FrancophonIA/ELRC3.0 huggingface dataset:
English: Advanced neuroendocrine tumours of pancreatic origin (pNET) RADIANT-3 (study CRAD001C2324), a phase III, multicentre, randomised, double-blind study of Afinitor plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pNET, demonstrated a statistically significant clinical benefit of Afinitor over placebo by a 2.4-fold prolongation of median progression-free-survival (PFS) (11.04 months versus 4.6 months), (HR 0.35; 95% CI: 0.27, 0.45; p<0.0001) (see Table 5 and Figure 3).
Icelandic: stigs rannsókn þar sem Afinitor ásamt bestu stuðningsmeðferð var borið saman við lyfleysu ásamt bestu stuðningsmeðferð hjá sjúklingum með langt gengið pNET, kom fram tölfræðilega marktækur klínískur ávinningur af Afinitor borið saman við lyfleysu þar sem miðgildi lifunar án sjúkdómsframgangs lengdist 2,4-falt (11,04 mánuðir á móti 4,6 mánuðum), (HR 0,35; 95% CI: 0,27; 0,45; p<0,0001) (sjá töflu 5 og mynd 3).
English: Rare (may affect up to 1 in 1,000 people)
Icelandic: Mjög sjaldgæfar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum)
English: Excipient with known effect Each tablet contains 297 mg lactose.
Icelandic: Hver tafla inniheldur 297 mg af laktósa.
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis, candidiasis or PJP/PCP and viral infections including reactivation of hepatitis B virus, have been described in patients taking Afinitor.
Icelandic: Staðbundnum og almennum sýkingum, þ.m.t. lungnabólgu, öðrum bakteríusýkingum, ífarandi sveppasýkingum, svo sem ýrumyglu (aspergillosis), hvítsveppasýkingu (candidiasis) eða PJP/PCP og veirusýkingum, þar með talið endurvirkjun lifrarbólgu
English: Includes (very common) pneumonitis, (common) interstitial lung disease, lung infiltration and (rare) pulmonary alveolar haemorrhage, pulmonary toxicity, and alveolitis d
Icelandic: Felur í sér (mjög algengar) lungnabólgu, (algengar) millivefslungnasjúkdóm, íferð í lungum og (mjög sjaldgæfar) blæðingu í lungnablöðrum, eiturverkanir á lungu og bólgu í lungnablöðrum d
English: Afinitor is an anticancer medicine containing the active substance everolimus.
Icelandic: Afinitor er krabbameinslyf og er virkt innihald þess efnið everolimus.
English: The primary endpoint for the study was PFS evaluated by RECIST (Response Evaluation Criteria in Solid Tumors).
Icelandic: Aðalendapunktur rannsóknarinnar var lifun án sjúkdómsframgangs, metið með RECIST (Response Evaluation Criteria in Solid Tumors).
English: In total, 410 patients were randomised 1:1 to receive either Afinitor 10 mg/day (n=207) or placebo (n=203).
Icelandic: Alls var 410 sjúklingum slembiraðað 1:1, þannig að þeir fengu annaðhvort Afinitor 10 mg/sólarhring (n=207) eða lyfleysu (n=203).
English: Patients in the placebo arm did not cross-over to everolimus at the time of progression.
Icelandic: Sjúklingum í lyfleysuhópnum var ekki skipt yfir á everolimus þegar sjúkdómurinn versnaði.
English: Reporting of side effects
Icelandic: - Niðurstöður varðandi virkni
English: Hence everolimus may affect the bioavailability of orally co-administered CYP3A4 substrates.
Icelandic: Því gæti everolimus haft áhrif á aðgengi CYP3A4 hvarfefna til inntöku.
English: Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Icelandic: Afinitor er ætlað til meðferðar hjá sjúklingum með langt gengið nýrnafrumukrabbamein, þegar sjúkdómurinn hefur ágerst meðan á VEGF-miðaðri meðferð hefur staðið eða eftir að henni lauk.
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.
