natgillin/translations-raw huggingface dataset:
Based on a population pharmacokinetic analysis of 593 patients with mild renal impairment (CLcr 60 to less than 90 mL/min), 254 patients with moderate renal impairment (CLcr 30 to <than 60 mL/min), 5 patients with severe renal impairment (CLcr 15 to <than 30 mL/min) and 502 patients with normal renal function (greater than or equal to 90 mL/min), osimertinib exposures were similar.
Na podlagi populacijske farmakokinetične analize 593 bolnikov z blago okvaro ledvic (očistek kreatinina od 60 do manj kot 90 ml/min), 254 bolnikov z zmerno okvaro ledvic (očistek kreatinina od 30 do manj kot 60 ml/min), 5 bolnikov s hudo okvaro ledvic (očistek kreatinina od 15 do manj kot 30 ml/min) ter 502 bolnikov z normalnim delovanjem ledvic (več kot ali enako 90 ml/min) so bile izpostavljenosti osimertinibu podobne.
The incidence of ILD was 10.4% in patients of Japanese ethnicity, 1.8% in patients of Asian ethnicity and 2.8% in non-Asian patients (see section 4.8).
Pojavnost IBP je bila pri bolnikih japonske etnične pripadnosti 10,4 %, pri bolnikih azijske etnične pripadnosti 1,8 % in pri neazijskih bolnikih 2,8 % (glejte poglavje 4.8).
In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered.
Pri bolnikih, ki se jim med zdravljenjem pojavijo pomembni srčni znaki ali simptomi, je treba razmisliti o nadziranju delovanja srca, vključno z ocenjevanjem LVEF.
If ILD is diagnosed, TAGRISSO should be discontinued and appropriate treatment initiated as necessary.
Če je diagnosticirana IBP, je treba ukiniti zdravljenje z zdravilom TAGRISSO in uvesti ustrezno zdravljenje, kot je potrebno.
At least 12 components were observed in the pooled urine and faecal samples in humans with 5 components accounting for >1% of the dose of which unchanged osimertinib, AZ5104 and AZ7550, accounted for approximately 1.9, 6.6 and 2.7% of the dose while a cysteinyl adduct (M21) and an unknown metabolite (M25) accounted for 1.5% and 1.9% of the dose, respectively.
V združenih vzorcih urina in blata pri človeku so ugotovili vsaj 12 sestavin; 5 sestavin je bilo zastopanih v deležih, ki so predstavljali > 1 % odmerka, pri čemer so nespremenjeni osimertinib, AZ5104 in AZ7550 predstavljali približno 1,9, 6,6 in 2,7 % odmerka, cisteinilni adukt (M21) in neznan presnovek (M25) pa 1,5 % oz. 1,9 % odmerka.
In a female fertility study in rats, administration of osimertinib at 20 mg/kg/day (approximately equal to the recommended daily clinical dose of 80 mg) had no effects on oestrus cycling or the number of females becoming pregnant, but caused early embryonic deaths.
V študiji plodnosti samic pri podganah uporaba osimertiniba v odmerku 20 mg/kg/dan (to je približno enakovredno priporočenemu kliničnemu dnevnemu odmerku 80 mg) ni vplivala na estrus ali na število brejih samic, povzročila pa je zgodnje smrti zarodkov.
However, osimertinib and its metabolites were detected in the suckling pups and there were adverse effects on pup growth and survival (see section 5.3).
Vendar so osimertinib in njegove presnovke našli pri dojenih mladičih in ugotovili so neželene učinke na rast in preživetje mladičev (glejte poglavje 5.3).
Patients were randomised in a 2:1 (TAGRISSO: platinum-based doublet chemotherapy) ratio to receive TAGRISSO (n=279) or platinum-based doublet chemotherapy (n=140).
Bolnike so v razmerju 2:1 (zdravilo TAGRISSO:dvojna kemoterapija na podlagi platine) randomizirali na prejemanje zdravila TAGRISSO (n = 279) ali dvojne kemoterapije na podlagi platine (n = 140).
• you have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease').
• če ste imeli vnetje pljuč (bolezen, ki jo imenujemo “intersticijska bolezen pljuč”),
The most commonly reported adverse drug reactions (ADRs) were diarrhoea (49%) and rash (47%).
