FrancophonIA/ELRC3.0 huggingface dataset:
English: Driving and using machines
Danish: Virkning og anvendelse
English: 3) Inhale your medicine • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Danish: • Hold inhalatoren væk fra munden, og foretag den dybeste udånding, du finder behagelig.
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Danish: Hver enkelt inhalation leverer en afgivet dosis (den dosis, der forlader inhalatorens mundstykke) på 55 mikrogram umeclidinium (umeclidinium) (svarende til 65 mikrogram umeclidiniumbromid (umeclidinii bromidum)).
English: If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Danish: Kontakt straks lægen eller apoteket, hvis du ved et uheld har taget for meget af Rolufta Ellipta, da du kan have brug for lægehjælp.
English: Summary of the safety profile
Danish: Oversigt over indlægssedlen
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Danish: Rolufta Ellipta 55 mikrogram inhalationspulver, afdelt umeclidinium (umeclidiniumbromid)
English: A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Rolufta Ellipta (-4.69 units, p<0.001∗) in the 24-week study.
Danish: I studiet af 24 ugers varighed viste Rolufta Ellipta en større forbedring sammenlignet med placebo i ændring i forhold til baseline af den samlede SRGQ-score ved uge 24 (-4,69 enheder, p < 0,001∗).
English: Marketing Authorisation Holder
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: Common side effects
Danish: Almindelige bivirkninger
English: If you use more Rolufta Ellipta than you should
Danish: Hvis du har taget for meget Rolufta Ellipta
English: Breathlessness:
Danish: Åndenød:
English: Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Danish: Rolufta Ellipta 55 mikrog inhalationspulver umeclidinium (umeclidiniumbromid)
English: Uncommon
Danish: Ikke almindelig
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Carton
Danish: Amning
English: Discard by:
Danish: Kasseres senest:
English: Package leaflet: Information for the user Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide) This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Rolufta Ellipta 55 mikrogram inhalationspulver, afdelt umeclidinium (umeclidiniumbromid) umeclidinium (umeclidinii bromidum)
English: Multipack of 3 x 30 dose inhalers.
Danish: Multipakning med 3 inhalatorer med hver 30 doser.
English: LIST OF EXCIPIENTS
Danish: KOL-eksacerbationer
English: Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide) Inhalation use
Danish: Rolufta Ellipta 55 mikrog inhalationspulver umeclidinium (umeclidinii bromidum) Til inhalation.
English: Excipients
Danish: Hoste
English: • cough
Danish: • hoste
English: Vision blurred
Danish: Versus placebo
English: The tray contains a desiccant sachet, to reduce moisture.
Danish: Bakken indeholder en pose med tørremiddel for at beskytte mod fugt.
English: The first time you use Rolufta Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Danish: Det er ikke nødvendigt at kontrollere, om inhalatoren virker korrekt, før du bruger Rolufta Ellipta første gang.
English: How to use Rolufta Ellipta
Danish: Sådan skal du tage Rolufta Ellipta
English: 1 inhaler of 7 doses.
Danish: 1 inhalator med 7 doser 1 inhalator med 30 doser
English: • itching • skin rash (hives) or redness
Danish: • kløe • udslæt (nældefeber) eller rødme.
English: Uncommon side effects
Danish: Ikke almindelige bivirkninger
English: For instructions for handling, see section 4.2.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN 16.
English: The “Discard by” date should be written on the inhaler label in the space provided.
Danish: Datoen for, hvornår inhalatoren skal kasseres, skal angives på etiketten i det dertil beregnede felt.
English: • dry mouth
Danish: • sløret syn
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevar lægemidlet utilgængeligt for børn.
English: 28 patches (7 x 2 mg/24h, 7 x 4 mg/24h, 7 x 6 mg/24h, 7 x 8 mg/24h)
Danish: 28 depotplastre (7 x 2 mg/24t, 7 x 4 mg/24t, 7 x 6 mg/24t, 7 x 8 mg/24t)
English: PE/Alu/ ET copolymer/paper)
Danish: Særnavn Styrke Lægemiddelfor m
English: Questions and answers
Danish: Spørgsmål og svar
English: The application was withdrawn at ‘day 180'.
