FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition to their approved uses, the three medicines were expected to be used to treat moderate to severe chronic (long-term) somatic pain in patients not regularly taking NSAID pain killers (non steroidal anti-inflammatory drugs).
Danish: Ud over de godkendte anvendelser forventedes de tre lægemidler anvendt til behandling af moderate til svære kroniske (langvarige) somatiske smerter hos patienter, der ikke regelmæssigt bruger NSAID mod smerter (non-steroide antiinflammatoriske lægemidler).
English: What is happening with Ariclaim, Cymbalta and Xeristar for in their approved indications?
Danish: Hvad sker der med Ariclaim, Cymbalta og Xeristar til de godkendte indikationer?
English: The active substance duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Danish: Det aktive stof duloxetin hæmmer genoptagelsen af serotonin og noradrenalin.
English: The change concerned the addition of a new indication, the treatment of moderate to severe chronic somatic pain in patients not taking NSAIDs regularly.
Danish: Ændringen vedrørte tilføjelse af en ny indikation: behandling af moderate til svære somatiske smerter hos patienter, der ikke regelmæssigt bruger NSAID.
English: The CHMP therefore concluded that the benefits of duloxetine in the treatment of moderate to severe chronic somatic pain in patients not regularly taking NSAIDs had not been shown to outweigh its risks.
Danish: CHMP konkluderede derfor, at det ikke er påvist, at fordelene ved duloxetin opvejer risiciene til behandling af moderate til svære kroniske somatiske smerter hos patienter, der ikke regelmæssigt bruger NSAID.
English: Since these neurotransmitters are involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may improve the symptoms of pain.
Danish: Når deres genoptagelse i nervecellerne blokeres, kan det derfor bedre smertesymptomerne.
English: Immediate Packaging
Danish: Lægemiddelform Administration Emballage Indhold Pakningsstørrrelse
English: Content (concentration)
Danish: Oral anvendelse flaske (HDPE)
English: The trials and programmes will continue as planned.
Danish: Undersøgelserne og programmerne vil fortsætte som planlagt.
English: • The long-term study did not show that the medicine was effective.
Danish: • Langtidsundersøgelsen viste ikke, at medicinen var effektiv.
English: The company that applied is Les Laboratoires Servier.
Danish: Firmaet, der har indgivet ansøgningen, er Les Laboratoires Servier.
English: Patients often suffer relapses (when the disease comes back after it has been treated).
Danish: Patienterne får ofte tilbagefald (når sygdommen vender tilbage, efter at den er blevet behandlet).
English: EMEA/37021/2007 - update
Danish: EMEA/522430/2006 - opdatering
English: International Non-proprietary Name (INN): agomelatine
Danish: Internationalt fællesnavn (INN): agomelatin
English: The effects of agomelatine were first tested in experimental models before being studied in humans.
Danish: Virkningerne af agomelatin blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The applicant requested a reexamination of the opinion, but withdrew this request before the CHMP completed the re-examination.
Danish: Ansøgeren anmodede om en revurdering af udtalelsen, men trak denne anmodning tilbage, inden CHMP havde gennemført revurderingen.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i et klinisk forsøg eller et program for specialudlevering og har behov for yderligere information om din behandling, kan du kontakte den læge, der er ansvarlig for behandlingen.
English: They looked at the short- and long-term effectiveness of the medicine (short-term studies lasting 6-8 weeks and the longterm studies lasting up to a year).
Danish: Undersøgelserne så på kort- og langtidseffektiviteten af lægemidlet (korttidsundersøgelserne varede 68 uger, og langtidsundersøgelserne varede op til et år).
English: The key symptoms are depressed mood and loss/diminished interest or pleasure.
Danish: Hovedsymptomerne er nedtrykt sindstilstand og tab/formindsket interesse eller glæde.
English: They may suffer from deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight.
Danish: De kan lide af en dyb følelse af tristhed, værdiløshed, miste interessen for deres yndlingsaktiviteter, få søvnforstyrrelser, få en følelse af, at alt går langsommere, blive angst og ændre vægt.
English: What documentation has been presented by the company to support the application to the CHMP?
Danish: Hvilken dokumentation har firmaet fremlagt til støtte for ansøgningen til CHMP?
