FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the recommended dose regimen (6 mg/kg given once every 2 weeks as a 1-hour infusion), panitumumab concentrations reached steady-state levels by the third infusion with mean (± Standard Deviation [SD]) peak and trough concentrations of 213 ± 59 and 39 ± 14 mcg/mL, respectively.
Croatian: Prateći preporučene dozne protokole (6 mg/kg jednom svaka 2 tjedna kao 1-satna infuzija), koncentracije panitumumaba dosezale su stanje dinamičke ravnoteže nakon treće infuzije, sa srednjom vrijednošću (± standardna devijacija [SD]) vršne i najniže koncentracije 213 ± 59, odnosno 39 ± 14 mcg/ml.
English: Skin rash most commonly occurred on the face, upper chest, and back, but could extend to the extremities.
Croatian: Kožni osip najčešće se pojavljuje na licu, gornjem dijelu prsišta i leđima, no može se proširiti i na ekstremitete.
English: CI = confidence interval a In patients that crossed over to panitumumab after progression on BSC alone (95% CI)
Croatian: CI = interval pouzdanosti a Kod bolesnika koji su prešli na panitumumab nakon progresije bolesti uz samo NPT (95% CI)
English: Therefore administration of Vectibix in combination with IFL should be avoided (see section 4.5).
Croatian: Stoga se primjena lijeka Vectibix u kombinaciji s IFL protokolom mora izbjegavati (vidjeti dio 4.5).
English: It is recommended that you limit sun exposure whilst receiving Vectibix and if you are experiencing skin reactions as sunlight can worsen these.
Croatian: Preporučuje se da ograničite svoju izloženost suncu tijekom liječenja lijekom Vectibix, osobito ako ste razvili neku od kožnih reakcija, jer ih sunčeve zrake mogu pogoršati.
English: Your doctor may decide to reduce the rate of your infusion or discontinue your treatment with Vectibix.
Croatian: Liječnik može odlučiti smanjiti brzinu infuzije ili prekinuti Vaše liječenje lijekom Vectibix.
English: Patients receiving Vectibix in combination with the IFL regimen [bolus 5-fluorouracil (500 mg/m2), leucovorin (20 mg/m2) and irinotecan (125 mg/m2)] experienced a high incidence of severe diarrhoea (see section 4.8).
Croatian: Bolesnici koji primaju Vectibix u kombinaciji s IFL protokolom [bolus 5-fluorouracila (500 mg/m2), leukovorin (20 mg/m2) i irinotekan (125 mg/m2)] imaju visoku učestalost jakih proljeva (vidjeti dio 4.8).
English: There are no adequate data from the use of Vectibix in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni lijeka Vectibix u trudnica.
English: Do not shake or vigorously agitate the vial.
Croatian: Bočicu nemojte tresti niti snažno mućkati.
English: The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or intravenous solutions.
Croatian: Infuzijska linija mora se isprati otopinom natrijevog klorida prije i nakon primjene lijeka Vectibix kako bi se izbjeglo miješanje s drugim lijekovima ili intravenskim otopinama.
English: In the post-marketing setting, serious cases of keratitis and ulcerative keratitis have been rarely reported (see section 4.4).
Croatian: U razdoblju nakon stavljanja lijeka u promet, ozbiljni slučajevi keratitisa i ulceroznog keratitisa rijetko su prijavljivani (vidjeti dio 4.4).
English: Other toxicities that were observed with a greater frequency relative to monotherapy included hypomagnesaemia, diarrhoea, and stomatitis.
Croatian: Ostale toksičnosti koje su primijećene s većom učestalošću u odnosu na monoterapiju uključivale su hipomagnezijemiju, proljev i stomatitis.
English: • in combination with oxaliplatin-based chemotherapy, if your RAS test shows that you have mutant RAS tumour, or if your RAS tumour status is unknown.
Croatian: • u kombinaciji s kemoterapijom temeljenoj na oksaliplatinu, ako Vaš RAS test pokazuje da imate tumor s mutiranim RAS, ili je Vaš RAS status tumora nepoznat.
