natgillin/translations-raw huggingface dataset:
I en yderligere undersøgelse blev der givet Zevalin til 57 patienter med follikulær lymfom, som tidligere var blevet behandlet med rituximab og ikke havde responderet på behandlingen. 
In an additional study, 57 patients with follicular lymphoma who had been previously treated and were not responding to rituximab received Zevalin.
• patienter, hos hvem rituximab (et andet middel mod non-Hodgkins lymfom) ikke længere virker eller hos hvem sygdommen er vendt tilbage efter behandling med rituximab. 
‘consolidation therapy' to improve the remission; patients in whom rituximab (another treatment for non Hodgkin's lymphoma) is no longer effective or whose disease has come back after rituximab treatment.
Hvad anvendes Zevalin til? 
What is Zevalin used for?
Hvordan blev Zevalin undersøgt? 
How has Zevalin been studied?
De patienter, som fik Zevalin som konsoliderende behandling, overlevede længere uden at sygdommen forværredes end de patienter, som ingen supplerende behandling fik. 
When Zevalin was used as consolidation therapy, patients survived for longer without their disease getting worse than when they received no further treatment.
Hvilken fordel viser undersøgelserne, at der er ved Zevalin? 
What benefit has Zevalin shown during the studies?
Hvordan virker Zevalin? 
How does Zevalin work?
Hvordan anvendes Zevalin? 
How is Zevalin used?
Dette sammendrag blev senest ajourført i 04-2014. 
This summary was last updated in 04-2014.
Kapslerne skal synkes hele med vand. 
The capsules should be swallowed whole with water.
Det anvendes til behandling af voksne med følgende lidelser: 
It is used to treat adults with the following conditions:
Yderligere information findes i sammendraget af risikohåndteringsplanen. 
Further information can be found in the summary of the risk management plan.
Lægemidlet er identisk med Lyrica, som i forvejen er godkendt i EU. 
This medicine is the same as Lyrica, which is already authorised in the European Union (EU).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pregabalin Pfizer den 10. april 2014. 
The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Pfizer on 10 April 2014.
Patienter med nyresygdomme skal have lavere dosis. 
Patients who have kidney problems need to take lower doses.
Pregabalin Pfizer udleveres kun på recept og leveres som kapsler (25, 50, 75, 100, 150, 200, 225 og 300 mg). 
The medicine can only be obtained with a prescription and is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg).
indtil den mest effektive dosis er nået. 
Doses can be increased up to twice more until the most effective dose is reached.
Den fuldstændige EPAR og et sammendrag af risikohåndteringsplanen for Pregabalin Pfizer findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR and risk management plan summary for Pregabalin Pfizer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Eventuelt ophør af behandlingen med Pregabalin Pfizer bør ligeledes ske gradvis i løbet af mindst en uge. 
Stopping treatment with Pregabalin Pfizer should also be done gradually, over at least a week.
Derved nedsætter det aktiviteten i visse nerveceller i hjernen og rygmarven og mindsker på denne måde frigivelsen af andre neurotransmittere, som er en medvirkende årsag til smerter, epilepsi og angst. 
This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
Det samme var tilfældet hos ca. 10 % af dem, der fik placebo. 
This compared with about 10% of the patients taking placebo.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pregabalin Pfizer. 
This is a summary of the European public assessment report (EPAR) for Pregabalin Pfizer.
Det vides endnu ikke nøjagtigt, hvordan pregabalin virker, men det menes at påvirke den måde, hvorpå calcium strømmer ind i nerveceller. 
The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Den virksomhed, som fremstiller Lyrica, har indvilget i, at dens videnskabelige oplysninger må anvendes for Pregabalin Pfizer (informeret samtykke). 
The company that makes Lyrica has agreed that its scientific data can be used for Pregabalin Pfizer (‘informed consent').
Der er udarbejdet en risikostyringsplan for at sikre, at Pregabalin Pfizer anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Pregabalin Pfizer is used as safely as possible.
Pregabalin Pfizer er blevet sammenlignet med placebo (virkningsløs behandling) i 22 undersøgelser. 
Pregabalin Pfizer has been compared with placebo (a dummy treatment) in 22 studies.
