FrancophonIA/ELRC3.0 huggingface dataset:
English: GENERA SI d.o.o., Dunajska 51, 1000 Ljubljana Slovenia
Danish: Slovenien GENERA SI d.o.o., Dunajska 51,
English: In a recent study from Italy, Russo et al. (2012)10 found that 30.34% of eighty-nine APEC (avian pathogenic E. coli) isolates from turkeys were classified as resistant to enrofloxacin and 40.45% as intermediately resistant with a breakpoint of 2 µg/ml.
Danish: I en nylig undersøgelse fra Italien, Russo et al. (2012)10, blev 30,34 % af 89 isolater af fuglepatogene E. coli fra kalkuner klassificeret som resistente over for enrofloxacin, og 40,45 % som intermediært resistente ved et breakpoint på 2 µg/ml.
English: The field study replicated the situation that would be encountered - a mixed infection which included Mycoplasma spp.
Danish: Feltundersøgelsen afspejlede den forventede situation - en blandet infektion, hvori der indgik
English: Romania Vetoquinol Biowet Sp.
Danish: Rumænien Vetoquinol Biowet Sp.
English: In a recent study from Italy, Russo et al. (2012) found that 30.34% of eighty-nine APEC (avian pathogenic E. coli) isolates from turkeys were classified as resistant to enrofloxacin and 40.45% as intermediately resistant with a breakpoint of 2 µg/ml.
Danish: I en nylig undersøgelse fra Italien fandt Russo et al. (2012), at 30,34 % af 89 isolater af fuglepatogene E. coli fra kalkuner blev klassificeret som resistente over for enrofloxacin og 40,45 % som intermediært resistente ved et breakpoint på 2 µg/ml.
English: Solution for use in drinking water
Danish: Opløsning til brug i drikkevand
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Chickens and turkeys
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ Kyllinger og kalkuner
English: • on the basis of the available data, the CVMP considered that indications for M.gallisepticum, M.synoviae, A.paragallinarium, P.multocida and E.coli in chickens and M.gallisepticum, M.synoviae, P.multocida and E.coli in turkeys should be maintained;
Danish: • på grundlag af de foreliggende data fandt CVMP, at indikationerne bør opretholdes for infektion med M.gallisepticum, M.synoviae, A.paragallinarium, P.multocida og E.coli hos kyllinger og M.gallisepticum, M.synoviae, P.multocida og E.coli hos kalkuner
English: According to the EFSA summary report, 2010, the level of resistance (defined by epidemiological cutoff values) to ciprofloxacin in Campylobacter jejuni isolates from broiler chickens was 47%, although there is variability between Member States.
Danish: Ifølge EFSA's sammenfattende rapport fra 2010 var der 47 % resistente organismer (defineret ved epidemiologiske afskæringsværdier) over for ciprofloxacin blandt isolater af Campylobacter jejuni fra slagtekyllinger, men andelen varierede medlemsstaterne imellem.
English: The indication for treatment of salmonella infections should be removed from the SPCs due to the lack of support for the dosing regimen, especially in regards to elimination of infection, and EU legislation in regards to national control programmes for the control of salmonella in poultry that state that antimicrobials should not be used except in exceptional circumstances (Regulation EC 1177/2006).
Danish: Indikationen behandling af salmonellainfektioner skal slettes fra produktresuméet på grund af manglende dokumentation af dosisregimet, navnlig til udryddelse af infektion, og i henhold til EU's lovgivning om nationale kontrolprogrammer for bekæmpelse af salmonella hos fjerkræ, der foreskriver, at antimikrobielle stoffer ikke må anvendes, bortset fra i ekstraordinære tilfælde (forordning (EF) nr.
English: 711, mag. 3 Sofia 1324
Danish: Bulgarien Asklep Farma Lyulin 7, bl. 711, mag. 3 Sofia 1324
English: 1107 Budapest, Hungary
Danish: 1107 Budapest, Ungarn
English: CVMP considered the impact of infections with fluoroquinolone-resistant foodborne bacteria on human health due to use of fluoroquinolones in food-producing animals in the EU in a CVMP Public Statement (2007)18.
Danish: CVMP gennemgik i en offentlig udtalelse fra 200718 sundhedsvirkningen af infektioner med fødevarebårne bakterier, der var blevet fluorquinolon-resistente som følge af anvendelse af fluorquinoloner i fødevareproducerende dyr i EU.
