FrancophonIA/ELRC3.0 huggingface dataset:
English: Includes (very common) stomatitis, (common) aphthous stomatitis, mouth and tongue ulceration and (uncommon) glossodynia, glossitis e
Croatian: Uključuje (vrlo često) stomatitis, (često) aftozni stomatitis, ulceraciju usne šupljine i jezika i (manje često) glosodiniju i glositis e
English: • Inflammation of the inner lining of the mouth, stomach, gut
Croatian: • Upala unutarnje sluznice usta, želuca, crijeva
English: if you have high cholesterol.
Croatian: ako se trebate cijepiti tijekom liječenja Afinitorom. ako imate visoki kolesterol.
English: The study did not meet the primary efficacy endpoint (progression-free-survival [PFS]) and the overall survival (OS) interim analysis numerically favoured the placebo plus depot octreotide arm.
Croatian: U ispitivanju nije postignuta mjera primarnog ishoda za djelotvornost (preživljenje bez progresije bolesti [engl. progression-free-survival - PFS]), a interim analiza ukupnog preživljenja brojčano je govorila u prilog skupine koja je primala placebo i depo preparat oktreotida.
English: The median duration of open-label treatment was 47.7 weeks among all patients; 67.1 weeks in the 53 patients randomised to everolimus who switched to open-label everolimus and 44.1 weeks in the 172 patients randomised to placebo who switched to open-label everolimus.
Croatian: Medijan trajanja otvorenog dijela liječenja bio je 47,7 tjedana za sve bolesnike; 67,1 tjedan u 53 bolesnika randomiziranih na everolimus koji su prešli na everolimus u otvorenom dijelu ispitivanja i 44,1 tjedan u 172 bolesnika randomiziranih na placebo koji su prešli na everolimus u otvorenom dijelu ispitivanja.
English: For all analysed subgroups (age, sensitivity to prior hormonal therapy, number of organs involved, status of bone-only lesions at baseline and presence of visceral metastasis, and across major demographic and prognostic subgroups) a positive treatment effect was seen with everolimus + exemestane with an estimated hazard ratio (HR) versus placebo + exemestane ranging from 0.25 to 0.60.
Croatian: U svim analiziranim podskupinama (dob, osjetljivost na ranije hormonsko liječenje, broj zahvaćenih organa, status samo koštanih lezija na početku liječenja i prisutnost visceralnih metastaza te u svim velikim demografskim i prognostičkim podskupinama) uočen je pozitivan učinak liječenja kombinacijom everolimusa i eksemestana s procijenjenim omjerom hazarda (engl. hazard ratio, HR) u usporedbi s kombinacijom placeba i eksemestana u rasponu od 0,25 do 0,60.
English: Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported (see section 4.8).
Croatian: Prijavljeno je sniženje vrijednosti hemoglobina, broja limfocita, neutrofila i trombocita (vidjeti dio 4.8).
English: Grade 3 & 4 (<50x10
Croatian: Stupanj 3 i 4 (<50x10
English: Talk to your doctor if you wish to father a child.
Croatian: Razgovarajte s Vašim liječnikom ako želite začeti dijete.
English: Figure 5 RADIANT-4 - Progression free survival results by pre-specified patient subgroup (independent radiological review)
Croatian: Slika 5 RADIANT-4 - Rezultati za preživljenje bez progresije bolesti prema unaprijed određenim podskupinama bolesnika (neovisna radiološka procjena)
English: Placebo + BSC
Croatian: Placebo + NPL
English: The median duration of blinded treatment was 40.4 weeks for patients receiving Afinitor and 19.6 weeks for those receiving placebo.
Croatian: Medijan trajanja slijepog dijela ispitivanja iznosio je 40,4 tjedana za bolesnike koji su primali Afinitor i 19,6 tjedana za one koji su primali placebo.
English: Afinitor is used to treat adult patients with: hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other treatments (so called “non-steroidal aromatase inhibitors”) no longer keep the disease under control.
Croatian: Afinitor se koristi za liječenje odraslih bolesnika koji imaju: uznapredovali rak dojke pozitivan na hormonske receptore u žena u postmenopauzi u kojih se drugim liječenjem (takozvanim “nesteroidnim inhibitorima aromataze”) bolest više ne može kontrolirati.
English: • Reddening of the skin (erythema)
Croatian: • Crvenilo kože (eritem)
English: 95% CI [0.27, 0.45] Log-rank p value = <0.001 Kaplan-Meier medians Afinitor : 11.04 months Placebo : 4.60 months
Croatian: Omjer hazarda = 0,35 95% CI [0,27, 0,45] Log-rank p vrijednost = <0,001 Kaplan-Meierovi medijani Afinitor : 11,04 mjeseci Placebo : 4,60 mjeseci Vrijeme cenzuriranja Afinitor (n=207) Placebo (n=203)
English: You should not breast-feed during treatment and for 2 weeks after the last dose of Afinitor.
