FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Infuzijsko linijo morate pred aplikacijo zdravila Vectibix in po njej sprati z raztopino natrijevega klorida, da boste preprečili mešanje z drugimi zdravili ali intravenskimi raztopinami.
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.
Slovenian: V obdobju trženja so bili poročani redki primeri nekroze kože, Stevens-Johnsonovega sindroma in toksične epidermalne nekrolize (glejte poglavje 4.4).
English: In the event of acute onset or worsening pulmonary symptoms, Vectibix treatment should be interrupted and a prompt investigation of these symptoms should occur.
Slovenian: Zato morate v primeru akutnega nastanka ali poslabšanja pljučnih simptomov zdravljenje z zdravilom Vectibix prekiniti in simptome takoj raziskati.
English: Doses up to 9 mg/kg have been tested in clinical trials.
Slovenian: V kliničnih preskušanjih so testirali odmerke do 9 mg/kg.
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”.
Slovenian: Zdravilo Vectibix se ne sme uporabljati v kombinaciji z bevacizumabom (drugo monoklonsko protitelo, ki se uporablja pri raku debelega črevesa) ali v kombinaciji s kemoterapijo, znano kot »IFL«.
English: Panitumumab binds to the ligand binding domain of EGFR and inhibits receptor autophosphorylation induced by all known EGFR ligands.
Slovenian: Panitumumab se veže na predel EGFR za vezavo liganda in zavre avtofosforilacijo receptorja, ki jo sprožijo vsi znani ligandi EGFR.
English: Your doctor may decide to reduce the rate of your infusion or discontinue your treatment with Vectibix.
Slovenian: Vaš zdravnik se lahko odloči, da zmanjša pogostnost odmerjanja vaših infuzij ali prekine vaše zdravljenje z zdravilom Vectibix.
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.
Slovenian: Mediana celokupnega preživetja v kraku s panitumumabom je bilo 19,4 (95 % IZ: 18,4, 20,8) in v kraku brez panitumumaba 24,5 (95 % IZ: 20,4, 24,5).
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.
Slovenian: • v kombinaciji s kemoterapijo na podlagi oksaliplatina, če preiskava RAS pokaže, da imate tumor z mutantnim RAS oz. če stanje RAS vašega tumorja ni znano.
English: There have been reports of acute renal failure in patients who develop diarrhoea and dehydration (see section 4.4).
Slovenian: Poročali so o primerih akutne odpovedi ledvic pri bolnikih, ki se jim pojavi driska in dehidracija (glejte poglavje 4.4).
English: In the post-marketing setting, serious infusion-related reactions have been reported, including rare post-marketing reports with a fatal outcome.
Slovenian: Med uporabo v obdobju trženja so poročali tudi o resnih z infundiranjem povezanih reakcijah, vključno z redkimi primeri s smrtnim izidom.
English: • The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid (glacial) and water for injections.
Slovenian: • Druge sestavine zdravila so natrijev klorid, natrijev acetat trihidrat, koncentrirana ocetna kislina (ledocet) in voda za injekcije.
English: Acute renal failure has been observed in patients who develop severe diarrhoea and dehydration.
Slovenian: Opisana je akutna odpoved ledvic pri bolnikih, ki se jim pojavi huda driska in dehidracija.
English: Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), water for injections.
Slovenian: Natrijev klorid, natrijev acetat trihidrat, koncentrirana ocetna kislina (ledocet), voda za injekcije.
English: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands
Slovenian: Minervum 7061, 4817 ZK Breda, Nizozemska
English: Formal male fertility studies have not been conducted; however, microscopic evaluation of male reproductive organs from repeat-dose toxicity studies in cynomolgus monkeys at doses up to approximately 5-fold the human dose on a mg/kg basis, revealed no differences compared to control male monkeys.
Slovenian: Vendar mikroskopski pregled reproduktivnih organov samcev opic cynomolgus v študijah ponavljajočih se odmerkov z odmerki, ki so bili do približno 5-kratnik odmerka za človeka na podlagi mg/kg, ni pokazal razlik v primerjavi s kontrolnimi samci.
English: Vectibix should not be administered in combination with bevacizumab containing chemotherapy (see sections 4.5 and 5.1).
Slovenian: Zdravila Vectibix se ne sme uporabljati v kombinaciji s kemoterapijo, ki vključuje bevacizumab (glejte poglavji 4.5 in 5.1).
English: If you develop a severe infection or fever as a result of skin reactions, your doctor may stop your treatment with Vectibix.
Slovenian: Če zaradi kožne reakcije pride do hude infekcije ali povišane telesne temperature, lahko zdravnik prekine vaše zdravljenje z zdravilom Vectibix.
