FrancophonIA/ELRC3.0 huggingface dataset:
English: • To prevent flu, it can be used in adults and children over 1 year of age who have been in contact with someone who has flu and flu is circulating in the community.
Danish: • Til forebyggelse af influenza kan det anvendes hos voksne og børn over ét år, der har været i berøring med en influenzaramt person, og når der er influenzavirus i omløb i befolkningen.
English: Therefore, the Agency's view was that, as for Tamiflu, the benefit of Ebilfumin outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Ebilfumin opvejer de identificerede risici som for Tamiflu, og at det kan godkendes til anvendelse i EU.
English: During a flu pandemic, Ebilfumin can also be used to prevent flu in babies below 1 year of age.
Danish: Under en influenzapandemi kan Ebilfumin også anvendes til forebyggelse hos børn under ét år.
English: In the treatment of flu, Ebilfumin must be started within two days of the onset of symptoms.
Danish: Behandlingen af influenza med Ebilfumin skal påbegyndes senest to dage efter, at symptomerne er startet.
English: How is Ebilfumin used?
Danish: Hvordan anvendes Ebilfumin?
English: How has Ebilfumin been studied?
Danish: Hvordan blev Ebilfumin undersøgt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ebilfumin have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ebilfumin.
English: In the prevention of flu, Ebilfumin must be started within two days of contact with someone who has flu.
Danish: Den forebyggende behandling af influenza med Ebilfumin skal påbegyndes senest to dage efter, at patienten har været i kontakt med en influenzaramt person.
English: How does Ebilfumin work?
Danish: Hvordan virker Ebilfumin?
English: The recommended dose is 800 mg on days 1 and 8 of each 3-week cycle.
Danish: Den anbefalede dosis er 800 mg på dag 1 og dag 8 i hvert 3-ugers behandlingsforløb.
English: Other information about Portrazza
Danish: Andre oplysninger om Portrazza
English: This is a summary of the European public assessment report (EPAR) for Portrazza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Portrazza.
English: The full EPAR and risk management plan summary for Portrazza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Portrazza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Most of the patients (95%) had cancer cells with EGFR.
Danish: Størstedelen af patienterne (95 %) havde kræftceller med EGFR.
English: A risk management plan has been developed to ensure that Portrazza is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Portrazza anvendes så sikkert som muligt.
English: During infusions, resources should be available to deal with reactions that may occur.
Danish: Under infusionerne skal der være hjælpemidler til rådighed til at håndtere de reaktioner, der kan forekomme.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Portrazza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Portrazza er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Portrazza must not be used in patients who have had a severe or life-threatening reaction to any of the ingredients of the medicine.
Danish: Portrazza må ikke anvendes hos patienter, der har haft en svær eller livstruende reaktion på nogen af indholdsstofferne i lægemidlet.
English: In case of a severe infusion or skin reaction, treatment may have to be stopped permanently.
Danish: I tilfælde af en svær infusions- eller hudreaktion kan det være nødvendigt at standse behandlingen varigt.
English: Why is Portrazza approved?
Danish: Hvorfor blev Portrazza godkendt?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom infusionshastighed eller ved hjælp af forebyggende medicin.
English: What is Portrazza and what is it used for?
Danish: Hvad er Portrazza, og hvad anvendes det til?
English: In addition, the company that markets the medicine will provide doctors with educational material with information on risk of blood clots and on the small number of cardiac arrest cases seen in studies.
Danish: Den virksomhed, der markedsfører lægemidlet, skal desuden udlevere informationsmateriale til lægerne med oplysninger om risikoen for blodpropper og om det lille antal tilfælde af hjertestop, der er set i undersøgelserne.
English: What measures are being taken to ensure the safe and effective use of Portrazza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Portrazza?
English: The most common side effects with Portrazza (which may affect more than 1 in 10 people) are skin reactions, vomiting, stomatitis (inflammation of the lining of the mouth), fever, weight loss and low blood measurements of various minerals (magnesium, calcium, phosphate and potassium).
Danish: De hyppigste bivirkninger ved Portrazza (som kan forekomme hos mere end 1 ud af 10 personer) er hudreaktioner, opkastning, mundbetændelse (stomatitis), feber, vægttab og lave blodkoncentrationer af forskellige mineraler (magnesium, calcium, fosfat og kalium).
