FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with mild hepatic impairment (n= 5) (total bilirubin [TB] greater than 1.0 to 1.5 times the upper limit of normal [ULN] and any aspartate aminotransferase [AST]); no clinically important differences in the exposure of cemiplimab were found compared to patients with normal hepatic function.
Croatian: U bolesnika s blagim oštećenjem jetrene funkcije (n = 5) (ukupan bilirubin više od 1,0 - 1,5 puta iznad gornje granice normale [GGN] i bilo koja vrijednost aspartat aminotransferaze [AST]) nisu opažene klinički važne razlike u izloženosti cemiplimabu u usporedbi s bolesnicima s normalnom jetrenom funkcijom.
English: b Observed with LIBTAYO or with other anti-PD-1/PD-L1 monoclonal antibodies
Croatian: b Opažene uz LIBTAYO ili druga monoklonska protutijela na PD-1/PD-L1
English: Thirty-three and 7/10 per cent (33.7%) of patients had received at least 1 prior anti-cancer systemic therapy, 90.2% of patients had received prior cancer related surgery, and 67.9% of patients had received prior radiotherapy.
Croatian: Trideset i tri cijela sedam posto (33,7%) bolesnika prethodno je primilo najmanje 1 sistemsku terapiju za rak, njih 90,2% prethodno je bilo podvrgnuto kirurškom zahvatu zbog raka, a njih 67,9% prethodno je primilo radioterapiju.
English: The primary endpoint of Study 1540 was confirmed objective response rate (ORR), as assessed by independent central review (ICR).
Croatian: Primarna mjera ishoda u ispitivanju 1540 bila je potvrđena stopa objektivnog odgovora (ORR) prema neovisnoj središnjoj ocjeni.
English: Look out for these side effects while you are having LIBTAYO.
Croatian: Pripazite na te nuspojave dok primate LIBTAYO.
English: Immune system disorders: Immune thrombocytopenic purpura Vascular disorders: Vasculitis
Croatian: Poremećaji imunološkog sustava: imuna trombocitopenična purpura Krvožilni poremećaji: vaskulitis
English: Regeneron Ireland Designated Activity Company (DAC) Europa House
Croatian: Regeneron Ireland Designed Activity Company (DAC) Europa House
English: • increased liver enzymes in blood, abnormal kidney function test
Croatian: • povišene vrijednosti jetrenih enzima u krvi, odstupanja u nalazima testova bubrežne funkcije
English: However, once you are treated with LIBTAYO, your doctor may give you corticosteroids to reduce the side effects that you may have with LIBTAYO.
Croatian: Međutim, nakon što započnete liječenje lijekom LIBTAYO, liječnik Vam može propisati kortikosteroide za ublažavanje nuspojava koje se mogu javiti kod primjene lijeka LIBTAYO.
English: • Lung problems (pneumonitis)
Croatian: • plućne tegobe (pneumonitis)
English: b. Meningitis is a composite term that includes meningitis and meningitis aseptic.
Croatian: Meningitis je skupni pojam koji obuhvaća meningitis i aseptički meningitis.
English: LIBTAYO has no or minor influence on your ability to drive and use machines.
Croatian: LIBTAYO ne utječe ili malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Data cut-off was Sep 20, 2018 for Groups 1 and 3 patients, and Oct 10, 2018 for Group 2 patients.
Croatian: Datum prestanka prikupljanja podataka bio je 20. rujna 2018. za bolesnike iz 1. i 3. skupine te 10. listopada 2018. za bolesnike iz 2. skupine.
English: Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and
Croatian: Cemiplimab je potpuno humano imunoglobulinsko G4 (IgG4) monoklonsko protutijelo, koje se vezuje za receptor proteina programirane stanične smrti (engl. programmed cell death-1, PD-1) i blokira njegovu interakciju s ligandima PD-L1 i PD-L2.
English: Grade 3 or 4 (excluding endocrinopathies) or recurrent Grade 2
Croatian: 3. ili 4. stupanj (izuzev endokrinopatija) ili rekurentan događaj 2. stupnja
English: • under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion preparation.
Croatian: • u hladnjaku na temperaturi od 2°C do 8°C tijekom najviše 24 sata od trenutka pripreme infuzije.
English: How you are given LIBTAYO • LIBTAYO will be given to you in a hospital or clinic - supervised by a doctor experienced in cancer treatment.
Croatian: • LIBTAYO ćete primati u bolnici ili klinici, pod nadzorom liječnika s iskustvom u liječenju raka.
English: The recommended dose is 350 mg cemiplimab, every 3 weeks, administered as an intravenous infusion over 30 minutes.
