FrancophonIA/ELRC3.0 huggingface dataset:
English: Although Pandemic influenza vaccine H5N1 AstraZeneca might increase wheezing in children aged 1 to 2 years, the risk is considered acceptable in a pandemic situation.
Danish: Selv om Pandemisk influenzavaccine H5N1 AstraZeneca kan øge forekomsten af hvæsende vejrtrækning hos børn i alderen 1-2 år, anses risikoen for at være acceptabel under en pandemi.
English: Since Pandemic influenza vaccine H5N1 AstraZeneca has been granted a conditional approval, the company that markets Pandemic influenza vaccine H5N1 AstraZeneca will conduct studies to gather more information on its effectiveness and side effects during its use in a pandemic as well as its shelf life.
Danish: Da Pandemisk influenzavaccine H5N1 AstraZeneca har fået en betinget godkendelse, skal virksomheden, der markedsfører Pandemisk influenzavaccine H5N1 AstraZeneca, gennemføre undersøgelser for at indsamle yderligere information om vaccinens virkning og bivirkninger ved brug under en pandemi samt om dens holdbarhed.
English: Three main studies involving 107 adults found that Pandemic influenza vaccine H5N1 AstraZeneca was able to prepare the immune system to defend itself against the H5N1 virus strain in individuals who had never come into contact with it. Antibodies against this type of vaccine are not easy to measure.
Danish: Tre hovedundersøgelser, der omfattede 107 voksne, har vist, at Pandemisk influenzavaccine H5N1 AstraZeneca kan forberede immunsystemet på at forsvare kroppen mod H5N1-virusstammen hos personer, der ikke tidligere har været eksponeret for den.
English: This is a summary of the European public assessment report (EPAR) for Pandemic influenza vaccine H5N1 AstraZeneca.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pandemisk influenzavaccine H5N1 AstraZeneca.
English: This showed that antibodies against Pandemic influenza vaccine H5N1 AstraZeneca increased substantially when vaccinated adults came into contact with the virus again.
Danish: Dette viser, at antistofferne mod Pandemisk influenzavaccine H5N1 AstraZeneca stiger betydeligt, når vaccinerede voksne eksponeres for virusset igen.
English: Previously known as Pandemic influenza vaccine H5N1 MedImmune
Danish: Tidligere kaldet Pandemisk influenzavaccine H5N1 MedImmune
English: When a child is given the vaccine, the immune system recognises the weakened virus in the vaccine as foreign and makes antibodies against it.
Danish: Når et barn vaccineres, opfatter immunsystemet det svækkede virus i vaccinen som "fremmed" og danner antistoffer mod det. Immunsystemet vil derefter være i stand til hurtigere at danne antistoffer, når det eksponeres for samme virus igen.
English: For more information about prevention of influenza with Pandemic influenza vaccine H5N1 AstraZeneca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pandemisk influenzavaccine H5N1 AstraZeneca, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Pandemic influenza vaccine H5N1 AstraZeneca has been given ‘conditional approval'.
Danish: Pandemisk influenzavaccine H5N1 AstraZeneca har fået en "betinget godkendelse".
English: For practical information about using Pandemic influenza vaccine H5N1 AstraZeneca, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pandemisk influenzavaccine H5N1 AstraZeneca, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: This is further supported by data in children given similar seasonal and pandemic live attenuated flu vaccines in large studies and in clinical practice.
Danish: Dette understøttes yderligere af data fra omfattende undersøgelser og klinisk praksis, hvor børn og unge har fået lignende levende, svækkede vacciner mod sæsonbestemt eller pandemisk influenza.
English: It is not intended to provide practical advice on how to use Pandemic influenza vaccine H5N1 AstraZeneca.
Danish: Det er ikke en praktisk vejledning i, hvordan Pandemisk influenzavaccine H5N1 AstraZeneca bør anvendes.
English: What measures are being taken to ensure the safe and effective use of Pandemic influenza vaccine H5N1 AstraZeneca?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pandemisk influenzavaccine H5N1 AstraZeneca?
English: Other information about Pandemic influenza vaccine H5N1 AstraZeneca
Danish: Andre oplysninger om Pandemisk influenzavaccine H5N1 AstraZeneca
English: Testing this pandemic preparedness vaccine helps to predict how people will react to the vaccine at the time of a pandemic, when the virus strain in the vaccine will be replaced by a weakened version of the actual strain causing the pandemic.
