natgillin/translations-raw huggingface dataset:
Samarbejde om stoffer af menneskelig oprindelse
Cooperation on substances of human origin (SoHO)
Revisionsretten
Court of Auditors
[EMA/MB/751837/2010] Bestyrelsen godkendte timeprisen for 2011 på 40 euro (samme sats som i 2009 og 2010).
[EMA/MB/751837/2010] The Management Board endorsed the hourly cost for 2011 of €40 (the same rate as in 2009 and 2010).
Medlemmerne tog den skriftlige opdatering fra cheferne for de nationale lægemiddelstyrelser til efterretning.
The members noted the written update from the Heads of Medicines Agencies (HMA).
[EMA/MB/739310/2010] På baggrund af de kommentarer, der blev modtaget i forbindelse med den skriftlige høringsprocedure, godkendte bestyrelsen kandidaterne til CVMP og afsluttede høringsproceduren.
[EMA/MB/739310/2010] Following the comments received during the written consultation procedure, the Management Board endorsed the nomination to the CVMP and concluded the consultation procedure.
[EMA/MB/739310/2010] Bestyrelsen drøftede måder at forbedre høringsproceduren på.
[EMA/MB/739310/2010] The Management Board discussed ways to streamline the consultation procedure.
• Præsentation: Projekt 2014 - Gennemførlighedsundersøgelse af Det Europæiske
• Presentation: Project 2014 - Feasibility study on the future accommodation of the European Medicines Agency.
• Lægemiddelovervågning (offentliggørelsen nærmer sig, og den nye lovgivning vil gælde fra midt i
• Pharmacovigilance legislation (the publication is imminent and the new legislation will be applicable mid 2012).
[EMA/MB/784261/2010; EMA/MB/132208/2010; EMA/MB/637740/2010] Efter vedtagelsen af EUbudgettet blev dette punkt fremlagt for bestyrelsen til vedtagelse.
[EMA/MB/784261/2010; EMA/MB/132208/2010; EMA/MB/637740/2010] Following the adoption of the EU budget, this agenda point was presented to the Management Board for adoption.
[EMA/MB/660138/2010] Dagsordenen blev vedtaget med ændringer.
[EMA/MB/660138/2010] The agenda was adopted with amendments.
• Præsentation: Udvikling af et overvågningssystem for stoffer af menneskelig oprindelse på EU-plan
• Presentation: Developing a vigilance system for substances of human origin (SoHO) at European level - Technical introduction.
• [EMA/MB/743560/2010] Ajourført rapport fra bestyrelsens telematikudvalg.
• [EMA/MB/743560/2010] Update report from the Management Board Telematics Committee.
[EMA/MB/754407/2010; EMA/MB/777113/2010] Bestyrelsen vedtog politikkerne vedrørende EudraVigilance-aktindsigt i forbindelse med lægemidler til mennesker og dyr.
[EMA/MB/754407/2010; EMA/MB/777113/2010] The Management Board adopted the EudraVigilance access policies for medicinal products for human and veterinary use.
[EMA/MB/628133/2010] Bestyrelsen vedtog referatet.
[EMA/MB/628133/2010] The Management Board adopted the minutes.
Gennemførelse af budget 2001 med foreløbig 12.
Implementation of budget 2011 with provisional twelfth
[EMA/MB/482208/2010] Bestyrelsen vedtog arbejdsprogrammet for 2011.
[EMA/MB/482208/2010] The Management Board adopted the work programme 2011.
[EMA/MB/783955/2010; EMA/520678/2010] Bestyrelsen godkendte arbejdsaftalerne med ECDC.
[EMA/MB/783955/2010; EMA/520678/2010] The Management Board endorsed the working arrangements with ECDC.
• [EMA/MB/719548/2010] Rapport om konsekvenser af askeskyen.
• [EMA/MB/719548/2010] Ash cloud impact report.
møde den 7. oktober 2010
24 November 2010.
[EMA/MB/784727/2010; EMA/MB/791259/2010] Europa-Kommissionen skal i henhold til lovgivningen iværksætte et system for overvågning og sporbarhed af stoffer af menneskelig oprindelse.
[EMA/MB/784727/2010; EMA/MB/791259/2010] According to the legislation, the European Commission has to set up a system for vigilance and traceability of SoHO. ECDC had prepared a paper outlining the management of operational EU-level tasks related to substances of human origin.
