FrancophonIA/ELRC3.0 huggingface dataset:
English: Then, the outer membranes that contain the ‘surface antigens' (proteins on the outer membrane of the virus that the body recognises as foreign) were extracted and purified before being included in the vaccine.
Danish: Derefter blev de ydre membraner, som indeholder "overfladeantigener" (proteiner på virussens ydre membran, som kroppen opfatter som fremmede) udvundet og renset, før de blev tilsat vaccinen.
English: The comparator vaccine contained different strains of seasonal flu virus, but the rest of the components were the same as in Aflunov.
Danish: Den vaccine, der blev brugt til sammenligning, indeholdt forskellige stammer af sæsonbestemt influenzavirus, mens resten af komponenterne var de samme som i Aflunov.
English: It consists of a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus strain called A/VietNam/1194/2004.
Danish: Det består af en suspension til injektion, som indeholder nogle dele (den ydre membran) af influenzavirusstammen A/VietNam/1194/2004.
English: Ref. EMEA/306731/2008
Danish: London, den 26. juni 2008 Referencedokument: EMEA/545135/2008
English: Aflunov contains small parts of the H5N1 strain of the flu virus.
Danish: Aflunov indeholder mindre dele af H5N1-stammen af influenzavirussen.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har indgivet sine svar på spørgsmålene, gennemgår CHMP disse og vil muligvis stille eventuelle ubesvarede spørgsmål på dag 180, inden det fremkommer med en udtalelse.
English: Therefore, at the time of the withdrawal, the CHMP could not conclude on the benefit-risk balance of Aflunov.
Danish: Derfor kunne CHMP ikke på tidspunktet for tilbagetrækningen drage nogen konklusioner om benefit/risk-forholdet ved Aflunov.
English: The immune system will be able to produce antibodies more quickly when it is exposed to flu virus of the same strain.
Danish: Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, hvis det møder influenzavirus af samme stamme igen.
English: How is Aflunov expected to work?
Danish: Hvordan forventes Aflunov at virke?
English: The company informed the CHMP that there are no consequences for individuals currently included in clinical trials with Aflunov.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ikke vil få nogen konsekvenser for personer, som i øjeblikket deltager i kliniske undersøgelser med Aflunov.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aflunov, for the prophylaxis of H5N1 avian influenza in adults and the elderly.
Danish: meddelte den 13. juni 2008 officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at det ønsker at trække sin ansøgning om en markedsføringstilladelse for Aflunov til profylakse af H5N1 fugleinfluenza hos voksne og ældre tilbage.
English: It compared Aflunov's safety and its ability to stimulate the production of antibodies (‘immunogenicity') with those of a similar vaccine against seasonal flu.
Danish: I dette forsøg blev Aflunovs sikkerhed og dets evne til at stimulere produktionen af antistoffer ("immunogenicitet") sammenlignet med en tilsvarende vaccine mod sæsonbestemt influenza.
English: When a person is given the vaccine, the immune system recognises the parts of the flu virus it contains as ‘foreign' and makes antibodies against them.
Danish: Når man bliver vaccineret, opfatter immunsystemet de dele af influenzavirussen, som vaccinen indeholder, som "fremmede" og producerer antistoffer mod dem.
English: Aflunov was expected to be used in adults and the elderly to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Danish: Man havde forventet, at Aflunov skulle anvendes til beskyttelse af voksne og ældre mod influenza forårsaget af H5N1-stammen (type) af influenzavirus A.
English: Aflunov is a ‘prepandemic' vaccine.
Danish: Aflunov er en præpandemisk vaccine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bondronat on 25 June 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bondronat den 25. juni 1996.
English: Bondronat is used in adults in the following ways:
Danish: Bondronat anvendes til voksne på følgende måder:
English: The full EPAR for Bondronat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Bondronat 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 Bondronat.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Bondronat.
English: Other information about Bondronat
Danish: Andre oplysninger om Bondronat
English: About three-quarters responded to a 4-mg dose.
