natgillin/translations-raw huggingface dataset:
Discard any unused portion of necitumumab left in a vial, as the product contains no antimicrobial preservatives. 
Bacite sav neupotrijebljen necitumumab preostao u bočici jer lijek ne sadrži antimikrobne konzervanse.
A similar observation was made in a clinical trial investigating necitumumab in combination with pemetrexed and cisplatin versus pemetrexed and cisplatin alone as the first-line therapy in patients with advanced non-squamous NSCLC. 
Slično je opaženo i u kliničkom ispitivanju u kojem se ispitivao necitumumab u kombinaciji s pemetreksedom i cisplatinom naspram samo pemetrekseda i cisplatina u prvoj liniji liječenja bolesnika s uznapredovalim neplanocelularnim NSCLC-om.
There is no known antidote for necitumumab overdose. 
Nema poznatog protulijeka za predoziranje necitumumabom.
What Portrazza contains - The active substance is necitumumab. 
Što Portrazza sadrži - Djelatna tvar je necitumumab.
Based on the results of the population pharmacokinetic analysis, there was no impact of renal function as assessed by creatinine clearance [CrCl] on the pharmacokinetics of necitumumab. 
Rezultati populacijske farmakokinetičke analize pokazali su da bubrežna funkcija ocijenjena na temelju klirensa kreatinina (CrCl) nije utjecala na farmakokinetiku necitumumaba.
STATEMENT OF ACTIVE SUBSTANCE(S) One vial of 50 mL contains 800 mg necitumumab (16 mg/mL). 
Jedna bočica od 50 ml sadrži 800 mg necitumumaba (16 mg/ml).
Severe skin rections were reported in approximately 6 % of patients while 1.7 % of patients discontinued due to skin reactions. 
dok je 1,7% bolesnika prekinulo liječenje zbog kožnih reakcija.
Symptoms may include difficulty breathing, chest pain, or an abnormal heartbeat and discomfort. 
Simptomi mogu uključivati otežano disanje, bolove u prsnom košu ili poremećene srčane otkucaje i nelagodu.
Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients and mainly present as stroke and myocardial infarction. 
Arterijski tromboembolijski (AT) događaji prijavljeni su u približno 4% bolesnika, a uglavnom su se manifestirali kao moždani udar i infarkt miokarda.
Severe ATEs were reported in 3 % of patients. 
Teški AT događaji prijavljeni su u 3% bolesnika.
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. 
(omjer hazarda [HR] = 1,52 [0,74; 3,12]) niti preživljenja bez progresije bolesti (omjer hazarda [HR] =
Distribution of Portrazza follow a biphasic decline. 
Distribucija lijeka Portrazza slijedi pad u dvije faze.
Infusion-related reactions were reported in 1.5 % of patients and mainly present as chills, fever or dyspnoea. 
Reakcije na infuziju prijavljene su u 1,5% bolesnika, a uglavnom su se manifestirale kao zimica,
o Description of cardiorespiratory disorders including incidence rates from clinical trials o Information that the incremental risk of cardiopulmonary arrest or sudden death in patients with a history of coronary artery disease, congestive heart failure, or arrhythmias as compared to those without these comorbid conditions is not known. 
o Opis kardiorespiratornih poremećaja, uključujući stope incidencije u kliničkim ispitivanjima o Informaciju o tome da nije poznat dodatno povećan rizik od kardiopulmonalnog zastoja ili iznenadne smrti u bolesnika koji u anamnezi imaju bolest koronarnih arterija, kongestivno zatajenje srca ili aritmije u odnosu na one koji nemaju ta komorbiditetna stanja o Naputak zdravstvenim radnicima da te materijale čitaju zajedno sa Sažetkom opisa svojstava lijeka.
Necitumumab therapy must be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. 
4.2 Doziranje i način primjene Necitumumab se mora primjenjivati pod nadzorom liječnika koji je kvalificiran za primjenu kemoterapije za liječenje raka.
