FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment in this population is not recommended (see section 4.4).
Croatian: Liječenje se u ovoj populaciji ne preporučuje (vidjeti dio 4.4).
English: Do not take GIOTRIF - if you are allergic to afatinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne uzimajte GIOTRIF - ako ste alergični na afatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • Decreased weight
Croatian: • Smanjena težina
English: GIOTRIF has not been studied in children or adolescents.
Croatian: GIOTRIF nije ispitivan na djeci i adolescentima.
English: Interactions with BCRP
Croatian: Interakcije s BCRP-om
English: Therefore, treatment of children or adolescents with this medicinal product is not recommended.
Croatian: Stoga se liječenje djece ili adolescenata ovim lijekom ne preporučuje.
English: There is no specific antidote for overdose with this medicinal product.
Croatian: Ne postoji specifičan antidot za predoziranje ovim lijekom.
English: By blocking the activity of these proteins this medicine can inhibit growth and spread of cancer cells.
Croatian: Blokiranjem aktivnosti ovih proteina ovaj lijek može zaustaviti rast i širenje stanica raka.
English: GIOTRIF is to be taken by mouth.
Croatian: GIOTRIF se uzima kroz usta.
English: Body System
Croatian: Tjelesni sustav
English: GIOTRIF may increase the blood levels of other medicines including but not limited to:
Croatian: GIOTRIF može povisiti vrijednosti drugih lijekova u krvi uključujući, ali ne ograničeno na:
English: • It is important to take this medicine without food
Croatian: • Važno je uzeti ovaj lijek bez hrane.
English: Interrupt until Grade 0/1
Croatian: Prekid do stupnja 0/1
English: The tablets should be swallowed whole with water.
Croatian: Tablete je potrebno progutati cijele s vodom.
English: Summary of the safety profile
Croatian: Pregled profila sigurnosti
English: Left ventricular dysfunction has been associated with HER2 inhibition.
Croatian: Disfunkcija lijevog ventrikula povezana je s HER2 inhibicijom.
English: This is because there may be a risk that an unborn baby is harmed.
Croatian: Ovo je potrebno jer postoji mogućnost štetnosti za nerođeno dijete.
English: If you experience any of the symptoms above, contact your doctor as soon as possible.
Croatian: Ako primijetite bilo koji od gore navedenih simptoma, javite se liječniku što je prije moguće.
English: If swallowing of whole tablets is not possible, these can be dispersed in approximately 100 ml of non-carbonated drinking water.
Croatian: Ako gutanje cijele tablete nije moguće, ona se može raspršiti u oko 100 ml negazirane vode za piće.
English: The median PFS was 12.0 months by independent review.
Croatian: Medijan PFS-a je bio 12,0 mjeseci na temelju nezavisne procjene.
English: Efficacy in EGFR-negative tumours has not been established.
Croatian: Djelotvornost u EGFR negativnih tumora nije ustanovljena.
English: If a dose is missed, it should be taken within the same day as soon as the patient remembers.
Croatian: U slučaju propuštene doze, ona se mora uzeti u istom danu čim se bolesnik sjeti.
English: Then carry on taking your tablets at regular times as usual.
Croatian: Zatim nastavite uzimati tablete u pravilnim intervalima na uobičajeni način.
English: > 48 hours of diarrhoea and/or > 7 days of rash
Croatian: > 48 sati proljeva i/ili > 7 dana osipa
English: Assessment of EGFR mutation status
Croatian: Procjena statusa mutacije EGFR
English: Diarrhoea may result in dehydration with or without renal impairment, which in rare cases has resulted in fatal outcomes.
Croatian: Proljev može rezultirati dehidracijom sa ili bez oštećenja bubrega, što je u rijetkim slučajevima rezultiralo fatalnim ishodima.
English: Adverse changes were restricted to toxic dose levels.
Croatian: Takve promjene bile su ograničene na vrijednosti do toksičnih doza.
