FrancophonIA/ELRC3.0 huggingface dataset:
English: Afinitor 5 mg tablets Each tablet contains 5 mg everolimus.
Danish: Afinitor 5 mg tabletter Hver tablet indeholder 5 mg everolimus.
English: • Disturbed taste (dysgeusia)
Danish: • Synkebesvær (dysfagi)
English: Avoid the use of concomitant potent CYP3A4 inducers.
Danish: Samtidig administration med potente CYP3A4-induktorer eller PgP-induktorer skal undgås.
English: • Low level of potassium in the blood (hypokalaemia)
Danish: • Lavt indhold af kalium i blodet (hypokaliæmi)
English: The pre-planned OS interim analysis after 101 deaths (out of 191 required for final analysis) and 33 months follow-up favoured the everolimus arm; however, no statistically significant difference in OS was noted (HR= 0.73 [95% CI: 0.48 to 1.11; p=0.071]).
Danish: Der blev dog ikke set en statistisk signifikant forskel i OS (HR= 0,73 [95 % CI: 0,48-1,11; p=0,071]).
English: • Bleeding (haemorrhage), for example in the gut wall
Danish: • Blødning, fx i tarmvæggen
English: Common Dyspnoea Uncommon Haemoptysis, pulmonary embolism Rare
Danish: Almindelig Dyspnø Ikke almindelig
English: EU/1/09/538/007 10 tablets EU/1/09/538/001 30 tablets EU/1/09/538/003 90 tablets
Danish: EU/1/09/538/007 10 tabletter EU/1/09/538/001 30 tabletter EU/1/09/538/003 90 tabletter
English: Figure 4 RADIANT-4 - Kaplan-Meier progression-free survival curves (independent radiological review)
Danish: Figure 4 RADIANT-4 - Kaplan-Meier-kurver for progressionsfri overlevelse (uafhængig radiologisk vurdering)
English: EU/1/09/538/008 10 tablets EU/1/09/538/004 30 tablets EU/1/09/538/006 90 tablets
Danish: EU/1/09/538/008 10 tabletter EU/1/09/538/004 30 tabletter EU/1/09/538/006 90 tabletter
English: Figure 2 BOLERO-6 Kaplan-Meier progression-free survival curves (investigator radiological review)
Danish: Figur 2 BOLERO-6 Kaplan-Meier-kurver for progressionsfri overlevelse (radiologisk investigator-vurdering)
English: Musculoskeletal and connective tissue disorders Common Arthralgia
Danish: Knogler, led, muskler og bindevæv Almindelig Artralgi
English: • Weakness, spontaneous bleeding or bruising and frequent infections with signs such as fever,
Danish: • Svaghed, spontan blødning eller blå mærker og hyppige infektioner med symtomer som fx feber, kulderystelser, ondt i halsen, mundsår (tegn på lavt niveau af blodceller, også kendt som pancytopeni)
English: Uncommon Amenorrhoea e*
Danish: Amenoré e*
English: Each tablet of Afinitor 2.5 mg contains 2.5 mg everolimus.
Danish: Hver Afinitor 2,5 mg tablet indeholder 2,5 mg everolimus.
English: Each tablet of Afinitor 10 mg contains 10 mg everolimus.
Danish: Hver Afinitor 10 mg tablet indeholder 10 mg everolimus.
English: Time (months)
Danish: Tid (mdr.)
English: Each tablet of Afinitor 5 mg contains 5 mg everolimus.
Danish: Hver Afinitor 5 mg tablet indeholder 5 mg everolimus.
English: Hazard Ratio = 0.48 95% CI [0.35, 0.67]
Danish: Risikorate = 0,48 95 % CI [0,35; 0,67]
English: dysphagia
Danish: Vægttab
English: • Hot flushes
Danish: • Ledsmerter
English: Breast-feeding
Danish: Bivirkinger
English: Tumour grading Liver tumour burden
Danish: Flushing, dyb venøs trombose
English: General disorders and administration site conditions Very common Fatigue, asthenia, oedema peripheral Common Pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig
English: Acute respiratory distress syndrome Gastrointestinal disorders Very common Stomatitis d, diarrhoea, nausea
Danish: Stomatitis d, diarré, kvalme
English: What Afinitor looks like and contents of the pack Afinitor 2.5 mg tablets are white to slightly yellowish, elongated tablets.
Danish: Afinitor 2,5 mg tabletter er hvide til svagt gullige, aflange tabletter.