• som tillægsbehandling ved epilepsi med partielle anfald (epileptiske anfald, der begynder i en bestemt del af hjernen), når anfaldene ikke kan kontrolleres med den nuværende behandling, 
• epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Det aktive stof i Pregabalin Pfizer, pregabalin, minder i struktur om kroppens eget signalstof GABA (neurotransmitteren gamma-aminosmørsyre), men dets biologiske virkninger er meget anderledes. 
The active substance in Pregabalin Pfizer, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Pregabalin Pfizer er et lægemiddel, der indeholder det aktive stof pregabalin. 
Pregabalin Pfizer is a medicine that contains the active substance pregabalin.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Pregabalin Pfizer, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Pfizer, including the appropriate precautions to be followed by healthcare professionals and patients.
CHMP konkluderede, at fordelene ved Pregabalin Pfizer overstiger risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Pregabalin Pfizer. 
The CHMP decided that Pregabalin Pfizer's benefits are greater than its risks and recommended that it be given marketing authorisation.
Ved neuropatiske smerter blev virkningen af Pregabalin Pfizer vurderet i op til 12 uger på et standardspørgeskema for smerter. 
In neuropathic pain, the benefits of Pregabalin Pfizer were evaluated for up to 12 weeks using a standard pain questionnaire.
De hyppigste bivirkninger ved Pregabalin Pfizer (som optræder hos mere end 1 ud af 10 patienter) er svimmelhed og søvnighed. 
The most common side effects with Pregabalin Pfizer (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pregabalin Pfizer? 
What measures are being taken to ensure the safe and effective use of Pregabalin Pfizer?
• smerter som følge af nervebeskadigelse (neuropatiske smerter) såsom ved sukkersyge eller helvedesild (herpes zoster) samt centrale neuropatiske smerter såsom ved rygmarvsskader, 
• neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Ved epilepsi blev virkningen af Pregabalin Pfizer vurderet i tre undersøgelser med 1 000 patienter, hvor det registreredes, hvor meget patienternes anfald aftog efter 11-12 ugers behandling. 
In epilepsy, the benefits of Pregabalin Pfizer were evaluated in 3 studies involving 1,000 patients that looked at how much it reduced the number of seizures patients had after 11 to 12 weeks.
Hvis du ønsker yderligere oplysninger om behandling med Pregabalin Pfizer, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Pregabalin Pfizer, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det er ikke en praktisk vejledning i, hvordan Pregabalin Pfizer bør anvendes. 
It is not intended to provide practical advice on how to use Pregabalin Pfizer.
Hvad er Pregabalin Pfizer, og hvad anvendes det til? 
What is Pregabalin Pfizer and what is it used for?
Andre oplysninger om Pregabalin Pfizer 
Other information about Pregabalin Pfizer
Den anbefalede startdosis af Pregabalin Pfizer er 150 mg dagligt fordelt på to eller tre doser. 
The recommended starting dose of Pregabalin Pfizer is 150 mg per day,
Hvis du ønsker praktisk vejledning om anvendelsen af Pregabalin Pfizer, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Pregabalin Pfizer, patients should read the package leaflet or contact their doctor or pharmacist.
Pregabalin Pfizer var mere effektivt end placebo mod generaliseret angst: I 8 undersøgelser med over 3 000 patienter fik 52 % af dem, der fik Pregabalin Pfizer, en bedring på mindst 50 % målt på et standardspørgeskema for angst, sammenholdt med 38 % af dem, der fik placebo. 
Pregabalin Pfizer was more effective than placebo in generalised anxiety disorder: in 8 studies involving over 3,000 patients, 52% of the patients taking Pregabalin Pfizer had an improvement of 50% or more in their anxiety measured with a standard anxiety questionnaire, compared with 38% of the patients taking placebo.
Hvilke risici er der forbundet med Pregabalin Pfizer? 
What are the risks associated with Pregabalin Pfizer?
Hvorfor er Pregabalin Pfizer blevet godkendt? 
Why is Pregabalin Pfizer approved?
Den fuldstændige liste over bivirkninger og begrænsninger med Pregabalin Pfizer fremgår af indlægssedlen. 
For the full list of all side effects and restrictions, see the package leaflet.
Antallet af anfald aftog med mindst 50 % hos ca. 45 % af de patienter, der fik Pregabalin Pfizer 600 mg dagligt, og ca. 35 % af dem, der fik Pregabalin Pfizer 300 mg dagligt. 
