natgillin/translations-raw huggingface dataset:
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.
b The table reflects the frequency of ADRs during the chemotherapy phase of study treatment in which Portrazza+GC was directly compared with GC.
b Tabela odraža pogostnost neželenih učinkov med fazo kemoterapije študijskega zdravljenja, v katerem so uporabo zdravila Portrazza+GC neposredno primerjali z uporabo GC.
Severe infusion-related reactions were reported in 0.4 % of patients.
O hudih reakcijah, povezanih z infuzijo, so poročali pri 0,4 % bolnikov.
Kaplan Meier plot of overall survival (ITT population)
Slika 1: Kaplan-Meierjeva krivulja celokupnega preživetja (ITT populacija)
Toxicity gradea
Stopnja toksičnostia
Table 2 - Management recommendations for skin reactions Toxicity gradea
Preglednica 2 - Priporočila za obravnavanje kožnih reakcij
Patients should be monitored during infusion for signs of infusion-related reactions (see section 4.4).
Bolnike je med infuzijo treba spremljati glede pojava znakov reakcij, povezanih z infuzijo (glejte poglavje 4.4).
Infusion solution: After dilution and preparation, the medicine must be used immediately.
Raztopina za infundiranje: Zdravilo je treba uporabiti takoj po razredčenju in pripravi.
Of the ITT population, 982 patients (89.8%) were evaluable for an EGFR protein expression analysis by immunohistochemistry (IHC) using Dako PharmDx Kit.
V ITT populaciji je bilo 982 bolnikov (89,8 %) mogoče oceniti z analizo izraženosti beljakovine EGFR s pomočjo imunohistokemijske preiskave (IHC-immunohistochemistry), ki uporablja komplet Dako PharmDx.
The majority of infusion-related reactions developed after the first or second administration of necitumumab.
Večina reakcij, povezanih z infuzijo, se je razvila po prvem ali drugem dajanju necitumumaba.
Prior to launch of Portrazza (necitumumab) in each Member State the MAH must agree about the content and format of the educational material, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
• Dodatni ukrepi za zmanjševanje tveganj Pred pričetkom trženja zdravila Portrazza (necitumumab) se mora imetnik dovoljenja za promet v vsaki državi članici strinjati z vsebino in obliko izobraževalnega gradiva, vključno s sredstvi komunikacije, načini razširjanja in vsemi drugimi vidiki programa, s pristojnim nacionalnim organom.
Infusion-related reactions were reported in 1.5 % of patients and mainly present as chills, fever or dyspnoea.
O reakcijah, povezanih z infuzijo so poročali pri 1,5 % bolnikov in so večinoma predstavljale mrzlico, vročino ali dispnejo.
• Temporarily withhold, for a maximum of 6 weeks following Day 1 of the most recent treatment cycle, until symptoms resolve to Grade ≤ 2.
• Začasno prekinite za največ 6 tednov po 1. dnevu zadnjega cikla zdravljenja, dokler se simptomi ne izboljšajo do stopnje ≤ 2.
In the Portrazza+GC arm, 51 % of patients continued with single-agent Portrazza after completing chemotherapy.
skupini Portrazza+GC je 51 % bolnikov nadaljevalo zdravljenje z zdravilom Portrazza v monoterapiji po zaključeni kemoterapiji.
Necitumumab should not be administered to patients with multiple risk factors for thromboembolic events unless the benefits outweigh the risks to the patient.
Necitumumaba se ne sme dati bolnikom z več dejavniki tveganja za trombembolične dogodke, razen če koristi odtehtajo tveganja za bolnika.
Clear to slightly opalescent and colourless to slightly yellow liquid, with pH 6.0.
Prozorna do rahlo opalescentna in brezbarvna do nekoliko rumenkasta tekočina s pH 6,0.
Forest plot for subgroup analysis of overall survival (ITT population)
Slika 2: Forestova krivulja analize podskupin celokupnega preživetja (ITT populacija)
The incidence of fatal VTEs was similar between arms (0.2%).
Incidenca smrtnih venskih trombemboličnih dogodkov je bila med obema skupinama zdravljenja podobna (0,2 %).
DO NOT dilute with other solutions or co-infuse with other electrolytes or medicines.
NE redčite z drugimi raztopinami in ne infundirajte sočasno z drugimi elektroliti ali zdravili.
