FrancophonIA/ELRC3.0 huggingface dataset:
English: - Itraconazole (for fungal infections).
Croatian: - Itrakonazol (za liječenje gljivičnih infekcija).
English: NC Not calculated for overall survival HR as the number of events is too few.
Croatian: Nije izračunato za omjer hazarda za ukupno preživljenje jer je premali broj događaja.
English: • Bleeding (such as nose bleed or blood in your urine).
Croatian: • krvarenje (poput krvarenja iz nosa ili krvi u mokraći)
English: Figures 1 and 2 - Efficacy outcomes in subgroups of non-Asian patients in the INTEREST study (N patients = Number of patients randomised)
Croatian: Slike 1 i 2 - Ishodi djelotvornosti u podskupinama bolesnika koji nisu Azijati u INTEREST ispitivanju (N bolesnika = broj randomiziranih bolesnika)
English: Talk to your doctor or pharmacist before taking Gefitinib Mylan - if you have ever had any other lung problems.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Gefitinib Mylan - ako ste ikad imali drugih tegoba s plućima.
English: FACT-L Functional assessment of cancer therapy-lung.
Croatian: FACT-L Funkcionalna procjena terapijeraka pluća (engl. functional assessment of cancer therapy-lung).
English: When gefitinib was administered to rats during organogenesis, there were no effects on embryofoetal development at the highest dose (30 mg/kg/day).
Croatian: Kad je gefitinib primijenjen štakorima tijekom organogeneze, nije bilo učinaka na razvoj embrija i fetusa pri najvišim dozama (30 mg/kg/dan).
English: N Objective response rates and 95% CI for difference between treatmentsa
Croatian: N Stope objektivnog odgovora i 95% CI za razliku između liječenjaa
English: Children and adolescents Gefitinib Mylan is not indicated in children and adolescents under 18 years.
Croatian: Djeca i adolescenti Gefitinib Mylan nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: • Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever.
Croatian: • ozbiljni nedostatak zraka ili nedostatak zraka koji se iznenada pogoršava, uz moguć kašalj ili vrućicu.
English: Do not take a double dose (two tablets at the same time) to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu (dvije tablete u isto vrijeme) kako biste nadoknadili propuštenu dozu.
English: • If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember.
Croatian: • Ako je do sljedeće doze ostalo 12 sati ili više: uzmite propuštenu tabletu čim se sjetite.
English: Bullous conditions including Toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme.
Croatian: Bulozna stanja uključujući toksičnu epidermalnu nekrolizu, Stevens-Johnsonov sindrom i eritema multiforme
English: EGFR activating mutation within a cancer cell is an important factor in promotion of tumour cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis.
Croatian: Aktivirajuća mutacija EGFRa unutar stanice raka je važan čimbenik u promociji rasta tumorske stanice, blokiranju apoptoze, povećanju stvaranja angiogenih faktora i omogućavanju procesa metastaziranja.
English: Pre-treated patients
Croatian: Prethodno liječeni bolesnici
English: An increased risk of ILD on gefitinib relative to chemotherapy was seen predominantly during the first 4 weeks of treatment (adjusted OR 3.8; 95% CI 1.9 to 7.7); thereafter the relative risk was lower (adjusted OR 2.5; 95% CI 1.1 to 5.8).
Croatian: Povećani rizik za ILD uz primjenu gefitiniba u odnosu na kemoterapiju uočen je uglavnom tijekom prva 4 tjedna liječenja (prilagođeni omjer izgleda (engl. odds ratio, OR) 3,8; 95% CI 1,9 do 7,7); nakon toga je relativni rizik bio manji (prilagođeni OR 2,5; 95% CI 1,1 do 5,8).
English: Following oral administration of C-14 labelled gefitinib to lactating rats 14 days post-partum, concentrations of radioactivity in milk were 11-19 fold higher than in blood.
