FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate measures should be taken to prevent contamination such as wearing protective clothes and disposable rubber gloves, since the vaccine has been prepared with modified live virus.
Danish: Der skal tages passende forholdsregler for at forebygge kontaminering som f.eks. brug af beskyttelsestøj og engangsgummihandsker, da vaccinen er klargjort med modificeret levende virus.
English: In case of skin or eye contact with the vaccine fluid the affected area should be rinsed immediately with water.
Danish: I tilfælde af hud- eller øjenkontakt med vaccinevæsken skal det berørte område omgående skylles med vand.
English: It presents a risk for people since it can be transmitted by bites or saliva from an infected animal.
Danish: Sygdommen udgør en risiko for mennesker, da den kan smitte gennem bid eller savl fra et inficeret dyr.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Rabitec, including the appropriate precautions to be followed by healthcare professionals and people who handle the product or come into contact with it.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Rabitec, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der håndterer produktet eller kommer i kontakt med det.
English: The baits should be handled with care.
Danish: Lokkemaden skal håndteres med forsigtighed.
English: Rabitec rabies virus vaccine (live)
Danish: Rabitec vaccine mod rabiesvirus (levende)
English: Rabitec is a veterinary vaccine used to protect wild foxes and raccoon dogs against rabies.
Danish: Rabitec er en veterinærvaccine, der anvendes til at beskytte vilde ræve og mårhunde mod rabies.
English: To protect rabies free areas, vaccination may also be carried out at the border of these areas (vaccination belts) or in the form of spot vaccinations.
Danish: Vaccination kan også gennemføres langs med grænsen til rabiesfrie områder for at beskytte dem (vaccionationsbælter) eller i form af spotvaccinationer.
English: Why is Rabitec approved?
Danish: Hvorfor blev Rabitec godkendt?
English: It is not intended to provide practical advice on how to use Rabitec.
Danish: Det er ikke en praktisk vejledning i, hvordan Rabitec bør anvendes.
English: For more information about treatment with Rabitec, read the package leaflet.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rabitec, kan du læse indlægssedlen.
English: animals are exposed to the rabies virus, the immune system will be able to respond more quickly, which will help to protect against the disease.
Danish: Hvis dyret efterfølgende udsættes for virussen, vil immunsystemet reagere hurtigere, og det vil hjælpe med at beskytte dyret mod sygdommen.
English: What is Rabitec and what is it used for?
Danish: Hvad er Rabitec, og hvad anvendes det til?
English: The number of baits distributed depends on the density of the fox and raccoon dog population and the nature of the vaccination area.
Danish: Antallet af lokkemadsenheder, der skal udlægges, afhænger af størrelsen af ræve- og mårhundebestanden og vaccinationsområdets beskaffenhed.
English: Medical advice should be sought immediately and the package leaflet or label shown to the doctor, who should follow WHO recommendations for rabies exposure.
Danish: Ved utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen, som skal følge WHO's anbefalinger for rabieseksponering.
English: Rabies is a life threatening viral disease that causes inflammation in the brain.
Danish: Rabies er en livstruende virussygdom, der medfører betændelse i hjernen.
English: What are the risks associated with Rabitec?
Danish: Hvilke risici er der forbundet med Rabitec?
English: Rabitec contains a modified live rabies virus which has been weakened so that it does not cause disease.
Danish: Rabitec indeholder en modificeret levende rabiesvirus, der er blevet svækket, så den ikke forårsager sygdom.
English: Rabitec contains a weakened rabies virus that does not cause the disease.
Danish: Rabitec indeholder en svækket rabiesvirus, som ikke forårsager sygdommen.
English: Other information about Rabitec?
Danish: Andre oplysninger om Rabitec
English: Rabitec is available as a liquid (suspension) contained in a bait pellet scented with fish meal to be chewed.
Danish: Rabitec fås som en væske (suspension) i lokkemadsenheder, der lugter kraftigt af fisk.
English: How is Rabitec used?
Danish: Hvordan anvendes Rabitec?
English: What benefits of Rabitec have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Rabitec?
English: How does Rabitec work?
Danish: Hvordan virker Rabitec?
English: When a fox or raccoon dog chews a bait and the vaccine is released in the animal's mouth, the immune system recognises the virus as ‘foreign' and makes defences against it.
Danish: Når en ræv eller en mårhund tygger på lokkemaden, frigives vaccinen i dyrets
English: This summary was last updated in 08-2016.
Danish: Dette sammendrag blev sidst ajourført i MM-2016.
English: The full EPAR for Atazanavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Atazanavir Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Atazanavir Mylan is available as capsules (150 mg, 200 mg and 300 mg).
Danish: Atazanavir Mylan fås som kapsler (150 mg, 200 mg og 300 mg).
English: It blocks an enzyme called protease, which is needed for the virus to multiply.
