FrancophonIA/ELRC3.0 huggingface dataset:
English: Paclitaxel/ bevacizumab (n=229)
Croatian: Paklitaksel/ bevacizumab (n = 229)
English: Name and address of the manufacturer responsible for batch release Pfizer Ireland Pharmaceuticals
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by intravenous infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or
Croatian: Bolesnici su randomizirani u skupinu koja je primala kemoterapiju na bazi platine (paklitaksel 200 mg/m2) i karboplatin AUC = 6,0, oba intravenskom infuzijom (PK) 1. dana svakog trotjednog ciklusa u trajanju do najviše šest ciklusa ili u skupinu koja je primala isti kemoterapijski protokol na bazi platine (PK) u kombinaciji s bevacizumabom u dozi od 15 mg/kg primijenjen intravenskom infuzijom 1. dana svakog trotjednog ciklusa.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-240), 1.8% of bevacizumab-treated patients and 1.4% of control patients were reported to have had nongastrointestinal vaginal, vesical, or female genital tract fistulae.
Croatian: U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim rakom cerviksa (ispitivanje GOG-240), fistule izvan gastrointestinalnog sustava, i to vaginalne, vezikalne ili fistule u ženskom genitalnom traktu, prijavljene su u 1,8 % bolesnica liječenih bevacizumabom te u 1,4 % bolesnica u kontrolnoj skupini.
English: The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka Zirabev iznosi 10 mg/kg tjelesne težine jednom svaka 2 tjedna ili 15 mg/kg tjelesne težine jednom svaka 3 tjedna, primijenjeno putem intravenske infuzije.
English: The secondary endpoint of Overall Survival (OS) was not mature.
Croatian: Podaci za sekundarnu mjeru ishoda, ukupno preživljenje, nisu bili spremni.
English: Number of patients Overall survival Median time (months) 95% CI
Croatian: Ukupno preživljenje Medijan vremena (mjeseci) 95 % CI
English: 5-fluorouracil intravenous bolus/infusion, each on days 1 and 2
Croatian: 22 h oksaliplatin 1. dana leukovorin 1. i 2. dana 5-fluorouracil intravenski bolus/infuzija, oboje 1. i 2. dana placebo ili bevacizumab
English: The analysis of the primary endpoint showed no difference between the bevacizumab + Placebo arm and the bevacizumab + Erlotinib arm (median PFS 8.5 versus 9.9 months).
Croatian: + erlotinib (medijan PFS-a 8,5 naspram 9,9 mjeseci).
English: • comparative incidences noted between clinical trial treatment arms (with at least a 10% difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2% difference compared to the control arm for NCI-CTCAE Grade 3-5 reactions,
Croatian: NCI-CTCAE ili s razlikom od najmanje 2 % u odnosu na kontrolnu skupinu za nuspojave stupnja 3-5 prema NCI-CTCAE),
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating bevacizumab 7.5 mg/kg in combination with oral capecitabine and intravenous oxaliplatin (XELOX), administered on a 3- weekly schedule; or bevacizumab 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Croatian: Riječ je o randomiziranom, dvostruko slijepom (za bevacizumab) kliničkom ispitivanju faze III u kojemu se ispitivala primjena bevacizumaba u dozi od 7,5 mg/kg svaka 3 tjedna u kombinaciji s peroralno primijenjenim kapecitabinom i intravenski primijenjenim oksalipaltinom (XELOX), odnosno primjena bevacizumaba u dozi od 5 mg/kg svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila, nakon čega je slijedila infuzija 5-fluorouracila uz intravensku primjenu oksaliplatina (FOLFOX-4).
English: An increased incidence of hypertension was observed in bevacizumab-treated patients.
Croatian: U bolesnika liječenih bevacizumabom opažena je povećana incidencija hipertenzije.
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: Lijekove za parenteralnu primjenu potrebno je prije primjene vizualno pregledati na moguću prisutnost čestica i promjenu boje.
