FrancophonIA/ELRC3.0 huggingface dataset:
English: Infusion related reaction * Immune-related adverse reaction based on medical review § Reaction only observed from study EMR 100070-003 (Part B) after the data cut-off of the pooled analysis, hence frequency estimated
Slovenian: Zelo pogosti reakcije, povezane z infundiranjem * Imunsko pogojeni neželeni učinek na osnovi medicinskega pregleda § Reakcijo so opazili le v študiji EMR100070-003 (Del B) glede na presečne podatke iz združene analize, zato je pogostnost ocenjena
English: • problems with your kidneys;
Slovenian: • težave z ledvicami,
English: If corticosteroids are used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Slovenian: Če se za zdravljenje neželenega učinka uporabijo kortikosteroidi, jih je treba ob izboljšanju zmanjševati postopoma, vsaj 1 mesec.
English: Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
Slovenian: Avelumab je humano monoklonsko protitelo IgG1, usmerjeno proti imunomodulacijskemu proteinskemu ligandu PD-L1 celične površine, ki je pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka.
English: ** CIs are derived using the log-log transformation with back transformation to untransformed scale.
Slovenian: * 1−stranska vrednost p na osnovi log-rank stratifikacije ** IZ so izpeljani z uporabo log-log transformacije s povratno transformacijo v netransformirano lestvico.
English: Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1).
Slovenian: Avelumab je humano imunoglobulinsko monoklonsko protitelo G1 (IgG1), usmerjeno proti ligandu programirane celične smrti 1 (PD-L1).
English: • problems with your hormone producing glands (the thyroid, adrenal and pituitary glands) that may affect how these glands work;
Slovenian: • težave z žlezami, v katerih nastajajo hormoni (ščitnica, nadledvična žleza in hipofiza), kar lahko vpliva na delovanje teh žlez,
English: Three patients were reported to be overdosed with 5% to 10% above the recommended dose of avelumab.
Slovenian: O prevelikem odmerjanju s 5 % do 10 % nad priporočenim odmerkom avelumaba so poročali pri treh bolnikih.
English: In both studies, avelumab was administered at 10 mg/kg every 2 weeks.
Slovenian: V obeh študijah so avelumab dajali v odmerku 10 mg/kg vsaka 2 tedna.
English: In clinical trials, 98.6% (433/439) of patients with infusion-related reactions had a first infusion-related reaction during the first 4 infusions of which 2.7% (12/439) were Grade ≥ 3.
Slovenian: V kliničnih preskušanjih se je pri 98,6 % (433/439) bolnikov z neželenimi učinki, povezanimi z infundiranjem, prvi neželeni učinek, povezan z infundiranjem, pojavil med prvimi 4 infundiranji, pri čemer jih je bilo 2,7 % (12/439) stopnje ≥ 3.
English: IHC: Immunohistochemistry; MCV: Merkel cell polyomavirus; ORR: objective response rate a Based on data from patients evaluable for PD-L1 b Based on data from patients evaluable for MCV by immunohistochemistry (IHC)
Slovenian: IHC: imunohistokemija; MCV: poliomavirus Merklovih celic; ORR: stopnja objektivnega odziva a Na podlagi podatkov o bolnikih, ki jih je bilo mogoče oceniti za PD-L1
English: Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
Slovenian: Pokazalo se je, da avelumab inducira tudi z naravnimi celicami ubijalkami posredovano tumorsko citolizo z mehanizmom citotoksičnosti, posredovane s protitelesi (ADCC, antibody-dependent cell-mediated cytotoxicity).
English: Objective response rate (ORR)
Slovenian: Stopnja objektivnega odziva (ORR)
English: Oedema peripheral, influenza like illness
Slovenian: Pogosti periferni edem, gripi podobna bolezen
English: • Decreased kidney function
Slovenian: • zmanjšano delovanje ledvic
English: Results (N=88)
Slovenian: Rezultati (n = 88)
English: 2.3 months).
Slovenian: 11 dni).
