natgillin/translations-raw huggingface dataset:
CHMP anbefalede, at kvinder, der bruger leverenzym-fremmere, i stedet bør anvende et ikke-hormonelt præventionsmiddel (f.eks. et kobberindlæg), som ikke påvirkes af leverenzymfremmende medicin. 
The CHMP recommended that women who use liver enzyme inducers should instead use a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) which is not affected by liver enzyme inducing medicines.
Der efterspurgtes feedback fra kvinder i målgruppen og fra relevante sundhedspersoner for at sikre, at kvinderne forstår ud fra de anførte oplysninger, hvornår de skal tage en dobbelt dosis i stedet for en enkelt dosis. 
Feedback was sought from patients and relevant healthcare professionals to ensure that women could identify when to use a double dose versus a single dose based on the information provided.
CHMP bemærkede, at de reduktioner i koncentrationen af levonorgestrel i blodet, der er observeret ved samtidig administration af efavirenz, svarer til dem, der ses med andre lægemidler (såkaldte leverenzym-fremmere), som interagerer med levonorgestrel (herunder visse lægemidler mod tuberkulose og epilepsi samt naturlægemidler indeholdende prikbladet perikon). 
The CHMP noted that the reductions in blood levels of levonorgestrel seen with efavirenz were similar to those seen with other medicines (so-called liver enzyme inducers) that interact with levonorgestrel (including certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort).
EMA's Udvalg for Lægemidler til Mennesker (CHMP) har anbefalet, at dosen af Levonelle fordobles, når lægemidlet tages sammen med visse interagerende lægemidler (herunder hiv-medicinen efavirenz og ritonavir, visse lægemidler mod tuberkulose og epilepsi samt naturlægemidler indeholdende prikbladet perikon). 
The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that when Levonelle is taken together with certain interacting medicines (including the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort) the dose of Levonelle should be doubled.
Ansøgningen var baseret på en undersøgelse, der viste, at koncentrationen af levonorgestrel i blodet blev reduceret med ca. 50 % hos kvinder, som tog efavirenz, et middel, der øger aktiviteten af et bestemt leverenzym (CYP3A4), som er involveret i nedbrydningen af levonorgestrel. 
around 50% in women taking efavirenz, which is known to increase the activity of a particular liver enzyme (CYP3A4) which is involved in the breakdown of levonorgestrel.
For at sikre korrekt brug af Levonelle anbefalede CHMP også, at det af yderpakningen og indlægssedlen fremgår, hvornår man skal tage en dobbelt dosis. 
In order to ensure the correct use of Levonelle, the CHMP also recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
For at sikre korrekt brug af Levonelle anbefalede CHMP, at det af yderpakningen og indlægssedlen fremgår, hvornår man skal tage en dobbelt dosis. 
In order to ensure the correct use of Levonelle, the CHMP recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
Det var hensigten, at det skulle leveres som kapsler. 
It was to be available as capsules.
Den virksomhed, der har indgivet ansøgningen, er Teva Pharma GmbH. 
The company that applied for authorisation is Teva Pharma GmbH.
Den 23. maj 2014 EMA/405477/2014 EMEA/H/C/002546 
EMA/311892/2014 EMEA/H/C/002546
Hvad er Nerventra? 
What is Nerventra?
Nerventra er et lægemiddel, der indeholder det aktive stof laquinimod. 
Nerventra is a medicine that contains the active substance laquinimod.
CHMP's udtalelse har ingen konsekvenser for disse undersøgelser. 
The CHMP opinion has no consequences on these trials.
Hvis du deltager i en klinisk undersøgelse med Nerventra og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen. 
If you are taking part in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Virkningerne af Nerventra blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of Nerventra were first tested in experimental models before being studied in humans.
Desuden var udvalget ikke overbevist om effektiviteten af de foranstaltninger, virksomheden påtænkte for at undgå graviditet hos kvinder, der tager lægemidlet. 
In addition, the Committee was not convinced about the effectiveness of the company's proposed measures to prevent pregnancies in women who would take the medicine.
