FrancophonIA/ELRC3.0 huggingface dataset:
English: There were significant dose reductions and delays of capecitabine or oxaliplatin administration mainly due to higher frequency of diarrhoea in the cetuximab containing arm.
Slovenian: Prišlo je do pomembnega zmanjšanja odmerkov in zakasnitve pri dajanju kapecitabina ali oksaliplatina, predvsem zaradi višje pogostnosti driske v skupini, ki je prejemala cetuksimab.
English: Take an appropriate sterile syringe and attach a suitable needle.
Slovenian: Vzemite ustrezno sterilno brizgo in nanjo pritrdite primerno iglo.
English: The initial dose is 400 mg cetuximab per m body surface area.
Slovenian: Začetni odmerek je 400 mg cetuksimaba na m² telesne površine.
English: Cetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology.
Slovenian: Cetuksimab je himerno monoklonsko IgG1 protitelo, izdelano v sesalski celični liniji (Sp2/0) z uporabo tehnologije rekombinantne DNA.
English: Mean peak cetuximab concentrations were 155.8 microgram per mL in week 3 and 151.6 microgram per mL in week 8, whereas the corresponding mean trough concentrations were 41.3 and 55.4 microgram per mL, respectively.
Slovenian: Srednja največja koncentracija cetuksimaba je bila 155,8 mikrograma/ml v 3. tednu in 151,6 mikrograma/ml v 8. tednu, ustrezna srednja najmanjša koncentracija pa je bila 41,3 mikrograma/ml in 55,4 mikrograma/ml.
English: What Erbitux is and what it is used for
Slovenian: Kaj je zdravilo Erbitux in za kaj ga uporabljamo
English: Your doctor will decide whether such pre-treatment is necessary for subsequent doses.
Slovenian: Vaš zdravnik se bo odločil, ali je taka premedikacija potrebna tudi pri naslednjih odmerkih.
English: In time related endpoints no trends indicating clinical benefit could be shown for patients who received cetuximab in combination with the XELOX regimen.
Slovenian: Pri od časa odvisnih končnih rezultatih študije ni bilo trendov, ki bi kazali na to, da so imeli bolniki, ki so prejemali cetuksimab v kombinaciji z režimom XELOX, klinične koristi.
English: Similar findings were also reported when cetuximab was given as add-on to XELOX in combination with bevacizumab (CAIRO2).
Slovenian: O podobnih izsledkih so poročali tudi, ko so cetuksimab dajali kot dodatno zdravilo k zdravilu XELOX v kombinaciji z bevacizumabom (CAIRO2).
English: A tumour was considered to be EGFR-expressing, if one stained cell could be identified.
Slovenian: Šteli so, da tumor izraža EGFR, če so našli eno obarvano celico.
English: Mild or moderate infusion-related reactions (see section 4.4); mucositis, in some cases severe.
Slovenian: blage ali zmerne reakcije, povezane z infundiranjem (glejte poglavje 4.4); mukozitis, v nekaterih primerih resen.
English: • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
Slovenian: • kot samostojno zdravilo pri bolnikih, pri katerih zdravljenje z oksaliplatinom in zdravljenje na osnovi irinotekana ni bilo uspešno in pri bolnikih, ki ne prenašajo irinotekana.
English: From the KRAS evaluated population 64% of the patients (192) had KRAS wildtype tumours and 108 patients KRAS mutations.
Slovenian: Iz populacije, pri katerih so ocenili tip KRAS, je imelo 64 % bolnikov (192) tumorje nemutiranega tipa KRAS in 108 bolnikov mutacije tipa KRAS.
English: Cetuximab should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Slovenian: Cetuksimab je treba uporabljati previdno pri bolnikih z anamnezo keratitisa, ulcerativnega keratitisa ali zelo suhih oči.
English: Erbitux 5 mg/mL is administered intravenously with an infusion pump, gravity drip or a syringe pump (for handling instructions, see section 6.6).
Slovenian: Zdravilo Erbitux 5 mg/ml se daje z intravensko infuzijo, in sicer z infuzijsko črpalko, težnostno kapalno infuzijo ali črpalko za brizgo (za navodila za pripravo glejte poglavje 6.6).
