FrancophonIA/ELRC3.0 huggingface dataset:
English: Two other main studies compared the ability of Thymanax and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Thymanax.
Danish: To andre hovedundersøgelser sammenlignede evnen hos Thymanax og placebo til at forhindre, at symptomerne kom igen, hos 706 patienter, hvis depression allerede var kontrolleret med Thymanax.
English: A patient booklet will also be distributed to all patients who are prescribed Thymanax so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for.
Danish: Der vil desuden blive udleveret en pjece til patienter, som får ordineret Thymanax, så de er opmærksomme på risikoen for at få leverskader og vigtigheden af at overvåge leverfunktionen og holde øje med tegn på leverproblemer.
English: The company that markets Thymanax will supply educational material for doctors prescribing Thymanax.
Danish: Desuden skal virksomheden, der markedsfører Thymanax, udlevere informationsmateriale til de læger, som ordinerer Thymanax.
English: The most common side effects with Thymanax (seen in more than 1 patient in 100) are headache, nausea (feeling sick) and dizziness.
Danish: De hyppigste bivirkninger ved Thymanax (som optræder hos flere end 1 ud af 100 patienter) er hovedpine, kvalme og svimmelhed.
English: Three of these studies included some patients treated with other antidepressants, either fluoxetine or paroxetine, as an ‘active comparator'.
Danish: Tre af disse undersøgelser omfattede patienter, som var behandlet med andre antidepressive lægemidler, enten fluoxetin eller paroxetin, som aktivt stof til sammenligning.
English: It must also not be used in patients who are taking medicines that slow down the breakdown of Thymanax in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Danish: Det må heller ikke anvendes af patienter, som tager lægemidler, der forsinker nedbrydningen af Thymanax i kroppen, såsom fluvoxamin (et andet antidepressivum) og ciprofloxacin (et antibiotikum).
English: Thymanax contains the active substance agomelatine.
Danish: Thymanax indeholder det aktive stof agomelatin.
English: In the two studies where no active comparator was used Thymanax was seen to be more effective than placebo.
Danish: I de to undersøgelser, hvor der intet aktivt sammenligningslægemiddel blev anvendt, var Thymanax mere effektivt end placebo.
English: The main measure of effectiveness was the number of patients whose symptoms returned during 24 to 26 weeks of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, som havde reageret på behandlingen efter 24-26 ugers behandling.
English: For more information about treatment with Thymanax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Thymanax, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Thymanax and what is it used for?
Danish: Hvad er Thymanax, og hvad anvendes det til?
English: Why is Thymanax approved?
Danish: Hvorfor blev Thymanax godkendt?
English: It is not intended to provide practical advice on how to use Thymanax.
Danish: Det er ikke en praktisk vejledning i, hvordan Thymanax bør anvendes.
English: In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Thymanax and those taking placebo.
Danish: I de andre tre undersøgelser, som ikke omfattede et sammenligningslægemiddel, var der ingen forskel i resultaterne mellem patienter, som tog Thymanax, og dem, der tog placebo.
English: What are the risks associated with Thymanax?
Danish: Hvilke risici er der forbundet med Thymanax?
English: For practical information about using Thymanax, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Thymanax, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Thymanax, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Thymanax fremgår af indlægssedlen.
English: Most side effects were mild or moderate in intensity, happened within the first two weeks of treatment and were temporary.
Danish: De forekom i løbet af behandlingens første to uger og var midlertidige.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thymanax 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 Thymanax.
English: This material explains the safety of the medicine, its interactions with other medicines, and includes guidance on the monitoring of liver function and management of possible symptoms of liver problems.
Danish: Det indeholder endvidere vejledning om overvågningen af leverfunktionen og håndteringen af eventuelle symptomer på leverproblemer.
English: How is Thymanax used?
Danish: Hvordan anvendes Thymanax?
English: What benefits of Thymanax have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Thymanax?
English: The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant), which showed that Thymanax was more effective than sertraline, with a reduction in HAM D scores after six weeks.
Danish: Virksomheden fremlagde også resultaterne af en yderligere undersøgelse, der sammenlignede Thymanax med sertralin (et andet antidepressivt middel).
English: How does Thymanax work?
Danish: Hvordan virker Thymanax?
English: Thymanax must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level.
Danish: Det må heller ikke anvendes af patienter, hos hvem antallet af transaminaser (leverenzymer) i blodet er tre gange højere end det normale niveau.
English: This summary was last updated in 01-2009.
Danish: Dette sammendrag blev sidst ajourført i 01-2009.
English: The marketing authorisation was renewed on 23 April 2002 and on 23 April 2007.
Danish: Markedsføringstilladelsen blev fornyet den 23. april 2002 og den 23. april 2007.
English: Vistide should not be injected directly into the eye.
Danish: Vistide må ikke sprøjtes direkte ind i øjet.
