos personer, der var vaccineret, sammenholdt med personer, som havde fået placebo (beregnet til to yderligere tilfælde pr. 1.000 vaccinerede personer over fem år).
English: Dengvaxia is a vaccine used to help protect against dengue disease.
Danish: Dengvaxia er en vaccine, der anvendes til at beskytte imod denguefeber.
English: Available data are not sufficient to confirm how well the vaccine works in individuals previously infected by dengue virus and younger than 9 years.
Danish: Det kan ikke bekræftes på baggrund af de tilgængelige data, hvor godt vaccinen virker hos personer, som tidligere har været smittet med denguevirus, og som er under 9 år gamle.
English: Dengvaxia contains attenuated (weakened) yellow fever viruses that have been manipulated so that they contain proteins from dengue virus.
Danish: Dengvaxia indeholder svækkede gul feber-virus, som er manipuleret, så de indeholder proteiner fra denguevirus.
English: Dengvaxia is only for use in people from 9 to 45 years of age who have been infected with dengue virus before and who live in areas where this infection is endemic.
Danish: Dengvaxia må kun gives til personer i alderen 9 til 45 år, som tidligere har været smittet med denguevirus, og som bor i endemiske områder.
English: Dengue disease is a mosquito-borne tropical disease caused by the dengue virus leading to mild, flulike symptoms in most people.
Danish: Dengue er en myggebåret tropesygdom, som forårsages af denguevirus og hos de fleste medfører lette influenzalignende symptomer.
English: Dengvaxia must only be given to people who have had a positive test result showing a previous infection with dengue virus.
Danish: Dengvaxia må kun gives til personer, hvor en positiv prøve viser, at de tidligere har været smittet med denguevirus.
English: The studies included both children who had and had not been infected with dengue virus in the past.
Danish: Studierne omfattede både børn, som tidligere havde været smittet med denguevirus, og børn, som ikke havde.
English: How is Dengvaxia used?
Danish: Hvordan anvendes Dengvaxia?
English: How does Dengvaxia work?
Danish: Hvordan virker Dengvaxia?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dengvaxia have also 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 Dengvaxia.
English: What benefits of Dengvaxia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Dengvaxia?
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: The educational leaflet shall contain the following key elements:
Danish: Brochuren med informationer bør indeholde følgende nøgleelementer:
English: • The loss of efficacy or other symptoms of the development of immunogenicity should be investigated
Danish: • Tab af effekt eller andre symptomer på udvikling af immunogenicitet skal undersøges
English: The Member States shall ensure that prior to launch the MAH provides health care professionals in dialysis centres and retail pharmacies with:
Danish: Medlemslandet skal sikre, at indehaveren af markedsføringstilladelsen ved lanceringen udleverer følgende til alle læger og plejepersonale på dialysecentre samt apoteker:
English: • Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling
Danish: • brochure med informationer • produktresumé og indlægsseddel og etikettering
English: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA)
Danish: • information om, at anvendelse af epoetin alfaprodukter kan forårsage immunogenicitet, hvilket i sjældne tilfælde kan føre sygdommen Pure Red Cell Aplasia (PRCA)
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: ANNEX BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES I HVERT MEDLEMSLAND
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES I HVERT MEDLEMSLAND
English: • Therefore, the sc route is not recommended for patients with CKD
Danish: • Subkutan indgivelse frarådes til patienter med CKD
English: • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Danish: • Ethvert mistænkt tilfælde af sygdommen Pure Red Cell Aplasia eller udvikling af immunogenicitet skal rapporteres til indehaveren af markedsføringstilladelsen.
English: • There is insufficient data on Epoetin alfa HEXAL to know the size of any increased immunogenicity risk with sc use
Danish: • information om, at der ikke findes tilstrækkelig data om Epoetin alfa HEXAL til at kunne fastslå størrelse af den øgede risiko for immunogenicitet ved subkutan anvendelse
English: • That with other epoetin products, the risk of immunogenicity in Chronic Kidney Disease (CKD) is increased with the subcutaneous (sc) route.
Danish: • information om, at der, som det er tilfældet med andre epoetinprodukter, er øget risiko for immunogenicitet ved kronisk nyresygdom (CKD) ved subkutan (sc) indgivelse.
English: Your body can also make too much sugar.
Danish: Din krop kan også danne for meget sukker.
English: Elimination Following administration of an oral [
Danish: Elimination Efter administration af en oral dosis [
English: Never take two doses at the same time (morning or evening).
Danish: Tag aldrig dobbeltdosis på samme tid (morgen eller aften).
English: What is type 2 diabetes?
Danish: Hvad er type 2-diabetes?
English: Multiple-dose study: data are restricted to one study.
Danish: Studie med multiple doser: Data er begrænset til ét studie.
English: It is unknown if this medicine is harmful to the unborn child.
Danish: Det vides ikke, om dette lægemiddel er skadeligt for det ufødte barn.
English: Due to the limited nature of the data set the results should be interpreted cautiously.
Danish: På grund af det begrænsede datasæt skal resultaterne fortolkes med forsigtighed.
English: (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Danish: 4.4, 4.5 og 5.1 for tilgængelige oplysninger om forskellige kombinationer).
English: Number of Subjects (%)
Danish: Antal personer (%)
English: There is no experience with doses above 600 mg in humans.
Danish: Der er ingen erfaring med doser over 600 mg hos mennesker.
English: Lipase increased*
Danish: Forhøjet lipase **
English: The clinical relevance of these decreases is unknown.
Danish: Den kliniske relevans af disse fald kendes ikke.
English: Take the medicine pack with you.
Danish: Tag medicinpakningen med.
