FrancophonIA/ELRC3.0 huggingface dataset:
English: The PFS hazard ratio for patients with DEL 19 mutations and L858R mutations was 0.76 (95% CI [0.55, 1.06]; p=0.1071), and 0.71 (95% CI [0.47, 1.06]; p=0.0856) respectively for afatinib vs gefitinib.
Slovenian: Razmerje tveganja za preživetje brez napredovanja bolezni (PFS) za bolnike z mutacjo DEL 19 in mutacijo L858R je bila 0,76 (95 % IZ [0,55; 1,06]; p = 0,1071) za afatinib in 0,71 (95 % IŻ [0,47; 1,06]; p = 0,0856) za gefitinib.
English: Body System
Slovenian: Telesna masa
English: Discontinuation due to ADRs diarrhoea and rash/acne was 1.3% and 0% in LUX-Lung 3 and 3.8% and 2.0% in LUX-Lung 8, respectively.
Slovenian: Zaradi neželenih reakcij na zdravilo v obliki driske in izpuščaja oziroma aken je zdravljenje prekinilo 1,3 % oziroma 0 % bolnikov v raziskavi LUX-Lung 3 oziroma 3,8 % in 2,0 % v raziskavi LUX-Lung 8.
English: Efficacy was similarly high in the group of patients who had received prior chemotherapy (N=68; ORR 57.4%; median PFS by independent review 8 months).
Slovenian: V skupini bolnikov, ki so prej prejemali kemoterapijo, je bila učinkovitost podobna (N = 68; objektivni odziv na zdravljenje 57,4%; mediani čas preživetja brez napredovanja bolezni po podatkih neodvisnega pregleda 8 mesecev).
English: Table 11: Symptom outcomes for GIOTRIF vs. erlotinib in trial LUX-Lung 8 (EORTC QLQ-C30 & QLQ-LC13)
Slovenian: Preglednica 11: Izidi glede na simptome za zdravilo GIOTRIF v primerjavi z erlotinibom v raziskavi LUX-Lung 8 (EORTC QLQ-C30 in QLQ-LC13)
English: Very common ADRs in GIOTRIF-treated patients occurring in at least 10% of patients in trial LUX-Lung 8 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 5.
Slovenian: Zelo pogosti neželeni učinki pri bolnikih, ki so se zdravili z zdravilom GIOTRIF, in so se v raziskavi LUX-Lung 8 pojavili pri najmanj 10% bolnikov, so navedeni po stopnjah v skladu z merili NCI-CTC (National Cancer Institute-Common Toxicity Criteria) v preglednici 5.
English: Other information on drug-drug interactions
Slovenian: Drugi podatki o medsebojnem delovanju z drugimi zdravili
English: Mechanistically, all EGFR targeting medicinal products have the potential to cause foetal harm.
Slovenian: Po mehanistični plati imajo lahko vsa zdravila, ki delujejo na EGFR, škodljive učinke na plod.
English: In patients with tumours harbouring exon 20 insertions (N=23) the confirmed ORR was 8.7% and the median duration of response was 7.1 months.
Slovenian: Pri bolnikih s tumorji, ki so nosilci mutacij z vstavljanjem v ekson 20 (N = 23) je bila potrjena stopnja objektivnega odziva na zdravljenje (ORR) 8,7 %, mediana trajanja odziva pa 7,1 meseca.
English: • if you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light.
Slovenian: • če se pojavijo akutna ali slabšajoča se pordelost ali bolečina v očesu, povečano solzenje oči,
English: Therefore, food should not be consumed for at least 3 hours before and at least 1 hour after taking GIOTRIF (see sections 4.2 and 4.5).
