FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the benefits and risks of Desloratadine Actavis?
Danish: Hvilken fordel og risiko er der forbundet med Desloratadine Actavis?
English: When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Danish: Når receptorerne er blokeret, mister histaminet sin virkning, og derfor dæmpes allergisymptomerne.
English: Desloratadine Actavis is a medicine containing the active substance desloratadine.
Danish: Desloratadine Actavis er et lægemiddel, der indeholder det aktive stof desloratadin.
English: Because Desloratadine Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Desloratadine Actavis er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Desloratadine Actavis is a ‘generic medicine'.
Danish: Desloratadine Actavis er et ‘generisk lægemiddel'.
English: Other information about Desloratadine Actavis
Danish: Andre oplysninger om Desloratadine Actavis:
English: Because Desloratadine Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Danish: Da Desloratadine Actavis er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Aerius.
English: It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally
Danish: Det virker ved at blokere de receptorer, hvortil histamin normalt binder sig.
English: Why has Desloratadine Actavis been approved?
Danish: Hvorfor blev Desloratadine Actavis godkendt?
English: How has Desloratadine Actavis been studied?
Danish: Hvordan blev Desloratadine Actavis undersøgt?
English: What is Desloratadine Actavis?
Danish: Hvad er Desloratadine Actavis?
English: What is Desloratadine Actavis used for?
Danish: Hvad anvendes Desloratadine Actavis til?
English: How is Desloratadine Actavis used?
Danish: Hvordan anvendes Desloratadine Actavis?
English: How does Desloratadine Actavis work?
Danish: Hvordan virker Desloratadine Actavis?
English: Hands and equipment should be disinfected after use.
Danish: Hænder og udstyr bør desinficeres efter brug.
English: Antibiotic treatment should not be given within one week before or after vaccination.
Danish: Antibiotikabehandling bør ikke gives inden for en uge før eller efter vaccination.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Poulvac E. coli on 15 June 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Poulvac E. coli den 15. juni 2012.
English: The full EPAR for Poulvac E. coli can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Poulvac E. coli findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Information on the prescription status of this product can be found on the label/outer package.
Danish: Oplysningerne om udleveringsbestemmelserne for produktet findes på etiketten/yderemballagen.
English: The bacterium is alive, but it has been weakened by removal of a gene (aroA) so that it does not cause disease, which makes it suitable for use in a vaccine.
Danish: Bakterien er levende, men svækket ved fjernelse af et gen (aroA), således at den ikke er sygdomsfremkaldende og derfor er egnet til brug i en vaccine.
English: In addition, a positive effect of the vaccine was shown on average daily weight gain, number of antibiotic treatment days and percentage of animals marketed compared to controls.
Danish: Desuden blev vaccinen påvist at have en positiv virkning på den gennemsnitlige daglige tilvækst, antallet af dage med antibiotikabehandling og andelen af solgte dyr sammenlignet med kontroldyrene.
English: It is also the time required after administration of a medicine before eggs may be used for human consumption.
Danish: Det er også den tid, der skal gå efter administration af et lægemiddel, før æggene kan anvendes til menneskeligt konsum.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Poulvac E. coli's benefits are greated that its risks and recommended that it be approved in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Poulvac E. coli opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The birds consume the vaccine when preening their feathers.
Danish: Fuglene indtager vaccinen, når de pudser deres fjer.
English: The vaccine may spread to in-contact birds.
Danish: Vaccinen kan spredes til andre fugle ved kontakt.
English: The withdrawal period for meat and eggs from chickens and turkeys treated with Poulvac E. coli is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og æg fra kyllinger og kalkuner behandlet med Poulvac E. coli er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: It contains the live bacteria Escherichia coli, type O78, strain EC34195 with a gene (aroA) deleted.
Danish: Det indeholder levende bakterier af arten Escherichia coli, type O78, stamme EC34195, som har fået fjernet et gen (aroA).
English: In the future, if the animals are exposed to the bacteria, the immune system will be able to make antibodies more quickly.
Danish: Hvis dyrene efterfølgende udsættes for bakterien, vil immunsystemet hurtigere kunne producere antistoffer.
