FrancophonIA/ELRC3.0 huggingface dataset:
English: Aflibercept acts as a soluble decoy receptor that binds to VEGF-A, with higher affinity than its native receptors, as well as the related ligands PlGF and VEGF-B. By acting as a ligand trap, aflibercept prevents binding of endogenous ligands to their cognate receptors and thereby blocks receptor mediated signaling.
Croatian: Aflibercept djeluje kao topljivi lažni receptor koji se veže za VEGF-A većim afinitetom nego njegovi prirodni receptori, a veže se i za povezane ligande PlGH i VEGF-B.
English: Dyspnoea Epistaxis
Croatian: ZALTRAP/FOLFIRI
English: Nephrotic syndrome (1) Thrombotic microangiopathy (1)
Croatian: trombotička mikroangiopatija (1)
English: Grade 3-4 neutropenia was observed in 36.7 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 29.5 % patients treated with the placebo/FOLFIRI regimen.
Croatian: Neutropenija stupnja 3-4 primijećena je u 36,7% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 29,5% bolesnika koji su primali protokol placebo/FOLFIRI.
English: Pulmonary embolism occurred in 4.6 % of patients treated with the ZALTRAP/FOLFIRI regimen and 3.5 % of patients treated with the placebo/FOLFIRI regimen.
Croatian: Plućna embolija javila se u 4,6% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 3,5% bolesnika koji su primali protokol placebo/FOLFIRI.
English: Table 3 - OS and PFS by prior bevacizumab exposure a
Croatian: Rezultati prema prethodnoj izloženosti bevacizumabu sažeti su u Tablici 3. Tablica 3 - OS i PFS prema prethodnoj izloženosti bevacizumabua - ITT populacija
English: What ZALTRAP looks like and contents of the pack ZALTRAP is a concentrate for solution for infusion (sterile concentrate).
Croatian: ZALTRAP je koncentrat za otopinu za infuziju (sterilni koncentrat).
English: Signs of infection may include fever, chills, cough, burning on passing water or muscle ache.
Croatian: Znakovi infekcije uključuju vrućicu, zimicu, kašalj,
English: FOLFIRI Dose modification when used in combination with ZALTRAP Severe stomatitis and Palmar-Plantar Erythrodysaesthesia syndrome
Croatian: Teški stomatitis i sindrom palmarnoplantarne eritrodizestezije
English: • Bleeding: Very common (may affect more than 1 in 10 people) - this includes bleeding from the nose, but may also include severe bleeding in your gut and other parts of the body, which may lead to death.
Croatian: • Krvarenje: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - uključuje krvarenje iz nosa,
English: A limited number of patients having moderate/severe renal impairment at baseline (N = 49) were treated with ZALTRAP.
Croatian: Lijekom ZALTRAP liječen je mali broj bolesnika koji su na početku liječenja imali umjereno/teško oštećenje bubrežne funkcije (N=49).
English: Baseline and periodic evaluations of left ventricular function should be considered while the patient is receiving Zaltrap.
Croatian: bolesnika koji primaju lijek ZALTRAP potrebno je razmotriti procjenu funkcije lijeve klijetke na početku, te periodički tijekom liječenja.
English: Suomi/Finland Sanofi Oy
Croatian: Suomi/Finland
English: In case of recurrent medically significant or severe hypertension, despite optimal treatment, aflibercept should be suspended until the hypertension is controlled and the aflibercept dose should be reduced to 2 mg/kg for subsequent cycles.
Croatian: U slučaju povrata medicinski značajne ili teške hipertenzije, unatoč optimalnom liječenju, treba privremeno prekinuti liječenje afliberceptom dok se hipertenzija ne stavi pod kontrolu,
English: Severe proteinuria, nephrotic syndrome, and thrombotic microangiopathy (TMA) have been observed in patients treated with aflibercept (see section 4.8).
Croatian: U bolesnika liječenih afliberceptom primijećene su teška proteinurija, nefrotski sindrom i trombotička mikroangiopatija (TMA) (vidjeti dio 4.8).
