FrancophonIA/ELRC3.0 huggingface dataset:
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Danish: Til generaliseret angst er den anbefalede startdosis 30 mg én gang dagligt, men dosis kan sættes op til 60, 90 eller 120 mg afhængigt af virkningen hos patienten.
English: For more information on generic medicines, see the question-and-answer document here.
Danish: Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med spørgsmål og svar her
English: For major depression, the recommended dose of Duloxetine Mylan is 60 mg once a day.
Danish: Til svær depression er den anbefalede dosis af Duloxetine Mylan 60 mg én gang dagligt.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Danish: Ved at blokere for genoptagelsen af neurotransmitterne øger duloxetin mængden af disse neurotransmittere i overgangen mellem nervecellerne og forbedrer derved kommunikationen mellem cellerne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Mylan has been shown to have comparable quality and to be bioequivalent to Cymbalta.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Duloxetine Mylan er af sammenlignelig kvalitet og er bioækvivalent med Cymbalta.
English: Duloxetine Mylan is used to treat adults with the following diseases:
Danish: Duloxetine Mylan anvendes til behandling af voksne med følgende tilstande:
English: For more information about treatment with Duloxetine Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Duloxetine Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Duloxetine Mylan duloxetine
Danish: Duloxetine Mylan duloxetin
English: What are the benefits and risks of Duloxetine Mylan?
Danish: Hvilke fordele og risici er der forbundet med Duloxetine Mylan?
English: In patients who respond to Duloxetine Mylan, treatment should continue for several months, to prevent the disorder coming back.
Danish: For patienter, hos hvem Duloxetine Mylan virker, skal behandlingen fortsætte i flere måneder for at undgå, at sygdommen vender tilbage.
English: What measures are being taken to ensure the safe and effective use of Duloxetine Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Duloxetine Mylan?
English: Therefore, the CHMP's view was that, as for Cymbalta, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Cymbalta.
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day.
Danish: Til smerter forårsaget af sukkersygebetingede nervelidelser er den anbefalede dosis 60 mg dagligt, men nogle patienter kan have behov for en højere dosis på 120 mg dagligt.
English: What is Duloxetine Mylan and what is it used for?
Danish: Hvad er Duloxetine Mylan, og hvad anvendes det til?
English: Other information about Duloxetine Mylan
Danish: Andre oplysninger om Duloxetine Mylan
English: It is not intended to provide practical advice on how to use Duloxetine Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Duloxetine Mylan bør anvendes.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Danish: • smerter ved sukkersygebetingede nervelidelser, der skyldes beskadigelse af nerverne uden for centralnervesystemet (perifer diabetisk neuropati)
English: Because Duloxetine Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cymbalta.
Danish: Da Duloxetine Mylan er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Cymbalta.
English: For practical information about using Duloxetine Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Duloxetine Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Because Duloxetine Mylan is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Duloxetine Mylan er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet Cymbalta.
English: Why is Duloxetine Mylan approved?
Danish: Hvorfor blev Duloxetine Mylan godkendt?
English: The dose of Duloxetine Mylan should be reduced gradually when stopping treatment.
Danish: Ophør af behandlingen bør ske ved gradvis nedsættelse af dosis af Duloxetine Mylan.
English: Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Danish: Ved at blokere for deres genoptagelse i nervecellerne opnås derfor bedring i symptomerne depression, angst og neuropatiske smerter.
English: Duloxetine Mylan contains the active substance duloxetine and is a ‘generic medicine'.
Danish: Duloxetine Mylan er et lægemiddel, der indeholder det aktive stof duloxetin.
English: How has Duloxetine Mylan been studied?
Danish: Hvordan blev Duloxetine Mylan undersøgt?
English: How does Duloxetine Mylan work?
Danish: Hvordan virker Duloxetine Mylan?
English: How is Duloxetine Mylan used?
Danish: Hvordan anvendes Docetaxel Mylan?
English: Vigabatrin should not be used in patients who already have visual field defects.
Danish: Vigabatrin bør ikke anvendes hos patienter, der i forvejen har synsfeltsdefekter.
English: Other common side effects include psychiatric disorders such as agitation, excitedness, aggression, nervousness, depression and paranoid reactions, as well as reduced consciousness and confusion.
Danish: Andre almindelige bivirkninger omfatter psykiske forstyrrelser som f.eks. uro, opstemthed, aggression, nervøsitet, depression og paranoide reaktioner samt reduceret bevidsthed og forvirring.
English: Further information on Kigabeq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Kigabeq findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the effects on vision can lead to blindness, vigabatrin should only be used after careful assessment of possible alternatives, and patients' vision must be regularly tested during treatment.
Danish: Da indvirkningen på synet kan medføre blindhed, bør vigabatrin kun anvendes efter omhyggelig overvejelse af mulige alternativer, og patienternes syn skal tjekkes regelmæssigt under behandlingen.
