FrancophonIA/ELRC3.0 huggingface dataset:
English: The major route of elimination of drug related radioactivity after oral administration of [14C] nintedanib was via faecal/biliary excretion (93.4 % of dose, 2.61 % gCV).
Croatian: Glavni put eliminacije radioaktivnosti vezane uz lijek nakon peroralne primjene [14C] nintedaniba bio je izlučivanjem stolicom/putem žuči (93,4 % doze, 2,61 % gCV).
English: Do not take Vargatef - if you are allergic to nintedanib, to peanut or soya, or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Vargatef - ako ste alergični na nintedanib, kikiriki ili soju, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Information about selected adverse reactions observed from the LUME-Lung 1 trial are described below.
Croatian: U nastavku su opisane informacije o odabranim nuspojavama opaženim u ispitivanju LUME-Lung 1.
English: Vargatef may have minor influence on your ability to drive and use machines.
Croatian: Vargatef može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: You will be prescribed the appropriate capsule strength by your doctor if this happens.
Croatian: Ako se to dogodi, liječnik će Vam propisati odgovarajuću jačinu kapsula.
English: In this trial single oral doses of 200 mg nintedanib as well as multiple oral doses of 200 mg nintedanib administered
Croatian: U ovom ispitivanju jednokratna peroralna doza od 200 mg nintedaniba kao i višekratne peroralne doze od
English: The HR for these patients for PFS and OS was 1.24 (95 % CI: 0.68, 2.28) and 1.09 (95 % CI: 0.70, 1.70), respectively.
Croatian: Omjer hazarda za ove bolesnike za preživljenje bez progresije i ukupno preživljenje iznosili su 1,24 (95 % CI: 0,68, 2,28) odnosno 1,09 (95 % CI: 0,70, 1,70).
English: Each capsule contains 1.8 mg of soya lecithin.
Croatian: Jedna kapsula sadrži 1,8 mg sojinog lecitina.
English: Treatment of these patients with nintedanib in combination with docetaxel reduced the risk of death by 25 %, compared with placebo plus docetaxel (HR 0.75; 95 % CI: 0.60 - 0.92; p = 0.0073).
Croatian: Liječenje ovih bolesnika nintedanibom u kombinaciji s docetakselom smanjilo je rizik od smrti za 25 %, u usporedbi s placebom i docetakselom (HR 0,75; 95 % CI: 0,60 - 0,92; p = 0,0073).
English: Vargatef 150 mg soft capsules Pack-size: 60 capsules.
Croatian: Vargatef 150 mg meke kapsule Veličina pakiranja: 60 kapsula.
English: In case of specific elevations of aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) values to > 3 x upper limit normal (ULN) in conjunction with an increase of total bilirubin to ≥ 2 x ULN and alkaline phosphatase (ALKP) < 2 x ULN (see Table 2) treatment with Vargatef should be interrupted.
Croatian: U slučaju specifičnog porasta vrijednosti aspartat aminotransferaze (AST)/alanin aminotransferaze (ALT) na > 3 x gornje granice normale (GGN) u kombinaciji s porastom ukupnog bilirubina na ≥ 2 x GGN i alkalne fosfataze (AP) < 2 x GGN (vidjeti tablicu 2), liječenje Vargatefom mora se prekinuti.
English: Capsule content Triglycerides, medium-chain Hard fat
Croatian: Trigliceridi srednje duljine lanca Tvrda mast
English: Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people) Treatment with Vargatef may lead to a reduced number of a type of your white blood cells (neutropenia) which are important for the body´s reaction against bacterial or fungal infections.
Croatian: - Febrilna neutropenija i sepsa (često, može se javiti u do 1 na 10 osoba) Liječenje Vargatefom može dovesti do smanjenog broja jedne vrste bijelih krvnih stanica (neutropenija), koje su važne za reakciju tijela protiv bakterijskih i gljivičnih infekcija.
English: In this case your doctor will prescribe Vargatef 150 mg soft capsules for your treatment.
