FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used when treatment with artificial tears (tear substitutes) is insufficient to improve the condition.
Danish: Det anvendes, når behandling med kunstige tårer (tåresubstitution) ikke er tilstrækkelig til at give bedring.
English: These symptoms are usually short lasting and occur at the time the eye drops are used.
Danish: Disse symptomer er sædvanligvis kortvarige og optræder på det tidspunkt, hvor øjendråberne bruges.
English: If other eye drops are used, the different medicines must be given at least 15 minutes apart.
Danish: Hvis der anvendes andre øjendråber, skal der være mindst 15 minutters mellemrum mellem anvendelsen af de forskellige lægemidler.
English: Ikervis contains the active substance ciclosporin.
Danish: Ikervis indeholder det aktive stof ciclosporin.
English: Regarding safety, the medicine was well tolerated, with mainly short-lasting effects on the eye at the time the eye drops are used; the risk of effects on the body as a whole was considered to be low.
Danish: Vedrørende sikkerheden var lægemidlet veltolereret med hovedsagelig kortvarige virkninger på øjet på anvendelsestidspunktet; risikoen for virkninger på hele kroppen blev anset for lav.
English: What measures are being taken to ensure the safe and effective use of Ikervis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ikervis?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ikervis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Ikervis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The doctor should confirm the need for continuing treatment at least every 6 months.
Danish: Lægen bør mindst hver sjette måned vurdere, om det er nødvendigt at fortsætte behandlingen.
English: Why is Ikervis approved?
Danish: Hvorfor blev Ikervis godkendt?
English: It is not intended to provide practical advice on how to use Ikervis.
Danish: Det er ikke en praktisk vejledning i, hvordan Ikervis bør anvendes.
English: The active substance in Ikervis, ciclosporin, acts on cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Danish: Det aktive stof i Ikervis, ciclosporin, virker på de celler i immunsystemet (kroppens naturlige forsvar), der er inddraget i inflammationsprocesserne.
English: Ikervis can only be obtained with a prescription and treatment should only be started by a healthcare professional trained in ophthalmology (eye medicine).
Danish: Ikervis fås kun på recept, og behandlingen må kun indledes af en sundhedsperson, der er uddannet i øjenmedicin (oftalmologi).
English: What are the risks associated with Ikervis?
Danish: Hvilke risici er der forbundet med Ikervis?
English: The most common side effects with Ikervis (which may affect more than 1 in 10 people) are pain and irritation in the eye; other common side effects are lacrimation (excessive tears), ocular hyperaemia (red eye), and erythema (redness) of the eyelid.
Danish: De hyppigste bivirkninger ved Ikervis (som kan forekomme hos mere end 1 ud af 10 personer) er smerter og irritation i øjet; andre almindelige bivirkninger er tåreflåd, røde øjne (okulær hyperæmi) og rødme (erytem) af øjenlåget.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ikervis, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ikervis, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: The medicine is available as single-dose eye drops and the recommended dose is one drop in each affected eye daily at bedtime.
Danish: Lægemidlet fås som øjendråber til engangsbrug, og den anbefalede dosis er én dråbe dagligt i hvert af de syge øjne ved sengetid.
English: For more information about treatment with Ikervis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ikervis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In patients with dry eye disease, either not enough tear fluid is produced to create the protective film of moisture that normally coats the surface of the eye, or abnormalities in the tear fluid cause it to dry out too quickly.
Danish: Hos patienter med tørre øjne dannes der enten ikke nok tårevæske til at frembringe den beskyttende film af fugt, der normalt dækker øjets overflade, eller også er tårevæsken unormal, så den tørrer ud for hurtigt.
English: The benefits of Ikervis have been shown in one main study involving 246 patients with severe dry eye disease, where Ikervis was compared with the vehicle (the same eye drop formula but without any active substance).
Danish: Fordelene ved Ikervis er påvist i én hovedundersøgelse med 246 patienter med svær øjentørhed, hvor Ikervis blev sammenlignet med vehiklet, dvs. samme øjendråber, men uden det aktive stof.
