FrancophonIA/ELRC3.0 huggingface dataset:
English: This is considered a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia.
Danish: Dette anses for at være et betydeligt fremskridt i diagnosticering af patienter med hukommelsesproblemer, der vurderes for Alzheimers sygdom og andre typer demens.
English: If few or no β-amyloid plaques are seen in the PET scan (a negative scan), the patient is unlikely to have Alzheimer's disease.
Danish: Hvis skanningen kun viser lidt eller ingen β-amyloidplak (et negativ skan), er det usandsynligt, at patienten har Alzheimers sygdom.
English: This means that the PET scans correctly identified as positive between 81-93% of the patients who had significant amounts of plaques in their brain.
Danish: Det betyder, PETskanningerne korrekt identificerede mellem 81 og 93 % af de patienter, der havde nævneværdige mængder plak i hjernen.
English: Vizamyl delivers a very low amount of radiation which poses a very low risk of cancer or any hereditary abnormalities.
Danish: Vizamyl afgiver en meget lille mængde stråling, som medfører en minimal risiko for kræft eller arvelige defekter.
English: For more information about treatment with Vizamyl, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vizamyl, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients should discuss the results of their PET scan with their doctor.
Danish: Patienten bør drøfte resultaterne af PETskanningen med lægen.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vizamyl, 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 Vizamyl, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: However, a positive scan on its own is not sufficient to make a diagnosis in patients with memory problems, as plaques may be seen in patients with different types of dementias as well as in older people with no symptoms.
Danish: En positiv skanning er dog i sig selv ikke nok til at stille diagnosen hos patienter med hukommelsesproblemer, da plak forekommer både hos patienter med forskellige typer demens og hos ældre uden symptomer.
English: Vizamyl can only be obtained with a prescription, and PET scans with Vizamyl should only be requested by doctors experienced in the clinical management of patients with diseases such as Alzheimer's disease and other dementias.
Danish: Vizamyl fås kun på recept, og PET-skanninger med Vizamyl bør kun rekvireres af læger med erfaring i klinisk behandling af patienter med sygdomme som Alzheimers sygdom og andre former for demens.
English: In addition, the usefulness of Vizamyl in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Danish: Desuden er det ikke fastslået, i hvilket omfang Vizamyl er egnet til at forudsige forløbet af Alzheimers sygdom hos patienter med hukommelsesproblemer eller til at overvåge behandlingens gavnlige virkning for patienterne.
English: The active substance in Vizamyl, flutemetamol (18F), is a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Danish: Det aktive stof i Vizamyl, flutemetamol (18F), er et radioaktivt lægemiddel, der afgiver små mængder stråling og virker ved at bindes til β-amyloidplak i hjernen.
English: The radiation it emits can be detected on the PET scan, enabling doctors to see whether or not significant amount of plaques are present.
Danish: Den afgivne stråling registreres på PETskanningen, så lægerne kan se, om der er nævneværdige mængder plak til stede.
English: After the image is obtained, it is read by nuclear medicine physicians specifically trained in interpreting PET scans with Vizamyl.
Danish: Når skanningen er udført, vurderes billedet af speciallæger i nuklearmedicin, der er særlig oplært i at tolke PET-skanninger med Vizamyl.
English: The Committee noted that PET scans with Vizamyl have a high sensitivity and specificity for detecting a significant amount of beta-amyloid plaques in the brain, and that scans closely reflect what was seen at autopsy.
Danish: Udvalget bemærkede, at PET-skanning med Vizamyl har høj følsomhed og specificitet til påvisning af nævneværdige mængder β-amyloidplak i hjernen, og at skanningen nøje afspejler obduktionsresultaterne.
English: For the full list of all side effects and restrictions reported with Vizamyl, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger med Vizamyl fremgår af indlægssedlen.
English: For practical information about using Vizamyl, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vizamyl, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Vizamyl is a radiopharmaceutical (a medicine containing small amounts of a radioactive substance) that contains the active substance flutemetamol (18F); it is for diagnostic use only.
Danish: Vizamyl er et lægemiddel, der indeholder små mængder af det radioaktive stof flutemetamol (18F); det bruges kun til undersøgelse af patienter (diagnostisk brug).
English: Vizamyl was investigated in one main study in 176 patients nearing the end of their lives who had consented to autopsies when they died, in order to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Danish: Vizamyl blev undersøgt i én hovedundersøgelse med 176 patienter, der var nær livets slutning og havde samtykket i at få foretaget obduktion for med sikkerhed at påvise, om de havde betydelige mængder ß-amyloidplak i hjernen.
English: At the end of the study, 68 had autopsies carried out on them to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Danish: Ved slutningen af undersøgelsen fik 68 patienter foretaget obduktion for med sikkerhed at afgøre, om de havde betydelige mængder β-amyloidplak i hjernen.
