FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare cases of abnormal hepatic function possibly associated with the use of nicardipine have been reported.
Danish: Patienter med hepatisk dysfunktion i anamnesen eller nedsat leverfunktion Der er i sjældne tilfælde rapporteret om abnorm leverfunktion, der muligvis var forbundet med brug af nicardipin.
English: Each [to be completed nationally] contains [to be completed nationally]
Danish: Hver [udfyldes individuelt] indeholder [udfyldes individuelt]
English: If you have any further questions, ask your doctor, pharmacist, or nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet.
English: Not known - hepatic enzyme increased
Danish: Ikke kendt - forhøjede leverenzymer
English: Manufacturer: [to be completed nationally]
Danish: Fremstiller: [udfyldes individuelt]
English: Other medicines and Nicardipine solution for injection
Danish: Brug af anden medicin sammen med Nicardipin injektionsvæske
English: Due to the possible risk of pulmonary oedema or excessive decrease in blood pressure, caution should be taken if magnesium sulphate is used concomitantly (see section 4.4) CYP3A4 inducers and inhibitors
Danish: På grund af den mulige risiko for lungeødem eller udtalt blodtryksfald skal der udvises forsigtighed ved samtidig anvendelse af magnesiumsulfat (se pkt.
English: Increased heart rate, feeling your heart beat (palpitations) Low blood pressure, especially on standing up.
Danish: Lavt blodtryk, især når du rejser dig op.
English: Severe aortic stenosis
Danish: Svær aortastenose
English: Continue blood pressure monitoring until desired effect is achieved.
Danish: Når der indledes behandling med et oralt antihypertensivum, skal der tages højde for tidsintervallet, indtil virkningen af det orale lægemiddel sætter ind. Blodtryksmonitorering skal fortsættes, indtil den ønskede virkning er opnået.
English: It is available in [to be completed nationally] containing [to be completed nationally]
Danish: Det fås i [udfyldes individuelt] indeholdende [udfyldes individuelt]
English: Nicardipine is also indicated for the treatment of post-operative hypertension 4.2 Posology and method of administration
Danish: • Svær præeklampsi, når andre intravenøse antihypertensiva frarådes eller er kontraindicerede Nicardipin er også indiceret til behandling af postoperativ hypertension 4.2 Dosering og administration
English: [Product name]
Danish: [Produktnavn], injektionsvæske
English: MARKETING AUTHORISATION HOLDER To be completed nationally 8.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt
English: What Nicardipine solution for injection is and what it is used for What you need to know before you take Nicardipine solution for injection How to take Nicardipine solution for injection Possible side effects
Danish: Det skal du vide, før du begynder at tage Nicardipin injektionsvæske Sådan skal du tage Nicardipin injektionsvæske Bivirkninger
English: Not applicable.
Danish: Der foreligger ingen data.
English: How to take Nicardipine solution for injection
Danish: Sådan skal du tage Nicardipin injektionsvæske
English: Limited pharmacokinetic data have shown that nicardipine i.v.
Danish: Begrænsede farmakokinetiske data har vist, at intravenøs nicardipin ikke akkumuleres og kun passerer placenta i lav grad.
English: Metabolism
Danish: Inhalationsanæstetika
English: - Dantrolene (used to treat long-term muscle stiffness) - Beta-blockers (used to treat high blood pressure and heart conditions) such as propranolol, atenolol and metoprolol - Medicines used to control seizures, such as carbamazepine , phenobarbitone, primidone and phenytoin - Baclofen (used to treat muscle spasms) - Medicines used to control the body's immune system, such as tacrolimus, sirolimus and ciclosporin - Itraconazole (used to treat certain types of fungal infection) - Rifampicin (used to treat tuberculosis and certain other types of infection) - Alpha-blockers (used to treat high blood pressure, or prostate problems in men) such as doxazosin,
Danish: - Dantrolen (anvendes til behandling af langvarig muskelstivhed) - Betablokkere (anvendes til behandling af højt blodtryk og hjertesygdomme), såsom propranolol,
English: Cardiac failure
Danish: Brystsmerter
English: 6.5 Nature and contents of container
Danish: 6.5 Emballagetype og pakningsstørrelser Udfyldes nationalt
English: Warnings
Danish: Blussen
English: Known hypersensitivity to nicardipine or to any of the excipients listed in section 6.1
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Significant difference has been identified with regard to clinical safety.
Danish: Der er konstateret en signifikant forskel for så vidt angår den kliniske sikkerhed.
English: Article 29(4) of Directive 2001/83/EC, as amended.
Danish: Artikel 29, stk. 4, i direktiv 2001/83/EF, som ændret.
