FrancophonIA/ELRC3.0 huggingface dataset:
English: • reduced white blood cells called granulocytes or monocytes - can increase your risk for infection
Croatian: • smanjeni broj bijelih krvnih stanica koje se nazivaju granulociti ili monociti - može povećati rizik za infekcije
English: Each tablet contains 15 mg trifluridine and 6.14 mg tipiracil
Croatian: Svaka tableta sadrži 15 mg trifluridina i 6,14 mg tipiracila
English: Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.75, 95% CI [0.59 to 0.94]).
Croatian: U toj skupini bolesnika, korist u smislu OS uz primjenu Lonsurfa je bila održana (omjer hazarda 0,75; 95% CI [0,59 do 0,94]).
English: The tablet is a white, biconvex, round, film-coated tablet, with a diameter of 7.1 mm and a thickness of 2.7 mm, imprinted with ‘15' on one side, and ‘102' and '15 mg' on the other side, in grey ink.
Croatian: Tableta je bijela, bikonveksna, okrugla filmom obložena tableta, promjera 7,1 mm i debljine 2,7 mm, s oznakom ‘15' na jednoj strani, i ‘102' i '15 mg' na drugoj, u sivoj tinti.
English: Median PFS (months)a [95% CI]b Hazard ratio [95% CI] P-value c
Croatian: Medijan PFS (mjeseci)a [95% CI]b Omjer hazarda [95% CI] P-vrijednostc
English: In a dedicated study the PK of trifluridine and tipiracil hydrochloride were evaluated in cancer patients with mild or moderate hepatic impairment (National Cancer Institute [NCI] Criteria Group B and C, respectively) and in patients with normal hepatic function.
Croatian: U posebnom PK ispitivanju trifluridina i tipiracilklorida ocjenjivani su onkološki bolesnici s blagim ili umjerenim oštećenjem jetrene funkcije (skupina B odnosno C prema kriterijima nacionalnog instituta za rak [engl.
English: Repeat-dose toxicity
Croatian: Ispitivanja toksičnosti ponovljenih doza
English: Lower respiratory tract infection
Croatian: Infekcija donjih dišnih puteva
English: In addition, a higher exposure of trifluridine and tipiracil was observed in patients with moderate renal impairment, compared with patients with normal renal function or patients with mild renal impairment (see section 5.2).
Croatian: Nadalje, kod bolesnika s umjerenim oštećenjem bubrega je primijećena veća izloženost trifluridinu i tipiracilu u usporedbi s bolesnicima s normalnom funkcijom bubrega ili bolesnicima s blagim oštećenjem bubrega (vidjeti dio
English: • inflammation, swelling or bleeding in your bowel
Croatian: • upala, oteklina ili krvarenje u crijevima
English: Whitening, breakage, and malocclusion were observed in teeth of rats treated with trifluridine/tipiracil hydrochloride, which are considered rodent specific and not relevant for human.
Croatian: Kod zubiju štakora kojima je davan trifluridin/tipiracilklorid je primjećeno izbjeljivanje, lomljivost te malokluzija, no to se smatra specifičnim za glodavce te nevažnim za ljude.
English: Gastrectomy
Croatian: Gastrektomija
English: • runny or bloody nose, sinus problems
Croatian: • curenje ili krvarenja nosa, poteškoće sa sinusima
English: C-reactive protein increased
Croatian: Povišen c-reaktivni protein Snižen hematokrit a.
English: • reduced white blood cells called leucocytes - can increase your risk for infection
Croatian: • smanjenje broja bijelih krvnih stanica koje se nazivaju leukociti - može povećati rizik za infekciju
English: • bone pain, muscle pain, muscle weakness or spasms, pain in tendons, nerves or ligaments
Croatian: • bol u kostima, bol u mišićima, slabost mišića ili grčevi, bol u tetivama, živcima ili ligamentima
English: Overall Survival Number of deaths, N (%) Median OS (months)a [95% CI]b Hazard ratio [95% CI] P-valuec
Croatian: Ukupno preživljenje (OS) Broj smrtnih slučajeva, N (%) Medijan OS (mjeseci)a [95% CI]b Omjer hazarda [95% CI] P-vrijednostc
English: • painful tongue, polyps inside your mouth, mouth ulcers, retching
Croatian: • bolnost jezika, polipi u ustima, vrijed u ustima, dizanje želudca
English: What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Croatian: Što Lonsurf sadrži Lonsurf 15 mg/6,14 mg tablete
English: Neutrophils
Croatian: Broj neutrofila
English: • more noticeable heart-beat, chest pain
Croatian: • jači osjećaj srčanih otkucaja, bolovi u prsima
English: - Printing ink: shellac, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine aluminium lake (E132), carnauba wax and talc.