English: Pulmonary embolism Epistaxis
Croatian: Plućna embolija Epistaksa
English: Discard the vial and any liquid remaining in the vial after the single-use.
Croatian: Bacite bočicu i svu preostalu tekućinu u bočici nakon jednokratne primjene.
English: Therefore, Vectibix has the potential to cause foetal harm when administered to pregnant women.
Croatian: Stoga, Vectibix može uzrokovati oštećenje ploda kada se primjenjuje kod trudnica.
English: No anti-tumour effects of panitumumab were observed in human tumour xenografts lacking EGFR expression.
Croatian: Antitumorski učinci panitumumaba nisu primijećeni u ljudi u ksenograftima tumora koji nisu eksprimirali EGFR.
English: Panitumumab binds to the ligand binding domain of EGFR and inhibits receptor autophosphorylation induced by all known EGFR ligands.
Croatian: Panitumumab se veže na EGFR domenu za vezanje liganda i inhibira autofosforilaciju receptora koju potiču svi poznati ligandi EGFR-a.
English: An additional analysis of efficacy data by KRAS (exon 2) status did not identify a subset of patients who benefited from panitumumab in combination with oxaliplatin- or irinotecan based chemotherapy and bevacizumab.
Croatian: Dodatna analiza podataka djelotvornosti prema statusu KRAS gena (egzon 2) nije identificirala podskupinu bolesnika koji bi imali korist u primjeni panitumumaba u kombinaciji s kemoterapijom temeljenoj na oksaliplatinu ili irinotekanu s bevacizumabom.
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Croatian: Bolesnici sa znacima i simptomima koji upućuju na keratitis, kao što su akutna ili pogoršavajuća: upala oka, lakrimacija, osjetljivost na svjetlo, zamagljen vid, bol u oku i/ili crveno oko, moraju se odmah uputiti specijalistu oftalmologu.
English: Skin rash and diarrhoea were the major findings observed in repeat-dose toxicity studies of up to 26 weeks duration in cynomolgus monkeys.
Croatian: Kožni osip i proljev bili su značajni nalazi u ispitivanjima toksičnosti ponavljanih doza u trajanju do 26 tjedana u cynomolgus majmuna.
English: Mutant RAS (n = 74)
Croatian: Mutirani tip RAS (n = 74)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg panitumumab.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 20 mg panitumumaba.
English: Prior to infusion, Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection to a final concentration not to exceed 10 mg/mL (for preparation instructions see section 6.6).
Croatian: Prije infuzije Vectibix mora biti razrijeđen 0,9%-tnom otopinom natrijeva klorida za injekciju (9 mg/ml) do konačne koncentracije koja ne smije prelaziti 10 mg/ml (za upute za pripremu, vidjeti dio 6.6).
English: Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies.
Croatian: Vectibix sadrži djelatnu tvar panitumumab koja pripada skupini lijekova koji se nazivaju monoklonska protutijela.
English: Anaphylactic reaction2
Croatian: Anafilaktička reakcija2
English: Patients with a history of, or evidence of, interstitial pneumonitis or pulmonary fibrosis were excluded from clinical studies.
Croatian: Bolesnici s anamnestičkim podacima ili dokazanim intersticijskim pneumonitisom ili plućnom fibrozom nisu uključivani u klinička ispitivanja.
English: In patients with a history of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with panitumumab versus the risk of pulmonary complications must be carefully considered.
Croatian: Kod bolesnika s anamnestičkim podacima o intersticijskom pneumonitisu ili plućnoj fibrozi, mora se razmotriti korist terapije s panitumumabom nasuprot riziku od plućnih komplikacija.
English: In patients experiencing a mild or moderate (CTCAE v 4.0 grades 1 and 2) infusion-related reaction the infusion rate should be reduced for the duration of that infusion.
Croatian: Kod bolesnika koji iskuse blagu ili umjerenu (CTCAE v 4.0 stupnjevi 1 i 2) reakciju povezanu s infuzijom, brzina infuzije mora biti smanjena tijekom trajanja te infuzije.
English: Additional mutations in KRAS and NRAS at exon 3 (codon 59) were subsequently identified (n = 7).
Croatian: Kasnije su identificirane dodatne mutacije (n = 7) na egzonima 3 KRAS i NRAS (kodon 59).
