FrancophonIA/ELRC3.0 huggingface dataset:
English: A population pharmacokinetic analysis was conducted with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy.
Croatian: Provedena je populacijska farmakokinetička analiza podataka prikupljenih u 1507 bolesnika s različitim vrstama uznapredovalih zloćudnih tumora koji su primali ZALTRAP u kombinaciji s kemoterapijom ili bez nje.
English: Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles (see section 4.2).
Croatian: U sljedećim se ciklusima može razmotriti premedikacija kortikosteroidima i/ili antihistaminicima (vidjeti dio 4.2).
English: Treatment assignment was stratified by the ECOG performance status (0 versus 1 versus 2) and according to prior therapy with bevacizumab (yes or no).
Croatian: Liječenje je dodijeljeno prema stratifikaciji na temelju ECOG statusa (0 naspram 1 naspram 2) i prethodnog liječenja bevacizumabom (da ili ne).
English: Signs may include chest pain or heaviness in the chest, sudden numb or weak feeling in the face, arms, or legs.
Croatian: Znakovi mogu uključivati bol ili težinu u prsima, iznenadnu utrnulost ili slabost u licu, rukama ili nogama.
English: In patients with RAS wild type tumours the HR (95 % CI) for OS was 0.7 (0.5-1.0) with a median OS of 16.0 months for patients treated with aflibercept, and 11.7 months for the patients treated with placebo.
Croatian: U bolesnika s RAS divljim tipom tumora, omjer hazarda (95% CI) za OS bio je 0,7 (0,5-1,0) s medijanom ukupnog preživljenja od 16,0 mjeseci za bolesnike liječene afliberceptom te 11,7 mjeseci za bolesnike koji su primali placebo.
English: In the pivotal MCRC study, 28.2 % of patients were aged ≥ 65 and < 75 and 5.4 % of patients were aged ≥ 75.
Croatian: U pivotalnom ispitivanju MKRK-a 28,2% bolesnika bilo je u dobi ≥ 65 i < 75 godina, a 5,4%
English: 0.817 (0.714 to 0.935)
Croatian: 0,817 (0,714 do 0,935)
English: Posterior reversible encephalopathy syndrome (PRES) PRES was not reported in the pivotal Phase III study of MCRC patients.
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES) PRES nije prijavljen u pivotalnom ispitivanju faze III u bolesnika s MKRK-om.
English: ZALTRAP should be temporarily suspended for at least 4 weeks prior to elective surgery (see section
Croatian: Primjena lijeka ZALTRAP mora se privremeno prekinuti najmanje 4 tjedna prije elektivnog kirurškog zahvata (vidjeti dio 4.4).
English: ZALTRAP 25 mg / ml sterile concentrate aflibercept
Croatian: ZALTRAP 25 mg/ml sterilni koncentrat aflibercept
English: Overall objective response rate by IRC
Croatian: Ukupna stopa objektivnog odgovora prema procjeni neovisnog ocjenjivačkog povjerenstva
English: The most common reported form of bleeding was minor (grade 1-2) epistaxis occurring in 27.7 % of patients treated with the ZALTRAP/FOLFIRI regimen.
Croatian: Najčešće prijavljen oblik krvarenja bila je blaga epistaksa (stupnja 1-2), koja se javila u 27,7% bolesnika liječenih protokolom ZALTRAP/FOLFIRI.
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba):
English: Osteonecrosis of the jaw (ONJ) Cases of ONJ have been reported in cancer patients treated with Zaltrap, several of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Croatian: U bolesnika s karcinomom koji su liječeni lijekom Zaltrap prijavljeni su slučajevi osteonekroze čeljusti, pri čemu je nekoliko bolesnika prethodno ili istodobno liječeno intravenskim bisfosfonatima, za koje je osteonekroza čeljusti identificiran rizik.
English: Exploratory biomarker analyses were undertaken in the VELOUR trial including analyses of RAS mutational status in 482 of 1,226 patients (n = 240 aflibercept; 242 placebo).
Croatian: mutacijskog statusa u 482 od 1226 bolesnika (n=240 aflibercept; 242 placebo).
English: It is unknown whether aflibercept is excreted in human milk.
Croatian: Nije poznato izlučuje li se aflibercept u majčino mlijeko.
English: There was no margin of exposure to patients in relation to these effects.
Croatian: Nije utvrđena granica izloženosti za navedene učinke u ljudi.