Danish: Afprøvningen af denne beredskabsvaccine er med til at forudsige, hvordan mennesker vil reagere på den, hvis der udbryder en pandemi.
English: For the full list of all side effects reported with Pandemic influenza vaccine H5N1 AstraZeneca, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Pandemisk influenzavaccine H5N1 AstraZeneca fremgår af indlægssedlen.
English: What is Pandemic influenza vaccine H5N1 AstraZeneca and what is it used for?
Danish: Hvad er Pandemisk influenzavaccine H5N1 AstraZeneca, og hvad anvendes den til?
English: pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Danish: Pandemisk influenzavaccine H5N1 AstraZeneca pandemisk influenzavaccine (H5N1) (levende svækket, nasal)
English: What information is still awaited for Pandemic influenza vaccine H5N1 AstraZeneca?
Danish: Hvilke oplysninger afventes der stadig for Pandemisk influenzavaccine H5N1 AstraZeneca?
English: Why is Pandemic influenza vaccine H5N1 AstraZeneca approved?
Danish: Hvorfor blev Pandemisk influenzavaccine H5N1 AstraZeneca godkendt?
English: Pandemic influenza vaccine H5N1 AstraZeneca is a pandemic preparedness vaccine.
Danish: Pandemisk influenzavaccine H5N1 AstraZeneca er en beredskabsvaccine til håndtering af en pandemi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pandemic influenza vaccine H5N1 AstraZeneca have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pandemisk influenzavaccine H5N1 AstraZeneca.
English: What are the risks associated with Pandemic influenza vaccine H5N1 AstraZeneca?
Danish: Hvilke risici er der forbundet med Pandemisk influenzavaccine H5N1 AstraZeneca?
English: Pandemic influenza vaccine H5N1 AstraZeneca is available as a nasal spray.
Danish: Pandemisk influenzavaccine H5N1 AstraZeneca fås som næsespray.
English: How does Pandemic influenza vaccine H5N1 AstraZeneca work?
Danish: Hvordan virker Pandemisk influenzavaccine H5N1 AstraZeneca?
English: How is Pandemic influenza vaccine H5N1 AstraZeneca used?
Danish: Hvordan anvendes Pandemisk influenzavaccine H5N1 AstraZeneca?
English: What benefits of Pandemic influenza vaccine H5N1 AstraZeneca have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Pandemisk influenzavaccine H5N1 AstraZeneca?
English: These changes were agreed accordingly.
Danish: Disse ændringer blev vedtaget.
English: Plendil has been approved through national procedures in the following countries in the European Economic Area (EEA): Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden and the United Kingdom.
Danish: Plendil er godkendt ved nationale procedurer i følgende lande i Det Europæiske Økonomiske Samarbejdsområde (EØS): Østrig, Belgien, Bulgarien, Kroatien, Cypern, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Spanien, Sverige og Det Forenede Kongerige.
English: The following wording was agreed:
Danish: Der blev vedtaget følgende ordlyd:
English: This formulation was available until 1994, though only launched in Australia.
Danish: Denne formulering var tilgængelig indtil 1994, men blev kun lanceret i Australien.
English: Overall summary of the scientific evaluation of Plendil and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Plendil og relaterede navne (se bilag I)
English: The CHMP therefore considers it necessary to include the following text in Section 4.4, including a reference to Section 4.5:
Danish: CHMP finder derfor behov for at indsætte følgende tekst i punkt 4.4, herunder en henvisning til punkt 4.5:
English: The CHMP requested some additional wordings.
Danish: CHMP anmodede om visse supplerende formuleringer.
English: Section 4.1 - Therapeutic Indications Plendil is indicated for:
Danish: Punkt 4.1 - Terapeutiske indikationer Plendil er indiceret til:
English: This method generates the Empirical Bayesian Geometric Mean (EBGM) with a 90% confidence interval (EB05 to EB95).
Danish: Ved metoden beregnes Empirical Bayesian Geometric Mean (EBGM) med 90 % sikkerhedsinterval (EB05 til EB95).
English: • stable angina pectoris.
Danish: • stabil angina pectoris
English: There are no data on the effects of felodipine on patient fertility.
Danish: Der foreligger ingen data om virkningerne af felodipin på patienternes fertilitet.
English: Therefore such combinations should be avoided (see section 4.5).'
Danish: Sådanne kombinationer bør derfor undgås (se pkt.
