FrancophonIA/ELRC3.0 huggingface dataset:
English: VPRIV is a powder for solution for infusion.
Danish: VPRIV er et pulver til infusionsvæske, opløsning.
English: • Annex: SmPC; Healthcare Professional Reconstitution Guide, Infusion diary
Danish: • Bilag: Produktresume, rekonstitutionsvejledning for læger og sundhedspersonale,
English: The most frequently reported symptoms of hypersensitivity include nausea, rash, dyspnoea, back pain, chest discomfort (including chest tightness), urticaria, arthralgia, and headache.
Danish: De hyppigst indberettede symptomer på overfølsomhed omfatter kvalme, udslæt, dyspnø, rygsmerter, brystgener (herunder trykken for brystet), urticaria, artralgi og hovedpine.
English: VPRIV is a long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
Danish: VPRIV er en langsigtet enzymerstatningsterapi, der anvendes ved Gauchers sygdom, type 1.
English: Table 1: Adverse reactions reported with VPRIV observed in patients with type 1 Gaucher disease Italic text denotes post-marketing event.
Danish: Tabel 1: Bivirkninger rapporteret ved behandling med VPRIV og observeret hos patienter med Gauchers sygdom, type 1.
English: Study 032 was a 12-month, randomized, double-blind, parallel-group efficacy study in 25 patients aged 2 years and older who were naïve to ERT (defined as having not been treated with ERT for at least 30 months prior to study entry).
Danish: Studie 032 var et 12-måneders, randomiseret, dobbeltblindet effektstudie med parallelle grupper med 25 patienter fra 2 år og opefter, der ikke tidligere var behandlet med enzymerstatningsterapi (defineret som, at de ikke havde fået enzymerstatningsterapi gennem de seneste 30 måneder før inklusion i studiet).
English: Powder for solution for infusion 5 vials
Danish: Pulver til infusionsvæske, opløsning 5 hætteglas
English: Upon reconstitution, mix vials gently.
Danish: Efter rekonstituering blandes indholdet af hætteglassene forsigtigt.
English: After reconstitution, one ml of solution contains 100 Units of velaglucerase alfa
Danish: Efter opløsning indeholder 1 ml infusionsvæske 100 enheder velaglucerase alfa.
English: Nervous system disorders headache, dizziness
Danish: Hovedpine, svimmelhed
English: If any of these happen tell your doctor immediately.
Danish: Hvis du oplever dette, skal du straks kontakte en læge.
English: No dosing adjustment is recommended in patients with renal or hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of velaglucerase alfa.
Danish: På baggrund af den aktuelle viden om velaglucerase alfas farmakokinetik og farmakodynamik anbefales dosisjustering ikke hos patienter med nedsat nyre- eller leverfunktion.
English: Description of selected adverse reactions Vomiting
Danish: Beskrivelse af udvalgte bivirkninger
English: Musculoskeletal and connective tissue disorders bone pain, arthralgia, back pain
Danish: Knoglesmerter, artralgi, rygsmerter
English: How to store VPRIV
Danish: Brug ikke VPRIV
English: The marketing authorisation holder is Boehringer Ingelheim International GmbH.
Danish: Indehaveren af markedsføringstilladelsen er Boehringer Ingelheim International GmbH.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mirapexin on 23 February 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Mirapexin den 23. februar 1998.
English: This document is a summary of the European Public Assessment Report (EPAR) for Mirapexin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Mirapexin.
English: The full EPAR for Mirapexin can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Mirapexin findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
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 Mirapexin.
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 Mirapexin.
English: Mirapexin must be given less often in patients who have problems with their kidneys.
Danish: Mirapexin skal gives mindre hyppigt til patienter, som har problemer med deres nyrer.
English: For more information about treatment with Mirapexin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mirapexin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Mirapexin is used to treat the symptoms of the following diseases:
Danish: Mirapexin anvendes til behandling af symptomerne på følgende sygdomme:
English: Mirapexin can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
Danish: Mirapexin kan enten anvendes alene eller i kombination med levodopa (et andet lægemiddel til behandling af Parkinsons sygdom) på ethvert stadium af sygdommen, herunder de senere stadier, når levodopa begynder at blive mindre effektivt.