English: Decreased appetite
Croatian: Smanjeni apetit
English: If patient cannot tolerate 20 mg/day, permanent discontinuation of GIOTRIF should be considered
Croatian: Ako bolesnik ne može podnijeti 20 mg/dan, potrebno je razmotriti trajni prekid primjene GIOTRIFA
English: If you take more GIOTRIF than you should
Croatian: Ako uzmete više GIOTRIFA nego što ste trebali
English: The individual effect sizes of these covariates were considered not clinically relevant.
Croatian: Važnost pojedinačnih učinaka ovih varijabli smatrani su klinički neznačajnima.
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.
Croatian: Rasa nije imala utjecaj na farmakokinetiku afatiniba na osnovi analize populacijske farmakokinetike, uključujući bolesnike azijske, bjelačke i crnačke rasne skupine.
English: This makes it easier to remember to take this medicine.
Croatian: Time ćete se lakše sjetiti da trebate uzeti lijek.
English: Objective Response Rate (CR+PR)
Croatian: Stopa objektivnog odgovora (CR+PR)
English: In some cases your doctor may need to interrupt treatment and reduce your dose or stop treatment:
Croatian: U nekim slučajevima liječnik će možda trebati prekinuti liječenje i smanjiti dozu ili prekinuti liječenje:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: No starting dose adjustment was considered necessary for any of the following covariates tested.
Croatian: Nije se smatralo potrebnim prilagođavati početnu dozu niti za jednu od sljedećih testiranih varijabli.
English: Contact your doctor or pharmacist immediately.
Croatian: Odmah se javite liječniku ili ljekarniku.
English: The maximum daily dose is 50 mg.
Croatian: Maksimalna dnevna doza je 50 mg.
English: Closer monitoring is recommended in patients with these risk factors.
Croatian: Preporučuje se pažljivije praćenje bolesnika s ovim rizičnim čimbenicima.
English: Polysorbate 80 (E433)
Croatian: polisorbat 80 (E433)
English: Therefore, an adverse effect of this medicinal product on human fertility cannot be excluded.
Croatian: Stoga se ne mogu isključiti štetni učinci ovog lijeka na ljudsku plodnost.
English: % of patients improved
Croatian: % bolesnika u kojih je došlo do poboljšanja
English: Therefore, this medicinal product is unlikely to interact with other medicines that modulate or are metabolised by CYP enzymes.
Croatian: Stoga se ne smatra da ovaj lijek ima interakcije s drugim lijekovima koji moduliraju ili se metaboliziraju putem CYP enzima.
English: In vitro binding of afatinib to human plasma proteins is approximately 95%.
Croatian: In vitro vezanje afatiniba na proteine ljudske plazme je oko 95%.
English: Treatment with this medicinal product should be interrupted pending investigation of these symptoms.
Croatian: Liječenje ovim lijekom mora biti prekinuto dok traje ispitivanje ovih simptoma.
English: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Croatian: Prilikom procjenjivanja statusa mutacije EGFR svakog pojedinog bolesnika, važno je odabrati dobro validiranu i sigurnu metodu kako bi se izbjegli lažno negativni ili lažno pozitivni razultati.
English: However, based on clinical data it is considered unlikely that GIOTRIF treatment will result in changes of the plasma concentrations of other P-gp substrates.
Croatian: Međutim, na osnovi kliničkih podataka ne smatra se vjerojatnim da će liječenje GIOTRIFOM rezultirati promjenama koncentracija drugih P-gp supstrata u plazmi.
English: GIOTRIF can be prescribed to you as your first treatment or if prior chemotherapy treatment has been insufficient.
Croatian: GIOTRIF Vam se može propisati kao prvo liječenje ili ako je ranije kemoterapijsko liječenje bilo neučinkovito;
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.
Croatian: Ako planirate zatrudnjeti nakon uzimanja posljednje doze ovog lijeka, obratite se svom liječniku za savjet, jer postoji mogućnost da Vaše tijelo još nije u potpunosti eliminiralo ovaj lijek.