English: Plendil was originally approved for marketing in Denmark on 16 March 1987, as an immediate release tablet.
Danish: Plendil blev oprindeligt godkendt til markedsføring i Danmark den 16. marts 1987 som tabletter med hurtig frigivelse.
English: Today, Plendil is available worldwide for oral administration as a prolonged release tablet (except in Japan where another immediate release tablet is marketed).
Danish: I dag markedsføres Plendil i hele verden til oral administration som depottabletter (bortset fra Japan, hvor der markedsføres en anden tablet med hurtig frigivelse).
English: If patients taking felodipine suffer from headache, nausea, dizziness or fatigue the ability to react may be impaired.
Danish: Hvis patienter, der tager Plendil, lider af svimmelhed, hovedpine, træthed eller kvalme, kan reaktionsevnen være nedsat.
English: Some MSs were missing a text referring to absorption, distribution, metabolism and elimination.
Danish: I nogle medlemsstater manglede en tekst med omtale af absorption, fordeling, metabolisering og udskillelse.
English: In Europe, the prolonged release tablet was first approved in December 1987 and was first launched in Denmark in 1988.
Danish: I Europa blev depottabletten første gang godkendt i december 1987 og første gang lanceret i Danmark 1988.
English: The final agreed wording is as follows: ‘Felodipine should not be given during pregnancy.
Danish: Den vedtagne endelige ordlyd er: “Plendil bør ikke anvendes under graviditet.
English: The prolonged release tablet is available in three tablet strengths 2.5mg, 5mg and 10mg.
Danish: Depottabletten fås i de tre styrker, nemlig 2,5 mg, 5 mg og 10 mg.
English: Searches were also conducted in the FDA Adverse Event Reporting System (AERS) database and in the WHO Vigibase database.
Danish: Der blev desuden er søgt i databasen FDA Adverse Event Reporting System (AERS) og i databasen
English: Plendil can also be used in the treatment of vasospastic (Prinzmetal's) angina”.
Danish: Plendil kan desuden anvendes til behandling af vasospastisk (Prinzmetals) angina”.
English: The divergences were due to differences in the indication, recommendation in maximum daily dose and down titration.
Danish: Afvigelserne bestod i forskelle i indikationen og anbefalingen for maksimal dagsdosis og nedtitrering.
English: For the indication “stable angina pectoris” there were several divergences.
Danish: For indikationen “stabil angina pectoris” var der en række afvigelser.
English: Section 4.6 - Fertility, pregnancy and lactation The wording in section 4.6 was divergent.
Danish: Punkt 4.6 - Fertilitet, graviditet og amning Ordlyden i punkt 4.6 var divergerende.
English: • the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: • Det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaverne af markedsføringstilladelse, blev vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelse i udvalget.
English: − UK/W/002/pdWS/001 Article 45 Paediatric Workshare, finalised 15 October 2009.
Danish: − UK/W/002/pdWS/001, pædiatrisk artikel 45-arbejdsdelingsprocedure afsluttet den 15. oktober
English: The proposal for the harmonised EU SmPC is based on the CPS from 2011 and CDS from October 2012.
Danish: Forslaget til det harmoniserede EU-produktresumé er baseret på den centrale sikkerhedsprofil fra 2011 og det centrale datablad fra oktober 2012.
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Plendil and associated names (see Annex I).
Danish: anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Plendil og relaterede navne (se bilag I).
English: It is expected that the patient has been informed to seek medical advice in that situation, and that all aspects of therapies are considered, included actions to be taken regarding discontinuation of felodipine treatment.
Danish: De må forventes, at patienten i denne situation er blevet tilrådet at søge lægelig vejledning, og at alle aspekter af behandlingen overvejes, herunder tiltag til seponering af felodipin.
English: Three European procedures have been completed leading to agreed wording in Plendil Summary of Product Characteristics (SmPCs):
Danish: Der er gennemført tre europæiske procedurer, som har ført til den vedtagne ordlyd af produktresuméet for Plendil:
English: There were also discrepancies regarding recommendations for special population groups namely elderly and paediatric, renal and hepatic impairment, administration with/ without food.
Danish: Der var desuden afvigelser vedrørende anbefalingerne for særlige patientgrupper, dvs. ældre, pædiatriske patienter og patienter med nedsat nyre- og leverfunktion, samt administration sammen med eller mellem måltider.
