FrancophonIA/ELRC3.0 huggingface dataset:
English: ¾ That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females o Patients concomitantly treated with CYP1A2 inhibitors (such as fluvoxamine) or dual CYP3A4/1A2 inhibitors (such as enoxacin and cimetidine)
Danish: ¾ At øget eksponering kan forekomme i visse befolkningsgrupper og øge risikoen for vedvarende intolerans: o Særlige populationer, der har forøget PDE4 hæmning såsom negroide, ikke-rygende kvinder o Patienter i samtidig behandling med en CYP1A2-hæmmer (såsom fluvoxamin) eller samtidigt med CYP3A4-/1A2-hæmmere (såsom enoxacin og cimetidin)
English: ¾ The potential cardiac risk: Daliresp has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Danish: ¾ Den potentielle kardielle risiko: Daliresp er ikke undersøgt hos patienter med kongestiv hjerteinsufficiens (NYHA grad 3 og 4), og derfor kan det ikke anbefales til denne population.
English: Daliresp is contraindicated in patients with moderate or severe liver impairment (Child Pugh B or C).
Danish: Daliresp er kontraindiceret til patienter med moderat eller svær nedsat leverfunktion (Child Pugh B eller C).
English: The fact that Daliresp is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
Danish: Samt den omstændighed, at Daliresp hverken er indiceret til behandling af andre KOL-patienter end dem, der er beskrevet i den godkendte indikation, eller er til brug til patienter med astma eller alfa-1-antitrypsinmangel.
English: ¾ The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
Danish: ¾ Risikoen for vægttab hos undervægtige patienter og behovet for at kontrollere kropsvægt ved hvert besøg, og at behandlingen skal stoppes i tilfælde af et uforklarligt og klinisk bekymrende vægttab.
English: ¾ The limited or missing information in patients with liver impairment.
Danish: ¾ De begrænsede eller manglende data hos patienter med nedsat leverfunktion.
English: ¾ The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide.
Danish: ¾ Risikoen for psykiske forstyrrelser, såsom søvnløshed, angst eller depression hos patienter, der tager Daliresp og den potentielle risiko for selvmord.
English: ¾ The potential risk of infections: Daliresp should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Danish: ¾ Den potentielle risiko for infektioner: Dalirespbehandling bør ikke påbegyndes eller skal stoppes hos patienter med svære akutte smitsomme sygdomme.
English: • Copies of the patient card to be given to patients before they receive Daliresp
Danish: • Kopier af patientkortet, der skal udleveres til patienten ved udskrivning af Daliresp
English: Daliresp is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Danish: Daliresp anbefales ikke til patienter med en tidligere depression og heraf afledte selvmordstanker eller -adfærd.
English: That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Danish: At Daliresp kan forårsage vægttab, og patienter regelmæssigt skal kontrollere og registrere deres vægt på patientkortet.
English: ¾ The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daliresp should not be initiated or should be stopped in these patients.
Danish: ¾ Den manglende erfaring hos patienter med HIV-infektion eller aktiv hepatitis, med alvorlige immunologiske sygdomme (multipel sklerose, lupus erythematosus, multifokal leukoenkefalopati) eller patienter i immunsupprimerende behandling (andre end korttids-systemiske kortikosteroider).
English: • Summary of Product Characteristics and Patient Information Leaflet for Daliresp
Danish: • Produktresumé og indlægsseddel for Daliresp.
English: on 29 November 2010.
Danish: den 29. november 2010.
English: This summary was last updated in 10-2010.
Danish: Dette sammendrag blev sidst ajourført i 10-2010.
English: The vaccine is given according to official recommendations.
Danish: Vaccinen gives i overensstemmelse med de officielle anbefalinger.
English: This may help to protect against the disease caused by the virus.
Danish: Dette er med til at beskytte mod den sygdom, som virussen forårsager.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Danish: En influenzapandemi bryder ud, når der opstår en ny stamme af en influenzavirus, der let kan spredes fra person til person, fordi mennesker ikke har nogen immunitet (beskyttelse) over for den. En pandemi kan berøre de fleste lande og regioner i verden.
English: This vaccine contains some parts of the H5N1 virus.
Danish: Vaccinen indeholder visse dele af H5N1-virussen.
English: However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Danish: I tilfælde af en pandemi kan det dog være hensigtsmæssigt alligevel at vaccinere sådanne patienter, forudsat at der er genoplivningsudstyr til rådighed.
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Danish: Ifølge de kriterier, der er fastlagt af CHMP, skal en pandemivaccine frembringe en beskyttende mængde antistoffer hos mindst 70 % af de vaccinerede personer, for at den anses for egnet.
English: The CHMP noted that it is likely that a H5N1 strain of the influenza will cause a pandemic in the future.
Danish: CHMP bemærkede, at det er sandsynligt, at en H5N1-stamme af influenzaen vil forårsage en pandemi i fremtiden.
