natgillin/translations-raw huggingface dataset:
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics. 
This is a summary of the European public assessment report (EPAR) for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
EPAR - sammendrag for offentligheden præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret) 
EPAR summary for the public prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
I den anden undersøgelse, som omfattede 240 personer, fik deltagerne Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, og der blev anvendt forskellige vaccinationsforløb. 
In the second study involving 240 people, subjects were given Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics using different vaccination schedules.
Undersøgelserne viste, at Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics generelt frembragte en antistofrespons, som opfyldt disse kriterier. 
The studies showed that overall Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics produced an antibody response that met these criteria.
Den fuldstændige liste over alle de indberettede bivirkninger ved Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticsfremgår af indlægssedlen. 
For the full list of all side effects reported with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, see the package leaflet.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er en "præpandemisk" vaccine. 
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a ‘prepandemic' vaccine.
Andre oplysninger om Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics: 
Other information about Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Der blev fremlagt data fra to hovedundersøgelser med Prepandemic influenza vaccine H5N1 Novartis hos raske voksne under og over 60 år. 
Two main studies provided data on vaccination with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in healthy adults aged below and above 60 years.
CHMP konkluderede, at fordelene ved Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticser større end risiciene, og anbefalede, at der blev udstedt markedsføringstilladelse for Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics. 
The CHMP decided that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics's benefits are greater than its risks and recommended that it be given marketing authorisation.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er en vaccine. 
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine.
Hvilken risiko er der forbundet med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics? 
What is the risk associated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Hvad er Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics? 
What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Hvordan blev Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics undersøgt? 
How has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been studied?
Hvorfor blev Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticsgodkendt? 
Why has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been approved?
Hvordan virker Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics? 
How does Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics work?
Hvordan anvendes Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics? 
How is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics used?
Hvad anvendes Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticstil? 
What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics used for?
Undersøgelsernes varighed var mellem 28 dage og 13 måneder. 
The studies varied between 28 days and 13 months.
Durogesic (fentanyl) depotplastre er registreret nationalt i følgende 24 lande i Det Europæiske Økonomiske Samarbejdsområde (EØS): Østrig, Belgien, Kroatien, Cypern, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Italien, Luxembourg, Malta, Nederlandene, Norge, Polen, Portugal, Slovenien, Spanien, Sverige og Det Forenede Kongerige. 
Durogesic (fentanyl) transdermal patches are registered nationally in the following 24 European Economic Area (EEA) countries: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden and United Kingdom.
I sådanne tilfælde anbefales det at overvåge patienten nøje for øget serumkoncentration. 
In such a case it is recommended that the patient should be monitored closely for increased serum concentrations.
Den nye underoverskrift om linearitet/ikke-linearitet er begrundet med fyldestgørende data og kan også godtages. 
The new sub heading on linearity/non linearity is justified by adequate data and also considered to be acceptable.
Hvad angår "Særlige populationer" er teksten velbegrundet ud fra dataene og kunne godtages med visse ændringer. 
With respect to ‘Special Populations' the text based on the data are justified and were considered to be acceptable with some amendments.
Depotplastrene findes i 5 forskellige styrker: 12, 25, 50, 75 og 
There are 5 different strengths of patch available: 12, 25, 50, 75 and 100 μg/h.
Teksterne til underpunkterne absorption, distribution, biotransformation og udskillelse kan godtages. 
The texts for the subsections absorption, distribution, biotransformation and excretion are considered acceptable.
Da betegnelsen "intraktable smerter" ikke er veldefineret, er den erstattet af "svære", som indbefatter betegnelsen "intraktabel". 
Since the term “intractable pain” is not properly defined, it has been replaced by ‘severe', which captures the term ‘intractable'.
De foreslåede farmakodynamikrelaterede interaktioner blev godkendt ved PSUR-arbejdsdelingen i 2010/2015. 
The proposed pharmacodynamic-related interactions were endorsed in the PSUR worksharings in 2010 and 2015.
