FrancophonIA/ELRC3.0 huggingface dataset:
English: Each tablet contains 250 mg gefitinib.
Croatian: Jedna tableta sadržava 250 mg gefitiniba.
English: This increase in exposure may be of clinical relevance since adverse experiences are related to dose and exposure to gefitinib.
Croatian: Taj porast izloženosti može biti od kliničkog značaja, jer su nuspojave povezane s dozom i izloženošću gefitinibu.
English: Interstitial lung disease (ILD) has occurred in 1.3% of patients, often severe (CTC grade 3-4).
Croatian: Intersticijska bolest pluća (ILD) se javila u 1,3% bolesnika i često je bila teška (CTC stupanj 3-4).
English: In a clinical trial in patients, gefitinib was co-administered with metoprolol (a CYP2D6 substrate).
Croatian: U jednom je kliničkom ispitivanju gefitinib primijenjen bolesnicima zajedno s metoprololom (supstratom CYP2D6).
English: Ever smoker
Croatian: Nekad pušili
English: Elevations in alanine aminotransferase, mainly mild to moderate
Croatian: Povišenje vrijednosti alanin aminotransferaze, većinom blago do umjereno
English: Women of childbearing potential
Croatian: Žene u generativnoj dobi
English: In the IPASS trial, IRESSA demonstrated superior PFS, ORR, QoL and symptom relief with no significant difference in overall survival compared to carboplatin/paclitaxel in previously untreated patients, with locally advanced or metastatic NSCLC, whose tumours harboured activating mutations of the EGFR tyrosine kinase.
Croatian: U ispitivanju IPASS, IRESSA se pokazala boljom što se tiče preživljenja bez progresije bolesti, stope objektivnog odgovora, kvalitete života i olakšanja simptoma, dok nije bilo značajne razlike u ukupnom preživljenju u usporedbi s liječenjem karboplatinom/paklitakselom u prethodno neliječenih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica, koji imaju tumor s aktivirajućom mutacijom tirozin kinaze EGFR-a.
English: Substances that inhibit CYP3A4 may decrease the clearance of gefitinib.
Croatian: Tvari koje inhibiraju CYP3A4 mogu smanjiti klirens gefitiniba.
English: IRESSA contains lactose.
Croatian: IRESSA sadrži laktozu.
English: Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers.
Croatian: Prethodno liječenje itrakonazolom (snažan inhibitor CYP3A4) u zdravih je dobrovoljaca izazvalo porast prosječnog AUC-a gefitiniba za 80%.
English: Pretreated patients
Croatian: Prethodno liječeni bolesnici
English: Further precautions for use
Croatian: Dodatne mjere opreza pri primjeni
English: Female
Croatian: Žene
English: IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section
Croatian: IRESSA je indicirana kao monoterapija za liječenje odraslih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća ne-malih stanica (non-small cell lung cancer, NSCLC) s aktivirajućim mutacijama tirozin kinaze receptora epidermalnog faktora rasta (epidermal growth factor receptor tyrosine kinase, EGFR-TK) (vidjeti dio 4.4).
English: Elevations in aspartate aminotransferase, mainly mild to moderate
Croatian: Povišenje vrijednosti aspartat aminotransferaze, većinom blago do umjereno
English: a Values presented are for IRESSA versus placebo.
Croatian: Prikazane su vrijednosti za lijek IRESSA u usporedbi s placebom.
English: If concomitant treatment with a potent CYP2D6 inhibitor is initiated, the patient should be closely monitored for adverse reactions.
Croatian: Ako se uvodi istodobno liječenje snažnim inhibitorom CYP2D6, bolesnika treba pomno nadzirati zbog mogućih nuspojava.
English: CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations.
Croatian: Induktori izoenzima CYP3A4 mogu pojačati metabolizam gefitiniba i sniziti koncentracije gefitiniba u plazmi.
English: IRESSA contains lactose
Croatian: IRESSA sadrži laktozu
English: In EGFR mutation-positive patients, significantly more IRESSA-treated patients experienced an improvement in quality of life and lung cancer symptoms vs. carboplatin/paclitaxel (see Table 4).
