natgillin/translations-raw huggingface dataset:
Vaccinen er bestemt til aktiv immunisering af svin mod pleuropneumoni forårsaget af A. pleuropneumoniae serotype 1 og 2 med henblik på mindskelse af de kliniske tegn og lungeforandringer, der er knyttet til sygdommen.
The vaccine is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, in order to reduce the clinical signs and lung lesions associated with the disease.
Coglapix er bestemt til aktiv immunisering af svin som hjælp til kontrol af pleuropneumoni forårsaget af A. pleuropneumoniae serotype 1 og 2, og i laboratorieundersøgelser er der påvist reduktion af de kliniske tegn og lungeforandringer, der er knyttet til sygdommen.
Coglapix is intended for active immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, and reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory studies.
Den fuldstændige EPAR for Pemetrexed Hospira UK Limited findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Pemetrexed Hospira UK Limited can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
I kroppen omdannes pemetrexed til en aktiv form, der blokerer de enzymer, der medvirker ved dannelsen af "nukleotider" (byggestenene i dna og rna, cellernes genetiske materiale).
In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
For at mindske bivirkningerne bør patienten få et kortikosteroid (en type lægemiddel, der mindsker betændelseslignende tilstande), folsyre (en type vitamin) og indsprøjtninger med vitamin B12 under behandlingen med Pemetrexed Hospira UK Limited.
To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Hospira UK Limited.
Det betyder, at Pemetrexed Hospira UK Limited indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Alimta.
This means that Pemetrexed Hospira UK Limited contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Der var ikke behov for "bioækvivalensundersøgelser" af, om Pemetrexed Hospira UK Limited absorberes på samme måde som referencelægemidlet for at producere samme niveau af det aktive stof i blodet.
There was no need for ‘bioequivalence' studies to investigate whether Pemetrexed Hospira UK Limited is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Udvalget anbefalede, at Pemetrexed Hospira UK Limited godkendes til anvendelse i EU.
The Committee recommended that Pemetrexed Hospira UK Limited be approved for use in the EU.
Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Alimta, og det er ikke nødvendigt at gentage disse med Pemetrexed Hospira UK Limited.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Hospira UK Limited.
Pemetrexed Hospira UK Limited er et kræftlægemiddel til behandling af to typer lungekræft:
Pemetrexed Hospira UK Limited is a cancer medicine used to treat two types of lung cancer:
Da Pemetrexed Hospira UK Limited er et generisk lægemiddel, antages det at have de samme fordele og risici som referencelægemidlet.
Because Pemetrexed Hospira UK Limited is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pemetrexed Hospira UK Limited er sammenligneligt med Alimta.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Hospira UK Limited has been shown to be comparable to Alimta.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pemetrexed Hospira UK Limited.
This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira UK Limited.
Dette skyldes, at Pemetrexed Hospira UK Limited gives ved infusion i en vene, så det aktive stof ledes direkte ind i blodbanen.
This is because Pemetrexed Hospira UK Limited is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Pemetrexed Hospira UK Limited.
As for every medicine, the company provided studies on the quality of Pemetrexed Hospira UK Limited.
Hvis du ønsker yderligere oplysninger om behandling med Pemetrexed Hospira UK Limited, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Pemetrexed Hospira UK Limited, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det aktive stof i Pemetrexed Hospira UK Limited er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter".
The active substance in Pemetrexed Hospira UK Limited is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Hvis du ønsker praktisk vejledning om anvendelsen af Pemetrexed Hospira UK Limited, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Pemetrexed Hospira UK Limited, patients should read the package leaflet or contact their doctor or pharmacist.
Det er ikke en praktisk vejledning i, hvordan Pemetrexed Hospira UK Limited bør anvendes.
It is not intended to provide practical advice on how to use Pemetrexed Hospira UK Limited.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Hospira UK Limited?
What measures are being taken to ensure the safe and effective use of Pemetrexed Hospira UK Limited?
