FrancophonIA/ELRC3.0 huggingface dataset:
English: Aflibercept should be discontinued in patients with compromised wound healing requiring medical intervention (see section 4.2).
Croatian: Treba prekinuti primjenu aflibercepta u bolesnika s otežanim zacjeljivanjem rana koje zahtijevaju medicinsku intervenciju (vidjeti dio 4.8).
English: 0.766 (0.645 to 0.908)
Croatian: 0,766 (0,645 do 0,908)
English: ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) have been observed in patients treated with aflibercept (see section 4.8).
Croatian: U bolesnika liječenih afliberceptom primijećeni su arterijski tromboembolijski događaji (uključujući tranzitornu ishemijsku ataku, cerebrovaskularni incident, anginu pektoris, intrakardijalni tromb, infarkt miokarda, arterijsku emboliju i ishemijski kolitis) (vidjeti dio 4.8).
English: There are no data regarding the administration of aflibercept in patients with severe hepatic impairment.
Croatian: Nema podataka o primjeni aflibercepta u bolesnika s teškim oštećenjem jetrene funkcije.
English: The most common adverse reactions (all grades, ≥ 20 % 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 leucopenia, diarrhoea, neutropenia, proteinuria, increased aspartate aminotransferase (AST), stomatitis, fatigue, thrombocytopenia, increased alanine aminotransferase (ALT), hypertension, weight loss, decreased appetite, epistaxis, abdominal pain, dysphonia, increased serum creatinine, and headache (see Table 1).
Croatian: proljev, neutropenija, proteinurija, povišene vrijednosti aspartat aminotransferaze (AST), stomatitis, umor, trombocitopenija, povišene vrijednosti alanin aminotransferaze (ALT), hipertenzija, gubitak tjelesne težine, smanjen tek, epistaksa, bol u abdomenu, disfonija, povišene vrijednosti kreatinina u serumu i glavobolja (vidjeti Tablicu 1).
English: One ml of concentrate contains 25 mg aflibercept.
Croatian: Jedan ml koncentrata sadrži 25 mg aflibercepta.
English: Compromised wound healing (1)
Croatian: otežano zacjeljivanje rana (1)
English: There have been no formal studies with ZALTRAP in patients with hepatic impairment (see section 5.2).
Croatian: Nisu provedena službena ispitivanja lijeka ZALTRAP u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: 6.9 (6.37 to 7.20)
Croatian: 6,9 (6,37 do 7,20)
English: • Blocking of the veins by a blood clot (also called ‘venous thrombo-embolic events'): Common (may affect up to 1 in 10 people) - this may include a blood clot in the lungs or legs.
Croatian: • Začepljenje vene zbog krvnog ugruška (poznato i kao ‘venski tromboembolijski događaji'): Često (mogu se javiti u manje od 1 na 10 osoba) - može uključivati krvni ugrušak u plućima ili nogama.
English: If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive or use machines (see section 4.8).
Croatian: Bolesnicima treba savjetovati da ne upravljaju vozilima i ne rukuju strojevima ako primijete simptome koji im utječu na vid, koncentraciju ili sposobnost reagiranja (vidjeti dio 4.8).
English: In the pivotal study of MCRC patients, positive responses in the ADA assay were observed at higher levels in patients treated with the placebo/FOLFIRI regimen [18/526 (3.4 %)] than with the ZALTRAP/FOLFIRI regimen [8/521 (1.5 %)].
Croatian: U pivotalnom ispitivanju u bolesnika s MKRK-om pozitivni odgovori u ADA testu primijećeni su u većem broju u bolesnika koji su primali protokol placebo/FOLFIRI [18/526 (3,4%)] nego u onih liječenih protokolom ZALTRAP/FOLFIRI [8/521 (1,5%)].
English: 0.788 (0.671 to 0.925)
Croatian: 0,788 (0,671 do 0,925)
English: In patients receiving ZALTRAP, the adverse reactions in patients with mild renal impairment at baseline in three Phase III placebo-controlled clinical studies (N = 352) were comparable with those of patients without renal impairment (N = 642).