English: Women of childbearing potential / Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while on ZALTRAP, and should be informed of the potential hazard to the foetus.
Croatian: Ženama reproduktivne dobi mora se savjetovati da izbjegavaju trudnoću za vrijeme liječenja lijekom ZALTRAP i treba ih upoznati s mogućim rizicima za plod.
English: In other studies, PRES was reported in patients treated with aflibercept as monotherapy and in combination with other chemotherapies (see section 4.8).
Croatian: U drugim je ispitivanjima PRES prijavljen u bolesnika liječenih afliberceptom u monoterapiji i u kombinaciji s drugim kemoterapijama (vidjeti dio 4.8).
English: ZALTRAP should be temporarily suspended until hypertension is controlled.
Croatian: Primjenu lijeka ZALTRAP treba privremeno prekinuti dok se hipertenzija ne stavi pod kontrolu.
English: In preclinical tumour models, biologically active doses of aflibercept correlated with those necessary to produce circulating concentrations of free aflibercept in excess of VEGF-bound aflibercept.
Croatian: U nekliničkim tumorskim modelima biološki aktivne doze aflibercepta bile su u korelaciji s dozama potrebnima za postizanje koncentracije slobodnog aflibercepta u krvotoku koja bi bila veća od koncentracije aflibercepta vezanog za VEGF.
English: ZALTRAP will be given with other chemotherapy medicines including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Croatian: ZALTRAP će se primjenjivati u kombinaciji s drugim kemoterapijskim lijekovima, uključujući ‘5-fluorouracil', ‘folnu kiselinu' i ‘irinotekan'.
English: More than one vial could be needed for the preparation of the infusion solution.
Croatian: Za pripremu otopine za infuziju možda će biti potrebno više od jedne bočice.
English: Sanofi-aventis Deutschland GmbH Industriepark Höchst D-65926 Frankfurt am Main Germany
Croatian: Sanofi-aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt na Majni
English: PRES may present with altered mental status, seizure, nausea, vomiting, headache, or visual disturbances.
Croatian: PRES se može manifestirati promjenom mentalnog statusa, napadajem, mučninom, povraćanjem,
English: Off-label intravitreal use
Croatian: Neodobrena intravitrealna primjena
English: 11.7 (9.66 to 13.27) 13.8 (11.01 to 15.87)
Croatian: 11,7 (9,66 do 13,27) 13,8 (11,01 do 15,87)
English: 12.06 (11.07 to 13.08) 13.50 (12.52 to 14.95)
Croatian: 12,06 (11,07 do 13,08) 13,50 (12,52 do 14,95)
English: Tel.: 0800 04 36 996 Tel. aus dem Ausland: +49 69 305 70 13
Croatian: Tel. aus dem Ausland: +49 69 305 70 13
English: What ZALTRAP is used for
Croatian: Za što se koristi ZALTRAP
English: The hazard ratio (95 % CI) of overall survival was 0.77 (0.64 to 0.93) for ECOG performance status 0 and 0.87 (0.71 to 1.06) for ECOG
Croatian: Omjer hazarda (95% CI) za ukupno preživljenje iznosio je 0,77 (0,64 do 0,93) za ECOG status 0 i 0,87 (0,71 do 1,06) za ECOG status 1.
English: ZALTRAP must not be administered as an intravitreal injection (see sections 4.3 and 4.4).
Croatian: ZALTRAP se ne smije primijeniti u obliku intravitrealne injekcije (vidjeti dio 4.3 i 4.4).
English: Monitoring of complete blood count (CBC) with platelets is recommended at baseline, prior to initiation of each cycle of aflibercept, and as clinically necessary.
Croatian: Preporučuje se kontrola kompletne krvne slike (KKS) i broja trombocita na početku liječenja, prije početka svakog ciklusa aflibercepta i kada je to klinički potrebno.
English: 0.645 (0.498 to 0.835)
Croatian: 0,645 (0,498 do 0,835)
English: Do not use ZALTRAP if you notice particles or discolouration of the medicine in the vial or infusion bag.
Croatian: Nemojte primijeniti ZALTRAP ako su njemu vidljive čestice ili je lijek u bočici ili infuzijskoj vrećici promijenio boju.
English: 0.812 (0.634 to 1.042)
Croatian: 0,812 (0,634 do 1,042)
English: Signs may include feeling very tired, weak, and/or dizzy, or having changes in the colour of your stool.
