FrancophonIA/ELRC3.0 huggingface dataset:
English: No. of patients still at risk Time (months) Afinitor
Slovenian: Št bolnikov, izpostavljenih tveganju čas (meseci)
English: Patients were stratified according to Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic score (favourable- vs. intermediate- vs. poor-risk groups) and prior anticancer therapy (1 vs. 2 prior VEGFR-TKIs).
Slovenian: Bolnike so stratificirali glede na prognostično lestvico MSKCC (lestvico Centra za zdravljenje raka Memorial Sloan-Kettering) (na skupino z ugodnim obetom, skupino s srednje ugodnim obetom in na skupino s slabim obetom), stratificirani pa so bili tudi glede na predhodno zdravljenje raka (na skupini s predhodno uporabo 1 ali 2 zdravil VEGFR-TKI).
English: In a post-marketing single-arm study in postmenopausal women with advanced breast cancer (N=92), topical treatment with dexamethasone 0.5 mg/5 ml alcohol-free oral solution was administered as a mouthwash (4 times daily for the initial 8 weeks of treatment) to patients at the time of initiating treatment with Afinitor (10 mg/day) plus exemestane (25 mg/day) to reduce the incidence and severity of stomatitis.
Slovenian: V študiji v obdobju trženja, z eno študijsko skupino pri postmenopavzalnih bolnicah z napredovalim rakom dojke (N=92), so bolnice na začetku zdravljenja z zdravilom Afinitor (10 mg na dan) skupaj z eksemestanom (25 mg na dan) prejemale lokalno zdravljenje z oralno raztopino z deksametazonom 0,5 mg/5 ml brez alkohola, ki so jo uporabljale kot raztopino za izpiranje ust (4-krat dnevno v prvih 8 tednih zdravljenja), s čimer so želeli zmanjšati pogostnost in izraženost stomatitisa.
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.
Slovenian: Pri vrednostih ključnih sekundarnih ciljev opazovanja za preživetje brez napredovanja bolezni je bilo ocenjeno razmerje tveganj 1,26 (90-odstotni IZ: 0,96, 1,66) v prid skupine s kapecitabinom v primerjavi s skupino s kombinacijo everolimusa in eksemestana na osnovi skupno 148 dogodkov v povezavi s preživetjem brez napredovanja bolezni.
English: The median duration of exemestane treatment was longer in the everolimus + exemestane group at 29.5 weeks (1.0-199.1) compared to 14.1 weeks (1.0-156.0) in the placebo + exemestane group.
Slovenian: Mediana trajanja zdravljenja z eksemestanom je bila daljša v skupini bolnic, ki je prejemala everolimus in eksemestan, in sicer 29,5 tedna (1,0 do 199,1) v primerjavi s 14,1 tedna (1,0 do 156,0 tedna) v skupini bolnic, ki je prejemala placebo in eksemestan.
English: In total, 416 patients were randomised 2:1 to receive Afinitor (n=277) or placebo (n=139).
Slovenian: Skupno so v razmerju 2:1 randomizirali 416 bolnikov, tako da so prejemali zdravilo Afinitor (n=277) ali placebo (n=139).
English: Patients in the placebo arm did not cross-over to everolimus at the time of progression.
Slovenian: Bolniki v skupini s placebom ob napredovanju bolezni niso prešli na jemanje everolimusa.
English: Secondary endpoints included overall survival (OS), objective response rate, clinical benefit rate, safety, change in quality of life (QoL) and time to ECOG PS (Eastern Cooperative Oncology Group performance status) deterioration.
Slovenian: Med sekundarnimi cilji opazovanja so bili celotno preživetje, delež bolnic z objektivnim odzivom, delež bolnic s klinično koristjo, varnost, spremembe v kakovosti življenja (QoL) in čas do poslabšanja stanja splošne zmogljivosti po lestvici ECOG (Eastern Cooperative Oncology Group).
