FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, there was a low incidence of both treatment-emergent anti-drug antibodies and neutralizing antibodies among necitumumab-treated patients, and no correlation with safety outcomes in these patients.
Slovenian: Skupno je bila med bolniki, zdravljenimi z necitumumabom, incidenca protiteles na zdravilo zaradi zdravljenja in nevtralizirajočih protiteles nizka, korelacije z varnostnimi izidi pri teh bolniki ni bilo.
English: Patients may be advised to apply moisturiser, sunscreen and topical steroid cream to face, hands, feet, neck, back and chest.
Slovenian: Bolnikom lahko svetujete, naj nanesejo sredstvo za vlaženje kože, sredstvo za zaščito kože pred soncem ali topikalno steroidno kremo na obraz, dlani, stopala, vrat, hrbet in prsi.
English: The ECOG PS was 0 for 31.5 %, 1 for 59.7 %, and 2 for 9 % of patients; over 50 % had metastatic disease at more than 2 sites.
Slovenian: in 2 pri 9 % bolnikov; več kot 50 % bolnikov je imelo metastatsko bolezen na več kot 2 mestih.
English: In case of previous hypersensitivity or infusion-related reaction, recommendations for management of hypersensitivity/infusion-related reactions should be followed, as for Table 1.
Slovenian: V primeru preobčutljivostne reakcije ali reakcije, povezane z infuzijo, je treba upoštevati priporočila za obravnavo preobčutljivostne reakcije/reakcije, povezane z infuzijo, kot je navedeno v Preglednici 1.
English: • If symptoms do not worsen at 600 mg for another treatment cycle, the dose may be further increased to 800 mg.
Slovenian: • Če se simptomi pri odmerku 400 mg ne poslabšajo vsaj 1 cikel zdravljenja, lahko odmerek povečate na 600 mg.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1084/001
Slovenian: EU/1/15/1084/001
English: Necitumumab is a recombinant human IgG1 monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 1 (EGFR) and blocks the ligand binding site, blocking activation by all known ligands and inhibiting relevant biological consequences in vitro.
Slovenian: Mehanizem delovanja Necitumumab je rekombinantno humano monoklonsko protitelo IgG1, ki se z visoko afiniteto in specifičnostjo veže na humani receptor 1 za epidermalni rastni dejavnik (EGFR) in zavira mesto vezave liganda, pri tem pa zavira z znanimi ligandi stimulirano aktivacijo receptorja in zavira pomembne biološke posledice in vitro.
English: No other formal interaction studies with necitumumab have been performed in humans.
Slovenian: Drugih formalnih študij medsebojnega delovanja z necitumumabom pri ljudeh niso opravili.
English: Portrazza may cause side effects involving the skin.
Slovenian: Zdravilo Portrazza lahko povzroči neželene učinke, ki vključujejo kožo.
English: If you have a severe infusion-related reaction, your doctor may recommend adjusting the dose of Portrazza, or stop your treatment with Portrazza.
Slovenian: Če se bodo pri vas pojavile hude reakcije, povezane z infuzijo, bo vaš zdravnik morda predlagal prilagoditev odmerka zdravila Portrazza, ali pa prekinil vaše zdravljenje z zdravilom Portrazza.
English: 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).
Slovenian: Bolniki so bili randomizirani v skupino zdravljenja prve izbire z zdravilom Portrazza v odmerku 800 mg in kemoterapijo, sestavljeno iz gemcitabina v odmerku 1250 mg/m2 in cisplatina v odmerku 75 mg/m2 (skupina Portrazza+GC), ali kemoterapijo s gemcitabinom in cisplatinom (skupina GC).
English: - Blood clots in the arteries or the veins
Slovenian: Krvni strdki v arterijah ali venah
English: Portrazza contains the active substance necitumumab, which belongs to a group of substances called monoclonal antibodies.
Slovenian: Zdravilo Portrazza vsebuje zdravilno učinkovino necitumumab, ki spada v skupino zdravilnih učinkovin, imenovanih monoklonska protitelesa.
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilen koncentrat)
English: Avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Portrazza as this medicine may potentially cause harm to your unborn child. Talk to your doctor about the best contraception for you.
Slovenian: Med prejemanjem tega zdravila in še najmanj 3 mesece po prejemu zadnjega odmerka zdravila Portrazza se morate izogibati zanositvi, saj bi to zdravilo lahko škodovalo vašemu nerojenemu otroku.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 800 mg/50 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 800 mg/50 ml
English: In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, an increased rate of infections was observed early after start of treatment, which led to subsequent infectious complications such as pneumonia and/or sepsis.