English: The CHMP considered that this was clinically meaningful, since none of the available medicines for the condition have been shown to reduce damage to the surface of the eye, which might help prevent the progression of the disease.
Danish: Dette blev af CHMP tillagt klinisk betydning, fordi man til denne sygdom ikke har andre lægemidler, der mindsker skaden på øjets overflade, hvilket kan tænkes at forebygge sygdommens fremadskriden.
English: Without sufficient protection from the tear fluid, the cornea can get damaged and become inflamed (keratitis), which can eventually lead to ulceration, infection and reduced vision.
Danish: Hvis hornhinden ikke er tilstrækkeligt beskyttet af tårevæsken, kan den lide skade og blive inflammeret (keratitis), så der efterhånden kommer sår, infektion og synsnedsættelse.
English: Applying it directly to the eye reduces inflammation and damage there but limits its effects elsewhere in the body.
Danish: Når det påføres direkte i øjet, mindskes inflammationen og beskadigelse af øjet, mens andre dele af kroppen kun påvirkes i begrænset omfang.
English: Although Ikervis had not been shown to be any better than the vehicle in improving symptoms such as discomfort and pain, there was evidence that it could reduce the inflammation and damage to the cornea associated with keratitis.
Danish: Det viste sig, at Ikervis ikke var bedre end vehiklet til at lindre symptomer i form af ubehag og smerter, men det blev påvist at kunne mindske den inflammation og beskadigelse af hornhinden, der forekommer ved keratitis.
English: How is Ikervis used?
Danish: Hvordan anvendes Ikervis?
English: For practical information about using Ikervis, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ikervis, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Ikervis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ikervis fremgår af indlægssedlen.
English: What benefits of Ikervis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ikervis?
English: The medicine must not be used in patients who have or are suspected to have an infection of the eye or the tissues around the eye. For the full list of restrictions, see the package leaflet.
Danish: Lægemidlet må ikke anvendes hos patienter, der har eller mistænkes for at have en infektion af øjet eller af vævet omkring øjet.
English: How does Ikervis work?
Danish: Hvordan virker Ikervis?
English: The proportion of patients who responded to treatment was therefore similar in the two groups, but when only the damage to the cornea was considered, Ikervis was significantly better than the vehicle at reducing it. Levels of HLADR (a measure of inflammation in eye cells) were also reduced in patients using Ikervis compared with the dummy treatment.
Danish: Behandlingen virkede således på omtrent samme andel af patienterne i de to grupper, men hvis man alene betragtede skade på hornhinden, var Ikervis betydeligt bedre end vehiklet til at mindske beskadigelsen.
English: Ikervis is a medicine used to treat severe keratitis, an inflammation of the cornea (the transparent layer covering the front of the eye) in adult patients with dry eye disease.
Danish: Ikervis er et lægemiddel til behandling af svær keratitis hos voksne patienter med øjentørhed.
English: The main measure of effectiveness was the proportion of patients whose condition responded to treatment after six months, as measured by a combination of damage to the cornea and a score for the level of symptoms, including discomfort and pain.
Danish: Bedømmelsen blev baseret på måling af skaden på hornhinden kombineret med score for symptomer i form af ubehag og smerter.
English: This summary was last updated in January 2014.
Danish: Dette sammendrag blev sidst ajourført in januar 2014.
English: After vaccination, animals may have a slightly raised temperature (usually not more than 0.5°C, but in individual cases up to about 2°C) for up to three days after vaccination.
Danish: Efter vaccination kan dyrene få en let temperaturstigning (som regel ikke mere end 0,5 °C, men i enkelte tilfælde op til ca. 2 °C) i højst tre dage efter vaccinationen.
English: Some animals may also have hypersensitivity (allergic) reactions.
Danish: Nogle dyr kan også få overfølsomhedsreaktioner (allergiske reaktioner).
English: The withdrawal period for both sheep and cattle for meat and milk is zero days.
Danish: Tilbageholdelsestiden for både får og kvæg for kød og mælk er nul dage.
English: In all studies the vaccinated cattle and sheep were compared with animals that were not immunised (controls).