English: This is a summary of the European Public Assessment Report (EPAR) for Poulvac E. coli.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Poulvac E. coli.
English: When giving by coarse spray vaccination the reconstituted vaccine should be diluted and sprayed onto the birds so that each bird receives enough for one dose.
Danish: Ved grov sprayvaccination bør den rekonstituerede vaccine fortyndes og sprayes på fuglene, så hver fugl får en dosis.
English: The field study with over 200,000 commercial broilers showed a significant reduction in colibacillosis lesions and deaths in vaccinated animals.
Danish: Feltundersøgelsen, der omfattede over 200 000 industrislagtekyllinger, viste en væsentlig reduktion af forandringer og dødelighed forårsaget af colibacillose hos vaccinerede dyr.
English: Colibacillosis can cause injuries to the sac that surrounds the heart (pericarditis), the sac surrounding the liver (perihepatitis) and the ‘air sacs', the specialised bags within the bird's body where air is stored during breathing (airsacculitis), and can lead to death of the bird.
Danish: Colibacillose kan forårsage skader på hjertesækken (perikarditis), på vævet omkring leveren (perihepatitis) og på luftsækkene, de særlige hulrum i fuglens krop, hvor der opbevares luft under vejrtrækningen (airsacculitis), og bevirke, at fuglen dør.
English: Personnel involved in attending vaccinated animals should follow general hygiene principles and take particular care in handling litter from vaccinated animals.
Danish: Det personale, der passer de vaccinerede dyr, skal foruden at overholde almindelige hygiejneregler udvise særlig forsigtighed ved håndtering af affald fra vaccinerede dyr.
English: Poulvac E. coli contains small amounts of the bacterium E. coli serotype O78.
Danish: Poulvac E. coli indeholder små mængder af bakterien E. coli serotype O78.
English: Immunosuppressed people should not be present during administration of the vaccine.
Danish: Personer med nedsat immunforsvar bør ikke være til stede, når vaccinen gives.
English: Poulvac E. coli, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Poulvac E. coli virker ligesom andre vacciner ved at "lære" immunsystemet (organismens naturlige forsvar), hvordan det skal forsvare organismen mod en sygdom.
English: When Poulvac E. coli is given to a chicken or turkey, the animal's immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign' and makes antibodies against it.
Danish: Når Poulvac E. coli gives til en kylling eller en kalkun, opfatter dyrets immunsystem de dele af bakterien, der er indeholdt i vaccinen, som "fremmede" og danner antistoffer mod dem.
English: It may also be present in faeces for up to five weeks post vaccination in chickens or seven days post vaccination in turkeys, and remain present in the environment until the end of the finishing (time to slaughter) or rearing period for chickens or for seven days for turkeys.
Danish: De kan desuden være til stede i kyllingernes afføring indtil fem uger efter vaccinationen eller indtil syv dage hos kalkuner, og kan findes i omgivelserne indtil slagtetidspunktet eller slutningen af opdrætsperioden hos kyllinger og indtil syv dage hos kalkuner.
English: The vaccine strain can be detected in tissues (liver and heart) for up to six days after vaccination in chickens or in tissues (air sacs) for up to four days after vaccination in turkeys.
Danish: Bakterier af vaccinestammen kan genfindes i væv (lever og hjerte) i op til seks dage efter vaccination hos kyllinger eller i væv (luftsække)i op til fire dage efter vaccination hos kalkuner.
English: Animals undergoing antibacterial or immunosuppressive treatment (treatment that reduces the activity of the immune system) should not be vaccinated.
Danish: Det bør undgås at vaccinere dyr, der er i antibakteriel eller immunsuppressiv behandling (behandling, der svækker immunsystemet).
English: When adding Poulvac E. coli to drinking water a sufficient amount to supply one dose of reconstituted vaccine for every chicken should be added to as much water as is consumed by the chickens in three hours.
Danish: Ved administration af Poulvac E. coli gennem drikkevandet bør der tilføres én dosis af rekonstitueret vaccine pr. kylling til en sådan mængde af vand, som indtages af kyllingerne på tre timer.
