natgillin/translations-raw huggingface dataset:
Listen over de berørte lægemiddelnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II sammen med det ændrede produktresumé, etiketteringen og indlægssedlen i bilag III.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Hydrochlorothiazid (HCTZ) er et thiazid-diuretikum, som også er blevet brugt som lægemiddel mod hypertension (højt blodtryk).
Hydrochlorothiazide (HCTZ) is a thiazide diuretic which has also been used as an antihypertensive agent.
Kombinationen af losartan og hydrochlorothiazid er indiceret til behandling af hypertension til patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af losartan eller hydrochlorothiazid alene.
The losartan/hydrochlorothiazide combination is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide.
Den 23. februar 2007 indbragte Danmark en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, for at harmonisere de nationalt godkendte produktresumeer, indlægsseddel og etikettering for lægemidlet Cozaar Comp. og tilknyttede navne.
On 23 February 2007, Denmark presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised summaries of product characteristics, package leaflet and labelling of the medicinal product Cozaar Comp. and associated names.
På mødet den 21.-24. april 2008 var CHMP, på baggrund af de samlede fremlagte oplysninger og den faglige drøftelse i udvalget, af den opfattelse, at forslaget til harmonisering af produktresumeet, etiketteringen og indlægssedlen var acceptabelt og følgelig burde ændres.
During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.
CHMP afgav en positiv udtalelse den 24. april 2008, hvori udvalget anbefalede harmonisering af produktresumeet, etiketteringen og indlægssedlen vedrørende Cozaar Comp. og tilknyttede navne.
The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, labelling and package leaflet for Cozaar Comp. and associated names.
Behandling af hypertension til patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af losartan eller hydrochlorothiazid, som det første skridt i behandlingen af patienter med moderat til alvorlig hypertension og til patienter med høj eller meget høj risiko for kardiovaskulære hændelser, reduktion af kardiovaskulær morbiditet og mortalitet hos hypertensive patienter med hypertrofi af venstre ventrikel.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Cozaar Comp. and associated names approved across EU Member States, with respect to the following indications: Treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide; As first step treatment in patients with moderate to severe hypertension and in patients with high or very high cardiovascular risk; Reduction of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.
Hvad er Levact?
What is Levact?
Hvorfor blev Levact revurderet?
Why was Levact reviewed?
Europa-Kommissionen traf en afgørelse den 7. juli 2010.
The European Commission issued a decision on 7 July 2010.
Harald Enzmann (Tyskland)
Harald Enzmann (Germany)
Jean-François Baurain (Belgien)
Jean-François Baurain (Belgium)
Resultat af en indbringelsesprocedure i henhold til artikel 29 i direktiv 2001/83/EF, med senere ændringer
Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Levact er også kendt under navnet Ribomustin.
Levact is also known as Ribomustin.
Det anvendes til behandling af følgende kræftformer:
It is used to treat the following types of cancer:
Det binder sig til DNA i cellerne, mens disse reproducerer sig selv, hvorved celledelingen standses.
It binds to the DNA of cells while they are reproducing, which stops cell division.
I Tyskland har bendamustin været anvendt i lægemidler mod kræft siden starten af 1970'erne.
Bendamustine has been used in anticancer medicines in Germany since the early 1970s.
Udvalget anbefalede derfor udstedelse af markedsføringstilladelse for Levact i Tyskland og i alle de berørte medlemsstater for alle de indikationer, som ansøgningen omhandlede.
The Committee therefore recommended that Levact be granted marketing authorisation in Germany and all concerned Member States for all the indications that were applied for.
På grundlag af vurderingen af disse data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved Levact opvejer risiciene til de to indikationer, der blev gjort indsigelse imod.
Based on the evaluation of these data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Levact outweigh its risks for the two indications for which objections were raised.
Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for lægemidlet Levact og relaterede navne.
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Levact and associated names.
