FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) (see section 4.5).
Danish: 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 (fx hævelse af luftvejene eller tungen med eller uden respiratorisk svækkelse) (se pkt.
English: For adverse reactions of Grade 1, dose adjustment is usually not required.
Danish: Dosisjustering er normalt ikke påkrævet ved bivirkninger af Grad 1.
English: The most common adverse reactions (incidence ≥1/10) from the pooled safety data were (in decreasing order): stomatitis, rash, fatigue, diarrhoea, infections, nausea, decreased appetite, anaemia, dysgeusia, pneumonitis, oedema peripheral, hyperglycaemia, asthenia, pruritus, weight decreased, hypercholesterolaemia, epistaxis, cough and headache.
Danish: De hyppigste bivirkninger (incidens ≥1/10) fra de samlede sikkerhedsdata var (efter faldende incidens): stomatitis, udslæt, træthed, diarré, infektioner, kvalme, nedsat appetit, anæmi, smagsforstyrrelser, pneumonitis, perifert ødem, hyperglykæmi, asteni, pruritus, vægttab, hyperkolesterolæmi, næseblod, hoste og hovedpine.
English: Prognostic factors in neuroendocrine tumours of gastrointestinal or lung origin In patients with non-functional gastrointestinal or lung neuroendocrine tumours and good prognostic baseline factors, e.g. ileum as primary tumour origin and normal chromogranin A values or without bone involvement, an individual benefit-risk assessment should be performed prior to the start of Afinitor therapy.
Danish: Prognostiske faktorer ved neuroendokrine tumorer udgået fra mave-tarm-kanalen eller lungerne Hos patienter med ikke-funktionelle neuroendokrine tumorer udgået fra mave-tarm-kanalen eller lungerne og med gode prognostiske baseline-faktorer, fx primærtumor udgået fra ileum og normale kromogranin A-værdier eller uden knoglepåvirkning, bør der foretages en individuel benefit/riskvurdering før opstart af behandling med Afinitor.
English: • High level of sugar in the blood (hyperglycaemia)
Danish: • Højt indhold af sukker i blodet (hyperglykæmi)
English: For the key secondary endpoint PFS the estimated HR was 1.26 (90% CI: 0.96, 1.66) in favour of capecitabine over the everolimus + exemestane combination arm based on a total of 148 PFS events observed.
Danish: Den estimerede HR var 1,26 (90 % CI: 0,96; 1,66) for det vigtigste sekundære endepunkt PFS og var til fordel for capecitabin frem for everolimus + exemestan-kombinationsarmen, baseret på i alt 148 observerede PFS-hændelser.
English: • Loss of sense of taste (ageusia)
Danish: • Manglende smagssansen (ageusi)
English: Male fertility Afinitor may affect male fertility.
Danish: Mænds frugtbarhed Afinitor kan påvirke mænds frugtbarhed.
English: • Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of serious allergic reaction, also known as hypersensitivity)
Danish: • Udslæt, kløe, nældefeber, vejrtræknings- eller synkebesvær, svimmelhed (tegn på en alvorlig allergisk reaktion, også kendt som overfølsomhed)
English: Monitoring of complete blood count is recommended prior to the start of Afinitor therapy and periodically thereafter.
Danish: Det anbefales at foretage en komplet blodtælling før opstart af behandling med Afinitor og med jævne mellemrum herefter.
English: The median duration of blinded study treatment was 37.8 weeks (range 1.1-129.9 weeks) for patients receiving everolimus and 16.1 weeks (range 0.4-147.0 weeks) for those receiving placebo.
Danish: Den mediane varighed af blindet forsøgsbehandling var 37,8 uger (interval 1,1-129,9 uger) for patienter, der fik everolimus, og 16,1 uger (interval 0,4-147,0 uger) for dem, der fik placebo.
English: Hence, concomitant treatment of Afinitor and potent inhibitors is not recommended.
Danish: Derfor frarådes samtidig behandling med Afinitor og potente hæmmere.
English: The primary endpoint for the study was progression-free survival (PFS) evaluated by RECIST (Response Evaluation Criteria in Solid Tumors), based on the investigator's assessment (local radiology).
Danish: Det primære endepunkt for studiet var progressionsfri overlevelse (PFS) evalueret ved RECIST (Response Evaluation Criteria in Solid Tumours) baseret på investigators vurdering (lokal radiologi).
English: Limited evidence of PFS benefit was reported in the subgroup of patients with ileum as primary tumour origin (see section 5.1).
Danish: Der blev rapporteret begrænset evidens for en PFSfordel hos en undergruppe af patienter med primærtumor udgået fra ileum (se pkt.
English: Stomatitis is the most commonly reported adverse reaction in patients treated with Afinitor (see sections 4.4 and 4.8).
