FrancophonIA/ELRC3.0 huggingface dataset:
English: New medicines for the treatment of neurodegenerative disorders
Danish: Nye lægemidler til behandling af neurodegenerative sygdomme
English: New therapies
Danish: Nye behandlingsformer
English: Twenty-two of these defect reports resulted in a product recall (20 related to human medicinal products and 2 related to veterinary medicinal products); the remainder were classified as minor.
Danish: I 22 af de indberettede tilfælde var det nødvendigt at tilbagekalde produktet (20 vedrørende humanmedicinske lægemidler og to vedrørende veterinærlægemidler).
English: 4.2 Medicines for veterinary use
Danish: 4.2 Veterinærlægemidler
English: The CHMP also gave its first scientific opinions in the context of cooperation with the World Health Organization (WHO) on medicines intended exclusively for use in countries outside of the EU.
Danish: I samarbejde med Verdenssundhedsorganisationen (WHO) fremsatte CHMP også sine første videnskabelige udtalelser om lægemidler, som udelukkende er beregnet til brug i lande uden for EU.
English: Availability of veterinary medicines
Danish: Udbuddet af veterinærlægemidler
English: Improving veterinary pharmacovigilance
Danish: Forbedring af overvågningen af veterinærlægemidler
English: its evaluation of available scientific data (well-established use) or on the historic use of that product in the European Community (traditional use).
Danish: En fællesskabsdrogemonografi omfatter HMPC's videnskabelige udtalelse om et givet plantelægemiddel baseret på udvalgets vurdering af de tilgængelige videnskabelige data (almindelig anerkendt anvendelse) eller på den historiske anvendelse af produktet i Det Europæiske Fællesskab (traditionel anvendelse).
English: A number of ‘Dear Doctor Letters' were agreed by the CHMP, in addition to public statements.
Danish: CHMP godkendte en række informationsbreve til læger og en række offentlige EMEA-meddelelser.
English: The Committee released for public consultation draft entries to the ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products' for Valerian root and Linseed.
Danish: Udvalget frigav udkast til fællesskabslisten over plantestoffer, plantepræparater og kombinationer heraf til anvendelse i traditionelle plantelægemidler vedrørende baldrianrod og hørfrø til offentlig høring.
English: 4.1 Medicines for human use
Danish: 4.1 humanmedicinske lægemidler
English: New medicines for the treatment of diabetes
Danish: Nye lægemidler til behandling af diabetes
English: Non-EU ADRs EU ADRs
Danish: ADR'er fra tredjelande ADR'er fra EU-lande
English: 5.4 Certificates of a medicinal product
Danish: 5.4 Certifikater for lægemidler
English: The Committee released for public consultation the first draft Community herbal monographs - for Valerian root, Psyllium seed, Linseed, Ispaghula husk and Ispaghula seed.
Danish: Udkastet omfattede baldrianrod, psylliumfrø, hørfrø, ispaghulaskaller og ispaghulafrø.
English: These include accelerated assessment, conditional marketing authorisation, and opinions on compassionate use of medicines.
Danish: Disse værktøjer omfatter en hurtigere vurdering, udstedelse af markedsføringstilladelser på visse betingelser og udtalelser om lægemidler, der anvendes af humanitære grunde.
English: 3.1 Medicines for human use 3.1.1 Orphan designation
Danish: 3.1 HUMANMEDICINSKE LÆGEMIDLER 3.1.1 Lægemidler til sjældne sygdomme
English: EMEA MISSION STATEMENT
Danish: EMEA'S IDÉGRUNDLAG
English: Commission Regulation (EC) No 2049/2005, OJ L329, 16.12.2005, p. 4.
Danish: For at fremme innovation og udvikling af nye lægemidler i små og mellemstore virksomheder og som følge af ikrafttrædelsen af den nye SMV-forordning2 om gennemførelse af bestemmelser om Kommissionens forordning (EF) nr. 2049/2005, EUT L 329 af 16.12.2005, s. 4.
English: The recommendations by the ad hoc working group to look at policy, compliance and regulatory aspects relating to EudraVigilance were adopted by the Heads of Medicines Agencies and the EMEA Management Board.