Danish: Ansøgningen blev trukket tilbage på ‘dag 180'.
English: It was expected to be used without prescription.
Danish: Det forventedes anvendt uden recept.
English: EMA/23377/2010 EMEA/H/C/1108
Danish: 20. januar 2010 EMA/285622/2010 EMEA/H/C/1108
English: The company presented the results of three main studies involving around 900 adults with pain.
Danish: Virksomheden fremlagde resultater af tre hovedundersøgelser, hvori der deltog ca. 900 voksne med smerter.
English: It was to be available as capsules.
Danish: Det skulle have været leveret som kapsler.
English: Summary of the application at the time of withdrawal
Danish: Sammendrag af ansøgningen på tidspunktet for tilbagetrækningen
English: There was also insufficient information on the safety of the medicine compared with medicines containing only one of the active substances.
Danish: Der forelå heller ikke tilstrækkelig information om lægemidlets sikkerhed i forhold til lægemidler, der kun indeholdt et af de aktive stoffer.
English: The main studies involved relatively young patients and therefore no conclusion could be drawn on how the medicine would work in other age groups.
Danish: Hovedundersøgelserne omfattede forholdsvis unge patienter, og der kunne derfor ikke drages nogen konklusioner om, hvordan lægemidlet virkede i andre aldersgrupper.
English: What was the recommendation of the CHMP at that time?
Danish: Hvad anbefalede CHMP på daværende tidspunkt?
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Danish: Det betyder, at CHMP havde evalueret den dokumentation, som virksomheden havde fremlagt, og udarbejdet en liste over spørgsmål.
English: How far into the evaluation was the application when it was withdrawn?
Danish: Hvor langt var vurderingen af ansøgningen nået, da den blev trukket tilbage?
English: What are the consequences for patients in clinical trials or compassionate use programmes?
Danish: Hvad er konsekvenserne for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse?
English: The letter from the company notifying the CHMP of the withdrawal of the application is available here.
Danish: Brevet fra virksomheden, hvori CHMP underrettes om tilbagetrækning af ansøgningen, kan ses her.
English: The main measures of effectiveness were based on the level of pain relief after two hours, the number of patients who were asleep after one hour and how long the patients slept.
Danish: De primære effektmål var, i hvor høj grad det lindrede smerterne efter to timer, hvor mange patienter der sov efter en time, og hvor længe de sov.
English: Its main action is to block receptors for histamine, which is involved in inflammation and allergic reactions, but it also leads to drowsiness which helps to improve sleep.
Danish: Dets vigtigste funktion er at blokere histaminreceptorer, som medvirker til at forårsage betændelse og allergiske reaktioner, men det har også en søvndyssende effekt, som hjælper med at forbedre søvnen.
English: When taken together, the two active substances were expected to provide benefits for patients with pain who have difficulty sleeping because of the pain.
Danish: Når de to aktive stoffer blev taget i kombination med hinanden, forventedes de at have gavnlige virkninger for patienter, som har problemer med at sove på grund af smerter.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af spørgsmålene på listen, var der fortsat visse uafklarede spørgsmål.
English: The studies compared the medicine with placebo (a dummy treatment) and a medicine containing ibuprofen alone.
Danish: I undersøgelserne blev lægemidlet sammenlignet med placebo (et virkningsløst præparat) og et lægemiddel, der kun indeholdt ibuprofen.
English: What were the reasons given by the company for withdrawing the application?
Danish: Hvilke begrundelser gav virksomheden for tilbagetrækningen af ansøgningen?
English: Ibuprofen is a painkiller that belongs to the class non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Ibuprofen er et smertestillende middel, som tilhører klassen af non-steroide antiinflammatoriske stoffer (NSAID).
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ibuprofen/Diphenhydramine Hydrochloride Wyeth could not have been approved.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at ibuprofen/diphenhydraminhydrochlorid Wyeth ikke kunne være blevet godkendt.
English: Diphenhydramine hydrochloride is an antihistamine.
Danish: Diphenhydraminhydrochlorid er et antihistamin.
