FrancophonIA/ELRC3.0 huggingface dataset:
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Danish: Ætiologien anses dog for at være multifaktoriel (anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
English: f n = 539 (TAF) or 841 (TFV) adults.
Danish: a n = 24 unge b n = 23 unge c AUClast d n = 15 unge e n = 19 voksne f n = 539 (TAF) eller 841 (TFV) voksne
English: Co-administration with Genvoya may result in increased plasma concentrations of salmeterol, which is associated with the potential for serious or life-threatening adverse reactions.
Danish: Samtidig administration af Genvoya kan føre til øgede plasmakoncentrationer af salmeterol, hvilket er forbundet med risikoen for alvorlige eller livstruende bivirkninger.
English: • emtricitabine, an antiretroviral medicine known as a nucleoside reverse transcriptase inhibitor
Danish: • emtricitabin, et antiretroviralt lægemiddel, der kaldes en nukleosid-revers transkriptase hæmmer (NRTI)
English: Norgestimate (0.180/0.215 mg once daily)/ Ethinyloestradiol (0.025 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)4
Danish: Norgestimat (0,180/0,215 mg én gang daglig)/Ethinylestradiol (0,025 mg én gang daglig)/Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)4
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment (see section 4.4).
Danish: Den rapporterede tidsperiode før sådanne opstår, er imidlertid variabel, og kan opstå mange måneder efter påbegyndelse af behandlingen (se pkt.
English: No clinically relevant differences in elvitegravir, cobicistat, or tenofovir alafenamide pharmacokinetics were observed in patients with end stage renal disease on chronic haemodialysis as compared to those with normal renal function.
Danish: Der blev ikke observeret nogen klinisk relevante forskelle i farmakokinetikken for elvitegravir, cobicistat eller tenofoviralafenamid hos patienter med nyresygdom i slutstadiet i kronisk hæmodialyse sammenlignet med hos patienter med normal nyrefunktion.
English: Due to the presence of cobicistat, co-administration with Genvoya may result in increased plasma concentrations of this medicinal product, which is associated with the potential for serious or life-threatening adverse reactions.
Danish: Da cobicistat er til stede kan samtidig administration af Genvoya føre til øgede plasmakoncentrationer af dette lægemiddel, hvilket er forbundet med risikoen for alvorlige og/eller livstruende bivirkninger.
English: The mean change from baseline in CD4+ cell count and percentage at Week 48 was -43 cells/mm3 and -0.1%, respectively.
Danish: Gennemsnitsændringen fra baseline i CD4+ celletal og procentdel ved 48 uger var henholdsvis -43 celler/mm3 og -0,1 %.
English: Do not chew or crush the tablet.
Danish: Tabletten må ikke tygges eller knuses.
English: HIV-1 RNA < 20 copies/mL Treatment difference
Danish: Hiv 1-rna < 20 kopier/ml
English: Co-administration of Genvoya and triazolam is contraindicated (see section 4.3).
Danish: Samtidig administration af Genvoya og triazolam er kontraindiceret (se pkt.
English: Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinyloestradiol (0.025 mg once daily)/ Emtricitabine/Tenofovir alafenamide (200/25 mg once daily)6
Danish: Norgestimat (0,180/0,215/0,250 mg en gang dagligt)/ethinylestradiol (0,025 mg en gang dagligt)/ emtricitabin/ tenofoviralafenamid (200/25 mg en gang dagligt)6
English: Treatment with cobicistat and elvitegravir during pregnancy results in lower elvitegravir exposure (see sections 4.4 and 5.2).
Danish: Behandling med cobicistat og elvitegravir under graviditet medfører lavere eksponering for elvitegravir (se pkt.
English: Clinical monitoring should be made upon co-administration with Genvoya.
Danish: Der skal udføres klinisk overvågning ved samtidig administration med Genvoya.
English: Gastrointestinal disorders Very common:
Danish: Mave-tarm-kanalen Meget almindelig:
English: Co-administration of Genvoya and orally administered midazolam is contraindicated (see section 4.3).
Danish: Samtidig administration af Genvoya og oralt administreret midazolam er kontraindiceret (se pkt.