Danish: Cheferne for lægemiddelstyrelserne og EMEA's bestyrelse vedtog anbefalingerne fra den ad hocarbejdsgruppe, der havde til opgave at undersøge de politiske og lovgivningsmæssige aspekter af EudraVigilance.
English: Public health impact of opinions in 2005 Of the medicinal products intended for the European market for which a positive opinion was adopted: 2 are for use in cancer therapy, including the treatment of lung cancer - one of the highest causes of cancer-related deaths in the EU 7 are anti-infectives, of which 2 are for the treatment of HIV and AIDS 4 are for the treatment of metabolic disorders, of which 1 offers a new route of administration for diabetes patients by allowing insulin to be delivered via the lungs 5 are for the treatment of diseases of the central nervous system and sensory organs 6 are for the diagnosis or treatment of cardiovascular or pulmonary diseases.
Danish: syv antibiotika, hvoraf to er beregnet til behandling af hiv og aids fire til behandling af metaboliske sygdomme, hvoraf det ene produkt byder på en ny indgiftsmåde for diabetespatienter ved at tillade dispensering af insulin via lungerne,
English: Scientific-advice and protocol-assistance requests received
Danish: Anmodninger om videnskabelig rådgivning og protokolbistand
English: With the aim of promoting innovation and the development of new medicinal products by micro, small and medium-sized enterprises, the Agency launched the ‘SME Office', dedicated to addressing the particular needs of smaller companies, following the entry into force of the new SME Regulation3
Danish: incitamenter for SMV'er i EU's nye lægemiddellovgivning har agenturet oprettet et SMV-kontor, som har til opgave at imødekomme mindre virksomheders særlige behov.
English: Scientific opinions for non-EU markets
Danish: Biologiske lægemidler, der svarer til allerede godkendte lægemidler Videnskabelige udtalelser til markeder uden for EU
English: Incentives, including fee waivers for scientific advice, were introduced in 2005 to encourage companies to use the core-dossier approach.
Danish: For at tilskynde firmaerne til at anvende denne fremgangsmåde med et hoveddossier blev der i 2005 indført forskellige incitamenter, herunder gebyrfritagelser for videnskabelig rådgivning.
English: Scientific-advice and follow-up requests Protocol-assistance and follow-up requests
Danish: Anmodninger om protokolbistand og opfølgning
English: Basic EU and EEA contribution
Danish: Basisbidrag fra EU og EØS 18 430 000 EUR
English: The new legislation contains new tools to reinforce the Agency's capacity to ensure the safety of medicines, especially new pharmacovigilance obligations on companies and new provisions for submission of risk management plans.
Danish: Det kan bl.a. nævnes, at firmaerne pålægges nye forpligtelser vedrørende lægemiddelovervågning, og at der indføres nye bestemmelser for fremsendelse af risikostyringsplaner.
English: Designated orphan medicinal products.
Danish: Lægemidler, der er udpeget som lægemidler til sjældne sygdomme.
English: Welcomed two representatives of patients', one representative of doctors' and one representative of veterinarians' organisations as members of the Board Welcomed observers from Bulgaria and Romania Reappointed Thomas Lönngren as Executive Director of the EMEA Adopted strengthened rules on the handling of conflicts of interest of committee members and experts
Danish: Bød to repræsentanter for patientorganisationer, en repræsentant for lægeorganisationer og en repræsentant for dyrlægeorganisationer velkommen som medlemmer af bestyrelsen.
English: Notification to the EMEA became mandatory following the implementation of the revised pharmaceutical legislation.
Danish: Efter gennemførelsen af den reviderede lægemiddellovgivning blev det obligatorisk at holde agenturet underrettet vedrørende paralleldistribution.
English: New medicinal products (non-orphan) Orphan medicinal products Similar biological products
Danish: Nye lægemidler (ikke til børn)
English: Scientific advice requests received
Danish: Anmodninger om videnskabelig rådgivning og opfølgning
English: Among the 5 positive opinions were: 1 for a third-generation cephalosporin used to treat bacterial infections in pigs 1 for a novel combination endoparasiticide to treat roundworms and tapeworms in cats 3 vaccines for horses, against equine influenza and tetanus.