Croatian: U tom slučaju liječnik će propisati Vargatef 150 mg meke kapsule za Vaše liječenje.
English: The following medicines may increase the blood levels of nintedanib, the active substance of Vargatef, and hence may increase the risk for side effects (see section 4): - Ketoconazole (used to treat fungal infections) - Erythromycin (used to treat bacterial infections) The following medicines may decrease the blood levels of nintedanib and thus may lead to reduction of the effectiveness of Vargatef: - Rifampicin (an antibiotic used to treat tuberculosis) - Carbamazepine, phenytoin (used to treat seizures) - St. John's Wort (a herbal medicine to treat depression)
Croatian: Navedeni lijekovi mogu povećati razinu nintedaniba u krvi, djelatne tvari Vargatefa te stoga mogu povećati rizik od nuspojava (vidjeti dio 4): - Ketokonazol (koji se koristi za liječenje gljivičnih infekcija) - Eritromicin (koji se koristi za liječenje bakterijskih infekcija) Navedeni lijekovi mogu smanjiti razinu nintedaniba u krvi i stoga mogu dovesti do smanjenja učinkovitosti Vargatefa: - Rifampicin (antibiotik koji se koristi za liječenje tuberkuloze) - Karbamazepin, fenitoin (koji se koriste za liječenje napadaja) - Gospina trava (biljni lijek za liječenje depresije)
English: The recommended dose is two capsules per day (this is a total of 300 mg nintedanib per day).
Croatian: Preporučena doza su dvije kapsule na dan (to čini ukupno 300 mg nintedaniba dnevno).
English: Recommended dose adjustments for Vargatef (nintedanib) in case of AST and/or ALT and bilirubin elevations
Croatian: Tablica 2 Preporučena prilagodba doze Vargatefa (nintedaniba) u slučaju povišenja AST-a i/ili ALT -a i bilirubina
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous system organs, with the most frequent being respiratory.
Croatian: Slučajevi krvarenja nakon stavljanja lijeka u promet uključuju, ali nisu ograničeni na organe probavnog, dišnog i središnjeg živčanog sustava, s time da su najučestaliji bili slučajevi dišnog krvarenja.
English: The safety data provided in the sections below are based on the global, double-blind randomised pivotal phase 3 trial 1199.13 (LUME-Lung 1) comparing treatment with nintedanib plus docetaxel against placebo plus docetaxel in patients with locally advanced, or metastatic, or recurrent NSCLC after first-line chemotherapy and based on data observed during the post-marketing period.
Croatian: Podaci o sigurnosti primjene, navedeni u nastavku, temelje se na globalnom, dvostruko slijepom, randomiziranom, pivotalnom ispitivanju faze 3, 1199.13 (LUME-Lung 1), u kojem se uspoređivalo liječenje kombinacijom nintedaniba i docetaksela naspram kombinacije placebo i docetaksel u bolesnika s lokalno uznapredovalim, metastatskim ili rekurentnim NSCLC-om nakon kemoterapije kao prve linije liječenja i na temelju podataka opaženih tijekom razdoblja nakon stavljanja lijeka u promet.
English: Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) status (0 versus 1), bevacizumab pretreatment (yes versus no), brain metastasis (yes versus no) and tumour histology (squamous versus non-squamous tumour histology).
Croatian: Randomizacija je bila stratificirana sukladno statusu Eastern Cooperative Oncology Group (ECOG-a) (0 naspram 1), prethodnog liječenja bevacizumabom (da naspram ne), metastaza u mozgu (da naspram ne) i histološkog nalaza tumora (skvamozni tumor naspram neskvamoznog tumora).
English: Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
Croatian: Vargatef je indiciran u kombinaciji s docetakselom za liječenje odraslih bolesnika s lokalno uznapredovalim, metastatskim ili lokalno rekurentnim rakom pluća nemalih stanica (NSCLC, engl. non-small cell lung cancer) s histološkim nalazom adenokarcinoma, nakon kemoterapije kao prve linije liječenja.