Icelandic: Algengustu aukaverkanirnar (tíðni ≥1/10) úr samanteknu öryggisupplýsingunum voru (taldar upp eftir lækkandi tíðni): munnbólga, útbrot, þreyta, niðurgangur, sýkingar, ógleði, minnkuð matarlyst, blóðleysi, bragðskynstruflanir, lungnabólga, bjúgur á útlimum, blóðsykurshækkun, þróttleysi, kláði, þyngdartap, kólesterólhækkun, blóðnasir, hósti og höfuðverkur.
English: Vaccinations The use of live vaccines should be avoided during treatment with Afinitor (see section 4.5).
Icelandic: Bólusetningar Forðast skal notkun lifandi bóluefna meðan á meðferð með Afinitor stendur (sjá kafla 4.5).
English: More frequent monitoring is recommended when Afinitor is co-administered with other medicinal products that may induce hyperglycaemia.
Icelandic: Mælt er með tíðara eftirliti þegar Afinitor er gefið samhliða öðrum lyfjum sem geta valdið blóðsykurshækkun.
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with everolimus (see section 5.3).
Icelandic: Samkvæmt forklínískum upplýsingum, getur everolimus meðferð haft áhrif á frjósemi karla og kvenna (sjá kafla 5.3).
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).
Icelandic: Aðalendapunktur rannsóknarinnar var lifun án sjúkdómsframgangs, sem var metin með RECIST (Response Evaluation Criteria in Solid Tumors) á grundvelli mats rannsóknarlæknis (staðbundin röntgengreining).
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.
Icelandic: Áætlað áhættuhlutfall fyrir lykil-aukaendapunktinn lifun án sjúkdómsframgangs var 1,26 (90% öryggisbil: 0,96; 1,66) capecitabini í vil fram yfir hópinn sem fékk samhliðameðferð með everolimus + exemestan samkvæmt samtals 148 tilvikum lifunar án sjúkdómsframgangs sem skoðuð voru.
English: Table 1 Afinitor dose adjustment recommendations
Icelandic: Tafla 1 Ráðleggingar varðandi breytingar á skömmtum
English: Uncommon Amenorrhoea e*
Icelandic: Tíðateppa e*
English: Table 3 Adverse reactions reported in clinical studies
Icelandic: Tafla 3 Aukaverkanir sem greint var frá í klínískum rannsóknum
English: Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets everolimus
Icelandic: Afinitor 2,5 mg töflur Afinitor 5 mg töflur Afinitor 10 mg töflur everolimus
English: Hazard ratio (95% CI) from stratified Cox model
Icelandic: Áhættuhlutfall (95% CI) úr lagskiptu Cox líkani.
English: Objective response rate = proportion of patients with complete or partial response c
Icelandic: Hlutlægt svörunarhlutfall = hlutfall sjúklinga sem svöruðu til fullnustu eða að einhverju leyti c
English: Afinitor 10 mg tablets everolimus
Icelandic: Afinitor 10 mg töflur everolimus
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.
Icelandic: Hvítar eða fölgular, ílangar töflur með sniðbrún, án deiliskoru, auðkenndar með „5“ á annarri hliðinni og „NVR“ á hinni.
English: No differences in the time to ≥5% deterioration in the global and functional domain scores of QLQ-C30 were observed in the two arms.
Icelandic: Enginn munur kom fram á tíma fram að ≥5% versnun, samkvæmt QLQ-C30 mælikvarða, á heildarlífsgæðum og líkamlegri færni, milli hópanna tveggja.
English: • Dry skin, skin exfoliation, skin lesions
Icelandic: Húðþurrkur, húðflögnun, sár á húð
English: Afinitor 2.5 mg tablets everolimus
Icelandic: Afinitor 2,5 mg töflur everolimus
English: Tumour grading Liver tumour burden
Icelandic: Stigun æxla Byrði lifraræxlis
English: Afinitor 2.5 mg tablets EU/1/09/538/009 EU/1/09/538/010
Icelandic: Afinitor 2,5 mg töflur EU/1/09/538/009 EU/1/09/538/010
English: Table 5 RADIANT-3 - efficacy results
Icelandic: Tafla 5 RADIANT-3
English: MSKCC prognostic score (blinded independent central review) Favourable risk
Icelandic: IDMC nefndin (the Independent Data Monitoring
English: Grade 2 If toxicity is tolerable, no dose adjustment required.
