natgillin/translations-raw huggingface dataset:
Progressive neuroendokrine tumorer udgået fra mave-tarm-kanalen eller lungerne RADIANT-4 (studie CRAD001T2302), et randomiseret, dobbeltblindt, fase III-multicenterstudie af Afinitor plus bedste understøttende behandling (BSC) versus placebo plus BSC blev udført hos patienter med fremskredne, veldifferentierede (grad 1 eller 2) ikke-funktionelle neuroendokrine tumorer udgået fra mave-tarm-kanalen eller lungerne uden tidligere eller nuværende aktive symptomer relateret til karcinoidt syndrom.
Advanced neuroendocrine tumours of gastrointestinal or lung origin RADIANT-4 (study CRAD001T2302), a randomised, double-blind, multicentre, phase III study of Afinitor plus best supportive care (BSC) versus placebo plus BSC was conducted in patients with advanced, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin without a history of and no active symptoms related to carcinoid syndrome.
Grad 2 Overvej pause i behandlingen, indtil symptomerne forbedres til Grad 1.
Grade 2 Consider interruption of therapy until symptoms improve to Grade 1.
Afinitor 2,5 mg tabletter Afinitor 5 mg tabletter Afinitor 10 mg tabletter
Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets
Almindelig Trombocytopeni, neutropeni, leukopeni, lymfopeni Ikke almindelig
Common Thrombocytopenia, neutropenia, leukopenia, lymphopenia Uncommon Pancytopenia
Neuroendokrine tumorer udgået fra mave-tarm-kanalen eller lungerne Afinitor er indiceret til behandling af inoperable eller metastaserende, veldifferentierede (grad 1 eller 2), ikke-funktionelle neuroendokrine tumorer udgået fra mave-tarm-kanalen eller lungerne hos voksne med progressiv sygdom (se pkt.
Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1).
Median progressionsfri overlevelse (måneder) (95% CI) Investigators radiologiske vurdering
Median progression-free survival (months) (95% CI) Investigator radiological review
Almindelig Opkastning, mundtørhed, abdominalsmerter, slimhindeinflammation, smerter i munden, dyspepsi, dysfagi
Common Vomiting, dry mouth, abdominal pain, mucosal inflammation, oral pain, dyspepsia,
Afinitor 10 mg tabletter
Afinitor 10 mg tablets
• Træthed, stakåndethed, svimmelhed, bleg hud, tegn på lavt indhold af røde blodlegemer
• Tiredness, breathlessness, dizziness, pale skin, signs of low level of red blood cells (anaemia)
Grad 3 (<1, ≥0,5x10 9/l)
Grade 3 (<1, ≥0.5x10
• Forhøjet indhold af fedtstoffer (lipider) i blodet (hyperkolesterolæmi)
• High level of lipids (fats) in the blood (hypercholesterolaemia)
Progressiv renalcellekarcinom
Advanced renal cell carcinoma
Afinitor 10 mg tabletter er hvide til svagt gullige, aflange tabletter.
Afinitor 10 mg tablets are white to slightly yellowish, elongated tablets.
• Stærkt nedsat vandladning, hævede ben, forvirring, rygsmerter (tegn på pludselig nyresvigt)
• Severely decreased urine output, swelling in the legs, feeling confused, pain in the back (signs of sudden kidney failure)
Figur 6 RECORD-1 - Kaplan-Meier-kurver for progressionsfri overlevelse (uafhængig central vurdering)
Figure 6 RECORD-1 - Kaplan-Meier progression-free survival curves (independent central review)
Ældre patienter (≥65 år)
Elderly patients (≥65 years) No dose adjustment is required (see section 5.2).
I alt blev 302 patienter randomiseret 2:1 til enten everolimus (10 mg dagligt) (n=205) eller placebo (n=97).
A total of 302 patients were randomised in a 2:1 ratio to receive either everolimus (10 mg daily) (n=205) or placebo (n=97).
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 74 mg lactose.
Excipient with known effect Each tablet contains 74 mg lactose.