Slovenian: Zato naj bolnik najmanj 3 ure pred jemanjem zdravila GIOTRIF in 1 uro po njem ne uživa hrane (glejte poglavji 4.2 in
English: • Inflammation of the lining of the bladder with burning sensations during urination and frequent,
Slovenian: • vnetje sluznice sečnega mehurja in pekoč občutek med odvajanjem urina ter pogosta nujna potreba po uriniranju (cistitis)
English: • Abnormal taste sensations (dysgeusia)
Slovenian: • nenormalno okušanje (disgevzija)
English: Co-administration of a high-fat meal with GIOTRIF resulted in a significant decrease of exposure to afatinib by about 50% in regard to Cmax and 39% in regard to AUC0-∞.
Slovenian: Pri sočasnem vnosu obroka z visoko vsebnostjo maščobe in zdravila GIOTRIF se je pomembno zmanjšala izpostavljenost afatinibu, in sicer za približno 50%, če upoštevamo Cmax, in 39%, če upoštevamo AUC0-∞.
English: Table 7: PFS and OS efficacy results of GIOTRIF vs pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) in the pre-defined EGFR mutation subgroups Del 19 and L858R (Independent review)
Slovenian: Preglednica 7: Podatki o učinkovitosti zdravila GIOTRIF v primerjavi s podatki o učinkovitosti pemetrekseda/cisplatina (LUX-Lung 3) in gemcitabina/cisplatina (LUX-Lung 6) za preživetje brez napredovanja bolezni in skupno preživetje v vnaprej opredeljenih podskupinah mutacij EGFRDel 19 in L858R (neodvisen pregled)
English: Renal impairment/ Renal failure
Slovenian: Bolezni sečil ledvična okvara/ ledvična odpoved
English: Contact your doctor immediately and start appropriate antidiarrhoeal treatment as soon as possible.
Slovenian: Nemudoma se posvetujte s svojim zdravnikom in čim prej začnite jemati ustrezno zdravilo proti driski, ki ga morate imeti vnaprej pripravljenega, še preden boste začeli jemati zdravilo GIOTRIF.
English: There were no Grade 3 ALT/AST elevations in patients with abnormal baseline liver tests in LUX-Lung 8 (see section 4.8).
Slovenian: Pri bolnikih z nenormalnimi izhodiščnimi izvidi jetrnih preiskav v raziskavi LUX-Lung 8 ni bilo povišanj vrednosti ALT/AST stopnje 3 (glejte poglavje 4.8).
English: The embryo-foetal development studies performed on afatinib revealed no indication of teratogenicity.
Slovenian: Raziskave o vplivu afatiniba na razvoj zarodka in ploda, niso pokazale teratogenega delovanja.
English: Very common ADRs in GIOTRIF-treated patients occurring in at least 10% of patients in trial LUX-Lung 3 and LUX-Lung 7 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Tables 3 and 4.
Slovenian: Zelo pogoste neželene reakcije na zdravilo pri bolnikih, ki so se zdravili z zdravilom GIOTRIF, in so se v raziskavah LUX-Lung 3 in LUX-Lung 7 pojavile pri najmanj 10 % bolnikov, so navedene po stopnjah v skladu z merili NCI-CTC (National Cancer Institute-Common Toxicity Criteria) v preglednicah 3 in 4.
English: Systemic exposure to afatinib is decreased by 50% (Cmax) and 39% (AUC0-∞), when administered with a high-fat meal compared to administration in the fasted state.
Slovenian: Sistemska izpostavljenost afatinibu je bila pri jemanju zdravila s hrano z visoko vsebnostjo maščob manjša za 50% (Cmax) oziroma za 39% (AUC0-∞) v primerjavi z jemanjem na tešče.
English: In the pre-defined subgroup of common mutations (combined Del 19 and L858R) for GIOTRIF and chemotherapy, the median PFS was 13.6 months vs. 6.9 months (HR 0.48; 95% CI 0.35-0.66; p<0.0001; N=307) in LUX-Lung 3, and 11.0 months vs. 5.6 months (HR 0.24; 95% CI 0.17-0.35; p<0.0001; N=324) in LUX-Lung 6, respectively.
