natgillin/translations-raw huggingface dataset:
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. 
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.
Probenecid anvendes, fordi det forhindrer ophobning af cidofovir i nyrerne, og saltvandsopløsningen forhindrer dehydrering. 
Probenecid is used because it prevents cidofovir building up in the kidneys, and saline is used to prevent dehydration.
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. 
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.
Virkningerne af Vistide på CMV-retinitis hos aids-patienter blev undersøgt i en behandlingsundersøgelse og en vedligeholdelsesundersøgelse. 
The effects of Vistide in CMV retinitis in AIDS patients were studied in one treatment study and one maintenance study.
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. 
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.
I 'induktionsfasen' gives Vistide som infusion af en times varighed 5 mg pr/kg legemsvægt én gang ugentligt i de første to uger. 
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.
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). 
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).
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) VISTIDE 
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VISTIDE EPAR summary for the public
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. 
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.
Før behandlingen med Vistide påbegyndes, skal patientens nyrer kontrolleres, da lægemidlet ikke må anvendes af patienter med nyresygdomme. 
Before receiving Vistide, the patient's kidneys must be checked, as the medicine must not be given to patients with kidney disease.
Det aktive indholdsstof i Vistide, cidofovir, er et antiviralt lægemiddel, som tilhører gruppen af 'nukleosidanaloger'. 
The active substance in Vistide, cidofovir, is an antiviral medicine that belongs to the class ‘nucleotide analogues'.
Det blokerer for de enzymer i CMV, der hedder 'DNA-polymeraser', som virussen bruger til at danne DNA. 
It blocks the activity of enzymes called ‘DNA polymerases' in CMV, which the virus uses to produce DNA.
I behandlingsundersøgelsen sammenlignedes Vistide med ingen behandling af 48 patienter, som ikke tidligere var blevet behandlet med noget lægemiddel mod CMV. 
The treatment study compared Vistide with no treatment in 48 patients who had not been treated with any medicine for CMV retinitis before.
Behandling med Vistide skal påbegyndes af en læge med erfaring i behandling af patienter, der er inficeret med human immundefekt virus (hiv). 
Treatment with Vistide should be prescribed by a doctor who has experience in the management of human immunodeficiency virus (HIV) infection.
Hvilken fordel viste undersøgelserne, at der var ved Vistide? 
What benefit has Vistide shown during the studies?
Den fuldstændige liste over de indberettede bivirkninger ved Vistide fremgår af indlægssedlen. 
For the full list of all side effects reported with Vistide, see the Package Leaflet.
Vistide er et koncentrat, der bruges til at fremstille en injektionsvæske (drop i en vene). 
Vistide is a concentrate that is made up into a solution for infusion (drip into a vein).
Behandlingens varighed afhænger af de lokale retningslinjer for behandling af patienter med hiv 
Treatment is continued for as long as recommended in local guidelines on the management of HIV-infected patients.
Vistide anvendes til behandling af retinitis forårsaget af cytomegalovirus (CMV), der er en virusinfektion i nethinden (den lysfølsomme hinde bagerst i øjet). 
Vistide is used to treat cytomegalovirus (CMV) retinitis, a viral infection of the retina (the lightsensitive surface at the back of the eye).
Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse den faglige 
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Vistide anvendes til behandling af patienter, som lider af erhvervet immundefekt syndrom (aids), og som ikke lider af nyresygdom. 
Vistide is used in patients with acquired immunodeficiency syndrome (AIDS) who do not have kidney disease.
I vedligeholdelsesundersøgelsen var dosen på 5 mg/kg mere virksom end dosis på 3 
In the maintenance study, the 5-mg/kg dose was more effective than the 3-mg/kg dose (115 days and 49 days, respectively).
Det indeholder 
What is Vistide?
Oral anvendelse Flaske (glas) 
Oral use bottle (glass)
14 tabletter + 14 tabletter + 14 tabletter + 14 tabletter 
treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
1 flaske + 1 målebæger + 1 oral sprøjte 
1 bottle + 1 measuring cup + 1 oral syringe
7. juli 2011 
7 July 2011
Europa-Kommissionen traf en afgørelse den 7. juni 2011. 