Croatian: U tri placebom kontrolirana klinička ispitivanja faze III nuspojave u bolesnika liječenih lijekom ZALTRAP koji su na početku liječenja imali blago oštećenje bubrežne funkcije (N=352) bile su usporedive s nuspojavama primijećenima u bolesnika s normalnom bubrežnom funkcijom (N=642).
English: ZALTRAP should be discontinued for (see section 4.4):
Croatian: Liječenje lijekom ZALTRAP mora se prekinuti u slučaju (vidjeti dio 4.4):
English: In the pivotal study of MCRC patients, proteinuria (compiled from clinical and laboratory data) was reported in 62.2 % patients treated with the ZALTRAP/FOLFIRI regimen compared to 40.7 % patients treated with the placebo/FOLFIRI regimen.
Croatian: U pivotalnom ispitivanju u bolesnika s MKRK-om proteinurija (prikupljeno iz kliničkih i laboratorijskih podataka) je prijavljena u 62,2% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 40,7% bolesnika koji su primali protokol placebo/FOLFIRI.
English: 6.9 (6.24 to 7.20)
Croatian: 6,9 (6,24 do 7,20)
English: Infections and infestations Very common
Croatian: Infekcije i infestacije vrlo često infekcija (1)
English: In sub-group analysis of overall survival, a benefit consistent with the overall population was observed in patients < 65 years old and ≥ 65 years old who received the ZALTRAP/FOLFIRI regimen.
Croatian: U analizi ukupnog preživljenja po podskupinama, u populaciji bolesnika u dobi od < 65 godina i
English: ZALTRAP must not be administered as an intravitreal injection (see section 4.3).
Croatian: ZALTRAP se ne smije primijeniti u obliku intravitrealne injekcije (vidjeti dio 4.3).
English: Stratified hazard ratio (95 % CI)
Croatian: Stratificirani omjer hazarda (95% CI)
English: Cardiac failure and ejection fraction decreased
Croatian: Zatajenje srca i smanjena ejekcijska frakcija
English: • Holes in the gut (also called ‘gastro-intestinal perforation'): Uncommon (may affect up to 1 in 100 people) - this is a hole in the stomach, food pipe, gut or bowel.
Croatian: • Pukotine u probavnom sustavu (poznate i kao ‘gastrointestinalne perforacije'): Manje često (mogu se javiti u manje od 1 na 100 osoba) - to je pukotina u želucu, jednjaku ili crijevima koja može uzrokovati smrt.
English: • Fistula formation
Croatian: • stvaranja fistule
English: One patient treated with the ZALTRAP/FOLFIRI regimen presenting with proteinuria and hypertension was diagnosed with thrombotic microangiopathy (TMA).
Croatian: Jednom je bolesniku s proteinurijom i hipertenzijom liječenom protokolom ZALTRAP/FOLFIRI dijagnosticirana trombotička mikroangiopatija (TMA).
English: A total of 1,226 patients were randomised (1:1) to receive either ZALTRAP (N = 612; 4 mg/kg as a 1 hour intravenous infusion on day 1) or placebo (N = 614), in combination with 5-fluouracil plus irinotecan [FOLFIRI: irinotecan 180 mg/m intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-FU 400 mg/m² intravenous bolus, followed by 5-FU 2,400 mg /m² continuous intravenous infusion over 46-hours].
Croatian: Ukupno je 1226 bolesnika randomizirano (1:1) da primaju ili ZALTRAP (N=612; 4 mg/kg u obliku jednosatne intravenske infuzije primijenjene 1. dana) ili placebo (N=614) u kombinaciji s 5-fluorouracilom i irinotekanom [FOLFIRI: intravenska infuzija irinotekana u dozi od 180 mg/m2
English: If recurrence, the treatment should be suspended until <2 grams per 24 hours and then the dose reduces to 2 mg/kg.
Croatian: U slučaju ponovne pojave, liječenje treba prekinuti dok proteinurija ne bude < 2 grama u 24 sata, a zatim smanjiti dozu na 2 mg/kg.
English: • Gastrointestinal (GI) perforation
Croatian: • gastrointestinalne perforacije
English: • Blocking of the arteries by a blood clot (also called ‘arterial thrombo-embolic events'): Common (may affect up to 1 in 10 people) - this may lead to a stroke or heart attack.