English: The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Vizamyl.
Danish: CHMP bemærkede dog, at der ikke er sikkert bevis for nogen øjeblikkelig bedring i udfaldet for patienterne efter PET-skanning med Vizamyl.
English: Vizamyl is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β‑amyloid plaques in the brain.
Danish: Vizamyl anvendes ved skanning af hjernen hos patienter med hukommelsesproblemer, for at lægerne kan se, om de har nævneværdige mængder β-amyloidplak i hjernen.
English: Vizamyl is available as a solution that is given by injection into a vein, about 90 minutes before obtaining an image from a PET scan.
Danish: Vizamyl fås som en opløsning, der gives ved injektion i en vene ca. 90 minutter før billedoptagelse med PET-skanning.
English: How does Vizamyl work?
Danish: Hvordan virker Vizamyl?
English: What benefits of Vizamyl have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vizamyl?
English: How is Vizamyl used?
Danish: Hvordan anvendes Vizamyl?
English: The study looked at the sensitivity of the PET scans (how well scans identified patients who had significant amounts of plaques in the brain) when interpreted by skilled readers.
Danish: Undersøgelsen vedrørte PET-skanningernes følsomhed (dvs. hvor sikkert de kunne skelne forsøgspersoner med nævneværdig plakdannelse i hjernen fra personer uden plak), når de blev fortolket af øvede undersøgere.
English: When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity between 81-93%.
Danish: Skanningerne viste sig at have en følsomhed på 81-93 %, når obduktionsresultaterne blev sammenholdt med PET-skanningerne.
English: There is, however, a risk of false positive results (when patients without plaques are rated as positive), therefore Vizamyl scans should not be used on their own to diagnose dementia, but together with a clinical evaluation of the patient.
Danish: Der er dog risiko for falske positive resultater (hvor patienter uden plak bedømmes som positive).
English: β-amyloid plaques are deposits sometimes present in the brain of people with memory problems caused by dementia (such as Alzheimer's disease, Lewy-body dementia and Parkinson's disease dementia) and also in the brain of some older people with no symptoms of dementia.
Danish: De forekommer således ved Alzheimers sygdom, Lewy body demens og demens ved Parkinsons sygdom foruden hos visse ældre uden symptomer på demens.
English: ‘Vernal' means that it usually occurs in the spring.
Danish: ‘Vernalis' betyder at det navnlig forekommer om foråret.
English: The disease can lead to loss of vision.
Danish: Denne sygdom kan føre til nedsat syn.
English: The application was at day 175 when the company withdrew.
Danish: Ansøgningen var på dag 175, da firmaet trak den tilbage.
English: This means that it reduces the activity of the immune system (the body's natural defences).
Danish: Det betyder, at det påvirker immunsystemets aktivitet (kroppens naturlige forsvar).
English: International non-proprietary name (INN): ciclosporin
Danish: Internationalt fællesnavn (INN): ciclosporin
English: The Committee also noted that the long-term effectiveness of the medicine had not been investigated.
Danish: Udvalget bemærkede også, at langtidsvirkningerne af lægemidlet ikke var blevet undersøgt.
English: Vernal keratoconjunctivitis is a long-term disease that mainly affects young boys living in warm, dry climates such as Mediterranean countries.
Danish: Keratoconjunctivitis vernalis er en langvarig sygdom, der hovedsagelig rammer unge drenge, som bor i et varmt og tørt klima såsom Middelhavslandene.
English: The patients were treated with Vekacia at a concentration of 0.05% (0.5 mg ciclosporin per millilitre) or of 0.1% (1 mg/ml), or with placebo (dummy eye drops).
Danish: Patienterne blev behandlet med Vekacia ved en koncentration på 0,05 % (0,5 mg ciclosporin pr. milliliter) eller på 0,1 % (1 mg/ml) eller med placebo (uvirksomme øjendråber).
English: In this case this was the ‘vehicle' (the same eye drops but without ciclosporin).
Danish: I dette tilfælde var dette bærestoffet (de samme øjendråber men uden ciclosporin).
English: The Committee's concerns related to the way the study was designed, in terms of the choice of the patients treated, how symptoms were measured and the way the study's results were analysed.
Danish: Udvalgets betænkeligheder vedrørte den måde undersøgelsen var udformet på, de patienter, der blev udvalgt til behandling, den måde symptomerne blev målt på, og den måde, hvorpå undersøgelsens resultater blev analyseret.
English: What is Vekacia?
Danish: Hvad er Vekacia?
English: Because ciclosporin has been used for many years, the applicant presented data on experimental models from the scientific literature.
Danish: Da ciclosporin har været anvendt i mange år, fremlagde ansøgeren data om forsøgsmodeller fra faglitteraturen
English: The main measure of effectiveness chosen was the change in the symptoms of the disease after four weeks, as scored by the doctor.
