natgillin/translations-raw huggingface dataset:
Ændringen vedrørte udvidelse af anvendelsen til også at omfatte behandling af brystkræft.
The change concerned an extension of indication to add treatment of breast cancer.
Virksomheden informerede CHMP om, at beslutningen ikke ville få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Javlor.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Javlor.
Den 26. september 2014 EMA/587197/2014
EMA/587197/2014
Den 25. september 2014 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om ændring af markedsføringstilladelsen for lægemidlet Javlor.
On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Javlor.
På daværende tidspunkt var CHMP derfor af den opfattelse, at fordelene ved Javlor til behandling af brystkræft ikke opvejede de ekstra risici, der var iagttaget.
Therefore, at that point in time, the CHMP was of the opinion that the modest effect of Javlor in the treatment of breast cancer did not outweigh the additional risks observed.
Det aktive stof i Javlor, vinflunin, tilhører en gruppe af kræftlægemidler kaldet vinkaalkaloider.
The active substance in Javlor, vinflunine, belongs to the group of cancer medicines known as ‘vinca alkaloids'.
Javlor forventedes også anvendt i kombination med kræftlægemidlet capecitabin til at behandle voksne med lokalt fremskreden eller metastatisk brystkræft.
Javlor was also expected to be used in combination with the cancer medicine capecitabine for the treatment of adult patients with locally advanced or metastatic breast cancer.
Det bindes i cellerne til proteinet tubulin, der er vigtigt for dannelsen af cellernes indvendige »skelet«, som cellerne behøver for at kunne dele sig.
It attaches to a cell protein called tubulin, which is important in the formation of the internal ‘skeleton' that cells need to allow them to divide.
I forhold til behandling med capecitabin alene var der flere patienter på Javlor plus capecitabin, der fik bivirkninger i form af et abnormt lavt antal hvide blodceller (neutropeni), bivirkninger fra mave-tarm-systemet i form af forstoppelse, kvalme, opkastning og mavesmerter, træthed og symptomer fra nervesystemet, såsom beskadigelse af nerverne i arme og ben.
Compared with patients given capecitabine alone, more patients receiving Javlor plus capecitabine experienced side effects including neutropenia (abnormally low blood levels of white blood cells), gastrointestinal events such as constipation, nausea and vomiting and stomach ache, fatigue and nervous system disorders such as damage to the nerves in the extremities.
CHMP bemærkede, at virkningen af Javlor i kombination med capecitabin ikke var tilstrækkeligt påvist.
The CHMP noted that the effectiveness of Javlor in combination with capecitabine had not been sufficiently demonstrated.
Når vinflunin bindes til tubulin i kræftcellerne, blokerer det dannelsen af dette skelet og forhindrer derved kræftcellerne i at dele sig og spredes.
By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.
Virksomheden fremlagde resultaterne af en hovedundersøgelse med 770 patienter, der havde fremskreden brystkræft og tidligere var behandlet med, eller ikke havde oplevet noget virkning af, et antracyclinderivat, og hos hvem taxaner heller ikke virkede.
The company presented the results of a main study involving 770 patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant.
Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om ændring af markedsføringstilladelsen?
What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisation?
Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede uden forværring af sygdommen (progressionsfri overlevelse).
The main measure of effectiveness was progression-free survival (how long patients lived without their disease getting worse).
CHMP anbefalede derfor et afslag på ansøgningen om ændring af markedsføringstilladelsen.
Hence, the CHMP recommended that the change to the marketing authorisation be refused.
I undersøgelsen blev Javlor i kombination med capecitabin sammenlignet med capecitabin alene.
In the study, Javlor given together with capecitabine was compared with capecitabine alone.
Det skulle anvendes hos patienter, der tidligere var blevet behandlet med, eller ikke havde oplevet nogen virkning af, et kræftlægemiddel i gruppen antracyclinderivater, og som heller ikke havde oplevet nogen virkning af en tredje type kræftlægemidler kaldet taxaner.
It was to be used in patients previously treated with, or resistant to, another type of cancer medicine called an anthracycline and who are also resistant to a third type of cancer medicines called taxanes.
Javlor indeholder det aktive stof vinflunin og fås som et koncentrat til infusionsvæske, opløsning, der gives med drop i en vene.
Javlor contains the active substance vinflunine and is available as a concentrate for solution for infusion (drip) into a vein.
Hvad sker der med Javlor til behandling af voksne med overgangscellekarcinom i urinvejene?
What is happening with Javlor for the treatment of transitional-cell carcinoma of the urothelial tract?
Det bruges i forvejen til behandling af voksne med fremskreden eller metastatisk kræft i slimhinden i blæren og resten af urinvejene (overgangscellekarcinom).