English: When taken in therapeutic doses by the nursing mother it is, however, not likely to affect the infant”.
Danish: Ved terapeutiske doser til den ammende moder forventes dette dog ikke at påvirke barnet”.
English: The wording for hypertension was divergent in all EU MSs.
Danish: Ordlyden vedrørende hypertension afveg i alle EU's medlemsstater.
English: Felodipine is a dihydropyridine-type calcium channel blocker (calcium antagonist) and is indicated for the control of hypertension and in many countries also for the treatment of stable angina pectoris.
Danish: Felodipin er en calciumkanalblokker (calciumantagonist) af dihydropyridintypen, der er indiceret til kontrol af hypertension og i mange lande desuden til behandling af stabil angina pectoris.
English: In a nonclinical reproductive study in the rat (see section 5.3), there were effects on fetal development but no effect on fertility at doses approximating to therapeutic.
Danish: I en præklinisk reproduktionsundersøgelse hos rotter (se punkt 5.3) fandtes påvirkning af fosterudviklingen, men ingen påvirkning af fertiliteten, ved doser tilnærmelsesvis svarende til de terapeutiske.
English: The MAH considered an EB05 >1.8 a possible signal i.e. the event is reported disproportional often in association with that drug.
Danish: Indehaveren af markedsføringstilladelsen anså EB05 >1,8 for at være et muligt signal om, at hændelsen indberettes uforholdsmæssigt ofte i forbindelse med det pågældende lægemiddel.
English: The total published experience of felodipine in vasospastic angina pectoris and the accumulated safety information is too limited to define a robust benefit risk ratio.
Danish: De publicerede erfaringer med felodipin ved vasospastisk angina pectoris og de akkumulerede sikkerhedsoplysninger er for begrænsede til fastlæggelse af et pålideligt benefit/risk-forhold.
English: ‘Concomitant administration of drugs that strongly induce or inhibit CYP3 A4 enzymes result in extensively decreased or increased plasma levels of felodipine, respectively.
Danish: “Samtidig administration af lægemidler, der virker kraftigt inducerende eller hæmmende på CYP3 A4-enzymer, medfører henholdsvis stærkt nedsat og forhøjet plasmakoncentration af felodipin.
English: − SK/H/PSUR/0006/002, PSUR (01 Jan 2010 to 31 Dec 2012), finalised 4 December 2013 and where no changes to the Product Information were proposed.
Danish: − SK/H/PSUR/0006/002, PSUR (1. januar 2010 til 31. december 2012) afsluttet den 4. december 2013, uden at produktoplysningerne blev foreslået ændret.
English: Some MSs were missing text from the CSP and some MSs had different text.
Danish: Hos nogle medlemsstater manglede der tekst fra CSP, og hos nogle afveg teksten.
English: The use in combination with potent inhibitors or inducers of CYP3A4 is more appropriately addressed in sections 4.5 and 5.2 of the MAH proposal for a harmonised EU SmPC for Plendil.
Danish: Anvendelse i kombination med potente inhibitorer eller induktorer af CYP3A4 bør mere passende omtales i punkt 4.5 og 5.2 af det harmoniserede EU-produktresumé for Plendil, der foreslås af indehaveren af markedsføringstilladelsen.
English: − SK/H/PSUR/0006/001, PSUR (01 Jan 2007 to 31 Dec 2009), finalised 20 October 2011 with agreed Core Safety Profile (CSP).
Danish: − SK/H/PSUR/0006/001, PSUR (1. januar 2007 til 31. december 2009) afsluttet den 20. oktober 2011 med vedtagelsen af den centrale sikkerhedsprofil (CSP).
English: The CHMP endorsed the MAH proposal of having “Hypertension” as the wording for this indication.
Danish: CHMP godkendte indehaveren af markedsføringstilladelsens forslag om “Hypertension” som ordlyd til denne indikation.
English: The results of the conducted studies on felodipine in vasospastic angina show an effect on the condition, as there are improvements in angina symptoms and reductions or disappearance of transient ST-segment elevations at hyperventilation or systemic ergonovine provocation.
Danish: Undersøgelser med felodipin ved vasospastisk angina viser virkning på denne tilstand, med bedring i anginasymptomer og reduktion eller forsvinden af forbigående ST-forhøjelse ved provokation med hyperventilation eller systemisk ergonovin.
