FrancophonIA/ELRC3.0 huggingface dataset:
English: Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Danish: Gennembrudssmerter er, når en patient oplever yderligere, pludselig smerte på trods af igangværende behandling med smertestillende midler.
English: Instanyl has been shown to provide rapid relief of pain in patients with cancer.
Danish: Instanyl er påvist at give hurtig smertelindring hos kræftpatienter.
English: Before starting treatment with Instanyl, the patient's long-term pain should be well controlled by opioid pain killers and they should have no more than 4 episodes of breakthrough pain a day.
Danish: Før behandlingen med Instanyl indledes, skal patientens længerevarende smerter være under kontrol ved hjælp af opioide smertestillende midler, og patienterne bør ikke have over fire tilfælde af gennembrudssmerter om dagen.
English: The patient should be given Instanyl for a maximum of 4 episodes of breakthrough pain a day.
Danish: Patienten bør få Instanyl for højst fire tilfælde af gennembrudssmerter om dagen.
English: If there has been insufficient pain relief, the same dose can be given again at the earliest after 10 minutes.
Danish: Hvis smertelindringen er utilstrækkelig, kan samme dosis gives igen, når der er gået mindst 10 minutter.
English: Instanyl must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing).
Danish: Instanyl må ikke anvendes til patienter, som ikke i forvejen tager opioider for at holde smerterne under kontrol, som har svær respirationsdepression (åndedrætsbesvær), eller som har svære obstruktive lungesygdomme (sygdomme, der giver alvorlige vejrtrækningsproblemer).
English: Treatment with Instanyl should be started by and remain under the supervision of a doctor who has experience in the management of opioid treatment in cancer patients.
Danish: Behandling med Instanyl bør indledes og løbende overvåges af en læge med erfaring i opioidbehandling af kræftpatienter.
English: Instanyl is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Danish: Instanyl anvendes hos voksne patienter, der allerede bruger opioider (en gruppe smertestillende midler, som omfatter morfin og fentanyl) for at kontrollere længerevarende kræftsmerter.
English: What benefits of Instanyl have been showed in studies?
Danish: Hvilke fordele viser studierne, at der er ved Instanyl?
English: Patients taking Instanyl were allowed to take a second spray 10 minutes after the first dose if there had been insufficient pain relief.
Danish: De patienter, der fik Instanyl, havde lov til at tage endnu et pust 10 minutter efter den første dosis, hvis smertelindringen ikke var tilstrækkelig.
English: The highest dose was 200 microgram given as one spray in one nostril and the patients were allowed to take a second spray after 10 minutes if there had been insufficient pain relief.
Danish: Den højeste dosis var 200 mikrogram, der blev givet som et pust i det ene næsebor, og patienterne havde lov til at tage endnu et pust efter 10 minutter, hvis smertelindringen ikke var tilstrækkelig.
English: It must also not be used in patients who have had facial radiotherapy (treatment with radiation to the face) or who have recurrent episodes of epistaxis (nosebleeds).
Danish: Det må heller ikke anvendes til patienter, som har fået strålebehandling i ansigtet, eller som har tilbagevendende episoder af epistaxis (næseblod).
English: The change in pain intensity after 10 minutes was between 2.0 and 2.7 points after receiving doses of Instanyl compared with 1.3 after receiving placebo.
Danish: Ændringen i smerteintensiteten efter 10 minutter lå på mellem 2,0 og 2,7 point efter indgivelse af doser af Instanyl sammenlignet med 1,3 efter indgivelse af placebo.
English: The reduction in pain intensity after 10 minutes was between 1.8 and 2.7 points on an 11-point pain scale for patients who took Instanyl, compared with 1.4 for patients who took placebo.
Danish: Faldet i smerteintensiteten efter 10 minutter lå på mellem 1,8 og 2,7 point på en 11-punkts-smerteskala hos de patienter, der fik Instanyl, sammenlignet med 1,4 hos de patienter, der fik placebo.
English: Instanyl is a medicine used to treat breakthrough pain in adults with cancer.
Danish: Instanyl er et lægemiddel, der anvendes til at behandle gennembrudssmerter hos voksne med kræft.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Danish: Når fentanyl er i blodbanen, virker det på receptorerne i hjernen og rygmarven og lindrer smerte.
English: The number of breakthrough pain episodes that responded to treatment was also higher among patients who received Instanyl than those who received placebo.
Danish: Antallet af gennembrudssmertetilfælde, der responderede på behandlingen, var også højere blandt de patienter, der fik Instanyl end blandt dem, der fik placebo.
English: In Instanyl, fentanyl is contained inside a nasal spray.
Danish: I Instanyl er fentanyl indeholdt i en næsespray.
English: It must not be used in patients treated with medicines containing sodium oxybate (used to treat narcolepsy, a sleep disorder).