English: Mirapexin pramipexole
Danish: Mirapexin pramipexol
English: Mirapexin is used when a specific cause for the disorder cannot be identified.
Danish: Mirapexin anvendes, når det ikke er muligt at fastslå en bestemt årsag til sygdommen.
English: Mirapexin tablets should be swallowed with water.
Danish: Mirapexin-tabletter sluges med vand.
English: Other information about Mirapexin:
Danish: Andre oplysninger om Mirapexin:
English: Mirapexin was also more effective than levodopa at improving movement symptoms in early disease.
Danish: Mirapexin var også mere effektivt end levodopa til at forbedre bevægelsessymptomer i et tidligt stadium af sygdommen.
English: The CHMP decided that Mirapexin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Mirapexin er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Mirapexin.
English: The results of the second study were insufficient to prove the long-term effectiveness of Mirapexin.
Danish: Resultaterne af den anden undersøgelse var ikke tilstrækkelige til at bevise, at Mirapexin var effektivt ved langtidsbehandling.
English: Mirapexin should not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients.
Danish: Mirapexin bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for pramipexol eller andre af indholdsstofferne.
English: Mirapexin is a medicine that contains the active substance pramipexole.
Danish: Mirapexin er et lægemiddel, der indeholder det aktive stof pramipexol.
English: The active substance in Mirapexin, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine).
Danish: Det aktive stof i Mirapexin, pramipexol, er en dopaminagonist (et stof, som efterligner virkningen af dopamin).
English: The first compared Mirapexin with placebo over 12 weeks in 344 patients and measured the improvement in symptoms.
Danish: Den første sammenlignede Mirapexin med placebo i 12 uger hos 344 patienter og målte forbedringerne i symptomerne.
English: For restless legs syndrome, Mirapexin immediate-release tablets should be taken once a day, two to three hours before going to bed.
Danish: Ved Restless Legs Syndrome skal Mirapexin-tabletter med øjeblikkelig frigivelse tages én gang dagligt to til tre timer før sengetid.
English: The most common side effect with Mirapexin (seen in more than 1 patient in 10) is nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Mirapexin (som optræder hos flere end 1 ud af 10 patienter) er kvalme.
English: In restless legs syndrome, Mirapexin immediate-release tablets were more effective than placebo at reducing symptoms over 12 weeks, but the difference between placebo and Mirapexin was greatest after four weeks before getting smaller.
Danish: Mirapexin-tabletter med øjeblikkelig frigivelse var mere effektive end placebo til at reducere symptomer ved Restless Legs Syndrome i løbet af 12 uger, men forskellen mellem placebo og Mirapexin var størst efter fire uger og blev siden mindre.
English: The second included 150 patients who took Mirapexin for six months, and compared the effects of remaining on Mirapexin with switching to placebo.
Danish: I den anden undersøgelse af 150 patienter, som fik Mirapexin i seks måneder, sammenlignedes virkningerne af at fortsætte med Mirapexin med at skifte til placebo.
English: For the full list of all side effects reported with Mirapexin, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Mirapexin fremgår af indlægssedlen.
English: Why has Mirapexin been approved?
Danish: Hvorfor blev Mirapexin godkendt?
English: In the study of patients with advanced Parkinson's disease, patients taking Mirapexin immediaterelease tablets had larger improvements after 24 weeks of steady-dose treatment than those taking placebo.
Danish: I undersøgelsen af patienter med fremskreden Parkinsons sygdom var der større bedring hos de patienter, der fik 24 ugers behandling med Mirapexin-tabletter med øjeblikkelig frigivelse i fast dosering, end hos dem, der fik placebo.
English: What is the risk associated with Mirapexin?
Danish: Hvilken risiko er der forbundet med Mirapexin?
English: In Parkinson's disease, Mirapexin immediate-release tablets have been studied in five main studies.