English: Best overall response (%) (95% CI) Objective response rate b
Slovenian: mediana celotnega preživetja (meseci) (95% IZ) mediana celotnega preživetja najboljši skupni odziv (%) (95 % IZ) delež bolnic z objektivnim odzivom b
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.
Slovenian: Napredovali rak dojke, pozitiven na hormonske receptorje Zdravilo Afinitor je indicirano za zdravljenje na hormonske receptorje pozitivnega in HER2/neu negativnega napredovalega raka dojke, in sicer v kombinaciji z eksemestanom pri ženskah v pomenopavzi, pri katerih ne gre za simptomatsko prizadetost visceralnih organov ob ponovitvi oziroma napredovanju bolezni po zdravljenju z nesteroidnim zaviralcem aromataze.
English: CYP3A4 and PgP inducers decreasing everolimus concentrations Substances that are inducers of CYP3A4 or PgP may decrease everolimus blood concentrations by increasing metabolism or the efflux of everolimus from intestinal cells.
Slovenian: Induktorji CYP3A4 in P-glikoproteina, ki znižujejo koncentracijo everolimusa Snovi, ki inducirajo CYP3A4 ali P-glikoprotein, lahko znižajo koncentracijo everolimusa v krvi, ker povečujejo njegov metabolizem ali njegov transport iz črevesnih celic.
English: The estimated PFS treatment effect was supported by planned subgroup analysis of PFS per investigator assessment.
Slovenian: Oceno vpliva zdravljenja na preživetje brez napredovanja bolezni so podprli z analizo preživetja brez napredovanja bolezni po načrtovanih podskupinah glede na oceno raziskovalca.
English: In clinical trials and post-marketing spontaneous reports, angioedema has been reported with and without concomitant use of ACE inhibitors (see section 4.4).
Slovenian: V poročilih iz kliničnih študij in spontanih poročilih po prihodu zdravila na trg so navajali angioedem tako pri sočasni uporabi zaviralcev angiotenzinske konvertaze kot brez sočasne uporabe teh zdravil (glejte poglavje 4.4).
English: • Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of serious allergic reaction, also known as hypersensitivity)
Slovenian: • izpuščaj, srbenje, koprivnica, oteženo dihanje ali požiranje, omotičnost (znaki resne alergijske reakcije, ki jo imenujemo tudi preobčutljivost)
English: Grade 2 Consider interruption of therapy until symptoms improve to Grade 1.
Slovenian: Stopnja 2 Razmislite o prekinitvi zdravljenja, dokler se simptomi ne izboljšajo do stopnje 1.
English: Hazard Ratio = 0.74 90% CI [0.57;0.97]
Slovenian: razmerje tveganj = 0,74 90% IZ [0,57;0,97]
English: Everolimus/Exemestane (n/N=80/104) Everolimus (n/N=74/103)
Slovenian: verjetnost (%) dogodka št. bolnikov izpostavljenih tveganju čas (tedni) everolimus/eksemestan everolimus časi cenzuriranja everolimus/eksemestan (n/N=80/104) everolimus (n/N=74/103)
English: Log-rank p value = <0.0001
Slovenian: Log-rank vrednost p = <0,0001
English: Uncommon Congestive cardiac failure Vascular disorders
Slovenian: Srčne bolezni občasni kongestivno popuščanje srca
English: Male fertility Afinitor may affect male fertility.
Slovenian: Zdravilo Afinitor lahko vpliva na plodnost pri moških.
English: • Nose bleeds (epistaxis)
Slovenian: • krvavitve iz nosu (epistaksa)
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of amenorrhoea (secondary amenorrhoea and other menstrual irregularities).
Slovenian: V poročilih iz kliničnih študij in spontanih poročilih na podlagi izkušenj po prihodu zdravila na trg so everolimus povezovali s primeri amenoreje (sekundarne amenoreje in drugih menstrualnih motenj).