About 45% of the patients taking 600 mg Pregabalin Pfizer a day and about 35% of those taking 300 mg Pregabalin Pfizer a day had a reduction in seizures of 50% or more.
I 10 undersøgelser med over 3 000 patienter med perifere neuropatiske smerter (forårsaget enten af sukkersyge eller helvedesild) fik 35 % af dem, der blev behandlet med Pregabalin Pfizer, et fald i smertescore på mindst 50 %, sammenholdt med 18 % af dem, der blev behandlet med placebo. 
In 10 studies involving over 3,000 patients with peripheral neuropathic pain (either diabetic pain or shingles), 35% of the patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo.
I en mindre undersøgelse med 137 patienter med perifere neuropatiske smerter efter rygmarvsskader fik 22 % af de patienter, der blev behandlet med Pregabalin Pfizer, et fald i smertescore på mindst 50 %, sammenholdt med 8 % af dem, der blev behandlet med placebo. 
In a smaller study involving 137 patients with central neuropathic pain due to a spinal cord injury, 22% of patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.
Hvordan anvendes Pregabalin Pfizer? 
How is Pregabalin Pfizer used?
Hvordan virker Pregabalin Pfizer? 
How does Pregabalin Pfizer work?
Hvilke fordele viser undersøgelserne, at der er ved Pregabalin Pfizer? 
What benefits of Pregabalin Pfizer have been shown in studies?
• en metaanalyse af tre WHO-undersøgelser3,4,5, der hovedsagelig omfattede afrikanske og asiatiske kvinder. 
• a meta-analysis of three WHO studies3,4,5, which primarily included African and Asian women.
Information til kvinden 
Information for women
EllaOne udleveres kun efter recept. 
EllaOne can only be obtained with a prescription.
Den 30. september 2014 EMA/631408/2014 
30 September 2014 EMA/631408/2014
Yderligere oplysninger om disse undersøgelser findes i CHMP's vurderingsrapport for ellaOne: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/001027/WC500023673.pdf 
For more information on these studies, see the CHMP assessment report for ellaOne: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/001027/WC500023673.pdf
Gennemgangen af fortrydelsesspiller med levonorgestrel og ulipristalacetat blev indledt i januar 2014 på anmodning af Sverige i medfør af artikel 31 i direktiv 2001/83/EF. 
The review of emergency contraceptives containing levonorgestrel and ulipristal acetate was initiated in January 2014 at the request of Sweden, under Article 31 of Directive 2001/83/EC.
• Kvinder, der ønsker yderligere oplysninger, bør kontakte lægen eller apotekspersonalet. 
• Women who have any questions or concerns should speak to their doctor or pharmacist.
Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse. 
The review was conducted by the Committee for Medicinal Products for Human Use (CHMP), the Committee responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Fortrydelsespillerne omfattet af denne gennemgang er lægemidler med levonorgestrel, såsom Norlevo, Levonelle/Postinor og Levodonna, der er godkendt i EU ved nationale procedurer. 
The emergency contraceptives included in this review are medicines containing levonorgestrel, such as Norlevo, Levonelle/Postinor and Levodonna, which have been authorised in the EU through national procedures.
Gennemgangen omfattede desuden et centralt godkendt lægemiddel, ellaOne, der indeholder ulipristalacetat og blev godkendt i EU i 2009. 
The review also included a centrally-authorised medicine, ellaOne, which contains ulipristal acetate and was granted a marketing authorisation in the EU in 2009.
Ingen af de to metaanalyser omfattede ikkegodkendt brug (dvs. indtagelse mere end 72 timer efter ubeskyttet samleje). 
Both meta-analyses did not include off-label use (i.e. intake later than 72 hours after unprotected sexual intercourse).
CHMP's anbefaling blev overgivet til Europa-Kommissionen, som den 30. september 2014 traf en retligt bindende afgørelse med gyldighed i hele EU. 
The CHMP recommendation was sent to the European Commission, which issued a legally binding decision valid throughout the EU on 30 September 2014.
CHMP's udtalelse blev overgivet til Europa-Kommissionen, som den 30. september 2014 vedtog en endelig, retligt bindende afgørelse. 
The CHMP opinion was then forwarded to the European Commission, which issued a final legally binding decision on 30 September 2014.
• Der er foretaget en EU-dækkende gennemgang for at vurdere, om fortrydelsespiller er mindre effektive hos overvægtige kvinder. 