Croatian: Znakovi mogu uključivati izrazit umor, slabost i/ili omaglicu te promjene u boji stolice.
English: Patients should be monitored for signs and symptoms of cardiac failure and ejection fraction decreased.
Croatian: U bolesnika je potrebno pratiti moguće znakove i simptome zatajenja srca i smanjene ejekcijske frakcije.
English: • High blood pressure (also called ‘hypertension'): Very common (may affect more than 1 in 10 people) - this may develop or get worse.
Croatian: • Visok krvni tlak (poznat i kao ‘hipertenzija'): Vrlo često (mogu se javiti u više od 1 na 10 osoba) - hipertenzija se može razviti ili pogoršati.
English: Weekly/every two weeks intravenous administration of aflibercept to cynomolgus monkeys for up to 6 months resulted in changes in the bone (effects on growth plate and the axial and appendicular skeleton), nasal cavity, kidney, ovary, and adrenal gland.
Croatian: Intravenska primjena aflibercepta u makaki majmuna svakih tjedan dana/svaka dva tjedna tijekom najviše 6 mjeseci uzrokovala je promjene na kostima (utjecaj na ploču rasta te aksijalni i apendikularni kostur), u nosnoj šupljini, na bubrezima, jajnicima i nadbubrežnoj žlijezdi.
English: Posterior reversible encephalopathy syndrome (PRES) PRES was not reported in the pivotal phase III study of MCRC patients.
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES) PRES nije prijavljen u pivotalnom ispitivanju faze III u kojem su sudjelovali bolesnici s MKRK-om.
English: The safety of ZALTRAP in combination with FOLFIRI was evaluated in 1,216 patients previously treated for metastatic colorectal cancer, of which 611 patients were treated with ZALTRAP 4 mg/kg every two weeks (one cycle) and 605 patients were treated with placebo/FOLFIRI in a phase III study.
Croatian: Sažetak sigurnosnog profila Sigurnost primjene lijeka ZALTRAP u kombinaciji s protokolom FOLFIRI ocijenjena je u ispitivanju faze III u kojem je sudjelovalo 1216 bolesnika prethodno liječenih zbog metastatskog kolorektalnog karcinoma, od kojih je njih 611 primalo ZALTRAP u dozi od 4 mg/kg svaka dva tjedna (jedan ciklus), a 605 protokol placebo/FOLFIRI.
English: ZALTRAP is given by a drip (infusion) into one of your veins (‘intra-venous') to treat advanced cancers of the colon or rectum.
Croatian: ZALTRAP se primjenjuje kapanjem (infuzijom) u jednu od vena (‘intravenski') za liječenje uznapredovalog raka debelog crijeva ili završnog dijela debelog crijeva.
English: • Arterial thromboembolic events (ATE)
Croatian: • arterijskih tromboembolijskih događaja (ATE)
English: ZALTRAP should be discontinued in patients with life-threatening (Grade 4) thromboembolic events (including pulmonary embolism) (see section 4.2).
Croatian: Primjenu lijeka ZALTRAP treba prekinuti u bolesnika s tromboembolijskim događajima opasnim po život (stupanj 4) (uključujući plućnu emboliju) (vidjeti dio 4.2).
English: If severe diarrhoea persists with both dose reductions, FOLFIRI should be discontinued.
Croatian: Ako se težak proljev nastavi i nakon tih smanjenja, treba obustaviti primjenu protokola FOLFIRI.
English: Stratified log-rank test p-value Overall Response Rate (CR+PR) (95 % CI) (%)
Croatian: Stopa ukupnog odgovora (CR+PR) (95% CI) (%)c
English: Other signs include swelling in one or both legs, pain or tenderness in one or both legs while standing or walking, warmth of the skin on the affected leg, red or discoloured skin in the affected leg or visible veins.
Croatian: Drugi znakovi mogu uključivati oticanje jedne ili obje noge, bol ili osjetljivost na dodir u jednoj ili obje noge pri stajanju ili hodanju, toplinu kože na zahvaćenoj nozi, crvenilo kože ili promjenu boje kože na zahvaćenoj nozi ili vidljive vene.
English: • Cardiac failure and ejection fraction decreased
Croatian: • zatajenja srca i smanjene ejekcijske frakcije
English: • Inspect the ZALTRAP vial visually prior to use.