It is already used to treat adults with advanced or metastatic ‘transitional-cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract).
Særnavn Navn Styrke Lægemiddelform
Strength Pharmaceutical Form
Administration
Route of Administration
1 Tidligere kendt som DuoCover.
1 Previously known as DuoCover.
Begge aktive stoffer har i en årrække været tilgængelige i Den Europæiske Union (EU).
Both active substances have been available in the European Union (EU) for a number of years.
Det fås som tabletter, der indeholder 75 mg clopidogrel, enten med 75 mg eller 100 mg acetylsalicylsyre.
It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Det kan anvendes til følgende patientgrupper, som har en sygdom, der kaldes "akut koronarsyndrom":
It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Den fuldstændige EPAR for Clopidogrel/Acetylsalicylsyre Zentiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Clopidogrel/Acetylsalicylic acid Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• patienter, der er i behandling for hjerteanfald med ST-segmentøgning, når lægen mener, at de kan have fordel af behandling, der opløser blodpropper.
• patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from treatment to dissolve blood clots.
Virksomheden fremlagde desuden resultater af tre tidligere undersøgelser med i alt over 61 000 patienter, der havde ustabil angina eller havde haft et hjerteanfald.
It also presented the results of 3 previous studies involving over 61,000 patients with unstable angina or who had had a heart attack.
Acetylsalicylsyre har kunnet fås i over 100 år.
Acetylsalicylic acid has been available for over 100 years.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Clopidogrel/Acetylsalicylsyre Zentiva skal anvendes.
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 Clopidogrel/Acetylsalicylic acid Zentiva.
Clopidogrel/Acetylsalicylsyre Zentiva må ikke tages i de sidste tre måneder af graviditeten.
Clopidogrel/Acetylsalicylic acid Zentiva must not be used during the last three months of pregnancy.
Clopidogrel har været godkendt siden 1998 til nedsættelse af blodpladers sammenklæbning og anvendes ofte sammen med acetylsalicylsyre.
Clopidogrel has been authorised since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid.
Lægemidlets navn blev ændret til Clopidogrel/Acetylsalicylsyre Zentiva den 15. januar 2016.
The name of the medicine was changed to Clopidogrel/Acetylsalicylic acid Zentiva on 15 January 2016.
Udvalget besluttede derfor, at fordelene ved Clopidogrel/Acetylsalicylsyre Zentiva opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee therefore decided that Clopidogrel/Acetylsalicylic acid Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel/Acetylsalicylsyre Zentiva.
This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel/Acetylsalicylic acid Zentiva.
Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel/Acetylsalicylsyre Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Clopidogrel/Acetylsalicylic acid Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel/Acetylsalicylsyre Zentiva den 15. marts 2010.
The European Commission granted a marketing authorisation valid throughout the EU for DuoCover on 15 March 2010.
Virkningen af de to aktive stoffer supplerer hinanden, dvs. risikoen for blodpropper nedsættes mere end med hvert lægemiddel for sig.
The combination of the two active substances has an additive effect, reducing the risk of blood clots forming more than either medicine alone.
Det må ikke anvendes hos patienter, som har en blødningssygdom som f.eks. mavesår eller blødning i hjernen, eller hos patienter med mastocytose (højt indhold i blodet af særlige hvide blodlegemer, der kaldes mastceller).
It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain, or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells).
De hyppigste bivirkninger ved Clopidogrel/Acetylsalicylsyre Zentiva (der optræder hos mellem 1 og 10 patienter ud af 100) er blodsamling under huden (hæmatom), næseblod (epistaksis), gastrointestinale blødninger (blødninger i mave eller tarm), diarré, mavesmerter, dyspepsi (halsbrand), blå mærker og blødning på punkturstedet.
The most common side effects with Clopidogrel/Acetylsalicylic acid Zentiva (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured.
Dette forhindrer blodpladerne i at blive "klæbrige" og nedsætter dermed risikoen for blodpropper.
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming.
Det reducerer produktionen af et stof, der kaldes tromboxan, som normalt er med til at få blodet til at klumpe sammen ved at få blodpladerne til at klæbe sammen.
This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together.
• patienter, der har svære, ustabile brystsmerter (angina) eller har haft et hjerteanfald uden den unormale forandring i elektrokardiogrammet (»ST-segmentøgning«), herunder patienter, der har fået indsat en kort slange (en stent) i en arterie for at undgå, at den blokeres
• patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Det må ikke anvendes hos patienter, som har alvorligt nedsat lever- eller nyrefunktion, eller som har en sygdom, der omfatter en kombination af astma, rhinitis (tilstoppet og løbende næse) og næsepolypper (gevækster i næsens slimhinde).