English: Rare (may affect up to 1 in 1,000 people) • Shortness of breath or rapid breath (signs of acute respiratory distress syndrome)
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) Forhøjet temperatur, kulderystelser (tegn på infektion) Feber, hoste, vejrtrækningsbesvær, hiven efter vejret (tegn på betændelse i lungerne (pneumonitis))
English: Uncommon Flushing, deep vein thrombosis Respiratory, thoracic and mediastinal disorders Very common Pneumonitis c, epistaxis, cough
Danish: Luftveje, thorax og mediastinum Meget almindelig
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of amenorrhoea (secondary amenorrhoea and other menstrual irregularities).
Danish: Everolimus er blevet forbundet med tilfælde af amenoré (sekundær amenoré og andre uregelmæssigheder i menstruationen) i kliniske forsøg og spontane rapporter post-marketing.
English: • Fever, coughing, difficulty breathing, wheezing (signs of inflammation of the lung, also known as pneumonitis)
Danish: • Stakåndethed eller hurtig vejrtrækning (tegn på akut lungeskade, der giver problemer med vejrtrækningen)
English: n/a d e a
Danish: Infektioner a
English: (20.9 to 32.4)
Danish: 4.2 og 4.4).
English: Invented name Strength Pharmaceutical form Route of administration Immediate packaging
Danish: Emballage Indhold Pakningsstørrelse
English: The European Commission issued a decision on 15 March 2010.
Danish: Europa-Kommissionen traf en afgørelse den 15. marts 2010.
English: Catherine Moraiti (Greece)
Danish: Catherine Moraiti (Grækenland)
English: Ref.: EMA/CHMP/736379/2009 rev.1 EMEA/H/A-30/1078
Danish: : EMA/CHMP/736379/2009 rev.1 EMEA/H/A-30/1078
English: Lescol is authorised in the EU via national procedures.
Danish: Lescol er godkendt i EU efter nationale procedurer.
English: What is Lescol?
Danish: Hvad er Lescol?
English: Lescol contains the active substance fluvastatin.
Danish: Lescol indeholder det aktive stof fluvastatin.
English: Why was Lescol reviewed?
Danish: Hvorfor blev Lescol vurderet igen?
English: The dosage in specific populations, such as children and patients with kidney problems, was also harmonised.
Danish: Dosis hos specifikke populationer, såsom børn og patienter med nyreproblemer, blev også harmoniseret.
English: Questions and answers on the referral for Lescol and associated names Capsules containing 20 mg or 40 mg fluvastatin Prolonged-release tablets containing 80 mg fluvastatin
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Lescol og relaterede navne Kapsler indeholdende 20 mg eller 40 mg fluvastatin Depottabletter indeholdende 80 mg fluvastatin
English: On 9 February 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Lescol in the EU.
Danish: Den 9. februar 2009 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Lescol i EU.
English: Lescol is also available in the EU under other trade names: Canef, Cardiol, Cardiol XL, Cranoc, Digardil, Digaril Prolib, Fluvastatin Novartis, Fluvastatina, Fractal, Leposit Prolib, Lescol Depot, Lescol Exel, Lescol LP, Lescol MR, Lescol Prolib, Lescol XL, Lipaxan, Lipaxin, Liposit, Locol, Lymetel, Primesin, Vaditon and Vaditon Prolib.
Danish: Lescol markedsføres ligeledes i EU under følgende andre særnavne: Canef, Cardiol, Cardiol XL, Cranoc, Digardil, Digaril Prolib, Fluvastatin Novartis, Fluvastatina, Fractal, Leposit Prolib, Lescol Depot, Lescol Exel, Lescol LP, Lescol MR, Lescol Prolib, Lescol XL, Lipaxan, Lipaxin, Liposit, Locol, Lymetel, Primesin, Vaditon og Vaditon Prolib.
English: The Committee concluded that initial dosing ranging from 20 to 80 mg/day is appropriate.
Danish: Udvalget konkluderede, at en startdosis på mellem 20 mg og 80 mg daglig er hensigtsmæssig.
English: The European Medicines Agency has completed a review of Lescol and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Lescol og relaterede navne.
English: Fluvastatin belongs to a group of medicines called ‘statins', which are cholesterol-lowering agents.
Danish: Fluvastatin tilhører en gruppe af lægemidler kaldet "statiner", som er kolesterolsænkende midler.
English: It works by blocking the activity of an enzyme called HMG-CoA reductase.
Danish: Det virker ved at blokere aktiviteten af et enzym kaldet HMG-CoA-reduktase.
English: London, 15 March 2010 Doc.
Danish: London, den 15. marts 2010 Dok.ref.
English: For patients with coronary heart disease after percutaneous coronary interventions, the CHMP agreed that the recommended daily dose is 80 mg.
