FrancophonIA/ELRC3.0 huggingface dataset:
English: You should speak with your doctor before driving or using machines, as some side effects may impair your ability to do so safely.
Slovenian: Preden vozite ali upravljate stroje, se morate posvetovati z zdravnikom, kajti nekateri neželeni učinki lahko poslabšajo sposobnost za varno izvajanje teh opravil.
English: Animal studies are insufficient with respect to embryo-foetal development since foetal panitumumab exposure levels were not examined.
Slovenian: Študije na živalih niso zadostne, kar zadeva razvoj zarodka in ploda, ker raven izpostavljenosti ploda panitumumabu ni raziskana.
English: Mutant RAS population PFS
Slovenian: Populacija z mutantnim RAS PFS
English: Following a single-dose administration of panitumumab as a 1-hour infusion, the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner and clearance (CL) of panitumumab decreased from 30.6 to 4.6 mL/day/kg as the dose increased from 0.75 to 9 mg/kg.
Slovenian: Po uporabi posamičnega odmerka panitumumaba v 1-urni infuziji se je površina pod krivuljo koncentracije po času (AUC) povečala bolj kot sorazmerno odmerku, očistek (Cl) panitumumaba pa se je ob povečanju odmerka od 0,75 na 9 mg/kg zmanjšal s 30,6 na 4,6 ml/dan/kg.
English: Vectibix is a colourless liquid that may contain visible particles and is supplied in a glass vial.
Slovenian: Zdravilo Vectibix je brezbarvna tekočina, ki lahko vsebuje vidne delce, in je na voljo v steklenih vialah.
English: Other key endpoints included the PFS, time to response, TTP, and duration of response.
Slovenian: Med drugimi ključnimi opazovanimi dogodki so bili PFS, čas do odziva, TTP in trajanje odziva.
English: CI = confidence interval a In patients that crossed over to panitumumab after progression on BSC alone (95% CI)
Slovenian: IZ = interval zaupanja a Pri bolnikih, ki so po napredovanju ob uporabi samo BSC prešli v skupino s panitumumabom (95 % IZ)
English: The solution should be colourless and may contain visible translucent-to-white, amorphous, proteinaceous particulates (which will be removed by in-line filtration).
Slovenian: Raztopina mora biti brezbarvna in lahko vsebuje vidne prosojne do bele amorfne beljakovinske delce (ki bodo odstranjeni z linijsko filtracijo).
English: Patients who experience severe diarrhoea should be instructed to consult a healthcare professional urgently.
Slovenian: Bolnikom, ki se jim pojavi huda driska, je treba naročiti, da se takoj posvetujejo z zdravnikom.
English: • in first-line in combination with FOLFOX or FOLFIRI.
Slovenian: • v prvi liniji zdravljenja v kombinaciji s FOLFOX ali FOLFIRI,
English: The mean (± SD) AUC0-tau and CL were 1,306 ± 374 mcg•day/mL and 4.9 ± 1.4 mL/kg/day, respectively.
Slovenian: Povprečna (± SD) AUC0-tau je bila 1.306 ± 374 mcg•dan/ml, povprečni (± SD) očistek pa 4,9 ± 1,4 ml/kg/dan.
English: BRAF mutations were not predictive of the outcome for panitumumab treatment in combination with FOLFOX or FOLFIRI.
Slovenian: Mutacije BRAF niso bile napovednik izida zdravljenja s panitumumabom v kombinaciji s FOLFOX ali FOLFIRI.
English: Therefore administration of Vectibix in combination with IFL should be avoided (see section 4.5).
Slovenian: Zato se je treba uporabi zdravila Vectibix v kombinaciji z IFL izogibati (glejte poglavje 4.5).
English: The observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medicinal products and underlying disease, therefore, comparison of the incidence of antibodies to other products may be misleading.
Slovenian: Na ugotovljeno incidenco pozitivnih izvidov za protitelesa z določenim preizkusom lahko vpliva več dejavnikov, med drugim metodologija preizkusa, ravnanje z vzorcem, čas odvzema vzorca, sočasno uporabljana zdravila in osnovna bolezen, zato je lahko primerjava incidence protiteles z drugimi zdravili zavajajoča.
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).
Slovenian: Če se vam akutno pojavijo ali poslabšajo pordelost in bolečina v očesu, povečano solzenje, zamegljenost vida in/ali občutljivost na svetlobo, morate to nemudoma povedati zdravniku ali medicinski sestri, saj boste mogoče potrebovali takojšnje zdravljenje (glejte poglavje »Možni neželeni učinki« spodaj).
