FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Vectibix in first-line in combination with FOLFIRI was evaluated in a single-arm study of 154 patients with the primary endpoint of objective response rate (ORR).
Croatian: Djelotvornost lijeka Vectibix u prvoj liniji liječenja u kombinaciji s FOLFIRI-jem ocijenjena je u ispitivanju s jednom skupinom od 154 bolesnika u kojem je primarni ishod ispitivanja bila stopa objektivnog odgovora (ORR).
English: Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in < 1% of patients.
Croatian: Teške (NCI-CTC stupanj 3) kožne reakcije bile su zabilježene u 23%, a po život opasne (NCI-CTC stupanj 4) u < 1% bolesnika.
English: Upon disease progression BSC alone patients were eligible to crossover to a companion study and receive Vectibix at a dose of 6 mg/kg given once every two weeks.
Croatian: Bolesnici s progresijom bolesti koji su primali samo najbolju potpornu terapiju prešli su na liječenje u sklopu srodnog ispitivanja u kojem su primali Vectibix u dozi od 6 mg/kg jednom svaka dva tjedna.
English: 20 mL of concentrate for solution for infusion.
Croatian: 20 ml koncentrata za otopinu za infuziju.
English: Chapped lips Dry lips
Croatian: Raspucane usne Suhe usne
English: Skin necrosis4
Croatian: Nekroza kože4
English: Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection (see section 4.2).
Croatian: Doze veće od 1000 mg moraju se razrijediti u 150 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju (vidjeti dio 4.2).
English: Cetuximab (n = 500)
Croatian: Cetuksimab (n = 500)
English: Dermatological reactions (including nail effects), observed in patients treated with Vectibix or other EGFR inhibitors, are known to be associated with the pharmacologic effects of therapy.
Croatian: Poznato je da su dermatološke reakcije (uključujući učinke na noktima), uočene kod bolesnika liječenih lijekom Vectibix ili drugim inhibitorima EGFR, povezane s farmakološkim učincima terapije.
English: • low white blood numbers (leucopenia); low calcium levels in the blood (hypocalcaemia); low phosphates in the blood (hypophosphataemia); high glucose in the blood (hyperglycaemia);
Croatian: • snižen broj bijelih krvnih stanica (leukopenija); snižena razina kalcija u krvi (hipokalcijemija); snižena razina fosfata u krvi (hipofosfatemija); povišena razina glukoze u krvi (hiperglikemija);
English: For clinical management of dermatological reactions, including dose modification recommendations, see section 4.4.
Croatian: Za kliničko liječenje dermatoloških reakcija, uključujući preporuke za prilagodbu doze, vidjeti dio 4.4.
English: BSC (n = 100)
Croatian: NPT (n = 100)
English: Interstitial lung disease3
Croatian: Intersticijska bolest pluća3
English: Vectibix will be administered in a healthcare facility under the supervision of a doctor experienced in the use of anti-cancer medicines.
Croatian: Vectibix se primjenjuje u zdravstvenim ustanovama pod nadzorom liječnika koji ima iskustva u primjeni antitumorskih lijekova.
English: Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Doze veće od 1000 mg moraju se razrijediti u 150 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju.
English: • in first-line in combination with FOLFOX or FOLFIRI.
Croatian: • u prvoj liniji liječenja u kombinaciji s kemoterapijskim protokolom FOLFOX ili FOLFIRI.
English: • growth of eyelashes; flow of tears (lacrimation increased); redness of the eye (ocular hyperaemia); dry eye; itchy eyes (eye pruritus); eye irritation; eyelid inflammation (blepharitis);
Croatian: • rast trepavica; pojačano lučenje suza (pojačano suzenje); crvenilo oka (okularna hiperemija); suho oko; svrbež očiju (očni pruritus); iritacija oka; upala očnog kapka (blefaritis);
English: Vectibix in combination with bevacizumab and chemotherapy regimens
Croatian: Vectibix u kombinaciji s bevacizumabom i drugim kemoterapijskim protokolima
English: For clinical management of skin reactions, including dose modification recommendations, see section 4.4.
Croatian: Za kliničko liječenje kožnih reakcija, uključujući preporuke za prilagodbu doze, vidjeti dio 4.4.