English: It is therefore proposed that a new dosing regimen should be elaborated that takes into account the evolution of the susceptibility profile of E. coli since enrofloxacin was first authorised in poultry and new PK/PD concepts aimed at limiting development of resistance in target pathogens.
Danish: Det foreslås derfor, at der fastlægges et nyt dosisregime, der tager hensyn til ændringen i følsomhedsprofilen af E. coli, siden enrofloxacin først blev godkendt til fjerkræ, samt nye farmakokinetiske/farmakodynamiske koncepter, der sigter mod at begrænse resistensudviklingen hos målpatogenerne.
English: This would indicate that suitable levels are not reached in lung tissue for efficacy against Mycoplasma spp with an MIC of ≥1 µg/ml.
Danish: Dette betyder, at koncentrationen i lungevævet ikke er tilstrækkelig til at være virksom mod Mycoplasma spp.
English: 1161 Budapest, Hungary
Danish: 1161 Budapest, Ungarn
English: Adequate data have been submitted to support indications for M.gallisepticum, M.synoviae, A.paragallinarium, P.multocida and E.coli in chickens and M.gallisepticum, M.synoviae, P.multocida and E.coli in turkeys.
Danish: Der er forelagt tilstrækkelig dokumentation for indikationerne infektion med M.gallisepticum, M.synoviae, A.paragallinarium, P.multocida og E.coli hos kyllinger og M.gallisepticum, M.synoviae, P.multocida og E.coli hos kalkuner.
English: Enrofloxacin 0,5% Solution for oral use
Danish: Enrofloxacin 0,5 % Oral opløsning
English: Dose rates from as low as 1.5 mg/kg bw up to dose rates of 13.02 mg/kg bw were successful in controlling mortality and morbidity.
Danish: Mortalitet og morbiditet kunne kontrolleres med doseringer så lave som 1,5 mg/kg kropsvægt og op til 13,02 mg/kg kropsvægt.
English: La Selva 135, 17170 - Amer (Girona) Spain
Danish: La Selva 135, 17170 - Amer (Girona) Spanien
English: Poultry and pigs
Danish: Fjerkræ og svin
English: There are adequate data to support the indication of Mycoplasma spp in turkeys, based on the fact that they are considered a minor species and extrapolation can be made from the data in chickens.
Danish: hos kalkuner er dokumentationen fyldestgørende, da dyrearten anses for mindre betydningsfuld, og da der kan ekstrapoleres fra data hos kyllinger.
English: La Selva 135, 17170 Amer (Girona) Spain
Danish: La Selva 135, 17170 Amer (Girona) Spanien
English: According to the EFSA summary report, 201014, the level of resistance (defined by epidemiological cut-off values) to ciprofloxacin in indicator (commensal) E.coli isolates from broiler chickens was 29%.
Danish: Ifølge EFSA's sammenfattende rapport fra 201014 var der 29 % resistens (defineret ved epidemiologiske afskæringsværdier) over for ciprofloxacin hos (kommensale) indikatorisolater af E.coli fra slagtekyllinger.
English: Romania Krka d.d.
Danish: Rumænien Krka d.d.
English: La Selva, 135, 17170 Amer (Girona) Spain
Danish: La Selva, 135, 17170 Amer (Girona) Spanien
English: Taking account of all the data, the indication for the treatment of P.multocida in turkeys is acceptable at a dose of 10 mg/kg bw for 35 days.
Danish: På grundlag af samtlige data godkendes indikationen behandling af infektion med P.multocida hos kalkuner ved en dosis på 10 mg/kg kropsvægt i 3-5 dage.
English: Germany aniMedica GmbH, Im Südfeld 9,
Danish: Tyskland aniMedica GmbH, Im Südfeld 9,
English: Oral solution for use in drinking water
Danish: Oral opløsning til brug i drikkevand
English: • Where there is a change to the dose regimen for chickens and/or turkeys, then adequate withdrawal periods should be established, according to current guidelines; a revised environmental risk assessment should also be provided; furthermore any potential effects on user and target species safety should be reviewed.
Danish: • Når der ændres i dosisregimet for kyllinger og/eller kalkuner, skal der fastsættes passende tilbageholdelsestider i henhold til de nuværende retningslinjer.