Danish: Omkring tre fjerdedele responderede på en 4 mg-dosis.
English: A risk management plan has been developed to ensure that Bondronat is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Bondronat anvendes så sikkert som muligt.
English: The main measure of effectiveness was based on the number of new bone complications.
Danish: Det primære effektmål var baseret på antallet af nye knoglekomplikationer.
English: Bondronat was not compared with any other treatments in these studies.
Danish: Bondronat blev ikke sammenlignet med andre behandlinger i disse undersøgelser.
English: Bondronat reduced the risk of having a skeletal event by about 40% compared with placebo.
Danish: Bondronat reducerede risikoen for at udvikle en knoglerelateret hændelse med omkring 40 % sammenlignet med placebo.
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 Bondronat.
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 Bondronat.
English: Bondronat treatment should only be started by a doctor who has experience in the treatment of cancer.
Danish: Behandling med Bondronat skal indledes af en læge med erfaring i kræftbehandling.
English: Bondronat must not be used in people with hypocalcaemia.
Danish: Bondronat må ikke anvendes af personer med hypocalcæmi.
English: Bondronat was more effective than placebo in preventing bone complications.
Danish: Bondronat var mere effektivt end placebo til at forebygge knoglekomplikationer.
English: What measures are being taken to ensure the safe and effective use of Bondronat?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bondronat?
English: The CHMP decided that Bondronat's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Bondronat opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: For more information about treatment with Bondronat, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Bondronat, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In addition, the company that markets Bondronat will provide a card to inform patients receiving Bondronat infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Danish: Virksomheden, som markedsfører Bondronat, vil desuden udarbejde et oplysningskort til patienter, der modtager Bondronat som infusion, om risikoen for osteonekrose i kæben og en instruks til dem om at kontakte deres læge, hvis de oplever symptomer.
English: The tablet should be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day.
Danish: Tabletten skal altid indtages om morgenen, efter at patienten ikke har spist i mindst seks timer, og mindst 30 minutter inden dagens første indtagelse af mad eller drikke.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein, and as tablets (50 mg).
Danish: Det fås som et koncentrat, der blandes til en opløsning til infusion (drop) i en vene, og som tabletter (50 mg).
English: The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit up for at least an hour.
Danish: Tabletterne må ikke anvendes hos patienter, som har abnormiteter i spiserøret, eller som ikke kan sidde eller stå op i mindst en time.
English: About a half to two-thirds of the patients responded to a 2-mg dose of Bondronat, with blood calcium levels returning to within the normal range.
Danish: Omkring halvdelen til to tredjedele af patienterne responderede på en 2 mg-dosis Bondronat, idet mængden af calcium i deres blod vendte tilbage til normalområdet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bondronat, 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 Bondronat, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat has been compared with placebo (a dummy treatment) in three main studies lasting two years: one with the infusions in 466 patients and two with the tablets in a total of 846 patients.
Danish: Til forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser blev Bondronat sammenlignet med placebo (en virkningsløs behandling) i tre hovedundersøgelser, som varede i to år: en med infusion til 466 patienter og to med tabletter til i alt 846 patienter.
English: Patients with moderate or severe kidney problems should receive Bondronat infusions at a lower dose over an hour, or the tablet every two days or every week.
Danish: Patienter med moderate eller svære nyreproblemer bør have infusionerne med Bondronat i en lavere dosis i løbet af en time eller tabletterne hver anden dag eller hver uge.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Danish: Det blokerer virkningen af osteoklasterne, der er de celler i kroppen, som medvirker ved nedbrydningen af knoglevævet.
English: Bondronat is a medicine that contains the active substance ibandronic acid.
Danish: Bondronat er et lægemiddel, der indeholder det aktive stof ibandronsyre.
English: The active substance in Bondronat, ibandronic acid, is a bisphosphonate.
