FrancophonIA/ELRC3.0 huggingface dataset:
English: The EDGE study included 7111 OA patients treated with a dose of etoricoxib 90 mg daily (1.5 times the dose recommended for OA) or diclofenac 150 mg daily for a mean period of 9.1 months (maximum 16.6 months, median 11.4 months).
Danish: En undersøgelse med ca. 7100 osteoarthrosepatienter sammenlignede den gastrointestinale tolerabilitet af etoricoxib 90 mg (1,5 gange den anbefalede OA dosis) med diclofenac 150 mg.
English: The CHMP concluded on 26 June 2008 that the data confirm the known relatively adverse renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure), but similar CV thrombotic risk as diclofenac and some degree of upper GI safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Danish: efter vurdering af: - de nye oplysninger om rofecoxib fra den kliniske undersøgelse APPROVe, der viste risiko for thrombotiske kardiovaskulære hændelser, - oplysningerne om celecoxib i APC-undersøgelsen, som tydede på en dosisrelateret øget risiko for alvorlige kardiovaskulære hændelser, - oplysningerne om valdecoxib og parecoxib i CABG- (koronararterie-bypass transplantation) og CABG II-undersøgelserne, der viste en højere forekomst af alvorlige kardiovaskulære thromboemboliske hændelser i parecoxib/valdecoxib-behandlingsformen sammenlignet med patienter, der får placebo, - oplysningerne om etoricoxib i EDGE-undersøgelsen og i samlede analyser af andre kliniske undersøgelser, som tyder på, at den tilknyttede thromboserisiko er højere end for naproxen,
English: The rate of confirmed thrombotic cardiovascular serious adverse events (consisting of cardiac, cerebrovascular, and peripheral vascular events) was comparable between etoricoxib and diclofenac, and data are summarized in the table below.
Danish: Størrelsesordenen for bekræftede øvre gastrointestinale perforationer, ulcerationer og blødninger var den samme for etoricoxib og diclofenac (1,11 hændelse pr. 100 patientår).
English: DATE OF REVISION OF THE TEXT [To be completed nationally.]
Danish: DATO FOR ÆNDRING AF TEKSTEN Måned dag, år
English: Farmacox - Companhia Farmacêutica Sociedade Unipessoal, Lda.
Danish: Addenda Pharma S.r.l.
English: In the study, the incidence of discontinuations due to hypertension-related adverse events was statistically significantly higher for etoricoxib than for diclofenac.
Danish: Forekomsten af kliniske gastrointestinale hændelser, som førte til tilbagetrækninger, var statistisk signifikant lavere for etoricoxib versus diclofenac (respektivt 7,1% versus 9,1%).
English: Merck Sharp and Dohme Ltd Hertford Road
Danish: Merck, Sharp & Dohme Ltd
English: Etoricoxib was included in previous CHMP referrals on the safety of COX-2 selective inhibitors in which concluded in 2004 and 2005.
Danish: Mellem november 2004 og juni 2005 afgav indehaveren af markedsføringstilladelsen mundtlige redegørelser til CHMP vedrørende de kardiovaskulære og hudrelaterede sikkerhedsaspekter for etoricoxib den 18. januar og 15. februar 2005.
English: Cardiovascular safety results:
Danish: Vaskulære (ekstrakardielle) lidelser:
English: Arcoxia 30 mg, comprimé pelliculé
Danish: Etoricoxib MSD 60 mg
English: In the pooled MEDAL Program, 0.3% of patients on etoricoxib and 2.7% of patients on diclofenac discontinued due to hepatic-related adverse experiences.
Danish: Forekomsten af behandlingsophør på grund af ødemer var 0,9% for etoricoxib versus 0,7% for diclofenac.
English: MEDAL Program Gastrointestinal Safety Results:
Danish: Gastrointestinale og kardiovaskulære sikkerhedsdata er opsummeret nedenfor.
English: ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg
Danish: Etoricoxib MSD 120 mg
English: Merck Sharp & Dohme BV PO Box 581
Danish: Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 2003 PC Haarlem Holland
English: SIA Merck Sharp & Dohme Latvija,
Danish: SIA ”Merck Sharp & Dohme Latvija” Skanstes iela 13
English: Carnauba wax
Danish: Puławska 303
English: These led to updates of the product information to include class warnings on the risk of CV thrombotic, GI and severe skin reactions with COX-2 selective inhibitors.