English: This disease can cause loss of vision.
Danish: Denne sygdom kan medføre synsnedsættelse.
English: It should only be used when other medicines are unsuitable.
Danish: Det bør kun anvendes, når andre lægemidler ikke er
English: Then, during the ‘maintenance' phase, it is given once every two weeks.
Danish: I den efterfølgende 'vedligeholdelsesfase' gives midlet én gang hver anden uge.
English: The marketing authorisation holder is Gilead Sciences International.
Danish: Indehaveren af markedsføringstilladelsen er Gilead Sciences International.
English: In both studies, the main measure of effectiveness was the time taken for the disease to get worse.
Danish: I begge undersøgelser var det vigtigste mål for virkningen den tid, der gik, før sygdommen forværredes.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vistide on 23 April 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vistide den 23. april 1997.
English: The Committee recommended that Vistide be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Vistide.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Danish: Det forklarer, hvordan udvalget for Humanmedicinske Lægemidler (CHMP) vurderede de gennemførte undersøgelser og nåede frem til sine anbefalinger om, hvordan lægemidlet skal
English: When the virus cannot produce DNA, it cannot reproduce, slowing down the spread of infection.
Danish: Når virussen ikke kan danne DNA, kan det ikke danne ny virus, hvorved udbredelsen af infektionen bliver langsommere.
English: In the treatment study, Vistide was more effective than no treatment.
Danish: I behandlingsundersøgelsen var Vistide mere virksom end ingen behandling.
English: To reduce the risk of kidney damage, patients must also take another medicine called probenecid (2 g three hours before the infusion, then 1 g two and eight hours after the infusion) and receive an infusion of one litre of saline solution one hour before the infusion of Vistide.
Danish: For at begrænse risikoen for nyreskader skal patienten samtidig anvende et andet lægemiddel kaldet probenecid (2 g tre timer før infusionen, dernæst 1 g to og otte timer efter infusionen) og gives en infusion på en liter saltvandsopløsning en time før infusionen med Vistide.
English: How has Vistide been studied?
Danish: Hvordan blev Vistide undersøgt?
English: Vistide should not be used in people who may be hypersensitive (allergic) to cidofovir or any of the other ingredients.
Danish: Vistide må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for cidofovir eller nogen af indholdsstofferne.
English: The most common side effects with Vistide (seen in more than 1 patient in 10) are neutropenia (low white blood cell counts), headache, nausea (feeling sick), vomiting, alopecia (hair loss), rash, proteinuria (protein in the urine), increased blood creatinine levels (a breakdown product of muscles), asthenia (weakness) and fever.
Danish: De hyppigste bivirkninger ved Vistide (set hos mere end 1 ud af 10 patienter) er neutropeni (lavt antal hvide blodlegemer), hovedpine, kvalme, opkastning, hårtab, udslæt, protein i urinen, forhøjet indhold af kreatinin i blodet (et stof, der stammer fra nedbrydningen af muskler), slaphed og feber.
English: Probenecid is used because it prevents cidofovir building up in the kidneys, and saline is used to prevent dehydration.
Danish: Probenecid anvendes, fordi det forhindrer ophobning af cidofovir i nyrerne, og saltvandsopløsningen forhindrer dehydrering.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Vistide's benefits are greater than its risks for the treatment of CMV retinitis in patients with AIDS and without kidney disease.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Vistide er større end risiciene ved behandling af CMV-retinitis hos patienter med aids og uden nyresygdom.
English: The effects of Vistide in CMV retinitis in AIDS patients were studied in one treatment study and one maintenance study.
Danish: Virkningerne af Vistide på CMV-retinitis hos aids-patienter blev undersøgt i en behandlingsundersøgelse og en vedligeholdelsesundersøgelse.
English: It took an average of 120 days for CMV retinitis to get worse in patients receiving Vistide, compared with 22 days in those who did not receive any treatment.
Danish: Det varede gennemsnitligt 120 dage, før der indtrådte en forværring i CMV-retinitis blandt de patienter, der blev behandlet med Vistide, sammenlignet med 22 dage blandt de patienter, der ikke modtog nogen behandling.
English: During the ‘induction' phase, Vistide is given as a one-hour infusion of 5 mg per kilogram body weight once a week for the first two weeks.
Danish: I 'induktionsfasen' gives Vistide som infusion af en times varighed 5 mg pr/kg legemsvægt én gang ugentligt i de første to uger.
English: The maintenance study compared two maintenance doses of Vistide (5 and 3 mg/kg body weight) in 100 patients who had stopped responding to, or could not receive other medicines for CMV retinitis (ganciclovir or foscarnet).
