natgillin/translations-raw huggingface dataset:
Det betyder, at de fæstner sig til aluminiumforbindelser for at hjælpe med at stimulere en bedre respons.
This means that they are fixed onto aluminium compounds to help stimulate a better response.
Vaccinationen skal udsættes hos personer med en alvorlig sygdom med feber.
Vaccination should be postponed for people with a severe illness with fever.
Den fuldstændige EPAR for HBVaxPro findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for HBVaxPro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Herefter vil immunsystemet være i stand til at producere antistoffer hurtigere, når personen senere bliver naturligt udsat for viraene.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the viruses.
Overfladeantigenerne bliver også "adsorberet".
The surface antigens are also ‘adsorbed'.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for HBVaxPro.
This is a summary of the European public assessment report (EPAR) for HBVaxPro.
Dette hjælper med at beskytte imod infektion med hepatitis B-virus.
This helps to protect against infection with the hepatitis B virus.
Udvalget var derfor af den opfattelse, at fordelene ved HBVaxPro opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that HBVaxPro's benefits are greater than its risks and recommended that it be given marketing authorisation.
HBVaxPro fås i to styrker (10 og 40 mikrogram/ml).
HBVaxPro is available in two strengths (10 and 40 micrograms/ml).
Tidspunktet for injektionerne afhænger af patientens alder, styrken af dennes immunsystem, reaktion på vaccination og sandsynligheden for, at han/hun bliver udsat for hepatitis B-virus.
The timing of injections depends on the patient's age, strength of the immune system, response to vaccination and likelihood of exposure to the hepatitis B virus.
Et vaccinationsforløb bør omfatte mindst tre injektioner med HBVaxPro.
A course of vaccination should include at least three injections of HBVaxPro.
Vaccinen udleveres kun efter recept.
The medicine can only be obtained with a prescription.
CHMP konkluderede, at fjernelse af thiomersal fra vacciner ikke reducerede deres effektivitet med hensyn til at beskytte mod infektion med hepatitis B-virus, men reducerede risiciene.
The CHMP concluded that the removal of thiomersal from vaccines did not reduce their effectiveness in protecting against hepatitis B virus infection, but reduced their risks.
Fordi det aktive stof i HBVaxPro allerede var godkendt til brug i EU, har der ikke været foretaget nogen formelle undersøgelser af HBVaxPro.
Because the active substance used in HBVaxPro was already authorised for use in the EU, there have been no formal studies with HBVaxPro.
Den indeholder dele af hepatitis B-virusset som det aktive stof.
It contains parts of the hepatitis B virus as the active substance.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for HBVaxPro den 27. april 2001.
The European Commission granted a marketing authorisation valid throughout the European Union for HBVaxPro to Sanofi Pasteur MSD SNC on 27 April 2001.
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.
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.
Når en person vaccineres, opfatter immunsystemet overfladeantigenerne som "fremmede" og reagerer ved at danne antistoffer imod dem.
When a person is given the vaccine, the immune system recognises the surface antigens as ‘foreign' and makes antibodies against them.
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.
For more information about treatment with HBVaxPro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Dette omfattede også de vacciner, som indeholder de samme aktive stoffer som HBVaxPro.
This included the vaccines that contain the same active substance as HBVaxPro.
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).
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).
HBVaxPro indeholder små mængder "overfladeantigener" (proteiner fra overfladen) af hepatitis B-virus.
HBVaxPro contains small amounts of ‘surface antigens' (proteins from the surface) of the hepatitis B virus.
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.
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.
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.
The company provided information comparing other vaccines with and without thiomersal, including studies of a vaccine that contains the same active substance as HBVaxPro.
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.
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.
HBVaxPro er en vaccine.
HBVaxPro is a vaccine.
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.
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.
Andre oplysninger om HBVaxPro
Other information about HBVaxPro
Den laveste styrke anvendes til alle patienter, undtagen dem, som er i eller skal til at have dialyse (en teknik til rensning af blodet).
