FrancophonIA/ELRC3.0 huggingface dataset:
English: It attaches to the HER2 protein on the cancer cells, and so blocks its action.
Danish: Det binder til HER2-proteinet på kræftcellerne og blokerer dermed proteinets virkning.
English: The European Medicines Agency considered that Nerlynx had been shown to be of benefit in women with HER2-positive early breast cancer, and that this benefit seemed to be mainly in women with hormone-receptor positive disease.
Danish: Det Europæiske Lægemiddelagentur var af den opfattelse, at det er påvist, at Nerlynx er gavnligt hos kvinder med tidlige stadier af HER2-positiv brystkræft, og at denne fordel hovedsagelig ses hos kvinder med hormonreceptor-positiv sygdom.
English: Nerlynx has been shown to be more effective than placebo (a dummy treatment) at preventing the cancer from coming back in one main study involving 2,840 women with HER2-positive early breast cancer who had already received trastuzumab.
Danish: Det er påvist, at Nerlynx er mere effektivt end placebo (ikke-aktivt stof) til at forhindre kræften i at vende tilbage, i et hovedstudie med 2.840 kvinder med tidlige stadier af HER2-positiv brystkræft, som allerede havde fået trastuzumab.
English: Nerlynx is a breast cancer medicine used to reduce the risk of the disease coming back in patients with early breast cancer who have had surgery.
Danish: Nerlynx er et lægemiddel til behandling af brystkræft, der anvendes til at reducere risikoen for, at sygdommen vender tilbage hos patienter med tidlige stadier af brystkræft, som er blevet opereret.
English: The company that markets Nerlynx will provide a guide for healthcare professionals who prescribe or dispense the medicine, and educational material for patients and carers.
Danish: Den virksomhed, der markedsfører Nerlynx, skal udarbejde en vejledning til sundhedspersoner, som ordinerer eller udleverer lægemidlet, og informationsmateriale til patienter og omsorgspersoner.
English: When only women with hormone-receptor positive cancer were considered, about 95% of those given Nerlynx lived another year without the cancer coming back versus 91% of those given placebo.
Danish: Hvis man kun ser på kvinder med hormonreceptor-positiv kræft, levede ca. 95 % af dem, der fik Nerlynx, et år mere, uden at kræften vendte tilbage, sammenholdt med 91 % af dem, der fik placebo.
English: What are the risks associated with Nerlynx?
Danish: Hvilke risici er der forbundet med Nerlynx?
English: Around 94% of the women given a year's treatment with Nerlynx lived for 1 further year after stopping Nerlynx without their cancer coming back versus 92% of those given placebo.
Danish: Ca. 94 % af de kvinder, der fik et års behandling med Nerlynx, levede 1 år mere efter ophør af Nerlynx, uden at kræften vendte tilbage, sammenholdt med 92 % af dem, der fik placebo.
English: These materials will explain the effects of Nerlynx on the gut, such as diarrhoea, and how to manage them, and will give advice on the need for patients to tell their healthcare professionals of side effects.
Danish: Disse materialer skal forklare virkningen af Nerlynx på mave-tarm-kanalen, herunder diarré, og hvordan dette kan behandles; materialerne skal understrege betydningen af, at patienterne fortæller deres sundhedspersoner om eventuelle bivirkninger.
English: How is Nerlynx used?
Danish: Hvordan anvendes Nerlynx?
English: For the full list of side effects of Nerlynx, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Nerlynx fremgår af indlægssedlen.
English: Nerlynx treatment should be started and supervised by a doctor experienced in giving cancer medicines and can only be obtained with a prescription.
Danish: Behandlingen med Nerlynx skal iværksættes og overvåges af en læge med erfaring i administration af kræftmedicin.
English: What benefits of Nerlynx have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Nerlynx?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nerlynx have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nerlynx.
English: How does Nerlynx work?
Danish: Hvordan virker Nerlynx?