English: • you have any bleeding problems or if you notice any bleeding after treatment (see section 4) or if you feel extreme tiredness, weakness, dizziness, or have changes in the colour of your stool.
Croatian: (vidjeti dio 4.), ako osjetite izraziti umor, slabost, omaglicu ili ako primijetite promjene u boji stolice.
English: • Wounds which heal slowly or not at all: Uncommon (may affect up to 1 in 100 people) - this is when a scar has trouble healing or staying closed, or if a healed wound re-opens.
Croatian: na 100 osoba) - ožiljak teško zacjeljuje ili teško ostaje zatvoren ili se zacijeljena rana ponovno otvori.
English: Do not re-enter the vial after the initial puncture.
Croatian: Nakon prvoga probijanja čepa ne smije se ponovno iglom ulaziti u bočicu.
English: How to store ZALTRAP
Croatian: Moguće nuspojave Kako čuvati ZALTRAP
English: Grade 4 hypertension (hypertensive crisis) was reported in 1 patient (0.2 %) treated with the ZALTRAP/FOLFIRI regimen.
Croatian: Hipertenzija stupnja 4 (hipertenzivna kriza) prijavljena je u 1 bolesnika (0,2%) liječenog protokolom
English: ZALTRAP 25 mg/ml concentrate for solution for infusion
Croatian: ZALTRAP 25 mg/ml koncentrat za otopinu za infuziju
English: Signs of allergic reaction may include rash or itching, skin redness, feeling dizzy or faint, being short of breath, tight chest or throat, or swelling of the face.
Croatian: crvenilo kože, omaglicu ili nesvjesticu, nedostatak zraka, stezanje u prsima ili grlu ili oticanje lica.
English: Cardiac failure
Croatian: Oštećenje funkcije bubrega
English: • you are 65 years of age or older and experience diarrhoea, dizziness, weakness, weight loss, or severe loss of body fluids (called ‘dehydration').
Croatian: Ako se pojave promjene vida ili smetenost, liječnik će možda prekinuti liječenje lijekom ZALTRAP. • ako imate 65 godina ili više i imate proljev, omaglicu, slabost, gubitak težine ili obilan gubitak tekućine iz tijela (što se zove ‘dehidracija').
English: Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles.
Croatian: U sljedećim se ciklusima može razmotriti premedikacija kortikosteroidima i/ili antihistaminicima.
English: Grade 3-4 GI perforation events occurred in 0.8 % of patients treated with ZALTRAP and 0.2 % of patients treated with placebo (see section 4.4).
Croatian: Gastrointestinalne perforacije stupnja 3-4 javile su se u 0,8% bolesnika liječenih lijekom ZALTRAP te u 0,2% bolesnika koji su primali placebo (vidjeti dio 4.4).
English: The most common reported grades 3-4 reactions ( ≥5 % incidence) reported at least 2 % greater incidence for the ZALTRAP/FOLFIRI regimen as compared to the placebo/FOLFIRI regimen in order of decreasing frequency, were neutropenia, diarrhoea, hypertension, leucopenia, stomatitis, fatigue, proteinuria, and asthenia (see Table 1).
Croatian: Najčešće prijavljene reakcije stupnja 3-4 (incidencija ≥ 5%) za koje je prijavljena incidencija u skupini koja je primala protokol ZALTRAP/FOLFIRI bila najmanje 2% veća od one u skupini koja je primala protokol placebo/FOLFIRI, navedene prema učestalosti u padajućem nizu, bile su neutropenija,
English: These were comparable between groups, and the difference between groups did not exceed ≥ 2 % incidence for the ZALTRAP/FOLFIRI regimen.
Croatian: Te su nuspojave bile slične u obje skupine, a njihova incidencija u skupini liječenoj protokolom ZALTRAP/FOLFIRI nije bila ≥ 2% veća od incidencije u skupini koja je primala placebo.
English: Dysphonia Oropharyngeal pain
Croatian: Osteonekroza čeljusti
English: GI perforation including fatal GI perforation has been reported in patients treated with aflibercept (see section 4.8).