Afslag på ansøgningen om markedsføringstilladelse for Nerventra (laquinimod) 
Refusal of the marketing authorisation for Nerventra (laquinimod)
Der var desuden en mulig risiko (igen ud fra dyreundersøgelserne) for påvirkning af det ufødte barn, når lægemidlet bruges af gravide kvinder. 
There was also a possible risk (again from animal studies) of effects on the unborn baby when the medicine is taken by pregnant women.
Det vides ikke nøjagtigt, hvordan Nerventra virker, men det menes at have modulerende virkning på kroppens naturlige forsvar (immunsystemet). 
The exact way Nerventra works is not known, but it is believed to have a modulator effect on the immune system (the body's defences).
Den 23. januar 2014 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Nerventra til behandling af multipel sklerose. 
On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis.
Hvad forventedes Nerventra anvendt til? 
What was Nerventra expected to be used for?
Hvordan forventes Nerventra at virke? 
How is Nerventra expected to work?
Under den fornyede overvejelse tog CHMP hensyn til rådgivningen fra en ekspertgruppe i nervesygdomme. 
During the re-examination, the CHMP considered advice from an expert group in neurology.
Virksomheden har til CHMP oplyst, at der på nuværende tidspunkt er en række igangværende og planlagte kliniske undersøgelser med Nerventra hos patienter med multipel sklerose. 
The company informed the CHMP that there are a number of ongoing and planned clinical trials with Nerventra in patients with multiple sclerosis.
CHMP bemærkede, at denne risiko ikke kunne udelukkes ud fra de foreliggende oplysninger, og at dyreundersøgelserne tyder på, at nogle af de skadelige virkninger optræder forsinket og først opdages senere i barnets liv. 
The CHMP noted that the risk could not be excluded with current data and that animal studies suggest that some of the harmful effects may be delayed and only seen later on in the child's life.
Ekspertgruppen udtalte, at risiciene i dyreundersøgelserne kunne have været accepteret, hvis de kliniske undersøgelser havde vist en klar fordel, men at det ville have krævet streng forebyggelse af graviditet. 
The expert group advised that the risks seen in animal studies could have been acceptable if a clear benefit was seen in clinical studies, although a strict pregnancy prevention scheme would have been required.
Afslag på ansøgningen om markedsføringstilladelse for Nerventra (laquinimod) EMA/405477/2014 
Refusal of the marketing authorisation for Nerventra (laquinimod) EMA/311892/2014
Nerventra forventedes anvendt til behandling af voksne med multipel sklerose, en sygdom, hvor immunsystemet fungerer dårligt og medfører inflammation, der ødelægger den beskyttende skede omkring nerverne i hjernen og rygmarven. 
Nerventra was expected to be used to treat multiple sclerosis (MS), a disease in which the immune system malfunctions, causing inflammation that destroys the protective sheath around the nerves in the brain and spinal cord.
CHMP gennemgik begrundelsen for anmodningen og foretog en fornyet overvejelse af den oprindelige udtalelse, men bekræftede den 22. maj 2014 afslaget på ansøgningen om markedsføringstilladelse. 
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Nerventra skulle anvendes ved den form af sygdommen, hvor der er gentagne tilbagefald af symptomerne (recidiv) efterfulgt af perioder med bedring (remission). 
Nerventra was to be used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Ved at modulere immunsystemet forventes det at begrænse inflammation og beskadigelse af nerverne og derved mindske symptomer og forværring af invaliditet hos patienter med multipel sklerose. 
control the inflammation and the damage to nerves, thus helping to reduce symptoms and the worsening of disability in patients with MS.
Den anden omfattede 1 331 patienter og sammenlignede Nerventra med placebo og et andet lægemiddel mod multipel sklerose, interferon-beta 1a. 
The company also provided results of two main studies in patients with relapsing-remitting MS. One of the studies involving 1,106 patients compared Nerventra with placebo (a dummy treatment), while the second study in 1,331 patients compared Nerventra with placebo and another medicine used to treat MS, interferon-beta 1a.
Virkningen blev hovedsagelig bedømt på faldet i antallet af tilbagefald pr. patient pr. år (den årlige tilbagefaldsrate). 
