FrancophonIA/ELRC3.0 huggingface dataset:
English: It may also present itself as a sudden numb or weak feeling in the face, arms, or legs.
Croatian: Također se može pojaviti kao iznenadan osjećaj utrnulosti ili slabosti u licu, rukama ili nogama.
English: The pharmacokinetic properties described below have to a large extent been derived from a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies.
Croatian: Farmakokinetička svojstva opisana u nastavku u velikoj su mjeri izvedena iz populacijske farmakokinetičke analize podataka prikupljenih u 1507 bolesnika s različitim vrstama uznapredovalih zloćudnih tumora.
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with ZALTRAP or after stopping treatment.
Croatian: Recite odmah Vašem liječniku ili stomatologu ako iskusite te simptome tijekom ili nakon prestanka liječenja lijekom ZALTRAP.
English: If the bleeding is severe, your doctor will stop your treatment with ZALTRAP.
Croatian: Ako je krvarenje teško, liječnik će prekinuti liječenje lijekom ZALTRAP.
English: Thrombotic and embolic events
Croatian: Trombotički i embolijski događaji
English: sanofi-aventis groupe 54, rue La Boétie 75008 Paris France
Croatian: sanofi-aventis groupe 54, rue La Boétie 75008 Paris Francuska
English: Caution should be used when retreating patients with prior hypersensitivity reactions as recurrent hypersensitivity reactions have been observed in some patients despite prophylaxis, including corticosteroids.
Croatian: Potreban je oprez kod ponovnog liječenja bolesnika u kojih su se prethodno javljale reakcije preosjetljivosti jer je u nekih bolesnika opažena ponovna pojava reakcija preosjetljivosti unatoč provedenoj profilaksi, uključujući i primjenu kortikosteroida.
English: If you also have previously received or are receiving intravenous bisphosphonates dental treatment or dental surgery, (e.g. tooth extractions), should be avoided.
Croatian: Ako ste ranije primali ili sad primate intravenske bisfosfonate, trebate izbjegavati stomatološko liječenje ili stomatološku operaciju (npr. vađenje zuba).
English: Dose modification of FOLFIRI regimen (see section 4.2), anti-diarrhoeal medicinal products, and rehydration as needed should be instituted.
Croatian: Prema potrebi treba prilagoditi doze protokola FOLFIRI (vidjeti dio 4.2) i uvesti liječenje antidijaroicima te rehidraciju.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal treba zbrinuti sukladno lokalnim propisima.
English: 4.67 (4.21 to 5.36)
Croatian: 4,67 (4,21 do 5,36)
English: Aflibercept has been shown to be embryotoxic and teratogenic when administered intravenously to pregnant rabbits every 3 days during the organogenesis period (gestation days 6 to18) at doses approximately 1 to 15 times the human dose of 4 mg/kg every 2 weeks.
Croatian: Reproduktivna i razvojna toksičnost Pokazalo se da aflibercept ima embriotoksična i teratogena svojstva kada se primjenjuje intravenski u skotnih ženki kunića svaka 3 dana tijekom razdoblja organogeneze (od 6. do 18. dana gestacije) pri dozama od približno 1 do 15 puta većima od doze od 4 mg/kg svaka 2 tjedna primijenjene u ljudi.
English: Shelf-life after dilution in the infusion bag
Croatian: Rok valjanosti nakon razrjeđivanja u infuzijskoj vrećici
English: How ZALTRAP is given
Croatian: Kako se primjenjuje ZALTRAP
English: ZALTRAP is a sterile, preservative-free and non-pyrogenic concentrate, therefore the solution for infusion should be prepared by a healthcare professional using safe-handling procedures and aseptic technique.
Croatian: ZALTRAP je sterilni nepirogeni koncentrat koji ne sadrži konzervanse, pa otopinu za infuziju mora pripremiti zdravstveni radnik uz korištenje postupaka za sigurno rukovanje i aseptičke tehnike.
English: 75 x 10
Croatian: ≥ 75 godina.
