FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults, ViraferonPeg was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to ViraferonPeg alone and around a half responding to the combination of ViraferonPeg and ribavirin.
Danish: Hos voksne var ViraferonPeg mere effektivt end interferon alfa-2b til ikke tidligere behandlede patienter, idet ca. en fjerdedel af patienterne responderede på ViraferonPeg alene, og ca. halvdelen responderede på kombinationen af ViraferonPeg og ribavirin.
English: What is the risk associated with ViraferonPeg?
Danish: Hvilken risiko er der forbundet med ViraferonPeg?
English: ViraferonPeg is a medicine that contains the active substance peginterferon alfa-2b.
Danish: ViraferonPeg er et lægemiddel, der indeholder det aktive stof peginterferon alfa-2b.
English: A 40% increase was seen among patients who had been treated before.
Danish: Blandt tidligere behandlede patienter var stigningen 40 %.
English: The active substance in ViraferonPeg, peginterferon alfa-2b, belongs to the group ‘interferons'.
Danish: Det aktive stof i ViraferonPeg, peginterferon alfa-2b, tilhører gruppen af "interferoner".
English: Other information about ViraferonPeg:
Danish: Andre oplysninger om ViraferonPeg
English: It is available as a powder and solvent that are made up into a solution for injection, and as a single-use prefilled pen.
Danish: Det leveres som et pulver med solvens, der blandes til en injektionsvæske (opløsning), og som fyldte engangspenne.
English: In ViraferonPeg, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I ViraferonPeg er interferon alfa-2b blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglycol).
English: In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, ViraferonPeg in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of ViraferonPeg with ribavirin alone.
Danish: I undersøgelserne med tredobbelt kombinationsbehandling hos patienter med hepatitis C type 1 og kompenseret leversygdom var ViraferonPeg i kombination med ribavirin og boceprevir mere effektivt end den dobbelte kombination af ViraferonPeg og ribavirin alene.
English: Why has ViraferonPeg been approved?
Danish: Hvorfor blev ViraferonPeg godkendt?
English: The full EPAR for ViraferonPeg can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for ViraferonPeg findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Hvis du ønsker yderligere oplysninger om behandling med ViraferonPeg, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In children and adolescents receiving ViraferonPeg in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Danish: Hos børn og unge, der fik ViraferonPeg i kombination med ribavirin, var bivirkningerne de samme som hos voksne.
English: There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Danish: Der var desuden en markant stigning i helbredelsesprocenten hos patienter med kronisk hepatitis C type 1, som fik den tredobbelte behandling bestående af ViraferonPeg i kombination med ribavirin og boceprevir.
English: The replacement acts in the same way as naturally produced interferon alpha.
Danish: Det kunstigt fremstillede interferon alfa virker på samme måde som det naturlige.
English: What is ViraferonPeg?
Danish: Hvad er ViraferonPeg?
English: ViraferonPeg is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Danish: ViraferonPeg anvendes til behandling af patienter i alderen 3 år og opad med langvarig hepatitis C (leverbetændelse forårsaget af hepatitis C-virus).
English: What is ViraferonPeg used for?
Danish: Hvad anvendes ViraferonPeg til?
English: The doses of ribavirin and ViraferonPeg may need to be adjusted for patients who experience side effects.
Danish: I tilfælde af bivirkninger kan det være nødvendigt at justere dosis af ribavirin og ViraferonPeg.
English: What benefit has ViraferonPeg shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ViraferonPeg?
English: How has ViraferonPeg been studied?
Danish: Hvordan blev ViraferonPeg undersøgt?
English: How is ViraferonPeg used?
Danish: Hvordan anvendes ViraferonPeg?
English: How does ViraferonPeg work?
Danish: Hvordan virker ViraferonPeg?
English: Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of ViraferonPeg in a triple therapy combination with ribavirin and boceprevir compared with ViraferonPeg and ribavirin alone.
Danish: Der blev udført to hovedundersøgelser med i alt 1 503 voksne patienter med hepatitis C type 1 og kompenseret leversygdom.
English: What is orBec?
Danish: Hvad er orBec?