Andre oplysninger om Pemetrexed Hospira UK Limited
Other information about Pemetrexed Hospira UK Limited
Hvilke fordele og risici er der forbundet med Pemetrexed Hospira UK Limited?
What are the benefits and risks of Pemetrexed Hospira UK Limited?
Hvad er Pemetrexed Hospira UK Limited, og hvad anvendes det til?
What is Pemetrexed Hospira UK Limited and what is it used for?
Når Pemetrexed Hospira UK Limited gives sammen med cisplatin, bør der desuden før eller efter cisplatin gives et lægemiddel mod kvalme og opkastning og væsketilskud for at forhindre udtørring.
When Pemetrexed Hospira UK Limited is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Pemetrexed Hospira UK Limited fås som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
Pemetrexed Hospira UK Limited is available as a powder that is made up into a solution for infusion (drip) into a vein.
Det kan desuden anvendes som vedligeholdelsesbehandling hos patienter, der har fået platinbaseret kemoterapi Pemetrexed Hospira UK Limited indeholder det aktive stof pemetrexed.
It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Hvorfor blev Pemetrexed Hospira UK Limited godkendt?
Why is Pemetrexed Hospira UK Limited approved?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pemetrexed Hospira UK Limited.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Hospira UK Limited have been included in the summary of product characteristics and the package leaflet.
• malignt pleuramesoteliom (kræft i lungehinderne), der sædvanligvis skyldes udsættelse for asbest.
• malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Hvordan anvendes Pemetrexed Hospira UK Limited?
How is Pemetrexed Hospira UK Limited used?
Hvordan blev Pemetrexed Hospira UK Limited undersøgt?
How has Pemetrexed Hospira UK Limited been studied?
Hvordan virker Pemetrexed Hospira UK Limited?
How does Pemetrexed Hospira UK Limited work?
Det gives over 1 time hver 8. time.
It is given over 1 hour, every 8 hours.
Zerbaxa fik en markedsføringstilladelse med gyldighed i hele EU den 18. september 2015.
Zerbaxa received a marketing authorisation valid throughout the EU on 18 September 2015.
Yderligere information om Zerbaxa findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/zerbaxa.
Further information on Zerbaxa can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zerbaxa.
Vedrørende sikkerheden ansås bivirkningerne for at være typiske og forventelige for et antibiotikum af denne art.
Regarding safety, side effects were considered to be typical and expected for an antibiotic of this kind.
Som for alle lægemidler bliver data vedrørende brugen af Zerbaxa løbende overvåget.
As for all medicines, data on the use of Zerbaxa are continuously monitored.
Andre oplysninger om Zerbaxa
Other information about Zerbaxa
Dosis og behandlingens varighed afhænger af den behandlede infektion og af, hvor godt lægemidlet virker på den.
The dose and duration of treatment depends on the infection being treated and how the infection responds to the medicine.
De hyppigste bivirkninger ved Zerbaxa (som kan forekomme hos op til 1 ud af 10 personer) er kvalme, hovedpine, forstoppelse, diarré og feber.
The most common side effects with Zerbaxa (which may affect up to 1 in 10 people) are nausea (feeling sick), headache, constipation, diarrhoea and fever.
Det andet studie omfattede 993 patienter med komplicerede intraabdominale infektioner.
The second study involved 993 patients with complicated intra-abdominal infections.
Agenturet fandt, at Zerbaxa var effektivt til at helbrede infektioner hos de undersøgte patienter, men anerkendte, at der kun var indgået et begrænset antal patienter med komplicerede urinvejsinfektioner.
The Agency considered that Zerbaxa was effective at curing infections in the patients studied, but acknowledged that only a limited number of patients with complicated urinary tract infections had been included.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Zerbaxa opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Zerbaxa's benefits are greater than its risks and it can be authorised for use in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zerbaxa?
What measures are being taken to ensure the safe and effective use of Zerbaxa?