English: Clinical monitoring is recommended upon co-administration of Genvoya.
Danish: Klinisk overvågning anbefales ved samtidig administration af Genvoya.
English: Cobicistat: AUC: ↔
Danish: Midazolam: AUC: ↔
English: HMG CO-A REDUCTASE INHIBITORS Rosuvastatin (10 mg single dose)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Danish: HMG CO-A-REDUKTASEHÆMMERE Rosuvastatin (10 mg enkeltdosis)/Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)
English: Atorvastatin: AUC: ↑ 160% Cmin: NC Cmax: ↑ 132%
Danish: Atorvastatin: AUC: ↑160 % Cmin: NC
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før De tager dette lægemiddel, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Cockcroft-Gault method, and urine protein to creatinine ratio and after 96 weeks treatment by urine albumin to creatinine ratio) compared to E/C/F/TDF (see also section 4.4).
Danish: I studier af behandlingsnaive patienter var Genvoya forbundet med en mindre påvirkning af renale sikkerhedsparametre (målt efter 144 ugers behandling ved estimeret glomerulær filtrationshastighed via Cockcroft-Gault-metoden, og forhold mellem protein og kreatinin i urinen efter 96 ugers behandling ved forhold mellem albumin og kreatinin i urinen) sammenlignet med E/C/F/TDF (se også pkt.
English: Concentrations of rosuvastatin are transiently increased when administered with elvitegravir and cobicistat.
Danish: Koncentrationerne af rosuvastatin øges forbigående ved samtidig administration af elvitegravir og cobicistat.
English: How to take Genvoya
Danish: Sådan skal De tage Genvoya
English: Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by subgroup
Danish: Andel (%) patienter med hiv 1-rna < 50 kopier/ml pr. undergruppe
English: 5.4% (95% CI: 1.5% to 9.2%)
Danish: 0,4 % (95 % CI: -3,0 % til 3,8 %) 5,4 % (95 % CI: 1,5 % til 9,2 %)
English: No virologic data at Week 48 or 144 window Discontinued study drug due to AE or deathd
Danish: Hiv 1-rna ≥ 50 kopier/mlc Ingen virologiske data ved uge 48- eller 144-vinduet
English: ANTICONVULSANTS Carbamazepine (200 mg twice daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Danish: ANTIKONVULSIVA Carbamazepin (200 mg to gange daglig)/Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)
English: alfuzosin (used to treat an enlarged prostate gland) dabigatran (used to prevent and treat blood clots) amiodarone, quinidine (used to correct irregular heartbeats)
Danish: alfuzosin (anvendes til at behandle en forstørret blærehalskirtel) dabigatran (anvendes til at forebygge og behandle blodpropper) amiodaron, quinidin (anvendes til at korrigere uregelmæssige hjerteslag) carbamazepin, phenobarbital, phenytoin (anvendes til at forebygge krampeanfald) rifampicin (anvendes til at forebygge og behandle tuberkulose og andre infektioner)
English: Concentrations of these antiarrhythmic drugs may be increased when co-administered with cobicistat.
Danish: Koncentrationer af disse antiarytmika kan øges ved samtidig administration af cobicistat.
English: • If you notice 18 hours or more after the time you usually take Genvoya, then do not take the missed dose.
Danish: • Hvis De kommer i tanker om det 18 timer eller længere efter det tidspunkt, De normalt tager
English: No dose adjustment of sofosbuvir/velpatasvir and Genvoya is warranted upon co-administration.
Danish: Dosisjustering af sofosbuvir/velpatasvir og Genvoya er ikke nødvendig ved samtidig administration.
English: The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1,498).
Danish: Det gennemsnitlige CD4+ celletal ved baseline var 636 celler/mm3 (interval: 263-1498).
English: • gastrointestinal motility agents: cisapride
Danish: • stoffer, der fremmer mave-tarm-mobiliteten: cisaprid
English: Each Genvoya film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Danish: Hver Genvoya filmovertrukken tablet indeholder 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabin og tenofoviralafenamidfumarat svarende til 10 mg tenofoviralafenamid.
English: Co-administration of Genvoya with carbamazepine is contraindicated (see section 4.3).