Croatian: Među bolesnicima pozitivnima na mutaciju EGFR-a, poboljšanje kvalitete života i simptoma raka pluća zabilježeno je u značajno većem broju onih liječenih lijekom IRESSA u odnosu na one liječene karboplatinom/paklitakselom (vidjeti Tablicu 4).
English: Numbers in square brackets are 95% confidence intervals for HR N Number of patients randomised.
Croatian: Brojevi u uglatim zagradama predstavljaju 95%-tni interval pouzdanosti za omjer rizika (HR).
English: Diarrhoea, mainly mild or moderate (CTC grade 1 or 2) Vomiting, mainly mild or moderate (CTC grade 1 or 2) Nausea, mainly mild (CTC grade 1)
Croatian: Povraćanje, većinom blago ili umjereno (CTC stupanj 1 ili 2) Mučnina, većinom blaga (CTC stupanj 1) Stomatitis, pretežno blag (CTC stupanj 1)
English: Bleeding (such as nose bleed or blood in your urine) Protein in your urine (shown in a urine test)
Croatian: • krvarenje (poput krvarenja iz nosa ili krvi u mokraći)
English: Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Croatian: Tvari koje uzrokuju značajno trajno povišenje želučanog pH mogu smanjiti plazmatske koncentracije gefitiniba te tako umanjiti djelotvornost gefitiniba.
English: Haemorrhage, such as epistaxis and haematuria
Croatian: Krvarenje, kao što su epistaksa i hematurija
English: Without crushing it, the tablet should be dropped in half a glass of drinking water.
Croatian: Tabletu treba ubaciti cijelu, bez drobljenja, u pola čaše pitke vode.
English: Table 4 Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Croatian: Tablica 4 Ishodi kvalitete života za gefitinib u usporedbi s karboplatinom/paklitakselom u ispitivanju IPASS
English: Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration
Croatian: Hepatocelularna nekroza i eozinofilna sinusoidalna infiltracija makrofagima.
English: IRESSA 250 mg tablets gefitinib
Croatian: IRESSA 250 mg tablete gefitinib
English: Inflammation of the liver.
Croatian: • upala jetre.
English: In vitro data indicate that gefitinib is a substrate for the membrane transport protein P-gp.
Croatian: Podaci dobiveni in vitro ukazuju da je gefitinib supstrat za membranski transportni protein
English: Adenocarcinoma
Croatian: Adenokarcinom
English: Primary endpoint Progression free survival (PFS)
Croatian: Preživljenje bez progresije bolesti (PFS)
English: Patients should be advised to seek medical advice immediately if they experience severe or persistent diarrhoea, nausea, vomiting or anorexia as these may indirectly lead to dehydration.
Croatian: • teški ili perzistirajući proljev, mučninu, povraćanje ili anoreksiju jer to može neizravno dovesti do dehidracije.
English: Haemorrhagic cystitis
Croatian: Hemoragijski cistitis
English: How to store IRESSA
Croatian: Kako čuvati lijek IRESSA
English: Weakness
Croatian: • slabost
English: Some lung problems may get worse during treatment with IRESSA.
Croatian: Neke tegobe s plućima mogu se pogoršati tijekom liječenja lijekom IRESSA. ako ste nekad imali tegoba s jetrom.
English: How to take IRESSA
Croatian: Kako uzimati lijek IRESSA
English: a Values presented are for IRESSA versus docetaxel.
Croatian: Prikazane su vrijednosti za lijek IRESSA u usporedbi s docetakselom.
English: HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
Croatian: Brojevi u uglatim zagradama predstavljaju 96%-tni interval pouzdanosti za omjer rizika za ukupno preživljenje u ukupnoj populaciji, odnosno 95%-tni interval pouzdanosti za omjer rizika c Interval pouzdanosti je u cijelosti ispod granice neinferiornosti od 1,154 N Broj randomiziranih bolesnika.
English: Overall survival a,b
Croatian: Ukupno preživljenje ab
English: Non-adenocarcinoma
Croatian: Neadenokarcinom
English: Red and sore eyelids
Croatian: • crveni i bolni kapci
English: Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Croatian: Tablica 6 Ishodi djelotvornosti za gefitinib u usporedbi s placebom u ispitivanju ISEL Populacija
English: Very common: side effects (may affect more than 1 in 10 people) Diarrhoea
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba
English: In situations of concomitant treatment with potent inhibitors of CYP3A4 the patient should be closely monitored for gefitinib adverse reactions.