English: • polyethylene lined PVC
Croatian: • polietilenom obloženog PVC-a
English: • Diarrhoea and dehydration: Very common (may affect more than 1 in 10 people) for diarrhoea and Common (may affect up to 1 in 10 people) for dehydration - severe diarrhoea and being sick (vomiting) can cause you to lose too much body fluid (called ‘dehydration') and body salts (electrolytes).
Croatian: • Proljev i dehidracija: Vrlo često (mogu se javiti u više od 1 na 10 osoba) za proljev i Često (mogu se javiti u manje od 1 na 10 osoba) za dehidraciju - težak proljev i povraćanje mogu izazvati prekomjeran gubitak tekućine (što se zove ‘dehidracija') i soli (elektrolita) iz tijela.
English: • painful sores in the mouth
Croatian: • bolne ranice u ustima
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given ZALTRAP and during your treatment if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite ZALTRAP i za vrijeme liječenja:
English: The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Croatian: Aneurizme i disekcije arterije Primjena inhibitora VEGF puta u bolesnika s hipertenzijom ili bez nje može potaknuti stvaranje aneurizama i/ili disekcija arterije.
English: No specific studies with aflibercept have been conducted in animals to evaluate the effect on fertility.
Croatian: Poremećaj plodnosti Nisu provedena posebna istraživanja na životinjama kojima bi se ocijenio učinak aflibercepta na plodnost.
English: Most aflibercept-induced effects were reversible after a 5-month drug free period with the exception of skeletal and nasal cavity findings.
Croatian: Većina učinaka izazvanih afliberceptom povukla se nakon razdoblja od 5 mjeseci bez primjene lijeka, osim nalaza na kostima i u nosnoj šupljini.
English: Danmark Sanofi A/S Tlf: +45 45 16 70 00
Croatian: Sanofi- A/S Tlf: +45 45 16 70 00
English: In the event of a mild to moderate hypersensitivity reaction to ZALTRAP (including flushing, rash, urticaria, and pruritus), aflibercept should be temporarily suspended until the reaction is resolved.
Croatian: U slučaju blage do umjerene reakcije preosjetljivosti na ZALTRAP (uključujući crvenilo praćeno osjećajem vrućine, osip i pruritus) treba privremeno prekinuti primjenu aflibercepta dok se reakcija ne povuče.
English: There was no effect of age on the pharmacokinetics of free aflibercept.
Croatian: Dob nije utjecala na farmakokinetiku slobodnog aflibercepta.
English: 5.4 (4.53 to 5.68)
Croatian: 5,4 (4,53 do 5,68)
English: For these reasons, comparison of the incidence of antibodies to ZALTRAP with the incidence of antibodies to other products may be misleading.
Croatian: Iz tog razloga usporedba incidencije protutijela na ZALTRAP s incidencijom protutijela na druge lijekove može navesti na krivi trag.
English: 5.3 (4.50 to 5.55)
Croatian: 5,3 (4,50 do 5,55)
English: Aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system.
Croatian: Aflibercept se proizvodi rekombinantnom DNA tehnologijom na ekspresijskom sustavu stanica sisavaca K-1 iz jajnika kineskog hrčka (CHO).
English: Ophthalmic / intravitreal use due to hyperosmotic properties of ZALTRAP (see section 4.4).
Croatian: Oftalmološka/intravitrealna primjena, zbog hiperosmotskih svojstava lijeka ZALTRAP (vidjeti dio 4.4).
English: Neutropenic infection/sepsis (1)
Croatian: često neutropenijska infekcija/sepsa (1)
English: At the recommended dose regimen of 4 mg/kg every two weeks, concentration of free aflibercept were near steady-state levels by the second cycle of treatment with essentially no accumulation (accumulation ratio of 1.2 at steady-state compared to the first administration).
Croatian: Pri preporučenom režimu doziranja od 4 mg/kg svaka dva tjedna koncentracije slobodnog aflibercepta do drugoga su ciklusa dosegle razinu približnu koncentracijama u stanju dinamičke ravnoteže, pri čemu je nakupljanje bilo zanemarivo (omjer nakupljanja iznosio je 1,2 u stanju dinamičke ravnoteže u odnosu na prvu primjenu).