Zerbaxa er et antibiotikum, der anvendes til at behandle voksne med:
Zerbaxa is an antibiotic used to treat adults with:
Zerbaxa (ceftolozan/tazobactam)
Zerbaxa (ceftolozane / tazobactam)
De indberettede bivirkninger ved Zerbaxa vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Zerbaxa are carefully evaluated and any necessary action taken to protect patients.
• komplicerede (svære at behandle) infektioner i væv og organer i maven (intraabdominale infektioner)
• complicated (difficult to treat) infections of tissues and organs within the belly (intra-abdominal infections);
Hvis du ønsker mere information om anvendelsen af Zerbaxa, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Zerbaxa, see the package leaflet or contact your doctor or pharmacist.
Hvorfor er Zerbaxa godkendt i EU?
Why is Zerbaxa authorised in the EU?
Agenturet bemærkede også, at tazobactam ikke er aktivt mod visse klasser af betalaktamase, hvilket kan medføre resistensproblemer.
The Agency also noted that tazobactam is not active against some classes of beta-lactamase that can cause problems of resistance.
En oversigt over Zerbaxa, og hvorfor det er godkendt i EU
An overview of Zerbaxa and why it is authorised in the EU
Det virker ved at gribe ind i dannelsen af molekyler, som bakterierne behøver for at opbygge deres beskyttende cellevægge.
It works by interfering with the production of molecules that bacteria need to build their protective cell walls.
Det tredje studie omfattede 726 patienter, der brugte respirator, og som enten havde hospitalserhvervet lungebetændelse eller respiratorrelateret lungebetændelse.
The third study involved 726 patients who were using a ventilator and who had either hospitalacquired pneumonia or ventilator-associated pneumonia.
Det ene studie omfattede 1.083 patienter, hovedsagelig med nyreinfektioner eller i visse tilfælde komplicerede urinvejsinfektioner.
One study involved 1,083 patients who mostly had kidney infection or in some cases a complicated urinary-tract infection.
Hvad er Zerbaxa, og hvad anvendes det til?
What is Zerbaxa and what is it used for?
Zerbaxa blev her sammenlignet med et andet antibiotikum, nemlig meropenem.
Zerbaxa was compared with another antibiotic, meropenem.
Zerbaxa må ikke anvendes hos personer, som er overfølsomme (allergiske) over for Zerbaxa eller nogen af indholdsstofferne heri, eller hos personer, som er allergiske over for andre antibiotika af cefalosporin-typen eller har haft en svær allergisk reaktion over for et andet betalaktamantibiotikum.
Zerbaxa must not be used in people who are hypersensitive (allergic) to Zerbaxa or any of its ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Begge lægemidler helbredte 94 % af patienterne (353 ud af 375, som fik Zerbaxa, og 375 ud af 399, som fik meropenem).
Both medicines cured 94% of patients (353 out of 375 given Zerbaxa and 375 out of 399 given meropenem).
• alvorlige nyreinfektioner (akut pyelonefrit)
• serious kidney infection (acute pyelonephritis);
Zerbaxa fås til infusion (drop) i en vene og fås kun på recept.
Zerbaxa is available for infusion (drip) into a vein and can only be obtained with a prescription.
De to aktive stoffer i Zerbaxa, ceftolozan og tazobactam, virker på forskellige måder.
The active substances in Zerbaxa, ceftolozane and tazobactam, work in different ways.
Zerbaxa er i tre hovedstudier påvist at være mindst lige så effektivt som andre antibiotika til at helbrede infektioner.
Zerbaxa has been shown to be at least as effective as other antibiotics in curing infections in three main studies.
Hvilke risici er der forbundet med Zerbaxa?
What are the risks associated with Zerbaxa?
Ved at blokere virkningen af disse enzymer giver tazobactam ceftolozan mulighed for at virke mod bakterier, der ellers ville være resistente over for ceftolozon.
By blocking the action of these enzymes, tazobactam allows ceftolozane to act against bacteria that would otherwise be resistant to ceftolozone.