Najpogostejša neželena učinka zdravila sta bila driska (49 %) in izpuščaj (47 %).
There is insufficient information on the excretion of osimertinib or its metabolites in animal milk.
Informacij o izločanju osimertiniba ali njegovih presnovkov v mleko pri živalih ni dovolj.
Active substances whose plasma concentrations may be altered by TAGRISSO Based on in vitro studies, osimertinib is a competitive inhibitor of BCRP transporters.
Učinkovine, katerih koncentracijo v plazmi lahko spremeni zdravilo TAGRISSO Na podlagi študij in vitro je osimertinib kompetitivni zaviralec prenašalcev BCRP.
The C30 was assessed every 6 weeks before and after progression.
C30 so ocenili na vsakih 6 tednov pred napredovanjem in po njem.
This side effect is uncommon: it may affect up to 1 in 100 people.
Ta neželeni učinek je občasen: pojavi se lahko pri največ 1 od 100 bolnikov.
If you forget to take TAGRISSO
Če ste pozabili vzeti zdravilo TAGRISSO
However, if a plasma-based ctDNA test is used and the result is negative, it is advisable to follow-up with a tissue test wherever possible due to the potential for false negative results using a plasma-based test.
A če je uporabljena preiskava za ctDNA iz plazme in je izvid negativen, je priporočljivo opraviti še preiskavo tkivnega vzorca, če je le mogoče.
In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered.
Pri bolnikih s srčnimi dejavniki tveganja in bolnikih s stanji, ki prizadenejo LVEF, je treba razmisliti o nadziranju delovanja srca, vključno z ocenjevanjem LVEF izhodiščno in med zdravljenjem.
In FLAURA and AURA3 the median time to onset was 19 days and 22 days, respectively, and the median duration of the Grade 2 events was 19 days and 6 days, respectively.
Mediani čas do pojava je bil v študiji FLAURA 19 dni in v študiji AURA3 22 dni, mediani čas trajanja učinkov 2. stopnje pa je bil v prvi 19 dni in v drugi 6 dni.
Irrespective of CNS lesion status at study entry, patients in the TAGRISSO arm demonstrated an efficacy benefit over those in the EGFR TKI comparator arm and there were fewer patients with new CNS lesions in the TAGRISSO arm compared to the EGFR TKI comparator arm (TAGRISSO, 11/279 [3.9%] compared to EGFR TKI comparator, 34/277 [12.3%]).
Ne glede na stanje lezij v CNS ob vstopu v študijo je bila pri bolnikih v skupini z zdravilom TAGRISSO ugotovljena korist glede učinkovitosti v primerjavi s skupino s primerjalnim EGFR TKI; v skupini z zdravilom TAGRISSO je bilo manj bolnikov z novimi lezijami v CNS kot v skupini s primerjalnim EGFR TKI (TAGRISSO 11/279 [3,9 %], primerjalni EGFR TKI 34/277 [12,3 %]).
Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist (see section 4.2 Table 1).
Bolnike z znaki in simptomi, ki nakazujejo keratitis (na primer vnetje očesa, solzenje, občutljivost na svetlobo, zamegljen vid, bolečine v očesu in/ali pordelost očesa), je treba nemudoma napotiti k specialistu oftalmologu (glejte poglavje 4.2, preglednica 1).
The first analysis of OS was performed approximately 4 months after the primary analysis of PFS.
Prva analiza celokupnega preživetja je bila opravljena približno 4 mesece po primarni analizi preživetja brez napredovanja bolezni.
Active substances that may increase osimertinib plasma concentrations In vitro studies have demonstrated that the Phase I metabolism of osimertinib is predominantly via CYP3A4 and CYP3A5.
Učinkovine, ki lahko povečajo koncentracijo osimertiniba v plazmi Študije in vitro so pokazale, da poteka presnova I. faze osimertiniba pretežno s CYP3A4 in CYP3A5.
In the FLAURA and AURA studies, the incidence of ILD was 10.4% in patients of Japanese ethnicity, 1.8% in patients of non-Japanese Asian ethnicity and 2.8% in non-Asian patients.
V študijah FLAURA in AURA je bila pojavnost intersticijske bolezni pljuč pri bolnikih japonske etnične pripadnosti 10,4 %, pri bolnikih nejaponske azijske etnične pripadnosti 1,8 % in pri neazijskih bolnikih 2,8 %.
