FrancophonIA/ELRC3.0 huggingface dataset:
English: • axial spondyloarthritis (inflammation of spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation
Danish: • aksial spondyloarthritis (betændelse i rygsøjlen, som giver rygsmerter), herunder ankyloserende spondylitis, og når der ved røntgen ikke ses sygdom, men der er tydelige tegn på betændelse
English: How is Humira used?
Danish: Hvordan anvendes Humira?
English: How does Humira work?
Danish: Hvordan virker Humira?
English: What benefits of Humira have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Humira?
English: • In polyarticular juvenile idiopathic arthritis, around 40% of patients aged between 4 and 17 years receiving Humira, either alone or in combination with methotrexate, had a flare-up of arthritis, compared with around 69% of those receiving placebo.
Danish: • Ved polyartikulær juvenil idiopatisk artritis hos patienter i alderen fra 4-17 år oplevede ca. 40 % af de patienter, der fik Humira, enten alene eller i kombination med methotrexat, en opblussen af artritis sammenlignet med ca. 69 % af dem, der fik placebo.
English: Patients adding Humira also had less joint damage and less reduction in physical function after a year.
Danish: Efter et år havde de patienter, der fik Humira som tillægsbehandling, også færre ledskader og mindre fysisk funktionsnedsættelse.
English: Why is Humira authorised in the EU?
Danish: Hvorfor blev Humira godkendt?
English: Humira and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using Humira.
Danish: Humira og andre lægemidler i denne klassse kan også påvirke immunsystemets evne til at bekæmpe infektioner og kræft.
English: In this study treatment failed in about 79% of patients receiving placebo compared with about 55% given Humira.
Danish: I denne undersøgelse virkede behandlingen ikke hos ca. 79 % af de patienter, der fik placebo, sammenlignet med ca. 55 % af dem, der fik Humira.
English: In this study, treatment failure occurred in about 55% of patients receiving placebo compared with 39% receiving Humira.
Danish: I denne undersøgelse virkede behandlingen ikke hos ca. 55 % af de patienter, der fik placebo, sammenlignet med 39 % af dem, der fik Humira.
English: • rheumatoid arthritis (a disease causing inflammation of the joints)
Danish: • rheumatoid arthritis (en sygdom, som forårsager betændelse i leddene)
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Humira have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Humira.
English: For the full list of side effects of Humira, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Humira fremgår af indlægssedlen.
English: • psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints)
Danish: • psoriatisk artritis (røde, afskallende pletter på huden og betændelse i leddene)
English: For the full list of restrictions with Humira, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Humira fremgår af indlægssedlen.
English: Fewer patients receiving Humira with methotrexate developed antibodies against Humira (which can reduce its effects), so the results found that the use of Humira with methotrexate was more effective than Humira used alone.
Danish: Af dem, som fik Humira sammen med methotrexat, var der færre, som udviklede antistoffer mod Humira (hvilket kan mindske lægemidlets virkning).
English: • plaque psoriasis, a disease causing red, scaly patches on the skin
Danish: • plaquepsoriasis (en sygdom, der giver rød, skællende hud)
English: • In rheumatoid arthritis, the greatest reductions in symptoms were seen in the studies on Humira as an add-on to methotrexate: around two-thirds of the patients adding Humira had at least a 20% reduction in symptoms after six months, compared with a quarter of those adding placebo.
Danish: Hos cirka to tredjedele af de patienter, som fik Humira som tillægsbehandling, var symptomerne reduceret med mindst 20 % efter seks måneder, sammenlignet med en fjerdedel af dem, der fik placebo som tillægsbehandling.
English: Aprotinin containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler, der indeholder aprotinin, og som har markedsføringstilladelse i Den Europæiske Union
English: 3641 RT Mijdrecht The Netherlands
Danish: 3641 RT Mijdrecht Holland
English: 151 25 , Marousi - Athens
Danish: 151 25 , Marousi
English: D-13353 Berlin postal address:
Danish: 13353 Berlin postadresse:
English: Bayer Austria GmbH Herbststraße 6-10 A-1160 Wien Austria
Danish: Bayer Austria GmbH Herbststraße 6-10 A-1160 Wien Østrig
English: 1103 Budapest, Hungary
Danish: 1103 Budapest
English: BAYER SANTE - 220, avenue de la recherche - 59120 LOOS
Danish: FR - Frankrig BAYER SANTE 220, avenue de la recherche 59120 LOOS
English: CZ - Czech Republic
Danish: CZ - Den Tjekkiske Republik
English: Mommaertslaan B- 1831 Diegem
Danish: Mommaertslaan B- 1831 Diegem Belgien
English: 555,6 Ph.Eur.u.