Croatian: • Začepljenje arterije zbog krvnog ugruška (poznato i kao ‘arterijski tromboembolijski događaji'): Često (mogu se javiti u manje od 1 na 10 osoba) - može prouzročiti moždani ili srčani udar.
English: 0.758 (0.661 to 0.869)
Croatian: 0,758 (0,661 do 0,869)
English: • Heart failure (also called cardiac failure); Uncommon (may affect up to 1 in 100 people) - Signs may include shortness of breath when you lie down or when you exert yourself, excessive tiredness or leg swelling.
Croatian: • Zatajenje srca: Manje često (mogu se javiti u manje od 1 na 100 osoba) - znakovi mogu uključiti nedostatak zraka kada ležite ili kad se naprežete, pretjeran umor ili oticanje nogu.
English: One vial of 4 ml contains 100 mg of aflibercept (25 mg / ml).
Croatian: Jedna bočica s 4 ml koncentrata sadrži 100 mg aflibercepta (25 mg/ml).
English: • The diluted solution should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: • Razrijeđenu otopinu treba prije primjene vizualno pregledati kako bi se utvrdilo sadrži li čestice i je li promijenila boju.
English: Dehydration (all grades) has been observed in 9.0 % of patients treated with ZALTRAP/FOLFIRI and 3.0 % of patients treated with placebo/FOLFIRI.
Croatian: Dehidracija (svih stupnjeva) je primijećena u 9,0% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 3,0% bolesnika koji su primali protokol placebo/FOLFIRI.
English: Table 1 - Adverse reactions reported in patients treated with the ZALTRAP/FOLFIRI regimen from the MCRC study
Croatian: Tablica 1 - Nuspojave prijavljene u bolesnika liječenih protokolom ZALTRAP/FOLFIRI u ispitivanju
English: Treatment with ZALTRAP is associated with potential for compromised wound healing (wound dehiscence, anastomotic leakage).
Croatian: Liječenje lijekom ZALTRAP može otežati zacjeljivanje rana (dehiscijencija rane, iscjedak iz anastomoze).
English: * Aflibercept is produced in a Chinese hamster ovary (CHO) K-1 mammalian expression system by recombinant DNA technology.
Croatian: * Aflibercept se proizvodi tehnologijom rekombinantne DNA na ekspresijskom sustavu stanica sisavaca K-1 iz jajnika kineskog hrčka (engl.
English: Post-hoc analyses excluding patients who progressed during or within 6 months of adjuvant therapy for patients with or without prior bevacizumab treatment are summarised in Table 4.
Croatian: U Tablici 4 sažete su post-hoc analize u bolesnika koji prethodno jesu i u onih koji prethodno nisu liječeni bevacizumabom; u analize nisu bili uključeni bolesnici u kojih je bolest uznapredovala tijekom ili unutar 6 mjeseci od adjuvantnog liječenja.
English: If any discolouration or particulate matter is observed, the reconstituted solution should be discarded.
Croatian: Ako se utvrdi promjena boje ili prisutnost čestica, pripremljenu otopinu treba baciti.
English: If there is recurrence, the administration should be suspended until <2 grams/24 hours and then the dose reduced to 2 mg/kg.
Croatian: U slučaju ponovne pojave, primjenu treba prekinuti dok proteinurija ne bude < 2 grama u 24 sata, a zatim smanjiti dozu na 2 mg/kg.
English: Signs may include stomach pain, being sick (vomiting), fever or chills.
Croatian: Znakovi mogu uključivati bol u želucu, povraćanje, vrućicu ili zimicu.
English: You may be advised to have a dental check-up before you start treatment with ZALTRAP.
Croatian: Prije početka liječenja lijekom ZALTRAP može Vam se savjetovati stomatološki pregled.
English: Overall across all clinical oncology studies, similar incidence of low titre anti-drug antibody (ADA) responses (post baseline) in the ADA assay were observed in both patients treated with placebo and ZALTRAP (3.3 % and 3.8 %, respectively).
Croatian: Ukupno je u svim onkološkim kliničkim ispitivanjima u testu protutijela na lijek (engl. anti-drug antibody, ADA) primijećena podjednaka incidencija odgovora s niskim titrom protutijela na lijek (nakon početka ispitivanja) i u bolesnika koji su primali placebo i u bolesnika liječenih lijekom ZALTRAP (3,3% naspram 3,8%).