English: The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') in line with the CHMP criteria for prepandemic vaccines.
Danish: I undersøgelserne så man på vaccinens evne til at udløse dannelsen af antistoffer ("immunogenicitet") i tråd med CHMP's kriterier for præpandemiske vacciner.
English: The vaccine contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Danish: Vaccinen indeholder en "adjuvans" (en olieholdig forbindelse), som giver en bedre immunrespons.
English: In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
Danish: I den første undersøgelse havde ca. 90 % af personerne under 60 år og ca. 80 % af personerne over 60 år opnået et antistofniveau, der ville beskytte dem mod H5N1, 21 dage efter den anden injektion.
English: Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.
Danish: Sundhedseksperter er bekymrede for, at en kommende influenzapandemi kan forårsages af H5N1-stammen af virussen.
English: This is a type of vaccine to be used to protect against a new strain of flu that may cause a future influenza pandemic.
Danish: Det er en vaccinetype, som anvendes for at beskytte mod en ny influenzastamme, der eventuelt vil forårsage en influenzapandemi i fremtiden.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The applicant presented data on experimental models with vaccines similar to Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Danish: Ansøgeren fremlagde data om forsøgsmodeller med vacciner, der ligner Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: 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.
Danish: 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.
English: This is a summary of the European public assessment report (EPAR) for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: EPAR summary for the public prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Danish: EPAR - sammendrag for offentligheden præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret)
English: 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.
Danish: 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.
English: 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.
Danish: Undersøgelserne viste, at Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics generelt frembragte en antistofrespons, som opfyldt disse kriterier.
English: 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.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticsfremgår af indlægssedlen.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a ‘prepandemic' vaccine.
Danish: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er en "præpandemisk" vaccine.
English: Other information about Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Danish: Andre oplysninger om Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
English: 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.
Danish: Der blev fremlagt data fra to hovedundersøgelser med Prepandemic influenza vaccine H5N1 Novartis hos raske voksne under og over 60 år.
English: 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.
Danish: 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.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine.
Danish: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er en vaccine.
English: What is the risk associated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Danish: Hvilken risiko er der forbundet med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Danish: Hvad er Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: How has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been studied?
Danish: Hvordan blev Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics undersøgt?
English: Why has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been approved?
Danish: Hvorfor blev Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticsgodkendt?
English: How does Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics work?
Danish: Hvordan virker Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: How is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics used?
Danish: Hvordan anvendes Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics used for?
Danish: Hvad anvendes Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticstil?
English: The studies varied between 28 days and 13 months.
Danish: Undersøgelsernes varighed var mellem 28 dage og 13 måneder.
English: 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.
Danish: 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.
English: In such a case it is recommended that the patient should be monitored closely for increased serum concentrations.
Danish: I sådanne tilfælde anbefales det at overvåge patienten nøje for øget serumkoncentration.
English: The new sub heading on linearity/non linearity is justified by adequate data and also considered to be acceptable.
Danish: Den nye underoverskrift om linearitet/ikke-linearitet er begrundet med fyldestgørende data og kan også godtages.
English: With respect to ‘Special Populations' the text based on the data are justified and were considered to be acceptable with some amendments.
Danish: Hvad angår "Særlige populationer" er teksten velbegrundet ud fra dataene og kunne godtages med visse ændringer.
English: There are 5 different strengths of patch available: 12, 25, 50, 75 and 100 μg/h.
Danish: Depotplastrene findes i 5 forskellige styrker: 12, 25, 50, 75 og
English: The texts for the subsections absorption, distribution, biotransformation and excretion are considered acceptable.
Danish: Teksterne til underpunkterne absorption, distribution, biotransformation og udskillelse kan godtages.
English: Since the term “intractable pain” is not properly defined, it has been replaced by ‘severe', which captures the term ‘intractable'.
Danish: Da betegnelsen "intraktable smerter" ikke er veldefineret, er den erstattet af "svære", som indbefatter betegnelsen "intraktabel".
English: The proposed pharmacodynamic-related interactions were endorsed in the PSUR worksharings in 2010 and 2015.
Danish: De foreslåede farmakodynamikrelaterede interaktioner blev godkendt ved PSUR-arbejdsdelingen i 2010/2015.
English: In these cases the benefits of such treatment should outweigh the risks (central nervous system depression and respiratory depression).
Danish: I sådanne tilfælde bør fordelene ved behandlingen opveje risiciene (CNS-depression og respirationsdepression).
English: The expected timeline of treatment is restricted to continuous and long-term opioid treatment of severe chronic pain.
Danish: Den forventede tidsplan for behandlingen er begrænset til kontinuerlig og langvarig opioidbehandling af svære kroniske smerter.
English: Vasodilation is effectively reversed by naloxone.
Danish: Vasodilatation ophæves effektivt af naloxon.