natgillin/translations-raw huggingface dataset:
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. 
o Potreba po natančnem razmisleku o uporabi necitumumaba pri bolnikih s trombemboličnimi dogodki v anamnezi ali obstoječimi faktorji tveganja za trombembolične dogodke o Informacije o relativnem tveganju venskih trombemboličnih dogodkov ali arterijskih trombemboličnih dogodkov pri bolnikih z venskimi trombemboličnimi dogodki ali arterijskimi trombemboličnimi dogodki v anamnezi o Priporočilo, da se necitumumaba ne sme dati bolnikom z več dejavniki tveganja za trombembolične dogodke, razen če koristi odtehtajo tveganja za bolnika o Potreba po razmisleku o tromboprofilaksi po natančni oceni bolnikovih dejavnikov tveganja o Pri bolnikih, pri katerih se pojavijo venski trombembolični dogodki in arterijski trombembolični dogodki, je treba po natančni oceni koristi in tveganj za posameznega bolnika razmisliti o prekinitvi zdravljenja z necitumumabom.
Administration of necitumumab should be carefully considered in those patients with a history of thromboembolic events (such as pulmonary embolism, deep vein thrombosis, myocardial infarction, stroke) or preexisting risk factors for thromboembolic events (such as advanced age, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with acquired or inherited thrombophilic disorders). 
O dajanju necitumumaba je treba natančno razmisliti pri bolnikih s trombemboličnimi dogodki v anamnezi (npr. pljučna embolija, globoka venska tromboza, miokardni infarkt, kap) ali obstoječimi faktorji tveganja za trombembolične dogodke (npr. višja starost, bolniki z daljšimi obdobji imobilizacije, bolniki s hudo hipovolemijo, bolniki s pridobljenimi ali podedovanimi trombofilnimi stanji).
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). 
dneh po zadnjem odmerku necitumumaba in je imelo sočasna obolenja, vključno s koronarno arterijsko boleznijo (n = 3), hipomagneziemijo (n = 4), kronično obstruktivno pljučno boleznijo (n = 7) in hipertenzijo (n = 5) v anamnezi.
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). 
vključno z vnaprej določenimi faktorji stratifikacije (ocena stanja zmogljivosti po ECOG [0-1 v primerjavi z 2] in geografsko regijo [Severna Amerika, Evropa in Avstralija v primerjavi z Južno Ameriko, Južno Afriko in Indijo v primerjavi z Vzhodno Azijo]); pri bolnikih, starih 70 let in več, je bilo razmerje tveganja za celokupno preživetje 1,03 (0,75; 1,42) (glejte Sliko 2).
Necitumumab hinders other proteins from binding to the EGFR and thus prevents the cancer cell from growth and division. 
Necitumumab drugim beljakovinam onemogoča vezavo na EGFR in na ta način preprečuje rast in delitev rakave celice.
The recommended dose of Portrazza is 800 mg on days 1 and 8 of each 3-week cycle. 
Priporočeni odmerek zdravila Portrazza je 800 mg 1. in 8. dan vsakega 3-tedenskega cikla.
The onset of events usually occurred after the first or second administration of necitumumab. 
Ti dogodki so običajno nastopili po prvem ali drugem infundiranju necitumumaba.
Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition. 
Zdravilo Portrazza je v kombinaciji s kemoterapijo z gemcitabinom in cisplatinom indicirano za zdravljenje odraslih bolnikov z lokalno napredovalim ali metastatskim skvamoznim nedrobnoceličnim rakom pljuč z ekspresijo receptorjev za epidermalni rastni dejavnik (EGFR-epidermal growth factor receptor), ki za to bolezen še niso prejeli predhodne kemoterapije.
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. 
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.
Patients may be advised to apply moisturiser, sunscreen and topical steroid cream to face, hands, feet, neck, back and chest. 
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.
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. 
in 2 pri 9 % bolnikov; več kot 50 % bolnikov je imelo metastatsko bolezen na več kot 2 mestih.
In case of previous hypersensitivity or infusion-related reaction, recommendations for management of hypersensitivity/infusion-related reactions should be followed, as for Table 1. 
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.
• If symptoms do not worsen at 600 mg for another treatment cycle, the dose may be further increased to 800 mg. 
• Če se simptomi pri odmerku 400 mg ne poslabšajo vsaj 1 cikel zdravljenja, lahko odmerek povečate na 600 mg.
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. 
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.
No other formal interaction studies with necitumumab have been performed in humans. 
Drugih formalnih študij medsebojnega delovanja z necitumumabom pri ljudeh niso opravili.
