natgillin/translations-raw huggingface dataset:
Stomatitis er den hyppigst rapporterede bivirkning hos patienter, der blev behandlet med Afinitor (se pkt. 
Stomatitis is the most commonly reported adverse reaction in patients treated with Afinitor (see sections 4.4 and 4.8).
Grad 3 Midlertidig behandlingspause. 
Grade 3 Temporary dose interruption.
De er præget med “LCL” på den ene side og “NVR” på den anden. 
They are engraved with “LCL” on one side and “NVR” on the other.
• Stakåndethed, vejrtrækningsbesvær i liggende stilling, hævede fødder eller ben (tegn på hjertesvigt) 
• Breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• Udslæt og smerter i håndflader eller fodsåler (hånd-fodsyndrom) 
• Rash and pain on the palms of your hands or soles of your feet (hand-foot syndrome)
Studiets primære endepunkt var progressionsfri overlevelse (PFS), evauleret ved Response Evaluation Criteria in Solid Tumours (RECIST), baseret på en uafhængig radiologisk vurdering. 
The primary endpoint for the study was progression-free survival (PFS) evaluated by Response Evaluation Criteria in Solid Tumors (RECIST), based on independent radiology assessment.
I alt 724 patienter blev randomiseret i forholdet 2:1 til kombinationen everolimus (10 mg dagligt) + exemestan (25 mg dagligt) (n=485) eller til placebo + exemestan (25 mg dagligt) (n=239). 
A total of 724 patients were randomised in a 2:1 ratio to the combination everolimus (10 mg daily) + exemestane (25 mg daily) (n=485) or to the placebo + exemestane arm (25 mg daily) (n=239).
Log-rank p-værdi = <0,001 
Log-rank p value = <0.001
RECORD-1 (studie CRAD001C2240), et fase III-, internationalt, randomiseret, dobbeltblindet multicenter-studie med sammenligning af everolimus 10 mg/dag og placebo, begge sammen med bedste understøttende behandling, blev udført med patienter med metastatisk renalcellekarcinom, hvis sygdom var progredieret under eller efter behandling (sunitinib, sorafenib eller både sunitinib og sorafenib) med VEGFR-TKI (vascular endothelial growth factor receptor tyrosine kinase inhibitor). 
RECORD-1 (study CRAD001C2240), a phase III, international, multicentre, randomised, double-blind study comparing everolimus 10 mg/day and placebo, both in conjunction with best supportive care, was conducted in patients with metastatic renal cell carcinoma whose disease had progressed on or after treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine kinase inhibitor) therapy (sunitinib, sorafenib, or both sunitinib and sorafenib).
Antal patienter i fortsat risiko Afinitor 
No. of patients still at risk Afinitor
De er præget med “UHE” på den ene side og “NVR” på den anden. 
They are engraved with “UHE” on one side and “NVR” on the other.
Log-rank p-værdi = <0,0001 
Log-rank p value = <0.0001
Immunsystemet Ikke almindelig 
Immune system disorders
Median progressionsfri overlevelse (måneder) (95% CI) 
Median progression-free survival (months) (95% CI)
• Forhøjet indhold af fedt (lipider) i blodet (hyperlipidæmi, forhøjede triglycerider) 
• High level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides)
• Udflåd fra øjnene med kløe, rødme og hævelse 
• Discharge from the eye with itching, redness and swelling
forårsage sår i munden og at sår udvikler sig. 
cause mouth ulcers and sores to develop.
Almindelig Tør hud, neglelidelse, let hårtab, akne, erytem, onychoclasis, palmoplantar erytrodysæstesi-syndrom, eksfoliation, hudlæsioner 
Common Dry skin, nail disorders, mild alopecia, acne, erythema, onychoclasis, palmar-plantar erythrodysaesthesia syndrome, skin exfoliation, skin lesion
Almindelig Proteinuri*, blod-kreatinin forhøjet, nyresvigt* Ikke almindelig 
Common Proteinuria*, blood creatinine increased, renal failure* Uncommon Increased daytime urination, acute renal failure* Reproductive system and breast disorders Common Menstruation irregular e
Tid(uger) 
Time (Weeks)
Samtidig brug af angiotensin-konverteringsenzym (ACE)-hæmmere Hos patienter, der samtidig behandles med en ACE-hæmmer (fx ramipril), kan der være forhøjet risiko for angioødem (se pkt. 
Concomitant use of angiotensin-converting enzyme (ACE) inhibitors Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (see section 4.4).
Grad 2 Dosisjustering ikke nødvendig. 
Grade 2 No dose adjustment required.
Der er dog observeret amenoré (sekundær amenoré og andre uregelmæssigheder i menstruationen) og associeret ubalance i luteiniserende hormon (LH)/follikelstimulerende hormon hos kvinder. 
The potential for everolimus to cause infertility in male and female patients is unknown, however amenorrhoea (secondary amenorrhoea and other menstrual irregularities) and associated luteinising hormone (LH)/follicle stimulating hormone (FSH) imbalance has been observed in female patients.
Hvis toksicitet recidiverer ved Grad 2, afbrydes behandlingen indtil bedring til Grad 1. 
If toxicity recurs at Grade 2, interrupt treatment until recovery to Grade 1.
• Åndenød (dyspnø) 
• Breathlessness (dyspnoea)
Grad 3 Midlertidig behandlingspause indtil bedring til Grad 2 (≥1,25x10 
Grade 3 Temporary dose interruption until recovery to Grade 2 (≥1.25x10
I alt blev 410 patienter randomiseret 1:1 til at få enten Afinitor 10 mg/dag (n=207) eller placebo (n=203). 
In total, 410 patients were randomised 1:1 to receive either Afinitor 10 mg/day (n=207) or placebo (n=203).
BOLERO-6 (studie CRAD001Y2201), et tre-armet, randomiseret, open-label, fase II-studie med everolimus i kombination med exemestan versus everolimus alene versus capecitabin til behandling af postmenopausale kvinder med østrogenreceptor-positiv, HER2/neu-negativ, lokalt fremskreden, recidiverende eller metastatisk brystcancer efter recidiv eller progression på tidligere behandling med letrozol eller anastrozol. 
BOLERO-6 (Study CRAD001Y2201), a three-arm, randomised, open-label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with oestrogen receptor-positive, HER2/neu negative, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole.
Dosering Afinitor er tilgængelig i 2,5 mg, 5 mg og 10 mg tabletter til forskellige doseringsmuligheder. 
Posology For the different dose regimens Afinitor is available as 2.5 mg, 5 mg and 10 mg tablets.
Meget almindelige (forekommer hos flere end 1 ud af 10 patienter) 
Very common (may affect more than 1 in 10 people)
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 297 mg lactose. 
Excipient with known effect Each tablet contains 297 mg lactose.
I kliniske studier og post-marketing spontane rapporter er everolimus blevet forbundet med tilfælde af nyresvigt (inklusive letale tilfælde) og proteinuria. 
In clinical studies and post-marketing spontaneous reports, everolimus has been associated with renal failure events (including fatal outcome) and proteinuria.
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.