The European Commission issued a decision on 7 July 2011.
Resultat af en procedure i henhold til artikel 29 i direktiv 2001/83/EF med senere ændringer 
Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette 
This is a procedure where one Member State (the ‘reference Member State',
Hvilke konklusioner traf CHMP? 
What are the conclusions of the CHMP?
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. 
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.
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. 
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).
Da det ikke lykkedes medlemsstaterne at opnå enighed, indbragte Nederlandene dog sagen for CHMP med henblik på voldgift den 29. juli 2010. 
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.
Docetaxel hæmmer kræftcellernes evne til at ødelægge det interne "skelet", der gør det muligt for dem at dele og sprede sig. 
Docetaxel blocks the ability of cancer cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Docetaxel Teva Generics er et generisk lægemiddel, der er baseret på et "referencelægemiddel", Taxotere, som har haft markedsføringstilladelse i hele EU siden 1995. 
Docetaxel Teva Generics is a generic medicine based on a ‘reference medicine', Taxotere, which has an EU-wide marketing authorisation since 1995.
Teva Generics BV indgav en ansøgning om Docetaxel Teva Generics til Nederlandene via den decentrale procedure. 
Teva Generics BV submitted an application for Docetaxel Teva Generics to the Netherlands for a decentralised procedure.
Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for Docetaxel Teva Generics. 
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.
Hvad er Docetaxel Teva Generics? 
What is Docetaxel Teva Generics?
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. 
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.
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. 
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.
Hvorfor blev Docetaxel Teva Generics vurderet igen? 
Why was Docetaxel Teva Generics reviewed?
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). 
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).
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. 
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.
Docetaxel påvirker også andre celler end kræftceller, f.eks. blodceller, hvilket kan medføre bivirkninger. 
Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Docetaxel Teva Generics er et lægemiddel, der indeholder det aktive stof docetaxel. 
Docetaxel Teva Generics is a medicine that contains the active substance docetaxel.
Spørgsmål og svar vedrørende Docetaxel Teva Generics (docetaxel, 20 mg og 80 mg pulver og solvens til infusionsvæske, opløsning) EMA/125006/2011 rev. 1 
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
Det aktive stof i Docetaxel Teva Generics, docetaxel, tilhører en gruppe lægemidler mod kræft, der er kendt som "taxaner". 
The active substance in Docetaxel Teva Generics, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Spørgsmål og svar vedrørende Docetaxel Teva Generics (docetaxel, 20 mg og 80 mg pulver og solvens til infusionsvæske, opløsning) 
Questions and answers on Docetaxel Teva Generics (docetaxel, 20 mg and 80 mg powder and solvent for solution for infusion)
Det fås som pulver og solvens til fremstilling af en infusionsvæske, opløsning (intravenøst drop). 
It is available as a powder and solvent to be made up into a solution for infusion (drip into a vein).
Begrundelsen for indbringelsen var, at der ikke var blevet foretaget en bioækvivalensundersøgelse hos mennesker med henblik på at påvise, at Docetaxel Teva Generics danner de samme mængder af det aktive stof i kroppen som Taxotere. 
The grounds for the referral were that a ‘bioequivalence' study in humans, to show that Docetaxel Teva Generics produces comparable levels of the active substance in the body as Taxotere, had not been performed.
Resultat af en procedure i henhold til artikel 31 i direktiv 2001/83/EF, som ændret 
Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 3. september 2012. 
The European Commission issued a decision on this opinion on 3 September 2012.
Lægemidler indeholdende trimetazidin har været godkendt siden 1970'erne og markedsføres på nuværende tidspunkt i Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Spanien. 
Medicines containing trimetazidine have been available since the 1970s and are currently marketed in Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Den 3. september 2012 EMA/412151/2012 rev 1 EMEA/H/A-31/1305 
EMA/608974/2012 Rev 1 EMEA/H/A-31/1305
Hvad er trimetazidin? 
What is trimetazidine?
Hvilke anbefalinger gives der til patienterne? 
What are the recommendations for patients?
Hvorfor blev trimetazidin vurderet igen? 
Why was trimetazidine reviewed?
Hvilke data vurderede CHMP? 
Which data has the CHMP reviewed?
