natgillin/translations-raw huggingface dataset:
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.
U ključnim ispitivanjima porast alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST) stupnja 3 primijećen je kod 2,4% (LUX-Lung 3) i 1,6% (LUX-Lung 8) bolesnika s urednim početnim vrijednostima jetrenih enzima koji su bili liječeni s 40 mg/dan.
The primary endpoint was progression free survival (PFS) by independent review; the secondary endpoints included overall survival and objective response rate.
Primarni ishod bio je preživljenje bez progresije bolesti (engl. progression free survival, PFS) na temelju nezavisne procjene; sekundarni ishodi su uključivali ukupno preživljenje i stopu objektivnog odgovora.
What GIOTRIF contains - The active substance is afatinib.
Što GIOTRIF sadrži - Djelatna tvar je afatinib.
Bullous, blistering and exfoliative skin conditions have been reported including rare cases suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis although in these cases there were potential alternative aetiologies (see section 4.4).
Prijavljena su bulozna, vezikulozna i eksfolijativna stanja uključujući rijetke slučajeve koji ukazuju na Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, iako su u ovim slučajevima potencijalno postojale i druge etiologije (vidjeti dio 4.4).
Anti-diarrhoeal medicinal products should be readily available to the patients so that treatment can be initiated at first signs of diarrhoea and continued until loose bowel movements cease for 12 hours.
Lijekovi protiv proljeva moraju biti lako dostupni bolesnicima tako da liječenje može početi s pojavom prvih znakova proljeva i nastaviti se do 12 sati od nestanka mekane stolice.
This means preferably 6 hours (for P-gp inhibitors dosed twice daily) or 12 hours (for P-gp inhibitors dosed once daily) apart from GIOTRIF (see section 4.5).
To znači po mogućnosti 6 sati (za P-gp inhibitore s doziranjem dva puta dnevno) ili 12 sati (za P-gp inhibitore s jednokratnim dnevnim doziranjem) razmaka od GIOTRIFA (vidjeti dio 4.5).
• Eye irritation or inflammation
• Nadraženost oka ili upala
GIOTRIF treatment should be continued until disease progression or until no longer tolerated by the patient (see Table 1 below).
Liječenje GIOTRIFOM se nastavlja do progresije bolesti ili razvoja nepodnošljivosti kod bolesnika (vidjeti tablicu 1 u nastavku).
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.
Sistemska izloženost afatinibu je smanjena za 50% (Cmax) i 39% (AUC0-∞), kada se primjenjuje s obrokom s visokim udjelom masnoća u usporedbi s primjenom lijeka natašte.
Both trials demonstrated significant improvement in PFS of EGFR mutation positive patients treated with GIOTRIF compared to chemotherapy.
Oba ispitivanja pokazala su značajno poboljšanje PFS-a u bolesnika pozitivnih na EGFR mutaciju i liječenih GIOTRIFOM u usporedbi s kemoterapijom.
Treatment with this medicinal product should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions (see section 4.8).
Liječenje ovim lijekom se mora privremeno ili trajno prekinuti ako bolesnik razvije teška bulozna, vezikulozna ili eksfolijativna stanja (vidjeti dio 4.8).
NSCLC tumours with common activating EGFR mutations (Del 19, L858R) and several less common EGFR mutations in exon 18 (G719X) and exon 21 (L861Q) are particularly sensitive to afatinib treatment in non-clinical and clinical settings.
NSCLC tumori s čestim aktivirajućim mutacijama EGFR-a (Del 19, L858R), te nekoliko manje čestih mutacija EGFR-a u egzonu 18 (G719X) i egzonu 21 (L861Q) su osobito osjetljivi na liječenje afatinibom u nekliničkom i kliničkom okruženju.
In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered.
Kod bolesnika koji razviju značajne srčane znakove/simptome tijekom liječenja, potrebno je razmotriti praćenje srčane funkcije, uključujući procjenu LVEF-a.
It is important to treat the rash early.
Osip je važno rano započeti liječiti.
Breast-feeding Do not breast-feed while taking this medicine as a risk to the breast-fed child cannot be excluded.
Dojenje Nemojte dojiti tijekom primjene ovog lijeka jer se ne može isključiti rizik za dojenče.