Croatian: - Tinta za označavanje: šelak, željezov oksid crveni (E172), željezov oksid žuti (E172), titanijev dioksid (E171), boja indigo carmin aluminium lake (E132), karnauba vosak i talk.
English: The median OS was 5.7 months (95% CI: 4.8, 6.2) for the Lonsurf group versus 3.6 months (95% CI: 3.1, 4.1) for the placebo group; with 1-year survival rates of 21.2% and 13.0%, respectively.
Croatian: (95% CI: 4,8; 6,2) u usporedbi sa 3,6 mjeseci kod placeba (95% CI: 3,1; 4,1); sa stopom jednogodišnjeg preživljenja od 21,2% u usporedbi sa 13,0% kod placeba.
English: The signs include unusual bruising or bleeding (see section 2).
Croatian: Znaci uključuju neobjašnjive modrice ili krvarenja (pogledajte dio
English: - Film coating: hypromellose, macrogol (8000), titanium dioxide (E171), iron oxide red (E172) and magnesium stearate.
Croatian: - Film ovojnica: hipromeloza, makrogol (8000), titanijev dioksid (E171), željezov oksid crveni (E172) i magnezijev stearat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Lonsurf 15 mg/6.14 mg film-coated tablets
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Lonsurf 15 mg/6,14 mg filmom obložene tablete
English: Each tablet contains 20 mg trifluridine and 8.19 mg tipiracil.
Croatian: Svaka tableta sadrži 20 mg trifluridina i 8,19 mg tipiracila
English: No correlation was seen for trifluridine nor tipiracil hydrochloride between PK parameters and AST or/and total blood bilirubin.
Croatian: Nije dokazana povezanost između PK parametara i AST i/ili ukupnog bilirubina u krvi niti za trifluridin niti za tipiracilklorid.
English: In total, 507 patients were randomised 2:1 to receive Lonsurf (N = 337) plus best supportive care (BSC) or placebo (N = 170) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Croatian: Ukupno je 507 bolesnika bilo randomizirano u omjeru 2:1 ili u skupinu koja je primala Lonsurf (N=337) uz najbolju potpornu njegu (eng. best supportive care, BSC) ili u skupinu koja je primala placebo (N = 170) uz BSC.
English: EU/1/16/1096/006 60 film-coated tablets
Croatian: EU/1/16/1096/006 60 filmom obloženih tableta
English: The tablet is a pale red, biconvex, round, film-coated tablet, with a diameter of 7.6 mm and a thickness of 3.2 mm, imprinted with ‘20' on one side, and ‘102' and ‘20 mg' on the other side, in grey ink.
Croatian: Tableta je blijedo crvena, bikonveksna, okrugla filmom obložena tableta, promjera 7,6 mm i debljine 3,2 mm, s oznakom ‘20' na jednoj strani, i ‘102' i '20 mg' na drugoj, u sivoj tinti.
English: SIA Servier Latvia Tel: +371 67502039
Croatian: Tel: +371 67502039
English: Lonsurf is for oral use.
Croatian: Lonsurf se primjenjuje peroralno.
English: EU/1/16/1096/005 40 film-coated tablets
Croatian: EU/1/16/1096/005 40 filmom obloženih tableta
English: No adjustment of the starting dose is recommended in patients with mild or moderate renal impairment (see sections 4.4 and 5.2).
Croatian: Nije potrebno prilagoditi početnu dozu u bolesnika s blagim i umjerenim oštećenjem bubrega (vidjeti dijelove 4.4 i 5.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1096/004 20 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1096/004 20 filmom obloženih tableta
English: Servier Polska Sp. z o.o.
Croatian: Servier Italia S.p.A.
