FrancophonIA/ELRC3.0 huggingface dataset:
English: It contains parts of the hepatitis B virus as the active substance.
Danish: Den indeholder dele af hepatitis B-virusset som det aktive stof.
English: The European Commission granted a marketing authorisation valid throughout the European Union for HBVaxPro to Sanofi Pasteur MSD SNC on 27 April 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for HBVaxPro den 27. april 2001.
English: HBVaxPro is used to vaccinate against hepatitis B in people who are at risk of exposure to the hepatitis B virus, as determined on the basis of official recommendations.
Danish: HBVaxPro anvendes til at vaccinere imod hepatitis B hos mennesker, som risikerer at blive udsat for hepatitis B-virus som fastlagt på basis af officielle anbefalinger.
English: When a person is given the vaccine, the immune system recognises the surface antigens as ‘foreign' and makes antibodies against them.
Danish: Når en person vaccineres, opfatter immunsystemet overfladeantigenerne som "fremmede" og reagerer ved at danne antistoffer imod dem.
English: For more information about treatment with HBVaxPro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med HBVaxPro, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This included the vaccines that contain the same active substance as HBVaxPro.
Danish: Dette omfattede også de vacciner, som indeholder de samme aktive stoffer som HBVaxPro.
English: The most common side effects with HBVaxPro (seen in between 1 and 10 patients in 100) are reactions at the injection site, including temporary soreness, erythema (redness) and induration (hardening).
Danish: De hyppigste bivirkninger ved HBVaxPro (som optræder hos mellem 1 og 10 patienter ud af 100) er reaktioner på injektionsstedet, inklusive forbigående ømhed, erythem (rødme) og induration (forhærdning).
English: HBVaxPro contains small amounts of ‘surface antigens' (proteins from the surface) of the hepatitis B virus.
Danish: HBVaxPro indeholder små mængder "overfladeantigener" (proteiner fra overfladen) af hepatitis B-virus.
English: The surface antigens in HBVaxPro are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Danish: Overfladeantigenerne i HBVaxPro fremstilles ved hjælp af en metode, der kaldes "rekombinant DNAteknologi", dvs. de fremstilles af gær, som har modtaget et gen (DNA), der sætter den i stand til at danne proteiner.
English: The company provided information comparing other vaccines with and without thiomersal, including studies of a vaccine that contains the same active substance as HBVaxPro.
Danish: Virksomheden har indsendt oplysninger, som sammenlignede andre vacciner med og uden thiomersal, herunder undersøgelser af en vaccine, som indeholder det samme aktive stof som HBVaxPro.
English: HBVaxPro should not be given to people who may be hypersensitive (allergic) to the active substance or any of the other ingredients including substances present at very low (trace) levels, such as formaldehyde and potassium thiocyanate, used in the manufacture of the vaccine.
Danish: HBVaxPro må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne, herunder stoffer, som er til stede i meget lave mængder såsom formaldehyde og kaliumthiocyanat, der anvendes ved fremstilling af vaccine.
English: HBVaxPro is a vaccine.
Danish: HBVaxPro er en vaccine.
English: HBVaxPro was specifically developed from a vaccine that was already in use in the European Union (EU), in order to produce a vaccine that does not contain the preservative thiomersal.
Danish: HBVaxPro blev specifikt udviklet på basis af en vaccine, som allerede var i brug i Den Europæiske Union, for at fremstille en vaccine, der ikke indeholder konserveringsstoffet thiomersal.
English: Other information about HBVaxPro
Danish: Andre oplysninger om HBVaxPro
English: The higher strength (40 micrograms/ml) is used in patients who are undergoing or are about to undergo dialysis (a blood clearance technique).
Danish: Den laveste styrke anvendes til alle patienter, undtagen dem, som er i eller skal til at have dialyse (en teknik til rensning af blodet).
English: The results of the studies presented showed that the thiomersal-free vaccines produced protective levels of antibodies against hepatitis B virus to a similar extent to the vaccines that contained thiomersal at the end of the vaccination course.
Danish: Resultaterne af de fremlagte undersøgelser viste, at de thiomersalfrie vacciner ved afslutningen af vaccinationsforløbet gav samme mængde antistoffer, der beskytter imod hepatitis B-virus, som de vacciner, der indeholdt thiomersal.