Som et resultat heraf kan kræftcellerne ikke dele sig, hvilket hæmmer svulsternes vækst.
As a result, the cancer cells cannot divide and the growth of tumours slows down.
Begrundelserne for indbringelsen var, at en medlemsstat, Det Forenede Kongerige, ikke kunne godkende indikationen non-Hodgkins lymfom, og at to medlemsstater, Belgien og Frankrig, ikke kunne godkende indikationen multipelt myelom, eftersom der ikke forelå tilstrækkelige data om dette lægemiddels virkning til at støtte disse indikationer.
The grounds for the referral were that one Member State, the United Kingdom, could not approve the indication non-Hodgkin's lymphoma, and two Member States, Belgium and France, could not approve the indication multiple myeloma because not enough data on the effectiveness of this medicine were available to support these indications.
Levact er et lægemiddel mod kræft.
Levact is an anticancer medicine.
14. januar 2010 og 17. februar 2010
14 January 2010 and 17 February 2010
Medlemsstaterne kunne imidlertid ikke nå til enighed, og den tyske lægemiddelkontrolmyndighed indbragte den 2. oktober 2009 sagen for CHMP med henblik på voldgift.
However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 2 October 2009.
Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Tyskland) vurderer et lægemiddel med henblik på at udstede en markedsføringstilladelse, som gælder i dette land og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Østrig, Belgien, Danmark, Finland, Frankrig, Irland, Italien, Luxembourg, Norge, Polen, Spanien og Det Forenede Kongerige).
This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom).
22. oktober 2009
22 October 2009
EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Levact opvejede risiciene, og at der kan udstedes markedsføringstilladelse i Tyskland og i følgende medlemsstater: Østrig, Belgien, Danmark, Finland, Frankrig, Irland, Italien, Luxembourg, Norge, Polen, Spanien og Det Forenede Kongerige.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Levact outweigh its risks, and that the marketing authorisation can be granted in Germany and in the following Member States: Austria, Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom.
Astellas Pharma GmbH indgav en ansøgning om Levact til den tyske lægemiddelkontrolmyndighed via den decentrale procedure.
Astellas Pharma GmbH submitted Levact to the German medicines regulatory agency for a decentralised procedure.
CHMP vurderede de to kliniske undersøgelser, som virksomheden havde fremlagt til støtte for indikationerne multipelt myelom og non-Hodgkins lymfom.
The CHMP assessed the two clinical studies presented by the company to support the multiple myeloma and non-Hodgkin's lymphoma indications.
18. marts 2010
18 March 2010
Startdato for indbringelse:
Referral start date:
Det aktive stof i Levact, bendamustinhydrochlorid, tilhører en gruppe af lægemidler mod kræft, der kaldes "alkylerende midler".
The active substance in Levact, bendamustine hydrochloride, belongs to a group of anticancer medicines called ‘alkylating agents'.
07. juli 2010
7 July 2010
Spørgsmål og svar vedrørende Levact og relaterede navne (bendamustinhydrochlorid, 2,5 mg/ml, pulver til koncentrat til infusionsvæske, opløsning)
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion)
• multipelt myelom (knoglemarvskræft) i kombination med prednison hos patienter over 65 år, som ikke er egnede til stamcelletransplantation, og som ikke kan behandles med thalidomid eller bortezomib (andre lægemidler mod kræft).
• multiple myeloma (a cancer of the bone marrow) in combination with prednisone in patients older than 65 years who are not eligible for stem-cell transplantation and cannot be treated with thalidomide or bortezomib (other anticancer medicines).