English: The skin rash and diarrhoea observed in monkeys are considered related to the pharmacological action of panitumumab and are consistent with the toxicities observed with other anti-EGFR inhibitors.
Slovenian: Izpuščaj na koži in driska, opažena pri opicah, veljata za povezana s farmakološkim delovanjem panitumumaba in se skladata s toksičnimi učinki, ugotovljenimi z drugim zaviralci anti-EGFR.
English: These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with 23% severe (grade 3 NCI-CTC) and < 1% life-threatening (grade 4 NCI-CTC).
Slovenian: Te reakcije so povezane s farmakološkimi učinki zdravila Vectibix in so večinoma blage do zmerne, 23 % je hudih (3. stopnja po NCI-CTC) in < 1 % je življensko ogrožujočih (4. stopnja po NCI-CTC).
English: In the final analysis, the hazard ratio for PFS was 1.27 (95% CI: 1.06, 1.52).
Slovenian: Končna analiza je pokazala razmerje ogroženosti za PFS 1,27 (95 % IZ: 1,06, 1,52).
English: Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Slovenian: Panitumumab je popolnoma humano monoklonsko protitelo IgG2, pridobljeno na sesalski celični liniji (CHO) s tehnologijo rekombinantne DNA.
English: Patients who have severe dermatologic reactions or soft tissue toxicity or who develop worsening reactions whilst receiving Vectibix should be monitored for the development of inflammatory or infectious sequelae (including cellulitis and necrotising fasciitis), and appropriate treatment promptly initiated.
Slovenian: Bolnike s hudimi dermatološkimi reakcijami ali toksičnostjo mehkih tkiv ali poslabšanjem reakcij med uporabo zdravila Vectibix morate spremljati zaradi možnih vnetnih ali infekcijskih posledic (vključno s celulitisom in nekrotizirajočim fasciitisom) ter jim ob pojavu le teh nemudoma uvesti ustrezno zdravljenje.
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.
Slovenian: Pri bolnikih, ki so imeli poleg KRAS eksona 2 dodatne mutacije RAS, ni bilo verjetno, da bi jim dodatek panitumumaba poleg FOLFIRI koristil, po dodatku panitumumaba poleg FOLFOX pa so pri teh bolnikih opažali škodljiv učinek.
English: Data from an interaction study involving Vectibix and irinotecan in patients with mCRC indicated that the pharmacokinetics of irinotecan and its active metabolite, SN-38, are not altered when the medicinal products are co-administered.
Slovenian: Podatki študije o medsebojnem delovanju zdravil, ki je vključevala zdravili Vectibix in irinotekanom, pri bolnikih z mKRR kažejo, da se med sočasno uporabo zdravil farmakokinetika irinotekana in njegovega aktivnega metabolita SN-38 ne spremeni.
English: Patients with ECOG 2 performance status treated with Vectibix in combination with chemotherapy
Slovenian: Bolniki z zmogljivostnim stanjem 2 po ECOG, zdravljeni z zdravilom Vectibix v kombinaciji s kemoterapijo
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.
Slovenian: Na podlagi analize vseh bolnikov z mKRR v kliničnih preskušanjih, ki so prejemali monoterapijo z zdravilom Vectibix in zdravilo Vectibix v kombinaciji s kemoterapijo (n = 2.224), so najpogosteje poročani neželeni učinki kožne reakcije; pojavijo se pri približno 94 % bolnikov.
English: In combination with irinotecan- or oxaliplatin-based chemotherapy:
Slovenian: V kombinaciji s kemoterapijo na podlagi irinotekana ali oksaliplatina:
English: In vitro assays and in vivo animal studies have shown that panitumumab inhibits the growth and survival of tumour cells expressing EGFR.
Slovenian: Preizkusi in vitro in študije na živalih in vivo so pokazali, da panitumumab zavre rast in preživetje tumorskih celic z eksprimiranim EGFR.
English: Your doctor will also check your blood levels of magnesium and calcium periodically during your treatment, and for up to 8 weeks after you have finished your treatment.
Slovenian: Zdravnik vam bo v rednih časovnih presledkih tudi med zdravljenjem in še do 8 tednov po koncu zdravljenja preverjal koncentraciji magnezija in kalcija v krvi.
English: • eye inflammation (conjunctivitis);
Slovenian: • vnetje oči (konjunktivitis),
English: If you experience blistering, you should notify your doctor immediately.
Slovenian: Če se vam pojavijo mehurji, morate nemudoma obvestiti svojega zdravnika.
English: Very rarely, serious allergic (hypersensitivity) reactions involving symptoms similar to an infusion reaction (see “Infusion reactions”) have occurred more than 24 hours after treatment and resulted in a fatal outcome.