Tidligere kemoterapi Oprindelsessted for primærtumor
Prior chemotherapy Primary tumour origin
• Lavt indhold af calcium i blodet (hypokalcæmi)
• Low level of calcium in the blood (hypocalcaemia)
Afinitor 2,5 mg tabletter
Afinitor 2.5 mg tablets
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 149 mg lactose.
Excipient with known effect Each tablet contains 149 mg lactose.
Fald i hæmoglobin, lymfocytter, neutrofiler og trombocytter er rapporteret (se pkt.
Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported (see section 4.8).
Non-kardielle brystsmerter, dårlig sårheling
Uncommon Non-cardiac chest pain, impaired wound healing Investigations
Afinitor 5 mg tabletter er hvide til svagt gullige, aflange tabletter.
Afinitor 5 mg tablets are white to slightly yellowish, elongated tablets.
Grad 4 (<0,5x10 9/l)
Grade 4 (<0.5x10
Hvide til svagt gullige aflange tabletter med facetslebet kant og uden delekærv, præget med “5” på den ene side og “NVR” på den anden side.
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other.
Afinitor 2,5 mg tabletter Afinitor 5 mg tabletter Afinitor 10 mg tabletter everolimus
Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets everolimus
Dosisjustering af Afinitor
Afinitor dose adjustment
• Unormal sårheling
• Abnormal wound healing
Grad 3 Afbryd behandlingen, indtil symptomerne forbedres til Grad 1.
Grade 3 Interrupt treatment until symptoms resolve to Grade 1.
Afinitor 5 mg tabletter
Afinitor 5 mg tablets
Infektioner og parasitære sygdomme Meget almindelig
Infections and infestations Very common Infections a, *
Almindelig Hypertriglyceridæmi, hypofosfatæmi, diabetes mellitus, hyperlipidæmi,
Very common Decreased appetite, hyperglycaemia, hypercholesterolaemia Common Hypertriglyceridaemia, hypophosphataemia, diabetes mellitus, hyperlipidaemia,
Hvide til svagt gullige aflange tabletter med facetslebet kant og uden delekærv, præget med “LCL” på den ene side og “NVR” på den anden side.
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other.
Afinitor 2,5 mg tabletter EU/1/09/538/009 EU/1/09/538/010
Afinitor 2.5 mg tablets EU/1/09/538/009 EU/1/09/538/010
• Lavt indhold af fosfat i blodet (hypofosfatæmi)
• Low level of phosphate in the blood (hypophosphataemia)
Afinitor 2,5 mg tabletter everolimus
Afinitor 2.5 mg tablets everolimus
Hvide til svagt gullige aflange tabletter med facetslebet kant og uden delekærv, præget med “UHE” på den ene side og “NVR” på den anden side.
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other.
Placebo + BSC: 3.91 [3.58;7.43] mdr.
Everolimus + BSC: 11.01 [9.23;13.31] months Placebo + BSC: 3.91 [3.58;7.43] months
Afinitor 10 mg tabletter everolimus
Afinitor 10 mg tablets everolimus
Spørg din læge, hvis du vil vide mere om Afinitor, og hvorfor du har fået det ordineret.
If you have any questions about Afinitor or why it has been prescribed for you, ask your doctor.
BOLERO-2 (studie CRAD001Y2301), et randomiseret, dobbeltblindet, multicenter fase III-studie af Afinitor + exemestan versus placebo + exemestan, blev udført hos postmenopausale kvinder med fremskreden østrogenreceptorpositiv, HER2/neu-negativ brystcancer efter recidiv eller progression efter tidligere behandling med letrozol eller anastrozol.
Hormone receptor-positive advanced breast cancer BOLERO-2 (study CRAD001Y2301), a randomised, double-blind, multicentre phase III study of Afinitor + exemestane versus placebo + exemestane, was conducted in postmenopausal women with oestrogen receptor-positive, HER2/neu negative advanced breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole.
Afinitor 5 mg og Afinitor 10 mg fås i blisterpakninger med 10, 30 eller 90 tabletter.