English: Depending on the finding, these changes occurred at exposures below, in the range of or above clinically relevant levels.
Croatian: Ovisno o nalazu, spomenute su se promjene pojavile pri izloženosti ispod, u rasponu ili iznad klinički značajnih vrijednosti.
English: What GIOTRIF is and what it is used for
Croatian: Što je GIOTRIF i za što se koristi
English: Hepatic failure, including fatalities, has been reported during treatment with this medicinal product in less than 1% of patients.
Croatian: Zatajenje jetre, uključujući smrtne ishode, tijekom liječenja ovim lijekom prijavljeno je kod manje od 1% bolesnika.
English: If used during pregnancy or if the patient becomes pregnant while or after receiving GIOTRIF, she should be informed of the potential hazard to the foetus.
Croatian: Ako se primjenjuje tijekom trudnoće ili ako bolesnica zatrudni tijekom ili nakon primjene GIOTRIFA, potrebno ju je obavijestiti o potencijalnom riziku za fetus.
English: Other medicines and GIOTRIF
Croatian: Drugi lijekovi i GIOTRIF
English: Afatinib may increase the bioavailability of orally administered BCRP substrates (including but not limited to rosuvastatin and sulfasalazine).
Croatian: Afatinib može povećati bioraspoloživost oralno primijenjenih BCRP supstrata (uključujući, ali ne ograničeno na rosuvastatin i sulfasalazin).
English: • Abnormal taste sensations (dysgeusia)
Croatian: • Poremećen osjet okusa (disgeuzija)
English: Left ventricular function
Croatian: Funkcija lijevog ventrikula
English: GIOTRIF has minor influence on the ability to drive and use machines.
Croatian: GIOTRIF malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Diarrhoea can be treated.
Croatian: Proljev se može liječiti.
English: • Skin rash (very common).
Croatian: • Osip na koži (vrlo često).
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).
Croatian: Za prikaz učestalosti nuspojava koristili su se sljedeći termini: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000).
English: If you do not take this medicine as prescribed by your doctor your cancer may grow again.
Croatian: Ako ne uzimate ovaj lijek prema liječničkim uputama, rak bi mogao opet narasti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 September 2013
Croatian: Datum prvog odobrenja: 25. rujna 2013.
English: At the first signs of diarrhoea drink plenty of fluids.
Croatian: Na prve znakove proljeva, pijte mnogo tekućine.
English: Mutation in EGFR defines a distinct molecular subtype of lung cancer.
Croatian: Mutacija EGFR-a definira poseban molekularni podtip raka pluća.
English: Smoking history, alcohol consumption (limited data), or presence of liver metastases had no significant impact on the pharmacokinetics of afatinib.
Croatian: Pušenje u anamnezi, konzumiranje alkohola (ograničeni podaci) ili prisustvo jetrenih metastaza nisu imali značajan utjecaj na farmakokinetiku afatiniba.
English: • Pain, redness, swelling or peeling of the skin of your hands and feet
Croatian: • Bol, crvenilo, oticanje ili ljuštenje kože na rukama i stopalima
English: Treatment with this medicine is not recommended if you have a severe liver disease.
Croatian: Liječenje ovim lijekom se ne preporučuje u slučaju teških bolesti jetre.
English: If you have difficulties swallowing the tablet, dissolve it in a glass of still water.
Croatian: Ako imate probleme s gutanjem tablete, otopite je u čaši obične vode.
English: These elevations were mainly transient and did not lead to discontinuation.
Croatian: Ova povišenja uglavnom su bila prolazna, te nisu vodila do trajnog prekida liječenja.
English: This medicinal product should be taken without food.
Croatian: Ovaj lijek se uzima bez hrane.
English: Resume with dose reduction by 10 mg decrements a
Croatian: Nastaviti sa snižavanjem doze za po 10 mg a
English: Afatinib binds to proteins both non-covalently (traditional protein binding) and covalently.