Danish: I alle undersøgelserne blev de vaccinerede kvæg og får sammenlignet med dyr, der ikke var immuniserede (kontroller).
English: The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the quality, safety and efficacy of the vaccine.
Danish: Det Europæiske Lægemiddelagentur (EMA) gennemgik de i henhold til en aftalt tidsplan fremsendte supplerende oplysninger om vaccinens kvalitet, sikkerhed og virkning.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelsen af lægemidlet, før dyret kan slagtes, og kødet eller mælken kan anvendes til menneskeligt konsum.
English: Bovilis BTV8 was initially authorised under ‘exceptional circumstances'.
Danish: Bovilis BTV8 blev oprindelig godkendt under "særlige omstændigheder".
English: In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly.
Danish: Hvis dyrene senere udsættes for samme type bluetongue-virus, vil immunsystemet hurtigere kunne producere antistoffer.
English: This means that it was not possible at the time of the initial authorisation to obtain complete information about Bovilis BTV8.
Danish: Det betyder, at det på tidspunktet for den oprindelige godkendelse ikke var muligt at indhente fyldestgørende oplysninger om Bovilis BTV8.
English: Inactivated adjuvanted vaccine against bluetongue virus serotype 8
Danish: Inaktiveret, adjuveret vaccine mod bluetongue-virus serotype 8
English: The risk of bluetongue transmission to cattle following vaccination with Bovilis BTV8 was further investigated in two epidemiological models.
Danish: Risikoen for overførsel af bluetongue til kvæg efter vaccination med Bovilis BTV8 blev undersøgt yderligere i to epidemiologiske modeller.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Bovilis BTV8 on 06/09/2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bovilis BTV8 den 6. september 2010.
English: One injection is enough to vaccinate sheep, but cattle will need a second injection approximately three weeks later.
Danish: Én injektion er nok til at vaccinere får, mens kvæg skal have en yderligere injektion ca. tre uger senere.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) in sheep and to limit viraemia in cattle.
Danish: Vaccinen anvendes til at forebygge viræmi (tilstedeværelse af virus i blodet) hos får og til at begrænse viræmi hos kvæg.
English: The CVMP concluded that the benefits of Bovilis BTV8 exceed the risks and recommended that Bovilis BTV8 be given a marketing authorisation.
Danish: CVMP besluttede, at fordelene ved Bovilis BTV8 opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Bovilis BTV8.
English: When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produce antibodies against it.
Danish: Når vaccinen gives til kvæg og får, registrerer dyrets immunsystem virussen som "fremmed" og reagerer ved at danne antistoffer imod den.
English: There can also be a temporary swelling at the injection site, lasting for up to three weeks in sheep and six weeks in cattle.
Danish: Der kan ligeledes forekomme en midlertidig hævelse på injektionsstedet, som varer i op til tre uger hos får og i op til seks uger hos kvæg.
English: It is available as a suspension for injection.
Danish: Det fås som en injektionsvæske, suspension.
English: The main measure of effectiveness was the level of the bluetongue virus in the blood (viraemia) of animals.
Danish: Virkningen blev hovedsagelig målt på bluetongue-virusniveauet i blodet (viræmi) hos dyrene.
English: The studies showed that the vaccine is safe for both sheep and cattle and that it prevents viraemia in sheep from one month of age when infected with bluetongue virus serotype 8, whereas Bovilis BTV8 reduces viraemia in cattle from six weeks of age.
Danish: Undersøgelserne viste, at vaccinen er sikker for både får og kvæg, og at den forebygger viræmi hos får i alderen én måned og opefter, når de smittes med bluetongue-virus serotype 8, mens Bovilis BTV8 reducerer viræmi hos kvæg i alderen seks uger og opefter.
English: The safety of the vaccine was studied in laboratory safety studies carried out with an overdose of Bovilis BTV8 in young lambs and calves and in pregnant ewes and cows.
Danish: Vaccinens sikkerhed blev undersøgt i sikkerhedsundersøgelser i laboratorium gennemført med en overdosis Bovilis BTV8 hos unge lam og kalve samt drægtige får og køer.