English: Because Ibuprofen/Diphenhydramine Hydrochloride Wyeth was intended to be available without a prescription, the Committee requested more information on how it would interact with other medicines.
Danish: Da det var hensigten, at ibuprofen/diphenhydraminhydrochlorid Wyeth skulle kunne udleveres uden recept, anmodede udvalget om flere oplysninger om, hvordan det interagerede med andre lægemidler.
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation and pain.
Danish: Det virker ved at blokere et enzym kaldet cyclo-oxygenase, som producerer prostaglandiner.
English: On 7 January 2010, Wyeth Consumer Healthcare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth, for use in the treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain.
Danish: Den 7. januar 2010 meddelte Wyeth Consumer Healthcare officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om ændring af markedsføringstilladelsen for ibuprofen/diphenhydraminhydrochlorid Wyeth til behandling af milde til moderate smerter hos voksne, som har problemer med at sove på grund af smerter.
English: Ibuprofen is found in medicines used to treat pain, inflammation and fever.
Danish: Ibuprofen findes i lægemidler mod smerter, betændelse og feber.
English: The effects of Ibuprofen/Diphenhydramine Hydrochloride Wyeth were first tested in experimental models before being studied in humans.
Danish: Virkningerne af ibuprofen/diphenhydraminhydrochlorid Wyeth blev først undersøgt i forsøgsmodeller, inden det blev undersøgt hos mennesker.
English: What documentation did the company present to support its application?
Danish: Hvilken dokumentation fremlagde virksomheden i forbindelse med ansøgningen?
English: The CHMP noted that the applicant had not shown enough evidence that there was a relevant advantage of using Ibuprofen/Diphenhydramine Hydrochloride Wyeth over using ibuprofen alone.
Danish: CHMP bemærkede, at ansøgeren ikke havde fremlagt tilstrækkelig dokumentation for, at der var en relevant fordel ved at anvende ibuprofen/diphenhydraminhydrochlorid Wyeth frem for ibuprofen alene.
English: Diphenhydramine hydrochloride is found in medicines used to treat allergies, cough and sleep problems.
Danish: Diphenhydraminhydrochlorid findes i lægemidler, der anvendes mod allergier, hoste og søvnproblemer.
English: Ibuprofen/Diphenhydramine Hydrochloride Wyeth contains two active substances that have been available in the European Union for many years in commonly used non-prescription medicines.
Danish: Ibuprofen/diphenhydraminhydrochlorid Wyeth indeholder to aktive stoffer, som i mange år har været tilgængelige i Den Europæiske Union i almindeligt anvendte lægemidler, der udleveres uden recept.
English: Ibuprofen/Diphenhydramine Hydrochloride Wyeth was expected to be used for the short-term treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain.
Danish: Ibuprofen/diphenhydraminhydrochlorid Wyeth forventedes anvendt til kortvarig behandling af milde til moderate smerter hos voksne, som har problemer med at sove på grund af smerter.
English: Ibuprofen/Diphenhydramine Hydrochloride Wyeth is a medicine that contains the active substances ibuprofen and diphenhydramine hydrochloride.
Danish: Ibuprofen/diphenhydraminhydrochlorid Wyeth er et lægemiddel, der indeholder de to aktive stoffer ibuprofen og diphenhydraminhydrochlorid.
English: The company informed the CHMP that at present there are no ongoing clinical trials or compassionate use programmes with Ibuprofen/Diphenhydramine Hydrochloride Wyeth.
Danish: Virksomheden har oplyst CHMP om, at der på nuværende tidspunkt ikke er nogen igangværende kliniske undersøgelser med eller programmer for anvendelse af ibuprofen/diphenhydraminhydrochlorid Wyeth med særlig udleveringstilladelse.
English: What is Ibuprofen/Diphenhydramine Hydrochloride Wyeth?
Danish: Hvad er ibuprofen/diphenhydraminhydrochlorid Wyeth?
English: What was Ibuprofen/Diphenhydramine Hydrochloride Wyeth expected to be used for?
Danish: Hvad forventedes ibuprofen/diphenhydraminhydrochlorid Wyeth anvendt til?