Danish: Disse oplysninger førte til, at indehaveren af markedsføringstilladelsen den 30. september 2004 trak Vioxx (rofecoxib) tilbage fra verdensmarkedet, og satte spørgsmålstegn ved den kardiovaskulære sikkerhed ved andre Cox-2hæmmere.
English: A significantly lower rate of overall upper GI events was observed with etoricoxib compared to diclofenac.
Danish: Forekomsten af venstresidig hjerteinsufficiens var 0,4% for etoricoxib versus 0,2% for diclofenac.
English: This information should inform healthcare professionals on the cardiorenal risks associated with etoricoxib and should be in line with the DHPC endorsed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen overvåger fortsat patienteksponeringen for etoricoxib i GPRD og evaluerer mulige resultater fra observationsundersøgelsen(-erne).
English: Do not take more than the recommended dose for your condition.
Danish: Dosis for hver indikation er derfor den maksimalt anbefalede dosis.
English: List of the names, pharmaceutical form, strength of the medicinal product(s), route of administration, marketing authorisation holders in the member states
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform, styrke(r), indgivelsesvej, indehavere af markedsføringstilladelser i medlemsstaterne
English: Marketing authorisaton holder
Danish: Indehaver af markedsføringstilladelse
English: Jenapharm GmbH & Co. KG Otto-Schott-Str. 15
Danish: KG Otto-Schott-Str. 15
English: Packaging Content Package size
Danish: Emballage Indhold Pakningss tørrelse
English: Strength Pharmaceutical form
Danish: MF (EU)-nummer Særnavn Styrke Lægemiddelform Måldyrearter Administr ation
English: Every year, the
Danish: Hvert år gennemgår Det
English: European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Danish: Europæiske Lægemiddelagentur alle nye oplysninger, der måtte foreligge, og ajourfører om nødvendigt dette sammendrag.
English: Raxone has been authorised under ‘exceptional circumstances'.
Danish: Raxone er godkendt under "særlige omstændigheder".
English: This is a summary of the European public assessment report (EPAR) for Raxone.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Raxone.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Raxone are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Raxone er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Raxone is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Raxone anvendes så sikkert som muligt.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Raxone contains idebenone at a different strength.
Danish: Det vil sige, at det svarer til et "referencelægemiddel", der indeholder samme aktive stof, men Raxone indeholder en anden styrke af idebenon.
English: Raxone is a ‘hybrid medicine'.
Danish: Raxone er et "hybridt lægemiddel".
English: Other information about Raxone
Danish: Andre oplysninger om Raxone
English: Furthermore, some patients who were classified as ‘off chart' (unable to read any letters on the chart) at the beginning of the study were able to read at least one line during the eye test after treatment, and this was also considered clinically important.
Danish: Nogle patienter, der i begyndelsen af undersøgelsen slet ikke kunne læse nogen bogstaver på tavlen ("off chart"), kunne desuden ved synsprøven efter behandlingen læse mindst én linje, og også dette blev anset for klinisk vigtigt.
English: This is because it has not been possible to obtain complete information about Raxone due to the rarity of the disease.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for Raxone, fordi sygdommen er sjælden.
English: Raxone idebenone
Danish: Raxone idebenon
English: The reference medicine for Raxone is Mnesis (45 mg tablets).
Danish: Referencelægemidlet for Raxone er Mnesis (45 mg tabletter).
English: Patients affected by LHON have mutations (defects) in the genetic material of mitochondria.
Danish: Patienter med LHON har defekter (mutationer) i mitokondriernes genetiske materiale.
English: Because the number of patients with Leber's hereditary optic neuropathy is low, the disease is considered ‘rare', and Raxone was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 February 2007.
Danish: Da antallet af patienter med Lebers hereditære opticus-neuropati er lavt, betragtes sygdommen som "sjælden", og Raxone blev udpeget som "lægemiddel til sjældne sygdomme" den 15. februar 2007.
English: Raxone contains the active substance idebenone.
