natgillin/translations-raw huggingface dataset:
Immunsystemet kan således danne antistoffer hurtigere, når det eksponeres for det samme virus igen.
The immune system will then be able to produce antibodies more quickly when it comes into contact with the virus again.
De hyppigste bivirkninger ved Foclivia (der kan forekomme hos op til 1 ud af 10 personer) er hovedpine, svedtendens, ledsmerter, muskelsmerter, reaktioner på injektionsstedet (rødme, hævelse, hård hud, blå mærker og smerter), feber, utilpashed, træthed og kulderystelser.
The most common side effects with Foclivia (which may affect up to 1 people in 10) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, feeling unwell, tiredness and shivering.
Da Foclivia er godkendt under særlige omstændigheder, skal den virksomhed, der markedsfører Foclivia, indsamle oplysninger om sikkerheden og virkningen ved den endelige pandemivaccine, når den influenzastamme, der forårsager en pandemi, inkluderes i vaccinen.
Since Foclivia has been authorised under exceptional circumstances, the company that markets Foclivia will collect information on the safety and effectiveness of the final pandemic vaccine when it includes the flu strain responsible for a pandemic in the vaccine.
De indberettede bivirkninger ved Foclivia vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Foclivia are carefully evaluated and any necessary action taken to protect people who receive Foclivia.
Under en pandemi skal virusstammen i Foclivia erstattes med den stamme, der forårsager pandemien, inden vaccinen kan bruges.
During a pandemic, the virus strain in Foclivia will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Vaccinen indeholder også en såkaldt adjuvans (en olieholdig forbindelse), som gør vaccinen mere effektiv.
The vaccine also contains an ‘adjuvant' to increase the vaccine's effectiveness.
Hvilke oplysninger afventes der stadig for Foclivia?
What information is still awaited for Foclivia?
Når en person vaccineres, opfatter immunsystemet virusset som fremmed og producerer antistoffer mod det.
When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Hos de personer, der fik 15 mikrogram, var den tilsvarende andel 85 %.
The figure was 85% in people who received the 15-microgram dose.
Hvilke risici er der forbundet med Foclivia?
What are the risks associated with Foclivia?
Deltagerne fik med 21 dages mellemrum to injektioner af Foclivia med enten 7,5 eller 15 mikrogram hæmagglutinin (et protein, der findes i influenzavira).
The participants received two injections of Foclivia, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart.
Den fuldstændige liste over bivirkninger ved Foclivia fremgår af indlægssedlen.
For the full list of all side effects of Foclivia, see the package leaflet.
Hvordan anvendes Foclivia?
How is Foclivia used?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Foclivia.
Recommendations and precautions to be followed by healthcare professionals and their patients for the safe and effective use of Foclivia have been included in the summary of product characteristics and the package leaflet.
Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om den endelige pandemiske vaccine, da det er en pandemisk beredskabsvaccine, som endnu ikke indeholder den influenzavirusstamme, der forårsager en pandemi.
This means that, because the vaccine is a pandemic preparedness vaccine and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
Derved kan det forudsiges, hvordan mennesker vil reagere, når den influenzastamme, der er årsag til en pandemi, inkluderes i vaccinen.
They test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing a pandemic is included in the vaccine.
Hvordan virker Foclivia?
How does Foclivia work?
Foclivia er en pandemisk beredskabsvaccine, dvs. en særlig vaccinetype, der kan udvikles for at kontrollere en fremtidig pandemi.
This is a special type of vaccine that can be developed to help with the management of a future pandemic.
Hvilke fordele viser studierne, at der er ved Foclivia?
What benefits of Foclivia have been shown in studies?
Foclivia indeholder visse dele af H5N1-virusset.
Foclivia contains some parts the H5N1 virus.The virus has been first inactivated so that it does not cause disease.
Influenzavaccine, hele virion, inaktiveret, indeholder antigen af pandemisk stamme*: A/California/07/2009 (H1N1)v
Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*: A/California/7/2009 (H1N1)v 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin.