Danish: Det må ikke anvendes til patienter behandlet med lægemidler, der indeholder natriumoxybat (til behandling af narkolepsi, en søvnforstyrrelse).
English: How is Instanyl used?
Danish: Hvordan anvendes Instanyl?
English: For the full list of side effects with Instanyl, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Instanyl fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Instanyl have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Instanyl.
English: How does Instanyl work?
Danish: Hvordan virker Instanyl?
English: The first dose of Instanyl is 50 micrograms (one spray of the lowest strength) in one nostril; this is increased as necessary until reaching the dose that gives the patient adequate pain relief.
Danish: Den første dosis Instanyl er 50 mikrogram (et pust med den laveste styrke) i det ene næsebor.
English: Annex IV Conditions for lifting the suspension
Danish: Bilag IV Betingelser for ophævelse af suspenderingen
English: The new formulation must be approved by the National Competent Authorities of the concerned Member States.
Danish: Den nye formulering skal godkendes af de nationale kompetente myndigheder i de berørte medlemsstater.
English: Evidence that the product has been reformulated, that it exhibits an acceptable release profile with the same quality, safety and efficacy profile of the currently authorised formulation but without the clinically significant interaction with alcohol.
Danish: Bevis for, at lægemidlet er blevet reformuleret, at det udviser en acceptabel udløsningsprofil med samme kvalitets-, sikkerheds- og effektprofil som den aktuelt godkendte formulering, men uden den klinisk signifikante interaktion med alkohol.
English: Only applicable to products containing a polymethacrylate-triethylcitrate coating as modified-release mechanism
Danish: Gælder kun lægemidler med polymethacrylat-triethylcitrat-overtræk som mekanisme til modificeret udløsning
English: This summary was last updated in May 2015.
Danish: Dette sammendrag blev sidst ajourført i maj 2015.
English: The European Commission granted a marketing authorisation valid throughout the EU for Innovax-ILT on 3 July 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Innovax-ILT den 3. juli 2015.
English: The full EPAR for Innovax-ILT can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Innovax-ILT findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Innovax-ILT.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Innovax-ILT.
English: The vaccine can be given to one-day-old chicks as a single injection under the skin in the neck.
Danish: Vaccinen kan gives til daggamle kyllinger som en enkelt injektion under huden i nakken.
English: In the future if the animals are exposed to a similar virus the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for et lignende virus, vil immunsystemet reagere hurtigere.
English: This will help protect the chickens against ILT and MD.
Danish: Dette beskytter kyllingerne mod ILT og MD.
English: The withdrawal period for meat and eggs from chickens treated with Innovax-ILT is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og æg fra kyllinger, der behandles med Innovax-ILT, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The level of protection in general was higher when Innovax-ILT was given alone.
Danish: Beskyttelsesgraden var generelt højere, når Innovax-ILT blev givet alene.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that InnovaxILT's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Innovax-ILT opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
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 indgivelsen af et lægemiddel, før æg kan anvendes til menneskeligt konsum.
English: Chickens were taken from the field trial and challenged (exposed to infection) in the laboratory to demonstrate protection after vaccination.
Danish: Kyllingerne blev udtaget fra feltundersøgelsen og belastet (udsat for smitte) i laboratoriet for at påvise beskyttelse efter vaccination.
English: A field trial in chickens was performed to evaluate the effects of the vaccine against ILT and MD. Mortality was low, no disease related signs were observed and the condition of the chickens was good throughout the trial, indicating effectiveness of the vaccine.
Danish: Der er udført en feltundersøgelse hos kyllinger for at vurdere vaccinens virkning mod ILT og MD. Dødeligheden var lav, der blev ikke iagttaget sygdomstegn, og kyllingernes tilstand var god under hele forsøget som tegn på, at vaccinen var effektiv.
English: Protection against ILT starts 4 weeks after vaccination and lasts 60 weeks.
Danish: Beskyttelsen mod ILT begynder 4 uger efter vaccinationen og varer i 60 uger.
English: The disease is caused by a herpesvirus and can be mild (causing watery eyes, nasal discharge and mild inflammation of the windpipe) or severe, causing dyspnoea (difficulty breathing), respiratory depression and coughing up of blood.
Danish: Sygdommen skyldes et herpesvirus og kan være af mild grad (med løbende øjne, udflåd fra næsen og let inflammation af luftrøret) eller af alvorlig grad med vejrtrækningsbesvær (dyspnø), nedsat vejrtrækning (respirationsdepression) og ophostning af blod.
English: Since Innovax-ILT is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Danish: Da Innovax-ILT er en levende vaccine, udskilles vaccinestammen fra de vaccinerede fugle og kan spredes til kalkuner.