Slovenian: Pri vnaprej opredeljeni podskupini pogostih mutacij (združeni Del 19 in L858R) za GIOTRIF in kemoterapijo je bila mediana preživetja brez napredovanja bolezni 13,6 meseca pri zdravilu GIOTRIF in 6,9 meseca pri kemoterapiji (razmerje tveganja 0,48; 95-odstotni IZ 0,35-0,66; p < 0,0001; N = 307) v raziskavi LUX-Lung 3 in 11,0 mesecev v primerjavi s 5,6 meseca (razmerje tveganja 0,24; 95-odstotni IZ 0,17-0,35; p < 0,0001; N = 324) v raziskavi LUX-Lung 6.
English: 7.7 vs. 1.7 HR 0.53; p<0.0001
Slovenian: 7,7 v primerjavi z 1,7 razmerje tveganja 0,53; p < 0,0001
English: Subjects with moderate renal impairment (n=8; eGFR 30-59 mL/min/1.73m², according to the Modification of Diet in Renal Disease [MDRD] formula) had an exposure of 101% (Cmax) and 122% (AUC0-tz) in comparison to their healthy controls.
Slovenian: Pri bolnikih z zmerno ledvično okvaro (n=8; ocenjena hitrost glomerularne filtracije (eGFR) 30-59 ml/min/1,73m² po enačbi Modification of Diet in Renal Disease [MDRD]), je znašala izpostavljenost afatinibu 101 % (Cmax) in 122 % (AUC0-tz) v primerjavi z zdravimi prostovoljci.
English: GIOTRIF in patients with Non-Small Cell Lung Cancer (NSCLC) with EGFR mutations
Slovenian: Zdravilo GIOTRIF pri bolnikih z nedrobnoceličnim pljučnim rakom z mutacijami EGFR
English: If you could become pregnant, you should use adequate birth control methods during treatment and for at least 1 month after taking the last dose of this medicine.
Slovenian: Če je možno, da bi zanosili, uporabljajte med zdravljenjem in še najmanj 1 mesec po zadnjem odmerku zdravila GIOTRIF ustrezno kontracepcijo.
English: Left ventricular function
Slovenian: Delovanje levega prekata
English: Adjustments to the starting dose are not necessary in patients with mild or moderate hepatic impairment.
Slovenian: Bolnikom z blago ali zmerno jetrno okvaro začetnega odmerka ni treba prilagoditi.
English: Tell your doctor immediately if you develop new or sudden worsening of shortness of breath, possibly with a cough or fever.
Slovenian: Nemudoma obvestite zdravnika o prvem pojavu zasoplosti ali nenadnemu poslabšanju zasoplosti, ki ju lahko spremljata kašelj ali vročina.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični krči
English: The primary endpoint was PFS; OS was the key secondary endpoint.
Slovenian: Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS); skupno preživetje (OS) je bil ključni sekundarni opazovani dogodek.
English: Other secondary endpoints included ORR, DCR, change in tumour size and HRQOL.
Slovenian: Med druge sekundarne opazovane dogodke so bili zajeti stopnja objektivnega odziva na zdravljenje (ORR), stopnja nadzora bolezni (DCR) ter spremembe velikosti tumorja in kakovosti življenja povezane z zdravjem (HRQOL).
English: Therefore, it is recommended to administer strong P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Slovenian: Zatorej je priporočljivo močne zaviralce P-gp (tudi, toda ne samo, ritonavir, ciklosporin A, ketokonazol, itrakonazol, eritromicin, verapamil, kinidin, takrolimus,
English: No starting dose adjustment was considered necessary for any of the following covariates tested.
Slovenian: Pri nobeni od v nadaljevanju opisanih sočasnih spremenljivk ni potrebno prilagajanje odmerka.
English: Afatinib is eliminated mainly by biliary/faecal excretion.
Slovenian: Afatinib se pretežno izloča z žolčem in blatom.
English: In particular, if taken before GIOTRIF, the following medicines may increase the blood levels of GIOTRIF and therefore the risk of side effects.