Danish: Raxone indeholder det aktive stof idebenon.
English: The most common side effects with Raxone (which may affect more than 1 in 10 people) are nasopharyngitis and cough; mild to moderate diarrhoea and back pain are also common (affecting up to 1 in 10 people).
Danish: De hyppigste bivirkninger med Raxone (som kan forekomme hos mere end 1 ud af 10 personer) er betændelse i næse og svælg (nasofaryngitis) og hoste; let til moderat diarré, forkølelse og rygsmerter er også almindelige (forekommer hos op til 1 ud af 10 personer).
English: The Committee noted the lack of treatments for preventing or reversing the vision loss in patients with LHON.
Danish: Udvalget bemærkede, at der savnes behandlinger, der forebygger eller afhjælper synstabet hos patienter med LHON.
English: Why is Raxone approved?
Danish: Hvorfor blev Raxone godkendt?
English: Additionally, 30% of patients treated with Raxone (16 out of 53) had a clinically relevant recovery of vision in at least one eye, compared with 10% of patients (3 out of 29) in the placebo group.
Danish: Endvidere fik 30 % af de patienter, der blev behandlet med Raxone (16 ud af 53) klinisk betydningsfuld bedring af synet på mindst ét øje, sammenholdt med 10 % (3 ud af 29) af dem, der fik placebo.
English: Idebenone is thought to help improve production of energy by restoring mitochondrial function, thereby preventing the cellular damage and the loss of sight seen in LHON.
Danish: Idebenon menes at forbedre energiproduktionen ved at genetablere mitokondriernes funktion, hvorved det forebygger den cellebeskadigelse og det synstab, der ses ved LHON.
English: The full EPAR and risk management plan summary for Raxone can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Raxone findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Raxone?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Raxone?
English: The main measure of effectiveness was improvement in vision, mostly based on the numbers of letters patients were able to read on a standard eye test chart.
Danish: Det vigtigste mål for virkningen var forbedringen i synet, hovedsagelig ud fra det antal bogstaver, patienterne kunne læse på en almindelig synstavle.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Raxone can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Raxone findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Raxone can only be obtained with a prescription and treatment should be started and supervised by a doctor with experience in LHON.
Danish: Raxone fås kun på recept, og ordination og behandlingen bør påbegyndes og overvåges af en læge med erfaring i LHON.
English: By the end of the study, patients treated with Raxone were able to read on average 3 to 6 letters more compared with patients receiving placebo.
Danish: Ved slutningen af undersøgelsen var de patienter, der havde fået Raxone, i gennemsnit i stand til at læse tre til seks bogstaver mere end de, der havde fået placebo.
English: What is Raxone and what is it used for?
Danish: Hvad er Raxone, og hvad anvendes det til?
English: The results of the main study showed an improvement in vision in patients treated with Raxone, and this trend towards a beneficial effect was confirmed by additional data from an expanded access program and a case record survey.
Danish: Hovedundersøgelsen viste bedring i synet hos patienter behandlet med Raxone, og denne tendens til gavnlig virkning blev bekræftet af supplerende oplysninger fra et program til udvidet adgang og en gennemgang af journaler.
English: With regard to the safety of Raxone, the majority of side effects seen with the medicine were mild or moderate in intensity.
Danish: Vedrørende sikkerheden af Raxone var størstedelen af de iagttagne bivirkninger med lægemidlet lette til moderate i styrke.
English: Raxone is a medicine used to treat visual impairment in adults and adolescents aged 12 years and over with Leber's hereditary optic neuropathy (LHON), an inherited disease characterised by progressive loss of sight.
Danish: Raxone er et lægemiddel til behandling af nedsat syn hos voksne og unge over 12 år med den arvelige sygdom Lebers hereditære opticus-neuropati (LHON), der er kendetegnet ved fremadskridende synstab.
English: The active substance in Raxone, idebenone, is an anti-oxidant agent that acts on mitochondria (the structures inside cells that produce the energy necessary for cells to function).
Danish: Det aktive stof i Raxone, idebenon, er et antioxiderende middel, der virker på mitokondrierne, som er cellernes indvendige strukturer, der producerer den energi, cellerne behøver for at fungere.
