FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Ženama reproduktivne dobi treba savjetovati da izbjegavaju trudnoću dok primaju avelumab te da koriste učinkovitu kontracepciju tijekom liječenja avelumabom i najmanje 1 mjesec nakon zadnje doze avelumaba.
English: Negative (n=31)
Croatian: negativan (n=31)
English: Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity.
Croatian: Primjena aksitiniba mogla se odgoditi ili doza smanjiti na 3 mg dvaput na dan, a potom na 2 mg dvaput na dan zbog zbrinjavanja toksičnosti.
English: Progression-free survival (PFS)
Croatian: Preživljenje bez progresije bolesti (PFS)
English: For at least the first 4 treatments, you will receive paracetamol and an antihistamine before being given Bavencio, to help to prevent possible side effects related to the infusion.
Croatian: Prije nego što dobijete lijek Bavencio, pri najmanje prva 4 puta primjene dobit ćete paracetamol i antihistaminik koji će pomoći spriječiti moguće nuspojave povezane s infuzijom.
English: The efficacy and safety of avelumab in combination with axitinib was demonstrated in study B9991003, a randomised, multicentre, open-label study of avelumab in combination with axitinib in 886 patients with untreated advanced or metastatic RCC with a clear-cell component.
Croatian: Djelotvornost i sigurnost primjene avelumaba u kombinaciji s aksitinibom dokazana je u ispitivanju B9991003, randomiziranom, multicentričnom, otvorenom ispitivanju avelumaba u kombinaciji s aksitinibom u 886 neliječenih bolesnika s uznapredovalim ili metastatskim karcinomom bubrežnih stanica sa svijetlostaničnom komponentom.
English: If refrigerated, allow the diluted solution in the intravenous bags to come to room temperature prior to use.
Croatian: Ako su vrećice s razrijeđenom intravenskom otopinom bile u hladnjaku, omogućite im da prije primjene dosegnu sobnu temperaturu.
English: Weight decreased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased
Croatian: Vrlo često smanjena tjelesna težina, povišena alanin aminotransferaza (ALT), povišena aspartat aminotransferaza (AST)
English: The efficacy and safety of avelumab was investigated in the study EMR100070-003 with two parts.
Croatian: Djelotvornost i sigurnost avelumaba ispitana je u ispitivanju EMR100070-003 u dva dijela.
English: 10 mL of concentrate in a vial (Type I glass) with a halobutyl rubber stopper and an aluminium seal fitted with a removable plastic cap.
Croatian: 10 ml koncentrata u bočici (staklo tipa I) s čepom od halobutilne gume i aluminijskim prstenom pokrivenim uklonjivim plastičnim zatvaračem.
English: • Sunitinib 50 mg once daily orally for 4 weeks followed by 2 weeks off (N=444) until radiographic or clinical progression or unacceptable toxicity.
Croatian: • Sunitinib u dozi od 50 mg peroralno jedanput na dan tijekom 4 tjedna, a zatim 2 tjedna bez lijeka (N=444) sve do radiografske ili kliničke progresije ili neprihvatljive toksičnosti.
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).
Croatian: Međutim, na mišjem modelu trudnoće pokazalo se da blokada PD-L1 signalizacije ometa toleranciju prema fetusu i rezultira povećanim gubitkom fetusa (vidjeti dio 5.3).
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.
Croatian: U kliničkim je ispitivanjima 98,6 % (433/439) bolesnika s reakcijama povezanima s infuzijom imalo prvu reakciju povezanu s infuzijom tijekom prve 4 infuzije, od čega je njih 2,7 % (12/439) bilo
English: In symptomatic patients, obtain cardiologic consultation and laboratory investigations to ensure the initiation of appropriate measures at an early stage.
Croatian: U simptomatskih bolesnika treba zatražiti savjet kardiologa i provesti laboratorijske pretrage kako bi se provođenje odgovarajućih mjera započelo u ranoj fazi.
English: Bavencio is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate).
Croatian: Bavencio je bistar, bezbojan do blago žut koncentrat za otopinu za infuziju (sterilni koncentrat).
English: The active substance is avelumab.
Croatian: Djelatna tvar je avelumab.
English: • problems due to inflammation of your lungs (pneumonitis);
Croatian: • problemi zbog upale pluća (pneumonitisa)
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Croatian: upitajte liječnika kada možete dogovoriti primjenu sljedeće doze.