Danish: Det primære mål for virkningen var ændringer i symptomerne på sygdommen efter fire uger ifølge lægens opgørelser.
English: It was to be available as eye drops.
Danish: Det skulle have været leveret som øjendråber.
English: Vekacia was designated as an orphan medicinal product on 6 April 2006.
Danish: Vekacia blev udpeget som lægemiddel til sjældne sygdomme den 6. april 2006.
English: Ciclosporin has been used since the mid1980s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Danish: Ciclosporin er siden midten af 1980'erne blevet anvendt til at mindske afstødningen hos transplantationspatienter (når immunsystemet angriber det transplanterede organ).
English: Ref. EMEA/611497/2008
Danish: London, den 20. november 2008 Dok.-ref. EMEA/611497/2008
English: Questions and answers on the withdrawal of the marketing application for Vekacia
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Vekacia
English: Vekacia is a medicine that contains ciclosporin.
Danish: Vekacia er et lægemiddel, der indeholder ciclosporin.
English: On 14 November 2008, Novagali Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vekacia, for the treatment of vernal keratoconjunctivitis.
Danish: Den 14. november 2008 meddelte Novagali Pharma S.A officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Vekacia til behandling af keratoconjunctivitis vernalis.
English: The active substance in Vekacia, ciclosporin, is an immunosuppressant.
Danish: Det aktive stof i Vekacia, ciclosporin, er et immunosupressivt stof.
English: In patients with vernal keratoconjunctivitis, ciclosporin given as eye drops was expected to suppress the local immune reactions that trigger inflammation in the conjunctiva and cornea.
Danish: Hos patienter med keratoconjunctivitis vernalis forventedes ciclosporin givet som øjendråber at svække de lokale immunreaktioner, der forårsager betændelse i bindehinden og hornhinden.
English: Vekacia was expected to be used to treat vernal keratoconjunctivitis.
Danish: Vekacia forventedes anvendt til behandling af keratoconjunctivitis vernalis.
English: What was Vekacia expected to be used for?
Danish: Hvad forventedes Vekacia anvendt til?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vekacia could not have been approved for the treatment of vernal keratoconjunctivitis.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Vekacia ikke kunne godkendes til keratoconjunctivitis vernalis.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Vekacia?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Vekacia eller i programmer for anvendelse med særlig udleveringstilladelse?
English: Symptoms that were looked at included: burning, itching, pain, sticky eyelids, the sensation of a foreign body in the eyes or photophobia (oversensitivity of the eyes to light).
Danish: De symptomer, der blev set på var: brændende fornemmelse, kløe, smerte, klæbrige øjenlåg, fornemmelse af fremmedlegeme i øjet eller lysoverfølsomhed.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Vekacia had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Vekacia ikke var tilfredsstillende godtgjort, og at eventuelle fordele ikke opvejede de fundne risici.
English: How is Vekacia expected to work?
Danish: Hvordan forventes Vekacia at virke?
English: The CHMP had concerns that the effectiveness of Vekacia had not been shown when compared to the vehicle.
Danish: CHMP fandt grund til betænkelighed ved, at virkningen af Vekacia ikke var blevet påvist i forhold til bærestoffet.
English: This is inflammation of the conjunctiva (the membrane that lines the eyelid) and the cornea (the transparent layer in front of the pupil), which is caused by allergy.
Danish: Det er betændelse i bindehinden (den membran, der dækker øjets forreste halvdel og bagsiden af øjenlåget) og hornhinden (den gennemsigtige forreste del af øjeæblets ydre hinde), som skyldes allergi.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes with Vekacia in Europe.
Danish: Firmaet har til CHMP oplyst, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Vekacia i Europa.
English: To support the use of Vekacia in vernal keratoconjunctivitis, the company presented the results of one study in 118 children (over the age of four years) and adolescents.
Danish: Virksomheden fremlagde resultaterne af en undersøgelse af 118 børn (over fire år) og unge for at støtte anvendelsen af Vekacia til behandling af keratoconjunctivitis vernalis.
English: This overview was last updated in September 2018.
Danish: Denne oversigt blev sidst ajourført i september 2018.
English: Not all strengths may be available in every country.
Danish: Ikke alle styrker markedsføres nødvendigvis i hvert land.
English: Econor received a marketing authorisation valid throughout the European Union on 12 March 1999.
Danish: Econor fik en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 12. marts
English: Further information on Econor can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPARs/Econor.
Danish: Yderligere oplysninger om Econor findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPARs/Econor.
English: Econor is an antibiotic.
Danish: Econor er et antibiotikum.
English: Other information about Econor
Danish: Andre oplysninger om Econor
English: The European Medicines Agency decided that Econor's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Econor opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The withdrawal period is the time required after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter administration af et lægemiddel, før et dyr kan slagtes, og kødet kan anvendes til menneskeligt konsum.