English: The company provided information from the published literature on the benefits and risks of vigabatrin in the approved uses.
Danish: Virksomheden fremlagde information fra den offentliggjorte litteratur om fordele og risici ved vigabatrin i de godkendte behandlinger.
English: The medicine is available as soluble tablets of 100 or 500 mg, with a score-line so they can be halved.
Danish: Lægemidlet fås som opløselige tabletter a 100 eller 500 mg med en delekærv, så de kan halveres.
English: This helps suppress the abnormal electrical activity that leads to infantile spasms and partial epilepsy, and so controls the symptoms of these conditions.
Danish: Dette medvirker til at undertrykke den unormale elektriske aktivitet, der medfører infantile spasmer og partiel epilepsi, og dermed til at kontrollere symptomerne på disse sygdomme.
English: GABA reduces the electrical activity of the brain.
Danish: GABA mindsker den elektriske aktivitet i hjernen.
English: Kigabeq is a medicine for treating epilepsy in children between 1 month and 7 years of age.
Danish: Kigabeq er et lægemiddel til behandling af epilepsi hos børn i alderen 1 måned til 7 år.
English: • together with other medicines to treat partial epilepsy (seizures affecting one part of the brain), including when the seizures spread to other parts of the brain and become more generalised.
Danish: • sammen med andre lægemidler for at behandle partiel epilepsi (krampeanfald, der kun rammer en del af hjernen), herunder når krampeanfaldene spreder sig til andre dele af hjernen og bliver mere generaliserede.
English: The dose depends on the condition being treated and the patient's body weight, and is adjusted according to the patient's response to treatment.
Danish: Dosen afhænger af den sygdom, der skal behandles, og patientens legemsvægt, og den tilpasses til patientens respons på behandlingen.
English: Kigabeq is only used in partial epilepsy when patients have already tried all other appropriate treatments or cannot use them because of side effects.
Danish: Kigabeq anvendes kun til behandling af partiel epilepsi, når patienterne allerede har forsøgt alle andre relevante behandlinger, eller når de ikke kan anvende dem på grund af bivirkninger.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Kigabeq is available in a different form and strengths.
Danish: Det vil sige, at det svarer til et "referencelægemiddel", der indeholder samme aktive stof, men Kigabeq fås i en anden form og i andre styrker.
English: The reference medicine for Kigabeq is Sabril (500 mg granules).
Danish: Referencelægemidlet for Kigabeq er Sabril (500 mg granulat).
English: Side effects reported with Kigabeq are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Kigabeq vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: The tablets are dissolved in water to make a solution for the patient to drink.
Danish: Tabletterne opløses i vand for at opnå en opløsning, som patienten skal drikke.
English: For more information about using Kigabeq, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Kigabeq, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Other information about Kigabeq
Danish: Andre oplysninger om Kigabeq
English: What measures are being taken to ensure the safe and effective use of Kigabeq?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kigabeq?
English: • on its own to treat infantile spasms (West syndrome), a rare epilepsy disorder that starts at a very young age, usually in the first few months of life;
Danish: • alene ved behandling af infantile spasmer (Wests syndrom), der er en sjælden sygdom, som starter i en meget tidlig alder, typisk i løbet af de første måneder efter fødslen
English: The most common side effects with vigabatrin (which may affect more than 1 in 10 people) are visual field defects (effects on vision), tiredness, sleepiness and joint pains.
Danish: De hyppigste bivirkninger ved vigabatrin (der forekommer hos mere end 1 ud af 10 patienter) er synsfeltsdefekter, træthed, søvnighed og ledsmerter.
English: As for all medicines, data on the use of Kigabeq are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Kigabeq løbende overvåget.
English: Blocking the enzyme that breaks it down increases the amount of GABA present in the brain, and so increases its effect.
Danish: Blokeringen af enzymet medfører en stigning i mængden af GABA i hjernen, og det øger dets virkning.
English: The active substance in Kigabeq, vigabatrin, blocks the action of an enzyme called GABA transaminase, which breaks down a substance in the brain called GABA (gamma aminobutyric acid).
Danish: Det aktive stof i Kigabeq, vigabatrin, blokerer virkningen af et enzym, der hedder GABA-transaminase, og som nedbryder et stof i hjernen, der kaldes GABA (gammaaminosmørsyre).
English: An overview of Kigabeq and why it is authorised in the EU
Danish: En oversigt over Kigabeq, og hvorfor det er godkendt i EU
English: Kigabeq contains the active substance vigabatrin and is a ‘hybrid medicine'.
Danish: Kigabeq indeholder det aktive stof vigabatrin og er et "hybridt lægemiddel".
