FrancophonIA/ELRC3.0 huggingface dataset:
English: 100 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Danish: Hætteglas 100 ml (type 1-glas) med prop (butylgummi) og hætte (aluminium) indeholdende 250 mg paclitaxel formuleret som albuminbundne nanopartikler.
English: Day 15: If Day 8 doses were reduced: Day 15 ≥ 1000
Danish: Dag 15: Hvis Dag 8 doser blev reduceret:
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D bar code carrying the unique identifier
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: Common: Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes
Danish: Almindelig: Negleforandringer, pruritus, tør hud, erytem, misfarvning/pigmentering af negle, hyperpigmentering af hud, onykolyse, negleændringer
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas
English: increased blood sugar, increased phosphorus in the blood
Danish: nedsat blodsukker, nedsat natrium i blodet
English: Occurrence Dose of Abraxane (mg/m2)1
Danish: Abraxane-dosis (mg/m2)1
English: Reduce doses 2 dose levels from Day 1 doses
Danish: Reducer dosis med 2 dosisniveauer fra Dag 1 dosis
English: Stability of the reconstituted suspension in the vial Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C in the original carton, protected from light.
Danish: Stabilitet af den rekonstituerede suspension i hætteglasset Kemisk og fysisk stabilitet under brug er blevet påvist i 24 timer ved 2 °C-8 °C i den originale emballage, beskyttet mod lys.
English: Very common: Decreased appetite Common: Dehydration
Danish: Meget almindelig: Nedsat appetit
English: Talk to your doctor or nurse if you experience any of these conditions whilst being treated with Abraxane, your doctor may wish to stop treatment or reduce the dose:
Danish: Kontakt lægen eller sundhedspersonalet, hvis du får nogen af disse tilstande, mens du behandles med Abraxane.
English: Abraxane contains sodium
Danish: Abraxaneindeholder natrium
English: Reduce doses 1 dose level from Day 1 doses
Danish: Reducer dosis 1 dosisniveau fra Dag 1 dosis
English: Each vial contains 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Danish: Hvert hætteglas indeholder 100 mg eller 250 mg paclitaxel formuleret som albuminbundne nanopartikler.
English: Withhold doses
Danish: Afbryd doser
English: toxic epidermal necrolysis)
Danish: Ikke-hæmatologisk toksicitet
English: Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Danish: Hvert hætteglas indeholder 250 mg paclitaxel formuleret som albuminbundne nanopartikler.
English: Survival (months) Progression-free Survival Death or progression, n (%) Median Progression-free Survival, months (95% CI) HRA+G/G (95% CI)a P-valueb
Danish: 75. percentil samlet overlevelse (måneder) Progressionsfri overlevelse Død eller progression, n (%) Median progressionsfri overlevelse, måneder (95 % CI)
English: • Increased weight, increased lactate dehydrogenase in the blood, decreased kidney function,
Danish: • Øget vægt, øget mælkesyredehydrogenase i blodet, nedsat nyrefunktion, øget blodsukker, øget fosfor i blodet
English: Very common: Rash, alopecia Common: Pruritus, nail disorder Uncommon: Skin exfoliation, dermatitis allergic, urticaria
Danish: Almindelig: Hyperbilirubinæmi Hud og subkutane væv Meget almindelig: Udslæt, alopeci Almindelig: Pruritus, neglesygdom Ikke almindelig: Hudeksfoliation, allergisk dermatit, urticaria
English: Table 11: Efficacy results from randomized study in patients with pancreatic adenocarcinoma (Intent-to-treat population)
Danish: Tabel 11: Virkningsresultater fra randomiseret studie hos patienter med adenokarcinom i pancreas (intent-to-treat-population) Abraxane(125 mg/m2)/gemcitabin (N=431)
English: 250 mg vial: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Danish: 250 mg hætteglas: Ved brug af en steril sprøjte injiceres 50 ml natriumchloridinfusionsvæske 9 mg/ml (0,9 %) langsomt (i løbet af mindst et minut) ind i et hætteglas med Abraxane.
English: patients with metastatic breast cancer.
Danish: 30 minutters infusion hos 63 patienter med metastaserende brystkræft.
English: Very common: Fatigue, asthenia, pyrexia Common: Peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, influenza-like illness, malaise, lethargy, hyperpyrexia
Danish: Meget almindelig: Træthed, asteni, pyreksi Almindelig: Perifert ødem, slimhindeinflammation, smerter, stivhed, ødem, svaghed, nedsat performance-status, brystsmerter, influenzalignende sygdom, generel utilpashed, letargi, hyperpyreksi Ikke almindelig: Ubehag i brystet, gangforstyrrelser, hævelser, reaktion på injektionsstedet
English: nevirapine)
Danish: ketoconazol)
English: 100 mg vial: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Danish: 100 mg hætteglas: Ved brug af en steril sprøjte injiceres 20 ml natriumchloridinfusionsvæske 9 mg/ml (0,9 %) langsomt (i løbet af mindst et minut) ind i et hætteglas med Abraxane.