The anti-cancer medicines it is combined with are gemcitabine and cisplatin.
Zdravili za zdravljenje raka, s katerima se kombinira, sta gemcitabin in cisplatin.
It is unknown whether necitumumab is excreted in human milk.
Ni znano, ali se necitumumab izloča v materino mleko.
The most common serious adverse reactions (Grade ≥3) observed in necitumumab-treated patients are skin reactions (6.3 %) and venous thromboembolic events (4.3 %).
Najpogostejši resni neželeni učinki (stopnja ≥3), ki so jih opazili pri bolnikih, zdravljenih z necitumumabom, so bili kožne reakcije (6,3 %) in venski trombembolični dogodki (4,3 %).
a Grade per NCI-CTCAE, Version 3.0
a Stopnja po NCI-CTCAE (Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja), različica 3.0.
This should be taken into consideration by patients on a controlled sodium diet.
To morajo upoštevati bolniki na dieti z malo natrija.
These include low blood levels of magnesium, calcium, potassium or phosphate.
Te vključujejo nizke ravni magnezija, kalcija, kalija ali fosfatov v krvi.
Patients with significant coronary artery disease, myocardial infarction within 6 months, uncontrolled hypertension, and uncontrolled congestive heart failure were not enrolled in the pivotal study.
Bolniki s pomembno boleznijo koronarnih arterij, miokardnim infarktom v zadnjih 6 mesecih, nenadzorovano hipertenzijo in nenadzorovanim kongestivnim srčnim popuščanjem niso bili vključeni v ključno študijo.
Based on the results of the population pharmacokinetic analysis, hepatic status (as assessed by alanine aminotransferase, aspartate transaminase and total bilirubin) had no significant effect on the pharmacokinetics of necitumumab.
Na podlagi rezultatov analize populacijske farmakokinetike stanje jeter (ocenjeno na podlagi vrednosti alanin aminotransferaze, aspartat transaminaze in celokupnega bilirubina) ni imelo pomembnega učinka na farmakokinetiko necitumumaba.
There were no relevant differences in the distribution of demographics, disease characteristics, or the use of post-study systemic therapy between the subset of patients with detectable EGFR protein expression and the ITT population.
V distribuciji demografskih podatkov, lastnosti bolezni in uporabe sistemskega zdravljenja po zaključku študije ni bilo pomembnih razlik med podskupino bolnikov z vzorci, ki so izražali beljakovino EGFR in ITT populacijo.
Women of childbearing potential/contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on necitumumab and should be informed of the potential hazard to the pregnancy and foetus.
Ženske v rodni dobi/kontracepcija pri ženskah Ženskam v rodni dobi je treba svetovati, naj se izognejo zanositvi med zdravljenjem z necitumumabom in jih je treba seznaniti z možnim tveganjem za nosečnost in plod.
Any unused medicines or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
a Grade per NCI-CTCAE, Version 3.0 b Once the infusion rate has been reduced for a Grade 1 or 2 hypersensitivity/infusion-related reaction, it is recommended that the lower infusion rate be utilized for all subsequent infusions.
a Stopnja po NCI-CTCAE (Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja), različica 3.0. b Če hitrost infundiranja zmanjšate zaradi preobčutljivostne reakcije/reakcije, povezane z infuzijo stopnje 1 ali 2, je priporočljivo, da zmanjšano hitrost infundiranja uporabljate pri vseh nadaljnjih infuzijah.
Portrazza can cause blood clots in your arteries or your veins.
Zdravilo Portrazza lahko povzroči krvne strdke v vaših arterijah ali venah.
Key elements of the physician educational material: o Importance of assessing the risks before starting treatment with necitumumab o Description of thromboembolic events including incidence rates from clinical trials o Advice that patients and physicians should be aware of signs and symptoms of thromboembolism.
Ključni elementi izobraževalnega gradiva za zdravnike: o Pomen ocene tveganj pred začetkom zdravljenja z necitumumabom o Opis trombemboličnih dogodkov, vključno s stopnjami incidence iz kliničnih preskušanj o Svetujte bolnikom in zdravnikom, naj bodo pozorni na znake in simptome trombembolije.
Brief exposure to ambient light is acceptable while preparation and administration is taking place.
Kratka izpostavljenost svetlobi okolice med pripravo in dajanjem zdravila je sprejemljiva.