Portrazza may cause side effects involving the skin. 
Zdravilo Portrazza lahko povzroči neželene učinke, ki vključujejo kožo.
If you have a severe infusion-related reaction, your doctor may recommend adjusting the dose of Portrazza, or stop your treatment with Portrazza. 
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.
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). 
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).
- Blood clots in the arteries or the veins 
Krvni strdki v arterijah ali venah
Portrazza contains the active substance necitumumab, which belongs to a group of substances called monoclonal antibodies. 
Zdravilo Portrazza vsebuje zdravilno učinkovino necitumumab, ki spada v skupino zdravilnih učinkovin, imenovanih monoklonska protitelesa.
Concentrate for solution for infusion (sterile concentrate). 
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilen koncentrat)
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. 
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.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 800 mg/50 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 800 mg/50 ml
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. 
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.
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. 
Na podlagi rezultatov analize populacijske farmakokinetike ni bilo vpliva delovanja ledvic, ocenjenega s pomočjo očistka kreatinina [CrCl], na farmakokinetiko necitumumaba.
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 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.
- Infusion-related reaction 
- Reakcija, povezana z infuzijo
Discard any unused portion of necitumumab left in a vial, as the product contains no antimicrobial preservatives. 
Morebitno neuporabljeno učinkovino necitumumab, ki ostane v viali, zavrzite, saj izdelek ne vsebuje antimikrobnih konzervansov.
Vials contain 800 mg as a 16 mg/mL solution of necitumumab; one 50 mL vial contains the complete dose. 
Viale vsebujejo 800 mg v obliki raztopine necitumumaba 16 mg/ml; ena 50-mililitrska viala vsebuje celoten odmerek.
Breast-feeding should be discontinued during treatment with Portrazza and for at least 4 months after the last dose. 
Ženske morajo med zdravljenjem z zdravilom Portrazza prekiniti dojenje in ne smejo dojiti še vsaj 4 mesece po zadnjem odmerku.
Symptoms may include swelling, pain and tenderness of the limb. 
Simptomi lahko vključujejo otekanje, bolečine in občutljivost uda.
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. 
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.
Distribution of Portrazza follow a biphasic decline. 
Porazdelitev zdravila Portrazza kaže dvofazni upad.
Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling. 
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.
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). 
- če ste že kdaj imeli hudo alergično reakcijo na necitumumab ali katero koli sestavino tega zdravila
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. 
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.
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. 
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.
There are no data on the effect of necitumumab on human fertility. 
Ni podatkov o vplivu necitumumaba na plodnost pri človeku.
- Cardiorespiratory disorders 
- Kardiorespiratorna obolenja
There have been no studies performed with other routes of administration. 
Študij uporabe zdravila z drugimi potmi uporabe niso opravili.
No dose adjustments are required in patients with mild or moderate renal impairment (see section 5.2). 
Pri bolnikih z blago ali zmerno okvaro levic prilagajanja odmerkov niso potrebna (glejte poglavje 5.2).
Women of childbearing potential have to use effective contraception during necitumumab treatment and up to 3 months after last administration of necitumumab treatment. 
Ženske v rodni dobi morajo med zdravljenjem z necitumumabom in še do 3 mesece po zadnjem odmerku necitumumaba uporabljati učinkovito kontracepcijo.
Symptoms may include swelling, pain and tenderness of the limb, difficulty breathing, chest pain, or an abnormal heartbeat and discomfort. 
Simptomi lahko vključujejo otekanje, bolečine in občutljivost uda, težave z dihanjem, bolečine v prsih ali nenormalen srčni utrip in občutek nelagodja.
The addition of necitumumab did not improve the efficacy outcome over pemetrexed and cisplatin alone in advanced non-squamous NSCLC. 
Dodajanje necitumumaba ni izboljšalo izida učinkovitosti pri napredovalem neskvamoznem NSCLC v primerjavi s pemetreksedom in cisplatinom v monoterapiji.
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 (%) 
Celokupno preživetje Število dogodkov (n) Mediana - meseci (95-% IZa) Razmerje tveganja (95-%
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). 
Portrazza za vse podskupine pediatrične populacije za nedrobnocelični rak pljuč (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
You may be given medicines to reduce the risk of an infusion-related reaction or a skin reaction before you receive Portrazza. 
Preden boste prejeli zdravilo Portrazza, boste morda prejeli zdravila za zmanjšanje tveganja za reakcijo, povezano z infuzijo, ali za kožno reakcijo.
Management recommendations (any occurrence) Grades 1 and 2 • No dose adjustment necessary Grade 3 
Stopnji 1 in 2 • Prilagajanje odmerka ni potrebno.