Croatian: Tijekom liječenja i još 2 tjedna nakon posljednje doze Afinitora ne smijete dojiti.
English: Demographics and disease characteristics were generally balanced (median age 63 years [range 22 to 86], 76% Caucasian, history of prior somatostatin analogue [SSA] use).
Croatian: Demografski podaci i karakteristike bolesti bili su općenito uravnoteženi (medijan dobi od 63 godine [raspon 22 do 86], 76% bijelci, prijašnja upotreba analoga somatostatina [SSA].
English: Grade 3 Temporary dose interruption.
Croatian: Stupanj 3 Privremeni prekid primjene.
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.
Croatian: uzeti u obzir period ispiranja organizma od najmanje 2 do 3 dana (prosječno vrijeme eliminacije za najčešće korištene umjerene inhibitore) prije povratka doze Afinitora na dozu primjenjivanu prije početka istodobne primjene.
English: If patients require co-administration of a moderate CYP3A4 or PgP inhibitor, dose reduction to 5 mg daily or 2.5 mg daily may be considered.
Croatian: Ako je u bolesnika potrebno istodobno primijeniti umjereni inhibitor CYP3A4 ili PgP, može se razmotriti sniženje doze na 5 mg dnevno ili 2,5 mg dnevno.
English: If patients require co-administration of a potent CYP3A4 inducer, an Afinitor dose increase from 10 mg daily up to 20 mg daily should be considered using 5 mg increments or less applied on Day 4 and 8 following start of the inducer.
Croatian: Ako je u bolesnika potrebna istodobna primjena potentnog CYP3A4 induktora, mora se razmotriti povećanje doze Afinitora s 10 mg dnevno do najviše 20 mg dnevno s povišenjima od po 5 mg ili manje primijenjenima na 4. i 8. dan nakon početka primjene induktora.
English: • Fever, sore throat, mouth ulcers due to infections (signs of low level of white blood cells,
Croatian: • Vrućica, grlobolja, ranice u ustima zbog infekcija (znakovi niske razine bijelih krvnih stanica;
English: Afinitor is only recommended for use in patients with severe hepatic impairment (Child-Pugh C) if the potential benefit outweighs the risk (see sections 4.2 and 5.2).
Croatian: Primjena Afinitora se preporučuje u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C), samo ako je moguća dobit veća od rizika (vidjeti dijelove 4.2 i 5.2).
English: Elevations of serum creatinine, usually mild, and proteinuria have been reported (see section 4.8).
Croatian: Prijavljen je porast kreatinina u serumu, obično umjeren te proteinurija (vidjeti dio 4.8).
English: Common Proteinuria*, blood creatinine increased, renal failure* Uncommon Increased daytime urination, acute renal failure* Reproductive system and breast disorders Common Menstruation irregular e
Croatian: Proteinurija*, povišenje kreatinina u krvi, zatajenje bubrega* Manje često Učestalo dnevno mokrenje, akutno zatajenje bubrega* Poremećaji reproduktivnog sustava i dojki Često
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).
Croatian: Bolesnici su bili stratificirani prema prognostičkoj ljestvici Centra za liječenje karcinoma Memorial Sloan-Kettering (MSKCC skupina s povoljnim, srednjim i niskim rizikom) i prethodnom citostatskom liječenju (na skupinu s prethodnom primjenom jednog ili dva VEGFR-TK inhibitora).
English: However, the corresponding oestradiol levels at steady state (4 weeks) were not different between the two treatment arms.
Croatian: Međutim, među dvjema skupinama bolesnica nije bilo razlika u usporedivim razinama estradiola u stanju dinamičke ravnoteže (4 tjedna).
English: Food, however, had no apparent effect on the post absorption phase concentration-time profile.
Croatian: No nakon apsorpcije lijeka hrana nije imala nikakvoga vidljivoga učinka na profil koncentracije lijeka u plazmi.
English: Treatment with Afinitor should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Croatian: Liječenje Afinitorom mora započeti i nadgledati liječnik s iskustvom u primjeni antineoplastičnih lijekova.
English: Grade 2 Consider interruption of therapy until symptoms improve to Grade 1.
Croatian: Stupanj 2 Razmotriti prekid liječenja dok se simptomi ne poboljšaju do stupnja 1.
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of PJP/PCP, some with fatal outcome (see section 4.4).