English: The most common serious side effects are severe skin reactions (6% of patients) and blood clots (4% of patients).
Danish: De hyppigste alvorlige bivirkninger er svære hudreaktioner (hos 6 % af patienterne) og blodpropper (hos 4 % af patienterne).
English: In this study, patients treated with Portrazza in addition to chemotherapy lived on average 1.6 months longer than those treated with chemotherapy alone (11.5 months versus 9.9 months).
Danish: I undersøgelsen overlevede de patienter, der blev behandlet med Portrazza foruden kemoterapi, i gennemsnit 1,6 måneder længere end de, der blev behandlet med kemoterapi alene (11,5 måneder mod 9,9 måneder).
English: Portrazza contains the active substance necitumumab.
Danish: Portrazza indeholder det aktive stof necitumumab.
English: What are the risks associated with Portrazza?
Danish: Hvilke risici er der forbundet med Portrazza?
English: It is not intended to provide practical advice on how to use Portrazza.
Danish: Det er ikke en praktisk vejledning i, hvordan Portrazza bør anvendes.
English: Portrazza is given as a one hour infusion (drip) into a vein.
Danish: Portrazza gives i et drop (som infusion) i løbet af en time.
English: EGFR normally controls the growth and division of cells, but in cancer cells EGFR is often overactive, causing them to divide uncontrollably.
Danish: EGFR kontrollerer normalt cellers vækst og deling, men i kræftceller er EGFR ofte overaktiv og får cellerne til at dele sig ukontrolleret.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Portrazza, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Portrazza, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: There was no improved survival in patients with non-EGFR cancer cells.
Danish: Overlevelsen blev ikke forbedret hos de patienter, der havde kræftceller uden EGFR.
English: For the first 6 cycles, Portrazza is given together with gemcitabine and cisplatin chemotherapy, after which it is given on its own for as long the disease remains stable and the patient can tolerate it.
Danish: I de første 6 behandlingsforløb gives Portrazza sammen med kemoterapi bestående af gemcitabin og cisplatin, hvorefter det gives som selvstændig behandling, så længe sygdommen holder sig stabil, og patienten kan tåle det.
English: Portrazza is available as a concentrate for making a solution and can only be obtained with a prescription.
Danish: Portrazza fås som et koncentrat til fremstilling af en opløsning og udleveres kun efter recept.
English: The risk of reactions can be reduced by adjusting the dose or infusion rate or by using preventive medicines.
Danish: Risikoen for reaktioner kan nedsættes ved at justere dosis eller
English: For more information about treatment with Portrazza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Portrazza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Portrazza, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Portrazza fremgår af indlægssedlen.
English: The active substance in Portrazza, necitumumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to EGFR on the surface of the cancer cells.
Danish: Det aktive stof i Portrazza, necitumumab, er et protein af typen monoklonalt antistof, som er fremstillet sådan, at det genkender EGFR og bindes til denne på kræftcellernes overflade.
English: In the main study, adding Portrazza to gemcitabine and cisplatin chemotherapy improved survival by a modest one and a half months without causing significant worsening in overall patient health.
Danish: I hovedundersøgelsen bevirkede tilføjelse af Portrazza til kemoterapi med gemcitabin og cisplatin en beskeden forbedring af overlevelsen med 1 1/2 måned uden forværring af patienternes generelle tilstand.
English: A main study of 1,093 patients with advanced squamous non-small cell lung cancer showed that adding Portrazza to gemcitabine and cisplatin chemotherapy can lead to a modest improvement in survival.
Danish: En hovedundersøgelse hos 1 093 patienter med fremskreden ikke-småcellet pladecellekræft i lungerne viste, at Portrazza kan bevirke en beskeden forbedring i overlevelse, når det anvendes som tillæg til kemoterapi med gemcitabin og cisplatin.
English: For practical information about using Portrazza, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Portrazza, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Portrazza have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Portrazza?
English: Portrazza is a medicine for treating advanced stages of a type of lung cancer known as squamous nonsmall cell lung cancer.
Danish: Portrazza er et lægemiddel til behandling af fremskreden ikke-småcellet pladecellekræft i lungerne hos voksne.