Slovenian: Zelo redko so se po več kot 24 urah po zdravljenju pojavile resne alergijske (preobčutljivostne) reakcije, ki so vključevale podobne simptome kot pri z infuzijo povezanih reakcijah (glejte poglavje »Z infuzijo povezane reakcije«) in se končale s smrtnim izidom.
English: In clinical studies, subsequent to the development of severe dermatologic reactions (including stomatitis), infectious complications including sepsis and necrotising fasciitis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported.
Slovenian: V kliničnih študijah so po pojavu hudih dermatoloških reakcij (vključno s stomatitisom) zabeležili infekcijske zaplete, vključno s sepso in nekrotizirajočim fasciitisom, ki so v redkih primerih povzročili smrt, ter lokalne abscese, ki so potrebovali incizijo in drenažo.
English: Progressively decreasing serum magnesium levels leading to severe (grade 4) hypomagnesaemia have been observed in some patients.
Slovenian: Pri nekaterih bolnikih so opažali napredujoče zniževanje koncentracije magnezija v serumu, ki je povzročilo hudo hipomagneziemijo (4. stopnje).
English: The incidence of these additional RAS mutations in the wild-type KRAS exon 2 population was approximately 16%.
Slovenian: Incidenca teh dodatnih mutacij RAS v populaciji z divjim tipom KRAS ekson 2 je bila približno 16 %.
English: Adverse events observed included skin toxicity, diarrhoea, dehydration and fatigue and were consistent with the safety profile at the recommended dose.
Slovenian: Opaženi neželeni učinki, med katerimi so toksični učinki na koži, driska, dehidracija in utrujenost, so se skladali z varnostnimi značilnostmi ob priporočenem odmerku.
English: The study was prospectively analysed by tumour KRAS (exon 2) status which was evaluable in 93% of the patients.
Slovenian: Študija je bila prospektivno analizirana po stanju KRAS tumorja (ekson 2), ki so ga ocenili pri 93 % bolnikov.
English: Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies.
Slovenian: Zdravilo Vectibix kot učinkovino vsebuje panitumumab, ki spada v skupino zdravil, imenovanih monoklonska protitelesa.
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%.
Slovenian: Incidenca teh dodatnih mutacij RAS (KRAS eksonov 3 in 4 in NRAS eksonov 2, 3 in 4) v populaciji z divjim tipom KRAS (ekson 2) je bila približno 19 %.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o redčenju zdravila pred uporabo glejte poglavje 6.6.
English: The study was prospectively analysed by tumour KRAS (exon 2) status which was evaluable in 91% of the patients.
Slovenian: Študija je bila prospektivno analizirana po stanju KRAS tumorja (ekson 2), ki so ga ocenili pri 91 % bolnikov.
English: The efficacy of Vectibix as monotherapy in patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior chemotherapy was studied in open-label, single-arm trials (585 patients) and in two randomised controlled trials versus best supportive care (463 patients) and versus cetuximab (1,010 patients).
Slovenian: Učinkovitost zdravila Vectibix v monoterapiji pri bolnikih z metastatskim kolorektalnim rakom (mKRR), ki jim je bolezen napredovala med predhodno kemoterapijo ali po njej, so raziskali v odprtih preskušanjih z eno skupino (585 bolnikov) in v dveh randomiziranih kontroliranih preskušanjih v primerjavi z najboljšo podporno oskrbo (463 bolnikov) v primerjavi s cetuksimabom (1.010 bolnikov).
English: Patients should be periodically monitored for hypomagnesaemia and accompanying hypocalcaemia prior to initiating Vectibix treatment, and periodically thereafter for up to 8 weeks after the completion of treatment (see section 4.8).
Slovenian: Bolnike je treba pred uvedbo zdravljenja, med zdravljenjem in še 8 tednov po končanem zdravljenju z zdravilom Vectibix, redno spremljati glede hipomagneziemije in spremljajoče hipokalciemije (glejte poglavje 4.8).
English: Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL.
Slovenian: Ena viala vsebuje 100 mg panitumumaba v 5 ml ali 400 mg panitumumaba v 20 ml.
English: Across all clinical trials, skin reactions occurred in approximately 94% of patients receiving Vectibix as monotherapy or in combination with chemotherapy (n = 2,224).
Slovenian: V vseh kliničnih preskušanjih so se kožne reakcije pojavile pri približno 94 % bolnikov, ki so prejemali zdravilo Vectibix v monoterapiji ali v kombinaciji s kemoterapijo (n = 2.224).