Croatian: Nakon peroralne primjene C14 obilježenog gefitiniba u ženki štakora u laktaciji 14 dana po okotu, koncentracije radioaktivnosti u mlijeku bile su 11 - 19 puta više nego u krvi.
English: Patients should be advised to seek medical advice immediately if they experience severe or persistent diarrhoea, nausea, vomiting or anorexia as these may indirectly lead to dehydration.
Croatian: Bolesnicima treba savjetovati da odmah potraže liječničku pomoć ako iskuse teški ili perzistirajući proljev, mučninu, povraćanje ili anoreksiju jer to može neizravno dovesti do dehidracije.
English: The safety profile presented in Table 1 is based on the gefitinib clinical development programme and post-marketed experience.
Croatian: Sigurnosni profil prikazan u Tablici 1 temelji se na programu kliničkog razvoja gefitiniba i iskustvu iz razdoblja nakon stavljanja lijeka u promet.
English: Histology
Croatian: Histologija
English: • Increase of creatinine levels in a blood test (related to kidney function).
Croatian: • porast razine kreatinina u nalazima krvnih pretraga (ukazuje na funkciju bubrega)
English: A further case of CNS haemorrhage has been reported in a child with an ependymoma from a trial with gefitinib alone.
Croatian: Još jedan slučaj krvarenja u SŽSu prijavljen je u djeteta s ependimomom u ispitivanju u kojem se primjenjivao samo gefitinib.
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with gefitinib should be interrupted, and if symptoms do not resolve, or if symptoms recur on reintroduction of gefitinib, permanent discontinuation should be considered.
Croatian: Ako je potvrđena dijagnoza ulceroznog keratitisa, liječenje gefitinibom treba prekinuti, a ako se simptomi ne povuku, ili se vrate nakon ponovnog uvođenja gefitiniba, treba razmotriti trajni prestanak uzimanja gefitiniba.
English: • Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking this medicine.
Croatian: • porast vrijednosti jetrenog enzima koji se zove alanin aminotransferaza u nalazima krvnih pretraga; ako su vrijednosti previsoke, liječnik Vam može reći da prestanete uzimati ovaj lijek.
English: Data from non-clinical (in vitro) studies indicate that gefitinib has the potential to inhibit the cardiac action potential repolarization process (e.g. QT interval).
Croatian: Podaci iz nekliničkih (in vitro) ispitivanja ukazuju da gefitinib ima potencijal za inhibiciju procesa repolarizacije srčanog akcijskog potencijala (npr. QT-intervala).
English: Overall survivala,b
Croatian: Ukupno preživljenjea,b
English: LCS symptom improvement ratea
Croatian: Stopa poboljšanja simptoma prema LCSa
English: • The recommended dose is one 250 mg tablet per day.
Croatian: • Preporučena doza je jedna tableta od 250 mg na dan.
English: • Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
Croatian: • alergijska reakcija (često), osobito ako simptomi uključuju oticanje lica, usana, jezika ili grla, otežano gutanje, koprivnjaču i otežano disanje.
English: HR NC NR vs 4.3 m
Croatian: HR NI ND vs 4,3 m
English: LSC Lung cancer subscale.
Croatian: Podljestvica za rak pluća (engl. lung cancer subscale).
English: 4.4 times higher in adenocarcinoma than in non-adenocarcinoma
Croatian: <0,0001 4,4 puta veći kod adenokarcinoma u odnosu na neadenokarcinome
English: Gefitinib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown.
Croatian: Gefitinib in vitro inhibira transportni protein BCRP (engl. breast cancer resistance protein), no klinički značaj tog nalaza nije poznat.
English: In the overall population, no statistically significant difference between gefitinib and docetaxel (75 mg/m2) was observed for overall survival, progression free survival and objective response rates (see Table 5).