Danish: 555,6 j. Ph.Eur.
English: Gedeon Richter Ltd. Gyomroi ut 19-21 Budapest HU-1103 Hungary
Danish: Gedeon Richter Ltd. Gyomroi ut 19-21 Budapest HU-1103 Ungarn
English: 1111,1 Ph.Eur.u.
Danish: 1111,1 j. Ph.Eur.
English: Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg. E39
Danish: HU - Ungarn Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg. E39
English: Bayer Hellas AG 18 - 20 , Sorou Str.
Danish: EL - Grækenland Bayer Hellas AG 18 - 20 , Sorou Str.
English: Richter Gedeon Nyrt.
Danish: HU - Ungarn Richter Gedeon Nyrt.
English: Bayer House Strawberry Hill Newbury,
Danish: Strawberry Hill Newbury,
English: 51368 Leverkusen, Germany
Danish: 51368 Leverkusen
English: QUIMICA FARMACEUTICA BAYER, S.L
Danish: ES - Spanien QUIMICA FARMACEUTICA BAYER, S.L.
English: Quinta do Pinheiro 5 2794-003 Carnaxide Portugal
Danish: Bayer Portugal, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Portugal
English: BE-Belgium Belgium Bayer S.A. 14, J.E.
Danish: Belgium Bayer S.A. 14, J.E.
English: Bayer House Strawberry Hill Newbury
Danish: Strawberry Hill Newbury
English: Bayer Pharma Aktiengesellschaft registered business address: Müllerstr.
Danish: DE - Tyskland Bayer Pharma Aktiengesellschaft registreret forretningsaddresse: Müllerstr.
English: Bayer Pharma AG Berlin, D-13342 Germany
Danish: Bayer Pharma AG 13342 Berlin Tyskland
English: Bayer Vital GmbH D-51373 Leverkusen
Danish: DE - Tyskland Bayer Vital GmbH 51368 Leverkusen
English: NL - Netherlands Bayer B.V. Energieweg 1
Danish: NL - Holland Bayer B.V.
English: Nordic Pharma Limited, Abbey House, 1650 Arlington Business Park, Theale, Reading, Berkshire RG7 4SA, UK
Danish: 1650 Arlington Business Park Theale, Reading
English: Richter Gedeon Nyrt., Budapest Pf. 27.,
Danish: Richter Gedeon Nyrt Budapest 10
English: 10000 KIE/ml solution for injection/infusion intravenous use
Danish: 10000 KIE/ml injektions-/ infusionsvæske, opløsning
English: Bayer HealthCare AG, 51368 Leverkusen, Germany solution for injection/infusion intravenous use
Danish: Bayer HealthCare AG 51368 Leverkusen Tyskland
English: H-1475 Hungary
Danish: Pf. 27., H-1475
English: Belgium
Danish: BARCELONA
English: Route of administration
Danish: Energieweg 1
English: PL - Poland
Danish: PL-Polen
English: Germany
Danish: Grækenland
English: Berkshire RG14 1JA United Kingdom trading as Bayer Plc, Pharmaceutical division
Danish: Berkshire RG14 1JA Storbritannien Handler som
English: Av. Baix Llobregat, 3-5 08970 Sant Joan Despi Barcelona - España
Danish: Sant Joan Despi 08970
English: 50.000U/50ml
Danish: 500 000 KUI / 50 mL
English: Bayer Plc
Danish: Bayer Plc, Pharmaceutical Division
English: HU - Hungary
Danish: Ungarn
English: Bayer Schering Pharma AG, Müllerstrasse 170-178, DE13342 Berlin, Germany
Danish: DK - Danmark Bayer Schering Pharma AG Müllerstrasse 170-178
English: UK - United Kingdom
Danish: Storbritannien
English: 10.000 K10.000 KIU/ml IU/ml solution for perfusion intravenous use
Danish: 10.000 K 10.000 KIU/ml IU/ml perfusionsvæske, opløsning
English: 20 mg Capsule, hard
Danish: 20 mg Kapsel, hård
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Danish: Styrke Lægemiddelform Administrationsvej
English: 23 October 2013
Danish: Den 23. oktober 2013
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder(s) as applicable):
Danish: Aftalen gennemføres af medlemsstaterne (ændringsansøgningen indsendes i givet fald af indehaverne af markedsføringstilladelse):
English: 19 December 2013
Danish: Den 19. december 2013
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement: 19 November 2013
Danish: Oversættelserne af aftalens bilag fremsendes til de nationale kompetente myndigheder:
English: The European Commission issued a decision on 13 December 2010.