Venous thromboembolic events (VTEs) were reported in approximately 8 % of patients and mainly present as pulmonary embolism and deep vein thrombosis. 
Venski tromboembolijski (VT) događaji prijavljeni su u približno 8% bolesnika, a uglavnom su se manifestirali kao plućna embolija i duboka venska tromboza.
It is unknown whether necitumumab is excreted in human milk. 
Nije poznato izlučuje li se necitumumab u majčino mlijeko.
Any grade 
Svi stupnjevi stupanj
Dose dependent reversible skin toxicity was observed in the 26-week monkey study. 
U 26-tjednom ispitivanju na majmunima primijećena je reverzibilna toksičnost za kožu ovisna o dozi.
In a clinical trial in advanced non-squamous NSCLC, venous thromboembolic events (VTEs) were reported in approximately 11 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 8 % in the pemetrexed and cisplatin alone arm) and mainly presented as pulmonary embolism and deep vein thrombosis. 
U kliničkom ispitivanju kod uznapredovalog neplanocelularnog NSCLC-a, venski tromboembolijski (VT) događaji prijavljeni su u približno 11% bolesnika liječenih necitumumabom u kombinaciji s pemetreksedom i cisplatinom (naspram 8% onih u skupini liječenoj samo pemetreksedom i cisplatinom), a manifestirali su se uglavnom kao plućna embolija i duboka venska tromboza.
Adverse drug reactions (ADRs) which were reported in patients with squamous non-small cell lung cancer are listed below in MedDRA body system organ class, frequency and grade of severity. 
Nuspojave prijavljene u bolesnika s planocelularnim rakom pluća nemalih stanica navedene su u nastavku prema MedDRA klasifikaciji organskih sustava, učestalosti i stupnju težine.
You may be given medicines to reduce the risk of an infusion-related reaction or a skin reaction before you receive Portrazza. 
Prije nego što primite lijek Portrazza, možda ćete primiti lijekove koji će smanjiti rizik od pojave reakcije na infuziju ili kožne reakcije.
System organ class 
Organski sustav Učestalost
Cardiovascular comorbidities, performance status and the likely tolerability to chemotherapy with add-on necitumumab should therefore be thoroughly evaluated prior to the initiation of treatment in patients above 70 years of age. 
Stoga u bolesnika starijih od 70 godina treba prije početka liječenja temeljito ocijeniti kardiovaskularne komorbiditete, funkcionalni status i vjerojatnu podnošljivost kemoterapije uz dodatak necitumumaba.
Appropriate medical resources for the treatment of severe infusion reactions should be available during necitumumab infusions. 
Tijekom infuzija necitumumaba na raspolaganju trebaju biti odgovarajući medicinski resursi za liječenje teških reakcija na infuziju.
Women of childbearing potential/contraception in females Based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies. 
S obzirom na mehanizam djelovanja i životinjske modele u kojima je ekspresija EGFR-a poremećena, necitumumab može naškoditi plodu ili uzrokovati razvojne anomalije.
Progression free survival Number of events (n) Median - months (95 % CI) Hazard ratio (95 % CI) b, c Two-sided log-rank p-value c a Abbreviations: CI = confidence interval b Hazard ratio is expressed as treatment/control and estimated from Cox model c Stratified by the randomization strata (ECOG PS [0-1 vs. 2], and geographic region [North 
Dvostrana log-rang p-vrijednost c a Kratice: CI = interval pouzdanosti b Omjer hazarda izražava se kao omjer između liječene i kontrolne skupine, a procjenjuje se na temelju Coxova modela c Stratificirano prema randomizacijskim stratumima (funkcionalni ECOG status [0 - 1 naspram 2]
Each mL of concentrate for solution for infusion contains 16 mg of necitumumab. 
Jedan ml koncentrata za otopinu za infuziju sadrži 16 mg necitumumaba.
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'). 