Dato for udtalelse:
Opinion date:
• non-Hodgkins lymfom (kræft i lymfevævet, som er en del af immunsystemet) hos patienter, hvis kræft er forværret under eller efter behandling med rituximab (et andet lægemiddel mod kræft)
• non-Hodgkin's lymphoma (a cancer of the lymph tissue, part of the immune system) in patients whose cancer got worse during or following treatment containing rituximab (another anticancer medicine);
• kronisk lymfatisk leukæmi (kræft i en type hvide blodlegemer, der kaldes lymfocytter) hos patienter, hvor behandling med fludarabin (et andet lægemiddel mod kræft) ikke er hensigtsmæssig
• chronic lymphocytic leukaemia (a cancer of a type of white blood cell called lymphocytes) in patients for whom treatment with fludarabine (another anticancer medicine) is not appropriate;
Spørgsmål og svar vedrørende Levact og relaterede navne1 (bendamustinhydrochlorid, 2,5 mg/ml, pulver til koncentrat til infusionsvæske, opløsning)
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) EMA/CHMP/735863/2009
Medrapportør:
Co-Rapporteur:
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Trumenba.
This is a summary of the European public assessment report (EPAR) for Trumenba.
Yderligere planlagte eller igangværende undersøgelser forventes at give flere oplysninger om Trumenbas effektivitet.
Further planned or ongoing studies are expected to provide more information on Trumenba's effectiveness.
Andre oplysninger om Trumenba
Other information about Trumenba
Den fuldstændige EPAR for Trumenba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Trumenba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Trumenba udleveres kun efter recept og bør anvendes i henhold til de officielle anbefalinger.
Trumenba can only be obtained with a prescription and should be used according to official recommendations.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Trumenba ud fra de tilgængelige data opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that based on available data Trumenba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Hos patienter med større risiko for invasiv meningokoksygdom kan det overvejes at give en supplerende boosterdosis senere.
In patients at greater risk of invasive meningococcal disease, an additional booster dose may be considered later on.
Behandlingen kan enten bestå af 2 injektioner med mindst 6 måneders mellemrum eller 2 injektioner med mindst 1 måneds mellemrum efterfulgt af en tredje injektion mindst 4 måneder senere.
Initial treatment may either involve 2 injections at least 6 months apart, or 2 injections at least 1 month apart followed by a third injection at least 4 months later.
Disse proteiner fastgøres på et stof, der indeholder aluminium (adsorberet), hvorved de stabiliseres, så immunsystemet kan reagere på dem.
These proteins are fixed onto a compound containing aluminium (adsorbed), which helps to stabilise them, allowing the immune system to respond to them.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trumenba?
What measures are being taken to ensure the safe and effective use of Trumenba?
Når personen derefter udsættes for bakterierne, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe bakterierne og beskytte mod sygdommen.
When the person is then exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.
Trumenba meningokok gruppe B-vaccine (rekombinant, adsorberet)
Trumenba meningococcal group B vaccine (recombinant, adsorbed)
De mest almindelige bivirkninger ved Trumenba (kan forekomme hos mere end 1 ud af 10 personer) er ømhed, rødme eller hævelse på injektionsstedet, hovedpine, træthed, kulderystelser, diarré, kvalme og muskel- og ledsmerter.
The most common side effects with Trumenba (which may affect more than 1 in 10 people) are pain, redness or swelling at the site of the injection, headache, tiredness, chills, diarrhoea, nausea (feeling sick), and muscle or joint pain.
Hvorfor blev Trumenba godkendt?
Why is Trumenba approved?
Trumenta fås i en fyldt sprøjte og gives ved injektion i en muskel, fortrinsvis i skulderen.
It is available in a pre-filled syringe and is given by injection into a muscle, preferably in the shoulder.
Hvad er Trumenba, og hvad anvendes det til?
What is Trumenba and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Trumenba bør anvendes.
It is not intended to provide practical advice on how to use Trumenba.
Invasiv sygdom optræder, når disse bakterier spreder sig i kroppen og forårsager alvorlige infektioner såsom meningitis (betændelse i hinderne rundt om hjernen og rygmarven) og septikæmi (blodforgiftning).
Invasive disease occurs when these bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spinal cord) and septicaemia (blood infection).