The higher strength (40 micrograms/ml) is used in patients who are undergoing or are about to undergo dialysis (a blood clearance technique).
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.
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.
Den fuldstændige liste over alle de indberettede bivirkninger ved HBVaxPro fremgår af indlægssedlen.
For the full list of all side effects reported with HBVaxPro, see the package leaflet.
Det forklarer, hvordan agenturet vurderede lægemidlet for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne.
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.
Hvorfor blev HBVaxPro godkendt?
Why has HBVaxPro been approved?
Hvilke risici er der forbundet med HBVaxPro?
What is the risk associated with HBVaxPro?
HBVaxPro leveres som injektionsvæske (suspension) i hætteglas og fyldte- sprøjter.
HBVaxPro is a vaccine, which is available as a suspension for injection in vials and pre-filled syringes.
Hvordan anvendes HBVaxPro?
How is HBVaxPro used?
Hvad er HBVaxPro, og hvad anvendes den til?
What is HBVaxPro used for?
Hvilke fordele viser undersøgelserne, at der er ved HBVaxPro?
What benefit has HBVaxPro shown during the studies?
Hvordan virker HBVaxPro?
How does HBVaxPro work?
27. marts 2015 EMA/149624/2015
27 March 2015 EMA/149624/2015
Gennemgangen af hydroxyzin blev indledt den 25. april 2014 på anmodning af Ungarn i medfør af artikel 31 i direktiv 2001/83/EF.
The review of hydroxyzine was initiated on 25 April 2014 at the request of Hungary, under Article 31 of Directive 2001/83/EC.
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.
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.
Dataene viste, at risikoen ikke afveg for forskellige indikationer.
The data showed that the risk did not differ between indications.
Lægemidlerne fås under forskellige handelsnavne, herunder Atarax.
These medicines are available under various trade names including Atarax.
Lægemidlerne tages sædvanligvis gennem munden, men undertiden ved injektion.
They are used generally by mouth or sometimes by injection.
Af tilsvarende grunde anbefaledes kortest mulig behandlingsvarighed.
For similar reasons, it was recommended that the treatment duration should be as short as possible.
I mellemtiden bør patienter, der har spørgsmål eller betænkeligheder, tale med lægen eller apotekspersonalet.
In the meantime, patients who have any concerns should speak to their doctor or pharmacist.
De nye foranstaltninger vil nu blive indført i de enkelte EU-lande i overensstemmelse med den vedtagne tidsplan.
The new measures will now be implemented according to an agreed timetable in the individual EU countries.
Denne potentielle risiko bekræftes af kliniske data og data efter markedsføring.
This potential risk was confirmed by clinical and post-marketing data.
• Indlægssedlen og den øvrige produktinformation for disse lægemidler skal ajourføres under hensyn til de nye foranstaltninger.
• The package leaflet and other product information for these medicines will be updated to take account of the new measures.
Der vil blive udsendt et brev til sundhedspersoner, hvor der redegøres for ændringerne.
A letter explaining the changes will be sent to healthcare professionals.
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.
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.
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.
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.
Denne risiko gælder hovedsagelig patienter, der i forvejen har hjerterytmeproblemer eller har risikofaktorer for sådanne problemer.
The risk is mostly seen in patients who already have heart rhythm problems or have risk factors for these problems.
Lægemidler indeholdende hydroxyzin fås i de fleste EU-lande.
Hydroxyzine medicines are available in most EU countries.
Det bør anvendes med forsigtighed, hvis man får visse andre lægemidler, der nedsætter i hjerterytmen eller nedsætter kaliumindholdet i blodet.
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.
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.
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.
I størstedelen af tilfældene forelå der andre risikofaktorer, elektrolytforstyrrelser eller sideløbende behandling, som kan have været medvirkende.