English: Based on data available, including the low incidence of immunogenicity, the impact of ADA on pharmacokinetics, efficacy and safety is uncertain, while the impact of neutralizing antibodies (nAb) is unknown.
Slovenian: Vpliv protiteles proti zdravilu na farmakokinetiko, učinkovitost in varnost na podlagi razpoložljivih podatkov, vključno z nizko pojavnostjo imunogenosti, ni dokončno ugotovljen, medtem ko vpliv nevtralizirajočih protiteles ni znan.
English: • inflammation of your muscles (myositis).
Slovenian: • vnetje mišic (miozitis).
English: Before you receive Bavencio
Slovenian: Preden dobite zdravilo Bavencio
English: When avelumab 10 mg/kg was administered in combination with axitinib 5 mg, the respective exposures of avelumab and axitinib were unchanged compared to the single agents.
Slovenian: Kadar je bil avelumab 10 mg/kg dan v kombinaciji z aksitinibom 5 mg, so bile vsakokratne izpostavljenosti avelumabu in aksitinibu nespremenjene v primerjavi s posameznim zdravilom.
English: For Part B, the major efficacy outcome measure was durable response, defined as objective response (complete response (CR) or partial response (PR)) with a duration of at least 6 months; secondary outcome measures included BOR, DOR, PFS, and OS.
Slovenian: Za del B je bilo glavno merilo izida učinkovitosti trajen odziv, opredeljen kot objektivni odziv (popolni odziv (CR) ali delni odziv (PR)) s trajanjem najmanj 6 mesecev; sekundarna merila učinkovitosti pa so
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Slovenian: Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Overall, there was no evidence of altered pharmacokinetic profile, increased incidence of infusion reactions or effects on efficacy with anti-avelumab antibody development.
Slovenian: S pojavom protiteles proti avelumabu na splošno ni bilo dokazov za spremembo farmakokinetičnega profila, povečanje pogostnosti reakcij, povezanih z infundiranjem, ali vplivov na učinkovitost.
English: However, in murine models of pregnancy, blockade of PD-L1 signalling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3).
Slovenian: Na modelih brejosti pri miših se je pokazalo, da blokada signaliziranja PD-L1 okvari toleranco za plod in poveča pogostnost izgube ploda (glejte poglavje 5.3).
English: All 31 patients with immune-related hepatitis were treated for hepatitis including 30 (96.8%) patients treated with corticosteroids and 1 patient with a non-steroidal immunosuppressant.
Slovenian: Vseh 31 bolnikov z imunsko pogojenim hepatitisom je bilo zdravljenih za hepatitis, vključno s 30 (96,8 %) bolniki, zdravljenimi s kortikosteroidi, in 1 bolnikom, zdravljenim z nesteroidnimi imunosupresivi.
English: From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the diluted solution should be infused immediately.
Slovenian: Z mikrobiološkega vidika je treba razredčeno raztopino takoj infundirati, razen če metoda redčenja zmanjša tveganje za mikrobiološko kontaminacijo.
English: Patients with prior systemic therapy directed at advanced or metastatic RCC; prior systemic immunotherapy treatment with IL-2, IFN-α, anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or active brain metastasis; active autoimmune disease that might deteriorate when receiving an immunostimulatory agents; a history of other malignancies within the last 5 years; organ transplant were ineligible.
Slovenian: Bolniki s predhodnim sistemskim zdravljenjem napredovalega ali metastatskega KLC, predhodnim sistemskim imunskim zdravljenjem z IL-2, IFN-α, anti-PD-1, anti-PD-L1, ali anti-CTLA-4 protitelesi ali z aktivnimi možganskimi metastazami, aktivno avtoimunsko boleznijo, ki bi se pri zdravljenju z imunostimulatorji lahko poslabšala, drugimi malignimi obolenji v zadnjih 5 letih, transplantacijo organa niso bili primerni.
English: Adverse reactions reported for 88 patients with metastatic MCC and for 1,650 patients in a phase I study in solid tumours are presented in Table 2.