English: For more information about treatment with Raxone, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Raxone, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What information is still awaited for Raxone?
Danish: Hvilke oplysninger afventes der stadig for Raxone?
English: It is not intended to provide practical advice on how to use Raxone.
Danish: Det er ikke en praktisk vejledning i, hvordan Raxone bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Raxone, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Raxone, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Since Raxone has been approved under exceptional circumstances, the company that markets Raxone will conduct additional studies on the long-term effects and safety of Raxone, and will establish and maintain a registry of LHON patients treated with Raxone.
Danish: Da Raxone er godkendt under særlige omstændigheder, skal den virksomhed, der markedsfører Raxone, udføre supplerende undersøgelser af Raxones virkninger og sikkerhed på lang sigt og skal føre et register over LHON-patienter, der får lægemidlet.
English: This means that mitochondria do not work properly to generate energy, and produce toxic forms of oxygen (free radicals) that damage nerve cells in the eye that are needed for vision.
Danish: Derfor fungerer mitokondriernes energiproduktion ikke som den skal, og de producerer giftige former for ilt (frie radikaler), som beskadiger de nerveceller i øjnene, der er nødvendige for synet.
English: What are the risks associated with Raxone?
Danish: Hvilke risici er der forbundet med Raxone?
English: For the full list of all side effects and restrictions with Raxone, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Raxone fremgår af indlægssedlen.
English: Raxone is available as 150 mg tablets, and the recommended dose is two tablets taken three times a day with food.
Danish: Den anbefalede dosis af Raxone er to tabletter tre gange dagligt, der tages sammen med måltiderne.
English: Analyses of all these data showed a consistent pattern whereby generally a larger proportion of patients treated with Raxone had vision improvement compared with untreated or placebo-treated patients.
Danish: Ved analyse af alle disse data sås et vedholdende mønster, hvor en større andel af de patienter, der blev behandlet med Raxone, fik bedre syn end de, der ikke blev behandlet eller blev behandlet med placebo.
English: Additional supportive data on the benefits of Raxone came from an expanded access program through which Raxone was made available to individual patients not participating in a clinical study, and from a case record survey, which included data from patients with LHON who did not receive any treatment.
Danish: Der var yderligere støttende oplysninger om fordelen ved Raxone, dels i et program til udvidet adgang, hvor Raxone blev stillet til rådighed for enkeltpatienter, der ikke deltog i en klinisk undersøgelse, dels en gennemgang af journaler med oplysninger om LHON-patienter, som ikke fik nogen behandling.
English: For practical information about using Raxone, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Raxone, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Raxone used?
Danish: Hvordan anvendes Raxone?
English: How does Raxone work?
Danish: Hvordan virker Raxone?
English: What benefits of Raxone have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Raxone?
English: Raxone has been investigated in one main study involving 85 patients with LHON, in which it was compared with placebo (a dummy treatment) over 24 weeks.
Danish: I undersøgelsen blev Raxone sammenlignet med placebo (virkningsløs behandling) i 24 uger.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MA (EU) nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold (koncentration)
English: 10 (2 x 5) pre-filled pens
Danish: 10 (2 x 5) fyldte penne
English: EU Procedure number Invented name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage
English: Packaging Content
Danish: Indhold
English: Date of first authorisation: 20 September 2006 Date of latest renewal: 15 July 2016
Danish: Dato for første tilladelse: 20. september 2006 Dato for seneste fornyelse: 15. juli 2016
English: No interaction studies have been performed and no other forms of interaction have been identified.
Danish: Der er ikke udført interaktionsundersøgelser, og der er ikke identificeret andre former for interaktion.
English: This product must only be administered intravenously.
Danish: Dette produkt må kun administreres intravenøst.
English: Tel:+353 1 223 3542
Danish: Tlf: +353 1 223 3542
English: The total dose of perflutren should not exceed 1.6 ml.
Danish: Totaldosis af perflutren bør ikke overstige 1,6 ml.
English: In the case of overdose the doctor will take appropriate action.
Danish: I tilfælde af en overdosering træffer lægen de nødvendige foranstaltninger.
English: • pain at the site of injection.
Danish: • Smerter ved indsprøjtningsstedet.