Danish: Samtidig administration af Genvoya og carbamazepin er kontraindiceret (se pkt.
English: No virologic data at Week 48/ Week 96 window Discontinued study drug due to AE or deathe
Danish: Hiv 1-rna ≥ 50 kopier/mld Ingen virologiske data ved uge 48-/uge 96-vinduet
English: Concentrations of atorvastatin are increased when co-administered with elvitegravir and cobicistat.
Danish: Koncentrationerne af atorvastatin øges ved samtidig administration af elvitegravir og cobicistat.
English: Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLf
Danish: Seponerede studiemedicin som følge af AE eller døde Seponerede studiemedicin som følge af andre årsager, og sidste tilgængelige hiv 1-rna < 50 kopier/mlf Manglende data i tidsvinduet, men får studiemedicin
English: Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Danish: Hver tablet indeholder 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabin og tenofoviralafenamidfumarat svarende til 10 mg tenofoviralafenamid.
English: Antimycobacterials Rifabutin (150 mg every other day)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Danish: Antimykobakterielle lægemidler Rifabutin (150 mg hver anden dag)/Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment.
Danish: Autoimmunsygdomme (som Graves sygdom og autoimmun hepatitis) er også rapporteret i tilfælde af immunreaktivering.
English: Buprenorphine: AUC: ↑ 35% Cmin: ↑ 66% Cmax: ↑ 12%
Danish: AUC: ↑ 35 % Cmin: ↑ 66 % Cmax: ↑ 12 %
English: The mean change from baseline in CD4+ cell count at Week 48 was -2 cells/mm3.
Danish: Den gennemsnitlige ændring i CD4+ celletal i forhold til baseline ved uge 48 var -2 celler/mm3.
English: Co-administration with Genvoya may result in increased plasma concentrations of this medicinal product, which is associated with the potential for serious or life-threatening adverse reactions.
Danish: Samtidig administration af Genvoya kan føre til øgede plasmakoncentrationer af dette lægemiddel, hvilket er forbundet med risikoen for alvorlige og/eller livstruende bivirkninger.
English: HIV-1 RNA ≥ 50 copies/mLd
Danish: Hiv 1-rna < 50 kopier/ml
English: Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Danish: Hver filmovertrukken tablet indeholder 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabin og tenofoviralafenamidfumarat svarende til 10 mg tenofoviralafenamid.
English: • medicines used to treat gout:
Danish: • lægemidler, der anvendes til behandling af podagra:
English: The antiviral activity of elvitegravir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cells, monocyte/macrophage cells, and peripheral blood lymphocytes and the 50% effective concentration (EC50) values were in the range of 0.02 to 1.7 nM. Elvitegravir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.1 to 1.3 nM) and activity against HIV-2 (EC50 of 0.53 nM).
Danish: De 50 % effektive koncentrationsværdier (EC50) var i intervallet fra 0,02 til 1,7 nM. Elvitegravir viste antiviral aktivitet i cellekultur mod hiv 1-kladerne A, B, C, D, E, F, G og O (EC50-værdier var i intervallet fra 0,1 til 1,3 nM) og aktivitet mod hiv 2 (EC50 af 0,53 nM).
English: Seventy-nine percent were male, 63% were White, 18% were
Danish: 79 % var mænd, 63 % var hvide, 18 % var sorte og 14 % var asiater.
English: Possible serious side effects: tell a doctor immediately
Danish: Alvorlige bivirkninger: Fortæl det straks til lægen • Ethvert tegn på betændelse eller infektion.
English: 4.2% (95% CI: 0.6% to 7.8%)
Danish: 2,0 % (95 % CI: -0,7 % til 4,7 %) 4,2 % (95 % CI: 0,6 % til 7,8 %)
English: Anti-hepatitis C virus medicinal products Ledipasvir (90 mg once daily)/ Sofosbuvir (400 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Danish: Lægemidler mod hepatitis C-virus Ledipasvir (90 mg én gang daglig)/Sofosbuvir (400 mg én gang daglig)/Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)/Emtricitabin (200 mg én gang daglig)/Tenofoviralafenamid (10 mg én gang daglig)5
English:  If any of these applies to you, do not take Genvoya and tell your doctor immediately.