Slovenian: Navedena zdravila lahko zvišajo raven zdravila GIOTRIF v krvi in s tem nevarnost neželenih učinkov zdravila, če jih jemljete pred zdravilom GIOTRIF.
English: The efficacy and safety of GIOTRIF as second-line treatment for patients with advanced NSCLC of squamous histology was investigated in a randomized open-label global Phase III trial LUX-Lung 8.
Slovenian: V drugi liniji zdravljenja so učinkovitost in varnost zdravila GIOTRIF pri bolnikih z napredovalim NSCLC s ploščatocelično histologijo ocenjevali v globalni, randomizirani, odprti raziskavi faze III LUX-Lung 8.
English: In the first-line setting, the efficacy and safety of GIOTRIF in patients with EGFR mutation-positive locally advanced or metastatic NSCLC (stage IIIB or IV) were assessed in a global, randomised, multicentre, open-label trial.
Slovenian: V zdravljenju prve linije so učinkovitost in varnost zdravila GIOTRIF pri bolnikih s pozitivno mutacijo EGFR in napredovalim ali metastatskim NSCLC (stopnja IIIB ali IV) ocenjevali v globalni, randomizirani, multicentrični, odprti raziskavi.
English: 2.6 vs. 1.9 HR 0.79; p=0.0078
Slovenian: 2,6 v primerjavi z 1,9 razmerje tveganja 0,79; p = 0,0078
English: No starting dose adjustments appear necessary in patients with mild or moderate hepatic impairment (see section 4.2).
Slovenian: Kaže, da bolnikom z blago ali zmerno jetrno okvaro ni treba prilagajati začetnega odmerka (glejte poglavje 4.2).
English: If ILD is diagnosed, GIOTRIF should be discontinued and appropriate treatment initiated as necessary (see section 4.4).
Slovenian: Če je diagnoza IPB potrjena, je treba zdravilo GIOTRIF ukiniti in po potrebi uvesti ustrezno zdravljenje (glejte poglavje 4.4).
English: In the pivotal trials Grade 3 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations were observed in 2.4% (LUX-Lung-3) and 1.6% (LUX-Lung 8) of patients with normal baseline liver tests treated with 40 mg/day.
Slovenian: V ključnih raziskavah so med bolniki z normalnimi izhodiščnimi izvidi jetrnih preiskav, ki so se zdravili z odmerki po 40 mg na dan, opazili povečanje vrednosti alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (AST) stopnje 3 pri 2,4 % (LUX-Lung 3) in 1,6 % bolnikov (LUX-Lung 8).
English: 31.1 vs. 10.3 HR 0.46; p=0.0001
Slovenian: 31,1 v primerjavi z razmerje tveganja 0,46; p = 0,0001
English: Patients had a tumour sample with an EGFR mutation categorised as either exon 19 deletion (58%) or exon 21 L858R substitutions (42%).
Slovenian: Vzorce tumorjev z mutacijami EGFR so opredelili kot delecije v eksonu 19 (58 %) ali kot substitucije v eksonu 21 L858R
English: MedDRA Preferred Term
Slovenian: Priporočeni izraz v MedDRA
English: Gemcitabine/ Cisplatin (N=122)
Slovenian: gemcitabin/ cisplatin (N = 122)
English: • Nausea
Slovenian: • nahod
English: The efficacy and safety of GIOTRIF in Asian patients with Stage IIIB/IV EGFR mutation-positive locally advanced or metastatic adenocarcinoma of the lung was evaluated in a randomised, multicentre, open-label trial.
Slovenian: Učinkovitost in varnost zdravila GIOTRIF pri bolnikih azijskega porekla z lokalno napredovalim ali metastatskim pljučnim adenokarcinomom stopnje IIIB ali IV in pozitivno mutacijo EGFR so ocenjevali v randomiziranem, multicentričnem, odprtem preskušanju.
English: • Fever
Slovenian: • vročina
English: This medicine contains a sugar called lactose.