Danish: Det blokerer et enzym kaldet protease, som virusset har brug for for at kunne formere sig.
English: This is a summary of the European public assessment report (EPAR) for Atazanavir Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Atazanavir Mylan.
English: This means that Atazanavir Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Reyataz.
Danish: Det betyder, at Atazanavir Mylan er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Reyataz.
English: The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Mylan (protease inhibitors) do not work.
Danish: Lægemidlet forventes ikke at virke hos patienter, hos hvem mange lægemidler fra samme klasse som Atazanavir Mylan (proteasehæmmere) ikke har virket.
English: Atazanavir Mylan does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Atazanavir Mylan kurerer ikke hiv-infektion eller aids, men det kan forsinke den beskadigelse af immunsystemet og den udvikling af infektioner og sygdomme, der er forbundet med aids.
English: Therefore, the CHMP's view was that, as for Reyataz, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Reyataz.
English: The Committee recommended that Atazanavir Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Atazanavir Mylan godkendes til anvendelse i EU.
English: Atazanavir Mylan is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Danish: Atazanavir Mylan gives normalt sammen med ritonavir for at forstærke dets virkning, men lægerne kan overveje at stoppe behandlingen med ritonavir hos voksne i visse situationer.
English: Atazanavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Atazanavir Mylan tages i kombination med andre antivirale lægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Atazanavir Mylan has been shown to have comparable quality and to be bioequivalent to Reyataz.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Atazanavir Mylan kvalitetsmæssigt kan sammenlignes og er bioækvivalent med Reyataz.
English: Atazanavir Mylan is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Danish: Atazanavir Mylan er et lægemiddel til behandling af patienter, der er smittet med humant immundefektvirus type 1 (hiv-1), som er årsag til erhvervet immundefektsyndrom (aids).
English: For more information about treatment with Atazanavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Atazanavir Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Atazanavir Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Atazanavir Mylan?
English: Atazanavir Mylan is a ‘generic medicine'.
Danish: Atazanavir Mylan er et "generisk lægemiddel".
English: It is not intended to provide practical advice on how to use Atazanavir Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Atazanavir Mylan bør anvendes.
English: The active substance in Atazanavir Mylan, atazanavir, is a protease inhibitor.
Danish: Det aktive stof i Atazanavir Mylan, atazanavir, er en proteasehæmmer.
English: Because Atazanavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Atazanavir Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Atazanavir Mylan
Danish: Andre oplysninger om Atazanavir Mylan
English: What is Atazanavir Mylan and what is it used for?
Danish: Hvad er Atazanavir Mylan, og hvad anvendes det til?
English: Doctors should prescribe Atazanavir Mylan only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Atazanavir Mylan.
Danish: Inden Atazanavir Mylan ordineres til en patient, bør lægen først undersøge, hvilke lægemidler patienten i øvrigt har fået, og foretage test for at fastslå, om det er sandsynligt, at virusset vil respondere på Atazanavir Mylan.
English: Atazanavir Mylan contains the active substance atazanavir.
Danish: Atazanavir Mylan indeholder det aktive stof atazanavir.
English: What are the benefits and risks of Atazanavir Mylan?
Danish: Hvilken fordel og risiko er der forbundet med Atazanavir Mylan?
English: Because Atazanavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Reyataz.
Danish: Da Atazanavir Mylan er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Reyataz.
English: For practical information about using Atazanavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Atazanavir Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In younger patients, the dose of Atazanavir Mylan depends on body weight.
Danish: Atazanavir Mylan-dosen til yngre patienter afhænger af disses kropsvægt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Atazanavir Mylan on 22 August 2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Atazanavir Mylan den <dato for udstedelse af markedsføringstilladelse>.
English: It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
Danish: Atazanavir Mylan udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af hivinfektion.
English: Why is Atazanavir Mylan approved?
Danish: Hvorfor blev Atazanavir Mylan godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atazanavir Mylan have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Atazanavir Mylan.
English: How has Atazanavir Mylan been studied?
Danish: Hvordan blev Atazanavir Mylan undersøgt?
English: How is Atazanavir Mylan used?
Danish: Hvordan anvendes Atazanavir Mylan?
English: How does Atazanavir Mylan work?
Danish: Hvordan virker Atazanavir Mylan?
English: Evaluation of patients' compliance was regarded as important.
Danish: Evaluering af patienternes komplians ansås for at være vigtigt.
English: Craving and cognitive aspects may also be considered as secondary outcome measures.
Danish: Trang og kognitive aspekter kan også overvejes som sekundære effektmål.
English: A design focusing on either of these endpoints with only supplementary data on the other might be acceptable.
Danish: Et design, der fokuserer på ét af disse endepunkter med udelukkende supplerende data for det andet, kunne være acceptabelt.
English: Like GABA, it exerts an overall inhibiting effect on the central nervous system (CNS).
