natgillin/translations-raw huggingface dataset:
The MAH proposed a wording in line with its Core Data Sheet and provided supporting data. 
Imetnik dovoljenja za promet z zdravilom je predlagal besedilo v skladu s svojim podatkovnim listom in predložil podporne podatke.
The combination of piperacillin and tazobactam in a ratio of 8:1 is effective in the treatment of moderate to severe polymicrobial infections including intra-abdominal, skin and soft-tissue and is approved and marketed for the treatment of a number of infections caused by gram-positive and gram-negative aerobic and anaerobic organisms. 
Kombinacija piperacilina in tazobaktama v razmerju 8:1 je učinkovita za zdravljenje zmernih do hudih polimikrobnih okužb, vključno z okužbami trebušne votline, kože in mehkih tkivih.
The CHMP also implemented a tabular presentation of the doses. 
Uvedel je tudi prikaz odmerkov v preglednici.
The CHMP considered Tazocin to be a very valuable agent due to its broad antibacterial activity including many Gram-positive and Gram-negative pathogens, anaerobes as well as several multi-drug resistant organisms common in nosocomial infections. 
Menil je, da je zdravilo Tazocin zaradi svoje široke protibakterijske aktivnosti, ki pokriva številne grampozitivne in gramnegativne bolezenske povzročitelje, anaerobe ter različne večkratno odporne organizme, ki pogosto povzročajo bolnišnične okužbe, zelo dragoceno sredstvo.
Section 4.2 Posology and method of administration 
Poglavje 4.2 - Odmerjanje in način uporabe
Following discussions with the CHMP drafting group and based on the total available data, the CHMP decided to restrict the indication and adopted the following indication: 
CHMP se je po razpravah s skupino za osnutke in na podlagi vseh razpoložljivih podatkov odločil omejiti indikacijo in sprejel naslednjo indikacijo:
The MAH agreed and the CHMP adopted a harmonised wording for Section 5.3. 
Imetnik dovoljenja za promet z zdravilom se je strinjal in CHMP je sprejel usklajeno besedilo za poglavje 5.3.
The MAH stated that all required information is present in all countries, but the statements differ in the depth of elaborations. 
Imetnik dovoljenja za promet z zdravilom je navedel, da so v vseh državah prisotne vse potrebne informacije, vendar se izjave razlikujejo v izčrpnosti.
The MAH proposal was in line with its Core Data Sheet. 
Predlog imetnika dovoljenja za promet z zdravilom je bil v skladu s podatkovnim listom s temeljnimi podatki.
Information on hypersensitivity to the active substances or any of the other ingredients and class specific hypersensitivity to β-lactams and β-lactamase inhibitors was included and the MAH proposed a harmonised wording in line with its current Core Data Sheet. 
Podatki o preobčutljivosti za zdravilni učinkovini ali kateri koli drugi sestavini zdravila ter o skupinsko specifični preobčutljivosti za laktame beta in zaviralce laktamaz beta so bili vključeni.
The MAH proposed a harmonised wording, in line with its Core Data Sheet. 
Imetnik dovoljenja za promet z zdravilom je predlagal usklajeno besedilo v skladu s trenutnim podatkovnim listom s temeljnimi podatki.
The CHMP adopted a revised harmonised wording for Section 4.7. 
CHMP je sprejel popravljeno usklajeno besedilo poglavja 4.7.
The MAH stated that although the required information is present in all member states, the statements differ in the depth of elaborations. 
Imetnik dovoljenja za promet z zdravilom je navedel, da so vse potrebne informacije prisotne v vseh državah članicah, vendar se izjave razlikujejo v izčrpnosti.
The CHMP agreed to the revised proposal and adopted a harmonised wording for Section 5.1. 
CHMP se je s popravljenih predlogom strinjal in sprejel usklajeno besedilo za poglavje
Regarding HAP, the CHMP noted the presented comparative studies which included patients with HAP only, HAP including VAP or VAP only. 
CHMP je v zvezi z bolnišnično pridobljeno pljučnico obravnaval predložene primerjalne študije, ki so vključevale bolnike samo z bolnišnično pridobljeno pljučnico, bolnike z bolnišnično pridobljeno pljučnico, vključno z ventilatorji povezano pljučnico, ali bolnike samo z ventilatorji povezano pljučnico.