English: For the full list of all side effects reported with HBVaxPro, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved HBVaxPro fremgår af indlægssedlen.
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 HBVaxPro.
Danish: Det forklarer, hvordan agenturet vurderede lægemidlet for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne.
English: Why has HBVaxPro been approved?
Danish: Hvorfor blev HBVaxPro godkendt?
English: What is the risk associated with HBVaxPro?
Danish: Hvilke risici er der forbundet med HBVaxPro?
English: HBVaxPro is a vaccine, which is available as a suspension for injection in vials and pre-filled syringes.
Danish: HBVaxPro leveres som injektionsvæske (suspension) i hætteglas og fyldte- sprøjter.
English: How is HBVaxPro used?
Danish: Hvordan anvendes HBVaxPro?
English: What is HBVaxPro used for?
Danish: Hvad er HBVaxPro, og hvad anvendes den til?
English: What benefit has HBVaxPro shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved HBVaxPro?
English: How does HBVaxPro work?
Danish: Hvordan virker HBVaxPro?
English: 27 March 2015 EMA/149624/2015
Danish: 27. marts 2015 EMA/149624/2015
English: The review of hydroxyzine was initiated on 25 April 2014 at the request of Hungary, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af hydroxyzin blev indledt den 25. april 2014 på anmodning af Ungarn i medfør af artikel 31 i direktiv 2001/83/EF.
English: Hydroxyzine-containing medicines have been authorised by national procedures in 22 Member States of the EU (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden and United Kingdom) plus Norway and Iceland.
Danish: Lægemidler indeholdende hydroxyzin er godkendt ved nationale procedurer i 22 EU-medlemsstater (Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Luxembourg, Malta, Nederlandene, Polen, Portugal, Slovakiet, Spanien, Sverige og Det Forenede Kongerige) samt Norge og Island.
English: The data showed that the risk did not differ between indications.
Danish: Dataene viste, at risikoen ikke afveg for forskellige indikationer.
English: These medicines are available under various trade names including Atarax.
Danish: Lægemidlerne fås under forskellige handelsnavne, herunder Atarax.
English: They are used generally by mouth or sometimes by injection.
Danish: Lægemidlerne tages sædvanligvis gennem munden, men undertiden ved injektion.
English: For similar reasons, it was recommended that the treatment duration should be as short as possible.
Danish: Af tilsvarende grunde anbefaledes kortest mulig behandlingsvarighed.
English: In the meantime, patients who have any concerns should speak to their doctor or pharmacist.
Danish: I mellemtiden bør patienter, der har spørgsmål eller betænkeligheder, tale med lægen eller apotekspersonalet.
English: The new measures will now be implemented according to an agreed timetable in the individual EU countries.
Danish: De nye foranstaltninger vil nu blive indført i de enkelte EU-lande i overensstemmelse med den vedtagne tidsplan.
English: This potential risk was confirmed by clinical and post-marketing data.
Danish: Denne potentielle risiko bekræftes af kliniske data og data efter markedsføring.
English: • The package leaflet and other product information for these medicines will be updated to take account of the new measures.
Danish: • Indlægssedlen og den øvrige produktinformation for disse lægemidler skal ajourføres under hensyn til de nye foranstaltninger.
English: A letter explaining the changes will be sent to healthcare professionals.
Danish: Der vil blive udsendt et brev til sundhedspersoner, hvor der redegøres for ændringerne.
English: As hydroxyzine-containing medicines are all authorised nationally, the PRAC recommendation was forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), for a position.
Danish: Da lægemidler indeholdende hydroxyzin alle er godkendt nationalt, blev PRAC's anbefaling overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh), med henblik på fremsættelse af en udtalelse.
English: The CMDh is a regulatory body representing EU Member States plus Iceland, Liechtenstein and Norway, and is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMDh repræsenterer EU's medlemsstater samt Island, Liechtenstein og Norge og har ansvaret for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
English: The risk is mostly seen in patients who already have heart rhythm problems or have risk factors for these problems.
Danish: Denne risiko gælder hovedsagelig patienter, der i forvejen har hjerterytmeproblemer eller har risikofaktorer for sådanne problemer.
English: Hydroxyzine medicines are available in most EU countries.
Danish: Lægemidler indeholdende hydroxyzin fås i de fleste EU-lande.