English: Patients with ECOG performance status ≥ 2 or having significant co-morbidities may be at greater risk for a poor clinical outcome and should be carefully monitored for early clinical deterioration.
Croatian: U bolesnika s ECOG statusom ≥ 2 ili značajnim popratnim bolestima može postojati povećan rizik od lošeg kliničkog ishoda, pa te bolesnike treba pažljivo motriti zbog moguće pojave ranih znakova kliničkog pogoršanja.
English: Further increases in the aflibercept dose resulted in dose-related increases in circulating free aflibercept concentrations but only small further increases in the VEGF-bound aflibercept concentration.
Croatian: Daljnja povećanja doze aflibercepta dovela su do s dozom povezanog povećanja koncentracije slobodnog aflibercepta u krvotoku, ali samo do malog dodatnog povećanja koncentracije aflibercepta vezanog za VEGF.
English: Patients treated with ZALTRAP have an increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events.
Croatian: U bolesnika liječenih lijekom ZALTRAP postoji povećan rizik od krvarenja, uključujući teške i ponekad smrtonosne događaje krvarenja.
English: • haemorrhoids, bleeding or pain in the back passage
Croatian: • hemoroidi, krvarenje ili bol u završnom dijelu debelog crijeva
English: In the event of a severe hypersensitivity reaction (including bronchospasm, dyspnoea, angioedema, and anaphylaxis), aflibercept should be discontinued and appropriate medical measures should be administered (see section 4.2).
Croatian: U slučaju teške reakcije preosjetljivosti (uključujući bronhospazam, dispneju, angioedem i anafilaksiju) treba obustaviti liječenje afliberceptom i primijeniti odgovarajuće mjere liječenja (vidjeti dio 4.2).
English: Increased AST (2) Increased ALT (2)
Croatian: često povišene vrijednosti AST-a (2) povišene vrijednosti ALT-a (2)
English: • drop in the number of certain cells in the blood that help it to clot (thrombocytopenia)
Croatian: • pad broja određenih stanica u krvi koje pomažu u zgrušavanju krvi (trombocitopenija)
English: / L (see section 4.2).
Croatian: (vidjeti dio 4.2).
English: The patient should remain under close medical supervision to monitor any adverse reactions (see section 4.8).
Croatian: Bolesnik mora ostati pod strogim liječničkim nadzorom kako bi se uočile moguće nuspojave (vidjeti dio 4.8).
English: The side effects listed below were seen when ZALTRAP was given together with chemotherapy.
Croatian: Nuspojave navedene u nastavku primijećene su kada se ZALTRAP primjenjivao zajedno s kemoterapijom.
English: • change of the voice, e.g. developing a hoarse voice
Croatian: • promjene glasa, npr. promuklost
English: Caution should be exercised when treating patients with history of clinically significant cardiovascular disease such as coronary artery disease, or congestive heart failure with ZALTRAP.
Croatian: Potreban je pojačani oprez kad se ZALTRAP primjenjuje u bolesnika s klinički značajnom kardiovaskularnom bolešću u anamnezi, poput bolesti koronarnih arterija ili kongestivnog zatajenja srca.
English: Treatment with anti-diarrhoeal medicinal products and rehydration can be used as needed.
Croatian: Po potrebi se mogu uvesti liječenje antidijaroicima i rehidracija.
English: Among those patients treated with the ZALTRAP/FOLFIRI regimen developing grade 3-4 hypertension, 54 % had onset during the first two cycles of treatment (see section 4.4).
Croatian: Među bolesnicima liječenima protokolom ZALTRAP/FOLFIRI u kojih se razvila hipertenzija stupnja 3-4, u njih 54% je ona nastupila tijekom prva dva ciklusa liječenja (vidjeti dio 4.4).
English: Proteinuria (see section 4.4)
Croatian: Proteinurija (vidjeti dio 4.4).
English: Signs may include chest pain, coughing, being short of breath, difficulty breathing or coughing up blood.
