FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on these considerations, the MAH was requested to demonstrate that the significance shown for clinical signs in some laboratory efficacy studies is sufficient to overcome the non-significance of the same parameter in ‘non-significant' laboratory efficacy studies.
Danish: På baggrund af disse overvejelser blev indehaveren af markedsføringstilladelsen anmodet om at påvise, at den signifikans, der i nogle laboratorieundersøgelser af virkning var påvist for de kliniske tegn, er tilstrækkelig til at opveje den manglende signifikans af samme parameter i "ikke-signifikante" laboratorieundersøgelser af virkning.
English: Six additional laboratory studies were also provided, but these studies were carried out for the marketing authorisation of Coglapix in a country outside the EU and in some elements did not meet the criteria of Ph. Eur.
Danish: De er imidlertid udført med henblik på markedsføringstilladelsen for Coglapix i et land uden for EU, og visse elementer opfylder ikke kriterierne i Ph. Eur.
English: Hungary CEVA-Phylaxia Veterinary Biologicals Co. Ltd
Danish: CEVA-Phylaxia Veterinary Biologicals Co. Ltd Szállás u. 5.
English: Amendments in the relevant sections of the Summary of Product Characteristics and package leaflet
Danish: Tilføjelser i de relevante afsnit i Produktresuméet og indlægssedlen
English: Special attention was given to the use of a combined analysis using a limited number of animals for sample size and the use of global clinical scores as measure of the primary efficacy parameter.
Danish: Specielt blev der redegjort for en kombineret analyse, hvor global klinisk score blev anvendt som mål for den primære virkningsparameter for et begrænset antal dyr.
English: Germany Ceva Tiergesundheit GmbH
Danish: Ceva Tiergesundheit GmbH
English: An overview of the statistical analyses to demonstrate significant differences between vaccinated and control animals in terms of reduction of clinical signs and lung lesions was also provided.
Danish: Der blev desuden forelagt en oversigt over de statistiske analyser til påvisning af signifikante forskelle mellem vaccinerede dyr og kontroldyr i reduktion af kliniske tegn og lungeforandringer.
English: Slovenia Ceva Santé Animale 10, av. de La
Danish: Slovenien Ceva Santé Animale 10, av. de La
English: The MAH presented the results of all the laboratory studies to support the efficacy claims.
Danish: Indehaveren af markedsføringstilladelsen fremlagde resultaterne af alle laboratorieundersøgelser til støtte for påstandene om virkning.
English: The MAH clarified that inferential statistics was used for the data analysis and addressed the relevance of the method used.
Danish: Indehaveren af markedsføringstilladelsen præciserede, at der var anvendt en induktiv statistisk metode til dataanalysen og redegjorde for relevansen af den anvendte metode.
English: The amended sections of the Summary of Product Characteristics and package leaflet of the reference Member State are set out in Annex III.
Danish: Referencemedlemsstatens ændrede produktresumé og indlægsseddel fremgår af bilag III.
English: Following vaccination of pigs with Coglapix reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory efficacy studies, although some concerns on the statistical significance of the results still remain.
Danish: Efter vaccination af svin med Coglapix er der i laboratorieundersøgelser af virkning påvist reduktion af de kliniske tegn og lungeforandringer, som er knyttet til sygdommen, skønt der tilbagestår visse betænkeligheder vedrørende den statistiske signifikans af resultaterne.
English: However, the MAH clarified that the efficacy in the field has only been partially demonstrated and that lack of relevant information could be reflected in the Summary of Product Characteristics.
Danish: Indehaveren af markedsføringstilladelsen præciserede imidlertid, at virkningen i felten kun er delvis godtgjort, og at de manglende oplysninger herom kunne fremgå af produktresuméet.
English: Belgium Ceva Santé Animale S.A/N.V.
Danish: Ceva Santé Animale S.A/N.V.
English: The MAH conducted 2 studies to evaluate the onset of immunity and 4 studies to evaluate the duration of immunity, using appropriate challenge strains for both A. pleuropneumoniae serotypes (1 and 2) included in the vaccine.