Both studies lasted two years and the main measure of effectiveness was based on the reduction in the number of relapses per patient per year (what is known as the ‘annualised relapse rate').
Udvalget konkluderede derfor, at fordelene ved Nerventra ved den undersøgte dosis ikke var tilstrækkelige til at opveje de mulige risici for patienter med recidiverende/remitterende multipel sklerose. 
Therefore the Committee concluded that the benefits of Nerventra at the dose studied were not sufficient to outweigh the potential risks in patients with relapsing remitting MS and maintained its recommendation that the medicine be refused marketing authorisation.
På tidspunktet for den oprindelige anbefaling var der i CHMP betænkelighed ved resultaterne af dyreundersøgelserne, der viste højere forekomst af kræft efter lang tids udsættelse for lægemidlet. 
At the time of the initial recommendation, the CHMP had concerns about results from animal studies showing a higher occurrence of cancers after long-term exposure to the medicine and noted that a similar long-term cancer risk could not be excluded in humans, especially when considering that the way the medicine works in the body is unclear.
Selv om det havde nogen virkning ved at bremse udviklingen af invaliditet, manglede der stadig bekræftelse heraf. 
The CHMP noted that the effect of the medicine in preventing relapses was modest, and though its effect in slowing the worsening of disability was encouraging it still needed to be confirmed.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv 
What measures are being taken to ensure the safe and effective use of
Hvad er Fexeric, og hvad anvendes det til? 
What is Fexeric and what is it used for?
Den maksimale dosis er 12 tabletter dagligt. 
The maximum dose is 12 tablets per day.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Fexeric 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 Fexeric can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om Fexeric 
Other information about Fexeric
Alvorlige bivirkninger var ikke almindelige og berørte hovedsagelig tarm og mave. 
Serious side effects were uncommon and mainly affected the gut and stomach.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fexeric. 
This is a summary of the European public assessment report (EPAR) for Fexeric.
Den overordnede sikkerhedsprofil blev anset for acceptabel og sammenlignelig med profilen af andre fosfatbindere. 
The overall safety profile was considered acceptable and comparable to other phosphate binders.
Der er udarbejdet en risikostyringsplan for at sikre, at Fexeric anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Fexeric is used as safely as possible.
Fexeric leveres som 1 g tabletter. 
Fexeric is available as 1 g tablets.
I den anden undersøgelse fik 149 patienter, som ikke var i dialyse, enten Fexeric eller placebo i 3 måneder. 
In the second study, 149 patients who were not on dialysis received either Fexeric or placebo for 3 months.
Hvilke risici er der forbundet med Fexeric? 
What are the risks associated with Fexeric?
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Fexeric opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Fexeric's benefits are greater than its risks and recommended that it be approved for use in the EU.
Den anbefalede startdosis er 3-6 tabletter dagligt, der tages i flere doser sammen med måltiderne. 
The recommended starting dose is 3 to 6 tablets per day, taken in divided doses together with meals.
Blodets indhold af fosfat bør overvåges regelmæssigt under behandlingen. 
Blood-phosphate levels should be monitored regularly during treatment.
De hyppigste bivirkninger ved Fexeric (som kan forekomme hos over 1 ud af 10 personer) er ændringer i afføringen (diarré eller forstoppelse) og misfarvet afføring. 
The most common side effects with Fexeric (which may affect more than 1 in 10 people) are changes in bowel movements (diarrhoea or constipation) and discoloured faeces.
Den virksomhed, der markedsfører Fexeric, skal desuden udføre en undersøgelse der skal give flere oplysninger om den langsigtede sikkerhed af Fexeric, navnlig hos ældre. 
In addition, the company that markets Fexeric will carry out a study to gain further information on the long-term safety of Fexeric, particularly in older patients.
Derved undgås, at fosfatet optages i kroppen, hvilket medvirker til at holdes fosfatindholdet i blodet nede. 
This prevents the phosphate from being absorbed into the body and helps to keep down the phosphate levels in the blood.
Det er ikke en praktisk vejledning i, hvordan Fexeric bør anvendes. 
It is not intended to provide practical advice on how to use Fexeric.
