FrancophonIA/ELRC3.0 huggingface dataset:
English: TRIBUTE was a 52-week activecontrolled study comparing Trydonis with a fixed combination of indacaterol/glycopyrronium 85/43 micrograms inhalation powder, hard capsule, one inhalation once daily (1,532 randomised patients).
Danish: TRIBUTE var et 52-ugers aktivt kontrolleret studie, der sammenlignede Trydonis med en fastdosiskombination af indacaterol/glycopyrronium 85/43 mikrogram inhalationspulver, hård kapsel, en inhalation én gang dagligt (1.532 randomiserede patienter).
English: Study TRILOGY compared Trydonis with a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily (1,368 randomised patients).
Danish: TRILOGY-studiet sammenlignede Trydonis med en fastdosiskombination af beclometasondipropionat og formoterol 100/6 mikrogram givet som to inhalationer to gange dagligt (1.368 randomiserede patienter).
English: In patients with severe hepatic impairment, Trydonis should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Danish: Hos patienter med svært nedsat leverfunktion må Trydonis kun anvendes, hvis den forventede fordel opvejer den mulige risiko (se pkt.
English: Use of Trydonis in patients with severe renal impairment or end-stage renal disease requiring dialysis, especially if associated with significant body weight reduction, should be considered only if the expected benefit outweighs the potential risk (see section 4.4 and section 5.2).
Danish: Anvendelsen af Trydonis til patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet der kræver dialyse, især hvis det er forbundet med en signifikant vægttab, bør kun overvejes, hvis den forventede fordel opvejer den mulige risiko (se pkt.
English: Compared with tiotropium, Trydonis improved pre-dose FEV1 by 51 mL after 26 weeks of treatment and by 61 mL after 52 weeks of treatment.
Danish: Sammenlignet med tiotropium forbedrede Trydonis FEV1 før dosering med 51 ml efter 26 ugers behandling og med 61 ml efter 52 ugers behandling.
English: TRISTAR was a 26-week active-controlled open label study comparing Trydonis with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Danish: TRISTAR var et 26-ugers, åbent, aktivt kontrolleret studie, der sammenlignede Trydonis med en ekstemporær kombination bestående af en fastdosiskombination af fluticason/vilanterol 92/22 mikrogram inhalationspulver, en inhalation én gang dagligt plus tiotropium 18 mikrogram inhalationspulver, hård kapsel, en inhalation én gang dagligt (1.157 randomiserede patienter).
English: Other medicines and Trydonis
Danish: Brug af anden medicin sammen med Trydonis
English: How to use Trydonis
Danish: Sådan skal du bruge Trydonis
English: Additionally, due to the anticholinergic effect of glycopyrronium, the long-term co-administration of Trydonis with other anticholinergic-containing medicinal products is not recommended (see section 4.5).
Danish: Desuden bør en langvarig administration af Trydonis sammen med andre lægemidler, der indeholder antikolinergika, ikke anvendes, på grund af den antikolinerge virkning af glycopyrronium (se pkt.
English: Compared with a fixed combination of indacaterol and glycopyrronium, Trydonis reduced the rate of moderate/severe exacerbations over 52 weeks by 15% (rate: 0.50 versus 0.59 events per patient/year; p = 0.043).
Danish: Sammenlignet med en fastdosiskombination af indacaterol og glycopyrronium nedsatte Trydonis hyppigheden af moderate/svære eksacerbationer i løbet af 52 uger med 15 % (hyppighed: 0,50 versus 0,59 hændelser pr. patient/år, p = 0,043).
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trydonis significantly improved 2-hour post dose FEV1 by 117 mL after 26 weeks of treatment and by 103 mL after 52 weeks of treatment (p < 0.001).
Danish: Sammenlignet med en fast kombination af beclometasondipropionat og formoterol forbedrede Trydonis FEV1 2-timer efter dosering med 117 ml efter 26 ugers behandling, og med 103 ml efter 52 ugers behandling (p < 0,001).
English: Trydonis 87/5/9 micrograms pressurised inhalation beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium Inhalation use
Danish: Trydonis 87/5/9 mikrogram inhalationsspray beclometasoni dipropionas/formoteroli fumaras dihydricus/glycopyrronium Til inhalation
English: Compared with tiotropium, Trydonis reduced the rate of moderate/severe exacerbations over 52 weeks by 20% (rate: 0.46 versus 0.57 events per patient/year; p = 0.003).
Danish: Sammenlignet med tiotropium nedsatte Trydonis hyppigheden af moderate/svære eksacerbationer i løbet af 52 uger med 20 % (hyppighed: 0,46 versus 0,57 hændelser pr. patient/år, p = 0,003).