English: Monitoring as above and repletion as appropriate of these electrolytes is also recommended.
Croatian: Preporučuju se kontrole kako je gore navedeno i nadoknada tih elektrolita u slučaju potrebe.
English: 4 Ulcerative keratitis, skin necrosis, Stevens-Johnson syndrome and toxic epidermal necrolysis are panitumumab ADRs that were reported in the post-marketing setting.
Croatian: 4 Ulcerozni keratitis, nekroza kože, Stevens-Johnsonov sindrom i toksična epidermalna nekroliza su nuspojave panitumumaba koje su bile prijavljivane nakon stavljanja lijeka u promet.
English: • blue colouration of the skin and mucous membranes (cyanosis);
Croatian: • plava obojenost kože i sluznice (cijanoza);
English: Panitumumab may impact the ability of a woman to become pregnant.
Croatian: Panitumumab bi mogao utjecati na mogućnost da žena zatrudni.
English: For patients whose sera tested positive in either screening immunoassay, an in vitro biological assay was performed to detect neutralising antibodies.
Croatian: Kod bolesnika čiji su se serumi pokazali pozitivnima u bilo kojim od navedenih imunotestova probira, bio je proveden biološki test in vitro za detekciju neutralizirajućih protutijela.
English: Using only a 21-gauge or smaller diameter hypodermic needle, withdraw the necessary amount of Vectibix for a dose of 6 mg/kg.
Croatian: Koristeći samo hipodermalnu iglu od 21 G ili manjeg promjera, izvucite potrebnu količinu lijeka Vectibix za dozu od 6 mg/kg.
English: Binding of panitumumab to EGFR results in internalisation of the receptor, inhibition of cell growth, induction of apoptosis, and decreased interleukin 8 and vascular endothelial growth factor production.
Croatian: Vezivanje panitumumaba na EGFR rezultira internalizacijom receptora, inhibicijom rasta stanica, poticanjem apopotoze i smanjenom produkcijom interleukina 8 i vaskularnog endotelnog čimbenika rasta (VEGF).
English: Vectibix in combination with irinotecan, bolus 5-fluorouracil, and leucovorin (IFL) chemotherapy
Croatian: Vectibix u kombinaciji s kemoterapijom koja sadrži irinotekan, bolus 5-fluorouracila i leukovorin (IFL)
English: The hazard ratio for overall survival was 1.43 (95% CI: 1.11, 1.83).
Croatian: Omjer hazarda za ukupno preživljenje iznosio je 1,43 (95% CI: 1,11; 1,83).
English: Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).
Croatian: Vectibix se primjenjuje intravenski (u venu) pomoću infuzijske pumpe (aparat koji lijek daje kao sporu injekciju).
English: Vectibix is used alone or in combination with other anti-cancer medicines.
Croatian: Vectibix se primjenjuje sam ili u kombinaciji s drugim protutumorskim lijekovima.
English: Initial occurrence Withhold 1 or 2 doses
Croatian: Kod treće pojave Izostaviti 1 ili 2 doze
English: x1 vial
Croatian: x1 bočica
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/423/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/423/001
English: PHARMACEUTICAL FORM AND CONTENTS 5 mL of concentrate for solution for infusion.
Croatian: OBLIK I SADRŽAJ 5 ml koncentrata za otopinu za infuziju.
English: A multinational, randomised, controlled trial was conducted in 463 patients with EGFR-expressing metastatic carcinoma of the colon or rectum after confirmed failure of oxaliplatin and irinotecancontaining regimens.
Croatian: Višenacionalno, randomizirano, kontrolirano ispitivanje provedeno je kod 463 bolesnika s metastatskim karcinomom kolona ili rektuma s eksprimiranim EGFR nakon potvrđenog neuspjeha liječenja protokolima koji su sadržavali oksaliplatin ili irinotekan.
English: • eye inflammation (conjunctivitis);
Croatian: • upala oka (konjunktivitis);
English: Rash pustular Cellulitis1
Croatian: Pustularni osip Celulitis1
English: Wild-type RAS population PFS
Croatian: Populacija s divljim tipom RAS PFS
English: There have been reports of acute renal failure in patients who develop diarrhoea and dehydration (see section 4.4).