Danish: Stomatitis er den hyppigst rapporterede bivirkning hos patienter, der blev behandlet med Afinitor (se pkt.
English: Grade 3 Temporary dose interruption.
Danish: Grad 3 Midlertidig behandlingspause.
English: They are engraved with “LCL” on one side and “NVR” on the other.
Danish: De er præget med “LCL” på den ene side og “NVR” på den anden.
English: • Breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
Danish: • Stakåndethed, vejrtrækningsbesvær i liggende stilling, hævede fødder eller ben (tegn på hjertesvigt)
English: • Rash and pain on the palms of your hands or soles of your feet (hand-foot syndrome)
Danish: • Udslæt og smerter i håndflader eller fodsåler (hånd-fodsyndrom)
English: 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.
Danish: Studiets primære endepunkt var progressionsfri overlevelse (PFS), evauleret ved Response Evaluation Criteria in Solid Tumours (RECIST), baseret på en uafhængig radiologisk vurdering.
English: 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).
Danish: 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).
English: Log-rank p value = <0.001
Danish: Log-rank p-værdi = <0,001
English: 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).
Danish: 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).
English: No. of patients still at risk Afinitor
Danish: Antal patienter i fortsat risiko Afinitor
English: They are engraved with “UHE” on one side and “NVR” on the other.
Danish: De er præget med “UHE” på den ene side og “NVR” på den anden.
English: Log-rank p value = <0.0001
Danish: Log-rank p-værdi = <0,0001
English: Immune system disorders
Danish: Immunsystemet Ikke almindelig
English: Median progression-free survival (months) (95% CI)
Danish: Median progressionsfri overlevelse (måneder) (95% CI)
English: • High level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides)
Danish: • Forhøjet indhold af fedt (lipider) i blodet (hyperlipidæmi, forhøjede triglycerider)
English: • Discharge from the eye with itching, redness and swelling
Danish: • Udflåd fra øjnene med kløe, rødme og hævelse
English: cause mouth ulcers and sores to develop.
Danish: forårsage sår i munden og at sår udvikler sig.
English: Common Dry skin, nail disorders, mild alopecia, acne, erythema, onychoclasis, palmar-plantar erythrodysaesthesia syndrome, skin exfoliation, skin lesion
Danish: Almindelig Tør hud, neglelidelse, let hårtab, akne, erytem, onychoclasis, palmoplantar erytrodysæstesi-syndrom, eksfoliation, hudlæsioner
English: Common Proteinuria*, blood creatinine increased, renal failure* Uncommon Increased daytime urination, acute renal failure* Reproductive system and breast disorders Common Menstruation irregular e
Danish: Almindelig Proteinuri*, blod-kreatinin forhøjet, nyresvigt* Ikke almindelig
English: Time (Weeks)
Danish: Tid(uger)
English: 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).
Danish: 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.
English: Grade 2 No dose adjustment required.
Danish: Grad 2 Dosisjustering ikke nødvendig.
English: 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.
Danish: Der er dog observeret amenoré (sekundær amenoré og andre uregelmæssigheder i menstruationen) og associeret ubalance i luteiniserende hormon (LH)/follikelstimulerende hormon hos kvinder.
English: If toxicity recurs at Grade 2, interrupt treatment until recovery to Grade 1.
Danish: Hvis toksicitet recidiverer ved Grad 2, afbrydes behandlingen indtil bedring til Grad 1.
English: • Breathlessness (dyspnoea)
Danish: • Åndenød (dyspnø)
English: Grade 3 Temporary dose interruption until recovery to Grade 2 (≥1.25x10
Danish: Grad 3 Midlertidig behandlingspause indtil bedring til Grad 2 (≥1,25x10
English: In total, 410 patients were randomised 1:1 to receive either Afinitor 10 mg/day (n=207) or placebo (n=203).
Danish: I alt blev 410 patienter randomiseret 1:1 til at få enten Afinitor 10 mg/dag (n=207) eller placebo (n=203).
English: 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.
Danish: 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.
English: Posology For the different dose regimens Afinitor is available as 2.5 mg, 5 mg and 10 mg tablets.
Danish: Dosering Afinitor er tilgængelig i 2,5 mg, 5 mg og 10 mg tabletter til forskellige doseringsmuligheder.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (forekommer hos flere end 1 ud af 10 patienter)
English: Excipient with known effect Each tablet contains 297 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 297 mg lactose.
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with renal failure events (including fatal outcome) and proteinuria.
Danish: I kliniske studier og post-marketing spontane rapporter er everolimus blevet forbundet med tilfælde af nyresvigt (inklusive letale tilfælde) og proteinuria.
English: 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.
Danish: 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.
English: Grade 2 Consider interruption of therapy until symptoms improve to Grade 1.
Danish: Grad 2 Overvej pause i behandlingen, indtil symptomerne forbedres til Grad 1.
