FrancophonIA/ELRC3.0 huggingface dataset:
English: Mozobil is used together with the hormone granulocyte-colony stimulating factor (G-CSF) and is only for patients in whom collection of stem cells is difficult.
Danish: Mozobil anvendes sammen med et hormon kaldet G-CSF (granulocytkoloni-stimulerende faktor) og anvendes kun hos patienter, hvor indsamling af stamceller er vanskeligt.
English: Mozobil is given 6 to 11 hours before the patient's blood is taken and the stem cells are extracted.
Danish: Mozobil gives 6-11 timer, før der tages blod fra patienten, og stamcellerne udvindes.
English: For the full list of side effects and restrictions with Mozobil, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Mozobil fremgår af indlægssedlen.
English: Mozobil is a medicine used to mobilise blood stem cells from a patient's bone marrow so that they can be collected and used later for transplantation in the same patient.
Danish: Mozobil er et lægemiddel, der anvendes til at mobilisere blodstamceller fra en patients knoglemarv, således at de kan indsamles og anvendes senere til transplantation hos den samme patient.
English: After the patient has been given Mozobil, the patient's stem cells are extracted from the blood and stored before transplantation.
Danish: Efter patienten har fået Mozobil, udvindes patientens stamceller af blodet og opbevares forud for transplantationen.
English: In two main studies involving 298 adults with non-Hodgkin's lymphoma and 302 adults with multiple myeloma, more patients who received Mozobil achieved the target number of stem cells and had successful engraftment of stem cells (the cells started growing and producing normal blood cells after transplantation) than patients who received placebo (a dummy treatment).
Danish: I to hovedstudier, der omfattede 298 voksne med non-Hodgkin-lymfom og 302 voksne med multipelt myelom, var der flere patienter blandt dem, der fik Mozobil, som opnåede det ønskede antal stamceller, og som fik en vellykket stamcelletransplantation (cellerne begyndte at gro og producere normale blodlegemer), end blandt dem, der fik placebo (en uvirksom behandling).
English: What benefits of Mozobil have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Mozobil?
English: How does Mozobil work?
Danish: Hvordan virker Mozobil?
English: Mozobil is used to mobilise the stem cells from the bone marrow so they can be released into the blood.
Danish: Mozobil anvendes til at mobilisere stamcellerne fra knoglemarven, så de kan frigives i blodet.
English: In a main study involving 45 children with lymphoma or solid tumours, 80% (24 out of 30) of patients who received Mozobil had at least a doubling of the number of stem cells in the blood, compared with 29% (4 out of 14) patients who received standard mobilisation treatment alone.
Danish: I et hovedstudie, som omfattede 45 børn med lymfom eller faste svulster, opnåede 80 % (24 ud af 30) af de patienter, der fik Mozobil, mindst en fordobling af antallet af stamceller i blodet sammenlignet med 29 % (4 ud af 14) af de patienter, der fik standardmobiliseringsbehandling alene.
English: How is Mozobil used?
Danish: Hvordan anvendes Mozobil?
English: Among the adults with multiple myeloma, 72% (106 out of 148) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 34% (53 out of 154) of the patients receiving placebo.
Danish: Blandt de voksne med multipelt myelom opnåede 72 % (106 ud af 148) af dem, der fik Mozobil, det ønskede antal stamceller i løbet af fire indsamlingsdage sammenlignet med 34 % (53 ud af 154) af de patienter, der fik placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mozobil have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Mozobil.
English: Among the adults with lymphoma, 59% (89 out of 150) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 20% (29 out of 148) of the patients receiving placebo.
Danish: Blandt de voksne patienter med lymfom opnåede 59 % (89 ud af 150) af dem, der fik Mozobil, det ønskede antal stamceller i løbet af fire indsamlingsdage sammenlignet med 20 % (29 ud af 148) af de patienter, der fik placebo.
English: By blocking its activity, Mozobil allows the stem cells to be released into the blood, so that they can be collected.
Danish: Når Mozobil blokerer for proteinets aktivitet, frigives stamcellerne til blodet, hvorefter de kan indsamles.