English: Bovilis BTV8 is a vaccine.
Danish: Bovilis BTV8 er en vaccine.
English: Bovilis BTV8 contains bluetongue virus that has been inactivated so that it cannot cause the disease.
Danish: Bovilis BTV8 indeholder bluetongue-virus, som er blevet inaktiveret, så den ikke kan fremkalde sygdommen.
English: Bovilis BTV8 was shown to be safe for use in pregnant ewes and cattle.
Danish: Bovilis BTV8 viste sig at være sikker at bruge til drægtige får og køer.
English: The efficacy of the vaccine in cattle and sheep was studied in a number of laboratory trials; in cattle from six weeks of age and in sheep from one month of age..
Danish: Vaccinens virkning hos kvæg og får blev undersøgt i en række laboratorieundersøgelser hos kvæg i alderen seks uger og opefter og hos får i alderen én måned og opefter.
English: Bovilis BTV8 is used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Danish: Bovilis BTV8 anvendes til kvæg og får for at beskytte dem mod sygdommen bluetongue, som er en infektion, der forårsages af bluetongue-virus, som overføres af myg.
English: Bovilis BTV8 is a vaccine that contains an inactivated (killed) bluetongue serotype 8 virus as the active substance.
Danish: Bovilis BTV8 er en vaccine, der som det aktive stof indeholder inaktiveret (dræbt) bluetongue-virus serotype 8.
English: Other information about Bovilis BTV8:
Danish: Andre oplysninger om Bovilis BTV8:
English: What is the risk associated with Bovilis BTV8?
Danish: Hvilken risiko er der forbundet med Bovilis BTV8?
English: The virus exists in several forms (serotypes) throughout the world; the type used in Bovilis BTV8 is serotype 8.
Danish: Virussen eksisterer i flere former (serotyper) over hele verden.
English: Why has Bovilis BTV8 been approved?
Danish: Hvorfor blev Bovilis BTV8 godkendt?
English: The first injection is given from one month of age in sheep and from six weeks of age in cattle.
Danish: Hos får gives den første injektion, når dyret er en måned gammelt, og hos kvæg gives den første injektion, når dyret er seks uger gammelt.
English: What is Bovilis BTV8?
Danish: Hvad er Bovilis BTV8?
English: How has Bovilis BTV8 been studied?
Danish: Hvordan blev Bovilis BTV8 undersøgt?
English: What is Bovilis BTV8 used for?
Danish: Hvad anvendes Bovilis BTV8 til?
English: How does Bovilis BTV8 work?
Danish: Hvordan virker Bovilis BTV8?
English: What benefit has Bovilis BTV8 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Bovilis BTV8?
English: This summary was last updated in 02-2018.
Danish: Dette sammendrag blev sidst ajourført i 02-2018.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Omnitrope on 12 April 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Omnitrope den 12. april 2006.
English: As with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope).
Danish: Som det er tilfældet med alle proteinbaserede lægemidler, kan nogle patienter udvikle antistoffer (proteiner, der produceres som reaktion på Omnitrope).
English: • do not grow normally because they do not have enough growth hormone;
Danish: • børn, der ikke vokser normalt, fordi de ikke har nok væksthormon
English: The full EPAR for Omnitrope can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Omnitrope findes på agenturets websted under: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • have a genetic condition called Prader-Willi syndrome.
Danish: • børn, der har en genetisk lidelse kaldet Prader-Willis syndrom.
English: This is a summary of the European public assessment report (EPAR) for Omnitrope.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Omnitrope.
English: These side effects are uncommon in children (may affect between 1 and 10 patients in 1,000).
Danish: Hos børn ses disse bivirkninger med hyppigheden ikke almindelig (kan forekomme hos mellem 1 og 10 ud af 1.000 patienter).
English: Children receiving Omnitrope and Genotropin grew at a similar rate of about 10.7 cm per year.
Danish: Børn, som fik Omnitrope og Genotropin, voksede med samme hastighed (ca. 10,7 cm om året).
English: The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.