Croatian: Preporučena doza je 350 mg cemiplimaba svaka 3 tjedna, a primjenjuje se intravenskom infuzijom tijekom 30 minuta.
English: f. Hepatitis is a composite term that includes hepatitis and autoimmune hepatitis.
Croatian: Hepatitis je skupni pojam koji obuhvaća hepatitis i autoimuni hepatitis.
English: • you have lung or breathing problems
Croatian: • ako imate plućnih ili dišnih tegoba
English: Clear to slightly opalescent, colourless to pale yellow solution with a pH of 6.0 and osmolality between 300 and 360 mmol/kg.
Croatian: Bistra do blago opalescentna, bezbojna do blijedo žuta otopina, pH vrijednosti 6,0 i osmolarnosti između 300 i 360 mmol/kg.
English: The effect of renal impairment on the exposure of cemiplimab was evaluated by a population PK analysis in patients with mild (CLcr 60 to < 89 ml/min; n= 197), moderate (CLcr 30 to < 60 ml/min; n= 90), or severe (CLcr <30 ml/min; n= 4) renal impairment.
Croatian: Utjecaj oštećenja bubrežne funkcije na izloženost cemiplimabu ocjenjivao se u populacijskoj farmakokinetičkoj analizi koja je obuhvatila bolesnike s blagim (klirens kreatinina [CLcr] od 60 do < 89 ml/min; n = 197), umjerenim (CLcr od 30 do < 60 ml/min; n = 90) ili teškim (CLcr < 30 ml/min; n = 4) oštećenjem bubrežne funkcije.
English: If you have any questions about your treatment, ask your doctor.
Croatian: Ako imate bilo kakvih pitanja o liječenju, obratite se svom liječniku.
English: Cardiac Disorders: Myocarditis c, Pericarditis
Croatian: Srčani poremećaji: miokarditis c, perikarditis
English: CI: confidence interval; ICR: Independent Central Review; NR: Not Reached; +: Denotes ongoing at last assessment a.
Croatian: CI (engl. confidence interval): interval pouzdanosti; ND = nije dosegnut; ‘+' znači da je odgovor i dalje trajao pri posljednjoj ocjeni.
English: Depending upon the severity of the adverse reaction, cemiplimab should be withheld or permanently discontinued (see section 4.2).
Croatian: Ovisno o težini nuspojave, primjenu cemiplimaba treba odgoditi ili trajno prekinuti (vidjeti dio 4.2).
English: LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Croatian: LIBTAYO je u monoterapiji indiciran za liječenje odraslih bolesnika s metastatskim ili lokalno uznapredovalim planocelularnim karcinomom kože koji nisu kandidati za kurativno kirurško liječenje ili kurativnu radioterapiju.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake ‘EXP'.
English: Patients should be monitored for evidence of suspected severe skin reactions and exclude other causes.
Croatian: Bolesnike treba nadzirati kako bi se uočili mogući dokazi suspektnih teških kožnih reakcija te isključili drugi uzroci.
English: Alanine aminotransferase increased Common Aspartate aminotransferase increased Common Blood alkaline phosphatase increased Common Blood creatinine increased
Croatian: Pretrage povišene vrijednosti alanin aminotransferaze često povišene vrijednosti aspartat aminotransferaze često povišene vrijednosti alkalne fosfataze u krvi često povišene vrijednosti kreatinina u krvi često
English: The safety of cemiplimab has been evaluated in 591 patients with advanced solid malignancies including 219 advanced CSCC patients who received cemiplimab monotherapy in 2 clinical studies (R2810-ONC-1423 and R2810-ONC-1540).
Croatian: Sigurnost cemiplimaba ocjenjivala se u 591 bolesnika s uznapredovalim solidnim zloćudnim bolestima, uključujući 219 bolesnika s uznapredovalim planocelularnim karcinomom kože koji su primali monoterapiju cemiplimabom u 2 klinička ispitivanja (R2810-ONC-1423 i R2810-ONC-1540).
English: For suspected immune-related adverse reactions, patients should be evaluated to confirm an immune-related adverse reaction and to exclude other possible causes.
Croatian: U slučaju sumnje na imunološki uzrokovane nuspojave potrebno je provesti ocjenu bolesnika kako bi se potvrdila imunološki uzrokovana nuspojava i isključili drugi mogući uzroci.
English: Clearance of cemiplimab is linear at doses of 1 mg/kg to 10 mg/kg every two weeks.
Croatian: Klirens cemiplimaba linearan je kod primjene doza od 1 mg/kg do 10 mg/kg svaka dva tjedna.