English: Therefore, it is recommended to clean and disinfect bird houses where the vaccine was administered after completion of the finishing or rearing period.
Danish: Det anbefales derfor, at fjerkræstalde, hvor vaccinen er blevet anvendt, rengøres og desinficeres efter slagtetidspunktet eller efter opdrætsperioden.
English: Poulvac E. coli is available as a freeze dried powder (lyophilisate) which can be made into a suspension.
Danish: Poulvac E. coli leveres som et frysetørret pulver (lyofilisat), der benyttes til at fremstille en suspension.
English: Poulvac E. coli avian colibacillosis vaccine (live)
Danish: Aviær colibacillose-vaccine (levende)
English: Laboratory studies showed that the vaccine is safe and that protection against colibacillosis lesions starts two weeks after vaccination in chickens and three weeks after vaccination in turkeys.
Danish: Laboratorieundersøgelserne viste, at vaccinen er sikker og giver beskyttelse mod forandringer forårsaget af colibacillose hos kyllinger fra to uger efter vaccinationen og hos kalkuner fra tre uger efter vaccinationen.
English: In chickens it is given as a single dose either by coarse spray vaccination from one day of age or by adding to drinking water from five days of age.
Danish: Det gives til kyllinger enten som en grov sprayvaccination fra de er daggamle eller gennem drikkevand fra de er fem dage gamle.
English: Other information about Poulvac E. coli:
Danish: Andre oplysninger om Poulvac E. coli:
English: In turkeys it is given by coarse spray vaccination from one day of age with a second dose three weeks later.
Danish: Det gives som en grov sprayvaccination til kalkuner fra de er daggamle med endnu en dosis tre uger senere.
English: The studies also demonstrated that the vaccine provides chickens with eight weeks protection against colibacillosis lesions and 12 weeks protection against mortality from colibacillosis with spray vaccination and 12 weeks protection against lesions and mortality with drinking water vaccination.
Danish: Undersøgelserne påviste desuden, at vaccinen ved sprayvaccination kan yde beskyttelse til kyllinger i 8 uger mod forandringer forårsaget af colibacillose og beskyttelse i 12 uger mod dødelighed forårsaget af colibacillose, når det gives som sprayvaccination, og at vaccinen ved administration gennem drikkevandet kan yde beskyttelse i 12 uger mod forandringer og dødelighed forårsaget af colibacillose.
English: Poulvac E. coli is a vaccine that is used in chickens and turkeys for active immunisation against an infection caused by Escherichia coli serotype O78 called colibacillosis.
Danish: Poulvac E. coli er en vaccine til aktiv immunisering af kyllinger og kalkuner mod en infektion, som kaldes colibacillose, og som forårsages af Escherichia coli serotype O78.
English: The vaccine should not be used within six weeks before the start of the laying period or in birds in lay (currently producing eggs).
Danish: Vaccinen bør ikke anvendes inden for seks uger før æglægningsperioden eller hos æglæggende fugle.
English: What is Poulvac E. coli and what is it used for?
Danish: Hvad er Poulvac E. coli, og hvad anvendes det til?
English: The vaccine, which is for use in broiler chickens (reared for meat), future layers or breeders (reared for egg production) and turkeys, helps reduce injuries and deaths caused by the infection.
Danish: Vaccinen anvendes til slagtekyllinger, kommende æglæggere, avlshøns og kalkuner og mindsker også skader og dødeligheden ved denne infektion.
English: Why is Poulvac E. coli approved?
Danish: Hvorfor er Poulvac E. coli blevet godkendt?
English: What are the risks associated with Poulvac E. coli?
Danish: Hvilke risici er der forbundet med Poulvac E. coli?
English: The use of eye-protection, gloves and a nose-mouth mask by the operator is recommended during administration.
Danish: Det anbefales, at den, der giver vaccinen, bruger øjenværn, handsker og næse-mund-maske.
English: For practical information about using Poulvac E. coli animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som dyreejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Poulvac E. coli, bør du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For more information about treatment with Poulvac E. coli, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Poulvac E. coli, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: What benefits of Poulvac E. coli have been shown in the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Poulvac E. coli?