English: It should be used with care if taking certain other medicines that slow the heart rate or decrease the level of potassium in the blood.
Danish: Det bør anvendes med forsigtighed, hvis man får visse andre lægemidler, der nedsætter i hjerterytmen eller nedsætter kaliumindholdet i blodet.
English: On 25 March 2015 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Danish: Den 25. marts 2015 vedtog CMDh udtalelsen enstemmigt, og de af PRAC anbefalede foranstaltninger vil nu blive gennemført direkte af de medlemsstater, hvor lægemidlerne er godkendt, i henhold til en vedtagen tidsplan.
English: Most cases had other risk factors, electrolyte abnormalities or concomitant treatment that may have been contributory.
Danish: I størstedelen af tilfældene forelå der andre risikofaktorer, elektrolytforstyrrelser eller sideløbende behandling, som kan have været medvirkende.
English: • Medicines containing the antihistamine hydroxyzine are available in most EU countries.
Danish: • Lægemidler indeholdende antihistaminet hydroxyzin fås i de fleste EU-lande.
English: The above risk minimisation measures were taken following an assessment of the available evidence, including published studies and data from regular safety monitoring.
Danish: Ovenstående risikohåndteringsforanstaltninger blev truffet efter en vurdering af den foreliggende evidens, herunder offentliggjorte undersøgelser og data fra rutinemæssig sikkerhedsovervågning.
English: In particular, the product information of hydroxyzine-containing medicines will be updated with new dosing recommendations and warnings on use in patients who have risk factors for heart rhythm disturbances or who are taking certain other medicines.
Danish: Navnlig skal produktinformationen for lægemidler indeholdende hydroxyzin ajourføres med nye dosisanbefalinger og advarsler om anvendelse hos patienter, som har risikofaktorer for hjerterytmeforstyrrelser eller får visse andre lægemidler.
English: • Hydroxyzine must not be taken by patients who already have disturbances of heart rhythm or are taking other medicines that can cause similar effects on the heart.
Danish: • Hydroxyzin må ikke tages af patienter, der i forvejen har hjerterytmeforstyrrelser eller får andre lægemidler med tilsvarende virkning på hjertet.
English: • To reduce the risk to a minimum, new measures have been agreed for these medicines to ensure they are used for as short a time as possible at the lowest effective dose, and that their use is avoided in those at higher risk.
Danish: • For at mindske risikoen mest muligt er der vedtaget nye foranstaltninger, der sikrer, at disse lægemidler anvendes i kortest mulig tid i laveste effektive dosis, og at de ikke anvendes hos patienter med forhøjet risiko.
English: • Hydroxyzine has the potential to block hERG channels and other types of cardiac channels, resulting in a potential risk of QT interval prolongation and cardiac arrhythmia events.
Danish: • Hydroxyzin har potentiale for at blokere hERG-kanaler og andre typer kardiale kanaler med deraf følgende risiko for QT-forlængelse og arytmier.
English: The CMDh1 has agreed by consensus new measures to minimise the risk of effects on heart rhythm with medicines containing the antihistamine hydroxyzine.
Danish: CMDh1 har enstemmigt vedtaget nye foranstaltninger, der skal minimere risikoen for påvirkning af hjerterytmen fra lægemidler indeholdende antihistaminet hydroxyzin.
English: • The potential risk of QT interval prolongation and torsades de pointes can therefore be adequately minimised through measures targeting the identified risk factors and restricting the use of hydroxyzine to the lowest effective dose for the shortest possible duration.
Danish: • Den potentielle risiko for QT-forlængelse og torsade de pointes kan derfor minimeres tilstrækkeligt ved foranstaltninger over for de konstaterede risikofaktorer og ved begrænsning af anvendelsen af hydroxyzin til laveste effektive dosis i kortest mulige tid.
English: It was considered appropriate to restrict the maximum daily dose in adults, with corresponding changes in the paediatric and elderly populations based on pharmacokinetic data, in order to minimise exposure.
Danish: Til minimering af eksponeringen blev det fundet hensigtsmæssigt at begrænse den maksimale daglige dosis til voksne og indføre tilsvarende ændringer for den pædiatriske og ældre population på grundlag af farmakokinetiske data.