English: How is Portrazza used?
Danish: Hvordan anvendes Portrazza?
English: Portrazza is only used in adults whose cancer cells have a specific protein (EGFR) on their surface and it is used together with gemcitabine and cisplatin chemotherapy.
Danish: Portrazza anvendes kun hos voksne, hos hvem kræftcellerne har et særligt protein (EGFR) på overfladen.
English: How does Portrazza work?
Danish: Hvordan virker Portrazza?
English: By attaching to and blocking EGFR, necitumumab helps to reduce the growth and spread of the cancer.
Danish: Necitumumab nedsætter kræftens vækst og spredning ved at bindes til EGFR og blokere den.
English: Dissolution was evaluated over an 8-hour period.
Danish: Opløsningen blev vurderet over en periode på otte timer.
English: Overall summary of the scientific evaluation of Ethirfin and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Ethirfin og relaterede navne (se bilag I)
English: At the end of the CMD(h) procedure, and since there could be no agreement the procedure was referred to the CHMP.
Danish: Efter afslutningen af proceduren i CMD(h), og eftersom der ikke blev opnået enighed, blev proceduren henvist til CHMP.
English: Source; Brennan et al., Addiction 2005; 100 : 777-86
Danish: Kilde; Brennan et al., Addiction 2005; 100 : 777-86
English: This strength is considered representative for the other (20, 60 and 120 mg) strengths as all strengths are dose proportional and manufactured with the same microgranules.
Danish: Denne styrke vurderes at være repræsentativ for de øvrige styrker (20, 60 og 120 mg), da alle styrker er dosisproportionale og fremstillet med de samme mikrogranulater.
English: The amount of pain at baseline was a significant predictive factor for alcohol use in the 3-years follow-up period.
Danish: Smerte ved baseline var en væsentlig prædiktiv faktor for alkoholforbrug i den treårige opfølgningsperiode.
English: The application was submitted to the reference Member State Denmark and to the concerned Member States (CMS) Germany, Ireland, Italy and the United Kingdom.
Danish: Ansøgningen blev indsendt til referencemedlemsstaten Danmark og til de berørte medlemsstater Tyskland, Irland, Italien og Det Forenede Kongerige.
English: This film acts as a membrane allowing the diffusion of the active substance depending on its permeability.
Danish: Filmen virker som en membran, der tillader diffusion af det aktive stof afhængigt af dens permeabilitet.
English: It was shown that the dissolution rate increases with increased concentration of ethanol in the dissolution medium.
Danish: Det blev påvist, at opløsningshastigheden stiger med øget koncentration af ethanol i opløsningsmediet.
English: The CHMP considered the matter and adopted an Opinion in July 2010 recommending the renewal of the marketing authorisation subject to conditions considered essential to the safe and effective use of the product.
Danish: CHMP behandlede spørgsmålet og vedtog en udtalelse i juli 2010, der anbefalede fornyelse af markedsføringstilladelsen med forbehold af betingelser, der vurderes at være afgørende for sikker og effektiv anvendelse af lægemidlet.
English: Out of specification results were obtained after 0.25 hours in 20% alcohol, after 0.5 hour in 10% alcohol and after 2 hours in 5% alcohol.
Danish: Resultater uden for specifikationen blev opnået efter 0,25 timer i 20 % alkohol, efter 0,5 time i 10 % alkohol og efter 2 timer i 5 % alkohol.
English: Ethypharm submitted an application for the renewal, under the mutual recognition procedure, of Ethirfin and associated names, 20mg, 60 mg, 120 mg and 200 mg.
Danish: Ethypharm indsendte via den gensidige anerkendelsesprocedure en ansøgning om fornyelse af Ethirfin og relaterede navne, 20 mg, 60 mg, 120 mg og 200 mg.
English: Concurrent depression and pain have a much greater impact than either disorder alone and, in patients with pain, depression is associated to more pain sites, greater pain intensity, longer duration of pain, and greater likelihood of poor treatment response (Bair, J et al., Psychosom Med. 2008 October; 70(8): 890-897).