English: 3 See section 4.4 Pulmonary complications
Slovenian: 3 Glejte poglavje 4.4 Zapleti na pljučih.
English: What Vectibix is and what it is used for What you need to know before you use Vectibix How to use Vectibix
Slovenian: Kaj je zdravilo Vectibix in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Vectibix Kako uporabljati zdravilo Vectibix Možni neželeni učinki
English: Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Slovenian: Bolniki z anamnezo hude ali smrtno nevarne preobčutljivosti na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).
English: A case of fatal angioedema occurred in a patient with recurrent and metastatic squamous cell carcinoma of the head and neck treated with Vectibix in a clinical trial.
Slovenian: Opisan je primer smrtnega angioedema pri bolniku z recidivnim in metastatskim ploščatoceličnim karcinomom glave in vratu, ki je v kliničnem preskušanju dobival zdravilo Vectibix.
English: Occurrence of skin symptom(s): ≥ grade 31
Slovenian: Pojav kožnih simptomov: ≥ 3. stopnje1
English: • severe skin reaction with blistering of the skin (toxic epidermal necrolysis);
Slovenian: • huda kožna reakcija z mehurji na koži (toksična epidermalna nekroliza),
English: Using only a 21-gauge or smaller diameter hypodermic needle, withdraw the necessary amount of Vectibix for a dose of 6 mg/kg.
Slovenian: Z uporabo hipodermične igle, ki je lahko le velikosti 21 ali manjšega premera, izvlecite potrebno količino zdravila Vectibix za odmerek 6 mg/kg.
English: In an exploratory analysis of banked tumour specimens from this study, 11 of 72 patients (15%) with wild-type RAS tumours receiving panitumumab had an objective response compared to only 1 of 95 patients (1%) with mutant RAS tumour status.
Slovenian: V eksplorativni analizi shranjenih vzorcev tumorjev iz te študije je objektivni odziv doseglo 11 od 72 bolnikov (15 %) s tumorji z divjim tipom RAS, ki so prejemali panitumumab, pa le 1 od 95 bolnikov (1 %), ki so imeli tumor z mutiranim statusom RAS.
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.
Slovenian: Pri bolnikih z anamnezo intersticijskega pnevmonitisa ali pljučne fibroze je potrebno skrbno razmisliti o koristih zdravljenja s panitumumabom v primerjavi s tveganjem za zaplete na pljučih.
English: • inflammation of the lungs (interstitial lung disease).
Slovenian: • vnetje pljuč (intersticijska pljučna bolezen).
English: PHARMACEUTICAL FORM AND CONTENTS 5 mL of concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 5 ml koncentrata za raztopino za infundiranje.
English: • inability to sleep (insomnia);
Slovenian: • nespečnost (insomnija),
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.
Slovenian: Narejeno je bilo multinacionalno, randomizirano, kontrolirano preskušanje 463 bolnikov z metastatskim karcinomom na kolonu ali rektumu in eksprimiranim EGFR, po potrjenem neuspehu shem z oksaliplatinom in irinotekanom.
English: Vectibix should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Slovenian: Zdravilo Vectibix morate uporabljati previdno pri bolnikih z anamnezo keratitisa, ulcerativnega keratitisa ali zelo suhih oči.
English: Patient tumour samples with wild-type KRAS exon 2 (codons 12/13) status were tested for additional RAS mutations in KRAS exon 3 (codons 61) and exon 4 (codons 117/146) and NRAS exon 2 (codons 12/13), exon 3 (codon 61), and exon 4 (codons 117/146) and BRAF exon 15 (codon 600).
Slovenian: Vzorce tumorjev bolnikov z divjim tipom KRAS ekson 2 (kodoni 12/13) so testirali za dodatne mutacije RAS v KRAS eksonu 3 (kodoni 61) in eksonu 4 (kodoni 117/146) ter NRAS eksonu 2 (kodoni 12/13), eksonu 3 (kodoni 61) in eksonu 4 (kodoni 117/146) in BRAF eksonu 15 (kodon 600).
English: There was an increase in mortality in the panitumumab arm.
Slovenian: Umrljivost v kraku s panitumumabom se je povečala.
English: Data on the development of anti-panitumumab antibodies has been evaluated using two different screening immunoassays for the detection of binding anti-panitumumab antibodies (an ELISA which detects high-affinity antibodies, and a Biosensor Immunoassay which detects both high and low-affinity antibodies).
