natgillin/translations-raw huggingface dataset:
Afhængigt af brystkræftens art og stadium kan det også anvendes sammen med andre midler mod kræft (doxorubicin, cyclophosphamid, trastuzumab eller capecitabin) til patienter, der endnu ikke har fået nogen behandling mod deres kræftsygdom, eller hos hvem andre behandlinger har været uden effekt,
It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Hvorfor blev Docetaxel Kabi godkendt?
Why has Docetaxel Kabi been approved?
Dagen før infusionen med Docetaxel Kabi gives patienten endvidere et antiinflammatorisk lægemiddel såsom dexamethason.
An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Kabi infusion.
Hvad er Docetaxel Kabi?
What is Docetaxel Kabi?
Hvordan blev Docetaxel Kabi undersøgt?
How has Docetaxel Kabi been studied?
Hvad anvendes Docetaxel Kabi til?
What is Docetaxel Kabi used for?
Hvordan anvendes Docetaxel Kabi?
How is Docetaxel Kabi used?
Hvordan virker Docetaxel Kabi?
How does Docetaxel Kabi work?
Dette sammendrag blev senest ajourført i december 2014.
This summary was last updated in December 2014.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Suvaxyn CSF Marker den 10/02/2015.
The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn CSF Marker on 10/02/2015.
Vaccinen gives til svin fra 7-ugers alderen som en enkelt injektion i en muskel.
The vaccine is given to pigs from seven weeks of age as a single injection into the muscle.
Beskyttelsen varede mindst seks måneder efter vaccinationen.
Protection lasted at least six months after vaccination.
Effektiviteten blev hovedsagelig bedømt på dannelsen af antistoffer mod E2-proteinet 14 dage efter vaccinationen.
The main measure of effectiveness was development of antibodies against E2 protein 14 days after vaccination.
Klassisk svinefeber vaccine (levende, rekombinant)
Classical swine fever vaccine (live recombinant)
Beskyttelsen indtræder to uger efter vaccinationen og varer mindst seks måneder.
Protection starts two weeks after vaccination and lasts for at least six months.
Effektiviteten af Suvaxyn CSF Marker blev nærmere undersøgt i en lille undersøgelse med 30 otte uger gamle smågrise.
The effectiveness of Suvaxyn CSF Marker was further investigated in a small scale study with 30 eight-week-old piglets.
Formålet med undersøgelserne var at fastslå, hvor lang tid det tog for svin at opnå fuld beskyttelse, og hvor længe de var beskyttet mod klassisk svinefebervirus.
The purpose of these studies was to establish how long it took for pigs to be fully protected and the length of time protection lasts against CSFV.
CVMP konkluderede, at fordelene ved Suvaxyn CSF Marker overstiger risiciene til den anbefalede anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Suvaxyn CSF Marker.
The CVMP concluded that the benefits of Suvaxyn CSF Marker exceed the risks for the approved indication and recommended that Suvaxyn CSF Marker be given a marketing authorisation.
Sygdommen medfører høj feber, hudlæsioner og kramper, og er ofte dødelig.
This disease causes fever, skin lesions, convulsions and often leads to death of the animals.
Vaccinen forhindrer, at dyrene dør, og begrænser infektionen og sygdommen.
Protection prevents mortality and reduces infection and disease.
Når vaccinen gives til et raskt svin, opfatter dyrets immunsystem vaccinevirusset som “fremmed”, og danner antistoffer mod det.
When the vaccine is given to a healthy pig, the animal's immune system recognises the vaccine virus as ‘foreign' and makes antibodies against it.
Vaccinen fås som et frysetørret pulver (lyofilisat) med opløsningsvæske (solvens) til injektion.
The vaccine is available as a lyophilisate (freeze dried powder) and solvent for injection.
Da klassisk svinefeber er en anmeldelsespligtig sygdom, kan der ikke udføres sædvanlige feltundersøgelser.
As CSF is a notifiable disease, it is not possible to conduct standard field studies.
Tilbageholdelsestiden for Suvaxyn CSF Marker for svin er 0 døgn.
The withdrawal period for Suvaxyn CSF Marker for pigs is zero days.
Laboratorieundersøgelserne viste, at vaccinen gav fuld virkning mod klassisk svinefebervirus inden for to uger.
The laboratory studies showed that the vaccine had its full effect against CSFV by two weeks.
Suvaxyn CSF Marker må ikke anvendes til vaccination af søer.
Suvaxyn CSF Marker should not be used to vaccinate sows.
Der er ingen kendte bivirkninger ved Suvaxyn CSF Marker, når det anvendes til den godkendte anvendelse (indikation) som anført i produktinformationen.
There are no known side effects with Suvaxyn CSF Marker when it is used according to the approved indication of the product information.