English: London, 30 May 2008 Doc.
Danish: London, den 30. maj 2008 Ref.dok.
English: Ref. EMEA/266786/2008
Danish: EMEA/304437/2008
English: The application was at day 180 when the company withdrew.
Danish: Ansøgningen var på dag 180, da firmaet trak den tilbage.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for ORBEC
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for ORBEC
English: International non-proprietary name (INN): beclomethasone dipropionate
Danish: Internationalt fællesnavn (INN): beclometasondipropionat
English: It works by dampening down the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cell.
Danish: Det virker ved at dæmpe aktiviteten af immunsystemet (kroppens naturlige forsvar) ved at bindes til receptorer i forskellige typer immunceller.
English: What was orBec expected to be used for?
Danish: Hvad forventedes orBec anvendt til?
English: The main measure of effectiveness was how long it took for treatment to fail during the 50 days of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor lang tid der gik, før behandlingen svigtede i løbet af en behandlingsperiode på 50 dage.
English: orBec was designated as an orphan medicinal product on 13 March 2002.
Danish: OrBec blev udpeget som lægemiddel til sjældne sygdomme den 13. marts 2002.
English: What documentation did the company present to support its application to the CHMP?
Danish: Hvilken dokumentation fremlagde firmaet til støtte for ansøgningen til CHMP?
English: The CHMP had also concerns that most of the patients who took part in the study came from one study centre, and therefore the results were not representative for the overall population.
Danish: I CHMP var der desuden betænkelighed ved, at størstedelen af de patienter, der deltog i undersøgelsen, kom fra kun ét undersøgelsescenter, og at resultaterne derfor ikke var repræsentative for alle patienter.
English: orBec was not significantly better than placebo in increasing the time until the disease came back during the 50-day treatment period.
Danish: OrBec var ikke klart bedre end placebo til at øge den tid, der gik, før sygdommen vendte tilbage i løbet af en behandlingsperiode på 50 dage.
English: Graft-versus-host disease can occur in patients following tissue or organ transplantation, when the cells in the transplanted tissue or organ recognise the patient as ‘foreign' and attack the body.
Danish: Transplantat-mod-vært-reaktion kan optræde hos patienter efter organtransplantation, idet cellerne i det transplanterede væv eller organ opfatter patienten som "fremmed" og angriber organismen.
English: It was to be available as two separate tablets, to be taken together: one immediate-release tablet (immediate-release means that the tablet has been made to allow the active substance to be released immediately) and one gastro-resistant tablet (gastro-resistant means that the tablet's content passes through the stomach without being broken down until it reaches the intestine).
Danish: Det var hensigten, at det skulle leveres som to forskellige tabletter, der skulle tages samtidig: En tablet med hurtig udløsning (hurtig udløsning betyder, at det aktive stof i tabletterne opløses øjeblikkeligt) og en enterotablet (enterotabletter passerer igennem mavesækken uden at opløses, før de når tarmen).
English: This was expected to lead to a reduction in damage to the stomach and intestine.
Danish: Dette forventedes at mindske skaden på mavesækken og tarmene.
English: How is orBec expected to work?
Danish: Hvordan forventes orBec at virke?
English: On 22 May 2008, DOR BIOPHARMA UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for orBec, for the treatment of gastrointestinal graft-versus-host disease.
Danish: Den 22. maj 2008 meddelte DOR BIOPHARMA UK Ltd officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at trække sin ansøgning om markedsføringstilladelse for orBec til behandling af transplantat-mod-vært-reaktion i mave-tarmsystemet tilbage.
English: It was expected to block receptors in the stomach and intestine, reducing locally the production of substances that are involved in recognising foreign cells and in the inflammation process.
Danish: Stoffet forventedes at blokere receptorer i mavesækken og tarmene ved lokalt at nedsætte produktionen af stoffer, der medvirker ved genkendelse af fremmede celler og ved betændelsesreaktionen.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of orBec had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved orBec ikke var tilfredsstillende godtgjort, og at eventuelle fordele ikke opvejede de fundne risici.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Danish: Efter at CHMP havde vurderet firmaets besvarelse af en række spørgsmål, tilbagestod der fortsat nogle uafklarede punkter.