Danish: For patienter med koronar hjertesygdom efter perkutan koronarintervention konkluderede CHMP, at den anbefalede daglige dosis er 80 mg.
English: The CHMP harmonised the SPC section on special warnings and included warnings related to the use of Lescol in children.
Danish: CHMP harmoniserede produktresuméets afsnit om særlige advarsler og medtog advarsler vedrørende anvendelse af Lescol hos børn.
English: HMG-CoA reductase is responsible for the production of cholesterol.
Danish: HMG-CoA-reduktase er ansvarlig for dannelsen af kolesterol.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Lescol and associated names in the European Union (EU), as well as Norway and Iceland.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der var behov for at harmonisere ordinationsoplysningerne for Lescol og relaterede navne i Den Europæiske Union (EU) samt Norge og Island.
English: The contra-indications that were removed were: use in children, in patients with myopathic disorders and patient with severe renal impairment, as warnings and cautionary statements are already included in sections 4.2 and 4.4.
Danish: De kontraindikationer, der blev fjernet, var: anvendelse hos børn, hos patienter med myopatiske lidelser og patienter med svær nyreinsufficiens, idet afsnit 4.2 og 4.4 allerede indeholder advarsler og forholdsregler.
English: This has led to divergences among Member States in the way the medicine can be used, as seen in the differences in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Danish: Dette har medført, at lægemidlet blev anvendt på forskellige måder i medlemsstaterne, sådan som det fremgår af forskellene i produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: By blocking this enzyme, the amount of cholesterol in the blood is reduced.
Danish: Når dette enzym blokeres, falder mængden af kolesterol i blodet.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de fremlagte oplysninger og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméet, etiketteringen og indlægssedlen skulle harmoniseres inden for EU.
English: The CHMP agreed on two harmonised indications (the diseases for which the medicine may be used): “Dyslipidaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Danish: CHMP godkendte to harmoniserede indikationer (de sygdomme, som lægemidlet kan anvendes til): "Dyslipidæmi Behandling af primær hyperkolesterolæmi eller blandet dyslipidæmi som et supplement til diæt, når responsen på diætbehandling og andre ikkefarmakologiske behandlinger (f.eks. motion og vægttab) er utilstrækkelig.
English: Patients with mixed dyslipidaemia have high blood levels of ‘bad' LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good' HDL cholesterol.
Danish: Patienter med blandet dyslipidæmi har høje koncentrationer af det "dårlige" LDL-kolesterol og triglycerider (en type fedtstof) i blodet og lave koncentrationer af det "gode" HDLkolesterol.
English: The CHMP noted that for the treatment of dyslipidaemia, the main differences in dosing recommendations were related to the starting dose.
Danish: CHMP bemærkede, at de vigtigste forskelle i doseringsanbefalingerne for behandling af dyslipidæmi vedrørte startdosis.
English: Lescol is used to treat dyslipidaemia (abnormal levels of fat in the blood), particularly ‘primary hypercholesterolaemia' and ‘mixed dyslipidaemia'.
Danish: Lescol anvendes til at behandle dyslipidæmi (abnormt høje koncentrationer af fedtstoffer i blodet), særlig "primær hyperkolesterolæmi" og "blandet dyslipidæmi".
English: Lescol is also used to prevent further serious cardiac events (such as a heart attack) in patients after they went through percutaneous coronary intervention (a surgical procedure that is used to unblock narrowed coronary arteries).
Danish: Lescol anvendes endvidere til at forebygge yderligere alvorlige hjertehændelser (såsom hjerteanfald) hos patienter, der har gennemgået perkutan koronarintervention (et kirurgisk indgreb, der udføres for at fjerne blokeringer i forsnævrede koronararterier).
English: Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high.
Danish: Primær hyperkolesterolæmi betyder, at koncentrationerne af kolesterol i blodet er høje.
English: Lescol has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det er blevet bestemt af koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure (lægemidler til mennesker) (CMD(h)), at Lescol bør harmoniseres.
English: Secondary prevention in coronary heart disease Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).” The Committee noted that the indication “to slow the progression of coronary atherosclerosis in patients with primary hypercholesterolemia, including mild forms, and coronary heart disease”, which was not approved in some Member States, should be removed because the results from the clinical study did not supported this indication.
Danish: Udvalget bemærkede, at indikationen "til at forsinke progressionshastigheden af koronar arterosklerose hos patienter med primær hyperkolesterolæmi, herunder milde former, og koronar hjertesygdom", som ikke var godkendt i visse medlemsstater, skulle fjernes, fordi resultaterne af den kliniske undersøgelse ikke understøttede denne indikation.