English: How was Ibuprofen/Diphenhydramine Hydrochloride Wyeth expected to work?
Danish: Hvordan forventedes ibuprofen/diphenhydraminhydrochlorid Wyeth at virke?
English: The recommended dose is one tablet once daily with a meal.
Danish: Den anbefalede dosis er én tablet én gang dagligt sammen med et måltid.
English: Further information on Juluca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Juluca findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Juluca must not be used with the following medicines because they may reduce its effectiveness:
Danish: Juluca må ikke anvendes sammen med følgende lægemidler, da de kan nedsætte dets virkning:
English: Other information about Juluca
Danish: Andre oplysninger om Juluca
English: It does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Det helbreder ikke HIV-infektion eller AIDS, men kan sinke den skade på immunsystemet og udvikling af de infektioner og sygdomme, der er forbundet med AIDS.
English: As for all medicines, data on the use of Juluca are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Juluca løbende overvåget.
English: Because Juluca does not contain an NRTI, it is free of long-term side effects caused by NRTIs.
Danish: Da Juluca ikke indeholder et NRTI, er det uden de langsigtede bivirkninger, der forårsages af NRTI.
English: For more information about using Juluca, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Juluca, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Juluca?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Juluca?
English: In this way, Juluca helps to prevent the spread of HIV-1 and keep the amount of the virus in the blood at a low level.
Danish: På denne måde hjælper Juluca med at forhindre spredning af HIV-1 og holde mængden af virusset i blodet på et lavt niveau.
English: The most serious side effects (which may affect up to 1 in 100) include allergic reactions that include rash or liver damage.
Danish: De alvorligste bivirkninger (som kan forekomme hos op til 1 ud af 100 behandlede), er allergiske reaktioner, herunder udslæt og leverskade.
English: Juluca (dolutegravir / rilpivirine)
Danish: Juluca (dolutegravir/rilpivirin)
English: Side effects reported with Juluca are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet for Juluca vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: It is not suitable for patients in whom any HIV medicine has stopped working or who are infected with HIV that is resistant to medicines that work in the same way as Juluca's active substances.
Danish: Det er ikke egnet til patienter, hos hvem ethvert HIV-lægemiddel er holdt op med at virke, eller patienter, som er smittet med HIV, der er resistent over for lægemidler, som virker på samme måde som de aktive indholdsstoffer i Juluca.
English: • dexamethasone given by mouth or by injection (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single-dose treatment;
Danish: • dexamethason indgivet gennem munden eller ved injektion (et antiinflammatorisk og immunundertrykkende steroidt lægemiddel), undtagen når anvendes som enkeltdosisbehandling
English: The proportion of patients whose viral load was below 50 copies/ml after 48 weeks was the same for patients switching compared with those remaining on the current medicines (95% in both cases).
Danish: Andelen af patienter med viral belastning under 50 kopier/ml efter 48 uger var den samme for de patienter, der skiftede, som for dem, der fortsatte med de eksisterende lægemidler (95 % i begge tilfælde).
English: Why is Juluca authorised in the EU?
Danish: Hvorfor er Juluca godkendt i EU?
English: An overview of Juluca and why it is authorised in the EU
Danish: En oversigt over Juluca og hvorfor det er godkendt i EU
English: The Agency decided that Juluca's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet afgjorde, at fordelene ved Juluca opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The studies involved a total of 1,028 patients whose HIV infection was well controlled for at least 6 months on a combination of three HIV medicines that included a class of HIV medicines called nucleoside (or nucleotide) reverse transcriptase inhibitors (NRTIs).
Danish: Undersøgelserne havde deltagelse af i alt 1.028 patienter, hos hvem HIV-infektionen var velkontrolleret i mindst 6 måneder på en kombination af tre HIV-lægemidler, der omfattede en klasse af HIV-lægemidler, der kaldes nukleosid- (eller nukleotid-) reverse transkriptasehæmmere (NRTI).
English: What is Juluca and what is it used for?
Danish: Hvad er Juluca, og hvad anvendes det til?
English: Juluca can only be obtained with a prescription and it should be prescribed by doctors experienced in managing HIV infection.