Key lung cancer symptoms analysis
Analiza ključnih simptomov raka pljuč
In a population based pharmacokinetic analyses (n=1367), no clinically significant relationships were identified between predicted steady-state exposure (AUCss) and patient's age (range: 25 to 91 years), gender (65% female), ethnicity (including White, Asian, Japanese, Chinese and non-Asian-non-White patients), line of therapy and smoking status (n=34 current smokers, n=419 former smokers).
V populacijskih farmakokinetičnih analizah (n = 1367) niso ugotovili klinično pomembne povezanosti med predvideno izpostavljenostjo v stanju dinamičnega ravnovesja (AUCss) in bolnikovo starostjo (razpon: od 25 do 91 let), spolom (65 % žensk), etnično pripadnostjo (vključno z belci, Azijci, Japonci, Kitajci in neazijskimi nebelskimi bolniki), linijo zdravljenja in kadilskim statusom (n = 34 trenutnih kadilcev, n = 419 nekdanjih kadilcev).
Other medicines and TAGRISSO
Druga zdravila in zdravilo TAGRISSO
A pharmacokinetic/pharmacodynamic analysis predicted a drug-related QTc interval prolongation at 80 mg of 14 msec with an upper bound of 16 msec (90% CI).
Farmakokinetična/farmakodinamična analiza je ob odmerku 80 mg predvidela z zdravilom povezano podaljšanje intervala QTc za 14 msec, z zgornjo mejo 16 msec (90 % IZ).
• You should not become pregnant while taking this medicine.
• Med jemanjem tega zdravila ne smete zanositi.
Efficacy results from AURA3 by investigator assessment
Rezultati učinkovitosti v študiji AURA3 po oceni raziskovalca
There are no data available on patients with severe hepatic impairment (see section 4.2).
O bolnikih s hudo okvaro jeter ni podatkov (glejte poglavje 4.2).
A validated test should be performed using either tumour DNA derived from a tissue sample or circulating tumour DNA (ctDNA) obtained from a plasma sample.
Opraviti je treba validirano preiskavo tumorske DNK, dobljene iz vzorca tkiva, ali tumorske DNK v obtoku (ctDNA - circulating tumor DNA), dobljene iz vzorca plazme.
In vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against EGFR across a range of all clinically relevant EGFR sensitising-mutant and T790M mutant non-small cell lung cancer (NSCLC) cell lines (apparent IC50s from 6 nM to 54 nM against phospho-EGFR).
Študije in vitro so pokazale, da osimertinib zelo močno in učinkovito zaviralno deluje na EGFR v celičnih linijah nedrobnoceličnega raka pljuč (NSCLC) z vsemi klinično pomembnimi aktivacijskimi mutacijami in mutacijo T790M EGFR (navidezne IC50 proti fosfo EGFR so od 6 nM do 54 nM).
• Sudden difficulty in breathing together with a cough or fever - this may be a sign of inflamed lungs (a condition called ‘interstitial lung disease').
• Nenadno težko dihanje skupaj s kašljem ali vročino - to je lahko znak vnetja pljuč (bolezni, ki jo imenujemo “intersticijska bolezen pljuč”); Večino primerov je mogoče zdraviti, a nekateri primeri so lahko smrtni.
The geometric mean exposure of both AZ5104 and AZ7550, based on AUC, was approximately 10% each of the exposure of osimertinib at steady-state.
Geometrična srednja izpostavljenost AZ5104 in AZ7550 je bila na podlagi AUC približno 10 % (vsak od presnovkov) izpostavljenosti osimertinibu v stanju dinamičnega ravnovesja.
Efficacy results from FLAURA by investigator assessment
Rezultati učinkovitosti v študiji FLAURA po oceni raziskovalca
EGFR TKI comparator (gefitinib or erlotinib) N=67
Primerjalni EGFR TKI (gefitinib ali erlotinib) N = 67
Mixed Model Repeated Measures - Key lung cancer symptoms - mean change from baseline in TAGRISSO patients compared with chemotherapy
Mešani model s ponavljajočimi se meritvami - Ključni simptomi raka pljučpovprečna sprememba od izhodišča z zdravilom TAGRISSO v primerjavi s kemoterapijo
Discontinue TAGRISSO (see Section 4.4)
Ukinite zdravljenje z zdravilom TAGRISSO (glejte poglavje 4.4).