Croatian: Znakovi mogu uključivati bol u prsima, kašalj, nedostatak daha, otežano disanje ili iskašljavanje krvi.
English: Overall efficacy results for the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen are summarised in Figure 1 and Table 2.
Croatian: Ukupni rezultati djelotvornosti za protokol ZALTRAP/FOLFIRI u usporedbi s protokolom placebo/FOLFIRI sažeti su na Slici 1 i u Tablici 2.
English: In these patients, non-renal events were generally comparable between patients with renal impairment and those without renal impairment, except a > 10 % higher incidence in dehydration (all grades) was noted (see section 4.4).
Croatian: U tih su bolesnika događaji nevezani uz bubrege u načelu bili usporedivi između bolesnika s oštećenjem bubrežne funkcije i onih s normalnom bubrežnom funkcijom, izuzevši > 10% veću incidenciju dehidracije (svih stupnjeva) (vidjeti dio 4.4).
English: Intensity of the adverse reactions is graded according to NCI CTC version 3.0 (grade ≥ 3 = G ≥ 3).
Croatian: Nacionalnog instituta za rak (NCI CTC) (stupanj ≥ 3 = G ≥ 3).
English: Patients should be monitored for signs and symptoms of GI bleeding and other severe bleeding.
Croatian: Bolesnike treba motriti zbog moguće pojave znakova i simptoma gastrointestinalnog krvarenja ili drugog teškog krvarenja.
English: If severe diarrhoea recurs on a subsequent cycle, the 5-FU bolus and infusion dose should also be reduced by 20 %.
Croatian: Ako se u sljedećem ciklusu ponovno pojavi težak proljev, dozu bolusne injekcije i infuzije 5-FU također treba smanjiti za 20%.
English: A numerically lower treatment effect on OS with the ZALTRAP/FOLFIRI regimen was reported for patients with prior bevacizumab as compared to patients without prior bevacizumab exposure, with no evidence of heterogeneity in treatment effect (non significant interaction test).
Croatian: U bolesnika koji su prethodno liječeni bevacizumabom prijavljen je brojčano niži učinak liječenja protokolom ZALTRAP/FOLFIRI na OS nego u bolesnika koji prethodno nisu bili izloženi bevacizumabu, ali nisu pronađeni dokazi heterogenosti učinka liječenja (test interakcije nije značajan).
English: It will be given with other medicines called ‘chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Croatian: Primjenjuje se u kombinaciji s drugim lijekovima koji se nazivaju ‘kemoterapijom', uključujući ‘5-fluorouracil', ‘folnu kiselinu' i ‘irinotekan'.
English: Hypertension (see section 4.4)
Croatian: Hipertenzija (vidjeti dio 4.4).
English: • you have severe or long-lasting diarrhoea, feel sick (nausea) or are being sick (vomiting) - these could cause severe loss of body fluids (called ‘dehydration').
Croatian: • ako imate težak ili dugotrajan proljev, mučninu ili povraćanje - ove nuspojave mogu izazvati ozbiljan gubitak tekućine iz tijela (što se zove ‘dehidracija').
English: • you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Croatian: • ako imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile
English: In case of recurrent medically significant or severe hypertension, despite optimal treatment, ZALTRAP should be suspended until the hypertension is controlled and the dose reduced to 2 mg / kg for subsequent cycles.
Croatian: U slučaju povrata medicinski značajne ili teške hipertenzije, unatoč optimalnom liječenju, ZALTRAP treba privremeno prekinuti dok se hipertenzija ne stavi pod kontrolu, a dozu u sljedećim ciklusima smanjiti na 2 mg/kg.
English: • A side effect which affects your nervous system (called ‘posterior reversible encephalopathy syndrome' or PRES): Uncommon (may affect up to 1 in 100 people) - signs may include headache, sight changes, feeling confused or fits with or without high blood pressure.
Croatian: • Nuspojava koja zahvaća živčani sustav (poznata kao‘sindrom posteriorne reverzibilne encefalopatije' ili PRES): Manje često (mogu se javiti u manje od 1 na 100 osoba) - znakovi mogu uključivati glavobolju, promjene vida, osjećaj smetenosti ili napadaje, koji mogu ili ne moraju biti praćeni visokim krvnim tlakom.