English: Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection by healthcare professional using aseptic technique.
Croatian: Vectibix mora razrijediti zdravstveni radnik s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekciju koristeći se aseptičkom tehnikom.
English: Diarrhoea when reported was mainly mild or moderate in severity.
Croatian: Prijavljivani proljev uglavnom je bio blage do umjerene težine.
English: For the mutant KRAS subset, the hazard ratio for PFS was 1.25 with 95% CI: 0.91-1.71.
Croatian: Za podskupinu s mutiranim tipom KRAS omjer hazarda za preživljenje bez progresije bolesti iznosio je 1,25 s 95% CI: 0,91-1,71.
English: These findings were observed at doses approximately equivalent to the recommended human dose and were reversible upon termination of administration of panitumumab.
Croatian: Pojava simptoma poklapala se s dozama koje odgovaraju preporučenim dozama u ljudi i pri prestanku primjene panitumumaba simptomi su se povlačili.
English: • skin ulcer; scab; excess hair growth (hypertrichosis); redness and swelling of palms of hands or soles of feet (hand-foot syndrome); excess sweating (hyperhidrosis); skin reaction (dermatitis);
Croatian: • vrijedovi kože; krusta; pojačana dlakavost (hipertrihoza); crvenilo i oticanje dlanova i tabana (sindrom šaka-stopalo); prekomjerno znojenje (hiperhidroza); kožne reakcije (dermatitis);
English: The incidence of these additional RAS mutations (KRAS exons 3, 4 and NRAS exons 2, 3, 4) in the wild-type KRAS (exon 2) population was approximately 10%.
Croatian: Incidencija tih dodatnih RAS mutacija (egzoni 3, 4 gena KRAS i egzoni 2, 3, 4 gena NRAS) u populaciji s divljim tipom gena KRAS (egzon 2) bila je približno 10%.
English: The study was prospectively analysed by tumour KRAS (exon 2) status which was evaluable in 91% of the patients.
Croatian: Učinjena je prospektivna analiza ispitivanja prema statusu gena KRAS (egzon 2) za tumor, koji je bilo moguće procijeniti u 91% bolesnika.
English: Vectibix contains sodium
Croatian: Vectibix sadrži natrij
English: Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Croatian: Liječenje lijekom Vectibix mora biti pod nadzorom liječnika koji ima iskustva u primjeni antitumorskih lijekova.
English: (mucosal inflammation);
Croatian: (hirzutizam);
English: Median Duration of response (months) (95% CI)
Croatian: Medijan trajanja odgovora (mjeseci) (95% CI)
English: The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment.
Croatian: Sigurnost i djelotvornost lijeka Vectibix nisu ispitivane kod bolesnika s oštećenjem funkcije bubrega ili jetre.
English: The incidence of these additional RAS mutations (KRAS exons 3, 4 and NRAS exons 2, 3, 4) in the wild-type KRAS (exon 2) population was approximately 19%.
Croatian: Incidencija dodatnih mutacija RAS (egzoni 3, 4 KRAS i egzoni 2, 3, 4 NRAS) u populaciji s divljim tipom KRAS (egzon 2) bila je približno 19%.
English: Skin and subcutaneous tissue disorders1
Croatian: Poremećaji kože i potkožnog tkiva1
English: The incidence of these additional RAS mutations in the wild-type KRAS exon 2 population was approximately 16%.
Croatian: Incidencija tih dodatnih mutacija RAS u populaciji s divljim tipom na egzonu 2 gena KRAS iznosila je približno 16%.
English: Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological reactions as follows:
Croatian: U slučajevima teških (≥ stupnja 3) dermatoloških reakcija može biti neophodna prilagodba doze lijeka Vectibix kako slijedi:
English: Hypertrichosis
Croatian: Hipertrihoza Onihoklazija
English: • eyelid irritation; chapped lips and/or dry lips; eye infection; eyelid infection; nasal dryness;
Croatian: • iritacija očnog kapka; raspucane usne i/ili suhe usne; infekcija oka; infekcija očnog kapka;
English: Growth of eyelashes Lacrimation increased Ocular hyperaemia Dry eye
Croatian: Rast trepavica Pojačana lakrimacija Hiperemija oka Suhoća oka Svrbež oka Iritacija oka
English: Each vial contains 400 mg of panitumumab.