Danish: Europa-Kommissionen traf en afgørelse den 13. december 2010.
English: 23 September 2010
Danish: Den 23. september 2010
English: What is Lipitor?
Danish: Hvad er Lipitor?
English: The amended information to doctors and patients is available here.
Danish: De ændrede produktoplysninger til læger og patienter findes her.
English: Lipitor is authorised in the EU via national procedures.
Danish: Lipitor blev godkendt i EU via nationale procedurer.
English: The company that markets these medicines is Pfizer.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Pfizer.
English: EMA/595578/2010 rev.1 EMEA/H/A-30/1154
Danish: Den 13. december 2010 EMA/595578/2010 Rev.1 EMEA/H/A-30/1154
English: The maximum dose is 80 mg once a day.
Danish: Den maksimale dosis er 80 mg dagligt.
English: Adjustment of dose should be made at intervals of four weeks or more.
Danish: Dosisjustering bør finde sted med intervaller på mindst fire uger.
English: Why was Lipitor reviewed?
Danish: Hvorfor blev Lipitor revurderet?
English: The usual starting dose is 10 mg once a day.
Danish: Startdosis er normalt 10 mg to gange dagligt.
English: The CHMP harmonised the wording for lowering blood lipids as follows:
Danish: CHMP harmoniserede ordlyden vedrørende sænkning af blodlipider som følger:
English: On 15 December 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Lipitor in the EU.
Danish: Den 15. december 2009 indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Lipitor i EU.
English: The European Medicines Agency has completed a review of Lipitor.
Danish: Det Europæiske Lægemiddelagentur har foretaget en gennemgang af Lipitor.
English: It must not be used in patients with active liver disease or unexplained persistent elevations of serum transaminases (proteins in the blood) exceeding three times the upper limit of normal.
Danish: Det må ikke anvendes hos patienter med aktiv leversygdom eller uafklaret vedholdende forhøjelse af serumtransaminaser (leverproteiner i blodet) til mere end tre gange den øvre normalgrænse.
English: It must also not be used during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraception.
Danish: Det må heller ikke anvendes under graviditet, under amning eller hos kvinder, der er i den fødedygtige alder og ikke anvender egnet prævention.
English: Lipitor is also available in the EU under other trade names: Atorvastatin, Atorvastatina Nostrum, Atorvastatina Parke-Davis, Atorvastatina Pharmacia, Cardyl, Edovin, Liprimar, Orbeos, Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator and Zarator.
Danish: Lipitor er desuden tilgængeligt i EU under andre handelsnavne: Atorvastatin, Atorvastatina Nostrum, Atorvastatina Parke-Davis, Atorvastatina Pharmacia, Cardyl, Edovin, Liprimar, Orbeos, Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator og Zarator.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, hvorpå lægemidlet kan anvendes, hvilket ses af forskellene mellem produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: The CHMP agreed on the following wording for the prevention of cardiovascular events: ‘Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors'.
Danish: CHMP fastsatte følgende ordlyd for forebyggelse af hjerte-kar hændelser: "Forebyggelse af kardiovaskulære hændelser hos patienter, der skønnes at have høj risiko for en første kardiovaskulær hændelse, som supplement til korrektion af andre risikofaktorer".
English: It is also used for the prevention of a first cardiovascular event (such as a heart attack) in patients considered to be at high risk.
Danish: Det anvendes desuden til forebyggelse af første hjerte-kar-hændelse (såsom et hjerteanfald) hos patienter i højrisikogruppen.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de indsendte data og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméer, etikettering og indlægssedler bør harmoniseres i hele EU.