English: London, 18 November 2006 Doc.Ref.
Danish: London, 16/01/2007 Dok.ref.
English: What were the major concerns that led to the CHMP to recommend a refusal of the marketing authorisation?
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede afslag på ansøgning om markedsføringstilladelse?
English: All patients treated suffered from a major depressive disorder, the severity of which was assessed using a standard rating scale (the Hamilton Rating Scale for Depression, HAM-D).
Danish: Alle behandlede patienter led af svære depressive forstyrrelser, hvis sværhedsgrad blev vurderet ved brug af en standardiseret vurderingsskala (Hamiltons depressionsskala, HAM-D).
English: Some studies included a control group where patients were treated with fluoxetine or paroxetine (other medicines used in depression).
Danish: Nogle forsøg omfattede en kontrolgruppe, hvor patienterne blev behandlet med fluoxetin eller paroxetin (andre lægemidler der anvendes mod depression).
English: The effectiveness was measured by looking at the score in the HAM-D rating scale before and at the end of the study.
Danish: Effektiviteten blev målt ved vurdering af pointtallene i HAM-D vurderingsskalaen før undersøgelsen og efter afslutning af undersøgelsen.
English: This means that agomelatine stimulates the melatonin receptors MT1 and MT2 (these receptors are normally activated by a natural hormone, melatonin) and it blocks the 5-HT2C receptors (these receptors are normally activated by a chemical messenger, serotonin).
Danish: Dette betyder, at agomelatin stimulerer melatoninreceptorerne MT1 og MT2 (disse receptorer aktiveres normalt af et naturligt hormon, melatonin) og det blokerer 5-HT2C -receptorerne (disse receptorer aktiveres normalt af en kemisk budbringer, serotonin).
English: In major depressive disorder, patients have disturbances of mood that interfere with their everyday life.
Danish: Patienter med svære depressive forstyrrelser lider af humørforstyrrelser, der griber forstyrrende ind i dagligdagen.
English: See here for information on the outcome of the resubmission
Danish: Information om resultatet af denne genansøgning findes her.
English: On 27 July 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a marketing authorisation for the medicinal product Valdoxan/Thymanax, 25 mg film-coated tablets intended for the treatment of major depressive disorder.
Danish: Den 27. juli 2006 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvori det anbefalede at give afslag på ansøgningen om markedsføringstilladelse for lægemidlet Valdoxan/Thymanax, 25 mg filmovertrukne tabletter, beregnet til behandling af svære depressive forstyrrelser.
English: The main studies involved more than 2,400 patients that took Valdoxan/Thymanax.
Danish: Hovedundersøgelserne omfattede flere end 2.400 patienter, der tog Valdoxan/Thymanax.
English: Valdoxan/Thymanax was compared with a placebo (a dummy treatment).
Danish: Valdoxan/Thymanax blev sammenlignet med en placebo (en uvirksom behandling).
English: Valdoxan/Thymanax was expected to be used in adult patients to treat major depressive disorder.
Danish: Valdoxan/Thymanax forventedes anvendt til brug hos voksne patienter til behandling af svære depressive forstyrrelser.
English: Valdoxan/Thymanax are orange-yellow tablets containing 25 mg of the active substance agomelatine.
Danish: Valdoxan/Thymanax er orange-gule tabletter, der indeholder 25 mg af det aktive stof agomelatin.
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR REFUSAL OF MARKETING AUTHORISATION for VALDOXAN/THYMANAX
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALINGEN AF AFSLAG PÅ ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for VALDOXAN/THYMANAX
English: The major concern of the CHMP was that the effectiveness of Valdoxan/Thymanax had not been sufficiently shown:
Danish: CHMP's største bekymring var, at effektiviteten af Valdoxan/Thymanax ikke var blevet tilstrækkeligt påvist:
English: The active substance in Valdoxan/Thymanax, agomelatine, is a ‘melatonergic agonist' and a ‘5-HT2C antagonist'.
Danish: Det aktive stof i Valdoxan/Thymanax, agomelatin, er en ‘melatoninagonist' og en ‘5-HT2Cantagonist'.
English: At this point in time, the CHMP was of the opinion that the benefits of Valdoxan/Thymanax did not outweigh its risks.
