FrancophonIA/ELRC3.0 huggingface dataset:
English: Flolan is indicated for the treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH associated with connective tissue diseases) in patients with WHO
Danish: Forbedring af den fysiske kapacitet ved pulmonal arteriel hypertension (PAH) (idiopatisk eller hereditær PAH og PAH ved bindevævssygdomme) hos patienter med symptomer af WHO
English: Over 12 weeks, a statistical difference (p<0.001) in the change from baseline for the 6MWT was observed in the group receiving epoprostenol and conventional therapy as compared to the group receiving conventional therapy alone (median: 63.5 vs. -36.0 meters; mean: 42.9 vs. -40.7 meters).
Danish: Gennem 12 uger var der statistisk signifikant forskel (p<0.001) i ændringen i 6MWT fra baseline mellem den gruppe, der fik epoprostenol plus konventionel terapi, og den gruppe, der fik konventionel terapi alene (median: 63,5 versus -36,0 meter; gennemsnit: 42,9 versus -40,7 meter).
English: A statistically significant increase in cardiac index (CI), and statistically significant decreases in mean pulmonary arterial pressure (PAPm), mean right atrial pressure (RAPm), pulmonary vascular resistance (PVR), and mean systemic arterial pressure (SAPm) after 12 weeks of treatment were observed in patients who received epoprostenol chronically compared to those who did not.
Danish: Efter 12ugers behandling var der statistisk signifikant stigning i kardialt indeks (CI) og statistisk signifikant fald i pulmonal arterielt middeltryk (PAPm), middeltryk i højre atrium (RAPm), pulmonal vaskulær modstand (PVR) og systemisk arterielt middeltryk (SAPm) hos patienter, der blev behandlet kronisk med epoprostenol, i forhold til dem, der ikke fik denne behandling.
English: More patients stopped bleeding with epoprostenol and of those that continued to bleed, bleeding severity improved more often than in patients dialysed with heparin.
Danish: Ved behandling med epoprostenol ophørte blødningen hos en større andel af patienterne, og ved fortsat blødning aftog blødningen oftere end hos patienter i dialyse med heparin.
English: In major controlled studies, when all dialyses were combined, slightly more epoprostenol patients appeared to bleed during the pre-dialysis, dialysis and post-dialysis days compared to heparin patients during the same periods.
Danish: For alle dialyser i de kontrollerede hovedundersøgelser under ét syntes der at være lidt flere patienter på epoprostenol, der blødte i døgnene før dialysen, under dialysen og efter dialysen, end patienterne på heparin i de samme perioder.
English: Flolan is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients, in patients with congestive heart failure arising from severe left ventricular dysfunction.
Danish: Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne samt kronisk hjerteinsufficiens som følge af svær dysfunktion af venstre ventrikel.
English: Flolan is indicated for use in haemodialysis in emergency situations when use of heparin carries a high risk of causing or exacerbating bleeding or when heparin is otherwise contraindicated (see section 5.1).
Danish: Anvendelse ved hæmodialyse i akutte situationer, hvor heparin medfører højere risiko for blødning eller forværring af blødning, eller hvor heparin på anden måde er kontraindiceret
English: The combined baseline 6-minute walk test median values for the conventional therapy group and epoprostenol plus conventional therapy group was 266 meters and 301 meters, respectively.
Danish: De kombinerede medianværdier af 6minutters gangtest var henholdsvis 266 m og 301 m for gruppen på konventionel terapi og gruppen på epoprostenol plus konventionel terapi.
English: The median baseline value for the conventional therapy group and epoprostenol plus conventional therapy group was 240 meters and 270 meters, respectively.
Danish: Den mediane baseline-værdi var henholdsvis 240 m og 270 m i gruppen på konventionel terapi og i gruppen på epoprostenol plus konventionel terapi.
English: Chronic continuous infusions of epoprostenol in patients with pulmonary arterial hypertention/scleroderma spectrum of diseases (PAH/SSD) were studied in a prospective, open, randomised trial of 12 weeks' duration comparing epoprostenol plus conventional therapy (N = 56) to conventional therapy alone (N = 55).
Danish: I en prospektiv, åben, randomiseret 12-ugers undersøgelse hos patienter med sygdom i spektret pulmonal arteriel hypertension/sklerodermi (PAH/SSD) blev epoprostenol, givet som kroniske kontinuerlige infusioner kombineret med konventionel terapi (N = 56), hvilket sammenlignedes med konventionel terapi alene (N = 55).