English: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 250 mg vial of Abraxane over a minimum of 1 minute.
Danish: Ved brug af en steril sprøjte injiceres 50 ml natriumchloridinfusionsvæske 9 mg/ml (0,9 %) langsomt (i løbet af mindst et minut) ind i et hætteglas med 250 mg Abraxane.
English: Common: Insomnia, depression, anxiety Uncommon: Restlessness
Danish: Almindelig: Søvnløshed, depression, angst
English: Very common: Alopecia, rash Common: Pruritus, dry skin, nail disorder, flushing
Danish: Almindelig: Pruritus, tør hud, negleforandringer, flushing
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Abraxane over a minimum of 1 minute.
Danish: Ved brug af en steril sprøjte injiceres 20 ml natriumchloridinfusionsvæske 9 mg/ml (0,9 %) langsomt (i løbet af mindst et minut) ind i et hætteglas med 100 mg Abraxane.
English: • medicines used to help you stabilize your mood also sometimes referred to as anti-depressants (e.g.
Danish: De kaldes også antidepressive lægemidler (f.eks.
English: Very common: Nausea, diarrhoea, vomiting, constipation, abdominal pain, abdominal pain upper
Danish: Meget almindelig: Diarré, opkastning, kvalme, forstoppelse Almindelig: Stomatit, dyspepsi, abdominalsmerter, dysfagi
English: Delay of next cycle due to persistent neutropenia2 (Nadir ANC <1500/mm3)
Danish: Udsættelse af næste cyklus på grund af vedvarende neutropeni2
English: Day 15: IF Day 8 doses were withheld: Day 15 ≥ 1000
Danish: Dag 15: Hvis Dag 8 doser blev afbrudt:
English: - If you have any further questions, ask your doctor or nurse.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Uncommon: Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, flank pain, limb discomfort, muscle weakness
Danish: Meget almindelig: Artralgi, myalgi Almindelig: Ekstremitetssmerter, knoglesmerter, rygsmerter, muskelkramper, smerter i lemmerne Ikke almindelig: Smerter i brystvæggen, muskelsvaghed, halssmerter, lyskensmerter, muskelspasmer, smerter i bevægeapparatet, flankesmerter, ubehag i lemmerne, muskelsvaghed
English: For combination use of Abraxane and gemcitabine, if Grade 3 or higher peripheral neuropathy develops, withhold Abraxane; continue treatment with gemcitabine at the same dose.
Danish: Ved kombination af Abraxane og gemcitabin skal Abraxane afbrydes, hvis der udvikles perifer neuropati af grad 3 eller derover.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C in the original carton, protected from light.
Danish: Stabilitet for den rekonstituerede suspension i hætteglasset Kemisk og fysisk stabilitet under brug er blevet påvist i 24 timer ved temperaturer på 2 °C-8 °C i den originale emballage, beskyttet mod lys.
English: Very common: Nausea, diarrhoea, vomiting, constipation, stomatitis Common: Abdominal pain, abdominal distension, upper abdominal pain, dyspepsia, gastrooesophageal reflux disease, oral hypoaesthesia Uncommon: Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, loose stools, oesophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal haemorrhage
Danish: Ikke almindelig: Dysfagi, flatulens, glossodyni, mundtørhed, gingivalsmerter, løs afføring, øsofagit, nedre abdominalsmerter, mundsår, oral smerte, rektalblødning
English: For patients with total bilirubin > 5 x ULN or AST > 10 x ULN, there are insufficient data to permit dosage recommendations regardless of indication (see sections 4.4 and 5.2).
Danish: Uanset indikation er data utilstrækkelige til at give doseringsanbefalinger hos patienter med totalbilirubin > 5 x øvre normalværdi eller ASAT > 10 x øvre normalværdi (se pkt.
English: and including medicines for treating fungal infections (e.g. ketoconazole)
Danish: Anvendelse af medicinsk udstyr med siliconeolie som smøremiddel (f.eks. kanyler og intravenøse (i.v.)
English: Very common: Peripheral neuropathy2 Common: Dysgeusia, headache, dizziness
Danish: Almindelig: Dysgeusi, hovedpine, svimmelhed
English: Celgene Europe B.V. Winthontlaan 6 N 3526 KV Utrecht Netherlands
Danish: Celgene Europe B.V.