English: 130 mg/m2 intravenous 2 h
Croatian: 130 mg/m 2 intravenski
English: Gastrointestinal (GI) perforations and fistulae (see section 4.4)
Croatian: Gastrointestinalne perforacije i fistule (vidjeti dio 4.4)
English: Other special populations Elderly patients
Croatian: Ostale posebne populacije
English: The recommended dose of Zirabev is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka Zirabev iznosi 7,5 mg/kg ili 15 mg/kg tjelesne težine, primijenjeno jednom svaka 3 tjedna putem intravenske infuzije.
English: Myalgia, Arthralgia, Muscular weaknes s, Back pain
Croatian: mialgija, artralgija, mišićna slabost, bol u leđima osteonekroza čeljusti b,c
English: In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026.
Croatian: U podskupini bolesnika liječenih režimom XELOX medijan preživljenja bez progresije bolesti je iznosio 7,4 mjeseca u bolesnika koji su primali placebo, u usporedbi s 9,3 mjeseca u bolesnika liječenih bevacizumabom: HR = 0,77; 97,5 % CI = [0,63; 0,94]; pvrijednost = 0,0026.
English: Paclitaxel 135 mg/m2 intravenous over 24 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m intravenous over 3 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 1 plus bevacizumab 15 mg/kg intravenous on Day 1 (q3w)
Croatian: paklitaksel u dozi od 135 mg/m2 intravenski tijekom 24 sata 1. dana i cisplatin u dozi od 50 mg/m2 intravenski 2. dana u kombinaciji s bevacizumabom u dozi od 15 mg/kg intravenski 2. dana (svaka 3 tjedna); ili paklitaksel u dozi od 175 mg/m 2 intravenski tijekom 3 sata 1. dana i cisplatin u dozi od
English: In a randomized phase II study (BO20924) a total of 154 patients aged ≥ 6 months to <18 years with newly diagnosed metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma were treated with standard of care (Induction IVADO/IVA+/- local therapy followed by Maintenance Vinorelbine and cyclophosphamide) with or without bevacizumab (2.5 mg/kg/week) for a total duration of treatment of approximately 18 months.
Croatian: U randomiziranom ispitivanju faze II (BO20924) ukupno su 154 bolesnika u dobi od ≥ 6 mjeseci do < 18 godina s novodijagnosticiranim metastatskim rabdomiosarkomom ili sarkomom mekog tkiva koji nije rabdomiosarkom bila liječena standardnom terapijom (uvodno liječenje režimom IVADO/IVA
English: After discontinuation of bevacizumab treatment, ovarian function recovered in the majority of patients.
Croatian: U većine se bolesnica funkcija jajnika oporavila nakon prekida liječenja bevacizumabom.
English: The administration of Zirabev should be permanently discontinued if you develop
Croatian: Primjenu lijeka Zirabev treba trajno obustaviti
English: Gallbladder perforation b,c
Croatian: Poremećaji jetre i žuči perforacija žučnog mjehura b,c
English: The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka Zirabev iznosi 10 mg/kg tjelesne težine, primijenjeno jednom svaka 2 tjedna putem intravenske infuzije.
English: Some of the adverse reactions are reactions commonly seen with chemotherapy; however, bevacizumab may exacerbate these reactions when combined with chemotherapeutic agents.
Croatian: Međutim, bevacizumab može pogoršati te reakcije kada se primjenjuje u kombinaciji s kemoterapeuticima.
English: Congestive heart failure b,d
Croatian: Srčani poremećaji kongestivno zatajenje srca b,d supraventrikularna tahikardija
English: Objective response rate (ORR) Patients included in analysis Rate
Croatian: Stopa objektivnog odgovora (ORR)
English: B-cell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
Croatian: Opažena je povećana incidencija kongestivnog zatajenja srca u kliničkom ispitivanju bolesnika s difuznim velikostaničnim limfomom B-limfocita kada su primali bevacizumab s doksorubicinom u kumulativnoj dozi višoj od 300 mg/m2.