Afbud
Apology received
Eventuelt
Other
Repræsentanter for lægeorganisationer
Representative of healthcare professionals' organisations
Referat af det 68.
Minutes from the 68th meeting, held on 7 October 2010
Lægemidlerne bør fortsat anvendes som hidtil.
These medicines should continue to be used as before.
Europa-Kommissionen traf sin artikel 31-afgørelse vedrørende orlistat den 24. april 2012.
The European Commission issued a decision for Orlistat Art. 31 on 24 April 2012.
Hvad er orlistat?
What is orlistat?
Xenical og Alli skønnes tilsammen at være blevet anvendt af over 53 millioner mennesker i hele verden, heraf over 20 millioner i EU.
Xenical and Alli are together estimated to have been used by over 53 million people worldwide, with over 20 million in the EU.
Desuden er der godkendt en række generiske lægemidler indeholdende orlistat via nationale procedurer i Belgien, Bulgarien, Danmark, Estland, Letland, Litauen, Norge, Portugal, Slovakiet, Nederlandene og Det Forenede Kongerige.
A number of generic orlistat-containing medicines have also been authorised via national procedures in Belgium, Bulgaria, Denmark, Estonia, Latvia, Lithuania, Norway, Portugal, Slovakia, the Netherlands, and the United Kingdom.
Hvorfor blev orlistat vurderet igen?
Why was orlistat reviewed?
Denne risiko er blevet tæt overvåget af CHMP, og der er indført foranstaltninger til håndtering af de kendte risici.
This risk has been closely monitored by the CHMP and measures to manage the known risks were put in place.
Produktinformationen for Alli, der på nuværende tidspunkt angiver “hepatitis”, skal ajourføres i overensstemmelse hermed.
The product information for Alli, which currently lists ‘hepatitis', will be updated accordingly.
Patienterne bør ophøre med at bruge orlistat og fortælle det til lægen, hvis de får nogen af disse symptomer.
Patients should stop taking orlistat and inform their doctor if they experience any of these symptoms.
Den ændrede produktinformation til læger og patienter findes her.
The amended information to doctors and patients are detailed here.
Orlistat er et lægemiddel, der anvendes mod fedme og ikke påvirker appetitten.
Orlistat is an anti-obesity medicine, which does not affect appetite.
Siden godkendelsen er der indberettet nogle tilfælde af alvorlige leverproblemer hos brugere af disse lægemidler.
Since authorisation, there have been some reports of severe liver problems in users of these medicines.
Kroppen absorberer ikke dette fedtstof, og derved bliver det lettere for patienten at tabe sig.
The body does not absorb this fat and this helps the patient reduce their weight.
To lægemidler indeholdende orlistat er godkendt til markedsføring i hele EU.
Two orlistat-containing medicines hold an EU-wide marketing authorisation.
Europa-Kommissionen anmodede derfor CHMP om at udarbejde en udtalelse om orlistat og om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende orlistat bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
Consequently, the European Commission asked the CHMP to issue an opinion on orlistat and on whether the marketing authorisation for orlistat-containing medicines should be maintained, varied, suspended or withdrawn across the EU.
Orlistat blokerer virkningen af gastrointestinale lipaser (enzymer, der nedbryder fedt).
Orlistat blocks the action of gastrointestinal lipases (enzymes that digest fat).
Siden 2001 har man vidst, at nogle patienter, der får orlistat, kan få meget sjældne leverrelaterede bivirkninger.
Since 2001 it has been recognised that some patients taking orlistat could experience very rare liverrelated side effects.
Den nuværende europæiske offentlige vurderingsrapport for Alli findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The current European public assessment report for Alli can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Xenical blev godkendt i 1998 og leveres som kapsler (120 mg), der kun udleveres mod recept.
Xenical was authorised in 1998 and is available as capsules (120 mg) which can only be obtained with a prescription.
Den nuværende europæiske offentlige vurderingsrapport for Xenical findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The current European public assessment report for Xenical can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
• Patienterne bør være opmærksomme på, at symptomerne på hepatitis kan bestå i gulfarvning af hud og øjne, kløe, mørkfarvet urin, mavesmerter og ømhed i leveren (mærkes som smerter under forkanten af brystkassen), undertiden med appetitløshed.
• Patients should note that symptoms of hepatitis can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage), sometimes with a loss of appetite.
