FrancophonIA/ELRC3.0 huggingface dataset:
English: Aripiprazole Zentiva is used in patients aged 15 years or over;
Danish: Aripiprazole Zentiva anvendes til patienter over 15 år,
English: The orodispersible tablets can be used in patients who have difficulty swallowing tablets.
Danish: Patienter, der har vanskeligt ved at synke tabletter, kan få smeltetabletter.
English: For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Danish: Til skizofreni er den anbefalede startdosis til voksne 10 eller 15 mg dagligt gennem munden, efterfulgt af en vedligeholdelsesdosis på 15 mg én gang dagligt.
English: Aripiprazole Zentiva is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Danish: Aripiprazole Zentiva anvendes desuden hos patienter over 13 år til behandling af moderate til svære maniske episoder i op til 12 uger.
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Danish: Til behandling af maniske episoder ved bipolar sygdom er den anbefalede startdosis til voksne 15 mg gennem munden én gang dagligt.
English: Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Danish: Aripiprazol bevirker derfor, at hjerneaktiviteten bliver normal, så de psykotiske eller maniske symptomer mindskes og ikke kommer igen.
English: For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Danish: Til behandling af maniske episoder hos patienter mellem 13 og 17 år er startdosis 2 mg dagligt (hertil bruges aripiprazol-produkt i flydende form).
English: Aripiprazole Zentiva contains the active substance aripiprazole and is a ‘generic medicine'.
Danish: Aripiprazole Zentiva er et "generisk lægemiddel".
English: Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Danish: Patientundersøgelserne har derfor kun skullet vise, at det er bioækvivalent med referencelægemidlet, Abilify.
English: The company wanted the authorisation to be recognised in Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom (the ‘concerned Member States').
Danish: Virksomheden ønskede, at markedsføringstilladelsen skulle anerkendes i Cypern, Den Tjekkiske Republik, Frankrig, Italien, Polen, Portugal, Spanien og Det Forenede Kongerige ("de berørte medlemsstater").
English: The CHMP also recommended that the product information for the medicine should be amended in all the Member States where it is authorised.
Danish: CHMP anbefalede ligeledes, at produktinformationen for lægemidlet blev ændret i alle de medlemsstater, hvor det har markedsføringstilladelse.
English: Questions and answers on the referral for Avalox solution for infusion containing moxifloxacin 400 mg/250 ml
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Avalox infusionsvæske, opløsning, indeholdende moxifloxacin 400 mg/250 ml
English: Bayer Vital GmbH submitted Avalox solution for infusion for mutual recognition on the basis of the initial authorisation granted by Germany on 30 April 2002.
Danish: Bayer Vital GmbH ansøgte om gensidig anerkendelse for Avalox infusionsvæske, opløsning, på baggrund af den første markedsføringstilladelse, der blev udstedt af Tyskland den 30. april 2002.
English: The grounds for the referral were concerns expressed by the United Kingdom that the use of intravenous moxifloxacin in community acquired pneumonia and complicated skin and soft tissues infections should be limited to when the standard treatments for these infections are not appropriate, and concerns from France regarding the medicine's risk of causing problems with the heart rhythm (QT-interval prolongation).
Danish: Begrundelserne for indbringelsen var Det Forenede Kongeriges betænkeligheder med hensyn til, at brugen af intravenøst moxifloxacin ved samfundserhvervet pneumoni og komplicerede hud- og bløddelsinfektioner skulle begrænses til de tilfælde, hvor standardbehandlingerne af disse infektioner ikke er velegnede, og Frankrigs betænkeligheder med hensyn til lægemidlets risiko for at medføre problemer med hjerterytmen (QT-intervalforlængelse).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Avalox solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom.
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Avalox infusionsvæske, opløsning, opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Tyskland, kan anerkendes i andre EU-medlemsstater, nemlig Cypern, Den Tjekkiske Republik, Frankrig, Italien, Polen, Portugal, Spanien og Det Forenede Kongerige.
English: The active substance in Avalox solution for infusion, moxifloxacin, belongs to the group ‘fluoroquinolones'.
Danish: Det aktive stof i Avalox infusionsvæske, opløsning, moxifloxacin, hører til gruppen af "fluorquinoloner".
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Avalox solution for infusion.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for lægemidlet Avalox infusionsvæske, opløsning.
