FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who have difficulty swallowing can have the content of the capsules sprinkled on soft food such as apple sauce, yoghurt or pudding.
Danish: Patienter med synkebesvær kan få indholdet af kapslerne drysset på bløde fødevarer såsom æblesauce, yoghurt eller budding.
English: After 30 weeks, patients taking Numient had their symptoms improve by an average of between 11.7 and 14.9 points (depending on dose) on a standard symptom scale (Unified Parkinson's Disease Rating Scale, UPDRS Part II and Part III).
Danish: Efter 30 uger fik de patienter, der fik Numient, i gennemsnit en bedring i symptomerne på mellem 11,7 og 14,9 point (afhængigt af dosis) på en standardskala for symptomer på Parkinsons sygdom (Unified Parkinson's Disease Rating Scale, UPDRS Part II og Part III).
English: In Numient, a portion of the active substances is released immediately, while the remaining is released gradually, leading to more steady levodopa levels.
Danish: I Numient bliver en del af de aktive stoffer frigivet straks, mens resten frigives gradvis, hvilket medfører et mere stabilt indhold af levodopa.
English: It contains the active substances levodopa and carbidopa.
Danish: Det indeholder de aktive stoffer levodopa og carbidopa.
English: It is not intended to provide practical advice on how to use Numient.
Danish: Det er ikke en praktisk vejledning i, hvordan Numient bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Numient, 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 Numient, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: What are the risks associated with Numient?
Danish: Hvilke risici er der forbundet med Numient?
English: The combination of levodopa and carbidopa is used in other medicines for Parkinson's disease.
Danish: Kombinationen af levodopa og carbidopa anvendes i andre lægemidler mod Parkinsons sygdom.
English: The doctor may then increase the dose depending on how the condition responds to treatment.
Danish: Lægen vil derefter muligvis øge dosis, alt efter hvordan behandlingen virker på patientens tilstand.
English: Studies show that Numient is effective at reducing symptoms in patients with early and late stage Parkinson's disease.
Danish: Undersøgelserne viser, at Numient er effektivt til at nedsætte symptomerne hos patienter med Parkinsons sygdom i tidligt og sent stadium.
English: More serious side effects include bleeding from the gut and allergic reactions, and have been reported uncommonly.
Danish: Mere alvorlige bivirkninger er blødning fra tarmen og allergiske reaktioner, som dog ikke almindeligt bliver beskrevet.
English: In a study of 381 patients with early stage Parkinson's disease, Numient at various doses was more effective at improving symptoms than placebo (a dummy treatment).
Danish: I en undersøgelse med deltagelse af 381 patienter med Parkinsons sygdom i tidligt stadium var Numient i forskellige doser mere effektivt til at give bedring i symptomerne end virkningsløs behandling (placebo).
English: A second study compared Numient with another treatment containing levodopa and carbidopa in 393 patients with advanced Parkinson's disease.
Danish: I en anden undersøgelse blev Numient sammenlignet med en anden behandling indeholdende levodopa og carbidopa hos 393 patienter med fremskreden Parkinsons sygdom.
English: Another benefit is the way the active substances are formulated in Numient, which helps maintain more steady levodopa levels.
Danish: En anden fordel er formuleringen af de aktive stoffer i Numient, som bevirker et mere stabilt indhold af levodopa.
English: Numient is available as capsules to be taken by mouth.
Danish: Numient fås som kapsler, der tages gennem munden.
English: It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of certain medical conditions.
Danish: Det må heller ikke anvendes hos patienter, der får lægemidler af typen ikke-selektive MAO-hæmmere (monoaminoxidasehæmmere) eller hos patienter, der har visse tidligere sygdomme.
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Numient fremgår af indlægssedlen.
English: 95 mg/23.75 mg, 145 mg/36.25 mg, 195 mg/48.75 mg and 245 mg/61.25 mg. For further information on how to use Numient, see the summary of product characteristic (also part of the EPAR).
Danish: Numient udleveres kun mod recept og fås i følgende styrker: 95 mg/23,75 mg, 145 mg/36,25 mg, 195 mg/48,75 mg og 245 mg/61,25 mg.
English: The carbidopa in Numient stops the levodopa from converting into dopamine while still in the general circulation, before it has reached the brain.
Danish: Carbidopa i Numient forhindrer levodopa i at omdannes til dopamin, mens det endnu er i blodbanen, før det har nået hjernen.
English: For more information about treatment with Numient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Numient, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Numient is used in adults to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking and muscular stiffness and slows down movement.