English: Neurotoxicity Dysaesthesia Hyperaesthesia Hypoaesthesia Syncope
Croatian: Neurotoksičnost Disestezija Hiperestezija Hipoestezija
English: Gastrooesophageal reflux disease Proctalgia
Croatian: Dispepsija Gastroezofagealna refluksna bolest
English: • inflammation and infection in your gut
Croatian: • upala i infekcija u crijevima
English: Hyperbilirubinaemia Hepatotoxicity Biliary dilatation
Croatian: Hiperbilirubinemija Hepatotoksičnost
English: The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (TAGS) in patients with previously treated metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction), who had been previously treated with at least two prior systemic treatment regimens for advanced disease, including fluoropyrimidine-, platinum-, and either taxane- or irinotecan-based chemotherapy, plus if appropriate human epidermal growth factor receptor 2 (HER2) -targeted therapy.
Croatian: Klinička djelotvornost i sigurnost Lonsurfa ispitivane su u internacionalnom, randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju faze III (TAGS) u bolesnika s prethodno liječenim metastatskim karcinomom želuca (uključujući adenokarcinom gastroezofagealnog spoja) koji su prethodno bili liječeni s najmanje dva režima sistemskog liječenja uznapredovale
English: Metastatic gastric cancer
Croatian: Metastatski karcinom želuca
English: Lonsurf plus BSC (N=534)
Croatian: (N=534)
English: Administration is not recommended in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin > 1.5 x ULN) as, a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see sections 4.4 and 5.2).
Croatian: National Cancer Institute, NCI] definirano ukupnim bilirubinom > 1,5 x gornja granica normale) budući da je zabilježena povećana incidencija hiperbilirubinemije 3. ili 4. stupnja u bolesnika s umjerenim oštećenjem jetre na početku liječenja, iako se ovo temelji na vrlo ograničenim podacima (vidjeti dijelove 4.4 i 5.2).
English: • reduced number of white blood cells called lymphocytes - can increase your risk for infection
Croatian: • smanjeni broj bijelih krvnih stanica koje se nazivaju limfociti - može povećati rizik za infekcije
English: Hazard ratio for progression or death, 0.48 (95% CI, 0.41-0.57) P<0.0001 by log-rank test
Croatian: Omjer hazarda za progresiju bolesti ili smrt, 0,48 (95% CI, 0,41-0,57) P<0,0001; log-rank test
English: Les Laboratoires Servier Tel: +33 (0)1 55 72 60 00
Croatian: Tel: +33 (0)1 55 72 60 00
English: • problems passing water (urine retention), loss of bladder control (incontinence)
Croatian: • promjene u nalazu testa mokraće, krv u mokraći • problemi s mokrenjem (zadržavanje mokraće), gubitak kontroliranja mokraćnog mjehura
English: Approximately half (55.4%) of patients received prior irinotecan, 33.3% received prior ramucirumab, and 16.6% received prior HER2-targeted therapy.
Croatian: Približno polovica (55,4%) bolesnika primila je ranije irinotekan, 33,3%
English: Placebo plus BSC (N=266)
Croatian: (N=266)
English: The median time to PS ≥ 2 for the Lonsurf group and placebo group was 5.7 months and 4.0 months, respectively, with a hazard ratio of 0.66 (95% CI: [0.56, 0.78]), p < 0.0001.
Croatian: Medijan vremena do PS ≥ 2 u skupini liječenoj Lonsurfom bio je 5,7 mjeseci, a u placebo skupini 4,0 mjeseci s omjerom hazarda 0,66 (95% CI [0,56; 0,78]), p < 0,0001.
English: PFS was significantly improved in patients receiving Lonsurf plus BSC compared to placebo plus BSC (HR of 0.57; 95% CI [0.47 to 0.70]; p < 0.0001 (see Table 7, Figure 3 and Figure 4).
Croatian: Preživljenje bez progresije (PFS) je značajno bolje u bolesnika koji su primali Lonsurf uz BSC u usporedbi sa skupinom koja je primala placebo uz BSC (omjer hazarda 0,57; 95% CI [0,47 do 0,70]; p < 0,0001 (vidjeti Tablicu 7, Sliku 3 i Sliku 4).
English: Lonsurf 20 mg/8.19 mg tablet
Croatian: Lonsurf 20 mg/8,19 mg tablete
English: An OS analysis of the study, carried out as planned at 72% (N = 574) of events, demonstrated a clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.68; 95% confidence interval [CI] [0.58 to 0.81]; p < 0.0001) and a median OS of 7.1 months vs 5.3 months, respectively; with 1-year survival rates of 26.6% and 17.6%, respectively.