Icelandic: Ef eiturverkunin er þolanleg, er ekki þörf á að breyta skömmtum.
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).
Icelandic: Samtals 302 sjúklingum var slembiraðað í hlutfallinu 2:1 og fengu annaðhvort everolimus (10 mg á sólarhring) (n=205) eða lyfleysu (n=97).
English: • Low level of phosphate in the blood (hypophosphataemia)
Icelandic: Lítið magn af fosfati í blóði (blóðfosfatlækkun)
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.
Icelandic: Langt gengin taugainnkirtlaæxli með uppruna í meltingarfærum eða lungum RADIANT-4 (rannsókn CRAD001T2302) var slembuð, tvíblind, fjölsetra III stigs rannsókn þar sem gerður var samanburður á Afinitor ásamt stuðningsmeðferð og lyfleysu ásamt stuðningsmeðferð hjá sjúklingum með langt gengin, mjög sérhæfð (differentiated) (af stigi 1 eða stigi 2) óvirk taugainnkirtlaæxli með uppruna í meltingarfærum eða lungum án sögu um og án virkra einkenna sem tengjast heilkenni silfurfrumuæxlis.
English: • Increased temperature, chills (signs of infection)
Icelandic: Hækkaður hiti, kuldahrollur (einkenni sýkingar)
English: • Severely decreased urine output, swelling in the legs, feeling confused, pain in the back (signs of sudden kidney failure)
Icelandic: Verulega minnkaður þvagútskilnaður, þroti á fótleggjum, ringlun, verkir í baki (einkenni bráðrar nýrnabilunar)
English: Time (Weeks)
Icelandic: Tími(vikur)
English: The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 6 and Figure 4).
Icelandic: Niðurstöður varðandi verkun fyrir aðalendapunktinn voru fengnar úr lokagreiningu á lifun án sjúkdómsframgangs (sjá töflu 6 og mynd 4).
English: Hormone receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Icelandic: Afinitor er ætlað til meðferðar við langt gengnu hormónaviðtaka-jákvæðu, HER2/neu neikvæðu brjóstakrabbameini, í samsettri meðferð með exemestan, hjá konum eftir tíðahvörf sem ekki eru með sjúkdóm í innri líffærum sem veldur einkennum, eftir bakslag eða versnun að undangenginni meðferð með aromatasa-hemli sem ekki er steri.
English: Avoid the use of concomitant potent CYP3A4 inducers.
Icelandic: Forðast skal samhliða gjöf öflugra CYP3A4-hvata.
English: ANNEX II
Icelandic: 2. stig
English: Consider re-initiating treatment at 5 mg daily.
Icelandic: Íhuga skal að hefja aftur meðferð með 5 mg á sólarhring.
English: Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
Icelandic: Afinitor er ætlað til meðferðar við mjög eða í meðallagi mikið sérhæfðum (differentiated) taugainnkirtlaæxlum með uppruna í brisi, sem eru óskurðtæk eða með meinvörpum, hjá fullorðnum með versnandi sjúkdóm.
English: Grade 3 Temporary dose interruption until recovery to Grade 2 (≥1.25x10
Icelandic: 3. stig Gera skal tímabundið hlé á meðferð þar til einkenni eru 2. stigs (≥1,25x10
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of amenorrhoea (secondary amenorrhoea and other menstrual irregularities).
Icelandic: Í klínískum rannsóknum og aukaverkanatilkynningum eftir markaðssetningu hefur everolimus verið tengt tilvikum tíðaleysis (síðkomins tíðaleysis og annarra tíðaraskana).
English: Moderate hepatic impairment (Child-Pugh B) - the recommended dose is 5 mg daily.
Icelandic: Í meðallagi mikið skert lifrarstarfsemi (Child-Pugh B) - ráðlagður skammtur er 5 mg á sólarhring.