English: • inflammation inside the mouth
Croatian: • upala u ustima
English: 3 vials
Croatian: 3 godine
English: • polyurethane
Croatian: • poliuretana
English: Infections occurred at a higher frequency in patients receiving the ZALTRAP/FOLFIRI regimen (46.2 %, all grades; 12.3 %, grade 3-4) than in patients receiving the placebo/FOLFIRI regimen (32.7%, all grades; 6.9 %, grade 3-4), including urinary tract infection, nasopharyngitis, upper respiratory tract infection, pneumonia, catheter site infection, and tooth infection.
Croatian: 32,7%; stupanj 3-4: 6,9%), uključujući infekciju mokraćnih putova, nazofaringitis, infekciju gornjih dišnih putova, upalu pluća, infekciju na mjestu katetera i infekciju zuba.
English: Grade 3-4 events occurred in 11 patients (1.8 %) treated with the ZALTRAP/FOLFIRI regimen and 3 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
Croatian: Događaji stupnja 3-4 javili su se u 11 bolesnika (1,8%) liječenih protokolom ZALTRAP/FOLFIRI i u 3 bolesnika (0,5%) koja su primala protokol placebo/FOLFIRI.
English: • Protein in the urine (also called ‘proteinuria'): Very common (may affect more than 1 in 10 people) - this is very commonly seen in tests.
Croatian: • Proteini u mokraći (poznato i kao ‘proteinurija'): Vrlo često (mogu se javiti u više od 1 na
English: One vial of 8 ml contains 200 mg of aflibercept (25 mg / ml).
Croatian: Jedna bočica s 8 ml koncentrata sadrži 200 mg aflibercepta (25 mg/ml).
English: ZALTRAP should be suspended when proteinuria ≥2 grams per 24 hours and resumed when proteinuria < 2 grams per 24 hours.
Croatian: Primjenu lijeka ZALTRAP treba privremeno prekinuti kada je proteinurija ≥ 2 grama u 24 sata i nastaviti kada proteinurija bude < 2 grama u 24 sata.
English: The following adverse reactions and laboratory abnormalities were reported with a ≥ 5 % difference (all grades) in patients treated with the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen (in order of decreasing frequency): leucopenia (78.3 % versus 72.4 % all grades; 15.6 %
Croatian: Sljedeće nuspojave i laboratorijska odstupanja (svih stupnjeva) prijavljena su u ≥ 5% više bolesnika liječenih protokolom ZALTRAP/FOLFIRI u odnosu na bolesnike koji su primali protokol placebo/FOLFIRI (navedene prema učestalosti u padajućem nizu): leukopenija (svi stupnjevi: 78,3%
English: Grade 3 GI fistula formation occurred in 2 patients treated with ZALTRAP (0.3 %) and in 1 placebo-treated patient (0.2 %).
Croatian: Do stvaranja gastrointestinalnih fistula stupnja 3 došlo je u 2 bolesnika liječena lijekom ZALTRAP (0,3%) te u 1 bolesnika koji je primao placebo (0,2%).
English: Other subgroup analyses for overall survival and progression free survival according to age (< 65; ≥ 65), gender, presence of liver metastasis only, history of prior hypertension, and number of organs involved, showed a treatment effect favouring the ZALTRAP/FOLFIRI regimen over the placebo/FOLFIRI regimen.
Croatian: (< 65; ≥ 65), spolu, prisutnosti metastaza samo u jetri, hipertenziji u anamnezi i broju zahvaćenih organa ukazale su na bolji učinak liječenja protokolom ZALTRAP/FOLFIRI nego protokolom placebo/FOLFIRI.
English: Compromised wound healing
Croatian: Otežano zacjeljivanje rana
English: Table 2 - Main efficacy endpoints a
Croatian: Tablica 2 - Glavne mjere ishoda za djelotvornosta - ITT populacija
English: ZALTRAP must not be administered as an intravitreal injection (see section 2 of the package leaflet).
Croatian: ZALTRAP se ne smije primijeniti u obliku intravitrealne injekcije (vidjeti dio 2. Upute o lijeku).