Danish: På dette tidspunkt var CHMP af den opfattelse, at fordelene ved Valdoxan/Thymanax ikke opvejede risiciene.
English: The Company has informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Valdoxan/Thymanax.
Danish: Firmaet har informeret CHMP om, at der ikke er konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser eller programmer for specialudlevering af Valdoxan/Thymanax.
English: What is Valdoxan/Thymanax?
Danish: Hvad er Valdoxan/Thymanax?
English: What are the consequences of the refusal for patients undergoing clinical trials/compassionate use programmes with Valdoxan/Thymanax?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser/ programmer for specialudlevering af Valdoxan/Thymanax?
English: What was Valdoxan/Thymanax expected to be used for?
Danish: Hvad forventedes Valdoxan/Thymanax anvendt til?
English: How is Valdoxan/Thymanax expected to work?
Danish: Hvordan forventes Valdoxan/Thymanax at virke?
English: Hence, the CHMP recommended that Valdoxan/Thymanax be refused marketing authorisation.
Danish: CHMP anbefalede derfor afslag på markedsføringstilladelse for Valdoxan/Thymanax.
English: • The short-term studies showed that the medicine has an effect, but the extent of this did not allow the Committee to draw a firm conclusion on the medicine's effectiveness The CHMP had no special concerns regarding the side effects associated with Valdoxan/Thymanax, as these could have been managed using the standard risk management tools.
Danish: • Korttidsundersøgelsen viste, at medicinen har en virkning, men omfanget af denne gjorde det ikke muligt for udvalget at drage en sikker konklusion vedrørende lægemidlets effektivitet.
English: The maximum recommended dosing frequency is one tablet per day.
Danish: Den maksimalt anbefalede dosishyppighed er én tablet dagligt.
English: The full EPAR for Vizarsin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Vizarsin findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vizarsin on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vizarsin den 21. september 2009.
English: It is available as film-coated tablets (25, 50 and 100 mg) and as orodispersible tablets (25, 50 and 100 mg).
Danish: Det fås som filmovertrukne tabletter (25, 50 og 100 mg) og som smeltetabletter (25, 50 og 100 mg).
English: This is a summary of the European public assessment report (EPAR) for Vizarsin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vizarsin.
English: Patients with reduced liver or severely reduced kidney function should start treatment with the 25 mg dose.
Danish: Patienter med nedsat leverfunktion eller svært nedsat nyrefunktion skal påbegynde behandlingen med en dosis på 25 mg.
English: Vizarsin is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Danish: Vizarsin anvendes til behandling af voksne mænd med erektil dysfunktion (undertiden kaldet impotens), når de ikke kan få eller fastholde en stiv penis (erektion), som er tilstrækkelig til tilfredsstillende seksuel aktivitet.
English: Other information about Vizarsin
Danish: Andre oplysninger om Vizarsin
English: The recommended dose of Vizarsin is 50 mg taken as needed about one hour before sexual activity.
Danish: Den anbefalede dosis Vizarsin er 50 mg, som tages efter behov ca. 1 time før seksuel aktivitet.
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 Vizarsin.
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 anvendelsesbetingelserne for Vizarsin.
English: For more information about treatment with Vizarsin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vizarsin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Vizarsin is a ‘generic medicine'.
Danish: Vizarsin er et ‘generisk lægemiddel'.
English: By blocking the breakdown of cGMP, Vizarsin restores erectile function.
Danish: Ved at blokere nedbrydningen af cGMP genopretter Vizarsin den erektile funktion.
English: What are the benefits and risks of Vizarsin?
Danish: Hvilke fordele og risici er der forbundet med Vizarsin?
English: For Vizarsin to be effective, sexual stimulation is required.
Danish: For at få Vizarsin til at virke kræves der seksuel stimulering.
English: The Committee recommended that Vizarsin be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Vizarsin.
English: Vizarsin is a medicine that contains the active substance sildenafil.
Danish: Vizarsin er et lægemiddel, der indeholder det aktive stof sildenafil.
English: The active ingredient in Vizarsin, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Det aktive stof i Vizarsin, sildenafil, tilhører en gruppe af lægemidler kaldet phosphodiesterase type 5(PDE5) hæmmere.