Afinitor 5 mg and Afinitor 10 mg are available in blister packs containing 10, 30 or 90 tablets.
• Ophostning af blod (hæmoptyse)
• Coughing up blood (haemoptysis)
Afinitor 2,5 mg tabletter Pakninger indeholdende 30 eller 90 tabletter.
Afinitor 2.5 mg tablets Packs containing 30 or 90 tablets.
Afinitor 10 mg tabletter Pakninger indeholdende 10, 30 eller 90 tabletter.
Afinitor 10 mg tablets Packs containing 10, 30 or 90 tablets.
Hos patienter med fremskreden hormonreceptorpositiv brystcancer, der fik denne kombination, sås der ingen stigning i bivirkninger relateret til exemestan.
No increase in adverse reactions related to exemestane was observed in patients with hormone receptor-positive advanced breast cancer receiving the combination.
Afinitor 5 mg tabletter everolimus
Afinitor 5 mg tablets everolimus
EU/1/09/538/009 30 tabletter EU/1/09/538/010 90 tabletter
EU/1/09/538/009 30 tablets EU/1/09/538/010 90 tablets
Afinitor 10 mg tabletter Hver tablet indeholder 10 mg everolimus.
Afinitor 10 mg tablets Each tablet contains 10 mg everolimus.
Grad 2 Midlertidig behandlingspause indtil bedring til Grad 1.
Grade 2 Temporary dose interruption until recovery to Grade 1.
Afinitor 5 mg tabletter EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
Afinitor 5 mg tablets EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
Grad 3 Midlertidig behandlingspause indtil bedring til Grad 1.
Grade 3 Temporary dose interruption until recovery to Grade 1.
Afinitor 10 mg tabletter EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
Afinitor 10 mg tablets EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
Figur 3 RADIANT-3 - Kaplan-Meier-kurver for progressionsfri overlevelse (radiologisk vurdering af investigator)
Figure 3 RADIANT-3 - Kaplan-Meier progression-free survival curves (investigator radiological review)
Almindelige (kan forekomme hos op til 1 ud af 10 patienter)
Common (may affect up to 1 in 10 people)
Afinitor 2,5 mg tabletter Hver tablet indeholder 2,5 mg everolimus.
Afinitor 2.5 mg tablets Each tablet contains 2.5 mg everolimus.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter)
Uncommon (may affect up to 1 in 100 people)
Kongestivt hjertesvigt
Hepatic impairment
Figur 1 BOLERO-2 Kaplan-Meier-kurver for progressionsfri overlevelse (radiologisk vurdering af investigator)
Figure 1 BOLERO-2 Kaplan-Meier progression-free survival curves (investigator radiological review)
• Let hårtab
• Mild loss of hair
4.4 og 4.8).
(2.8 to 4.1)
Afinitor 5 mg tabletter Pakninger indeholdende 10, 30 eller 90 tabletter.
Afinitor 5 mg tablets Packs containing 10, 30 or 90 tablets.
Afinitor 2,5 mg fås i blisterpakninger med 30 eller 90 tabletter.
Afinitor 2.5 mg is available in blister packs containing 30 or 90 tablets.
Bivirkning
Food effect
Brug af anden medicin sammen med Afinitor Afinitor kan påvirke virkningen af anden medicin.
Afinitor may affect the way some other medicines work.
• Hudrødme (erytem)
• Reddening of the skin (erythema)
4.2 og 5.2).
(0.5 to 4.2)
Afinitor 5 mg tabletter Hver tablet indeholder 5 mg everolimus.
Afinitor 5 mg tablets Each tablet contains 5 mg everolimus.
• Synkebesvær (dysfagi)
• Disturbed taste (dysgeusia)
Samtidig administration med potente CYP3A4-induktorer eller PgP-induktorer skal undgås.
Avoid the use of concomitant potent CYP3A4 inducers.