Croatian: Jedna bočica sadrži 400 mg panitumumaba.
English: Among patients with wild-type RAS mCRC, PFS, OS, and ORR were improved for subjects receiving panitumumab plus chemotherapy (FOLFOX or FOLFIRI) compared with those receiving chemotherapy alone.
Croatian: Među bolesnicima s mKRK-om s divljim tipom RAS, preživljenje bez progresije bolesti, ukupno preživljenje i stopa objektivnog odgovora bili su poboljšani u ispitanika koji su dobivali panitumumab i kemoterapiju (FOLFOX ili FOLFIRI) u usporedbi s onima koji su dobivali samo kemoterapiju.
English: First-line combination with bevacizumab and oxaliplatin or irinotecan-based chemotherapy
Croatian: Prva linija liječenja u kombinaciji s bevacizumabom i kemoterapijom temeljenoj na oksaliplatinu ili irinotekanu
English: If you experience blistering, you should notify your doctor immediately.
Croatian: Ukoliko primijetite stvaranje mjehura, odmah se javite liječniku.
English: Your doctor will check your blood levels of several substances such as magnesium, calcium and potassium in your blood before you start Vectibix treatment.
Croatian: Prije početka liječenja lijekom Vectibix Vaš liječnik će provjeriti razinu nekoliko tvari u krvi poput magnezija, kalcija i kalija.
English: Package Leaflet: Information for the user Vectibix 20 mg/mL concentrate for solution for infusion panitumumab
Croatian: Uputa o lijeku: Informacije za korisnika Vectibix 20 mg/ml koncentrat za otopinu za infuziju panitumumab
English: Electrolyte disturbances
Croatian: Poremećaji elektrolita
English: • low red blood cell numbers (anaemia); low potassium levels in the blood (hypokalaemia); low magnesium levels in the blood (hypomagnesaemia);
Croatian: • snižen broj crvenih krvnih stanica (anemija); snižena razina kalija u krvi (hipokalijemija);
English: • skin cell death (skin necrosis);
Croatian: • odumiranje stanica kože (nekroza kože);
English: • severe skin reaction with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);
Croatian: • teška kožna reakcija sa stvaranjem mjehura na koži, ustima, očima i genitalijama
English: How to use Vectibix
Croatian: Kako primjenjivati Vectibix
English: Vectibix plus BSC (n = 124)
Croatian: Vectibix i NPT (n = 124)
English: • ulcerative keratitis (a serious condition of ulceration of the front part of the eye (cornea)
Croatian: • ulcerozni keratitis (ozbiljno stanje sa stvaranjem vrijedova prednjeg dijela oka (rožnice) koje zahtijeva hitno liječenje);
English: Cyanosis
Croatian: Cijanoza
English: A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates on panitumumab pharmacokinetics.
Croatian: Kako bi se utvrdili mogući učinci određenih popratnih čimbenika na farmakokinetiku panitumumaba izvršeno je populacijsko farmakokinetičko ispitivanje.
English: Wild-type KRAS (exon 2) population
Croatian: Populacija s divljim tipom gena KRAS (egzon 2)
English: The fatal event occurred after re-exposure following a prior episode of angioedema; both episodes occurred greater than 24 hours after administration (see sections 4.3 and 4.4).
Croatian: Obje epizode pojavile su se više od 24 sata po primjeni lijeka (vidjeti dijelove 4.3 i 4.4).
English: Combination with FOLFIRI
Croatian: Liječenje u kombinaciji s FOLFIRI-jem
English: • spreading infection below the skin (cellulitis); hair follicle inflammation (folliculitis); localised infection; skin rash with pus-filled blisters (rash pustular); urinary tract infection;
Croatian: • infekcija koja zahvaća potkožno tkivo (celulitis); upala folikula dlake (folikulitis); lokalizirana infekcija; kožni osip s gnojnim mjehurima (pustularni osip); infekcija mokraćnog sustava;
English: A positive benefitrisk balance has not been documented in patients with ECOG 2 performance status.