Croatian: U ukupnoj populaciji nije zabilježena statistički značajna razlika između gefitiniba i docetaksela (75 mg/m²) u ukupnom preživljenju, preživljenju bez progresije bolesti i stopi objektivnog odgovora (vidjeti Tablicu 5).
English: If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking Gefitinib Mylan.
Croatian: Ako se nešto od navedenog odnosi na Vas, ili niste sigurni, porazgovarajte s liječnikom ili ljekarnikom prije nego uzmete lijek Gefitinib Mylan.
English: In most cases this is associated with other known risk factors, including concomitant medicinal products such as steroids or NSAIDS, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.
Croatian: Većinom je to udruženo s drugim poznatim čimbenicima rizika, uključujući istodobnu primjenu drugih lijekova kao što su steroidi ili NSAIL, postojeću anamnezu gastrointestinalnih ulceracija, dob, pušenje ili metastaze u crijevima na mjestima perforacije.
English: Most NSCLC tumours with sensitising EGFR kinase mutations eventually develop resistance to gefitinib treatment, with a median time to disease progression of 1 year.
Croatian: Većina NSCLC-a sa senzibilizirajućim mutacijama EGFR kinaze naposljetku razvije rezistenciju na liječenje gefitinibom, s medijanom vremena do progresije bolesti od 1 godine.
English: Gefitinib binds to serum albumin and alpha 1-acid glycoprotein.
Croatian: Gefitinib se veže na serumski albumin i alfa 1 kiseli glikoprotein.
English: Only limited data are available in patients with creatinine clearance ≤ 20 ml/min and caution is advised in these patients (see section 5.2).
Croatian: Dostupni su samo ograničeni podaci u bolesnika s klirensom kreatinina ≤ 20 ml/min te se u tih bolesnika savjetuje oprez (vidjeti dio 5.2).
English: • Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin.
Croatian: • kožne reakcije kao što je osip u obliku akni, koji ponekad svrbi, a koža je suha i/ili napukla
English: Women of childbearing potential Women of childbearing potential must be advised not to get pregnant during therapy.
Croatian: Žene u reproduktivnoj dobi Ženama u reproduktivnoj dobi mora se savjetovati da tijekom liječenja ne smiju zatrudnijeti.
English: Primary endpoint Progression free survival (PFS) a,b
Croatian: Primarna mjera ishoda Preživljenje bez progresije bolesti (PFS)a,b
English: Do not use this medicine after the expiry date which is stated on the blister and carton or pouch after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji ili vrećici iza oznake „EXP“.
English: • Inflammation of the blood vessels in the skin.
Croatian: • upala krvnih žila u koži.
English: Other medicines and Gefitinib Mylan
Croatian: Drugi lijekovi i Gefitinib Mylan
English: • Red or sore mouth.
Croatian: • crvena ili bolna usta
English: • Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking Gefitinib Mylan.
Croatian: • porast vrijednosti bilirubina i drugog jetrenog enzima koji se zove aspartat aminotransferaza u nalazima krvnih pretraga; ako su vrijednosti previsoke, liječnik Vam može reći da prestanete uzimati Gefitinib Mylan
English: Quality of life.
Croatian: Kvaliteta života (engl. quality of life).
English: What Gefitinib Mylan is and what it is used for 2.
Croatian: Što je Gefitinib Mylan i za što se koristi
English: - Herbal remedies containing St John's wort (Hypericum perforatum, used for depression and anxiety).
Croatian: - Biljne lijekove koji sadrže gospinu travu (Hypericum perforatum, koja se koristi za liječenje depresije i tjeskobe).
English: What Gefitinib Mylan contains - The active substance is gefitinib.
Croatian: Što Gefitinib Mylan sadrži - Djelatna tvar je gefitinib.
English: Gefitinib Mylan is used to treat adults with non-small cell lung cancer.
Croatian: Gefitinib Mylan koristi se za liječenje odraslih bolesnika s rakom pluća ne-malih stanica.