English: CLlung was found to be significantly reduced (51%) in females compared to males (all subjects).
Danish: CLlung fandtes at være betydeligt reduceret (51 %) hos kvinder sammenlignet med mænd (alle patienter).
English: These levels are substantially above the recommended maximal clinical dose.
Danish: Disse niveauer er betragteligt over anbefalet maksimal klinisk dosis.
English: Treatment of an overdose should be directed towards the support of all vital functions and prompt institution of symptomatic therapy.
Danish: Behandling af overdosis bør omfatte understøttelse af alle vitale funktioner og prompte institution af symptomatisk behandling.
English: These side effects usually go away quickly without any treatment.
Danish: Disse bivirkninger forsvinder som regel hurtigt og uden behandling.
English: - The active substance is perflutren.
Danish: Aktivt stof er; perflutren.
English: EXP After activation: use within 12 hours
Danish: EXP Efter aktivering: anvendes inden for 12 timer
English: Fertility Animal studies do not indicate direct or indirect harmful effects on fertility.
Danish: Fertilitet Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår fertiliteten.
English: All lipids are metabolised to free fatty acids.
Danish: Alle lipider metaboliseres til frie fedtsyrer.
English: There is however a risk that these allergic type reactions become severe and may include anaphylactic shock (a serious, potentially life-threatening allergic response).
Danish: Der er imidlertid en risiko for, at disse allergilignende reaktioner kan blive alvorlige og kan omfatte anafylaktiske shock (en alvorlig, potentielt livstruende allergisk reaktion).
English: Pharmacokinetics in special population groups
Danish: Farmakokinetik hos specielle befolkningsgrupper
English: Resuscitation equipment and trained personnel must always be readily available.
Danish: Genoplivningsudstyr og trænet personale skal altid være umiddelbart tilgængeligt.
English: Overdose is not likely to happen since the medicine is administered by a doctor.
Danish: Overdosering er ikke sandsynlig, eftersom lægemidlet gives af en læge.
English: Contrast-enhanced echocardiography should only be considered in such patients if the results are likely to produce a change in individual patient management.
Danish: Kontrastforstærket ekkokardiografi må kun overvejes til sådanne patienter, hvis det er sandsynligt at resultaterne giver en ændring i den individuelle patientbehandling.
English: This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion' of microspheres of perflutren gas of the right size to get a good quality image.
Danish: Dette sikrer, at lægemidlet omrystes korrekt og i så lang tid, at der opstår en “dispersion" af mikrosfærer med perflutrengas af den rigtige størrelse for at opnå et billede af god kvalitet.
English: The pharmacokinetics and metabolism of MPEG5000 DPPE have not been evaluated in humans.
Danish: Farmakokinetik og metabolisme af MPEG5000 DPPE er ikke undersøgt hos mennesker.
English: The clinical consequences of overdose with Luminity are not known.
Danish: De kliniske konsekvenser af overdosis af Luminity kendes ikke.
English: • feeling hot and
Danish: • Følelse af varme og
English: Microspheres in the 1 to < 10 µm diameter size range contribute to the contrast effect by generating strongly enhanced echoes.
Danish: Mikrosfærer i størrelsesordenen 1 til <10 µm diameter bidrager til kontrasteffekten ved at generere meget forstærkede ekkoer.
English: Patients with unstable cardiopulmonary status should be monitored during and for at least 30 minutes following Luminity administration.
Danish: Patienter med ustabil kardiopulmonal status skal monitoreres under og mindst 30 minutter efter administration af Luminity.
English: Luminity is activated by using the Vialmix which has a programmed shaking time of 45 seconds.
Danish: Luminity aktiveres ved hjælp af Vialmixeren, som har en programmeret rystetid på 45 sekunder.
English: Activation process and administration
Danish: Aktiveringsproces og administration
English: The observed 99% drop in Doppler signal intensity within 10 minutes (t1/2 approximately 2 minutes) was in agreement with the decline in measurable blood levels of perflutren.
Danish: Det observerede fald på 99 % i intensitet i Doppler-signal inden for 10 minutter (t1/2 ca. 2 minutter) var i overensstemmelse med faldet i målelige blodniveauer af perflutren.