I sådanne tilfælde bør fordelene ved behandlingen opveje risiciene (CNS-depression og respirationsdepression). 
In these cases the benefits of such treatment should outweigh the risks (central nervous system depression and respiratory depression).
Den forventede tidsplan for behandlingen er begrænset til kontinuerlig og langvarig opioidbehandling af svære kroniske smerter. 
The expected timeline of treatment is restricted to continuous and long-term opioid treatment of severe chronic pain.
Vasodilatation ophæves effektivt af naloxon. 
Vasodilation is effectively reversed by naloxone.
Den laveste tilgængelige styrke er 12,5 μg/h, der betegnes 12 μg/h for at skelne den fra doseringen 125 μg/h, der kan tænkes ordineret ved brug af flere plastre. 
The lowest available patch strength is 12.5 μg/h, which is designated as 12μg/h to distinguish it from a 125μg/h dosage that could be prescribed by using multiple patches.
Oplysningerne i punkt 4.2 er delvis opdelt i indtil tre tabeller og anvendes kun til omregning fra andre opioider til Durogesic, ikke omvendt: 
The information provided in section 4.2 is partly presented in up to three tables and are only be used to convert from other opioids to Durogesic and not vice versa:
Ordlyden af dette punkt er i henhold til PSUR-arbejdsdelingen (2010) ændret til, at Durogesic kan nedsætte den psykiske og/eller fysiske evne til at udføre potentielt farligt arbejde såsom at føre motorkøretøj eller betjene maskiner. 
The wording in this section has been amended according to the PSUR worksharing (2010), that Durogesic may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving or operating machinery.
I henhold til EMA's retningslinjer om klinisk udvikling af lægemidler til smertebehandling ("Guideline on the Clinical Development of Medicinal Products Intended for the Treatment of Pain") (EMA/CHMP/970057/2011, Corr. 11) og WHO's retningslinjer om smertelindring ved kræft ("Guideline on Cancer Pain Relief") kan smerter inddeles i lette, moderate og svære. 
According to the EMA Guideline on the Clinical Development of Medicinal Products Intended for the Treatment of Pain (EMA/CHMP/970057/2011, Corr. 11) and the WHO Guideline on Cancer Pain Relief, pain severity can be classified as mild, moderate and severe.
Virkningen af Durogesic er påvist i seks undersøgelser hos voksne med ikke-maligne smerter, hvoraf fem var åbne og tre var uden sammenligningsarm. 
The efficacy of Durogesic has been shown in six studies in adults with non-malignant pain, of which five were open-label and 3 did not have a comparator arm.
Den analgetiske virkning af fentanyl antages at medieres hovedsagelig gennem µopioidreceptorer. 
The analgesic action of fentanyl is thought to be mediated mainly through µopioid-receptors.
Opioidnaive patienter 
Opioid-naïve patients
Pædiatrisk indikation 
Paediatric indication
Punkt 4.7 - Virkning på evnen til at føre motorkøretøj og betjene maskiner 
Section 4.7 - Effects on ability to drive and use machines
Den foreslåede liste over de hyppigst indberettede bivirkninger baseret på de poolede sikkerhedsdata kunne godtages med en mindre ændring til forbedring af læseligheden. 
The proposed listing of most commonly reported adverse reactions from the pooled safety data was considered to be acceptable, with a minor amendment to improve the readability.
• udvalget behandlede indbringelsen i henhold til artikel 30 i direktiv 2001/83/EF vedrørende lægemidlet Durogesic, depotplastre 
• The committee considered the referral under Article 30 of Directive 2001/83/EC concerning the medicinal product Durogesic transdermal patches;
Fentanyls høje lipidopløselighed og potens gør det velegnet til transdermal administration. 
Fentanyl has high lipid solubility and potency, which make it suitable for transdermal administration.
Af hensyn til sikkerheden er det i dette underpunkt tilføjet, at der bør gives den laveste effektive dosis. 