Danish: 1 en ny kombination af endoparasitter til behandling af rundorm og bændelorm hos katte
English: Eight applications for extension of a marketing authorisation were received: 6 related to pharmaceuticals and 2 to immunologicals.
Danish: Der blev modtaget otte ansøgninger om udvidelse af markedsføringstilladelser.
English: Payments to national authorities for rapporteur services
Danish: Udbetalinger til nationale myndigheder for indberetningstjenester 35 492 000 EUR
English: The infusion should last around 4 hours.
Danish: Infusionen skal vare omkring fire timer.
English: The recommended dose is 2 mg per kilogram body weight, given once a week.
Danish: Den anbefalede dosis er 2 mg pr. kg legemsvægt én gang ugentligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vimizim on 28 April 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vimizim den 28. april 2014.
English: These are usually mild or moderate and more frequent in the first 12 weeks of treatment.
Danish: Normalt er disse bivirkninger lette eller moderate, og de optræder oftere i de første 12 uger af behandlingen.
English: This is a summary of the European public assessment report (EPAR) for Vimizim.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vimizim.
English: Patients may also be given a medicine to prevent fever.
Danish: Der kan også gives et lægemiddel til at forebygge feber.
English: The company will also set up a registry to assess the long-term benefits and risks of Vimizim.
Danish: Virksomheden skal derudover oprette et register til vurdering af de langsigtede fordele og risici ved Vimizim.
English: Other information about Vimizim
Danish: Andre oplysninger om Vimizim
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vimizim'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) afgjorde, at fordelene ved Vimizim overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Vimizim is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vimizim anvendes så risikofrit som muligt.
English: If the enzyme is not present, or only present in very small quantities, GAGs cannot be broken down and they build up in bones and organs.
Danish: Hvis det mangler eller kun findes i meget små mængder, bliver GAG ikke nedbrudt, men ophobes i knogler og organer.
English: Because the number of patients with MPS IVA is low, the disease is considered ‘rare', and Vimizim was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009.
Danish: Da antallet af patienter med mukopolysakkaridose type IVA er lavt, bliver sygdommen anset for at være “sjælden”, og Vimizim blev udpeget som “lægemiddel til sjældne sygdomme” den 24. juli 2009.
English: What measures are being taken to ensure the safe and effective use of Vimizim?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vimizim?
English: The medicine can only be obtained with a prescription and should be given by an appropriately trained healthcare professional.
Danish: Lægemidlet fås kun på recept og skal gives af en fagligt kvalificeret sundhedsperson.
English: Before treatment, the patients could walk on average just over 200 metres in six minutes.
Danish: Før behandlingen kunne patienterne i gennemsnit gå lidt over 200 meter på seks minutter.
English: What is Vimizim and what is it used for?
Danish: Hvad er Vimizim, og hvad anvendes det til?
English: Why is Vimizim approved?
Danish: Hvorfor er Vimizim blevet godkendt?
English: The full EPAR and risk management plan summary for Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og en sammenfatning af risikohåndteringsplanen for Vimizim findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is not intended to provide practical advice on how to use Vimizim.
Danish: Det er ikke en praktisk vejledning i, hvordan Vimizim bør anvendes.
English: What are the risks associated with Vimizim?
Danish: Hvilke risici er der forbundet med Vimizim?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Vimizim findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Serious but uncommon infusion-related reactions include anaphylaxis (severe allergic reaction).
Danish: En alvorlig, men ikke almindelig reaktion på infusionen er svær allergisk reaktion (anafylaksi).
English: Before receiving Vimizim, the patient should be given a medicine to prevent an allergic reaction to Vimizim.
Danish: Før Vimizim indgives, skal der gives et lægemiddel, der forebygger allergisk reaktion på Vimizim.
English: Study results also suggested that the medicine could improve how well patients breathe or climb stairs, and in children, how well they grew.
Danish: Undersøgelsen tyder desuden på, at lægemidlet kan forbedre patienternes vejrtrækning og evne til at gå op ad trapper samt deres vækst.
English: For more information about treatment with Vimizim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vimizim, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Vimizim, elosulfase alfa, is a copy of the human enzyme N-acetylgalactosamine-6-sulfatase.
Danish: Det aktive stof i Vimizim, elosulfase alfa, er en kopi af det naturlige menneskelige enzym N-acetylgalactosamin-6-sulfatase.