Danish: Ligesom GABA har det en generel hæmmende effekt på centralnervesystemet (CNS).
English: Furthermore, reference to other existing marketing authorisations is not relevant due to different targets populations and/or safety profile.
Danish: Henvisning til andre eksisterende markedsføringstilladelser er desuden ikke relevant, da der er tale om forskellige målpopulationer og/eller sikkerhedsprofiler.
English: The application was submitted to the reference Member State (RMS): Austria and the concerned Member States (CMS): Denmark, Spain, Finland, France, Germany, Ireland, The Netherlands, Poland, Portugal, Sweden and the United Kingdom.
Danish: Ansøgningen blev fremsendt til referencemedlemsstaten, Østrig, og de berørte medlemsstater, Danmark, Spanien, Finland, Frankrig, Tyskland, Irland, Nederlandene, Polen, Portugal, Sverige og Det Forenede Kongerige.
English: The application in Germany was withdrawn during the DCP.
Danish: Ansøgningen i Tyskland blev trukket tilbage under den decentrale procedure.
English: The study duration should enable to conclude on efficacy and include at least 3 months of treatment and a predefined follow-up period.
Danish: Undersøgelsens varighed bør gøre det muligt at vurdere virkningen endegyldigt og bør omfatte mindst 3 måneders behandling og en prædefineret opfølgningsperiode.
English: However the experts acknowledged that it may be difficult to evaluate and to have successful results for both endpoints within the same trial design.
Danish: De anerkendte imidlertid, at det kan være vanskeligt at evaluere og opnå tilfredsstillende resultater for begge endepunkter inden for det samme forsøgsdesign.
English: Following the adoption of the CHMP Opinion during the June 2017 CHMP meeting, the applicant Debrégeas & Associés (D&A) requested a re-examination of the Opinion.
Danish: Efter at CHMP havde vedtaget en udtalelse på sit møde i juni 2017, anmodede ansøgeren, Debrégeas & Associés (D&A), om en revurdering af udtalelsen.
English: A stronger signal of efficacy was found in the most severe population which was a promising result as those patients are less prone to placebo response and have limited therapeutic options.
Danish: Der blev i den hårdest ramte population fundet et stærkt signal på virkning, hvilket er lovende, idet disse patienter er mindre tilbøjelige til at reagere på placebo og har begrænsede behandlingsmuligheder.
English: The experts noted that only a minority of those patients receive indeed a pharmacotherapy and usually only a limited proportion of them respond to these treatments.
Danish: Eksperterne bemærkede, at kun en lille del af disse patienter faktisk får en medicinsk behandling, og at det typisk kun er en begrænset andel af dem, som reagerer på disse behandlinger.
English: As the efficacy of the medicinal product is not established, the relevance of the risk minimization measures could not be confirmed.
Danish: Da lægemidlets effekt ikke er klarlagt, kan relevansen af de risikominimeringsforanstaltninger ikke bekræftes.
English: The experts agreed that psychiatric comorbidities in stabilised patients should not be an exclusion criterion, considering the high medical need in this patient group.
Danish: Eksperterne var enige om, at samtidige psykiatriske sygdomme hos stabiliserede patienter ikke bør være et eksklusionskriterium i betragtning af det store medicinske behov i denne patientgruppe.
English: Therefore, it would be advisable to monitor the cognitive adverse effects of sodium oxybate, particularly in patients with pre-existing cognitive impairments.
Danish: Det er derfor tilrådeligt at overvåge natriumoxybats kognitive bivirkninger, især hos patienter med eksisterende kognitive forstyrrelser.
English: The target population expected to benefit most should be refined based on the data available and expert advice.
Danish: Den målpopulation, der forventes at have størst gavn, bør præciseres på basis af de tilgængelige data og efter høring af eksperter.
English: Sodium oxybate is a partial agonist on both GABAA and GABAB receptors and also binds with high affinity to GHB-specific receptors.
Danish: Natriumoxybat er en partiel agonist for både GABAA- og GABAB-receptorerne og binder også med høj affinitet til de GHB-specifikke receptorer.
English: However, it was recognised that it could be useful from the clinical perspective to have a product that could be used in both settings (acute withdrawal and maintenance of abstinence).
Danish: De anerkendte dog, at det ud fra et klinisk synspunkt kunne være nyttigt at have et produkt, der kunne anvendes i begge indikationer (akutte abstinenssymptomer og vedligeholdelse af afholdenhed).
English: As the objections raised on the efficacy, safety and overall benefit-risk during the procedure were considered to be a potential serious risk to public health and no agreement could be reached during the CMDh procedure, the procedure was referred to the CHMP under Article 29(4) of Directive 2001/83/EC by the RMS Austria.