English: The European Medicines Agency decided that in accordance with EU requirements, Kigabeq has been shown to have comparable quality and to be bioequivalent to Sabril.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Kigabeq er af sammenlignelig kvalitet og er bioækvivalent med Sabril.
English: Kigabeq can only be obtained with a prescription and treatment must started and supervised by a doctor specialising in the treatment of epilepsy or nervous system disorders.
Danish: Kigabeq udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af epilepsi eller sygdomme i nervesystemet.
English: In patients who cannot drink it can be given by a tube into the stomach.
Danish: Patienter, der ikke kan drikke opløsningen, kan få den administreret ved hjælp af en sonde i maven.
English: Rarely there may be effects on the retina (the light-sensing layer at the back of the eye), encephalopathy (brain damage) or attempts at suicide.
Danish: Der ses i sjældne tilfælde påvirkning af nethinden (det lysfølsomme væv bagerst i øjet), hjerneskade (encefalopati) og selvmordsforsøg.
English: Why is Kigabeq authorised in the EU?
Danish: Hvorfor blev Kigabeq godkendt i EU?
English: As for every medicine, the company provided studies on the quality of Kigabeq.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Kigabeq.
English: Therefore, the Agency's view was that, as for Sabril, Kigabeq's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Kigabeq opvejer risiciene, som for Sabril, og at det kan godkendes til anvendelse i EU.
English: What is Kigabeq and what is it used for?
Danish: Hvad er Kigabeq, og hvad anvendes det til?
English: It is used in the following ways:
Danish: Kigabeq anvendes på følgende måder:
English: What are the risks associated with Kigabeq?
Danish: Hvilke risici er der forbundet med Kigabeq?
English: For the full list of side effects and restrictions with Kigabeq, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Kigabeq fremgår af indlægssedlen.
English: It also carried out a study that showed that Kigabeq is bioequivalent to the reference medicine, Sabril.
Danish: Virksomheden gennemførte også et studie, der viste, at lægemidlet er bioækvivalent med referencelægemidlet (Sabril).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kigabeq have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Kigabeq.
English: How is Kigabeq used?
Danish: Hvordan anvendes Kigabeq?
English: How does Kigabeq work?
Danish: Hvordan virker Kigabeq?
English: What benefits of Kigabeq have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Kigabeq?
English: This summary was last updated on 05/08/2011.
Danish: Dette sammendrag blev sidst ajourført den 05/08/2011.
English: The horses should be revaccinated every year.
Danish: Hestene skal revaccineres hvert år.
English: They may also have a temporary swelling at the injection site which usually disappears within four days.
Danish: De kan også få en midlertidig hævelse på injektionsstedet, som normalt forsvinder inden for fire dage.
English: Protection starts four weeks after the first injection and lasts for a year.
Danish: Beskyttelsen indtræder fire uger efter den første injektion og varer et år.
English: In all studies the vaccinated horses were compared with horses that were not vaccinated.
Danish: I alle undersøgelserne blev de vaccinerede heste sammenlignet med heste, der ikke var vaccineret.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Proteq West Nile to MERIAL on 05/08/2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Proteq West Nile til MERIAL den 05/08/2011.
English: The first injection is given from five months of age and the second injection is given four to six weeks later.
Danish: Den første injektion gives, når dyret er fem måneder gammelt, og den anden injektion gives fire til seks uger senere.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum, eller æg og mælk kan anvendes til menneskeligt konsum.
English: The vaccine also contains an ‘adjuvant' to enhance the immune response.
Danish: Vaccinen indeholder desuden et "adjuvans", som giver en bedre immunrespons.
English: If someone accidentally injects themselves with the medicine, the person should seek medical advice immediately and show the package leaflet or label to the doctor.
Danish: Hvis en person ved et uheld kommer til at injicere sig selv med medicinen, skal personen straks søge læge, og indlægssedlen eller etiketten skal medbringes og vises til lægen.
English: The vaccine is given to young horses as two injections into the neck muscles.
Danish: Vaccinen gives til unge heste som to injektioner i nakkemusklerne.
English: Horses vaccinated with Proteq West Nile may have a slightly raised body temperature (up to 1.5°C) lasting up to two days.
Danish: Heste, der er vaccineret med Proteq West Nile, kan have en lettere forhøjet kropstemperatur (op til 1,5° C) i op til to dage.
English: Proteq West Nile is a vaccine.
Danish: Proteq West Nile er en vaccine.
English: It is available as a suspension for injection.
Danish: Den findes som injektionsvæske, suspension.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to West Nile virus, and this helps to protect against mortality due to West Nile disease.
Danish: Fremover vil immunsystemet kunne producere antistoffer hurtigere, når det udsættes for West Nile-virus, og dette hjælper med at beskytte mod dødsfald som følge af sygdommen West Nile.