Slovenian: Zdravilo vsebuje sladkor laktozo.
English: GIOTRIF (40 mg/day) N=229
Slovenian: GIOTRIF (40 mg/dan) N = 392
English: 1-year PFS Rate Objective Response Rate (CR+PR)
Slovenian: Stopnja PFS po 1 letu Stopnja objektivnega odziva (CR+PR) Razmerje obetov (95-%IZ)
English: When to take GIOTRIF
Slovenian: Kdaj jemati zdravilo GIOTRIF
English: There have been reports of ILD or ILD-like adverse reactions (such as lung infiltration, pneumonitis, acute respiratory distress syndrome, allergic alveolitis), including fatalities, in patients receiving GIOTRIF for treatment of NSCLC.
Slovenian: Pri bolnikih, ki so prejemali zdravilo GIOTRIF za zdravljenje NSCLC so poročali o IPB ali njej podobnih neželenih reakcijah (kot so pljučna infiltracija, pnevmonitis, akutni sindrom dihalne stiske, alergijski alveolitis), tudi takšnih s smrtnimi izidi.
English: Titanium dioxide (E171) Talc (E553b)
Slovenian: • titanov dioksid (E171)
English: MedDRA Preferred Term Infections and infestations
Slovenian: Priporočeni izraz v MedDRA Infekcijske in parazitske bolezni paronihija
English: Second-line GIOTRIF significantly improved PFS and OS of patients with squamous NSCLC compared to erlotinib.
Slovenian: V drugi liniji zdravljenja z zdravilom GIOTRIF se je bistveno izboljšalo preživetje brez napredovanja bolezni (PFS) in skupno preživetje (OS) pri bolnikih s ploščatoceličnim NSCLC v primerjavi z zdravilom erlotinib.
English: • Decreased weight
Slovenian: • zmanjšan tek
English: The dispersion can also be administered through a gastric tube.
Slovenian: Disperzijo je možno dajati po želodčni sondi.
English: Diarrhoea, including severe diarrhoea, has been reported during treatment with GIOTRIF (see section 4.8).
Slovenian: V povezavi z zdravljenjem z zdravilom GIOTRIF so poročali o driski, tudi o hudi obliki (glejte poglavje 4.8).
English: 4.5 vs. 3.7 HR 0.89; p=0.2562
Slovenian: 4,5 v primerjavi s 3,7 razmerje tveganja 0,89; p = 0,2562
English: Warnings and precautions Talk to your doctor or pharmacist before taking this medicine:
Slovenian: Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom ali farmacevtom:
English: How to take GIOTRIF
Slovenian: Kako jemati zdravilo GIOTRIF
English: P-glycoprotein (P-gp) interactions Concomitant treatment with strong inducers of P-gp may decrease exposure to afatinib (see section 4.5).
Slovenian: Pri sočasnem zdravljenju z močnimi induktorji P-gp se lahko zmanjša izpostavljenost afatinibu (glejte poglavje 4.5).
English: Table 3: Very common ADRs in trial LUX-Lung 3
Slovenian: Preglednica 3: Zelo pogoste neželene reakcije v raziskavi LUX-Lung 3
English: In contrast, when ritonavir was administered simultaneously or 6 hours after 40 mg GIOTRIF, the relative bioavailability of afatinib was 119% (AUC0-∞) and 104% (Cmax) and 111% (AUC0-∞) and 105% (Cmax), respectively.
Slovenian: Za razliko pa je bila relativna biološka uporabnost afatiniba 119% (AUC0-∞) oz. 104% (Cmax) ali 111% (AUC0-∞) oz. 105% (Cmax), če so ritonavir dajali sočasno ali 6 ur po dajanju 40 mg zdravila GIOTRIF.
English: Respiratory, thoracic and mediastinal disorders Rhinorrhoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa rinoreja intersticijska pljučna bolezen
English: Based on in vitro data, afatinib is a moderate inhibitor of P-gp.