English: From analyses of population pharmacokinetic data in cancer patients, no relationships were identified between predicted steady-state trough concentration and patient age, body weight, gender, ethnicity or creatinine clearance (above 20 ml/min).
Croatian: Iz analiza podataka o populacijskoj farmakokinetici u bolesnika s rakom nije utvrđena povezanost između predviđene najniže koncentracije u stanju dinamičke ravnoteže i bolesnikove dobi, tjelesne težine, spola, etničke pripadnosti te klirensa kreatinina (iznad 20 ml/min).
English: When considering the use of Gefitinib Mylan as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients.
Croatian: Kada se razmatra primjena lijeka Gefitinib Mylan za liječenje lokalno uznapredovalog ili metastatskog NSCLC-a, važno je pokušati procijeniti status mutacije EGFR-a u tumorskom tkivu kod svih bolesnika.
English: EGFR mutation-unknown
Croatian: Mutacija EGFR nepoznata
English: Treatment with Gefitinib Mylan should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Croatian: Liječenje lijekom Gefitinib Mylan mora započeti i nadgledati liječnik s iskustvom u primjeni antineoplastičnih lijekova.
English: In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients), the most frequently reported adverse drug reactions (ADRs), occurring in more than 20% of the patients, are diarrhoea and skin reactions (including rash, acne, dry skin and pruritus).
Croatian: U zbirnim podacima iz kliničkih ispitivanja faze III ISEL, INTEREST i IPASS (2462 bolesnika liječena gefitinibom), najčešće prijavljene nuspojave, koje se javljaju u više od 20% bolesnika, su proljev i kožne reakcije (uključujući osip, akne, suhu kožu i svrbež).
English: 28/70 (40%) of never smokers are M+.
Croatian: 28/70 (40%) osoba koje nikada nisu pušile su M+ 47/716 (7%) osoba koje su ikada pušile su M+
English: • Weakness.
Croatian: • slabost
English: Gefitinib has a mean steady-state volume of distribution of 1400 L indicating extensive distribution into tissue.
Croatian: Gefitinib ima srednji volumen raspodjele u stanju dinamičke ravnoteže od 1400 l, što ukazuje na opsežnu raspodjelu u tkivu.
English: - Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
Croatian: - Inhibitore protonske pumpe, antagoniste H2-receptora i antacide (za liječenje čira, probavnih tegoba, žgaravice i smanjenje kiseline u želucu).
English: • Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes.
Croatian: • problemi s očima (manje često), kao što su bol, crvenilo, suzenje očiju, osjetljivost na svjetlost, promjene vida ili urastanje trepavica.
English: If patients experience worsening of respiratory symptoms such as dyspnoea, cough and fever, Gefitinib Mylan should be interrupted and the patient should be promptly investigated.
Croatian: Ako se u bolesnika pogoršaju respiratorni simptomi kao što su dispneja, kašalj i vrućica, liječenje lijekom Gefitinib Mylan treba prekinuti i bolesnika se mora odmah pregledati.
English: Brown, round, biconvex film-coated tablets with approximately 11.1 mm x 5.6 mm of dimension and marked with “250” on one side and plain on the other.
Croatian: Smeđe, okrugle, bikonveksne filmom obložene tablete približnih dimenzija 11,1 mm × 5,6 mm s oznakom „250” na jednoj i bez oznaka na drugoj strani.
English: Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy (see section 4.3).
Croatian: Gefitinib je kontraindiciran tijekom dojenja, stoga se dojenje mora prekinuti tijekom liječenja gefitinibom (vidjeti dio 4.3).
English: Approximately 8% of patients had a severe ADR (common toxicity criteria, (CTC) grade 3 or 4).
Croatian: Približno 8% bolesnika imalo je teške nuspojave (stupnja 3 ili 4 prema općim kriterijima toksičnosti (engl. common toxicity criteria, CTC)).