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administrationsvej Dyreart
English: VETLIMA - Soc. distribuidora de produtos agro-pecuários, LDA Av. 5 de Outubro, 35-3º Esq.
Danish: VETLIMA - Soc. distribuidora de produtos agro-pecuários, LDA
English: Poultry (broilers), bovine (calves), pigs
Danish: Fjerkræ (slagtekyllinger), kvæg (kalve), svin
English: Oral solution to be administered in drinking water
Danish: Oral opløsning til administration i drikkevand
English: Romania UNIVERSAL PHARMA Gran Via Carlos III 98-7a 08028-Barcelona
Danish: Rumænien UNIVERSAL PHARMA Gran Via Carlos III 98-7a 08028-Barcelona
English: A comprehensive review of data regarding resistance in E.coli, Salmonella sp and Campylobacter spp (bacteria of concern to human health) from poultry from EU Member States isolated during 2002-2009 was provided.
Danish: Der blev fremlagt en omfattende gennemgang af resistensdata for E.coli, Salmonella sp og Campylobacter spp.
English: It is currently unknown if enrofloxacin usage is associated with CTX-M1 selection and shedding, but ESBL E. coli can also be resistant to fluoroquinolones.
Danish: Problemet vedrørende E.coli udvikler sig, idet der er evidens for bredspektret betalactamase-producerende (ESBL) E. coli (CTX-M1) i forarbejdede kødprodukter og stigende human prævalens af infektioner med ESBL CTX-M1. På nuværende tidspunkt vides det ikke, om anvendelse af enrofloxacin har sammenhæng med selektion og spredning af CTX-M1, men ESBL E. coli kan også være resistente over for fluorquinoloner.
English: Netherlands aniMedica GmbH, Im Südfeld 9,
Danish: Nederlandene aniMedica GmbH, Im Südfeld 9,
English: CHEMO IBÉRICA, S.A. Gran Vía Carlos III 98 - 7a, 08028 Barcelona Spain
Danish: CHEMO IBÉRICA, S.A. Gran Vía Carlos III 98 - 7a, 08028 Barcelona Spanien
English: One field study was submitted to support the indication of P.multocida using an inclusion rate of
Danish: Der blev forelagt en feltundersøgelse til støtte for indikationen infektion med P.multocida ved et iblandingsforhold på 50 ppm.
English: http://www.efsa.europa.eu/en/scdocs/doc/1372.pdf 16 Luangtongkum T, Jeon B, Han J, Plummer P, Logue CM, Zhang Q (2009) Antibiotic resistance in Campylobacter:
Danish: 16 Luangtongkum T, Jeon B, Han J, Plummer P, Logue CM, Zhang Q (2009) Antibiotic resistance in Campylobacter:
English: Treatment of Mycoplasma spp infections may not eradicate the organism.
Danish: Behandling af infektioner med Mycoplasma spp.
English: Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010.
Danish: European Food Safety Authority and European Centre for Disease Prevention and Control; The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010.
English: Chickens, pigs and turkeys
Danish: Kyllinger, svin og kalkuner
English: Netherlands Krka d.d.
Danish: Nederlandene Krka d.d.
English: isolation rate; however, in severe experimental infections, dose rates of 35 and 66 mg/kg bw reduced mortality and the severity of the pathological findings.
Danish: Undersøgelserne viste, at en dosis på 10 mg/kg kropsvægt i fem dage kontrollerede de kliniske tegn i felten, men at andelen med reisolation kun blev reduceret; ved sværere eksperimentelle infektioner resulterede en dosering på 35 og 66 mg/kg kropsvægt imidlertid i nedsat mortalitet og sværhed af patologiske fund.
English: 11-500 Giżycko
Danish: Bialostocka 12, 11-500 Giżycko Polen
English: A study by Haritova et al (2011)11 demonstrated that when E.coli O78/H12 infected chickens (MIC 0.01 µg/ml) were treated with either 10 mg/kg bw or 50 mg/kg bw enrofloxacin for 3 days, both dose
Danish: En undersøgelse af Haritova et al (2011)11 viste, at når kyllinger smittet med E.coli O78/H12 (MIC 0,01 µg/ml) blev behandlet med enten 10 mg/kg kropsvægt eller 50 mg/kg kropsvægt enrofloxacin i tre dage, kontrollerede begge doseringer de kliniske tegn, men op til 25 dage efter infektionen kunne patogenet stadig reisoleres fra milten i gruppen på 50 mg/kg kropsvægt, og i lunger, lever, hjerte og milt i gruppen på 10 mg/kg kropsvægt.