The CHMP assessed the submitted data but considered that the terms “respiratory tract infection” (RTI) and “lower respiratory tract infections” (LRTI) are non-specific and that their precise meaning is open to interpretation and therefore separated the discussion into community acquired pneumonia (CAP) and hospital acquired pneumonia (HAP), including ventilator acquired pneumonia (VAP). 
CHMP je ovrednotil predložene podatke in menil, da sta izraza „okužba dihal“ in „okužba spodnjih dihal“ nespecifična in da je njun natančen pomen odvisen od interpretacije.
The CHMP adopted a harmonised wording for Section 4.6. 
CHMP je sprejel usklajeno besedilo poglavja 4.6.
In conclusion, the CHMP adopted a harmonised wording for Section 4.9. 
CHMP je sprejel usklajeno besedilo za poglavje 4.9.
The CHMP adopted a harmonised wording for Section 4.3. 
CHMP je sprejel usklajeno besedilo poglavja 4.3.
The CHMP adopted a harmonised wording for Section 4.4. 
CHMP je sprejel usklajeno besedilo poglavja 4.4.
In conclusion, the CHMP adopted a harmonised wording for Section 4.2. 
CHMP je sprejel usklajeno besedilo za poglavje 4.2.
The MAH presented a proposed wording in line with its Core Data Sheet. 
Imetnik dovoljenja za promet z zdravilom je predstavil predlog v skladu s podatkovnim listom s temeljnimi podatki.
The CHMP concluded that the MAH provided satisfactory evidence demonstrating the efficacy of 
CHMP je menil, da je imetnik dovoljenja za promet z zdravilom predložil zadostne dokaze o učinkovitosti zdravila Tazocin za zdravljenje okužbe spodnjih dihal.
c Based on laboratory assessments. 
c Na podlagi laboratorijskih ocen.
Such reactions may be allergic. 
Takšne reakcije so lahko alergijske.
Availability of resuscitation equipment must be ensured. 
Zagotoviti je treba razpoložljivost opreme za oživljanje.
The causes of these deaths and their relationship to treatment were not always known. 
Vzroki za te smrti in njihova povezanost z zdravljenjem niso bili vedno znani.
This corresponds to a half-life of approximately 14 days. 
To ustreza razpolovnemu času, ki znaša približno 14 dni.
Eleven of the 12 patients had an unwitnessed death. 
Pri enajstih od 12 bolnikov je prišlo do smrti brez prič.
a MedDRA preferred term (Version 16). 
a Priporočeni izraz po MedDRA (različica 16).
Portrazza should not be given to patients under the age of 18 years because there is no information about how it works in this age group. 
Zdravila Portrazza se ne sme dajati bolnikom, mlajšim od 18 let, saj ni podatkov o njegovem delovanju v tej starostni skupini.
The predicted time to reach steady state was approximately 70 days. 
Predvideni čas za doseganje stanja dinamičnega ravnovesja je bil približno 70 dni.
• Monitor patient for worsening of condition. 
• Bolnika spremljajte glede poslabšanja stanja.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 February 2016 
Datum prve odobritve: 15. februar 2016
Portrazza may increase this risk. 
Zdravilo Portrazza lahko to tveganje poveča.
The onset of events occurred mainly during the first cycle of treatment. 
Ti dogodki so se pojavili v glavnem v času prvega cikla zdravljenja.
Efficacy results are shown in Table 4. 
Rezultati učinkovitosti so prikazani v Preglednici 4.
If these levels are too low, your doctor may prescribe appropriate supplements. 
Če bodo te ravni prenizke, vam bo zdravnik morda predpisal ustrezna dopolnila.
It is recommended that the prepared dosing solution be used immediately in order to minimize the risk of microbial contamination. 
Priporočljivo je, da pripravljeno raztopino za odmerjanje uporabite takoj, da zmanjšate tveganje za kontaminacijo z mikrobi.
Pre-emptive treatment for skin reaction was not permitted prior to the beginning of the second treatment cycle. 
Profilaktično zdravljenje kožnih reakcij pred začetkom drugega cikla zdravljenja ni bilo dovoljeno.