English: If you forget to take Gefitinib Mylan
Croatian: Ako ste zaboravili uzeti Gefitinib Mylan
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER S JEDINIČNIM DOZAMA
English: If ILD is confirmed, Gefitinib Mylan should be discontinued and the patient treated appropriately.
Croatian: Ako se potvrdi ILD, treba prekinuti liječenje lijekom Gefitinib Mylan i bolesnika liječiti na odgovarajući način.
English: Very common Skin reactions, mainly a mild or moderate (CTC grade 1 or 2) pustular rash, sometimes itchy with dry skin, including skin fissures, on an erythematous base.
Croatian: Kožne reakcije, uglavnom blage ili umjerene (CTC stupanj 1 ili 2) pustulozni osip na eritematoznoj podlozi, ponekad uz svrbež i suhu kožu, uključujući i fisure kože
English: Gefitinib and metabolites of gefitinib accumulated in milk of lactating rats (see section 5.3).
Croatian: Gefitinib i njegovi metaboliti izlučuju se u mlijeko ženki štakora u laktaciji (vidjeti dio 5.3).
English: What Gefitinib Mylan looks like and contents of the pack Gefitinib Mylan tablets are brown, round, biconvex film-coated tablets with approximately 11.1 mm x 5.6 mm of dimension and marked with “250” on one side and plain on the other.
Croatian: Kako Gefitinib Mylan izgleda i sadržaj pakiranja Gefitinib Mylan tablete su smeđe, okrugle, bikonveksne filmom obložene tablete približnih dimenzija 11,1 mm x 5,6 mm s oznakom „250” na jednoj i bez oznaka na drugoj strani.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1321/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1321/001
English: Table 7 - Summary of multivariate logistic regression analysis to identify factors that independently predicted for the presence of EGFR mutations in 786 Caucasian patients* Factors that predicted for presence of EGFR mutation p-value
Croatian: Tablica 7 - Sažetak multivarijatne logističke regresijske analize za utvrđivanje čimbenika koji su neovisno pretkazali prisutnost mutacije EGFR u 786 bolesnika bijele rase* Čimbenici koji su pretkazali prisutnost mutacije EGFR
English: Mechanism of action and pharmacodynamic effects The epidermal growth factor (EGF) and its receptor (EGFR [HER1; ErbB1]) have been identified as key drivers in the process of cell growth and proliferation for normal and cancer cells.
Croatian: Utvrđeno je da su epidermalni faktor rasta (EGF) i njegov receptor (EGFR [HER1; ErbB1]) ključni čimbenici u procesu rasta i proliferacije normalnih stanica i stanica raka.
English: These medicines may affect the way this medicine works.
Croatian: Ovi lijekovi mogu utjecati na djelovanje lijeka Gefitinib Mylan.
English: • Dry, red or itchy eyes.
Croatian: • suhoća, crvenilo ili svrbež očiju
English: Gefitinib Mylan contains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor' (EGFR).
Croatian: Gefitinib Mylan sadrži djelatnu tvar gefitinib koja blokira protein zvan „receptor epidermalnog faktora rasta” (engl. epidermal growth factor receptor, EGFR).
English: Gefitinib has been evaluated in a clinical trial conducted in 41 patients with solid tumours and normal hepatic function, or moderate or severe hepatic impairment (classified according to baseline Common Toxicity Criteria grades for AST, alkaline phosphatase and bilirubin) due to liver metastases.
Croatian: Gefitinib je ispitan u kliničkom ispitivanju provedenom u 41 bolesnika sa solidnim tumorima i normalnom funkcijom jetre, ili umjerenim ili teškim oštećenjem jetrene funkcije (klasificirano prema početnim stupnjevima općeg kriterija toksičnosti (CTC) za AST, alkalnu fosfatazu i bilirubin) uslijed metastaza u jetri.
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib.
Croatian: Bolesnici s umjerenim do teškim oštećenjem jetrene funkcije (Child Pugh B ili C) uslijed ciroze imaju povišene koncentracije gefitiniba u plazmi.