Feltundersøgelsen viste, at vaccination med Suvaxyn CSF Marker resulterede i, at 19 ud af 20 smågrise dannede antistoffer mod E2-proteinet.
The field study showed that vaccination with Suvaxyn CSF Marker resulted in 19 out of 20 piglets developing antibodies against E2 protein.
Suvaxyn CSF Marker er en vaccine, der indeholder bovint viral diarré virus, som kan smitte svin, men som normalt ikke forårsager sygdom.
Suvaxyn CSF Marker is a vaccine containing bovine viral diarrhoea virus, which can infect pigs but does not normally cause disease in them.
20 af smågrisene fik Suvaxyn CSF Marker, mens de 10 fik en virkningsløs injektion (placebo).
Twenty piglets were given Suvaxyn CSF Marker and 10 piglets were given a placebo (dummy) injection.
Suvaxyn CSF Marker er en rekombinant veterinær vaccine, der indeholder levende bovin viral diarré virus (BVDV), der er modificeret, så genet (E2) for kapslen hos BVDV er erstattet med det tilsvarende gen fra klassisk svinefebervirus (CSFV).
Suvaxyn CSF Marker is a recombinant veterinary vaccine that contains live bovine viral diarrhoea virus (BVDV) which has been modified to replace the envelope (E2) gene of BVDV with the corresponding gene of classical swine fever virus (CSFV).
Hvis dyret efterfølgende udsættes for klassisk svinefebervirus, vil immunsystemet reagere hurtigere på virusset.
In the future, if the animals are exposed to CSFV, their immune system will be triggered by the virus and be able to respond more quickly.
Vaccinevirusset i Suvaxyn CSF Marker er modificeret, så det producerer E2-proteinet, der indgår i den ydre kapsel hos det nært beslægtede virus klassisk svinefebervirus, som det giver beskyttelse mod.
The vaccine virus in Suvaxyn CSF Marker has been modified so that it will produce the E2 protein, which is part of the outer coat of the closely related virus CSFV, which it provides protection against.
Suvaxyn CSF Marker anvendes til at beskytte svin mod udbrud af klassisk svinefeber (svinepest), der er en meget alvorlig og stærkt smitsom virussygdom hos vildsvin og tamsvin.
Suvaxyn CSF Marker is used to protect pigs against outbreaks of classical swine fever, a very severe and highly contagious viral disease of both wild and domestic pigs.
Andre oplysninger om Suvaxyn CSF Marker:
Other information about Suvaxyn CSF Marker:
Det vil sige, at svin smittet med klassisk svinefebervirus af vildtypen kan skelnes fra vaccinerede svin i overensstemmelse med princippet om DIVA (differentiering af infektion fra vaccination).
The vaccine has potential marker properties which may allow detection of pigs infected with field CSFV as distinct from Suvaxyn CSF Marker vaccinated pigs, in accordance with the DIVA principle (differentiation of infection from vaccination).
Hvilken risiko er der forbundet med Suvaxyn CSF Marker?
What is the risk associated with Suvaxyn CSF Marker?
Hvorfor blev Suvaxyn CSF Marker godkendt?
Why has Suvaxyn CSF Marker been approved?
Hvad er Suvaxyn CSF Marker?
What is Suvaxyn CSF Marker?
Grunden er, at hvis det gives til drægtige søer, forhindrer dette ikke, at de smitter deres afkom med klassisk svinefebervirus.
This is because if given to pregnant sows it does not prevent them from passing CSFV infection to their offspring but can hide signs of infection in the piglets, allowing them to spread the disease.
Hvad anvendes Suvaxyn CSF Marker til?
What is Suvaxyn CSF Marker used for?
Hvordan blev Suvaxyn CSF Marker undersøgt?
How has Suvaxyn CSF Marker been studied?
Hvilken fordel viser undersøgelserne, at der er ved Suvaxyn CSF Marker?
What benefit has Suvaxyn CSF Marker shown during the studies?
Hvordan virker Suvaxyn CSF Marker?
How does Suvaxyn CSF Marker work?
3. august 2009 Dok.
3 August 2009 Doc.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 3. august
The final opinion was converted into a Decision by the European Commission on 3 August 2009.
Ansøgningen blev indgivet i henhold til artikel 32 i direktiv 2001/82/EF, med senere ændringer, hvor referencemedlemsstaten var Det Forenede Kongerige og de berørte medlemsstater Østrig, Belgien, Danmark, Frankrig, Tyskland, Grækenland, Irland, Italien, Nederlandene, Portugal og Spanien.
The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, The Netherlands, Portugal and Spain.
Den udpegede rapportør og medrapportør var dr. Bruno Urbain og dr. Michael Holzhauser-Alberti.