No clinical studies have been conducted to specifically evaluate the effect of renal impairment on the pharmacokinetics of osimertinib.
Kliničnih študij za specifično ovrednotenje vpliva okvare ledvic na farmakokinetiko osimertiniba niso izvedli.
Al/Al perforated unit dose blisters.
Al/Al perforirani pretisni omoti za enkratni odmerek.
The resulting 30 mL of liquid should be administered as per the naso-gastric tube manufacturer's instructions with appropriate water flushes.
Tako dobljenih 30 ml tekočine je treba dati po nazogastrični sondi v skladu z navodili izdelovalca sonde in z ustreznim izpiranjem sonde z vodo.
• the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
• prvo linijo zdravljenja odraslih bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč (NSCLC - non-small-cell lung cancer), katerega receptor za epidermalni rastni faktor (EGFR - epidermal growth factor receptor) ima aktivirajoče mutacije.
Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g. QTc interval greater than 470 ms) were excluded from these studies.
Bolniki s klinično pomembnimi nepravilnostmi srčnega ritma oziroma prevajanja, izmerjenimi na elektrokardiogramu (EKG) v mirovanju (npr. interval QTc, daljši od 470 ms) niso bili vključeni v te študije.
Treatment with this medicinal product should be interrupted pending investigation of these symptoms.
V času preiskovanja teh simptomov je treba zdravljenje s tem zdravilom prekiniti.
Do not crush, split or chew the tablet.
Tablet ne drobite, ne lomite in ne zgrizite.
It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M.
Je ireverzibilni zaviralec receptorjev za epidermalni rastni faktor (EGFR), ki imajo aktivacijske mutacije (EGFRm) in mutacijo za odpornost proti TKI T790M.
Studies in EGFR mutation-positive NSCLC patients The data described below reflect exposure to TAGRISSO in 1142 patients with EGFR mutationpositive non-small cell lung cancer.
Študije pri bolnikih z NSCLC in pozitivno mutacijo EGFR Spodaj prikazani podatki povzemajo izpostavljenost zdravilu TAGRISSO pri 1142 bolnikih z nedrobnoceličnim rakom pljuč in pozitivno mutacijo EGFR.
Serious side effects Tell your doctor straight away if you notice the following serious side effects:
Zdravnika morate takoj obvestiti, če opazite naslednje resne neželene učinke:
In case of suspected overdose, TAGRISSO should be withheld and symptomatic treatment initiated.
V primeru suma na preveliko odmerjanje je treba uporabo zdravila TAGRISSO prekiniti in uvesti simptomatsko zdravljenje.
The ORR by BICR in AURAex was 62% (95% CI: 55, 68) and 70% (95% CI: 63, 77) in AURA2.
ORR po BICR je bil v študiji AURAex 62 % (95 % IZ: 55; 68) in v študiji AURA2 70 % (95 % IZ: 63; 77).
• Women-keep using contraception for 2 months after.
• Ženske - kontracepcijo uporabljajte še 2 meseca po koncu zdravljenja.
In vitro, osimertinib does not inhibit OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 and MATE2K at clinically relevant concentrations.
In vitro osimertinib v klinično pomembnih koncentracijah ne zavira OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 ali MATE2K.
TAGRISSO is supplied in blisters containing 30 x 1 film-coated tablets, packed in cartons containing 3 blisters of 10 tablets each.
Zdravilo TAGRISSO je na voljo v pretisnih omotih, ki vsebujejo 30 x 1 filmsko obloženo tableto, pakiranih v škatlah, ki vsebujejo 3 pretisne omote, vsak od njih pa 10 tablet.
The PFS benefit of TAGRISSO compared to EGFR TKI comparator was consistent across all predefined subgroups analysed, including ethnicity, age, gender, smoking history, CNS metastases status at study entry and EGFR mutation type (Exon 19 deletion or L858R).
Korist zdravila TAGRISSO na PFS je bila v primerjavi s primerjalnim EGFR TKI dosledna v vseh vnaprej določenih analiziranih podskupinah, vključno z etnično pripadnostjo, starostjo, spolom, anamnezo kajenja, stanjem metastaz v CNS ob vstopu v študijo ter tipom mutacije EGFR (delecija eksona 19 ali L858R).