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trydonis improved pre-dose FEV1 by 81 mL after 26 weeks of treatment and by 63 mL after 52 weeks of treatment.
Danish: Sammenlignet med en fast kombination af beclometasondipropionat og formoterol forbedrede Trydonis FEV1 før dosering med 81 ml efter 26 ugers behandling og med 63 ml efter 52 ugers behandling.
English: Package leaflet: Information for the user Trydonis 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Danish: Indlægsseddel: Information til brugeren Trydonis 87 mikrogram/5 mikrogram/9 mikrogram inhalationsspray, opløsning beclometasondipropionat/formoterolfumaratdihydrat/glycopyrronium (beclometasoni dipropionas/formoteroli fumaras dihydricus/glycopyrronium)
English: Trydonis 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Danish: Trydonis 87/5/9 mikrogram inhalationsspray, opløsning beclometasoni dipropionas/formoteroli fumaras dihydricus/glycopyrronium
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trydonis reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005).
Danish: Sammenlignet med en fastdosiskombination af beclometasondipropionat og formoterol nedsatte Trydonis hyppigheden af moderate/svære eksacerbationer i løbet af 52 uger med 23 % (hyppighed: 0,41 versus 0,53 hændelser pr. patient/år, p = 0,005).
English: The daily dose of Trydonis corresponds to a medium dose of inhaled corticosteroid; furthermore, these effects are much less likely to occur than with oral corticosteroids.
Danish: Den daglige dosis af Trydonis svarer til en medium dosis af inhaleret kortikosteroid.
English: Compared with tiotropium, Trydonis also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017).
Danish: moderate eksacerbationer) med 32 % (hyppighed: 0,067 versus 0,098 hændelser pr. patient/år, p = 0,017).
English: Study TRINITY compared Trydonis with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients).
Danish: Desuden blev virkningerne sammenlignet med en ekstemporær trippelkombination, der bestod af en fast kombination af to inhalationer af beclometasondipropionat og formoterol 100/6 mikrogram to gange dagligt plus tiotropium 18 mikrogram inhalationspulver, hård kapsel, en inhalation én gang dagligt (2.691 randomiserede patienter).
English: What Trydonis is and what it is used for What you need to know before you use Trydonis How to use Trydonis
Danish: Det skal du vide, før du begynder at bruge Trydonis Sådan skal du bruge Trydonis Bivirkninger
English: What Trydonis looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Tell your doctor if you have any of the following while using Trydonis as they could be symptoms of a lung infection (may affect up to 1 in 10 people):
Danish: De kan være tegn på lungebetændelse (kan forekomme hos op til 1 ud af 10 personer):
English: The European Commission granted a marketing authorisation valid throughout the European Union for Matever on 03 October 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Matever den 03. oktober 2011.
English: Other information about Matever
Danish: Andre oplysninger om Matever
English: The full EPAR for Matever can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Matever findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Secondary generalisation occurs when the overactivity later reaches the whole brain.
Danish: Sekundær generalisering forekommer, når denne overaktivitet senere breder sig til hele hjernen.
English: This is a summary of the European public assessment report (EPAR) for Matever.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Matever.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Danish: Det er stadig uklart, hvordan levetiracetam præcis virker, men det synes at gribe ind i funktionen af et protein kaldet synaptisk vesikelprotein 2A, som findes i mellemrummene mellem nerverne og er involveret i frigivelsen af kemiske signalstoffer fra nervecellerne.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Danish: Det er en form for epilepsi, hvor en for stærk elektrisk aktivitet i den ene side af hjernen medfører symptomer som pludselige stødvise bevægelser af en del af kroppen, forvrænget hørelse, lugtesans eller syn, følelsesløshed eller pludselig angst.
English: Matever is a ‘generic medicine'.
Danish: Matever er et "generisk lægemiddel".
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 Matever.
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, hvordan Matever skal anvendes.
English: Matever tablets are swallowed with liquid.
Danish: Matever tabletter synkes med væske.
English: This helps Matever to stabilise electrical activity in the brain and prevent seizures.
Danish: Det er med til at bevirke, at Matever kan stabilisere den elektriske aktivitet i hjernen og forhindre anfald.
English: For more information about treatment with Matever, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Matever, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Lower doses are used in patients who have problems with their kidneys (such as older patients).
Danish: Der anvendes lavere doser til patienter, som har nyreproblemer (f.eks. ældre patienter).
English: This means that Matever is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Danish: Det betyder, at Matever er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Keppra.
English: The active substance in Matever, levetiracetam, is an anti-epileptic medicine.