English: The CHMP was concerned that the single main study did not demonstrate orBec's effectiveness.
Danish: I CHMP var der betænkelighed ved, at denne eneste hovedundersøgelse ikke godtgjorde virkningen af orBec.
English: The effectiveness of orBec was studied in one main study, in which orBec was compared with placebo (a dummy treatment) in 129 patients with gastrointestinal graft-versus-host disease.
Danish: Virkningen af orBec blev undersøgt i én hovedundersøgelse, hvor orBec blev sammenlignet med placebo (virkningsløs behandling) hos 129 patienter med transplantat-mod-vært-reaktion i mavetarmsystemet.
English: orBec is a medicine containing the active substance beclomethasone dipropionate.
Danish: OrBec er et lægemiddel, der indeholder det aktive stof beclometasondipropionat.
English: The active substance of orBec, beclomethasone dipropionate, is a corticosteroid that has been used in inhaled, nasal and skin medicines since the 1970s.
Danish: Det aktive stof i orBec, beclometasondipropionat, er et binyrebarkhormon, der har været anvendt i lægemidler, som gives ved inhalation, gennem næsen og på huden siden 1970'erne.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with orBec.
Danish: Firmaet har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der aktuelt deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for orBec.
English: In orBec, beclomethasone dipropionate was to be taken orally so that it could act within the stomach and intestine.
Danish: I orBec skulle beclometasondipropionat indtages oralt, så det kunne virke i maven og tarmene.
English: Patients with gastrointestinal graft-versus-host disease have damage to the stomach and the intestine, which causes severe inflammation of these organs.
Danish: Patienter med transplantat-mod-vært-reaktioner får skader i mavesækken og tarmene med svære betændelsesreaktioner i disse organer.
English: Based on the review of the data and the company's response to the CHMP list of question at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that orBec could not have been approved for the treatment of gastrointestinal graft-versus-host disease.
Danish: Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af CHMP's spørgsmål var der i CHMP visse betænkeligheder, og udvalgets foreløbige standpunkt var, at orBec ikke ville kunne godkendes til behandling af transplantat-mod-vært-reaktion i mave-tarmsystemet.
English: In addition, the Committee noted that there was a lack of data to demonstrate how the active substance in orBec works in the stomach and intestine, when used for treatment of gastrointestinal graft-versus-host disease.
Danish: Desuden hæftede udvalget sig ved de manglende oplysninger om, hvordan det aktive stof i orBec virker i mavesækken og tarmene, når det anvendes til behandling transplantat-mod-vært-reaktion i mave-tarmsystemet.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with orBec?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med orBec eller i programmer for anvendelse med særlig udleveringstilladelse?
English: The applicant presented data on experimental models for beclomethasone dipropionate from the scientific literature.
Danish: Firmaet fremlagde oplysninger fra faglitteraturen om anvendelse af beclometasondipropionat i forsøgsmodeller.
English: orBec was expected to be used for the treatment of gastrointestinal graft-versus-host disease.
Danish: OrBec forventedes anvendt til behandling af transplantat-mod-vært-reaktion i mave-tarmsystemet.
English: The potential risk for humans is unknown.
Danish: Den mulige risiko for mennesker er ukendt.
English: Patients over 65 years
Danish: Patienter over 65 år
English: This must be for at least 30 days and to be decided by your doctor.
Danish: Det skal have varet mindst 30 dage, og skal bestemmes af lægen.
English: Important aspects to consider during treatment:
Danish: Vigtige aspekter, der skal overvejes i løbet af behandlingen:
English: • The patient should be able to lie on their back.
Danish: • Patienten skal være i stand til at ligge på ryggen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1369/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1369/001
English: Please attend all of these necessary appointments.
Danish: Du bedes venligst møde op til alle de nødvendige besøg.
English: Treating doctor (name / contact information):
Danish: Behandlende læge (navn / kontaktoplysninger):
English: Local representative contact
Danish: Kontakt for lokal repræsentant
English: • social support system
Danish: • socialt støttesystem
English: 747 70 Opava, Komarov CZECH REPUBLIC
Danish: 747 70 Opava, Komarov TJEKKIET
English: This endpoint was considered to be of clinical relevance in the targeted indication.