English: The European Commission issued a decision on 20 November 2013.
Danish: Europa-Kommissionen traf en beslutning den 20. november 2013.
English: What is Didanosine?
Danish: Hvad er Didanosin?
English: Why was Didanosine reviewed?
Danish: Hvorfor blev Didanosin vurderet igen?
English: Two medicines are bioequivalent if they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, hvis de frembringer samme mængde aktivt stof i kroppen.
English: EMA/562334/2013 rev.1 EMEA/H/A-29/1367
Danish: Den 20. november 2013 EMA/562334/2013 rev.1 EMEA/H/A-29/1367
English: On 19 September 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Didanosine.
Danish: Den 19. september 2013 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelsen af lægemidlet Didanosin.
English: authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance France, Germany, Italy, Netherlands, Portugal, Romania and Spain).
Danish: en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de “berørte medlemsstater”, her Frankrig, Italien, Nederlandene, Portugal, Rumænien, Spanien og Tyskland).
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing
Danish: Ved denne procedure vurderer én medlemsstat (“referencemedlemsstaten”, her Det Forenede Kongerige) et lægemiddel med henblik på udstedelse af
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 4 March 2013.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Det Forenede Kongeriges lægemiddelstyrelse indbragte den 4. marts 2013 sagen for CHMP med henblik på voldgift.
English: This prevents the active substance from being destroyed by the acid in the stomach.
Danish: Derved undgås det, at det aktive stof ødelægges af mavesyren.
English: The CHMP therefore concluded that the benefits of Didanosine outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Didanosin opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse i de berørte medlemsstater.
English: Didanosine does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Didanosin helbreder ikke hiv-infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: Aurobindo Pharma (Malta) Limited submitted Didanosine to the UK medicines regulatory agency for a decentralised procedure.
Danish: Aurobindo Pharma (Malta) Limited søgte Didanosin godkendt hos Det Forenede Kongeriges lægemiddelstyrelse ved den decentrale procedure.
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected.
Danish: Det blokerer enzymet reverse transcriptase, der produceres af HIV-1 og gør det muligt for virusset at producere flere virus i de celler, det har inficeret.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Didanosine outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: France, Germany, Italy, the Netherlands, Portugal, Romania and Spain.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved Didanosin opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i følgende EU-medlemsstater: Frankrig, Italien, Nederlandene, Portugal, Rumænien, Spanien og Tyskland.
English: By blocking this enzyme, didanosine, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved at blokere dette enzym mindsker Didanosin i kombination med andre antivirale lægemidler hiv-mængden i blodet og holder den nede.
English: ‘Gastroresistant' means that the tablet's contents pass through the stomach without being broken down until they reach the intestine.
Danish: “Enterotabletter” er tabletter, hvis indhold passerer gennem mavesækken uden at nedbrydes, før det når tarmen.
English: The grounds for the referral were objections raised by France and the Netherlands that the bioequivalence study carried out under fed conditions did not show that Didanosine was bioequivalent to its reference medicine, Videx EC.
Danish: Begrundelsen for indbringelsen var indvendinger rejst af Frankrig og Nederlandene, som fandt, at bioækvivalensundersøgelsen, der var udført under ikke-fastende betingelser, ikke viste, at Didanosin var bioækvivalent med referencelægemidlet Videx EC.
English: Although the Committee noted that the maximum concentrations of active substance in the blood when taken with food were somewhat higher after Didanosine than after the reference medicine, it considered that the difference was not clinically relevant since the medicine should be taken on an empty stomach, which produces much higher concentrations, and these small variations in the concentration of the active substance in the blood would therefore not increase the risks.
Danish: Udvalget bemærkede dog, at de maksimale koncentrationer af aktivt stof i blodet ved indtagelse sammen med føde var noget højere efter Didanosin end efter referencelægemidlet, men fandt, at forskellen er uden klinisk betydning fordi lægemidlet skal tages på tom mave, hvilket medfører langt højere koncentrationer, og at denne lille forskel i koncentrationen af det aktive stof i blodet derfor ikke vil øge risiciene.