Danish: Virkningen af Mirapexin-tabletter med øjeblikkelig frigivelse til behandling af Parkinsons sygdom er blevet undersøgt i fem hovedundersøgelser.
English: The fifth study compared Mirapexin with levodopa in 300 patients with early disease, and measured the number of patients who had movement symptoms.
Danish: I den femte undersøgelse blev virkningen af Mirapexin sammenlignet med virkningen af levodopa hos 300 patienter med sygdommen i et tidligt stadium.
English: What is Mirapexin?
Danish: Hvad er Mirapexin?
English: How has Mirapexin been studied?
Danish: Hvordan blev Mirapexin undersøgt?
English: What is Mirapexin used for?
Danish: Hvad anvendes Mirapexin til?
English: Four studies compared Mirapexin with placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa.
Danish: Tre undersøgelser omfattede i alt 886 patienter, som var i et tidligt stadium af sygdommen, og som ikke fik levodopa.
English: What benefit has Mirapexin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Mirapexin?
English: How is Mirapexin used?
Danish: Hvordan anvendes Mirapexin?
English: How does Mirapexin work?
Danish: Hvordan virker Mirapexin?
English: In restless legs syndrome, Mirapexin immediate-release tablets have been studied in two main studies.
Danish: Der blev også foretaget to hovedundersøgelser af virkningen af Mirapexin-tabletter med øjeblikkelig frigivelse til behandling af Restless Legs Syndrome.
English: Conditions to the marketing authorisations for Numeta G16%E and associated names
Danish: Betingelser for markedsføringstilladelserne for Numeta G16%E og relaterede navne
English: By the end of Q3 2015 Within 3 months after CMDh agreement
Danish: Senest ved udgangen af Q3 2015
English: The MAH should submit a revised risk management plan including proposals for evaluating the effectiveness of the risk minimisation measures.
Danish: Indehaveren af markedsføringstilladelsen forelægger en revideret risikostyringsplan med forslag til evaluering af effektiviteten af risikominimeringsforanstaltningerne.
English: The MAH should conduct a prospective non-interventional postauthorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice.
Danish: Indehaveren af markedsføringstilladelsen udfører en prospektiv, ikke-interventionel sikkerhedsundersøgelse efter markedsføring til yderligere vurdering af de iagttagne magnesiumværdier hos nyfødte og børn op til to år, der behandles med Numeta G16%E i rutinemæssig klinisk praksis.
English: National competent authorities of Member States or reference Member State if applicable, shall ensure that the following conditions are fulfilled by the MAH for Numeta G16%E:
Danish: De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaten sikrer, at indehaveren af markedsføringstilladelsen for Numeta G16%E opfylder følgende vilkår:
English: In very rare cases a higher temperature may occur for up to 2 days.
Danish: I meget sjældne tilfælde kan der forekomme en højere temperatur i op til 2 dage.
English: It is sometimes associated with pain and very rarely with mild depression.
Danish: Det er undertiden forbundet med smerte og meget sjældent med mild depression.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Equip WNV on 21 November 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Equip WNV den 21. november 2008.
English: The vaccine is initially given as two injections into the muscles in the neck.
Danish: Vaccinen gives først som to injektioner i musklerne i halsen.
English: As with any vaccine rare, occasional allergic reactions may occur.
Danish: Som med alle vacciner kan der i sjældne tilfælde forekomme allergiske reaktioner.
English: West Nile virus strain VM-2
Danish: Vest-Nil-virusstamme VM-2
English: A number of field trials were also conducted involving vaccinated and non-vaccinated horses.
Danish: Der blev derudover udført en række feltundersøgelser med vaccinerede og ikke-vaccinerede heste.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet (organismens naturlige forsvar), hvordan det skal forsvare sig imod en sygdom.
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 milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og kødet eller mælken kan anvendes til menneskeligt konsum.
English: The laboratory studies showed that horses developed protection three weeks after the primary vaccination course.