Danish: Da indvendingerne under proceduren mod lægemidlets effekt, sikkerhed og overordnede benefit/risk-forhold, blev anset for at udgøre en potentiel alvorlig risiko for folkesundheden, og da man ikke kunne nå til enighed under CMDh-proceduren, blev sagen indbragt for CHMP af referencemedlemsstaten, Østrig, i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF.
English: As none of the subgroup analyses had been pre-specified, these are inherently weakened by their post-hoc derived nature.
Danish: Da ingen af undergruppeanalyserne var blevet præspecificeret, svækkes disse i sig selv af at være foretaget post hoc.
English: Also experts were in favor of further monitoring the risk of seizures, particularly without convulsions.
Danish: Eksperterne var også positive over for yderligere overvågning af risikoen for anfald, især anfald uden kramper.
English: Risks of abuse / misuse are higher in polymedication users (cocaine or heroin) and/or patients with severe psychiatric comorbidities.
Danish: Risikoen for misbrug/fejlbrug er højere hos blandingsmisbrugere (kokain eller heroin) og/eller patienter med svære psykiske komorbiditeter.
English: Furthermore, it was noted by the CHMP that, despite the limited sample size in the clinical trials, this patient population cannot be considered as a ‘small population' as defined by the EMA Guideline on Clinical Trials in Small Populations (CHMP/EWP/83561/2005).
Danish: Derudover bemærker CHMP, at patientpopulationen på trods af den begrænsede populationsstørrelse i de kliniske undersøgelser ikke kan anses for at være en "lille population" som defineret i EMA's retningslinjer om kliniske forsøg med små populationer (Guideline on Clinical Trials in Small Populations (CHMP/EWP/83561/2005)).
English: Finally, it was noticed that it could be anticipated that long-term use of sodium oxybate might have effects on cognitive function.
Danish: Det blev også bemærket, at det kunne forventes, at langtidsbrug af natriumoxybat kan have en indvirkning på den kognitive funktion.
English: Furthermore, safety was considered to be acceptable taking into account the proposed risk minimisation measures (RMM).
Danish: Desuden vurderedes sikkerheden som værende acceptabel i betragtning af de anførte risikominimeringsforanstaltninger.
English: With regards to the treatment of acute withdrawal syndrome, the experts shared the views that there are well-established, evidence-based pharmacological treatments currently available, namely benzodiazepines, which are used throughout the European Union.
Danish: Hvad angår behandling af akutte abstinenssymptomer, var eksperterne enige om, at der er veletablerede, evidensbaserede farmakologiske behandlinger på markedet, nemlig benzodiazepiner, som anvendes i hele Den Europæiske Union.
English: The experts agreed that while the data currently available support a plausible effect and is encouraging, the strength of efficacy evidence is insufficient.
Danish: Eksperterne var enige om, at selvom de aktuelt tilgængelige data understøtter en plausibel virkning, hvilket er opløftende, så er styrken af evidens for virkning utilstrækkelig.
English: Regarding the outcome measures, the experts considered that data should be collected both on continuous abstinence and harm reduction.
Danish: Hvad angår målingen af resultater, fandt eksperterne, at der bør indsamles data både for fortsat afholdenhed og for skadesbegrænsning.
English: The experts considered that the company has generated an interesting hypothesis which requires confirmation in a prospective, well designed trial in the target population.
Danish: Eksperterne var af den opfattelse, at virksomheden havde fremsat en interessant hypotese, der kræver bekræftelse i en prospektiv, hensigtsmæssigt designet undersøgelse i målpopulationen.
English: Alcover granules in sachet contains the active substance sodium oxybate, which is the sodium salt of Gamma-hydroxybutyric acid (GHB), a derivative of gamma-aminobutyric acid (GABA).
Danish: Alcover-granulat i brev indeholder det aktive stof natriumoxybat, der er natriumsaltet i gammahydroxybutansyre (GHB), et derivativ af gammaaminobutansyre (GABA).
English: It was underlined, however, that the pharmacokinetics properties of the product may be unfavourable for substitution due to short half-life and from clinical perspective the complete abstinence may not always be achievable.
Danish: Det blev imidlertid understreget, at de farmakokinetiske egenskaber kan gøre lægemidlet uegnet til substitutionsbehandling, da halveringstiden er kort, og da det ud fra et klinisk perspektiv ikke altid er muligt at opnå fuldstændig afholdenhed.
English: Grounds for the CHMP opinion following the re-examination procedure
Danish: Begrundelse for CHMP's udtalelse efter revurderingsproceduren
English: However, the conduct of the proposed post-authorisation study would not impact or change the Committee's conclusion that the efficacy of the medicinal product is not established.
Danish: Gennemførelsen af en sådan effektundersøgelse efter markedsføringstilladelse ville imidlertid ikke påvirke eller ændre udvalgets konklusion om, at lægemidlets effekt ikke er klarlagt.