English: Capsule content:Triglyceridesmedium-chain, hard fat, soya lecithin(E322)
Croatian: trigliceridi srednje duljine lanca, kruta mast, soja lecitin (E322)
English: Vargatef 100 mg soft capsules EU/1/14/954/001
Croatian: Vargatef 100 mg meke kapsule EU/1/14/954/001
English: The most frequently reported adverse drug reactions (ADRs) specific for nintedanib were diarrhoea, increased liver enzyme values (ALT and AST) and vomiting.
Croatian: Najčešće prijavljene nuspojave na lijek, specifične za nintedanib, bile su proljev, povećane vrijednosti jetrenih enzima (ALT i AST) te povraćanje.
English: In the post-marketing period non-serious and serious bleeding events, some of which fatal, have been reported, including patients with or without anticoagulant therapy or other medicinal products that could cause bleeding.
Croatian: U razdoblju nakon stavljanja lijeka u promet bilo je prijavljenih slučajeva krvarenja koje nije bilo ozbiljno i slučajeva ozbiljnog krvarenja od kojih su neki bili sa smrtnim ishodom, uključujući bolesnike sa ili bez terapije antikoagulansima ili drugim lijekovima koji mogu uzrokovati krvarenje.
English: Each capsule contains 1.2 mg of soya lecithin.
Croatian: Jedna kapsula sadrži 1,2 mg sojinog lecitina.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 120 (2 packs of 60 x1) soft capsules.
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje: 120 (2 pakiranja po 60 x 1) mekih kapsula.
English: Pregnancy testing should be conducted at least prior to treatment with Vargatef.
Croatian: Mora se provesti testiranje na trudnoću prije liječenja Vargatefom.
English: The addition of nintedanib to docetaxel led to a statistically significant reduction in the risk of progression or death by 21 % for the overall population (hazard ratio (HR) 0.79; 95 % confidence interval (CI): 0.68 - 0.92; p = 0.0019) as determined by the Independent Review Committee.
Croatian: Dodatak nintedaniba docetakselu uzrokovao je statistički značajno smanjenje u riziku od progresije bolesi ili smrti za 21 % za ukupnu populaciju (omjer hazarda (HR) 0,79; 95 % interval pouzdanosti (CI): 0,68-0,92; p = 0,0019) kako je odredilo nezavisno povjerenstvo za procjenu.
English: Table 3 summarizes the frequencies of adverse drug reactions that were reported in the pivotal trial LUME-Lung 1 for patients with NSCLC of adenocarcinoma tumour histology (n = 320) or from the post-marketing period.
Croatian: Tablica 3 sažima učestalost nuspojava lijeka, koje su bile prijavljene u pivotalnom ispitivanju LUME-Lung 1 za bolesnike s NSCLC-om s histološkim nalazom adenokarcinoma (n = 320) ili tijekom razdoblja nakon stavljanja lijeka u promet.
English: Objective response [%] Odds ratio (95 % CI) p-value+
Croatian: Objektivni odgovor [%] Omjer šansi (95 % CI) p-vrijednost
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (100 mg)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER (100 mg)
English: Effects on the development of the axial skeleton and on the development of the great arteries were also noted at subtherapeutic exposure levels.
Croatian: Pri subterapijskim razinama izloženosti primijećeni su učinci na razvoj aksijalnog skeleta i na razvoj velikih arterija.
English: A statistically significant improvement in OS favouring treatment with nintedanib plus docetaxel was demonstrated in patients with adenocarcinoma with a 17 % reduction in the risk of death (HR 0.83, p = 0.0359) and a median OS improvement of 2.3 months (10.3 versus 12.6 months, Figure 1).
Croatian: Dokazano je statistički značajno poboljšanje u ukupnom preživljenju u korist liječenja kombinacijom nintedaniba i docetaksela u bolesnika s adenokarcinomom, obzirom na 17 %-tno smanjenje rizika od smrti (HR 0,83, p = 0,0359) i medijan poboljšanja ukupnog preživljenja od 2,3 mjeseci (10,3 naspram 12,6 mjeseci, slika 1).