English: Care is also required when hydroxyzine is co-administered with drugs known to be potent inhibitors of alcohol dehydrogenase or CYP3A4/5.
Danish: Forsigtighed bør endvidere udvises ved samtidig administration af hydroxyzin og lægemidler, der er potente hæmmere af alkoholdehydrogenase eller CYP3A4/5.
English: The SmPC and package leaflet of the affected medicines will be amended accordingly.
Danish: Produktresuméet og indlægssedlen for de omfattede lægemidler vil blive ændret tilsvarende.
English: • Use of hydroxyzine is contraindicated in patients with known acquired or congenital QT interval prolongation, or with a known risk factor for QT interval prolongation such as cardiovascular disease, significant electrolyte imbalance (hypokalaemia, hypomagnesaemia), family history of sudden cardiac death, significant bradycardia, or concomitant use of drugs known to prolong the QT interval and/or induce torsades de pointes.
Danish: • Hydroxyzin er kontraindiceret ved kendt erhvervet eller kongenit forlænget QT-interval, ved kendte risikofaktorer for forlænget QT-interval såsom kardiovaskulær sygdom, nævneværdige elektrolytforstyrrelser (hypokaliæmi, hypomagnesiæmi), ved familiær anamnese med pludselig hjertedød, ved nævneværdig bradykardi eller ved sideløbende anvendelse af lægemidler, der forlænger QT-intervallet og/eller forårsager torsade de pointes.
English: The medicine should be used with caution in patients with bradycardia, or who are taking hypokalaemia-inducing medicines.
Danish: Forsigtighed bør udvises ved anvendelse hos patienter, som har bradykardi eller er i behandling med hypokaliæmi-inducerende lægemidler.
English: • In countries where the medicines are approved for use in children, the maximum dose depends on their weight, and the daily total should not be more than 2 mg per kg of body weight in children weighing up to 40 kg (children over 40 kg should be given the adult dose).
Danish: • I lande, hvor lægemidlerne er godkendt til børn, afhænger den maksimale dosis af barnets vægt, og den samlede dagsdosis må ikke være over 2 mg/kg legemsvægt for børn på op til 40 kg (børn over 40 kg skal have samme dosis som voksne).
English: The measures include restricting use of hydroxyzine in patients at high risk of heart rhythm problems and using the medicine at the lowest effective dose for as short a time as possible.
Danish: Foranstaltningerne består i, at anvendelsen af hydroxyzin begrænses hos patienter med høj risiko for hjerterytmeproblemer, og at der skal anvendes den laveste effektive dosis i kortest mulig tid.
English: The PRAC therefore recommended that the risk be managed by restricting hydroxyzine use in those most at risk of heart rhythm problems and reducing exposure to the medicine.
Danish: PRAC anbefalede derfor, at risikoen imødegås ved at begrænse anvendelsen af hydroxyzin hos de patienter, der har størst risiko for hjerterytmeproblemer, og ved at nedsætte eksponeringen for lægemidlet.
English: As the CMDh has now agreed the PRAC measures by consensus, the measures will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Danish: Da CMDh nu har vedtaget PRAC's anbefalinger enstemmigt, skal de i henhold til en vedtagen tidsplan gennemføres direkte af de medlemsstater, hvor lægemidlerne er godkendt.
English: • Use is not recommended in elderly patients, due to reduced elimination of hydroxyzine in these patients and greater vulnerability to anticholinergic effects and other adverse reactions.
Danish: • Anvendelse hos ældre frarådes pga. nedsat udskillelse af hydroxyzin og øget sårbarhed for antikolinerge virkninger og andre bivirkninger.
English: • The maximum daily dose in children up to 40 kg in weight should be 2 mg/kg/day; children over 40 kg should be given the adult dose.
Danish: • Maksimaldosis til børn op til 40 kg legemsvægt er 2 mg/kg/dag; til børn over 40 kg anvendes samme dosis som til voksne.
English: • The maximum dose in adults should be a total of 100 mg daily; in the elderly, if use cannot be avoided the maximum daily dose should be 50 mg.
Danish: • Dosis til voksne bør ikke overstige 100 mg dagligt; kan anvendelse til ældre ikke undgås, bør dagsdosis ikke overstige 50 mg.
English: The approved uses are different in different countries, but may include treatment of anxiety, relief of itching, use as one of the medicines given before an operation (premedication) or treatment of sleep problems.