Croatian: U slučaju istodobnog liječenja snažnim inhibitorima CYP3A4 bolesnika treba pomno nadzirati zbog mogućih nuspojava gefitiniba.
English: Gastrointestinal perforation has been reported in patients taking gefitinib.
Croatian: U bolesnika koji su uzimali gefitinib zabilježene su perforacije u gastrointestinalnom traktu.
English: EGFR mutation status and clinical characteristics Clinical characteristics of never smoker, adenocarcinoma histology, and female gender have been shown to be independent predictors of positive EGFR mutation status in a multivariate analysis of 786 Caucasian patients from gefitinib studies* (see Table 7).
Croatian: U multivarijatnoj analizi 786 bolesnika bijele rase iz ispitivanja s gefitinibom*, pokazalo se da su klinička obilježja da osoba nikada nije pušila, da ima histologiju adenokarcinoma i da je ženskog spola neovisni pretkazatelji pozitivnog statusa mutacije EGFR (vidjeti Tablicu 7).
English: Nail problems
Croatian: • problemi s noktima
English: Unadjusted analysis PP population for clinical factors ITT population for biomarker factors
Croatian: Neprilagođena analiza Populacija liječena prema protokolu (PP) za kliničke čimbenike
English: PC: {number} SN: {number} NN: {number}
Croatian: PC: SN: NN:
English: IRESSA 250 mg film-coated tablets gefitinib
Croatian: IRESSA 250 mg filmom obložene tablete gefitinib
English: Progression free survival ab
Croatian: Preživljenje bez progresije bolesti ab
English: IRESSA 250 mg film-coated tablets
Croatian: IRESSA 250 mg filmom obložene tablete
English: INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Croatian: U nekih bolesnika koji su istodobno uzimali varfarin prijavljene su povišene INR vrijednosti i/ili krvarenja (vidjeti dio 4.4).
English: Table 5 Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study
Croatian: Tablica 5 Ishodi djelotvornosti za gefitinib u usporedbi s docetakselom u INTEREST ispitivanju Populacija
English: EGFR Mutation+
Croatian: + mutacija EGFR
English: Corneal epithelia atrophy and corneal translucencies Renal papillary necrosis
Croatian: Atrofija epitela rožnice i prozirnost rožnice Bubrežna papilarna nekroza
English: Table 3 Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Croatian: Tablica 3 Ishodi djelotvornosti za gefitinib u usporedbi s karboplatinom/paklitakselom u IPASS ispitivanju
English: N FACT-L QoL improvement rate
Croatian: N Stopa poboljšanja kvalitete života prema FACT-L
English: Trial outcome index results were supportive of FACT-L and LCS results
Croatian: Indeksirani ishodi ispitivanja podržali su FACT-L i LCS rezultate a Prikazane su vrijednosti za lijek IRESSA u usporedbi s karboplatinom/paklitakselom.
English: International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Croatian: U nekih bolesnika koji su zajedno s gefitinibom uzimali varfarin zabilježen je porast međunarodnog normaliziranog omjera (international normalised ratio, INR) i/ili epizode krvarenja (vidjeti dio 4.5).
English: • Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA Increase of creatinine levels in a blood test (related to kidney function) Cystitis (burning sensations during urination and frequent, urgent need to urinate)
Croatian: • porast vrijednosti bilirubina i drugog jetrenog enzima koji se zove aspartat aminotransferaza u nalazima krvnih pretraga; ako su vrijednosti previsoke, liječnik Vam može reći da prestanete uzimati lijek IRESSA
English: Active substances that may reduce gefitinib plasma concentrations Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Croatian: Tvari koje su induktori aktivnosti CYP3A4 mogu pojačati metabolizam i sniziti koncentracije gefitiniba u plazmi te time umanjiti djelotvornost gefitiniba.