Danish: Det aktive stof i Bondronat, ibandronsyre, er et bisphosphonat.
English: What is the risk associated with Bondronat?
Danish: Hvilken risiko er der forbundet med Bondronat?
English: The main measure of effectiveness was the change in blood calcium levels.
Danish: Det primære effektmål var ændringen i mængden af calcium i blodet.
English: • as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Danish: • som en infusion til behandling af hypercalcæmi (en øget mængde calcium i blodet), der skyldes svulster.
English: Bondronat was also effective in treating hypercalcaemia caused by tumours.
Danish: Bondronat var også effektivt til behandling af hypercalcæmi forårsaget af svulster.
English: Bondronat has also been studied in the treatment of hypercalcaemia caused by tumours in three fourweek studies involving a total of 343 patients.
Danish: Bondronat blev også undersøgt i behandlingen af hypercalcæmi som følge af svulster i tre undersøgelser af fire ugers varighed, hvor i alt 343 patienter deltog.
English: • as an infusion or as a tablet to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
Danish: • som en infusion eller som en tablet til at forebygge knoglerelaterede hændelser (frakturer [knoglebrud] eller knoglekomplikationer, der kræver behandling) hos patienter med brystkræft og kræft, der har spredt sig til knoglerne (knoglemetastaser)
English: Bondronat ibandronic acid
Danish: Bondronat ibandronsyre
English: For the full list of all side effects and restrictions reported with Bondronat, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Bondronat fremgår af indlægssedlen.
English: By preventing the breakdown of bones, Bondronat also helps to reduce the amount of calcium released into the blood.
Danish: Idet Bondronat forebygger nedbrydningen af knoglerne, hjælper det samtidig med at reducere den mængde calcium, der afgives til blodet.
English: In the prevention of skeletal events, Bondronat is either given as a 6-mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day.
Danish: Til forebyggelse af knoglerelaterede hændelser gives Bondronat enten som en 6 mg-infusion over mindst 15 minutter hver tredje til fjerde uge eller som én tablet én gang dagligt.
English: It took longer for patients on Bondronat infusions or tablets to develop a new bone complication (50 to 76 weeks) than for patients on placebo (33 to 48 weeks).
Danish: Patienter, der fik Bondronat som infusion eller tabletter, var længere tid om at udvikle nye knoglekomplikationer end patienter, der fik placebo, (50-76 uger sammenlignet med 33-48 uger).
English: These included spine fractures, fractures outside the spine and any bone complications that needed treatment with radiotherapy or surgery.
Danish: Disse omfattede brud på rygsøjlen, knoglebrud andre steder end på rygsøjlen og alle andre knoglekomplikationer, der krævede strålebehandling eller operation.
English: The most serious side effects with Bondronat are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), and eye inflammation.
Danish: De alvorligste bivirkninger ved Bondronat er en anafylaktisk reaktion (svær overfølsomhedsreaktion), atypiske frakturer i femur (lårbenet), osteonekrose (henfald af knoglevævet i kæben, som kan forårsage smerter, bylder i munden eller tandudfald) og øjenbetændelse.
English: The most common side effects with the tablets are hypocalcaemia and dyspepsia (heartburn).
Danish: De hyppigste bivirkninger ved tabletterne er hypocalcæmi og dyspepsi (halsbrand).
English: Patients with tumours can have high levels of calcium in their blood, released from the bones.
Danish: Patienter med svulster kan have forhøjet mængde calcium i blodet, der er afgivet fra knoglerne.
English: Why has Bondronat been approved?
Danish: Hvorfor blev Bondronat godkendt?
English: where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used).
Danish: Tabletterne skal indtages sammen med et helt glas almindeligt vand (i områder med hårdt vand, hvor postevandet indeholder en del opløst calcium, kan flaskevand med lavt mineralindhold anvendes).
English: The most common side effects with Bondronat infusions are a rise in body temperature, hypocalcaemia (low blood calcium levels), asthenia (weakness) and headache.
