FrancophonIA/ELRC3.0 huggingface dataset:
English: As a precautionary measure, women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with GIOTRIF.
Croatian: Kao mjera opreza, ženama reproduktivne dobi mora se savjetovati izbjegavanje trudnoće tijekom liječenja GIOTRIFOM.
English: Patients with severe skin reactions may also require temporary interruption of therapy, dose reduction (see section 4.2), additional therapeutic intervention, and referral to a specialist with expertise in managing these dermatologic effects.
Croatian: Bolesnici s teškim kožnim reakcijama također mogu zahtijevati privremeni prekid terapije, smanjenje doze (vidjeti dio 4.2), dodatnu terapijsku intervenciju, te upućivanje specijalistu s iskustvom u zbrinjavanju ovih dermatoloških reakcija.
English: Table 1: Dose adjustment information for adverse reactions
Croatian: Tablica 1: Informacije o prilagodbi doze za nuspojave
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE13.
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE13.
English: The adverse reactions observed at these doses were primarily dermatological (rash/acne) and gastrointestinal events (especially diarrhoea).
Croatian: Nuspojave primijećene pri ovim dozama bile su prvenstveno dermatološke (osip/akne) i gastrointestinalne (osobito proljev).
English: Grade 3 diarrhoea most frequently occurred within the first 6 weeks of treatment.
Croatian: Proljev stupnja 3 najčešće se javlja u prvih 6 tjedana liječenja.
English: The parent compound afatinib accounted for 88% of the recovered dose.
Croatian: Ishodišni spoj, afatinib je činio 88% pronađene doze.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene u padajućem slijedu prema ozbiljnosti.
English: In 61 patients treated in the first-line setting, confirmed ORR was 65.6% and DCR was 86.9% according to independent review.
Croatian: Kod 61 bolesnika liječenog u prvoj liniji, potvrđeni ORR je bio 65,6%, a DCR 86,9% na temelju nezavisne procjene.
English: You may experience increased side effects and your doctor may interrupt your treatment and provide supportive care.
Croatian: Možda ćete imati pojačane nuspojave, te će liječnik možda prekinuti Vaše liječenje i primijeniti potporno liječenje.
English: Carcinogenicity Carcinogenicity studies have not been conducted with GIOTRIF.
Croatian: Kancerogenost Nisu provođena ispitivanja kancerogenosti s GIOTRIFOM.
English: Approximately 2% of the afatinib dose was metabolized by FMO3 and the CYP3A4-dependent N-demethylation was too low to be quantitatively detected.
Croatian: Oko 2% doze afatiniba metabolizirano je putem FMO3, a N-demetilacija ovisna o CYP3A4 je bila preniska da bi se dobio kvantitativni rezultat.
English: • Decreased appetite
Croatian: • Smanjeni apetit
English: Overall, dose reduction (see section 4.2) led to a lower frequency of common adverse reactions.
Croatian: Općenito, smanjenje doze (vidjeti dio 4.2) dovelo je do pada učestalosti čestih nuspojava.
English: Based on population pharmacokinetic data derived from clinical trials in various tumour types, an average decrease of 26% in AUCτ,ss was observed when food was consumed within 3 hours before or 1 hour after taking GIOTRIF.
Croatian: Temeljem populacijskih farmakokinetičkih podataka dobivenih iz kliničkih ispitivanja na raznim tipovima tumora, prosječno smanjenje od 26% AUC-aτ,ss primijećeno je kada je hrana bila konzumirana unutar 3 sata prije ili 1 sat nakon unosa GIOTRIFA.
English: The efficacy results are summarized in Table 9.
Croatian: Rezultati djelotvornosti sažeti su u Tablici 9.
English: There are no or limited amount of data from the use of this medicinal product in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni ovog lijeka u trudnica ograničeni.
English: A fertility study in male and female rats up to the maximum tolerated dose revealed no significant impact on fertility.
Croatian: Ispitivanja plodnosti na muškim i ženskim štakorima do maksimalno podnošene doze nisu otkrila značajan utjecaj na plodnost.
English: Following administration of an oral solution of 15 mg afatinib, 85.4% of the dose was recovered in the faeces and 4.3% in urine.
Croatian: Nakon primjene oralne otopine 15 mg afatiniba, 85,4% doze pronađeno je u fecesu, a 4,3% u urinu.
English: • Sulfasalazine, used to treat inflammation/infection.
Croatian: • Sulfasalazin, primjenjuje se za liječenje upale/infekcije.
English: Tell your doctor if a rash starts.
Croatian: Obavijestite liječnika ako se pojavi osip.