English: However, in phase I clinical trials, a limited number of patients were treated with daily doses of up to 1000 mg. An increase of frequency and severity of some adverse reactions was observed, mainly diarrhoea and skin rash.
Croatian: Međutim, u kliničkom ispitivanju faze I ograničen broj bolesnika liječen je dnevnim dozama do 1000 mg.
English: Primary endpoint overall survival ab
Croatian: Primarna mjera ishoda ukupno preživljenje ab
English: An average 3.1-fold increase in exposure to gefitinib in patients with moderate and severe hepatic impairment was observed.
Croatian: U bolesnika s umjerenim i teškim oštećenjem jetre opažen je porast izloženosti gefitinibu za prosječno 3,1 puta.
English: Factors that predicted for presence of EGFR mutation p-value
Croatian: p-vrijednost Izgledi za mutaciju EGFR
English: In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86).
Croatian: U tom se ispitivanju za analizu mutacije EGFR-a koristila ctDNK iz seruma, a ne iz plazme, a provedena je uz pomoć kompleta testnih reagensa EGFR
English: The formation of O-desmethyl gefitinib has been shown, in vitro, to be via CYP2D6.
Croatian: Nastajanje O-demetil gefitiniba se odvija putem CYP2D6, kako je pokazano in vitro.
English: 6.1List of excipients
Croatian: 6.1 Popis pomoćnih tvari
English: Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia
Croatian: Dehidracija kao posljedica proljeva, mučnina, povraćanje ili anoreksija Suha usta*, pretežno blaga (CTC stupanj
English: Active substances that may increase gefitinib plasma concentrations In vitro studies have shown that gefitinib is a substrate of p-glycoprotein (Pgp).
Croatian: In vitro ispitivanja su pokazala da je gefitinib supstrat P-glikoproteina (Pgp).
English: Asthenia, predominantly mild (CTC grade 1)
Croatian: Astenija, pretežno blaga (CTC stupanj 1)
English: AstraZeneca AB SE-151 85
Croatian: AstraZeneca AB SE-151 85 Södertälje Švedska
English: Proportion of tumour M- that are Mby ctDNA)
Croatian: Udio M- tumora kod kojih je ctDNK bio M
English: HR 0.82 [0.70 to 0.96] 18.9 m vs. 17.2 m
Croatian: HR 0,82 [0,70 do 0,96] 18.9 m vs 17,2 m a Prikazane su vrijednosti za lijek IRESSA u usporedbi s karboplatinom/paklitakselom.
English: 42.9 v. 20.0 EGFR Mutation+
Croatian: 6.2 v. 7.3 Ukupno 42.9 v. 20.0 + mutacija EGFR 5.5 v. 9.1 - mutacija EGFR 23.7 v. 13.3 Nikad nisu pušili 3.9 v. 6.5 Nekad pušili
English: The proportion of ILD-type events with a fatal outcome was
Croatian: Udio događaja tipa ILD-a sa smrtnim ishodom iznosio je 38,6%.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/ALUMINIUM FOIL LAMINATE FLOW WRAP
Croatian: BLISTER/OMOT OD SLOJEVITE ALUMINIJSKE FOLIJE
English: EGFR Mutation
Croatian: - mutacija EGFR
English: EGFR mutation-negative
Croatian: Negativni na mutaciju EGFR
English: 9.8 v. 13.1 Female
Croatian: 9.4 v. 9.4 Adenokarcinom 2.8 v. 5.0 Neadenokarcinom 9.8 v. 13.1 Žene 4.4 v. 4.6 Muškarci
English: Odds of EGFR mutation
Croatian: Pozitivni na mutaciju EGFR
English: Vomiting
Croatian: • povraćanje
English: 11.2 m vs 12.7 m
Croatian: 11,2 m vs 12,7 m mutacija EGFR nepoznata
English: Measure
Croatian: Mjerilo
English: Table 1 Adverse reactions
Croatian: Tablica 1 Nuspojave
English: 4m p=0.1087
Croatian: 18,8 m vs 17,4 m p<0,1087
English: Ever-smoker
Croatian: Pušački status
English: 1 bottle +1 adaptor + 3 oral syringes
Croatian: 1 boca +, 1 adapter + 3 štrcaljke za usta
English: MA (EU) number Invented name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: EU/1/04/303/005 Orfadin 4 mg/ml
Croatian: 4 mg/ml
English: Bottle (glass)
Croatian: Oralna suspenzija Primjena kroz usta Boca (staklo)
English: Immediate Packaging Content
Croatian: Unutarnje pakovanje Sastav (koncentracija)
English: Oral suspension
Croatian: Put primjene
English: Film-coated tablet Oral use blister (PVC/PE/PCTFE/Alu)
Croatian: Kroz usta blister (PVC/PE/PCTFE/Al) 56 (4x14) tableta (višestruko pakiranje)
English: (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: This schedule is repeated in cycles of 4 weeks.