Danish: Numient er et lægemiddel til behandling af symptomerne på Parkinsons sygdom, der er en fremadskridende hjernesygdom, som medfører rysten, muskelstivhed og langsomme bevægelser.
English: For practical information about using Numient, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Numient, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Numient contains levodopa which converts into dopamine in the brain and helps to restore dopamine levels.
Danish: Numient indeholder levodopa, som i hjernen omdannes til dopamin og genopretter indholdet af dopamin.
English: What benefits of Numient have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Numient?
English: How is Numient used?
Danish: Hvordan anvendes Numient?
English: In patients with Parkinson's disease, the cells in the brain that produce dopamine, a neurotransmitter important for controlling movement, begin to die and the amount of dopamine in the brain decreases.
Danish: Hos patienter med Parkinsons sygdom begynder de celler i hjernen at dø, der producerer dopamin (en neurotransmitter, der er vigtig for kontrollen med bevægelser).
English: Numient must not be used in patients with narrow angle glaucoma (an eye disorder) or pheochromocytoma (a tumour of the adrenal glands).
Danish: Numient må ikke anvendes hos patienter med øjensygdommen snævervinklet glaukom eller binyrebarksvulsten fæokromocytom.
English: How does Numient work?
Danish: Hvordan virker Numient?
English: Revaccination: 12 months after vaccination.
Danish: Revaccination: 12 måneder efter vaccination.
English: These local reactions gradually reduce and disappear without need for treatment.
Danish: Disse lokale reaktioner reduceres gradvist og forsvinder uden behov for behandling
English: Keep the bottle in the outer carton in order to protect from light.
Danish: Opbevar flasken i den ydre karton som beskyttelse mod lys.
English: No available data.
Danish: Der foreligger ingen data.
English: A transient temperature increase slightly above 40 ºC might very commonly occur between two or three days following vaccination.
Danish: En forbigående øget temperatur på lidt over 40 ºC kan meget ofte forekomme mellem to eller tre dage efter vaccination.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: De aktive stoffer er stoffer af biologisk oprindelse beregnet til at fremkalde en aktiv immunitet og er således ikke underlagt Forordning (EF) nr. 470/2009.
English: Each dose of 0.5 ml contains:
Danish: Hver dosis på 0,5 ml indeholder:
English: Pregnant does should be handled with special care to avoid stress and risk of abortion
Danish: Drægtige hunkaniner skal håndteres med særlig forsigtighed for at undgå stress og risiko for abort.
English: Date of first authorisation: 22 September 2016
Danish: Dato for første markedsføringstilladelse: 22.09.2016
English: Onset of immunity: 1 week.
Danish: Indtræden af immunitet: En uge.
English: Mineral oil
Danish: Mineralsk olie
English: Duration of immunity: 12 months demonstrated by challenge
Danish: Varighed af immunitet: 12 måneder demonstreret ved ”challenge”
English: This slight temperature increase resolves spontaneously without treatment by day 5 post vaccination.
Danish: Denne lette temperaturstigning ophører spontant uden behandling på femte dag efter vaccinationen.
English: Overdose (symptoms, emergency procedures, antidotes): No available data.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift): Der foreligger ingen data.
English: Pharmacotherapeutic group: Inactivated viral vaccines for Leporidae, inactivated viral vaccine for rabbits.
Danish: Farmakoterapeutisk gruppe: Inaktiverede virale vacciner til leporidae, inaktiveret viral vaccine til kaniner.
English: Sorbitan mono-oleate Polysorbate 80
Danish: Sorbitanmonooleat Polysorbat 80
English: Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Water for injections
Danish: Dinatriumphosphatdodecahydrat Kaliumdihydrogenphosphat Vand til injektionsvæske
English: Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Laboratorios Hipra, S.A.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Må ikke bruges efter den udløbsdato, der står på etiketten efter UDL.D.
English: {MM/YYYY}
Danish: {måneder/år}
English: Vaccination of rabbits induced the production of hemagglutination inhibition antibodies that persisted for at least 12 months.
Danish: Vaccination af kaniner inducerede produktionen af hæmagglutinationsinhiberende antistoffer, der bestod i mindst 12 måneder.
English: Lethargy and/or inappetence may be observed very rarely in the first 48 hours after injection, based on post-authorisation pharmacovigilance reporting.
Danish: Sløvhed og/eller mangel på appetit kan observeres meget sjældent i de første 48 timer efter injektion, ifølge rapportering fra bivirkningsobservation.
English: Detailed information on this veterinary medicinal product us available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu)
English: Nodules or swelling (< 2 cm) can be very commonly observed in the injection site, which may last 24 hours.
