natgillin/translations-raw huggingface dataset:
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.
Population pharmacokinetic analysis suggested age, gender, and race had no effect on the pharmacokinetics of necitumumab, while CL and volume of distribution had a less than proportional positive correlation with body weight. 
Posebne skupine bolnikov Analiza populacijske farmakokinetike je nakazala, da starost, spol in rasa niso vplivali na farmakokinetiko necitumumaba, očistek (CL) in porazdelitveni volumen pa sta imela manj kot sorazmerno pozitivno korelacijo s telesno maso.
The most common adverse reactions were skin reactions, venous thromboembolic events and laboratory abnormalities (hypomagnesaemia and albumin-corrected hypocalcaemia). 
Najpogostejši neželeni učinki so bili kožne reakcije, venski trombembolični dogodki in nenormalni izvidi laboratorijskih preiskav (hipomagneziemija in za albumin korigirana hipokalciemija).
Cases of cardiorespiratory disorders and unexplained death were observed in patients treated with Portrazza in combination with gemcitabine and cisplatin and in patients treated with gemcitabine and cisplatin alone. 
Primere kardiorespiratornih obolenj in nepojasnjeno smrt so opazili pri bolnikih, zdravljenih z zdravilom Portrazza v kombinaciji z gemcitabinom in cisplatinom, in pri bolnikih, ki so bili zdravljeni samo z gemcitabinom in cisplatinom.
The number of infusions that you receive will depend on how and for how long you respond to treatment with Portrazza. 
Število infuzij, ki jih boste prejeli, bo odvisno od vašega odziva na zdravljenje z zdravilom Portrazza in od trajanja tega odziva.
Elderly No dose reductions other than those recommended for all patients are necessary (see sections 4.4 and 
Zmanjšanja odmerkov z izjemo zmanjšanj, priporočenih za vse bolnike, niso potrebna (glejte poglavji
Excipients: sodium citrate dihydrate, citric acid anhydrous, sodium chloride, glycine, mannitol, polysorbate 80 and water for injections. 
Pomožne snovi: natrijev citrat dihidrat, brezvodna citronska kislina, natrijev klorid, glicin, manitol, polisorbat 80 in voda za injekcije.
The recommended dose of Portrazza is 800 mg (flat dose) administered as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle. 
Priporočeni odmerek zdravila Portrazza je 800 mg (fiksen odmerek), ki se daje v obliki intravenske infuzije v 60 minutah 1. in 8. dan vsakega 3-tedenskega cikla.
Human IgG1 is known to cross the placenta; therefore, necitumumab has the potential to be transmitted from the mother to the developing foetus. 
Za humano protitelo IgG1 je znano, da prehaja skozi placento, zato ima necitumumab potencial za placentni prenos z matere na razvijajoči se plod.
Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se morate posvetovati z zdravnikom, preden začnete z zdravljenjem.
The important side effects of Portrazza are skin reactions and blood clots in the veins. 
Pomembni neželeni učinki zdravila Portrazza so kožne reakcije in krvni strdki v venah.
The following table provides the frequency and severity of ADRs based on results from SQUIRE, a global, multicenter, two-arm, randomized Phase 3 study in adult patients with squamous NSCLC randomised to treatment with necitumumab in combination with gemcitabine/cisplatin or gemcitabine/cisplatin. 
V naslednji preglednici pogostnost in resnost neželenih učinkov zdravila temeljita na izidih študije SQUIRE, globalne, multicentrične, randomizirane študije 3. faze z dvema skupinama zdravljenja pri odraslih bolnikih s skvamoznim NSCLC, ki so bili randomizirani v skupino za zdravljenje z necitumumabom v kombinaciji z gemcitabinom/cisplatinom ali pa v skupino za zdravljenje z gemcitabinom/cisplatinom.
The incidence of fatal ATEs was 0.6% in the experimental arm versus 0.2% in the control arm (see also section 4.4). 
Incidenca smrtnih arterijskih trombemboličnih dogodkov je bila 0,6 % v skupini eksperimentalnega zdravljenja v primerjavi z 0,2 % v kontrolni skupini (glejte tudi poglavje
Specific animal studies to test necitumumab for carcinogenic potential or potential to impair fertility have not been performed. 
Specifičnih študij na živalih, v katerih bi testirali karcinogeni potencial necitumumaba ali potencial necitumumaba za škodljivo delovanje na plodnost, niso izvedli.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 800 mg/ 50 mL 
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 800 mg/50 ml
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). 
Bolniki s preteklo hudo ali življenjsko nevarno preobčutljivostjo na zdravilno učinkovino ali na katero koli pomožno snov, navedeno v poglavju 6.1.
If not used immediately, the prepared necitumumab dosing solution must be stored at 2°C to 8°C for a duration not to exceed 24 hours, or may be held at 9°C to 25°C for up to 4 hours. 
Če pripravljene raztopine necitumumaba za odmerjanje ne uporabimo takoj, jo je treba shraniti pri 2 ºC 8 ºC za največ 24 ur, ali pa jo hraniti pri temperaturi od 9°C do 25°C največ 4 ure.
Portrazza and gemcitabine were administered on days 1 and 8 of each 3-week treatment cycle, and cisplatin was administered on day 1 of each 3-week treatment cycle. 