English: When prescribing cetuximab, the cardiovascular and performance status of the patients and concomitant administration of cardiotoxic compounds such as fluoropyrimidines should be taken into account.
Slovenian: Pri predpisovanju cetuksimaba je treba upoštevati kardiovaskularno stanje in indeks zmogljivosti bolnika in sočasno dajanje kardiotoksičnih učinkovin kot so fluoropirimidini.
English: • loss of appetite, leading to weight decrease
Slovenian: • izguba teka, kar povzroči zmanjšanje telesne mase
English: MARKETING AUTHORISATION NUMBERS EU/1/04/281/003
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/04/281/003
English: Your doctor may consider reducing the infusion rate of Erbitux to manage these symptoms.
Slovenian: Zdravnik vam bo po potrebi zmanjšal hitrost infuzije zdravila Erbitux, da bi ublažil te simptome.
English: The European Medicines Agency has waived the obligation to submit the results of studies with cetuximab in all subsets of the paediatric population in the indications adenocarcinoma of the colon and rectum and oropharyngeal, laryngeal or nasal epithelial carcinoma (excluding nasopharyngeal carcinoma or lymphoepithelioma, see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s cetuksimabom za vse podskupine pediatrične populacije za indikacije adenokcarcinoma debelega črevesa in danke ter za karcinom orofaringealnega, laringealnega ali nazalnega epitelija (razen nazofaringealnega karcinoma ali limfoepitelioma; za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: However, in preclinical wound healing models EGFR selective tyrosine kinase inhibitors were shown to retard wound healing.
Slovenian: V predkliničnih modelih celjenja ran pa se je izkazalo, da za EGFR selektivni zaviralci tirozinske kinaze upočasnijo celjenje ran.
English: There is no relevant use of cetuximab in the paediatric population in the granted indications.
Slovenian: Cetuksimab ni namenjen za uporabo pri pediatrični populaciji za odobrene indikacije.
English: Immunohistochemical detection of EGFR expression was not performed since more than 90% of patients with squamous cell cancer of the head and neck have tumours that express EGFR.
Slovenian: Imunohistokemičnega določanja ekspresije EGFR niso izvajali, ker se EGFR izraža v tumorjih pri več kot 90% bolnikih z rakom skvamoznih celic glave in vratu.
English: Do not use Erbitux
Slovenian: Ne uporabljajte zdravila Erbitux
English: Erbitux is contraindicated in patients with known severe (grade 3 or 4) hypersensitivity reactions to cetuximab.
Slovenian: Zdravilo Erbitux je kontraindicirano pri bolnikih z znano hudo preobčutljivostno reakcijo (3. ali 4. stopnje) na cetuksimab.
English: • in first-line in combination with FOLFOX,
Slovenian: • kot primarno zdravljenje v kombinaciji s FOLFOX;
English: Cetuximab was started one week before radiation therapy and administered at the doses described in section 4.2 until the end of the radiation therapy period.
Slovenian: Cetuksimab so začeli dajati en teden pred radioterapijo in so ga dajali do konca obdobja radioterapije, v odmerkih opisanih v poglavju 4.2.
English: Headache.
Slovenian: glavobol.
English: Cetuximab binds to the epidermal growth factor receptor (EGFR), an antigen on the surface of certain cancer cells.
Slovenian: Cetuksimab se veže na receptor za epidermalni rastni faktor (EGFR, epidermal growth factor receptor), antigen na površini nekaterih rakavih celic.
English: Frequency not known: Aseptic meningitis.
Slovenian: aseptični meningitis.
English: Mild or moderate infusion-related reactions are very common comprising symptoms such as fever, chills, dizziness, or dyspnoea that occur in a close temporal relationship mainly to the first cetuximab infusion.
Slovenian: Zelo pogoste so blage ali zmerne reakcije, povezane z infundiranjem, ki vključujejo simptome, kot so zvišana telesna temperatura, mrzlica, omotica ali dispneja, ki se pojavijo časovno zelo povezano zlasti s prvim infundiranjem cetuksimaba.