Danish: Samtidig tilstedeværelse af depression og smerter har en langt større indvirkning end hver af disse lidelser alene, og hos patienter med smerter er depression forbundet med flere smertesteder, større smerteintensitet, længerevarende smerter og større sandsynlighed for ringe respons på behandling (Bair, J et al., Psychosom Med. 2008 oktober; 70(8): 890-897).
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR NON-RENEWAL OF THE MARKETING AUTHORISATION
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR AFSLAG PÅ FORNYELSE AF MARKEDSFØRINGSTILLADELSEN
English: No adverse events have been reported for Ethirfin and associated names suspect to be related to the concomitant use of alcohol.
Danish: Der er ikke rapporteret utilsigtede hændelser for Ethirfin og relaterede navne, der er mistænkt for at være relateret til samtidig indtagelse af alkohol.
English: It is noted that the product already contains a specific contraindication for concomitant intake of alcohol.
Danish: Det bemærkes, at der for lægemidlet allerede er angivet en specifik kontraindikation for samtidig indtagelse af alkohol.
English: Dissolution profiles have been performed using the 200 mg capsule strength only.
Danish: Der er kun udfærdiget opløsningsprofiler for kapslen med en styrke på 200 mg.
English: Both problem drinkers as non-problem drinkers reported to use alcohol to manage pain, although in the latter group to less extent (see figure 1).
Danish: Både alkoholikere og ikke-alkoholikere rapporterede, at de brugte alkohol til at håndtere smerte, i sidstnævnte gruppe dog i mindre grad (se figur 1).
English: The dissolution test method used was the routine test, i.e. paddle apparatus at 100 rpm with 1000 ml of medium.
Danish: Den anvendte metode til opløsningstest var rutinetesten, dvs. paddle-apparat ved 100 o/m med 1000 ml medium.
English: In this study, subjects were interviewed about their number of alcohol consumptions of the last week and frequency of binge drinking in the last month (5292 responders).
Danish: Deltagerne i denne undersøgelse blev bedt om at oplyse, hvor mange alkoholgenstande de havde indtaget i løbet af den seneste uge, og hvor hyppigt de havde været på druk i løbet af den seneste måned (5.292 respondenter).
English: Grounds for non-renewal of the marketing authorisation
Danish: Begrundelser for afslag på fornyelse af markedsføringstilladelsen
English: However, alcohol use is common in patients with chronic pain due to the fact that it reduces pain perception.
Danish: Indtagelse af alkohol er dog almindelig blandt patienter med kroniske smerter, idet det reducerer smerteopfattelsen.
English: No in vivo studies have been performed to investigate the effect of alcohol on the absorption of the product.
Danish: Der er ikke foretaget in vivo-undersøgelser af virkningen af alkohol på absorptionen af lægemidlet.
English: The prolonged release properties of this product are ensured by the film coating composed of the polymethacrylate derivative plasticized by triethylcitrate (TEC) to which talc and hydrophobic colloidal silica are added.
Danish: Depotegenskaberne for dette lægemiddel sikres af filmovertrækket, der består af polymethacrylatderivat, som er blødgjort af triethylcitrat (TEC) tilsat talkum og hydrofob kolloid silikum.
English: Whereas
Danish: Men
English: Germany and the United Kingdom raised potential serious risk to public health concerns due to the dissolution profile of the modified-release product allowing the release of up to 80% of the active substance within 30 minutes, when exposed to 20% alcohol.
Danish: Tyskland og Det Forenede Kongerige gav udtryk for betænkeligheder ved, at lægemidlet kan udgøre en alvorlig risiko for menneskers sundhed, da dette lægemiddel med modificeret udløsning har en opløsningsprofil, som indebærer, at op til 80 % af det aktive stof kan frigives inden for 30 minutter ved eksponering for 20 % alkohol.
English: The polymethacrylate is a polymer that forms a continuous film when processed.
Danish: Polymethacrylat er en polymer, der danner en ubrudt film ved behandling.
English: • The Committee considered the procedure under Article 29(4) of Directive 2001/83/EC, as amended for Ethirfin and associated names,
Danish: • Udvalget fulgte proceduren i artikel 29, stk. 4, i direktiv 2001/83/EF med senere ændringer for Ethirfin og relaterede navne,
English: • A pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
Danish: • Der kan forekomme en farmakodynamisk interaktion mellem opioide lægemidler og alkohol uanset formulering.