The co-primary endpoints include PFS by independent review and OS.
Koprimarne mjere ishoda su uključivale PFS na temelju nezavisne procjene i OS.
In particular, if taken before GIOTRIF, the following medicines may increase the blood levels of GIOTRIF and therefore the risk of side effects.
Osobito ako se uzimaju prije GIOTRIFA, sljedeći lijekovi mogu povisiti vrijednosti GIOTRIFA u krvi te na taj način povećati rizike nuspojava.
• Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Jako stvaranje mjehura na koži ili ljuštenje kože (ukazuje na Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu)
Trial Population Alive at 18-months Alive at 24-months
1, ukupna populacija ispitivanja Živi u 18. mjesecu Živi u 24. mjesecu
Aspartate aminotransferase increased
Povišene vrijednosti aspartat aminotransferaze
OS results based on primary OS analysis as of April 2016 at event rates of 109 (68.1%) and 117 (73.6%) in the GIOTRIF and gefitinib arms, respectively p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on stratified logistic regression
OS rezultati temeljeni na primarnoj analizi ukupnog preživljenja iz travnja 2016. pri stopama događaja od 109 (68,1%) i 117 (73,6%) u skupinama liječenim GIOTRIFOM odnosno gefitinibom p-vrijednost za PFS/OS na temelju stratificiranog log-rank testa; p-vrijednost za stopu objektivnog odgovora na temelju stratificirane logističke regresije
P-glycoprotein (P-gp) interactions Concomitant treatment with strong inducers of P-gp may decrease exposure to afatinib (see section 4.5).
Interakcije s P-glikoproteinom (P-gp interakcije) Istodobno liječenje snažnim P-gp induktorima može smanjiti izloženost afatinibu (vidjeti dio 4.5).
If you experience treatment-related symptoms affecting your eye sight (e.g. redness and/or irritation of the eye, dry eye, tearing, light-sensitivity) or your ability to concentrate and react, it is recommended that you do not drive or use machines until the side effect disappears (see section 4 Possible side effects).
Ako, povezano s liječenjem, imate simptome koji utječu na Vaš vid (npr. crvenilo i/ili nadraženost oka, sindrom suhog oka, pojačano suzenje, preosjetljivost na svjetlo) ili na Vašu sposobnost koncentriranja i reagiranja, preporučuje se ne upravljati vozilima ili strojevima dok nuspojave ne nestanu (vidjeti dio 4. Moguće nuspojave).
EGFR mutation status should be established prior to initiation of GIOTRIF therapy (see section 4.4).
Potrebno je utvrditi status mutacije EGFR prije početka liječenja GIOTRIFOM (vidjeti dio 4.4).
Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Snažni P-gp induktori (uključujući, ali ne ograničeno na rifampicin, karbamazepin, fenitoin, fenobarbital ili gospinu travu (Hypericum perforatum)) mogu smanjiti izloženost afatinibu (vidjeti dio 4.4).
• Carbamazepine, phenytoin, phenobarbital - used to treat seizures.
• Karbamazepin, fenitoin, fenobarbital - primjenjuju se za liječenje napadaja.
• if you develop new or sudden worsening of shortness of breath, possibly with a cough or fever.
• ako razvijete novo ili iznenadno pogoršanje nedostatka zraka, moguće praćeno kašljem i vrućicom.
In humans it was found that enzyme-catalyzed metabolic reactions play a negligible role for the metabolism of afatinib.
U ljudi je pronađeno da reakcije katalizirane enzimima imaju zanemarivu ulogu za metabolizam afatiniba.
GIOTRIF is a medicine which contains the active substance afatinib.
GIOTRIF je lijek koji sadrži djelatnu tvar afatinib.
Pemetrexed/ Cisplatin N=111
Pemetreksed/ cisplatin N=111
Diarrhoea, including severe diarrhoea, has been reported during treatment with GIOTRIF (see section 4.8).
Proljev, uključujući teški proljev, prijavljen je tijekom liječenja GIOTRIFOM (vidjeti dio 4.8).
Table 7 shows outcomes in the subgroups of patients with two common EGFR mutations - Del 19 and L858R.
Tablica 7 pokazuje ishode u podskupinama bolesnika s dvjema čestim EGFR mutacijama - Del 19 i L858R.