Slovenian: V kliničnem preskušanju 2. faze, v katerem so preučevali necitumumab v kombinaciji s paklitakselom in karboplatinom v primerjavi s paklitakselom in karboplatinom samima kot zdravljenje prve izbire pri bolnikih z metastatskim skvamoznim nedrobnoceličnim pljučnim rakom v IV. stadiju, so kmalu po začetku zdravljenja opazili povečano stopnjo okužb, ki so povzročile posledične zaplete, kot so pljučnica in/ali sepsa.
English: 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.
Slovenian: Na podlagi rezultatov analize populacijske farmakokinetike ni bilo vpliva delovanja ledvic, ocenjenega s pomočjo očistka kreatinina [CrCl], na farmakokinetiko necitumumaba.
English: 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.
Slovenian: o Opis kardiorespiratornih obolenj, vključno s stopnjami incidence iz kliničnih preskušanj o Informacije o prirastnem tveganju za kardiopulmonarni zastoj ali nenadno smrt pri bolnikih z boleznijo koronarnih arterij, kongestivnim srčnim popuščanjem ali aritmijami v anamnezi v primerjavi z bolniki, ki teh sočasnih stanj nimajo, niso znane.
English: - Infusion-related reaction
Slovenian: - Reakcija, povezana z infuzijo
English: Discard any unused portion of necitumumab left in a vial, as the product contains no antimicrobial preservatives.
Slovenian: Morebitno neuporabljeno učinkovino necitumumab, ki ostane v viali, zavrzite, saj izdelek ne vsebuje antimikrobnih konzervansov.
English: Vials contain 800 mg as a 16 mg/mL solution of necitumumab; one 50 mL vial contains the complete dose.
Slovenian: Viale vsebujejo 800 mg v obliki raztopine necitumumaba 16 mg/ml; ena 50-mililitrska viala vsebuje celoten odmerek.
English: Breast-feeding should be discontinued during treatment with Portrazza and for at least 4 months after the last dose.
Slovenian: Ženske morajo med zdravljenjem z zdravilom Portrazza prekiniti dojenje in ne smejo dojiti še vsaj 4 mesece po zadnjem odmerku.
English: Symptoms may include swelling, pain and tenderness of the limb.
Slovenian: Simptomi lahko vključujejo otekanje, bolečine in občutljivost uda.
English: 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.
Slovenian: Prirastno tveganje za kardiopulmonarni zastoj ali nenadno smrt pri bolnikih z boleznijo koronarnih arterij, kongestivnim srčnim popuščanjem ali aritmijami v anamnezi v primerjavi z bolniki, ki teh sočasnih stanj nimajo, ni znano.
English: Distribution of Portrazza follow a biphasic decline.
Slovenian: Porazdelitev zdravila Portrazza kaže dvofazni upad.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Slovenian: Bolnikom je treba dati navodila, naj poiščejo zdravniško pomoč, če se pri njih razvijejo simptomi, kot so kratka sapa, bolečine v prsih, otekanje rok ali nog.
English: You must not be given Portrazza - if you have ever had a severe allergic reaction to necitumumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste že kdaj imeli hudo alergično reakcijo na necitumumab ali katero koli sestavino tega zdravila
English: Patients should be carefully monitored for serum electrolytes, including serum magnesium, potassium, and calcium, prior to each necitumumab administration and after completion of necitumumab treatment, until within normal limits.
Slovenian: Bolnike je treba pred vsakim dajanjem necitumumaba in po zaključku zdravljenja z necitumumabom natančno spremljati glede serumskih elektrolitov, vključno z magnezijem, kalijem in kalcijem v serumu, dokler se ne vrnejo na normalne vrednosti.
English: In patients with detectable EGFR protein expression (indicated patient population), overall survival was statistically significantly improved in the Portrazza+GC Arm as compared to the GC Arm with an estimated reduction in risk of death of 21% (hazard ratio [HR] = 0.79 [0.69, 0.92]; p = 0.002) and a median OS of 11.7 months in the Portrazza+GC Arm and 10.0 months in the GC Arm. A statistically significant improvement in progression-free survival was also observed (HR = 0.84 [0.72, 0.97]; p = 0.018), with a median PFS of 5.7 months in the Portrazza+GC Arm and 5.5 months in the GC Arm.
Slovenian: Pri bolnikih z izraženostjo beljakovine EGFR (zadevna populacija bolnikov) se je celokupno preživetje statistično pomembno izboljšalo v skupini Portrazza+GC v primerjavi s skupino GC z ocenjenim zmanjšanjem tveganja smrti za 21 % (razmerje tveganja [HR] = 0,79 [0,69; 0,92]; p = 0,002) in mediano celokupnega preživetja 11,7 mesecev v skupini Portrazza+GC in 10,0 mesecev v skupini GC.