English: Your doctor also may delay your next dose of LIBTAYO or stop your treatment.
Croatian: Osim toga, liječnik će Vam možda odgoditi primjenu lijeka LIBTAYO ili prekinuti liječenje.
English: Cemiplimab has not been studied in patients with CLcr <25 ml/min (see section 4.2).
Croatian: Cemiplimab se nije ispitivao u bolesnika koji su imali CLcr < 25 ml/min (vidjeti dio 4.2).
English: A total of 161 (83.4 %) patients were male, and 187 (96.9%) patients were White; the ECOG performance score was 0 (44.6%) or 1 (55.4%).
Croatian: Ukupno 161 (83,4%) bolesnik bio je muškarac, 187 (96,9%) bolesnika bili su bijelci, a funkcionalni ECOG status iznosio je 0 (44,6%) ili 1 (55,4%).
English: Overall in Studies 1423 and 1540, PD-L1 IHC results were available for 75 advanced CSCC patients.
Croatian: U ispitivanjima 1423 i 1540 rezultati imunohistokemijskog testa na PD-L1 bili su dostupni za ukupno 75 bolesnika s uznapredovalim planocelularnim karcinomom kože.
English: Recommended modifications to manage adverse reactions are provided in Table 1.
Croatian: Preporučene prilagodbe radi zbrinjavanja nuspojava navedene su u Tablici 1.
English: • you have diabetes
Croatian: • ako imate šećernu bolest
English: Detailed guidelines for the management of immune-related adverse reactions are described in Table 1.
Croatian: Detaljne smjernice za zbrinjavanje imunološki uzrokovanih nuspojava opisane su u Tablici 1.
English: L-histidine monohydrochloride monohydrate Sucrose
Croatian: L-histidinklorid hidrat saharoza
English: • a temporary inflammation of the nerves that cause pain, weakness, and paralysis in the extremities; a condition in which the muscles become weak and tire easily
Croatian: • prolazna upala živaca koja može uzrokovati bol, slabost i paralizu udova; stanje kod kojeg mišići postaju slabi i brzo se umaraju
English: The use of systemic corticosteroids or immunosuppressants before starting cemiplimab, except for physiological doses of systemic corticosteroid (≤10 mg/day prednisone or equivalent), should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of cemiplimab.
Croatian: Treba izbjegavati primjenu sistemskih kortikosteroida ili imunosupresiva prije uvođenja cemiplimaba, osim fizioloških doza sistemskih kortikosteroida (≤ 10 mg prednizona ili ekvivalenta na dan), jer ti lijekovi mogu utjecati na farmakodinamičku aktivnost i djelotvornost cemiplimaba.
English: Mix the diluted solution by gentle inversion.
Croatian: Promiješajte razrijeđenu otopinu nježnim okretanjem vrećice.
English: Grades 1-5 (Frequency category)
Croatian: 1. - 5. stupanj (kategorija učestalosti)
English: Cemiplimab is primarily distributed in the vascular system with a volume of distribution at steady-state (Vss) is 5.2 l.
Croatian: Cemiplimab se prvenstveno distribuira u krvožilni sustav, a njegov volumen distribucije u stanju dinamičke ravnoteže (Vss) iznosi 5,2 l.
English: If you stop receiving LIBTAYO
Croatian: Ako prestanete primati LIBTAYO
English: LIBTAYO is an anti-cancer medicine that contains the active substance cemiplimab, which is a monoclonal antibody.
Croatian: LIBTAYO je lijek za liječenje raka koji sadrži djelatnu tvar cemiplimab, koja je monoklonsko protutijelo.
English: Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
Croatian: Cemiplimab potencira T-stanične odgovore, uključujući protutumorske odgovore, tako što blokira vezivanje PD-1 za ligande PD-L1 i PD-L2.
English: Tumour response assessments were performed every 8 or 9 weeks (for patients receiving 3 mg/kg every 2 weeks or 350 mg every 3 weeks, respectively).
Croatian: Tumorski se odgovor ocjenjivao svakih 8 ili 9 tjedana (za bolesnike koji su primali dozu od 3 mg/kg svaka 2 tjedna odnosno 350 mg svaka 3 tjedna).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA
English: • Liver problems (hepatitis)
Croatian: • jetrene tegobe (hepatitis)
English: You should not be given LIBTAYO if:
Croatian: Ne smijete primiti LIBTAYO:
English: Cemiplimab has no or negligible influence on the ability to drive and use machines.