Hætteglas (glas) 0,5 ml
Intramuscular use vial (glass) 0.5 ml
Emballage
Packaging Content (concentration)
Benefit/risk-forhold
Benefit/risk
Indtil juni 2005 var veraliprid godkendt i Spanien.
Until June 2005, veralipride was authorised in Spain.
Det blev første gang godkendt i 1979, og i EU er det på nuværende tidspunkt godkendt i Belgien, Frankrig, Italien, Luxembourg og Portugal under navnene Agreal og Agradil.
It was first authorised in 1979 and is currently authorised in the EU in Belgium, France, Italy, Luxembourg and Portugal under the names Agreal and Agradil.
Der foreligger kun få data, der rækker ud over 3 måneder, og disse er hovedsagelig fra ikke-sammenlignende undersøgelser.
Few data are available beyond 3 months, mostly in non comparative studies.
Produtos Farmacêuticos, S.A. PRT Empreendimento Lagoas Park - Edificio 72° e 3° Porto Salvo
Produtos Farmacêuticos, S.A. PRT Empreendimento Lagoas Park - Edifício 72º e 3º Porto Salvo
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE VERALIPRID (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING VERALIPRIDE (see Annex I)
De 27 års markedsføring har givet mulighed for overvågning af sikkerhedsprofilen i lang tid.
The 27-year post-marketing period offers a long period of safety profile surveillance.
• udvalget behandlede indbringelsen i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende veraliprid
• The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing veralipride
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR TILBAGEKALDELSE AF MARKEDSFØRINGSTILLADELSEN FREMLAGT AF EMEA
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATION PRESENTED BY THE EMEA
Endelig er forlænget QT-interval en klassevirkning af dopaminantagonister.
Lastly, QT-prolongation is a class-effect of dopamine-antagonists.
Udvalget tog desuden i betragtning, at de foreslåede tiltag til risikominimering ikke gør det muligt at mindske risiciene til et acceptabelt niveau eller forudsige, hvilke kvinder, der kan være udsat for risiko
In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level or predict which women may be at risk;
Spanien tilbagekaldte derfor markedsføringstilladelsen for veraliprid den 27. juni 2005.
Spain therefore withdrew veralipride's marketing authorisation on 27 June 2005.
I denne gennemgang vurderede CHMP alle de foreliggende oplysninger om sikkerheden og virkningen af veraliprid.
In this review, the CHMP assessed all of the available information on the safety and efficacy of veralipride.
Efter indberetninger om alvorlige bivirkninger fra nervesystemet konkluderede de kompetente spanske myndigheder, at produktets fordele ikke opvejer dets potentielle risici.
Following reports of serious side effects affecting the nervous system, the Spanish National Competent Authority concluded that its benefits did not outweigh its potential risks.
Europa-Kommissionen indledte derfor en indbringelsesprocedure den 7. september 2006 og anmodede CHMP om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for produkter indeholdende veraliprid burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU efter vurdering af disse sikkerhedsrisici og deres betydning for benefit/risk-vurderingen for veraliprid.
Consequently, the European Commission triggered a referral procedure on 7 September 2006 and requested the CHMP to give its opinion on whether the marketing authorisations for products containing veralipride should be maintained, varied, suspended or withdrawn across the European Union following the assessment of these safety risks their impact on the benefit/risk assessment of veralipride.
De fleste satte ind efter mere end tre måneders behandling.
Most of them occurred beyond 3 months of treatment.
Oplysningerne bestod hovedsagelig i 11 undersøgelser med tilsammen ca. 600 kvindelige patienter, hvor veraliprid blev sammenlignet med placebo, og to andre undersøgelser med tilsammen ca. 100 kvindelige patienter, hvor det blev sammenlignet med konjugerede østrogener.
This included mainly 11 studies involving around 600 women, in which veralipride was compared with placebo, and two studies in around 100 women where it was compared with conjugated oestrogens.
At der i databasen ikke findes tilfælde, der tyder på QT-forlængelse, er ikke tilstrækkeligt til at konkludere, at denne effekt ikke optræder i forbindelse med veraliprid.