English: What you need to know before you take Gefitinib Mylan
Croatian: Što morate znati prije nego počnete uzimati lijek Gefitinib Mylan
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose (101), crospovidone (type A), povidone (K30), sodium laurilsulfate, magnesium stearate in the tablet core.
Croatian: - Drugi sastojci su laktoza hidrat, mikrokristalična celuloza (101), krospovidon (vrsta A), povidon (K30), natrijev laurilsulfat, magnezijev stearat u jezgri tablete.
English: Tablet coating Polyvinyl alcohol (E1203) Macrogol 4000 (E1521) Talc (E553b) Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Croatian: Ovojnica tablete poli(vinilni alkohol) (E1203) makrogol 4000 (E1521) talk (E553b) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172)
English: • Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
Croatian: • dehidracija (često) uzrokovana dugotrajnim ili teškim proljevom, povraćanje, mučnina ili gubitak apetita.
English: If you take more Gefitinib Mylan than you should If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.
Croatian: Ako ste uzeli više tableta nego što ste trebali, odmah se obratite liječniku ili ljekarniku.
English: In a phase III open-label clinical trial (IPASS) in 1217 patients comparing gefitinib to carboplatin/paclitaxel doublet chemotherapy as first-line treatment in selected patients with advanced NSCLC in Asia, the incidence of ILD-type events was 2.6% on the gefitinib treatment arm versus 1.4% on the carboplatin/paclitaxel treatment arm.
Croatian: U otvorenom kliničkom ispitivanju faze III (IPASS) s 1217 bolesnika, u kojem se uspoređivao gefitinib s dvostrukom kemoterapijom karboplatinom/paklitakselom u prvoj liniji liječenja u odabranih bolesnika s uznapredovalim NSCLC-om u Aziji, incidencija nuspojava tipa ILD-a iznosila je 2,6% u skupini liječenoj gefitinibom u usporedbi s 1,4% u skupini koja je primala karboplatin/paklitaksel.
English: The randomised phase III first line IPASS study was conducted in patients in Asia1 with advanced (stage IIIB or IV) NSCLC of adenocarcinoma histology who were ex-light smokers (ceased smoking ≥ 15 years ago and smoked ≤ 10 pack years) or never smokers (see Table 3).
Croatian: Randomizirano kliničko ispitivanje faze III prve linije liječenja (IPASS) provedeno je u bolesnika u Aziji1 koji su imali uznapredovali NSCLC (stadij IIIB ili IV) s histološkom slikom adenokarcinoma, a koji su bili bivši laki pušači (prestali su pušiti prije 15 ili više godina, a pušili su ≤ 10 kutija godišnje) ili nikada nisu pušili (vidjeti Tablicu 3).
English: The tablet coating contains polyvinyl alcohol (E1203), macrogol 4000 (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
Croatian: Ovojnica tablete sadrži poli(vinilni alkohol) (E1203), makrogol 4000 (E1521), talk (E553b), titanijev dioksid (E171), crveni željezov oksid (E172), žuti željezov oksid (E172).
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows: - Corneal epithelia atrophy and corneal translucencies - Renal papillary necrosis - Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration.
Croatian: Nuspojave koje nisu uočene u kliničkim ispitivanjima, no koje su zapažene u životinja pri razinama izloženosti sličnim kliničkim, i s mogućim značajem za kliničku primjenu, bile su sljedeće: - Atrofija epitela rožnice i prozirnost rožnice - Bubrežna papilarna nekroza - Hepatocelularna nekroza i eozinofilna sinusoidalna infiltracija makrofagima.
English: 63/396 (16%) of patients with adenocarcinoma histology are M+.
Croatian: 63/396 (16%) osoba s histologijom adenokarcinoma su M+ 12/390 (3%) osoba s histologijom neadenokarcinoma su M+