English: --1 Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Danish: --1 Levende myxoma vector RHD virus stamme 009 : ≥103.0 og ≤106.1 FFU* *Focus Forming Units
English: Package size Withdrawal period
Danish: Indhold Pakningsstørrelse
English: Lyophilisate: vial (glass); Solvent: vial (PET)
Danish: Hætteglas (PET)
English: Content
Danish: EU-nummer
English: Blister (PVC/PE/PCTFE/ALU)
Danish: Oral anvendelse Blisterfolie (PVC/PE/PCTFE/ALU)
English: 56 tablets (multipack)
Danish: 56 tabletter (multipakning)
English: MA(EU) Number
Danish: MF (EU)-nummer
English: 250 mg Film-coated tablet Oral use
Danish: 250 mg Filmovertrukket tablet
English: Two studies also looked at the how long it took before the patients had their first severe exacerbation.
Danish: I to af undersøgelserne så man ligeledes på, hvor lang tid det varede, inden patienterne oplevede den første alvorlige forværring.
English: The main measures of effectiveness in the studies were based on the change in FEV1 after 12 weeks.
Danish: De primære effektmål i undersøgelserne var baseret på ændringen i FEV1 efter 12 uger.
English: What is Zenhale?
Danish: Hvad er Zenhale?
English: The effects of Zenhale were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Zenhale blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Formoterol is a long-acting beta-2 agonist.
Danish: Formoterol er en langtidsvirkende beta-2-agonist.
English: Mometasone is a corticosteroid with anti-inflammatory effects.
Danish: Mometason er et kortikosteroid med antiinflammatorisk virkning.
English: Both formoterol and mometasone have been available in the European Union for the maintenance treatment of asthma for a number of years.
Danish: Både formoterol og mometason har i flere år kunnet fås i Den Europæiske Union til behandling af astma.
English: On 5 November, Schering-Plough Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zenhale, for the maintenance treatment of asthma.
Danish: Den 5. november meddelte Schering-Plough Europe officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Zenhale til vedligeholdelsesbehandling af astma.
English: The CHMP also had concerns with one of the comparator medicines, mometasone furoate, which was not in an approved formulation.
Danish: CHMP havde ligeledes betænkeligheder med hensyn til et af sammenligningslægemidlerne, mometasonfuroat, som ikke var i en godkendt formulering.
English: The company was asked to provide further data to justify the use of that comparator, specifically to show how mometasone furoate in the comparator was released in the body compared with the approved mometasone furoate.
Danish: Virksomheden blev bedt om at fremlægge yderligere data for at begrunde brugen af dette sammenligningslægemiddel, navnlig for at vise, hvordan mometasonfuroat i sammenligningslægemidlet blev frigivet i kroppen sammenlignet med det godkendte mometasonfuroat.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Danish: Brevet fra virksomheden, hvori EMA underrettes om tilbagetrækningen af ansøgningen, kan ses under fanen "All documents".
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Danish: Den virker ved at binde sig til beta-2-receptorer, som findes i muskelcellerne i mange organer, og som får musklerne til at slappe af.
English: What was Zenhale expected to be used for?
Danish: Hvad forventedes Zenhale anvendt til?
English: Zenhale is a medicine that contains the active substances mometasone furoate and formoterol fumarate.
Danish: Zenhale er et lægemiddel, der indeholder de aktive stoffer mometasonfuroat og formoterolfumarat.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål.
English: Following a routine inspection of study sites, the CHMP had concerns over the way the studies were conducted in some sites, which cast doubt on the reliability of the results.
Danish: Efter en rutineinspektion af undersøgelsesstederne gav CHMP udtryk for betænkeligheder med hensyn til den måde, som undersøgelserne blev foretaget på visse steder, og som skaber tvivl om resultaternes pålidelighed.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zenhale could not have been approved for the maintenance treatment of asthma.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's lister med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Zenhale ikke kunne være blevet godkendt til vedligeholdelsesbehandling af astma.
English: Zenhale was expected to be used in adults and adolescents aged 12 years and older as a maintenance treatment for asthma, including for reducing exacerbations (where asthma gets worse, requiring rescue treatment with other medicines).