The rapporteur and co-rapporteur appointed were: Dr Bruno Urbain and Dr Michael Holzhauser-Alberti, respectively.
Florfenicol er et syntetisk bredspektret antibiotikum med en række virkeområder, herunder mange gramnegative og grampositive organismer.
Florfenicol is a synthetic broad spectrum antibiotic with a range of activity, including many Gramnegative and Gram-positive organisms.
Den gensidige anerkendelsesprocedure blev indledt den 28. februar 2008.
The Mutual Recognition Procedure started on 28 February
Der blev afgivet mundtlige redegørelser den 16. april 2009.
Oral explanations were given on 16 April 2009.
CVMP fandt imidlertid også, at ordlyden af den terapeutiske indikation, som var godkendt i referencemedlemsstaten, burde ændres med henblik på tydeligt at angive begrænsningerne for den godkendte anvendelse og undgå ukorrekt fortolkning.
However, the CVMP also considered that the wording of the therapeutic indication as authorised in the Reference Member State should be amended to clearly state the limitations of the approved use and avoid incorrect interpretation.
På grundlag af evalueringen af rapportørernes vurdering af de aktuelt foreliggende oplysninger vurderede CVMP, at den anbefalede anvendelse af lægemidlet udelukkende til terapeutisk behandling ikke udgjorde en miljørisiko.
Based on the evaluation of the rapporteurs' assessment of the currently available data, the CVMP considered that the use of the product as recommended for therapeutic use only does not constitute a risk for the environment.
På grund af betænkeligheder rejst af Tyskland og Nederlandene under den gensidige anerkendelsesprocedure om, at Shotaflor 300 mg/ml injektionsvæske, opløsning, til kvæg, kan udgøre en potentielt alvorlig miljørisiko, indbragte Det Forenede Kongerige sagen for EMEA den 31. juli 2008 i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF.
Due to concerns raised by Germany and The Netherlands during the Mutual Recognition Procedure that Shotaflor 300 mg/ml solution for injection for cattle could present a potential serious risk to the environment, the United Kingdom referred the matter to the EMEA on 31 July 2008 under Article 33(4) of Directive 2001/82/EC.
Udvalget vedtog derfor en udtalelse den 14. maj 2009, hvori det anbefalede godkendelse af ændringen af markedsføringstilladelsen i overensstemmelse med de foreslåede ændringer i produktresumé og indlægsseddel.
Therefore the Committee adopted an opinion on 14 May 2009 recommending the variation of the Marketing Authorisation in line with the proposed amendments to the Summary of Product Characteristics and package leaflet.
Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 15. januar 2009.
Written explanations were provided by the Marketing Authorisation Holder on 15 January 2009.
Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, og det ændrede produktresumé og den ændrede indlægsseddel findes 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 Summary of Product Characteristics and package leaflet in the Annex III.
Indbringelsesproceduren blev indledt den 16. september 2008.
The referral procedure started on 16 September 2008.
Indehaveren af markedsføringstilladelsen Virbac S.A. indgav en ansøgning om gensidig anerkendelse af Shotaflor 300 mg/ml injektionsvæske, opløsning, til kvæg, på grundlag af en markedsføringstilladelse udstedt af Det Forenede Kongerige.
The Marketing Authorisation Holder, Virbac S.A., submitted an application via mutual recognition for Shotaflor 300 mg/ml solution for injection for cattle, on the basis of the marketing authorisation granted by the United Kingdom.
SHOTAFLOR 300 MG/ML INJEKTIONSVÆSKE, OPLØSNING, TIL KVÆG Internationalt fællesnavn (INN): florfenicol
OPINION FOLLOWING AN ARTICLE 33 (4)1 REFERRAL FOR SHOTAFLOR 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE International Non-Proprietary Name (INN): Florfenicol
DuoPlavin må ikke anvendes under de sidste tre måneder af graviditeten.
DuoPlavin must not be used during the last three months of pregnancy.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for DuoPlavin den 15. marts 2010.
The European Commission granted a marketing authorisation valid throughout the EU for DuoPlavin on 15 March 2010.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for DuoPlavin.
This document is a summary of the European Public Assessment Report (EPAR) for DuoPlavin.
Den fuldstændige EPAR for DuoPlavin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for DuoPlavin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om DuoPlavin:
Other information about DuoPlavin:
Det fås som tabletter, der indeholder 75 mg clopidogrel og enten 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 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 DuoPlavin 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 DuoPlavin.
Hvis du ønsker yderligere oplysninger om behandling med DuoPlavin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with DuoPlavin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Den fremlagde også resultaterne af tre tidligere undersøgelser, der omfattede mere end 61 000 patienter med svære, ustabile brystsmerter (angina), eller som 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.