English: There are no data on the effect of necitumumab on human fertility.
Slovenian: Ni podatkov o vplivu necitumumaba na plodnost pri človeku.
English: - Cardiorespiratory disorders
Slovenian: - Kardiorespiratorna obolenja
English: There have been no studies performed with other routes of administration.
Slovenian: Študij uporabe zdravila z drugimi potmi uporabe niso opravili.
English: No dose adjustments are required in patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro levic prilagajanja odmerkov niso potrebna (glejte poglavje 5.2).
English: Women of childbearing potential have to use effective contraception during necitumumab treatment and up to 3 months after last administration of necitumumab treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z necitumumabom in še do 3 mesece po zadnjem odmerku necitumumaba uporabljati učinkovito kontracepcijo.
English: Symptoms may include swelling, pain and tenderness of the limb, difficulty breathing, chest pain, or an abnormal heartbeat and discomfort.
Slovenian: Simptomi lahko vključujejo otekanje, bolečine in občutljivost uda, težave z dihanjem, bolečine v prsih ali nenormalen srčni utrip in občutek nelagodja.
English: The addition of necitumumab did not improve the efficacy outcome over pemetrexed and cisplatin alone in advanced non-squamous NSCLC.
Slovenian: Dodajanje necitumumaba ni izboljšalo izida učinkovitosti pri napredovalem neskvamoznem NSCLC v primerjavi s pemetreksedom in cisplatinom v monoterapiji.
English: Overall survival Number of events (n) Median - months (95 % CIa) Hazard ratio (95 % CI)b, c Two-sided log-rank p-valuec 1-year Overall survival rate (%)
Slovenian: Celokupno preživetje Število dogodkov (n) Mediana - meseci (95-% IZa) Razmerje tveganja (95-%
English: The European Medicines Agency has waived the obligation to submit the results of studies with Portrazza in all subsets of the paediatric population in non-small cell lung cancer (see section 4.2 for information on paediatric use).
Slovenian: Portrazza za vse podskupine pediatrične populacije za nedrobnocelični rak pljuč (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: You may be given medicines to reduce the risk of an infusion-related reaction or a skin reaction before you receive Portrazza.
Slovenian: Preden boste prejeli zdravilo Portrazza, boste morda prejeli zdravila za zmanjšanje tveganja za reakcijo, povezano z infuzijo, ali za kožno reakcijo.
English: Management recommendations (any occurrence) Grades 1 and 2 • No dose adjustment necessary Grade 3
Slovenian: Stopnji 1 in 2 • Prilagajanje odmerka ni potrebno.
English: GC Arm N=548
Slovenian: Skupina z GC N = 548
English: Management recommendations (any occurrence)
Slovenian: Priporočila za obravnavanje
English: Portrazza infusions should not be administered or mixed with glucose solutions.
Slovenian: Infuzij zdravila Portrazza ne smete dajati z raztopinami glukoze ali jih mešati z njimi.
English: After dilution When prepared as directed, infusion solutions of Portrazza contain no antimicrobial preservatives.
Slovenian: Raztopine za infundiranje Portrazza, ki so pripravljene po navodilih, ne vsebujejo antimikrobnih konzervansov.
English: There has been limited experience with necitumumab overdose in human clinical trials.
Slovenian: Izkušnje s prevelikim odmerjanjem necitumumaba v kliničnih preskušanjih pri ljudeh so omejene.
English: Skin reactions were reported with necitumumab (see section 4.8).
Slovenian: Pri uporabi necitumumaba so poročali o kožnih reakcijah (glejte poglavje 4.8).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of 50 mL contains 800 mg necitumumab (16 mg/mL).
Slovenian: Ena viala s 50 ml vsebuje 800 mg necitumumaba (16 mg/ml).
English: Grade
Slovenian: Stopnja
English: Patients should be instructed to seek medical care if they develop symptoms of thromboembolism such as shortness of breath, chest pain, arm or leg swelling.
Slovenian: Bolnikom je treba dati navodila, naj poiščejo zdravniško pomoč, če se pri njih razvijejo simptomi trombembolije, kot so kratka sapa, bolečine v prsih, otekanje rok ali nog.