Croatian: Afatinib se veže na proteine, i nekovalentno (tradicionalno vezanje na proteine) i kovalentno.
English: • Cyclosporine A, tacrolimus - medicines that affect your immune system.
Croatian: • Ciklosporin A, takrolimus - lijekovi koji utječu na imunološki sustav.
English: Any Grade
Croatian: Svaki stupanj
English: Proactive management of diarrhoea including adequate hydration combined with anti-diarrhoeal medicinal products especially within the first 6 weeks of the treatment is important and should start at first signs of diarrhoea.
Croatian: Proaktivno zbrinjavanje proljeva, uključujući odgovarajuću hidraciju u kombinaciji s lijekovima protiv proljeva, osobito tijekom prvih 6 tjedana liječenja, je osobito važno i mora započeti s pojavom prvih znakova proljeva.
English: GIOTRIF contains lactose
Croatian: GIOTRIF sadrži laktozu
English: • Do not break, chew or crush the tablet.
Croatian: • Ne lomite, žvačite i drobite tabletu.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: This medicine is used on its own to treat adult patients with a specific type of cancer of the lung (non-small cell lung cancer):
Croatian: Ovaj lijek se primjenjuje zasebno u liječenju odraslih osoba sa specifičnim tipom raka pluća (rak pluća nemalih stanica):
English: Your doctor may do some liver tests.
Croatian: Liječnik će možda učiniti testove jetrene funkcije.
English: Do not stop taking this medicine without first consulting your doctor.
Croatian: Ne prekidajte primjenu ovog lijeka bez prethodnog savjetovanja s vašim liječnikom.
English: • that is identified by a change (mutation) in the gene for EGFR.
Croatian: • koji se prepoznaje promjenom (mutacijom) gena za EGFR.
English: A study in rats up to the maximum tolerated doses revealed no significant impact on pre-/postnatal development.
Croatian: Ispitivanje na štakorima do maksimalno podnošene doze nije otkrilo značajan utjecaj na pre-/postnatalni razvoj.
English: Less than 5% of a single dose of afatinib is excreted via the kidneys.
Croatian: Manje od 5% jednostruke doze afatiniba se izlučuje putem bubrega.
English: Additionally, in various organs pharmacodynamically mediated atrophy of epithelia was observed in both species.
Croatian: Nadalje, u raznim organima primijećena je farmakodinamički posredovana atrofija epitela u obje vrste.
English: Contact lens use is also a risk factor for keratitis and ulceration (see section 4.8).
Croatian: Upotreba kontaktnih leća također je rizični čimbenik za razvoj keratitisa i ulceracija (vidjeti dio 4.8).
English: Afatinib is eliminated mainly by biliary/faecal excretion.
Croatian: Afatinib se eliminira uglavnom putem bilijarnog izlučivanja/fecesa.
English: Patients with common EGFR mutations accounted for 89% of the study population.
Croatian: Bolesnici s čestim EGFR mutacijama činili su 89% populacije u ispitivanju.
English: The updated median OS for first- and second-line was 31.7 months and 23.6 months, respectively.
Croatian: Ažurirani medijan OS u prvoj liniji bio je 31,7 mjeseci, a u drugoj 23,6 mjeseca.
English: • Increased levels of the liver enzymes (aspartate aminotransferase and alanine aminotransferase) in blood tests.
Croatian: • Povišene vrijednosti jetrenih enzima (aspartat aminotransferaze i alanin aminotransferaze) u krvnim pretragama
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.
Croatian: Srednji rezultati tijekom vremena za ukupnu kvalitetu života, opći zdravstveni status te fizičko, kognitivno, društveno i emocionalno funkcioniranje i funkcioniranje u socijalnim ulogama bili su značajno bolji u skupini na GIOTRIFU.
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.