• An EU-wide review was carried out to assess whether emergency contraceptives are less effective in overweight or obese women.
For produkter med levonorgestrel har nogle kliniske undersøgelser tydet på nedsat effektivitet hos kvinder med høj legemsvægt, mens der i andre ikke er set tendens til nedsat virkning med stigende legemsvægt. 
For levonorgestrel-containing products, some clinical studies have suggested a reduced effectiveness in women with high bodyweight, but in others no trend for a reduced effect with increasing bodyweight was observed.
CHMP anbefalede, at resultaterne af disse undersøgelser indsættes i produktinformationen for fortrydelsespiller, men at omtalen af indvirkningen af legemsvægt slettes fra produktinformationen for Norlevo. 
The CHMP recommended that the results of these studies should be included in the product information of emergency contraceptives, but that the statements on the impact of bodyweight in the product information for Norlevo should be deleted.
Piller med levonorgestrel kan anvendes op til 72 timer efter ubeskyttet samleje eller svigt af prævention, mens ulipristalacetat kan anvendes i op til 120 timer. 
Those containing levonorgestrel can be used up to 72 hours after unprotected sexual intercourse or contraceptive failure, while ulipristal acetate can be used up to 120 hours.
For postcoitale kontraceptiva indeholdende levonorgestrel tog agenturet følgende data i betragtning: 
For emergency contraceptives containing levonorgestrel, the Agency considered the following data:
For at få størst mulig sikkerhed for, at pillerne virker, er det dog vigtigt at tage dem snarest efter ubeskyttet samleje. 
However, in order to maximise the likelihood that they will work, it is important that they are taken as soon as possible after unprotected intercourse.
Fortrydelsespiller virker ved at standse eller forsinke ægløsningen. 
Emergency contraceptives work by stopping or delaying ovulation.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) anbefalede, at de pågældende fortrydelsespiller fortsat skal kunne anvendes af kvinder uanset legemsvægt, da fordelene fandtes at opveje risiciene. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that these emergency contraceptives could continue to be used in women of all weights as the benefits were considered to outweigh the risks.
• Sundhedspersoner bør fortsat minde kvinden om, at postcoital kontraception er en nødforanstaltning til lejlighedsvis brug og ikke en erstatning for regelmæssig brug af kontraceptiva. 
• Healthcare professionals should continue to remind women that emergency contraception is an occasional ‘rescue' method and should not replace a regular contraceptive method.
Kvinden bør mindes om, at fortrydelsespiller bør tages snarest muligt efter ubeskyttet samleje. 
Women should be reminded that emergency contraceptives should be taken as soon as possible following unprotected sexual intercourse.
For ulipristalacetat gennemgik agenturet følgende data: 
For ulipristal acetate, the Agency considered the following data:
De bør kun bruges lejlighedsvis som nødforanstaltning, da de ikke virker lige så godt som sædvanlig prævention. 
They should only be used as an occasional ‘rescue' method as they do not work as well as regular contraceptive methods.
Tilsvarende gælder det for ulipristalacetat, at kliniske undersøgelser tyder på tendens til nedsat svangerskabsforebyggende virkning, men at oplysningerne er for begrænsede og ikke tilstrækkelig nøjagtige til at drage præcise konklusioner. 
Similarly, for ulipristal acetate, although limited data from clinical trials suggest a possible trend for a reduced contraceptive effect, the data are too limited and insufficiently precise to draw definite conclusions.
Efter vurdering af al tilgængelig dokumentation om effektiviteten af fortrydelsespiller fandt CHMP, at de foreliggende oplysninger er for begrænsede og ikke fyldestgørende til med sikkerhed at afgøre, at den præventive virkning nedsættes ved øget legemsvægt som nævnt i produktinformationen for Norlevo. 
Having assessed all the available evidence on the effectiveness of emergency contraceptives, the CHMP considered that the data available are too limited and not robust enough to conclude with certainty that contraceptive effect is reduced with increased bodyweight, as stated in the product information for Norlevo.
CHMP fandt, at fortrydelsespiller med deres sædvanligvis lette bivirkninger har en gunstig sikkerhedsprofil og fortsat kan anvendes uanset kvindens legemsvægt. 
The CHMP considered that, with side effects generally mild, the safety profile of emergency contraceptives is favourable and they can continue to be taken regardless of the woman's bodyweight.