English: In a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy, 63 patients with mild hepatic impairment (total bilirubin > 1.0 x - 1.5 x ULN and any AST) and 5 patients with moderate hepatic impairment (total bilirubin > 1.5 x - 3 x ULN and any AST) were treated with ZALTRAP.
Croatian: U populacijskoj farmakokinetičkoj analizi podataka prikupljenih u 1507 bolesnika s različitim vrstama uznapredovalih zloćudnih tumora koji su primali ZALTRAP u kombinaciji s kemoterapijom ili bez nje, 63 bolesnika s blagim oštećenjem jetrene funkcije (ukupni bilirubin > 1,0 x - 1,5 x GGN i bilo koja vrijednost AST-a) i 5 bolesnika s umjerenim oštećenjem jetrene funkcije (ukupni bilirubin > 1,5 x
English: Patients with Grade 3 DVT should be treated with anticoagulation as clinically indicated, and aflibercept therapy should be continued.
Croatian: Bolesnike s dubokom venskom trombozom stupnja 3 treba liječiti antikoagulantnom terapijom prema kliničkoj indikaciji te nastaviti liječenje afliberceptom.
English: Elderly patients ≥65 years had an increased risk of diarrhoea, dizziness, asthenia, weight loss and dehydration.
Croatian: U starijih osoba u dobi od ≥ 65 godina postoji povećan rizik od proljeva, omaglice, astenije, gubitka tjelesne težine i dehidracije.
English: In sexually mature female cynomolgus monkeys inhibition of ovarian function and follicular development was evidenced.
Croatian: U spolno zrelih ženki makaki majmuna pronađeni su dokazi inhibicije funkcije jajnika i razvoja folikula.
English: • you have illnesses where your gut is inflamed, such as an infected section of the bowel wall (also called ‘diverticulitis'), stomach ulcers or colitis.
Croatian: • ako imate bolest kod koje dolazi do upale crijeva, poput infekcije dijela crijevne stijenke (naziva se i ‘divertikulitis'), želučane vrijedove ili kolitis.
English: Diluted solutions of ZALTRAP should be administered using infusion sets containing a 0.2 micron polyethersulfone filter.
Croatian: Razrijeđena otopina lijeka ZALTRAP mora se primijeniti setovima za infuziju koji sadrže polietersulfonski filtar veličine 0,2 mikrona.
English: If this happens, do not drive or use any tools or machines.
Croatian: nemojte upravljati vozilima niti rukovati alatima i strojevima.
English: Circulating concentrations of VEGF-bound aflibercept increase with the aflibercept dose until most available VEGF is bound.
Croatian: Koncentracije aflibercepta vezanog za VEGF u krvotoku povećavaju se s dozom aflibercepta sve dok većina dostupnog VEGF-a nije vezana.
English: Patients received a median number of 9 cycles of the ZALTRAP/FOLFIRI regimen.
Croatian: Bolesnici su primili medijan od 9 ciklusa liječenja protokolom ZALTRAP/FOLFIRI.
English: • kidney problem with an increase in creatinine (a marker of kidney function)
Croatian: • tegobe s bubrezima uz povišene vrijednosti kreatinina (biljega bubrežne funkcije)
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na bočici iza oznake "Rok valjanosti".
English: A side effect called osteonecrosis (bone damage in the jaw) has been reported in cancer patients treated with ZALTRAP.
Croatian: Nuspojava koja se naziva osteonekroza (oštećenje kostiju čeljusti) prijavljena je u bolesnika s karcinomom koji su liječeni lijekom ZALTRAP.
English: Corresponding data in patients with RAS mutant type tumours showed a HR for OS of 0.9 (0.7-1.2) with median 12.6 and 11.2 months for aflibercept and placebo, respectively.