Danish: Knuder eller hævelse (<2 cm) kan ofte dannes på injektionsstedet, og disse kan forblive op til 24 timer.
English: ATCvet code: QI08AA
Danish: ATCvet-kode: lavest tilgængelige niveau QI08AA
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof, adjuvans eller over for et eller flere af hjælpestofferne.
English: Do not mix with any other veterinary medicinal products.
Danish: Må ikke blandes med andre veterinærlægemiddeler.
English: Incompatibilities: Do not mix with any other veterinary medicinal products.
Danish: Uforligeligheder: Må ikke blandes med andre dette veterinærlægemiddeler.
English: Laboratory studies in doe rabbits in the last third of gestation have not been produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Danish: Laboratorieundersøgelser hos hunkaniner i den sidste tredjedel af drægtigheden har ikke afsløret nogen tegn på teratogene, føtotoksiske og maternotoksiske virkninger .
English: Whitish emulsion.
Danish: Hvidlig emulsion.
English: Vial label (1, 10 or 40 doses)
Danish: Flasker (1, 10 eller 40 doser)
English: Expert, prompt, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Danish: Der kræves ØJEBLIKKELIG kirurgisk behandling, og der kan opstå behov for tidlig incision og irrigation af det injicerede område, navnlig når det drejer sig om fingerbløddele eller -sener.
English: Special precautions for use in animals: Vaccination is recommended where RHDV2 is epidemiologically relevant.
Danish: Special forholdsregler til brug hos dyr: Det anbefales at vaccinere på steder, hvor RHDV2 er epidemiologisk relevant.
English: Administer 1 dose (0.5 ml) of the veterinary medicinal product to rabbits from the age of 30 days by subcutaneous injection in the lateral thoracic wall.
Danish: Giv 1 dosis (0,5 ml) af veterinærlægemidlet, til kaniner fra en alder af 30 dage, ved subkutan injektion i den laterale thorax væg.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).
Danish: Til aktiv immunisering af kaniner fra 30 dages alderen, for at reducere dødelighed forårsaget af kanin hæmoragisk sygdom type 2 virus (RHDV2).
English: The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated.
Danish: Der er ikke påvist krydsbeskyttelse mod klassisk RHDV.
English: CARTON NAME OF THE VETERINARY MEDICINAL PRODUCT
Danish: KARTON VETERINÆRLÆGEMIDLETS NAVN
English: Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Det anbefales at vaccinere på steder, hvor RHDV2 er epidemiologisk relevant.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DE BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Type I colourless glass vials with 0.5 ml (1 dose), 5 ml (10 doses) and 20 ml (40 doses).
Danish: Type I-hætteglas af farveløst glas indeholdende 0,5 ml (1 dosis), 5 ml (10 doser) eller 20 ml (40 doser).
English: Shake well before administration.
Danish: Omrystes godt før brug.
English: Mineral oil…………104.125 mg
Danish: Mineralsk olie…………104,125 mg
English: Mineral oil: ………………..104.125 mg
Danish: Mineralsk olie: ………………..104,125 mg
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter anbrud af indre emballage: Anvendes straks
English: Disposal: read the package leaflet.
Danish: Bortskaffelse: læs indlægssedlen inden brug.
English: 1 x 40 doses (20 ml).
Danish: 1 x 40 doser (20 ml).
English: Shelf life after first opening the immediate packaging: Use immediately.
Danish: Opbevaringstid efter anbrud af indre emballage: Anvendes straks
English: To stimulate active immunity against the rabbit haemorrhagic disease type 2 virus (RHDV2).
Danish: Til stimulering af immuniteten mod kanin hæmoragisk lidelse type 2 virus (RHDV2).
English: (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Danish: (*) ≥70 % af de vaccinerede kaniner skal opnå en cELISA-antistoftiter på mindst 40.
English: 1 x 10 doses (5 ml).
Danish: 1 x 10 doser (5 ml).
English: Before use allow the vaccine to reach room temperature.
Danish: Lad vaccinen nå stuetemperatur inden indgivelsen.
English: 10 x 1 dose (0.5 ml).
Danish: 10 x 1 dosis (0,5 ml).
English: ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Danish: ≥70 % af de vaccinerede kaniner skal opnå en cELISA-antistoftiter på mindst 40.
English: Cardboard box of 1 glass vial of 40 doses (20 ml).
Danish: Kartonæske med 1 hætteglas a 40 doser (20 ml).
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 …..≥70% cELISA40* (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Danish: Inaktiveret kanin hæmoragisk lidelse type 2 virus (RHDV2), stamme V-1037: ……≥70 % cELISA40* (*) ≥70 % af de vaccinerede kaniner skal opnå en cELISA-antistoftiter på mindst 40.
