FrancophonIA/ELRC3.0 huggingface dataset:
English: More patients receiving Stocrin had viral loads below 400 copies/ml than those taking placebo after 24 weeks
Danish: Blandt de patienter, der fik Stocrin, var der flere med en virusbelastning under 400 kopier/ml efter 24 uger end blandt dem, der fik placebo.
English: • in the first study, Stocrin in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine.
Danish: • I den første undersøgelse blev Stocrin i kombination med lamivudin og zidovudin eller med indinavir (andre antivirale lægemidler) sammenlignet med kombinationen af indinavir, lamivudin og zidovudin.
English: For practical information about using Stocrin, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Stocrin, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Stocrin used?
Danish: Hvordan anvendes Stocrin?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stocrin 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 Stocrin.
English: What benefits of Stocrin have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Stocrin?
English: • the second study compared Stocrin in combination with nelfinavir and two other antiviral medicines with the same combination without Stocrin.
Danish: • I den anden undersøgelse blev Stocrin i kombination med nelfinavir og to andre antivirale lægemidler sammenlignet med samme kombination uden Stocrin.
English: • the third study compared adding Stocrin or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection.
Danish: • I den tredje undersøgelse blev Stocrin sammenlignet med placebo (ikke-aktivt stof) som tillægsbehandling til en kombination af antivirale lægemidler, herunder indinavir og to andre antivirale lægemidler, hos patienter, der i forvejen var blevet behandlet for hiv-infektion.
English: How does Stocrin work?
Danish: Hvordan virker Stocrin?
English: The Stocrin combination was more effective than the combination without Stocrin: 70% and 30% of the patients, respectively, had viral loads below 500 copies/ml after 48 weeks;
Danish: Hos henholdsvis 70 % og 30 % af patienterne var virusbelastningen under 500 kopier/ml efter 48 ugers behandling.
English: It also noted that there is little information on the benefits of treatment that includes a protease inhibitor in patients who have been treated with Stocrin in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.
Danish: Agenturet konstaterede desuden, at der kun findes få oplysninger om fordelene ved at anvende en protease-hæmmer som tillægsbehandling hos patienter, hos hvem Stocrin er holdt op med at virke.
English: Stocrin has shown benefit in controlling HIV infection in three main studies involving over 1,100 adults.
Danish: Det er i tre hovedundersøgelser med over 1.100 voksne påvist, at Stocrin har en gavnlig virkning på hiv-infektion.
English: To investigate this further the Agency recommended that a study be carried out.
Danish: Agenturet anbefalede, at der gennemføres et studie for at undersøge dette yderligere.
English: Previously known as Laventair.
Danish: Tidligere kendt som Laventair.
English: Further information on Laventair Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Laventair Ellipta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Laventair Ellipta received a marketing authorisation valid throughout the EU on 8 May 2014.
Danish: Laventair Ellipta fik en markedsføringstilladelse med gyldighed i hele EU den 8. maj 2014.
English: The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily.
Danish: Den kombinerede virkning af de to aktive stoffer hjælper med at holde luftvejene åbne og gør det lettere for patienten at trække vejret.
English: In all 4 studies, involving over 4,700 patients, the main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Danish: Det primære mål for virkningen i alle 4 studier, hvor flere end 4.700 patienter deltog, var ændringer i patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde, som en person kan udånde på et sekund).
English: As medicines of the same class as Laventair Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets the medicine will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.
Danish: Da lægemidler af samme klasse som Laventair Ellipta kan påvirke hjertet og blodkarrene i hjernen, skal den virksomhed, der markedsfører lægemidlet, gennemføre et langtidsstudie med patienter for at indsamle yderligere oplysninger om lægemidlets sikkerhed sammenholdt med tiotropium.
English: As for all medicines, data on the use of Laventair Ellipta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Laventair Ellipta løbende overvåget.
English: The Agency also noted that there were no major safety concerns with Laventair Ellipta, with side effects being manageable, although the longterm safety data so far are limited.
Danish: Agenturet bemærkede desuden, at der ikke var større sikkerhedsmæssige problemer med Laventair Ellipta, da bivirkningerne kan behandles, selvom dataene for langsigtet sikkerhed indtil videre er begrænsede.
English: It is available as an inhalation powder in a portable inhaler device.
Danish: Det fås som et inhalationspulver i en bærbar inhalator.