The absence of cases of suggestive QT-prolongation in the database is not sufficient to conclude that this effect does not occur with veralipride.
Desuden indtræder visse af disse bivirkninger ikke kun under behandlingen, men også efter behandlingsophør, og det ikke muligt at forudsige, hvilke kvinder der er udsat.
In addition, some of these side effects can occur not only during treatment, but also after it is stopped and it is also impossible to predict which women may be at risk.
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, INDEHAVER AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Der er imidlertid også beskrevet tilfælde af tardiv dyskinesi inden for de første 3 måneders behandling.
However, cases of tardive dyskinesia have also been reported within the first 3 months of treatment.
Også hyperprolaktinæmi og risikoen for QT-forlængelse giver anledning til betænkelighed
In addition, hyperprolactinemia and the risk of QT prolongation are also concerns;
Der blev ikke udført undersøgelser til vurdering af, om veraliprid har indvirkning på QT-intervallet.
No studies were performed to evaluate whether veralipride has an effect on QT.
CHMP konkluderede derfor den 19. juli 2007, at benefit/risk-forholdet for lægemidler indeholdende veraliprid ikke er gunstigt under normale anvendelsesbetingelser.
The CHMP therefore concluded on 19 July 2007 that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Den foreslåede tætte overvågning, herunder neurologisk undersøgelse for hver 20 dages behandling, vil muligvis mindske denne risiko, men vil være en betydelig byrde for både patient og læge.
The proposal of close monitoring including neurological examination after each 20 day treatment cycle might reduce these risks, but is a measure of considerable burden to both patient and doctor.
CHMP anbefalede derfor tilbagekaldelse af alle markedsføringstilladelser for lægemidler indeholdende veraliprid i hele EU.
Therefore, the CHMP recommended the withdrawal of all Marketing Authorisations for medicinal products containing veralipride throughout Europe.
Det må bemærkes, at tardive dyskinesier ikke er forudsigelige og kan sætte ind selv efter behandlingsophør.
It has to be noted that tardive dyskinesias are not predictable and can develop even after the treatment has been discontinued.
En række andre små undersøgelser blev desuden taget i betragtning af CHMP.
The CHMP also looked at other small studies.
Effekten af hyperprolaktinæmi hos kvinder med brystkræft i anamnesen er imidlertid ikke udredt.
But the effect of hyperprolactinemia in women with history of breast cancer is not elucidated.
-Indskrænkning af behandlingsvarigheden til 3 måneder kombineret med undersøgelse en gang om måneden med henblik på at begrænse psykiske og neurologiske bivirkninger.
-Restriction of the treatment duration to 3 months in combination with monthly examination in an effort to limit the psychiatric and neurological adverse events.
Tardiv dyskinesi kan imidlertid sætte ind i løbet af de første 3 måneders behandling.
However, tardive dyskinesia may still occur within the first 3 months of treatment.
Også i visse andre EU-medlemsstater, hvor produktet er godkendt, greb tilsynsmyndighederne ind og indførte begrænsninger i produktinformationen med henblik på at mindske risikoen for bivirkninger.
Regulatory actions were also taken in some other EU Member States where the product is authorised and veralipride's product information was restricted with the aim to reduce the risk of patients developing side effects.
-Indførelse af kontraindikationerne Parkinsons sygdom og kombination med andre neuroleptika og dopaminagonister.
-Introduction of the contraindications in patients with Parkinson's disease, or in combination with other neuroleptics and dopaminergic agonists.
Af de øvrige bivirkninger, der er knyttet til blokering af dopaminerge receptorer, giver især hyperprolaktinæmi anledning til betænkelighed.
As for the other adverse events related with the blockage of the dopamine receptor, especially hyperprolactinemia is a concern.
Overordnet anses begrænsningen af anvendelsen af veraliprid til 3 måneder, kombineret med månedlige neurologiske undersøgelser og overvågning af brysterne, ikke for tilstrækkelig til at begrænse risikoen for alle de bivirkninger, der er indberettet for veraliprid, og samtidig tilfredsstillende behandle de vasomotoriske symptomer forbundet med menopausen.