Slovenian: Podatki iz raziskav in vitro kažejo, da je afatinib zmeren zaviralec P-gp.
English: Mothers should be advised against breast-feeding while receiving this medicinal product.
Slovenian: Materam, ki jemljejo to zdravilo, je treba dojenje odsvetovati.
English: GIOTRIF treatment in patients with eGFR <15 mL/min/1.73m² or on dialysis is not recommended.
Slovenian: Zdravila GIOTRIF ne priporočamo bolnikom z eGFR < 15 ml/min/1,73 m² in tistim, ki so na dializi.
English: Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.
Slovenian: Za bolnike, ki so izpostavljeni soncu, so priporočljiva zaščitna oblačila in uporaba zaščitnih sredstev pred soncem.
English: Exposure to afatinib is not significantly changed in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z blago (ocena A po Child Pughu) ali zmerno (ocena B po Child Pughu) jetrno okvaro izpostavljenost afatinibu ni pomembno spremenjena (glejte poglavje 5.2).
English: 2.5 vs. 2.4 HR 0.99; p=0.8690
Slovenian: 2,5 v primerjavi z 2,4 razmerje tveganja 0,99; p = 0,8690
English: Adjustments to the starting dose are not necessary in patients with mild (eGFR 60-89 mL/min/1.73m²), moderate (eGFR 30-59 mL/min/1.73m²) or severe (eGFR 15-29 mL/min/1.73m²) renal impairment.
Slovenian: Bolnikom z blago (ocenjena hitrosti glomerularne filtracije (eGFR) 60-89 ml/min/1,73 m²), zmerno (eGFR 30-59 ml/min/1,73 m²) ali hudo (eGFR 15-29 ml/min/1,73 m²) ledvično okvaro začetnega odmerka ni treba prilagoditi.
English: Overall Survival (OS) Months (median) Hazard Ratio (HR) (95%CI) p-value p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on logistic regression CR=complete response; PR=partial response
Slovenian: Vrednost p vrednost p za PFS/OS na osnovi stratificiranega testa log-rank; vrednost p za stopnjo objektivnega odziva na osnovi logistične regresije CR = popoln odziv; PR = delni odziv
English: Table 6: Efficacy results of GIOTRIF vs. pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) (Independent review)
Slovenian: Preglednica 6: Podatki o učinkovitosti zdravila GIOTRIF v primerjavi s podatki o učinkovitosti pemetrekseda/cisplatina (LUX-Lung 3) in gemcitabina/cisplatina (LUX-Lung 6) (neodvisen pregled)
English: 27.0 vs. 8.0 HR 0.60; p=0.0062
Slovenian: 27,0 v primerjavi z razmerje tveganja 0,60; p = 0,0062
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400,
Slovenian: - Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza (E460), brezvodni koloidni silicijev dioksid (E551), krospovidon tip A, magnezijev stearat (E470b), hipromeloza (E464), makrogol 400, titanov dioksid (E171), smukec (E553b), polisorbat 80 (E433).
English: 65% vs. 50%; p=0.0078
Slovenian: 65 % v primerjavi s p = 0,0078
English: In patients who develop severe hepatic impairment while taking GIOTRIF, treatment should be discontinued.
Slovenian: Če se med zdravljenjem z zdravilom GIOTRIF razvije huda jetrna okvara, ga je treba ukiniti.
English: Covalent adducts to proteins were the major circulating metabolites of afatinib.
Slovenian: Glavni presnovki afatiniba v obtoku so bili kovalentni adukti z beljakovinami.
English: Dermatitis acneiform Pruritus Dry skin
Slovenian: Bolezni kože in podkožja izpuščaj akneiformni dermatitis suha koža pruritus
English: If you experience any of the symptoms above, contact your doctor as soon as possible.
Slovenian: Če opazite katerega koli od spodaj navedenih resnih neželenih učinkov, se nemudoma pogovorite s svojim zdravnikom.