Danish: Væksthormonmanglen kan være begyndt i barndommen eller i voksenalderen og skal bekræftes ved test forud for behandling.
English: This means that Omnitrope is highly similar to a biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Omnitrope svarer til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i EU.
English: Other information about Omnitrope
Danish: Andre oplysninger om Omnitrope
English: Somatropin is produced by a method known as ‘recombinant DNA technology': the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.
Danish: Somatropin fremstilles ved hjælp af en metode kaldet "rekombinant dna-teknologi": Hormonet fremstilles af bakterier, der har fået indsat et gen (dna), som sætter bakterierne i stand til at producere somatropin.
English: In adults, side effects related to fluid retention, such as peripheral oedema (swelling, especially of the ankles and feet), paraesthesia (numbness or tingling), joint and muscle pain, and stiffness of the limbs are common (may affect between 1 and 10 patients in 100).
Danish: Bivirkninger relateret til væskeretention, herunder perifert ødem (hævelse, navnlig hævede ankler og fødder), paræstesi (følelsesløshed eller prikkende fornemmelse), led- og muskelsmerter samt stivhed i lemmerne ses hos voksne med hyppigheden almindelig (kan forekomme hos mellem 1 og 10 ud af 100 patienter).
English: The patient or caregiver can inject Omnitrope, after being trained by a doctor or a nurse.
Danish: Patienten eller omsorgspersonen kan injicere Omnitrope efter at være blevet instrueret heri af en læge eller sygeplejerske.
English: Omnitrope is given to improve their growth and body composition (by reducing fat and improving muscle mass).
Danish: Omnitrope gives for at fremme væksten og forbedre kropsbygningen (ved at nedbringe fedtmængden og øge muskelmassen).
English: Omnitrope was compared with Genotropin in 89 children with a lack of growth hormone who had not been treated before.
Danish: Omnitrope blev sammenlignet med Genotropin hos 89 børn med mangel på væksthormon, som ikke tidligere havde modtaget behandling.
English: The European Medicines Agency considered that, in accordance with EU requirements for biosimilar medicines, Omnitrope has been shown to have a comparable quality, safety and effectiveness to Genotropin.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Omnitrope har samme kvalitet, sikkerhed og virkning som Genotropin.
English: The doctor calculates the dose for each patient individually according to the body weight and the condition being treated.
Danish: Lægen beregner doseringen individuelt under hensyn til patientens kropsvægt og den pågældende sygdom.
English: It must also not be used for promoting growth in children with closed epiphyses (when the large bones have finished growing).
Danish: Omnitrope må ikke anvendes til at fremme væksten hos børn med lukkede epifyser (når de store knogler ikke vokser mere).
English: It is given by injection under the skin, once a day.
Danish: Omnitrope gives ved injektion under huden én gang dagligt.
English: What is Omnitrope and what is it used for?
Danish: Hvad er Omnitrope, og hvad anvendes det til?
English: The diagnosis must be confirmed by genetic testing.
Danish: Diagnosen skal bekræftes ved gentest.
English: Omnitrope can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with growth disorders.
Danish: Omnitrope udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af patienter med vækstforstyrrelser.
English: The dose may need to be adjusted over time, depending on change in body weight and response to treatment.
Danish: Med tiden kan det være nødvendigt at tilpasse dosis efter ændringen i kropsvægten og behandlingens virkning.
English: Results showed that, after treatment for 9 months, Omnitrope was as effective as Genotropin in improving growth.
Danish: Resultaterne viste, at Omnitrope efter 9 måneders behandling var lige så effektivt som Genotropin til at fremme væksten.
English: Omnitrope contains the active substance somatropin and is a ‘biosimilar' medicine.
Danish: Omnitrope indeholder det aktive stof somatropin og er et "biosimilært" lægemiddel.
English: Omnitrope must not be used if the patient has an active tumour or an acute life-threatening illness.
Danish: Omnitrope må ikke anvendes til patienter, der har en aktiv tumor eller en akut livstruende sygdom.
English: Why is Omnitrope approved?
Danish: Hvorfor blev Omnitrope godkendt?