English: Of the patients who continued to bleed, severity generally improved more often and worsened less often in patients receiving heparin in major controlled studies.
Danish: Hos de patienter i de kontrollerede hovedundersøgelser, der fortsat havde blødninger, aftog sværheden generelt oftere og tiltog sjældnere, når patienterne fik heparin.
English: The following data from clinical studies have been presented by the MAH and discuss during the assessment of these procedure.
Danish: Følgende data fra kliniske undersøgelser er fremlagt af indehaveren af markedsføringstilladelsen og blev drøftet som led i denne procedure:
English: Statistically significant improvement was observed in exercise capacity (p=0.001), as measured by the 6 minutes walking test (6MWT) in patients receiving continuous intravenous epoprostenol plus conventional therapy (N=52) for 8 or 12 weeks compared to those receiving conventional therapy alone (N=54) (combined week 8 and 12 change from baseline - median: 49 vs. -4 meters; mean: 55 vs. -4 meters).
Danish: Hos de patienter, der fik kontinuerlig intravenøs epoprostenol plus konventionel terapi (N=52) i 812 uger, sås statistisk signifikant bedring i fysisk kapacitet (p=0,001), målt ved seks minutters gangtest (6MWT), i forhold til dem, der fik konventionel terapi alene (N=54) (kombineret ændring fra baseline i uge 8 og uge 12 - median: 49 versus -4 meter; gennemsnit: 55 versus -4 meter).
English: Except for 2 New York Heart Association (NYHA) functional Class II patients, all patients were either functional Class III or Class IV. As results were similar in the 2 studies, the pooled results are described.
Danish: Bortset fra 2 patienter med NYHA (New York Heart Association) funktionsklasse II var alle patienter af funktionsklasse III eller IV.
English: The available clinical studies on both these indications were presented by the MAH together with post-marketing data and published literature and discussed by the CHMP both regarding the efficacy and safety aspects.
Danish: De foreliggende kliniske undersøgelser ved begge disse indikationer blev fremlagt af indehaveren af markedsføringstilladelsen sammen med data fra undersøgelser efter markedsføring og publiceret litteratur.
English: Following all the changes in the SmPC there are several corresponding changes to the Package Leaflet After the corrections were implemented a Readability Testing was performed which was submitted and assessed during the referral procedure.
Danish: Efter ændringerne blev der foretaget en læsbarhedstest, som blev vurderet i henvisningsproceduren.
English: Section 4.2 - Posology and method of administration There were differences in Section 4.2 of the SmPCs across Member States.
Danish: Der er divergenser mellem medlemsstaterne med hensyn til afsnit 4.2 i produktresuméet.
English: In emergency studies, compared to each pre-dialysis assessment, incidence of bleeding was generally reduced with each epoprostenol dialysis.
Danish: I undersøgelserne ved akut anvendelse var blødningsforekomsten sædvanligvis lavere ved dialyse med epoprostenol end før dialyse.
English: Eight of 40 (20%) patients receiving conventional therapy alone died, whereas none of the 41 patients receiving epoprostenol died (p=0.003).
Danish: Ved afslutningen af behandlingsperioden i 12-ugers undersøgelsen var overlevelsen forbedret for patienter med NYHA funktionsklasse III og IV. 8 af 40 (20 %) af de patienter, der fik konventionel terapi alene, afgik ved døden, hvorimod der ikke var dødsfald blandt de 41 patienter, der fik epoprostenol (p=0,003).
English: 1.45 mm Hg), mean right atrial pressure (-2.26 vs. 0.59 mm Hg), total pulmonary resistance (-4.52 vs. 1.41 Wood U), pulmonary vascular resistance (-3.60 vs. 1.27 Wood U), and systemic vascular resistance (-4.31 vs. 0.18 Wood U) were statistically different between patients who received epoprostenol chronically and those who did not.