English: • Flu-like illness (includes feeling of fever, muscle aches)
Croatian: • bolest nalik gripi (uključuje osjećaj vrućice, bolnost mišića)
English: Grade 3 or Grade 4 infusion-related reaction
Croatian: Reakcija 3. ili 4. stupnja povezana s infuzijom
English: • Persistent Grade 2 or Grade 3 immune-mediate adverse reactions lasting 12 weeks or longer
Croatian: • Perzistentne imunološki posredovane nuspojave 2. ili 3. stupnja u trajanju od 12 tjedana ili dulje
English: Before you receive Bavencio
Croatian: Prije nego što primite Bavencio
English: The most common Grade ≥ 3 adverse reactions were anaemia (6.0%), dyspnoea (3.9%), and abdominal pain (3.0%).
Croatian: Najčešće nuspojave ≥ 3. stupnja bile su anemija (6,0 %), dispneja (3,9 %) i bol u abdomenu (3,0 %).
English: Overall, there was no evidence of altered pharmacokinetic profile, increased incidence of infusion reactions or effects on efficacy with anti-avelumab antibody development.
Croatian: Sveukupno, nije bilo dokaza da je razvoj protutijela na avelumab promijenio farmakokinetički profil, povećao incidenciju reakcija na infuziju ili utjecao na djelotvornost.
English: Serious adverse reactions were immune-related adverse reactions and infusion-related reaction (see section 4.4).
Croatian: Ozbiljne nuspojave bile su imunološki posredovane nuspojave i reakcije povezane s infuzijom (vidjeti dio 4.4).
English: Serum creatinine more than 1.5 and up to 6 times ULN
Croatian: Kreatinin u serumu više od 1,5 te do 6 puta iznad GGN-a
English: You must not use Bavencio if you are pregnant unless your doctor specifically recommends it.
Croatian: Ako ste trudni, ne smijete primati Bavencio osim ako to liječnik nije posebno preporučio.
English: All 5 patients with Type 1 diabetes mellitus were treated with insulin.
Croatian: 5 bolesnika sa šećernom bolešću tipa 1 liječeno je inzulinom.
English: Dry mouth
Croatian: Često suha usta
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).
Croatian: U slučaju ponovne pojave reakcije 1. ili 2. stupnja povezane s infuzijom, bolesnik može nastaviti primati avelumab uz strogo praćenje, nakon odgovarajuće prilagodbe brzine infuzije i premedikacije paracetamolom i antihistaminikom (vidjeti dio 4.2).
English: • Type 1 diabetes, including acid in the blood produced from diabetes (diabetic ketoacidosis);
Croatian: • šećerna bolest tipa 1, uključujući kiselinu u krvi koja nastaje zbog šećerne bolesti (dijabetička ketoacidoza) • problemi s bubrezima
English: This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Croatian: Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
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.
Croatian: U dijelu B, glavna mjera ishoda djelotvornosti bila je trajni odgovor, definiran kao objektivni odgovor (potpuni odgovor [CR] ili djelomični odgovor [PR]) koji traje najmanje 6 mjeseci; sekundarne mjere ishoda uključivale su najbolji ukupni odgovor, trajanje odgovora, preživljenje bez progresije bolesti i ukupno preživljenje.
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.
Croatian: Bavencio sadrži djelatnu tvar avelumab, monoklonsko protutijelo (vrsta proteina) koje se veže za određenu ciljnu molekulu u tijelu pod nazivom PD-L1.
English: PD-L1 status was determined by immunohistochemistry.
Croatian: Status PD-L1 bio je određen imunohistokemijski.
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).
Croatian: Bavencio u kombinaciji s aksitinibom indiciran je kao prva linija liječenja u odraslih bolesnika s uznapredovalim karcinomom bubrežnih stanica (engl. renal cell carcinoma, RCC) (vidjeti dio 5.1).
English: • Renal cell carcinoma (RCC), a type of kidney cancer, when it is advanced (has spread beyond the kidney or to other parts of the body).
Croatian: • karcinoma bubrežnih stanica, vrste raka bubrega, kad je uznapredovao (proširio se izvan bubrega ili na druge dijelove tijela).
English: For instructions on the preparation and administration of the medicinal product, see section 6.6.
Croatian: Za upute o pripremi i primjeni lijeka vidjeti dio 6.6.
English: Patients received a median of 7 doses of avelumab (range: 1 dose to 95 doses), and the median duration of treatment was 17 weeks (range: 2 weeks to 208 weeks).