Danish: Laboratorieundersøgelserne viste, at hestene udviklede beskyttelse tre uger efter det indledende vaccinationsforløb.
English: The vaccine also contains an ‘adjuvant' to enhance the immune response.
Danish: Vaccinen indeholder desuden et "adjuvans", der styrker immunreaktionen.
English: The first is given from six month of age and the second is given three to five weeks later.
Danish: Den første injektion gives, når dyret er 6 måneder gammelt, og den anden injektion gives tre til fem uger senere.
English: The withdrawal period for Equip WNV is zero days.
Danish: Tilbageholdelsestiden for Equip WNV er 0 dage.
English: A small number of animals may show temporary local reactions, in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter), that resolve by themselves within 1 to 2 days.
Danish: Et lille antal dyr kan få midlertidige lokale reaktioner i form af en mild, lokal hævelse på injektionsstedet efter vaccinationen (maksimalt 1 cm i diameter), der forsvinder af sig selv i løbet af 1-2 dage.
English: Equip WNV is a vaccine that contains inactivated (killed) West Nile virus.
Danish: Equip WNV er en vaccine, der indeholder en inaktiveret (dræbt) Vest-Nil-virus.
English: It is available as an emulsion for injection.
Danish: Den leveres som injektionsvæske, emulsion.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equip WNV outweigh the risks for the approved indication and recommended that Equip WNV be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Equip WNV opvejer risiciene ved den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Equip WNV.
English: If the product is accidentally self-injected, ingested or spilled onto skin medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Ved uforvarende selvinjektion, indtagelse eller spild på huden skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: In addition a laboratory study was performed in which vaccinated and non-vaccinated horses were injected with West Nile virus lineage 2 directly into the central nervous system three weeks after initial vaccination.
Danish: Desuden blev der udført en laboratorieundersøgelse, hvor vaccinerede og ikke-vaccinerede heste blev inficeret med Vest-Nil-virus, oprindelse 2, direkte i centralnervesystemet tre uger efter den indledende vaccination.
English: West Nile virus is an infection that is transmitted by mosquitoes and can cause severe disease and fatal brain infections in infected horses.
Danish: Vest-Nil-virus er en infektion, der overføres af myg, og som kan medføre svær sygdom og dødelig hjernebetændelse hos angrebne heste.
English: Other information about Equip WNV:
Danish: Andre oplysninger om Equip WNV:
English: The main measure of effectiveness was reduction of virus in the blood and the frequency and duration of clinical signs.
Danish: Virkningen blev hovedsagelig bedømt på reduktionen af virus i blodet og hyppigheden og varigheden af kliniske tegn.
English: When Equip WNV is given to horses, their immune system recognises the virus contained in the vaccine as ‘foreign' and makes antibodies to defend against it.
Danish: Når Equip WNV gives til heste, opfatter dyrets immunsystem virussen i vaccinen som "fremmed" og danner antistoffer til forsvar mod denne.
English: The duration of protection was 12 months after the primary vaccination course for lineage 1 strains but was not established for lineage 2 strains.
Danish: Beskyttelsen varede i 12 måneder efter det primære vaccinationsforløb for oprindelse 1-virusstammer, men blev ikke bedømt for oprindelse 2-stammer.
English: Equip WNV is used to vaccinate horses from six months of age against West Nile virus.
Danish: Equip WNV anvendes til vaccination af heste, når dyret er seks måneder gammelt, mod Vest-Nilvirus.
English: Outbreaks of West Nile virus in Europe have been caused by two strains of the virus called lineage 1 and lineage 2.
Danish: Udbrud af Vest-Nil-virus i Europa skyldes to stammer af denne virus, der betegnes oprindelse 1 og oprindelse 2.
English: In the future, if the animals are exposed to West Nile virus the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for Vest-Nil-virus, vil immunsystemet kunne reagere hurtigere, hvilket vil hjælpe til at beskytte mod sygdommen.
English: After this a single injection should be given each year as a booster.
Danish: Vaccinationen gentages hvert år med en enkelt injektion af en "boosterdosis".