English: • blue colouration of the skin and mucous membranes (cyanosis);
Slovenian: • modro obarvanje kože in sluznic (cianoza),
English: A shortened progression-free survival (PFS) and overall survival (OS) time were observed in patients with mutant KRAS (exon 2) tumours and additional RAS mutations (KRAS [exons 3 and 4] or NRAS [exons 2, 3, 4]) who received panitumumab in combination with infusional 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus FOLFOX alone (see section 5.1).
Slovenian: Ugotovili so krajše preživetje brez napredovanja (PFS - Progression Free Survival) in krajše celokupno preživetje (OS - Overall Survival) pri tistih bolnikih s tumorjem z mutantnim KRAS (ekson 2) in dodatnimi mutacijami RAS (KRAS [eksona 3 in 4] ali NRAS [eksoni 2, 3, 4]), ki so dobivali panitumumab v kombinaciji z infuzijo 5-fluorouracila, levkovorina in oksaliplatina (FOLFOX), kot pri tistih, ki so dobivali samo FOLFOX (glejte poglavje 5.1).
English: Subsequent to the development of severe skin and subcutaneous reactions, infectious complications including sepsis, in rare cases leading to death, cellulitis and local abscesses requiring incisions and drainage were reported.
Slovenian: Po pojavu hudih kožnih in podkožnih reakcij so zabeležili infekcijske zaplete, vključno s sepso, ki so v redkih primerih povzročili smrt, celulitis in lokalne abscese, ki so potrebovali incizijo in drenažo.
English: The most serious side effects and main side effects for Vectibix are listed below:
Slovenian: Spodaj so navedeni najresnejši neželeni učinki in glavni neželeni učinki za zdravilo Vectibix:
English: Clinical efficacy as monotherapy
Slovenian: Klinična učinkovitost v monoterapiji
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.
Slovenian: Zdravnik vam bo morda svetoval uporabo vlažilnega sredstva, sredstva za zaščito pred soncem (zaščitni faktor > 15), lokalnega steroida in/ali peroralnih antibiotikov; vse to vam lahko pomaga obvladovati toksične učinke na koži, ki lahko spremljajo uporabo zdravila Vectibix.
English: Skin rash most commonly occurred on the face, upper chest, and back, but could extend to the extremities.
Slovenian: Izpuščaj na koži se je najpogosteje pojavil na obrazu, zgornjem delu prsnega koša in hrbtu, vendar se je lahko razširil na ude.
English: The recommended dose of Vectibix is 6 mg/kg of bodyweight given once every two weeks.
Slovenian: Priporočeni odmerek zdravila Vectibix je 6 mg/kg telesne mase enkrat na dva tedna.
English: What Vectibix looks like and contents of the pack
Slovenian: Izgled zdravila Vectibix in vsebina pakiranja
English: Colourless, pH 5.6 to 6.0 solution that may contain translucent to white, visible amorphous, proteinaceous panitumumab particles.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Brezbarvna raztopina s pH od 5,6 do 6,0, ki lahko vsebuje prosojne do bele vidne amorfne beljakovinske delce panitumumaba.
English: Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):
Slovenian: Zdravilo Vectibix je indicirano za zdravljenje odraslih bolnikov z metastatskim kolorektalnim rakom (mKRR) z divjim tipom RAS:
English: Median PFS was 10.0 (95% CI: 8.9, 11.0) and 11.4 (95% CI: 10.5, 11.9) months in the panitumumab and the non-panitumumab arm, respectively.
Slovenian: Mediana PFS je bila v kraku s panitumumabom 10,0 (95 % IZ: 8,9, 11,0) in v kraku brez panitumumaba 11,4 (95 % IZ: 10,5, 11,9) mesecev.
English: Other toxicities that were observed with a greater frequency relative to monotherapy included hypomagnesaemia, diarrhoea, and stomatitis.
Slovenian: Drugi toksični učinki, ki so bili pogostejši kot med monoterapijo, so bili hipomagneziemija, driska in stomatitis.
English: A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates on panitumumab pharmacokinetics.
Slovenian: Za proučitev možnih učinkov izbranih sospremenljivk na farmakokinetiko panitumumaba je bila narejena analiza populacijske farmakokinetike.
English: Severe diarrhoea (NCI-CTC grade 3 and 4) was reported in 2% of patients treated with Vectibix as a monotherapy and in 16% of patients treated with Vectibix in combination with chemotherapy.
Slovenian: O hudi (3. in 4. stopnja po NCI-CTC) driski so poročali pri 2 % bolnikov, zdravljenih z zdravilom Vectibix v monoterapiji, in pri 16 % bolnikov, zdravljenjih z zdravilom Vectibix v kombinaciji s kemoterapijo.