English: The vaccine was tested in nine laboratory studies in horses from five months of age.
Danish: Vaccinen blev testet hos heste fra femmånedsalderen i ni laboratorieundersøgelser.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Danish: Risk/benefit-forholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: West Nile recombinant canarypox virus (vCP2017 virus)
Danish: West Nile rekombinant canarypox-virus (vCP2017-virus)
English: Other information about Proteq West Nile:
Danish: Andre oplysninger om Proteq West Nile:
English: When a horse is given the vaccine, the immune system recognises the West Nile proteins PreM and E as ‘foreign' and makes antibodies against it.
Danish: Når en hest bliver vaccineret, genkender immunsystemet West Nile-proteinerne PreM og E som "fremmede" og danner antistoffer mod dem.
English: The studies showed that the vaccine prevents viraemia in horses and reduces clinical signs in horses infected with West Nile virus.
Danish: Undersøgelserne viste, at vaccinen forebygger viræmi hos heste og reducerer de kliniske tegn hos heste, der er inficeret med West Nile-virus.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that Proteq West Nile is generally well tolerated and useful in reducing clinical outbreaks of West Nile disease.
Danish: Udvalget for Veterinærlægemidler (CVMP) vurderede, at Proteq West Nile generelt er veltålt og nyttigt til reducering af kliniske udbrud af sygdommen West Nile.
English: Proteq West Nile is used to protect horses from 5 months of age against West Nile disease.
Danish: Proteq West Nile anvendes til at beskytte heste fra femmånedsalderen mod sygdommen West Nile.
English: The main measure of effectiveness was based on the number of horses who had viraemia or clinical signs of West Nile disease.
Danish: De primære effektmål var baseret på antallet af heste, som havde viræmi eller kliniske tegn på sygdommen West Nile.
English: The vaccine strain vCP2017 in Proteq West Nile is a ‘carrier' canarypox virus that has been given a gene that makes it able to produce part of the West Nile virus, the proteins PreM and E. The canarypox viruses do not spread or multiply in the vaccinated horses.
Danish: Vaccinestammen vCP2017 i Proteq West Nile er en canarypox-virus, der fungerer som ”bærer”, og som har fået et gen, der sætter den i stand til at producere den del af West Nile-virussen, der består af proteinerne PreM og E. Canarypox-virussen spreder sig ikke og deler sig ikke hos de vaccinerede heste.
English: The CVMP therefore concluded that the benefits of Proteq West Nile exceed the risks for the vaccination of horses from 5 months of age against West Nile disease and recommended that Proteq West Nile be given a marketing authorisation.
Danish: CVMP konkluderede derfor, at fordelene ved Proteq West Nile var større end risiciene, når heste vaccineres mod sygdommen West Nile fra femmånedsalderen, og anbefalede udstedelse af markedsføringstilladelse for Protec West Nile.
English: For a full list of the side-effects reported with Proteq West Nile, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Proteq West Nile fremgår af indlægssedlen.
English: Proteq West Nile is a vaccine that contains West Nile recombinant canarypox virus (vCP2017 virus).
Danish: Proteq West Nile er en vaccine, der indeholder den rekombinante canarypox-virus West Nile (vCP2017virus).
English: What is the risk associated with Proteq West Nile?
Danish: Hvilken risiko er der forbundet med Proteq West Nile?
English: Why has Proteq West Nile been approved?
Danish: Hvorfor blev Proteq West Nile godkendt?
English: West Nile disease is a mosquito-borne viral disease that can cause encephalitis (inflammation of the brain) and meningitis (inflammation of the lining of the brain and spinal cord).The vaccine is used to reduce the number of horses with the West Nile virus in their blood (viraemia) or with clinical signs of the disease.
Danish: West Nile er en virussygdom, som overføres af myg og kan forårsage encefalitis (betændelse i hjernen) og meningitis (betændelse i hjernehinden og rygmarven).
English: What is Proteq West Nile?
Danish: Hvad er Proteq West Nile?
English: How has Proteq West Nile been studied?
Danish: Hvordan blev Proteq West Nile undersøgt?
English: What is Proteq West Nile used for?
Danish: Hvad anvendes Proteq West Nile til?
English: What benefit has Proteq West Nile shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Proteq West Nile?
English: How does Proteq West Nile work?
Danish: Hvordan virker Proteq West Nile?
English: Note: P values in the table are nominal.
Danish: Bemærk: P-værdierne i tabellen er nominelle.
English: (See the end of section 2 - Important information about the contents of Orkambi.)
Danish: (Se sidst i punkt 2 - Vigtige oplysninger om indholdet af Orkambi).
English: As such, risks to the suckling child cannot be excluded.
Danish: Som sådan kan en risiko for det ammende barn ikke udelukkes.