Danish: Der var statistisk signifikant forskel for følgende parametre mellem de patienter, fik kronisk behandling med epoprostenol, og dem, der ikke fik det: Bedring fra baseline i kardialt indeks (0,33 versus -0,12 l/min/m2), slagvolumen (6,01 versus -1,32 ml/slag), arteriel iltmætning (1,62 versus -0,85 %), pulmonalt arterielt middeltryk (-5,39 versus 1,45 mmHg), middeltryk i højre atrium (2,26 versus 0,59 mmHg), total pulmonal modstand (-4,52 versus 1,41 Wood U), pulmonal vaskulær modstand (-3,60 versus 1,27 Wood U) og systemisk vaskulær modstand (-4,31 versus 0,18 Wood U).
English: Other Sections of the SmPC
Danish: Andre afsnit i produktresuméet
English: Chronic continuous infusions of epoprostenol in patients with idiopathic or heritable pulmonary arterial hypertension (PAH) were studied in two prospective, open, randomised trials of 8 and 12 weeks' duration (N=25 and N=81, respectively) comparing epoprostenol plus conventional therapy to conventional therapy alone.
Danish: Der er udført to prospektive, åbne, randomiserede undersøgelser af 8 og 12 ugers varighed hos patienter med idiopatisk eller hereditær pulmonal arteriel hypertension (PAH) (henholdsvis med N=25 og N=81).
English: In conclusion, based on the assessment of the MAH proposal and responses and following the discussions of the committee, the CHMP adopted the harmonised product information for Flolan and associated names.
Danish: Afsluttende vedtog CHMP den harmoniserede produktinformation for Flolan og relaterede navne på grundlag af vurderingen af forslaget og besvarelsen fra indehaveren af markedsføringstilladelsen og efter drøftelserne i udvalget.
English: The CHMP assessed the harmonised Product Information proposed by the marketing Authorisation Holder (MAH) of the product taking into account the current national ones and the existing scientific data and discussed the indications for each individual medical condition.
Danish: Herunder tog udvalget hensyn til de nuværende nationale produktinformationer og de foreliggende videnskabelige data, og drøftede hver af de enkelte sygdomstilstande.
English: This was reiterated in the SmPC section.
Danish: Dette blev anført i det pågældende afsnit i produktresuméet.
English: It is available as:
Danish: Det fås som:
English: The medicines are normally given shortly before a meal, but can be given just after a meal if necessary.
Danish: Lægemidlerne gives normalt kort tid før et måltid, men kan gives lige efter et måltid, hvis det er nødvendigt.
English: NovoMix received a marketing authorisation valid throughout the EU on 1 August 2000.
Danish: NovoMix fik en markedsføringstilladelse med gyldighed i hele EU den 1. august 2000.
English: Further information on NovoMix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/novomix.
Danish: Yderligere information vedrørende NovoMix findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/novomix.
English: Other information about NovoMix
Danish: Andre oplysninger om NovoMix
English: As for all medicines, data on the use of NovoMix are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af NovoMix løbende overvåget.
English: NovoMix 30 can be used in patients from 10 years of age.
Danish: NovoMix 30 kan anvendes til patienter fra 10 år.
English: In type 2 diabetes, NovoMix can be given on its own or together with other diabetes medicines.
Danish: Ved type 2-diabetes kan NovoMix gives alene eller sammen med andre lægemidler mod diabetes.
English: The medicines are given by injection under the skin of the abdomen (belly), thigh, upper arm or buttock.
Danish: Lægemidlerne gives ved injektion under huden i abdomen (maven), låret, øvre arm eller ballen.
English: The European Medicines Agency decided that NovoMix's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved NovoMix opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: NovoMix 50 and NovoMix 70 can only be used in adults (from 18 years of age).
Danish: NovoMix 50 og NovoMix 70 kan kun anvendes til voksne (fra 18 år).
English: What measures are being taken to ensure the safe and effective use of NovoMix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af NovoMix?
English: For more information about using NovoMix, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af NovoMix, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: By restoring the effects of insulin, the level of blood glucose is controlled better and the symptoms and complications of diabetes are reduced.
Danish: Ved at genoprette virkningerne af insulin reguleres blodsukkeret bedre og mindsker symptomerne og komplikationerne ved diabetes.
English: An overview of NovoMix and why it is authorised in the EU
Danish: Oversigt over NovoMix, og hvorfor det er godkendt i EU
English: Side effects reported with NovoMix are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved NovoMix vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Why is NovoMix authorised in the EU?
Danish: Hvorfor er NovoMix godkendt i EU?
English: The most common side effect with NovoMix (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels).