English: - during pregnancy and lactation (see section 4.6).” The Committee noted that some contra-indications that were included in the SPC in some Member States could be removed.
Danish: Udvalget bemærkede, at nogle kontraindikationer i produktresuméet i nogle medlemsstater kunne fjernes.
English: The referral procedure started on 15 September 2011.
Danish: Henvisningsproceduren blev indledt den 15. september 2011.
English: Background (MRL status)
Danish: Baggrund (MRL-status)
English: National Competent Authorities, coordinated by a reference Member State, shall ensure that the following condition is fulfilled by the marketing authorisation holders:
Danish: De nationale kompetente myndigheder, koordineret af en referencemedlemsstat, sikrer, at følgende betingelse opfyldes af indehaverne af markedsføringstilladelse:
English: The detailed grounds for the re-examination were submitted on 10 June 2013.
Danish: Den detaljerede begrundelse for den fornyede overvejelse blev forelagt den 10. juni 2013.
English: However, injection sites cannot be expected to be identifiable months or possibly years following administration.
Danish: Injektionsstederne kan imidlertid ikke forventes at kunne lokaliseres flere måneder eller eventuelt år efter administrationen.
English: Any health based reference value must be capable of reflecting non-serious adverse effects;
Danish: Enhver sundhedsbaseret referenceværdi skal kunne afspejle ikke-alvorlige bivirkninger
English: At present no appropriate withdrawal periods can be set for these veterinary medicinal products.
Danish: På nuværende tidspunkt kan der ikke fastsættes passende tilbageholdelsesperioder for disse veterinærlægemidler.
English: Broomhill Road Tallaght
Danish: Broomhill Road
English: It could only be considered that the data obtained in this study do not contradict the in vitro data.
Danish: Det kunne kun konstateres, at denne undersøgelse ikke modsiger in vitro-dataene.
English: List of the names, pharmaceutical forms, strength of the veterinary medicinal products, animal species, route of administration, withdrawal period and applicant/marketing authorisation holders in the member states
Danish: Liste over veterinærlægemidlets navne, lægemiddelformer, styrker, dyrearter, administrationsvej, tilbageholdelsesperiode og indehaver af markedsføringstilladelsen i medlemsstaterne
English: The decentralised procedure was finalised during the referral procedure and the resulting national marketing authorisations have been granted except in Germany.
Danish: Den decentrale procedure blev afsluttet under indbringelsesproceduren, og de resulterende nationale markedsføringstilladelser er blevet udstedt undtagen i Tyskland.
English: CVMP conclusion after re-examination
Danish: CVMP's konklusion efter fornyet overvejelse
English: The complete list of all veterinary medicinal products involved in this referral procedure is provided in annex I above.
Danish: Den fuldstændige liste over alle veterinærlægemidler omfattet af denne indbringelsesprocedure fremgår af ovenstående bilag I.
English: Among available products, long acting injectables represent a convenient alternative but there are other possibilities including:
Danish: Af de tilgængelige produkter er depotinjektionsvæsker et bekvemt valg, men der er andre muligheder, herunder:
English: 3 Archer, JA and Judson, GJ (1994): Availability of Barium Selenate administered orally to sheep.
Danish: 3 Archer, JA, og Judson, GJ (1994): Availability of Barium Selenate administered orally to sheep.
English: Calves: 1-2 ml
Danish: Kalve: 1-2 ml
English: The procedure involved 3 veterinary medicinal products with 18 marketing authorisations granted nationally or subject to on-going applications under a decentralised procedure.
Danish: Proceduren omfattede 3 veterinærlægemidler med 18 markedsføringstilladelser, der enten var udstedt nationalt eller omfattet af ansøgninger under behandling ved en decentral procedure.
English: The condition for lifting the suspension of the marketing authorisations is described in annex III.
Danish: Betingelsen for ophævelse af suspenderingen af markedsføringstilladelserne er beskrevet i bilag III.
English: Risk management measures
Danish: Risikohåndteringsforanstaltninger
English: Thus the figure of 5% bioavailability is still considered appropriate for use in residue calculations;
Danish: Biotilgængeligheden på 5 % anses således stadig for passende i forbindelse med restkoncentrationsberegninger
English: However, the evaluation of consumer safety concerns needs to consider all possible adverse effects (not only the most severe), and these are unlikely to be detected by pharmacovigilance systems.
Danish: Vurdering af forbrugersikkerhedsmæssige betænkeligheder skal imidlertid omfatte alle mulige bivirkninger (ikke kun de sværeste), hvilket ikke kan forventes af ordninger til lægemiddelovervågning.