Croatian: • Prije uporabe vizualno pregledajte bočicu lijeka ZALTRAP.
English: This is because it is not known if the medicine passes into breast milk.
Croatian: Naime, nije poznato izlučuje li se ovaj lijek u majčino mlijeko.
English: • The other ingredients are: 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: • Drugi sastojci su: saharoza, natrijev klorid, natrijev citrat dihidrat, citratna kiselina hidrat, polisorbat 20, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat hidrat, natrijev hidroksid i/ili kloridna kiselina i voda za injekcije.
English: GI perforation (1) Rectal haemorrhage Fistula (1) Aphthous stomatitis Proctalgia
Croatian: gastrointestinalna perforacija (1) rektalno krvarenje fistula (1) aftozni stomatitis proktalgija
English: For additional toxicities related to irinotecan, 5-FU, or folinic acid, refer to the current respective summary of product characteristics.
Croatian: Za dodatne toksičnosti povezane s irinotekanom, 5-FU ili folnom kiselinom vidjeti važeći Sažetak opisa svojstava lijeka za svaki od navedenih lijekova.
English: Note: Adverse reactions are reported using MedDRA version MEDDRA13.1 and graded using NCI CTC version 3.0 (1) See “Description of selected adverse reactions” in this section (2) Based on laboratory values (percentages done on patients with laboratory assessments) (3) Compilation of clinical and laboratory data
Croatian: (1) Vidjeti "Opis odabranih nuspojava" u ovome dijelu (2) Na temelju laboratorijskih vrijednosti (postoci u bolesnika u kojih su provedene laboratorijske procjene)
English: Grade 3 hypertension (requiring adjustment in existing anti-hypertensive therapy or treatment with more than one medicinal product) was reported in 1.5 % of patients treated with the placebo/FOLFIRI regimen and 19.1 % of patients treated with the ZALTRAP/FOLFIRI regimen.
Croatian: Hipertenzija stupnja 3 (koja zahtijeva prilagođavanje postojeće antihipertenzivne terapije ili liječenje više nego jednim lijekom) prijavljena je u 1,5% bolesnika koji su primali protokol placebo/FOLFIRI te u 19,1% bolesnika liječenih protokolom ZALTRAP/FOLFIRI.
English: Patients with prior bevacizumab (n (%))
Croatian: Bolesnici prethodno liječeni bevacizumabom (n (%))
English: Clinical data suggest that no change in starting dose is required in patients with mild to moderate renal impairment.
Croatian: Klinički podaci pokazuju da nije potrebna prilagodba početne doze u bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije.
English: 0.862 (0.676 to 1.100)
Croatian: 0,862 (0,676 do 1,100)
English: Hazard ratio (95 % CI)
Croatian: Omjer hazarda (95% CI)
English: Each vial of concentrate for solution for infusion is for single use (single-dose) only.
Croatian: Jedna bočica koncentrata za otopinu za infuziju namijenjena je isključivo za jednokratnu (jednodoznu)
English: • urinary tract infection
Croatian: • infekcija mokraćnih putova
English: Cardiac failure and ejection fraction decreased have been reported in patients treated with ZALTRAP.
Croatian: Zatajenje srca i smanjena ejekcijska frakcija prijavljeni su u bolesnika liječenih lijekom ZALTRAP.
English: 0.777 (0.655 to 0.921)
Croatian: 0,777 (0,655 do 0,921)
English: 6.90 (6.51 to 7.20)
Croatian: 6,90 (6,51 do 7,20)
English: In the pivotal study of MCRC patients, ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) were reported in 2.6 % of patients treated with the ZALTRAP/FOLFIRI regimen and 1.5 % of patients treated with the placebo/FOLFIRI regimen.
Croatian: U pivotalnom ispitivanju u bolesnika s MKRK-om arterijski tromboembolijski događaji (uključujući tranzitornu ishemijsku ataku, cerebrovaskularni incident, anginu pektoris, intrakardijalni tromb, infarkt miokarda, arterijsku emboliju i ishemijski kolitis) prijavljeni su u 2,6% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 1,5% bolesnika koji su primali protokol placebo/FOLFIRI.
English: If recurrence, 5-FU bolus and infusion doses should additionally be reduced by 20 % in subsequent cycles.
Croatian: Ako se ponovno javi, doze bolusne injekcije i infuzije 5-FU u sljedećim ciklusima treba smanjiti za dodatnih 20%.