English: ERAVAC emulsion for injection for rabbits
Danish: ERAVAC Injektionsvæske, emulsion til kaniner
English: Thiomersal: ………………..0.05 mg
Danish: Thiomersal: ………………..0,05 mg Hvidlig emulsion.
English: ERAVAC emulsion for injection for rabbits.
Danish: ERAVAC injektionsvæske, emulsion til kaniner.
English: CLINICAL PARTICULARS 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Kaniner
English: Cardboard box of 1 glass vial of 10 doses (5 ml).
Danish: Kartonæske med 1 hætteglas a 10 doser (5 ml).
English: Cardboard box of 10 glass vials of 1 dose (0.5 ml).
Danish: Kartonæske med 10 hætteglas a 1 dosis (0,5 ml).
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037……≥70% cELISA40*
Danish: Inaktiveret kanin hæmoragisk lidelse type 2 virus (RHDV2), stamme V-1037…………≥70 % cELISA40*
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ……≥70% cELISA40*
Danish: Inaktiveret kanin hæmoragisk lidelse type 2 virus (RHDV2), stamme V-1037 ..........≥70% cELISA40
English: Pregnancy:
Danish: INDLÆGSSEDDEL :
English: The European Commission granted a marketing authorisation valid throughout the EU for Controloc Control on 12 June 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Controloc Control den 12. juni 2009.
English: The full EPAR for Controloc Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Controloc Control findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Controloc Control.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Controloc Control.
English: The recommended dose of Controloc Control is one tablet once a day until symptoms have stopped.
Danish: Den anbefalede dosis Controloc Control er én tablet én gang dagligt, indtil symptomerne forsvinder.
English: Controloc Control pantoprazole
Danish: Controloc Control pantoprazol
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 Controloc Control.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Controloc Control.
English: It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Controloc Control.
Danish: Det anvendes til langtidsbehandling og anvendes desuden til behandling af et større felt af gastrointestinale sygdomme (lidelser i tarmene) end Controloc Control.
English: For more information about treatment with Controloc Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Controloc Control, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effects with Controloc Control (seen in around 1 patient in 100) are diarrhoea and headache.
Danish: De hyppigste bivirkninger ved Controloc Control (som optræder hos omkring 1 ud af 100 patienter) er diarré og hovedpine.
English: Controloc Control is a medicine that contains the active substance pantoprazole.
Danish: Controloc Control er et lægemiddel, der indeholder det aktive stof pantoprazol.
English: Controloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Danish: Controloc Control må ikke anvendes af patienter, der er overfølsomme (allergiske) over for pantoprazol, soja eller andre af indholdsstofferne.
English: Controloc Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Controloc.
Danish: Controloc Control svarer til et referencelægemiddel ved navn Controloc, som allerede er godkendt i Den Europæiske Union (EU).
English: Controloc Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Danish: Controloc Control anvendes til korttidsbehandling af symptomer på syrerefluks hos voksne.
English: The active substance in Controloc Control, pantoprazole, is a proton pump inhibitor.
Danish: Det aktive stof i Controloc Control, pantoprazol, er en protonpumpehæmmer.
English: Other information about Controloc Control
Danish: Andre oplysninger om Controloc Control:
English: Controloc Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Controloc Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Controloc Control.
English: The reference medicine, Controloc, is only available with a prescription.
Danish: Referencelægemidlet Controloc udleveres kun efter recept.
English: It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of Controloc Control without medical supervision is appropriate.
Danish: CHMP var også af den opfattelse, at adgangen til Controloc Control uden lægelig overvågning, baseret på erfaringerne med anvendelsen af pantoprazol, er passende.
English: What is the risk associated with Controloc Control?
Danish: Hvilken risiko er der forbundet med Controloc Control?
English: Why has Controloc Control been approved?
Danish: Hvorfor blev Controloc Control godkendt?
English: How has Controloc Control been studied?
Danish: Hvordan blev Controloc Control undersøgt?
English: What benefit has Controloc Control shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Controloc Control?
English: What is Controloc Control?
Danish: Hvad er Controloc Control?
English: How is Controloc Control used?
Danish: Hvordan anvendes Controloc Control?
English: What is Controloc Control used for?
Danish: Hvad anvendes Controloc Control til?
English: Outcome of re-examination
Danish: Resultat af re-vurderingen
English: Therefore, Caelyx was used instead.
Danish: Derfor blev Caelyx anvendt i stedet.
English: The recommendation was confirmed after re-examination.
Danish: Anbefalingen blev bekræftet efter revurderingen.