Croatian: Prijavljeni su slučajevi akutnog zatajenja bubrega kod bolesnika koji su razvili proljev i dehidraciju (vidjeti dio 4.4).
English: Median overall survival was 19.4 (95% CI: 18.4, 20.8) and 24.5 (95% CI: 20.4, 24.5) in the panitumumab arm and the non-panitumumab arm.
Croatian: Medijan ukupnog preživljenja u skupini s panitumumabom iznosio je 19,4 (95% CI: 18,4; 20,8) te 24,5 (95% CI: 20,4; 24,5) u skupini bez panitumumaba.
English: Panitumumab has been shown to cause foetal abortions and/or foetal deaths in cynomolgus monkeys when administered during the period of organogenesis at doses approximately equivalent to the recommended human dose.
Croatian: Primijećeno je da panitumumab izaziva fetalni pobačaj i/ili fetalnu smrt u cynomolgus majmuna kad je lijek primjenjivan u razdoblju organogeneze te u dozama koje odgovaraju preporučenim dozama u ljudi.
English: Patients who experience severe diarrhoea should be instructed to consult a healthcare professional urgently.
Croatian: Bolesnicima koji dobiju teški oblik proljeva potrebno je savjetovati da se hitno obrate zdravstvenom radniku.
English: Other key endpoints included the PFS, time to response, TTP, and duration of response.
Croatian: Drugi ključni ishodi ispitivanja uključivali su PFS, vrijeme do odgovora, TTP te trajanje odgovora.
English: Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR.
Croatian: Panitumumab je rekombinantno, u potpunosti ljudsko monoklonsko protutijelo IgG2, koje se veže visokim afinitetom i specifičnošću za ljudski EGFR.
English: Treatment and management of dermatologic reactions should be based on severity and may include a moisturiser, sun screen (SPF > 15 UVA and UVB), and topical steroid cream (not stronger than 1% hydrocortisone) applied to affected areas, and/or oral antibiotics (e.g. doxycycline).
Croatian: Liječenje i zbrinjavanje kožnih reakcija mora se temeljiti na težini reakcije i može uključivati sredstvo za ovlaživanje kože, sredstvo za zaštitu od sunca (SPF > 15 UVA i UVB) i topikalne steroidne kreme (ne jače od 1% hidrokortizona), koji se nanose na zahvaćeno područje i/ili oralne antibiotike (npr. doksiciklin).
English: It is unknown whether panitumumab is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se panitumumab u majčino mlijeko.
English: Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in combination with chemotherapy (n = 2,224), the most commonly reported adverse reactions are skin reactions occurring in approximately 94% of patients.
Croatian: Na temelju analize svih bolesnika u kliničkom ispitivanju s mKRK-om koji su primali Vectibix kao monoterapiju i u kombinaciji s kemoterapijom (n = 2224), najčešće prijavljene nuspojave su kožne reakcije koje se pojavljuju u otprilike 94% bolesnika.
English: Eye infection Eyelid infection
Croatian: Infekcija oka Infekcija očnog kapka
English: A greater frequency of pulmonary embolism, infections (predominantly of dermatologic origin), diarrhoea, electrolyte imbalances, nausea, vomiting and dehydration was also observed in the treatment arms using Vectibix in combination with bevacizumab and chemotherapy.
Croatian: Veća učestalost plućne embolije, infekcija (pretežno dermatološkog porijekla), proljeva, poremećaja elektrolita, mučnine, povraćanja i dehidracije također je primijećena u skupini bolesnika koji su primali lijek Vectibix u kombinaciji s bevacizumabom i kemoterapijom.
English: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands
Croatian: Minervum 7061, 4817 ZK Breda, Nizozemska
English: Vectibix must be administered using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter.
Croatian: Vectibix se mora primijeniti upotrebljavajući 0,2 ili 0,22 mikrometarski in-line filter s niskim afinitetom vezanja proteina, perifernom linijom ili putem postavljenog katetera.
English: Shortened progression-free survival time and increased deaths were observed in the patients receiving Vectibix in combination with bevacizumab and chemotherapy.