English: Patients who receive cetuximab in combination with platinum-based chemotherapy are at an increased risk for the occurrence of severe neutropenia, which may lead to subsequent infectious complications such as febrile neutropenia, pneumonia or sepsis.
Slovenian: Pri bolnikih, ki prejemajo cetuksimab v kombinaciji s kemoterapijo na osnovi platine, obstaja večje tveganje za pojav hude nevtropenije, ki lahko povzroči nadaljnje zaplete zaradi okužb, kot je febrilna nevtropenija, pljučnica ali sepsa.
English: Toxicity studies with co-administration of cetuximab and chemotherapeutic agents have not been performed.
Slovenian: Študije toksičnosti pri sočasni uporabi cetuksimaba in kemoterapevtikov niso bile opravljene.
English: If you receive Erbitux in combination with radiation therapy, treatment with Erbitux is usually started one week before radiation therapy.
Slovenian: Če zdravilo Erbitux prejemate v kombinaciji z obsevanjem, se zdravljenje z zdravilom Erbitux navadno začne en teden pred obsevanjem.
English: • redness and swelling of the palms of the hands or the soles of the feet which may cause the skin to peel (hand-foot syndrome)
Slovenian: • rdečica in otekanje dlani ali podplatov, ki lahko povzroči luščenje kože (sindrom dlani in stopal)
English: The combination of Erbitux with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS metastatic colorectal cancer (mCRC) or for whom RAS mCRC status is unknown (see also section 4.4).
Slovenian: Kombinacija zdravila Erbitux s kemoterapijo, ki vsebuje oksaliplatin, je kontraindicirana pri bolnikih z metastatskim kolorektalnim rakom (mCRC, metastatic colorectal cancer) z mutiranim tipom RAS ali kadar mCRC status RAS ni znan (glejte tudi poglavje 4.4).
English: It is recommended to start cetuximab therapy one week before radiation therapy and to continue cetuximab therapy until the end of the radiation therapy period.
Slovenian: Priporoča se, da se zdravljenje s cetuksimabom začne en teden pred radioterapijo in da se nadaljuje do konca obdobja radioterapije.
English: Please also read 'Side effects concerning the skin' in section 4 for details, as some skin reactions may have serious consequences for you, including life-threatening conditions.
Slovenian: Za podrobnosti preberite tudi poglavje 4 "Neželeni učinki, povezani s kožo", saj imajo lahko nekatere kožne reakcije za vas hude posledice, vključno take, ki so lahko smrtno nevarne.
English: In vitro cetuximab inhibits the production of angiogenic factors by tumour cells and blocks endothelial cell migration.
Slovenian: In vitro cetuksimab zavira tvorbo angiogenih faktorjev v tumorskih celicah in blokira migracijo endotelijskih celic.
English: CRS is normally most severe in relation to the first infusion.
Slovenian: Sindrom sproščanja citokinov je običajno najbolj resen v povezavi s prvim infundiranjem.
English: Intravenous infusions of cetuximab exhibited dose-dependent pharmacokinetics at weekly doses ranging from 5 to 500 mg/m body surface area.
Slovenian: Pri intravenskem infundiranju cetuksimaba so ugotavljali od odmerka odvisno farmakokinetiko s tedenskimi odmerki od 5 do 500 mg/m² telesne površine.
English: Determination of serum electrolyte levels is recommended prior to and periodically during cetuximab treatment.
Slovenian: Priporoča se določanje koncentracije elektrolitov v serumu pred zdravljenjem in periodično med zdravljenjem s cetuksimabom.
English: Severe infusion-related reactions, including anaphylactic reactions, may commonly occur, in some cases with fatal outcome.
Slovenian: Pogosto se lahko pojavijo hude reakcije, povezane z infundiranjem, vključno z anafilaktičnimi, v nekaterih primerih s smrtnim izidom.
English: No clinical benefit could be demonstrated in patients with KPS ≤ 80 who were 65 years of age or older.
Slovenian: Klinične koristi ni bilo možno pokazati pri bolnikih, ki so imeli KPS ≤ 80 in so bili stari ≥ 65.