Danish: De hyppigste bivirkninger ved infusioner med Bondronat er stigning i kropstemperaturen, hypocalcæmi (lavt indhold af calcium i blodet), asteni (kraftesløshed) og hovedpine.
English: The patient should not lie down for one hour after taking the tablet.
Danish: Efter at patienten har taget tabletten, må vedkommende ikke ligge ned i en time.
English: How has Bondronat been studied?
Danish: Hvordan blev Bondronat undersøgt?
English: In the treatment of hypercalcaemia caused by tumours, Bondronat is given over 2 hours as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is.
Danish: Ved behandling af hypercalcæmi forårsaget af svulster gives Bondronat over en periode på to timer som en infusion på enten 2 eller 4 mg afhængigt af, hvor alvorlig hypercalcæmien er. Infusionen vil sædvanligvis bringe mængden af calcium i blodet ned på et normalt niveau inden for en uge.
English: This leads to less bone loss.
Danish: Derved nedsættes knogletabet.
English: What benefit has Bondronat shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Bondronat?
English: What is Bondronat used for?
Danish: Hvad anvendes Bondronat til?
English: How is Bondronat used?
Danish: Hvordan anvendes Bondronat?
English: What is Bondronat?
Danish: Hvad er Bondronat?
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Danish: Nedsættelsen af knogletabet mindsker risikoen for knoglebrud.
English: How does Bondronat work?
Danish: Hvordan virker Bondronat?
English: Intravenous use vial (glass) 12 (12x1) vials (multipack)
Danish: Intravenøs anvendelse Hætteglas (glas) 12 (12x1) hætteglas (multipakning)
English: MA (EU) number
Danish: MF (EU)-nummer (Særnavn) Navn
English: Intravenous use vial (glass) 1 vial
Danish: Intravenøs anvendelse Hætteglas (glas) 1 hætteglas
English: Route of administration
Danish: Lægemiddelform Administration
English: Convincing data to identify a patient population in which the benefits of meprobamate clearly outweigh its identified risks.
Danish: Overbevisende data, der identificerer en patientpopulation, hos hvem fordelene ved meprobamat klart overstiger de fundne risici.
English: Annex III Conditions for lifting the suspension of the marketing authorisations
Danish: Bilag III Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
English: For the suspension to be lifted, the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Danish: For at suspenderingen kan ophæves, skal indehaverne af markedsføringstilladelserne fremlægge følgende for de nationale kompetente myndigheder:
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: Do not pass it on to others.
Danish: De bør ikke give det videre til andre.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen referer til den sidste dag i den pågældende måned.
English: Approximately 2% of the radioactivity was eliminated in the urine.
Danish: Omkring 2% af radioaktiviteten blev elimineret i urinen.
English: You should keep in regular contact with your doctor.
Danish: De bør være i jævnlig kontakt med din læge.
English: Results continuously improved with increasing experience over the course of 11 years.
Danish: Resultaterne blev kontinuerligt forbedrede med øget erfaring over en periode på 11år.
English: Benefit/Risk considerations
Danish: Benefit/Risk-hensyn
English: However, the following efficacy and safety issues were addressed:
Danish: Derimod er følgende spørgsmål vedrørende virkning og sikkerhed blevet behandlet:
English: Your doctor will tell you exactly how many capsules to take and how often.
Danish: Lægen vil oplyse dig om præcis hvor mange kapsler De skal tage og hvor ofte.
English: Efficacy results of the largest studies in each indication are summarised below.
Danish: Effektresultaterne af de største studier i hver indikation er resumeret nedenfor.
English: Most of the data supporting this indication are as expected retrospective.
Danish: De fleste data til støtte for denne indikation er som forventet retrospektive.
English: To date, no other relevant epidemiological data are available.
Danish: Der er indtil videre ingen relevante epidemiologiske data tilgængelige.