Croatian: Skraćeno vrijeme preživljenja bez progresije bolesti i povećana smrtnost primijećeni su kod bolesnika koji su primali Vectibix u kombinaciji s bevacizumabom i kemoterapijom.
English: The efficacy of Vectibix was also evaluated in an open-label trial in patients with wild-type KRAS (exon 2) mCRC.
Croatian: Djelotvornost lijeka Vectibix je također procijenjena u otvorenom ispitivanju u bolesnika s mKRK-om s divljim tipom gena KRAS (egzon 2).
English: Vectibix should not be used in combination with bevacizumab (another monoclonal antibody used in cancer of the bowel) or with a chemotherapy combination known as “IFL”.
Croatian: Vectibix se ne smije primjenjivati u kombinaciji s bevacizumabom (drugo monoklonsko protutijelo koje se primjenjuje kod raka debelog crijeva) ili s kombinacijskom kemoterapijom poznatom kao „IFL“.
English: Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), water for injections.
Croatian: Natrijev klorid, natrijev acetat trihidrat, acetatna kiselina (ledena), voda za injekcije.
English: Your doctor may ask you to use a moisturiser, sun screen (SPF > 15), topical steroid, and/or oral antibiotics which may help in the management of skin toxicities that can be associated with the use of Vectibix.
Croatian: Vaš liječnik Vam može preporučiti upotrebu sredstava za ovlaživanje kože, zaštitu od sunca (SPF > 15), lijekove sa steroidima koji se primjenjuju izvana i/ili oralni antibiotik (primjenjuju se kroz usta), koji mogu biti od pomoći u liječenju kožnih toksičnosti moguće povezanih s upotrebom lijeka Vectibix.
English: The most serious side effects and main side effects for Vectibix are listed below:
Croatian: Niže su navedene najozbiljnije nuspojave i glavne nuspojave lijeka Vectibix:
English: Patients with ECOG 2 performance status treated with Vectibix in combination with chemotherapy
Croatian: Bolesnici s funkcionalnim statusom ECOG 2 liječeni lijekom Vectibix u kombinaciji s kemoterapijom
English: A high incidence of severe diarrhoea was observed when panitumumab was administered in combination with IFL (see section 4.4), and increased toxicity and deaths were seen when panitumumab was combined with bevacizumab and chemotherapy (see sections 4.4 and 5.1).
Croatian: Visoka incidencija teških proljeva bila je primijećena pri primjeni panitumumaba u kombinaciji s kemoterapijom IFL-om (vidjeti dio 4.4), a povećana toksičnost i smrtnost primijećeni su kad je panitumumab bio kombiniran s bevacizumabom i kemoterapijom (vidjeti dijelove 4.4 i 5.1).
English: Also, dry skin, fissures (cracks in the skin) on the fingers or toes, fingernail bed or toenail bed infection (paronychia) or inflammation has been reported.
Croatian: Također su zabilježene suha koža, fisure (pukotine na koži) na prstima ruku i nogu, infekcije ležišta noktiju na rukama i nogama (paronihija) ili upala.
English: Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 94%) treated with Vectibix.
Croatian: Dermatološke reakcije vezane uz farmakološki učinak koji je uočen pri liječenju inhibitorima receptora epidermalnog čimbenika rasta (EGFR) primijećene su kod gotovo svih bolesnika (približno 94%) liječenih lijekom Vectibix.
English: Acute renal failure has been observed in patients who develop severe diarrhoea and dehydration.
Croatian: Akutno zatajenje bubrega primijećeno je kod bolesnika koji razviju teški proljev i dehidraciju.
English: Serious cases of keratitis and ulcerative keratitis have been rarely reported in the post-marketing setting.
Croatian: Ozbiljni slučajevi keratitisa i ulceroznog keratitisa prijavljeni su u rijetkim slučajevima u razdoblju nakon stavljanja lijeka u promet.
English: • Each mL of concentrate contains 20 mg panitumumab.
Croatian: • Jedan ml koncentrata sadrži 20 mg panitumumaba.