Croatian: Bolesnici su primili medijan od 7 doza avelumaba (raspon: od 1 doze do 95 doza), a medijan trajanja liječenja iznosio je 17 tjedana (raspon: od 2 tjedna do 208 tjedana).
English: Data for immune-related adverse reactions for avelumab as a monotherapy are based on 1,650 patients in the phase I study EMR100070-001 in solid tumours and 88 patients in study EMR100070-003, and for avelumab in combination with axitinib are based on 489 patients in study B9991002 and B9991003 (see section 5.1).
Croatian: Podaci za imunološki posredovane nuspojave za avelumab kao monoterapiju temelje se na 1650 bolesnika sa solidnim tumorima u ispitivanju EMR100070-001 faze I i 88 bolesnika u ispitivanju EMR100070-003, a za avelumab u kombinaciji s aksitinibom na 489 bolesnika u ispitivanjima B9991002 i B9991003 (vidjeti dio 5.1).
English: The key secondary endpoints were PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PD-L1 expression.
Croatian: Ključne sekundarne mjere ishoda bile su PFS prema procjeni BICR-a na temelju kriterija RECIST v1.1 i OS neovisno o ekspresiji PD-L1.
English: Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1).
Croatian: Avelumab je ljudski imunoglobulin G1 (IgG1), monoklonsko protutijelo usmjereno na ligand 1 programirane smrti stanice (PD-L1).
English: Dry mouth, colitis
Croatian: Često suha usta, kolitis
English: • Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking)
Croatian: • povišeni mišićni enzimi u krvi • Guillain-Barréov sindrom (poremećaj imunološkog sustava koji uzrokuje upalu živaca i može dovesti do bola, utrnulosti, slabosti mišića i otežanog hodanja)
English: • Decrease in the number of red blood cells
Croatian: • smanjenje broja crvenih krvnih stanica
English: Based on a population PK analysis for avelumab as monotherapy and in combination with axitinib, there are no expected clinically meaningful differences in exposure of avelumab between settings administered every 2 weeks at 800 mg or 10 mg/kg.
Croatian: Na temelju analize populacijske farmakokinetike avelumaba u monoterapiji i u kombinaciji s aksitinibom nije bilo očekivanih klinički značajnih razlika u izloženosti avelumabu kad se primjenjivao svaka 2 tjedna u dozi od 800 mg ili u dozi od 10 mg/kg.
English: • Increase in the number of a type of white blood cells (eosinophils)
Croatian: • povećanje broja jedne vrste bijelih krvnih stanica (eozinofila)
English: For Grade 1 infusion-related reactions, the infusion rate should be slowed by 50% for the current infusion.
Croatian: Kod reakcija 1. stupnja povezanih s infuzijom, brzinu trenutno primjenjivane infuzije potrebno je smanjiti za 50 %.
English: There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations.
Croatian: Nema dovoljno podataka o bolesnicima s umjerenim ili teškim oštećenjem jetre da bi se mogle dati preporuke za doziranje.
English: • Feeling tired or weak
Croatian: • osjećaj umora ili slabosti
English: Analysis of progression-free survival (PFS) was based on 39 patients who received at least one dose of avelumab, with median PFS of 9.1 months (95% CI: 1.9, not estimable) and estimated 3-month PFS rate by Kaplan-Meier of 67% (95% CI: 48, 80).
Croatian: Analiza preživljenja bez progresije bolesti (PFS) temeljila se na 39 bolesnika koji su primili najmanje jednu dozu avelumaba, uz medijan PFS-a od 9,1 mjeseci (95 % CI: 1,9 nije se moglo procijeniti) i procijenjenu stopu 3-mjesečnog PFS-a KaplanMeierovom analizom od 67 % (95 % CI: 48; 80).
English: Overall, 52 (59%) patients were reported to have had 1 prior anti-cancer therapy for MCC, 26 (30%) with 2 prior therapies, and 10 (11%) with 3 or more prior therapies.
Croatian: Sveukupno je za 52 (59 %) bolesnika bilo zabilježeno da su prethodno primili 1 antitumorsku terapiju zbog karcinoma Merkelovih stanica, njih 26 (30 %) prethodno je primilo 2 terapije, a njih 10 (11 %) prethodno je primilo 3 ili više terapija.
English: Bavencio will be added to an infusion bag containing a sodium chloride solution before use.
Croatian: Bavencio će se prije primjene dodati u infuzijsku vrećicu koja sadrži otopinu natrijevog klorida.