English: • Safety issues
Danish: • Sikkerhedsspørgsmål
English: Distribution and elimination
Danish: Fordeling og elimination
English: Austria, Cyprus, Czech Republic, Denmark, Germany, Greece, Spain, Finland, France, Hungary, Ireland, Italy, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden,United Kingdom.
Danish: Østrig, Cypern, Den Tjekkiske Republik, Danmark, Tyskland, Grækenland, Spanien, Finland, Frankrig, Ungarn, Irland, Italien, Norge, Polen, Portugal, Slovakiet, Slovenien, Sverige, England.
English: The capsules should be swallowed whole with a glass of water.
Danish: Kapslerne skal sluges hele med et glas vand.
English: This should be dealt with as a follow-up request.
Danish: Disse bør indhentes gennem en efterfølgende anmodning.
English: Possible side effects are listed according to the following categories:
Danish: De mulige bivirkninger opdeles i følgende kategorier:
English: Classification and terminology were amended according to the MedDRA system organ class.
Danish: Klassifikation og terminologi er ændret i overensstemmelse med organklassen i MedDRA-systemet.
English: The use of live attenuated vaccines should be avoided.
Danish: Brug af levende, afsvækkede vacciner skal undgås.
English: - This medicine has been prescribed for you.
Danish: - Dette lægemiddel er ordineret til Dem personligt.
English: The three studies demonstrated similar survival rates.
Danish: De 3 studier viser ens overlevelsesrater.
English: Section on contraindications (4.3) remained unchanged.
Danish: Afsnittet Kontraindikationer (4.3) forbliver uændret.
English: 2600 Glostrup Denmark
Danish: 2600 Glostrup Danmark
English: 1640 Nicosia
Danish: 1640 Nikosia
English: One pitfall for the renal paediatric indication is, however, the lack of longterm data.
Danish: En mangel ved den renale pædiatriske indikation er imidlertid, at der ikke foreligger nogen langsigtede data.
English: 28223 Pozuelo de Alarcón (Madrid) Spain
Danish: 28223 Pozuelo de Alarcón (Madrid) Spanien
English: There are several metabolites identified.
Danish: Der er identificeret adskillige metabolitter.
English: 2350 AC Leiderdorp The Netherlands
Danish: 2350 AC Leiderdorp Nederlandene
English: There is no evidence currently available to indicate that dosing should be adjusted in elderly patients.
Danish: I dag er der intet der tyder på at doseringen skal justeres i ældre patienter.
English: Box 25676
Danish: P.O. Box 25676
English: The safety database for tacrolimus is fragmented and uncertain.
Danish: Sikkerhedsdatabasen for tacrolimus er fragmenteret og usikker.
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Danish: I den systemiske cirkulation findes kun en af de inaktive metabolitter i lave koncentrationer.
English: Quality aspects do not form part of the current arbitration procedure.
Danish: De kvalitetsmæssige forhold er ikke omfattet af voldgiftsproceduren.
English: The capsules should be swallowed with fluid (preferably water).
Danish: Kapslerne skal indtages med væske (helst vand).
English: In addition, synergistic/additive nephrotoxic effects can occur.
Danish: Yderligere kan der forekomme synergistisk/additiv nefrotoksicitet.
English: Your dose depends on your general condition and on which other immunosuppressive medication you are taking.
Danish: Doseringen afhænger af din generelle tilstand og af hvilke anden immundæmpende medicin De tager.
English: WHAT <INVENTED NAME> IS AND WHAT IT IS USED FOR
Danish: HVAD <[(SÆR)NAVN]> ER, OG HVAD DET ANVENDES TIL
English: BATCH NUMBER Batch: {number}
Danish: BATCHNUMMER Batch: {nummer}
English: Do not take a double dose to make up for forgotten individual doses.
Danish: De må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: General considerations
Danish: Generelle overvejelser
English: Belgium, Luxembourg, The Netherlands.
Danish: Balgien, Luxemburg, Holland.