Croatian: Ovaj raspored ponavlja se u ciklusima od 4 tjedna.
English: Each pack contains 1 bottle.
Croatian: Svako pakiranje sadrži 1 bočicu.
English: 7 days (1 week)
Croatian: 7 dana (jedan tjedan)
English: Taking with food and drink
Croatian: Uzimanje s hranom i pićem
English: • Both you and your partner must use effective contraception.
Croatian: • I Vi i Vaš partner morate koristiti djelotvornu kontracepciju.
English: It was reported as serious in one patient.
Croatian: Kao ozbiljna prijavljena je kod jednog bolesnika.
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kao Vam je rekao liječnik.
English: There was no effect of food on the overall exposure (AUC).
Croatian: Hrana nije imala nikakav učinak na ukupnu izloženost (AUC).
English: In the ITT population there was a small numerical difference between the two arms in terms of overall survival.
Croatian: U ITT populaciji postojala je mala brojčana razlika između dvije skupine što se tiče ukupnog preživljenja.
English: Do not take Fotivda:
Croatian: Nemojte uzimati Fotivdu:
English: The capsules must be swallowed whole with a glass of water and must not be opened.
Croatian: Kapsule se moraju progutati cijele sa čašom vode i ne smiju se otvarati.
English: This includes herbal medicines and other medicines you have bought without a prescription.
Croatian: To se odnosi i na biljne lijekove i ostale lijekove koje ste kupili bez recepta.
English: • Do not take Fotivda if you are pregnant.
Croatian: • Nemojte uzimati Fotivdu ako ste trudni.
English: Do not stop taking this medicine unless your doctor tells you to.
Croatian: Nemojte prestati uzimati ovaj lijek osim ako Vam tako ne kaže liječnik.
English: • Difficulty speaking
Croatian: • Teškoće s govorom
English: What Fotivda is and what it is used for
Croatian: Što je Fotivda i zašto se koristi
English: Tell your doctor if you are taking any of the following medicines; they may decide to change your medication:
Croatian: Obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova; on može odlučiti promijeniti Vašu terapiju:
English: Do not give Fotivda to children and adolescents under 18 years of age.
Croatian: Nemojte davati Fotivdu djeci i adolescentima mlađima od 18 godina.
English: If you take more Fotivda than you should
Croatian: Ako uzmete više Fotivde nego što ste trebali
English: Tell your doctor immediately if you think you have high blood pressure.
Croatian: Odmah obavijestite svog liječnika ako mislite da imate povišen krvni tlak.
English: • Taste changes or loss of taste.
Croatian: • Promjena ili gubitak okusa
English: Fotivda must be taken with a glass of water and can be taken either with or without food.
Croatian: Fotivda se mora uzimati sa čašom vode i može se uzimati s hranom ili bez nje.
English: The following terms have been combined:
Croatian: Kombinacije uključuju sljedeće izraze:
English: • Loss of appetite; weight loss.
Croatian: • Gubitak apetita; gubitak težine
English: Continue to take your next dose at the usual time.
Croatian: Nastavite s uzimanjem sljedeće doze u uobičajeno vrijeme.
English: Tell your doctor who will discuss with you the risks of taking Fotivda to you and your child.
Croatian: Obavijestite svog liječnika i on će zajedno s Vama raspraviti rizike uzimanja Fotivde za Vas i Vaše dijete.
English: See also Section 4 “Possible side effects”.
Croatian: Vidjeti dio 4. „Moguće nuspojave“.