Special attention should be given to patients with clinical evidence of concomitant infectious conditions including early signs of active infections. 
Posebno pozornost je treba nameniti bolnikom s klinično dokazanimi sočasnimi infekcijskimi stanji, ki vključujejo zgodnje znake aktivnih okužb.
Talk to your doctor or nurse immediately if any of the following applies to you (or you are not sure) during or after treatment with Portrazza: 
Takoj se morate pogovoriti z zdravnikom ali medicinsko sestro, če kar koli od naslednjega velja za vas (ali če niste prepričani, ali to velja za vas) med ali po zdravljenju z zdravilom Portrazza:
Treatment of any infection should be initiated according to local standards. 
Z zdravljenjem morebitne okužbe je treba začeti v skladu z lokalnimi standardi.
Manufacturer Lilly S.A., Avda de la Industria, 30, Alcobendas, Madrid, 28108, Spain 
Izdelovalec Lilly S.A., Avda de la Industria, 30, Alcobendas, Madrid, 28108, Španija
Contraceptive measures or abstinence are recommended. 
Priporočamo kontracepcijske ukrepe ali abstinenco.
Progressively decreasing serum magnesium levels occur frequently (81.3%) and may lead to severe Hypomagnesaemia (18.7%) (see also section 4.8). 
Pogosto se pojavi progresivno zniževanje ravni magnezija v serumu (81,3 %), ki lahko povzroči hudo hipomagneziemijo (18,7 %) (glejte tudi poglavje 4.8).
No overall differences in efficacy between arms were observed in patients above 70 years of age. 
Med skupinama zdravljenja niso opazili razlik v učinkovitosti pri bolnikih, starejših od 70 let.
The risk of fertility impairment is unknown. 
Tveganje za okvare plodnosti je neznano.
Unopened vial 2 years. 
Neodprte viale 2 leti
Your doctor will discuss with you whether you need any preventive measures. 
Zdravnik se bo z vami pogovoril o tem, ali so pri vas potrebni preventivni ukrepi.
Detailed instructions for your doctor or your nurse on how to prepare Portrazza infusion are included at the end of this package leaflet (see ‘Handling instructions'). 
Podrobna navodila za zdravnika ali medicinsko sestro o pripravi infuzije zdravila Portrazza so vključena na koncu tega navodila za uporabo (glejte "Navodila za ravnanje z zdravilom").
The skin effects were consistent with the known class effects of EGFR inhibitors. 
Učinki na kožo so bili konsistentni z znanimi učinki razreda zaviralcev EGFR.
• Immediately and permanently discontinue treatment with necitumumab. 
• Takoj in trajno prekinite zdravljenje z necitumumabom.
Other medicines and Portrazza 
Druga zdravila in zdravilo Portrazza
Your doctor will discuss with you whether you need any preventive measures or early treatment. 
Zdravnik se bo z vami pogovoril o tem, ali so pri vas potrebni preventivni ukrepi ali zgodnje zdravljenje.
Median age was 62 (32-86), 83 % of patients were men; 83.5 % were Caucasian; and 91 % were smokers. 
Mediana starosti je bila 62 let (32-86), 83 % bolnikov je bilo moškega spola; 83,5 % bolnikov je bilo belcev in 91 % bolnikov je bilo kadilcev.
The majority of skin reactions developed during the first cycle of treatment and resolved within 17 weeks after onset (see also section 4.4). 
Večina kožnih reakcij se je razvila v prvem ciklu zdravljenja in je izzvenela v 17 tednih po nastopu (glejte tudi poglavje 4.4).
Most of these side effects usually disappear over time after the end of Portrazza therapy. 
Večina teh stranskih učinkov običajno po zaključku zdravljenja z zdravilom Portrazza sčasoma izzveni.
Recommendations for the management of infusion-related and skin reactions are provided in tables 1 and 2. 
Priporočila za obravnavanje reakcij, povezanih z infuzijo, in kožnih reakcij so navedena v preglednicah 1 in 2.
Store protected from light. 
Shranjujte zaščiteno pred svetlobo.
Patients and physicians should be aware of signs and symptoms of thromboembolism. 