Croatian: Analiza ukupnog preživljenja (OS), provedena kako je planirana, za 72% (N=574) događaja, pokazala je klinički i statistički značajnu korist u smislu preživljenja kod primjene Lonsurfa uz BSC u usporedbi sa primjenom placeba uz BSC (omjer hazarda 0,68%, 95% interval pouzdanosti [CI] [0,58 do 0,81]; p < 0,0001) te medijan OS iznosi 7,1 mjesec u usporedbi sa 5,3 mjeseca kod placeba; sa stopom jednogodišnjeg preživljenja od 26,6% u usporedbi sa 17,6% kod placeba.
English: PFS was significantly improved in patients receiving Lonsurf plus BSC (hazard ratio: 0.48; 95% CI [0.41 to 0.57]; p < 0.0001 (see Table 6, Figure 1 and Figure 2).
Croatian: Preživljenje bez progresije (PFS) je značajno bolje u bolesnika koji su primali Lonsurf uz BSC (omjer hazarda 0,48 %; 95% CI [0,41 do 0,57]; p < 0,0001 (vidjeti Tablicu 6, Sliku 1 i Sliku 2).
English: Pulmonary embolismb
Croatian: Plućna embolija
English: Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Croatian: Lonsurf 15 mg/6,14 mg filmom obložene tablete Lonsurf 20 mg/8,19 mg filmom obložene tablete trifluridin/tipiracil
English: An updated OS analysis, carried out at 89% (N = 712) of events, confirmed the clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.69; 95% CI [0.59 to 0.81]; p < 0.0001) and a median OS of 7.2 months vs 5.2 months; with 1-year survival rates of 27.1% and 16.6%, respectively.
Croatian: Ažurirana analiza OS u ispitivanju provedena je za 89% (N=712) događaja, te je potvrdila kliničku i statistički značajnu korist u smislu preživljenja kod primjene Lonsurfa uz BSC u usporedbi sa primjenom placeba uz BSC (omjer hazarda 0,69%, 95% [CI] [0,59 do 0,81]; p < 0,0001) te medijan OS koji iznosi 7,2 mjeseca u usporedbi sa 5,2 mjeseca kod placeba; sa stopom jednogodišnjeg preživljenja od 27,1% u usporedbi sa 16,6% kod placeba.
English: Reflux gastritis
Croatian: Refluksni gastritis Ezofagitis
English: Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the apparent volume of distribution (Vd/F) for trifluridine and tipiracil hydrochloride was 21 L and 333 L, respectively.
Croatian: Nakon jedne doze Lonsurfa (35 mg/m2) u bolesnika s uznapredovalim solidnim tumorima, prividni volumen distribucije (Vd/F) za trifluridin iznosio je 21 L, a za tipiracilklorid 333 L.
English: Angina pectoris Arrhythmia Palpitations
Croatian: Angina pektoris
English: Table 5 - Adverse drug reactions reported in clinical trials in patients treated with Lonsurf System Organ Class (MedDRA)a
Croatian: Tablica 5 - Nuspojave prijavljene u bolesnika liječenih s Lonsurfom u kliničkim ispitivanjima
English: Visual acuity reduced Vision blurred Diplopia
Croatian: Slabljenje vidne oštrine Zamućenje vida Dvoslike
English: In the pharmacokinetic (PK) analyses of the multiple dose administration of Lonsurf (35 mg/m2/dose, twice daily for 5 days a week with 2 days rest for 2 weeks followed by a 14-day rest, repeated every 4 weeks), trifluridine area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) was approximately 3-fold higher and maximum concentration (Cmax) was approximately 2-fold higher after multiple dose administration (Day 12 of Cycle 1) of Lonsurf than after single-dose (Day 1 of Cycle 1).
Croatian: Ciklus se ponovljao svaka 4 tjedna), površina ispod krivulje koncentracija vrijeme za trifluridin je od vremena 0 do zadnje mjerljive koncentracije (AUC0-zadnje) bila oko 3 puta veća, a maksimalna koncentracija (Cmax) je bila oko 2 puta veća nakon višekratne primjene (12. dan, 1. ciklus) Lonsurfa u usporedbi s vrijednostima nakon jedne doze (1. dan, 1. ciklus).