English: Treatment with Vargatef is not recommended in patients with moderate or severe hepatic impairment (see section 4.2).
Croatian: Liječenje Vargatefom nije preporučeno u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre (vidjeti dio 4.2).
English: Vargatef 150 mg soft capsules EU/1/14/954/004
Croatian: Vargatef 150 mg meke kapsule EU/1/14/954/004
English: In case of bleeding, dose adjustment, interruption or discontinuation should be considered based on clinical judgement (see section 4.2).
Croatian: U slučaju krvarenja, potrebno je razmotriti prilagodbu doze, privremeni ili trajni prekid primjene na temelju kliničke procjene (vidjeti dio 4.2).
English: In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to nintedanib decreased to 50.3 % based on AUC and to 60.3 % based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone.
Croatian: U ispitivanju interakcija s potentnim induktorom P-gp-a rifampicinom, izloženost nintedanibu smanjila se na 50,3 % na temelju AUC i na 60,3 % na temelju Cmax nakon istodobne primjene s rifampicinom u usporedbi s primjenom nintedaniba kao monoterapije.
English: The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (< 30 ml/min creatinine clearance).
Croatian: Sigurnost, djelotvornost i farmakokinetika nintedaniba nisu ispitani u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min.).
English: Elevation of AST and/or ALT values to > 5 x ULN
Croatian: Povišenje vrijednosti AST-a i/ili ALT-a > 5 x GGN
English: Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study.
Croatian: Istodobna primjena s potentnim inhibitorom P-gp-a ketokonazolom, povećala je izloženost nintedanibu 1,61 puta na temelju AUC i 1,83 puta na temelju Cmax u ciljanom ispitivanju interakcija s drugim lijekovima.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (100 mg - 60 capsules for multipack - without Blue Box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (100 mg - 60 kapsula za višestruko pakiranje - bez plavog okvira)
English: In preclinical disease models nintedanib, as single agent, effectively interfered with the formation and maintenance of the tumour vascular system resulting in tumour growth inhibition and tumour stasis.
Croatian: U pretkliničkim modelima bolesti nintedanib, kao pojedinačna tvar, učinkovito interferira s nastankom i održavanjem tumorskog krvožilnog sustava što rezultira inhibicijom tumorskog rasta i tumorskom stazom.
English: In case of specific changes in liver values (AST/ALT > 3 x ULN; total bilirubin ≥ 2 x ULN and ALKP < 2 x ULN) treatment with Vargatef should be interrupted.
Croatian: U slučaju specifičnih promjena jetrenih vrijednosti (AST/ALT > 3 x GGN; ukupni bilirubin ≥ 2 x GGN i AP < 2 x GGN) mora se prekinuti liječenje Vargatefom.
English: Figure 1: Kaplan-Meier curve for overall survival for patients with adenocarcinoma tumour histology by treatment group in trial LUME-Lung 1
Croatian: Kaplan-Meierova krivulja za ukupno preživljenje bolesnika s histološkim nalazom adenokarcinoma po liječenoj skupini u ispitivanju LUME-Lung 1
English: Warnings and precautions Talk to your doctor or pharmacist before taking this medicine - if you have or had liver problems, if you have or had bleeding problems, particularly recent bleeding in the lung - if you have or ever had problems with your kidney - if you take blood-thinning medicines (such as warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clotting.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek - ako imate ili ste imali probleme s jetrom, ako imate ili ste imali probleme s krvarenjem, naročito nedavno krvarenje u plućima - ako imate ili ste ikad imali probleme s bubrezima - ako uzimate lijekove za razrjeđivanje krvi (poput varfarina, fenprokumona, heparina ili acetilsalicilatne kiseline) radi sprečavanja zgrušavanja krvi.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (150 mg)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER (150 MG)
English: Stratified Log-Rank Test p-value** Disease control [%] Odds ratio (95 % CI) p-value+
Croatian: Stratified Log-Rank Test p-vrijednost** Kontrola bolesti [%] Omjer šansi (95 % CI) p-vrijednost
English: Recommended dose adjustments for Vargatef (nintedanib) in case of diarrhoea, vomiting and other non-haematological or haematological adverse reactions
Croatian: Preporučena prilagodba doze Vargatefa (nintedaniba) u slučaju proljeva, povraćanja i drugih nehematoloških ili hematoloških nuspojava CTCAE* nuspojave
English: Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A; see sections 4.2 and 5.2).