English: Main side effects concerning the skin include:
Slovenian: Glavni neželeni učinki, povezani s kožo, so:
English: Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS and NRAS (exons 2, 3, and 4) mutations (see section 4.4 and 5.1).
Slovenian: Mutacijski status mora ugotoviti izkušen laboratorij z uporabo validiranih testnih metod za detekcijo mutacij genov KRAS in NRAS (eksoni 2, 3 in 4).
English: They generally resolve, without sequelae, over time following cessation of treatment if the recommended adjustments in dose regimen are followed (see section 4.4).
Slovenian: Navadno po koncu zdravljenja sčasoma izginejo brez posledic, če upoštevate priporočeno prilagoditev odmerjanja (glejte poglavje 4.4).
English: Cetuximab plus FOLFIRI
Slovenian: Cetuximab in FOLFIRI
English: An integrated analysis across all clinical studies showed that the pharmacokinetic characteristics of cetuximab are not influenced by race, age, gender, renal or hepatic status.
Slovenian: Integrirana analiza vseh kliničnih študij je pokazala, da rasa, starost, spol ter delovanje ledvic ali jeter ne vplivajo na farmakokinetične značilnosti cetuksimaba.
English: They normally occur during the infusion, within 1 hour afterwards, or sometimes also after this period.
Slovenian: Navadno se pojavijo med infundiranjem, eno uro po njem, včasih pa tudi pozneje.
English: If interstitial lung disease is diagnosed, cetuximab must be discontinued and the patient be treated appropriately.
Slovenian: Če ugotovite intersticijsko bolezen pljuč, morate zdravljenje s cetuksimabom prekiniti, in bolnika ustrezno zdraviti.
English: • For administration with infusion pump or gravity drip (undiluted): Calculate the required volume of Erbitux.
Slovenian: • Za uporabo z infuzijsko črpalko ali težnostno kapalno infuzijo (nerazredčeno): Izračunajte potrebni volumen zdravila Erbitux.
English: In a study of cetuximab administered in combination with irinotecan, the mean cetuximab trough levels were 50.0 microgram per mL in week 12 and 49.4 microgram per mL in week 36.
Slovenian: V študiji kombinirane terapije s cetuksimabom in irinotekanom je bila srednja najmanjša koncentracija 50,0 mikrograma/ml v 12. tednu in 49,4 mikrograma/ml v 36. tednu.
English: Cetuximab in combination with radiation therapy for locally advanced disease
Slovenian: Cetuksimab v kombinaciji z radioterapijo za lokalno napredovalo bolezen
English: Frequency not known:Superinfection of skin lesions*.
Slovenian: superinfekcija kožnih lezij*.
English: Only in study EMR 62 202-007, a post-hoc analysis was not possible.
Slovenian: Post-hoc analiza ni bila mogoča samo v študiji EMR 62 202-007.
English: In the KRAS wild-type population of the CALGB/SWOG 80405 study (n=1137), superiority of cetuximab plus chemotherapy over bevacizumab plus chemotherapy was not shown based on an interim analysis.
Slovenian: Za populacijo nemutiranega tipa KRAS v študiji CALGB/SWOG 80405 (n = 1.137) na podlagi vmesne analize ni bila dokazana superiornost cetuksimaba in kemoterapije pred bevacizumabom in kemoterapijo.
English: Side effects in combination with other anticancer treatments
Slovenian: Neželeni učinki pri kombinaciji z drugimi oblikami zdravljenja proti raku
English: This may lead to infectious complications including life-threatening conditions, especially if you experience skin reactions, inflammation of the lining of the intestine and mouth or diarrhoea.
Slovenian: To lahko povzroči zaplete zaradi okužb, vključno s smrtno nevarnimi boleznimi, še posebej, če se pojavijo kožne reakcije, vnetje črevesja in ustne sluznice ali driska.
English: Skin lesions induced by cetuximab may predispose patients to superinfections (e.g. with S. aureus), which may lead to subsequent complications, e.g. cellulitis, erysipelas, or, potentially with fatal outcome, staphylococcal scalded skin syndrome, necrotising fasciitis or sepsis.