Slovenian: Pojav protiteles proti panitumumabu so ovrednotili z dvema različnima presejalnima imunskima preizkusoma za odkrivanje protiteles, ki vežejo panitumumab (ELISA, ki odkrije visokoafinitetna protitelesa, in Biosensor Immunoassay, ki odkrije visoko- in nizkoafinitetna protitelesa).
English: This medicinal product contains 3.45 mg sodium per mL, equivalent to 0.017% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 3,45 mg natrija na ml, kar je enako 0,017 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: A predefined retrospective subset analysis of 641 patients of the 656 patients with wild-type KRAS (exon 2) mCRC was performed.
Slovenian: Opravljena je bila vnaprej opredeljena retrospektivna analiza podskupine 641 od 656 bolnikov z mKRR z divjim tipom KRAS (ekson 2).
English: If a severe or life-threatening reaction occurs during an infusion or at any time post-infusion [e.g. presence of bronchospasm, angioedema, hypotension, need for parenteral treatment, or anaphylaxis], Vectibix should be permanently discontinued (see sections 4.3 and 4.8).
Slovenian: Če se kadarkoli med ali po infundiranju pojavi huda ali smrtno nevarna reakcija (npr. z bronhospazmom, angioedemom, hipotenzijo, potrebo po parenteralnem zdravljenju ali anafilaksijo), je treba uporabo zdravila Vectibix za stalno prekiniti (glejte poglavje 4.3 in 4.8).
English: Hypersensitivity reactions occurring more than 24 hours after infusion have been reported including a fatal case of angioedema that occurred more than 24 hours after the infusion.
Slovenian: Poročali so o preobčutljivostnij reakcijah, ki so se pojavile več kot 24 ur po infundiranju, vključno s smrtnim primerom angioedema, ki se je pojavil več kot 24 ur po infundiranju.
English: Vectibix will be administered in a healthcare facility under the supervision of a doctor experienced in the use of anti-cancer medicines.
Slovenian: Zdravilo Vectibix boste dobili v zdravstveni ustanovi, pod nadzorstvom zdravnika, izkušenega z uporabo zdravil za zdravljenje raka.
English: For patients whose sera tested positive in either screening immunoassay, an in vitro biological assay was performed to detect neutralising antibodies.
Slovenian: Pri bolnikih, ki so imeli pozitiven izvid enega ali drugega imunskega preizkusa, so opravili in vitro biološki preizkus za odkritje nevtralizacijskih protiteles.
English: Skin-related reactions are likely to occur in approximately 94 out of 100 people who take Vectibix and are usually mild to moderate.
Slovenian: Reakcije, povezane s kožo, se predvidoma pojavijo pri približno 94 od 100 bolnikov, ki uporabljajo zdravilo Vectibix in so navadno blage do zmerne.
English: If you experience a severe skin reaction, your doctor may recommend an adjustment of the dose of Vectibix.
Slovenian: Če se vam pojavi kakšna huda kožna reakcija, lahko zdravnik svetuje prilagoditev odmerka zdravila Vectibix.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema anemija levkopenija
English: Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium.
Slovenian: En mililiter koncentrata vsebuje 0,150 mmol natrija, kar je 3,45 mg natrija.
English: The study was retrospectively analysed by wild-type KRAS (exon 2) status versus mutant KRAS (exon 2) status.
Slovenian: Študijo so retrospektivno analizirali po stanju divjega tipa KRAS (ekson 2) v primerjavi z mutantnim tipom KRAS (ekson 2).
English: Electrolyte disturbances
Slovenian: Elektrolitske motnje
English: If ILD is diagnosed, Vectibix should be permanently discontinued and the patient should be treated appropriately.
Slovenian: Če diagnosticirate ILD, morate zdravljenje z zdravilom Vectibix za stalno prekiniti in bolnika ustrezno zdraviti.
English: The diluted solution should be mixed by gentle inversion, do not shake.
Slovenian: Razredčeno raztopino premešajte s previdnim obračanjem; ne stresajte je.
English: The efficacy of Vectibix was also evaluated in an open-label trial in patients with wild-type KRAS (exon 2) mCRC.
Slovenian: Učinkovitost zdravila Vectibix so ocenili tudi v odprtem preskušanju pri bolnikih z mKRR z divjim tipom KRAS (ekson 2).
English: Paronychial inflammation was associated with swelling of the lateral nail folds of the toes and fingers.
Slovenian: Obnohtno vnetje je spremljala oteklost lateralnih nohtnih gub prstov na nogah in rokah.
English: Human IgG is known to cross the placental barrier, and panitumumab may therefore be transmitted from the mother to the developing foetus.