Croatian: U kliničkim ispitivanjima i spontanim prijavama nakon stavljanja lijeka u promet, everolimus je bio povezan sa slučajevima PJP/PCP, od kojih su neki imali smrtni ishod (vidjeti dio 4.4).
English: (9.8 to 15.9)
Croatian: (9,8 do 15,9)
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).
Croatian: Primarni ishod ispitivanja bilo je preživljenje bez progresije bolesti prema RECIST kriterijima (Response Evaluation Criteria in Solid Tumors), na temelju ocjene ispitivača (lokalna radiologija).
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).
Croatian: Istodobna primjena inhibitora angiotenzin konvertirajućeg enzima (ACE) Bolesnici koji istodobno uzimaju terapiju ACE inhibitorima (npr. ramipril) mogu imati povećan rizik od angioedema (vidjeti dio 4.4).
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of amenorrhoea (secondary amenorrhoea and other menstrual irregularities).
Croatian: U kliničkim ispitivanjima i spontanim prijavama nakon stavljanja lijeka u promet, everolimus je bio povezan sa slučajevima amenoreje (sekundarna amenoreja i druge menstrualne nepravilnosti).
English: The primary objective of the study was to estimate the HR of PFS for everolimus + exemestane versus everolimus alone.
Croatian: Primarni cilj ispitivanja bio je procijeniti HR preživljenja bez progresije bolesti (PFS-a) za everolimus i eksemestan u odnosu na sam everolimus.
English: (6.9 to 8.5)
Croatian: (6,9 do 8,5)
English: The most frequent Grade 3-4 adverse reactions (incidence ≥1/100 to <1/10) were stomatitis, anaemia, hyperglycaemia, infections, fatigue, diarrhoea, pneumonitis, asthenia, thrombocytopenia, neutropenia, dyspnoea, proteinuria, lymphopenia, haemorrhage, hypophosphataemia, rash, hypertension, pneumonia, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased and diabetes mellitus.
Croatian: Najučestalije nuspojave stupnja 3-4 (incidencija ≥1/100 do <1/10) su bile stomatitis, anemija, hiperglikemija, infekcije, umor, proljev, pneumonitis, astenija, trombocitopenija, neutropenija, dispneja, proteinurija, limfopenija, hemoragija, hipofosfatemija, osip, hipertenzija, pneumonija, povišena alanin aminotransferaza (ALT), povišena aspartat aminotransferaza (AST) i šećerna bolest.
English: Take Afinitor once a day, at about the same time every day, consistently either with or without food.
Croatian: Afinitor uzimajte jednom dnevno, svakoga dana u isto vrijeme.
English: Hepatic impairment Mild hepatic impairment (Child-Pugh A) - the recommended dose is 7.5 mg daily.
Croatian: Blago oštećenje funkcije jetre (Child-Pugh A) - preporučena doza je 7,5 mg dnevno.
English: The estimated HR for the comparison of OS in the everolimus + exemestane combination arm relative to capecitabine arm was 1.33 (90% CI: 0.99, 1.79).
Croatian: Procijenjeni HR usporedbe ukupnog preživljenja skupine koja je primala kombinaciju everolimusa i eksemestana u odnosu na skupinu koja je primala kapecitabin bio je 1,33 (90% CI: 0,99, 1,79).
English: The median duration of blinded study treatment was 141 days (range 19-451 days) for patients receiving everolimus and 60 days (range 21-295 days) for those receiving placebo.
Croatian: Medijan trajanja slijepog dijela ispitivanja iznosio je 141 dan (raspon 19-451 dana) za bolesnike koji su primali Afinitor i 60 dana (raspon 21-295 dana) za one koji su primali placebo.
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.
Croatian: U ispitivanju s jednom skupinom ispitanika, provedenom nakon stavljanja lijeka u promet u postmenopauzalnih žena s uznapredovalim rakom dojke (N=92), topikalno liječenje bezalkoholnom oralnom otopinom deksametazona 0,5 mg/5 ml primijenjeno je kao otopina za ispiranje usta (4 puta dnevno tijekom prvih 8 tjedana liječenja) bolesnicama u vrijeme započinjanja liječenja Afinitorom (10 mg/dan) uz eksemestan (25 mg/dan), radi smanjenja incidencije i težine stomatitisa.
English: • Upset stomach including feeling sick (nausea) or diarrhoea
Croatian: • Nadražen želudac uključujući mučninu ili proljev
English: Time (months)
Croatian: Vrijeme(mjeseci)
English: Decreased exposure expected.
Croatian: Očekuje se smanjena izloženost.
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).