Danish: Det aktive stof i Matever, levetiracetam, er et antiepileptikum.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1000 mg) and as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Danish: Det fås som tabletter (250 mg, 500 mg, 750 mg og 1000 mg) og som et koncentrat, der anvendes til at fremstille en infusionsvæske, opløsning (drop i en vene, 100 mg/ml).
English: • partial-onset seizures with or without generalisation in patients from one month of age;
Danish: • partielle anfald med eller uden generalisering hos patienter, der er over 1 måned gamle
English: What are the benefits and risks of Matever?
Danish: Hvilken fordel og risiko er der forbundet med Matever?
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Danish: • primære generaliserede tonisk-kloniske anfald (alvorlige krampeanfald, herunder med bevidsthedstab) hos patienter over 12 år med idiopatisk generaliseret epilepsi (den type epilepsi, som menes at have en genetisk årsag).
English: The Committee recommended that Matever be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Matever.
English: Matever can also be used as an add-on to other anti-epileptic medicines to treat:
Danish: Matever kan også anvendes som en tillægsbehandling til andre antiepileptika til behandling af:
English: Matever can be given as an infusion using the same doses at the same frequency when using the tablets or the oral solution is not possible.
Danish: Matever kan gives som en infusion i samme doser og med samme hyppighed, når det ikke er muligt at anvende tabletterne eller den orale opløsning.
English: Matever is a medicine that contains the active substance levetiracetam.
Danish: Matever er et lægemiddel, der indeholder det aktive stof levetiracetam.
English: Because Matever 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: Eftersom Matever er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som referencelægemidlets.
English: Matever can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Danish: Matever kan anvendes alene til patienter over 16 år med nydiagnosticeret epilepsi til behandling af partielle anfald med eller uden sekundær generalisering.
English: The CHMP concluded that, in accordance with EU requirements, Matever has been shown to have comparable quality and to be bioequivalent to Keppra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Matever er af sammenlignelig kvalitet og er bioækvivalent/sammenlignelig med Keppra.
English: Because Matever is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Danish: Eftersom Matever er et generisk lægemiddel, har undersøgelserne hos patienter været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet, Keppra.
English: Why has Matever been approved?
Danish: Hvorfor er Matever blevet godkendt?
English: In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Danish: Til patienter mellem seks måneder og 17 år, som vejer under 50 kg, er startdosis 10 mg pr. kg legemsvægt to gange dagligt, og den kan øges til 30 mg/kg to gange dagligt.
English: The daily dose can be increased up to 1500 mg twice a day.
Danish: Den daglige dosis kan øges til op til 1.500 mg to gange dagligt.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Danish: • myoklone anfald (kortvarige, rykvise trækninger i en muskel eller muskelgruppe) hos patienter over 12 år med juvenil myoklon epilepsi
English: What is Matever?
Danish: Hvad er Matever?
English: When Matever is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Danish: Når Matever anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
English: When Matever is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Danish: Når Matever anvendes som tillægsbehandling til en anden behandling med antiepileptika, er startdosis hos patienter over 12 år, som vejer mere end 50 kg, 500 mg to gange dagligt.
English: What is Matever used for?
Danish: Hvad anvendes Matever til?
English: How has Matever been studied?
Danish: Hvordan er Matever blevet undersøgt?
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1500 mg twice a day.
Danish: Dosis kan alt efter patientens respons sættes yderligere op hver anden uge til en maksimal dosis på 1.500 mg to gange dagligt.
English: How is Matever used?
Danish: Hvordan anvendes Matever?
English: How does Matever work?
Danish: Hvordan virker Matever?
English: This summary was last updated on 16 April 2009.
Danish: Dette sammendrag blev sidst ajourført den 16. april 2009.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Netvax to Intervet International B.V. on 16 April 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Netwax til Intervet International BV den 16. april 2009.
English: Other information about Netvax:
Danish: Andre oplysninger om Netwax:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NETVAX EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) NETVAX EPAR sammendrag for offentligheden
English: Netvax is a vaccine.
Danish: Netwax er en vaccine.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare sig mod sygdomme.
English: The vaccination schedule consists of two doses: the first dose is given at 10 to 14 weeks of age, and then a second dose is given four to 10 weeks after the first.
Danish: Vaccinationsplanen består af to doser: Den første vaccination gives i 10-14 ugers alderen, og den anden vaccination gives fire til 10 uger efter den første.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Danish: Hvilke foranstaltninger skal der træffes af den, der giver medicinen eller kommer i berøring med dyret?
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysninger om udleveringsbestemmelser for dette produkt findes på etiketten/emballagen.
English: Swelling after the first vaccination normally resolves within 30 days, and may last at least 35 days following the second vaccination.