Croatian: In vitro podaci su ukazali da se interakcije lijekova s afatinibom zbog inhibicije OATB1B1, OATP1B3, OATP2B1, OAT1, OAT3, OCT1, OCT2, i OCT3 prijenosnika ne smatraju vjerojatnima.
English: The primary endpoint was PFS; OS was the key secondary endpoint.
Croatian: Primarni ishod je bio PFS; OS je bio ključni sekundarni ishod.
English: If indicated, elimination of unabsorbed afatinib may be achieved by emesis or gastric lavage.
Croatian: Ako je indicirano, može se postići eliminacija neapsorbiranog afatiniba putem emeze ili lavaže želuca.
English: Dry skin
Croatian: Suha koža
English: Stevens-Johnson syndrome Toxic epidermal necrolysis
Croatian: StevensJohnsonov sindrom Toksična epidermalna nekroliza
English: Afatinib is a potent and selective, irreversible ErbB Family Blocker.
Croatian: Afatinib je potentan i selektivan ireverzibilni blokator obitelji ErbB.
English: This medicinal product should be administered without food (see sections 4.2 and 5.2).
Croatian: Ovaj lijek je potrebno primijeniti bez hrane (vidjeti dijelove 4.2 i 5.2).
English: Based on the available clinical trial data, there is no suggestion that this medicinal product causes an adverse reaction on cardiac contractility.
Croatian: Na temelju dostupnih podataka iz kliničkih ispitivanja, ne postoji naznaka da ovaj lijek dovodi do poremećaja srčane kontraktilnosti.
English: Afatinib is not an inhibitor or an inducer of CYP enzymes.
Croatian: Afatinib nije inhibitor ili induktor CYP enzima.
English: Interactions with Cytochrome P450 (CYP) enzymes
Croatian: Interakcije s citokrom P450 (CYP) enzimima
English: Treatment with GIOTRIF should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Croatian: Liječenje GIOTRIFOM mora početi i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: Diarrhoea usually occurred within the first 2 weeks of treatment.
Croatian: Proljev se obično javlja unutar prva 2 tjedna liječenja.
English: Patients were enrolled in the first-line (N=61) or second-line setting (N=68) (i.e. after failure of 1 prior chemotherapy regimen).
Croatian: Bolesnici su bili uključeni u prvu liniju (N=61) ili drugu liniju terapije (N=68) (tj. nakon neuspjeha 1 prethodne linije kemoterapije).
English: It works by blocking the activity of a group of proteins called the ErbB family (including EGFR [epidermal growth factor receptor or ErbB1], HER2 [ErbB2], ErbB3 and ErbB4).
Croatian: On djeluje blokiranjem aktivnosti skupine proteina koji se nazivaju ErbB obitelj (uključujući EGFR [receptor epidermalnog faktora rasta ili ErbB1], HER2 [ErbB2], ErbB3 i ErbB4).
English: Alive at 12 months Alive at 18 months
Croatian: Živi u 12.-tom mjesecu Živi u 18.-tom mjesecu
English: Cmax and AUC0-∞ values increased slightly more than proportionally in the dose range from 20 mg to 50 mg GIOTRIF.
Croatian: Cmax i AUC0-∞ vrijednosti su se povećale malo iznad proporcionalnih u rasponu doza od 20 mg do 50 mg GIOTRIFA.
English: • of squamous type if prior chemotherapy treatment has been insufficient.
Croatian: • skvamoznog tipa ako je ranije kemoterapijsko liječenje bilo neučinkovito.
English: GIOTRIF film-coated tablets are available in packs containing 1, 2 or 4 perforated unit dose blisters.
Croatian: GIOTRIF filmom obložene tablete su dostupne u pakiranjima koja sadrže 1, 2 ili 4 perforirana blistera s jediničnim dozama.
English: • Rifampicin, an antibiotic used to treat tuberculosis.
Croatian: • Rifampicin, antibiotik koji se primjenjuje za liječenje tuberkuloze.
English: If you could become pregnant, you should use adequate birth control methods during treatment and for at least 1 month after taking the last dose of this medicine.