Danish: De godkendte anvendelser afhænger af det pågældende land, men kan være behandling af angst, modvirkning af kløe, anvendelse som et af de lægemidler, der gives før en operation (præmedicinering), eller behandling af søvnproblemer.
English: Their approved uses (indications) vary between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and treatment of sleep disorders.
Danish: De godkendte anvendelser (indikationer) afviger landene imellem og kan være behandling af angstlidelser, modvirkning af kløe, præmedicinering før operation og behandling af søvnforstyrrelser.
English: Approved uses vary between countries, but may include treatment of anxiety disorders, relief of pruritus (itching) including that due to urticaria, premedication before surgery, and treatment of sleep disorders.
Danish: De godkendte anvendelser varierer landene imellem, men kan være behandling af angstlidelser, modvirkning af kløe, herunder kløe forårsaget af nældefeber, præmedicinering før operation og behandling af søvnforstyrrelser.
English: Having assessed the available evidence, including published studies and data from regular safety monitoring, the PRAC concluded that the risk did not differ between indications and that such events are most likely to occur in patients who have risk factors.
Danish: Udvalget konkluderede, at risikoen for sådanne hændelser ikke var forskellig for forskellige indikationer, og at de hovedsagelig optræder hos patienter med risikofaktorer.
English: Recommendations for these new measures were originally made by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a previously known risk of QT interval prolongation and torsades de pointes, alterations in the electrical activity of the heart that can lead to abnormal heart rhythms and cardiac arrest (stopping of the heart).
Danish: Dette bekræftede den allerede kendte risiko for abnorm hjerterytme og hjertestop, som skyldes visse forandringer i hjertets elektriske aktivitet (forlænget QT-interval og torsade de pointes).
English: Use to be avoided in patients at greatest risk and doses to be kept low
Danish: Anvendelse af lægemidlet skal undgås hos de patienter, der har størst risiko.
English: Elderly patients should not use these medicines, but if they do the maximum dose should be 50 mg a day.
Danish: • Den samlede dagsdosis til voksne må ikke overstige 100 mg. Ældre bør ikke anvende sådanne lægemidler, men bør i givet fald ikke få en dagsdosis, der overstiger 50 mg.
English: • There is a small risk of altered electrical activity of the heart when taking these medicines, which can lead to abnormal heart rhythm or even cause the heart to stop (cardiac arrest).
Danish: • Disse lægemidler medfører en lille risiko for forandret elektrisk aktivitet i hjertet.
English: The Mutual Recognition Procedure started on 23 August 2006.
Danish: Den gensidige anerkendelsesprocedure indledtes den 23. august 2006.
English: London, 30 July 2007 EMEA/CHMP/247760/2007
Danish: London, den 30. juli 2007 EMEA/CHMP/247760/2007
English: The final opinion was converted into a Decision by the European Commission on 30 July 2007.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 30. juli 2007.
English: The Reference Member State was Denmark and the Concerned Member States were Germany, Spain, Ireland, Italy and the United Kingdom.
Danish: Referencemedlemsstaten var Danmark og de berørte medlemsstater var Tyskland, Spanien, Irland, Italien og Det Forenede Kongerige.
English: The arbitration procedure started on 22 February 2007 with the adoption of a list of questions.
Danish: Voldgiftsproceduren indledtes den 22. februar 2007 med vedtagelsen af en liste med spørgsmål.
English: Germany, Spain, Ireland, Italy and the United Kingdom referred the reasons for disagreement to the EMEA on 1 February 2007.
Danish: Tyskland, Spanien, Irland, Italien og Det Forenede Kongerige fremsendte begrundelserne for uenighederne til EMEA den 1. februar 2007.
English: The reasons for disagreement was that, according to some Member States, the efficacy of Vantas was not demonstrated in comparison to other approved, effective treatments and that the safety of Vantas also was not adequately demonstrated.
Danish: Begrundelserne for uenighederne var ifølge visse medlemsstater, at virkningen af Vantas ikke var blevet sammenlignet med andre godkendte og effektive behandlinger, og at der heller ikke var tilstrækkelig dokumentation for lægemidlets sikkerhed.
English: The Marketing Authorisation Holder provided written explanations on 7 March 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 7. marts 2007.