English: London, 12 September 2008 EMEA/CHMP/496102/2008
Danish: London, den 12. september 2008 EMEA/CHMP/496105/2008
English: The Mutual Recognition Procedure started on 20 September 2007.
Danish: Den gensidige anerkendelsesprocedure indledtes den 20. september 2007.
English: The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Bulgaria, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Slovenia, Slovak Republic and United Kingdom.
Danish: Referencemedlemsstaten var Sverige, og de berørte medlemsstater var Østrig, Belgien, Bulgarien, Tjekkiet, Tyskland, Danmark, Estland, Spanien, Finland, Frankrig, Ungarn, Irland, Island, Italien, Litauen, Luxembourg, Letland, Nederlandene, Norge, Portugal, Rumænien, Slovenien, Slovakiet og Det Forenede Kongerige.
English: Sweden referred the reasons for disagreement to the EMEA on 3 March 2008.
Danish: Sverige indbragte grundene til uenigheden for EMEA den 3. marts 2008.
English: The arbitration procedure started on 19 March 2008 with the adoption of a list of questions.
Danish: Voldgiftssagen indledtes den 19. marts 2008 med vedtagelsen af en liste med spørgsmål.
English: The final opinion was converted into a Decision by the European Commission on 11 September 2008.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 11. september
English: The Marketing Authorisation Holder provided written explanations on 5 May 2008.
Danish: Indehaveren af markedsføringstilladelsen indsendte skriftlige redegørelser den 5. maj 2008.
English: A positive opinion was adopted by majority on 26 June
Danish: Udvalget vedtog en positiv udtalelse efter en flertalsafstemning den 26. juni 2008.
English: The Rapporteur was Dr Pierre Demolis (FR) as Rapporteur and Co-Rapporteur(s) was Dr Ingemar Persson (SE).
Danish: Rapportør var dr. Pierre Demolis (F) og medrapportør dr. Ingemar Persson (S).
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Danish: Listen med berørte produktnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II, og produktresuméet findes i bilag III.
English: During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Activelle and associated names, that the objections raised by France and Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: Efter gennemgang af alle fremlagte oplysninger og den faglige drøftelse i Udvalget vurderede CHMP på sit møde i juni 2008, at benefit/risk-forholdet for Activelle og tilknyttede navne er positivt, at Frankrigs og Tysklands indvendinger ikke skulle stå i vejen for udstedelse af en markedsføringstilladelse, og at produktresuméet, etiketteringen og indlægssedlen i referencemedlemsstaten skulle ændres.
English: This refers to endometrial safety of Activelle 0.5 mg/0.1 mg, which had been insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/CHMP/021/97 rev 1) and this was considered to be of serious public health concern.
Danish: Forskellen vedrører den endometrielle sikkerhed af Activelle 0,5 mg/0,1 mg, som er blevet utilstrækkeligt påvist i henhold til CHMP's retningslinjer for HRT-produkter (EMEA/CHMP/021/97 rev 1), og dette gav anledning til alvorlig bekymring for folkesundheden.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Activelle and associated names International Non-Proprietary Name (INN): Estradiol and norethisterone acetate
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41, OM Activelle og tilknyttede navne Internationalt fællesnavn (INN): estradiol og norethisteronacetat
English: Novo Nordisk A/S submitted applications for mutual recognition of Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets on the basis of the marketing authorisation granted by Sweden on 3 August 2007.
Danish: Novo Nordisk A/S indgav ansøgninger om gensidig anerkendelse af Activelle og tilknyttede navne, estradiol 0,5 mg og norethisteronacetat 0,1 mg filmovertrukne tabletter, på grundlag af den markedsføringstilladelse, som Sverige havde udstedt den 3. august 2007.
English: Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets is a continuous combined hormone replacement therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause.
Danish: Activelle og tilknyttede navne, estradiol 0,5 mg og norethisteronacetat 0,1 mg filmovertrukne tabletter, er en kontinuerlig, kombineret hormonsubstitutionsbehandling (HRT) mod symptomer på østrogenmangel hos postmenopausale kvinder mere end 1 år efter menopausen.
English: ‘Idiopathic' means that the cause of the disease is unknown.
Danish: "Idiopatisk" betyder, at sygdommens årsag er ukendt.
English: The CHMP also noted the lack of effective alternative treatments.
Danish: CHMP bemærkede ligeledes, at der manglede effektive alternative behandlinger.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Esbriet on 28 February 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Esbriet den 28. februar 2011.
English: Esbriet pirfenidone
Danish: Esbriet pirfenidon
English: This is a summary of the European public assessment report (EPAR) for Esbriet.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Esbriet.
English: Other information about Esbriet
Danish: Andre oplysninger om Esbriet
English: The first study also found Esbriet to be most effective at the higher dose.