Overall, the restriction to limit the use of veralipride to 3 months in combination with monthly medical neurological examinations and breast monitoring is not considered adequate to limit the risk of all adverse effects reported with veralipride and adequately treat the vasomotor symptoms associated with the menopause.
-Anbefalinger om lægelig overvågning af brysterne og intermitterende doseringsplan (20 dage efterfulgt af 10 dage uden behandling) for at mindske risikoen for hyperprolaktinæmi med henblik på at øge sikkerheden for brysterne (det vides dog ikke, om denne foranstaltning har nogen virkning på det iagttagne bivirkningsmønster knyttet til hyperprolaktinæmi, således mammahypertrofi, galaktorré og risici for patienter med prolaktinafhængige tumorer som f.eks. hypofyse-prolaktinom og brystcancer).
-Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).
Desuden var undersøgelserne for kortvarige til at give tilstrækkelig mulighed for at vurdere, om virkningen vedblev.
In addition, the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Den foreslåede intermitterende behandling på 20 dage efterfulgt af en 10-dages behandlingsfri periode kan muligvis dæmpe effekten på prolaktinindholdet, men det vides ikke, om den vil få indflydelse på bivirkningsmønsteret.
The proposed intermittent treatment of 20 days, followed by a 10 day period of non-treatment, may temper this effect on the prolactin level, but it is unknown whether this measure has any effect on the adverse event pattern.
CHMP noterede sig de forslag til begrænsning af sådanne risici, der var stillet af indehaveren af markedsføringstilladelsen, og hvoraf nogle allerede var indført i nogle stater, således:
The CHMP took note of the MAH's proposals, some of which had already been introduced in some countries, in an effort to limit these risks like:
Indehaver af markedsføringstilladelse Særnavn
Member State Marketing Authorisation Holder
• udvalget konkluderede på baggrund af de foreliggende data, at risiciene ved anvendelse af veraliprid til behandling af hedeture i forbindelse med menopausen opvejer de begrænsede fordele.
• The Committee concluded, in view of available data, that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause outweigh the limited benefits.
På baggrund af de foreliggende kliniske data konkluderede CHMP, at de risici, der er forbundet med anvendelse af veraliprid til behandling af hedeture forbundet med menopausen, især de neurologiske reaktioner (dyskinesi, ekstrapyramidale lidelser, Parkinson-syndrom) og psykiske reaktioner (depression, angst, abstinenssyndrom), opvejer de begrænsede fordele.
In view of the available clinical data the CHMP concluded that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause, mainly the neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) outweigh the limited benefits.
Veraliprid er kontraindiceret ved prolaktinafhængige tumorer som f.eks. prolaktinomer i hypofysen samt brystkræft.
Veralipride treatment is contra-indicated in patients with prolactindependent tumours such as pituitary gland prolactinoma and breast cancer.
-Indførelse af advarsler om neuroleptikas klassevirkninger (malignt neuroleptikasyndrom, QTforlængelse, tardiv dyskinesi) og abstinenssymptomer som angst og depressivt syndrom.
-Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety and depressive syndrome.
For at undgå psykiske bivirkninger, ekstrapyramidale symptomer og tardiv dyskinesi foreslog indehaveren af markedsføringstilladelsen, at den tilladte behandlingsvarighed med veraliprid begrænses til 3 måneder.
In order to avoid psychiatric AE, extrapyramidal symptoms and tardive dyskinesia, the MAH proposed a maximally allowed duration of 3 months veralipride treatment.
(Der blev således som regel ikke angivet baseline-værdier, hvorfor fyldestgørende vurdering af den observerede bedring ikke er mulig, og hverken den statistiske signifikans eller kliniske betydning af virkningen kan kvantificeres nøjagtigt, da den statistiske plan var uklar eller helt manglede, og da beskrivelsen af resultaterne var mangelfuld.)