English: Due to hyperosmolality (1000 mOsmol/kg) of the ZALTRAP concentrate, undiluted ZALTRAP concentrate must not be administered as an intravenous push or bolus.
Croatian: Zbog hiperosmolarnosti (1000 mOsmol/kg) ZALTRAP koncentrata, nerazrijeđeni ZALTRAP koncentrat ne smije se primijeniti brzom niti bolusnom intravenskom injekcijom.
English: Caution should be exercised when Zaltrap and intravenous bisphosphonates are administered concurrently or sequentially.
Croatian: Potreban je oprez kod istodobne ili uzastopne primjene lijeka Zaltrap i intravenskih bisfosfonata.
English: Patients with no prior bevacizumab excluding adjuvant only (n ( %))
Croatian: Bolesnici koji su prethodno primali bevacizumab, izuzevši samo adjuvantno liječenje(n (%))
English: 0.661 (0.512 to 0.852)
Croatian: 0,661 (0,512 do 0,852)
English: OS in ITT population excluding patients who progressed during or within 6 months of adjuvant therapy demonstrated an HR (95 % CI) of 0.78 (0.68 to 0.90) [median OS (95 % CI) with Placebo/FOLFIRI 11.9 months (10.88 to 13.01) and with ZALTRAP/FOLFIRI 13.8 months (12.68 to 15.44)]
Croatian: a Određeno korištenjem sustava interaktivnog glasovnog odgovora b OS u ITT populaciji, izuzevši bolesnike u kojih je bolest uznapredovala tijekom ili unutar 6 mjeseci od adjuvantnoga liječenja, ukazalo je na omjer hazarda (95% CI) od 0,78 (0,68 do 0,90) [medijan OS-a (95% CI) uz placebo/FOLFIRI iznosio je 11,9 mjeseci (10,88 do 13,01), a uz ZALTRAP/FOLFIRI 13,8 mjeseci (12,68 do 15,44)]
English: 5-FU bolus should be reduced and the infusion dose reduced by 20 %.
Croatian: Treba smanjiti dozu bolusne injekcije i infuzije 5-FU za 20%.
English: In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Croatian: U pivotalnom ispitivanju bolesnika s MKRK-om prijavljene su teške reakcije preosjetljivosti u bolesnika liječenih protokolom ZALTRAP/FOLFIRI (vidjeti dio 4.8).
English: Clinical data suggest that no change in aflibercept dose is required in patients with mild to moderate hepatic impairment.
Croatian: Klinički podaci pokazuju da nije potrebna prilagodba doze aflibercepta u bolesnika s blagim do umjerenim oštećenjem jetrene funkcije.
English: 11.7 (9.96 to 13.77) 12.5 (10.78 to 15.47)
Croatian: 11,7 (9,96 do 13,77) 12,5 (10,78 do 15,47)
English: The hazard ratio (95 % CI) of progression free survival was 0.76 (0.63 to 0.91) for ECOG performance status 0 and 0.75 (0.61 to 0.92) for ECOG performance status 1.
Croatian: Omjer hazarda (95% CI) preživljenja bez progresije bolesti iznosio je 0,76 (0,63 do 0,91) za ECOG status 0 i 0,75 (0,61 do 0,92) za ECOG status 1.
English: Due to hyperosmolality (1000 mOsmol / kg) of the ZALTRAP concentrate, undiluted ZALTRAP concentrate must not be administered as an intravenous push or bolus.
Croatian: Zbog hiperosmolalnosti (1000 mOsmol/kg) ZALTRAP koncentrata, nerazrijeđeni ZALTRAP koncentrat ne smije se primijeniti brzom niti bolusnom intravenskom injekcijom.
English: In patients, ZALTRAP is administered at the dose of 4 mg/kg intravenously every two weeks for which there is an excess of circulating free aflibercept compared to VEGF-bound aflibercept.
Croatian: U bolesnika se ZALTRAP primjenjuje u intravenskoj dozi od 4 mg/kg svaka dva tjedna, pri čemu se u krvotoku postižu koncentracije slobodnog aflibercepta veće od koncentracija aflibercepta vezanog za
English: 6.7 (5.75 to 8.21)
Croatian: 6,7 (5,75 do 8,21)
English: For contraindications related to FOLFIRI components (irinotecan, 5-FU, and folinic acid), refer to the current respective summary of product characteristics.