Croatian: U bolesnika liječenih afliberceptom prijavljena je gastrointestinalna perforacija, uključujući smrtonosnu gastrointestinalnu perforaciju (vidjeti dio 4.8).
English: Leucopenia (2) Neutropenia (1),(2) Thrombocytopenia (2)
Croatian: Poremećaji krvi i limfnog sustava vrlo često leukopenija (2) neutropenija (1),(2) trombocitopenija (2)
English: One 8 ml vial of concentrate contains 200 mg aflibercept.
Croatian: Jedna bočica od 8 ml koncentrata sadrži 200 mg aflibercepta.
English: Grade 3-4 compromised wound healing occurred in 0.2 % of patients treated with ZALTRAP and none of patients treated with placebo (see section 4.4).
Croatian: Otežano zacjeljivanje rana stupnja 3-4 javilo se u 0,2% bolesnika liječenih lijekom ZALTRAP, no ni u jednog bolesnika koji je primao placebo (vidjeti dio 4.4).
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of nephrotic syndrome was 0.5 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Croatian: U tri placebom kontrolirana klinička ispitivanja faze III (populacije s kolorektalnim karcinomom, karcinomom gušterače i karcinomom pluća) incidencija nefrotskog sindroma iznosila je 0,5% u bolesnika liječenih lijekom ZALTRAP i 0,1% u bolesnika koji su primali placebo (vidjeti dio 4.4).
English: In the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 9 of 611 patients (1.5 %) treated with the ZALTRAP/FOLFIRI
Croatian: U pivotalnom ispitivanju u bolesnika s MKRK-om fistule (analne, enterovezikalne, enterokutane, kolovaginalne i crijevne) su prijavljene u 9 od 611 bolesnika (1,5%) liječenih protokolom ZALTRAP/FOLFIRI i u 3 od 605 bolesnika (0,5%) koji su primali protokol placebo/FOLFIRI.
English: There have been no formal studies with ZALTRAP in patients with hepatic impairment.
Croatian: Nisu provedena službena ispitivanja lijeka ZALTRAP u bolesnika s oštećenjem bubrežne funkcije.
English: An increased risk of grade 3-4 hypertension (including hypertension and one case of essential hypertension) has been observed in patients receiving the ZALTRAP/FOLFIRI regimen.
Croatian: U bolesnika liječenih protokolom ZALTRAP/FOLFIRI primijećen je povećan rizik od hipertenzije stupnja 3-4 (uključujući hipertenziju i jedan slučaj esencijalne hipertenzije).
English: Neutropenic infection/sepsis (1) Urinary tract infection Nasopharyngitis
Croatian: infekcija mokraćnih putova nazofaringitis neutropenijska infekcija/sepsa (1)
English: Aflibercept treatment should be discontinued in patients who develop fistula (see section 4.2).
Croatian: U bolesnika u kojih nastane fistula treba obustaviti liječenje afliberceptom (vidjeti dio 4.2).
English: Discontinue ZALTRAP in patients who experience cardiac failure and ejection fraction decreased.
Croatian: U bolesnika koji dožive zatajenje srca i smanjenu ejekcijsku frakciju potrebno je prekinuti liječenje lijekom ZALTRAP.
English: Administration of the ZALTRAP/FOLFIRI should be delayed until platelet count is 75 x 10
Croatian: Primjenu protokola ZALTRAP/FOLFIRI treba odgoditi dok broj trombocita ne bude ≥ 75 x 109/l (vidjeti dio 4.2).
English: One 4 ml vial of concentrate contains 100 mg aflibercept.
Croatian: Jedna bočica od 4 ml koncentrata sadrži 100 mg aflibercepta.
English: Median PFS (95 % CI) (months)
Croatian: Medijan PFS-a (95% CI) (mjeseci)
English: Grade 3-4 fistula occurred in 0.2 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Croatian: Fistule stupnja 3-4 nastale su u 0,2% bolesnika liječenih lijekom ZALTRAP te u 0,1% bolesnika koji su primali placebo (vidjeti dio 4.4).
English: Grade 3-4 VTE occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen and in 6.3 % of patients treated with the placebo/FOLFIRI regimen.