In patients who develop severe hepatic impairment while taking GIOTRIF, treatment should be discontinued.
Kod bolesnika koji razviju teško oštećenje jetre tijekom primjene GIOTRIFA, mora se prekinuti liječenje.
89% of patients had common EGFR mutations (Del 19 or L858R).
89% bolesnika imalo je česte EGFR mutacije (Del 19 ili L858R).
The types of adverse reactions (ADRs) were generally associated with the EGFR inhibitory mode of action of afatinib.
Tipovi nuspojava na lijek bili su općenito povezani s EGFR inhibicijskim načinom djelovanja afatiniba.
This medicinal product has not been studied in patients with severe (Child Pugh C) hepatic impairment.
Ovaj lijek nije ispitivan u bolesnika s teškim (Child Pugh C) oštećenjem jetre.
The dispersion should be consumed immediately.
Otopina se mora popiti odmah.
Eye irritation or inflammation may occur (conjunctivitis/keratoconjunctivitis occurs commonly and keratitis uncommonly).
Može doći do pojave nadraženosti ili upale oka (konjunktivitis/keratokonjunktivitis se javlja često, a keratitis manje često).
Effects of afatinib on P-gp substrates
Učinci afatiniba na P-gp supstrate
The total systemic exposure (AUC0-24) in male and female rats was in the range or less than that observed in patients (1.3 times and 0.51 times, respectively).
Ukupna sistemska izloženost (AUC0-24) kod muških i ženskih štakora bila je ili u rasponu ili manja od iste primijećene u bolesnika (1,3 puta odnosno 0,51 puta).
NCI Common Terminology Criteria for Adverse Events In case of diarrhoea, anti-diarrhoeal medicinal products (e.g. loperamide) should be taken immediately and continued for persistent diarrhoea until loose bowel movements cease.
NCI zajednički kriteriji terminologije za nuspojave (Common terminology Criteria for Adverse Events) U slučaju proljeva, potrebno je odmah započeti s primjenom lijekova protiv proljeva (npr. loperamid), te nastaviti primjenu tijekom trajanja proljeva dok ne prestane mekana stolica.
Effects of P-gp and breast cancer resistance protein (BCRP) inhibitors on afatinib In vitro studies have demonstrated that afatinib is a substrate of P-gp and BCRP.
P-gp inhibitora i inhibitora proteina za rezistenciju na rak dojke (BCRP) na afatinib In vitro ispitivanja su pokazala da je afatinib supstrat P-gp-a i BCRP-a.
Uncommon side effects (may affect up to 1 in 100 people): • Inflammation of the pancreas (pancreatitis)
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): • Upala gušterače (pankreatitis)
Months (median)
Mjeseci (medijan)
The acquisition of a secondary T790M mutation is a major mechanism of acquired resistance to afatinib and gene dosage of the T790M-containing allele correlates with the degree of resistance in vitro.
Stjecanje sekundarne mutacije T790M glavni je mehanizam stečene rezistencije na afatinib, a broj kopija alela koji sadrži mutaciju T790M korelira sa stupnjem rezistencije in vitro.
• If your next scheduled dose is due within 8 hours, skip the missed dose and take your next dose at the usual time.
• Ako je Vaša sljedeća doza unutar idućih 8 sati, preskočite propuštenu dozu, a sljedeću dozu uzmite u uobičajeno vrijeme.
Grade > 3
Stupanj ≥ 3
GIOTRIF as monotherapy is indicated for the treatment of
GIOTRIF je, u obliku monoterapije, indiciran za liječenje:
• St. John's wort (Hypericum perforatum), a herbal medicine to treat depression.
• Gospina trava (Hypericum perforatum), biljni lijek za liječenje depresije.
• if you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light.
• ako razvijete novo ili dođe do pogoršanja crvenila i boli očiju, pojačanog suzenja, zamagljenja vida i/ili preosjetljivosti na svjetlost.
Bullous, blistering and exfoliative skin conditions have been reported including rare cases suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis.
Prijavljeni su slučajevi buloznih, vezikuloznih i eksfolijativnih stanja kože, uključujući rijetke slučajeve koji ukazuju na Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu.
When the strong P-gp and BCRP inhibitor ritonavir (200 mg twice a day for 3 days) was administered 1 hour before a single dose of 20 mg GIOTRIF, exposure to afatinib increased by 48% (area under the curve (AUC0-∞)) and 39% (maximum plasma concentration (Cmax)).
Kada je primjenjivan snažan P-gp i BCRP inhibitor, ritonavir (200 mg dvaput dnevno u trajanju 3 dana) 1 sat prije jednostruke doze od 20 mg GIOTRIFA, izloženost afatinibu se povećala za 48% (površina ispod krivulje (AUC0-∞)) i 39% (vršne koncentracije u plazmi za (Cmax)).
Patients had a tumour sample with an EGFR mutation categorised as either exon 19 deletion (58%) or exon 21 L858R substitutions (42%).
Bolesnici su imali uzorak tumora s mutacijom EGFR kategoriziranom bilo kao delecija egzona 19 (58%) ili kao supstitucije L858R u egzonu 21 (42%).
• Diarrhoea (very common, may affect more than 1 in 10 people).
• Proljev (vrlo često, može se javiti u više od 1 na 10 osoba).
GIOTRIF in patients with Non-Small Cell Lung Cancer (NSCLC) with EGFR mutations
GIOTRIF kod bolesnika s rakom pluća nemalih stanica (NSCLC) s EGFR mutacijama
The overall survival hazard ratio in patients < 65 years of age was 0.68 (95% CI 0.55, 0.85) and in patients 65 years of age and older it was 0.95 (95% CI 0.76, 1.19).
Omjer hazarda za ukupno preživljenje u bolesnika u dobi ispod 65 godina bio je 0,68 (95% CI 0,55; 0,85), a u bolesnika starih 65 godina i više bio je 0,95 (95% CI 0,76; 1,19).
Patients with severe diarrhoea may require interruption and dose reduction or discontinuation of therapy with GIOTRIF (see section 4.2).
Bolesnici s teškim proljevom mogu zahtijevati prekid i smanjenje doze ili trajni prekid liječenja GIOTRIFOM (vidjeti dio 4.2).
Figure 1: Kaplan-Meier curve for PFS by independent review by treatment group in trial LUX-Lung 3 (Overall Population)
Slika 1: Kaplan-Meierova krivulja za PFS na temelju nezavisne procjene po liječenim skupinama u ispitivanju LUX-Lung 3 (Ukupna populacija)
Each blister contains 7 x 1 film-coated tablets and is packed in an aluminium pouch together with a desiccant sachet that should not be swallowed.
Svaki blister sadrži 7 x 1 filmom obloženu tabletu te je pakiran u aluminijskoj vrećici zajedno s vrećicom sa sredstvom za sušenje koje se ne smije progutati.
Exposure to afatinib moderately increased with lowering of the creatinine clearance (CrCL, calculated according to Cockcroft Gault), i.e. for a patient with a CrCL of 60 mL/min or 30 mL/min exposure (AUCτ,ss) to afatinib increased by 13% and 42%, respectively, and decreased by 6% and 20% for a patient with CrCL of 90 mL/min or 120 mL/min, respectively, compared to a patient with the CrCL of 79 mL/min (median CrCL of patients in the overall patient population analysed).
Izloženost afatinibu se umjereno povećala sa sniženjem klirensa kreatinina (CrCL, izračunato prema Cockcroft Gaultu), tj. u bolesnika s CrCL-om od 60 ml/min ili 30 ml/min izloženost (AUCτ,ss) afatinibu se povećala za 13% odnosno 42%, a smanjila za 6% i 20% u bolesnika s CrCL-om od 90 ml/min odnosno 120 ml/min, u usporedbi s bolesnicima s CrCL-om od 79 ml/min (medijan CrCL bolesnika u ukupnoj analiziranoj bolesničkoj populaciji).
Pre-treatment with rifampicin (600 mg once daily for 7 days), a potent inducer of P-gp, decreased the plasma exposure to afatinib by 34% (AUC0-∞) and 22% (Cmax) after administration of a single dose of 40 mg GIOTRIF.
Prethodno liječenje rifampicinom (600 mg jedanput dnevno u trajanju od 7 dana), snažnim induktorom P-gp-a, smanjilo je izloženost afatinibu u plazmi za 34% (AUC0-∞) i 22% (Cmax) nakon primjene jednostruke doze od 40 mg GIOTRIFA.
Alanine aminotransferase increased
Povišene vrijednosti alanin aminotransferaze
If treatment for rash is not working and the rash is getting more severe (for example, you have peeling or blistering of the skin) you should notify your doctor immediately, since your doctor may decide to stop your treatment with GIOTRIF.
Ako liječenje osipa ne djeluje i osip postaje sve teži (na primjer, koža Vam se ljušti ili dobivate mjehuriće na koži), potrebno je odmah obavijestiti liječnika jer
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).
Izloženost afatinibu ne mijenja se značajno u bolesnika s blagim (Child Pugh A) ili umjerenim (Child Pugh B) oštećenjem jetre (vidjeti dio 5.2).
The pharmacokinetics of afatinib have not been studied in subjects with severe (Child Pugh C) hepatic dysfunction (see section 4.4).
Farmakokinetika afatiniba nije ispitivana na pojedincima s teškom (Child Pugh C) disfunkcijom jetre (vidjeti dio 4.4).
Each blister is packed together with a desiccant sachet in a laminated aluminium pouch and contains 7 x 1 film-coated tablets.
Jedan blister je pakiran zajedno s vrećicom u kojoj je sredstvo za sušenje u laminiranu aluminijsku vrećicu te sadrži 7 x 1 filmom obloženu tabletu.
• if you have a history of eye problems such as severe dry eyes, inflammation of the transparent layer at the front of the eye (cornea) or ulcers involving the outer part of the eye, or if you use contact lenses.
• ako imate pozitivnu anamnezu bolesti očiju, kao sindrom suhog oka, upale prozirnog sloja na prednjoj strani oka (kornea) ili ranice koje uključuju vanjski dio oka, ili ako koristite kontaktne leće.
This medicinal product is for oral use.
Ovaj lijek je namijenjen za peroralnu primjenu.
Second-line GIOTRIF significantly improved PFS and OS of patients with squamous NSCLC compared to erlotinib.
Druga linija GIOTRIFA značajno je poboljšala PFS i OS bolesnika sa skvamoznim NSCLC u usporedbi s erlotinibom.
No dose adjustment
Bez prilagodbe doze
GIOTRIF 20 mg film-coated tablets GIOTRIF 30 mg film-coated tablets GIOTRIF 40 mg film-coated tablets GIOTRIF 50 mg film-coated tablets
GIOTRIF 20 mg filmom obložene tablete GIOTRIF 30 mg filmom obložene tablete GIOTRIF 40 mg filmom obložene tablete GIOTRIF 50 mg filmom obložene tablete
Table 2 summarises the frequencies of ADRs from all NSCLC trials and from post-marketing experience with daily GIOTRIF doses of 40 mg or 50 mg as monotherapy.
Tablica 2 prikazuje sažeti pregled učestalosti nuspojava na lijek iz svih ispitivanja NSCLC-a te iz iskustva nakon stavljanja lijeka u promet, s dnevnim dozama GIOTRIFA od 40 mg ili 50 mg u obliku monoterapije.
® EGFR RGQ PCR Kit, Qiagen Manchester Ltd.
RGQ, Qiagen Manchester Ltd.
In patients with tumours harbouring either G719X (N=18), L861Q (N=16), or S768I substitution mutation (N=8), the confirmed ORR was 72.2%, 56.3%, 75.0%, respectively, and the median duration of response was 13.2 months, 12.9 months and 26.3 months, respectively.
U bolesnika s tumorima koji su imali supstitucijsku mutaciju G719X (N=18), L861Q (N=16) ili S768I (N=8), potvrđeni ORR iznosio je 72,2%, 56,3% odnosno 75,0%, a medijan trajanja odgovora bio je 13,2 mjeseca, 12,9 mjeseci odnosno 26,3 mjeseca.
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.
Kod bolesnika s čimbenicima rizika za razvoj srčanih bolesti i bolesnika sa stanjima koja mogu utjecati na LVEF, potrebno je razmotriti praćenje srčane funkcije, uključujući procjenu LVEF-a na početku i tijekom liječenja.
Animal studies with afatinib did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Ispitivanja na životinjama s afatinibom ne ukazuju na izravan ili neizravan učinak na reprodukciju (vidjeti dio 5.3).
Patients were randomised (2:1) to receive GIOTRIF 40 mg once daily or up to 6 cycles of pemetrexed/cisplatin.
Bolesnici su bili randomizirani (2:1) u grupu liječenu GIOTRIFOM 40 mg jedanput dnevno ili do 6 ciklusa pemetreksed/cisplatina.
LUX-Lung 7 is a randomised, global, open label Phase IIb trial investigating the efficacy and safety of GIOTRIF in patients with locally advanced or metastatic lung adenocarcinoma (stage IIIB or IV) with EGFR mutations in the first-line setting.
LUX-Lung 7 je randomizirano, globalno, otvoreno ispitivanje faze IIb koje je istraživalo djelotvornost i sigurnost primjene GIOTRIFA u prvoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim adenokarcinomom pluća (stadij IIIB ili IV) s EGFR mutacijama.
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)
Tablica 7: Rezultati djelotvornosti za PFS i OS za GIOTRIF naspram kombinacije pemetreksed/cisplatin (LUX-Lung 3) i gemcitabin/cisplatin (LUX-Lung 6) u prethodno definiranim podskupinama EGFR mutacija Del 19 i L858R (nezavisna procjena)
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.
Djelotvornost i sigurnost GIOTRIFA kao druge linije liječenja za bolesnike s uznapredovalim NSCLC sa skvamoznim stanicama u histološkom nalazu istraženi su u randomiziranom otvorenom globalnom ispitivanju faze III LUX-Lung 8.
4 Any Grade
4 Svaki stupanj
PFS benefit was accompanied by improvement in disease-related symptoms and delayed time to deterioration (see Table 11).
Korist u PFS-u bila je popraćena poboljšanjem simptoma izazvanih bolešću, te odgodom vremena do pogoršanja (vidjeti tablicu 11).
If you stop taking GIOTRIF
Ako prestanete uzimati GIOTRIF
Among the patients randomised, 62% were female, the median age was 63 years, 16% of patients had brain metastases, the baseline ECOG performance status was 0 (31%) or 1 (69%), 57% were Asian and 43% were non-Asian.
Među randomiziranim bolesnicima, 62% su bile žene, medijan dobi je bio 63 godine, 16% bolesnika je imalo metastaze u mozgu, početno funkcionalno stanje ECOG bilo je 0 (31%) ili 1 (69%), 57% su bili azijati, a 43% neazijati.
In patients treated with once daily GIOTRIF 40 mg, dose reductions due to ADRs occurred in 57% of the patients in the LUX-Lung 3 trial and in 25% of the patients in the LUX-Lung 8 trial.
Kod bolesnika liječenih GIOTRIFOM 40 mg jedanput dnevno smanjenje doze zbog nuspojava na lijek bilo je potrebno kod 57% bolesnika u ispitivanju LUX-Lung 3 te kod 25% bolesnika u ispitivanju LUX-Lung 8.
• Nail infection
• Infekcija nokta
In patients with tumours harbouring de-novo T790M mutations (N=14) the confirmed ORR was 14.3% and the median duration of response was 8.3 months.
U bolesnika čiji su tumori nosili de-novo mutacije T790M (N=14) potvrđeni ORR iznosio je 14,3%, a medijan trajanja odgovora bio je 8,3 mjeseca.
PFS benefit was accompanied by improvement in disease-related symptoms and delayed time to deterioration (see Table 8).
Korist u PFS-u bila je popraćena poboljšanjem simptoma izazvanih bolešću, te odgodom vremena do pogoršanja (vidjeti tablicu 8).
You should have antidiarrhoeal medicine available prior to taking GIOTRIF.
Morate imati lijek protiv proljeva prije nego započnete liječenje GIOTRIFOM.
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-∞.
Istodobna primjena GIOTRIFA i obroka bogatog visokim udjelom masnoća rezultirala je značajnim smanjenjem izloženosti afatinibu za oko 50% Cmax,odnosno za oko 39% AUC0-∞.
In vitro studies indicated that afatinib is a substrate and an inhibitor of the transporter BCRP.
In vitro ispitivanja su pokazala da je afatinib supstrat i inhibitor prijenosnika BCRP-a.