Danish: Indehaveren af markedsføringstilladelsen udførte to undersøgelser til vurdering af indsætten af immunitet og fire undersøgelser til vurdering af immunitetens varighed ved anvendelse af passende belastningsstammer af begge serotyper (1 og 2) af A. pleuropneumoniae, der er indeholdt i vaccinen.
English: This referral was raised due to concerns regarding the overall efficacy of the vaccine.
Danish: Denne indbringelse blev indledt på grund af betænkeligheder vedrørende vaccinens overordnede virkning.
English: In these studies vaccinated animals showed lower incidence of the typical clinical signs (dyspnoea, coughing and vomiting) and lung lesions of porcine pleuropneumonia associated with infection by the microorganism when compared with controls.
Danish: I disse undersøgelser udviste de vaccinerede dyr lavere forekomst end kontroldyrene af de typiske kliniske tegn (dyspnø, hoste og opkastning) og lungeforandringer, der er knyttet til porcin pleuropneumoni forårsaget af denne mikroorganisme.
English: The variability of the results observed in the efficacy studies was suggested to be correlated with the quality of the vaccine batches administered in the trials, with sub-potent batches formulated with insufficient antigen content.
Danish: Det blev fremført, at variabiliteten af resultaterne fra undersøgelserne af virkning kan have sammenhæng med kvaliteten af de vaccinebatcher, der var anvendt i forsøgene, fordi nogle af batcherne havde utilstrækkeligt antigenindhold.
English: Non-significant results have been obtained in 3 out of 5 studies carried out for both serotypes 1 and 2.
Danish: Tre af fem undersøgelser for både serotype 1 og 2 har givet ikke-signifikante resultater.
English: From the available laboratory efficacy studies, there was little evidence, if any, concerning the measurement of the impact of the vaccination on weight gain.
Danish: I de foreliggende laboratorieundersøgelser af virkning er der kun få eller ingen målinger af vaccinationens virkning på tilvæksten.
English: Vaccination of pigs reduces the clinical signs and lung lesions associated with the disease, thus reducing the need for antimicrobial treatment and increasing the range of available prophylactic treatment possibilities against pneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Danish: Vaccination af svin mindsker de kliniske tegn og lungeforandringer, der er knyttet til sygdommen, og nedsætter derved behovet for antimikrobiel behandling og udvider de tilgængelige muligheder for profylaktisk behandling af pneumoni forårsaget af A. pleuropneumoniae serotype 1 og 2.
English: The vaccine contains five, formaldehyde-inactivated strains of Actinobacillus pleuropneumoniae.
Danish: Vaccinen indeholder fem formaldehyd-inaktiverede stammer af Actinobacillus pleuropneumoniae.
English: Regarding the three field studies no significant differences in mortality rate and lung lesion scores were observed between vaccinated and control groups but the level of field challenge from A. pleuropneumoniae in the one significant field study was low.
Danish: I de tre feltundersøgelser blev der ikke iagttaget signifikante forskelle mellem de vaccinerede dyr og kontroldyrene i dødelighed eller score for lungeforandringer, men i den eneste signifikante feltundersøgelse var belastningen i felten med A. pleuropneumoniae lav.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Coglapix suspension for injection for pigs
Danish: Videnskabelige konklusioner og begrundelse for udstedelsen af markedsføringstilladelse for Coglapix, injektionsvæske, suspension, til svin
English: Vaccinated pigs develop active immunity against disease caused by serotype 1 or 2 of Actinobacillus pleuropneumoniae.
Danish: Vaccinerede svin udvikler aktiv immunitet mod sygdomme forårsaget af serotype 1 eller 2 af Actinobacillus pleuropneumoniae.
English: The MAH explained that the positive effect on clinical signs and lung lesions would lead to at least partial protection of the losses in weight gain due to A. pleuropneumaniae infections.
Danish: Indehaveren af markedsføringstilladelsen forklarede, at den positive virkning på kliniske tegn og lungeforandringer i det mindste ville medføre delvis beskyttelse mod nedsat tilvækst forårsaget af infektioner med A. pleuropneumaniae.
English: In particular, the MAH was requested to provide evidence that the reduction of lung lesions and clinical signs would result in reduced weight losses in vaccinated animals as compared to controls.