Danish: Dette endepunkt blev anset for at være af klinisk relevans for den målrettede indikation.
English: • participation in a structured activity/job
Danish: • deltagelse i en struktureret aktivitet/arbejde
English: Do not attempt to remove the implants by yourself as this could be very dangerous.
Danish: Du må ikke forsøge på selv at fjerne implantaterne, da det kan være meget farligt.
English: Sixmo is provided in a carton.
Danish: Sixmo leveres i en karton.
English: Patient name:
Danish: Patientnavn:
English: • Always keep this card with you while on treatment.
Danish: • Du bør altid have dette kort på dig, mens du får behandlingen.
English: Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse.
Danish: Derfor skal doseringerne være begrænsede, og denne kombination skal undgås i tilfælde, hvor der er risiko for misbrug.
English: 50018 Scandicci (Firenze), Italy
Danish: 50018 Scandicci (Firenze), Italien
English: The closer the implants lie to each other at the time of insertion, the more easily they can be removed.
Danish: Jo tættere implantaterne er på hinanden på indsættelsestidspunktet, jo nemmere kan de fjernes.
English: Percentage of negative results
Danish: Procentdel negative resultater
English: Higher than normal doses and repeated administration may be necessary.
Danish: Det kan være nødvendigt med højere doser end normalt, og gentagne administrationer.
English: The implant time was 24 weeks.
Danish: Implantatperioden var 24 uger.
English: Non-Caucasian population
Danish: Ikke-kaukasisk population
English: Generally, other buprenorphine treatments/formulations are considered more appropriate in this situation.
Danish: Generelt anses andre behandlinger/formuleringer med buprenorphin for at være mere hensigtsmæssige i denne situation.
English: Patient characteristics in these studies are shown below.
Danish: Patientkarakteristikken i disse studier er vist nedenfor.
English: • general weakness and poor health, or you are elderly
Danish: • generel svaghed og dårligt helbred, eller hvis du er ældre
English: • The incision site should be inspected for infection.
Danish: • Indsnitstedet skal inspiceres for infektion.
English: Avoid grapefruit juice to prevent possible side effects.
Danish: Undgå grapefrugtjuice for at undgå bivirkninger.
English: Scandicci ITALY
Danish: Scandicci ITALIEN
English: Misuse and diversion
Danish: Misbrug og diversion
English: The experience of a second treatment cycle is limited.
Danish: Erfaringen med en ekstra behandlingscyklus er begrænset.
English: • Drowsiness may occur especially in the first week after insertion.
Danish: • Der kan opstå døsighed, især i løbet af den første uge efter indsættelsen.
English: Higher doses may be required for analgesic effect.
Danish: Højere doser kan være nødvendige for en analgetisk virkning.
English: Therefore, a higher potential for toxicity exists with opioid administration.
Danish: Derfor er der et større potentiale for toksicitet med opioidadministration.
English: Weeks 17 to 24
Danish: Uge 17 til 24
English: Despite the use of an open-label comparator arm, this endpoint is considered robust, as it is based on urine toxicology.
Danish: Trods anvendelsen af en åben komparatorarm, anses dette endepunkt som værende robust, da det er baseret på urintoksikologi.
English: The recommended visit schedule for most patients is a frequency of no less than once-monthly for continued counselling and psychosocial support.
Danish: Det anbefalede besøgsskema for de fleste patienter er en hyppighed på ikke mindre end én gang månedligt til fortsat rådgivning og psykosocial støtte.
English: The syndrome is generally delayed for several hours to several days after birth.
Danish: Syndromet er generet forsinket i flere timer til flere dage efter fødslen.
English: The nature of the syndrome may vary depending upon the mother's drug use history.
Danish: Arten af syndromet kan variere, afhængigt af moderens brug af lægemidler.
English: • This medicine can cause dependence, but at a lower level than other substances such as morphine.
Danish: • Dette lægemiddel kan forårsage afhængighed, men i mindre grad end for andre stoffer, såsom morfin.