Portrazza nalaze se na kraju ove upute (pogledajte odlomak 'Upute za rukovanje').
The pharmacokinetics of gemcitabine/cisplatin were not affected when co-administered with necitumumab and the pharmacokinetics of necitumumab were not affected when co-administered with gemcitabine/cisplatin. 
Istodobna primjena necitumumaba nije utjecala na farmakokinetiku gemcitabina/cisplatina, jednako kao što ni istodobna primjena gemcitabina/cisplatina nije utjecala na farmakokinetiku necitumumaba.
This medicine is given as an intravenous (into a vein) infusion via a drip. 
Ovaj se lijek primjenjuje kao intravenska infuzija ukapavanjem u venu (drip), a traje približno 60 minuta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Portrazza 800 mg sterile concentrate necitumumab 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Portrazza 800 mg sterilni koncentrat necitumumab
Symptoms may include swelling, pain and tenderness of the limb. 
Simptomi mogu uključivati oticanje, bol i osjetljivost udova na dodir.
o The need to carefully consider use of necitumumab in patients with a history of thromboembolic events or pre-existing risk factors for thromboembolic events o Information on relative risk of VTE or ATE in patients with a history of VTE or ATE o Advice that necitumumab should not be administered to patients with multiple risk factors for thromboembolic events unless the benefits outweigh the risks to the patient o The need to consider thromboprophylaxis after careful assessment of a patient's risk factors o Discontinuation of necitumumab in patients who experience a VTE or ATE should be considered after a thorough benefit risk assessment for the individual patient. 
AT događaja o Preporuku da se necitumumab ne smije primjenjivati bolesnicima s višestrukim faktorima rizika za tromboembolijske događaje, osim ako koristi od liječenja nadmašuju rizike za bolesnika o Potrebu da se razmotri tromboprofilaksa nakon pažljive ocjene bolesnikovih faktora rizika o Potrebno je razmotriti prekid liječenja necitumumabom u bolesnika u kojih nastupi VT ili
In approximately 5 out of 100 patients these skin reactions are likely to be severe. 
Te će kožne reakcije vjerojatno biti teške u približno 5 od 100 bolesnika.
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) 
- svrbež, suha koža, ljuskanje kože, poremećaji noktiju (kožne reakcije) - povraćanje - vrućica ili visoka tjelesna temperatura (pireksija)
Abbreviations: C = cisplatin; G = gemcitabine; ITT = intent-to-treat. 
Kratice: C = cisplatin; G = gemcitabin; ITT = populacija koju se namjeravalo liječiti
A doctor experienced in the use of anti-cancer medicines will supervise your Portrazza therapy. 
Kako ćete primati lijek Portrazza Terapiju lijekom Portrazza nadzirat će liječnik s iskustvom u primjeni lijekova za liječenje raka.
Hypersensitivity/Infusion-related reactions 
Reakcije preosjetljivost/reakcije na infuziju
Each millilitre of the concentrate for solution for infusion contains 16 mg of necitumumab. 
Jedan mililitar koncentrata za otopinu za infuziju sadrži 16 mg necitumumaba.
Each 50 mL vial contains 800 mg of necitumumab. 
Jedna bočica od 50 ml sadrži 800 mg necitumumaba.
In a clinical trial in advanced non-squamous NSCLC, patients experienced an increased rate of serious thromboembolic events (including fatal events) in the necitumumab plus pemetrexed and cisplatin arm as compared to the pemetrexed and cisplatin arm (see also section 4.8). 
U kliničkom ispitivanju kod uznapredovalog neplanocelularnog NSCLC-a, bolesnici u skupini liječenoj necitumumabom plus pemetreksedom i cisplatinom imali su veću stopu ozbiljnih tromboembolijskih događaja (uključujući događaje sa smrtnim ishodom) nego oni u skupini liječenoj samo pemetreksedom i cisplatinom (vidjeti i dio 4.8).