Patienter med svær nyresygdom har vanskeligt ved at udskille fosfat. 
Patients with severe kidney disease have difficulty eliminating phosphate from their bodies.
I den første undersøgelse var Fexeric lige så effektivt som det godkendte lægemiddel sevelamercarbonat til at sænke fosfatindholdet hos 359 patienter med langvarig nyresygdom: Efter 12 uger resulterede begge behandlinger i en nedsættelse af fosfatindholdet på ca. 2 mg/dl. 
In the first study, Fexeric was as effective as sevelamer carbonate, an approved medicine, in lowering phosphate levels in 359 patients with long-term kidney disease: after 12 weeks both treatments resulted in a reduction in phosphate levels of around 2 mg/dl.
Når det tages sammen med et måltid, bindes jernindholdet i Fexeric til fosfatet fra føden i tarmen og danner en forbindelse, der derefter udskilles i afføringen. 
When taken with meals, the iron contained in Fexeric binds to phosphate from food in the gut, forming a compound that is then eliminated in the stools.
I begge undersøgelser blev ændringen i blodets fosfatindhold målt i enheden mg/dl. 
Both studies looked at the change in the amount of phosphate in the blood, measured in mg/dl.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Fexeric, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fexeric, including the appropriate precautions to be followed by healthcare
Hvis du ønsker yderligere oplysninger om behandling med Fexeric, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Fexeric, read the package leaflet (also part of the EPAR) or contact
Fexeric må ikke anvendes ved lavt fosfatindhold i blodet, ved alvorlige problemer med maven og tarmen (såsom blødning fra tarmen) eller ved sygdomme, hvor jern ophobes, såsom hæmokromatose. 
Fexeric must not be used in patients with low blood-phosphate levels, patients who have severe problems with the stomach and gut (such as bleeding from the gut), and those with iron accumulation disorders such as haemochromatosis.
I undersøgelsen faldt blodets indhold af fosfat gennemsnitligt med 0,7 mg/dl med Fexeric, 
The study showed that blood-phosphate levels fell on average by 0.7 mg/dl with Fexeric compared with 0.3 mg/dl with placebo.
Det aktive stof i Fexeric er et koordinationskompleks af ferricitrat, som er en fosfatbinder. 
The active substance in Fexeric, ferric citrate coordination complex, is a phosphate binder.
Hvilke fordele viser undersøgelserne, at der er ved Fexeric? 
What benefits of Fexeric have been shown in studies?
Fexeric blev påvist at være effektivt til at kontrollere blodets indhold af fosfat i to hovedundersøgelser hos patienter med langvarig nyresygdom og hyperfosfatæmi. 
Fexeric was shown to be effective at controlling blood-phosphate levels in 2 main studies in patients with long-term kidney disease and hyperphosphataemia.
CHMP fandt, at Fexeric er effektivt til at kontrollere blodets indhold af fosfat hos patienter med langvarig nyresygdom, hvad enten de er i dialyse eller ej. 
The CHMP considered that Fexeric is effective at controlling blood-phosphate levels in patients with long-term kidney disease, whether they are on dialysis or not.
Fexeric er et lægemiddel, der anvendes til at kontrollere for højt fosfatindhold i blodet (hyperfosfatæmi) hos voksne med langvarig nyresygdom. 
Fexeric is a medicine used to control hyperphosphataemia (high levels of phosphate in the blood) in adults with long-term kidney disease.
Ophobning af fosfat medfører for højt fosfatindhold i blodet (hyperfosfatæmi), hvilket i det lange løb kan give komplikationer i form af 
A build-up of phosphate leads to hyperphosphataemia and in the long-term can cause complications such as heart
Det indeholder det aktive stof jerncitrat (ferricitrat) som koordinationskompleks. 
It contains the active substance ferric citrate coordination
Hvis du ønsker praktisk vejledning om anvendelsen af Fexeric, kan du læse indlægssedlen eller 
For practical information about using Fexeric, patients should read the package leaflet or contact their
Patienten bør overholde den fosfatfattige kost, der er 
Patients should keep to their prescribed low
Den fuldstændige liste over indberettede bivirkninger ved Fexeric fremgår af indlægssedlen. 