• Phenytoin, carbamazepine or phenobarbital -used for seizures or fits.
• fenitoin, karbamazepin ali fenobarbital - uporabljajo se za zdravljenje napadov krčev
AURA3 demonstrated a statistically significant improvement in PFS for patients receiving TAGRISSO compared to those receiving chemotherapy irrespective of CNS metastases status at study entry.
Študija AURA3 je pokazala statistično značilno izboljšanje PFS za bolnike, zdravljene z zdravilom TAGRISSO kot tiste, zdravljene s kemoterapijo, ne glede na stanje metastaz v CNS ob vstopu v študijo.
Both metabolites appeared slowly in plasma after administration of TAGRISSO to patients, with a median (min-max) tmax of 24 (4-72) and 24 (6-72) hours, respectively.
Oba presnovka sta se po uporabi zdravila TAGRISSO pri bolnikih počasi pojavila v plazmi, prvi z medianim (minimum-maksimum) tmax 24 (4-72) ur in drugi 24 (6-72) ur.
If you stop taking TAGRISSO
Če ste prenehali jemati zdravilo TAGRISSO
Adverse events of leukopenia, lymphopenia, neutropenia and thrombocytopenia have been reported, most of which were mild or moderate in severity and did not lead to dose interruptions.
Poročali so o neželenih učinkih levkopeniji, limfopeniji, nevtropeniji in trombocitopeniji; večina je bila blago do zmerno izrazitih in niso povzročili prekinitve uporabe zdravila.
In TAGRISSO clinical trials a limited number of patients were treated with daily doses of up to 240 mg without dose limiting toxicities.
V kliničnih preskušanjih z zdravilom TAGRISSO so majhno število bolnikov zdravili v dnevnih odmerkih do 240 mg.
CNS metastases efficacy data in Phase 2 studies (AURAex and AURA2) A BICR assessment of CNS efficacy by RECIST v 1.1 was performed in a subgroup of 50 (out of 411) patients identified to have measurable CNS metastases on a baseline brain scan.
Podatki o učinkovitosti pri metastazah v CNS v študijah 2. faze (AURAex in AURA2) Ocena učinkovitosti v CNS z BICR in uporabo meril RECIST v1.1 je bila opravljena v podskupini 50 (od 411) bolnikov z ugotovljenimi merljivimi metastazami v CNS na izhodiščnem slikanju možganov.
Across clinical trials, Left Ventricular Ejection Fraction (LVEF) decreases greater than or equal to 10% and a drop to less than 50% occurred in 3.9% (35/908) of patients treated with TAGRISSO who had baseline and at least one follow-up LVEF assessment.
V kliničnih preskušanjih se je zmanjšanje iztisnega deleža levega prekata (LVEF - left ventricular ejection fraction) za ≥ 10 % ali na manj kot 50 % pojavilo pri 3,9 % (35/908) bolnikov, zdravljenih z zdravilom TAGRISSO, ki so imeli LVEF izmerjen izhodiščno in vsaj še enkrat med obdobjem spremljanja.
Administration of osimertinib once daily results in approximately 3 fold accumulation with steady-state exposures achieved by 15 days of dosing.
Uporaba osimertiniba enkrat na dan povzroči približno 3-kratno kopičenje in izpostavljenosti v stanju dinamičnega ravnovesja so dosežene do 15. dne uporabe.
Careful assessment of all patients with an acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever) should be performed to exclude ILD.
Vse bolnike z akutnim nastankom in/ali nepojasnjenim poslabšanjem pljučnih simptomov (dispneja, kašelj, zvišana telesna temperatura) je treba skrbno pregledati, da bi izključili IBP.
Based on its mechanism of action and preclinical data, osimertinib may cause foetal harm when administered to a pregnant woman.
Glede na mehanizem delovanja in predklinične podatke lahko osimertinib škoduje plodu, če je uporabljen pri nosečnici.
• If your partner becomes pregnant while you are taking this medicine, tell your doctor straight away.
• Če vaša partnerka zanosi, medtem ko jemljete to zdravilo, morate o tem takoj obvestiti zdravnika.
• St. John's Wort (Hypericum perforatum) - an herbal medicine used for depression.
• šentjanževka (Hypericum perforatum) - zdravilo rastlinskega izvora za zdravljenje depresije.
TAGRISSO is supplied in blisters containing 28 x 1 film-coated tablets, packed in cartons containing 4 blisters of 7 tablets each.
Zdravilo TAGRISSO je na voljo v pretisnih omotih, ki vsebujejo 28 x 1 filmsko obloženo tableto, pakiranih v škatlah, ki vsebujejo 4 pretisne omote, vsak od njih pa 7 tablet.
Includes cases reported within the clustered terms: Dry skin, skin fissures, xerosis, eczema, xeroderma.
Združuje primere, poročane z izrazi: suha koža, fisure na koži, kseroza, ekcem, kseroderma.
Early reductions in the median laboratory counts of leukocytes, lymphocytes, neutrophils and platelets have been observed in patients treated with TAGRISSO, which stabilised over time and then remained above the lower limit of normal.
Pri bolnikih, zdravljenih z zdravilom TAGRISSO, so opažali zgodnje zmanjšanje medianih laboratorijskih vrednosti levkocitov, limfocitov, nevtrofilcev in trombocitov, ki pa so se sčasoma stabilizirale in so ostale nad spodnjo mejo normalnih vrednosti.
Based on studies in animals, female fertility may be impaired by treatment with osimertinib.
Glede na študije na živalih lahko zdravljenje z osimertinibom okvari plodnost samic.
Clinical studies that were conducted excluded patients with AST or ALT >2.5x upper limit of normal (ULN), or if due to underlying malignancy, >5.0x ULN or with total bilirubin >1.5x ULN.
Opravljene klinične študije niso vključile bolnikov z AST ali ALT > 2,5-kratno zgornjo mejo normalne vrednosti (ZMN), ali - če je šlo za posledico osnovne maligne bolezni - > 5,0-kratno ZMN ali s celokupnim bilirubinom > 1,5-kratno ZMN.
If you do become pregnant during treatment, tell your doctor straight away.
Če med zdravljenjem zanosite, morate o tem takoj obvestiti zdravnika.
Patients taking concomitant medications with disposition dependent upon P-gp and with narrow therapeutic index (e.g. digoxin, dabigatran, aliskiren) should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving TAGRISSO (see section 5.2).
Bolnike, ki sočasno jemljejo zdravila, katerih odstranjevanje je odvisno od P-gp in imajo ozek terapevtski indeks (npr. digoksin, dabigatran, in aliskiren), je treba skrbno spremljati glede znakov spremenjenega prenašanja zaradi večje izpostavljenosti sočasnemu zdravilu v času prejemanja zdravila TAGRISSO (glejte poglavje 5.2).
Adverse reactions reported in FLAURA and AURA studies
Neželeni učinki, o katerih so poročali v študijah FLAURA in AURA
Baseline characteristics of the overall study population (AURAex and AURA2) were as follows: median age 63 years, 13% of patients were ≥75 years old, female (68%), White (36%), Asian (60%).
Izhodiščne značilnosti skupne študijske populacije (AURAex in AURA2) so bile: mediana starost 63 let, 13 % bolnikov je bilo starih ≥ 75 let, 68 % žensk, 36 % belcev, 60 % Azijcev.
In vitro studies indicate that osimertinib is metabolised predominantly by CYP3A4, and CYP3A5.
Študije in vitro kažejo, da se osimertinib presnavlja predvsem s CYP3A4 in CYP3A5.
TAGRISSO improved patient-reported lung cancer symptoms compared to chemotherapy by demonstrating a statistically significant difference in mean change from baseline versus chemotherapy during the overall time period from randomisation until 6 months for 5 pre-specified primary PRO symptoms (appetite loss, cough, chest pain, dyspnoea, and fatigue) as shown in Table 7.
Zdravilo TAGRISSO je v primerjavi s kemoterapijo izboljšalo simptome raka pljuč po navedbi bolnikov, in sicer je med celotnim obdobjem od randomizacije do 6 mesecev v primerjavi s kemoterapijo doseglo statistično značilno razliko povprečne spremembe od izhodišča za 5 vnaprej določenih primarnih simptomov PRO (izguba apetita, kašelj, bolečine v prsih, dispneja in utrujenost), kot prikazuje preglednica 7.
• The active substance is osimertinib (as mesylate).
• Učinkovina je osimertinib (v obliki mesilata).