English: The CHMP also harmonised wording for other sections of the SmPC including sections on special warnings, interaction with other medicinal products, precautions for use, pregnancy and lactation, and adverse effects.
Danish: CHMP harmoniserede desuden ordlyden af andre afsnit af produktresuméet, herunder afsnittene med særlige advarsler, interaktion med andre lægemidler, forsigtighedsregler vedrørende brugen, graviditet og amning samt bivirkninger.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Lipitor in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktoplysningerne for Lipitor i Den Europæiske Union (EU).
English: The CHMP agreed that Lipitor should not be used in patients who are hypersensitive (allergic) to atorvastatin or to any of the ingredients of the medicine.
Danish: CHMP fastslog, at Lipitor bør ikke anvendes hos patienter, der er overfølsomme (allergiske) over for atorvastatin eller andre af indholdsstofferne.
English: Lipitor is used together with diet to lower lipids (fats) known as cholesterol and triglycerides in the blood in patients with various types of hypercholesterolaemia (high blood cholesterol levels).
Danish: Lipitor anvendes sammen med diæt til at sænke blodets indhold af kolesterol og triglycerider hos patienter med forskellige former for hyperkolesterolæmi (højt kolesterolindhold i blodet).
English: Lipitor is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.'
Danish: Lipitor er desuden indiceret til reduktion af total-C and LDL-C hos patienter med homozygot familiær hyperkolesterolæmi som supplement til anden lipidsænkende behandling, f.eks. LDL-aferese, eller når anden behandling ikke kan anvendes."
English: ‘Lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDLcholesterol (LDL-C), apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Danish: "Lipitor er indiceret som supplement til diæt til nedsættelse af forhøjet total kolesterol (total-C), LDLkolesterol (LDL-C), apolipoprotein B og triglycerider hos patienter med primær hyperkolesterolæmi, herunder familiær hyperkolesterolæmi (heterozygot variant) og kombineret (blandet) hyperlipidæmi (svarende til type IIa og IIb i Fredericksons klassifikation), når diæt og andre ikke-farmakologiske foranstaltninger er utilstrækkelige.
English: Lipitor was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentrale godkendelsesprocedurerhuman (CMD(h)) fandt, at det er nødvendigt med harmonisering af Lipitor.
English: Company responses provided on: 29 March 2010, 17 June 2010 Opinion date:
Danish: Dato for indledning af henvisningsproceduren: Den 17. december 2009 Virksomhedens besvarelse indkommet den:
English: Referral start date:
Danish: Dato for fremsættelse af udtalelsen:
English: Wait at least 1 hour until the next meal.
Danish: Vent mindst 1 time før det næste måltid.
English: However, cases of spontaneous abortion have been reported.
Danish: Imidlertid er tilfælde af spontane aborter blevet rapporteret.
English: Date of first authorisation: 23 April 2007 Date of latest renewal: 13 April 2012
Danish: Dato for første markedsføringstilladelse: 23 april 2007 Dato for seneste fornyelse: 13 april 2012
English: The three studies demonstrated similar survival rates.
Danish: De 3 undersøgelser viser de samme overlevelsesrater.
English: Your doctor will tell you exactly how many capsules to take.
Danish: Lægen vil oplyse Dem om præcis, hvor mange kapsler, De skal tage.
English: Efficacy results of the largest studies in each indication are summarised below.
Danish: Effektresultaterne af de største undersøgelser af hver indikation er opsummeret nedenfor.
English: This medicine should be taken once a day.
Danish: Denne medicin bør tages én gang daglig.
English: Experience with overdose is limited.
Danish: Erfaring med overdosering er begrænset.
English: Lecithin (soya)
Danish: Lecithin (soja)
English: Once daily.
Danish: En gang daglig
English: Advagraf is used in adults.
Danish: Advagraf anvendes til voksne.
English: Advagraf with food and drink
Danish: Brug af Advagraf sammen med mad og drikke
English: Take Advagraf on an empty stomach or 2 to 3 hours after a meal.
Danish: Tag Advagraf på tom mave eller 2 til 3 timer efter et måltid.
English: If you have forgotten to take your Advagraf capsules in the morning, take them as soon as possible on the same day.