English: How is Poulvac E. coli used?
Danish: Hvordan anvendes Poulvac E. coli?
English: How does Poulvac E. coli work?
Danish: Hvordan virker Poulvac E. coli?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/16/1139/001 OCALIVA
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage
English: Meropenem has been authorised in the EU since the 1990s.
Danish: Meropenem har været godkendt i EU siden 1990'erne.
English: It is given every 8 hours and the duration of treatment depends on the type of infection and its severity.
Danish: Det gives hver 8. time, og varigheden af behandlingen afhænger af infektionstypen og sværhedsgraden.
English: Further information on Vabomere can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Vabomere.
Danish: Yderligere information om Vabomere findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Vabomere.
English: Other information about Vabomere
Danish: Andre oplysninger om Vabomere
English: As for all medicines, data on the use of Vabomere are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Vabomere løbende overvåget.
English: For more information about using Vabomere, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Vabomere, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Vabomere was compared with the doctor's choice of the best available antibiotic treatment.
Danish: Vabomere blev sammenholdt med lægens valg af den bedste tilgængelige antibiotiske behandling.
English: What measures are being taken to ensure the safe and effective use of Vabomere?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vabomere?
English: Side effects reported with Vabomere are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Vabomere vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: It works by interfering with the activity of certain proteins that bacteria need to build their cell walls.
Danish: Det virker ved at gribe ind i aktiviteten af visse proteiner, som bakterierne behøver for at opbygge deres cellevægge.
English: The Agency decided that Vabomere's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede, at fordelene ved Vabomere opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Vabomere is an antibiotic used in adults to treat the following infections, including when they have spread into the blood (bacteraemia):
Danish: Vabomere er et antibiotikum, der anvendes til voksne til behandling af følgende infektioner, herunder når de har spredt sig til blodet (bakteriæmi):
English: Vabomere is given by infusion (drip) into a vein over 3 hours.
Danish: Vabomere indgives ved infusion (drop) i en blodåre over 3 timer.
English: An overview of Vabomere and why it is authorised in the EU
Danish: En oversigt over Vabomere, og hvorfor det er godkendt i EU
English: What is Vabomere and what is it used for?
Danish: Hvad er Vabomere, og hvad anvendes det til?
English: Vabomere can only be obtained with a prescription.
Danish: Vabomere udleveres kun efter recept.
English: Tests for bacteria in the urine found that 67% (128 out of 192) of patients treated with Vabomere were cured, compared with 58% (105 out of 182) of patients treated with piperacillin and tazobactam.
Danish: Test for bakterier i urin viste, at 67 % (128 ud af 192) af de patienter, der fik Vabomere, blev helbredt, sammenholdt med 58 % (105 ud af 182) af de patienter, der fik piperacillin og tazobactam.
English: Why is Vabomere authorised in the EU?
Danish: Hvorfor blev Vabomere godkendt i EU?
English: It can also be used for infections caused by Gram-negative bacteria when other treatments might not work.
Danish: Vabomere kan også anvendes mod infektioner forårsaget af gramnegative bakterier, når andre behandlinger ikke virker.
English: However, the Agency recognised that Vabomere cannot deal with all types of bacteria resistant to meropenem.
Danish: Agenturet anerkendte dog, at Vabomere ikke kan behandle alle typer af meropenemresistente bakterier.
English: No special concerns about side effects have been raised by the addition of vaborbactam to meropenem.
Danish: Der er ikke konstateret særlige betænkeligheder i forhold til bivirkninger ved tilføjelsen af vaborbactam til meropenem.
English: What are the risks associated with Vabomere?
Danish: Hvilke risici er der forbundet med Vabomere?
English: These enzymes break down beta-lactam antibiotics such as meropenem and stop them from working.
Danish: Disse enzymer nedbryder beta-laktamantibiotika som f.eks. meropenem og forhindrer dem i at virke.
English: The European Medicines Agency noted that there were limited options for treating infections with bacteria that carry beta-lactamases.