Croatian: Venski tromboembolijski događaji stupnja 3-4 javili su se u 7,9% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 6,3% bolesnika koji su primali protokol placebo/FOLFIRI.
English: There have been no formal studies with ZALTRAP in patients with renal impairment.
Croatian: Nisu provedena službena ispitivanja lijeka ZALTRAP u bolesnika s oštećenjem funkcije bubrega
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Krvarenje
English: Aflibercept should be discontinued in patients that develop PRES (see section 4.2).
Croatian: U bolesnika u kojih se razvije PRES treba obustaviti liječenje afliberceptom (vidjeti dio 4.2).
English: Treatment with corticosteroids and/or antihistamines can be used as clinically indicated.
Croatian: Prema kliničkoj indikaciji može se primijeniti liječenje kortikosteroidima i/ili antihistaminicima.
English: Among the 1,226 randomised patients, 89.4 % and 90.2 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively, received prior oxaliplatin-based combination chemotherapy in the metastatic/advanced setting.
Croatian: i 90,2% liječenih protokolom ZALTRAP/FOLFIRI prethodno je primalo kombiniranu kemoterapiju na bazi oksaliplatina za metastatsku/uznapredovalu bolest.
English: In the pivotal study of MCRC patients, all grades VTE occurred in 9.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 7.3 % of patients treated with the placebo/FOLFIRI regimen.
Croatian: U pivotalnom ispitivanju u bolesnika s MKRK-om venski tromboembolijski događaji svih stupnjeva javili su se u 9,3% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 7,3% bolesnika koji su primali protokol placebo/FOLFIRI.
English: Febrile neutropenia Thrombocytopenia (2)
Croatian: često neutropenijska vrućica neutropenijska vrućica trombocitopenija (2)
English: • Connections or passageways inside the body between internal organs and skin or other tissues (also called ‘fistula'): Common (may affect up to 1 in 10 people) - these abnormal tube-like connections or passageways can form for example, between the gut and your skin.
Croatian: ‘fistule'): Često (mogu se javiti u manje od 1 na 10 osoba) - te abnormalne poveznice ili prolazi u obliku cjevčice mogu nastati između, primjerice, crijeva i kože.
English: A higher incidence of neutropenic complications (febrile neutropenia and neutropenic infection) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Croatian: U bolesnika liječenih protokolom ZALTRAP/FOLFIRI primijećena je povišena incidencija neutropenijskih komplikacija (neutropenijske vrućice i neutropenijske infekcije) (vidjeti dio 4.8).
English: • ZALTRAP is a single-use vial.
Croatian: • Bočica lijeka ZALTRAP namijenjena je za jednokratnu uporabu.
English: Tabulated summary of adverse reactions
Croatian: Tablični zbirni prikaz nuspojava
English: Fistula formation involving GI and non-GI sites has occurred in patients treated with aflibercept (see section 4.8).
Croatian: U bolesnika liječenih afliberceptom došlo je do stvaranja fistula na mjestima unutar probavnog sustava i izvan njega (vidjeti dio 4.8).
English: Of the 1,226 patients randomised in the study, the median age was 61 years, 58.6 % were male, 97.8 % had a baseline ECOG performance status (PS) of 0 or 1, and 2.2 % had a baseline ECOG performance status (PS) of 2.
Croatian: 97,8% bolesnika je početni ECOG funkcionalni status bio 0 ili 1, a u 2,2% bolesnika je početni ECOG
English: VTE including deep vein thrombosis (DVT) and pulmonary embolism (infrequently fatal) have been reported in patients treated with aflibercept (see section 4.8).
Croatian: U bolesnika liječenih afliberceptom prijavljeni su venski tromboembolijski događaji, uključujući duboku vensku trombozu (DVT) i plućnu emboliju (smrtonosna u manjem broju slučajeva) (vidjeti dio 4.8).