Danish: Hvis De har glemt at tage Deres Advagraf-kapsler om morgenen, skal De tage dem så hurtigt som muligt den samme dag.
English: Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Advagraf.
Danish: Kør ikke bil og lad være med at bruge værktøj eller maskiner, hvis De føler Dem svimmel eller søvnig eller har problemer med at se klart, efter De har taget Advagraf.
English: Limited data are available but no recommendation on a posology can be made.
Danish: Begrænsede data er tilgængelig, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Danish: Bær passende beskyttende beklædning og anvend en solcreme med høj solbeskyttende faktor.
English: Advagraf and Prograf are not interchangeable.
Danish: Advagraf og Prograf kan ikke udskiftes med hinanden.
English: A number of associated cases of transplant rejection have been reported (frequency cannot be estimated from available data).
Danish: Et antal relaterede sager med transplantatafstødning er rapporteret (frekvensen kan ikke estimeres ud fra de tilgængelige data).
English: If you are, think you might be or are planning to become pregnant, ask your doctor for advice before using Advagraf.
Danish: Hvis De er, tror De er eller planlægger at blive gravid, spørg da Deres læge til råds, før De tager Advagraf.
English: You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Advagraf.
Danish: De bør begrænse Deres udsættelse for sollys og UV (ultraviolet) lys, mens De tager Advagraf.
English: A forgotten morning dose should be taken as soon as possible on the same day.
Danish: En glemt dosis om morgenen bør indtages så hurtigt som muligt den samme dag.
English: Your dose depends on your general condition and on which other immunosuppressive medication you are taking.
Danish: Dosis afhænger af Deres generelle tilstand og af, hvilken anden immundæmpende medicin De tager.
English: Tacrolimus is not compatible with PVC (polyvinylchloride).
Danish: Tacrolimus er ikke forligelig med PVC (polyvinylchlorid).
English: Like all medicines, Advagraf can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan, som al anden medicin, give bivirkninger, men ikke alle får bivirkninger.
English: Advagraf should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption (see section 5.2).
Danish: Advagraf bør som regel indtages på tom mave eller mindst 1 time før eller 2-3 timer efter et måltid for at opnå maksimal absorption (se pkt.5.2).
English: Always take Advagraf exactly as your doctor has told you.
Danish: Tag altid Advagraf nøjagtigt efter lægens anvisning.
English: The capsules should be swallowed whole with fluid (preferably water).
Danish: Kapslerne skal synkes hele med væske (helst vand).
English: If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Danish: I tilfælde af overdosering må man benytte almene understøttende midler og symptomatisk behandling.
English: Older peoples There is no evidence currently available to indicate that dosing should be adjusted in older people.
Danish: Ældre personer På nuværende tidspunkt er der intet, der tyder på, at doseringen skal justeres hos ældre personer.
English: Severe effects may occur, including allergic and anaphylactic reactions.
Danish: Alvorlige bivirkninger kan forekomme, herunder allergiske og anafylaktiske reaktioner.
English: This is because Advagraf capsules allow for a prolonged release (more slow release over a longer period) of tacrolimus.
Danish: Dette skyldes, at Advagrafkapsler har en langvarig frigivelse (langsommere frigivelse over en længere periode) af tacrolimus.
English: Following your organ transplant (liver, kidney), your body's immune system will try to reject the new organ.
Danish: Efter Deres organtransplantation (lever, nyre), vil kroppens immunsystem forsøge at afstøde det nye organ.
English: Advagraf doses are usually reduced in the post-transplant period.
Danish: Doseringen af Advagraf reduceres sædvanligvis i perioden efter transplantationen.
English: If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Danish: Hvis medicinen ikke ser ud, som den plejer, eller hvis doseringen er ændret, så kontakt Deres læge eller apotek hurtigst muligt for at sikre, at De har fået den rigtige medicin.
English: Avoid grapefruit (also as juice) while on treatment with Advagraf, since it can affect its levels in the blood.
Danish: Undgå grapefrugt (også som juice) under behandling med Advagraf, da det kan påvirke indholdet af Advagraf i blodet.
English: 0.10 - 0.30 mg per kg body weight per day depending on the transplanted organ.
Danish: 0,10 - 0,30 mg/kg legemsvægt per døgn afhængigt af, hvilket organ der er transplanteret.