English: Vimizim is a medicine that contains the active substance elosulfase alfa.
Danish: Vimizim er et lægemiddel, der indeholder det aktive stof elosulfase alfa.
English: This causes the signs of the disease, the most noticeable being short bones, difficulty moving and breathing, clouding of the eyes and hearing loss.
Danish: Tegn på sygdommen er især korte knogler, nedsat bevægelighed og vejrtrækning, sløret syn og høretab.
English: Vimizim must not be used in patients who have experienced life-threatening allergic reactions to elosulfase alfa or any of the other ingredients in Vimizim.
Danish: Vimizim må ikke anvendes hos patienter, der har haft en livstruende allergisk reaktion på elosulfase alfa eller på andre af indholdsstofferne.
English: After 6 months, patients treated with the recommended dose of Vimizim could walk an extra 37 metres on average in six minutes, compared with an increase of 14 metres in patients receiving placebo.
Danish: Efter seks måneders behandling kunne de patienter, der havde fået den anbefalede dosis af Vimizim, gå gennemsnitligt 37 m længere på seks minutter, mens de, der fik placebo, kunne gå 14 m længere.
English: Treatment with Vimizim should be supervised by a doctor experienced in MPS IVA or similar diseases.
Danish: Behandlingen med Vimizim skal ske under opsyn af en læge, der har erfaring med mukopolysakkaridose type IVA eller tilsvarende sygdomme.
English: The main measure of effectiveness was the change in the distance patients could walk in six minutes after 6 months of treatment.
Danish: Virkningen blev hovedsagelig bedømt på ændringen i den distance, patienten kunne gå på seks minutter efter 6 måneders behandling.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vimizim, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Vimizim er der sikkerhedsoplysninger baseret på denne plan, bl.a. passende forholdsregler for sundhedspersonale og patienter.
English: For the full list of all side effects reported with Vimizim, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Vimizim fremgår af indlægssedlen.
English: The Committee also considered that the safety profile of Vimizim appears manageable and serious side effects are uncommon, but further long-term safety data are to be collected.
Danish: Alvorlige bivirkninger er ualmindelige, men der må indsamles yderligere langsigtede sikkerhedsdata.
English: Enzyme replacement therapy provides patients with the enzyme they are lacking.
Danish: Ved behandlingen får patienten tilført det manglende enzym.
English: For practical information about using Vimizim, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vimizim, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Elosulfase alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce the enzyme.
Danish: Det produceres af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere enzymet.
English: The replacement enzyme helps to break down GAGs and stop them building up in cells, thereby improving the symptoms of MPS IVA.
Danish: Erstatningsenzymet nedbryder GAG og forhindrer, at de ophobes i cellerne.
English: Vimizim has been investigated in one main study involving 176 patients with MPS IVA, which compared Vimizim with placebo (a dummy treatment).
Danish: Vimizim blev undersøgt i én hovedundersøgelse, der omfattede 176 patienter med mukopolysakkaridose type IVA.
English: What benefits of Vimizim have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vimizim?
English: Vimizim is an enzyme replacement therapy.
Danish: Vimizim er enzymerstatningsbehandling.
English: The CHMP concluded that, following 6 months of treatment, Vimizim was shown to be effective at improving the distance patients could walk in six minutes, and this was accompanied by other beneficial effects, including improved ability to carry out daily activities.
Danish: CHMP konkluderede, at det var påvist, at Vimizim var effektivt til at forbedre den afstand, patienterne kunne gå på seks minutter efter 6 måneders behandling.
English: How does Vimizim work?
Danish: Hvordan virker Vimizim?
English: Vimizim is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Danish: Vimizim leveres som et koncentrat, der opløses og derefter indgives med drop (ved infusion) i en vene.
English: How is Vimizim used?
Danish: Hvordan anvendes Vimizim?
English: This disease is caused by the lack of an enzyme called N-acetylgalactosamine-6-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
Danish: Dette enzym er nødvendigt for at nedbryde stoffer af typen glycosaminoglycaner (GAG).
English: The most common side effects with Vimizim (which may affect more than 1 in 10 people) are infusionrelated reactions, including headache, nausea (feeling sick), vomiting, fever, chills and abdominal pain (stomach ache).