English: Lonsurf plus BSC (N=337)
Croatian: (N=337)
English: • pain or discomfort in your arms or legs
Croatian: • bol ili nelagoda u rukama ili nogama
English: Placebo plus BSC (N=170)
Croatian: (N=170)
English: Figure 2 - Kaplan-Meier curves of progression-free survival in patients with metastatic colorectal cancer
Croatian: Slika 2 - Kaplan-Meierova krivulja preživljenja bez progresije bolesti u bolesnika s metastatskim kolorektalnim karcinomom
English: Following multiple doses of Lonsurf (35 mg/m2/dose twice daily) in patients with advanced solid tumours, the mean times to peak plasma concentrations (tmax) of trifluridine and tipiracil hydrochloride were around 2 hours and 3 hours, respectively.
Croatian: Nakon višekratnih doza lijeka Lonsurf (35 mg/m2/dozi, dva puta dnevno) u bolesnika s uznapredovalim solidnim tumorom, srednja vrijednost vremena do postizanja vršne koncentracije u plazmi (tmax) trifluridina je iznosilo oko 2 sata, a tipiracilklorida oko 3 sata.
English: Resumption criteriaa
Croatian: Kriterij za nastavak primjenea
English: Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P<0.0001
Croatian: Omjer hazarda za smrt, 0,68 (95% CI, 0,58-0,81) P<0,0001
English: • feeling dizzy, headache
Croatian: • osjećaj omaglice, glavobolja
English: • inflammation or infection of bile ducts, increase in the diameter of the bile duct
Croatian: • upala ili infekcija žučnih vodova, povećanje promjera žučnog voda
English: * Common terminology criteria for adverse events Table 4 - Dose reductions according to body surface area (BSA)
Croatian: Common Terminology Criteria for Adverse Events, CTCAE)
English: Candida infection Bacterial infection Infection
Croatian: Bakterijske infekcije
English: In total, 800 patients were randomised 2:1 to receive Lonsurf (N = 534) plus best supportive care (BSC) or matching placebo (N = 266) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Croatian: Ukupno je 800 bolesnika bilo randomizirano u omjeru 2:1 ili u skupinu koja je primala Lonsurf (N=534) uz najbolju potpornu njegu (eng. best supportive care, BSC) ili u skupinu koja je primala placebo uz BSC.
English: Paraesthesia Burning sensation Lethargy Dizziness Headache
Croatian: Parestezija Osjećaj pečenja Letargija Omaglica Glavobolja
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg tablets trifluridine/tipiracil
Croatian: NAZIV LIJEKA Lonsurf 15 mg/6,14 mg tablete trifluridin/tipiracil
English: Lonsurf is not recommended for use in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin > 1.5 x ULN), as a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see section 5.2).
Croatian: National Cancer Institute, NCI] definirano ukupnim bilirubinom > 1,5 x gornja granica normale) budući da je zabilježena povećana incidencija hiperbilirubinemije 3. ili 4. stupnja u bolesnika s umjerenim oštećenjem jetre na početku liječenja, iako se ovo temelji na vrlo ograničenim podacima (vidjeti dio
English: This is because it may harm your unborn baby.
Croatian: Vašem nerođenom djetetu.
English: Dyspnoea
Croatian: Disfonija
English: Figure 4 - Kaplan-Meier curves of progression-free survival in patients with metastatic gastric cancer
Croatian: Slika 4 - Kaplan-Meierova krivulja preživljenja bez progresije bolesti u bolesnika s metastatskim karcinomom želuca
English: Titanium dioxide (E171) Iron oxide red (E172) Magnesium stearate
Croatian: Željezov oksid crveni (E172) Magnezijev stearat
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg tablets trifluridine/tipiracil
Croatian: NAZIV LIJEKA Lonsurf 20 mg/8,19 mg tablete trifluridin/tipiracil
English: Renal failure Cystitis noninfective Micturition disorder Haematuria Leukocyturia
Croatian: Septički šokb Infektivni enteritis Infekcija pluća Infekcija bilijarnog trakta
English: No adjustment of the starting dose is recommended in patients with mild hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagoditi početnu dozu u bolesnika s blagim oštećenjem jetre (vidjeti dio 5.2).
English: Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the oral clearance (CL/F) for trifluridine and tipiracil hydrochloride were 10.5 L/hr and 109 L/hr, respectively.