Danish: Zenhale forventedes anvendt hos voksne og unge over 12 år som vedligeholdelsesbehandling af astma, herunder til at mindske forværringer (hvor astma bliver værre og kræver rescuebehandling med andre lægemidler).
English: How is Zenhale expected to work?
Danish: Hvordan forventes Zenhale at virke?
English: It was to be available as a suspension for inhalation in a metered-dose inhaler.
Danish: Det var meningen, at det skulle kunne fås som en suspension til inhalation i en inhalator med afmålte doser.
English: When inhaled, it relieves the symptoms of asthma by blocking the release from white blood cells of substances that are involved in inflammatory reactions in the airways.
Danish: Når det inhaleres, lindrer det symptomerne på astma ved at blokere frigivelsen fra de hvide blodlegemer af stoffer, der er med til at skabe inflammatoriske reaktioner i luftvejene.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af den sidste række spørgsmål, var der fortsat nogle uafklarede spørgsmål.
English: The company informed the CHMP that this withdrawal does not have any consequences for patients in ongoing trials or on compassionate use programmes.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter i igangværende kliniske undersøgelser eller i programmer med særlig udleveringstilladelse.
English: The application was withdrawn after ‘day 181'.
Danish: Ansøgningsproceduren var ved dag 181, da virksomheden trak sin ansøgning tilbage.
English: When inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Danish: Når det inhaleres, får det musklerne i luftvejene til at slappe af, hvilket er med til at holde luftvejene åbne og gøre det lettere for patienterne at trække vejret.
English: There were four main studies involving a total of 2,977 adults and adolescents who had been receiving treatment with inhaled corticosteroids or a combination of inhaled corticosteroid and a long-acting beta-2 agonist.
Danish: Der var fire hovedundersøgelser, som omfattede i alt 2 977 voksne og unge, der havde modtaget behandling med inhalerede kortikosteroider eller en kombination af inhalerede kortikosteroider og en langtidsvirkende beta-2-agonist.
English: The patients were treated with one of the following: Zenhale, mometasone furoate alone, formoterol fumarate alone, an asthma medicine containing fluticasone propionate and salmeterol (another combination of a steroid and a long-acting bronchodilator used in asthma), or placebo (a dummy treatment).
Danish: Patienterne blev behandlet med en af følgende: Zenhale, mometasonfuroat alene, formoterolfumarat alene, et astmalægemiddel indeholdende fluticasonpropionat og salmeterol (en anden kombination af et steroid og en langtidsvirkende bronkodilatator) eller placebo (en virkningsløs behandling).
English: It was also expected to be used in patients whose asthma was already controlled with both an inhaled corticosteroid and a long-acting beta-2 agonist.
Danish: Det forventedes ligeledes anvendt til patienter, hvis astma allerede var kontrolleret ved hjælp af både et inhaleret kortikosteroid og en langtidsvirkende beta-2-agonist.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Zenhale eller i programmer for anvendelse af Zenhale med særlig udleveringstilladelse?
English: It was developed for use in patients whose asthma was not adequately controlled by an inhaled corticosteroid used, when needed, with an inhaled short-acting ‘beta-2 agonist' (a bronchodilator, a medicine that widens the airways in the lungs).
Danish: Zenhale blev udviklet til anvendelse hos patienter, hvis astma ikke var tilstrækkeligt kontrolleret ved hjælp af et inhaleret kortikosteroid, der om nødvendigt anvendes sammen med en inhaleret korttidsvirkende "beta-2-agonist" (en bronkodilatator, som er et lægemiddel, der får luftvejene i lungerne til at udvide sig).
English: (Contact the distributor for specific data.)
Danish: (Kontakt forhandleren for specifikke data).
English: It is eliminated from the plasma in 5-7 days.
Danish: Den er elimineret fra plasmaen på 5 til 7 dage.