English: Each vial contains 400 mg bevacizumab.
Croatian: Jedna bočica sadrži 400 mg bevacizumaba.
English: Zirabev may impair female fertility.
Croatian: Lijek Zirabev može štetno djelovati na plodnost žena.
English: • In a retrospective single institution series, 12 consecutive (2005 to 2008) children with relapsed or progressive high-grade glioma (3 with WHO Grade IV, 9 with Grade III) were treated with bevacizumab (10 mg/kg) and irinotecan (125 mg/m²) every 2 weeks.
Croatian: • Retrospektivnim pregledom u jednoj ustanovi, 12 uzastopno (od 2005. do 2008.) otkrivene djece s relapsirajućim ili progresivnim gliomom visokog stupnja malignosti (3 stupnja IV
English: The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Zirabev fails to stop your tumour growing.
Croatian: Trebali biste nastaviti primati ovaj lijek sve dok Zirabev uspješno sprječava rast tumora.
English: ● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with bevacizumab treatment.
Croatian: Liječenje bevacizumabom povezano je s rijetkom neurološkom nuspojavom koju nazivamo sindrom posteriorne reverzibilne encefalopatije.
English: 200 mg/m2 intravenous 2 h
Croatian: 200 mg/m2 intravenski
English: Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Croatian: , plućna embolija, epistaksa, dispneja, hipoksija plućna hipertenzija c,
English: Sodium hydroxide (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari saharoza sukcinatna kiselina dinatrijev edetat polisorbat 80 natrijev hidroksid (za prilagođavanje pH) voda za injekcije
English: The efficacy results are presented in Table 13 Table 13 Efficacy results for trial BO17705
Croatian: Rezultati djelotvornosti za ispitivanje BO17705
English: Pulmonary haemorrhage/ Haemoptysis a,b
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja plućno krvarenje/hemopti za a,b
English: Pulmonary haemorrhage/ Haemoptysis b,d
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurija b,d
English: Paclitaxel 135 mg/m intravenous over 24 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 2, every 3 weeks (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 (q3w); or
Croatian: paklitaksel u dozi od 135 mg/m2 intravenski tijekom 24 sata 1. dana i cisplatin u dozi od 50 mg/m2 intravenski 2. dana, svaka 3 tjedna; ili paklitaksel u dozi od 175 mg/m2 intravenski tijekom 3 sata 1. dana i cisplatin u dozi od
English: Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and topotecan 0.75 mg/m2
Croatian: • paklitaksel u dozi od 175 mg/m 2 intravenski tijekom 3 sata 1. dana i topotekan u dozi od
English: In a randomized phase II study (BO25041) a total of 121 patients aged ≥ 3 years to <18 years with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG)
Croatian: U randomiziranom ispitivanju faze II (BO25041) ukupno je 121 bolesnik u dobi od ≥ 3 godine do < 18 godina s novodijagnosticiranim supratentorijalnim ili infratentorijalnim cerebelarnim ili pedunkularnim gliomom visokog stupnja malignosti bio liječen poslijeoperacijskom radioterapijom (RT) i adjuvantnim temozolomidom (T) u kombinaciji s bevacizumabom i bez njega: 10 mg/kg svaka 2 tjedna intravenski.
English: Overall survival Median (months) Hazard ratio 95% CI
Croatian: Medijan (mjeseci) Omjer hazarda [95 % CI]
English: The recommended dose of Zirabev is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka Zirabev iznosi 15 mg/kg tjelesne težine, primijenjeno jednom svaka 3 tjedna putem intravenske infuzije.
English: • blocking of the blood vessels of the lungs by a blood clot,
Croatian: ● u slučaju krvnog ugruška u krvnim žilama u plućima, ● u slučaju bilo kojeg teškog krvarenja.
English: Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
Croatian: U bolesnica u kojih dođe do gastrointestinalne perforacije liječenje treba trajno obustaviti.