Danish: Herunder blev der anmodet om evidens for, at reduktionen af lungeforandringer og kliniske tegn vil medføre mindre vægttab hos vaccinerede dyr end hos kontroldyr.
English: The vaccine contains inactivated Actinobacillus pleuropneumoniae bacteria.
Danish: Vaccinen indeholder inaktiverede Actinobacillus pleuropneumoniae bakterier.
English: However, the MAH confirmed that a re-test was carried out according to the finished product specifications agreed during the MRP and the vaccine batches were found to conform to them.
Danish: Indehaveren af markedsføringstilladelsen bekræftede imidlertid, at testen var gentaget i henhold til de specifikationer for det færdige produkt, der blev vedtaget ved den gensidige anerkendelsesprocedure, og at vaccinebatcherne blev fundet at holde dem.
English: Sweden Ceva Animal Health A.B.
Danish: Ceva Animal Health A.B.
English: The MAH confirmed that a meta-analysis of all the results obtained from the different studies has been provided.
Danish: Indehaveren af markedsføringstilladelsen bekræftede, at metaanalysen omfatter alle resultater fra de forskellige undersøgelser.
English: Based on the data presented in relation to the concerns notified for this referral procedure, the benefitrisk balance is considered to be favourable.
Danish: Benefit/risk-forholdet anses for at være positivt på grundlag af de forelagte data vedrørende de betænkeligheder, der er anmeldt ved denne indbringelsesprocedure.
English: Grounds for the granting of the marketing authorisations for Coglapix suspension for injection for pigs
Danish: Begrundelse for udstedelse af markedsføringstilladelse for Coglapix, injektionsvæske, suspension, til svin
English: Coglapix is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Danish: Coglapix er bestemt til aktiv immunisering af svin mod pleuropneumoni forårsaget af A. pleuropneumoniae serotype 1 and 2.
English: The concern related to the overall efficacy of the vaccine have been assessed and it is concluded that Coglapix is expected to be efficacious in immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Danish: Betænkeligheden vedrørende vaccinens overordnede virkning er blevet vurderet, og det konkluderes, at Coglapix forventes at være effektivt til immunisering af svin som hjælp til kontrol af pleuropneumoni forårsaget af A. pleuropneumoniae serotype 1 og 2 gennem reduktion af de kliniske tegn og lungeforandringer knyttet til sygdommen.
English: A sentence is included in section 5 Immunological properties of the Summary of Product Characteristics to reflect the lack of data from field trials.
Danish: I produktresuméets punkt 5, Immunologiske egenskaber, er der således indsat en sætning, der afspejler de manglende data fra feltundersøgelser: "Virkning er påvist under laboratoriebetingelser, men ikke under feltbetingelser".
English: 1130 Brussel
Danish: Metrologielaan 6 1130 Brussel Belgien
English: The CVMP agreed that although the incidence of typical clinical signs and lung lesions were not significantly lower for vaccinates, when compared with controls, in all laboratory efficacy studies, the overall results of the efficacy of the vaccine were supportive for reduction of lung lesions and clinical signs.
Danish: Skønt forekomsten af typiske kliniske tegn og lungeforandringer ikke var væsentligt lavere for vaccinerede dyr end for kontroldyrene, fandt CVMP, at reduktionen af lungeforandringer og kliniske tegn blev underbygget af alle laboratorieundersøgelserne af virkning under et.
English: 227 64 Lund
Danish: Annedalsvägen 9 227 64 Lund Sverige
English: For the active immunisation of pigs as an aid to control pleuropneumonia caused by Actinobacillus pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Danish: Til aktiv immunisering af grise som en hjælp til at kontrollere pleuropneumoni forårsaget af Actinobacillus pleuropneumoniae serotype 1 og 2, ved reduction af kliniske symptomer og lungeforandringer associeret med sygdommen.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: Den fuldstændige EPAR for Pemetrexed Hospira UK Limited findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The Committee recommended that Pemetrexed Hospira UK Limited be approved for use in the EU.
Danish: Udvalget anbefalede, at Pemetrexed Hospira UK Limited godkendes til anvendelse i EU.
English: 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.
Danish: 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.