The benefit could be qualified as limited, however the effect size cannot be accurately quantified due to methodological deficiencies of available studies (e. g. in most cases baseline values were not stated, precluding an adequate assessment of the improvement observed; neither the statistical nor the clinical significance of this effect size could be precisely quantified, as the statistical plan was not clear or was absent; the presentation of the results was poor).
Desuden kan virkningens størrelse ikke bestemmes nøjagtigt, da undersøgelserne var for kortvarige til at muliggøre en fyldestgørende vurdering af, om virkningen vedblev.
In addition, the effect size cannot be accurately quantified due to methodological shortcomings and the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
I forbindelse med anvendelse af veraliprid er beskrevet tilfælde af uforudsigelig og potentielt irreversibel tardiv dyskinesi samt tidlige ekstrapyramidale symptomer, depression, angst og abstinenssyndrom; sammen med risikoen for hyperprolaktinæmi og for QT-forlængelse, der er en klasseeffekt, findes disse risici at give anledning til betænkelighed.
Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidal symptoms, depression, anxiety and withdrawal reactions have been reported with veralipride treatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QTprolongation are considered a concern.
Veraliprid er et neuroleptikum i benzamidgruppen, som er indiceret til behandling af vasomotoriske symptomer knyttet til menopausen.
Veralipride is a benzamide neuroleptic medicine indicated in the treatment of vasomotor symptoms associated with the menopause.
CHMP konkluderede, at de forelagte data kun viser begrænset virkning af veraliprid til behandling af vasomotoriske symptomer knyttet til menopausen.
The CHMP concluded that the data submitted showed only limited effect of veralipride in the treatment of vasomotor symptoms associated with the menopause.
• udvalget tog i betragtning, at der i forbindelse med anvendelse af veraliprid er beskrevet neurologiske reaktioner (dyskinesi, ekstrapyramidale lidelser, Parkinson-syndrom) og psykiske reaktioner (depression, angst, abstinenssyndrom), herunder potentielt irreversibel tardiv dyskinesi.
• The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) have been reported with veralipride, including tardive dyskinesia which may be potentially irreversible.
Det må her bemærkes, at det ikke altid klart fremgår, hvordan årsagssammenhængen med veraliprid er blevet vurderet.
It should be noted that in the evaluation of the causality assessment of veralipride in the psychiatric events, the role of veralipride is not always clear.
De forelagte oplysninger synes at vise, at veraliprid har virkning på vasomotoriske symptomer knyttet til menopausen.
Based on the submitted data, there appears to be an effect for veralipride in the treatment of vasomotor symptoms associated with the menopause.
• udvalget fandt, at de forelagte data kun viser begrænset virkning af veraliprid til behandling af hedeture knyttet til menopausen
• The Committee considered that veralipride containing medicinal products only showed limited efficacy in the treatment of hot flushes associated with the menopause;
Desuden er der i forbindelse med veraliprid beskrevet psykiske bivirkninger, hovedsagelig depression og angst.
Psychiatric adverse events mainly referred to depressive and anxiety states have also been reported with veralipride.
• CHMP konkluderede derfor, at benefit/risk-forholdet for lægemidler indeholdende veraliprid ikke er gunstigt under normale anvendelsesbetingelser anbefalede CHMP tilbagekaldelse af markedsføringstilladelserne for de i bilag I omhandlede lægemidler indeholdende veraliprid.
• The Committee, as a consequence, concluded that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
BEGRUNDELSE FOR TILBAGEKALDELSEN AF MARKEDSFØRINGSTILLADELSEN
GROUNDS FOR THE WITHDRAWAL OF THE MA
De neurologiske bivirkninger vedrørte ekstrapyramidale symptomer, specielt er der beskrevet tardiv dyskinesi.
Neurological adverse events referred to extrapyramidal symptoms and particularly tardive dyskinesias have been reported with veralipride and represent a real concern due to their potential seriousness and irreversibility.
• Risikoen for infektioner, inklusive opportunistiske infektioner samt kontraindikation for anvendelse
• The risk of infections, including opportunistic infections, and the contraindication for use in