For at afhjælpe de manglende langsigtede oplysninger om trimetazidin vil der blive udført en undersøgelse af langtidsvirkningerne af trimetazidin. 
To address the lack of long-term data on trimetazidine, a study investigating the long-term effects of trimetazidine will be carried out.
Yderligere oplysninger om den ændrede produktinformation til læger og patienter findes her. 
The full changes made to the information to doctors and patients are detailed here.
Desuden anbefalede udvalget nye kontraindikationer og advarsler for at mindske og håndtere risikoen for bevægelsesforstyrrelser ved anvendelse af dette lægemiddel. 
In addition, the Committee recommended new contraindications and warnings to reduce and manage the possible risk of movement disorders, associated with the use of this medicine.
Vedrørende anvendelse af trimetazidin til behandling af angina pectoris bemærkede udvalget, at de undersøgelser, der er udført til påvisning af dets virkninger, havde visse begrænsninger og ofte var af kort varighed. 
Regarding the use of trimetazidine in angina pectoris, the Committee noted that the studies carried out to show its effects had some limitations and were often of short duration.
Hvis parkinsonsymptomerne vedvarer længere end fire måneder efter ophør af behandlingen, bør patienten henvises til en neurolog. 
If parkinsonian symptoms persist for more than four months after discontinuation, a neurologist's opinion should be sought.
Læger underrettes skriftligt på nationalt plan om ændringerne i de godkendte anvendelser af trimetazidin. 
Written communication will be distributed to doctors at national level to inform them of the changes to the approved uses of trimetazidine.
Det menes at beskytte mod myokardieiskæmi (nedsat blodforsyning til hjertemusklen) ved at øge nedbrydningshastigheden af glukose. 
It is believed to protect against myocardial ischaemia (reduced blood supply to the heart muscle) by increasing the rate at which glucose is broken down.
• Patienter, der ønsker yderligere oplysninger, bør kontakte deres læge eller apotek. 
• Patients who have any questions should speak to their doctor or pharmacist.
Den 21. juni 2012 afsluttede Det Europæiske Lægemiddelagentur en vurdering af sikkerheden og virkningen af trimetazidin som følge af betænkeligheder med hensyn til dets virkning og indberetninger om bevægelsesforstyrrelser såsom parkinsonsymptomer i forbindelse med disse lægemidler. 
On 21 June 2012, the European Medicines Agency completed a review of the safety and effectiveness of trimetazidine following concerns over its effectiveness and reports of movement disorders such as parkinsonian symptoms with these medicines.
Hos patienter med moderat nedsat nyrefunktion og ældre patienter bør vælges en lavere dosis. 
For patients with moderately reduced kidney failure and elderly patients, the dose should be reduced.
Derfor anmodede den franske lægemiddelstyrelse den 22. april 2011 CHMP om at afgive en udtalelse om risk/benefit-forholdet for lægemidler indeholdende trimetazidin og tage stilling til, om markedsføringstilladelserne for disse lægemidler bør opretholdes, ændres, suspenderes eller tilbagetrækkes i hele EU. 
Consequently, on 22 April 2011 it asked the CHMP to issue an opinion on the benefit-risk balance of trimetzidine-containing medicines, and on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Desuden var der betænkeligheder vedrørende sikkerheden af lægemidler indeholdende trimetazidin som følge af indberetninger om Parkinsonisme (en gruppe symptomer bestående af rysten, langsomme bevægelser og muskelstivhed), og andre bevægelsesforstyrrelser såsom tremor (rysten), muskelstivhed og gangforstyrrelser samt “restless legs syndrome” (en tilstand, hvor patienten føler uimodståelig trang til at bevæge lemmerne for at standse ubehagelige, smertefulde eller mærkelige følelser i kroppen, sædvanligvis om natten). 
In addition, there were concerns regarding the safety of trimetazidine-containing medicines following reports of Parkinson syndrome (a group of symptoms that include shaking, slow movement and muscle stiffness) and other motor disorders such as tremor (shaking), muscle rigidity and walking disorders, and restless legs syndrome (a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night).