Croatian: Nakon primjene jedne doze Lonsurfa (35 mg/m2) u bolesnika s uznapredovalim solidnim tumorom, klirens nakon peroralne primjene (CL/F) za trifluridin je bio 10,5 L/h, a za tipiracilklorid 109 L/h.
English: Lonsurf 15 mg/6.14 mg film-coated tablets
Croatian: Lonsurf 15 mg/6,14 mg filmom obložene tablete
English: Lonsurf has been shown to cause embryo-foetal lethality and embryo-foetal toxicity in pregnant rats when given at dose levels lower than the clinical exposure.
Croatian: Doze Lonsurfa manje od onih koje su propisane su pokazale embrio-fetalnu smrtnost i embrio-fetalnu toksičnost u skotnih ženki štakora.
English: BATCH NUMBER Lot
Croatian: 13. BROJ SERIJE Lot:
English: Skin exfoliation Urticaria
Croatian: Eksfolijacije kože
English: • feeling of numbness or pins and needles in hands or feet
Croatian: • osjećaj utrnulosti ili osjećaj trnaca i bockanja u šakama ili stopalima
English: Сервие Медикал ЕООД Тел.
Croatian: anti-VEGF lijekove i anti-EGFR lijekove.
English: Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride).
Croatian: Svaka filmom obložena tableta sadrži 15 mg trifluridina i 6,14 mg tipiracila (u obliku tipiracilklorida).
English: a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: KRAS status, time since diagnosis of first metastasis, region)
Croatian: <0,0001 (1-strano i 2-strano) a Procijenjeno pomoću Kaplan-Meierove metode b Brookmeyerovom i Crowleyjevom metodom c Stratificirani log-rank test (stratifikacija: KRAS status, vrijeme od dijagnoze prve metastaze, regija) Slika 1 - Kaplan-Meierova krivulja ukupnog preživljenja bolesnika s metastatskim kolorektalnim karcinomom
English: Febrile neutropenia Lymphopenia
Croatian: Febrilna neutropenija
English: • you have kidney problems
Croatian: • ako imate poteškoće s bubrezima
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets
Croatian: Lonsurf 15 mg/6,14 mg filmom obložene tablete Lonsurf 20 mg/8,19 mg filmom obložene tablete
English: Each film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride).
Croatian: Svaka filmom obložena tableta sadrži 20 mg trifluridina i 8,19 mg tipiracila (u obliku tipiracilklorida).
English: Figure 3- Kaplan-Meier curves of overall survival in patients with metastatic gastric cancer
Croatian: Slika 3 - Kaplan-Meierova krivulja ukupnog preživljenja bolesnika s metastatskim karcinomom želuca
English: mild (CrCl = 60 to 89 mL/min) or moderate (CrCl = 30 to 59 mL/min) renal impairment subgroups.
Croatian: Ukupna incidencija štetnih događaja slična je u podskupinama s normalnom funkcijom bubrega (CrCl ≥ 90 mL/min), blagim (CrCl = 60 to 89 mL/min) ili umjerenim (CrCl = 30 to 59 mL/min) oštećenjem funkcije bubrega.
English: • rash, itchy or flaky skin
Croatian: • osip, svrbež ili perutanje kože,
English: The effect was also maintained in regorafenib-naive patients (hazard ratio: 0.69, 95% CI [0.57 to 0.83]).
Croatian: Učinak je bio također održan i kod bolesnika koji nisu prije primili regorafenib (omjer hazarda 0,69; 95% CI [0,57 do 0,83]).
English: Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the mean times to peak plasma concentrations (tmax) of trifluridine and tipiracil hydrochloride were around 2 hours and 3 hours, respectively.
Croatian: Nakon primjene jedne doze Lonsurfa (35 mg/m2) u bolesnika s uznapredovalim solidnim tumorom, srednja vrijednost vremena postizanja vršne koncentracije u plazmi (tmax) trifluridina je iznosila oko 2 sata, a tipiracilklorida oko 3 sata.
English: Lonsurf 20 mg/8.19 mg film-coated tablets Hypromellose
Croatian: Lonsurf 20 mg/ 8,19 mg mg filmom obložene tablete Hipromeloza
English: Hyperkalaemia
Croatian: Hiperkalijemija Hipokalijemija
English: • inflammation or infection in your bladder
Croatian: • upala ili infekcije mokraćnog mjehura