English: Avalox solution for infusion is an antibiotic given by infusion (drip into a vein).
Danish: Avalox infusionsvæske, opløsning, er et antibiotikum, der gives som infusion (drop i en vene).
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Avalox solution for infusion outweigh its risks, and therefore the marketing authorisation for Avalox solution for infusion should be granted in all concerned Member States.
Danish: På grundlag af vurderingen af de tilgængelige data og den faglige drøftelse i udvalget konkluderede CHMP, at fordelene ved Avalox infusionsvæske, opløsning, opvejer risiciene, og at der derfor bør udstedes markedsføringstilladelse for Avalox infusionsvæske, opløsning, i alle de berørte medlemsstater.
English: It is used to treat the following bacterial infections: - community-acquired pneumonia (an infection of the lungs that is caught outside of hospital); - complicated infections of the skin and the soft tissues below the skin.
Danish: Det anvendes til behandling af følgende bakterieinfektioner: - samfundserhvervet pneumoni (en lungeinfektion, som man smittes med uden for hospitalerne), - komplicerede hud- og bløddelsinfektioner.
English: However, the prescribing information for Avalox solution for infusion should be amended in all the Member States where it is authorised.
Danish: Ordinationsoplysningerne for Avalox infusionsvæske, opløsning, skal dog ændres i alle de medlemsstater, hvor lægemidlet har markedsføringstilladelse.
English: Why was Avalox solution for infusion reviewed?
Danish: Hvorfor blev Avalox infusionsvæske, opløsning, vurderet igen?
English: What is Avalox solution for infusion?
Danish: Hvad er Avalox infusionsvæske, opløsning?
English: This was not the case.
Danish: Dette var ikke tilfældet.
English: These PECs were considered acceptable.
Danish: Disse PEC-værdier blev anset for at være acceptable.
English: This experiment began three weeks later than the first experiment.
Danish: Dette forsøg blev indledt tre uger senere end det første forsøg.
English: Given all the problems with the study recorded above, the fact that the value approaches the maximum difference allowed is a cause for concern.
Danish: På grund af alle de ovenfor anførte problemer med undersøgelsen giver den omstændighed, at værdien nærmer sig den maksimale tilladte forskel, anledning til bekymring.
English: The decision on the acceptability of the data from these studies was of key importance to the re-examination and so both studies have been re-evaluated critically.
Danish: Beslutningen om acceptabiliteten af dataene fra disse undersøgelser var af afgørende betydning for revurderingen, så begge undersøgelser har været genstand for en kritisk revurdering.
English: As the tests were carried out 3 weeks apart it is unlikely that conditions were the same.
Danish: Da forsøgene blev gennemført med 3 ugers mellemrum, er det usandsynligt at forholdene var de samme.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION 1.
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING 1.
English: (EMEA/CVMP/ERA/418282/2005).
Danish: Products" (EMEA/CVMP/ERA/418282/2005).
English: The product is a generic of the reference product Tylan W.O and intended to be used as follows:
Danish: Produktet er en generisk form af referenceproduktet Tylan W.O og skal anvendes på følgende måder:
English: The reporting and analysis of the results did not follow the OECD guideline.
Danish: Indberetningen og analysen af resultaterne fulgte ikke OECD's retningslinje.
English: 1 Marketing Authorisation granted
Danish: 1 Markedsføringstilladelse udstedt
English: Effects on Daphnia magna were determined based on data from published literature.
Danish: Virkningerne på Daphnia magna blev bestemt på grundlag af data fra den offentliggjorte litteratur.
English: Only for courgette was one concentration below this PEC (0.25 PEC).
Danish: Kun for courgette lå en enkelt koncentration under denne PECværdi (0,25 PEC).
English: There was very low nitrate production in the control soil between days 0 and 7, but this phenomenon was not observed at later time points.
Danish: Der var en meget lav nitratproduktion i kontroljorden mellem dag 0 og dag 7, men dette fænomen blev ikke observeret på senere tidspunkter.
English: Some serious deficiencies with the plant study were identified.