English: Uncommon1: Hypersensitivity Rare: Severe hypersensitivity
Danish: Sjælden: Svær overfølsomhed
English: Uncommon: Flushing
Danish: Almindelig: Dehydrering
English: Very common: Arthralgia, myalgia Common: Back pain, pain in extremity, musculoskeletal pain
Danish: Almindelig: Rygsmerter, ekstremitetssmerter, muskuloskeletale smerter
English: Lactation (see section 4.6).
Danish: Abraxane (angivet i punkt 6)
English: Abraxane was administered to patients (N=521) as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8 and
Danish: Abraxane blev administreret til patienter (N=521) som intravenøs infusion i løbet af 30 minutter med en dosis på 100 mg/m2 på Dag 1, 8 og 15 af i hver 21-dages cyklus uden præmedicinering med steroid og uden profylakse med granulocyt kolonistimulerende vækstfaktor (G-CSF).
English: The product is currently approved in Sweden, Denmark, Finland, Iceland and Norway.
Danish: Lægemidlet er i øjeblikket godkendt i Sverige, Danmark, Finland, Island og Norge.
English: This program is on-going and overall from 01 September 2009 to 30 June 2011, 12,830 women have been exposed.
Danish: Det er et løbende program, og i perioden fra den 1. september 2009 til den 30. juni 2011 blev i alt 12 830 kvinder behandlet.
English: Overall summary of the scientific evaluation of Mifepristone Linepharma and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Mifepristone Linepharma og relaterede navne (se bilag I)
English: • The Committee considered the notification of the referral triggered by France under Article 29(4) of Council Directive 2001/83/EC;
Danish: • Udvalget har behandlet meddelelsen om indbringelsen fra Frankrig i henhold til artikel 29, stk. 4, i Rådets direktiv 2001/83/EF.
English: The results of these trials show a very high success rate and no unexpected adverse events.
Danish: Resultaterne af disse undersøgelser viser en meget høj succesrate og ingen uventede bivirkninger.
English: This protocol has been designed to provide further reassurance of the safety and efficacy of the product.
Danish: Formålet med denne protokol er at skabe yderligere sikkerhed for lægemidlets sikkerhed og virkning.
English: The clinical trials have been performed in co-operation with two organisations which have administered the medicinal product to a large number of women.
Danish: De kliniske undersøgelser er blevet udført i samarbejde med to organisationer, der har administreret lægemidlet til et stort antal kvinder.
English: The success rate is of 97.3%, comparable to studies reported in published literature.
Danish: Succesraten er på 97,5 %, hvilket er sammenligneligt med undersøgelser angivet i litteraturen.
English: For the 12,830 women who have received this treatment via the program, the efficacy and safety of the method was as expected from clinical studies reported in the literature.
Danish: For de 12 830 kvinder, der modtog denne behandling gennem programmet, var metodens virkning og sikkerhed som forventet i forhold til kliniske undersøgelser angivet i litteraturen.
English: - The second organisation (Marie Stopes International Australia) has set up a pre-launch training program in Australia under Therapeutic Goods Administration (TGA) Authorised Prescriber Program.
Danish: - Den anden organisation (Marie Stopes International Australia) har oprettet et uddannelsesprogram i Australien forud for lanceringen inden for rammerne af Therapeutic Goods Administration (TGA) Authorised Prescriber Program.
English: The two bioequivalence studies were performed against Mifegyne (approved in EEA) and Mifeprex (approved in the USA).
Danish: De to bioækvivalensundersøgelser blev udført med Mifegyne (godkendt i EØS) og Mifeprex (godkendt i USA).
English: In addition, the CHMP noted that the study with Mifeprex demonstrates bioequivalence for both AUC and Cmax.
Danish: CHMP bemærkede desuden, at undersøgelsen med Mifeprex påviser bioækvivalensen for både AUC og Cmax.
English: • The Committee considered that the overall efficacy and safety have been proven by the studies presented ;
Danish: • Udvalget mente, at de forelagte undersøgelser har påvist den overordnede virkning og sikkerhed.
English: The fact that buccal misoprostol and not vaginal gemeprost (as proposed in the current application) was used as follow up treatment would, if anything, lower the success rates and therefore is reassuring to the CHMP.
Danish: Det forhold, at oralt misoprostol og ikke vaginal gemeprost (som foreslået i den nuværende ansøgning) blev anvendt som opfølgende behandling, ville tværtimod sænke succesraten, hvilket således er betryggende for CHMP.