English: For detailed information on using the inhaler correctly, see the instructions in the package leaflet or contact your doctor and pharmacist.
Danish: For mere information om korrekt brug af inhalatoren, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Laventair Ellipta1 (umeclidinium bromide / vilanterol)
Danish: Laventair Ellipta1 (umeclidiniumbromid/vilanterol)
English: It works by attaching to beta-2 receptors found in the muscle cells of many organs including the airways in the lungs.
Danish: Det virker ved at binde til beta-2-receptorer i muskelcellerne i mange organer, herunder luftvejene i lungerne.
English: Laventair Ellipta contains two active substances.
Danish: Laventair Ellipta indeholder to aktive stoffer.
English: Side effects reported with Laventair Ellipta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Laventair Ellipta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Laventair Ellipta is used for maintenance (regular) treatment.
Danish: Laventair Ellipta anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: Each inhalation provides 65 micrograms of umeclidinium bromide (equivalent to 55 micrograms of umeclidinium) and 22 micrograms of vilanterol.
Danish: Hver inhalation indeholder 65 mikrogram umeclidiniumbromid (svarende til 55 mikrogram umeclidinium) og 22 mikrogram vilanterol.
English: The most common side effects with Laventair Ellipta (which may affect up to 1 in 10 people) are upper respiratory tract infections (nose and throat infection), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth.
Danish: De hyppigste bivirkninger ved Laventair Ellipta (der kan forekomme hos op til 1 ud af 10 patienter) er infektioner i de øvre luftveje (næse og svælg), urinvejsinfektioner, halsbetændelse, bihulebetændelse, betændelse i næse og svælg, hovedpine, hoste, smerter i mund og svælg, forstoppelse og mundtørhed.
English: Umeclidinium bromide is a muscarinic receptor antagonist.
Danish: Umeclidiniumbromid er en såkaldt muskarinreceptor-antagonist.
English: When inhaled, vilanterol reaches the receptors in the airways and activates them.
Danish: Når Laventair Ellipta inhaleres, når vilanterol frem til receptorerne i luftvejene og aktiverer dem.
English: What measures are being taken to ensure the safe and effective use of Laventair Ellipta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Laventair Ellipta?
English: It works by blocking other receptors called muscarinic receptors, which control the contraction of muscles.
Danish: Det virker ved at blokere virkningen af de såkaldte muskarinreceptorer, der styrer musklernes sammentrækning.
English: The European Medicines Agency decided that Laventair Ellipta's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Laventair Ellipta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Other information about Laventair Ellipta
Danish: Andre oplysninger om Laventair Ellipta
English: The results for the higher dose combination of umeclidinium bromide and vilanterol did not consistently show relevant improvements in lung function to justify its use.
Danish: Kombinationen af umeclidiniumbromid og vilanterol i den højere dosis medførte ikke tilstrækkeligt væsentlige forbedringer af lungefunktionen til at retfærdiggøre dens anvendelse.
English: Laventair Ellipta contains the active substances umeclidinium bromide and vilanterol.
Danish: Laventair Ellipta indeholder de aktive stoffer umeclidiniumbromid og vilanterol.
English: The average increase in FEV1 with Laventair Ellipta was 90 ml more than with tiotropium after 24 weeks of treatment.
Danish: Den gennemsnitlige stigning i FEV1 med Laventair Ellipta var 90 ml mere end med tiotropium efter 24 ugers behandling.
English: Laventair Ellipta and a higher-dose combination of umeclidinium bromide and vilanterol were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium bromide alone and another COPD medicine called tiotropium in 4 main studies.
Danish: Laventair Ellipta og en kombination af umeclidiniumbromid og vilanterol i en højere dosis blev sammenlignet med placebo (ikke-aktivt stof), vilanterol alene, umeclidiniumbromid alene og tiotropium (et andet KOL-middel) i 4 hovedstudier.
English: Laventair Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Laventair Ellipta er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: Laventair Ellipta can only be obtained with a prescription.
Danish: Laventair Ellipta udleveres kun efter recept.
English: An overview of Laventair Ellipta and why it is authorised for use in the EU
Danish: En oversigt over Laventair Ellipta, og hvorfor det er godkendt i EU
English: Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Danish: Kombinationen af muskarinreceptor-antagonister og langtidsvirkende beta-2-agonister er almindelig ved behandling af KOL.
English: Laventair Ellipta also increased FEV1 by an average of 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone.