It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose).
Det betyder, at de forhindrer blodpladerne i at klæbe til hinanden og danne blodpropper og dermed forebygger nye hjerteanfald.
This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
Clopidogrel/Acetylsalicylsyre Zentiva er et lægemiddel, som indeholder to aktive stoffer, clopidogrel og acetylsalicylsyre (også kendt som aspirin).
Clopidogrel/Acetylsalicylic acid Zentiva is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin).
Acetylsalicylsyre forhindrer blodpladerne i at klæbe til hinanden ved at blokere enzymet prostaglandin cyclooxygenase.
Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase.
Clopidogrel/Acetylsalicylsyre Zentiva må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for clopidogrel, non-steroide antiinflammatoriske stoffer (såsom acetylsalicylsyre) eller andre af indholdsstofferne i Clopidogrel/Acetylsalicylsyre Zentiva.
Clopidogrel/Acetylsalicylic acid Zentiva must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in Clopidogrel/Acetylsalicylic acid Zentiva.
Clopidogrel forhindrer blodpladerne i at klæbe til hinanden ved at forhindre stoffet ADP i at binde sig til en særlig receptor på blodpladernes overflade.
Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a special receptor on their surface.
Begge aktive stoffer i Clopidogrel/Acetylsalicylsyre Zentiva, clopidogrel og acetylsalicylsyre, er antitrombocytlægemidler.
Both active substances in Clopidogrel/Acetylsalicylic acid Zentiva, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
CHMP bemærkede, at Clopidogrel/Acetylsalicylsyre Zentiva svarer til clopidogrel- og acetylsalicylsyretabletter, der tages separat, og udvalget konkluderede, at en kombination af begge aktive stoffer i én Clopidogrel/Acetylsalicylsyre Zentiva-tablet gør behandlingen enklere for patienterne, eftersom de skal tage færre tabletter.
The CHMP noted that Clopidogrel/Acetylsalicylic acid Zentiva is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single Clopidogrel/Acetylsalicylic acid Zentiva tablet simplifies treatment for patients as they will need to take fewer tablets.
Det blev påvist, at Clopidogrel/Acetylsalicylsyre Zentiva kan sammenlignes med clopidogrel og acetylsalicylsyre taget separat, og det kan derfor anvendes i stedet for de clopidogrel- og acetylsalicylsyretabletter, som patienterne tidligere har taget.
Clopidogrel/Acetylsalicylic acid Zentiva was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.
Den fuldstændige liste over indberettede bivirkninger ved Clopidogrel/Acetylsalicylsyre Zentiva fremgår af indlægssedlen.
For the full list of all side effects reported with Clopidogrel/Acetylsalicylic acid Zentiva, see the package leaflet.
Der skal tages én Clopidogrel/Acetylsalicylsyre Zentiva-tablet om dagen i stedet for de clopidogrel- og acetylsalicylsyretabletter, som patienten tidligere har taget separat.
Clopidogrel/Acetylsalicylic acid Zentiva is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
Virksomheden fremlagde derfor undersøgelser, der viser, at de aktive stoffer i Clopidogrel/Acetylsalicylsyre Zentiva optages på samme måde i kroppen, når de tages som en enkelt tablet, som når de to lægemidler tages hvert for sig.
Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in Clopidogrel/Acetylsalicylic acid Zentiva are absorbed in the body in the same way when taken in a single tablet as when the two medicines are taken separately.
Undersøgelserne viste, at kombinationen clopidogrel og acetylsalicylsyre, taget som separate tabletter, var bedre til at forebygge tilfælde som hjerteanfald end acetylsalicylsyre alene.
Results from the 3 studies in patients with unstable angina or who had had a heart attack showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.
Det anvendes til at forebygge problemer forårsaget af blodpropper, såsom hjerteanfald, hos voksne, der i forvejen får både clopidogrel og acetylsalicylsyre (aspirin) som separate tabletter.
Clopidogrel/Acetylsalicylic acid Zentiva is used to prevent problems caused by blood clots, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Hvilken risiko er der forbundet med Clopidogrel/Acetylsalicylsyre Zentiva?
What is the risk associated with Clopidogrel/Acetylsalicylic acid Zentiva?
Andre oplysninger om Clopidogrel/Acetylsalicylsyre Zentiva
Other information about Clopidogrel/Acetylsalicylic acid Zentiva:
Hvorfor blev Clopidogrel/Acetylsalicylsyre Zentiva godkendt?
Why has Clopidogrel/Acetylsalicylic acid Zentiva been approved?