Croatian: U slučaju povećane izloženosti može postojati povećan rizik od štetnih događaja u bolesnika s blagim oštećenjem funkcije jetre (Child Pugh A; vidjeti dijelove 4.2 i 5.2).
English: The efficacy of nintedanib has not been investigated in patients with moderate hepatic impairment (Child Pugh B).
Croatian: Djelotvornost nintedaniba nije ispitana u bolesnika s umjerenim oštećenjem funkcije jetre (Child Pugh B).
English: For recommended measures and dosing adjustments in case of diarrhoea, see sections 4.4 and 4.2, respectively.
Croatian: Za preporučene mjere i prilagodbu doze u slučaju proljeva vidjeti dio 4.4 odnosno 4.2.
English: Non-serious and serious bleeding events, some of which were fatal, have been reported in the postmarketing period, including patients with or without anticoagulant therapy or other medicinal products that could cause bleeding (for clinical trials' data, see also ‘Therapeutic anticoagulation' below).
Croatian: U razdoblju nakon stavljanja lijeka u promet bilo je prijavljenih slučajeva krvarenja koje nije bilo ozbiljno i slučajeva ozbiljnog krvarenja od kojih su neki bili sa smrtnim ishodom, uključujući bolesnike sa ili bez terapije antikoagulansima ili drugim lijekovima koji mogu uzrokovati krvarenje (za podatke iz kliničkih ispitivanja, vidjeti također „Terapija antikoagulansima“ niže).
English: Talk to your doctor or pharmacist before taking this medicine - if you have or had liver problems, if you have or had bleeding problems, particularly recent bleeding in the lung - if you have or ever had problems with your kidney - if you take blood-thinning medicines (such as warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clotting.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek - ako imate ili ste imali probleme s jetrom, ako imate ili ste imali probleme s krvarenjem, naročito nedavno krvarenje u plućima; - ako imate ili ste ikad imali probleme s bubrezima; - ako uzimate lijekove za razrjeđivanje krvi (poput varfarina, fenprokumona, heparina ili acetilsalicilatne kiseline) radi sprečavanja zgrušavanja krvi.
English: The majority of adverse reactions appeared in close temporal relationship with the administration of docetaxel.
Croatian: Glavnina nuspojava pojavila se u uskoj vremenskoj povezanosti u odnosu na primjenu docetaksela.
English: In the overall population, 16.0 % of the patients had disease stage < IIIB/IV, 22.4 %, had disease stage IIIB and 61.6 % had disease stage IV. 9.2 % of the patients entered the trial with locally recurrent disease stage as had been evaluated at baseline.
Croatian: U ukupnoj populaciji 16,0 % bolesnika imalo je stadij bolesti < IIIB/IV, 22,4 % imalo je stadij bolesti IIIB, a 61,6 % imalo je stadij bolesti IV.
English: ° Adjusted mean of best-% change from baseline and p-value generated from an ANOVA model adjusting for baseline ECOG PS (0 versus 1), brain metastases at baseline (yes versus no) and prior treatment with bevacizumab (yes versus no).
Croatian: ° Prilagođena srednja vrijednost najboljih %-tnih promjena od početne vrijednosti i p-vrijednosti generirane iz modela ANOVA prilagođavanjem za početnu vrijednost ECOG PS (0 naspram 1), metastaze u mozgu na početku ispitivanja (da naspram ne) i prethodnom liječenju bevacizumabom (da naspram ne).