English: Common Haemorrhage b, hypertension
Icelandic: Blæðingar b, háþrýstingur
English: If the moderate inhibitor is discontinued, consider a washout period of at least 2 to 3 days (average elimination time for most commonly used moderate inhibitors) before the Afinitor dose is returned to the dose used prior to initiation of the co-administration.
Icelandic: öfluga hemlinum er hætt, skal íhuga útskilnaðartímabil (washout period) í að minnsta kosti 2 til 3 daga (meðalbrotthvarfstími flestra algengra í meðallagi öflugra hemla) áður en aftur er notaður sami skammtur af Afinitor og notaður var áður en samhliða meðferðin hófst.
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.
Icelandic: Hvítar eða fölgular, ílangar töflur með sniðbrún, án deiliskoru, auðkenndar með „LCL“ á annarri hliðinni og „NVR“ á hinni.
English: • Breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
Icelandic: Mæði, öndunarerfiðleikar þegar legið er út af, þroti á fótum eða fótleggjum (einkenni hjartabilunar)
English: The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 4 and Figure 1).
Icelandic: Niðurstöður varðandi verkun fyrir aðalendapunktinn fengust úr lokagreiningu á lifun án sjúkdómsframgangs (sjá töflu 4 og mynd 1).
English: Angioedema*
Icelandic: Mæði (andþyngsli)
English: Intermediate risk
Icelandic: Áhættuhlutfall p gildi
English: Those randomised to placebo were then able to receive open-label Afinitor.
Icelandic: Þeir sem höfðu fengið lyfleysu gátu þá fengið opna meðferð með Afinitor.
English: Secondary endpoints included safety, objective response rate, response duration and overall survival (OS).
Icelandic: Aukaendapunktar voru öryggi, hlutlægt svörunarhlutfall (objective response rate), svörunarlengd og heildarlifun.
English: Afinitor 5 mg tablets everolimus
Icelandic: Afinitor 5 mg töflur everolimus
English: Everolimus + BSC
Icelandic: Everolimus + stuðningsmeðferð
English: Hazard Ratio = 0.33 95% CI [0.25, 0.43]
Icelandic: Áhættuhlutfall = 0,33 95% CI [0,25, 0,43]
English: The recommended dose is 10 mg everolimus once daily.
Icelandic: Ráðlagður skammtur er 10 mg af everolimus einu sinni á sólarhring.
English: What Afinitor contains The active substance is everolimus.
Icelandic: - Virka innihaldsefnið er everolimus.
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.
Icelandic: frumæxli með uppruna í dausgörn og eðlileg gildi chromogranin A eða án beina meinvarpa, skal framkvæma einstaklingsbundið mat á ávinningi-áhættu áður en meðferð með Afinitor er hafin.
English: Grade 2 No dose adjustment required.
Icelandic: 2. stig Ekki þarf að breyta skömmtum.
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.
Icelandic: Hvítar eða fölgular, ílangar töflur með sniðbrún, án deiliskoru, auðkenndar með „UHE“ á annarri hliðinni og „NVR“ á hinni.
English: Everolimus + BSC (n/N = 113/205) Placebo + BSC (n/N = 65/97)
Icelandic: Everolimus + stuðningsmeðferð (n/N = 113/205) Lyfleysa + stuðningsmeðferð (n/N = 65/97)
English: In animal reproductive studies female fertility was not affected.
Icelandic: Í dýrarannsókn á æxlun komu ekki fram áhrif á frjósemi hjá kvendýrum.
English: Figure 1 BOLERO-2 Kaplan-Meier progression-free survival curves (investigator radiological review)
Icelandic: Mynd 1 BOLERO-2 Kaplan-Meier ferlar fyrir lifun án sjúkdómsframgangs (myndgreining samkvæmt mati rannsakanda)
English: Excipient with known effect Each tablet contains 149 mg lactose.
Icelandic: Hver tafla inniheldur 149 mg af laktósa.
English: Afinitor 10 mg tablets are white to slightly yellowish, elongated tablets.
Icelandic: Afinitor 10 mg töflur eru hvítar eða fölgular, ílangar töflur.
English: Afinitor 5 mg tablets EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
Icelandic: Afinitor 5 mg töflur EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
English: The estimated PFS treatment effect was supported by planned subgroup analysis of PFS per investigator assessment.