English: Paclitaxel (n=354)
Croatian: Ukupno preživljenje paklitaksel (n = 354)
English: (12.0 vs 15.0 months; p = 0.6267)
Croatian: (12,0 naspram 15,0 mjeseci; p
English: Each vial contains 100 mg bevacizumab.
Croatian: Jedna bočica sadrži 100 mg bevacizumaba.
English: For intravenous use after dilution Read the package leaflet before use
Croatian: Za intravensku primjenu nakon razrjeđivanja
English: Congestive heart failure a,b
Croatian: Srčani poremećaji kongestivno zatajenje srca a,b supraventrikularna tahikardija
English: Aneurysms and artery dissections, Renal thrombotic microangiopathy a,b
Croatian: b,d krvarenje b,d duboka venska tromboza aneurizme i disekcije arterije, bubrežna trombotička mikroangiopatija a,
English: Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Naus ea, Vomiting, Abdominal pain
Croatian: Poremećaji probavnog sustava rektalno krvarenje, stomatitis, konstipacija, proljev, mučnina, povraćanje, bol u abdomenu gastrointestinalna perforacija b,d perforacija crijeva, ileus, opstrukcija crijeva, rektovaginalna fistula d,e,
English: Pulmonary hypertension a,
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurija a,b
English: Investigator assessment
Croatian: Procjena neovisnog ocjenjivačkog povjerenstva paklitaksel
English: Table 2
Croatian: Tablica 2.
English: No trials have been conducted to investigate the pharmacokinetics of bevacizumab in renally impaired patients since the kidneys are not a major organ for bevacizumab metabolism or excretion.
Croatian: Budući da bubrezi nisu glavni organ metaboliziranja ili izlučivanja bevacizumaba, nisu provedena ispitivanja farmakokinetike bevacizumaba u bolesnika s oštećenjem bubrežne funkcije.
English: Cellulitis, Infection, Urinary tract infection
Croatian: Infekcije i infestacije sepsa, celulitis, apsces a,b infekcija, infekcija mokraćnih putova nekrotizirajući fasciitis
English: Intestinal perforation, Ileus , Intes tinal obstruction, Recto-vaginal fistulae c,d
Croatian: Infekcije i infestacije sepsa, apsces b,d celulitis, infekcija, infekcija mokraćnih putova nekrotizirajući fasciitis
English: Febrile neutropenia, Leucopenia, Neutropenia b, Thrombo-cytopenia
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija, leukopenija, neutropenija b, trombocitopenija anemija, limfopenija
English: Responders (Response rate
Croatian: Stopa odgovora
English: The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
Croatian: Kod istodobne primjene bevacizumaba i antineoplastičkih lijekova, karakteristična vrijednost volumena raspodjele u perifernom odjeljku (Vp) iznosila je 1,69 l za bolesnike ženskog spola i 2,35 l za bolesnike muškog spola.
English: 600 mg/m2 intravenous 22 h
Croatian: 600 mg/m2 intravenski
English: PC in combination with bevacizumab at a dose of 15 mg/kg intravenous infusion day 1 of every 3-week cycle.
Croatian: 50 mg/m2 intravenski 1. dana u kombinaciji s bevacizumabom u dozi od 15 mg/kg intravenski 1. dana (svaka 3 tjedna)
English: Pre-existing hypertension should be adequately controlled before starting Zirabev treatment.
Croatian: Prije početka liječenja lijekom Zirabev postojeću hipertenziju potrebno je odgovarajuće regulirati.
English: Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with bevacizumab.
Croatian: Kada se liječe bevacizumabom, bolesnici s anamnezom hipertenzije mogu biti izloženi povećanom riziku od razvoja proteinurije.