English: EFSA Journal 2009; 7(11):1372.
Danish: EFSA Journal 2009; 7(11):1372.http://www.efsa.europa.eu/en/scdocs/doc/1372.pdf
English: Belgium HIPRA LABORATORIOS Avda.
Danish: HIPRA LABORATORIOS Avda.
English: Chicken and pigeon
Danish: Kyllinger og duer
English: Germany Laboratorios Hipra S.A. Avda.
Danish: Tyskland Laboratorios Hipra S.A. Avda.
English: Pigs, calves, lambs, kids, poultry (chicken and turkey)
Danish: Svin, kalve, lam, gedekid, fjerkræ (kyllinger og kalkuner)
English: Poultry, rabbits
Danish: Fjerkræ, kaniner
English: Chickens and rabbits
Danish: Kyllinger og kaniner
English: Germany Global Vet Health S.L.
Danish: Tyskland Global Vet Health S.L.
English: Enrofloxacin 100 mg Oral solution Oral
Danish: Enrofloxacin 100 mg Oral opløsning
English: Germany Vetpharma Animal Health S.L.,
Danish: Tyskland Vetpharma Animal Health S.L.,
English: Germany Laboratorios Karizoo S.A., Pol. Ind. La Borda,
Danish: Tyskland Laboratorios Karizoo S.A., Pol. Ind. La Borda,
English: Netherlands Laboratorios Karizoo S.A., Pol. Ind. La Borda,
Danish: Nederlandene Laboratorios Karizoo S.A., Pol. Ind. La Borda,
English: Four experimental studies which used a variety of different doses were submitted in support of the indication for P.multocida in turkeys.
Danish: For indikationen infektion med P.multocida hos kalkuner blev der forelagt fire eksperimentelle undersøgelser med en række forskellige doseringer.
English: Lithuania Krka d.d.
Danish: Slovenien Krka d.d.
English: Both proprietary and published data were provided to form a picture of the depletion of residues from edible tissues resulting from treatment with enrofloxacin-containing, orally-administered veterinary
Danish: Der blev forelagt både interne og publicerede data til at belyse et billede af depletionen af rester i spiseligt væv efter oral behandling med veterinærlægemidler indeholdende enrofloxacin i en dosis på 10 mg/kg kropsvægt/dag i 5 på hinanden følgende dage til kyllinger og kalkuner.
English: Enrofloxacin 10% Solution for oral use
Danish: Enrofloxacin 10 % Oral opløsning
English: Spectron 100 mg/ml roztwór do podawania w wodzie do picia dla kurcząt i indyków
Danish: Spectron 100 mg/ml roztwór do podawania w wodzie do picia dla kurcząt i
English: Baytril 100 mg/mlLösung zum Eingeben für Hühner und Puten
Danish: Baytril 100 mg/ml - Lösung zum Eingeben für Hühner und Puten
English: Netherlands S.P. VETERINARIA, S.A. Ctra.
Danish: Nederlandene S.P. VETERINARIA, S.A. Ctra.
English: Chicken and turkeys
Danish: Slagtekyllinger og kalkuner
English: Netherlands Vetpharma Animal Health S.L.,
Danish: Nederlandene Vetpharma Animal Health S.L.,
English: Universal Farma, S.L., Gran Via Carlos III 98 - 7a, 08028 Barcelona Spain
Danish: Universal Farma, S.L., Gran Via Carlos III 98 - 7a, 08028 Barcelona Spanien
English: According to the EFSA summary report, 2010, 24% of Salmonella spp isolates from breeding, layer and broiler flocks were resistant (defined by epidemiological cut-off values) to ciprofloxacin.
Danish: EFSA's sammenfattende rapport fra 2010 angav en andel af resistens (defineret ved epidemiologiske afskæringsværdier) på 24 % over for ciprofloxacin for isolater af Salmonella spp.