Slovenian: Znano je, da humani IgG prehajajo skozi placentno pregrado, tako da bi panitumumab lahko prešel od matere v razvijajoči se plod.
English: Shortened progression-free survival time and increased deaths were observed in the patients receiving Vectibix in combination with bevacizumab and chemotherapy.
Slovenian: Krajši čas preživetja brez napredovanja in več smrti so opazili med bolniki, ki so dobivali zdravilo Vectibix v kombinaciji z bevacizumabom in kemoterapijo.
English: Other medicines and Vectibix
Slovenian: Druga zdravila in zdravilo Vectibix
English: In the post-marketing setting, serious cases of keratitis and ulcerative keratitis have been rarely reported (see section 4.4).
Slovenian: Med uporabo v obdobju trženja so bili redko poročani resni primeri keratitisa in ulcerativnega keratitisa (glejte poglavje 4.4).
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.
Slovenian: Dodatna analiza podatkov o učinkovitosti glede na stanje KRAS (ekson 2) ni odkrila bolnikov, ki bi jim bil koristil panitumumab v kombinaciji s kemoterapijo na podlagi oksaliplatina ali irinotekana ter bevacizumab.
English: The hazard ratio for overall survival was 1.43 (95% CI: 1.11, 1.83).
Slovenian: Razmerje ogroženosti za celokupno preživetje je bilo 1,43 (95 % IZ: 1,11, 1,83).
English: If a patient develops dermatologic reactions that are grade 3 (CTCAE v 4.0) or higher, or that are considered intolerable, see the recommendation for dose modification in section 4.2.
Slovenian: Če se pri bolniku pojavijo dermatološke reakcije 3. ali višje stopnje (po CTCAE verzija 4.0) ali dermatološke reakcije, ocenjene kot neznosne, glejte priporočilo za prilagoditev odmerka v poglavju 4.2.
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with Vectibix should be interrupted or discontinued.
Slovenian: Če je potrjena diagnoza ulcerativnega keratitisa, je treba zdravljenje z zdravilom Vectibix začasno ali trajno prekiniti.
English: Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR.
Slovenian: Panitumumab je rekombinantno, povsem humano monoklonsko protitelo IgG2, ki se z veliko afiniteto in specifičnostjo veže na humani 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).
Slovenian: Zdravljenje in obvladovanje dermatoloških reakcij mora temeljiti na izrazitosti le-teh in lahko vključuje vlažilno sredstvo, sredstvo za zaščito pred soncem (zaščitni faktor UVA in UVB > 15) in lokalno steroidno kremo (ne močnejšo kot 1 % hidrokortizon), nanešene na prizadete predele, in/ali peroralne antibiotike (npr. doksiciklin).
English: • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
Slovenian: • v drugi liniji zdravljenja v kombinaciji s FOLFIRI pri bolnikih, ki so v prvi liniji zdravljenja prejemali kemoterapijo, ki je vključevala fluoropirimidin (vendar ni vključevala irinotekana),
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.
Slovenian: Med bolniki z mKRR z divjim tipom RAS so bili PFS, OS in ORR pri prejemnikih panitumumaba in kemoterapije (FOLFOX ali FOLFIRI) izboljšani v primerjavi s tistimi, ki so prejemali samo kemoterapijo.
English: Moreover, panitumumab treatment was associated with improved PFS compared to BSC in patients with wild-type RAS tumours (HR = 0.38 [95% CI: 0.27, 0.56]), but not in patients with tumours harbouring a RAS mutation (HR = 0.98 [95% CI: 0.73, 1.31]).
Slovenian: Poleg tega je bilo zdravljenje s panitumumabom v primerjavi z najboljšo standardno oskrbo pri bolnikih s tumorjem z divjim tipom RAS povezano z boljšim PFS (razmerje ogroženosti = 0,38 [95 % IZ: 0,27, 0,56]), pri bolnikih s tumorjem z mutacijo RAS pa ne (razmerje ogroženosti = 0,98 [95 % IZ: 0,73, 1,31]).
English: Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).
Slovenian: Zdravilo Vectibix se daje intravensko (v veno) z infuzijsko črpalko (napravo, ki omogoča počasno injiciranje).
English: Wild-type RAS population PFS
Slovenian: Populacija z divjim tipom RAS PFS
English: It is recommended that you limit sun exposure whilst receiving Vectibix and if you are experiencing skin reactions as sunlight can worsen these.
Slovenian: Priporočljivo je, da med zdravljenjem z zdravilom Vectibix omejite izpostavljenost soncu; prav tako izpostavljenost soncu omejite, če se vam pojavijo kožne reakcije, saj jih sončna svetloba lahko poslabša.
