natgillin/translations-raw huggingface dataset:
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics må ikke gives til patienter, der har haft en anafylaktisk reaktion (en alvorlig allergisk reaktion) på nogen af vaccinens komponenter, herunder de komponenter, der indgår som sporstoffer (dvs. i meget små mængder), f.eks. æg eller kyllingeprotein, ovalbumin (et protein i æggehvide), kanamycin- og neomycinsulfat (antibiotika), formaldehyd og cetyltrimethylammoniumbromid.
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low levels) such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Den fuldstændige EPAR for Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticsfindes på EMA's websted ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Når en person får vaccinen, opfatter immunsystemet virusdelene som "fremmede" og danner antistoffer imod dem. Immunsystemet kan således danne antistoffer hurtigere, når det eksponeres for samme virus igen.
When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Såfremt der er tale om en officielt erklæret pandemi, der skyldes H5N1-stammen af influenza A, kan personer, der allerede er blevet vaccineret med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (med en eller to doser), kun få én dosis mere i stedet for de to doser, der anbefales for ikke-vaccinerede personer.
In the event of an officially declared pandemic caused by the H5N1 strain of the influenza A, people who have already been vaccinated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (with one or two doses) may be given only one more dose, instead of the two doses recommended for unvaccinated people.
Hvis du ønsker yderligere oplysninger om behandling med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
De mest almindelige bivirkninger ved Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics(som forekommer hos flere end 1 ud af 10 patienter) er hovedpine, myalgi (muskelsmerter), reaktioner på injektionsstedet (hævelse, smerte, hårdhed og rødme) og træthed.
The most common side effects with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
I en af undersøgelserne, som omfattede 3 372 personer, fik deltagerne enten vaccine mod sæsoninfluenza efterfulgt af to doser Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics med tre ugers mellemrum eller placebo (en virkningsløs vaccine) efterfulgt af to doser af en adjuveret vaccine mod sæsoninfluenza med tre ugers mellemrum.
In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics three weeks apart, or a placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics indeholder en influenzastamme kaldet en A/Vietnam/1194/2004 (H5N1)-lignende stamme (NIBRG-14).
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains a flu strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticstil Novartis Vaccines and Diagnostics S.r.l.
The European Commission granted a marketing authorisation valid throughout the European Union for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics to Novartis Vaccines and Diagnostics S.r.l.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er en vaccine, som anvendes til voksne for at beskytte mod influenza, der skyldes H5N1 ("fugleinfluenza")-stammen af influenza A-virus.
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults to protect against flu caused by the H5N1 (“bird flu”) strain of the influenza A virus.
Ansøgeren fremlagde data om forsøgsmodeller med vacciner, der ligner Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
The applicant presented data on experimental models with vaccines similar to Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Den anden undersøgelse gav dokumentation for, at Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics skulle gives som to doser med mindst tre ugers mellemrum.
The second study established that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should be given as two doses at least three weeks apart.
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.