• Patienter og ordinerende læger gøres opmærksomme på, at fordelene ved orlistat fortsat overstiger risiciene.
• Patients and prescribers are reminded that the benefits of orlistat-containing medicines continue to outweigh the risks.
Alli blev godkendt i 2007 og leveres som kapsler (60 mg) og tyggetabletter (27 mg), der udleveres uden recept (i håndkøb).
Alli was authorised in 2007 and is available as capsules (60 mg) and chewable tablets (27 mg) which can be obtained without a prescription (‘over-the-counter').
Samlet har der fra 1997 til januar 2011 været 21 tilfælde af svære leverskader, hvor Xenical blev anset for at være en mulig årsag, selv om der også var andre faktorer til stede, der kan have forårsaget leverskaderne.
Overall, from 1997 to January 2011, 21 cases of severe liver toxicity were reported where Xenical was considered a possible cause, although other factors that could have caused the liver injury were present.
Der er fortsat ingen klare beviser for, at det aktive stof er årsag til sådanne reaktioner.
There remains no clear evidence that orlistat causes these reactions.
Udvalget konkluderede, at antallet af indberettede alvorlige leverreaktioner hos brugere af orlistat var lavt, og at det var under den forventede baggrundsforekomst hos de pågældende, når det store antal brugere tages i betragtning.
The Committee concluded that the number of reported severe liver reactions in orlistat users was low and below the background rate expected in these people, given the large number of users.
• Patienter, der ønsker yderligere oplysninger, bør kontakte deres læge eller apotek.
• Patients who have any questions should speak to their doctor or pharmacist at a routine appointment.
CHMP fandt, at der ikke var stærke beviser for, at orlistat øger risikoen for alvorlige leverskader, og at der ikke var nogen kendt mekanisme, som giver formodning om, at orlistat kan forårsage leverlidelser.
The CHMP considered that there was no strong evidence that orlistat increased the risk of severe liver injury, and there was no known mechanism by which orlistat was expected to cause liver disorders.
CHMP gennemgik de foreliggende data om risikoen for leverskade og andre bivirkninger med orlistat, herunder data fra overvågning efter markedsføring, fra undersøgelser, der blev anvendt til støtte for ansøgningerne om markedsføringstilladelse, og fra publicerede befolkningsgruppeundersøgelser.
The CHMP reviewed the available data on the risk of liver injury and other side effects with orlistat, including post-marketing surveillance, data from the studies supporting the marketing authorisations and population-based studies in the published literature.
Det Europæiske Lægemiddelagentur har foretaget en vurdering af lægemidler indeholdende orlistat, efter at der er rejst betænkeligheder ved den mulige risiko for alvorlige leverskader forårsaget af sådanne lægemidler.
The European Medicines Agency has completed a review of orlistat-containing medicines, following concerns about the possible risk of severe liver injury with these medicines.
CHMP bemærkede desuden, at befolkningsgruppeundersøgelser tyder på, at fedme i sig selv kan være forbundet med øget risiko for leversygdom.
The CHMP also noted that published population-based studies suggest that obesity may be associated with a higher risk of liver disease.
I de fleste tilfælde var der desuden andre faktorer til stede, som må forventes at øge risikoen for leverskader, såsom eksisterende helbredsproblemer eller brug af andre lægemidler.
A pattern was not seen in the type of liver problems reported, and in most cases there were other factors which were likely to increase the risk of liver injury such as existing health problems or the use of other medicines.
Produktinformationen for lægemidler indeholdende orlistat nævner leverbetændelse (hepatitis), galdesten (cholelithiasis) og ændringer i niveauet af leverenzymer som mulige leverrelaterede bivirkninger.
The product information for orlistat-containing medicines lists hepatitis, cholelithiasis (gall stones) and a change in liver enzyme levels as potential liver-related side effects.
Den senere tids sikkerhedsovervågning har vist, at der fra august 2009 til januar 2011 var fire tilfælde, hvor patienter, der brugte Xenical, fik svære leverskader, hvor det ikke kunne udelukkes, at orlistat spillede en rolle.
Recent safety monitoring showed that from August 2009 to January 2011 four cases of severe liver injury were reported in patients using Xenical where the role of orlistat could not be excluded, including one fatal case of liver failure and one case leading to liver transplantation.