Danish: I den første undersøgelse viste det sig også, at Esbriet var mest effektivt ved den højere dosis.
English: Esbriet contains the active substance pirfenidone.
Danish: Esbriet indeholder det aktive stof pirfenidon.
English: What measures are being taken to ensure the safe and effective use of Esbriet?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Esbriet?
English: Why is Esbriet approved?
Danish: Hvorfor blev Esbriet godkendt?
English: Because the number of patients with IPF is low, the disease is considered ‘rare', and Esbriet was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 November 2004.
Danish: Da antallet af patienter, der lider af IPF, er lavt, betragtes sygdommen som "sjælden", og Esbriet blev udpeget som "lægemiddel til sjældne sygdomme" den 16. november 2004.
English: What is Esbriet and what is it used for?
Danish: Hvad er Esbriet, og hvad anvendes det til?
English: Patients who have side effects such as stomach problems, skin reactions to light or significant changes in the levels of liver enzymes may need to take a lower dose at least temporarily.
Danish: Patienter, der oplever bivirkninger såsom maveproblemer, lysfølsomhedsreaktioner i huden eller væsentlige ændringer i leverenzymniveauerne, skal måske tage en lavere dosis, i det mindste midlertidigt.
English: In both studies, the main measure of effectiveness was the change in the functioning of the patients' lungs after 72 weeks of treatment, measured by their ‘forced vital capacity' (FVC).
Danish: I begge undersøgelser var det primære effektmål ændringen i patienternes lungefunktion efter 72 ugers behandling, målt ved hjælp af deres "forcerede vitalkapacitet" (FVC).
English: For more information about treatment with Esbriet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Esbriet, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The first study also compared two doses of Esbriet (399 mg and 801 mg three times a day).
Danish: I den første undersøgelse sammenlignede man også to forskellige doser af Esbriet (399 mg og 801 mg tre gange dagligt).
English: The higher dose results from the first study, combined with the results of the second study (which involved the same higher dose), showed that the average reduction in FVC was 8.5% for patients taking Esbriet compared with 11% for patients taking placebo.
Danish: Resultaterne fra de højere doser i den første undersøgelse kombineret med resultaterne af den anden undersøgelse (hvor samme høje dosis var anvendt) viste, at den gennemsnitlige reduktion i FVC var 8,5 % for patienter, der tog Esbriet, sammenlignet med 11 % for patienter, der tog placebo.
English: Esbriet can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of IPF.
Danish: Esbriet udleveres kun efter recept, og behandlingen bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af IPF.
English: The dose of Esbriet is increased steadily, starting with 267 mg three times a day in the first week, 534 mg three times a day in the second week and 801 mg three times a day from the third week onwards.
Danish: Dosen af Esbriet øges gradvist og starter med 267 mg tre gange dagligt den første uge, 534 mg tre gange dagligt den anden uge og 801 mg tre gange dagligt den tredje uge og fremefter.
English: The full EPAR for Esbriet can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Esbriet findes på agenturets websted under:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common side effects with Esbriet during clinical studies were nausea (feeling sick), rash, tiredness, diarrhoea, dyspepsia (heartburn), loss of appetite, headache and photosensitivity reactions (sunburn-like reactions following exposure to light).
Danish: De hyppigste bivirkninger under de kliniske undersøgelser med Esbriet var kvalme, udslæt, træthed, diarré, dyspepsi (halsbrand), appetitløshed, hovedpine og lysoverfølsomhedsreaktioner (reaktioner, der ligner solskoldning, efter at have været udsat for lys).
English: The company must also ensure that all doctors who are expected to prescribe Esbriet are provided with information material containing safety information on liver function and light-sensitive reactions.
Danish: Virksomheden skal ligeledes sikre, at alle læger, som forventes at ordinere Esbriet, får udleveret informationsmateriale med sikkerhedsinformation om leverfunktion og lysfølsomhedsreaktioner.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Esbriet.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Esbriet skal anvendes.
English: In the first study, the patients taking Esbriet had a smaller reduction in FVC after 72 weeks than the patients taking placebo.
Danish: I den første undersøgelse havde de patienter, der tog Esbriet, en mindre reduktion i FVC efter 72 uger end de patienter, der tog placebo.
English: Esbriet was more effective than placebo (a dummy treatment) at slowing down the worsening of lung function in two main studies involving a total of 779 IPF patients.
Danish: Esbriet viste sig mere virksomt end placebo (en uvirksom behandling) i henseende til at forsinke forværringen af lungefunktionen i to hovedundersøgelser, der omfattede i alt 779 IPF-patienter.
English: Esbriet must not be used by patients already taking fluvoxamine (a medicine used to treat depression and obsessive compulsive disorder) or patients with severe liver or kidney problems.