English: • The Committee reviewed all available data submitted by the marketing authorisation holder to address the potential serious risk to public health, in particular the efficacy and safety in respect of the 200 mg Mifepristone Linepharma dosing regimen;
Danish: • Udvalget har gennemgået alle tilgængelige data indsendt af indehaveren af markedsføringstilladelsen med henblik på at vurdere den potentielle alvorlige risiko for folkesundheden, navnlig virkningen af og sikkerheden ved en dosering på 200 mg Mifepristone Linepharma.
English: (complete termination, no need for additional surgical procedure) was 96.7%.
Danish: I hele populationen var succesraten (fuldstændig afbrydelse, intet behov for yderligere kirurgiske indgreb) 96,7 %.
English: Bioequivalence with the reference product (Mifegyne) was demonstrated for AUC while the Cmax was slightly above the conventional acceptance range of 80-125% (the Cmax ratio (90% CI) was 114.4 (103.33-126.66)).
Danish: Bioækvivalens med referencelægemidlet (Mifegyne) blev godtgjort for AUC, hvorimod Cmax lå lidt uden for det almindelige acceptinterval på 80-125 % (Cmax (90 % CI) lå på 114,4 (103,33-126,66)).
English: During the following CMDh-referral procedure no consensus was reached and the CMDh referred the matter to the CHMP through an article 29(4) referral procedure.
Danish: Under den efterfølgende procedure for indbringelse af sager for CMDh nåede parterne ikke til enighed, og CMDh henviste sagen til CHMP gennem indsigelsesproceduren i henhold til artikel 29, stk. 4.
English: The marketing authorisation holder has provided clinical efficacy and safety data from 2 studies, performed both with Mifepristone Linepharma in Mexico and Australia respectively.
Danish: Indehaveren af markedsføringstilladelsen har fremlagt kliniske data om virkning og sikkerhed på baggrund af to undersøgelser, der begge blev udført med Mifepristone Linepharma i henholdsvis Mexico og Australien.
English: During the repeat use procedure potential serious risk to public health was raised by the France as bioequivalence with the reference product had not been demonstrated for Cmax.
Danish: Under proceduren for gentagen anvendelse gjorde Frankrig indsigelse og påpegede, at der var en potentiel alvorlig risiko for folkesundheden, da bioækvivalensen med referencelægemidlet ikke var blevet påvist for Cmax.
English: Some other specific methodological comments were also raised by the CHMP such as representativity of prescribers, sample size and inclusion criteria.
Danish: CHMP fremsatte desuden en række andre specifikke bemærkninger vedrørende metoden, bl.a. vedrørende de ordinerende lægers repræsentativitet, populationsstørrelsen og inklusionskriterier.
English: Scientific conclusions and grounds for positive opinion subject to condition to the marketing authorisation and amendment of the summary of product characteristics and package leaflet presented by the European Medicines Agency
Danish: Videnskabelige konklusioner og begrundelser for positiv udtalelse underlagt betingelse for markedsføringstilladelsen og ændring af produktresumé og indlægsseddel fremlagt af Det Europæiske Lægemiddelagentur
English: The application for Mifepristone Linepharma 200 mg tablets is a hybrid application made according to Article 10(3) of Directive 2001/83/EC, with Mifegyne 200 mg tablet as reference product.
Danish: Ansøgningen for 200 mg tabletter Mifepristone Linepharma er en hybridansøgning indgivet i henhold til artikel 10, stk. 3, i direktiv 2001/83/EF med Mifegyne 200 mg tabletter som referencelægemiddel.
English: The clinical documentation submitted by the MAH to support this article 10(3) application includes clinical data and supportive pharmacokinetic data in the form of two bioequivalence studies.
Danish: Den kliniske dokumentation fremlagt af indehaveren af markedsføringstilladelsen til støtte for denne ansøgning i henhold til artikel 10, stk. 3, omfatter kliniske data og understøttende farmakokinetiske data i form af to bioækvivalensundersøgelser.
English: The marketing authorisation holder was in agreement with the amendments of the section 4.2 of the SmPC and section 3 of the Package Leaflet as proposed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen var enig i ændringerne af punkt 4.2 i produktresuméet og punkt 3 i indlægssedlen som foreslået af CHMP.
English: Mifepristone Linepharma is submitted as a hybrid application.
Danish: Ansøgningen for Mifepristone Linepharma er en hybridansøgning.
English: However the CHMP expressed some remaining concerns with regards to the required investigations on the potential risk of off label use of mifepristone, either using a higher dose or a combination with another prostaglandin analogue than gemeprost per vaginam.