English: • swelling and numbness of the hands and feet that happens with chemotherapy (called
Croatian: • oticanje i utrnulost šaka i stopala koje se javlja kod kemoterapije (poznato kao ‘sindrom palmarno-plantarne eritrodizestezije')
English: ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
Croatian: (FOLFIRI) indiciran u liječenju odraslih osoba s metastatskim kolorektalnim karcinomom (MKRK) u kojih je bolest rezistentna na ili je napredovala nakon liječenja protokolom koji sadrži oksaliplatin.
English: Severe diarrhoea
Croatian: Ozbiljne nuspojave
English: Of the 611 patients treated with the ZALTRAP/FOLFIRI regimen in the pivotal study of MCRC patients, 172 (28.2 %) were aged ≥ 65 and < 75 and 33 (5.4 %) were age ≥ 75.
Croatian: MKRK-om, njih 172 (28,2%) bila su u dobi ≥ 65 i < 75 godina, a 33 bolesnika (5,4%) bila su u dobi od ≥ 75 godina.
English: The most common grade 3-4 neutropenic complication was the occurrence of febrile neutropenia in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.7 % of patients treated with the placebo/FOLFIRI regimen.
Croatian: Najčešća neutropenijska komplikacija stupnja 3-4 bila je neutropenijska vrućica, koja se javila u 4,3% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 1,7% bolesnika koji su primali protokol placebo/FOLFIRI.
English: One ml of concentrate for solution for infusion contains 25 mg aflibercept*.
Croatian: Jedan ml koncentrata za otopinu za infuziju sadrži 25 mg aflibercepta*.
English: An increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events has been reported in patients treated with aflibercept (see section 4.8).
Croatian: U bolesnika liječenih afliberceptom prijavljen je povećan rizik od krvarenja, uključujući teške i ponekad smrtonosne događaje krvarenja (vidjeti dio 4.8).
English: Venous thromboembolic events (VTE)
Croatian: Venski tromboembolijski događaji (VTE)
English: Grade 3-4 neutropenic infection/sepsis occurred in 1.5 % of patients treated with the ZALTRAP/FOLFIRI regimen and 1.2 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Croatian: Neutropenijska infekcija/sepsa stupnja 3-4 javila se u 1,5% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 1,2% bolesnika koji su primali protokol placebo/FOLFIRI (vidjeti dio 4.4).
English: • Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Croatian: • teških reakcija preosjetljivosti (uključujući bronhospazam, dispneju, angioedem i anafilaksiju)
English: Nephrotic syndrome occurred in 2 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen compared to none of the patients treated with the placebo/FOLFIRI regimen.
Croatian: Nefrotski sindrom je nastupio u 2 bolesnika (0,5%) liječena protokolom ZALTRAP/FOLFIRI, no ni u jednog bolesnika koji je primao protokol placebo/FOLFIRI.
English: Arterial thromboembolism (1) Venous thromboembolism (1) Haemorrhage (1)
Croatian: arterijska tromboembolija (1) venska tromboembolija (1) krvarenje (1)
English: Musculoskeletal and connective tissue disorders Uncommon
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često osteonekroza čeljusti
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given ZALTRAP and during your treatment.
Croatian: Ako se nešto od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite ZALTRAP i za vrijeme liječenja.
English: No metabolism studies have been conducted with aflibercept since it is a protein.
Croatian: Budući da je aflibercept protein, nisu provedena ispitivanja metabolizma.
English: Proteinuria (1),(3) Increased serum creatinine
Croatian: Poremećaji bubrega i mokraćnog sustava vrlo često proteinurija (1),(3) povišene vrijednosti kreatinina u serumu često proteinurija (1),(3)
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ZALTRAP therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Uzimajući u obzir korist dojenja za dijete i dobrobit liječenja za majku, mora se donijeti odluka hoće li se prekinuti dojenje ili privremeno ili trajno prekinuti liječenje lijekom ZALTRAP.
English: EXP Shelf life after dilution: see package leaflet.
Croatian: Rok valjanosti Rok valjanosti nakon razrjeđivanja: vidjeti uputu o lijeku.