English: Log-rank p value = <0.001
Slovenian: log-rank vrednost p = <0,001
English: Rare (may affect up to 1 in 1,000 people)
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov)
English: Median progression-free survival (months) (95% CI)
Slovenian: vrednost p mediana preživetja brez napredovanja bolezni (meseci) (95 % IZ)
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.
Slovenian: Med sekundarnimi cilji opazovanja so bili celotno preživetje (overall survival, OS), delež bolnikov z odzivom na zdravljenje (overall response rate), delež bolnikov z obvladano boleznijo (disease control rate), varnost, sprememba kakovosti življenja glede na oceno po vprašalniku FACT-G in čas do poslabšanja stanja zmogljivosti po lestvici Svetovne zdravstvene organizacije (WHO PS).
English: • Breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
Slovenian: • zadihanost, oteženo dihanje v ležečem položaju, otekanje stopal ali nog (znaki srčnega popuščanja)
English: • Menstruation disorders such as irregular periods
Slovenian: • motnje menstrualnega ciklusa, kot so neredne krvavitve
English: Grade 3 Temporary dose interruption.
Slovenian: Stopnja 3 Začasno prekinite zdravljenje.
English: Approximately 20% of the everolimus concentration in whole blood is confined to plasma in cancer patients given everolimus 10 mg/day.
Slovenian: Pri bolnikih z rakom, ki jemljejo everolimus v odmerku 10 mg na dan, je približno 20 % koncentracije everolimusa v celotni krvi omejene na plazmo.
English: • Loss of sense of taste (ageusia)
Slovenian: • izguba zmožnosti okušanja (agevzija)
English: Psychiatric disorders Common Insomnia Nervous system disorders Very common Dysgeusia, headache Uncommon Ageusia Eye disorders
Slovenian: Bolezni živčevja zelo pogosti disgevzija, glavobol občasni agevzija
English: MSKCC prognostic score (blinded independent central review) Favourable risk
Slovenian: a prognostična lestvica MSKCC (slepo neodvisno centralno pregledovanje) ugoden obet srednje ugoden obet slab obet a stratificiran log-rank test
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.
Slovenian: Pri bolnikih, ki so jemali zdravilo Afinitor, so opisovali lokalne in sistemske okužbe, vključno s pljučnico, z drugimi bakterijskimi okužbami, z invazivnimi glivičnimi okužbami, kot so aspergiloza, kandidoza in PJP/PCP in z virusnimi okužbami, vključno z reaktivacijo virusa hepatitisa B. Nekatere od teh okužb so potekale v hudi obliki (so povzročile na primer sepso, odpoved dihanja ali jeter), v nekaterih primerih so se končale s smrtjo.
English: Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets
Slovenian: Afinitor 2,5 mg tablete Afinitor 5 mg tablete Afinitor 10 mg tablete
English: Placebo
Slovenian: Afinitor placebo
English: Monitoring of blood cholesterol and triglycerides prior to the start of Afinitor therapy and periodically thereafter, as well as management with appropriate medical therapy, is recommended.
Slovenian: Pred začetkom zdravljenja z zdravilom Afinitor in periodično med zdravljenjem je priporočeno spremljanje holesterola in trigliceridov v krvi ter ustrezno zdravljenje.
English: One-sided p-value from a stratified log-rank test
Slovenian: ocena radiološkega izvida s strani neodvisnega pregledovalca ocena radiološkega izvida s strani raziskovalca a vrednost p enosmernega stratificiranega log-rank testa
English: The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 4 and Figure 1).
Slovenian: Rezultati učinkovitosti glede primarnega cilja opazovanja izhajajo iz končne analize preživetja brez napredovanja bolezni (glejte preglednico 4 in sliko 1).
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.
Slovenian: Študija BOLERO-6 (z oznako CRAD001Y2201) je bila randomizirana odprta študija faze II s tremi skupinami za primerjavo kombinacije everolimusa z eksemestanom, samega everolimusa in kapecitabina pri zdravljenju pomenopavzalnih žensk z na estrogenske receptorje pozitivnim in HER2/neu negativnim in lokalno napredovalim, ponovljenim ali metastatskim rakom dojke po ponovitvi ali napredovanju bolezni ob zdravljenju z letrozolom ali anastrozolom.
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).
Slovenian: Skupno so v razmerju 2:1 randomizirali 302 bolnika, in sicer tako da so bolniki prejemali bodisi everolimus (10 mg na dan) (n=205) ali placebo (n=97).
English: • Discharge from the eye with itching, redness and swelling
Slovenian: • izcedek iz očesa s srbenjem, rdečino in oteklino
English: Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein or serum creatinine, is recommended prior to the start of Afinitor therapy and periodically thereafter.
Slovenian: Pred začetkom zdravljenja z zdravilom Afinitor in občasno med zdravljenjem je priporočeno spremljanje ledvične funkcije, vključno z določanjem vrednosti dušika sečnine v krvi (BUN), proteinov v urinu ali kreatinina v serumu.
English: The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 6 and Figure 4).
Slovenian: Rezultati učinkovitosti glede primarnega cilja opazovanja izhajajo iz končne analize preživetja brez napredovanja bolezni (glejte preglednico 6 in sliko 4).
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.
Slovenian: Napredovali nevroendokrini tumorji gastrointestinalnega ali pljučnega izvora Študija RADIANT-4 (študija CRAD001T2302) je bila randomizirana, dvojno slepa, multicentrična študija faze III, v kateri so primerjali zdravilo Afinitor s placebom, oba skupaj z najboljšo podporno oskrbo, pri bolnikih z napredovalimi dobro diferenciranimi (gradus 1 ali gradus 2) nefunkcionalnimi nevroendokrinimi tumorji gastrointestinalnega ali pljučnega izvora, ki nimajo in niso nikdar imeli simptomov karcinoidnega sindroma.
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).
Slovenian: Skupno so 724 bolnic randomizirali v razmerju 2:1 tako, da so prejemale kombinacijo everolimusa (10 mg dnevno) in eksemestana (25 mg dnevno) (n=485) ali kombinacijo placeba in eksemestana (25 mg dnevno) (n=239).
English: • Rash and pain on the palms of your hands or soles of your feet (hand-foot syndrome)
Slovenian: • izpuščaj in bolečine po dlaneh in podplatih (sindrom dlani in stopal)
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.
Slovenian: V združenih podatkih o varnosti zdravila so bili najpogostejši neželeni učinki (s pogostnostjo ≥1/10, navedeni po padajoči pogostnosti) vnetje ustne sluznice, izpuščaj, utrujenost, diareja, okužbe, navzea, zmanjšan apetit, anemija, disgevzija, pljučnica, periferni edemi, hiperglikemija, astenija, srbenje, znižana telesna masa, hiperholesterolemija, krvavitev iz nosu, kašelj in glavobol.
English: • High level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides)
Slovenian: • zvišana raven lipidov (maščob) v krvi (hiperlipidemija, zvišana raven trigliceridov)
English: Median progression-free survival (months) (95% CI) Investigator radiological review
Slovenian: razmerje tveganj vrednost p mediana preživetja brez napredovanja bolezni (meseci) (95 % IZ) ocena radiološkega izvida s strani raziskovalca
English: Figure 6 RECORD-1 - Kaplan-Meier progression-free survival curves (independent central review)
Slovenian: Slika 6 Študija RECORD-1 - Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni (neodvisno centralno pregledovanje)
English: if you need to receive a vaccine while taking Afinitor.
Slovenian: če morate biti med zdravljenjem z zdravilom Afinitor cepljeni.
English: Everolimus + BSC: 11.01 [9.23;13.31] months Placebo + BSC: 3.91 [3.58;7.43] months
Slovenian: Kaplan-Meierjeve mediane everolimus + BSC: 11,01 [9,23;13,31] meseca placebo + BSC: 3,91 [3,58;7,43] meseca časi cenzuriranja everolimus + BSC (n/N = 113/205) placebo + BSC (n/N = 65/97)
English: In a male fertility study in rats, testicular morphology was affected at 0.5 mg/kg and above, and sperm motility, sperm head count, and plasma testosterone levels were diminished at 5 mg/kg which caused a reduction in male fertility.
Slovenian: Poleg tega je prišlo do zmanjšane motilitete spermijev, zmanjšanega števila spermijev in zmanjšane koncentracije testosterona v plazmi pri odmerku 5 mg/kg, kar je povzročilo zmanjšanje plodnosti pri samcih.
English: Exposure to everolimus was increased in patients with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z blago (razreda A po Child-Pughovi lestvici), zmerno (razreda B po Child-Pughovi lestvici) in hudo (razreda C po Child-Pughovi lestvici) okvaro jeter je bila izpostavljenost everolimusu povečana (glejte poglavje 5.2).
English: Patients in the placebo + exemestane arm did not cross over to everolimus at the time of progression.
Slovenian: Bolnice iz skupine, ki je prejemala placebo in eksemestan, ob napredovanju bolezni niso prešle na zdravljenje z everolimusom.
English: • severe itching of the skin, with a red rash or raised bumps
Slovenian: • hudo srbenje kože z rdečim izpuščajem ali s spremembami nad nivojem kože.
English: Moderate CYP3A4/PgP inhibitors Erythromycin
Slovenian: Zmerni zaviralci CYP3A4/P-glikoproteina eritromicin
English: Secondary endpoints included safety, objective response rate, response duration and overall survival (OS).
Slovenian: Med sekundarnimi cilji opazovanja so bili varnost, delež bolnikov z objektivnim odzivom, trajanje odziva in celotno preživetje.
English: Afinitor 10 mg tablets
Slovenian: Afinitor 10 mg tablete
English: Other secondary objectives included the evaluation of OS, objective response rate, clinical benefit rate, safety, time to ECOG performance deterioration, time to QoL deterioration, and treatment satisfaction (TSQM).
Slovenian: Med drugimi sekundarnimi cilji so bili ovrednotenje celotnega preživetja, deleža bolnic z objektivnim odzivom, deleža bolnic s klinično koristjo, varnosti, časa do poslabšanja stanja splošne zmogljivosti po lestvici ECOG, časa do poslabšanja kakovosti življenja (QoL) in zadovoljstva z zdravljenjem (z vprašalnikom TSQM za oceno zadovoljstva zdravljenja z zdravilom).
English: Supportive PFS analysis was based on local investigator review.
Slovenian: Podporno analizo preživetja brez napredovanja bolezni so opravili na osnovi pregleda lokalnih raziskovalcev v študiji.
English: Grade 4 (<0.5x10
Slovenian: Stopnja 4 (<0,5x10 9/l)
English: Dexamethasone
Slovenian: deksametazon
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.
Slovenian: Podolgovate tablete, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “5” na eni strani in “NVR” na drugi.
English: Results of the secondary endpoint OS were not consistent with the primary endpoint PFS, with a trend observed favouring the everolimus alone arm.
Slovenian: Rezultati za sekundarni cilj opazovanja celotnega preživetja se niso ujemali z rezultati za primarni cilj opazovanja (preživetje brez napredovanja bolezni), saj so vrednosti kazale trend v prid skupini z uporabo samo everolimusa.
English: Very common Decreased appetite, hyperglycaemia, hypercholesterolaemia Common Hypertriglyceridaemia, hypophosphataemia, diabetes mellitus, hyperlipidaemia,
Slovenian: Presnovne in prehranske motnje zelo pogosti zmanjšan apetit, hiperglikemija, hiperholesterolemija pogosti hipertrigliceridemija, hipofosfatemija, sladkorna bolezen, hiperlipidemija, hipokaliemija, dehidracija, hipokalciemija Psihiatrične motnje pogosti nespečnost
English: In total, 410 patients were randomised 1:1 to receive either Afinitor 10 mg/day (n=207) or placebo (n=203).