Icelandic: Áætluð verkun með tilliti til lifunar án sjúkdómsframgangs var studd af áætlaðri greiningu á lifun án sjúkdómsframgangs hjá undirhópum, samkvæmt mati rannsóknarlæknis.
English: Afinitor 10 mg tablets EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
Icelandic: Afinitor 10 mg töflur EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
English: • Excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of diabetes)
Icelandic: Mikill þorsti, mikil þvaglát, aukin matarlyst ásamt þyngdartapi, þreyta (einkenni sykursýki)
English: • Low level of calcium in the blood (hypocalcaemia)
Icelandic: Lítið magn af kalíum í blóði (blóðkalíumlækkun)
English: Afinitor 5 mg tablets are white to slightly yellowish, elongated tablets.
Icelandic: Afinitor 5 mg töflur eru hvítar eða fölgular, ílangar töflur.
English: Hazard Ratio = 0.45 95% CI [0.38, 0.54]
Icelandic: Áhættuhlutfall = 0,45 95% CI [0,38; 0,54]
English: Each tablet of Afinitor 2.5 mg contains 2.5 mg everolimus.
Icelandic: - Hver tafla af Afinitor 2,5 mg inniheldur 2,5 mg af everolimus.
English: • Inflammation of the inner lining of the mouth, stomach, gut
Icelandic: Bólga í slímhúðinni í munninum, maganum og meltingarveginum
English: Each tablet of Afinitor 10 mg contains 10 mg everolimus.
Icelandic: - Hver tafla af Afinitor 10 mg inniheldur 10 mg af everolimus.
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with renal failure events (including fatal outcome) and proteinuria.
Icelandic: Í klínískum rannsóknum og aukaverkanatilkynningum eftir markaðssetningu hefur everolimus verið tengt nýrnabilun (þar með talið banvænum tilvikum) og próteinmigu.
English: Each tablet contains 2.5 mg everolimus.
Icelandic: Hver tafla inniheldur 2,5 mg af everolimus.
English: Primary analysis All (blinded independent central review)
Icelandic: Allir (blinduð óháð miðlæg endurskoðun)
English: Hazard Ratio = 0.48 95% CI [0.35, 0.67]
Icelandic: Áhættuhlutfall = 0,48 95% CI [0,35; 0,67]
English: Monitoring of complete blood count is recommended prior to the start of Afinitor therapy and periodically thereafter.
Icelandic: Mælt er með eftirliti með blóðmynd áður en meðferð með Afinitor er hafin og reglulega eftir það.
English: Uncommon Non-cardiac chest pain, impaired wound healing Investigations
Icelandic: Brjóstverkur sem ekki tengist hjarta, sár gróa illa Rannsóknaniðurstöður Mjög algengar
English: • Thirst, low urine output, dark urine, dry flushed skin, irritability (signs of dehydration)
Icelandic: Þorsti, lítið þvagmagn, dökkleitt þvag, þurr rauðleit húð, erting (einkenni vökvaskorts)
English: Figure 6 RECORD-1 - Kaplan-Meier progression-free survival curves (independent central review)
Icelandic: Mynd 6 RECORD-1 - Kaplan-Meier línurit fyrir lifun án sjúkdómsframgangs (óháð miðlæg endurskoðun)
English: Each tablet of Afinitor 5 mg contains 5 mg everolimus.
Icelandic: - Hver tafla af Afinitor 5 mg inniheldur 5 mg af everolimus.
English: • Weight loss
Icelandic: Vægt hárlos
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]).
Icelandic: Hinsvegar kom ekki fram neinn tölfræðilega marktækur munur á heildarlifun (HR=0,73 [95% CI: 0,48 til 1,11; p=0,071]).
English: Afinitor 2.5 mg tablets
Icelandic: Afinitor 2,5 mg töflur
English: • Heartburn (dyspepsia)
Icelandic: Brjóstsviði (meltingartruflanir)
English: Hyperglycaemia has been reported (see section 4.8).
Icelandic: Greint hefur verið frá blóðsykurshækkun (sjá kafla 4.8).