English: This means that Vizarsin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Danish: Det betyder, at Vizarsin er identisk med et referencelægemiddel, der allerede er godkendt i EU, nemlig Viagra.
English: The CHMP concluded that, in accordance with EU requirements, Vizarsin has been shown to have comparable quality and to be bioequivalent to Viagra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Vizarsin er af sammenlignelig kvalitet og er bioækvivalent med Viagra.
English: If Vizarsin is taken with food, the onset of activity may be delayed compared with taking Vizarsin without food.
Danish: Hvis Vizarsin tages sammen med et måltid, kan virkningens indtræden forsinkes i forhold til, hvis Vizarsin tages uden et måltid.
English: Because Vizarsin is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Vizarsin er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Orodispersible means that the tablet dissolves in the mouth.
Danish: Smeltetabletter er tabletter, som opløser sig i munden.
English: Because Vizarsin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Danish: Da Vizarsin er et generisk lægemiddel, har undersøgelserne af patienterne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Viagra.
English: Why has Vizarsin been approved?
Danish: Hvorfor blev Vizarsin godkendt?
English: What is Vizarsin?
Danish: Hvad er Vizarsin?
English: What is Vizarsin used for?
Danish: Hvad anvendes Vizarsin til?
English: How has Vizarsin been studied?
Danish: Hvordan blev Vizarsin undersøgt?
English: How is Vizarsin used?
Danish: Hvordan anvendes Vizarsin?
English: How does Vizarsin work?
Danish: Hvordan virker Vizarsin?
English: One death occurred in each group.
Danish: Der skete ét dødsfald i hver gruppe.
English: Thereafter, the difference between the two groups was not significant.
Danish: Derefter er forskellen mellem de to grupper ikke signifikant.
English: Alcohol may modify or increase the effect of other medicines.
Danish: Alkohol kan ændre eller øge virkningen af anden medicin.
English: *Note: p-values not controlled for multiple testing.
Danish: * Note: p-værdierne blev ikke kontrolleret for multiple test.
English: At present, there is minimal experience with overdose.
Danish: Der er på nuværende tidspunkt minimal erfaring med overdosering.
English: These may be symptoms of a serious allergic reaction.
Danish: Det kan være symptomer på en alvorlig allergisk reaktion.
English: Interaction studies have only been performed in adults.
Danish: Interaktionsforsøg er kun udført hos voksne.
English: 30 days for opened bottle.
Danish: 30 dage for en åbnet flaske.
English: Rapamune reduces your body's own defence mechanisms.
Danish: Rapamune nedsætter kroppens egne forsvarsmekanismer.
English: There was a large variability for individuals within the age groups.
Danish: Der er stor individuel variation inden for aldersgrupperne.
English: Therefore, absorption and the subsequent elimination of sirolimus may be influenced by substances that affect these proteins.
Danish: Derfor kan absorption og efterfølgende elimination af sirolimus påvirkes af stoffer, som påvirker disse proteiner.
English: You may need to repeat step 3 more than once to deliver your dose.
Danish: Det kan være nødvendigt at gentage trin 3 mere end 1 gang for at kunne give dosis.
English: Consequently your body will not be as good as normal at fighting infections.
Danish: Som en følge deraf vil Deres krop ikke kunne bekæmpe infektioner så godt som normalt.
English: General supportive measures should be initiated in all cases of overdose.
Danish: Der bør iværksættes generel understøttende behandling ved alle tilfælde af overdosering.
English: Once the bottle has been opened, the contents should be kept refrigerated and used within 30 days.
Danish: Efter at flasken er åbnet, skal indholdet opbevares i køleskab og anvendes inden for 30 dage.
English: The concentration values obtained by these different methodologies are not interchangeable.
Danish: De koncentrationer, der opnås ved disse forskellige metoder, kan ikke erstatte hinanden.
English: Periodic quantitative monitoring of urinary protein excretion is recommended.
Danish: Periodisk, kvantitativ kontrol af udskillelse af urinprotein anbefales.
English: After that, continue to take your medicines as usual.
Danish: Herefter skal De fortsætte med at tage medicinen som normalt.