Croatian: Istodobna primjena inhibitora angiotenzin konvertirajućeg enzima (ACE) Bolesnici koji istodobno uzimaju terapiju ACE inhibitorima (npr. ramipril) mogu imati povećan rizik od angioedema (npr. oticanje dišnih puteva ili jezika, sa ili bez respiratornog oštećenja) (vidjeti dio 4.5).
English: AUC ↑ 3.7-fold Cmax ↑ 2.2-fold
Croatian: AUC ↑ 3,7-puta Cmax ↑ 2,2-puta
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome.
Croatian: U kliničkim ispitivanjima i spontanim prijavama nakon stavljanja lijeka u promet, everolimus je bio povezan s ozbiljnim slučajevima reaktivacije hepatitisa B, uključujući smrtni ishod.
English: Following documented radiological progression, patients could be unblinded by the investigator.
Croatian: Nakon zabilježene radiološke progresije, ispitivač je mogao otkriti terapiju koju su primali bolesnici.
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo česte (mogu se javiti kod više od 1 na 10 osoba)
English: • Breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
Croatian: • Nedostatak zraka, otežano disanje u ležećem položaju, oticanje stopala ili nogu (znakovi zatajenja srca)
English: Common Dry skin, nail disorders, mild alopecia, acne, erythema, onychoclasis, palmar-plantar erythrodysaesthesia syndrome, skin exfoliation, skin lesion
Croatian: Suha koža, poremećaj noktiju, blaga alopecija, akne, eritem, onihoklaza, sindrom palmarno-plantarne eritrodizestezije, ljuštenje kože, kožne lezije
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).
Croatian: U kliničkim ispitivanjima i spontanim prijavama nakon stavljanja lijeka u promet prijavljen je angioedem uz istodobnu primjenu ili bez istodobne primjene s ACE inhibitorima (vidjeti dio 4.4).
English: Dose adjustment due to adverse reactions
Croatian: Prilagodba doze zbog nuspojava
English: • Headache, dizziness (sign of high blood pressure, also known as hypertension)
Croatian: • Glavobolja, omaglica (znakovi visokog krvnog tlaka, također poznatog kao hipertenzija)
English: Number of Patients still at Risk
Croatian: Broj bolesnika koji su još pod rizikom
English: If co-administration of a moderate CYP3A4 and/or PgP inhibitor or inducer cannot be avoided, dose adjustments of Afinitor can be taken into consideration based on predicted AUC (see section 4.5).
Croatian: Ako se ne može izbjeći istodobna primjena umjerenog inhibitora ili induktora CYP3A4 i/ili PgP, potrebno je razmotriti prilagodbu doze Afinitora prema predviđenom AUC-u (vidjeti dio 4.5).
English: Log-rank p value: <0.0001
Croatian: Log-rank p vrijednost: <0,0001
English: Afinitor dose adjustment
Croatian: Prilagođavanje doze Afinitora
English: The use of live vaccines should be avoided during treatment with Afinitor (see section 4.4).
Croatian: Primjenu živih cjepiva potrebno je izbjegavati tijekom liječenja Afinitorom (vidjeti dio 4.4).
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.
Croatian: Afinitor je indiciran za liječenje bolesnika s uznapredovalim karcinomom bubrežnih stanica u kojih je bolest napredovala tijekom ili nakon liječenja lijekovima koji ciljano djeluju protiv čimbenika rasta vaskularnog endotela (VEGF-ciljana terapija).
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.
Croatian: Za ključnu mjeru sekundarnog ishoda preživljenja bez progresije bolesti procijenjeni omjer hazarda bio je 1,26 (90% CI: 0,96, 1,66) u prilog skupine koja je primala kapecitabin u odnosu na skupinu koja je primala kombinaciju everolimusa i eksemestana na temelju ukupno 148 zabilježenih PFS događaja.
English: This is because these can also be affected by Afinitor.
Croatian: Ovo je stoga što Afinitor može utjecati na sve gore navedeno.
English: A total of 309 patients were randomised in a 1:1:1 ratio to the combination of everolimus (10 mg daily) + exemestane (25 mg daily) (n=104), everolimus alone (10 mg daily) (n=103), or capecitabine (1250 mg/m dose twice daily for 2 weeks followed by one week rest, 3-week cycle) (n=102).
Croatian: Ukupno je 309 bolesnika bilo randomizirano u omjeru 1:1:1 ili u skupinu koja je primala kombinaciju everolimusa (10 mg dnevno) i eksemestana (25 mg dnevno) (n=104), ili u skupinu koja je primala samo everolimus (10 mg dnevno) (n=103) ili u skupinu koja je primala kapecitabin (doza od 1250 mg/m dvaput dnevno tijekom dva tjedna, nakon čega je uslijedio tjedan odmora, trotjedni ciklus) (n=102).