Danish:  Hvis noget af dette gælder for Dem, må De ikke tage Genvoya.
English: Therapeutic monitoring is recommended upon co-administration with Genvoya.
Danish: Der anbefales terapeutisk overvågning ved samtidig administration af Genvoya.
English: Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLe
Danish: Seponerede studiemedicin som følge af AE eller dødd Seponerede studiemedicin som følge af andre årsager, og sidste tilgængelige hiv 1-rna < 50 kopier/mle Manglende data i tidsvinduet, men får studiemedicin
English: COBIa
Danish: EVGa COBIa
English: Sofosbuvir (400 mg once daily)/ Velpatasvir (100 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Danish: Sofosbuvir (400 mg én gang daglig)/Velpatasvir (100 mg én gang daglig)/Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)/Emtricitabin (200 mg én gang daglig)/Tenofoviralafenamid (10 mg én gang daglig)5
English: This is because some of the active substances in this medicine pass into human breast milk.
Danish: • De må ikke amme, mens De er i behandling med Genvoya, fordi nogle af de aktive stoffer i denne medicin udskilles i mælken hos mennesker.
English: ANTACIDS
Danish: ANTACIDA
English: What Genvoya is and what it is used for What you need to know before you take Genvoya How to take Genvoya
Danish: Det skal De vide, før De begynder at tage Genvoya Sådan skal De tage Genvoya Bivirkninger
English: Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by prior treatment regimen EFV/FTC/tenofovir disoproxil
Danish: Andel (%) patienter med hiv 1-rna < 50 kopier/ml pr. tidligere behandlingsregime
English: Concentrations of antidepressant agents may be increased when co-administered with cobicistat.
Danish: Koncentrationer af antipressiva kan øges ved samtidig administration af cobicistat.
English: Atorvastatin (10 mg single dose)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)/Emtricitabine (200 mg once daily)/Tenofovir alafenamide (10 mg once daily)
Danish: Atorvastatin (10 mg enkeltdosis)/Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)/Emtricitabin (200 mg én gang daglig)/Tenofovir alafenamid (10 mg én gang daglig)
English: ANTIDEPRESSANTS Sertraline (50 mg single dose)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Danish: ANTIDEPRESSIVA Sertralin (50 mg enkeltdosis)/ Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)/Emtricitabin (200 mg én gang daglig)/Tenofoviralafenamid (10 mg én gang daglig)5
English: Cmax: ↑ 41%
Danish: AUC: ↔ Cmax: ↑ 41 %
English: Cmin: ↑ 103% Cmax: ↔
Danish: AUC: ↔ Cmin: ↑ 103 % Cmax: ↔
English: AUC: ↓ 69% Cmin: ↓ 97% Cmax: ↓ 45%
Danish: AUC: ↓ 69 % Cmin: ↓ 97 %
English: Caution is warranted and clinical monitoring is recommended upon co-administration with Genvoya.
Danish: Der rådes til forsigtighed og klinisk overvågning ved samtidig administration af Genvoya.
English: • erectile dysfunction medicines, used to treat impotence, such as:
Danish: • lægemidler mod erektionsproblemer, der anvendes til at behandle impotens, såsom: sildenafil, tadalafil og vardenafil
English: Five subjects had virologic failure through the end of the study; no phenotypic or genotypic resistance to Genvoya was detected.
Danish: Der blev ikke detekteret nogen fænotypisk eller genotypisk resistens over for Genvoya.
English: Mean percent change in AUC,
Danish: Gennemsnitlig ændring (%) i AUC, Cmax, Cmin1
English: • tenofovir alafenamide
Danish: • tenofoviralafenamid
English: Race
Danish: Etnicitet
English: Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Danish: Elvitegravir (150 mg én gang dagligt)/ Cobicistat (150 mg én gang dagligt)/ Emtricitabin (200 mg én gang dagligt)/Tenofoviralafenamid (10 mg én gang dagligt)5
English: FTCa
Danish: FTCe TAFf
English: 25 July 2014 EMEA/H/C/002418
Danish: Den 25. juli 2014 EMEA/H/C/002418
English: This means that it was intended to be similar to a ‘reference medicine' containing the same active substance, but in a higher strength.