Danish: Hævelsen efter den første vaccination forsvinder normalt inden for 30 dage, og den kan vare mindst 35 dage efter den anden vaccination.
English: The vaccine protected the chicks during the early period of life, when they are at greatest risk of the disease.
Danish: Vaccinen beskyttede kyllingerne i den tidlige del af livet, hvor de er udsat for den største risiko for at blive ramt af sygdommen.
English: The hen can continue to pass on immunity to her chicks for almost a year after the end of vaccination.
Danish: Hønen kan fortsætte med at videregive sin immunitet til kyllingerne i næsten et år efter den sidste vaccination.
English: Vaccination causes swelling at the site of injection.
Danish: Vaccinen forårsager hævelse på injektionsstedet.
English: The effectiveness of Netvax has been studied in several trials under laboratory and field conditions in chickens and their chicks.
Danish: Virkningen af Netwax er blevet undersøgt i flere undersøgelser under laboratorie- og feltbetingelser hos kyllinger og deres kyllinger.
English: The studies compared chickens vaccinated with Netvax with birds that did not receive the vaccine.
Danish: I undersøgelserne sammenlignedes kyllinger vaccineret med Netwax med fugle, der ikke modtog vaccinen.
English: This second dose should be given at least six weeks before the hen will start to lay eggs.
Danish: Det anbefales at den anden vaccination bliver givet mindst 6 uger, før hønen begynder at lægge æg.
English: Necrotising enteritis is a disease that causes damage to the gut.
Danish: Nekrotisk enteritis er en sygdom, der forårsager skader på tarmen.
English: Accidental injection of Netvax can cause severe pain and swelling, particularly if it is accidentally injected into a joint or finger.
Danish: Uforsætlig injektion med Netwax kan medføre alvorlige smerter og hævelser, navnlig ved uforsætlig injektion i led eller fingre.
English: What is the risk associated with Netvax?
Danish: Hvilke risici er der forbundet med Netwax?
English: The vaccine was well tolerated by the chickens, with no effect on the production of eggs or chicks.
Danish: Vaccinen tolereres godt af kyllingerne og har ingen virkning på produktionen af æg eller kyllinger.
English: Why has Netvax been approved?
Danish: Hvorfor blev Netwax godkendt?
English: Birds with the disease fail to thrive.
Danish: Fugle, der er ramt af sygdommen, trives ikke.
English: Netvax is used to reduce the number of deaths, and the incidence and severity of the disease.
Danish: Netwax anvendes til at nedbringe dødeligheden og forekomsten og alvoren af sygdommen.
English: The vaccine also contains an ‘adjuvant' (mineral oil) to stimulate a better response.
Danish: Vaccinen indeholder desuden et "adjuvans" (mineralsk olie), der forstærker immunresponset.
English: The studies showed that the vaccine is effective in stimulating the production of antibodies in chickens and in their eggs.
Danish: Undersøgelserne viste, at vaccinen er effektiv til at stimulere produktionen af antistoffer hos kyllinger og deres æg.
English: Netvax is given by injection into the breast muscle.
Danish: Netwax indgives ved injektion i en brystmuskel.
English: If accidental injection happens, seek prompt medical advice and show the package leaflet to the doctor.
Danish: I tilfælde af uforsætlig injektion søges straks lægehjælp, og indlægssedlen skal vises til lægen.
English: What is Netvax used for?
Danish: Hvad anvendes Netwax til?
English: The main measure of effectiveness was the production of protective antibodies against C. perfringens type A in the chickens' blood and in their eggs.
Danish: Det primære effektmål var produktionen af beskyttende niveauer af antistoffer over for C. perfringens i kyllingernes blod og i deres æg.
English: Netvax is a vaccine that contains a toxoid (a weakened toxin) from the bacterium Clostridium perfringens (C. perfringens) type A. The vaccine is an emulsion (a mixture of oil- and water-based liquids) for injection.
Danish: Netwax er en vaccine, der indeholder et toksoid (et svækket toksin) fra bakterien Clostridium perfringens (C. perfringens) type A. Vaccinen er en emulsion (en blanding af olie- og vandbaserede væsker) til injektion.
English: The studies also looked at death rates in the chicks hatched by vaccinated hens, and at the incidence and the severity of lesions caused by necrotic enteritis in the gut after the chicks were deliberately infected with the bacterium at three weeks of age.
Danish: Undersøgelserne så ligeledes på dødshyppigheden hos kyllinger fra æg lagt af vaccinerede høner og forekomsten og alvoren af skader forårsaget af nekrotisk enteritis i tarmen, efter at kyllingerne forsætligt blev inficeret med bakterien, da de var tre uger.