English: Gloves should be worn when handling the product.
Danish: Der skal anvendes handsker ved håndtering af lægemidlet.
English: Extreme care should, therefore, be taken when using Econor in pigs of Scandinavian origin.
Danish: Der bør derfor udvises den yderste forsigtighed ved brug af Econor til svin af skandinavisk oprindelse.
English: Econor had a positive effect in terms of reducing the severity of disease and improving its outcome.
Danish: Econor havde en positiv virkning ved at nedsætte sygdommens sværhedsgrad og forbedre udfaldet.
English: Valnemulin is active against a range of bacteria including those responsible for the diseases listed above.
Danish: Valnemulin er aktivt mod en række bakterier, herunder dem, der er årsag til ovennævnte sygdomme.
English: However, infection with Mycoplasma hyopneumoniae was not eliminated.
Danish: Det var dog ikke i stand til at udrydde infektionen med Mycoplasma hyopneumoniae.
English: It works by blocking the production of proteins inside the bacteria and thereby stopping their growth.
Danish: Det virker ved at blokere proteinproduktionen i bakterien, og derved standses bakteriernes vækst.
English: An overview of Econor and why it is authorised in the EU
Danish: En oversigt over Econor, og hvorfor det er godkendt i EU
English: Direct contact with the skin, mouth and nose should be avoided when mixing Econor and handling the final feed containing the medicine.
Danish: Direkte kontakt med hud, mund og næse bør undgås ved iblandingen af Econor i foderet og ved håndtering af det færdige foder indeholdende lægemidlet.
English: Econor can only be obtained with a prescription.
Danish: Econor udleveres kun efter recept.
English: Tympanism (distension of the abdomen) is more frequent in rabbits treated with Econor than in untreated rabbits.
Danish: Tympani (udspiling af maven) optræder oftere hos kaniner behandlet med Econor end hos ubehandlede kaniner.
English: If Econor is accidentally consumed by a person, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Hvis en person utilsigtet indtager Econor, bør der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Econor is available as a premix for medicated feeding stuff for pigs (10% and 50%) and rabbits (10%), and as an oral powder for pigs (10%).
Danish: Econor fås som en premix til medicineret foder til svin (10 % og 50 %) og kaniner (10 %) og som et oralt pulver til svin (10 %).
English: Why is Econor authorised in the EU?
Danish: Hvorfor blev Econor godkendt i EU?
English: What is Econor and what is it used for?
Danish: Hvad er Econor, og hvad anvendes det til?
English: Econor contains the active substance valnemulin.
Danish: Econor indeholder det aktive stof valnemulin.
English: The withdrawal period for meat and offal from pigs treated with Econor is one day and for meat and offal from rabbits treated with Econor it is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og indvolde fra svin, der behandles med Econor, er én dag, og for kød og indvolde fra kaniner, der behandles med Econor, er tilbageholdelsestiden "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: This is a disease associated with changes in the normal balance of bacteria in the gut which allow growth of clostridia, bacteria that produce a toxin which paralyses the intestine.
Danish: Denne sygdom er forbundet med ændringer i den normale bakteriebalance i tarmen, hvilket medfører vækst af clostridia, som er bakterier, der producerer et toksin, der lammer tarmen.
English: For further information about using Econor, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Econor, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: What are the risks associated with Econor?
Danish: Hvilke risici er der forbundet med Econor?
English: The oral powder is mixed into pig feed by the pig owner and is used to treat individual pigs.
Danish: Det orale pulver blandes i svinefoderet af dyrets ejer og anvendes til behandling af de enkelte dyr.
English: The dose and length of treatment depend on the condition, the animal for which it is being used and its bodyweight.
Danish: Dosis og behandlingsvarighed afhænger af den pågældende sygdom, det behandlede dyr og dyrets kropsvægt.
English: Econor improves the health and reduces weight loss of the treated pigs, but may not completely eliminate the bacteria that cause lung infection.
Danish: Econor forbedrer de behandlede dyrs sundhedstilstand og mindsker vægttab, men udrydder ikke nødvendigvis helt de bakterier, der forårsager lungeinfektionen.
English: The active substance of Econor is valnemulin, an antibiotic of the pleuromutilin group.
Danish: Det aktive stof i Econor er valnemulin, som er et antibiotikum i pleuromutilin-gruppen.
English: Econor premix is mixed into pig or rabbit feed by an authorised feed mill and the resulting “medicated feeding stuff” is then distributed to the farmer to treat a large number of pigs or rabbits.
Danish: Econor premix blandes i svine- eller kaninfoderet med en godkendt foderblander, og det medicinerede foder udleveres derpå til landmanden til behandling af et større antal svin eller kaniner.