Danish: Der blev påvist nogle alvorlige mangler ved planteundersøgelsen.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REFUSAL TO GRANT NEW MARKETING AUTHORISATIONS AND FOR THE REVOCATION OF EXISTING MARKETING AUTHORISATIONS
Danish: FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR AFSLAG PÅ UDSTEDELSE AF NYE MARKEDSFØRINGSTILLADELSER OG FOR TILBAGEKALDELSE AF EKSISTERENDE MARKEDSFØRINGSTILLADELSER
English: However, the CVMP does not agree with the approach and conclusions in respect to specific parts of the assessment and therefore the overall conclusions on the environmental risk assessment.
Danish: CVMP er dog ikke enigt i fremgangsmåden og konklusionerne med hensyn til bestemte dele af vurderingen og dermed i de overordnede konklusioner på vurderingen af miljørisikoen.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: FORTEGNELSE OVER VETERINÆRLÆGEMIDLETS NAVNE, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ, ANSØGER/INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: However, the proposed NOEC cannot be accepted as information on the statistical analysis was presented for only three species.
Danish: Den foreslåede NOEC-værdi kan dog ikke accepteres, da der kun blev fremlagt information om den statistiske analyse for tre arter.
English: As a result it is considered that the design of the second experiment is seriously flawed as radish should have been included in this experiment.
Danish: Som følge heraf anses udformningen af det andet forsøg for at være alvorligt fejlbehæftet, da radise skulle have været medtaget i dette forsøg.
English: Risk mitigation measures
Danish: Risikobegrænsende foranstaltninger
English: The requirements of the VICH guidelines were not fulfilled.
Danish: Kravene i VICH's retningslinjer var ikke opfyldt.
English: The study does not fully comply with this criterion as the differences between 2 replicates of control soil at day 14 were above 15%.
Danish: Undersøgelsen lever ikke fuldt ud op til dette kriterium, da forskellen mellem to kontrolprøver af jord på dag 14 var over 15 %.
English: The absence of reliable effects data for plants and microorganisms means that reducing exposure, i.e. lowering the PECsoil by restricting indications and species does not alter the potential for an unacceptable risk.
Danish: Manglen på pålidelige oplysninger om virkningerne på planter og mikroorganismer betyder, at en nedbringelse af eksponeringen, dvs. en nedbringelse af PECjord ved at begrænse indikationerne og arterne ikke ændrer muligheden for en uacceptabel risiko.
English: The difference in nitrate production between control and the lowest (1X) PEC at 28 days is 23% which is only just below the 25% maximum allowed by the OECD guideline.
Danish: Forskellen i nitratproduktionen mellem kontrollen og den laveste (1X) PEC-værdi på dag 28 er 23 %, hvilket kun lige er under den maksimale forskel på 25 %, der tillades i OECD's retningslinje.
English: A low risk for fish and aquatic invertebrates is expected.
Danish: Der forventes en lav risiko for fisk og hvirvelløse vanddyr.
English: GROUNDS FOR REFUSAL AND REVOCATION OF THE MARKETING AUTHORISATIONS Considering that:
Danish: BEGRUNDELSER FOR AFSLAG PÅ OG TILBAGEKALDELSE AF MARKEDSFØRINGSTILLADELSERNE Ud fra følgende betragtninger:
English: At present a risk for the terrestrial compartment cannot be excluded.
Danish: I øjeblikket kan en risiko for det terrestriske miljø ikke udelukkes.
English: 2.1.3 Effect on emergence and growth of plants
Danish: 2.1.3 Virkning på fremkomsten og væksten af planter
English: A new study would be necessary in order to draw a conclusion on the risk to plants.
Danish: Der er behov for en ny undersøgelse, hvis der skal drages en konklusion om risikoen for planter.
English: 2.2.2 Effects on algae (cyanobacteria)
Danish: 2.2.2 Virkninger på alger (cyanobakterier)
English: A previously reported endpoint for Microcystis aeruginosa was not used in the assessment as it was not in line with the relevant OECD guideline 201.
Danish: Et tidligere indberettet slutpunkt for Microcystis aeruginosa blev ikke anvendt i vurderingen, da det ikke var i overensstemmelse med OECD's retningslinje 201.
English: Without a tier II-B assessment, no further conclusions with regards to the risk for cyanobacteria can be drawn.
Danish: Uden en trin II-B vurdering kan der ikke drages nogen yderligere konklusioner om risikoen for cyanobakterier.
English: These deviations from the OECD guideline may have contributed to the high standard deviations seen in nitrate production at each of the time points and concentrations tested.