Udvalget besluttede derfor, at fordelene ved DuoPlavin opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
The Committee therefore decided that DuoPlavin's benefits are greater than its risks and recommended that it be given marketing authorisation.
DuoPlavin clopidogrel/acetylsalicylsyre
DuoPlavin clopidogrel / acetylsalicylic acid
• patienter, der behandles for hjerteanfald med elevation af ST-segmentet, når lægen mener, at de ville have gavn af trombolytisk behandling (behandling til opløsning af blodpropper).
• patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from thrombolytic treatment (treatment to dissolve blood clots).
Hvilken risiko er der forbundet med DuoPlavin?
What is the risk associated with DuoPlavin?
DuoPlavin er et lægemiddel, som indeholder to aktive stoffer, clopidogrel og acetylsalicylsyre (også kendt som aspirin).
DuoPlavin is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin).
De hyppigste bivirkninger ved DuoPlavin (der optræder hos mellem 1 og 10 patienter af 100) er hæmatom (blodsamling under huden), epistaksis (næseblod), gastrointestinale blødninger (blødninger i mave eller tarm), diarré, mavesmerter, dyspepsi (halsbrand), blå mærker og blødning på punkturstedet.
The most common side effects with DuoPlavin (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.
Hvorfor er DuoPlavin blevet godkendt?
Why has DuoPlavin been approved?
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.
Den fuldstændige liste over alle de indberettede bivirkninger ved DuoPlavin fremgår af indlægssedlen.
For the full list of all side effects reported with DuoPlavin, see the package leaflet.
Begge aktive stoffer i DuoPlavin, nemlig clopidogrel og acetylsalicylsyre, er antitrombocytlægemidler.
Both active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
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 kaldet 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).
Resultaterne af de tre undersøgelser omfattende patienter, der havde ustabile brystsmerter eller havde haft et hjerteanfald, viste, at kombinationen clopidogrel og acetylsalicylsyre, taget som separate tabletter, var bedre til at forebygge hændelser 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 reducerer produktionen af et stof, der kaldes tromboxan, som normalt medvirker til blodets koagulering 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.
CHMP bemærkede, at DuoPlavin svarer til clopidogrel- og acetylsalicylsyretabletter, der tages separat, og udvalget konkluderede, at en kombination af begge aktive stoffer i én DuoPlavin-tablet gør behandlingen enklere for patienterne, eftersom de skal tage færre tabletter.
The CHMP noted that DuoPlavin is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single DuoPlavin tablet simplifies treatment for patients as they will need to take fewer tablets.
• 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;
DuoPlavin anvendes til forebyggelse af problemer, der skyldes blodpropper og åreforkalkning, såsom hjerteanfald hos voksne, der allerede tager både clopidogrel og acetylsalicylsyre som separate tabletter.
DuoPlavin is used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Det må ikke anvendes hos patienter, som har alvorligt nedsat levereller 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).
DuoPlavin må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for clopidogrel, nonsteroide antiinflammatoriske stoffer (såsom acetylsalicylsyre) eller andre af indholdsstofferne i DuoPlavin.
DuoPlavin 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 DuoPlavin.
Det betyder, at de ved at forhindre blodpladerne i at klæbe til hinanden og danne blodpropper er med til forebygge 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.
Der skal tages én DuoPlavin-tablet om dagen i stedet for de clopidogrel- og acetylsalicylsyretabletter, som patienten tidligere har taget separat.
DuoPlavin 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.
Det blev påvist, at DuoPlavin svarer til clopidogrel og acetylsalicylsyre taget separat, og det kan derfor anvendes i stedet for de clopidogrel- og acetylsalicylsyretabletter, som patienterne tidligere har taget.
DuoPlavin 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.
Virksomheden fremlagde derfor undersøgelser, der viser, at de aktive stoffer i DuoPlavin 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 DuoPlavin are absorbed in the body in the same way when taken in a single tablet as when the two medicines are taken separately.
Hvilken fordel viser undersøgelserne, at der er ved DuoPlavin?
What benefit has DuoPlavin shown during the studies?
Hvordan er DuoPlavin blevet undersøgt?
How has DuoPlavin been studied?
Hvad anvendes DuoPlavin til?
What is DuoPlavin used for?
Hvordan anvendes DuoPlavin?
How is DuoPlavin used?
Hvordan virker DuoPlavin?
How does DuoPlavin work?
Yderligere information om Pelmeg findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/pelmeg.
Further information on Pelmeg can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pelmeg.
Andre oplysninger om Pelmeg
Other information about Pelmeg
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pelmeg?
What measures are being taken to ensure the safe and effective use of Pelmeg?