Croatian: Za kontraindikacije povezane s lijekovima protokola FOLFIRI (irinotekanom, 5-FU ili folnom kiselinom) vidjeti važeći Sažetak opisa svojstava lijeka za svaki od tih lijekova.
English: • Low white blood cell count (also called ‘neutropenia'): Very common (may affect more than 1 in 10 people) - this can cause serious infections.
Croatian: • Nizak broj bijelih krvnih stanica (poznato i kao ‘neutropenija'): Vrlo često (mogu se javiti u više od 1 na 10 osoba) - može izazvati teške infekcije.
English: 6.7 (5.72 to 8.21)
Croatian: 6,7 (5,72 do 8,21)
English: Proteinuria should be monitored by urine dipstick analysis and/or urinary protein creatinine ratio (UPCR) for the development or worsening of proteinuria before each aflibercept administration.
Croatian: Proteinuriju treba kontrolirati tako da se prije svake primjene aflibercepta provjeri mogući razvoj ili pogoršanje proteinurije analizom urina pomoću test trakica i/ili određivanjem omjera proteina i kreatinina u mokraći.
English: Other signs may include swelling in one or both legs, pain or tenderness in one or both legs, discolouration and warmth of the skin on the affected leg or visible veins.
Croatian: Drugi znakovi mogu uključivati oticanje jedne ili obje noge, bol ili osjetljivost na dodir u jednoj ili obje noge, promjenu boje i toplinu kože na zahvaćenoj nozi ili vidljive vene.
English: Monitoring of complete blood count (CBC) with differential count is recommended at baseline and prior to initiation of each cycle of aflibercept.
Croatian: Preporučuje se kontrola kompletne krvne slike (KKS) i diferencijalne krvne slike na početku liječenja i prije početka svakog ciklusa aflibercepta.
English: Aflibercept administration should be suspended for ≥ 2 grams of proteinuria/24 hours and restarted when proteinuria is <2 grams/24 hours.
Croatian: Primjenu aflibercepta treba prekinuti kada je proteinurija u 24 sata ≥ 2 grama i ponovno uvesti kada proteinurija u 24 sata bude < 2 grama.
English: Arterial thromboembolic events (ATE)
Croatian: Arterijski tromboembolijski događaji (ATE)
English: Adverse reactions and laboratory abnormalities reported in patients treated with the ZALTRAP/FOLFIRI regimen compared to patients treated with the placebo/FOLFIRI regimen are listed in Table 1 according to MedDRA system organ class and frequency categories.
Croatian: ZALTRAP/FOLFIRI u usporedbi s bolesnicima koji su primali protokol placebo/FOLFIRI navedeni su u Tablici 1 prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
English: Compromised wound healing Aflibercept impaired wound healing in animal models (see section 5.3).
Croatian: Otežano zacjeljivanje rana Aflibercept je u životinjskim modelima otežao zacjeljivanje rana (vidjeti dio 5.3).
English: In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase, and hyperbilirubinaemia occurred in ≥ 20 % of patients.
Croatian: U pivotalnom ispitivanju MKRK-a u ≥ 20% bolesnika pojavili su se anemija, mučnina, povraćanje, konstipacija, alopecija, povišene vrijednosti alkalne fosfataze i hiperbilirubinemija.
English: Aflibercept should not be administered to patients with severe haemorrhage (see section 4.2).
Croatian: Aflibercept se ne smije primjenjivati u bolesnika s teškim krvarenjem (vidjeti dio 4.2).
English: A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Zaltrap.
Croatian: Prije početka liječenja lijekom Zaltrap treba razmotriti provođenje stomatološkog pregleda i primjerenih preventivnih stomatoloških mjera.
English: 12.4 (11.17 to 13.54) 13.9 (12.72 to 15.64)
Croatian: 12,4 (11,17 do 13,54) 13,9 (12,72 do 15,64)
English: Positive results in the neutralising antibody assay in the MCRC pivotal study were also higher in patients treated with the placebo/FOLFIRI regimen [2/526 (0.38 % )] than with the ZALTRAP/FOLFIRI regimen [1/521 (0.19 %)].
Croatian: MKRK-om pozitivni nalazi testa na neutralizirajuća protutijela također su primijećeni u većem broju u bolesnika koji su primali protokol placebo/FOLFIRI [2/526 (0,38%)] nego u onih liječenih protokolom ZALTRAP/FOLFIRI [1/521 (0,19%)].