English: Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets
Danish: Afinitor 2,5 mg tabletter Afinitor 5 mg tabletter Afinitor 10 mg tabletter
English: Common Thrombocytopenia, neutropenia, leukopenia, lymphopenia Uncommon Pancytopenia
Danish: Almindelig Trombocytopeni, neutropeni, leukopeni, lymfopeni Ikke almindelig
English: 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).
Danish: 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.
English: Median progression-free survival (months) (95% CI) Investigator radiological review
Danish: Median progressionsfri overlevelse (måneder) (95% CI) Investigators radiologiske vurdering
English: Common Vomiting, dry mouth, abdominal pain, mucosal inflammation, oral pain, dyspepsia,
Danish: Almindelig Opkastning, mundtørhed, abdominalsmerter, slimhindeinflammation, smerter i munden, dyspepsi, dysfagi
English: Afinitor 10 mg tablets
Danish: Afinitor 10 mg tabletter
English: • Tiredness, breathlessness, dizziness, pale skin, signs of low level of red blood cells (anaemia)
Danish: • Træthed, stakåndethed, svimmelhed, bleg hud, tegn på lavt indhold af røde blodlegemer
English: Grade 3 (<1, ≥0.5x10
Danish: Grad 3 (<1, ≥0,5x10 9/l)
English: • High level of lipids (fats) in the blood (hypercholesterolaemia)
Danish: • Forhøjet indhold af fedtstoffer (lipider) i blodet (hyperkolesterolæmi)
English: Advanced renal cell carcinoma
Danish: Progressiv renalcellekarcinom
English: Afinitor 10 mg tablets are white to slightly yellowish, elongated tablets.
Danish: Afinitor 10 mg tabletter er hvide til svagt gullige, aflange tabletter.
English: • Severely decreased urine output, swelling in the legs, feeling confused, pain in the back (signs of sudden kidney failure)
Danish: • Stærkt nedsat vandladning, hævede ben, forvirring, rygsmerter (tegn på pludselig nyresvigt)
English: Figure 6 RECORD-1 - Kaplan-Meier progression-free survival curves (independent central review)
Danish: Figur 6 RECORD-1 - Kaplan-Meier-kurver for progressionsfri overlevelse (uafhængig central vurdering)
English: Elderly patients (≥65 years) No dose adjustment is required (see section 5.2).
Danish: Ældre patienter (≥65 år)
English: 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).
Danish: I alt blev 302 patienter randomiseret 2:1 til enten everolimus (10 mg dagligt) (n=205) eller placebo (n=97).
English: Excipient with known effect Each tablet contains 74 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 74 mg lactose.
English: Prior chemotherapy Primary tumour origin
Danish: Tidligere kemoterapi Oprindelsessted for primærtumor
English: • Low level of calcium in the blood (hypocalcaemia)
Danish: • Lavt indhold af calcium i blodet (hypokalcæmi)
English: Afinitor 2.5 mg tablets
Danish: Afinitor 2,5 mg tabletter
English: Excipient with known effect Each tablet contains 149 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 149 mg lactose.
English: Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported (see section 4.8).
Danish: Fald i hæmoglobin, lymfocytter, neutrofiler og trombocytter er rapporteret (se pkt.
English: Uncommon Non-cardiac chest pain, impaired wound healing Investigations
Danish: Non-kardielle brystsmerter, dårlig sårheling
English: Afinitor 5 mg tablets are white to slightly yellowish, elongated tablets.
Danish: Afinitor 5 mg tabletter er hvide til svagt gullige, aflange tabletter.
English: Grade 4 (<0.5x10
Danish: Grad 4 (<0,5x10 9/l)
English: White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other.
Danish: 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.
English: Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets everolimus
Danish: Afinitor 2,5 mg tabletter Afinitor 5 mg tabletter Afinitor 10 mg tabletter everolimus
English: Afinitor dose adjustment
Danish: Dosisjustering af Afinitor
English: • Abnormal wound healing
Danish: • Unormal sårheling
English: Grade 3 Interrupt treatment until symptoms resolve to Grade 1.
Danish: Grad 3 Afbryd behandlingen, indtil symptomerne forbedres til Grad 1.
English: Afinitor 5 mg tablets
Danish: Afinitor 5 mg tabletter
English: Infections and infestations Very common Infections a, *
Danish: Infektioner og parasitære sygdomme Meget almindelig
English: Very common Decreased appetite, hyperglycaemia, hypercholesterolaemia Common Hypertriglyceridaemia, hypophosphataemia, diabetes mellitus, hyperlipidaemia,
Danish: Almindelig Hypertriglyceridæmi, hypofosfatæmi, diabetes mellitus, hyperlipidæmi,
English: White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other.
Danish: 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.