It is available in packs of: - 1 vial of 50 mL 
Dostupna je u pakiranjima od:
Patients were randomised to receive first-line Portrazza at 800 mg plus chemotherapy consisting of gemcitabine at 1,250 mg/m2 and cisplatin at 75 mg/m2 (Portrazza+GC Arm), or gemcitabine-cisplatin chemotherapy alone (GC Arm). 
Bolesnici su bili randomizirani u skupine koje su kao prvu liniju terapije primale lijek Portrazza u dozi od 800 mg plus kemoterapiju koja se sastojala od gemcitabina u dozi od 1250 mg/m2 i cisplatina u dozi od 75 mg/m2
NAME OF THE MEDICINAL PRODUCT Portrazza 800 mg concentrate for solution for infusion 
NAZIV LIJEKA Portrazza 800 mg koncentrat za otopinu za infuziju
Clinically relevant toxicities with respect to the elderly and those patients with Eastern Cooperative Oncology Group (ECOG) performance status score 2 (ECOG PS2) were similar to the overall population in patients receiving necitumumab plus chemotherapy consisting of gemcitabine and cisplatin. 
Eastern Cooperative Oncology Group) status 2 bile su slične onima primijećenima u cjelokupnoj populaciji bolesnika liječenih necitumumabom plus kemoterapijom koja se sastojala od gemcitabina i cisplatina.
Twelve of the fifteen patients died within 30 days of the last dose of necitumumab and had comorbid conditions including history of coronary artery disease (n=3), hypomagnesemia (n=4), chronic obstructive pulmonary disease (n=7), and hypertension (n=5). 
Dvanaest od tih 15 bolesnika umrlo je unutar 30 dana nakon posljednje doze necitumumaba, a imalo je komorbiditetna stanja, uključujući bolest koronarnih arterija
Venous thromboembolic events (VTE) and arterial thromboembolic events (ATE), including fatal cases, were observed with necitumumab in combination with gemcitabine and cisplatin (see also section 4.8). 
Kod primjene necitumumaba u kombinaciji s gemcitabinom i cisplatinom prijavljeni su venski tromboembolijski (VT) događaji i arterijski tromboembolijski (AT) događaji, uključujući slučajeve sa smrtnim ishodom (vidjeti i dio 4.8).
Vascular disorders Common Venous thromboembolic events 
Krvožilni poremećaji često venski tromboembolijski događaji često arterijski tromboembolijski događaji često flebitis
If symptoms worsen at 400 mg, permanently discontinue. 
400 mg, trajno prekinuti liječenje.
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. 
Ispitivanje SQUIRE - globalno, multicentrično, randomizirano ispitivanje lijeka Portrazza s dvije skupine - provedeno je u 1093 bolesnika s planocelularnim NSCLC-om stadija IV (American Joint
Eyelash trichomegaly Isolated cases of Grade 1 trichomegaly have been reported in patients treated with necitumumab. 
U bolesnika liječenih necitumumabom prijavljeni su izolirani slučajevi trihomegalije 1. stupnja.
Pre-emptive skin treatment including skin moisturiser, sun screen, topical steroid cream (1 % hydrocortisone) and an oral antibiotic (e.g. doxycycline) may be useful in the management of dermatologic reactions as clinically appropriate. 
topikalne steroidne kreme (hidrokortizon u koncentraciji od 1%) i oralnog antibiotika (npr. doksiciklina).
Do not freeze or shake the infusion solution. 
Otopina za infuziju ne smije se zamrzavati ni tresti.
DO NOT FREEZE OR SHAKE the infusion solution. 
Otopina za infuziju NE SMIJE SE ZAMRZAVATI NI TRESTI.
Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 6 % in the pemetrexed and cisplatin alone arm) and mainly present as stroke and myocardial infarction. 
Arterijski tromboembolijski (AT) događaji prijavljeni su u približno 4% bolesnika liječenih necitumumabom u kombinaciji s pemetreksedom i cisplatinom (naspram 6% onih u skupini liječenoj samo pemetreksedom i cisplatinom), a manifestirali su se uglavnom kao moždani udar i infarkt miokarda.