Udvalget fastslog, at skønt det ikke kan udelukkes, at orlistat i meget sjældne tilfælde er en mulig årsag til leverskader, giver disse tilfælde ikke solidt holdepunkt for en årsagssammenhæng.
The Committee considered that while there may be very rare cases of serious liver injury for which orlistat cannot be excluded as a possible cause, the cases do not provide good evidence of a causal link.
Når disse enzymer blokeres, kan de ikke nedbryde kostens indhold af visse fedtstoffer.
When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to be passed out in the stools undigested.
Efter vurderingen af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende orlistat fortsat er større end risiciene.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of orlistat continue to outweigh its risks, and therefore recommended that the marketing authorisations be maintained for orlistat-containing medicines.
CHMP anså det derfor for nødvendigt at vurdere, om benefit/risk-forholdet for lægemidler indeholdende orlistat var ændret på baggrund af den dokumentation om risikoen for alvorlige leverproblemer, der med tiden var blevet indsamlet.
Therefore, the CHMP considered it necessary to assess whether the evidence gathered over time on the risk of severe liver problems had altered the benefit-risk balance of orlistat-containing medicines.
Oplysningerne vedrørte det skønnede antal personer, der anvender lægemidlerne, og en analyse af antallet af indberetninger om alvorlige leverproblemer i forhold til den forventede baggrundsforekomst af leverproblemer hos disse personer.
The Committee also reviewed information requested from the companies that market orlistat-containing medicines, including the estimated number of people using these medicines and an analysis of the observed number of reports of severe liver problems compared with the expected background rate of liver problems in these people.
• Patienter og ordinerende læger bør have for øje, at der er indberettet visse leverproblemer, herunder meget sjældne reaktioner som hepatitis.
• Patients and prescribers should be aware that certain liver-related problems, including very rare serious reactions such as hepatitis, have been reported and are listed in the product information for orlistat-containing medicines as possible side effects.
Der er indberettet 9 tilfælde af leversvigt hos personer, der har anvendt Alli, fra det kom på markedet i maj 2007 og indtil januar 2011.
There were 9 reports of liver failure in people using Alli since it was marketed in May 2007 until January 2011, although in some cases there were other possible explanations and in some cases there was insufficient information to assess the cause.
Udvalget fastlagde endvidere mindre ændringer af indlægssedlen for alle lægemidler indeholdende orlistat for at sikre, at de indeholder samme oplysninger.
The Committee also agreed on minor amendments to the package leaflet for all orlistat-containing medicines to ensure they give the same information, including a description of the symptoms of hepatitis to alert patients to these symptoms.
Udvalget bemærkede, at produktinformationen for Xenical i forvejen nævner “hepatitis, som kan være alvorlig” som en bivirkning med ikke kendt hyppighed.
It noted that the product information for Xenical already listed ‘hepatitis that may be serious' as a side effect of unknown frequency, and recommended that the product information for all orlistat-containing medicines should be harmonised to include this information.
Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved orlistat fortsat overstiger risiciene, og anbefalede opretholdelse af markedsføringstilladelserne.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of orlistat continue to outweigh its risks, and recommended that the marketing authorisations be maintained with minor amendments to the product information to ensure the same information on very rare liver-related side effects is provided for all orlistat-containing medicines.
Styrke Lægemiddelform
(Invented) name Strength Pharmaceutical form Route of administration
Dato for første markedsføringstilladelse: 28. september 2012 Dato for seneste fornyelse: 13. juli 2017
Date of first authorisation: 28 September 2012 Date of latest renewal: 13 July 2017
Der er ingen data fra anvendelse af Enurev Breezhaler til gravide kvinder.
There are no data from the use of Enurev Breezhaler in pregnant women.
Infektioner og parasitære sygdomme Nasofaryngitis1)
Infections and infestations Nasopharyngitis1)
Dental karies
Dental caries
Akut forgiftning ved utilsigtet oral indtagelse af Enurev Breezhaler-kapsler er ikke sandsynlig pga. den lave orale biotilgængelighed (omkring 5 %).
Acute intoxication by inadvertent oral ingestion of Enurev Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Det er ikke relevant at anvende Enurev Breezhaler hos den pædiatriske population (under 18 år) ved indikationen KOL.
There is no relevant use of Enurev Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Enurev Breezhaler én gang dagligt har ligeledes vist en statistisk signifikant virkning på helbredsrelateret livskvalitet målt ved hjælp af St. George's Respiratory Questionnaire (SGRQ).