Danish: Laventair Ellipta medførte også en gennemsnitlig stigning i FEV1 på 95 ml mere end vilanterol alene og på 52 ml mere end umeclidiniumbromid alene.
English: Why is Laventair Ellipta authorised in the EU?
Danish: Hvorfor blev Laventair Ellipta godkendt i EU?
English: This relaxes the muscles of the airways.
Danish: Dette får musklerne i luftvejene til at slappe af.
English: What is Laventair Ellipta and what is it used for?
Danish: Hvad er Laventair Ellipta, og hvad anvendes det til?
English: The Agency concluded that Laventair Ellipta was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
Danish: Agenturet fandt, at det er påvist, at Laventair Ellipta er effektivt til at forbedre lungefunktionen og lindre symptomerne på KOL sammenholdt med placebo, indholdsstofferne hver for sig og tiotropium.
English: Results showed that Laventair Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment.
Danish: Resultaterne viste, at behandling med Laventair Ellipta medførte en forbedring af lungefunktionen med en gennemsnitlig stigning i FEV1 på 167 ml mere end placebo efter 24 ugers behandling.
English: Laventair Ellipta was also shown to improve symptoms such as breathlessness and wheezing.
Danish: Det blev også påvist, at Laventair Ellipta lindrer symptomer som f.eks. åndenød og hvæsende vejrtrækning.
English: What are the risks associated with Laventair Ellipta?
Danish: Hvilke risici er der forbundet med Laventair Ellipta?
English: How is Laventair Ellipta used?
Danish: Hvordan anvendes Laventair Ellipta?
English: What benefits of Laventair Ellipta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Laventair Ellipta?
English: Recommendations and precautions to be followed by healthcare professionals and patients have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Laventair Ellipta.
English: How does Laventair Ellipta work?
Danish: Hvordan virker Laventair Ellipta?
English: Strength Pharmaceutical Form Route of Administration Packaging
Danish: Styrke Lægemiddel-form Indgivelsesvej
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Danish: Styrke Lægemiddelform Indgivelsesvej
English: < PC: {number} SN: {number} NN: {number} >
Danish: <PC: {nummer} SN: {nummer} NN: {nummer}>
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 09 Desember 2016
Danish: Dato for første markedsføringstilladelse: 20 april 2012 Dato for seneste fornyelse: 9 december 2016
English: Risk reduction of suffering from multiple events**
Danish: Reduktion i risiko for gentagne hændelser**
English: If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Danish: Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge.
English: Baseline Creatinine Clearance (ml/min)
Danish: Baseline kreatinin clearance (ml/min)
English: Median time to normocalcaemia was 4 days.
Danish: Mediantid til normo calcæmi var 4 dage.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du får denne medicin da den indeholder vigtige oplysninger.
English: 20014 Nerviano (MI) Italy
Danish: 20014 Nerviano (MI) Italien
English: <2D barcode carrying the unique identifier included.> <Not applicable.>
Danish: <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.> <Ikke relevant.>
English: - if you have or have had a kidney problem.
Danish: − hvis du har eller har haft en nyrelidelse.
English: Women of childbearing potential should be advised to avoid becoming pregnant.
Danish: Kvinder i den fertile alder skal tilrådes at undgå at blive gravide.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Danish: Farmakoterapeutisk klassifikation: Lægemidler til brug for behandling af knoglesygdomme, bisfosfonater, ATC-kode: M05BA08
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2°C - 8°C.
English: Pack sizes: 1, 4 or 10 vials.
Danish: Pakningsstørrelser: 1, 4 eller 10 hætteglas.
English: - The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Danish: - Den normale enkeltdosis er 4 mg. - Hvis du har problemer med nyrerne, vil lægen give dig en lavere dosis afhængig af sværhedsgraden af dine nyreproblemer.
English: If refrigerated, the solution must be allowed to reach room temperature before administration.
Danish: Ved opbevaring i køleskab skal opløsningen have lov at nå stuetemperatur før administration.
English: If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Danish: Hvis hypocalcæmi, hypofosfatæmi eller hypomagnesiæmi forekommer kan supplement behandling være nødvendigt i kort tid.