Croatian: Kod bolesnika s funkcionalnim statusom ECOG 2 nije zabilježen pozitivan omjer koristi i rizika.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of panitumumab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 100 mg panitumumaba.
English: Efficacy results in patients with wild-type RAS mCRC and mutant RAS mCRC are shown in the below table.
Croatian: Rezultati djelotvornosti u bolesnika s mKRK-om s divljim tipom RAS i mKRK-om s mutiranim RAS prikazani su u sljedećoj tablici.
English: • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Croatian: • kao monoterapija nakon neuspjeha kemoterapijskih protokola koji sadrže fluoropirimidin,
English: When growth factors (other body proteins) attach to the EGFR, the cancer cell is stimulated to grow and divide.
Croatian: Kad se faktori rasta (drugi tjelesni proteini) vežu za EGFR, tumorske stanice su stimulirane na rast i dijeljenje, a panitumumab, vežući se na EGFR, sprječava da tumorske stanice primaju poruku koja im je nužna za rast i dijeljenje.
English: If you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light, please tell your doctor or nurse immediately as you may need urgent treatment (see “Possible side effects” below).
Croatian: Vam se razvije novo (akutno) ili pogoršavajuće crvenilo i bol u oku, pojačano vlaženje oka, zamagljen vid i/ili osjetljivost na svjetlo, obzirom da možda trebate hitno liječenje (pogledajte Moguće nuspojave, u nastavku).
English: Mutant KRAS (exon 2) population
Croatian: Populacija s mutiranim genom KRAS (egzon 2)
English: Skin exfoliation Exfoliative rash Dermatitis
Croatian: Ulceracije kože Ljuštenje kože Eksfolijativni osip Dermatitis
English: It is recommended that women do not breast-feed during treatment with Vectibix and for 2 months after the last dose.
Croatian: Preporučuje se da žene ne doje tijekom liječenja lijekom Vectibix, kao i 2 mjeseca nakon primjene zadnje doze lijeka.
English: There was an increase in mortality in the panitumumab arm.
Croatian: U skupini bolesnika koji su primali panitumumab bila je povećana smrtnost.
English: No overall differences in safety or efficacy were observed in elderly patients (≥ 65 years of age) treated with Vectibix monotherapy.
Croatian: Kod starijih bolesnika (dob ≥ 65 godina) liječenih lijekom Vectibix u monoterapiji nisu opažene ukupne razlike u sigurnosti ili učinkovitosti.
English: • chest pain; pain; chills; pain in the extremity; immune reaction (hypersensitivity); rapid heart rate (tachycardia);
Croatian: • bol u prsištu; bol; zimica; bol u udovima; imunološka reakcija (preosjetljivost); ubrzan rad srca (tahikardija);
English: ORR (%)
Croatian: ORR (%) (95% CI)
English: The efficacy of Vectibix in second-line in combination with irinotecan, 5-fluorouracil (5-FU) and leucovorin (FOLFIRI) was evaluated in a randomised, controlled trial of 1,186 patients with mCRC with the primary endpoints of OS and PFS. Other key endpoints included the ORR, time to response, TTP, and duration of response.
Croatian: Djelotvornost lijeka Vectibix u drugoj liniji liječenja u kombinaciji s irinotekanom, 5-fluorouracilom (5 FU) i leukovorinom (FOLFIRI) ocijenjena je u randomiziranom, kontroliranom ispitivanju na 1186 bolesnika s mKRK-om u kojem su primarni ishodi ispitivanja bili OS i PFS.
English: Median (months) (95% CI) Hazard ratio (95% CI) ORR n (%) (95% CI) Odds ratio (95% CI)
Croatian: Ukupno preživljenje Medijan (mjeseci) (95% CI) Omjer hazarda (95% CI) Preživljenje bez progresije bolesti Medijan (mjeseci) (95% CI) Omjer hazarda (95% CI) Ukupna stopa odgovora n (%) (95% CI)
English: Headache Dizziness
Croatian: Dispneja Kašalj
English: Vectibix must not be administered as an intravenous push or bolus.
Croatian: Vectibix se ne smije primjenjivati u obliku brzih intravenskih ili bolus injekcija.
English: In women of childbearing potential, appropriate contraceptive measures must be used during treatment with Vectibix, and for 2 months following the last dose.