For safety reasons, addition of the text that the lowest effective dose should be used has been included this subsection.
Overdosering med et opioid såsom fentanyl kan medføre vedholdende hypotension på grund af perifer vasodilatation. 
Overdose of an opioid such as fentanyl could lead to persistent hypotension due to peripheral vasodilation.
Oplysninger vedrørende undersøgelser ved indikationen postoperative smerter hos opioidnaive patienter er ikke bibeholdt, da dette ikke indgår i indikationen for Durogesic. 
Information related to studies in the post-operative pain indication in opioid naïve subjects has not been retained since this is not in the indication of Durogesic.
På grund af medlemsstaternes divergerende nationale afgørelser om markedsføringstilladelsen for Durogesic og relaterede navne anmeldte Europa-Kommissionen en officiel indbringelse til Det Europæiske Lægemiddelagentur i henhold til artikel 30 i direktiv 2001/83/EF med henblik på at ophæve divergenserne mellem de nationalt godkendte produktresuméer for ovennævnte produkt og dermed harmonisere produktresuméerne i EU. 
Due to the divergent national decisions taken by Member States concerning the authorisation of Durogesic and associated names, the European Commission (EC) notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the authorised summary of product characteristics (SmPCs) for the above-mentioned product, and thus to harmonise the SmPCs across the EU.
Skift af depotplaster inden 72 timer kan medføre forhøjet serumkoncentration af fentanyl, som kan øge risikoen for bivirkninger. 
Replacing the patch before 72 hours may result in increased serum concentrations of fentanyl, which could increase the risk for adverse events.
De vigtigste forskelle mellem produktresuméerne hvad angår de anførte hyppigheder for de enkelte bivirkninger blev drøftet og afklaret. 
Major differences between SmPCs regarding the assigned frequencies for individual adverse reactions were discussed and resolved.
Ældre og patienter med nedsat nyre eller leverfunktion bør observeres tæt, og dosis om nødvendigt nedsættes. 
Elderly or patients with renal or hepatic impairment should be closely observed and dose reductions made if necessary.
Da der ikke var nævneværdige forskelle i sikkerhedsprofil mellem voksne og pædiatriske patienter, blev markedsføringstilladelsesindehaverens beslutning om ikke at indsætte en separat tabel godtaget. 
As there were no striking differences in the safety profile between adult and paediatric subjects, the MAH's decision not to include a separate table was considered to be acceptable.
Hvis hypotensionen persisterer efter administration af naloxon, anbefales det at overveje standardbehandling af hypovolæmi, herunder væskebehandling. 
If hypotension persists after naloxone administration, standard medical care for hypovolemia, including fluid management is recommended to be considered.
Da ordlyden vedrørende den potentielle risiko for serotoninsyndrom indgår i punkt 4.4 og 4.5 af det harmoniserede produktresumé, er punkt 4.8 i det harmoniserede produktresumé ligeledes ajourført med en erklæring om, at der er indberettet tilfælde af serotoninsyndrom, når lægemidler indeholdende fentanyl administreres sammen med stærkt serotonerge lægemidler. 
As the wording about the potential risk of serotonin syndrome has been included in sections 4.4 and 4.5 of the harmonised SmPC, section 4.8 of the harmonised SmPC has also been updated with a statement that cases of serotonin syndrome have been reported when fentanyl-containing products are administered concomitantly with highly serotonergic medicinal products.
Tabel 1 - Omregning til ækvianalgetisk styrke: På grund af forskelle i forskellige opioiders relative potens er vejledning om ækvianalgetiske doser af forskellige lægemidler påkrævet. 
Table 1 - Equianalgesic potency conversion: Due to differences in the relative potency of various opioid analgesics, guidance is necessary regarding equianalgesic doses of various medications.
• udvalget gennemgik alle data, som markedsføringstilladelsesindehaveren har forelagt til underbygning af den foreslåede harmonisering af produktinformationen 
• The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the Product Information.