English: Overall Survival (OS) Months (median) Hazard Ratio (HR) (95%CI) p-value
Slovenian: Skupno preživetje (OS) Meseci (mediana) Razmerje tveganja (95-%IZ)
English: Weight decreased Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration Includes group of rash preferred terms Includes Acne, Acne pustular, Dermatitis acneiform Includes Pruritus, Pruritus generalised Includes Dry skin, Skin chapped Based on post-marketing experience Includes Nail disorder, Onycholysis, Nail toxicity, Onychoclasis, Ingrowing nail, Nail pitting, Onychomadesis, Nail discoloration, Nail dystrophy, Nail ridging, and Onychogryphosis
Slovenian: Preiskave zmanjšanje telesne mase zajema paronihijo, okužbo nohtov, okužbo nohtnega ležišča zajema stomatitis, aftozni stomatitis, vnetje sluznice, ulceracijo v ustni votlini, erozijo ustne sluznice, erozijo sluznice, ulceracije sluznice zajema skupino priporočenih izrazov za izpuščaj zajema akne, pustularne akne, akneiformni dermatitis zajema pruritus, generalizirani pruritus zajema suho kožo, razpokano kožo na osnovi izkušenj v obdobju trženja zajema bolezni nohtov, oniholizo, nohtno toksičnost, onihoklazo, vraščanje nohtov, jamice na nohtih, onihomadezo, obarvanost nohtov, distrofijo nohtov, brazde na nohtih in onihogripozo
English: 43% vs. 35%; p=0.0294
Slovenian: 43 % v primerjavi s p = 0,0294
English: A dose escalation to a maximum of 50 mg/day may be considered in patients who tolerate a 40 mg/day starting dose (i.e. absence of diarrhoea, skin rash, stomatitis, and other adverse reactions with CTCAE Grade > 1) in the first cycle of treatment (21 days for EGFR mutation positive NSCLC and 28 days for squamous NSCLC).
Slovenian: Pri bolnikih, ki so v prvem ciklusu zdravljenja (21 dni pri bolnikih z NSCLC s pozitivno mutacijo EGFR in 28 dni pri bolnikih s ploščatoceličnim NSCLC) prenašali začetni odmerek po 40 mg na dan (nimajo driske, kožnega izpuščaja, stomatitisa ali drugih neželenih reakcij stopnje > 1 po enotnih terminoloških merilih za neželene dogodke CTCAE (Common Terminology Criteria for Adverse Events)), lahko razmislimo o povečanju odmerka, in sicer do največ 50 mg na dan.
English: Treatment at the first signs of diarrhoea is important.
Slovenian: Pomembno je, da se začne drisko zdraviti, ko se pojavijo prvi znaki.
English: In general, rash manifests as a mild or moderate erythematous and acneiform rash, which may occur or worsen in areas exposed to sun. For patients who are exposed to sun, protective clothing, and use of sun screen is advisable.
Slovenian: Izpuščaj ima večinoma obliko blagega ali zmerno hudega eritematoznega in akneiformnega izpuščaja, ki se lahko pojavi ali poslabša na predelih, ki so izpostavljeni soncu.
English: Gemcitabine/ Cisplatin (N=62)
Slovenian: gemcitabin/ cisplatin (N = 62)
English: 71% vs. 48%; p<0.0001
Slovenian: 71 % v primerjavi z p < 0,0001
English: 60% vs. 48%; p=0.0427
Slovenian: 60 % v primerjavi z p = 0,0427
English: Table 5: Very common ADRs in trial LUX-Lung 8* GIOTRIF (40 mg/day)
Slovenian: Preglednica 4: Zelo pogosti neželeni učinki zdravila v raziskavi LUX-Lung 7 GIOTRIF (40 mg/dan)
English: It is important to treat the rash early.
Slovenian: Pri izpuščaju je pomembno zgodnje zdravljenje.
English: Gemcitabine/ Cisplatin (N=46)
Slovenian: gemcitabin/ cisplatin (N = 46)