English: Sodium chloride
Croatian: Kancerogenost i mutagenost
English: ZALTRAP 25 mg / ml concentration for solution for infusion aflibercept
Croatian: ZALTRAP 25 mg/ml koncentrat za otopinu za infuziju aflibercept
English: Arterial thromboembolism (1) Venous thromboembolism (1)
Croatian: hipertenzija često arterijska tromboembolija (1) venska tromboembolija (1)
English: Elderly people should be closely monitored for the development of diarrhoea and potential dehydration (see section 4.4).
Croatian: Starije osobe treba pažljivo motriti zbog razvoja proljeva i moguće dehidracije
English: Dyspnoea Epistaxis Dysphonia
Croatian: Prijavljivanje nuspojava
English: France
Croatian: Deutschland
English: In other studies, severe intracranial haemorrhage and pulmonary haemorrhage/haemoptysis including fatal events have occurred in patients receiving ZALTRAP (see section 4.4).
Croatian: drugim je ispitivanjima u bolesnika liječenih lijekom ZALTRAP primijećeno teško intrakranijalno krvarenje i plućno krvarenje/hemoptiza, uključujući smrtne slučajeve (vidjeti dio 4.4).
English: Grade 3-4 dehydration was reported in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.3 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Croatian: 4,3% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 1,3% bolesnika koji su primali protokol placebo/FOLFIRI (vidjeti dio 4.4).
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of GI perforation (all grades) was 0.8 % for patients treated with ZALTRAP and 0.3 % for patients treated with placebo.
Croatian: U tri placebom kontrolirana klinička ispitivanja faze III (populacije s kolorektalnim karcinomom, karcinomom gušterače i karcinomom pluća) incidencija gastrointestinalnih perforacija (svih stupnjeva) iznosila je 0,8% u bolesnika liječenih lijekom ZALTRAP i 0,3% u bolesnika koji su primali placebo.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of ATE (all grades) was 2.3 % for patients treated with ZALTRAP and 1.7 % for patients treated with placebo.
Croatian: U tri placebom kontrolirana klinička ispitivanja faze III (populacije s kolorektalnim karcinomom, karcinomom gušterače i karcinomom pluća) incidencija arterijskih tromboembolijskih događaja (svih stupnjeva) iznosila je 2,3% u bolesnika liječenih lijekom ZALTRAP i 1,7% u bolesnika koji su primali placebo.
English: Tel.: +36 1 505 0050
Croatian: SANOFI-AVENTIS zrt. Tel.: +36 1 505 0050
English: An increased risk of grade 3-4 hypertension (including hypertension and one case of essential hypertension) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section
Croatian: U bolesnika liječenih protokolom ZALTRAP/FOLFIRI primijećen je povećan rizik od hipertenzije stupnja 3-4 (uključujući hipertenziju i jedan slučaj esencijalne hipertenzije) (vidjeti dio 4.8).
English: ZALTRAP/FOLFIRI Treatment delay or dose modification Neutropenia or thrombocytopenia (see sections 4.4 and 4.8)
Croatian: Neutropenija ili trombocitopenija (vidjeti dio 4.4 i 4.8).
English: • 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I), sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Croatian: • 8 ml koncentrata u prozirnoj bočici volumena 10 ml od borosilikatnog stakla (tip I), zatvorenoj čepom s rubnikom koji ima "flip-off" kapicu i uloženu obloženu zaštitnu pločicu.
English: GI perforation including fatal GI perforation has been reported in patients treated with ZALTRAP.
Croatian: U bolesnika liječenih lijekom ZALTRAP prijavljena je gastrointestinalna perforacija, uključujući smrtonosnu gastrointestinalnu perforaciju.
English: • 4 ml of concentrate in a 5 ml clear borosilicate glass vial (type I), sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Croatian: • 4 ml koncentrata u prozirnoj bočici volumena 5 ml od borosilikatnog stakla (tip I), zatvorenoj čepom s rubnikom koji ima "flip-off" kapicu i uloženu obloženu zaštitnu pločicu.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of compromised wound healing (all grades) was 0.5 % for patients treated with ZALTRAP and 0.4 % for patients treated with placebo.