English: Both problem drinkers and non-problem drinkers were included.
Danish: Der indgik både alkoholikere og ikke-alkoholikere.
English: • The Committee considered all the data submitted by the MAH,
Danish: • Udvalget behandlede alle de tilgængelige data fra indehaveren af markedsføringstilladelsen,
English: During the assessment, major issues on safety were raised by Germany and the United Kingdom, hence the procedure was referred to CMD(h), under Article 29, paragraph 1 of Directive 2001/83/EC, as amended.
Danish: Under vurderingen rejste Tyskland og Det Forenede Kongerige vigtige spørgsmål, og sagen blev derfor henvist til CMD(h) i henhold til artikel 29, stk. 1, i direktiv 2001/83/EF med senere ændringer.
English: Having considered the overall submitted data provided by the MAH, the CHMP concluded that
Danish: Efter at have analyseret de oplysninger, som indehaveren af markedsføringstilladelsen havde indsendt, konkluderede CVMP følgende:
English: The triethylcitrate acts as a plasticizer.
Danish: Triethylcitrat virker som en blødgører.
English: Triethylcitrate is water-soluble and miscible in ethanol.
Danish: Triethylcitrat er vandopløseligt og kombinerbart med ethanol.
English: Following a request from the European Commission, in September 2010 the CHMP further considered, in light of the benefit-risk balance and the requirements of article 24(2) of Directive 2001/83/EC as amended, the recommendation previously adopted for the product.
Danish: På opfordring af Europa-Kommissionen overvejede CHMP i september 2010 i lyset af benefit/risk-forholdet og kravene i artikel 24, stk. 2, i direktiv 2001/83/EF med senere ændringer, yderligere den tidligere anbefaling for lægemidlet.
English: for conventional-release products (NLT 75% dissolved active substance within 45 minutes) and therefore experiences severe alteration, leading to an uncontrolled rapid release of the majority of the active substance.
Danish: Resultaterne af opløsningstestene viser, at formuleringen ligger inden for Den Europæiske Farmakopés grænse for lægemidler med konventionel udløsning (NLT 75 % opløst aktivt stof inden for 45 minutter) og derfor ændres betydeligt, hvilket medfører en ukontrolleret hurtig frigivelse af størstedelen af det aktive stof.
English: • In addition, the dissolution profile of Ethirfin is significantly affected in the presence of alcohol, leading to an uncontrolled rapid release of the majority of the active substance, and therefore the product exhibits a significant interaction with alcohol with potentially significant clinical effects (e.g. respiratory depression and death),
Danish: • Opløsningsprofilen for Ethirfin påvirkes endvidere betydeligt under tilstedeværelsen af alkohol, hvilket medfører en ukontrolleret hurtig frigivelse af størstedelen af det aktive stof, og lægemidlet udviser således en signifikant interaktion med alkohol med potentielt signifikante kliniske effekter (såsom respirationsdepression eller død).
English: • The Committee considered that the dissolution profile of Ethirfin and associated names is significantly affected in the presence of alcohol, leading to an uncontrolled rapid release of the majority of the active substance, therefore the product exhibits a significant interaction with alcohol with potentially significant clinical effects (e.g. respiratory depression and death),
Danish: • Udvalget var af den opfattelse, at opløsningsprofilen for Ethirfin og relaterede navne i betydelig grad påvirkes af alkohol, hvilket medfører en ukontrolleret hurtig frigivelse af størstedelen af det aktive stof, og lægemidlet udviser således en signifikant interaktion med alkohol med potentielt signifikante kliniske effekter (såsom respirationsdepression eller død),
English: The polymethacrylate preparation is miscible in water and in ethanol.
Danish: Polymethacrylatproduktet er kombinerbart med vand og etanol.
English: The dissolution medium was water, loaded with 5, 10 and 20% ethanol in line with the EMA QWP Q&A document Need for in vitro Dissolution Studies with Alcohol for Modified Release Oral Products Including Opioid Drug Products.
Danish: Opløsningsmediet var vand tilsat 5, 10 og 20 % ethanol i overensstemmelse med dokumentet med spørgsmål og svar "Need for in vitro Dissolution