English: Inform your doctor immediately while taking this medicine:
Croatian: Odmah obavijestite liječnika ako tijekom primjene ovog lijeka:
English: If a diagnosis of ulcerative keratitis is confirmed, treatment should be interrupted or discontinued.
Croatian: Ako se potvrdi dijagnoza ulceroznog keratitisa, liječenje se mora privremeno ili trajno prekinuti.
English: Population pharmacokinetic analysis in special populations A population pharmacokinetic analysis was performed in 927 cancer patients (764 with NSCLC) receiving GIOTRIF monotherapy.
Croatian: Populacijska farmakokinetička analiza u posebnim populacijama Populacijska farmakokinetička analiza provedena je na 927 bolesnika s rakom (764 s NSCLC-om) koji su primali monoterapiju GIOTRIFOM.
English: This medicine contains a sugar called lactose.
Croatian: Ovaj lijek sadrži šećer koji se naziva laktoza.
English: Recommended dosing
Croatian: Preporučeno doziranje
English: The dispersion can also be administered through a gastric tube.
Croatian: Otopina se može također primijeniti putem gastrične sonde.
English: This means preferably 6 hours (for medicines taken twice daily) or 12 hours (for medicines taken once daily) apart from GIOTRIF:
Croatian: Ovo znači po mogućnosti nakon 6 sati (za lijekove koji se uzimaju dva puta dnevno) ili 12 sati (za lijekove koji se uzimaju jednom dnevno) od primjene GIOTRIFA:
English: Among randomized patients, 65% were female, the median age was 58 years and all patients were of Asian ethnicity.
Croatian: Među randomiziranim bolesnicima, 65% su bile žene, medijan dobi je bio 58 godina, a svi bolesnici su bili azijatskog etničkog podrijetla.
English: Hypersensitivity to afatinib or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na afatinib ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: However, systemic exposures achieved in animals were either in a similar range or below the levels observed in patients (see section 5.3).
Croatian: Međutim, sistemska izloženost postignuta kod životinja bila je ili u sličnom rasponu ili ispod vrijednosti primijećenih kod ljudi (vidjeti dio 5.3).
English: Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim, nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Aberrant ErbB signalling triggered by receptor mutations, and/or amplification, and/or receptor ligand overexpression contributes to the malignant phenotype.
Croatian: Aberantni ErbB prijenos signala koji pokreću mutacije i/ili amplifikacija receptora, i/ili prekomjerna ekspresija liganda receptora pridonosi malignom fenotipu.
English: Patients who become dehydrated may require administration of intravenous electrolytes and fluids.
Croatian: Bolesnici koji dehidriraju mogu zahtijevati intravensku primjenu elektrolita i otopina.
English: A risk to the breast-feeding child cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: Limited non-clinical and/or clinical activity was observed in NSCLC tumours with insertion mutations in exon 20.
Croatian: Ograničena neklinička i/ili klinička aktivnost primijećena je u NSCLC tumorima s insercijskim mutacijama u egzonu 20.
English: If you are not able to swallow and have a gastric tube your doctor might suggest that the medicine is given to you via the tube.
Croatian: Ako ne možete gutati i imate gastričnu sondu, liječnik Vam može predložiti primjenu lijeka putem sonde.
English: Diarrhoea lasting more than 2 days or more severe diarrhoea may lead to fluid loss (common, may affect up to 1 in 10 people), low blood potassium (common) and worsening kidney function (common).
Croatian: Proljev koji traje dulje od 2 dana ili teži proljev može dovesti do gubitka tekućine (često, može se javiti u do 1 na 10 osoba), niske razine kalija u krvi (često) i pogoršanja bubrežne funkcije (često).
English: • if you develop skin rash.
Croatian: • ako razvijete osip na koži.
English: Based on the mechanism of action, all EGFR targeting medicinal products including GIOTRIF have the potential to cause foetal harm.
Croatian: Na osnovi mehanizma djelovanja, svi lijekovi koji ciljaju EGFR, uključujući GIOTRIF, imaju potencijal izazivanja oštećenja fetusa.
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Croatian: Ako se dijagnosticira keratitis, potrebno je pažljivo razmotriti omjer koristi i rizika nastavka liječenja.
English: Food should not be consumed for at least 3 hours before and at least 1 hour after taking this medicinal product (see sections 4.5 and 5.2).
Croatian: Hrana se ne smije konzumirati najmanje 3 sata prije, te najmanje 1 sat poslije uzimanja ovog lijeka (vidjeti dijelove 4.5 i 5.2).
English: Delay of time to deterioration (months)
Croatian: Odgoda vremena do pogoršanja (mjeseci)
English: • Swallow the tablet whole with a glass of still water.
Croatian: • Progutajte tabletu cijelu s čašom obične vode.
English: The efficacy results are summarized in Figure 1 (LUX-Lung 3) and Tables 6 and 7 (LUX-Lung 3 and 6).
Croatian: Rezultati djelotvornosti sažeti su na slici 1 (LUX-Lung 3) i u tablicama 6 i 7 (LUX-Lung 3 i 6).
English: Do not use this medicine after the expiry date which is stated on the carton, the pouch and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, vrećici i blisteru iza oznake „EXP“.
English: If you become pregnant while receiving this medicine, you should immediately inform your doctor.
Croatian: Ako zatrudnite tijekom primjene ovog lijeka, potrebno je odmah obavijestiti liječnika.
English: Effect of UDP-glucuronosyltransferase 1A1 (UGT1A1) inhibition on afatinib In vitro data indicated that drug-drug interactions with afatinib due to inhibition of UGT1A1 are considered unlikely.
Croatian: Učinak inhibicije UDP-glukuronosiltransferaze 1A1 (UGT1A1) na afatinib In vitro podaci ukazuju da se interakcije lijekova s afatinibom zbog inhibicije UGT1A1 ne smatraju vjerojatnima.
English: The dose should not be escalated in any patients with a prior dose reduction.
Croatian: Doza se ne smije povećati u bolesnika kod kojih je prethodno doza bila snižena.
English: Dermatitis acneiform Pruritus Dry skin
Croatian: Akneiformni dermatitis Pruritus Suha koža
English: Studies in animals have shown no signs of teratogenicity up to and including maternally lethal dose levels.
Croatian: Ispitivanja na životinjama nisu pokazala teratogenost do, i uključujući, doze koje su smrtonosne za majku.
English: The highest dose of afatinib studied in a limited number of patients in Phase I clinical trials was 160 mg once daily for 3 days and 100 mg once daily for 2 weeks.
Croatian: Najviša doza afatiniba ispitivana na ograničenom broju bolesnika u kliničkim ispitivanjima faze I bila je 160 mg jedanput dnevno u trajanju 3 dana i 100 mg jedanput dnevno u trajanju 2 tjedna.
English: Drop the tablet into the water without crushing it, and occasionally stir for up to 15 min until the tablet is broken up into very small particles.
Croatian: Ubacite tabletu u vodu bez drobljenja, te povremeno miješajte do 15 min dok se tableta ne rastopi u vrlo male čestice.
English: Secondary endpoints include ORR and DCR.
Croatian: Sekundarne mjere ishoda su uključivale ORR i DCR.
English: In humans, excretion of afatinib is primarily via the faeces.
Croatian: U ljudi, izlučivanje afatiniba prvenstveno se odvija putem fecesa.
English: You should avoid becoming pregnant while taking this medicine.
Croatian: Potrebno je izbjegavati trudnoću tijekom primjene ovog lijeka.
English: Grade 1 or Grade 2
Croatian: Stupanj 1 ili stupanj 2
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture and light.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnom pakiranju radi zaštite od vlage i svjetlosti.
English: • Adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy (see section 5.1).
Croatian: • odraslih bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om sa skvamoznim stanicama u histološkom nalazu, koje pokazuju progresiju tijekom ili nakon kemoterapije temeljene na platini (vidjeti dio 5.1).
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).
Croatian: Djelotvornost je bila približno jednako velika u skupini bolesnika koji su prethodno primili kemoterapiju (N=68; ORR 57,4%; PFS na temelju nezavisne procjene 8 mjeseci).
English: What you need to know before you take GIOTRIF
Croatian: Što morate znati prije nego počnete uzimati GIOTRIF
English: Afatinib covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4.
Croatian: Afatinib se kovalentno veže, te ireverzibilno blokira prijenos signala sa svih homo- i heterodimera koje stvaraju članovi ErbB obitelji, EGFR (ErbB1), HER2 (ErbB2), ErbB3 i ErbB4.
English: • Ritonavir, ketoconazole (except in shampoo), itraconazole, erythromycin, nelfinavir, saquinavir - used to treat different kinds of infections.
Croatian: • Ritonavir, ketokonazol (osim u obliku šampona), itrakonazol, eritromicin, nelfinavir, sakvinavir primjenjuju se za liječenje različitih vrsta infekcija.
English: Oral administration of single doses to mice and rats indicated a low acute toxic potential of afatinib.
Croatian: Oralna primjena jednostruke doze na miševima i štakorima ukazala je na niski potencijal akutne toksičnosti afatiniba.
English: Other information on drug-drug interactions
Croatian: Druge informacije o interakcijama s lijekovima
English: Delay of median time to deterioration (months)
Croatian: Odgoda medijana vremena do pogoršanja (mjeseci)
English: The tablet should be dropped into the water without crushing it, and stirred occasionally for up to 15 min until it is broken up into very small particles.
Croatian: Tabletu je potrebno staviti u vodu bez drobljenja, te ju povremeno promiješati u trajanju do 15 min, dok se ne rastopi u vrlo male čestice.
English: No significant impact of age (range: 28 years - 87 years) on the pharmacokinetics of afatinib could be observed.
Croatian: Dob Nije bio primijećen značajan utjecaj dobi (raspon: 28 - 87 godina) na farmakokinetiku afatiniba.
English: In patients treated with afatinib for more than 6 months a terminal half-life of 344 h was estimated.
Croatian: Terminalni poluvijek u bolesnika liječenih afatinibom duže od 6 mjeseci procijenjen je na 344 h.
English: 1-year PFS Rate Objective Response Rate (CR+PR)
Croatian: 1-godišnja stopa PFS-a Stopa objektivnog odgovora (CR+PR)
English: Liver function test abnormalities (including elevated ALT and AST) were observed in patients receiving GIOTRIF 40 mg.
Croatian: Abnormalni nalazi testova jetrene funkcije (uključujući povišene ALT i AST) primijećeni su kod bolesnika koji su uzimali GIOTRIF 40 mg.
English: • if you have a history of lung inflammation (interstitial lung disease).
Croatian: • ako imate pozitivnu anamnezu upale pluća (bolest plućnog intersticija).
English: There is no relevant use of GIOTRIF in the paediatric population in the indication of NSCLC.
Croatian: Nema relevantne primjene GIOTRIFA u pedijatrijskoj populaciji za indikaciju NSCLC-a.
English: Fertility studies in humans have not been performed with afatinib.
Croatian: Ispitivanja plodnosti u ljudi nisu provedena s afatinibom.
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).
Croatian: Stoga se hrana ne smije konzumirati najmanje 3 sata prije i najmanje 1 sat poslije unosa GIOTRIFA (vidjeti dio 4.2 i 4.5).
English: ILD-like adverse reactions were reported in 0.7% of patients treated with GIOTRIF across all clinical trials (including 0.5% of patients with CTCAE Grade ≥ 3 ILD-like adverse reactions).
Croatian: Nuspojave slične BPI-u prijavljene su kod 0,7% bolesnika liječenih GIOTRIFOM u svim kliničkim ispitivanjima (uključujući 0,5% bolesnika s CTCAE stupnjem ≥ 3 nuspojava sličnih BPI-u).
English: Other secondary endpoints included ORR, DCR, change in tumour size and HRQOL.
Croatian: Drugi sekundarni ishodi uključivali su ORR, DCR, promjenu u veličini tumora i HRQOL.
English: Other potential mechanisms of resistance to afatinib have been suggested preclinically and MET gene amplification has been observed clinically.
Croatian: Pretklinički su predloženi drugi potencijalni mehanizmi rezistencije na afatinib, dok je klinički uočena amplifikacija MET gena.
English: Like all medicines, GIOTRIF can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, GIOTRIF može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Randomisation was stratified according to EGFR mutation status (Del 19; L858R) and presence of brain metastases (yes; no).
Croatian: Randomizacija je bila stratificirana sukladno statusu EGFR mutacije (Del 19; L858R) i prisutnosti metastaza u mozgu (da; ne).
English: During treatment, ocular adverse reactions (conjunctivitis, dry eye, keratitis) have been reported in some patients (see section 4.8) which may affect patients ability to drive or use machines.
Croatian: Tijekom liječenja, prijavljene su nuspojave na očima (konjunktivitis, sindrom suhog oka, keratitis) kod nekih bolesnika (vidjeti dio 4.8) koje mogu utjecati na bolesnikovu sposobnost upravljanja vozilima i rada sa strojevima.
English: Contact your doctor as soon as possible if you suffer from any of the serious side effects listed below.
Croatian: Javite se liječniku što je prije moguće ako imate neku od teških nuspojava navedenih u nastavku.
English: 3 4 Any Grade
Croatian: 3 4 Svaki stupanj
English: Adjustments to the starting dose are not necessary in patients with mild or moderate hepatic impairment.
Croatian: Prilagodbe početne doze nisu potrebne kod bolesnika s blagim ili umjerenim oštećenjem jetre.
English: 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.
Croatian: Potrebna je pažljiva procjena svih bolesnika s akutnim nastupom i/ili neobjašnjenim pogoršanjem plućnih simptoma (dispneja, kašalj, vrućica) kako bi se isključio BPI.
English: Median PFS (months), Overall Trial Population 18-months PFS rate 24-months PFS rate
Croatian: Medijan PFS-a (mjeseci), ukupna populacija ispitivanja 18-mjesečna stopa PFS-a 24-mjesečna stopa PFS-a
English: The European Medicines Agency has waived the obligation to submit the results of trials with this medicinal product in all subsets of the paediatric population in NSCLC indications (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka GIOTRIF u svim podskupinama pedijatrijske populacije za indikaciju NSCLC-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: However, if the next scheduled dose is due within 8 hours then the missed dose must be skipped.
Croatian: Međutim, ako je sljedeća doza prema režimu doziranja za manje od 8 sati, onda se propuštena doza mora preskočiti.
English: Based on this, it is likely that afatinib is excreted in human milk.
Croatian: Na osnovi spomenutog, vjerojatno je da se afatinib izlučuje u majčino mlijeko u ljudi.
English: Duration of response Months (median)
Croatian: Trajanje odgovora Mjeseci (medijan)
English: Patients who received at least 4 cycles of platinum-based therapy in the first line setting were subsequently randomized 1:1 to daily GIOTRIF 40 mg or erlotinib 150 mg until progression.
Croatian: Bolesnici koji su primili najmanje 4 ciklusa terapije temeljene na platini u prvoj liniji liječenja, randomizirani su potom 1:1 na dnevnu dozu GIOTRIFA 40 mg ili erlotiniba 150 mg do progresije bolesti.
English: • if you have a history of heart problems.
Croatian: • ako imate pozitivnu anamnezu srčanih bolesti.
English: Warnings and precautions Talk to your doctor or pharmacist before taking this medicine:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek:
English: However, this medicinal product has not been studied in patients with abnormal left ventricular ejection fraction (LVEF) or those with significant cardiac history.
Croatian: Međutim, ovaj lijek nije ispitivan u bolesnika s abnormalnom ejekcijskom frakcijom lijevog ventrikula (LVEF) kao niti u bolesnika s pozitivnom srčanom anamnezom.
English: Subjects with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment had similar exposure in comparison to healthy volunteers following a single dose of 50 mg GIOTRIF.
Croatian: Pojedinci s blagim (Child Pugh A) ili umjerenim (Child Pugh B) oštećenjem jetre imali su sličnu izloženost u usporedbi sa zdravim dobrovoljcima nakon jednostruke doze od 50 mg GIOTRIFA.
English: Female gender, lower body weight, and underlying renal impairment Higher exposure to afatinib has been observed in female patients, patients with lower body weight and those with underlying renal impairment (see section 5.2).
Croatian: Ženski spol, niža tjelesna težina i postojeće oštećenje bubrega Veća izloženost afatinibu primijećena je kod bolesnica ženskog spola, bolesnika s manjom tjelesnom težinom, te bolesnika s postojećim oštećenjem bubrega (vidjeti dio 5.2).
English: Exposure to afatinib in subjects with renal impairment was compared to healthy volunteers following a single dose of 40 mg GIOTRIF.
Croatian: Izloženost afatinibu u ispitanika s oštećenjem bubrega bila je uspoređena sa zdravim dobrovoljcima nakon jednostruke doze od 40 mg GIOTRIFA.
English: The respective total systemic exposure (AUC) was either slightly above (2.2 times in rats) or below (0.3 times in rabbits) compared with levels in patients.
Croatian: Ukupna sistemska izloženost (AUC) bila je ili malo iznad (2,2 puta kod štakora) ili ispod (0,3 puta kod kunića) u usporedbi s vrijednostima u bolesnika.
English: ILD-like adverse reactions were reported in 0.7% of afatinib treated patients.
Croatian: Nuspojave nalik BPI-u prijavljene su kod 0,7% bolesnika liječenih afatinibom.
English: Available pharmacokinetic data in animals have shown excretion of afatinib in milk (see section 5.3).
Croatian: Dostupni farmakokinetički podaci u životinja pokazuju da se afatinib izlučuje u mlijeko (vidjeti dio 5.3).
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.
Croatian: Za razliku od toga, kada je ritonavir bio primjenjivan istodobno ili 6 sati nakon 40 mg GIOTRIFA, relativna bioraspoloživost afatiniba bila je 119% (AUC0-∞) i 104% (Cmax) odnosno 111% (AUC0-∞) te 105% (Cmax).
English: Use of P-glycoprotein (P-gp) inhibitors
Croatian: Primjena inhibitora P-glikoproteina (P-gp)