Croatian: Ako biste mogli zatrudnjeti, potrebno je koristiti odgovarajuće metode kontracepcije tijekom liječenja i najmanje 1 mjesec nakon uzimanja posljednje doze ovog lijeka.
English: In these patients, confounding factors have included pre-existing liver disease and/or comorbidities associated with progression of underlying malignancy.
Croatian: Kod ovih bolesnika, dodatni čimbenici bili su od ranije postojeća bolest jetre i/ili komorbiditeti povezani s progresijom primarne maligne bolesti.
English: Adequate contraceptive methods should be used during therapy and for at least 1 month after the last dose.
Croatian: Potrebno je koristiti odgovarajuće kontracepcijske metode tijekom terapije kao i najmanje 1 mjesec nakon uzimanja posljednje doze.
English: Early treatment of skin rash is important.
Croatian: Rano liječenje osipa na koži je važno.
English: Early intervention (such as emollients, antibiotics) of dermatologic reactions can facilitate continuous GIOTRIF treatment.
Croatian: Rano liječenje (kao što su sredstva za njegu kože, antibiotici) dermatoloških reakcija može olakšati liječenje GIOTRIFOM.
English: Following oral administration of GIOTRIF, Cmax of afatinib were observed approximately 2 to 5 hours post dose.
Croatian: Nakon oralne primjene GIOTRIFA, Cmax afatiniba je primijećen oko 2 do 5 sati nakon doziranja.
English: This is consistent with population pharmacokinetic data derived from clinical trials in various tumour types (see “Population pharmacokinetic analysis in special populations” below).
Croatian: Ovo odgovara populacijskim farmakokinetičkim podacima dobivenim iz kliničkih ispitivanja na raznim tipovima tumora (vidjeti “Populacijska farmakokinetička analiza u posebnim populacijama” u nastavku).
English: Dehydration Hypokalaemia
Croatian: Dehidracija Hipokalemija
English: • Bleeding from the nose
Croatian: • Krvarenje iz nosa
English: Antidiarrhoeal medicinal products (e.g. loperamide) should be used and if necessary their dose should be escalated to the highest recommended approved dose.
Croatian: U tu svrhu primjenjuju se lijekovi protiv proljeva (npr. loperamid), a prema potrebi njihova se doza povećava do najviše preporučene odobrene doze.
English: Contact your doctor immediately and start appropriate antidiarrhoeal treatment as soon as possible.
Croatian: Odmah se javite liječniku te počnite s primjenom odgovarajućeg liječenja protiv proljeva što je prije moguće.
English: These could be symptoms of an inflammation of the lungs (interstitial lung disease) and can be lifethreatening.
Croatian: Ovo mogu biti simptomi upale pluća (bolest plućnog intersticija), te mogu biti opasni po život.
English: The efficacy results are provided in Figure 1, Tables 6 and 7.
Croatian: Rezultati djelotvornosti prikazani su na slici 1, tablicama 6 i 7.
English: Gender Female patients had a 15% higher plasma exposure (AUCτ,ss, body weight corrected) than male patients.
Croatian: Bolesnice su imale 15% veću izloženost u plazmi (AUCτ,ss, korigiran za tjelesnu težinu) nego muški bolesnici.
English: Phototoxicity An in vitro 3T3 test showed that afatinib may have phototoxicity potential.
Croatian: Fototoksičnost In vitro 3T3 test je pokazao da afatinib može imati fototoksičan potencijal.
English: Food effect on afatinib
Croatian: Utjecaj hrane na afatinib
English: Pack sizes of 7 x 1, 14 x 1 or 28 x 1 film-coated tablets.
Croatian: Veličine pakiranja su 7 x 1, 14 x 1 ili 28 x 1 filmom obložena tableta.
English: • Rosuvastatin, used for lowering cholesterol.
Croatian: • Rosuvastatin, primjenjuje se za snižavanje kolesterola.