For the full list of all side effects reported with
Hvad er Sliwens? 
What is Sliwens?
20. januar 2009 EMA/139264/2010 EMEA/H/C/1102 
EMA/23705/2010 EMEA/H/C/1102
Virkningerne af Sliwens blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of Sliwens were first tested in experimental models before being studied in humans.
Det skulle have været leveret som tabletter. 
It was to be available as tablets.
Hvad forventedes Sliwens anvendt til? 
What was Sliwens expected to be used for?
De vigtigste mål for virkningen var baseret på, hvor lang tid patienterne lå vågne, efter at de først var faldet i søvn, samt forbedringer af søvnkvaliteten i løbet af de første fire til 12 uger af behandlingen. 
The main measures of effectiveness were based on the amount of time the patients spent awake after they had first fallen asleep and improvements in the quality of sleep over the first four to 12 weeks of treatment.
Sliwens er et lægemiddel, der indeholder det aktive stof eplivanserin. 
Sliwens is a medicine that contains the active substance eplivanserin.
Virksomheden fremlagde resultater af fire hovedundersøgelser med deltagelse af over 3 000 voksne med søvnproblemer. 
The company presented results of four main studies involving over 3,000 adults who had difficulty staying asleep.
Det skulle anvendes til patienter, som har besvær med at sove igennem. 
It was to be used in patients who have difficulty staying asleep.
Der manglede også oplysninger om effekten af langvarig brug af Sliwens sammenlignet med placebo. 
There was also a lack of information comparing the long-term use of Sliwens with placebo.
Det aktive stof i Sliwens, eplivanserin, er en 5-hydroxytryptamin-receptorantagonist. 
The active substance in Sliwens, eplivanserin, is a 5-hydroxytryptamine receptor antagonist.
I undersøgelserne blev Sliwens sammenlignet med placebo (en virkningsløs behandling). 
The studies compared Sliwens with placebo (a dummy treatment).
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Sliwens (eplivanserin) 
Withdrawal of marketing authorisation application for Sliwens (eplivanserin)
Udvalget havde også betænkeligheder med hensyn til risikoen for diverticulitis (betændelse i små lommer i tarmene) hos patienter, der får medicinen. 
The Committee was also concerned about the risk of diverticulitis (inflammation in little sacs or pouches in the intestines) in patients taking the medicine.
Den 18. december 2009 meddelte Sanofi-Aventis officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om markedsføringstilladelse for Sliwens til behandling af voksne med kronisk (langvarig) insomni, som har besvær med at sove igennem. 
On 18 December 2009, Sanofi-Aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sliwens, for use in adults with chronic (long-term) insomnia who have difficulty staying asleep.
CHMP fandt, at Sliwens' effekt på søvn var lille. 
The CHMP considered the effect of Sliwens on sleep to be small.
Det blokerer receptorer i hjernen kaldet 5-hydroxytryptamin type 2-receptorer, som medvirker ved reguleringen af de perioder i døgnet, hvor man er vågen eller sover. 
It blocks receptors in the brain called 5-hydroxytryptamine type 2 receptors, which are involved in regulating the daily cycle of being asleep and being awake.
I den femte undersøgelse med deltagelse af 283 voksne blev Sliwens sammenlignet med lormetazepam (et andet lægemiddel til behandling af insomni), og man så på, hvor søvnige patienterne var om morgenen efter at have taget Sliwens. 
study involving 283 adults compared Sliwens with lormetazepam (another medicine used to treat insomnia) looked at how sleepy the patients were the morning after taking Sliwens.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Sliwens ikke kunne have været godkendt. 
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Sliwens could not have been approved.
Virksomheden har informeret CHMP om, at der ikke er nogen konsekvenser for patienter, som deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse, eftersom alle igangværende kliniske undersøgelser er blevet afbrudt. 
The company informed the CHMP that there were no consequences for patients in clinical trials or compassionate use, since all ongoing clinical trials have been discontinued.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Sliwens (eplivanserin) EMA/139264/2010 
Withdrawal of marketing authorisation application for Sliwens (eplivanserin) EMA/23705/2010