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).
Croatian: Slučajevi zatajenja bubrega (uključujući akutno zatajenje bubrega), neki sa smrtnim ishodom, bili su prijavljeni u bolesnika liječenih Afinitorom (vidjeti dio 4.8).
English: Afinitor 5 mg and Afinitor 10 mg are available in blister packs containing 10, 30 or 90 tablets.
Croatian: Afinitor 5 mg i Afinitor 10 mg dostupni su u blister pakiranjima od 10, 30 ili 90 tableta.
English: n/a d e
Croatian: n/p d e
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.
Croatian: CYP3A4 i PgP induktori snižavaju koncentraciju everolimusa Tvari koje induciraju CYP3A4 ili PgP mogu sniziti koncentraciju everolimusa u krvi povećanjem metabolizma everolimusa ili njegovog izbacivanja iz stanica crijeva.
English: CYP3A4 and PgP inhibitors increasing everolimus concentrations Substances that are inhibitors of CYP3A4 or PgP may increase everolimus blood concentrations by decreasing metabolism or the efflux of everolimus from intestinal cells.
Croatian: CYP3A4 i PgP inhibitori povisuju koncentraciju everolimusa Tvari koje inhibiraju CYP3A4 ili PgP mogu povisiti koncentraciju everolimusa u krvi smanjenjem metabolizma everolimusa ili njegovog izbacivanja iz stanica crijeva.
English: • Abnormal results of renal blood tests (increased creatinine)
Croatian: • Poremećeni rezultati testova bubrežne funkcije u krvi (povišeni kreatinin)
English: If toxicity becomes intolerable, temporary dose interruption until recovery to Grade 1.
Croatian: Ako toksičnost postane nepodnošljiva, privremeno prekinuti primjenu do oporavka do stupnja 1. Ponovno započeti liječenje u istoj dozi.
English: Non-infectious pneumonitis (including interstitial lung disease) has been frequently reported in patients taking Afinitor (see section 4.8).
Croatian: Neinfektivni pneumonitis (uključujući intersticijsku bolest pluća) učestalo se prijavljuje u bolesnika koji uzimaju Afinitor (vidjeti dio 4.8).
English: • Rash and pain on the palms of your hands or soles of your feet (hand-foot syndrome)
Croatian: • Osip i bol u dlanovima ili tabanima (sindrom šaka-stopalo)
English: Everolimus + BSC
Croatian: Everolimus+NPL
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).
Croatian: Uznapredovali neuroendokrini tumori s primarnim sijelom u gušterači (pNET) RADIANT-3 (ispitivanje CRAD001C2324), multicentrično, randomizirano, dvostruko slijepo ispitivanje faze III, u kojem je uspoređivana kombinacija Afinitora i najboljeg potpornog liječenja s kombinacijom placeba i najboljeg potpornog liječenja u bolesnika s uznapredovalim pNET-om, pokazalo je statistički značajnu kliničku dobit za Afinitor u odnosu na placebo, s 2,4-puta duljim medijanom preživljenja bez progresije bolesti (11,04 mjeseca naspram 4,6 mjeseci), (omjer hazarda 0,35; 95% CI: 0,27; 0,45; p<0,0001) (vidjeti Tablicu 5 i Sliku 3).
English: Psychiatric disorders Common Insomnia Nervous system disorders Very common Dysgeusia, headache Uncommon Ageusia Eye disorders
Croatian: Poremećaji živčanog sustava Vrlo često Disgeuzija, glavobolja Manje često Ageuzija
English: • Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of serious allergic reaction, also known as hypersensitivity)
Croatian: • Osip, svrbež, koprivnjača, otežano disanje ili gutanje, omaglica (znakovi ozbiljne alergijske reakcije, također poznate kao preosjetljivost)
English: Consider re-initiating treatment at 5 mg daily.
Croatian: Razmotriti ponovno uvođenje liječenja u dozi od 5 mg dnevno.
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).
Croatian: Neuroendokrini tumori s primarnim sijelom u probavnom sustavu ili plućima Afinitor je indiciran za liječenje neresektabilnih ili metastatskih, dobro diferenciranih (gradus 1 ili gradus 2) nefunkcionalnih neuroendokrinih tumora s primarnim sijelom u probavnom sustavu ili plućima, u odraslih bolesnika s progresivnom bolešću (vidjeti dijelove 4.4 i 5.1).
English: Hazard ratio p value
Croatian: Omjer hazarda p vrijednost