Croatian: Odgovarajući podaci u bolesnika s RAS mutiranim tipovima tumora pokazali su omjer hazarda za ukupno preživljenje od 0,9 (0,7-1,2) s medijanom od 12,6 mjeseci za aflibercept odnosno 11,2 mjeseca za placebo.
English: Patients should be monitored for signs and symptoms of GI perforation.
Croatian: Bolesnike treba motriti zbog moguće pojave znakova i simptoma gastrointestinalne perforacije.
English: Aflibercept administration resulted in a delay in wound healing in rabbits.
Croatian: Primjena aflibercepta uzrokovala je otežano zacjeljivanje rana u kunića.
English: Approximately 10 % of patients (10.4 % and 9.8 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively) received prior oxaliplatin-based adjuvant chemotherapy and progressed on or within 6 months of completion of adjuvant chemotherapy.
Croatian: Približno je 10% bolesnika (10,4% bolesnika koji su primali protokol placebo/FOLFIRI i 9,8% bolesnika liječenih protokolom ZALTRAP/FOLFIRI) prethodno primalo adjuvantnu kemoterapiju na bazi oksaliplatina, a bolest im je progredirala tijekom ili unutar 6 mjeseci nakon završetka adjuvantne kemoterapije.
English: (4) Not reported in MCRC study; however, PRES was reported in patients from other studies treated with aflibercept as monotherapy and in combination with chemotherapies other than FOLFIRI
Croatian: (3) Skup kliničkih i laboratorijskih podataka (4) Nije prijavljeno u ispitivanju MKRK-a; međutim, PRES je prijavljen u bolesnika iz drugih ispitivanja koji su liječeni afliberceptom u monoterapiji ili u kombinaciji s drugim kemoterapijama, osim protokola FOLFIRI
English: Weight had an effect on free aflibercept clearance and volume of distribution resulting with a 29 % increase in aflibercept exposure in patients weighing ≥ 100 kg.
Croatian: Tjelesna težina utjecala je na klirens i volumen distribucije slobodnog aflibercepta pa je u bolesnika tjelesne težine ≥ 100 kg izloženost afliberceptu bila 29% veća.
English: This is because ZALTRAP may increase the risk of developing holes in the gut wall.
Croatian: Naime, ZALTRAP može povećati rizik od nastanka pukotina u stijenci crijeva.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C and for 8 hours at 25°C.
Croatian: Dokazana je kemijska i fizikalna stabilnost razrijeđenog lijeka tijekom 24 sata na temperaturi od 2°C
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie 75008 Paris
Croatian: Nositelj odobrenja za stavljanje lijeka u promet sanofi-aventis groupe 54, rue La Boétie 75008 Paris Francuska
English: Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main Germany
Croatian: Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt na Majni
English: 200 mg / 8 ml 1 vial
Croatian: 200 mg/8 ml
English: • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
Croatian: • proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije)
English: Aneurysms and artery dissections
Croatian: nepoznato aneurizme i disekcije arterije
English: Your doctor may give you medicines to stop or treat diarrhoea and being sick (vomiting).
Croatian: Liječnik će Vam možda dati lijekove za zaustavljanje ili liječenje proljeva i povraćanja.
English: The FOLFIRI regimen to be used is 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-fluorouracil (5-FU) 400 mg / m² intravenous bolus, followed by 5-FU 2400 mg / m² continuous intravenous infusion over 46 hours.
Croatian: Protokol FOLFIRI koji se primjenjuje uključuje intravensku infuziju irinotekana u dozi od 180 mg/m2 tijekom 90 minuta i intravensku infuziju folne kiseline (dl racemična) u dozi od 400 mg/m² tijekom2 sata, koje se primjenjuju 1. dana istodobno kroz Y-liniju, nakon čega slijedi intravenska bolusna injekcija 5-fluorouracila (5-FU) u dozi od 400 mg/m², a nakon nje kontinuirana intravenska infuzija 5-FU u dozi od 2400 mg/m² tijekom 46 sati.
English: Treatment with corticosteroids and/or antihistamines can be initiated as clinically indicated.
Croatian: Može se započeti liječenje kortikosteroidima i/ili antihistaminicima ako je klinički indicirano.