Danish: CHMP havde imidlertid stadig visse betænkeligheder vedrørende de krævede undersøgelser af den potentielle risiko for anden anvendelse af mifepriston end den foreskrevne, enten anvendelse af en højere dosis eller en kombination med en anden prostaglandinanalog end gemeprost vaginalt.
English: The CHMP is of the opinion that the marketing authorisation holder should submit a revised protocol to the national competent authorities, for final agreement prior the start of the clinical trial.
Danish: CHMP er af den opfattelse, at indehaveren af markedsføringstilladelsen skal indsende en revideret protokol til de nationale kompetente myndigheder til endelig godkendelse inden indledningen af den kliniske undersøgelse.
English: In addition, the MAH provided supportive pharmacokinetic data in the form of two bioequivalence studies.
Danish: Indehaveren af markedsføringstilladelsen fremlagde desuden understøttende farmakokinetiske data i form af to bioækvivalensundersøgelser.
English: Grounds for positive opinion subject to condition to the marketing authorisation and amendment of the summary of product characteristics and package leaflet
Danish: Begrundelser for positiv udtalelse underlagt betingelse for markedsføringstilladelsen og ændring af produktresumé og indlægsseddel
English: Hence the CHMP is of the opinion that a revised protocol should be submitted to the national competent authorities, for final agreement prior the start of the clinical trial, as a condition to the marketing authorisation.
Danish: CHMP er således af den opfattelse, at der skal indsendes en revideret protokol til de nationale kompetente myndigheder til endelig godkendelse inden indledningen af den kliniske undersøgelse som en betingelse for markedsføringstilladelsen.
English: The posology of Mifepristone Linepharma is not the same as for the reference product Mifegyne.
Danish: Doseringen af Mifepristone Linepharma er ikke den samme som for referencelægemidlet Mifegyne.
English: • The CHMP is of the opinion that a dose higher than 200 mg should not be administered and that this should be clearly indicated in the Product Information.
Danish: • CHMP er af den opfattelse, at den maksimale dosis skal være 200 mg, og at dette skal angives klart i produktoplysningerne.
English: No serious unexpected events were related to the regimen studied.
Danish: Der blev ikke konstateret alvorlige uventede bivirkninger af den pågældende behandling.
English: Based on the results of the 2 clinical studies and taking into consideration that Mifepristone Linepharma is only given once and as a single dose, the CHMP was of the opinion that the higher Cmax would not affect safety or efficacy of Mifepristone Linepharma.
Danish: Baseret på resultaterne af de to kliniske undersøgelser og under hensyntagen til, at Mifepristone Linepharma kun administreres en gang og som en enkelt dosis, var CHMP af den opfattelse, at den højere Cmax ikke ville indvirke på sikkerheden og virkningen af Mifepristone Linepharma.
English: Women were entitled to be treated with 200 mg of Mifepristone Linepharma orally followed by 800 μg of misoprostol if their pregnancy age was 63 days of amenorrhea or less.
Danish: Kvinderne havde ret til at blive behandlet med 200 mg Mifepristone Linepharma oralt efterfulgt af 800 μg misoprostol ved graviditet på 63 dages amenorré eller derunder.
English: Based on the above, the CHMP considers that the overall efficacy and safety profile of the Mifepristone Linepharma has been sufficiently proven by the studies presented and therefore concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indication “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea” is favourable.
Danish: I lyset af ovenstående mener CHMP, at Mifepristone Linepharmas overordnede virkning og sikkerhedsprofil er blevet tilstrækkelig påvist i de fremlagte undersøgelser og har derfor konkluderet, at benefit/risk-forholdet for Mifepristone Linepharma til den anvendte indikation "medicinsk afbrydelse af intrauterin graviditet under udvikling, i sekventiel anvendelse med en prostaglandinanalog, op til 63 dage med amenorré" er gunstigt.
English: Compared to Mifegyne, which could be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg is approved for Mifepristone Linepharma.
Danish: I forhold til Mifegyne, der kan administreres ved en høj dosis på 600 mg eller en lavere dosis på 200 mg, er det kun den lavere dosis på 200 mg, der er godkendt for Mifepristone Linepharma.
English: The approved indication for Mifepristone Linepharma through the initial Mutual Recognition Procedure is “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea”.
Danish: Indikationen for Mifepristone Linepharma, der er blevet godkendt gennem den første gensidige anerkendelsesprocedure, er: "medicinsk afbrydelse af intrauterin graviditet under udvikling, i sekventiel anvendelse med en prostaglandinanalog, op til 63 dage med amenorré".