Danish: Juluca udleveres kun på recept, og bør ordineres læger med erfaring i behandling af HIV-infektioner.
English: The European Medicines Agency considered that Juluca's effectiveness was comparable to that of combination treatment with three HIV medicines that include NRTIs.
Danish: Det Europæiske Lægemiddelagentur fandt, at effektiviteten af Juluca var sammenlignelig med kombinationsbehandling med tre HIV-lægemidler, hvori der indgår NRTI.
English: What are the risks associated with Juluca?
Danish: Hvilke risici er der forbundet med Juluca?
English: Juluca is only used for patients whose levels of HIV-1 in the blood (viral load) have been below 50 copies/ml for at least 6 months on their current HIV treatment combination.
Danish: Juluca anvendes kun til patienter, hos hvem mængden af HIV-1 i blodet (deres virale belastning) har været under 50 kopier/ml i mindst 6 måneder på deres nuværende kombinerede HIV-behandling.
English: The most common side effects with Juluca are diarrhoea and headache.
Danish: De hyppigste bivirkninger ved Juluca er diarré og hovedpine.
English: • rifampicin, rifapentine (antibiotics);
Danish: • rifampicin og rifapentin (antibiotika)
English: Two main studies found that the combination of dolutegravir and rilpivirine (the active substances in Juluca) was effective for keeping HIV infection under control.
Danish: To hovedundersøgelser viste, at kombinationen af dolutegravir og rilpivirin (de aktive stoffer i Juluca) var effektiv til at holde HIV-infektionen under kontrol.
English: The two active substances in Juluca, dolutegravir and rilpivirine, block the actions of enzymes that the HIV needs to make copies of itself in the cells it has infected.
Danish: De to aktive stoffer i Juluca, dolutegravir og rilpivirin, blokerer virkningerne af enzymer, som HIV behøver for at danne kopier af sig selv i de celler, det har smittet.
English: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);
Danish: • carbamazepin, oxcarbazepin, phenobarbital, phenytoin (lægemidler mod epilepsi)
English: Juluca is a HIV medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Juluca er et HIV-lægemiddel, der anvendes til behandling af voksne smittet med humant immundefektvirus type 1 (HIV-1), som er årsag til erhvervet immundefektsyndrom (AIDS).
English: The side effects of Juluca are well known and manageable.
Danish: Bivirkningerne af Juluca er velkendte og kan behandles.
English: The active substances in Juluca are dolutegravir and rilpivirine.
Danish: De aktive indholdsstoffer i Juluca er dolutegravir og rilpivirin.
English: Both active substances are already available in the European Union: dolutegravir has been authorised since 2014 and rilpivirine has been authorised since 2011.
Danish: Dolutegravir har været godkendt siden 2014, og rilpivirin har været godkendt siden 2011.
English: The studies compared the effectiveness of switching to the combination of dolutegravir and rilpivirine with that of remaining on the current combination of HIV medicines.
Danish: Undersøgelserne sammenlignede effektiviteten af at skifte til kombinationen af dolutegravir og rilpivirin med at fortsætte med den nuværende kombination af HIVlægemidler.
English: For the full list of restrictions and side effects of Juluca, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og bivirkninger med Juluca fremgår af indlægssedlen.
English: • St John's wort (a herbal medicine used for treating depression).
Danish: • perikum (et naturlægemiddel, der anvendes til behandling af depression).
English: How is Juluca used?
Danish: Hvordan anvendes Juluca?
English: • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
Danish: • omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol (syrepumpehæmmere, der nedsætter mavesyreproduktionen)
English: What benefits of Juluca have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Juluca?
English: How does Juluca work?
Danish: Hvordan virker Juluca?
English: Dolutegravir, an integrase inhibitor, blocks an enzyme called integrase while rilpivirine, a non-nucleoside reverse-transcriptase inhibitor, blocks the activity of another enzyme called reverse transcriptase.
Danish: Rilpivirin er en ikke-nukleosid reverse transkriptasehæmmer, dvs. det blokerer aktiviteten af enzymet reverse transkriptase.