English: Date of first authorisation: 13 March 2001 Date of latest renewal: 13 March 2011
Danish: Dato for første tilladelse: 13. marts 2001 Dato for seneste fornyelse: 13. marts 2011
English: Rapamune should not be used during pregnancy unless clearly necessary.
Danish: De må ikke tage Rapamune under graviditet, medmindre det er klart nødvendigt.
English: All patients who developed PTLD were aged below 18 years.
Danish: Alle patienter, som udviklede PTLD, var under 18 år.
English: Information directly related to the tablet formulation is summarised specifically in the Oral tablet section.
Danish: Oplysninger, der er direkte relateret til tabletformuleringen, resumeres specifikt i afsnittet om oral tabletter.
English: The changes may be related to chronic immunosuppression.
Danish: Ændringerne kan hænge sammen med kronisk immunsuppression.
English: Sirolimus is the major component in human whole blood and contributes to greater than 90% of the immunosuppressive activity.
Danish: Sirolimus er hovedkomponenten i humant fuldblod og bidrager til mere end 90% af den immunsupprimerende aktivitet.
English: Immunosuppressants may affect response to vaccination.
Danish: Immunsuppressiva kan påvirke responsen ved vaccination.
English: System organ class
Danish: Systemorgan klasse
English: These data indicate that younger children might require higher bodyweight-adjusted doses than adolescents and adults to achieve similar target concentrations.
Danish: Disse data tyder på, at yngre børn muligvis kræver højere legemsvægtsjusterede doser end unge og voksne for at opnå målkoncentrationer af tilsvarende størrelse.
English: You should contact your doctor if you experience symptoms that are serious, unusual, or prolonged.
Danish: De skal kontakte Deres læge, hvis De får symptomer, som er alvorlige, usædvanlige eller langvarige.
English: Follow your doctor's instructions exactly, and never change the dose yourself.
Danish: Lægens instrukser skal følges nøje, og De må aldrig selv ændre dosis.
English: Much of the general pharmacokinetic information was obtained using the Rapamune oral solution, which is summarised first.
Danish: Mange af de generelle farmakokinetiske oplysninger blev fremskaffet ved brug af Rapamune oral opløsning, hvilket resumeres først.
English: Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG United Kingdom
Danish: Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG Storbritannien
English: The maximum Rapamune dose administered on any day should not exceed 40 mg.
Danish: Den maksimale Rapamune-dosis, som gives på en hvilken som helst dag, bør ikke overstige 40 mg.
English: Your doctor will decide exactly what dose of Rapamune you must take and how often to take it.
Danish: Lægen beslutter, præcis hvilken dosis Rapamune De skal tage, og hvor ofte medicinen skal tages.
English: Once a stable dose is achieved, therapeutic drug monitoring should be performed at least every 3 months.
Danish: Når en stabil dosis er opnået, bør en terapeutisk lægemiddelmonitorering udføres mindst hver 3. måned.
English: Rapamune with food and drink
Danish: Brug af Rapamune sammen med mad og drikke
English: Do not take Rapamune:
Danish: Tag ikke Rapamune:
English: You may have been instructed to take your Rapamune oral solution at a particular time of day.
Danish: De kan have fået besked på at tage den orale Rapamune-opløsning på et bestemt tidspunkt på dagen.
English: Bioavailability has not been determined for tablets after they have been crushed, chewed or split, and therefore this cannot be recommended.
Danish: Biotilgængeligheden er ikke fastlagt for tabletterne, hvis de knuses, tygges eller deles, og dette kan derfor ikke anbefales.
English: if you are allergic to peanut or soya.
Danish: - hvis De er allergisk over for jordnødder eller soja
English: Therapeutic monitoring of the medicinal product should not be the sole basis for adjusting sirolimus therapy.
Danish: Terapeutisk lægemiddelmonitorering bør ikke være den eneste årsag til at justere sirolimus-behandlingen.
English: During treatment with immunosuppressants, including Rapamune, vaccination may be less effective.
Danish: Under behandling med immunsuppressiva, herunder Rapamune, kan vaccinationen være mindre effektiv.
English: There are no or limited amount of data from the use of sirolimus in pregnant women.
Danish: Der er ingen eller utilstrækkelige data for anvendelse af sirolimus til gravide kvinder.