Danish: Den hyppigste bivirkning ved NovoMix (som kan forekomme hos mere end 1 ud af 10 personer) er for lavt blodsukker (hypoglykæmi).
English: What is NovoMix and what is it used for?
Danish: Hvad er NovoMix, og hvad anvendes det til?
English: NovoMix 30 gave almost identical results as biphasic human insulin 30 (a combination of 30% rapidacting and 70% intermediate-acting human insulin) in 294 adults with type 1 diabetes (when the pancreas cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively), and in 167 patients aged between 10 and 17 years with type 1 diabetes.
Danish: NovoMix 30 gav resultater, der var næsten identiske med bifasisk human insulin 30 (en kombination af 30 % hurtigtvirkende og 70 % intermediært-virkende human insulin), hos 294 voksne med type 1diabetes (når bugspytkirtlen ikke kan producere insulin) eller type 2-diabetes (når kroppen ikke kan bruge insulin effektivt) og hos 167 patienter mellem 10 og 17 år med type 1-diabetes.
English: NovoMix 50 and NovoMix 70 gave better overall control of blood glucose than biphasic human insulin 30 in 664 patients with type 1 or type 2 diabetes.
Danish: NovoMix 50 og NovoMix 70 gav bedre generel regulering af blodsukkeret end bifasisk human insulin 30 hos 664 patienter med type 1- eller type 2-diabetes.
English: Patients can inject themselves with NovoMix once they have been trained appropriately.
Danish: Patienterne kan give sig selv indsprøjtningerne med NovoMix, hvis de har fået passende instruktion.
English: The dose of NovoMix depends on the patient's blood glucose levels, which should be tested regularly to find an effective dose.
Danish: Dosen af NovoMix afhænger af patientens blodsukker, som skal kontrolleres regelmæssigt for at fastsætte en virksom dosis.
English: NovoMix is a replacement insulin.
Danish: NovoMix er et erstatningsinsulin.
English: The active substance in NovoMix, insulin aspart, is absorbed faster by the body than natural insulin and it starts working soon after it is injected.
Danish: Det aktive stof i NovoMix, insulin aspart, absorberes hurtigere af kroppen end naturligt insulin og begynder at virke kort tid efter indsprøjtningen.
English: Several studies have found NovoMix to be effective either at reducing glycosylated haemoglobin (HbA1c, a substance which indicates how well blood glucose is controlled over 12 to 28 weeks) or in reducing blood glucose levels after a meal.
Danish: En række studier har vist, at NovoMix er effektivt enten til at reducere glykosyleret hæmoglobin (HbA1c, et stof, der viser, hvor godt blodsukkeret er reguleret i 12-28 uger), eller til at reducere blodsukkeret efter et måltid.
English: What are the risks associated with NovoMix?
Danish: Hvilke risici er der forbundet med NovoMix?
English: NovoMix medicines contain the active substance insulin aspart (100 units/ml) combined with protamine to make it longer acting.
Danish: NovoMix-lægemidler indeholder det aktive stof insulin aspart (100 enheder/ml) kombineret med protamin, for at det skal virke i længere tid.
English: NovoMix contains both insulin aspart and a longer-acting form called insulin aspart protamine, which is absorbed more slowly and works for longer.
Danish: NovoMix indeholder både insulin aspart og en form med en længere virkningstid kaldet insulin aspart protamin, som optages langsommere og virker i længere tid.
English: NovoMix is a range of insulin medicines used to treat patients who have diabetes and need insulin to keep their blood glucose (sugar) level controlled.
Danish: NovoMix er en række lægemidler med insulin, som anvendes til behandling af patienter, der har diabetes, og som har brug for insulin til regulering af blodsukkeret (glukose).
English: For the full list of side effects and restrictions of NovoMix, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved NovoMix fremgår af indlægssedlen.
English: NovoMix acts in the same way as naturally produced insulin and helps glucose from the blood to enter cells.
Danish: NovoMix virker på samme måde som naturligt produceret insulin og bevirker, at sukkeret fra blodet føres ind i cellerne.
English: In 5 studies involving a total of around 1,350 patients with type 2 diabetes, adding NovoMix medicines to other diabetes medicines (metformin, sulphonylureas, pioglitazone and liraglutide) also resulted in better control of blood glucose than the other medicines or NovoMix used alone.