English: Figure 2 presents the Kaplan-Meier curve for PFS from the subsequent interim analysis with 116 patients enrolled into Part B with a minimum follow-up of 7 months.
Croatian: Slika 2 prikazuje Kaplan-Meierovu krivulju preživljenja bez progresije bolesti iz kasnije interim analize sa 116 bolesnika uključenih u dio B za minimalno trajanje praćenja od 7 mjeseci.
English: Prior to launch of Bavencio in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Bavencio u promet u svakoj zemlji članici, nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti s nacionalnim nadležnim tijelom sadržaj i oblik edukacijskog programa,
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
Croatian: Vrlo često reakcije povezane s infuzijom * Imunološki posredovana nuspojava na temelju medicinskog pregleda § Reakcija opažena samo u ispitivanju EMR100070-003 (dio B) nakon prestanka prikupljanja podataka za objedinjenu analizu, otkuda je procijenjena učestalost
English: The clinical utility of PD-L1 as a predictive biomarker in MCC has not been established.
Croatian: Klinička korisnost PD-L1 kao prediktivnog biološkog biljega kod karcinoma Merkelovih stanica nije ustanovljena.
English: Treatment should be initiated and supervised by a physician experienced in the treatment of cancer.
Croatian: 4.2 Doziranje i način primjene Liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju karcinoma.
English: If you miss a dose of Bavencio
Croatian: Ako propustite dozu lijeka Bavencio
English: Each mL of concentrate contains 20 mg of avelumab.
Croatian: Jedan ml koncentrata sadrži 20 mg avelumaba.
English: In ADA positive patients, there may be an increased risk for infusion-related reactions (about 40% and 25% in ADA ever-positive and ADA never-positive patients, respectively).
Croatian: U bolesnika s pozitivnim protutijelima na lijek može postojati povećan rizik od reakcija povezanih s infuzijom (oko 40% u bolesnika koji su ikad imali pozitivan test na protutijela na lijek i 25% u bolesnika koji nikad nisu imali pozitivan test na protutijela na lijek).
English: * Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.03)
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0,
English: A population pharmacokinetic analysis suggested no difference in the total systemic clearance of avelumab based on age, gender, race, PD-L1 status, tumour burden, renal impairment and mild or moderate hepatic impairment.
Croatian: Analiza populacijske farmakokinetike pokazala je da nema razlike u ukupnom sistemskom klirensu avelumaba na temelju dobi, spola, rase, PD-L1 statusa, tumorskog opterećenja, oštećenja funkcije bubrega i blagog ili umjerenog oštećenja funkcije jetre.
English: • Signs of infusion-related reactions such as shortness of breath or wheezing, chills or shaking,
Croatian: • Znakovi reakcije povezane s infuzijom kao što su nedostatak zraka ili piskanje pri disanju,
English: • Increases or decreases in blood pressure
Croatian: • povišenja ili sniženja krvnog tlaka
English: Bavencio has a low sodium content
Croatian: Bavencio sadrži malu količinu natrija
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.
Croatian: Avelumab je ljudsko monoklonsko IgG1 protutijelo usmjereno na PD-L1, imunomodulatorni proteinski ligand na površini stanice, proizvedeno u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
English: Confirmed best overall response (BOR)
Croatian: Potvrđeni najbolji ukupni odgovor
English: Results (N=88)
Croatian: Rezultati (N=88)
English: Suspected pancreatitis
Croatian: Sumnja na pankreatitis
English: In this patient population, the most common adverse reactions with avelumab were fatigue (32.4%), nausea (25.1%), diarrhoea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight decreased (16.6%), and vomiting (16.2%).
Croatian: U toj populaciji bolesnika najčešće nuspojave avelumaba bile su umor (32,4 %), mučnina (25,1 %), proljev (18,9 %), smanjen apetit (18,4 %), konstipacija (18,4 %), reakcije povezane s infuzijom (17,1 %), smanjena tjelesna težina (16,6 %) i povraćanje (16,2 %).
English: Myocarditis
Croatian: Miokarditis
English: If persistent (greater than 5 days), corticosteroid therapy with prednisone or equivalent followed by a taper should be considered.
Croatian: Ako se ne povlače (traju dulje od 5 dana), potrebno je razmotriti primjenu kortikosteroidne terapije prednizonom ili ekvivalentnim lijekom s postupnim snižavanjem doze.
English: Adrenal insufficiency resolved in 4 (44.4%) of the 9 patients at the time of data cut-off.