De foreliggende data er begrænsede og ikke fyldestgørende til at bekræfte den tidligere konklusion om nedsat kontraceptiv effekt med stigende legemsvægt/BMI. 
The available data are limited and not robust enough to support with certainty the previous conclusion of decreased contraceptive effect with increased bodyweight/BMI.
• Kvinder mindes om, at fortrydelsespiller er en nødforanstaltning til lejlighedsvis brug og ikke virker lige så godt som almindelig prævention, såsom p-piller. 
• Women are reminded that emergency contraception is an occasional ‘rescue' method, which does not work as well as regular methods of contraception, such as the pill.
Fortrydelsespiller med levonorgestrel fås i håndkøb i flere europæiske lande. 
Levonorgestrel-containing emergency contraceptives are available 'over the counter' in several European countries.
Det blev herunder anført, at Norlevo er mindre effektivt hos kvinder, der vejer 75 kg og derover, og at det ikke er effektivt hos kvinder, der vejer over 80 kg. Der blev derefter indledt en EU-gennemgang med henblik på at vurdere, om tilsvarende oplysninger burde stå i produktinformationen for andre fortrydelsespiller med levonorgestrel og for ellaOne, som er fortrydelsespiller med ulipristalacetat. 
In November 2013, following a national procedure, the product information of one emergency contraceptive containing levonorgestrel, Norlevo, was updated on the basis of results from two clinical studies to state that Norlevo is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg. An EU-wide review was then started to assess whether similar information should be included in the product information for other emergency contraceptives that contain levonorgestrel, and for ellaOne, an emergency contraceptive that contains ulipristal acetate.
• Postcoital kontraception kan fortsat anvendes til at undgå utilsigtet graviditet uanset kvindens vægt og legemsmasseindeks (BMI). 
• Emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index (BMI).
Resultaterne af analysen er i modstrid med ovenstående resultater og viser ingen tendens til nedsat virkning med stigende legemsvægt/BMI (graviditetsraten var 0,99 % (SI: [0,70; 1,35] hos kvinder med BMI 18,5-25, 0,57 % (SI: [0,21; 1,24]) hos kvinder med BMI 25-30 og 1,17 % (SI: [0,24; 3,39]) hos kvinder med BMI ≥30). 
The results of this analysis conflict with the results above and show no trend for a reduced efficacy with increasing bodyweight/BMI (pregnancy rate was 0.99% [CI: 0.70-1.35] in women with BMI 18.525; 0.57% [CI: 0.21-1.24] in women with BMI 25-30; and 1.17% [CI: 0.24-3.39] in women with BMI ≥30).
Gennemgangen mundede ud i, at de begrænsede foreliggende oplysninger ikke giver sikkerhed for den tidligere konklusion om, at den svangerskabsforebyggende virkning er mindre hos kvinder med høj legemsvægt. 
It concluded that the limited data available do not support with certainty the previous conclusion that their contraceptive effect is reduced in women with high bodyweight.
• Fortrydelsespiller kan fortsat anvendes efter ubeskyttet samleje eller svigt af prævention uanset kvindens legemsvægt. 
• Emergency contraceptives can continue to be taken after unprotected intercourse or contraceptive failure, regardless of the woman's bodyweight.
• en metaanalyse af to publicerede undersøgelser1,2, hovedsagelig med kaukasiske kvinder, hvor der fandtes nedsat antikonceptiv virkning med stigende legemsvægt eller BMI (graviditetsraten var 0,96 % (SI: [0,44; 1,82]) hos kvinder med BMI 18,5-25, 2,36 % (SI: [1,02; 4,60]) hos kvinder med BMI 25-30 og 5,19 % (SI: [2,62; 9,09]) hos kvinder med BMI ≥30) 
• a meta-analysis of two published studies1,2, which primarily included Caucasian women, where a reduced contraceptive efficacy was observed with increased bodyweight or BMI (pregnancy rate was 0.96% [CI: 0.44-1.82] in women with BMI 18.5-25; 2.36% [CI: 1.02-4.60] in women with BMI 25-30; and 5.19% [CI: 2.62-9.09] in women with BMI ≥30).
Fortrydelsespiller er svangerskabsforebyggende medicin, der anvendes til at undgå uønsket graviditet efter ubeskyttet samleje eller svigt af prævention. 
Emergency contraceptives are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.