English: 125 ml - 5years
Danish: 125 ml - 5 år
English: <Batch> <Lot> {number}
Danish: <Batch>, >Lot>,{nummer}
English: Haematology: No interference.
Danish: Hæmatologi: Ingen forstyrrelse.
English: Do not combine the contents of more than one bag.
Danish: Bland ikke indholdet af mere end en pose sammen.
English: Do not use after the expiry date stated on the label.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på etiketten
English: None known.
Danish: Ingen kendte
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktivt stof:
English: The use in such animals is not recommended.
Danish: Anvendelse af produktet på disse dyr kan ikke anbefales.
English: Do not store above 30 °C.
Danish: Må ikke opbevares over 30 °C.
English: Date of first authorisation: 29/11/1999 Date of last renewal: 01/10/2009
Danish: Dato for første markedsføringstilladelse: 29/11/1999 Dato for seneste fornyelse af markedsføringstilladelse: 01/10/2009
English: The plasma half-life is 30-40 hours.
Danish: Plasmaens halveringstid er 30 til 40 timer.
English: (See Table A Pharmacokinetic Parameters)
Danish: (Se skema A Pharmacokinetiske parametre)
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (http://www.ema.europa.eu/).
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Danish: Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes De kontakte Deres dyrlæge.
English: In certain clinical situations, a dosage of 15-30 ml/kg may be appropriate.
Danish: I visse kliniske situationer vil en dosering på 15-30 ml/kg/st være passende.
English: Urinalysis: Sediment examination is accurate.
Danish: Urinanalyse: Sedimentundersøgelsen er nøjagtig.
English: * range based on mean ± SD ** range based on estimated mean value with bounds of a 95 % prediction interval *** range based on 5 terminal half-lives
Danish: * område baseret på ringe ± SD ** område baseret på vurderet middel værdier inden for 95 % af forudsigelige intervaller *** område baseret på 5 terminale halv-liv
English: Cleared from plasma (days)***
Danish: Renset for plasma (dage)***
English: Shelf-life of the veterinary medicinal product as packaged for sale: 60 ml - 3 years
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 60 ml - 3 år
English: Clinical Pathology
Danish: Klinisk patologi
English: A box with one (1) polyolefin infusion bag (containing either 60 ml or 125 ml), within an overwrap.
Danish: En æske med en (1) polyolefin infusionspose (indeholdende enten 60 ml eller 125 ml) i en overfolie.
English: Do not add medications or other solutions to the bag.
Danish: Bland ikke andre medikamenter eller andre opløsninger i posen.
English: Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) can be accurately determined using methods that are mechanical, magnetic, and light scattering.
Danish: Koagulering: Prothrombintiden (PT) og den aktiverede partielle thromboplastintid (aPTT) kan nøje bestemmes med metoder, som kan være mekaniske, magnetiske og lysspredning.
English: Use within 24 hours.
Danish: Anvend præparatet indenfor 24 timer.
English: Pharmacotherapeutic group: Blood substitutes, ATCvet code: QB05AA10.
Danish: Farmakoterapeutisk gruppe: Erstatningsprodukter for blod, ATCvet-kode: QB05AA10
English: Shelf-life after first opening the immediate packaging: 24 hours.
Danish: Opbevaringstid efter første åbning af den indre emballage: 24 timer
English: Do not microwave.
Danish: Mikrobølger må ikke anvendes.
English: Treatment of circulatory overload may be necessary.
Danish: Det kan være nødvendigt at behandle for overbelastning af kredsløbet.
English: Remove overwrap prior to use.
Danish: Fjern overfolien lige før brugen.
English: Use within 24 hours of removing overwrap.
Danish: Skal anvendes inden for 24 timer, efter at overfolien er fjernet.
English: The animal should not be over-hydrated prior to administration.
Danish: Dyret må ikke overhydreres før behandlingen.
English: Immediate postinfusion plasma concentration* (g/dl)
Danish: Omgående postinfusion plasma koncentration* (g/dl)
English: A small amount of unstabilised tetrameric haemoglobin (<5 %) may be excreted through the kidneys, resulting in transient haemoglobinuria for < 4 hours.