English: Didanosine is a hybrid medicine which means that it is similar to a ‘reference medicine' already authorised in the EU called Videx EC.
Danish: Det betyder, at Didanosin svarer til et “referencelægemiddel”, som i forvejen er godkendt i EU (Videx EC).
English: Didanosine is an antiviral medicine used in combination with other medicines to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Didanosin er et antiviralt lægemiddel, der anvendes sammen med andre lægemidler til behandling af patienter smittet med hiv-1 (humant immundefektvirus type 1).
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicine has been shown when taken on an empty stomach, and under fed conditions when considering the overall exposure to the active substance (a measure known as AUC).
Danish: Efter at have vurderet de aktuelt foreliggende data og efter den videnskabelige drøftelse i udvalget konkluderede CHMP, at der var påvist bioækvivalens med referencelægemidlet på tom mave og under ikke-fastende betingelser, når man betragter den samlede eksponering for det aktive stof (en målestørrelse, der kaldes AUC).
English: Although the presence of food in the stomach lowers the amount of active substance that can be absorbed and these medicines should therefore be taken on an empty stomach, as Didanosine is a gastro-resistant preparation bioequivalence in fed conditions must be shown to grant the marketing authorisation.
Danish: Når der er mad i maven, nedsættes den mængde aktivt stof, der kan optages, og derfor skal disse lægemidler tages på tom mave; men da Didanosin er et enteropræparat, skal der påvises bioækvivalens under ikke-fastende betingelser, for at der kan udstedes markedsføringstilladelse.
English: Didanosine belongs to a class of medicines called nucleoside analogues or nucleoside reversetranscriptase inhibitors (NRTIs).
Danish: Didanosin tilhører lægemiddelgruppen nukleosidanaloger, også kaldet nukleosid-reverse-transcriptasehæmmere (NRTI).
English: It is available as gastroresistant tablets.
Danish: Det leveres som enterotabletter.
English: “+” indicates an ongoing response.
Danish: “+” indikerer en igangværende respons.
English: Day 7 or 8 or 9:
Danish: Dag 7 eller 8 eller 9:
English: 66 months.
Danish: 66 måneder.
English: No growth
Danish: Ingen vækst
English: Your doctor will tell you if this applies to you.
Danish: Din læge vil fortælle dig det, hvis det gælder for dig.
English: Please ask your doctor how this may affect you, especially if you are planning on having children in the future.
Danish: Spørg lægen om, hvordan dette kan påvirke dig, især hvis du planlægger at få et barn i fremtiden.
English: Table 1 summarizes efficacy data from this study.
Danish: Tabel 1 giver et resume af effektivitetsdata fra dette studie.
English: This results in the ability to kill both targeted and neighbouring cells.
Danish: Dette resulterer i evnen til at dræbe både målrettede og omkringliggende celler.
English: Zevalin will only be used in special controlled areas.
Danish: Zevalin vil kun blive anvendt i særligt kontrollerede områder.
English: The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Danish: Den mest passende MedDRA-betegnelse er anvendt til at beskrive en bestemt reaktion og dens synonymer og tilhørende tilstande.
English: • Treatment with growth factors
Danish: ● Behandling med vækstfaktorer
English: There are no known interactions with other medicinal products.
Danish: Der er ingen kendte interaktioner med andre medicinske produkter.
English: Your doctor will immediately stop the treatment.
Danish: Din læge vil straks stoppe behandlingen.
English: Median progression free survival (PFS) was calculated at a median follow-up of 2.9 years.
Danish: Median progressionsfri overlevelse (PFS) blev beregnet ved en median followup på 2,9 år.
English: The Package Leaflet should also be amended accordingly.
Danish: Indlægssedlen skal ligeledes ændres i overensstemmelse hermed.