Croatian: Žene reproduktivne dobi moraju koristiti odgovarajuću kontracepciju tijekom liječenja lijekom Vectibix i tijekom 2 mjeseca od primitka zadnje doze lijeka.
English: The safety of Vectibix has not been studied in patients with renal or hepatic impairment.
Croatian: Sigurnost primjene lijeka Vectibix nije ispitana kod bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Vectibix administered as a single agent or in combination with chemotherapy exhibits nonlinear pharmacokinetics.
Croatian: Vectibix primijenjen u monoterapiji ili u kombinaciji s kemoterapijom pokazuje nelinearnu farmakokinetiku.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vectibix 20 mg/ml sterile concentrate panitumumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vectibix 20 mg/ml sterilni koncentrat panitumumab i.v.
English: Continuing infusion at 100% of original dose
Croatian: Poboljšan (< stupnja 3) Nastaviti infuziju sa 100% početne doze
English: It is not recommended to breast-feed your baby during treatment with Vectibix and for 2 months after the last dose.
Croatian: Ne proporučuje se dojenje za vrijeme liječenja lijekom Vectibix i tijekom 2 mjeseca nakon posljednje primljene doze.
English: Deep vein thrombosis Hypotension Hypertension Flushing
Croatian: Duboka venska tromboza Hipotenzija
English: Vectibix plus BSC (n = 84)
Croatian: Vectibix i NPT (n = 84)
English: Uncommon (≥ 1/1,000 to
Croatian: Manje često (≥ 1/1000 i < 1/100)
English: The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown (see sections 4.3 and 5.1).
Croatian: Kombinacija lijeka Vectibix s kemoterapijom koja sadrži oksaliplatin kontraindicirana je kod bolesnika koji imaju mKRK s mutiranim RAS ili kod bolesnika koji imaju mKRK s nepoznatim statusom RAS (vidjeti dio 4.3 i 5.1).
English: NAME OF THE MEDICINAL PRODUCT Vectibix 20 mg/mL concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Vectibix 20 mg/ml koncentrat za otopinu za infuziju.
English: Palmar-plantar erythrodysaesthesia syndrome
Croatian: Poremećaji noktiju Hiperhidroza Sindrom palmoplantarne eritrodisestezije
English: Vectibix in combination with oxaliplatin-based chemotherapy in patients with mutant RAS mCRC or for whom RAS tumour status is unknown
Croatian: Vectibix u kombinaciji s kemoterapijom na bazi oksaliplatina kod bolesnika s mKRK-om s mutiranim RAS ili nepoznatim mutacijskim statusom RAS.
English: Type I glass vial with an elastomeric stopper, aluminium seal and flip-off plastic cap. One vial contains either 100 mg of panitumumab in 5 mL, or 400 mg panitumumab in 20 mL of concentrate for solution for infusion.
Croatian: Jedna bočica sadrži ili 100 mg panitumumaba u 5 ml, ili 400 mg panitumumaba u 20 ml koncentrata za otopinu za infuziju.
English: • dry mouth; indigestion (dyspepsia); rectal bleeding (rectal haemorrhage); lip inflammation (cheilitis); heartburn (gastroesophageal reflux);
Croatian: • suha usta; probavne tegobe (dispepsija); krvarenje iz završnog dijela debelog crijeva (rektalno krvarenje); upala usana (heilitis); žgaravica (gastroezofagealni refluks);
English: However, an increased number of serious adverse reactions were reported in elderly patients treated with Vectibix in combination with FOLFIRI or FOLFOX chemotherapy compared to chemotherapy alone (see section 4.8).
Croatian: No, kod starijih bolesnika liječenih lijekom Vectibix u kombinaciji s kemoterapijskim protokolom FOLFIRI ili FOLFOX prijavljen je povećan broj ozbiljnih nuspojava u usporedbi s liječenjem samo kemoterapijom (vidjeti dio 4.8).
English: • back pain;
Croatian: • bol u leđima;
English: Life-threatening and fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients treated with Vectibix (see section 4.4).
Croatian: Kod bolesnika liječenih lijekom Vectibix opažene su komplikacije u obliku infekcija opasnih po život i sa smrtnim ishodom, uključujući nekrotizirajući fasciitis i sepsu (vidjeti dio 4.4).