English: The addition of panitumumab to radiation, chemotherapy or other targeted therapeutic agents, in animal studies resulted in an increase in antitumour effects compared to radiation, chemotherapy or targeted therapeutic agents alone.
Slovenian: Dodatek panitumumaba obsevanju, kemoterapiji ali drugim ciljanim terapevtskim sredstvom je v študijah na živalih povečal protitumorske učinke v primerjavi z uporabo obsevanja, kemoterapije ali ciljanih terapevtskih sredstev samih.
English: Non-serious cases of keratitis have been observed in 0.3% of clinical trial patients.
Slovenian: Pri 0,3 % bolnikov v kliničnih preskušanjih so zabeležili primere keratitisa, ki niso bili resni.
English: • severe skin reaction with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);
Slovenian: • huda kožna reakcija z mehurji na koži, v ustih, na očeh in spolovilih (Stevens-Johnsonov sindrom),
English: For clinical management of skin reactions, including dose modification recommendations, see section 4.4.
Slovenian: Za klinično obvladovanje kožnih reakcij, vključno s priporočili za prilagoditev odmerka, glejte poglavje 4.4.
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.
Slovenian: Bolnikom, ki se jim pojavi blaga ali zmerna (1. in 2. stopnja po CTCAE verzija 4.0) z infundiranjem povezana reakcija, je treba hitrost infundiranja za čas te infuzije zmanjšati.
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.
Slovenian: Dokazano je, da panitumumab povzroča splave plodov in/ali smrt plodov, če je pri opicah cynomolgus uporabljen med obdobjem organogeneze v odmerkih, približno enakovrednih priporočenemu odmerku za človeka.
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).
Slovenian: Bolniki, ki so dobivali zdravilo Vectibix v kombinaciji z IFL shemo [bolus 5-fluorouracila (500 mg/m2), levkovorina (20 mg/m2) in irinotekana (125 mg/m2)], so zelo pogosto dobili hudo drisko
English: The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) given once every two weeks.
Slovenian: Priporočeni odmerek zdravila Vectibix je 6 mg/kg (miligramov na kilogram telesne mase) enkrat na dva tedna.
English: Vectibix is used in the treatment of metastatic colorectal cancer (cancer of the bowel) for adult patients with a certain type of tumour known as a “Wild-type RAS tumour”.
Slovenian: Zdravilo Vectibix se uporablja za zdravljenje metastatskega kolorektalnega raka (raka debelega črevesa) pri odraslih bolnikih, ki imajo določen tip tumorja, ki je znan kot »tumor z divjim tipom RAS«.
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).
Slovenian: Pred infundiranjem je treba zdravilo Vectibix razredčiti z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje na končno koncentracijo; ta ne sme preseči 10 mg/ml (navodila za pripravo so navedena v poglavju 6.6).
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.
Slovenian: Bolnike, ki se jim med prejemanjem zdravila Vectibix pojavijo znaki in simptomi, ki kažejo na keratitis, kot so akutni pojav ali poslabšanje: vnetja očesa, solzenja, občutljivosti na svetlobo, zamegljenega vida, bolečine v očesu in/ali rdečih oči, je priporočljivo takoj napotiti k specialistu oftalmologu.
English: Diarrhoea when reported was mainly mild or moderate in severity.
Slovenian: Driska, o kateri so poročali, je bila v glavnem blaga ali zmerno izrazita.
English: Do not use needle-free devices (e.g. vial adapters) to withdraw vial contents.
Slovenian: Da bi izvlekli vsebino iz viale, ne smete uporabljati pripomočkov brez igle (npr. adapterjev za vialo).
English: A predefined retrospective subset analysis of 586 patients of the 597 patients with wild-type KRAS (exon 2) mCRC was performed, where tumour samples from these patients were tested for additional RAS and BRAF mutations as previously described.
Slovenian: Opravljena je bila vnaprej opredeljena retrospektivna analiza podskupine 586 od 597 bolnikov z mKRR z divjim tipom KRAS (ekson 2), pri kateri so vzorce tumorja teh bolnikov testirali glede dodatnih mutacij RAS in BRAF, kot je bilo predhodno opisano.
English: Overall, panitumumab treatment combined with chemotherapy and bevacizumab is associated with an unfavourable benefit-to-risk profile irrespective of tumour KRAS mutational status.
Slovenian: V celoti je zdravljenje s panitumumabom v kombinaciji s kemoterapijo in bevacizumabom povezano z neugodnim profilom koristi in tveganja, ne glede na mutacijsko stanje KRAS tumorja.