English: Patients (%) receiving rescue treatment
Danish: Patienter (%), der modtog akut behandling
English: These changes are not likely to be clinically meaningful.
Danish: Disse ændringer har sandsynligvis ikke klinisk betydning.
English: Organic cation transporters (OCT)
Danish: Organiske kationtransportere (OCT)
English: The mean volume of distribution (Vd) ranged between 63-276 l.
Danish: Det gennemsnitlige fordelingsvolumen (Vd) lå på 63-276 l.
English: Your doctor will tell you exactly the dose of this medicine to take.
Danish: Lægen vil fortælle dig præcist, hvilken dosis du skal tage.
English: Safety data from this study was in line with previous known safety profile of linagliptin.
Danish: Sikkerhedsdata fra dette studie var i overensstemmelse med den tidligere kendte sikkerhedsprofil ved linagliptin.
English: This is to help keep your blood sugar under control.
Danish: Dette lægemiddel er med til at holde dit blodsukker under kontrol.
English: The effect of Jentadueto on human fertility has not been studied.
Danish: Jentaduetos virkning på human fertilitet er ikke blevet undersøgt.
English: Children and adolescents This medicine is not recommended for use in children and adolescents under 18 years.
Danish: Børn og unge Dette lægemiddel bør ikke anvendes til børn og unge under 18 år.
English: In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Danish: Hos patienter med øget risiko for yderligere progression af nyreinsufficiens og hos ældre bør nyrefunktionen vurderes oftere, f.eks. hver 3.-6. måned.
English: Results were consistent for patients treated with or without metformin.
Danish: Resultaterne var konsistente for patienter behandlet med eller uden metformin.
English: How to take this medicine - one tablet twice daily by mouth in the dose prescribed by your doctor.
Danish: Sådan skal du tage dette lægemiddel - 1 tablet to gange dagligt gennem munden i den dosis, din læge har ordineret.
English: These hormones are rapidly degraded by the enzyme DPP-4.
Danish: Disse hormoner nedbrydes hurtigt af enzymet DPP-4.
English: Oral contraceptives:
Danish: Orale kontraceptiva:
English: * PY=patient years ** Test on non-inferiority to demonstrate that the upper bound of the 95% CI for the hazard ratio is less than 1.3
Danish: * PY=patientår ** Test for non-inferioritet for at vise, at den øvre grænse af det 95 % CI for hazard ratio er under 1,3
English: Incidence Rate per 1000 PY*
Danish: Incidensrate pr. 1000 PY*
English: Based on these studies there is no concern for carcinogenicity in humans.
Danish: Studierne giver ikke anledning til bekymring for karcinogenicitet hos mennesker.
English: Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Danish: Type 2-diabetes er en tilstand, hvor din krop ikke danner tilstrækkeligt meget insulin samtidig med, at det insulin, som kroppen danner, ikke virker så godt, som det burde.
English: Doses of background anti-diabetic therapy were kept stable during the first 12 weeks, after which adjustments were permitted.
Danish: Dosis af den anti-diabetiske baggrundsbehandling blev holdt stabil gennem de første 12 uger, hvorefter dosisjustering var tilladt.
English: Diabetic skin problems are a common complication of diabetes.
Danish: Hudproblemer er en almindelig komplikation ved diabetes.
English: Alcohol
Danish: Alkohol
English: During treatment with Jentadueto, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Under behandlingen med Jentadueto vil lægen kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, og/eller hvis din nyrefunktion bliver dårligere.
English: Renal clearance at steady-state was approximately 70 ml/min.
Danish: Renal clearance ved steady state var ca. 70 ml/min.
English: Linagliptin and its main metabolite did not show a genotoxic potential.
Danish: Linagliptin og dets hovedmetabolit viste ikke genotoksisk potentiale.
English: 83% of patients were taking metformin in combination with insulin in this trial.
Danish: 83 % af patienterne tog metformin i kombination med insulin i dette studie.
English: However, if it is nearly time for the next dose, skip the missed dose.
Danish: Hvis det næsten er tid til næste dosis, så spring den glemte dosis over.
English: The safety and efficacy of Jentadueto in children and adolescents aged 0 to 18 years have not been established.
Danish: Jentaduetos sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er ikke klarlagt.
English: The clinical trials before marketing authorization have been performed up to a BMI equal to 40 kg/m
Danish: De kliniske studier før markedsføringstilladelsen er gennemført hos personer med et BMI op til 40 kg/m
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Danish: Patienten bør informeres herom, og der bør foretages hyppigere monitorering af blodglucose, især ved start af behandling med sådanne lægemidler.
English: If you forget to take a dose, take it as soon as you remember it.
Danish: Hvis du har glemt at tage en dosis, så tag den straks, du kommer i tanke om det.
English: Strong pseudo-allergic reactions were observed in dogs at medium doses, secondarily causing cardiovascular changes, which were considered dog-specific.
Danish: Stærke pseudo-allergiske reaktioner blev observeret i hunde ved mellemstore doser og medførte sekundært kardiovaskulære forandringer, som blev anset for at være hunde-specifikke.
English: Not all pack sizes may be marketed in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført i dit land.
English: Vitamin B12 deficiency very rare
Danish: B12-vitaminmangel meget sjælden
English: Metformin is a substrate of both transporters OCT1 and OCT2.
Danish: Metformin er et substrat af begge transportere, OCT1 og OCT2.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Danish: Efter en oral dosis er den tilsyneladende terminale halveringstid ca. 6,5 timer.
English: Effects on plasma lipids were generally neutral.
Danish: Virkningerne på plasmalipider var generelt neutrale.