English: Posology For the different dose regimens Afinitor is available as 2.5 mg, 5 mg and 10 mg tablets.
Icelandic: Skammtar Afinitor er fáanlegt sem 2,5 mg, 5 mg og 10 mg töflur, fyrir mismunandi skömmtunaráætlanir.
English: Table 7 RECORD-1 - Progression-free survival results
Icelandic: RECORD-1 - Lifun án sjúkdómsframgangs
English: • Fever, coughing, difficulty breathing, wheezing (signs of inflammation of the lung, also known as pneumonitis)
Icelandic: Hiti, hósti, öndunarerfiðleikar, hvæsandi öndun (einkenni bólgu í lungum, einnig kallað lungnabólga)
English: Common Dry skin, nail disorders, mild alopecia, acne, erythema, onychoclasis, palmar-plantar erythrodysaesthesia syndrome, skin exfoliation, skin lesion
Icelandic: Húðþurrkur, sjúkdómur í nöglum, vægt hárlos, þrymlabólur, roðaþot, brotnar neglur, handa- og fótaheilkenni (palmar-plantar erythrodysaesthesia syndrome), húðflögnun, sáramyndun í húð Mjög sjaldgæfar Ofsabjúgur* Stoðkerfi og bandvefur
English: • Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of serious allergic reaction, also known as hypersensitivity)
Icelandic: Útbrot, kláði, ofsakláði, öndunar- eða kyngingarerfiðleikar, sundl (einkenni alvarlegra ofnæmisviðbragða, kallast einnig ofnæmi)
English: Agents whose plasma concentration may be altered by everolimus Based on in vitro results, the systemic concentrations obtained after oral daily doses of 10 mg make inhibition of PgP, CYP3A4 and CYP2D6 unlikely.
Icelandic: Everolimus getur haft áhrif á plasmaþéttni annarra lyfja Samkvæmt in vitro niðurstöðum er ólíklegt að hömlun á PgP, CYP3A4 og CYP2D6 eigi sér stað við þá blóðþéttni sem næst eftir 10 mg skammta til inntöku.
English: Secondary endpoints included overall survival (OS), overall response rate, disease control rate, safety, change in quality of life (FACT-G) and time to World Health Organisation performance status (WHO PS) deterioration.
Icelandic: Aukaendapunktar voru m.a. heildarlifun, heildarsvörunarhlutfall, tíðni sjúkdómsstjórnunar, öryggi, breyting á lífsgæðum (FACT-G) og tími að sjúkdómsversnun samkvæmt
English: Limited evidence of PFS benefit was reported in the subgroup of patients with ileum as primary tumour origin (see section 5.1).
Icelandic: Greint var frá takmörkuðum vísbendingum um ávinning varðandi lifun án sjúkdómsframgangs hjá undirhóp sjúklinga með frumæxli með uppruna í dausgörn (sjá kafla 5.1).
English: Secondary endpoints included safety, objective tumour response rate, overall survival, disease-related symptoms, and quality of life.
Icelandic: Aukaendapunktar tóku til öryggis, hlutlægri svörun æxlis, heildarlifunar, einkennum sem tengdust sjúkdómnum og lífsgæða.
English: EU/1/09/538/009 30 tablets EU/1/09/538/010 90 tablets
Icelandic: EU/1/09/538/009 30 töflur EU/1/09/538/010 90 töflur
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.
Icelandic: Aðalendapunktur rannsóknarinnar var lifun án sjúkdómsframgangs, metin með RECIST (Response Evaluation Criteria in Solid Tumours), samkvæmt myndgreiningu óháðs aðila.
English: Co-administration of everolimus and exemestane increased exemestane Cmin and C2h by 45% and 64%, respectively.
Icelandic: Samhliða notkun everolimus og exemestans jók Cmin og C2klst.
English: Afinitor 10 mg tablets
Icelandic: Afinitor 10 mg töflur
English: Afinitor 5 mg tablets
Icelandic: Afinitor 5 mg töflur
English: Each tablet contains 10 mg everolimus.
Icelandic: Hver tafla inniheldur 10 mg af everolimus.