Bolniki in zdravniki morajo biti pozorni na znake in simptome trombembolije.
- Infections If you have signs of infection before start of treatment please tell your doctor. 
- Okužbe Če imate pred začetom zdravljenja znake okužbe, se posvetujte z zdravnikom.
The skin rash commonly resembles acne and often involves the face, upper chest and back, but can affect any area of the body. 
Izpuščaj na koži je običajno podoben aknam in pogosto zajema obraz, zgornji del prsnega koša in hrbet, lahko pa prizadene kateri koli del telesa.
What you need to know before you are given Portrazza 3. 
Kaj morate vedeti, preden boste prejeli zdravilo Portrazza 3.
Venous blood clots are likely to occur in approximately 8 out of 100 patients. 
Krvni strdki v venah Strdki venske krvi se lahko pojavijo pri približno 8 od 100 bolnikov.
Animal studies to assess fertility directly have not been conducted (see section 5.3). 
Študij pri živalih za neposredno oceno plodnosti niso bile opravljene (glejte poglavje 5.3).
No dose reductions are recommended. 
Zmanjšanja odmerkov niso priporočljiva.
The MAH shall ensure that in each Member State where Portrazza (necitumumab) is marketed, all physicians (i.e. oncologists) are notified about the key conditions for the safe use of necitumumab. 
Imetnik dovoljenja za promet mora v vsaki državi članici, kjer se zdravilo Portrazza (necitumumab) trži, zagotoviti, da so vsi zdravniki (tj. onkologi) obveščeni o ključnih pogojih za varno uporabo necitumumaba.
No dose adjustment is necessary for these subpopulations. 
Pri teh populacijah prilagajanje odmerka ni potrebno.
The materials will address the risks concerning arterial / venous thromboembolic events and cardiorespiratory disorders. 
Gradiva bodo obravnavala tveganja v zvezi z arterijskimi/venskimi trombemboličnimi dogodki in kardiorespiratornimi obolenji.
Skin reactions may occur in approximately 80 out of 100 patients who take Portrazza and are usually mild to moderate. 
Kožne reakcije Kožne reakcije se lahko pojavijo pri približno 80 od 100 bolnikov, ki jemljejo zdravilo Portrazza in so običajno blage do zmerne.
The highest dose of necitumumab studied clinically in a human dose-escalation Phase 1 study is 1,000 mg once a week or once every other week. 
Najvišji odmerek necitumumaba, ki so ga klinično preučevali pri ljudeh v študiji faze I. stopnjevanja odmerka, je bil 1000 mg enkrat na teden ali enkrat vsak drugi teden.
In patients with detectable EGFR protein expression, there was no trend observed for increased efficacy with increasing levels of EGFR expression. 
Pri bolnikih z zaznano izraženostjo beljakovine EGFR ni bilo opaziti trenda k povečani učinkovitosti s povečanimi ravnmi izraženosti EGFR.
Hypomagnesaemia may reoccur at the same grade or worse after a dose delay. 
Hipomagneziemija se lahko po zakasnitvi odmerka pojavi ponovno v enaki ali višji stopnji.
Based on animal models, epidermal growth factor receptor (EGFR) is involved in prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo. 
Na podlagi živalskih modelov je receptor epidermalnega rastnega dejavnika (EGFR) vključen v prenatalni razvoj in je lahko ključnega pomena za normalno organogenezo, proliferacijo in diferenciacijo pri razvijajočem se zarodku.
What Portrazza is and what it is used for 2. 
Kaj je zdravilo Portrazza in za kaj ga uporabljamo 2.
Patients underwent radiographic assessment of disease status every six weeks, until radiographic documentation of progressive disease (PD). 
Bolnikom so vsakih šest tednov ocenili bolezen s pomočjo radiografije do radiografske dokumentacije o napredovanju bolezni.
Contraceptive measures or abstinence are recommended (see section 4.6). 
Priporočamo kontracepcijske ukrepe ali abstinenco (glejte poglavje 4.6).
Use of post-study systemic therapy was similar in the 2 arms (47.3 % in the Portrazza+GC arm and 44.7 % in the GC arm). 