Most cases had other risk factors, electrolyte abnormalities or concomitant treatment that may have been contributory.
• Lægemidler indeholdende antihistaminet hydroxyzin fås i de fleste EU-lande.
• Medicines containing the antihistamine hydroxyzine are available in most EU countries.
Ovenstående risikohåndteringsforanstaltninger blev truffet efter en vurdering af den foreliggende evidens, herunder offentliggjorte undersøgelser og data fra rutinemæssig sikkerhedsovervågning.
The above risk minimisation measures were taken following an assessment of the available evidence, including published studies and data from regular safety monitoring.
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.
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.
• Hydroxyzin må ikke tages af patienter, der i forvejen har hjerterytmeforstyrrelser eller får andre lægemidler med tilsvarende virkning på hjertet.
• 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.
• 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.
• 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.
• Hydroxyzin har potentiale for at blokere hERG-kanaler og andre typer kardiale kanaler med deraf følgende risiko for QT-forlængelse og arytmier.
• 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.
CMDh1 har enstemmigt vedtaget nye foranstaltninger, der skal minimere risikoen for påvirkning af hjerterytmen fra lægemidler indeholdende antihistaminet hydroxyzin.
The CMDh1 has agreed by consensus new measures to minimise the risk of effects on heart rhythm with medicines containing the antihistamine hydroxyzine.
• 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.
• 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.
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.
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.
Forsigtighed bør endvidere udvises ved samtidig administration af hydroxyzin og lægemidler, der er potente hæmmere af alkoholdehydrogenase eller CYP3A4/5.
Care is also required when hydroxyzine is co-administered with drugs known to be potent inhibitors of alcohol dehydrogenase or CYP3A4/5.
Produktresuméet og indlægssedlen for de omfattede lægemidler vil blive ændret tilsvarende.
The SmPC and package leaflet of the affected medicines will be amended accordingly.
• 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.
• 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.
Forsigtighed bør udvises ved anvendelse hos patienter, som har bradykardi eller er i behandling med hypokaliæmi-inducerende lægemidler.
The medicine should be used with caution in patients with bradycardia, or who are taking hypokalaemia-inducing medicines.
• 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).
• 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).
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.
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.
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.
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.
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.
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.
• Anvendelse hos ældre frarådes pga. nedsat udskillelse af hydroxyzin og øget sårbarhed for antikolinerge virkninger og andre bivirkninger.
• 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.
• Maksimaldosis til børn op til 40 kg legemsvægt er 2 mg/kg/dag; til børn over 40 kg anvendes samme dosis som til voksne.
• 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.
• Dosis til voksne bør ikke overstige 100 mg dagligt; kan anvendelse til ældre ikke undgås, bør dagsdosis ikke overstige 50 mg.
• 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.
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.
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.
De godkendte anvendelser (indikationer) afviger landene imellem og kan være behandling af angstlidelser, modvirkning af kløe, præmedicinering før operation og behandling af søvnforstyrrelser.
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.
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.
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.
Udvalget konkluderede, at risikoen for sådanne hændelser ikke var forskellig for forskellige indikationer, og at de hovedsagelig optræder hos patienter med risikofaktorer.
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.
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).
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).
Anvendelse af lægemidlet skal undgås hos de patienter, der har størst risiko.
Use to be avoided in patients at greatest risk and doses to be kept low
• 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.
Elderly patients should not use these medicines, but if they do the maximum dose should be 50 mg a day.
• Disse lægemidler medfører en lille risiko for forandret elektrisk aktivitet i hjertet.
• 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).
Den gensidige anerkendelsesprocedure indledtes den 23. august 2006.
The Mutual Recognition Procedure started on 23 August 2006.
London, den 30. juli 2007 EMEA/CHMP/247760/2007
London, 30 July 2007 EMEA/CHMP/247760/2007
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 30. juli 2007.
The final opinion was converted into a Decision by the European Commission on 30 July 2007.