Slovenian: Neželeni učinki, o katerih so poročali pri 88 bolnikih z metastatskim KMC in pri 1.650 bolnikih v študiji faze I s čvrstimi tumorji, so predstavljeni v preglednici 2.
English: Avelumab pharmacokinetics (PK) was assessed using a population PK approach for avelumab as monotherapy and avelumab in combination with axitinib.
Slovenian: Farmakokinetiko (FK) avelumaba so ocenili z uporabo populacijskega FK pristopa za avelumab v monoterapiji in v kombinaciji z aksitinibom.
English: AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
Slovenian: AST ali ALT, ki je več kot 5-krat večja od ULN, ali vrednost celokupnega bilirubina, ki je več kot 3-krat večja od
English: Hepatotoxicity occurred in patients treated with avelumab in combination with axitinib with higher than expected frequencies of Grade 3 and Grade 4 ALT and AST elevation compared to avelumab alone (see section 4.8).
Slovenian: Hepatotoksičnost (v kombinaciji z aksitinibom) Hepatotoksičnost se je pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, pojavila z večjimi pogostnostmi zvišanja vrednosti ALT in AST 3. stopnje in 4. stopnje od pričakovanih, v primerjavi z uporabo samo avelumaba (glejte poglavje 4.8).
English: For suspected immune-related adverse reactions, ensure adequate evaluation to confirm aetiology or to rule out other causes.
Slovenian: Pri sumu na imunsko pogojene neželene učinke zagotovite ustrezen pregled za potrditev etiologije bolezni ali izključitev drugih vzrokov.
English: Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Slovenian: Zdravilo Bavencio je indicirano kot monoterapija za zdravljenje odraslih bolnikov z metastatskim karcinomom Merklovih celic (KMC).
English: Median, months (95% CI)
Slovenian: Mediana, meseci (95 % IZ)
English: Treatment with avelumab should be resumed when metabolic control is achieved on insulin replacement therapy.
Slovenian: Zdravljenje z avelumabom je treba nadaljevati, ko je dosežena presnovna urejenost z nadomestnim zdravljenjem z insulinom.
English: • Red, itchy, scaly patches on the skin
Slovenian: • rdeče, srbeče, luskaste zaplate na koži
English: Fatigue, pyrexia, oedema peripheral
Slovenian: Zelo pogosti utrujenost, pireksija, periferni edem
English: Efficacy results are presented in Table 7 and Figure 3 based on a data cut-off date of 28 January 2019.
Slovenian: Rezultati učinkovitosti so predstavljeni v preglednici 7 in sliki 3 na osnovi presečnih podatkov z dne
English: In case of recurrence of Grade 1 or Grade 2 infusion-related reaction, the patient may continue to receive avelumab under close monitoring, after appropriate infusion rate modification and premedication with paracetamol and antihistamine (see section 4.2).
Slovenian: Pri ponovnem pojavu neželenih učinkov 1. ali 2. stopnje, povezanih z infundiranjem, lahko bolnik avelumab prejema še naprej, ob natančnem spremljanju, po ustrezni spremembi hitrosti infundiranja in premedikaciji s paracetamolom in antihistaminikom (glejte poglavje 4.2).
English: Bavencio contains the active substance avelumab, a monoclonal antibody (a type of protein) that attaches to a specific target in the body called PD-L1.
Slovenian: Zdravilo Bavencio vsebuje učinkovino avelumab, ki je monoklonsko protitelo (vrsta beljakovine), ki se veže na določene tarče v telesu, imenovane PD-L1.
English: Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, Guillain-Barré syndrome)
Slovenian: Drugi imunsko pogojeni neželeni učinki (vključno z miozitisom, hipopituitarizmom, uveitisom, GuillainBarréjevim sindromom)
English: There was no evidence to suggest a clinically relevant change of avelumab clearance over time in patients with advanced RCC.
Slovenian: Ni bilo dokazov, ki bi pri bolnikih z napredovalim KLC kazali na klinično pomembno spremembo očistka avelumaba v odvisnosti od časa.
English: Negative (n=31)
Slovenian: Negativen (n = 31)
English: Tiredness is a very common side effect of Bavencio and can affect your ability to drive or to use machines.