Danish: Esbriet må ikke tages af patienter, der allerede tager fluvoxamin (et lægemiddel, der anvendes til behandling af depression og obsessiv-kompulsiv tilstand), eller patienter med svære lever- eller nyreproblemer.
English: What are the risks associated with Esbriet?
Danish: Hvilke risici er der forbundet med Esbriet?
English: Esbriet is available as capsules (267 mg) and tablets (267, 534 and 801 mg) that are taken at mealtimes.
Danish: Esbriet fås som kapsler (267 mg) og tabletter (267 mg, 534 mg og 801 mg) til indtagelse sammen med et måltid.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that Esbriet has been shown to slow down the progression of IPF, as measured by FVC, without serious risks for patients.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) fandt, at det er påvist, at Esbriet bremser progressionen af IPF, målt ved hjælp af FVC, uden at der var nogen alvorlige risici for patienterne.
English: Esbriet is a medicine used to treat adults with mild to moderate idiopathic pulmonary fibrosis (IPF).
Danish: Esbriet er et lægemiddel, der anvendes til behandling af voksne med mild til moderat idiopatisk pulmonal fibrose (IPF).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Esbriet can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Esbriet findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: IPF is a long-term disease in which fibrous scar tissue continuously forms in the lungs, causing persistent cough, frequent lung infections and severe shortness of breath.
Danish: IPF er en langvarig sygdom, hvor der til stadighed dannes fibrøst arvæv i lungerne, hvilket medfører vedvarende hoste, hyppige lungeinfektioner og svær kortåndethed.
English: It therefore decided that Esbriet's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Esbriet er større end risiciene, og anbefalede, at der udstedes markedsføringstilladelse for Esbriet.
English: The mechanism of action of pirfenidone, the active substance in Esbriet, is not fully understood but it has been shown to reduce the production of fibroblasts and other substances involved in the formation of fibrous tissue during the body's tissue repair process, thereby slowing down the progression of the disease in IPF patients.
Danish: Det er ikke helt klart, hvordan pirfenidon, som er det aktive stof i Esbriet, virker, men det har vist sig, at det reducerer dannelsen af fibroblaster og andre stoffer, som er involveret i dannelsen af fibrøst væv under kroppens vævsrepareringsproces, og at det dermed hæmmer sygdommens udvikling hos IPF-patienter.
English: The company that makes Esbriet has set up a post-authorisation safety study in order to collect additional information on patients prescribed Esbriet and suspected side effects.
Danish: Den virksomhed, der fremstiller Esbriet, har indledt en sikkerhedsundersøgelse efter godkendelsen for at indsamle yderligere information om patienter, som får ordineret Esbriet, og om formodede bivirkninger.
English: FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath, which decreases as the condition gets worse.
Danish: FVC er den maksimale mængde luft, som en patient kan udånde med stor kraft efter at have taget en dyb indånding.
English: For the full list of all side effects reported with Esbriet, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Esbriet fremgår af indlægssedlen.
English: What benefits of Esbriet have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Esbriet?
English: How is Esbriet used?
Danish: Hvordan anvendes Esbriet?
English: How does Esbriet work?
Danish: Hvordan virker Esbriet?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Esbriet 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 Esbriet.
English: Packaging Content
Danish: Emballage Indhold Pakningsstørrelse
English: administration
Danish: Indgivelsesvej
English: Trelegy Ellipta received a marketing authorisation valid throughout the EU on 15 November 2017.
Danish: Trelegy Ellipta fik en markedsføringstilladelse med gyldighed i hele EU den 15. november 2017.
English: More serious side effects include pneumonia (which may affect up to 1 in 10 people).
Danish: De mere alvorlige bivirkninger omfatter lungebetændelse (som kan forekomme hos op til 1 ud af 10 personer).
English: Further information on Trelegy Ellipta can be found on the Agency's website: ema.europa.eu/ medicines/Human/EPAR/Trelegy-Ellipta.
Danish: Yderligere information om Trelegy Ellipta findes på agenturets websted under: ema.europa.eu/ medicines/Human/EPAR/Trelegy-Ellipta.
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; patienten bør inhalere lægemidlet én gang dagligt på omtrent samme tidspunkt hver dag.
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 fik en kombination af budesonid og formoterol i samme periode.
English: For more information about using Trelegy Ellipta, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Trelegy Ellipta, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Trelegy Ellipta is used for maintenance (regular) treatment on a daily basis.
Danish: Trelegy Ellipta anvendes til vedligeholdelsesbehandling (regelmæssig behandling) på daglig basis.
English: As for all medicines, data on the use of Trelegy Ellipta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Trelegy Ellipta løbende overvåget.
English: In this study, Trelegy 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 Trelegy 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.