Der blev også gennemført understøttende undersøgelser, der viste, at 2 doser af vaccinen gav næsten samme antistofrespons som 3 doser; selvom de beskyttende antistofniveauer faldt over tid, kunne de forbedres med en supplerende boosterdosis efter både 2- og 3-dosisbehandlingen.
Supportive studies were also carried out, which showed that 2 doses of the vaccine achieved a broadly similar antibody response to 3 doses, and that even though protective antibody levels declined over time they could be improved by an additional booster dose after both 2- and 3-dose treatments.
Hvilke risici er der forbundet med Trumenba?
What are the risks associated with Trumenba?
Hvis du ønsker yderligere oplysninger om behandling med Trumenba, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Trumenba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Undersøgelserne så også på reaktionen på 10 andre, sekundære stammer af N. meningitidis gruppe B.
The studies also looked at response to 10 other, secondary strains of N. meningitidis group B.
Der sås også antistofrespons mod de 10 sekundære stammer, og responsen på de 4 hovedstammer blev bekræftet.
Antibody responses were also seen against the 10 secondary strains and confirmed the responses seen with the 4 main strains.
Når en person vaccineres, opfatter immunsystemet bakteriedelene i vaccinen som "fremmede" og danner antistoffer mod dem.
When a person is given the vaccine, the immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign' and makes antibodies against them.
Den fuldstændige liste over bivirkninger og begrænsninger ved Trumenba fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Trumenba, see the package leaflet.
Der forekommer hyppige bivirkninger, men de vurderes at være acceptable.
Although side effects were common, they appeared to be within acceptable limits.
Da undersøgelser har vist, at den opnåede beskyttelse falder over tid, bør det overvejes at give en boosterdosis til personer, der vurderes at være i fortsat risiko for invasiv meningokoksygdom.
As the protection provided seemed to decline over time, a booster dose should be considered in recipients who were thought to be at continued risk of invasive meningococcal disease.
I den anden undersøgelse blev der produceret tilstrækkelige mængder antistoffer hos 79-90 % af deltagerne, og beskyttende niveauer af antistoffer mod alle 4 stammer sås hos 85 %.
In the second study sufficient amounts of antibodies were produced in 79 to 90% of cases, and protective levels of antibodies against all 4 strains were seen in 85% of participants.
Trumenba er en vaccine, der anvendes til at beskytte personer fra 10 års-alderen mod invasiv meningokoksygdom forårsaget af en gruppe bakterier, der kaldes Neisseria meningitidis gruppe B.
Trumenba is a vaccine used to protect individuals from 10 years old against invasive meningococcal disease caused by a group of bacteria called Neisseria meningitidis group B.
Hvis du ønsker praktisk vejledning om anvendelsen af Trumenba, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Trumenba, patients should read the package leaflet or contact their doctor or pharmacist.
I den første undersøgelse blev der produceret antistoffer i mængder, der var tilstrækkelige til at beskytte mod de 4 hovedstammer, hos 80-90 % af deltagerne, alt efter hvilken stamme der var tale om; 84 % af de vaccinerede deltagere havde beskyttende antistoffer mod alle 4 stammer, da de blev testet.
Antibodies were produced in sufficient quantities to provide protection against the 4 main test strains in between 80 and 90% of those in the first study, depending on the strain; 84% of those given the vaccine had protective antibodies against all 4 strains when tested.
Trumenba indeholder to komponenter, nemlig proteiner, der findes på overfladen af Neisseria meningitidis gruppe B-bakterier.
Trumenba contains two components, proteins that are found in the outer coats of Neisseria meningitidis group B bacteria.
Hvilke fordele viser undersøgelserne, at der er ved Trumenba?
What benefits of Trumenba have been shown in studies?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Trumenba.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trumenba have been included in the summary of product characteristics and the package leaflet.
Hvordan anvendes Trumenba?
How is Trumenba used?
Hvordan virker Trumenba?