English: 1 See section “Description of selected adverse reactions” below 2 See section 4.4 Infusion-related reactions
Croatian: 1 Vidjeti dolje navedeni dio „Opis odabranih nuspojava“
English: Vectibix plus FOLFOX (months) Median (95% CI)
Croatian: Vectibix i FOLFOX (mjeseci) Medijan (95% CI)
English: The major study objective was comparison of PFS in the oxaliplatin cohort.
Croatian: Glavni cilj ispitivanja bila je usporedba preživljenja bez progresije bolesti u skupini koja je primala oksaliplatin.
English: The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown (see section 4.4).
Croatian: Kombinacija lijeka Vectibix i kemoterapije koja sadrži oksaliplatin kontraindicirana je kod bolesnika s mKRK-om s mutiranim RAS ili kod bolesnika s mKRK-om kod kojih status RAS nije poznat (vidjeti dio 4.4).
English: The efficacy of Vectibix in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (FOLFOX) was evaluated in a randomised, controlled trial of 1,183 patients with mCRC with the primary endpoint of PFS. Other key endpoints included the OS, ORR, time to response, time to progression (TTP), and duration of response.
Croatian: Djelotvornost lijeka Vectibix u kombinaciji s oksaliplatinom, 5-fluorouracilom (5-FU) i leukovorinom (FOLFOX) ocijenjena je u randomiziranom, kontroliranom ispitivanju na 1183 bolesnika s mKRK-om u kojem je PFS bio primarni ishod ispitivanja.
English: Hirsutism Ingrowing nail Onycholysis
Croatian: Hirzutizam Urasli nokat Oniholiza
English: FOLFOX (months) Median (95% CI)
Croatian: FOLFOX (mjeseci) Medijan (95% CI)
English: FOLFIRI (months) Median (95% CI)
Croatian: FOLFIRI (mjeseci) medijan (95% CI)
English: Pack of 1 vial.
Croatian: Pakiranje sadrži 1 bočicu.
English: Blood magnesium decreased
Croatian: Smanjenje tjelesne težine Snižena razina magnezija u krvi
English: NAME OF THE MEDICINAL PRODUCT Vectibix 20 mg/mL concentrate for solution for infusion panitumumab
Croatian: Vectibix 20 mg/ml koncentrat za otopinu za infuziju panitumumab
English: Results in patients with wild-type RAS mCRC and mutant RAS mCRC from the primary analysis are presented in the table below.
Croatian: Rezultati primarne analize u bolesnika s mKRK s divljim tipom RAS i mKRK s mutiranim tipom RAS prikazani su u tablici ispod.
English: Administration of Vectibix
Croatian: Primjena lijeka Vectibix
English: Hypersensitivity reactions occurring more than 24 hours after infusion have also been reported in the post-marketing setting.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljene su reakcije preosjetljivosti koje su se pojavile više od 24 sata nakon primjene infuzije.
English: loosening of the nails (onycholysis); ingrowing nail; excessive hair growth (hirsutism);
Croatian: suhoća nosa; odvajanje nokta od ležišta (oniholiza); urastanje nokta; pojačani rast dlaka
English: The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.
Croatian: Kombinacija lijeka Vectibix s kemoterapijom koja sadrži oksaliplatin kontraindicirana je kod bolesnika s mKRK-om s mutiranim RAS ili kod bolesnika s mKRK-om s nepoznatim statusom RAS.
English: • The incidence of binding antibodies (excluding predose and transient positive patients) was
Croatian: • Incidencija neutralizirajućih protutijela (isključujući bolesnike pozitivne prije primjene prve doze i prolazno pozitivne bolesnike) bila je < 1%;
English: Vectibix plus FOLFIRI (months) Median (95% CI)
Croatian: Vectibix i FOLFIRI (mjeseci) medijan (95% CI)
English: EGFR is a transmembrane glycoprotein that is a member of a subfamily of type I receptor tyrosine kinases including EGFR (HER1/c-ErbB-1), HER2, HER3, and HER4.
Croatian: EGFR je transmembranski glikoprotein koji pripada podskupini receptora tirozin-kinaza tipa