English: Despite the slow rate of residue depletion, a withdrawal period of 31 days for cattle meat and offal has been set for the concerned veterinary medicinal products (see annex I).
Danish: Trods den langsomme depletion af rester er der fastsat en tilbageholdelsestid på 31 dage for kød og indmad fra kvæg for de pågældende veterinærlægemidler (se bilag I).
English: However, in this case no data on acute toxicity using more sensitive acute endpoints were available.
Danish: I dette tilfælde forelå der imidlertid ikke data vedrørende mere følsomme akutte endepunkter for akut toksicitet.
English: The appropriateness of the covered time period needs to be justified and advice provided on identification and removal of the contaminated injection site area.
Danish: Hensigtsmæssigheden af den omfattede periode skal begrundes, og der skal gives vejledning i identifikation og fjernelse af de kontaminerede områder omkring injektionsstedet.
English: The study also showed that even one year after treatment high amounts of selenium were found at the injection site (up to 53.229 mg/kg).
Danish: Undersøgelsen viste desuden, at der ét år efter behandlingen var høje koncentrationer af selen på injektionsstedet (op til 53,229 mg/kg).
English: The CVMP assessed the detailed grounds for the re-examination and the CVMP's conclusions in relation to each of the bullets above are summarised below:
Danish: CVMP vurderede den detaljerede begrundelse for fornyet overvejelse, og CVMP's konklusioner om hvert af ovenstående punkter er sammenfattet nedenfor:
English: Furthermore, while it is the case that the ADI is based on repeated exposure, the alternative threshold proposed by the marketing authorisation holders (i.e. the LD50) is not appropriate as this represents the value at which 50% mortality is expected.
Danish: Mens ADI-værdien er baseret på gentagen eksponering, er den alternative tærskelværdi, der foreslås af indehaverne af markedsføringstilladelse (dvs. LD50), desuden ikke hensigtsmæssig, da den repræsenterer den værdi, hvor der forventes 50 % mortalitet.
English: Considering that the lowest LD50 is less than 10 times the possible consumer's exposure it is obvious that also a fraction of an injection site might cause toxicity if ingested.
Danish: I betragtning af, at den laveste LD50 er mindre end 10 gange den mulige eksponering af forbrugere, er det indlysende, at selv en brøkdel af et injektionssted kan være toksisk ved indtagelse.
English: The scientific rational for this withdrawal period is not known as no product specific residue depletion data for the above-mentioned veterinary medicinal were provided in this referral procedure.
Danish: Det videnskabelige rationale for denne tilbageholdelsestid kendes ikke, da der ikke blev forelagt produktspecifikke restkoncentrationsdata for ovennævnte veterinærlægemidler under denne indbringelsesprocedure.
English: Following the CVMP opinion of 10 April 2013 on this referral procedure, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) requested a reexamination of that CVMP opinion.
Danish: Efter CVMP's udtalelse af 10. april 2013 om denne indbringelsesprocedure anmodede Cross Vetpharm Group Limited og Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) om fornyet overvejelse af CVMP's udtalelse.
English: Marketing authorisation not granted
Danish: Markedsføringstilladelse ikke udstedt
English: However, the design of this study did not allow for an estimation of the bioavailable selenium fraction and thus these data are supportive only.
Danish: Undersøgelsens design gjorde det dog ikke muligt at beregne den biotilgængelige brøkdel af selen, hvorfor disse data kun er støttende.
English: The marketing authorisation holders should provide data and propose measures that will ensure consumer safety following use of the products and in particular:
Danish: Indehaverne af markedsføringstilladelse forelægger data og forslag til foranstaltninger, der giver sikkerhed for forbrugerne efter anvendelse af lægemidlerne, herunder:
English: This implies that the colourant has the same distribution behaviour and residence time as barium selenate.
Danish: Dette indebærer, at farvestoffet har samme fordelingsegenskaber og opholdstid som bariumselenat.
English: Unmarked injection sites are not clearly identifiable in all animals, especially if long periods of time elapse between injection and slaughter.
Danish: Umærkede injektionssteder kan ikke tydeligt lokaliseres på alle dyrene, navnlig hvis der går lang tid mellem injektion og slagtning.
English: The grounds for re-examination of the CVMP opinion of 10 April 2013 focused on the following arguments:
Danish: Begrundelsen for fornyet overvejelse af CVMP's udtalelse af 10. april 2013 rettede sig mod følgende:
English: With regard to acute toxicity reference is made to studies measuring LD50 values.
Danish: Vedrørende akut toksicitet henvises til undersøgelser, hvor der er bestemt LD50-værdier.