English: Other information about Innovax-ILT
Danish: Andre oplysninger om Innovax-ILT
English: It is not intended to provide practical advice on how to use Innovax-ILT.
Danish: Det er ikke en praktisk vejledning i, hvordan Innovax-ILT bør anvendes.
English: The turkey herpesvirus strain HVT/ILT-138 has been modified so that it will produce the glycoproteins gD and gI which form part of the outer coat of the ILT virus.
Danish: Kalkunherpesvirus stamme HVT/ILT-138 er blevet modificeret, så den producerer glykoproteinerne gD og gI, som er en del af den ydre kapsel på ILT-virusset.
English: Innovax-ILT is a vaccine containing turkey herpesvirus serotype 3, a type of herpesvirus which is closely related to MD virus but does not cause disease in chickens.
Danish: Innovax-ILT er en vaccine, der indeholder kalkunherpesvirus serotype 3, en type herpesvirus, der er nært beslægtet med MD-virus, men som ikke forårsager sygdom hos kyllinger.
English: Chickens become infected at an early age via inhalation of dander (flakes of skin) containing the virus which can remain infectious for several months after being shed from the body.
Danish: Kyllingerne bliver inficeret i en tidlig alder ved indånding af skæl fra huden, som indeholder virus og kan forblive smittefarlige i flere måneder efter at være drysset fra kroppen.
English: What is Innovax-ILT and what is it used for?
Danish: Hvad er Innovax-ILT, og hvad anvendes det til?
English: Avian infectious laryngotracheitis and Marek's disease vaccine (live recombinant)
Danish: Aviær infektiøs laryngotrakeitis og Mareks sygdom vaccine (levende, rekombinant)
English: When Innovax-ILT is given to chickens, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når Innovax-ILT gives til kyllinger, registrerer dyrenes immunsystem virusset som "fremmet" og reagerer ved at danne antistoffer mod det.
English: Innovax-ILT is a veterinary vaccine used to protect chickens against infectious laryngotracheitis (ILT) and Marek's disease (MD).
Danish: Innovax-ILT er en veterinær vaccine til beskyttelse af kyllinger mod infektiøs laryngotrakeitis (ILT) og Mareks sygdom (MD).
English: Innovax-ILT contains live turkey herpesvirus strain HVT/ILT-138.
Danish: Innovax-ILT indeholder levende kalkunherpesvirus af stamme HVT/ILT-138.
English: Protection against MD starts 9 days after vaccination and lasts for life.
Danish: Beskyttelsen mod MD begynder i 9 dage efter vaccinationen og er varig.
English: MD is another herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs.
Danish: MD (Mareks sygdom) er en anden herpesvirusinfektion hos kyllinger, som kan medføre lammelser af vinger og ben og forårsager tumorer i forskellige organer.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Innovax-ILT, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Innovax-ILT, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Why is Innovax-ILT approved?
Danish: Hvorfor er Innovax-ILT blevet godkendt?
English: When Innovax-ILT was applied mixed with Nobilis Rismavac, the start of protection against ILT was delayed by up to 10 weeks after vaccination.
Danish: Når Innovax-ILT blev anvendt blandet med Nobilis Rismavac, blev begyndelsen af beskyttelsen mod ILT forsinket med op til 10 uger efter vaccinationen.
English: Innovax-ILT is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Danish: Innovax-ILT fås som en suspension med solvens, hvoraf der fremstilles en suspension til injektion.
English: ILT is an infection of the airways which may affect growth and decrease egg production in chickens.
Danish: ILT (infektiøs laryngotrakeitis) er en luftvejsinfektion, der kan påvirke væksten og nedsætte ægproduktionen hos kyllinger.
English: What are the risks associated with Innovax-ILT?
Danish: Hvilke risici er der forbundet med Innovax-ILT?
English: Birds infected with MD virus can be carriers and shedders of the virus for life.
Danish: Fugle, der er smittet med MD-virus, kan bære og udskille virusset for livstid.
English: When Innovax-ILT is given mixed with Nobilis Rismavac protection against MD starts at 5 days after vaccination.
Danish: Når Innovax-ILT gives blandet med Nobilis Rismavac, begynder beskyttelsen mod MD 5 dage efter vaccinationen.
English: To evaluate the effects of the vaccine against MD, chickens vaccinated either with Innovax-ILT alone or Innovax-ILT mixed with Nobilis Rismavac (a vaccine which also protects against Marek's disease) were infected with very virulent strains of the MD virus.
Danish: For at vurdere vaccinens virkning mod MD blev kyllinger, der var vaccineret med Innovax-ILT alene eller med Innovax-ILT, blandet med Nobilis Rismavac (en vaccine, der også beskytter mod Mareks sygdom), smittet med meget smittefarlige stammer af MD-virusset.