Danish: Det Europæiske Lægemiddelagentur vurderede, at der er begrænsede muligheder for behandling af infektioner med bakterier, der bærer beta-laktamaser.
English: By blocking the action of these enzymes, vaborbactam allows meropenem to act against bacteria that would otherwise be resistant to it.
Danish: Ved at blokere virkningen af disse enzymer giver vaborbactam meropenem mulighed for at virke mod bakterier, der ellers ville være resistente over for det.
English: The most common side effects with Vabomere (which may affect up to 1 in 10 people) are headache, diarrhoea, inflammation of the vein around the infusion site and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Vabomere (der kan forekomme hos op til 1 ud af 10 personer) er hovedpine, diarré, betændelse i blodåren ved injektionsstedet og kvalme.
English: The active substances in Vabomere, meropenem and vaborbactam, work in different ways.
Danish: De to aktive stoffer i Vabomere, meropenem og vaborbactam, virker på forskellig måde.
English: Fewer patients treated with Vabomere (14%) died within 4 weeks compared with those receiving best available antibiotic treatment (26%).
Danish: Der døde færre patienter inden for 4 uger blandt dem, der fik Vabomere (14 %), end blandt dem, der fik den bedste tilgængelige antibiotiske behandling (26 %).
English: Of those treated with Vabomere, overall 60% (21 out of 35) of patients were cured, compared with 32% (6 out of 19) of patients receiving best available antibiotic treatment.
Danish: Blandt dem, der fik Vabomere, blev i alt 60 % (21 ud af 35) helbredt, sammenholdt med 32 % (6 ud af 19) af de patienter, der fik den bedste tilgængelige antibiotiske behandling.
English: Vabomere contains the active substances meropenem and vaborbactam.
Danish: Vabomere indeholder de aktive stoffer meropenem og vaborbactam.
English: Vabomere must not be used in patients who are hypersensitive (allergic) to any carbapenem antibiotic or in patients who have had a severe allergic reaction to the broader class of beta-lactam antibiotics (such as penicillins and cephalosporins).
Danish: Vabomere må ikke anvendes hos patienter, der er overfølsomme over for carbapenemantibiotika, eller hos patienter, der har haft en alvorlig allergisk reaktion på den bredere klasse af betalaktamantibiotika (f.eks. penicilliner og cephalosporiner).
English: • complicated abdominal infections of the tissues and organs in the belly (intra-abdominal infections);
Danish: • komplicerede infektioner i mavevæv og -organer (intraabdominale infektioner)
English: Vabomere was found effective at treating infections in two studies.
Danish: Det er påvist i to studier, at Vabomere er effektivt til at behandle infektioner.
English: Vaborbactam allows meropenem to work in many such infections by blocking certain beta-lactamases.
Danish: Vaborbactam sætter meropenem i stand til at virke mod mange af denne type infektioner ved at blokere visse beta-laktamaser.
English: How is Vabomere used?
Danish: Hvordan anvendes Vabomere?
English: The second study involved patients with complicated urinary tract infection (including kidney infection), complicated intra-abdominal infections, lung infections caught in hospital and bacteraemia.
Danish: Det andet studie omfattede patienter med kompliceret urinvejsinfektion (herunder nyreinfektion), komplicerede intraabdominale infektioner, hospitalserhvervede lungeinfektioner og bakteriæmi.
English: Vaborbactam is a beta-lactamase inhibitor, which means that it blocks the action of bacterial enzymes called beta-lactamases.
Danish: Vaborbactam er en beta-laktamasehæmmer, dvs. det blokerer virkningen af de bakterielle enzymer, der kaldes beta-laktamaser.
English: The first study, involving patients with complicated urinary tract infection (including kidney infection), compared Vabomere with a combination of piperacillin (another beta-lactam antibiotic) and tazobactam (a beta-lactamase inhibitor).
Danish: I det første studie, der omfattede patienter med kompliceret urinvejsinfektion (herunder nyreinfektion), blev Vabomere sammenlignet med en kombination af piperacillin (et andet beta-laktamantibiotikum) og tazobactam (en beta-laktamasehæmmer).