English: It may be necessary to perform a dilution (1:100) before application of the [
Danish: Det kan være nødvendigt at foretage en fortynding (1:100), inden den [
English: • Additional testing that might be required for suitability assessment: Process-specific impurities:
Danish: • Yderligere tests, der kan være nødvendige til vurdering af egnethed: Proces-specifikke urenheder:
English: Zevalin contains 1 of each of the following:
Danish: Zevalin indeholder 1 af hver af følgende:
English: Please be cautious until you are sure you are not affected.
Danish: Vær forsigtig, indtil du er sikker på, at du ikke er påvirket af medicinen.
English: • The following minimum yttrium-90 characteristics are recommended: Radioactivity concentration at time of use
Danish: • Følgende minimumsspecifikationer for yttrium-90 anbefales: Koncentration af radioaktivitet på anvendelsestidspunktet
English: You may, therefore, need to be tested for special antibodies.
Danish: Det kan derfor blive nødvendigt, at du bliver testet for specielle antistoffer.
English: Zevalin is indicated in adults.
Danish: Zevalin er indiceret til voksne.
English: Y occurs in a radius of 5 mm around the isotope.
Danish: Y sker i en radius på 5 mm rundt om isotopen.
English: Individual metals*
Danish: Individuelle metaller*
English: Pregnancy must be excluded before the start of treatment in women.
Danish: Graviditet skal udelukkes inden påbegyndelse af behandling af kvinder.
English: Zevalin is not used directly, but must be prepared by your healthcare professional first.
Danish: Zevalin anvendes ikke direkte, men skal forberedes først af dit sundhedspersonale.
English: In all cases it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Danish: Det er i alle tilfælde nødvendigt at sikre, at risiciene fra strålingen er mindre end risiciene fra selve sygdommen.
English: However, after Yttrium-90 is added, adequate shielding of the final preparation must be maintained.
Danish: Efter tilsætning af Yttrium-90 skal en tilstrækkelig afskærmning af det endelige præparat imidlertid opretholdes.
English: Tell your doctor immediately if you notice symptoms of any of the following:
Danish: Informer omgående din læge hvis du oplever et af følgende symptomer:
English: These usually decrease around two months after start of treatment.
Danish: Disse tal falder normalt omkring to måneder efter behandlingens start.
English: 3; or neutrophil count <1,500
Danish: 3; eller neutrofiltal <1.500
English: Below limit of quantitation*
Danish: Under kvantiseringsgrænsen*
English: Y] in a total volume of 10 ml.
Danish: Y] i et totalt volumen på 10 ml.
English: This medicine will be stored by a healthcare professional.
Danish: Denne medicin bliver opbevaret af sundhedspersonalet.
English: HCl concentration
Danish: HCl-koncentration
English: Do not use Zevalin after the expiry date which is stated on the pack.
Danish: Brug ikke Zevalin efter den udløbsdato, der står på pakningen.
English: Labelling time longer than six minutes or shorter than four minutes will result in inadequate radioincorporation.
Danish: Inkubationstider, der er længere end seks minutter eller kortere end fire minutter, vil resultere i utilstrækkelig radioaktiv inkorporation.
English: The secondary endpoints, duration of response and time to progression, were not significantly different between the two treatment arms.
Danish: De sekundære endepunkter, varighed af respons og tid til progression, viste ikke signifikante forskelle mellem de to behandlingsarme.
English: Expected haematological toxicity was observed, including grade 3 or 4.
Danish: Der blev observeret forventet hæmatologisk toksicitet, herunder grad 3 eller grad 4.
English: In total, 87% of patients were in CR(u); 76% in CR and 11% in CRu.
Danish: I alt var 87 % af patienterne i CR(u), 76 % i CR og 11 % i CRu.
English: Date of latest renewal: 16 January 2009
Danish: Dato for første markedsføringstilladelse: 16. januar 2004 Dato for seneste fornyelse: 16. januar 2009
English: Intravenous infusion, after preparation.
Danish: Intravenøs infusion, efter præparation
English: Your doctor will perform tests to exclude pregnancy before you start the treatment.
Danish: Din læge vil tage nogle prøver for at udelukke graviditet, før du starter på behandlingen.