How does Trumenba work?
Ingen af deltagerne var tidligere blevet vaccineret mod N. meningitidis gruppe B. Deltagerne fik 3 doser af vaccinen, og der blev målt antistofrespons mod 4 af bakteriens hovedstammer (dem, der normalt forårsager sygdom i Europa) 1 måned efter den sidste injektion.
The first study involved around 3,600 participants aged 10 to 18 years, and the second study involved around 3,300 young adults between 18 and 25 years of age; none of the participants had previously been vaccinated against N. meningitidis group B. Those taking part were given 3 doses of the vaccine and antibody response against 4 main test strains of the bacteria (the ones usually responsible for disease in Europe) was measured one month after the last injection.
De tilgængelige data viser, at Trumenba, i form af en 2- eller 3-dosisbehandling, giver bred beskyttelse mod stammerne af Neisseria meningitidis gruppe B, som i øjeblikket findes i Europa.
The available data indicated that Trumenba should provide broad protection against the strains of Neisseria meningitidis group B that are currently found in Europe, whether given in a 3-dose or a 2dose schedule.
Dette kan tage op til 60 minutter.
This may take up to 60 minutes.
Disse reaktioner går normalt væk inden for nogle få dage.
These reactions usually go away within a few days.
Hvis dette sker, bør du vente, til reaktionerne er forsvundet.
If this happens, you should wait until the reactions have disappeared.
Vask hænder: Vask dine hænder grundigt.
Wash your hands thoroughly.
Lad det tørre (i mindst 30 sekunder).
Allow to dry (at least 30 seconds).
Klargør en ren arbejdsflade.
Prepare a clean work area.
Det er meget vigtigt at infundere lægemidlet med den rigtige hastighed.
It is very important to infuse the medicine at the correct speed.
(renhed på mindst 98 % IgG)
(purity of at least 98% IgG)
Mulige komplikationer kan ofte undgås ved at sikre, at:
Potential complications can often be avoided by:
Registreringen er frivillig.
Participation in the registry is voluntary.
Alle andre patienter bør observeres i mindst 20 minutter efter administrationen.
All other patients should be observed for at least 20 minutes after the administration.
Følgerne af en overdosis er ikke kendte.
Consequences of an overdose are not known.
Positiv direkte Coombs' test
Direct Coombs' test positive
Tmax [dage]
Tmax [days]
Dato for første markedsføringstilladelse: 16. maj 2013 Dato for fornyelse: 8. januar 2018
Date of first authorisation: 16 May 2013 Date of renewal: 8 Jan 2018
Formålet med dette register er at indsamle og dele data alene med de offentlige sundhedsmyndigheder, der er ansvarlige for overvågning af sikkerheden ved dette produkt.
The purpose of such registry is to collect and share data only with the public health authorities responsible for monitoring the safety of this product.
Tegn og symptomer på disse sjældne allergiske reaktioner omfatter:
Signs or symptoms of these rare allergic reactions include:
Dette kan forekomme, hvis du har IgA-mangel.
This may occur if you have IgA deficiency.
Egentlige overfølsomhedsreaktioner er sjældne.
True hypersensitivity reactions are rare.
Sikkerheden af IG 10% er blevet påvist i flere ikke-kliniske studier.
The safety of IG 10% has been demonstrated in several non-clinical studies.
Der er anført en national unik kode.
National unique code included.
En detaljeret brugsanvisning findes i afsnittet nedenfor.
Detailed Instructions for Use are provided in the section below.
Hypertension, stigning i blodtryk
Hypertension, blood pressure increase
Trombose kan også forekomme, uden at kendte risikofaktorer er til stede.
Thrombosis may also occur in the absence of known risk factors.
Protein (gram)
Protein (grams)
Af og til vil din læge muligvis anbefale, at større doser deles op og indgives to steder på en gang.
Sometimes your doctor may recommend that larger doses are split and given at two sites at once.