English: Paclitaxel (n=273)
Croatian: (n = 273)
English: Disodium edetate
Croatian: Nuspojave prema učestalosti
English: Vascular disorders Hypertension b,d
Croatian: Krvožilni poremećaji hipertenzija b,d tromboembolija (venska)
English: Bevacizumab vs. No Bevacizumab
Croatian: bevacizumab naspram bez bevacizumaba cisplatin + paklitaksel
English: A reduction of circulating VEGF concentration has been demonstrated following intravitreal anti-VEGF therapy.
Croatian: Nakon intravitrealne terapije inhibitorima vaskularnog endotelnog faktora rasta (engl. vascular endothelial growth factor,VEGF) zabilježeno je smanjenje koncentracije VEGF-a u cirkulaciji.
English: Patients may be at increased risk for the development of fistulae when treated with bevacizumab.
Croatian: Tijekom liječenja bevacizumabom bolesnici mogu biti izloženi povećanom riziku od nastanka fistula.
English: Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy.
Croatian: Prije početka i tijekom terapije preporučuje se kontrola proteinurije analizom mokraće pomoću test trakica.
English: Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed in patients treated with some myelotoxic chemotherapy regimens plus bevacizumab in comparison to chemotherapy alone.
Croatian: U bolesnika liječenih nekim mijelotoksičnim kemoterapijskim protokolima u kombinaciji s bevacizumabom, u usporedbi s primjenom samo kemoterapije, opažene su povećane stope teške neutropenije, febrilne neutropenije ili infekcije praćene teškom neutropenijom ili bez nje (uključujući neke slučajeve sa smrtnim ishodom).
English: Thromboemboli sm arterial a,b
Croatian: Krvožilni poremećaji hipertenzija a,b arterijska tromboembolija a,b krvarenje a,b tromboembolija (venska)
English: Febrile neutropenia, Leucopenia, Neutropenia a,
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija, leukopenija, neutropenija a, trombocitopenij anemija, limfopenija
English: b 10 mg/kg every 2 weeks.
Croatian: + bevacizumab 15 mg/kg svaka 3 tjedna
English: No trials have been conducted to investigate the pharmacokinetics of bevacizumab in patients with hepatic impairment since the liver is not a major organ for bevacizumab metabolism or excretion.
Croatian: Budući da jetra nije glavni organ metaboliziranja i izlučivanja bevacizumaba, nisu provedena ispitivanja farmakokinetike bevacizumaba u bolesnika s oštećenjem jetrene funkcije.
English: No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses.
Croatian: Rezultati analiza populacijske farmakokinetike pokazali su da nema klinički značajne interakcije istodobno primijenjene kemoterapije na farmakokinetiku bevacizumaba.
English: a 5 mg/kg every 2 weeks.
Croatian: 5 mg/kg svaka 2 tjedna 10 mg/kg svaka 2 tjedna u odnosu na kontrolnu skupinu
English: were reported in up to 2.7% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
Croatian: Cerebrovaskularni incidenti (uključujući i tranzitorne ishemijske atake) prijavljeni su u najviše 2,7 % bolesnika liječenih bevacizumabom u kombinaciji s kemoterapijom u odnosu na najviše 0,5 % bolesnika liječenih samo kemoterapijom.