Zerbaxa behandlede infektionen med vellykket resultat i omkring 85 % af de tilfælde, hvor det blev anvendt (288 af 340), sammenholdt med 75 % (266 af 353) af de tilfælde, hvor der blev anvendt et andet antibiotikum, nemlig levofloxacin.
Zerbaxa successfully treated the infection in about 85% of the cases where it was given (288 of 340), compared with 75% (266 of 353) of those given another antibiotic called levofloxacin.
• komplicerede infektioner i urinvejene (de strukturer, der fremfører urin, såsom blæren)
• complicated infections of the urinary tract (structures that carry urine, such as the bladder);
Zerbaxa indeholder de aktive stoffer ceftolozan og tazobactam.
Zerbaxa contains the active substances ceftolozane and tazobactam.
Disse enzymer sætter bakterier i stand til at nedbryde betalaktam-antibiotika som ceftolozan, hvorved bakterierne bliver resistente over for den antibakterielle virkning.
These enzymes enable bacteria to break down beta-lactam antibiotics like ceftolozane, making the bacteria resistant to the antibiotic's action.
Den fuldstændige liste over bivirkninger ved Zerbaxa fremgår af indlægssedlen.
For the full list of side effects of Zerbaxa, see the package leaflet.
Ceftolozan er et antibiotikum af cefalosporin-typen, der tilhører den større gruppe betalaktamer.
Ceftolozane is a type of antibiotic called a cephalosporin, which belongs to the wider group of antibiotics called betalactams.
Hvordan anvendes Zerbaxa?
How is Zerbaxa 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 Zerbaxa.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zerbaxa have been included in the summary of product characteristics and the package leaflet.
Infektionen gik væk hos 54 % af patienterne (197 out of 362) efter 7 til 14 dages behandling med Zerbaxa sammenlignet med 53 % af de patienter (194 ud af 362), som fik meropenem.
It found Zerbaxa to be at least as effective as meropenem: the infection had resolved in 54% of patients (197 out of 362) after 7 to 14 days of treatment with Zerbaxa compared with 53% of patients (194 out of 362) on meropenem.
Hvilke fordele viser studierne, at der er ved Zerbaxa?
What benefits of Zerbaxa have been shown in studies?
Hvordan virker Zerbaxa?
How does Zerbaxa work?
(lungebetændelse pådraget fra en respirator, der hjælper patienten med at trække vejret).
• hospital-acquired pneumonia (an infection of the lungs that is caught in the hospital), including ventilator-associated pneumonia (pneumonia in patients using a ventilator, a machine that helps a patient to breathe).
Europa-Kommissionen traf en afgørelse den 10. januar 2010.
The European Commission issued a decision on 10 January 2010.
Hvad er Extraneal?
What is Extraneal?
Denne ændring skulle godkendes i Østrig, Belgien, Danmark, Finland, Frankrig, Tyskland, Grækenland, Irland, Italien, Luxembourg, Nederlandene, Portugal, Spanien og Sverige (de berørte medlemsstater).
This variation was to be recognised in Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden (the concerned Member States).
Hvorfor blev Extraneal vurderet igen?
Why was Extraneal reviewed?
Dr. Ian Hudson (Det Forenede Kongerige)
Dr Ian Hudson (United Kingdom)
Dr. Barbara van Zwieten Boot (Nederlandene)
Dr Barbara van Zwieten Boot (Netherlands)
Extraneal er godkendt i EU efter en gensidig anerkendelsesprocedure på baggrund af den oprindelige markedsføringstilladelse, der blev udstedt af Det Forenede Kongerige i 1997.
Extraneal is authorised in the European Union under a mutual recognition procedure on the basis of the initial authorisation granted by the United Kingdom in 1997.
Icodextrin er en type sukker, der anvendes til at holde blodsukkeret på det korrekte niveau.
Icodextrin is a type of sugar that is used to keep blood glucose at the correct level.
23. juli 2009
23 July 2009
Extraneal bruges navnlig til patienter, der ikke kan behandles med opløsninger, som indeholder glukose.
Extraneal is used in particular in patients who cannot be treated with solutions containing glucose.