English: Broilers, rearing poultry, turkeys
Danish: Slagtekyllinger, fjerkræ til opdræt, kalkuner
English: Pigs, calves, chicken (broilers), turkeys
Danish: Svin, kalve, (slagte)kyllinger, kalkuner
English: Belgium Laboratorios Karizoo S.A., Pol. Ind. La Borda,
Danish: Grækenland Laboratorios Karizoo S.A., Pol. Ind. La Borda,
English: Romania Global Vet Health S.L.
Danish: Rumænien Global Vet Health S.L.
English: Chickens, turkeys and rabbits
Danish: Kyllinger, kalkuner og kaniner
English: Cattle (calves), pigs, chicken (broilers), cats, dogs
Danish: Kvæg (kalve), svin, (slagte)kyllinger, katte, hunde
English: • due to the lack of support for the dosing regimen, especially in regards to elimination of infection, and EU legislation in regards to national control programmes for the control of salmonella in poultry that state that antimicrobials should not be used except in exceptional circumstances (Regulation EC 1177/2006), the CVMP considered that the indication for treatment of salmonella infections should be removed from the SPCs;
Danish: • CVMP fandt, at indikationen behandling af salmonellainfektioner bør slettes af produktresuméerne på grund af manglende dokumentation af dosisregimet, navnlig til udryddelse af infektion, og i henhold til EU's lovgivning om nationale kontrolprogrammer for bekæmpelse af salmonella hos fjerkræ, der fastslår, at antimikrobielle stoffer ikke må anvendes, bortset fra i ekstraordinære tilfælde (forordning (EF) nr. 1177/2006)
English: • the CVMP considered that in order to take into account the evolution of the susceptibility profiles of E.coli since enrofloxacin was first authorised in poultry, and new PK/PD concepts, the dosing regimen should be optimised for efficacy and to limit the potential for further development of resistance in target pathogens;
Danish: • CVMP fandt, at dosisregimet bør optimeres af hensyn til virkningen og for at begrænse potentialet for yderligere resistensudvikling hos målpatogenerne under hensyntagen til den ændrede følsomhedsprofil af E. coli, siden enrofloxacin først blev godkendt til fjerkræ, og til nye farmakokinetiske/farmakodynamiske koncepter
English: Poultry (broilers and fattened turkeys), rabbits
Danish: Fjerkræ (slagtekyllinger og slagtekalkuner), kaniner
English: Calves, lambs, kids, piglets, poultry, dogs, cats
Danish: Kalve, lam, gedekid, smågrise, fjerkræ, hunde, katte
English: Ireland S.P. VETERINARIA, S.A. Ctra.
Danish: Grækenland S.P. VETERINARIA, S.A. Ctra.
English: Calves, pigs, dogs, cats, chickens (broilers), pigeons
Danish: Kalve, svin, hunde, katte, (slagte)kyllinger, duer
English: Enrofloxacin 10 % w/v Concentrate for oral solution
Danish: Enrofloxacin 10 % w/v
English: Chicken, turkey, pigeons, cattle, swine, dogs and cats
Danish: Kyllinger, kalkuner, duer, kvæg, svin, hunde og katte
English: Ireland Universal Farma, S.L., Gran Via Carlos III, 98-7a, 08028 Barcelona
Danish: Universal Farma, S.L., Gran Via Carlos III, 98-7a, 08028 Barcelona Spanien
English: Swine, cattle (calves), broiler chickens, dogs, cats
Danish: Svin, kvæg (kalve), slagtekyllinger, hunde, katte
English: Chickens, turkeys, rabbits
Danish: Kyllinger, kalkuner, kaniner
English: Chicken, cattle, swine, pigeons, dogs and cats
Danish: Kyllinger, kvæg, svin, duer, hunde og katte
English: Chickens, rabbits
Danish: Kyllinger, kaniner
English: Chickens, turkeys, guinea fowl, ducks, pheasant, quails, rabbits
Danish: Kyllinger, kalkuner perlehøns, ænder, fasaner, vagtler, kaniner
English: Poultry (broilers and broiler breeders)
Danish: Fjerkræ (slagtekyllinger og forældredyr til slagtekyllinger)
English: Dose dependent abnormalities were observed in the total index of lesions of femoral head, femoral condyles and tibial condyles in birds receiving ≥50 mg/kg bw/day for 5 days.