Danish: En lille mængde af ikke stabiliseret tetramerisk hæmoglobin (<5 %) kan udskilles igennem nyrerne, resulterende i forbigående hæmoglobinuria i <4 timer.
English: Metabolism and excretion: Haemoglobin dissociates in plasma and is progressively incorporated in the protein pool of the organism.
Danish: Metabolisme og udskillelse: Hæmoglobin udskilles i plasma og optages progressivt i organismens proteinbeholdning.
English: Confirm that haemoglobin is measured, not calculated from red blood cell number.
Danish: Kontroller at hæmoglobinen er målt og ikke udregnet på baggrund af antallet af røde blodceller.
English: Use of Oxyglobin does not require typing or cross-matching of the recipient's blood.
Danish: Anvendelsen af Oxyglobin kræver ikke type bestemmelse eller krydsbestemmelse af modtagerens blod.
English: D. STATEMENT OF THE MRLs
Danish: D. ANGIVELSE AF MRL-VÆRDIER
English: The optimum dosage is based upon the degree and chronicity of the anaemia and the desired duration of the effect.
Danish: Den optimale dosering baseres på baggrund af graden af kronisk anæmi og den ønskede varighed af effekten.
English: Optical methods are not reliable for coagulation assays in the presence of Oxyglobin.
Danish: De optiske metoder er ikke pålidelige til koagulationsprøver ved tilstedeværelsen af Oxyglobin.
English: Dipstick measurements (i.e., pH, glucose, ketones, protein) are inaccurate while gross discolouration of the urine is present.
Danish: Målepindsmåling (dvs. pH, glukose, ketoner, protein) er ikke nøjagtige ved tilstedeværelse af stor misfarvning af urinen.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af det pågældende batch
English: As with any intravenous fluid administration, Oxyglobin should be warmed to 37 °C prior to administration.
Danish: Som med alle former for administration af intravenøse væsker, bør Oxyglobin opvarmes til 37 ° C inden administrationen.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte lægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse med de lokale krav.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: Do not use in animals previously treated with Oxyglobin.
Danish: Bør ikke anvendes til dyr som tidligere er behandlet med Oxyglobin.
English: Concomitant treatment of the cause of the anaemia should be instituted.
Danish: Ledsagende behandling af årsagen til blodmangelen skal påbegyndes.
English: Modified Lactated Ringer's Solution containing the standard components: Water for injection, NaCl
Danish: Modificeret Lactat Ringer's opløsning, der indeholder standardkomponenterne: vand til injektion,
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE D. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG C. FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG D. ANGIVELSE AF MRL-VÆRDIER
English: 4.5 Special precautions for use Special precautions for use in animals
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler vedrørende brug til dyr
English: Treatment with Oxyglobin results in a mild decrease in PCV (packed cell volume) immediately post infusion.
Danish: Behandling med Oxyglobin resulterer i en svag stigning i PCV (pakket cellestørrelse) umiddelbart efter infusionen.
English: Marketing authorisation holder: OPK Biotech Netherlands BV Teleportboulevard 140
Danish: Indehaver af markedsføringstilladelsen : OPK Biotech Netherlands BV Teleportboulevard 140
English: Oxyglobin should be administered using aseptic technique via a standard intravenous infusion set and catheter.
Danish: Oxyglobin skal indgives ved anvendelse af aseptisk teknik via standard intravenøst infusionssæt og kateter.
English: Adverse effects commonly seen were vomiting, a loss of appetite, and fever.
Danish: Bivirkninger som ofte ses er opkasting, tab af appetit samt feber.
English: Do not overheat.
Danish: Må ikke overopvarmes.
English: <EXP {month/year}>
Danish: <UDL.D.> {måneder/år}
English: For animal treatment only - to be supplied only on veterinary prescription.
Danish: Kun til dyr - må kun udleveres efter veterinærrecept.