English: Total other Beta impurities (non-strontium-90)
Danish: Totale andre Beta-urenheder (non-strontium-90)
English: Y] was 28 h.
Danish: Y] 28 timer.
English: Irradiation by the emitted beta particles from
Danish: Stråling fra de udsendte beta-partikler fra
English: These persons will take special care for the safe use of this product and will keep you informed of their actions.
Danish: Disse personer vil tage særlige forholdsregler, så præparatet anvendes sikkert, og de vil holde dig informeret om deres handlinger.
English: Adverse reactions listed below are classified according to frequency and System Organ Class (MedDRA).
Danish: Bivirkningerne nedenfor er klassificeret i henhold til hyppighed og systemorganklasser (MedDRA).
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Danish: Der er en streng lovgivning angående anvendelse, håndtering og bortskaffelse af radioaktive lægemidler.
English: Most radioactivity will decay within the body, but a small part will be eliminated through your urine.
Danish: Det meste af radioaktiviteten vil henfalde i kroppen, men en lille del vil blive udskilt med urinen.
English: Contaminated materials must be disposed of as radioactive waste by the authorised route.
Danish: Kontaminerede materialer skal bortskaffes som radioaktivt affald ad autoriseret vej.
English: Therefore, women must discontinue breast-feeding, as the potential for absorption and immunosuppression in the infant is unknown.
Danish: Derfor skal kvinden stoppe med at amme, da risikoen for absorption og immunsuppression hos barnet er ukendt.
English: Count each vial in a beta counter or in an appropriate counter for one minute (CPM), record net counts, corrected for background.
Danish: Tæl hvert hætteglas i en beta-tæller eller i en passende tæller i ét minut (CPM), registrér nettotallene, korrigeret for baggrund.
English: The prepared solution must be given as a slow intravenous infusion over 10 minutes.
Danish: Den færdige opløsning skal indgives som en langsom intravenøs infusion over 10 minutter.
English: Appropriate aseptic precautions should be taken.
Danish: Der skal tages passende aseptiske forholdsregler.
English: Frequency groupings are defined according to the following convention: (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to 1/100, rare:  1/10,000 to <1/1,000; very rare: <1/10,000).
Danish: Hyppigheden af bivirkningerne er defineret på følgende måde: (meget almindelig ≥ 1/10, almindelig ≥ 1/100 til <1/10, ikke almindelig ≥ 1/1.000 til 1/100, sjælden:  1/10.000 til <1/1.000; meget sjælden: <1/10.000).
English: Patients should be advised that fertility may be affected and that male patients may wish to consider semen cryopreservation.
Danish: Patienten skal informeres om, at fertiliteten kan blive påvirket, og at mandlige patienter skal overveje nedfrysning af sæd.
English: Infections may be bacterial, fungal, viral including reactivation of latent viruses.
Danish: Infektioner kan være bakterielle, fungale, virale, herunder reaktivering af latente vira.
English: Blood samples, used to calculate residence times for red marrow, were drawn up to eight time-points.
Danish: Blodprøver til beregning af residenstider for rød knoglemarv blev udtaget på op til otte forskellige tidspunkter.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significang change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Organ region of interest Sacrum region of interest Whole body region of interest
Danish: 1 Organområde af interesse 2 Sacrumområde af interesse 3 Hele kroppens område af interesse
English: Name and address of the manufacturer of the biological active substance Biogen IDEC, Inc.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Biogen IDEC, Inc.
English: Zevalin must not be used during pregnancy.
Danish: Zevalin må ikke anvendes under graviditet.
English: Like all medicines, Zevalin can cause side effects, although not everybody gets them.
Danish: Zevalin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The estimated radiation-absorbed doses to normal organs were substantially below recognised upper safety limits.
Danish: De estimerede absorberede strålingsdoser til normale organer var væsentligt under de vedtagne øvre sikkerhedsgrænser.
English: (monotherapy) and <150,000/mm
Danish: (monoterapi) og <150.000/mm
English: There is no known specific antidote for [
Danish: Der er ingen kendt specifik antidot mod overdosering med [