GC Arm N=548 
Skupina z GC N = 548
Management recommendations (any occurrence) 
Priporočila za obravnavanje
Portrazza infusions should not be administered or mixed with glucose solutions. 
Infuzij zdravila Portrazza ne smete dajati z raztopinami glukoze ali jih mešati z njimi.
After dilution When prepared as directed, infusion solutions of Portrazza contain no antimicrobial preservatives. 
Raztopine za infundiranje Portrazza, ki so pripravljene po navodilih, ne vsebujejo antimikrobnih konzervansov.
There has been limited experience with necitumumab overdose in human clinical trials. 
Izkušnje s prevelikim odmerjanjem necitumumaba v kliničnih preskušanjih pri ljudeh so omejene.
Skin reactions were reported with necitumumab (see section 4.8). 
Pri uporabi necitumumaba so poročali o kožnih reakcijah (glejte poglavje 4.8).
STATEMENT OF ACTIVE SUBSTANCE(S) One vial of 50 mL contains 800 mg necitumumab (16 mg/mL). 
Ena viala s 50 ml vsebuje 800 mg necitumumaba (16 mg/ml).
Grade 
Stopnja
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. 
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.
Common Arterial thromboembolic events 
Pogosti arterijski trombembolični dogodki
Toxicity in the elderly or in patients with ECOG PS 2 
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
Women of childbearing potential should be advised to avoid becoming pregnant while on necitumumab. 
Ženskam v rodni dobi je treba svetovati, naj se izogibajo zanositvi med zdravljenjem z necitumumabom.
Infusion-related reactions may occur during treatment with Portrazza. 
Med zdravljenjem z zdravilom Portrazza lahko pride do reakcij, povezanih z infuzijo.
Portrazza has no known influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Portrazza nima znanega vpliva na sposobnost vožnje in upravljanja s stroji.
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). 
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).
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. 
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.
Effective contraception has to be used during necitumumab treatment and up to 3 months after last administration of necitumumab treatment. 
Med zdravljenjem z necitumumabom in še do 3 mesece po zadnjem odmerku necitumumaba je treba uporabljati učinkovito kontracepcijo.
An increased frequency of cardiorespiratory arrest or sudden death was observed with necitumumab. 
Pri uporabi necitumumaba so opazili povečano pogostnost kardiorespiratornega zastoja ali nenadne smrti.
Severe skin rections were reported in approximately 6 % of patients while 1.7 % of patients discontinued due to skin reactions. 
medtem ko je 1,7 % bolnikov zaradi kožnih reakcij prekinilo zdravljenje.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Parenteral medicines should be inspected visually for particulate matter prior to administration. 
Parenteralna zdravila je treba pred uporabo vizualno pregledati, da ne vsebujejo trdnih delcev.
Each 50 mL vial contains 800 mg of necitumumab. 
Ena 50-mililitrska viala vsebuje 800 mg necitumumaba.
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. 
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.
This medicine is given as an intravenous (into a vein) infusion via a drip. 
To zdravilo se daje v obliki intravenske (v veno) kapalne infuzije.
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. 
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.
Each millilitre of the concentrate for solution for infusion contains 16 mg of necitumumab. 
En mililiter koncentrata za raztopino za infundiranje vsebuje 16 mg necitumumaba.
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. 
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.
Cardiorespiratory disorders 
Kardiorespiratorna obolenja
See also section 2 under “Warnings and precautions”. 
Glejte tudi poglavje 2 pod naslovom
Albumin-corrected hypocalcaemiac 
Zelo pogosti za albumin korigirana hiperkalciemijac
• Stop the infusion; when the reaction has resolved to Grade ≤ 1, resume infusion at a 50 % decreased infusion rate.b 
• Ustavite infuzijo; ko se reakcija izboljša do stopnje ≤ 1,
Symptoms may include difficulty breathing, chest pain, or an abnormal heartbeat and discomfort. 
Simptomi lahko vključujejo težave z dihanjem, bolečine v prsih ali nenormalen srčni utrip in občutek nelagodja.
Blood clots can also lead to a blockage in the blood vessels of the lung. 
Krvni strdki lahko povzročijo tudi zamašitev krvnih žil v pljučih.
Venous thromboembolic events (VTEs) were reported in approximately 8 % of patients and mainly present as pulmonary embolism and deep vein thrombosis. 
O venskih trombemboličnih dogodkih so poročali pri približno 8 % bolnikov in so večinoma predstavljali pljučno embolijo in globoko vensko trombozo.