English: Afinitor 2.5 mg tablets EU/1/09/538/009 EU/1/09/538/010
Danish: Afinitor 2,5 mg tabletter EU/1/09/538/009 EU/1/09/538/010
English: • Low level of phosphate in the blood (hypophosphataemia)
Danish: • Lavt indhold af fosfat i blodet (hypofosfatæmi)
English: Afinitor 2.5 mg tablets everolimus
Danish: Afinitor 2,5 mg tabletter everolimus
English: White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other.
Danish: 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.
English: Everolimus + BSC: 11.01 [9.23;13.31] months Placebo + BSC: 3.91 [3.58;7.43] months
Danish: Placebo + BSC: 3.91 [3.58;7.43] mdr.
English: Afinitor 10 mg tablets everolimus
Danish: Afinitor 10 mg tabletter everolimus
English: If you have any questions about Afinitor or why it has been prescribed for you, ask your doctor.
Danish: Spørg din læge, hvis du vil vide mere om Afinitor, og hvorfor du har fået det ordineret.
English: 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.
Danish: 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.
English: Afinitor 5 mg and Afinitor 10 mg are available in blister packs containing 10, 30 or 90 tablets.
Danish: Afinitor 5 mg og Afinitor 10 mg fås i blisterpakninger med 10, 30 eller 90 tabletter.
English: • Coughing up blood (haemoptysis)
Danish: • Ophostning af blod (hæmoptyse)
English: Afinitor 2.5 mg tablets Packs containing 30 or 90 tablets.
Danish: Afinitor 2,5 mg tabletter Pakninger indeholdende 30 eller 90 tabletter.
English: Afinitor 10 mg tablets Packs containing 10, 30 or 90 tablets.
Danish: Afinitor 10 mg tabletter Pakninger indeholdende 10, 30 eller 90 tabletter.
English: No increase in adverse reactions related to exemestane was observed in patients with hormone receptor-positive advanced breast cancer receiving the combination.
Danish: Hos patienter med fremskreden hormonreceptorpositiv brystcancer, der fik denne kombination, sås der ingen stigning i bivirkninger relateret til exemestan.
English: Afinitor 5 mg tablets everolimus
Danish: Afinitor 5 mg tabletter everolimus
English: EU/1/09/538/009 30 tablets EU/1/09/538/010 90 tablets
Danish: EU/1/09/538/009 30 tabletter EU/1/09/538/010 90 tabletter
English: Afinitor 10 mg tablets Each tablet contains 10 mg everolimus.
Danish: Afinitor 10 mg tabletter Hver tablet indeholder 10 mg everolimus.
English: Grade 2 Temporary dose interruption until recovery to Grade 1.
Danish: Grad 2 Midlertidig behandlingspause indtil bedring til Grad 1.
English: Afinitor 5 mg tablets EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
Danish: Afinitor 5 mg tabletter EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
English: Grade 3 Temporary dose interruption until recovery to Grade 1.
Danish: Grad 3 Midlertidig behandlingspause indtil bedring til Grad 1.
English: Afinitor 10 mg tablets EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
Danish: Afinitor 10 mg tabletter EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
English: Figure 3 RADIANT-3 - Kaplan-Meier progression-free survival curves (investigator radiological review)
Danish: Figur 3 RADIANT-3 - Kaplan-Meier-kurver for progressionsfri overlevelse (radiologisk vurdering af investigator)
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter)
English: Afinitor 2.5 mg tablets Each tablet contains 2.5 mg everolimus.
Danish: Afinitor 2,5 mg tabletter Hver tablet indeholder 2,5 mg everolimus.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter)
English: Hepatic impairment
Danish: Kongestivt hjertesvigt
English: Figure 1 BOLERO-2 Kaplan-Meier progression-free survival curves (investigator radiological review)
Danish: Figur 1 BOLERO-2 Kaplan-Meier-kurver for progressionsfri overlevelse (radiologisk vurdering af investigator)
English: • Mild loss of hair
Danish: • Let hårtab
English: (2.8 to 4.1)
Danish: 4.4 og 4.8).
English: Afinitor 5 mg tablets Packs containing 10, 30 or 90 tablets.
Danish: Afinitor 5 mg tabletter Pakninger indeholdende 10, 30 eller 90 tabletter.
English: Afinitor 2.5 mg is available in blister packs containing 30 or 90 tablets.
Danish: Afinitor 2,5 mg fås i blisterpakninger med 30 eller 90 tabletter.
English: Food effect
Danish: Bivirkning
English: Afinitor may affect the way some other medicines work.
Danish: Brug af anden medicin sammen med Afinitor Afinitor kan påvirke virkningen af anden medicin.
English: • Reddening of the skin (erythema)
Danish: • Hudrødme (erytem)
English: (0.5 to 4.2)
Danish: 4.2 og 5.2).