No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of necitumumab. 
Nisu provedena formalna ispitivanja kojima bi se ocijenio učinak oštećenja bubrežne funkcije na farmakokinetiku necitumumaba.
Common Headache Common Dysgeusia 
Poremećaji živčanog sustava često glavobolja često disgeuzija
Stomatitis 
Nuspojavaa
An increased frequency of cardiorespiratory arrest or sudden death was observed with necitumumab. 
Kod liječenja necitumumabom primijećena je povećana učestalost kardiorespiratornog zastoja ili iznenadne smrti.
Portrazza must not be administered as an intravenous bolus or push. 
Portrazza se ne smije primijeniti bolusnom ni brzom intravenskom injekcijom.
Sodium citrate dihydrate (E331) Citric acid anhydrous (E330) Sodium chloride Glycine (E640) 
6.1 Popis pomoćnih tvari natrijev citrat, dihidrat (E331) citratna kiselina, bezvodna (E330) natrijev klorid glicin (E640) manitol (E421) polisorbat 80 (E433) voda za injekcije
Excipient with known effect Each 50 mL vial contains approximately 76 mg sodium. 
Jedna bočica od 50 ml sadrži približno 76 mg natrija.
Infusion-related reactions may occur during treatment with Portrazza. 
Tijekom liječenja lijekom Portrazza mogu se javiti reakcije na infuziju.
Hypersensitivity/infusion-related reactions (IRRs) were reported with necitumumab. 
Reakcije preosjetljivost/reakcije na infuziju Kod primjene necitumumaba prijavljene su reakcije preosjetljivost/reakcije na infuziju.
Musculoskeletal and connective tissue disorders 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva često mišićni grčevi
The addition of necitumumab did not improve the efficacy outcome over pemetrexed and cisplatin alone in advanced non-squamous NSCLC. 
U bolesnika s uznapredovalim neplanocelularnim NSCLC-om, dodavanje necitumumaba nije poboljšalo ishod za djelotvornost u odnosu na liječenje samo pemetreksedom i cisplatinom.
In case of previous hypersensitivity or infusion-related reaction, recommendations for management of hypersensitivity/infusion-related reactions should be followed, as for Table 1. 
treba se pridržavati preporuka za zbrinjavanje reakcija preosjetljivosti/reakcija na infuziju navedenih u Tablici 1.
Toxicity in the elderly or in patients with ECOG PS 2 
Toksičnost u starijih osoba ili u bolesnika s funkcionalnim ECOG statusom 2 Klinički značajne toksičnosti u starijih osoba i bolesnika s rezultatom za funkcionalni ECOG (engl.
Necitumumab hinders other proteins from binding to the EGFR and thus prevents the cancer cell from growth and division. 
Necitumumab onemogućuje vezivanje drugih proteina na EGFR
Handling instructions Portrazza 800 mg concentrate for solution for infusion necitumumab 
Upute za rukovanje Portrazza 800 mg koncentrat za otopinu za infuziju necitumumab
GC Arm N=548 
N=548
Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution. 
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Pripremite otopinu za infuziju aseptičnom tehnikom kako biste osigurali sterilnost pripremljene otopine.
Portrazza 800 mg concentrate for solution for infusion necitumumab 
Portrazza 800 mg koncentrat za otopinu za infuziju necitumumab
Severe ATEs were reported in approximately 3 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm). 
Teški AT događaji prijavljeni su u približno 3% bolesnika liječenih necitumumabom u kombinaciji s pemetreksedom i cisplatinom (naspram 4% onih u skupini liječenoj samo pemetreksedom i cisplatinom).
Severe VTEs were reported in approximately 6 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm). 
Teški VT događaji prijavljeni su u približno 6% bolesnika liječenih necitumumabom u kombinaciji s pemetreksedom i cisplatinom (naspram 4% onih u skupini liječenoj samo pemetreksedom i cisplatinom).