CHMP vurderede data fra kliniske undersøgelser, den offentliggjorte faglitteratur, spontane indberetninger af bivirkninger og oplysninger indsendt af de virksomheder, der markedsfører lægemidler indeholdende trimetazidin. 
The CHMP looked at data from clinical studies, the published literature, spontaneous reports of side effects and data submitted by the companies that market medicines containing trimetazidine.
• Behandlingen med trimetazidin bør permanent ophøre hos patienter, der udvikler bevægelsesforstyrrelser såsom parkinsonsymptomer. 
• Trimetazidine should be discontinued permanently in patients who develop movement disorders such as parkinsonian symptoms.
Disse symptomer forekom hos nogle patienter, der ikke tidligere havde haft parkinsonisme, og i mange tilfælde forsvandt symptomerne, når patienterne holdt op med at tage trimetazidin. 
These symptoms were seen in some patients with no previous history of Parkinson syndrome, and in many cases their symptoms resolved when they stopped taking trimetazidine.
Skønt advarslerne i ordineringsoplysningerne for disse lægemidler var blevet skærpet, var den franske lægemiddelstyrelse fortsat bekymret for, at fordelene ved trimetazidin ikke opvejede risiciene. 
Despite strengthening the warnings in the prescribing information of these medicines, the French agency remained concerned that the benefits for trimetazidine did not outweigh its risks.
I april 2011 konkluderede den franske lægemiddelstyrelse efter en gennemgang af oplysningerne fra Frankrig, at risiciene ved lægemidler indeholdende trimetazidin er større end fordelene for alle de godkendte indikationer. 
In April 2011, the French medicines regulatory agency concluded that, based on a review of the evidence in France, the risks of medicines containing trimetazidine were greater than the benefits for all the authorised indications.
Hvilke anbefalinger gives der til ordinerende læger? 
What are the recommendations for prescribers?
De markedsføres bl.a. under særnavnet Vastarel. 
They are marketed under the invented name Vastarel and other trade names.
Angina er almindeligvis forbundet med forsnævring af de blodkar, der forsyner hjertet (koronararterierne). 
Angina is commonly associated with a narrowing of the blood vessels that supply the heart, called the coronary arteries.
Hvad konkluderede CHMP? 
What are the conclusions of the CHMP?
• Der er ikke tvingende behov for at ændre behandlingen, men lægerne vil vurdere patienternes behandling ved næste planlagte besøg. 
• There is no need for an urgent change in treatment, but doctors will review their patients' treatment at their next routine appointment.
Vedrørende anvendelse af trimetazidin til tinnitus, vertigo og synsfeltforstyrrelser var undersøgelserne af ringe kvalitet og viste ingen klinisk fordel ved trimetazidin ved sammenligning med placebo (virkningsløs behandling) eller med andre lægemidler. 
Regarding the use of trimetazidine in tinnitus, vertigo and visual field disturbances, the studies had poor methodology and did not demonstrate a clinical benefit of trimetazidine when compared with placebo (a dummy treatment) or alternative medicines.
Trimetazidin er et “metabolisk stof”, dvs. et lægemiddel med virkning på stofskiftet. 
Trimetazidine is a ‘metabolic agent', a medicine which has an effect on metabolism (the process by which substances are broken down in the body).
• Der er ikke tvingende behov for at ændre behandlingen, men lægerne bør vurdere patienternes behandling ved næste planlagte besøg. 
• There is no need for an urgent change in treatment, but doctors should review their patients' treatment at their next routine appointment.
For symptomatisk behandling af tinnitus, vertigo og synsfeltforstyrrelser konkluderede CHMP, at fordelene ikke længere opvejer risiciene, og at disse anvendelser ikke længere bør være godkendt. 
For the symptomatic treatment of tinnitus, vertigo and visual field disturbances, the CHMP concluded that the benefits no longer outweigh the risks and that these uses should no longer be authorised.
• Patienter, der aktuelt får trimetazidin mod angina pectoris, bør kontakte deres læge med henblik på at sikre, at det er den mest egnede behandling af deres sygdom, eller om nødvendigt skifte til en anden behandling. 
• Patients currently receiving trimetazidine for angina pectoris should consult their doctor to ensure that it is the most appropriate treatment for their condition or to arrange alternative treatment if necessary.