Som beskrevet i den offentlige vurderingsrapport fra oktober 2007 om pædiatriske data er langtidsbehandling af svære kroniske smerter hos børn på 2 års-alderen, som er i behandling med opioider, indiceret i punkt 4.1 i det foreslåede harmoniserede produktresumé og indgår også i størstedelen af produktresuméerne. 
As outlined in the October 2007 Public Assessment Report regarding paediatric data, the long-term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy is indicated in section 4.1 of the proposed harmonised SmPC, and also present in the majority of SmPCs.
Med henblik på sådanne tilfælde er der tilføjet en advarsel om potentialet for livstruende hypoventilation. 
In such cases, the potential for life-threatening hypoventilation has been added as a warning.
Depotplastre blev udviklet som en ikke-invasiv parenteral behandling, der omgår first pass-metabolisering og medfører konstant frigivelse og plasmakoncentration. 
The transdermal patches were developed as a non-invasive parenteral treatment option to avoid the first pass mechanism and to achieve a constant release and plasma levels.
Durogesic, depotplastre, indeholder fentanyl, som er et potent syntetisk opioidanalgetikum, der tilhører piperidinderivaterne. 
Durogesic transdermal patch contains fentanyl, which is a potent, synthetic opioid analgesic belonging to the piperidine derivatives.
Tabel 2: Beregnet for voksne patienter, der behøver skift eller omregning fra et andet opioidregime (omregningsforholdet fra oralt morphin til fentanyl-depotplastre er ca. 150:1). 
Table 2: Designed for adult patients who have a need for rotation of, or conversion from, another opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 150:1).
Tidligt skift af depotplaster tilrådes derudover kun i det sjældne tilfælde, hvor plastrets vedhæftning volder problemer. 
In addition, early patch replacement is only advised in the rare case of a problem with patch adhesion.
Personerne (N=1 667) i undersøgelserne havde kroniske lændesmerter, osteoartritis eller reumatoid artritis eller smerter af uspecificeret oprindelse. 
The subjects (N=1667) included had chronic low back pain, osteoarthritis or rheumatoid arthritis or pain of unspecified origin.
Den foreslåede ordlyd er udformet, så den svarer til de populationer, der er vurderet i de kliniske undersøgelser, og så den opretholder overensstemmelsen mellem indikationerne for voksne og pædiatriske patienter. 
The proposed wording has been developed to align the populations evaluated in clinical studies and to maintain alignment between the indications for both adult and paediatric patients.
Børn på 16 år og derover følger voksendosis, og for børn mellem 2 og 16 år er de anbefalede doseringer af Durogesic til pædiatriske patienter angivet i tabelform på basis af daglig oral morphindosis. 
Children aged 16 years and above follow adult dosage, and for children 2-16 years a table with recommended Durogesic dosages for paediatric patients based upon daily oral morphine dose has been provided.
Indehaveren af markedsføringstilladelsen har gjort det klart, at et depotplaster kun ved første påføring kan skiftes efter 48 timer ved utilstrækkelig analgetisk virkning. 
The MAH has clarified that only at first application could a patch be replaced after 48 hours when analgesia is insufficient.
Indehaveren af markedsføringstilladelsen har sammenfattet de hyppigst indberettede bivirkninger i dette punkt på grundlag af poolede sikkerhedsdata udledt af 11 kliniske undersøgelser med deltagelse af i alt 1 854 voksne og pædiatriske patienter. 
The MAH has summarised the most commonly reported adverse reactions in this section based on the pooled safety data derived from 11 clinical trials with a total of 1854 participating adult and paediatric subjects.
Hos opioidnaive ældre og patienter med nedsat med nedsat nyre- eller leverfunktion kan der være tilfælde, hvor initiering af transdermal opioidbehandling er nødvendig og hensigtsmæssig (f.eks. ved synkebesvær). 