Danish: fik ≥ 50 mg/kg kropsvægt/dag i 5 dage, iagttoges dosisafhængigt unormalt totalindeks for forandringer i caput femoris, femurkondylerne og tibiakondylerne.
English: Chicken, turkey and pigeon
Danish: Kyllinger, kalkuner og duer
English: Lithuania Laboratorios Hipra S.A. Avda.
Danish: Grækenland Laboratorios Hipra S.A. Avda.
English: Belgium Global Vet Health S.L.
Danish: Bulgarien Global Vet Health S.L.
English: Poultry (broilers, replacement chickens, broiler breeders and turkeys)
Danish: Fjerkræ (slagtekyllinger, levekyllinger, forældredyr til slagtekyllinger kalkuner)
English: Enrofloxacin 10 g/100ml
Danish: Enrofloxacin 10 g/100m l
English: Chicken, cattle, pig, dog, cat and pigeon
Danish: Kyllinger, kvæg, svin, hunde, katte og duer
English: Chickens (broilers, replacement chickens, broiler breeders) and rabbits
Danish: Kyllinger (slagtekyllinger, levekyllinger, forældredyr til slagtekyllinger), kaniner
English: (See section 4.5) Types and mechanisms of resistance.
Danish: Resistenstyper og resistensmekanismer
English: Romania Bayer Animal Health GmbH, 51368 Leverkusen,
Danish: Rumænien Bayer Animal Health GmbH, 51368 Leverkusen, Tyskland
English: enrofloksacyna 100 mg/ml roztwór doustny dla kur, indyków i gołębi
Danish: ENROFLOKSACYN A 10 %, enrofloksacyna 100 mg/ml roztwór doustny dla kur, indyków i gołębi
English: Chicken (broilers, replacement chickens, broiler breeders), rabbit
Danish: Kyllinger (slagtekyllinger, levekyllinger, slagtekyllinger: forældredyr), kaniner
English: Chickens (broilers, replacement chickens, broiler breeders) and turkeys
Danish: Kyllinger (slagtekyllinger, forældredyr til slagtekyllinger, levekyllinger), kalkuner
English: Chickens (broilers, broiler breeders, replacement chickens), turkeys
Danish: Kyllinger (slagtekyllinger, levekyllinger, forældredyr til slagtekyllinger), kalkuner
English: Chicken broiler
Danish: Ikkeæglæggende fjerkræ
English: Belgium Vetpharma Animal Health S.L.,
Danish: Grækenland Vetpharma Animal Health S.L.,
English: Chicken broilers
Danish: Slagtekyllinger
English: The full EPAR for Entecavir Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Entecavir Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Entecavir Accord is taken once a day.
Danish: Entecavir Accord tages én gang dagligt.
English: This is a summary of the European public assessment report (EPAR) for Entecavir Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Entecavir Accord.
English: As for every medicine, the company provided studies on the quality of Entecavir Accord.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Entecavir Accord.
English: When treatment is considered appropriate in children, the dose depends on their body weight.
Danish: Når behandling vurderes at være hensigtsmæssigt hos børn, afhænger dosis af legemsvægten.
English: It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Danish: Det kan derudover overvejes at anvende lægemidlet til børn i alderen 2-18 år, men kun ved kompenseret leversygdom.
English: The Agency recommended that Entecavir Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at Entecavir Accord godkendes til anvendelse i EU.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Entecavir Accord has been shown to have comparable quality and to be bioequivalent to Baraclude.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Entecavir Accord er af sammenlignelig kvalitet og er bioækvivalent med Baraclude.
English: Treatment with Entecavir Accord should be started by a doctor with experience in the management of chronic hepatitis B.
Danish: Behandling med Entecavir Accord bør iværksættes af en læge med erfaring i behandling af kronisk hepatitis B.
English: Entecavir Accord can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg).
Danish: Entecavir Accord udleveres kun efter recept og fås som tabletter (0,5 mg og 1 mg).
English: What is Entecavir Accord and what is it used for?
Danish: Hvad er Entecavir Accord, og hvad anvendes det til?
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Accord.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Baraclude, og det er ikke nødvendigt at gentage disse med Entecavir Accord.
English: Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Danish: Entecavir standser virussets dna-produktion og forhindrer derved, at det formerer sig og spredes.