natgillin/translations-raw huggingface dataset:
Der forventes ingen øget risiko for bivirkninger som følge af den højere dosis.
No increased risk of side effects is expected from the higher dose.
Hvorfor blev Levonelle vurderet igen?
Why was Levonelle reviewed?
Frankrig, Tyskland, Grækenland, Irland, Italien, Letland, Luxembourg, Nederlandene, Norge, Polen, Portugal, Spanien og Sverige.
The company wanted this change to be recognised in Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain and Sweden.
Den 1. oktober 2015 indbragte Storbritannien sagen for CHMP med henblik på voldgift.
On 1 October 2015, the UK referred the matter to the CHMP for arbitration.
Det kan betyde, at Levonelles svangerskabsforebyggende virkning er reduceret.
This could mean that the contraceptive effects of Levonelle are reduced.
Europa-Kommissionen traf en juridisk bindende afgørelse om at gennemføre CHMP's anbefalinger vedrørende Levonelle med gyldighed i hele EU 01/08/2016.
The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Levonelle on 01/08/2016.
Selvom gennemgangen ikke vedrørte Levonelle 750 mikrogram-tabletterne, anbefalede CHMP, at lignende ændringer overvejes for disse lægemidler.
Although the review did not cover the 750 microgram Levonelle tablets, the CHMP recommended that similar changes should be considered for these medicines.
Denne gennemgang omfattede kun tabletter med 1 500 mikrogram.
This review only covered the 1500 microgram tablets.
Det fås som én tablet med 1 500 mikrogram levonorgestrel eller som to tabletter med hver 750 mikrogram levonorgestrel.
It is available as a single tablet containing 1500 microgram levonorgestrel or as two tablets each containing 750 microgram levonorgestrel.
Det Europæiske Lægemiddelagentur (EMA) afsluttede den 26. maj 2016 en gennemgang af nødpræventionsmidlet Levonelle (levonorgestrel, 1 500 mikrogram-tabletter) og relaterede navne.
On 26 May 2016, the European Medicines Agency completed a review for the emergency contraceptive Levonelle (levonorgestrel, 1500 microgram tablets) and associated names.
Levonelle indeholder levonorgestrel, der hovedsageligt virker ved at forhindre eller forsinke ægløsning.
Levonelle contains levonorgestrel, which works mainly by preventing or delaying ovulation.
På grundlag af data vedrørende interaktioner med disse lægemidler, der alle øger aktiviteten af leverenzymet CYP3A4, samt data for kombinerede hormonelle præventionsmidler, konkluderede CHMP, at interaktionerne mellem disse lægemidler og Levonelle kan forhindre Levonelle i at virke effektivt og føre til præventionssvigt.
Based on data on interactions with these medicines, which all increase the activity of the liver enzyme CYP3A4, as well as data on combined hormonal contraceptives, the CHMP concluded that interactions between these medicines and Levonelle may prevent Levonelle from working effectively and could lead to contraceptive failure.
Levonelle er et nødpræventionsmiddel, der bruges til at forebygge uønsket graviditet, og det skal tages inden for 72 timer (3 døgn) efter ubeskyttet samleje eller præventionssvigt.
Levonelle is an emergency contraceptive used to prevent unintended pregnancy when taken within 72 hours (3 days) of unprotected intercourse or failure of a contraceptive method.
Den 17. september 2014 ansøgte virksomheden, der markedsfører Levonelle, om en ændring af markedsføringstilladelsen, så den omfatter hiv-medicinen efavirenz som et interagerende lægemiddel i produktinformationen.
On 17 September 2014, the company for Levonelle applied for a change to the marketing authorisation to include the HIV medicine efavirenz as an interacting medicine in the product information.
Når dette ikke er muligt, mener CHMP dog, at en fordobling af dosen fra 1 500 mikrogram til 3 000 mikrogram bør anbefales for at kompensere for reduktionen af levonorgestrel-koncentrationen i blodet.
However, when this is not an option, the CHMP considered that doubling the dose of Levonelle from 1500 to 3000 microgram is recommended to compensate for the reduction in blood levonorgestrel levels.
Selvom medlemsstaterne var enige om, at efavirenz interagerer med levonorgestrel, og at denne oplysning bør fremgå af produktinformationen, kunne de ikke blive enige om, hvordan denne interaktion bør håndteres, og om det er nødvendigt med specifikke anbefalinger, f.eks. justering af dosen, for kvinder, der tager Levonelle samtidigt med efavirenz eller andre lægemidler, der også reducerer koncentrationen af levonorgestrel.
Although the Member States agreed that efavirenz interacts with levonorgestrel and that this information should be included in the product information, the Member States were unable to reach an agreement on how this interaction should be managed and whether specific recommendations such as dose adjustment were required for women taking Levonelle while on efavirenz or other medicines which also reduce levonorgestrel levels.
Levonelle bør imidlertid kun bruges sammen med disse lægemidler, når et ikke-hormonelt nødpræventionsmiddel (f.eks. et kobberindlæg) ikke er en mulighed.
However, Levonelle should only be used with these medicines when a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) is not an option.
Det er virksomheden Gedeon Richter Plc., der markedsfører disse lægemidler.
The company that markets these medicines is Gedeon Richter Plc.
Begrundelserne for indbringelsen er betænkeligheder fra Italien, der mener, at der er utilstrækkelige kliniske data til at understøtte en fordobling af Levonelle-dosen i de tilfælde, hvor kvinden samtidig tager et lægemiddel, der interagerer med Levonelle.
The grounds for the referral were concerns from Italy that there are insufficient clinical data to support doubling the dose of Levonelle in cases where the woman is also taking a medicine that interacts with Levonelle.
Der var også betænkeligheder ved følgende: Da Levonelle fås i håndkøb i mange EU-medlemsstater, vil udstedelsen af en ny vejledning ikke nødvendigvis forhindre medicineringsfejl, da kvinderne ikke altid rådfører sig med en sundhedsperson, inden de tager medicinen.
In addition there were concerns that, since Levonelle is available without prescription in many EU Member States, any new advice issued could lead to medication errors as there may not always be a consultation with a healthcare professional prior to taking the medicine.
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.