Uporaba sistemskega zdravljenja po zaključku študije je bila v obeh skupinah podobna (47,3 % v skupini Portrazza+GC in 44,7 % v skupini GC).
Prompt electrolyte repletion is recommended, as appropriate. 
Po potrebi se priporoča takojšnje nadomeščanje elektrolitov.
Grade 3-4 • Immediately and permanently discontinue treatment with necitumumab. 
Stopnja 3-4 • Takoj in trajno prekinite zdravljenje z necitumumabom.
Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity. 
Kot pri vseh beljakovinskih zdravilih, obstaja možnost nastanka imunogenosti.
A tumour was considered to be EGFRexpressing if at least one stained cell could be identified. 
Upoštevali so, da tumor izraža EGFR, če je bilo mogoče določiti najmanj eno obarvano celico.
The infusion duration should not exceed 2 hours. 
Trajanje infuzije ne sme preseči 2 ur.
The protein is known as epidermal growth factor receptor (EGFR). 
To beljakovino poznamo po imenu receptor za epidermalni rastni dejavnik (EGFR
The major efficacy outcome measure was overall survival (OS) and the supportive efficacy outcome measure was progression-free survival (PFS). 
Glavno merilo učinkovitosti je bilo celokupno preživetje (OS-overall survival), podporno merilo učinkovitosti pa preživetje brez poslabšanja bolezni (PFS-progression-free survival).
• Following improvement to Grade ≤ 2, resume at reduced dose of 
• Po izboljšanju do stopnje ≤ 2 nadaljujte z zmanjšanim odmerkom
Abbreviations: C = cisplatin; G = gemcitabine. 
Okrajšave: C = cisplatin; G = gemcitabin.
If you have an infusion-related reaction during treatment, your drip will be slowed down and future doses will also be given more slowly. 
Če se med zdravljenjem pojavi reakcija, povezana z infuzijo, bodo infuzijo upočasnili in tudi prihodnje infuzije boste prejeli počasneje.
Name and address of the manufacturer(s) of the biological active substance(s) ImClone Systems LLC 
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine ImClone Systems LLC
Portrazza should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the foetus. 
Zdravila Portrazza se ne sme uporabljati med nosečnostjo ter pri ženskah, ki ne uporabljajo učinkovite kontracepcije, razen če možne koristi za mater upravičujejo možna tveganja za plod.
It is administered as an intravenous infusion over approximately 60 minutes via an infusion pump. 
Zdravilo se daje kot intravenska infuzija v približno 60 minutah prek infuzijske črpalke.
It is available in packs of: - 1 vial of 50 mL 
Zdravilo je na voljo v pakiranjih po: - 1 viala po 50 ml
This leaflet was last revised in <{month YYYY}>. 
Navodilo je bilo nazadnje revidirano dne {mesec/LLLL}.
Activation of EGFR has been correlated with malignant progression, induction of angiogenesis and inhibition of apoptosis or cell death. 
Aktivacija EGFR je bila povezana z napredovanjem malignosti, indukcijo angiogeneze in zaviranjem apoptoze ali celične smrti.
Abbreviations: GC = gemcitabine and cisplatin alone; Portrazza+GC = necitumumab plus gemcitabine and cisplatin; MedDRA = Medical Dictionary for Regulatory Activities. 
Okrajšave: GC = samo gemcitabin in cisplatin; Portrazza+GC = necitumumab in gemcitabin ter cisplatin; MedDRA = podatkovna baza Medical Dictionary for Regulatory Activities (medicinski slovar za regulatorne aktivnosti).
In approximately 5 out of 100 patients these skin reactions are likely to be severe. 
Pri približno 5 od 100 bolnikov so te kožne reakcije lahko hude.
Permanently discontinue if symptoms do not resolve to Grade ≤ 2 after holding for 2 consecutive cycles (6 weeks) 
Trajno prekinite zdravljenje, če se simptomi ne izboljšajo do stopnje ≤ 2 po prekinitvi, ki je trajala 2 zaporedna cikla (6 tednov).
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept is posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC22 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC22
Adverse events observed included headache, vomiting and nausea and were consistent with the safety profile at the recommended dose. 