Slovenian: Utrujenost je zelo pogost neželeni učinek zdravila Bavencio in lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving avelumab and should use effective contraception during treatment with avelumab and for at least 1 month after the last dose of avelumab.
Slovenian: Ženske v rodni dobi/kontracepcija Ženskam v rodni dobi je treba svetovati, naj med prejemanjem avelumaba ne zanosijo in naj uporabljajo učinkovito kontracepcijo med zdravljenjem z avelumabom in še vsaj 1 mesec po zadnjem odmerku avelumaba.
English: Tumour response assessments were performed every 6 weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Slovenian: Tumorski odziv je vsakih 6 tednov ocenil neodvisni odbor za pregled izidov učinkovitosti (IERC, Independent Endpoint Review Committee) po merilih za oceno odgovora na zdravljenje pri čvrstih tumorjih (RECIST, Response Evaluation Criteria in Solid Tumors), v1.1.
English: This medicine has been given ‘conditional approval'.
Slovenian: Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet“.
English: The recommended dose of Bavencio in combination with axitinib is 800 mg administered intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.
Slovenian: Priporočeni odmerek zdravila Bavencio v kombinaciji z aksitinibom je 800 mg, ki se daje intravensko, v obliki 60-minutnega infundiranja, na vsaka 2 tedna, in aksitinib v odmerku 5 mg peroralno dvakrat na dan (v razmiku 12 ur) s hrano ali brez nje do napredovanja bolezni ali nesprejemljive toksičnosti.
English: Bavencio is a clear, colourless to slightly yellow solution.
Slovenian: Bavencio je bistra, brezbarvna do rahlo rumenkasta raztopina.
English: Withhold until adverse reactions recover to Grade 0-1
Slovenian: Zdravljenje odložite, dokler se neželeni učinki ne vrnejo na stopnjo 0-1
English: Colitis*, autoimmune colitis*, enterocolitis*, ileus
Slovenian: Občasni kolitis*, avtoimunski kolitis*, enterokolitis*, ileus
English: Patients should be more frequently monitored for changes in liver function and symptoms as compared to when avelumab is used as monotherapy.
Slovenian: Bolnike je treba bolj pogosto spremljati zaradi pojava spremenjenega delovanja jeter in jetrnih simptomov, kot pa če bi avelumab uporabljali v monoterapiji.
English: There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations.
Slovenian: Za priporočila o odmerjanju pri bolnikih z zmerno ali hudo okvaro jeter ni dovolj podatkov.
English: Package leaflet: Information for the patient Bavencio 20 mg/mL concentrate for solution for infusion avelumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Bavencio 20 mg/ml koncentrat za raztopino za infundiranje avelumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Hepatitis, hepatotoxicity, immune-mediated hepatitis, liver disorder
Slovenian: Občasni hepatitis, hepatotoksičnost, imunsko pogojeni hepatitis, motnja delovanja jeter
English: • Feeling less hungry, weight loss
Slovenian: • zmanjšan občutek lakote, izguba telesne mase
English: For renal cell cancer, Bavencio is to be used in combination with axitinib.
Slovenian: Za raka ledvičnih celic se zdravilo Bavencio uporablja v kombinaciji z aksitinibom.
English: Type 1 diabetes mellitus Avelumab can cause Type 1 diabetes mellitus, including diabetic ketoacidosis (see section 4.8).
Slovenian: Sladkorna bolezen tipa 1 Avelumab lahko povzroči sladkorno bolezen tipa 1, vključno z diabetično ketoacidozo (glejte poglavje 4.8).
English: If you stop receiving Bavencio
Slovenian: Če ste prenehali prejemati zdravilo Bavencio
English: Other clinically important immune-related adverse reactions were reported in less than 1% of patients: myositis, hypopituitarism, uveitis, and Guillain-Barré syndrome (see section 4.8).