English: Diarrhoea, Vomiting, Nausea, Abdominal pain
Croatian: Poremećaji probavnog sustava proljev, povraćanje, mučnina, bol u abdomenu,
English: This medicine is used in combination with another cancer medicine (docetaxel) to treat a cancer of the lung called non-small cell lung cancer (NSCLC).
Croatian: Ovaj lijek se primjenjuje u kombinaciji s drugim lijekom protiv raka (docetakselom) u liječenju raka pluća nemalih stanica.
English: As shown in Table 4, the addition of nintedanib to docetaxel led to a statistically significant reduction in the risk of progression or death by 23 % for the adenocarcinoma population (HR 0.77; 95 % CI: 0.62 - 0.96).
Croatian: Kao što je prikazano u tablici 4, dodatak nintedaniba docetakselu doveo je do statistički značajnog smanjenja rizika od progresije ili smrti za 23 % za populaciju s adenokarcinomom (HR 0,77; 95 % CI:
English: INFORMATION IN BRAILLE Vargatef 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vargatef 150 mg
English: Therefore, women should not breast-feed during treatment with Vargatef.
Croatian: Stoga žene ne bi trebale dojiti tijekom liječenja Vargatefom.
English: INFORMATION IN BRAILLE Vargatef 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vargatef 100 mg
English: Elevation of AST and/or ALT values to > 2.5 x ULN in conjunction with total bilirubin elevation to ≥ 1.5 x ULN
Croatian: Povišenje vrijednosti AST-a i/ili ALT-a > 2,5 x GGN zajedno s povišenjem ukupnog bilirubina ≥ 1,5 x GGN ILI
English: How to take Vargatef
Croatian: Kako uzimati Vargatef
English: Stratified Log-Rank Test p-value** Progression free survival (PFS)*** - follow-up analysis Patients, n
Croatian: Stratified Log-Rank Test p-vrijednost** Preživljenje bez progresije (PFS)***- analiza praćenja Bolesnici, n
English: Diarrhoea should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, for example loperamide, and may require interruption, dose reduction or discontinuation of therapy with Vargatef (see section 4.2).
Croatian: Proljev se mora liječiti pri pojavi prvih znakova odgovarajućim nadomještanjem tekućine i lijekovima protiv proljeva, na primjer loperamidom, a može biti potrebno i privremeno prekidanje, smanjenje doze ili trajni prekid terapije Vargatefom (vidjeti dio 4.2).
English: Most patients recovered from diarrhoea following treatment interruption, anti-diarrhoeal therapy and nintedanib dose reduction.
Croatian: Većina bolesnika se oporavila od proljeva nakon privremenog prekida liječenja nintedanibom, simptomatskog liječenja proljeva i smanjenja doze nintedaniba.
English: Pack-sizes: 60 or 120 capsules, or multipack of 120 (2 x 60) capsules (2 cartons of 60 capsules each,
Croatian: Veličina pakiranja: 60 ili 120 kapsula, ili višestruko pakiranje od 120 (2 x 60) kapsula (2 kutije po
English: A higher frequency of neutropenia of CTCAE grade ≥ 3 was observed in patients treated with Vargatef in combination with docetaxel as compared to treatment with docetaxel alone.
Croatian: Zamijećena je veća učestalost neutropenije ≥ stupnja 3 prema CTCAE-u u bolesnika liječenih kombinacijom Vargatefa i docetaksela u usporedbi s liječenjem docetakselom u monoterapiji.
English: Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Vargatef is not recommended (see sections 4.4 and 5.2).
Croatian: Liječenje Vargatefom ne preporučuje se u bolesnika s umjerenim (Child Pugh B) i teškim (Child Pugh C) oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: This daily dose should be split into two doses of two capsules about 12 hours apart, for example two capsules in the morning and two capsules in the evening.
Croatian: Ova dnevna doza se mora podijeliti na dvije doze od dvije kapsule u razmaku od približno 12 sati primjerice dvije kapsule ujutro i dvije kapsule navečer.
English: Breast-feeding should be discontinued during treatment with Vargatef.
Croatian: Dojenje se mora prekinuti za vrijeme liječenja Vargatefom.