Croatian: U tri placebom kontrolirana klinička ispitivanja faze III (populacije s kolorektalnim karcinomom, karcinomom gušterače i karcinomom pluća) incidencija otežanog zacjeljivanja rana (svih stupnjeva) iznosila je 0,5% u bolesnika liječenih lijekom ZALTRAP i 0,4% u bolesnika koji su primali placebo.
English: • 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Croatian: • 8 ml koncentrata u prozirnoj bočici od 10 ml od borosilikatnog stakla (tip I) zatvorenoj čepom s rubnikom koji ima "flip-off" kapicu i uloženu obloženu zaštitnu pločicu.
English: a
Croatian: U
English: The recommended dose of ZALTRAP, administered as an intravenous infusion over 1 hour, is 4 mg / kg of body weight, followed by the FOLFIRI regimen.
Croatian: 4 mg/kg tjelesne težine, a nakon nje se primjenjuje protokol FOLFIRI.
English: Aflibercept treatment should be discontinued in patients who develop nephrotic syndrome or TMA (see section 4.2).
Croatian: U bolesnika u kojih dođe do razvoja nefrotskog sindroma ili trombotičke mikroangiopatije treba obustaviti liječenje afliberceptom (vidjeti dio 4.2).
English: Pre-existing hypertension must be adequately controlled before starting aflibercept.
Croatian: Prije početka liječenja afliberceptom postojeću hipertenziju treba adekvatno regulirati.
English: Single-dose vial.
Croatian: • smanjen tek
English: Other special populations
Croatian: Druge posebne skupine bolesnika Starije osobe
English: • 4 ml of concentrate in a 5 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Croatian: • 4 ml koncentrata u prozirnoj bočici od 5 ml od borosilikatnog stakla (tip I) zatvorenoj čepom s rubnikom koji ima "flip-off" kapicu i uloženu obloženu zaštitnu pločicu.
English: In other studies, PRES was reported in patients treated with monotherapy ZALTRAP (0.5 %) and in combination with other chemotherapies (see section 4.4).
Croatian: (0,5%) te u kombinaciji s drugim kemoterapijama (vidjeti dio 4.4).
English: Number of events, n (%) Median PFS (95 % CI) (months)
Croatian: (n (%)) Medijan PFS-a (95% CI) (mjeseci)
English: In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 69.2 % of patients treated with ZALTRAP/FOLFIRI and 56.5 % of patients treated with placebo/FOLFIRI.
Croatian: 69,2% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 56,5% bolesnika koji su primali protokol placebo/FOLFIRI.
English: Also contains sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide and/or hydrochloric acid and water for injections.
Croatian: POPIS POMOĆNIH TVARI Također sadrži saharozu, natrijev klorid, natrijev citrat dihidrat, citratnu kiselinu hidrat, polisorbat 20,
English: Hepatic impairment
Croatian: Teški proljev
English: A higher incidence of severe diarrhoea has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Croatian: U bolesnika liječenih protokolom ZALTRAP/FOLFIRI primijećena je povećana incidencija teškog proljeva (vidjeti dio 4.8).
English: Hypertension (1) Haemorrhage (1)
Croatian: Krvožilni poremećaji vrlo često hipertenzija (1) krvarenje (1)
English: Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Croatian: dispneju, angioedem i anafilaksiju) (vidjeti dio 4.3 i 4.4).
English: EXP
Croatian: MKRK-a
English: Grade 3-4 proteinuria occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.2 % of patients treated with the placebo/FOLFIRI regimen.
Croatian: 7,9% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 1,2% bolesnika koji su primali protokol placebo/FOLFIRI.
English: Vistor hf.
Croatian: ZALTRAP/FOLFIRI.
English: In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in 0.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 0.5 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Croatian: 0,3% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 0,5% bolesnika koji su primali protokol placebo/FOLFIRI (vidjeti dio 4.4).
English: There are very limited data available for patients with severe renal impairment treated with aflibercept.
Croatian: Zbog vrlo ograničenih dostupnih podataka ne mogu se donijeti zaključci o primjeni u bolesnika s teškim oštećenjem bubrežne funkcije.
English: Magyarország SANOFI-AVENTIS zrt.
Croatian: Ελλάδα sanofi-aventis AEBE