Danish: Disse afvigelser fra OECD's retningslinje kan have bidraget til de høje standardafvigelser, der ses i nitratproduktionen på alle tidspunkter og ved alle de afprøvede koncentrationer.
English: Instead a second main experiment was begun using only two additional species, courgette and sunflower.
Danish: I stedet blev der indledt et andet hovedforsøg med kun to nye arter, nemlig courgette og solsikke.
English: The key omission in the report is the absence of tables for all endpoints determined in the study, for example the numbers of seeds germinating and the biomass (growth) is not reported for the control groups of any of the plants tested.
Danish: Den vigtigste udeladelse i rapporten er de manglende tabeller for alle slutpunkter fastlagt i undersøgelsen, f.eks. er antallet af frø, der spirede, og biomassen (vækst) ikke indberettet for kontrolgrupperne for nogen af de testede planter.
English: A new study and several published studies were provided which investigate the degradation of tylosin in cattle, pigs and poultry manure and soil/poultry mixtures.
Danish: Der blev fremlagt en ny undersøgelse og adskillige offentliggjorte undersøgelser, hvor nedbrydningen af tylosin i kvæg-, svine- og fjerkrægødning og blandinger af jord/fjerkrægødning undersøges.
English: The risk for plants cannot be determined based on the submitted data.
Danish: Risikoen for planter kan ikke bestemmes på grundlag af de fremlagte data.
English: The aspects of the Phase II assessment considered in this referral are the effects on the terrestrial compartment and the effects on the aquatic compartment.
Danish: De aspekter af fase II-vurderingen, der tages i betragtning i denne procedure, er virkningerne på det terrestriske miljø og virkningerne på vandmiljøet.
English: • no conclusion on the effects on terrestrial plants can be drawn;
Danish: • Der kan ikke drages nogen konklusioner om virkningerne på terrestriske planter.
English: This part of the experiment can be considered the Tier A study on three species.
Danish: Denne del af forsøget kan betragtes som trin A-undersøgelsen af tre arter.
English: The choice of 7264 µg/kg as the lowest PEC can be criticised as it is 1.6 times greater than the maximum PECsoil produced by use of this product, but the choice was justified in the report as a conservative approach.
Danish: Valget af 7.264 µg/kg som den laveste PEC-værdi er kritisabel, da den er 1,6 gange højere end den maksimale PECjord, som anvendelsen af dette produkt resulterer i, men valget var begrundet i rapporten som en konservativ fremgangsmåde.
English: Test concentrations were seen to decline over the test period and consequently it was considered justifiable to base the results on the geometric mean of the measured test concentrations.
Danish: Testkoncentrationerne faldt i løbet af testperioden, og det blev derfor anset for at være berettiget at basere resultaterne på det geometriske gennemsnit af de målte testkoncentrationer.
English: In particular the adequacy of the data provided in respect to the effects on aquatic and terrestrial organisms (Tier A) was questioned as these data do not enable a conclusion to be drawn on the environmental risk assessment.
Danish: Der blev i særdeleshed sat spørgsmålstegn ved, om de fremlagte data var tilstrækkelige med hensyn til virkningerne på vandlevende og terrestriske organismer (trin A), da disse data ikke gør det muligt at drage en konklusion af vurderingen af miljørisikoen.
English: Many of the failings described above arise from the poor reporting of the study which does not follow the requirements of the OECD guideline and may be a consequence of using a non-GLP compliant laboratory.
Danish: Mange af de ovenfor beskrevne mangler skyldes dårlig indberetning af undersøgelsen, der ikke følger kravene i OECD's retningslinje og kan være en konsekvens af, at der er anvendt et laboratorium, der ikke opfylder GLP-specifikationerne.
English: The TWA PEC was calculated over 3 days as this corresponds to the duration of the blue-green algae (cyanobacteria) study.
Danish: TWA PEC blev beregnet over 3 dage, da dette svarer til varigheden af undersøgelsen af blågrønalger (cyanobakterier).
English: No detailed records of greenhouse conditions except temperature are provided in the report so it is impossible to conclude if environmental conditions were identical.
Danish: Der anføres ikke nogen detaljerede oplysninger om forholdene i drivhuset bortset fra temperaturen i rapporten, så det er umuligt at afgøre, om miljøforholdene var identiske.
English: However, what was shown in the degradation study was that tylosin A could not be detected.