Clopidogrel/Acetylsalicylsyre Zentiva1
Clopidogrel/Acetylsalicylic acid Zentiva clopidogrel / acetylsalicylic acid
Hvordan blev Clopidogrel/Acetylsalicylsyre Zentiva undersøgt?
How has Clopidogrel/Acetylsalicylic acid Zentiva been studied?
Hvad er Clopidogrel/Acetylsalicylsyre Zentiva?
What is Clopidogrel/Acetylsalicylic acid Zentiva?
Hvordan anvendes Clopidogrel/Acetylsalicylsyre Zentiva?
How is Clopidogrel/Acetylsalicylic acid Zentiva used?
Hvad anvendes Clopidogrel/Acetylsalicylsyre Zentiva til?
What is Clopidogrel/Acetylsalicylic acid Zentiva used for?
Hvordan virker Clopidogrel/Acetylsalicylsyre Zentiva?
How does Clopidogrel/Acetylsalicylic acid Zentiva work?
Hvilken fordel viser undersøgelserne, at der er ved Clopidogrel/Acetylsalicylsyre Zentiva?
What benefit has Clopidogrel/Acetylsalicylic acid Zentiva shown during the studies?
Denne tilladelse byggede på den tilladelse, som blev udstedt for Plavix i 1998 (‘informeret samtykke').
This authorisation was based on the authorisation granted to Plavix in 1998 (‘informed consent').
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Winthrop den 16. juli 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Winthrop on 16 July 2008.
Den fuldstændige EPAR for Clopidogrel Zentiva findes på agenturets websted under: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Clopidogrel Zentiva can be found on the Agency's: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Lægemidlets navn blev ændret til Clopidogrel Zentiva den 23. august 2011.
The name of the medicine was changed to Clopidogrel Zentiva on 23 August 2011.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel Zentiva.
This is a summary of the European public assessment report (EPAR) for Clopidogrel Zentiva.
Dette viser, at Clopidogrel Zentiva mindsker risikoen for en hændelse.
This showed that Clopidogrel Zentiva reduces the risk of an event.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Clopidogrel Zentiva.
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 Clopidogrel Zentiva.
Nogle af disse patienter har fået indsat en stent (et kort rør) i en arterie for at forhindre denne i at indsnævre sig.
Some of these patients have had a stent inserted (a short tube) placed in an artery to prevent it from closing up.
Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Clopidogrel Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
I CAPRIE-undersøgelsen var der 939 hændelser i Clopidogrel Zentiva-gruppen og 1 020 i aspiringruppen.
In CAPRIE, there were 939 events in the Clopidogrel Zentiva group, and 1,020 in the aspirin group.
Clopidogrel Zentiva var mere effektivt end aspirin til forebyggelse af nye iskæmiske hændelser.
Clopidogrel Zentiva was more effective than aspirin at preventing new ischaemic events.
Dette betyder, at færre patienter vil opleve nye iskæmiske hændelser, når de får Clopidogrel Zentiva, end hvis de får aspirin.
This means that fewer patients will have new ischaemic events if they receive Clopidogrel Zentiva than if they receive aspirin.
CHMP besluttede, at fordelene ved Clopidogrel Zentiva opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Clopidogrel Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det vil sige, at ca. 10 patienter af 1 000 vil undgå en ny iskæmisk hændelse to år efter at de er begyndt at tage Clopidogrel Zentiva i stedet for aspirin.
In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Clopidogrel Zentiva instead of aspirin.
Clopidogrel Zentiva omdannes til sin aktive form i kroppen.
Clopidogrel Zentiva is converted into its active form in the body.
Visse patienter er af genetiske årsager måske ikke i stand til at omdanne Clopidogrel Zentiva lige så effektivt som andre og reagerer måske ikke lige så godt på lægemidlet.
For genetic reasons, some patients may not be able to convert Clopidogrel Zentiva as effectively as others, which could reduce their response to the medicine.
Clopidogrel Zentiva anvendes til forebyggelse af problemer forårsaget af blodpropper hos voksne, som
Clopidogrel Zentiva is used to prevent problems caused by blood clots in adults who have:
Standarddosis af Clopidogrel Zentiva er en tablet a 75 mg en gang dagligt.
The standard dose of Clopidogrel Zentiva is one 75-mg tablet once a day.
Dette forhindrer dem i at blive ‘klæbrige' og mindsker således risikoen for, at der dannes blodpropper, og medvirker til at forebygge endnu et hjerte- eller et slagtilfælde.
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Clopidogrel Zentiva bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for Clopidogrel eller andre af indholdsstofferne.
Clopidogrel Zentiva should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients.