FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Medijan trajanja slijepog dijela ispitivanja iznosio je 37,8 tjedana (raspon 1,1-129,9 tjedana) za bolesnike koji su primali everolimus i 16,1 tjedan (raspon 0,4-147,0 tjedana) za one koji su primali placebo.
English: if you have previously had hepatitis B, because this may be reactivated during treatment with Afinitor (see section 4 ‘Possible side effects').
Croatian: Možda će biti potrebno liječiti infekciju prije početka liječenja Afinitorom. ako ste ranije imali hepatitis B, jer se može reaktivirati tijekom liječenja Afinitorom (pogledajte dio 4 ‘Moguće nuspojave').
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must use a highly effective method of contraception (e.g. oral, injected, or implanted non-oestrogen-containing hormonal method of birth control, progesterone-based contraceptives, hysterectomy, tubal ligation, complete abstinence, barrier methods, intrauterine device [IUD], and/or female/male sterilisation) while receiving everolimus, and for up to 8 weeks after ending treatment.
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena Žene reproduktivne dobi moraju koristiti visoko učinkovitu kontracepciju tijekom uzimanja everolimusa i do 8 tjedana nakon završetka liječenja (npr. hormonski kontraceptivi koji ne sadrže estrogene namijenjeni za oralnu, injekcijsku ili implantacijsku primjenu, kontraceptivi koji sadrže progesteron, histerektomija, podvezivanje jajovoda, potpuna seksualna apstinencija, metode barijere, intrauterini uložak i/ili sterilizacija žene/muškarca).
English: Table 6 RADIANT-4 - Progression-free survival results
Croatian: Tablica 6 RADIANT-4 - Rezultati za preživljenje bez progresije bolesti
English: Secondary endpoints included safety, objective tumour response rate, overall survival, disease-related symptoms, and quality of life.
Croatian: Sekundarni ishodi ispitivanja uključivali su sigurnost primjene, stopu objektivnog tumorskog odgovora, ukupno preživljenje, simptome povezane s bolešću i kvalitetu života.
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.
Croatian: Najčešće nuspojave (incidencija ≥1/10) iz objedinjenih sigurnosnih podataka su (prema padajućem redoslijedu): stomatitis, osip, umor, proljev, infekcije, mučnina, smanjeni apetit, anemija, disgeuzija, pneumonitis, periferni edem, hiperglikemija, astenija, svrbež, gubitak tjelesne težine, hiperkolesterolemija, epistaksa, kašalj i glavobolja.
English: • Discharge from the eye with itching, redness and swelling
Croatian: • Iscjedak iz oka popraćen svrbežom, crvenilom i oticanjem
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.
Croatian: Nije bilo razlike između dvije skupine s obzirom na vrijeme do ≥5% pogoršanja rezultata ukupne i funkcionalne sposobnosti bolesnica prema ljestvici QLQ-C30.
English: Impaired wound healing is a class effect of rapamycin derivatives, including everolimus.
Croatian: Odgođeno cijeljenje rane je učinak povezan sa skupinom derivata rapamicina, uključujući everolimus.
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.
Croatian: Također se preporučuje praćenje kolesterola i triglicerida u krvi prije početka terapije Afinitorom i periodično nakon toga, kao i liječenje odgovarajućom terapijom.
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.
Croatian: Medijan trajanja liječenja eksemestanom bio je dulji u skupini koja je primala everolimus i eksemestan i iznosio je 29,5 tjedana (1,0-199,1) u usporedbi s 14,1 tjedan (1,0-156,0) u skupini koja je primala placebo i eksemestan.
English: Log-rank p value = <0.0001
Croatian: Log-rank p vrijednost = <0,0001
English: Rare (may affect up to 1 in 1,000 people)
Croatian: • Rijetke (mogu se javiti kod do 1 na 1000 osoba)
English: Monitoring of complete blood count is recommended prior to the start of Afinitor therapy and periodically thereafter.
Croatian: Preporučuje se kontrola kompletne krvne slike prije početka liječenja Afinitorom i periodično nakon toga.
English: • High level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides)
Croatian: • Visoka razina lipida (masnoća) u krvi (hiperlipidemija, povišeni trigliceridi)
English: Monitoring of fasting serum glucose is recommended prior to the start of Afinitor therapy and periodically thereafter.
Croatian: Praćenje glukoze u serumu natašte preporučuje se prije početka terapije Afinitorom i periodično nakon toga.
English: • Severely decreased urine output, swelling in the legs, feeling confused, pain in the back (signs of sudden kidney failure)
Croatian: • Jako smanjeno mokrenje, oticanje nogu, osjećaj smetenosti, bolovi u leđima (znakovi iznenadnog zatajenja bubrega)
English: Median progression-free survival (months) (95% CI)
Croatian: Medijan preživljenja bez progresije bolesti (mjeseci) (95% CI)
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).
Croatian: RECORD-1 (ispitivanje CRAD001C2240), je bilo internacionalno, multicentrično, randomizirano dvostruko slijepo ispitivanje faze III u kojem je uspoređivan everolimus u dozi od 10 mg/dan i placebo, oba uz najbolje potporno liječenje, i koje je provedeno u bolesnika s metastatskim karcinomom bubrežnih stanica u kojih je bolest napredovala tijekom ili nakon liječenja VEGFR-TK inhibitorom (inhibitorom tirozin kinaze receptora čimbenika rasta vaskularnog endotela; sunitinib, sorafenib, ili i sunitinib i sorafenib).
English: At the time of data cut-off, the median duration of treatment was 27.5 weeks (range 2.0-165.7) in the everolimus + exemestane arm, 20 weeks (1.3-145.0) in the everolimus arm, and 26.7 weeks (1.4-177.1) in the capecitabine arm.
Croatian: U trenutku datuma zaključavanja podataka, medijan trajanja liječenja everolimusom i eksemestanom bio je 27,5 tjedana (raspon 2,0-165,7), 20 tjedana u skupini koja je primala everolimus (1,3-145,0) i 26,7 tjedana u skupini koja je primala kapecitabin (1,4-177,1).
English: • Excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of diabetes)
Croatian: • Pojačano žeđanje, često mokrenje, povećan apetita uz gubitak tjelesne težine, umor (znakovi šećerne bolesti)
English: Moderate CYP3A4/PgP inhibitors Erythromycin
Croatian: Umjereni inhibitori CYP3A4/PgP Eritromicin
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.
Croatian: Uznapredovali rak dojke pozitivan na hormonske receptore Afinitor je indiciran u kombinaciji s eksemestanom za liječenje uznapredovalog raka dojke pozitivnog na hormonske receptore, a negativnog na HER2/neu, u žena u postmenopauzi bez simptomatske visceralne bolesti nakon recidiva ili progresije bolesti do kojih je došlo nakon uzimanja nesteroidnog inhibitora aromataze.
English: Acute respiratory distress syndrome Gastrointestinal disorders Very common Stomatitis d, diarrhoea, nausea
Croatian: Sindrom akutnog respiratornog distresa Poremećaji probavnog sustava Vrlo često Stomatitis d, proljev, mučnina
English: • Fever, coughing, difficulty breathing, wheezing (signs of inflammation of the lung, also known as pneumonitis)
Croatian: • Vrućica, kašljanje, otežano disanje, zviždanje pri disanju (znakovi upale pluća, također poznate kao pneumonitis)
English: • Feeling weak or tired
Croatian: • Osjećaj slabosti ili umora
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.
Croatian: Na temelju in vitro rezultata, sistemske koncentracije postignute nakon dnevne peroralne doze od 10 mg vjerojatno ne utječu na inhibiciju PgP-a, CYP3A4 i CYP2D6.
English: Afinitor 2.5 mg is available in blister packs containing 30 or 90 tablets.
Croatian: Afinitor 2,5 mg dostupan je u blister pakiranjima od 30 ili 90 tableta.
English: Supportive PFS analyses were based on an independent central radiology review.
Croatian: Suportivne analize preživljenja bez progresije bolesti temeljile su se na neovisnoj centralnoj radiološkoj procjeni.
English: Treatment with somatostatin analogues was allowed as part of BSC.
Croatian: Liječenje analozima somatostatina bilo je dopušteno kao dio najboljeg potpornog liječenja.
English: The other ingredients are butylhydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and lactose anhydrous.
Croatian: Drugi sastojci su butilhidroksitoluen, magnezijev stearat, laktoza hidrat, hipromeloza, krospovidon tipa
English: Log-rank p value = <0.001
Croatian: Log-rang p vrijednost = <0,001
English: In total, 416 patients were randomised 2:1 to receive Afinitor (n=277) or placebo (n=139).
Croatian: Ukupno je bilo randomizirano 416 bolesnika u odnosu 2:1 u skupinu koja je primala Afinitor (n =277) ili u skupinu koja je primala placebo (n =139).
English: Patients in the placebo + exemestane arm did not cross over to everolimus at the time of progression.
Croatian: Bolesnice u skupini koja je primala placebo i eksemestan nisu prešle na everolimus u trenutku progresije bolesti.
English: *Non-ileum: stomach, colon, rectum, appendix, caecum, duodenum, jejunum, carcinoma of unknown primary origin and other gastrointestinal origin
Croatian: *Ne-ileum: želudac, debelo crijevo, rektum, crvuljak, slijepo crijevo, dvanaesnik, jejunum, karcinom nepoznatog primarnog sijela i sijela u drugim djelovima probavnog sustava GGN: Gornja granica normale
English: Stomatitis, including mouth ulcerations and oral mucositis, is the most commonly reported adverse reaction in patients treated with Afinitor (see section 4.8).
Croatian: Stomatitis, koji uključuje ulceracije u usnoj šupljini i oralni mukozitis, najčešće je zabilježena nuspojava u bolesnika liječenih Afinitorom (vidjeti dio 4.8).
English: Everolimus + BSC (n/N = 113/205) Placebo + BSC (n/N = 65/97)
Croatian: Vrijeme cenzuriranja Everolimus + NPL (n/N = 113/205) Placebo + NPL (n/N = 65/97)
English: Butylhydroxytoluene Magnesium stearate Lactose monohydrate Hypromellose Crospovidone type A Lactose anhydrous
Croatian: 6.1 Popis pomoćnih tvari butilhidroksitoluen magnezijev stearat laktoza hidrat hipromeloza krospovidon tipa
English: Large decrease in exposure expected.
Croatian: Očekuje se jako smanjena izloženost.
English: Secondary endpoints included safety, objective response rate, response duration and overall survival (OS).
Croatian: Sekundarni ishodi ispitivanja uključivali su sigurnost primjene, stopu objektivnog odgovora, trajanje odgovora i ukupno preživljenje.
English: Grade 3 Interrupt treatment until symptoms resolve to Grade 1.
Croatian: Stupanj 3 Privremeno prekinuti liječenje dok simptomi ne dođu do stupnja 1.
English: They are engraved with “LCL” on one side and “NVR” on the other.
Croatian: Na jednoj strani utisnuta je oznaka “LCL”, a na drugoj oznaka „NVR“.
English: • Spontaneous bleeding or bruising (signs of low level of platelets, also known as thrombocytopenia)
Croatian: • Spontano krvarenje ili pojava modrica (znakovi niske razine krvnih pločica, također poznate kao trombocitopenija)
English: Hazard Ratio = 0.74 90% CI [0.57;0.97]
Croatian: Omjer hazarda = 0,74 90% CI [0,57;0,97]
English: chills, sore throat or mouth ulcers (signs of low level of blood cells, also known as pancytopenia)
Croatian: zimice, grlobolje ili ranica u ustima (znakovi niske razine krvnih stanica, također poznate kao pancitopenija)
English: Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets
Croatian: Afinitor 2,5 mg tablete Afinitor 5 mg tablete Afinitor 10 mg tablete
English: Grade 3 Temporary dose interruption until recovery to Grade 2 (≥1.25x10
Croatian: Stupanj 3 Privremeni prekid primjenu do oporavka do stupnja 2 (≥1,25x10
English: Uncommon Non-cardiac chest pain, impaired wound healing Investigations
Croatian: Manje često Ne-srčana bol u prsima, otežano cijeljenje rane Pretrage
English: Common Thrombocytopenia, neutropenia, leukopenia, lymphopenia Uncommon Pancytopenia
Croatian: Trombocitopenija, neutropenija, leukopenija, limfopenija Manje često Pancitopenija
English: No. of patients still at risk Afinitor
Croatian: Broj bolesnika koji su još pod rizikom Afinitor
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).
Croatian: Ukupno je 302 bolesnika bilo randomizirano u odnosu 2:1 u skupinu koja je primala everolimus (10 mg na dan) (n=205) ili placebo (n=97).
English: • Nail disorders, breaking of your nails
Croatian: • Poremećaji noktiju, pucanje noktiju
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.
Croatian: Sekundarni ishodi ispitivanja uključivali su ukupno preživljenje, ukupnu stopu odgovora, stopu kontrole bolesti, sigurnost primjene, promjenu u kvaliteti života (FACT-G) i vrijeme do pogoršanja funkcionalnog stanja prema SZO-u (FS SZO).
English: Uncommon Congestive cardiac failure Vascular disorders
Croatian: Manje često Konjunktivitis Srčani poremećaji
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).
Croatian: Ukupno 724 bolesnice bile su randomizirane u omjeru 2:1 ili u skupinu koja je primala kombinaciju everolimusa (10 mg dnevno) i eksemestana (25 mg dnevno) (n=485) ili u skupinu koja je primala kombinaciju placeba i eksemestana (25 mg dnevno) (n=239).
English: dysphagia
Croatian: Dispneja
English: Median progression-free survival (months) (95% CI) Investigator radiological review
Croatian: Medijan preživljenja bez progresije bolesti (mjeseci) (95% CI) Radiološka procjena od strane ispitivača
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.
Croatian: Uznapredovali neuroendokrini tumori s primarnim sijelom u probavnom sustavu ili plućima RADIANT-4 (ispitivanje CRAD001T2302), randomizirano, dvostruko slijepo, multicentrično ispitivanje faze III u kojem je uspoređivana kombinacija Afinitora i najboljeg potpornog liječenja (NPL) s kombinacijom placeba i NPL-a, provedeno je u bolesnika s uznapredovalim, dobro diferenciranim (gradus 1 ili gradus 2) nefunkcionalnim neuroendokrinim tumorima s primarnim sijelom u probavnom sustavu ili plućima bez karcinoidnog sindroma u anamnezi ili aktivnih simptoma povezanih s karcinoidnim sindromom.
English: • Heartburn (dyspepsia)
Croatian: • Žgaravica (dispepsija)
English: Posology For the different dose regimens Afinitor is available as 2.5 mg, 5 mg and 10 mg tablets.
Croatian: Doziranje Afinitor je dostupan u obliku tableta od 2,5 mg, 5 mg i 10 mg za različite režime doziranja.
English: Based on analysis of population pharmacokinetics, CL/F is on average 20% higher in black transplant patients.
Croatian: CL/F je u prosjeku 20% viši u crnaca s presatkom, na temelju analize populacijske farmakokinetike.
English: Afinitor 10 mg tablets are white to slightly yellowish, elongated tablets.
Croatian: Afinitor 10 mg tablete su bijele do žućkaste izduljene tablete.
English: Afinitor 10 mg tablets
Croatian: Afinitor 10 mg tablete
English: Figure 6 RECORD-1 - Kaplan-Meier progression-free survival curves (independent central review)
Croatian: Slika 6 RECORD-1 - Kaplan-Meierove krivulje preživljenja bez progresije bolesti (neovisna centralna procjena)
English: • Severely decreased urine output (sign of kidney failure)
Croatian: • Jako smanjeno mokrenje (znakovi zatajenja bubrega)
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.
Croatian: BOLERO-6 (CRAD001Y2201 ispitivanje), s tri skupine, randomizirano, otvoreno ispitivanje faze II everolimusa u kombinaciji s eksemestanom u odnosu na sam everolimus te u odnosu na kapecitabin u liječenju postmenopauzalnih žena s lokalno uznapredovalim, rekurentnim ili metastatskim rakom dojke pozitivnim na estrogenske receptore i negativnim na HER2/neu, nakon recidiva ili progresije bolesti do kojih je došlo nakon prethodnog uzimanja letrozola ili anastrozola.
English: • High level of lipids (fats) in the blood (hypercholesterolaemia)
Croatian: • Visoka razina lipida (masnoća) u krvi (hiperkolesterolemija)
English: Uncommon Flushing, deep vein thrombosis Respiratory, thoracic and mediastinal disorders Very common Pneumonitis c, epistaxis, cough
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često Pneumonitis c, epistaksa, kašalj
English: Vaccinations The use of live vaccines should be avoided during treatment with Afinitor (see section 4.5).
Croatian: Cijepljenja Tijekom liječenja Afinitorom mora se izbjegavati primjena živih cjepiva (vidjeti dio 4.5).
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).
Croatian: Drugi sekundarni ciljevi uključivali su procjenu ukupnog preživljenja, stopu objektivnog odgovora, stopu kliničke dobiti, sigurnosti primjene, vremena do pogoršanja općeg stanja prema ECOG-u, vremena do pogoršanja kvalitete života i zadovoljstva liječenjem.
English: Female fertility
Croatian: Muška plodnost
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with renal failure events (including fatal outcome) and proteinuria.
Croatian: U kliničkim ispitivanjima i spontanim prijavama nakon stavljanja lijeka u promet, everolimus je bio povezan s događajima zatajenja bubrega (uključujući smrtni ishod) i proteinurije.
English: Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets everolimus
Croatian: Afinitor 2,5 mg tablete Afinitor 5 mg tablete Afinitor 10 mg tablete everolimus
English: Afinitor 5 mg tablets are white to slightly yellowish, elongated tablets.
Croatian: Afinitor 5 mg tablete su bijele do žućkaste izduljene tablete.
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.
Croatian: Bijele do žućkaste, izduljene tablete ukošenoga ruba bez ureza, s utisnutom oznakom „5” na jednoj te oznakom „NVR” na drugoj strani.
English: Results of the secondary endpoint OS were not consistent with the primary endpoint PFS, with a trend observed favouring the everolimus alone arm.
Croatian: Rezultati mjere sekundarnog ishoda ukupnog preživljenja nisu bili u skladu s mjerom primarnog ishoda preživljenja bez progresije bolesti, s tim da su opaženi rezultati bili u prilog skupini koja je primala samo everolimus.
English: Afinitor 2.5 mg tablets
Croatian: Afinitor 2,5 mg tablete
English: Very common Decreased appetite, hyperglycaemia, hypercholesterolaemia Common Hypertriglyceridaemia, hypophosphataemia, diabetes mellitus, hyperlipidaemia,
Croatian: Hipertrigliceridemija, hipofosfatemija, diabetes mellitus, hiperlipidemija, hipokalijemija, dehidracija, hipokalcijemija Psihijatrijski poremećaji Često
English: Grade 3 (<1, ≥0.5x10
Croatian: Stupanj 3 (<1, ≥0,5x10 9/l)
English: Mean oral clearance (CL/F) of everolimus after 10 mg daily dose in patients with advanced solid tumours was 24.5 l/h.
Croatian: Nakon primjene dnevne doze od 10 mg, u bolesnika s uznapredovalim solidnim tumorima srednja vrijednost oralnog klirensa (CL/F) everolimusa iznosila je 24,5 l/h.
English: Grade 4 (<0.5x10
Croatian: Stupanj 4 (<0,5x10 9/l)
English: Prior chemotherapy Primary tumour origin
Croatian: Primarno sijelo tumora
English: Afinitor 5 mg tablets
Croatian: Afinitor 5 mg tablete
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.
Croatian: Uznapredovali rak dojke pozitivan na hormonske receptore BOLERO-2 (CRAD001Y2301 ispitivanje), randomizirano, dvostruko slijepo, multicentrično ispitivanje faze III Afinitora i eksemestana u odnosu na placebo i eksemestan, provedeno je u postmenopauzalnih žena s uznapredovalim rakom dojke pozitivnim na estrogenske receptore i negativnim na HER2/neu, u kojih je došlo do recidiva ili progresije bolesti nakon prethodnog liječenja letrozolom ili anastrozolom.
English: Afinitor 10 mg tablets everolimus
Croatian: Afinitor 10 mg tablete everolimus
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.
Croatian: Bijele do žućkaste, izduljene tablete ukošenoga ruba bez ureza, s utisnutom oznakom „LCL” na jednoj te oznakom „NVR” na drugoj strani.
English: Afinitor 2.5 mg tablets EU/1/09/538/009 EU/1/09/538/010
Croatian: Afinitor 2,5 mg tablete EU/1/09/538/009 EU/1/09/538/010
English: • Disturbed taste (dysgeusia)
Croatian: • Promijenjen osjet okusa (disgeuzija)
English: Afinitor 2.5 mg tablets everolimus
Croatian: Afinitor 2,5 mg tablete 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.
Croatian: Bijele do žućkaste, izduljene tablete ukošenoga ruba bez ureza, s utisnutom oznakom „UHE” na jednoj te oznakom „NVR” na drugoj strani.
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.
Croatian: U bolesnika s nefunkcionalnim neuroendokrinim tumorima probavnog sustava ili pluća i dobrim početnim prognostičkim čimbenicima, npr. ileumom kao primarnim sijelom tumora i normalnim vrijednostima kromogranina