Danish: I vedligeholdelsesundersøgelsen sammenlignedes to vedligeholdelsesdoser af Vistide (5 og 3 mg/kg legemsvægt) hos 100 patienter, som ikke længere reagerede på eller som ikke tålte andre lægemidler mod CMV-retinitis (ganciclovir eller foscarnet).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VISTIDE EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) VISTIDE
English: It should also not be used in patients who have kidney disease or who are taking other medicines that might be harmful to the kidneys, or in patients who cannot take probenecid or other ‘sulfa-containing' medicines.
Danish: Midlet bør ikke anvendes af patienter med nyresygdom eller som anvender anden medicin, der kan være skadelig for nyrerne, eller af patienter, der ikke kan tage probenecid eller andre 'sulfaholdige' lægemidler.
English: Before receiving Vistide, the patient's kidneys must be checked, as the medicine must not be given to patients with kidney disease.
Danish: Før behandlingen med Vistide påbegyndes, skal patientens nyrer kontrolleres, da lægemidlet ikke må anvendes af patienter med nyresygdomme.
English: The active substance in Vistide, cidofovir, is an antiviral medicine that belongs to the class ‘nucleotide analogues'.
Danish: Det aktive indholdsstof i Vistide, cidofovir, er et antiviralt lægemiddel, som tilhører gruppen af 'nukleosidanaloger'.
English: It blocks the activity of enzymes called ‘DNA polymerases' in CMV, which the virus uses to produce DNA.
Danish: Det blokerer for de enzymer i CMV, der hedder 'DNA-polymeraser', som virussen bruger til at danne DNA.
English: The treatment study compared Vistide with no treatment in 48 patients who had not been treated with any medicine for CMV retinitis before.
Danish: I behandlingsundersøgelsen sammenlignedes Vistide med ingen behandling af 48 patienter, som ikke tidligere var blevet behandlet med noget lægemiddel mod CMV.
English: Treatment with Vistide should be prescribed by a doctor who has experience in the management of human immunodeficiency virus (HIV) infection.
Danish: Behandling med Vistide skal påbegyndes af en læge med erfaring i behandling af patienter, der er inficeret med human immundefekt virus (hiv).
English: What benefit has Vistide shown during the studies?
Danish: Hvilken fordel viste undersøgelserne, at der var ved Vistide?
English: For the full list of all side effects reported with Vistide, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Vistide fremgår af indlægssedlen.
English: Vistide is a concentrate that is made up into a solution for infusion (drip into a vein).
Danish: Vistide er et koncentrat, der bruges til at fremstille en injektionsvæske (drop i en vene).
English: Treatment is continued for as long as recommended in local guidelines on the management of HIV-infected patients.
Danish: Behandlingens varighed afhænger af de lokale retningslinjer for behandling af patienter med hiv
English: Vistide is used to treat cytomegalovirus (CMV) retinitis, a viral infection of the retina (the lightsensitive surface at the back of the eye).
Danish: Vistide anvendes til behandling af retinitis forårsaget af cytomegalovirus (CMV), der er en virusinfektion i nethinden (den lysfølsomme hinde bagerst i øjet).
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse den faglige
English: Vistide is used in patients with acquired immunodeficiency syndrome (AIDS) who do not have kidney disease.
Danish: Vistide anvendes til behandling af patienter, som lider af erhvervet immundefekt syndrom (aids), og som ikke lider af nyresygdom.
English: In the maintenance study, the 5-mg/kg dose was more effective than the 3-mg/kg dose (115 days and 49 days, respectively).
Danish: I vedligeholdelsesundersøgelsen var dosen på 5 mg/kg mere virksom end dosis på 3
English: What is Vistide?
Danish: Det indeholder
English: Oral use bottle (glass)
Danish: Oral anvendelse Flaske (glas)
English: treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Danish: 14 tabletter + 14 tabletter + 14 tabletter + 14 tabletter
English: 1 bottle + 1 measuring cup + 1 oral syringe
Danish: 1 flaske + 1 målebæger + 1 oral sprøjte
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/12/750/001 Esmya
Danish: EU/1/12/750/004 EU/1/12/750/005
English: 7 July 2011
Danish: 7. juli 2011
English: The European Commission issued a decision on 7 July 2011.
Danish: Europa-Kommissionen traf en afgørelse den 7. juni 2011.
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Danish: Resultat af en procedure i henhold til artikel 29 i direktiv 2001/83/EF med senere ændringer
English: This is a procedure where one Member State (the ‘reference Member State',
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette
English: What are the conclusions of the CHMP?
Danish: Hvilke konklusioner traf CHMP?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Docetaxel Teva Generics outweigh its risks, and that the marketing authorisation can be granted in the Netherlands as well as in Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom and Norway.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Docetaxel Teva Generics er større end risiciene, og at der kan udstedes markedsføringstilladelse i Nederlandene samt i Østrig, Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Rumænien, Slovakiet, Slovenien, Spanien, Sverige, Det Forenede Kongerige og Norge.