English: Fistula formation
Croatian: Stvaranje fistula
English: Median overall survival (95 % CI) (months)
Croatian: Medijan ukupnog preživljenja (95% CI) (mjeseci)
English: Male and female fertility are likely to be compromised during treatment with aflibercept based on studies in monkeys (see section 5.3).
Croatian: Na temelju rezultata istraživanja na majmunima, postoji vjerojatnost štetnog utjecaja liječenja afliberceptom na plodnost u muškaraca i žena (vidjeti dio 5.3).
English: Grade 3-4 haemorrhage including GI haemorrhage, haematuria, and post-procedural haemorrhage was reported in 2.9 % of patients receiving the ZALTRAP/FOLFIRI regimen compared with 1.7 % of patients receiving the placebo/FOLFIRI regimen.
Croatian: Krvarenje stupnja 3-4, uključujući gastrointestinalno krvarenje, hematuriju i postproceduralno krvarenje, prijavljeno je u 2,9% bolesnika liječenih protokolom ZALTRAP/FOLFIRI te 1,7% bolesnika koji su primali protokol placebo/FOLFIRI.
English: Median OS (95 % CI) (months)
Croatian: Medijan OS (95% CI) (mjeseci)
English: ZALTRAP should be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Croatian: 4.2 Doziranje i način primjene ZALTRAP se mora primjenjivati pod nadzorom liječnika koji ima iskustva u primjeni antitumorskih lijekova.
English: Administration of ZALTRAP/FOLFIRI should be delayed until neutrophil count is 1.5 x 10
Croatian: Primjenu protokola ZALTRAP/FOLFIRI treba odgoditi dok broj neutrofila ne bude ≥1,5 x 109/l ili broj trombocita ≥75 x 109/l.
English: Ejection fraction decreased Nervous system disorders Very common
Croatian: Poremećaji živčanog sustava vrlo često
English: Hypersensitivity (1)
Croatian: manje često preosjetljivost (1)
English: Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari saharoza natrijev klorid natrijev citrat dihidrat citratna kiselina hidrat polisorbat 20 natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat hidrat natrijev hidroksid i/ili kloridna kiselina (za podešavanje pH) voda za injekcije
English: The most frequent adverse reactions leading to permanent discontinuation in ≥ 1 % of patients treated with the ZALTRAP/FOLFIRI regimen were vascular disorders (3.8 %) including hypertension (2.3 %), infections (3.4 %), asthenia/fatigue (1.6 %, 2.1 %),diarrhoea (2.3 %), dehydration (1 %), stomatitis (1.1 %), neutropenia (1.1 %), proteinuria (1.5 %), and pulmonary embolism (1.1 %).
Croatian: (3,4%), astenija/umor (1,6%, 2,1%), proljev (2,3%), dehidracija (1%), stomatitis (1,1%), neutropenija
English: In the pivotal study of MCRC patients, GI perforation (all grades) was reported in 3 of 611 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
Croatian: U pivotalnom ispitivanju u bolesnika s MKRK-om gastrointestinalna perforacija (svih stupnjeva) bila je prijavljena u 3 od 611 bolesnika (0,5%) liječenih protokolom ZALTRAP/FOLFIRI i u 3 od 605 bolesnika (0,5%) koji su primali protokol placebo/FOLFIRI.
English: In the pivotal study for MCRC, compromised wound healing was reported in 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 5 patients (0.8 %) treated with the placebo/FOLFIRI regimen.
Croatian: U pivotalnom ispitivanju u bolesnika s MKRK-om otežano zacjeljivanje rana bilo je prijavljeno u 3 bolesnika (0,5%) liječena protokolom ZALTRAP/FOLFIRI i u 5 bolesnika (0,8%) koji su primali protokol placebo/FOLFIRI.
English: Additional adverse reactions and laboratory abnormalities reported with a ≥5 % difference (all grades) in patients treated with the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen
Croatian: Dodatne nuspojave i laboratorijska odstupanja (svih stupnjeva) prijavljena u ≥ 5% više bolesnika liječenih protokolom ZALTRAP/FOLFIRI u odnosu na bolesnike koji su primali protokol placebo/FOLFIRI
English: As determined per IVRS
Croatian: Interactive Voice Response System, IVRS)