• Lavt indhold af kalium i blodet (hypokaliæmi)
• Low level of potassium in the blood (hypokalaemia)
Der blev dog ikke set en statistisk signifikant forskel i OS (HR= 0,73 [95 % CI: 0,48-1,11; p=0,071]).
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]).
• Blødning, fx i tarmvæggen
• Bleeding (haemorrhage), for example in the gut wall
Almindelig Dyspnø Ikke almindelig
Common Dyspnoea Uncommon Haemoptysis, pulmonary embolism Rare
EU/1/09/538/007 10 tabletter EU/1/09/538/001 30 tabletter EU/1/09/538/003 90 tabletter
EU/1/09/538/007 10 tablets EU/1/09/538/001 30 tablets EU/1/09/538/003 90 tablets
Figure 4 RADIANT-4 - Kaplan-Meier-kurver for progressionsfri overlevelse (uafhængig radiologisk vurdering)
Figure 4 RADIANT-4 - Kaplan-Meier progression-free survival curves (independent radiological review)
EU/1/09/538/008 10 tabletter EU/1/09/538/004 30 tabletter EU/1/09/538/006 90 tabletter
EU/1/09/538/008 10 tablets EU/1/09/538/004 30 tablets EU/1/09/538/006 90 tablets
Figur 2 BOLERO-6 Kaplan-Meier-kurver for progressionsfri overlevelse (radiologisk investigator-vurdering)
Figure 2 BOLERO-6 Kaplan-Meier progression-free survival curves (investigator radiological review)
Knogler, led, muskler og bindevæv Almindelig Artralgi
Musculoskeletal and connective tissue disorders Common Arthralgia
• 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)
• Weakness, spontaneous bleeding or bruising and frequent infections with signs such as fever,
Amenoré e*
Uncommon Amenorrhoea e*
Hver Afinitor 2,5 mg tablet indeholder 2,5 mg everolimus.
Each tablet of Afinitor 2.5 mg contains 2.5 mg everolimus.
Hver Afinitor 10 mg tablet indeholder 10 mg everolimus.
Each tablet of Afinitor 10 mg contains 10 mg everolimus.
Tid (mdr.)
Time (months)
Hver Afinitor 5 mg tablet indeholder 5 mg everolimus.
Each tablet of Afinitor 5 mg contains 5 mg everolimus.
Risikorate = 0,48 95 % CI [0,35; 0,67]
Hazard Ratio = 0.48 95% CI [0.35, 0.67]
Vægttab
dysphagia
• Ledsmerter
• Hot flushes
Bivirkinger
Breast-feeding
Flushing, dyb venøs trombose
Tumour grading Liver tumour burden
Almene symptomer og reaktioner på administrationsstedet Meget almindelig
General disorders and administration site conditions Very common Fatigue, asthenia, oedema peripheral Common Pyrexia
Stomatitis d, diarré, kvalme
Acute respiratory distress syndrome Gastrointestinal disorders Very common Stomatitis d, diarrhoea, nausea
Afinitor 2,5 mg tabletter er hvide til svagt gullige, aflange tabletter.
What Afinitor looks like and contents of the pack Afinitor 2.5 mg tablets are white to slightly yellowish, elongated tablets.
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))
Rare (may affect up to 1 in 1,000 people) • Shortness of breath or rapid breath (signs of acute respiratory distress syndrome)
Luftveje, thorax og mediastinum Meget almindelig
Uncommon Flushing, deep vein thrombosis Respiratory, thoracic and mediastinal disorders Very common Pneumonitis c, epistaxis, cough
Everolimus er blevet forbundet med tilfælde af amenoré (sekundær amenoré og andre uregelmæssigheder i menstruationen) i kliniske forsøg og spontane rapporter post-marketing.
In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of amenorrhoea (secondary amenorrhoea and other menstrual irregularities).
• Stakåndethed eller hurtig vejrtrækning (tegn på akut lungeskade, der giver problemer med vejrtrækningen)
• Fever, coughing, difficulty breathing, wheezing (signs of inflammation of the lung, also known as pneumonitis)
Infektioner a
n/a d e a
4.2 og 4.4).