English: In a second challenge study the effectiveness of the vaccination with Innovax-ILT alone and InnovaxILT mixed with Nobilis Rismavac was also examined by evaluation of protection after infection under laboratory conditions with the ILT virus.
Danish: I endnu en belastningsundersøgelse blev virkningen af vaccination med Innovax-ILT alene og InnovaxILT blandet med Nobilis Rismavac også undersøgt ved at vurdere beskyttelsen efter infektion med ILTvirus under laboratorieforhold.
English: How is Innovax-ILT used?
Danish: Hvordan anvendes Innovax-ILT?
English: For more information about treatment with Innovax-ILT, 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 Innovax-ILT, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Chickens showed varying levels of protection after vaccination with either Innovax-ILT alone or Innovax-ILT mixed with Nobilis Rismavac.
Danish: Kyllingerne udviste varierende beskyttelse efter vaccination med enten Innovax-ILT alene eller med Innovax-ILT blandet med Nobilis Rismavac.
English: Chickens showed significant protection after both vaccination with Innovax-ILT alone and Innovax-ILT mixed with Nobilis Rismavac.
Danish: Kyllingerne udviste betydelig beskyttelse efter vaccination både med Innovax-ILT alene og med Innovax-ILT blandet med Nobilis Rismavac.
English: For practical information about using Innovax-ILT, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer af eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af InnovaxILT, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: What benefits of Innovax-ILT have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Innovax-ILT?
English: How does Innovax-ILT work?
Danish: Hvordan virker Innovax-ILT?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trobalt on 28 March 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Trobalt den 28. marts 2011.
English: It is available as tablets (50, 100, 200, 300 and 400 mg).
Danish: Det fås som tabletter (50, 100, 200, 300 og 400 mg).
English: The full EPAR for Trobalt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Trobalt findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Trobalt.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Trobalt.
English: Trobalt retigabine
Danish: Trobalt retigabin
English: Other information about Trobalt
Danish: Andre oplysninger om Trobalt
English: It is used in epilepsy with or without ‘secondary generalisation' (when the excessive electrical activity reaches the whole brain).
Danish: Det anvendes ved epilepsi med eller uden "sekundær generalisering" (når den overdrevne elektriske aktivitet når hele hjernen).
English: This will stop further transmission of electrical impulses thereby preventing epileptic seizures.
Danish: Dette standser yderligere overførsel af elektriske impulser, hvorved epileptiske anfald forebygges.
English: These are pores that let potassium move in and out of the cell and play a role in terminating electrical impulses.
Danish: Disse er porer, som lader kalium bevæge sig ind og ud af cellen og spiller en rolle, når de elektriske impulser skal bringes til ophør.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Trobalt.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Trobalt.
English: Lower doses should be used in older patients and in patients with moderate or severe liver or kidney problems.
Danish: Der bør anvendes lavere doser til ældre patienter og til patienter med moderate eller svære lever- eller nyresygdomme.
English: However, because of the risk of retinal discolouration, which could possibly result in impaired vision, the CHMP concluded that the use of Trobalt should be restricted only to those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated.
Danish: Men på grund af risikoen for misfarvning af nethinden, hvilket muligvis kunne føre til nedsat synsevne, konkluderede CHMP, at anvendelsen af Trobalt skulle begrænses til udelukkende at gælde de patienter, for hvem andre antiepileptika havde vist sig utilstrækkelige eller ikke var blevet tolereret.
English: In the other two studies, the main measure of effectiveness was the number of patients whose number of seizures was at least halved.
Danish: I de to øvrige undersøgelser blev virkningen hovedsagelig målt på antallet af patienter, for hvem antallet af anfald blev mindst halveret.
English: In the first study, the main measure of effectiveness was the change in the number of seizures per month.
Danish: I den første undersøgelse blev virkningen hovedsagelig målt på ændringen i antallet af anfald pr. måned.
English: Trobalt was more effective than placebo in reducing the number of seizures.
Danish: Trobalt var mere effektivt end placebo til at mindske antallet af anfald.
English: The CHMP noted that Trobalt is effective at reducing the number of seizures.
Danish: CHMP bemærkede, at Trobalt er effektivt til at reducere antallet af anfald.
English: The effect of Trobalt at 600 mg a day was inconclusive in this study.
Danish: Effekten af Trobalt i en dosis på 600 mg dagligt gav ikke noget entydigt resultat i denne undersøgelse.
English: The CHMP decided that the benefits of Trobalt are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Trobalt opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The recommended maintenance dose is between 600 mg a day and a maximum of 1,200 mg a day.
Danish: Den anbefalede vedligeholdelsesdosis ligger på mellem 600 mg dagligt og maksimalt 1 200 mg dagligt.
English: What measures are being taken to ensure the safe use of Trobalt?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Trobalt?