English: A predefined retrospective subset analysis of 641 patients of the 656 patients with wild-type KRAS (exon 2) mCRC was performed.
Croatian: Provedena je unaprijed definirana retrospektivna analiza podskupine od 641 bolesnika od ukupno 656 bolesnika s mKRK-om s divljim tipom KRAS gena (egzon 2).
English: In a randomised, open-label, controlled clinical trial, chemotherapy (oxaliplatin or irinotecan) and bevacizumab were given with and without panitumumab in the first-line treatment of patients with metastatic colorectal cancer (n = 1,053 [n = 823 oxaliplatin cohort, n = 230 irinotecan cohort]).
Croatian: U randomiziranom, otvorenom, kontroliranom kliničkom ispitivanju, kemoterapija (oksaliplatin ili irinotekan) i bevacizumab bili su primijenjeni sa i bez panitumumaba u prvoj liniji liječenja bolesnika s metastatskim kolorektalnim karcinomom (n = 1053 [n = 823 u skupini s oksaliplatinom, n = 230 u skupini s irinotekanom]).
English: 1.07 (0.77,1.48), p = 0.6880
Croatian: 0,49 (0,37; 0,65), p<0,0001 1,07 (0,77; 1,48), p = 0,6880
English: BRAF mutations were not predictive of the outcome for panitumumab treatment in combination with FOLFOX or FOLFIRI.
Croatian: Mutacije BRAF nisu bile pokazatelj ishoda liječenja panitumumabom u kombinaciji s FOLFOX-om, ili FOLFIRI-jem.
English: Vectibix should not be administered in combination with bevacizumab containing chemotherapy (see sections 4.5 and 5.1).
Croatian: Vectibix se ne smije primjenjivati u kombinaciji s kemoterapijskim protokolom koji sadrži bevacizumab (vidjeti dio 4.5 i 5.1).
English: Patients with additional RAS mutations beyond KRAS exon 2 were unlikely to benefit from the addition of panitumumab to FOLFIRI and a detrimental effect was seen with the addition of panitumumab to FOLFOX in these patients.
Croatian: Nije bilo vjerojatno da bi bolesnici s dodatnim mutacijama gena RAS, izvan egzona 2 gena KRAS, imali koristi od dodavanja panitumumaba FOLFIRI-ju, te je u takvih bolesnika primijećen štetan učinak prilikom dodavanja panitumumaba FOLFOX-u.
English: In the post-marketing setting, rare cases of skin necrosis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.4) have been reported.
Croatian: U razdoblju nakon stavljanja lijeka u promet, prijavljeni su rijetki slučajevi nekroze kože, Stevens-Johnsonovog sindroma i toksične epidermalne nekrolize (vidjeti dio 4.4).
English: For clinical management of infusion-related reactions, see section 4.4.
Croatian: Za kliničko liječenje reakcija povezanih s infuzijom, vidjeti dio 4.4.
English: In the post-marketing setting, serious infusion-related reactions have been reported, including rare post-marketing reports with a fatal outcome.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljene su ozbiljne reakcije povezane s infuzijom, uključujući rijetka izvješća sa smrtnim ishodom.
English: Patients were randomised 1:1 to receive Vectibix at a dose of 6 mg/kg given once every two weeks plus best supportive care (not including chemotherapy) (BSC) or BSC alone.
Croatian: Bolesnici su randomizirani u omjeru 1 : 1 na one koji primaju Vectibix u dozi od 6 mg/kg jednom svaka dva tjedna uz najbolju potpornu terapiju (ne uključujući kemoterapiju) (NPT) i na one kojima je pružena samo najbolja potporna terapija.
English: • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
Croatian: • u drugoj liniji liječenja u kombinaciji s kemoterapijskim protokolom FOLFIRI kod bolesnika koji su u prvoj liniji liječenja primili kemoterapiju temeljenu na fluoropirimidinima (isključujući irinotekan).
English: No clinical studies have been conducted to examine the pharmacokinetics of panitumumab in patients with renal or hepatic impairment.
Croatian: Nisu provedena klinička ispitivanja kako bi se ispitala farmakokinetika panitumumaba kod bolesnika s oštećenjem funkcije bubrega ili jetre.