Danish: I fem studier, der omfattede i alt ca. 1.350 patienter med type 2-diabetes, blev NovoMix lægemidler tilføjet til andre lægemidler mod diabetes (metformin, sulfonylurinstoffer, pioglitazon og liraglutid).
English: NovoMix medicines can only be obtained with a prescription and are available in cartridges and prefilled pens.
Danish: NovoMix-lægemidler fås kun på recept og i cylinderampuller og fyldte penne.
English: Diabetes is a disease in which the body does not produce enough insulin or is not able to use insulin effectively, resulting in raised levels of glucose in the blood.
Danish: Ved diabetes producerer kroppen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet effektivt, hvilket resulterer i forhøjet blodsukker.
English: How does NovoMix work?
Danish: Hvordan virker NovoMix?
English: How is NovoMix used?
Danish: Hvordan anvendes NovoMix?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NovoMix 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 NovoMix.
English: What benefits of NovoMix have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved NovoMix?
English: 18 May 2011
Danish: 18. maj 2011
English: The European Commission issued a decision on 18 May 2011.
Danish: Europa-Kommissionen traf en afgørelse den 18. maj 2011.
English: The marketing authorisation in the United Kingdom should also be suspended.
Danish: Endvidere bør markedsføringstilladelsen i Det Forenede Kongerige suspenderes.
English: What is Isotretinoin?
Danish: Hvad er Isotretinoin?
English: The company wanted the authorisation to be recognised in France and Spain (the ‘concerned Member States').
Danish: Virksomheden ønskede, at markedsføringstilladelsen skulle anerkendes i Frankrig og Spanien ("de berørte medlemsstater").
English: Why was Isotretinoin reviewed?
Danish: Hvorfor blev Isotretinoin vurderet igen?
English: However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 29 July 2010.
Danish: Da det ikke lykkedes medlemsstaterne at opnå enighed, indbragte Det Forenede Kongerige dog sagen for CHMP med henblik på voldgift den 29. juli 2010.
English: Isotretinoin is a retinoid (a substance derived from vitamin A) that is used to treat severe acne that has not responded to standard treatments.
Danish: Isotretinoin er et retinoid (et stof, der stammer fra A-vitamin), som anvendes til at behandle svær akne, som ikke har responderet på standardbehandlinger.
English: Isotretinoin capsules from Ranbaxy are a generic medicine based on a ‘reference medicine', Roaccutane, which has been marketed in the EU since 1984.
Danish: Isotretinoinkapsler fra Ranbaxy er et generisk lægemiddel, der er baseret på et "referencelægemiddel", Roaccutane, som har været markedsført i EU siden 1984.
English: The sebum accumulates under the skin and causes inflammation.
Danish: Talgen samler sig under huden og forårsager betændelse.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence of the generic isotretinoin capsules to the reference medicinal product has not been shown according to the current requirements.
Danish: På baggrund af en vurdering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at de generiske isotretinoinkapslers bioækvivalens med referencelægemidlet ikke er blevet påvist i henhold til de aktuelle krav.
English: As the product information states that the capsules should be taken with food, Spain considered that a bioequivalence study under fed conditions would be required for the granting of the marketing authorisation.
Danish: Eftersom der står i produktinformationen, at kapslerne skal tages sammen med mad, var Spanien af den opfattelse, at en bioækvivalensundersøgelse efter fødeindtagelse ville være nødvendig for udstedelse af en markedsføringstilladelse.
English: The CHMP therefore concluded that the benefits of the medicine do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Danish: CHMP konkluderede således, at fordelene ved lægemidlet ikke opvejer risiciene, og CHMP anbefalede, at der ikke udstedes markedsføringstilladelse i de berørte medlemsstater.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the generic isotretinoin-containing medicine from Ranbaxy (UK) Limited.
Danish: Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem EU-medlemsstater vedrørende markedsføringstilladelsen for det generiske lægemiddel, der indeholder isotretinoin, fra Ranbaxy (UK) Limited.
English: In addition, the Committee recommended that the marketing authorisation for Isotretinoin Ranbaxy (UK) Limited in the United Kingdom be suspended until bioequivalence in the fed state is shown.
Danish: Endvidere anbefalede udvalget, at markedsføringstilladelsen for Isotretinoin Ranbaxy (UK) Limited i Det Forenede Kongerige blev suspenderet, indtil der er påvist bioækvivalens efter fødeindtagelse.