Bolniki so prejeli zdravilo Portrazza in gemcitabin 1. in 8. dan vsakega 3tedenskega cikla zdravljenja, cisplatin pa 1. dan vsakega 3-tedenskega cikla zdravljenja.
Any grade 
Vseh stopenj
Based on the results of the population pharamacokinetic analysis, there was no impact of age on necitumumab exposure. 
Na podlagi rezultatov analize populacijske farmakokinetike ni bilo vpliva starosti na izpostavljenost necitumumabu.
Portrazza is for intravenous use only. 
Zdravilo Portrazza je namenjeno le za intravensko uporabo.
See also section 4 for the symptoms of blood clots. 
Za simptome krvnih strdkov glejte tudi poglavje 4.
For management and dose adjustments, see section 4.2. 
Za obravnavo in prilagajanje odmerka glejte poglavje 4.2.
o Instruction for healthcare professionals to read the materials in conjunction with the SmPC. 
o Navodilo za zdravstvene delavce, naj preberejo gradiva v povezavi s Povzetkom glavnih značilnosti zdravila.
In patients with no detectable EGFR protein expression, no improvement in overall survival (hazard ratio [HR] = 1.52 [0.74, 3.12]) or progression free survival (hazard ratio [HR] = 1.33 [0.65, 2.70] was observed. 
Pri bolnikih brez izražene beljakovine EGFR ni bilo opaziti izboljšanja celokupnega preživetja (razmerje tveganja [HR] = 1,52 [0,74; 3,12]) ali preživetja brez napredovanja bolezni (razmerje tveganja [HR] = 1,33 [0,65, 2,70]).
What Portrazza looks like and contents of the pack Portrazza 800 mg concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow liquid in a glass vial with a rubber stopper. 
Izgled zdravila Portrazza in vsebina pakiranja Portrazza 800 mg koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra ali rahlo opalescentna in brezbarvna ali nekoliko rumenkasta tekočina v stekleni viali z gumijastim zamaškom.
Do not administer the solution if you notice any particulate matter or discoloration. 
Ne dajajte raztopine, če opazite v njej delce ali obarvanost.
Inspect the contents of the vials for particulate matter and discolouration. 
Preglejte vsebino vial in bodite pozorni na trdne delce in obarvanost.
Animal reproduction studies have not been conducted with necitumumab. 
Študije razmnoževanja pri živalih z necitumumabom niso bile opravljene.
How you are given Portrazza 
Kako boste prejeli zdravilo Portrazza
There are no data from the use of necitumumab in pregnant women. 
Nosečnost V zvezi z uporabo necitumumaba pri nosečnicah ni podatkov.
The concentrate for solution for infusion must be clear to slightly opalescent and colourless to slightly yellow prior to dilution. 
Koncentrat za raztopino za infundiranje mora biti pred redčenjem bister do rahlo opalescenten in brezbarven do nekoliko rumenkast.
- The other ingredients are sodium citrate dihydrate (E331), citric acid anhydrous (E330), sodium chloride (see section 2 “Portrazza contains sodium”), glycine (E640), mannitol (E421), polysorbate 80 (E433) and water for injections. 
- Druge sestavine zdravila so natrijev citrat dihidrat (E331), brezvodna citronska kislina (E330), natrijev klorid (glejte poglavje 2 "Zdravilo Portrazza vsebuje natrij"), glicin (E640), manitol (E421), polisorbat 80 (E433) in voda za injekcije.
Very common (may affect more than 1 in 10 people): - itching; dry skin; scaling; nail disorders (skin reactions) - vomiting - fever or high temperature (pyrexia) - decreased weight - mouth ulcers and cold sores (stomatitis) 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - srbečica; suha koža; luščenje kože; bolezni nohtov (kožne reakcije)
They can lead to a blockage of a blood vessel in the leg. 
Povzročijo lahko zamašitev krvne žile v nogi.
If you have a severe skin reaction, your doctor may recommend adjusting the dose of Portrazza, or stop your treatment with Portrazza. 
Če se bodo pri vas pojavile hude kožne reakcije, bo vaš zdravnik morda predlagal prilagoditev odmerka zdravila Portrazza, ali pa prekinil vaše zdravljenje z zdravilom Portrazza.
Following the dose regimen of 800 mg necitumumab on day 1 and day 8 of a 21 day schedule, the geometric mean of necitumumab Cmin was 98.5 μg/mL (Coefficient of Variation 80 %) in serum from patients with squamous NSCLC after five cycles of treatment in combination with gemcitabine and cisplatin. 
Ob upoštevanju režima odmerjanja 800 mg necitumumaba 1. in 8. dan 21-dnevnega cikla so bile dosežene geometrične srednje vrednosti necitumumaba Cmin 98,5 μg/ml (koeficient variacije 80 %) v serumu bolnikov s skvamoznim NSCLC po petih ciklih zdravljenja v kombinaciji z gemcitabinom in cisplatinom.
ADRs reported in ≥ 1 % of necitumumab treated patients in SQUIRE 
Neželeni učinki, o katerih so poročali pri ≥ 1 % bolnikov, zdravljenih z necitumumabom v študiji SQUIRE