English: Common Arterial thromboembolic events
Slovenian: Pogosti arterijski trombembolični dogodki
English: Toxicity in the elderly or in patients with ECOG PS 2
Slovenian: Toksičnost pri starejših ali pri bolnikih z oceno stanja zmogljivosti 2 po ECOG Klinično pomembne toksičnosti pri starejših in bolnikih z oceno stanja zmogljivosti 2 po ECOG
English: Women of childbearing potential should be advised to avoid becoming pregnant while on necitumumab.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj se izogibajo zanositvi med zdravljenjem z necitumumabom.
English: Infusion-related reactions may occur during treatment with Portrazza.
Slovenian: Med zdravljenjem z zdravilom Portrazza lahko pride do reakcij, povezanih z infuzijo.
English: Portrazza has no known influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Portrazza nima znanega vpliva na sposobnost vožnje in upravljanja s stroji.
English: 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).
Slovenian: V kliničnem preskušanju z napredovalim neskvamoznim NSCLC so pri bolnikih zabeležili povečano stopnjo resnih trombemboličnih dogodkov (vključno s smrtnimi primeri) v skupini zdravljenja z necitumumabom in pemetreksedom ter cisplatinom v primerjavi s skupino s pemetreksedom in cisplatinom (glejte tudi poglavje 4.8).
English: Portrazza is administered in addition to gemcitabine and cisplatin-based chemotherapy for up to 6 cycles of treatment followed by Portrazza as a single agent in patients whose disease has not progressed, until disease progression or unacceptable toxicity.
Slovenian: Zdravilo Portrazza se daje kot dodatek gemcitabinu in cisplatinu največ 6 ciklov zdravljenja, ki jim sledi dajanje zdravila Portrazza v obliki monoterapije, do napredovanja bolezni ali nesprejemljive toksičnosti pri bolnikih, pri katerih bolezen ni napredovala.
English: Effective contraception has to be used during necitumumab treatment and up to 3 months after last administration of necitumumab treatment.
Slovenian: Med zdravljenjem z necitumumabom in še do 3 mesece po zadnjem odmerku necitumumaba je treba uporabljati učinkovito kontracepcijo.
English: An increased frequency of cardiorespiratory arrest or sudden death was observed with necitumumab.
Slovenian: Pri uporabi necitumumaba so opazili povečano pogostnost kardiorespiratornega zastoja ali nenadne smrti.
English: Severe skin rections were reported in approximately 6 % of patients while 1.7 % of patients discontinued due to skin reactions.
Slovenian: medtem ko je 1,7 % bolnikov zaradi kožnih reakcij prekinilo zdravljenje.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Parenteral medicines should be inspected visually for particulate matter prior to administration.
Slovenian: Parenteralna zdravila je treba pred uporabo vizualno pregledati, da ne vsebujejo trdnih delcev.
English: Each 50 mL vial contains 800 mg of necitumumab.
Slovenian: Ena 50-mililitrska viala vsebuje 800 mg necitumumaba.
English: 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.
Slovenian: Pri bolnikih, pri katerih je v preteklosti že nastopila preobčutljivostna reakcija stopnje 1-2 ali z infuzijo povezana reakcija na zdravilo Portrazza, je priporočena premedikacija s kortikosteroidom in antipiretikom kot dodatkom antihistaminiku.
English: This medicine is given as an intravenous (into a vein) infusion via a drip.
Slovenian: To zdravilo se daje v obliki intravenske (v veno) kapalne infuzije.
English: 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.
Slovenian: Do podobnih ugotovitev so prišli v kliničnem preskušanju, v katerem so preučevali necitumumab v kombinaciji s pemetreksedom in cisplatinom v primerjavi s pemetreksedom in cisplatinom samima kot zdravljenje prve izbire pri bolnikih z napredovalim neskvamoznim nedrobnoceličnim pljučnim rakom.
English: Each millilitre of the concentrate for solution for infusion contains 16 mg of necitumumab.
Slovenian: En mililiter koncentrata za raztopino za infundiranje vsebuje 16 mg necitumumaba.
English: In patients who have experienced a previous Grade 1 or 2 hypersensitivity or infusion related reaction to Portrazza, premedication with a corticosteroid and an antipyretic in addition to an antihistamine is recommended.
Slovenian: Pri bolnikih, pri katerih je v preteklosti že nastopila preobčutljivostna reakcija stopnje 1 ali 2 ali z infuzijo povezana reakcija na zdravilo Portrazza, je priporočena premedikacija s kortikosteroidom in antipiretikom kot dodatkom antihistaminiku.
English: Cardiorespiratory disorders
Slovenian: Kardiorespiratorna obolenja
English: See also section 2 under “Warnings and precautions”.