(20.9 to 32.4)
Emballage Indhold Pakningsstørrelse
Invented name Strength Pharmaceutical form Route of administration Immediate packaging
Europa-Kommissionen traf en afgørelse den 15. marts 2010.
The European Commission issued a decision on 15 March 2010.
Catherine Moraiti (Grækenland)
Catherine Moraiti (Greece)
: EMA/CHMP/736379/2009 rev.1 EMEA/H/A-30/1078
Ref.: EMA/CHMP/736379/2009 rev.1 EMEA/H/A-30/1078
Lescol er godkendt i EU efter nationale procedurer.
Lescol is authorised in the EU via national procedures.
Hvad er Lescol?
What is Lescol?
Lescol indeholder det aktive stof fluvastatin.
Lescol contains the active substance fluvastatin.
Hvorfor blev Lescol vurderet igen?
Why was Lescol reviewed?
Dosis hos specifikke populationer, såsom børn og patienter med nyreproblemer, blev også harmoniseret.
The dosage in specific populations, such as children and patients with kidney problems, was also harmonised.
Spørgsmål og svar vedrørende indbringelsesproceduren for Lescol og relaterede navne Kapsler indeholdende 20 mg eller 40 mg fluvastatin Depottabletter indeholdende 80 mg fluvastatin
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
Den 9. februar 2009 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Lescol i EU.
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.
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.
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.
Udvalget konkluderede, at en startdosis på mellem 20 mg og 80 mg daglig er hensigtsmæssig.
The Committee concluded that initial dosing ranging from 20 to 80 mg/day is appropriate.
Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Lescol og relaterede navne.
The European Medicines Agency has completed a review of Lescol and associated names.
Fluvastatin tilhører en gruppe af lægemidler kaldet "statiner", som er kolesterolsænkende midler.
Fluvastatin belongs to a group of medicines called ‘statins', which are cholesterol-lowering agents.
Det virker ved at blokere aktiviteten af et enzym kaldet HMG-CoA-reduktase.
It works by blocking the activity of an enzyme called HMG-CoA reductase.
London, den 15. marts 2010 Dok.ref.
London, 15 March 2010 Doc.
For patienter med koronar hjertesygdom efter perkutan koronarintervention konkluderede CHMP, at den anbefalede daglige dosis er 80 mg.
For patients with coronary heart disease after percutaneous coronary interventions, the CHMP agreed that the recommended daily dose is 80 mg.
CHMP harmoniserede produktresuméets afsnit om særlige advarsler og medtog advarsler vedrørende anvendelse af Lescol hos børn.
The CHMP harmonised the SPC section on special warnings and included warnings related to the use of Lescol in children.
HMG-CoA-reduktase er ansvarlig for dannelsen af kolesterol.
HMG-CoA reductase is responsible for the production of cholesterol.
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.
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.
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.
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.
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.
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.
Når dette enzym blokeres, falder mængden af kolesterol i blodet.
By blocking this enzyme, the amount of cholesterol in the blood is reduced.
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.
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.
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.
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.
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.
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.
CHMP bemærkede, at de vigtigste forskelle i doseringsanbefalingerne for behandling af dyslipidæmi vedrørte startdosis.
The CHMP noted that for the treatment of dyslipidaemia, the main differences in dosing recommendations were related to the starting dose.
Lescol anvendes til at behandle dyslipidæmi (abnormt høje koncentrationer af fedtstoffer i blodet), særlig "primær hyperkolesterolæmi" og "blandet dyslipidæmi".
Lescol is used to treat dyslipidaemia (abnormal levels of fat in the blood), particularly ‘primary hypercholesterolaemia' and ‘mixed dyslipidaemia'.
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).
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).
Primær hyperkolesterolæmi betyder, at koncentrationerne af kolesterol i blodet er høje.
Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high.
Det er blevet bestemt af koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure (lægemidler til mennesker) (CMD(h)), at Lescol bør harmoniseres.
Lescol has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
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.
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.