English: Your doctor will also give you a Patient Alert Card that provides the
Danish: Lægen vil også give dig et patientkort, som informerer om
English: Treat these patients with a non-opioid analgesic whenever possible.
Danish: Disse patienter skal behandles med ikke-opioide analgetika, når det er muligt.
English: Overdose symptoms include:
Danish: Symptomer på overdosering omfatter:
English: The implants should only be removed by a doctor who is familiar with the procedure.
Danish: Implantaterne må kun fjernes af en læge, som er bekendt med proceduren.
English: The clinical experience with Sixmo in non-Caucasian patients is currently limited.
Danish: Den kliniske erfaring med Sixmo hos ikke-kaukasiske patienter er aktuelt begrænset.
English: Weeks 1 to 16
Danish: Uge 1 til 16
English: • head injury or other circumstances where the pressure in the head may be increased
Danish: • hovedlæsioner eller andre omstændigheder, hvor trykket i hovedet kan være øget
English: There is no suspicion of carcinogenicity based on the clinical use of buprenorphine.
Danish: Der er ingen mistanke om karcinogenicitet baseret på den kliniske anvendelse af buprenorphin.
English: Acute alcoholism or delirium tremens
Danish: Akut alkoholisme eller delirium tremens
English: Number (%) of broken implants
Danish: Antal (%) knækkede implantater
English: Prescription opioids * For 1 patient (0.8%) primary opioid of abuse was “other”.
Danish: Receptpligtige opioider * For 1 patient (0,8 %) var det primære misbrugsopioid ”andet”.
English: Of these 309 patients, 107 patients were treated for an additional 6 months in extension studies (i.e. for 2 implant cycles).
Danish: Ud af disse 309 patienter blev 107 patienter behandlet i yderligere 6 måneder i forlængelsesstudier (dvs. i 2 implantatcyklusser).
English: • minimal to no desire or need to abuse opioids
Danish: • minimalt eller intet ønske om eller behov for at misbruge opioider
English: Preparations for handling or administering the medicinal product
Danish: Forberedelser for håndtering og administration af lægemidlet
English: This may be related to existing reduced liver function and ongoing injecting drug use.
Danish: Dette kan være forbundet med en eksisterende nedsat leverfunktion og aktuel injektion af stoffer.
English: Sixmo with food, drink and alcohol
Danish: Brug af Sixmo sammen med mad, drikke og alkohol
English: • lack of a white blood cell type called neutrophils
Danish: • mangel på en type hvide blodlegemer, der kaldes neutrofiler
English: • pressure bandage around 8 cm wide
Danish: • trykbandage ca. 8 cm bred
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: General precautions relevant to the administration of opioids
Danish: Generelle forsigtighedsregler, som er relevante for administrationen af opioider
English: Key instruction for proper insertion
Danish: Vigtige anvisninger i korrekt indsættelse
English: Inform your doctor immediately if the above symptoms occur, or go to the nearest hospital and bring this leaflet and your Patient Alert Card with you.
Danish: Du skal straks informere lægen, hvis de ovenstående symptomer opstår, og tage på det nærmeste sygehus og medbringe denne indlægsseddel og dit patientkort.
English: Location of implant: (upper arm: left / right)
Danish: Lokalisering af implantat: (overarm venstre / højre)
English: There was a greater occurrence of resorptions and an increase in the number of stillbirths.
Danish: Der var en større forekomst af resorptioner, og en stigning i antallet af dødfødsler.
English: Surgical intervention is necessary for removing an implant that has migrated.
Danish: Det er nødvendigt med kirurgisk intervention for at fjerne et implantat, som har migreret.
English: • period free from opioid drug abuse
Danish: • periode uden misbrug af opioide lægemidler
English: • adequate lighting, such as headlamp
Danish: • tilstrækkelige lysforhold, såsom en hovedlampe
English: The CDF results for co-primary endpoint 2 were fundamentally the same as for endpoint 1 (p < 0.0001).
Danish: CDF-resultaterne for det co-primære endepunkt 2 var i alt væsentlighed de samme as for endepunkt 1 (p < 0,0001).