English: in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance all other EU Member States (except Portugal) and Norway).
Danish: tilfælde Nederlandene) vurderer et lægemiddel med henblik på at udstede en markedsføringstilladelse, som gælder i dette land og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde alle andre EU-medlemsstater (undtagen Portugal) og Norge.
English: However, the Member States were not able to reach an agreement and the Netherlands referred the matter to the CHMP on 29 July 2010 for arbitration.
Danish: Da det ikke lykkedes medlemsstaterne at opnå enighed, indbragte Nederlandene dog sagen for CHMP med henblik på voldgift den 29. juli 2010.
English: Docetaxel blocks the ability of cancer cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Danish: Docetaxel hæmmer kræftcellernes evne til at ødelægge det interne "skelet", der gør det muligt for dem at dele og sprede sig.
English: Docetaxel Teva Generics is a generic medicine based on a ‘reference medicine', Taxotere, which has an EU-wide marketing authorisation since 1995.
Danish: Docetaxel Teva Generics er et generisk lægemiddel, der er baseret på et "referencelægemiddel", Taxotere, som har haft markedsføringstilladelse i hele EU siden 1995.
English: Teva Generics BV submitted an application for Docetaxel Teva Generics to the Netherlands for a decentralised procedure.
Danish: Teva Generics BV indgav en ansøgning om Docetaxel Teva Generics til Nederlandene via den decentrale procedure.
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 medicine Docetaxel Teva Generics.
Danish: Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for Docetaxel Teva Generics.
English: What is Docetaxel Teva Generics?
Danish: Hvad er Docetaxel Teva Generics?
English: Based on an evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that additional data was not needed because Docetaxel Teva Generics is expected to produce comparable levels of the active substance in the body as the reference medicine.
Danish: På baggrund af vurderingen af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at der ikke var behov for yderligere data, eftersom Docetaxel Teva Generics forventes at danne de samme mængder af det aktive stof i kroppen som referencelægemidlet.
English: Docetaxel Teva Generics is intended to treat the following types of cancer: breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer), and head and neck cancer.
Danish: Docetaxel Teva Generics er beregnet til behandling af følgende kræfttyper: brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk adenocarcinom (en form for mavekræft) samt hoved- og halskræft.
English: Why was Docetaxel Teva Generics reviewed?
Danish: Hvorfor blev Docetaxel Teva Generics vurderet igen?
English: Some Member States considered this needed since the form of Docetaxel Teva Generics (a powder and a solvent to be made into a solution) is different to the form of the reference medicine (a concentrated solution) and the two medicines contain different excipients (inactive ingredients).
Danish: Nogle medlemsstater mente, at dette var nødvendigt, eftersom Docetaxel Teva Generics' lægemiddelform (pulver og solvens til fremstilling af en infusionsvæske, opløsning) er en anden end referencelægemidlets form (en koncentreret opløsning), og de to lægemidler indeholder forskellige hjælpestoffer (inaktive stoffer).
English: The CHMP therefore concluded that the benefits of Docetaxel Teva Generics outweigh its risks and recommended that the marketing authorisation be granted in the Netherlands and the concerned Member States.
Danish: CHMP konkluderede således, at fordelene ved Docetaxel Teva Generics er større end risiciene, og at der derfor bør udstedes markedsføringstilladelse for Docetaxel Teva Generics i Nederlandene og i de berørte medlemsstater.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Danish: Docetaxel påvirker også andre celler end kræftceller, f.eks. blodceller, hvilket kan medføre bivirkninger.
English: Docetaxel Teva Generics is a medicine that contains the active substance docetaxel.
Danish: Docetaxel Teva Generics er et lægemiddel, der indeholder det aktive stof docetaxel.
English: Questions and answers on Docetaxel Teva Generics (docetaxel, 20 mg and 80 mg powder and solvent for solution for infusion) EMA/125006/2011 rev. 1
Danish: Spørgsmål og svar vedrørende Docetaxel Teva Generics (docetaxel, 20 mg og 80 mg pulver og solvens til infusionsvæske, opløsning) EMA/125006/2011 rev. 1
English: The active substance in Docetaxel Teva Generics, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Danish: Det aktive stof i Docetaxel Teva Generics, docetaxel, tilhører en gruppe lægemidler mod kræft, der er kendt som "taxaner".
English: Questions and answers on Docetaxel Teva Generics (docetaxel, 20 mg and 80 mg powder and solvent for solution for infusion)
Danish: Spørgsmål og svar vedrørende Docetaxel Teva Generics (docetaxel, 20 mg og 80 mg pulver og solvens til infusionsvæske, opløsning)
English: It is available as a powder and solvent to be made up into a solution for infusion (drip into a vein).
Danish: Det fås som pulver og solvens til fremstilling af en infusionsvæske, opløsning (intravenøst drop).