English: It is used where other treatments such as interferon-alpha or interleukin-2 have either not yet been used or have not helped to stop your disease.
Croatian: Koristi se tamo gdje se druge terapije, primjerice interferon-alfa ili interleukin-2, nisu još koristile ili nisu pomogle u zaustavljanju bolesti.
English: Other medicines and Fotivda
Croatian: Drugi lijekovi i Fotivda
English: This medicine has not been studied in children and adolescents.
Croatian: Ovaj lijek nije ispitivan u djece i adolescenata.
English: This leaflet was last approved in
Croatian: Ova uputa je zadnji puta odobrena
English: No capsules are taken
Croatian: Kapsule se ne uzimaju
English: Study AV-951-09-301
Croatian: Ispitivanje AV-951-09-301
English: • Sight problems including blurred vision.
Croatian: • Problemi s vidom, uključujući zamućen vid
English: This treatment schedule should be continued until disease progression or unacceptable toxicity.
Croatian: Ovaj raspored terapije potrebno je nastaviti do progresije bolesti ili neprihvatljive toksičnosti.
English: P-value (Log rank test)
Croatian: P-vrijednost (log-rang test)
English: • nafcillin, rifampicin, rifabutin, rifapentin (antibiotics);
Croatian: • nafcilin, rifampicin, rifabutin, rifapentin (antibiotici);
English: • If you are allergic to tivozanib or any of the other ingredients of this medicine (listed in section 6);
Croatian: • ako ste alergični na tivozanib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.);
English: The most important serious adverse reaction is hypertension.
Croatian: Najbitnija ozbiljna nuspojava je hipertenzija.
English: The next dose should be taken at the next scheduled time.
Croatian: Sljedeću dozu treba uzeti u iduće planirano vrijeme.
English: High blood pressure is the most serious and a very common side effect (see also in section 2 “Warnings and Precautions”).
Croatian: Povišen krvni tlak najozbiljnija je i vrlo česta nuspojava (vidjeti dio 2. „Upozorenja i mjere opreza“).
English: • Temporary reduced blood flow to the brain.
Croatian: • Privremeno smanjen dotok krvi u mozak
English: QT/QTc interval prolongation may lead to an increased risk for ventricular arrhythmias.
Croatian: Produženjem QT/QTc intervala može se povećati rizik od ventrikularnih aritmija.
English: The majority of AST and ALT elevations were not accompanied with concomitant elevations of bilirubin.
Croatian: Većina povišenih vrijednosti AST i ALT nije bila praćena istovremenim povišenim bilirubinom.
English: What Fotivda is and what it is used for What you need to know before you take Fotivda How to take Fotivda
Croatian: Što je Fotivda i zašto se koristi Što morate znati prije nego počnete uzimati Fotivdu Kako uzimati Fotivdu
English: In approximately one-third of the patients, hypertension developed within the first 2 months of treatment.
Croatian: Kod otprilike jedne trećine bolesnika, hipertenzija se razvila unutar prva 2 mjeseca liječenja.
English: • Talk to your doctor when planning a baby, as Fotivda may affect the fertility of men and women.
Croatian: • Obavijestite liječnika ako planirate trudnoću, jer Fotivda može djelovati na plodnost muškaraca i žena.
English: Fotivda may work less well when taken with some medicines.
Croatian: Fotivda može slabije djelovati ako se uzima s nekim lijekovima.
English: One patient experienced Grade 4 PRES and hypertension in Study AV-951-09-901.
Croatian: Jedan bolesnik imao je PRES 4. stupnja i hipertenziju u ispitivanju AV-951-09-901
English: Objective Response Rate (95% CI), ITT Population
Croatian: Stopa objektivnog odgovora (95% CI), ITT populacija
English: • Blocked ears.
Croatian: • Začepljene uši
English: What you need to know before you take Fotivda
Croatian: Što morate znati prije nego počnete uzimati Fotivdu
English: Both events were CTC Grade 3 (see section 4.4).
Croatian: Oba događaja bila su CTC 3. stupnja (vidjeti dio 4.4).
English: Swallow the capsule whole.
Croatian: Kapsulu progutajte cijelu.