Slovenian: Kožne razjede, ki jih povzroča cetuksimab, so lahko vzrok za pojav superinfekcij (npr. z bakterijo S. aureus), ki lahko povzročijo zaplete, kot so celulitis, erizipel ali, potencialno s smrtnim izidom, stafilokokni sindrom luščenja kože, nekrotizirajoči fasciitis ali sepso.
English: In combination with platinum-based chemotherapy, the frequency of severe leukopenia or severe neutropenia may be increased, and thus may lead to a higher rate of infectious complications such as febrile neutropenia, pneumonia and sepsis compared to platinum-based chemotherapy alone (see section 4.4).
Slovenian: V kombinaciji s kemoterapijo na osnovi platine se lahko pogostnost hude levkopenije ali hude nevtropenije poveča, kar lahko poveča pogostnost zapletov zaradi okužb, kot je febrilna nevtropenija, pljučnica ali sepsa, v primerjavi s kemoterapijo na osnovi platine brez cetuksimaba (glejte poglavje 4.4).
English: When cetuximab is used in combination with chemotherapeutic agents, also refer to their respective product information.
Slovenian: Kadar se cetuksimab uporablja v kombinaciji s kemoterapevtiki, glejte tudi zadevne informacije o zdravilu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/20 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg/20 ml
English: • decrease in blood levels of magnesium
Slovenian: • zmanjšana raven magnezija v krvi
English: Study data demonstrate that patients with metastatic colorectal cancer and activating RAS mutations are highly unlikely to benefit from treatment with cetuximab or a combination of cetuximab and chemotherapy and as add-on to FOLFOX4 a significant negative effect on progression-free survival time (PFS) was shown.
Slovenian: Podatki iz študije so pokazali, da je malo verjetno, da bi bolnikom z metastatskim kolorektalnim rakom in z aktivacijskimi mutacijami RAS zdravljenje s cetuksimabom ali kombinacijo cetuksimaba in kemoterapije koristilo, v primeru, da je šlo za dodatno zdravilo k FOLFOX4, pa so se pokazali pomembni negativni učinki na čas preživetja brez napredovanja bolezni (PFS).
English: Erbitux 5 mg/mL solution for infusion is supplied in vials containing 20 mL or 100 mL.
Slovenian: Erbitux 5 mg/ml raztopina za infundiranje je na voljo v vialah z 20 ml ali 100 ml raztopine.
English: Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Slovenian: Infundiranje zdravila Erbitux mora potekati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil z delovanjem na novotvorbe.
English: Cetuximab serum concentrations reached stable levels after three weeks of cetuximab monotherapy.
Slovenian: Serumske koncentracije cetuksimaba so dosegle stalno raven po treh tednih monoterapije s cetuksimabom.
English: In addition, cetuximab was investigated in combination with chemotherapy in an investigator-initiated randomised controlled phase-III study (COIN, COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy).
Slovenian: Poleg tega so cetuksimab raziskovali v kombinaciji s kemoterapijo v randomizirani kontrolirani študiji 3. faze na pobudo raziskovalca (stalna kemoterapija s cetuksimabom ali občasno kemoterapijoCOIN (COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy)).
English: Of these, 362 patients received cetuximab and oxaliplatin plus fluoropyrimidines (117 patients OxMdG and 245 patients XELOX) and 367 patients received oxaliplatin plus fluoropyrimidines alone (127 patients OxMdG and 240 patients XELOX).
Slovenian: Med njimi je 362 bolnikov prejelo cetuksimab in oksaliplatin ter fluoropirimidin (117 bolnikov OxMdG in 245 bolnikov XELOX), 367 bolnikov je prejelo samo oksaliplatin in fluoropirimidin (127 bolnikov OxMdG in 240 bolnikov XELOX).
English: In a randomised controlled clinical study with 424 patients, reporting rates of severe acute radiation dermatitis and mucositis as well as of late radiation-therapy-related events were slightly higher in patients receiving radiation therapy in combination with cetuximab than in those receiving radiation therapy alone.