In opioid-naïve elderly or patients with renal or hepatic impairment, there may be some instances in which the initiation of opioid treatment with a transdermal formulation is necessary and appropriate (e.g. in cases of difficulties swallowing).
For patienter med nedsat nyrefunktion er der indsat en advarsel om, at der kræves nøje observation for tegn på toksicitet af fentanyl (og om nødvendigt nedsat dosis), da farmakokinetikken af fentanyl ikke er undersøgt hos denne patientpopulation. 
A warning for renally impaired patients has been included that careful observation for signs of fentanyl toxicity is warranted (and the dose reduced if necessary) as fentanyl pharmacokinetics has not been evaluated in this patient population.
Ordlyden af underpunktet "Fertilitet" er ændret for at sikre overensstemmelse mellem de forskellige lægemidler indeholdende fentanyl. 
The wording for the subsection ‘Fertility' has been amended to ensure consistency across the different fentanyl-containing medicinal products.
I dette punkt er medtaget resultaterne af alle undersøgelserne af farmakodynamik og virkning hos pædiatriske patienter, og antallet af pædiatriske patienter er bragt i overensstemmelse med de øvrige punkter i det harmoniserede produktresumé. 
The results of all pharmacodynamic or efficacy studies conducted in paediatric patients has been included in this section and the number of paediatric patients has been brought in line with the other sections of the harmonised SmPC.
Ordlyden vedrørende tolerans og afhængighed, opioidabstinenser og neonatalt abstinenssyndrom følger nøje ordlyden i CSP og kan godtages. 
The wording regarding tolerance and dependence, opioid withdrawal symptoms, and neonatal withdrawal syndrome follow exactly the wording included in the CSP and is considered to be acceptable.
Andre advarsler, der er indsat i punkt 4.4: kronisk lungesygdom, lægemiddelafhængighed og misbrugspotentiale, centralnervesystemet inklusive forhøjet intrakranielt tryk, hjertesygdom, hypotension, nedsat leverfunktion, nedsat nyrefunktion, respirationsdepression, serotoninsyndrom, utilsigtet eksponering ved plasteroverførsel, anvendelse hos ældre patienter, mave-tarmsystemet, pædiatrisk population, laktation og patienter med myasthenia gravis. 
Other warnings included in section 4.4 are: chronic pulmonary disease, drug dependence and potential for abuse, central nervous system including increased intracranial pressure, cardiac disease, hypotension, hepatic impairment, renal impairment, respiratory depression, serotonin syndrome, accidental exposure by patch transfer, use in elderly patients, gastrointestinal tract, paediatric population, lactation, and patients with myasthenia gravis.
Da der ikke foreligger farmakokinetiske data til underbygning af sikkerheden af at skifte depotplastret med 48-timers intervaller, fraråder markedsføringstilladelsesindehaveren dosisintervaller på under 72 timer. 
Because there are no pharmacokinetic (PK) data available to support the safety of replacing patches at 48hour intervals, the MAH does not recommend dosing intervals of less than 72 hours.
Der er dog tilføjet en advarsel om, at der kræves længere tid for CYP3A4hæmmere med lang halveringstid (såsom af amiodaron) og CYP3A4-hæmmere med tidsafhængig eller mekanismeafhængig hæmning (såsom erythromycin, nicardipin, idelalisib og ritonavir), og at der skal søges oplysninger i produktinformationen for den pågældende CYP3A4-hæmmer med henblik på den hæmmende virknings halveringstid og varighed, før det første Durogesic depotplaster påsættes. 
However a warning has been added that more time would be needed for CYP3A4 inhibitors with a long half-life (such as amiodarone) or CYP3A4 inhibitors with time-dependent or mechanism-based inhibition (such as erythromycin, nicardipine, idelalisib, ritonavir), and that the product information of the CYP3A4 inhibitor must be consulted for the half-life and duration of the inhibitory effect before applying the first Durogesic patch.
Fentanyl har været markedsført som intravenøst anæstetikum siden 1960'erne. 
anaesthetic since the 1960s.