Thromboprophylaxis should be considered after careful assessment of a patient's risk factors (including the increased risk of serious bleeding in patients with tumour cavitation or tumour involvement of large central blood vessels). 
(uključujući povećan rizik od ozbiljnog krvarenja u bolesnika s kavitacijom tumora ili u kojih je tumor zahvatio velike središnje krvne žile).
To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicine into an empty intravenous container and add 200 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection to the container to bring the total volume to 250 mL. 
Aseptičnom metodom prebacite 50 ml necitumumaba u prazan spremnik za intravensku infuziju i dodajte 200 ml sterilne otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) u spremnik da biste dobili ukupan volumen od 250 ml.
Infections and infestations 
Infekcije i infestacije često infekcija mokraćnih putova
There are no data regarding necitumumab administration in patients with severe renal impairment. 
Nema podataka o primjeni necitumumaba u bolesnika s teškim oštećenjem bubrežne funkcije.
To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicinal product into an empty intravenous container and add 200 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to bring the total volume to 250 mL. 
Aseptičnom metodom prebacite 50 ml necitumumaba u prazan spremnik za intravensku infuziju i dodajte 200 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) u spremnik da biste dobili ukupan volumen od 250 ml.
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. 
U bolesnika liječenih lijekom Portrazza u kombinaciji s gemcitabinom i cisplatinom te u bolesnika koji su primali samo gemcitabin i cisplatin prijavljeni su slučajevi srčanih i dišnih poremećaja te neobjašnjive smrti.
Only sodium chloride 9 mg/mL (0.9 %) solution for injection should be used as a diluent. 
Kao sredstvo za razrjeđivanje smije se koristiti samo otopina natrijeva klorida za injekciju od 9 mg/ml (0,9%).
Animal reproduction studies have not been conducted with necitumumab. 
Nisu provedena ispitivanja učinaka necitumumaba na reprodukciju u životinja.
To administer using pre-filled intravenous infusion containers Aseptically remove 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection from the prefilled 250 mL container and transfer 50 mL of necitumumab medicine into the container to bring the final volume in the container back to 250 mL. 
Aseptičnom tehnikom izvadite 50 ml otopine natrijeva klorida za injekcijeuod 9 mg/ml (0,9%) iz napunjenog spremnika volumena 250 ml i zatim prebacite 50 ml necitumumaba u spremnik kako biste konačan volumen u njemu vratili na 250 ml.
An improvement was observed in subgroups for OS and PFS including the pre-specified stratification factors [ECOG PS score (0-1 vs. 2) and geographic region (North America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia)]; in patients age 70 and over, the hazard ratio for overall survival was 1.03 (0.75, 1.42) (see Figure 2). 
Primijećeno je poboljšanje u podskupinama za OS i PFS, uključujući unaprijed specificirane stratifikacijske faktore (rezultat za funkcionalni ECOG status [0 - 1 naspram 2] i geografska regija
In patients who have experienced a previous Grade 1-2 hypersensitivity or infusion-related reaction to Portrazza, premedication with a corticosteroid and an antipyretic in addition to an antihistamine is recommended. 
1. ili 2. stupnja, preporučuje se premedikacija kortikosteroidom i antipiretikom te antihistaminikom.
Inspect the contents of the vials for particulate matter and discolouration. 
Pregledajte sadržaj bočica kako biste se uvjerili da ne sadrži čestice i da nije promijenio boju.
Grade ≥ 3 
3. stupanj
Electrolyte abnormalities 
Trihomegalija trepavica
There was no premedication for Portrazza mandated by the study. 
Protokol ispitivanja nije zahtijevao premedikaciju uz lijek Portrazza.
Hepatic impairment 
Preživljenje bez progresije bolesti
Respiratory, thoracic and mediastinal disorders 
- Srčani i dišni poremećaji