English: Pemetrexed Hospira UK Limited is a cancer medicine used to treat two types of lung cancer:
Danish: Pemetrexed Hospira UK Limited er et kræftlægemiddel til behandling af to typer lungekræft:
English: Because Pemetrexed Hospira UK Limited is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pemetrexed Hospira UK Limited er et generisk lægemiddel, antages det at have de samme fordele og risici som referencelægemidlet.
English: 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.
Danish: 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.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira UK Limited.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pemetrexed Hospira UK Limited.
English: This is because Pemetrexed Hospira UK Limited is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Danish: Dette skyldes, at Pemetrexed Hospira UK Limited gives ved infusion i en vene, så det aktive stof ledes direkte ind i blodbanen.
English: As for every medicine, the company provided studies on the quality of Pemetrexed Hospira UK Limited.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Pemetrexed Hospira UK Limited.
English: 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.
Danish: 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.
English: 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'.
Danish: 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".
English: For practical information about using Pemetrexed Hospira UK Limited, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pemetrexed Hospira UK Limited, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Pemetrexed Hospira UK Limited.
Danish: Det er ikke en praktisk vejledning i, hvordan Pemetrexed Hospira UK Limited bør anvendes.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Hospira UK Limited?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Hospira UK Limited?
English: Other information about Pemetrexed Hospira UK Limited
Danish: Andre oplysninger om Pemetrexed Hospira UK Limited
English: What are the benefits and risks of Pemetrexed Hospira UK Limited?
Danish: Hvilke fordele og risici er der forbundet med Pemetrexed Hospira UK Limited?
English: What is Pemetrexed Hospira UK Limited and what is it used for?
Danish: Hvad er Pemetrexed Hospira UK Limited, og hvad anvendes det til?
English: 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.
Danish: 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.
English: Pemetrexed Hospira UK Limited is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Pemetrexed Hospira UK Limited fås som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
English: It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Danish: Det kan desuden anvendes som vedligeholdelsesbehandling hos patienter, der har fået platinbaseret kemoterapi Pemetrexed Hospira UK Limited indeholder det aktive stof pemetrexed.
English: Why is Pemetrexed Hospira UK Limited approved?
Danish: Hvorfor blev Pemetrexed Hospira UK Limited godkendt?
English: 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.
Danish: 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.
English: • 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;
Danish: • malignt pleuramesoteliom (kræft i lungehinderne), der sædvanligvis skyldes udsættelse for asbest.
English: How is Pemetrexed Hospira UK Limited used?
Danish: Hvordan anvendes Pemetrexed Hospira UK Limited?
English: How has Pemetrexed Hospira UK Limited been studied?
Danish: Hvordan blev Pemetrexed Hospira UK Limited undersøgt?
English: How does Pemetrexed Hospira UK Limited work?
Danish: Hvordan virker Pemetrexed Hospira UK Limited?
English: It is given over 1 hour, every 8 hours.
Danish: Det gives over 1 time hver 8. time.
English: Zerbaxa received a marketing authorisation valid throughout the EU on 18 September 2015.
Danish: Zerbaxa fik en markedsføringstilladelse med gyldighed i hele EU den 18. september 2015.
English: Further information on Zerbaxa can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zerbaxa.
Danish: Yderligere information om Zerbaxa findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/zerbaxa.
English: Regarding safety, side effects were considered to be typical and expected for an antibiotic of this kind.
Danish: Vedrørende sikkerheden ansås bivirkningerne for at være typiske og forventelige for et antibiotikum af denne art.
English: As for all medicines, data on the use of Zerbaxa are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Zerbaxa løbende overvåget.
English: Other information about Zerbaxa
Danish: Andre oplysninger om Zerbaxa
English: The dose and duration of treatment depends on the infection being treated and how the infection responds to the medicine.
Danish: Dosis og behandlingens varighed afhænger af den behandlede infektion og af, hvor godt lægemidlet virker på den.
English: 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.
Danish: De hyppigste bivirkninger ved Zerbaxa (som kan forekomme hos op til 1 ud af 10 personer) er kvalme, hovedpine, forstoppelse, diarré og feber.
English: The second study involved 993 patients with complicated intra-abdominal infections.
Danish: Det andet studie omfattede 993 patienter med komplicerede intraabdominale infektioner.