English: Dilute before use
Danish: Fortyndes før brug
English: Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland
Danish: Reykjavikurvegur 76-78 220 Hafnarfjöður Island
English: If you are given more Zoledronic acid Actavis than you should be
Danish: Hvis du har fået mere Zoledronsyre Actavis, end du skulle have haft
English: Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Danish: Ubehandlede hypercalcæmiske patienter har generelt nogen grad af nedsat nyrefunktion, hvorfor omhyggelig monitorering af nyrefunktionen bør overvejes.
English: NR 714
Danish: NR NR 424
English: Zoledronic acid Actavis can be given to people aged 65 years and over.
Danish: Zoledronsyre Actavis kan ordineres til patienter i alderen 65 år og derover.
English: - Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
Danish: - Følg nøje alle de andre instruktioner, som du har fået af din læge, apoteket eller din sygeplejerske.
English: Zoledronic acid Actavis should only be resumed when serum creatinine returns to within 10% of baseline.
Danish: Zoledronsyre Actavis bør kun genoptages, når serum-kreatinin igen er inden for 10% af baseline.
English: The following information is intended for healthcare professionals only: How to prepare and administer Zoledronic acid Actavis
Danish: Følgende oplysninger er kun tiltænkt sundhedspersonale: Tilberedelse og indgift af Zoledronsyre Actavis
English: The active substance in Zoledronic acid Actavis is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Danish: Det aktive stof i Zoledronsyre Actavis er zoledronsyre, der tilhører en gruppe af stoffer kaldet bisfosfonater.
English: - Low counts of white blood cells and blood platelets.
Danish: Lavt antal hvide blodceller og blodplader.
English: In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
Danish: I tilfælde af hypocalcæmi bør calciumglukonat-infusioner administreres, hvis det er klinisk indikeret.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: From a microbiological point of view, the solution for infusion should be used immediately after dilution.
Danish: Ud fra et mikrobiologisk synspunkt skal opløsningen til infusion anvendes straks.
English: If a lower dose of Zoledronic acid Actavis is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Danish: Hvis der kræves en nedsat dosis af Zoledronsyre Actavis, skal der først udtages en passende mindre volumen som angivet nedenfor og derefter fortynde yderligere med 100 ml infusionsopløsning.
English: - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Actavis and inform your doctor about your dental treatment.
Danish: − hvis du er under tandlægebehandling eller skal have en tandoperation, bør du fortælle tandlægen, at du er i behandling med Zoledronsyre Actavis og informere din læge om tandlægebehandlingen.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic acid Actavis.
Danish: Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandeftersyn og straks rapportere eventuelle orale symptomer såsom tandmobilitet, smerter eller hævelse eller vedvarende sår eller sekretion under behandling med Zoledronsyre Actavis.
English: Zoledronic acid Actavis is supplied as packs containing 1, 4 or 10 vials.
Danish: Zoledronsyre Actavis leveres i pakninger, som indeholder 1, 4 eller 10 hætteglas.
English: - Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Danish: - Behandling af voksne patienter med tumorinduceret hypercalcæmi (TIH).
English: EU/1/12/759/001 1vial EU/1/12/759/002 4 vials EU/1/12/759/003 10 vials
Danish: EU/1/12/759/001 1 hætteglas EU/1/12/759/002 4 hætteglas EU/1/12/759/003 10 hætteglas
English: Your doctor, pharmacist or nurse knows how to store Zoledronic acid Actavis properly.
Danish: Lægen, sygeplejersken og apoteket ved, hvordan Zoledronsyre Actavis skal opbevares korrekt.
English: No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.
Danish: Der eksisterer ingen farmakokinetiske data for zoledronsyre til patienter med hypercalcæmi eller patienter med leverinsufficiens.
English: In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Danish: I fase I doseringsundersøgelser i patienter med mild til moderat tumorindiceret hypercalcæmi (TIH), var den afprøvede effektive dosis cirka 1,2-2,5 mg.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic acid Actavis is used in combination with thalidomide.
Danish: Hos patienter med multiple myelomer kan risikoen for nedsat nyrefunktion øges når Zoledronsyre Actavis anvendes i kombination med thalidomid.
English: Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of Zoledronic acid Actavis along with driving and operating of machinery.
Danish: Bivirkninger såsom svimmelhed og somnolens kan påvirke evnen til at føre motorkøretøj eller betjene maskiner, der skal derfor iagttages forsiktighed når Zoledronsyre Actavis anvendes i forbindelse med bilkørsel og betjening af maskiner.
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic acid Actavis.
Danish: - Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én infusion med Zoledronsyre Actavis.