Slovenian: Glejte tudi poglavje 2 pod naslovom
English: Albumin-corrected hypocalcaemiac
Slovenian: Zelo pogosti za albumin korigirana hiperkalciemijac
English: • Stop the infusion; when the reaction has resolved to Grade ≤ 1, resume infusion at a 50 % decreased infusion rate.b
Slovenian: • Ustavite infuzijo; ko se reakcija izboljša do stopnje ≤ 1,
English: Symptoms may include difficulty breathing, chest pain, or an abnormal heartbeat and discomfort.
Slovenian: Simptomi lahko vključujejo težave z dihanjem, bolečine v prsih ali nenormalen srčni utrip in občutek nelagodja.
English: Blood clots can also lead to a blockage in the blood vessels of the lung.
Slovenian: Krvni strdki lahko povzročijo tudi zamašitev krvnih žil v pljučih.
English: Venous thromboembolic events (VTEs) were reported in approximately 8 % of patients and mainly present as pulmonary embolism and deep vein thrombosis.
Slovenian: O venskih trombemboličnih dogodkih so poročali pri približno 8 % bolnikov in so večinoma predstavljali pljučno embolijo in globoko vensko trombozo.
English: Dose dependent reversible skin toxicity was observed in the 26-week monkey study.
Slovenian: V 26-tedenski študiji na opicah so opazili reverzibilno kožno toksičnost, povezano z odmerkom.
English: • If symptoms do not worsen at 400 mg for at least 1 treatment cycle, the dose may be increased to 600 mg If symptoms worsen at 600 mg, temporarily withhold, for a maximum of 6 weeks following Day 1 of the most recent treatment cycle, until symptoms resolve to Grade ≤ 2.
Slovenian: Če se simptomi pri odmerku 600 mg poslabšajo, začasno prekinite zdravljenje za največ 6 tednov po 1. dnevu zadnjega cikla zdravljenja, dokler se simptomi ne izboljšajo do stopnje ≤ 2.
English: Appropriate medical resources for the treatment of severe infusion reactions should be available during necitumumab infusions.
Slovenian: Med infuzijami necitumumaba morajo biti na voljo ustrezna medicinska oprema in osebje za zdravljenje hudih alergičnih reakcij na infuzijo.
English: There are no data regarding necitumumab administration in patients with moderate or severe hepatic impairment (see section 5.2).
Slovenian: Okvara jeter Ni podatkov o dajanju necitumumaba bolnikom z zmerno ali hudo okvaro jeter (glejte poglavje 5.2).
English: 50 mL solution in a vial (Type I glass) with a chlorobutyl elastomer stopper, an aluminium seal and a polypropylene cap.
Slovenian: 6.5 Vrsta ovojnine in vsebina 50 ml raztopine v viali (iz stekla tipa I) z zamaškom iz klorobutilnega elastomera, aluminijasto zaporko in polipropilenskim pokrovčkom.
English: There are no data regarding necitumumab administration in patients with severe renal impairment.
Slovenian: Ni podatkov o dajanju necitumumaba bolnikom s hudo okvaro ledvic.
English: - Blood levels of magnesium, calcium, potassium and phosphate During treatment, your doctor will check your blood periodically for levels of several substances such as magnesium, calcium, potassium and phosphate.
Slovenian: Zdravnik bo v času vašega zdravljenja periodično preverjal ravni različnih snovi, kot so magnezij, kalcij, kalij in fosfati v vaši krvi.
English: There is no known antidote for necitumumab overdose.
Slovenian: Antidot za preveliko odmerjanje necitumumaba ni znan.
English: Necitumumab exhibits concentration-dependent clearance.
Slovenian: Očistek necitumumaba je odvisen od koncentracije zdravila.
English: Portrazza is administered as an intravenous infusion.
Slovenian: Zdravilo Portrazza se daje v obliki intravenske infuzije.
English: Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients and mainly present as stroke and myocardial infarction.
Slovenian: O arterijskih trombemboličnih dogodkih so poročali pri približno 4 % bolnikov in so večinoma predstavljali kap in miokardni infarkt.
English: There was no premedication for Portrazza mandated by the study.
Slovenian: Študija ni predvidevala obvezne premedikacije za uporabo zdravila Portrazza.
English: • Permanently discontinue if patients experience Grade 3 skin induration/fibrosis.
Slovenian: lahko odmerek povečate na 800 mg. • Trajno prekinite zdravljenje, če se pri bolnikih pojavijo kožne zatrdline/fibroza stopnje 3.
English: During each infusion, your doctor or nurse will check for side effects.
Slovenian: Vaš zdravnik ali medicinska sestra bosta med vsako infuzijo pozorna na neželene učinke.
English: Very common
Slovenian: Zelo pogosti stomatitis