Danish: Det vil sige, at det var hensigten, at det skulle svare til et "referencelægemiddel", der indeholder samme aktive stof, men i en højere styrke.
English: The Committee considered that controls to ensure suitable and consistent quality of the medicine have not been shown to be adequate.
Danish: Udvalget fandt, at det ikke var påvist, at der var tilstrækkelig kontrol til at sikre passende og ensartet kvalitet af lægemidlet.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application since it would not be possible to provide the additional data regarding the quality of the medicine within the timetable required by the procedure.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen angav virksomheden, at den trak ansøgningen tilbage, fordi det ikke ville være muligt at fremskaffe de nødvendige supplerende data vedrørende lægemidlets kvalitet inden for den tidsramme, som proceduren kræver.
English: It was to be available as 40 mg tablets.
Danish: Det var hensigten, at det skulle leveres som tabletter på 40 mg.
English: What is Neofordex?
Danish: Hvad er Neofordex?
English: Neofordex was developed as a ‘hybrid medicine'.
Danish: Neofordex blev udviklet som et "hybridt lægemiddel".
English: The company also presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.
Danish: Virksomheden forelagde desuden undersøgelser fra litteraturen om anvendelsen af dexamethason til behandling af multipelt myelom.
English: While the reference medicine Dectancyl is available as 0.5 mg tablets, Neofordex was to be available as 40 mg tablets.
Danish: Mens referencelægemidlet, Dectancyl, leveres som tabletter på 0,5 mg, skulle Neofordex have været leveret som tabletter på 40 mg.
English: On 17 July 2014, Laboratories CTRS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Neofordex, for the treatment of multiple myeloma.
Danish: Den 17. juli 2014 meddelte Laboratories CTRS officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Neofordex til behandling af multipelt myelom.
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 Neofordex could not have been approved for the treatment of multiple myeloma.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Neofordex ikke kunne godkendes til behandling af multipelt myelom.
English: What was Neofordex expected to be used for?
Danish: Hvad forventedes Neofordex anvendt til?
English: Neofordex was to be used in combination with other medicines to treat adult patients with multiple myeloma who have developed symptoms.
Danish: Neofordex forventedes anvendt i kombination med andre lægemidler til behandling af voksne patienter, som har multipelt myelom og har fået symptomer.
English: Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Neofordex did not outweigh its risks.
Danish: Derfor var CHMP op til tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Neofordex ikke opvejede risiciene på grund af betænkelighederne vedrørende dets kvalitet.
English: The active substance in Neofordex and Dectancyl, dexamethasone, belongs to a group of medicines known as corticosteroids, which reduce the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cells.
Danish: Det aktive stof i Neofordex og Dectancyl, dexamethason, tilhører lægemiddelgruppen binyrebarkhormoner, der dæmper aktiviteten af immunsystemet (kroppens naturlige forsvar) ved at bindes til receptorer i forskellige typer immunceller.
English: Multiple myeloma is a cancer of the plasma cells in the bone marrow.
Danish: Multipelt myelom er kræft udgående fra plasmacellerne i knoglemarven.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Neofordex.
Danish: Virksomheden 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 Neofordex.
English: How is Neofordex expected to work?
Danish: Hvordan forventes Neofordex at virke?
English: Neofordex was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 6 June 2010 for the treatment of multiple myeloma.
Danish: Neofordex blev udpeget som "lægemiddel til sjældne sygdomme" den 6. juni 2010 til behandling af multipelt myelom.
English: Neofordex is a corticosteroid medicine that contains the active substance dexamethasone.
Danish: Neofordex er et lægemiddel af typen binyrebarkhormoner og indeholder det aktive stof dexamethason.
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 Neofordex eller i programmer for anvendelse af Neofordex med særlig udleveringstilladelse?
English: dexamethasone is used together with chemotherapy to make chemotherapy more effective and to reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom høje doser sammen med kemoterapi for at få kemoterapien til at virke bedre og for at mindske visse bivirkninger ved kræftbehandling, såsom kvalme og opkastning.
English: Withdrawal of the marketing authorisation application for Neofordex (dexamethasone) EMA/443387/2014
Danish: EMA/443387/2014