English: Due to the divergent national decisions taken by Member States (MS) concerning the authorisation of Plendil and its associated names, these products were included in the list of products for SmPC harmonisation, requested by the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: På grund af divergerende nationale afgørelser blandt medlemsstaterne om godkendelsen af Plendil og relaterede navne blev lægemidlerne optaget på listen over lægemidler til harmonisering af produktresuméet efter anmodning fra koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)).
English: Modifications relate to deletion of unnecessary and outdated wording, table format and addition of Hypotension as an adverse drug reaction (ADR).
Danish: Ændringerne består i sletning af overflødige og forældede formuleringer, det anvendte tabelformat og tilføjelsen af hypotension som bivirkning.
English: Section 4.7 - Effects on ability to drive and use machines The CHMP proposed an alternative text in line with amlodipine harmonised SmPC for this section: “Felodipine can have minor or moderate influence on the ability to drive and use machines.
Danish: Punkt 4.7 - Virkning på evnen til at føre motorkøretøj og betjene maskiner CHMP foreslog en alternativ tekst svarende til samme punkt i det harmoniserede produktresumé for amlodipin: “Felodipin kan påvirke evnen til at føre motorkøretøj eller betjene maskiner i mindre til moderat grad.
English: The initial proposal from the MAH for the EU harmonised wording on Breastfeeding was “Felodipine is detected in breast milk.
Danish: Indehaveren af markedsføringstilladelsens indledende forslag til den EU-harmoniserede ordlyd om amning var: “Felodipin genfindes i modermælk.
English: The different MSs had “stable angina pectoris and vasospastic angina (variant of Prinzmetal's angina)”, “Prophylaxis of angina pectoris (stable and vasospastic forms)”, “Angina pectoris” and “Stable exertional angina pectoris; Plendil can be given as monotherapy or can be combined with a beta blocker.
Danish: De forskellige medlemsstater anvendte ordlyden “stabil angina pectoris og vasospastisk angina (variant af Prinzmetals angina)”, “profylakse af angina pectoris (stabil og vasospastisk form)”, “angina pectoris” og “stabil, anstrengelsesudløst angina pectoris; Plendil kan anvendes som monoterapi eller i kombination med en betablokker.
English: The MAH included the information regarding the preclinical data, and subsequent text added to state that it cannot be stated with certainty that the pharmacological effects are not relevant for humans.
Danish: Indehaveren af markedsføringstilladelsen indsatte oplysninger om prækliniske data og tilføjede en efterfølgende tekst om, at det ikke med sikkerhed kan fastslås, at de farmakologiske virkninger er uden relevans for mennesker.
English: A pre-referral meeting between the EMA and marketing authorisation holder (MAH) was held on 14 October 2013.
Danish: Den 14. oktober 2013 holdt EMA og indehaveren af markedsføringstilladelsen et forberedende møde til indbringelsen.
English: The CHMP endorses the MAH proposal in adopting the CPS text as the harmonised text, deleting text that is not present in the referred document.
Danish: CHMP støtter indehaveren af markedsføringstilladelsens forslag om at anvende teksten i den centrale sikkerhedsprofil som den harmoniserede tekst og slette tekst, der ikke står i det omtalte dokument.
English: The CHMP asked the MAH to comment on the following contraindications: stroke in the past 6 months, Hypertrophic cardiomyopathy, Atrioventricular block grade 2 and 3, Severe renal impairment (GFR <30 ml/min, creatinine > 1.8 mg/dl), Severe hepatic impairment/liver cirrhosis, Breast-feeding women/breast feeding infants and treatment with calcium channel blockers.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om at kommentere følgende kontraindikationer: Apopleksi inden for de seneste 6 foregående måneder, hypertrofisk kardiomyopati, atrioventrikulært blok af grad 2 og 3, svært nedsat nyrefunktion (GFR <30 ml/min, kreatinin > 1,8 mg/dl), svær leverfunktionsnedsættelse/levercirrhose, amning/brystbørn og behandling med calciumantagonister.
English: The MAH agreed to remove the parts suggested by the CHMP.
Danish: Indehaveren af markedsføringstilladelserne samtykkede i at fjerne de dele, der var angivet af CHMP.
English: The CHMP addressed a list of questions to the MAH, pointing out the sections of the products SmPC where divergences existed.
Danish: CHMP stillede en række spørgsmål til indehaveren af markedsføringstilladelsen og påpegede de afsnit i produktresuméet, hvor der var divergenser.