English: The vaccine is used to reduce the number of horses with the West Nile virus lineage 1 or 2 in their blood (viraemia) and to reduce the severity and duration of clinical signs of West Nile virus disease caused by lineage 2 strains.
Danish: Vaccinen anvendes til at reducere antallet af heste med Vest-Nil-virus, oprindelse 1 eller 2 i blodet (viræmi) og til at reducere sværhedsgraden og varigheden af de kliniske tegn på Vest-Nil-virussygdommen forårsaget af oprindelse 2-stammer.
English: What is the risk associated with Equip WNV?
Danish: Hvilken risiko er der forbundet med Equip WNV?
English: Why has Equip WNV been approved?
Danish: Hvorfor blev Equip WNV godkendt?
English: The field studies showed that Equip WNV protects horses from West Nile virus by reducing the number of viraemic horses after infection with West Nile virus lineage 1 or 2 strains and by reducing the duration and severity of clinical signs against lineage 2 strains.
Danish: Feltundersøgelserne viste, at Equip WNV beskytter heste mod Vest-Nil-virus, idet færre heste har virus i blodet efter infektion med Vest-Nil-virusstammer af oprindelse 1 eller 2, og varigheden og sværhedsgraden af de kliniske tegn ved infektion med oprindelse 2-virusstammer mindskes.
English: What is Equip WNV?
Danish: Hvad er Equip WNV?
English: The effectiveness of Equip WNV was studied in a number of laboratory studies that examined how long it took to achieve protection after vaccination and how long protection lasted in horses injected with West Nile virus lineage 1.
Danish: Det blev her registreret, hvor lang tid det tog at opnå beskyttelse efter vaccinationen, og hvor længe beskyttelsen varede hos heste, der var injiceret med Vest-Nil-virus, oprindelse 1.
English: How has Equip WNV been studied?
Danish: Hvordan blev Equip WNV undersøgt?
English: What is Equip WNV used for?
Danish: Hvad anvendes Equip WNV til?
English: What benefit has Equip WNV shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Equip WNV?
English: How does Equip WNV work?
Danish: Hvordan virker Equip WNV?
English: The Member States competent authorities will continue to keep the product under regular review.
Danish: Medlemsstaternes kompetente myndigheder vil fortsat overvåge produktet løbende.
English: The final opinion was converted into a Decision by the European Commission on 19 August 2005.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 19. august 2005.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 31 REFERRAL
Danish: UDTALELSE FRA UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 31
English: The referral procedure started on 20 January 2005.
Danish: Henvisningsproceduren indledtes den 20. januar 2005.
English: For more information see: http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con2018037.pdf
Danish: For yderligere oplysninger se: http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con2018037.pdf
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II.
Danish: Listen over de pågældende produktnavne findes i bilag I. De faglige konklusioner findes i bilag II.
English: Dr Barbara van Zwieten-Boot was appointed Rapporteur and Dr Gonzalo Calvo Rojas, Dr Eric Abadie, Dr Karl Broich and Dr Julia Dunne were appointed Co-Rapporteurs.
Danish: Dr. Barbara van Zwieten-Boot blev udpeget som rapportør, og dr. Gonzalo Calvo Rojas, dr. Eric Abadie, dr. Karl Broich og dr. Julia Dunne blev udpeget som medrapportører.
English: This Opinion recommended the maintenance of the Marketing Authorisations in accordance with the amendments to the relevant sections of the Summaries of Product Characteristics and Package Leaflets as set out in Annexes III and IV.
Danish: I denne udtalelse anbefaledes det at opretholde markedsføringstilladelserne i overensstemmelse med ændringerne af de relevante afsnit i produktresuméerne og indlægssedlerne som angivet i bilag III og IV.
English: Written explanations were provided by the Marketing Authorisation Holders by 22 February 2005.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige forklaringer den 22. februar 2005.
English: Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 21 April 2005.
Danish: Bemærkninger: Oplysningerne i dette dokument og i bilagene afspejler kun CHMP's udtalelse af 21. april 2005.