Danish: De almindeligste bivirkninger med Vimizim (som kan optræde hos mere end 1 af hver 10 behandlede) er reaktioner på infusionen.
English: In addition, the company that makes Vimizim must ensure that all healthcare professionals expected to prescribe or use the medicine are provided with educational material, informing them of how the medicine should be used and the risk of severe allergic reactions.
Danish: Desuden skal den virksomhed, der fremstiller Vimizim, udlevere oplysningsmateriale til de læger, som kan tænkes at ville ordinere lægemidlet.
English: It is used to treat patients with mucopolysaccharidosis type IVA (MPS IVA, also known as Morquio A syndrome).
Danish: Det bruges til behandling af sygdommen mukopolysakkaridose type IVA (kaldes også Morquio A-syndrom), som skyldes mangel på enzymet N-acetylgalactosamin-6-sulfatase.
English: Bioavailability was shown to be approximately 70%.
Danish: Biotilgængeligheden blev påvist at være cirka 70%.
English: ATCvet code: QP53BX03.
Danish: ATCvet-kode: QP53BX03.
English: Plasma protein binding is high (~99%).
Danish: Plasmaproteinbinding er høj (~99%).
English: The recommended dosage regimen should be followed.
Danish: Det anbefalede doseringsregime bør følges.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/02/2011.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 11/02/2011.
English: The recommended dosage regimen should be followed (see section 4.10 for information regarding overdose).
Danish: Det anbefalede dosisregime bør følges (se punkt 4.10 for information om overdosis).
English: Children should not come into contact with the veterinary medicinal product.
Danish: Børn må ikke komme i kontakt med veterinærlægemidlet.
English: Pharmacotherapeutic group: other ectoparasiticides for systemic use.
Danish: Farmakoterapeutisk gruppe: andre ektoparasiticider til systemisk brug.
English: Spinosad has been shown to be a substrate for P-glycoprotein (PgP).
Danish: Spinosad er blevet påvist at være et substrat for P-glykoprotein (PgP).
English: All dogs and cats within the household should be treated.
Danish: Alle hunde og katte i husstanden bør behandles.
English: These effects are caused primarily by activation of nicotinic acetylcholine receptors (nAChRs).
Danish: Disse virkninger er hovedsagligt forårsaget af aktivering af nikotinerge acetylkolin receptorer (nAChR'er).
English: EU/2/10/115/017 (90 mg, 6 tablets)
Danish: EU/2/10/115/017 (90 mg, 6 tabletter)
English: The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Danish: Veterinærlægemidlet kan anvendes som del af en behandlingsstrategi i kontrollen af loppebetinget allergisk dermatitis (FAD).
English: Regular monthly treatments with Comfortis break the fleas' life cycle and may be needed to control the flea population in contaminated households.
Danish: Regelmæssig månedlig behandling med Comfortis afbryder loppernes livscyklus og kan være nødvendigt for at kontrollere loppebestanden i kontaminerede husstande.
English: If the dog or cat does not accept the tablets directly they may be administered with food, or directly by opening the animal's mouth and placing the tablet onto the back of the tongue.
Danish: Hvis hunden eller katten ikke vil tage tabletterne direkte, kan de gives i maden eller direkte ved at åbne dyrets mund og anbringe tabletten bagerst på tungen.
English: The veterinary medicinal product should be administered with food or immediately after feeding.
Danish: Veterinærlægemidlet skal administreres med mad eller umiddelbart efter fodring.
English: SPECIAL STORAGE CONDITIONS Keep the blister in the outer carton.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar blisteren i den ydre karton.
English: Seek veterinary advice regarding information on the optimal time to start treatment with this product.
Danish: Spørg dyrlægen om råd angående det optimale tidspunkt for start af behandling med produktet.
English: If fleas reappear in the fourth week, the treatment interval can be shortened by up to 3 days in dogs.
Danish: Hvis der ses lopper igen i den fjerde uge, kan behandlingsintervallet afkortes med op til 3 dage hos hunde.
English: Insecticidal activity against new infestations persists for up to 4 weeks.
Danish: Insektbekæmpende aktivitet mod nye infestationer vedbliver i op til 4 uger.