Slovenian: V randomizirani, nadzorovani klinični študiji, v kateri je sodelovalo 424 bolnikov, je bila pogostnost hudega akutnega radiacijskega dermatitisa in mukozitisa ter tudi zakasnelih neželenih učinkov, povezanih z radioterapijo, o katerih so poročali, nekoliko večja pri bolnikih, ki so prejemali radioterapijo v kombinaciji s cetuksimabom, kot pri bolnikih, ki so prejemali radioterapijo v monoterapiji.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/281/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/281/003
English: When cetuximab was administered at an initial dose of 400 mg/m 2 body surface area, the mean volume of distribution was approximately equivalent to the vascular space (2.9 L/m 2 with a range of
Slovenian: Ko so cetuksimab dajali v začetnem odmerku 400 mg/m² telesne površine, je bil srednji porazdelitveni volumen približno enak znotrajžilnemu prostoru (2,9 l/m², razpon od 1,5 do 6,2 l/m²).
English: What Erbitux looks like and contents of the pack
Slovenian: Izgled zdravila Erbitux in vsebina pakiranja
English: • For administration with a syringe pump: Calculate the required volume of Erbitux.
Slovenian: • Za uporabo s črpalko za brizgo: Izračunajte potreben volumen zdravila Erbitux.
English: Transfer the Erbitux into a sterile evacuated container or bag.
Slovenian: Prenesite zdravilo Erbitux v sterilen prazen vsebnik ali vrečo.
English: For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these medicinal products.
Slovenian: Za odmerjanje ali priporočene spremembe odmerka sočasno uporabljenih kemoterapevtikov glejte informacije za ta zdravila.
English: They must not be administered earlier than 1 hour after the end of the cetuximab infusion.
Slovenian: Ne smejo se dati prej kot 1 uro po koncu infuzije cetuksimaba.
English: In both in vitro and in vivo assays, cetuximab inhibits the proliferation and induces apoptosis of human tumour cells that express EGFR.
Slovenian: Tako v in vitro kot v in vivo testih cetuksimab zavira proliferacijo in inducira apoptozo človeških tumorskih celic z ekspresijo EGFR.
English: In these patients, Erbitux is used alone or in combination with other anticancer medicines.
Slovenian: Pri teh bolnikih se zdravilo Erbitux uporablja samostojno ali skupaj z drugimi zdravili proti raku.
English: In the overall population, irrespective of KRAS status, the results reported for cetuximab plus irinotecan (648 patients) vs. irinotecan alone (650 patients) were: median overall survival time (OS) 10.71 vs. 9.99 months (HR 0.98), median progression free survival time (PFS) 4.0 vs. 2.6 months (HR 0.69), and objective response rate (ORR) 16.4% vs. 4.2%.
Slovenian: Pri celokupni populaciji ne glede na status KRAS so bili rezultati, o katerih so poročali za cetuksimab in irinotekan (648 bolnikov) v primerjavi s samo irinotekanom (650 bolnikov) naslednji: mediana celokupnega preživetja (OS) 10,71 v primerjavi z 9,99 meseci (razmerje tveganja 0,98), mediana časa preživetja brez napredovanja bolezni (PFS) 4,0 v primerjavi z
English: Special attention is recommended for patients with reduced performance status and pre-existing cardiopulmonary disease.
Slovenian: Pri bolnikih z zmanjšanim indeksom zmogljivosti in pri tistih z obstoječo srčno-pljučno boleznijo je priporočljiva posebna pozornost.
English: It is recommended that cetuximab treatment be continued until progression of the underlying disease.
Slovenian: Priporočljivo je, da z zdravljenjem s cetuksimabom nadaljujete do napredovanja osnovne bolezni.
English: Mild or moderate infusion-related side effects include:
Slovenian: Blagi ali zmerni neželeni učinki, povezani z infundiranjem, so:
English: Cetuximab in combination with platinum-based chemotherapy in recurrent and/or metastatic disease
Slovenian: Cetuksimab v kombinaciji s kemoterapijo na osnovi platine pri ponavljajoči se in/ali metastatski bolezni
English: Repeat this procedure until the calculated volume has been infused.
Slovenian: Ponavljajte ta postopek, dokler ne bo infundiran ves izračunani volumen.