Slovenian: Pri manj kot 1 % bolnikov so poročali o klinično pomembnih imunsko pogojenih neželenih dogodkih: miozitis, hipopituitarizem, uveitis in Guillain-Barréjev sindrom (glejte poglavje 4.8).
English: • Signs of inflammation of the muscles (myositis) may include muscle pain or weakness.
Slovenian: • Znaki vnetja mišic (miozitis) lahko vključujejo mišično bolečino in šibkost.
English: If refrigerated, allow the diluted solution in the intravenous bags to come to room temperature prior to use.
Slovenian: Pri shranjevanju v hladilniku pred uporabo razredčene raztopine počakajte, da doseže sobno temperaturo.
English: No studies have been conducted to assess the potential of avelumab for carcinogenicity or genotoxicity.
Slovenian: Študij za oceno kancerogenega in genotoksičnega potenciala avelumaba niso izvedli.
English: Myocarditis
Slovenian: Miokarditis
English: If persistent (greater than 5 days), corticosteroid therapy with prednisone or equivalent followed by a taper should be considered.
Slovenian: Če neželeni učinki ne izginejo (trajajo več kot 5 dni), je treba razmisliti o kortikosteroidnem zdravljenju s prednizonom ali enakovrednim zdravilom, ki mu sledi postopno zmanjševanje.
English: Positive (n=58) Negative (n=16)
Slovenian: Pozitivna (n = 58) Negativna (n = 16)
English: Serum creatinine more than 6 times ULN Permanently discontinue
Slovenian: Vrednosti kreatinina v serumu več kot 6-krat večje od ULN
English: Your doctor will check your general health before and during treatment with Bavencio.
Slovenian: Vaš zdravnik bo pred zdravljenjem z zdravilom Bavencio in med njim preveril vaše splošno zdravstveno stanje.
English: Very common (may affect more than 1 in 10 people)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, both Bavencio and axitinib should be permanently discontinued and corticosteroid therapy should be considered.
Slovenian: Če sta ALT ali AST ≥ 5-kratniku ULN ali > 3-kratniku ULN s sočasnim celokupnim bilirubinom ≥ 2-kratniku ULN ali celokupnim bilirubinom ≥ 3-kratniku ULN, je treba zdravilo Bavencio in aksitinib trajno ukiniti in razmisliti o zdravljenju s kortikosteroidi.
English: Merkel cell carcinoma
Slovenian: Karcinom Merklovih celic
English: Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).
Slovenian: Zdravilo Bavencio je v kombinaciji z aksitinibom indicirano kot zdravilo prve izbire za zdravljenje odraslih bolnikov z napredovalim karcinomom ledvičnih celic (KLC) (glejte poglavje 5.1).
English: Positive (n=19) Negative (n=55)
Slovenian: Pozitivna (n = 19) Negativna (n = 55)
English: Merkel cell carcinoma (study EMR100070-003)
Slovenian: Klinična učinkovitost in varnost Karcinom Merklovih celic (študija EMR100070-003)
English: The active substance is avelumab.
Slovenian: Učinkovina je avelumab.
English: Handling instructions
Slovenian: Navodila za ravnanje
English: What Bavencio looks like and contents of the pack
Slovenian: Izgled zdravila Bavencio in vsebina pakiranja
English: In patients with ALT ≥ 3 times ULN (Grades 2-4, n=82), ALT resolved to Grades 0-1 in 92%.
Slovenian: Pri bolnikih z ALT ≥ 3-kratnik ULN (2.-4. stopnje, n = 82) se je ALT zmanjšal na 0.-1. stopnjo pri
English: Tumour samples were evaluated for PD-L1 tumour cell expression, and for Merkel cell polyomavirus (MCV) using an investigational immunohistochemistry (IHC) assay.
Slovenian: V tumorskih vzorcih so izraženost PD-L1 v tumorskih celicah in prisotnost poliomavirusa Merklovih celic (MCV) ocenili z raziskovalnim imunohistokemičnim testom (IHC).
English: The Kaplan-Meier curve of PFS of the 88 patients (Part A) with metastatic MCC is presented in Figure 1.