Danish: Det fremgik dog af nedbrydningsundersøgelsen, at tylosin A ikke kunne påvises.
English: This may have been because of degradation of the substance, but could be due equally to the formation of bound residues which could become available in the soil.
Danish: Det kan skyldes, at stoffet er blevet nedbrudt, men det kan også skyldes, at der dannes bundne restkoncentrationer, der kan blive frigivet i jorden.
English: • a risk for cyanobacteria cannot be excluded on the basis of the data available;
Danish: • En risiko for cyanobakterier kan ikke udelukkes på grundlag af de tilgængelige data.
English: Member State Applicant/Marketing Authorisation Holder
Danish: Ansøger/indehaver af markedsføringstilladelse
English: Other degradation studies in manure suggest a significant role for biodegradation, resulting in differences between sterile and non-sterile conditions, which are not observed in this particular study.
Danish: Andre undersøgelser af nedbrydningen i gødning tyder på, at bionedbrydningen spiller en væsentlig rolle, hvilket resulterer i forskelle mellem sterile og ikke sterile forhold, som ikke observeres i denne bestemte undersøgelse.
English: For the soil nitrification study to be valid the difference between control replicates should be less than ±15%.
Danish: Hvis undersøgelsen af nitrifikationen i jorden skal være gyldig, skal forskellene mellem kontrolprøverne være mindre end ±15%.
English: The plant study did not meet the requirements of the VICH Phase II guideline in respect of the assessment of the risk for plants.
Danish: Planteundersøgelsen opfyldte ikke kravene i VICH's retningslinjer for fase II-undersøgelser med hensyn til vurdering af risikoen for planter.
English: A new study would be required with assessment of nitrate production continuing until after day 28 in order to draw a conclusion on the risk for soil microorganisms.
Danish: Der er behov for en ny undersøgelse med en vurdering af nitratproduktionen til efter dag 28, hvis der skal drages en konklusion om risikoen for mikroorganismerne i jorden.
English: At a later date data were presented in a form that enabled the comparison of nitrate production between control and treatment soils.
Danish: På et senere tidspunkt blev dataene fremlagt i en form, der muliggjorde sammenligning af nitratproduktionen mellem kontroljord og jord med prøvestoffet.
English: The seedlings should not exhibit visible phytotoxic effects (e.g. chlorosis, necrosis, wilting, leaf and stem deformations) and the plants should exhibit only normal variation in growth and morphology for that particular species.
Danish: Kimplanterne burde ikke fremvise synlige fytotoksiske virkninger (f.eks. klorose, nekrose, visnen, blad og stilkdeformationer), og planterne burde kun udvise normale variationer i vækst og morfologi for den pågældende art.
English: Huvepharma NV provided the statistical analysis for the proposed LOECs and NOECs for the three species (courgette, radish and sunflower).
Danish: Huvepharma NV fremlagde statistiske analyser for de foreslåede LOEC- og NOEC-værdier for de tre arter (courgette, radise og solsikke).
English: In order to follow VICH guidance when proceeding to Tier B the most sensitive species from the above experiment, i.e. radish, should have been retested together with two additional species from the same category.
Danish: Hvis VICH's retningslinje skulle være fulgt ved trin B-forsøget, skulle de mest følsomme arter fra ovenstående forsøg, dvs. radise, have været testet igen sammen med to andre arter fra samme kategori.
English: PECsurfacewater values for the same species were calculated as 2.14, 5.47, 2.72 and 3.93 µg/l respectively.
Danish: PECoverfladevand for de samme arter blev beregnet til henholdsvis 2,14, 5,47, 2,72 og 3,93 µg/l.
English: 2.2.4 Effects on fish
Danish: 2.2.4 Virkninger på fisk
English: The results of the study cannot be used in the environmental risk assessment.
Danish: Resultaterne af undersøgelsen kan ikke anvendes i vurderingen af miljørisikoen.
English: The maximum predicted surface water concentration was 4.44 μg/l.
Danish: Den maksimale forventede koncentration i overfladevand var 4,44 μg/l.
English: For the majority of climate and water body scenarios investigated, tylosin concentrations were below 0.001 µg/l.
Danish: For størstedelen af de undersøgte klima- og vandområdescenarier var tylosinkoncentrationerne under 0,001 µg/l.