Enurev Breezhaler once daily has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ).
Læs venligst den fulde anvisning for brug inden du bruger Enurev Breezhaler.
Please read the full Instructions for Use before using the Enurev Breezhaler.
Den anbefalede dosis er inhalation af indholdet i en kapsel én gang dagligt ved hjælp af Enurev Breezhaler-inhalatoren.
The recommended dose is the inhalation of the content of one capsule once daily using the Enurev Breezhaler inhaler.
Brug ikke Enurev Breezhaler - hvis du er allergisk over for glycopyrroniumbromid eller et af de øvrige indholdsstoffer i
Do not use Enurev Breezhaler - if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
Enurev Breezhaler 44 mikrogram én gang dagligt kan anvendes sikkert i alle alders- og vægtgrupper.
Enurev Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Patienter skal informeres om tegn og symptomer på akut snævervinklet glaukom og skal informeres om øjeblikkelig seponering af Enurev Breezhaler og kontakte lægen, hvis patienten udvikler nogle af disse tegn eller symptomer.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Enurev Breezhaler and to contact their doctor immediately should any of these signs or symptoms develop.
• Et eller flere blisterkort, som hver indeholder enten 6 eller 10 Enurev Breezhaler kapsler til brug i inhalatoren
• One or more blister cards, each containing either 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
Enurev Breezhaler bør derfor bruges med forsigtighed i disse patientgrupper.
Enurev Breezhaler should be used with caution in these patient groups.
Under behandling med Enurev Breezhaler, stop med at tage medicinen og fortæl det øjeblikkeligt til din læge: - hvis du oplever trykken for brystet, hoste, hvæsen eller åndenød umiddelbart efter, du har taget Enurev Breezhaler (tegn på bronkospasme).
During treatment with Enurev Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Enurev Breezhaler (signs of bronchospasm).
• Enurev Breezhaler kapsler skal altid opbevares i den originale blister og må først tages ud umiddelbart inden anvendelse.
• Enurev Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
- Når du starter på en ny pakning, skal du bruge den nye Enurev Breezhaler-inhalator, som er vedlagt pakningen.
- When you start a new pack, use the new Enurev Breezhaler inhaler that is supplied in the pack.
Efter oral inhalation med Enurev Breezhaler-inhalatoren blev glycopyrronium hurtigt absorberet og nåede maksimale plasmaniveauer 5 minutter efter dosis.
Following oral inhalation using the Enurev Breezhaler inhaler, glycopyrronium was rapidly absorbed and reached peak plasma levels at 5 minutes post dose.
Enurev Breezhaler kan bruges ved den anbefalede dosis til ældre patienter (75 år eller ældre) (se pkt.
Enurev Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).
Enurev Breezhaler 44 mikrogram én gang dagligt medførte konsekvent, statistisk signifikant forbedring af lungefunktionen (forceret udåndingsvolumen i et sekund, FEV1, forceret vitalkapacitet, FVC, og inspiratorisk kapacitet, IC) i en række kliniske studier.
Enurev Breezhaler 44 micrograms once daily provided consistently statistically significant improvement in lung function (forced expiratory volume in one second, FEV1, forced vital capacity, FVC, and inspiratory capacity, IC) in a number of clinical studies.
Der er rapporteret øjeblikkelige overfølsomhedsreaktioner efter administration af Enurev Breezhaler.
Immediate hypersensitivity reactions have been reported after administration of Enurev Breezhaler.
Den lange virkningsvarighed kan delvist tillægges vedvarende koncentrationer af det aktive stof i lungerne, som afspejles af den forlængede terminale eliminationshalveringstid for glycopyrronium efter inhalation via Enurev Breezhaler-inhalatoren i modsætning til halveringstiden efter intravenøs administration (se pkt.
The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Enurev Breezhaler inhaler in contrast to the half life after intravenous administration (see section 5.2).
Sådan skal du inhalere Enurev Breezhaler - Denne pakning indeholder en inhalator og kapsler (i blister), som indeholder medicinen i form af et inhalationspulver.
How to inhale Enurev Breezhaler - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Den absolutte biotilgængelighed for glycopyrronium, inhaleret med Enurev Breezhaler, blev estimeret til ca. 45 % af leveret dosis.
The absolute bioavailability of glycopyrromium inhaled via Enurev Breezhaler was estimated to be about 45% of the delivered dose.