Slovenian: Krivulja preživetja brez napredovanja bolezni po metodi Kaplan-Meier je za 88 bolnikov (del A) z metastatskim KMC predstavljena na sliki 1.
English: Hypothyroidism should be managed with replacement therapy and hyperthyroidism with anti-thyroid medicinal product, as needed.
Slovenian: Hipotiroidizem je treba zdraviti z nadomestnim zdravljenjem, hipertiroidizem pa z zdravili proti hipertiroidizmu.
English: Duration of response (DOR)
Slovenian: Trajanje odzivaa (DOR)
English: Excipients: Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections.
Slovenian: Pomožne snovi: manitol, koncentrirana ocetna kislina, polisorbat 20, natrijev hidroksid, voda za injekcije.
English: • Signs of inflammation of the kidney may include abnormal kidney function tests, urinating less than usual, blood in your urine, or swelling in your ankles.
Slovenian: • Znaki vnetja ledvic lahko vključujejo nenormalne teste delovanja ledvic, manj pogostejše uriniranje kot običajno, kri v urinu ali otekline v gležnjih.
English: Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of Bavencio.
Slovenian: Bolnike je treba pred prvimi 4 infuzijami zdravila Bavencio premedicirati z antihistaminikom in paracetamolom.
English: How to use Bavencio
Slovenian: Kako uporabljati zdravilo Bavencio
English: Weight decreased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased
Slovenian: Zelo pogosti zmanjšanje telesne mase, zvišanje vrednosti alanin-aminotransferaze (ALT), zvišanje vrednosti aspartat-aminotransferaze (AST)
English: PD-L1 status was determined by immunohistochemistry.
Slovenian: Status PD-L1 so ocenili z imunohistokemičnim testom.
English: Adrenal insufficiency*, hyperthyroidism*, thyroiditis*, autoimmune thyroiditis*, adrenocortical insufficiency acute*, autoimmune hypothyroidism*, hypopituitarism*
Slovenian: Občasni insuficienca nadledvične žleze*, hipertiroidizem*, tiroiditis*, avtoimunski tiroiditis*, akutna adrenokortikalna insuficienca*, avtoimunski hipotiroidizem*, hipopituitarizem*
English: Table 4 summarises efficacy endpoints in patients receiving avelumab at the recommended dose for study EMR100070-003, Part A, with a minimum follow-up of 36 months.
Slovenian: V preglednici 4 so povzeti izidi učinkovitosti pri bolnikih, ki so prejemali priporočene odmerke avelumaba, za študijo EMR100070-003, del A, z najkrajšim spremljanjem 36 mesecev.
English: Avelumab should be withheld and antihyperglycaemics in patients with Grade ≥ 3 hyperglycaemia should be administered.
Slovenian: Uporabo avelumaba je treba odložiti in bolnikom s hiperglikemijo stopnje ≥ 3 dati zdravila za zdravljenje hiperglikemije.
English: The prespecified interim analysis for Part B included 39 patients who received at least one dose of avelumab and 29 patients with a minimum 13 weeks of follow-up at the time of the data cut-off (cut-off date 24 March 2017).
Slovenian: Vnaprej določena vmesna analiza za del B je vključevala 39 bolnikov, ki so prejeli najmanj en odmerek avelumaba, in 29 bolnikov z najmanj 13-tedenskim spremljanjem v času zbiranja presečnih podatkov
English: Check with your doctor or nurse before you receive Bavencio if:
Slovenian: Preden prejmete zdravilo Bavencio, morate z vašim zdravnikom ali medicinsko sestro preveriti, ali:
English: Alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood creatine phosphokinase increased*, transaminases increased*
Slovenian: Občasni zvišanje vrednosti alanin-aminotransferaze (ALT)*, zvišanje vrednosti aspartataminotransferaze (AST)*, zvišanje vrednosti kreatin-fosfokinaze v krvi*, zvišanje vrednosti transaminaz*
English: Drug eruption, erythema multiforme, psoriasis
Slovenian: Občasni izpuščaj zaradi zdravila, multiformni eritem, psoriaza