English: A trend for OS favouring the control arm was observed in the wild-type KRAS subset of the oxaliplatin cohort (hazard ratio = 1.89; 95% CI: 1.30, 2.75).
Slovenian: V podskupini z divjim tipom KRAS je bil v oksaliplatinski kohorti opazen trend k boljšemu OS v kontrolnem kraku (razmerje ogroženosti = 1,89; 95 % IZ: 1,30, 2,75).
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);
Slovenian: • kožna razjeda, krasta, čezmerna rast dlak (hipertrihoza), pordelost in otekanje dlani ali podplatov (sindrom dlani in podplatov), prekomerno znojenje (hiperhidroza), kožna reakcija (dermatitis),
English: Vectibix (n = 499)
Slovenian: Zdravilo Vectibix (n = 499)
English: Your doctor may decide to treat the rash, adjust the dose or discontinue your treatment with Vectibix.
Slovenian: Zdravnik se lahko odloči, da zdravi izpuščaj, prilagodi odmerek ali prekine vaše zdravljenje z zdravilom Vectibix.
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).
Slovenian: Učinkovitost zdravila Vectibix v prvi liniji zdravljenja v kombinaciji s FOLFIRI so ocenili v študiji z eno samo skupino pri 154 bolnikih, primarni opazovani dogodek pa je bil objektivni delež odziva (ORR).
English: The safety profile of Vectibix in combination with chemotherapy consisted of the reported adverse reactions of Vectibix (as a monotherapy) and the toxicities of the background chemotherapy regimen.
Slovenian: Varnostne značilnosti zdravila Vectibix v kombinaciji s kemoterapijo so obsegale poročila o neželenih učinkih zdravila Vectibix (kot monoterapije) in toksičnosti osnovne sheme kemoterapije.
English: Deep vein thrombosis Hypotension Hypertension Flushing
Slovenian: Žilne bolezni globoka venska tromboza hipotenzija hipertenzija zardevanje
English: A variety of stimuli, including that from the EGFR activate KRAS and NRAS which in turn stimulate other intracellular proteins to promote cell proliferation, cell survival and angiogenesis.
Slovenian: KRAS in NRAS nato stimulirata druge znotrajcelične beljakovine za spodbudo proliferacije celic, preživetja celic in angiogeneze.
English: Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Slovenian: Zdravljenje z zdravilom Vectibix mora spremljati zdravnik z izkušnjami pri zdravljenju raka.
English: Vectibix in combination with irinotecan, bolus 5-fluorouracil, and leucovorin (IFL) chemotherapy
Slovenian: Zdravilo Vectibix v kombinaciji s kemoterapijo z irinotekanom, bolusnim 5-fluorouracilom in levkovorinom (IFL)
English: Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions (occurring within 24 hours of any infusion), which may include symptoms/signs such as chills, fever or dyspnoea, were reported in approximately 5% of Vectibix-treated patients, of which 1% were severe (NCI-CTC grade 3 and grade 4).
Slovenian: V kliničnih študijah (n = 2.224) monoterapije mKRR in terapije mKRR s kombinacijo zdravil so z infundiranjem povezane reakcije (pojavijo se v 24 urah po katerikoli infuziji), ki lahko vključujejo simptome/znake, kot so mrzlica, povišana telesna temperatura ali dispneja, zabeležili pri približno 5 % bolnikov, zdravljenih z zdravilom Vectibix, 1 % teh reakcij je bilo hudih (3. ali 4. stopnje po NCI-CTC).
English: The incidence of BRAF exon 15 mutation in the wild-type KRAS (exon 2) population was approximately 8%.
Slovenian: Incidenca mutacije BRAF eksona 15 je bila v populaciji z divjim tipom KRAS (ekson 2) približno 8 %.
English: Secondary endpoints included PFS and objective response rate (ORR).
Slovenian: Primarni opazovani dogodek je bilo OS. Sekundarna opazovana dogodka sta obsegala PFS in objektivni delež odziva (ORR - Objective Response Rate).
English: Vectibix must be administered as an intravenous infusion via an infusion pump.
Slovenian: Zdravilo Vectibix morate aplicirati v intravenski infuziji z infuzijsko črpalko.
English: It is also recommended that patients experiencing rash/dermatological toxicities wear sunscreen and hats and limit sun exposure as sunlight can exacerbate any skin reactions that may occur.
Slovenian: Priporočljivo je tudi, da bolniki, pri katerih se pojavi izpuščaj/dermatološki toksični učinki kožo zavarujejo s sredstvi za sončenje, nosijo klobuke in omejijo izpostavljenost soncu.