English: intravenous over 30 minutes on Days 1-3 plus bevacizumab 15 mg/kg intravenous on Day 1 (q3w)
Croatian: 0,75 mg/m2 intravenski tijekom 30 minuta od 1. do 3. dana u kombinaciji s bevacizumabom u dozi od 15 mg/kg intravenski 1. dana (svaka 3 tjedna)
English: Secondary endpoints Progression-free survival - Primary analysis 6
Croatian: Ukupno preživljenje - Primarna analiza
English: Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
Croatian: 1000 mg/m2 peroralno dva puta na dan oksaliplatin 1. dana kapecitabin, peroralno, dva puta na dan tijekom 2 tjedna (nakon čega slijedi jednotjedni prekid)
English: Gall bladder perforation (not known)
Croatian: Poremećaji jetre i žuči perforacija žučnog mjehura (nepoznato)
English: Diarrhoea, Nausea, Vomiting, Abdominal pain
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija, umor, bol, letargija, upala sluznice
English: Cerebrovascular accident, Syncope, Somnolence
Croatian: dizartrija, glavobolja, disgeuzija cerebrovaskularni incident, sinkopa, somnolencija sindrom posteriorne reverzibilne encefalopatije a,b,d hipertenzivna encefalopatija
English: Foetal abnormalities a,c
Croatian: Prirođeni, obiteljski i genetski poremećaji abnormalnosti fetusa a,c
English: Necrotising fasciitis c
Croatian: perforacija nosnog septuma
English: Pulmonary embolism, Hypoxia, Dysphonia a
Croatian: , plućna embolija, hipoksija, disfonija plućna hipertenzija a, perforacija nosnog septuma
English: Foetal abnormalities a,b
Croatian: Prirođeni, obiteljski i genetski poremećaji abnormalnosti fetusa a,b
English: were treated with post operative radiation therapy (RT) and adjuvant temozolomide (T) with and without bevacizumab: 10 mg/kg every 2 weeks intravenously.
Croatian: +/- lokalna terapija, a zatim terapija održavanja vinorelbinom i ciklofosfamidom) uz bevacizumab (2,5 mg/kg/tjedan) ili bez njega, a liječenje je ukupno trajalo približno 18 mjeseci.
English: Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 1 (q3w)
Croatian: 50 mg/m 2 intravenski 2. dana (svaka 3 tjedna); ili paklitaksel u dozi od 175 mg/m 2 intravenski tijekom 3 sata 1. dana i cisplatin u dozi od 50
English: Gallbladder perforation a,b
Croatian: Poremećaji jetre i žuči perforacija žučnog mjehura a,b
English: The observed changes were only partially reversible.
Croatian: Opažene promjene bile su samo djelomično reverzibilne.
English: Grade b All Grades % Grade 3/4 % All Grades % Grade 3/4 % All Grades % Grade 3/4 %
Croatian: Stupanj b Svi stupnjevi % Stupanj 3/4 % Svi stupnjevi % Supanj 3/4 % Svi stupnjevi % Stupanj 3/4 %
English: No improvement within 7 days or 2nd occurrence
Croatian: bez poboljšanja unutar 7 dana ili se pojavljuje 2. put
English: Stivarga should be taken at the same time each day.
Croatian: Stivarga se mora uzimati u isto vrijeme svakog dana.
English: This is 1 cycle of treatment.
Croatian: To je 1 ciklus liječenja.
English: An increase in AUC of irinotecan of approximately 28% was also observed.
Croatian: Opaženo je i povećanje AUC irinotekana za približno 28%.
English: Keep the bottle tightly closed.
Croatian: Bočicu čuvajte čvrsto zatvorenu.
English: • Median age: 63 years
Croatian: • Medijan dobi: 63 godine
English: This may be due to acceleration of an age-related physiological process.
Croatian: To može biti zbog ubrzanja fizioloških procesa povezanih s dobi.
English: This medicine may also affect the results of some blood tests.
Croatian: Ovaj lijek također može utjecati na rezultate nekih krvnih pretraga.
English: Your doctor may change your dose.
Croatian: Liječnik Vam može promijeniti dozu.
English: What Stivarga is and what it is used for
Croatian: Što je Stivarga i za što se koristi
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 22 May 2018
Croatian: Datum posljednje obnove odobrenja: 22. svibnja 2018.
English: • Median duration of sorafenib treatment: 7.8 months
Croatian: • Medijan trajanja liječenja sorafenibom: 7,8 mjeseci
English: Tell your doctor immediately if you have any of the following symptoms:
Croatian: Odmah obavijestite liječnika ako Vam se pojave neki od sljedećih simptoma:
English: The overall median time since most recent progression or relapse to randomisation was 6 weeks.
Croatian: Ukupni medijan vremena od zadnje progresije ili relapsa bolesti do randomizacije iznosio je 6 tjedana.