Neželeni učinki, ki so jih opazili, so vključevali glavobol, bruhanje in navzeo in so bili skladni z varnostnim profilom za priporočeni odmerek.
If a decreased infusion rate is indicated, the infusion duration should not exceed 2 hours. 
Če je indicirana zmanjšana hitrost infundiranja, trajanje infuzije ne sme preseči 2 ur.
Administer via an infusion pump. 
Dajajte prek infuzijske črpalke.
See section 4 for more details about skin reactions. 
Glejte poglavje 4 za več podatkov o kožnih reakcijah.
The large majority of patients (95.2% of evaluable patients; n = 935) had tumor samples expressing EGFR protein; 4.8% (n = 47) were not detectable for EGFR protein expression. 
Velika večina bolnikov (95,2 % bolnikov, ki jih je bilo mogoče oceniti; n = 935) je imela vzorce tumorja, ki je izražal beljakovino EGFR; pri 4,8 % bolnikov (n = 47) ni bilo mogoče določiti izraženosti beljakovine EGFR.
A doctor experienced in the use of anti-cancer medicines will supervise your Portrazza therapy. 
Zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka, bo nadziral vaše zdravljenje z zdravilom Portrazza.
However, no adverse effects on male or female reproductive organs were observed in monkeys treated for 26 weeks with necitumumab. 
Kljub temu pa niso opazili nobenih neželenih učinkov na reproduktivne organe samcev in samic opic, ki so bile 26 tednov zdravljene z necitumumabom.
The concentrate must be diluted before use (see section 6.6). 
Koncentrat je treba pred uporabo razredčiti (glejte poglavje 6.6).
Although modeling results suggest that the disposition of necitumumab was statistically dependent on body weight, simulations indicated that weight-based dosing would not significantly decrease PK variability. 
Čeprav so modelirani rezultati nakazali, da bi bilo odstranjevanje necitumumaba lahko statistično odvisno od telesne mase, pa je simulacija pokazala, da odmerjanje na podlagi telesne mase ne bi pomembno zmanjšalo farmakokinetično variabilnost.
What Portrazza is and what it is used for 
Kaj je zdravilo Portrazza in za kaj ga uporabljamo
Prepare the infusion solution using the aseptic technique to ensure the sterility of the prepared solution. 
Pripravite raztopino za infundiranje z uporabo aseptične tehnike, da boste zagotovili sterilnost pripravljene raztopine.
Necitumumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology. 
Necitumumab je humano monoklonsko protitelo IgG1, izdelano v celicah glodavcev (NS0) s pomočjo rekombinantne DNK tehnologije.
Only patients with baseline and at least one post-baseline result are included. 
Vključeni so le bolniki z rezultatom v izhodišču in najmanj enim rezultatom po izhodišču.
A pre-planned exploratory analysis performed after the primary analysis, determined clinical efficacy outcome according to the level of tumour EGFR protein expression. 
Vnaprej načrtovana poskusna analiza, ki so jo opravili po primarni analizi, je pokazala na klinično učinkovitost, skladno z ravnjo izraženosti beljakovine EGFR v tumorju.
• Decrease infusion rate by 50 % for the duration of infusion.b 
• Zmanjšajte hitrost infuzije za 50 % v celotnem času infundiranja.b
If symptoms worsen at 400 mg, permanently discontinue. 
Če se simptomi pri odmerku 400 mg poslabšajo, trajno prekinite zdravljenje.
Skin reactions were reported in approximately 78 % of patients and mainly presented as acneiform rash, dermatitis acneiform, dry skin, pruritus, skin fissures, paronychia and palmar-plantar erythrodysaesthesia syndrome. 
O kožnih reakcijah so poročali pri približno 78 % bolnikov in so večinoma predstavljale aknam podoben izpuščaj, akneiformni dermatitis, suho kožo, pruritus, fisure na koži, paronihijo in sindrom palmarno-plantarne eritrodizestezije.
Demographics and baseline characteristics were balanced between arms. 
Demografski podatki in izhodiščne lastnosti bolezni so bili uravnoteženi med skupinama.
In addition, necitumumab induces EGFR internalization and degradation in vitro. 
Poleg tega necitumumab inducira internalizacijo EGFR in njegovo degradacijo in vitro.