Prior to each necitumumab infusion, premedication for possible skin reactions must be considered (see section 4.4).
Pred vsako infuzijo necitumumaba je treba razmisliti o premedikaciji za morebitne kožne reakcije (glejte poglavje 4.4).
In approximately 4 out of 100 patients these side effects are likely to be severe.
Pri približno 4 od 100 bolnikov so ti neželeni učinki lahko hudi.
SQUIRE, a global, multicenter, two-arm, randomized study of Portrazza, was conducted in 1,093 patients with stage IV (American Joint Committee on Cancer Version 7) squamous NSCLC, including patients with ECOG PS2, who had received no prior anticancer therapy for metastatic disease.
Študija SQUIRE, globalna, multicentrična, randomizirana študija z dvema skupinama zdravljenja z zdravilom Portrazza je bila opravljena s 1093 bolnikov s skvamoznim NSCLC stopnje IV (po sistemu klasifikacije odbora American Joint Committee on Cancer, različica 7), vključno z bolniki z oceno stanja zmogljivosti 2 po ECOG, ki za metastatsko bolezen niso prejeli nobenega predhodnega zdravljenja proti raku.
Other body proteins (called growth factors) can attach to the EGFR and stimulate the cancer cell to grow and divide.
Druge beljakovine v telesu (imenovane rastni dejavniki) se lahko pritrdijo na EGFR in spodbujajo rast in delitev rakave celice.
Symptoms of severe skin reactions may include acne-like skin conditions and skin rash.
Simptomi hudih kožnih reakcij lahko vključujejo aknam podobne kožne spremembe in izpuščaj na koži.
Portrazza is used in combination with other anti-cancer medicines for the treatment of adults with certain type of lung cancer at an advanced stage (squamous non-small cell lung cancer), whose cancer cells have the EGFR protein on their surface.
Zdravilo Portrazza se uporablja v kombinaciji z drugimi zdravili za zdravljenje odraslih bolnikov z določeno vrsto pljučnega raka v napredovali fazi (skvamozni nedrobnocelični pljučni rak), pri katerih imajo rakave celice na površini beljakovino EGFR.
If patients experience treatment-related symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Če se pri bolnikih pojavijo z zdravljenjem povezani simptomi, ki vplivajo na njihovo sposobnost koncentracije in reagiranja, je priporočljivo, da z vozili in stroji ne upravljajo, dokler ti učinki ne izzvenijo.
Do not breast-feed your baby during treatment with Portrazza and for at least 4 months after you receive the last dose, as this medicine may harm the growth and development of your baby.
Med zdravljenjem z zdravilom Portrazza in vsaj še 4 mesece po prejemu zadnjega odmerka zdravila otroka ne smete dojiti, saj lahko to zdravilo škodi rasti in razvoju vašega otroka.
Abbreviations: C = cisplatin; G = gemcitabine; ITT = intent-to-treat.
Okrajšave: C = cisplatin; G = gemcitabin; ITT = intent-to-treat (skupina z namenom zdravljenja).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC, or up to 4 hours at 9 ºC to 25 ºC.
Če zdravila ne uporabite takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas ne sme biti daljši od 24 ur pri temperaturi od 2 do 8 ºC oziroma ne sme biti daljši od 4 ur pri temperaturi od 9 ºC
There is no relevant use of necitumumab in the paediatric population in the non-small cell lung cancer indication.
Pediatrična populacija Smotrne uporabe necitumumaba v pediatrični populaciji za indikacijo nedrobnocelični pljučni rak ni.
Mean total systemic clearance (CLtot) at steady state following 800 mg on Day 1 and Day 8 of a 21-day cycle was 0.014 l/hr (CV 39 %).
Povprečen skupni sistemski očistek (CLtot) v stanju dinamičnega ravnovesja je po odmerku 800 mg na 1. in 8. dan 21-dnevnega cikla znašal 0,014 l/uro (CV 39 %).
Portrazza is given in combination with the medicines gemcitabine and cisplatin for up to 6 cycles and then it is given on its own.
Zdravilo Portrazza se daje v kombinaciji z zdravilnima učinkovinama gemcitabin in cisplatin do 6 ciklov, nato pa samostojno.
Necitumumab therapy must be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Zdravljenje z necitumumabom je treba dajati pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije za zdravljenje raka.