1 Artikel 6, stk. 12, i forordning (EF) nr. 1084/2003, med senere ændringer, indbringelse på grund af en ændring i markedsføringstilladelsen.
Article 6(12) of Regulation (EC) 1084/2003 as amended, referral on a variation to a marketing authorisation
Disse medlemsstater kunne ikke nå til enighed, og derfor indbragte den nederlandske lægemiddelkontrolmyndighed den 9. juli 2009 sagen for CHMP med henblik på voldgift.
Because these Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 9 July 2009.
Extraneal er en opløsning, der indeholder det aktive stof icodextrin samt natriumlaktat, natriumchlorid, calciumchlorid og magnesiumchlorid.
Extraneal is a solution that contains icodextrin as the active substance, as well as sodium lactate, sodium chloride, calcium chloride and magnesium chloride.
På grundlag af vurderingen af de tilgængelige data og den faglige drøftelse i udvalget konkluderede CHMP, at ændringen af markedsføringstilladelsen for Extraneal kan godkendes i alle de berørte medlemsstater.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Extraneal can be approved in all concerned Member States.
Det er en blodclearanceteknik, der bruges til patienter med længerevarende nyresvigt, og hvor en væske pumpes ind i abdomen, mens en intern kropsmembran filtrerer blodet.
This is a blood clearance technique used in patients with long-term kidney failure, when a solution is pumped into the abdomen and an internal body membrane filters the blood.
Spørgsmål og svar vedrørende indbringelsesproceduren for Extraneal peritonealdialysevæske indeholdende icodextrin 7,5 %
Questions and answers on the referral for Extraneal icodextrin 7.5% solution for peritoneal dialysis
Peptidoglycaner var blevet sat i forbindelse med betændelse i peritoneum (bughinden) hos nogle af de patienter, der fik Extraneal.
Peptidoglycans had been linked to cases of inflammation of the peritoneum (the lining of the abdomen) in some patients receiving Extraneal.
Det Europæiske Lægemiddelagentur (EMEA) har gennemført en voldgiftsprocedure for Extraneal 7,5 % peritonealdialysevæske.
The European Medicines Agency has completed an arbitration procedure for Extraneal 7.5% solution for peritoneal dialysis.
Begrundelserne for indbringelsen var, at mere følsomme test end dem, som virksomheden foreslog, kunne anvendes til at spore peptidoglycaner i lægemidlet, og at de nuværende godkendte fremstillere af det aktive stof skulle ændre fremstillingsprocessen for icodextrin for at sikre, at peptidoglycanerne bliver fjernet.
The grounds for the referral were that more sensitive tests than those proposed by the company could be used to detect peptidoglycans in the medicine, and that one of the currently approved manufacturers of the active substance should modify the manufacturing process of icodextrin to ensure that peptidoglycans are removed.
Extraneal er en opløsning, der anvendes ved peritonealdialyse.
Extraneal is a solution that is used in peritoneal dialysis.
Revurderingen fandt sted inden for rammerne af en indbringelsesprocedure i henhold til artikel 6, stk.
The review was carried out under an ‘Article 6(12)' referral1.
Virksomheden ansøgte om en ændring af markedsføringstilladelsen med henblik på at medtage en test til måling af niveauet af en urenhed kaldet peptidoglycan under lægemidlets fremstillingsproces.
The company applied for a change (variation) to the marketing authorisation to include a test to measure the level of an impurity called peptidoglycan during the medicine's production process.
EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at ændringen af markedsføringstilladelsen for Extraneal med henblik på at medtage en peptidoglycantest kan godkendes, og at brugen af det aktive stof icodextrin fra en af de på nuværende tidspunkt godkendte fremstillere bør ophøre.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the change to the marketing authorisation for Extraneal to include a peptidoglycan test can be granted, and that the use of the active substance icodextrin sourced from one of the currently approved manufacturers should cease.
Dato for virksomhedens svar:
Company responses provided on: 31 August 2009 Opinion date: