FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean scores over time for overall quality of life, global health status and physical, role, cognitive, social and emotional functioning were significantly better for GIOTRIF.
Slovenian: Povprečne ocene skupne kakovosti življenja, globalnega zdravstvenega stanja in telesne funkcije, socialne vloge, kognitivne in čustvene funkcije so bile skozi čas pomembno boljše pri zdravljenju z zdravilom GIOTRIF.
English: At the first signs of diarrhoea drink plenty of fluids.
Slovenian: Ko se pojavijo prvi znaki driske, pijte veliko tekočine.
English: • if you have a history of heart problems.
Slovenian: • če ste imeli v preteklosti težave s srcem.
English: If you plan to become pregnant after taking the last dose of this medicine, you should ask your doctor for advice as your body may not have fully eliminated this medicine.
Slovenian: Če načrtujete nosečnost po tem, ko boste vzeli zadnji odmerek tega zdravila, se o tem posvetujte s svojim zdravnikom, ker je možno, da se zdravilo še ne bo povsem izločilo iz telesa.
English: Approximately 2% of the afatinib dose was metabolized by FMO3 and the CYP3A4-dependent N-demethylation was too low to be quantitatively detected.
Slovenian: Približno 2% odmerka afatiniba je presnovil FMO3, od CYP4A4 odvisna N-demetilacija pa je bila premajhna, da bi jo lahko količinsko določili.
English: Tell your doctor before taking these medicines together with GIOTRIF.
Slovenian: Obvestite zdravnika, preden boste našteta zdravila vzeli hkrati z zdravilom GIOTRIF.
English: The maximum daily dose is 50 mg.
Slovenian: Največji dnevni odmerek je 50 mg.
English: Polysorbate 80 (E433)
Slovenian: • polisorbat 80 (E433)
English: NCI-CTC Grade
Slovenian: Stopnja po NCI-CTC
English: • of squamous type if prior chemotherapy treatment has been insufficient.
Slovenian: • ploščatoceličnega tipa, v primeru da predhodna kemoterapija ni bila dovolj učinkovita.
English: • Cyclosporine A, tacrolimus - medicines that affect your immune system.
Slovenian: • ciklosporin A, takrolimus - zdravila z učinkom na imunski sistem.
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Slovenian: Pri diagnozi keratitisa je treba skrbno pretehtati koristi in tveganje zdravljenja.
English: Objective Response Rate (CR+PR)
Slovenian: Stopnja objektivnega odziva (CR+PR)
English: Race had no effect on the pharmacokinetics of afatinib based on a population pharmacokinetic analysis, including patients of Asian, White, and Black racial groups.
Slovenian: Rasa na farmakokinetiko afatiniba ni vplivala, kar je pokazala populacijska farmakokinetična analiza, ki je zajela Azijce, belce in črnce.
English: This leaflet was last approved in {MM/YYYY} Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Drugi viri informacij
English: If you have difficulties swallowing the tablet, dissolve it in a glass of still water.
Slovenian: Če tableto težko pogoltnete, jo raztopite v kozarcu negazirane vode.
English: If a diagnosis of ulcerative keratitis is confirmed, treatment should be interrupted or discontinued.
Slovenian: Če je potrjena diagnoza ulceroznega keratitisa, je treba zdravljenje prekiniti ali zdravilo ukiniti.
English: • Rifampicin, an antibiotic used to treat tuberculosis.
Slovenian: • rifampicin, antibiotik za zdravljenje tuberkuloze.
English: Cmax and AUC0-∞ values increased slightly more than proportionally in the dose range from 20 mg to 50 mg GIOTRIF.
Slovenian: Vrednosti Cmax in AUC0-∞ sta se pri razponu odmerkov od 20 mg do 50 mg zdravila GIOTRIF povečali nekoliko bolj kot proporcionalno.
English: The efficacy results at the time of the primary analysis of OS including all randomized patients are summarized in Figure 2 and Table 10.
Slovenian: Podatki o učinkovitosti v času primarne analize skupnega preživetja vključno z vsemi naključno izbranimi bolniki so povzeti na sliki 2 ter navedeni v preglednici 10.
English: Closer monitoring is recommended in patients with these risk factors.
Slovenian: Pri bolnikih s temi dejavniki tveganja so potrebni pogostejši kontrolni pregledi.
English: • Adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy (see section 5.1).
Slovenian: • odraslih bolnikov z lokalno napredovalim ali metastatskim NSCLC s ploščatocelično histologijo, ki napreduje med ali po opravljeni kemoterapiji na osnovi platine (glejte poglavje 5.1).
English: Patients who become dehydrated may require administration of intravenous electrolytes and fluids.
Slovenian: Dehidrirani bolniki včasih potrebujejo intravensko vnašanje elektrolitov in tekočin.
English: Interactions with drug transport systems
Slovenian: Medsebojno delovanje s transportnimi sistemi za zdravila
English: Afatinib is a potent and selective, irreversible ErbB Family Blocker.
Slovenian: Afatinib je močan in selektiven ireverzibilni zaviralec družine ErbB.
English: • Do not break, chew or crush the tablet.
Slovenian: • Tablet ne lomite, žvečite ali drobite.
English: If a dose is missed, it should be taken within the same day as soon as the patient remembers.
Slovenian: Če bolnik pozabi vzeti odmerek zdravila, ga mora vzeti še isti dan, takoj ko se spomni.
English: Contact your doctor as soon as possible if you suffer from any of the serious side effects listed below.
Slovenian: Čim prej obvestite svojega zdravnika, če opazite katerega od zgoraj navedenih neželenih učinkov.
English: Then carry on taking your tablets at regular times as usual.
Slovenian: Naslednje tablete jemljite ob običajnem času.
English: Food effect on afatinib
Slovenian: Učinek hrane na afatinib
English: GIOTRIF can be prescribed to you as your first treatment or if prior chemotherapy treatment has been insufficient.
Slovenian: Zdravilo GIOTRIF vam lahko predpišejo kot prvo zdravilo ali v primeru, da predhodna kemoterapija ni bila dovolj učinkovita;
English: The parent compound afatinib accounted for 88% of the recovered dose.
Slovenian: Matična spojina afatinib je sestavljala 88% izločenega odmerka.
English: The following terms are used to rank the ADRs by frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Neželene reakcije na zdravilo so po pogostnosti razdeljene v naslednje skupine: zelo pogoste (≥ 1/10); pogoste (≥ 1/100 do < 1/10); občasne (≥ 1/1.000 do < 1/100); redke (≥ 1/10.000 do < 1/1000); zelo redke (< 1/10.000).
English: You may experience increased side effects and your doctor may interrupt your treatment and provide supportive care.
Slovenian: Izkusite lahko izrazitejše neželene učinke, zato lahko zdravnik vaše zdravljenje prekine in uvede podporno zdravstveno oskrbo.
English: Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze tega zdravila ne smejo jemati.
English: If swallowing of whole tablets is not possible, these can be dispersed in approximately 100 ml of non-carbonated drinking water.
Slovenian: Če celih tablet ni možno pogoltniti, lahko bolnik tablete razpusti v približno 100 ml negazirane pitne vode.
English: Population pharmacokinetic analysis in special populations A population pharmacokinetic analysis was performed in 927 cancer patients (764 with NSCLC) receiving GIOTRIF monotherapy.
Slovenian: Populacijska farmakokinetična analiza pri posebnih populacijah Populacijska farmakokinetična analiza je zajela 927 bolnikov z rakom (764 z NSCLC), ki so se zdravili z monoterapijo z zdravilom GIOTRIF.
English: 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.
Slovenian: Če zdravilo proti izpuščaju ni učinkovito in postaja izpuščaj resnejši (pojavita se, na primer, luščenje ali mehurjavost kože), morate o tem takoj obvestiti zdravnika, ker je možno, da se bo odločil zdravljenje z zdravilom GIOTRIF ukiniti.
English: In vitro binding of afatinib to human plasma proteins is approximately 95%.
Slovenian: In vitro se na beljakovine v človeški plazmi veže približno 95% afatiniba.
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.
Slovenian: Največja odmerka afatiniba, ki so ju preskušali pri manjšem številu bolnikov v kliničnih raziskavah I. faze, sta bila 160 mg enkrat na dan 3 dni in 100 mg enkrat na dan 2 tedna.
English: Hypersensitivity to afatinib or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na afatinib ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Additionally, in various organs pharmacodynamically mediated atrophy of epithelia was observed in both species.
Slovenian: Poleg tega so v različnih organih pri obeh živalskih vrstah odkrili atrofijo epitelija, ki je bila povezana s farmakodinamičnim delovanjem.
English: Radiolabelled afatinib administered orally to rats on Day 11 of lactation was excreted in the breast milk of the dams.
Slovenian: Radioaktivno označeni afatinib, ki so ga peroralno dajali podganam 11. dan laktacije, se je izločal v mleko samic.
English: In vitro data indicated that drug-drug interactions with afatinib due to inhibition of OATB1B1, OATP1B3, OATP2B1, OAT1, OAT3, OCT1, OCT2, and OCT3 transporters are considered unlikely.
Slovenian: Medsebojno delovanje s transportnimi sistemi za privzem zdravil Podatki in vitro so pokazali, da medsebojni učinki afatiniba z drugimi zdravili zaradi zaviranja prenašalcev OATB1B1, OATP1B3, OATP2B1, OAT1, OAT3, OCT1, OCT2 in OCT3 niso verjetni.
English: Interactions with Cytochrome P450 (CYP) enzymes
Slovenian: Interakcije z encimi citokroma P450 (CYP)
English: This is consistent with population pharmacokinetic data derived from clinical trials in various tumour types (see “Population pharmacokinetic analysis in special populations” below).
Slovenian: To se ujema s podatki o farmakokinetiki v kliničnih preskušanjih pri različnih oblikah tumorjev (glejte spodaj ''Populacijska farmakokinetična analiza pri posebnih populacijah".)
English: Afatinib is not an inhibitor or an inducer of CYP enzymes.
Slovenian: Afatinib ni zaviralec niti induktor encimov CYP.
English: They should therefore be taken as far apart in time as possible from GIOTRIF.
Slovenian: Zato jih je treba vzeti s čim večjim časovnim razmikom od odmerka zdravila GIOTRIF.
English: If indicated, elimination of unabsorbed afatinib may be achieved by emesis or gastric lavage.
Slovenian: Če je indicirano, lahko neabsorbirani afatinib odstranimo z emezo ali izpiranjem želodca.
English: This is because there may be a risk that an unborn baby is harmed.
Slovenian: To je potrebno zaradi možnih škodljivih učinkov na nerojenega otroka.
English: What GIOTRIF is and what it is used for
Slovenian: Kaj je zdravilo GIOTRIF in za kaj ga uporabljamo
English: This means preferably 6 hours (for medicines taken twice daily) or 12 hours (for medicines taken once daily) apart from GIOTRIF:
Slovenian: To pomeni, najbolje 6 ur (pri zdravilih, ki se jih jemlje dvakrat na dan) ali 12 ur (pri zdravilih, ki se jih jemlje enkrat na dan) od jemanja zdravila GIOTRIF:
English: Other potential mechanisms of resistance to afatinib have been suggested preclinically and MET gene amplification has been observed clinically.
Slovenian: Predklinično so posumili na druge potencialne mehanizme odpornosti na afatinib, amplifikacijo gena MET pa so klinično ugotovili.
English: • Pain, redness, swelling or peeling of the skin of your hands and feet
Slovenian: • bolečina, pordelost, otekanje ali luščenje kože dlani in stopal
English: Limited non-clinical and/or clinical activity was observed in NSCLC tumours with insertion mutations in exon 20.
Slovenian: Omejeno neklinično in/ali klinično aktivnost so ugotovili pri tumorjih NSCLC z mutacijami z vstavljanjem v ekson 20.
English: Among randomized patients, 65% were female, the median age was 58 years and all patients were of Asian ethnicity.
Slovenian: Med naključno razvrščenimi bolniki je bilo 65 % žensk, njihova mediana starost je bila 58 let, vsi bolniki pa so bili azijskega porekla.
English: Hepatic failure, including fatalities, has been reported during treatment with this medicinal product in less than 1% of patients.
Slovenian: Pri zdravljenju s tem zdravilom so poročali o jetrni odpovedi, tudi usodni, pri manj kot 1% bolnikov.
English: The efficacy results are summarized in Figure 1 (LUX-Lung 3) and Tables 6 and 7 (LUX-Lung 3 and 6).
Slovenian: Podatki o učinkovitosti so povzeti na sliki 1 (LUX-Lung 3) ter navedeni v preglednicah 6 in 7 (LUX-Lung 3 in 6).
English: Depending on the finding, these changes occurred at exposures below, in the range of or above clinically relevant levels.
Slovenian: Naštete spremembe so se pojavile pri izpostavljenosti, ki je bila manjša, v enakem razponu ali večja od klinično pomembnih ravni.
English: GIOTRIF treatment should be continued until disease progression or until no longer tolerated by the patient (see Table 1 below).
Slovenian: Zdravljenje z zdravilom GIOTRIF naj traja, dokler bolezen ne začne napredovati ali do tedaj, ko bolnik zdravila več ne prenaša (glejte preglednico 1).
English: Less than 5% of a single dose of afatinib is excreted via the kidneys.
Slovenian: Skozi ledvice se izloči manj kot 5 % enkratnega odmerka afatiniba.
English: At the time of the analysis, 14 Nov 2013, 176 patients (76.5%) in the afatinib arm and 70 patients (60.9%) in the chemotherapy arm experienced an event contributing to the PFS analysis, i.e. disease progression as determined by central independent review or death.
Slovenian: V času analize, tj. 14. novembra 2013, se je pri 176 bolnikih (76,5 %) v skupini, ki je prejemala afatinib, in 70 bolnikih (60,9 %) v skupini, ki je prejemala kemoterapijo, pojavil dogodek, ki je prispeval k analizi PFS, tj. napredovanja bolezni, kot je bilo določeno s centralno neodvisno oceno ali smrt.
English: • Ritonavir, ketoconazole (except in shampoo), itraconazole, erythromycin, nelfinavir, saquinavir - used to treat different kinds of infections.
Slovenian: • ritonavir, ketokonazol (razen šampona), itrakonazol, eritromicin, nelfinavir, sakvinavir - za zdravljenje različnih oblik okužb,
English: This medicinal product should be administered without food (see sections 4.2 and 5.2).
Slovenian: Tega zdravila bolnik ne sme jemati s hrano (glejte poglavji 4.2 in 5.2).
English: Grade 3 diarrhoea most frequently occurred within the first 6 weeks of treatment.
Slovenian: Driska 3. stopnje se je najpogosteje pojavila v prvih 6 tednih.
English: • Rosuvastatin, used for lowering cholesterol.
Slovenian: • rosuvastatina, za zniževanje ravni holesterola.
English: • Increased levels of the liver enzymes (aspartate aminotransferase and alanine aminotransferase) in blood tests.
Slovenian: • povečanje vrednosti jetrnih encimov (aspartat-aminotransferaze in alanin-aminotransferaze) pri preiskavi krvi
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.
Slovenian: Če ne morete požirati in imate nameščeno želodčno sondo, lahko zdravnik predlaga dajanje zdravila skozi sondo.
English: Patients were treated with GIOTRIF 40 mg (all three trials) or 50 mg (LUX-Lung 2) orally once daily.
Slovenian: Bolnike so zdravili z zdravilom GIOTRIF 40 mg (vsa tri preskušanja) ali 50 mg (LUX-Lung 2) peroralno enkrat na dan.
English: Phototoxicity An in vitro 3T3 test showed that afatinib may have phototoxicity potential.
Slovenian: Fototoksičnost In vitro preskus 3T3 je pokazal, da ima afatinib lahko fototoksične učinke.
English: Other medicines and GIOTRIF
Slovenian: Druga zdravila in zdravilo GIOTRIF
English: In non-clinical disease models with ErbB pathway deregulation, afatinib as a single agent effectively blocks ErbB receptor signalling resulting in tumour growth inhibition or tumour regression.
Slovenian: V nekliničnih modelih bolezni z deregulacijo poti ErbB je afatinib kot edina učinkovina učinkovito zaviral signaliziranje receptorja ErbB, kar je zavrlo rast tumorja ali povzročilo njegovo regresijo.
English: Afatinib binds to proteins both non-covalently (traditional protein binding) and covalently.
Slovenian: Afatinib se veže na beljakovine nekovalentno (standardna vezava na beljakovine) in kovalentno.
English: GIOTRIF is a medicine which contains the active substance afatinib.
Slovenian: GIOTRIF je zdravilo, ki vsebuje zdravilno učinkovino afatinib.
English: GIOTRIF as monotherapy is indicated for the treatment of
Slovenian: Zdravilo GIOTRIF kot monoterapija je indicirano za zdravljenje
English: Indigo carmine aluminium hydroxide (E132)
Slovenian: • Indigokarmin aluminijev hidroksid (E132)
English: • Diarrhoea (very common, may affect more than 1 in 10 people).
Slovenian: • Driska (zelo pogosta, pojavi se lahko pri več kot 1 od 10 bolnikov).
English: No significant impact of age (range: 28 years - 87 years) on the pharmacokinetics of afatinib could be observed.
Slovenian: Starost Starost (razpon: 28-78 let) na farmakokinetiko afatiniba ni pomembneje vplivala.
English: Delay of median time to deterioration (months)
Slovenian: Podaljšanje mediane časa do poslabšanja (meseci)
English: Alive at 12 months Alive at 18 months
Slovenian: Skupno preživetje meseci (mediana) Živi po 12 mesecih Živi po 18 mesecih
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.
Slovenian: Učinek zaviranja UDP-glukuronoziltransferaze 1A1 (UGT1A1) na afatinib Podatki in vitro so pokazali, da medsebojni učinki z afatinibom zaradi zaviranja UGT1A1 niso verjetni.
English: The glass should be rinsed with approximately 100 ml of water which should also be consumed.
Slovenian: Nato naj kozarec spere s približno 100 ml vode in tudi to popije.
English: This medicinal product should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Slovenian: To zdravilo je treba pri bolnikih, ki imajo v anamnezi keratitis, ulcerozni keratitis ali hudo obliko suhega očesa, uporabljati previdno.
English: Symptomatic adverse reactions (e.g. severe/persistent diarrhoea or skin related adverse reactions) may be successfully managed by treatment interruption and dose reductions or treatment discontinuation of GIOTRIF as outlined in Table 1 (see sections 4.4 and 4.8).
Slovenian: Simptomatične neželene reakcije (npr. huda ali persistentna driska ali kožne reakcije) je možno uspešno obvladati s prekinitvijo zdravljenja in zmanjšanjem odmerka ali ukinitvijo zdravila GIOTRIF, kot je prikazano v preglednici 1 (glejte poglavji 4.4 in 4.8).
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.
Slovenian: Afatinib se kovalentno veže na vse homo- in heterodimere, ki jih tvorijo člani družine ErbB EGFR (ErbB1), HER2 (ErbB2), ErbB3 in ErbB4 in ireverzibilno zavira njihove signale.
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).
Slovenian: Pri driski, ki traja dlje kot 2 dni, in pri hudi driski lahko pride do izgube tekočine (pogosto, lahko se pojavi pri največ 1 od 10 bolnikov), nizke ravni kalija v krvi (pogosto) in poslabšanja ledvičnega delovanja (pogosto).
English: Exposure to afatinib in subjects with renal impairment was compared to healthy volunteers following a single dose of 40 mg GIOTRIF.
Slovenian: Izpostavljenost afatinibu pri bolnikih z ledvično okvaro so primerjali z izpostavljenostjo pri zdravih prostovoljcih po enkratnem odmerku 40 mg zdravila GIOTRIF.
English: Any Grade
Slovenian: Vse stopnje
English: p-value
Slovenian: Vrednost p
English: The median PFS was 12.0 months by independent review.
Slovenian: Mediana časa preživetja brez napredovanja bolezni (PFS) je bila po podatkih iz neodvisnega pregleda raziskave 12,0 meseca.
English: If P-gp inhibitors need to be taken, they should be administered using staggered dosing, i.e. the P-gp inhibitor dose should be taken as far apart in time as possible from the GIOTRIF dose.
Slovenian: Če je potrebno zdravljenje z zaviralci P-gp, jih je treba dajati z zamikom, in sicer je treba odmerek zaviralca P-gp vzeti s čim večjim časovnim razmikom do odmerka zdravila GIOTRIF.
English: Grade 2 (> 2.5 to 5.0 times upper limit of normal (ULN)) ALT elevations occurred in < 8% of patients treated with this medicinal product.
Slovenian: Povečanje ALT 2. stopnje (> 2,5- do 5,0-kratna zgornja meja normalne vrednosti (ULN)) se je pojavilo pri < 8% bolnikov, zdravljenih s tem zdravilom.
English: Treatment with this medicinal product should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions (see section 4.8).
Slovenian: Zdravljenje s tem zdravilom je treba prekiniti ali ukiniti, če se pri bolniku razvijejo huda bulozna, mehurjasta ali eksfoliativna stanja (glejte poglavje 4.8).
English: These elevations were mainly transient and did not lead to discontinuation.
Slovenian: Povečanje je bilo večinoma prehodno in zaradi njega zdravljenja ni bilo treba prekiniti.
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.
Slovenian: Pri bolnikih s hudimi kožnimi reakcijami je treba včasih zdravljenje začasno prekiniti, zmanjšati odmerek (glejte poglavje 4.2), uvesti dodatne terapevtske ukrepe in bolnike napotiti k specialistu, ki je strokovnjak za obravnavo tovrstnih dermatoloških reakcij.
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.
Slovenian: Na podlagi populacijskih farmakokinetičnih podatkov, pridobljenih v kliničnih preskušanjih različnih oblik tumorjev, so ugotovili, da je AUCτ,ss za 26% manjša, če bolnik uživa hrano v 3 urah, preden vzame zdravilo GIOTRIF ali v 1 uri po jemanju zdravila.
English: Other patient characteristics/intrinsic factors found with a significant impact on afatinib exposure were: ECOG performance score, lactate dehydrogenase levels, alkaline phosphatase levels and total protein.
Slovenian: Druge značilnosti bolnikov ali intrinzični dejavniki, ki so imeli pomemben vpliv na izpostavljenost afatinibu, so bili: ocena izhodiščnega stanja zmogljivosti (ECOG), raven laktat-dehidrogenaze, raven alkalne fosfataze in celokupne beljakovine.
English: However, systemic exposures achieved in animals were either in a similar range or below the levels observed in patients (see section 5.3).
Slovenian: Toda sistemska izpostavljenost je bila pri živalih podobna ali manjša kot pri bolnikih (glejte poglavje 5.3).
English: However, if the next scheduled dose is due within 8 hours then the missed dose must be skipped.
Slovenian: Če pa bi moral naslednji redni odmerek vzeti v naslednjih 8 urah, mora pozabljeni odmerek izpustiti.
English: Thus, steady state plasma concentrations of afatinib were achieved within 8 days of multiple dosing of afatinib resulting in an accumulation of 2.77-fold (AUC0-∞) and 2.11-fold (Cmax).
Slovenian: Tako je stanje dinamičnega ravnovesja plazemskih koncentracij afatiniba doseženo v 8 dneh po njegovem večkratnem dajanju, kar privede do njegovega kopičenja, ki je 2,77-kratno (AUC0-∞) in 2,11-kratno (Cmax).
English: Effects of afatinib on P-gp substrates
Slovenian: Učinki afatiniba na substrate P-gp