Slovenian: Skupno so v razmerju 1:1 randomizirali 410 bolnikov, in sicer tako da so prejemali bodisi zdravilo Afinitor 10 mg/dan (n=207) ali placebo (n=203).
English: However, oral doses of everolimus in female rats at ≥0.1 mg/kg (approximately 4% of the AUC0-24h in patients receiving the 10 mg daily dose) resulted in increases in pre-implantation loss.
Slovenian: V študijah vpliva na sposobnost razmnoževanja pri živalih niso opažali vpliva na plodnost pri samicah, je pa peroralno odmerjanje everolimusa podganjim samicam v odmerkih ≥0,1 mg/kg (kar ustreza približno 4 % vrednosti AUC0-24h pri bolnikih, ki prejemajo odmerek 10 mg dnevno) povzročilo povečano umrljivost zarodkov pred ugnezditvijo.
English: Grade 3 Temporary dose interruption until recovery to Grade 2 (≥1.25x10
Slovenian: Stopnja 3 Začasno prekinite zdravljenje, dokler se simptomi ne izboljšajo do stopnje 2 (≥1,25x10
English: Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets everolimus
Slovenian: Afinitor 2,5 mg tablete Afinitor 5 mg tablete Afinitor 10 mg tablete everolimus
English: Grade 3 (<1, ≥0.5x10
Slovenian: Stopnja 3 (<1, ≥0,5x10 9/l)
English: • Nail disorders, breaking of your nails
Slovenian: • bolezni nohtov, lomljivost nohtov
English: Afinitor 2.5 mg tablets
Slovenian: Afinitor 2,5 mg tablete
English: • Tiredness, breathlessness, dizziness, pale skin, signs of low level of red blood cells (anaemia)
Slovenian: • utrujenost, zadihanost, omotičnost, bledica, znaki zmanjšanega števila eritrocitov (anemija)
English: The primary objective of the study was to estimate the HR of PFS for everolimus + exemestane versus everolimus alone.
Slovenian: Primarni cilj študije je bila ocena razmerja tveganj za preživetje brez napredovanja bolezni pri zdravljenju s kombinacijo everolimusa in eksemestana v primerjavi z zdravljenjem s samo everolimusom.
English: Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with Afinitor (see section 4.8).
Slovenian: Pri bolnikih, ki so jemali zdravilo Afinitor, so opažali primere ledvične odpovedi (vključno z akutno ledvično odpovedjo), v nekaterih primerih s smrtnim izidom (glejte poglavje 4.8).
English: Clinical benefit rate c
Slovenian: n/a d e delež bolnic s klinično koristjo c
English: Hazard Ratio = 0.45 95% CI [0.38, 0.54]
Slovenian: razmerje tveganj = 0,45 95 % IZ [0,38, 0,54]
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.
Slovenian: Podolgovate tablete, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “LCL” na eni strani in “NVR” na drugi.
English: Afinitor 5 mg tablets
Slovenian: Afinitor 5 mg tablete
English: Afinitor 10 mg tablets everolimus
Slovenian: Afinitor 10 mg tablete everolimus
English: • Low level of calcium in the blood (hypocalcaemia)
Slovenian: • znižana raven kalcija v krvi (hipokalciemija)
English: Afinitor 2.5 mg tablets EU/1/09/538/009 EU/1/09/538/010
Slovenian: Afinitor 2,5 mg tablete EU/1/09/538/009 EU/1/09/538/010
English: Tell your doctor if you experience these symptoms.
Slovenian: Zdravniku povejte, če dojite.
English: Afinitor 2.5 mg tablets Packs containing 30 or 90 tablets.
Slovenian: Afinitor 2,5 mg tablete Pakiranja vsebujejo 30 ali 90 tablet.
English: Afinitor 2.5 mg tablets everolimus
Slovenian: Afinitor 2,5 mg tablete everolimus