Croatian: Adranalna insuficijencija povukla se u 4 (44,4 %) od 9 bolesnika u vrijeme prestanka prikupljanja podataka.
English: • Signs of inflammation of the lungs (pneumonitis) may be breathing difficulties or cough.
Croatian: • Znakovi upale pluća (pneumonitisa) mogu biti otežano disanje ili kašalj.
English: • inflammation of your muscles (myositis).
Croatian: • upala mišića (miozitis).
English: • inflammation of your liver (hepatitis) or other liver problems;
Croatian: • upala jetre (hepatitis) ili drugi problemi s jetrom
English: • inflammation of your heart (myocarditis);
Croatian: • upala srčanog mišića (miokarditis)
English: The management guidelines for these adverse reactions are described in section 4.4.
Croatian: Smjernice za zbrinjavanje ovih nuspojava opisane su u dijelu 4.4.
English: • you have ever had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C
Croatian: • imate ili ste ikad imali kroničnu virusnu infekciju jetre, uključujući hepatitis B (HBV) ili hepatitis C (HCV) • primate lijekove za potiskivanje aktivnosti imunološkog sustava
English: • Avelumab 10 mg/kg intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily orally (N=442).
Croatian: • Avelumab u dozi od 10 mg/kg intravenskom infuzijom svaka 2 tjedna u kombinaciji s aksitinibom u dozi od 5 mg peroralno dvaput na dan (N=442).
English: Endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia)
Croatian: Endokrinopatije (hipotireoza, hipertireoza, adrenalna insuficijencija, hiperglikemija)
English: It may cause side effects (see section 4).
Croatian: Lijek može uzrokovati nuspojave (pogledajte dio 4).
English: Part B included patients with histologically confirmed metastatic MCC who were treatment-naïve to systemic therapy in the metastatic setting.
Croatian: Dio B uključio je bolesnike s histološki potvrđenim metastatskim karcinomom Merkelovih stanica koji nisu bili liječeni sistemskom terapijom nakon pojave metastaza.
English: After Part B was fully enrolled, a subsequent interim analysis was conducted with 116 patients who received at least one dose of avelumab and with at least 7 months of follow-up at the time of the data cut-off (cut-off date 14 September 2018).
Croatian: Nakon što su svi bolesnici bili uključeni u dio B, kasnija interim analiza bila je provedena u 116 bolesnika koji su primili najmanje jednu dozu avelumaba i bili praćeni najmanje 7 mjeseci do trenutka prestanka prikupljanja podataka za analizu (datum prestanka prikupljanja podataka: 14. rujna 2018.).
English: How much Bavencio you will receive
Croatian: Koliko lijeka Bavencio ćete primiti
English: For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes.
Croatian: Kod sumnje na imunološki posredovane nuspojave mora se provesti odgovarajuća procjena radi potvrde etiologije ili isključenja drugih uzroka.
English: • Increased glucose in the blood
Croatian: • povišena glukoza u krvi
English: This is common.
Croatian: Ovo je često.
English: Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of Bavencio.
Croatian: Bolesnici moraju primiti premedikaciju antihistaminikom i paracetamolom prije prve 4 infuzije lijeka
English: Tiredness is a very common side effect of Bavencio and can affect your ability to drive or to use machines.
Croatian: Umor je vrlo česta nuspojava lijeka Bavencio i može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Preporučena doza lijeka Bavencio u kombinaciji s aksitinibom je 800 mg primijenjeno intravenski tijekom 60 minuta svaka 2 tjedna uz aksitinib 5 mg dvaput na dan peroralno (u razmaku od 12 sati) s hranom ili bez nje sve do progresije bolesti ili neprihvatljive toksičnosti.
English: Withhold until adverse reactions recover to Grade 0-1
Croatian: Odgoditi primjenu do poboljšanja nuspojava na 0.-1. stupanj
English: • Signs of inflammation of the muscles (myositis) may include muscle pain or weakness.
Croatian: • Znakovi upale mišića (miozitis) mogu uključivati bol ili slabost mišića.
English: Among the 73 patients who were rechallenged with either avelumab (59%) or axitinib (85%) monotherapy or with both (55%), 66% had no recurrence of ALT ≥ 3 times ULN.
Croatian: Od 73 bolesnika u kojih je ponovno uvedena ili monoterapija avelumabom (59 %) ili monoterapija aksitinibom (85 %) ili kombinacija oba lijeka (55 %), u njih 66 % nije se ponovilo povišenje ALT-a ≥ 3 puta iznad GGN-a.