Croatian: Cemiplimab ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: concentrate for solution for infusion 350 mg/7 ml
Croatian: koncentrat za otopinu za infuziju 350 mg/7 ml
English: Patients with any of the following were excluded: autoimmune disease that required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; history of pneumonitis within the last 5 years; prior treatment with anti-PD-1/PD-L1 or other immune checkpoint inhibitor therapy; active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus; chronic lymphocytic leukaemia (CLL); brain metastases or Eastern Cooperative Oncology Group (ECOG) performance score ≥ 2.
Croatian: U ispitivanja se nisu uključivali bolesnici koji su imali bilo što od sljedećega: autoimunu bolest koja je zahtijevala sistemsku terapiju imunosupresivima unutar 5 godina, presađivanje solidnog organa u anamnezi, pneumonitis unutar proteklih 5 godina, prethodno liječenje inhibitorima PD-1/PD-L1 ili drugim inhibitorima kontrolnih točaka imunosnog sustava, aktivnu infekciju koja zahtijeva liječenje, uključujući poznatu infekciju virusom humane imunodeficijencije ili aktivnu infekciju virusom hepatitisa B ili hepatitisa C, kroničnu limfocitnu leukemiju (KLL), moždane metastaze ili funkcionalni ECOG (engl.
English: This includes room temperature storage of the infusion solution in the intravenous container and time for administration of the infusion.
Croatian: To uključuje vrijeme čuvanja otopine za infuziju u spremniku za intravensku primjenu na sobnoj temperaturi i vrijeme potrebno za primjenu infuzije.
English: Grade 2 with AST or ALT >3 and ≤5×ULN or total bilirubin >1.5 and ≤3×ULN
Croatian: 2. stupanj uz AST ili ALT > 3 i ≤ 5 x GGN ili ukupan bilirubin > 1,5 i ≤ 3 × GGN
English: Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above
Croatian: Klinički znakovi ili simptomi imunološki uzrokovane nuspojave 3. stupnja koja nije prethodno opisana
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: If a woman chooses to be treated with cemiplimab, she should be instructed not to breast-feed while being treated with cemiplimab and for at least 4 months after the last dose.
Croatian: Ako se žena odluči liječiti cemiplimabom, treba joj napomenuti da ne doji tijekom liječenja cemiplimabom i još najmanje 4 mjeseca nakon posljednje doze.
English: Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.
Croatian: Cemiplimab se proizvodi tehnologijom rekombinantne DNK u kulturi stanica jajnika kineskog hrčka (engl.
English: No clinically important differences in the exposure of cemiplimab were found between patients with renal impairment and patients with normal renal function.
Croatian: Nisu opažene klinički važne razlike u izloženosti cemiplimabu između bolesnika s oštećenjem bubrežne funkcije i onih s normalnom bubrežnom funkcijom.
English: If refrigerated, the vials and/or intravenous bags must be allowed to reach room temperature prior to use.
Croatian: Ako se bočice i/ili vrećice za intravensku primjenu čuvaju u hladnjaku, prije primjene treba pričekati da se ugriju na sobnu temperaturu.
English: • Do not breast-feed while you are being treated with LIBTAYO and for at least 4 months after the last dose.
Croatian: • Nemojte dojiti tijekom liječenja lijekom LIBTAYO i još najmanje 4 mjeseca nakon posljednje doze.
English: What LIBTAYO contains The active substance is cemiplimab:
Croatian: Sadržaj pakiranja i druge informacije Što LIBTAYO sadrži Djelatna tvar je cemiplimab:
English: With 350 mg every 3 weeks, the mean steady-state concentration of cemiplimab ranged between Cmax of 168 mg/l and a Ctrough of 61 mg/l.
Croatian: Kod primjene doze od 350 mg svaka 3 tjedna srednja vrijednost koncentracije cemiplimaba u stanju dinamičke ravnoteže kretala se u rasponu od 168 mg/l (Cmax) do 61 mg/l (Ctrough).
English: Adverse reactions were serious in 8.6% patients and led to permanent discontinuation of cemiplimab in 5.8% of patients.
Croatian: Nuspojave su bile ozbiljne u 8,6% bolesnika, dok su u njih 5,8% dovele do trajnog prekida liječenja cemiplimabom.
English: The following clinically significant, immune-related adverse reactions occurred at an incidence of less than 1% of 591 patients treated with cemiplimab.
Croatian: Sljedeće klinički značajne imunološki uzrokovane nuspojave imale su incidenciju manju od 1% u 591 bolesnika liječenog cemiplimabom.
English: LIBTAYO is provided in a 10 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.
Croatian: LIBTAYO dolazi u prozirnoj staklenoj bočici (staklo tipa 1) volumena 10 ml, sa sivim klorobutilnim čepom obloženim zaštitnim slojem (FluroTec) i sa zaštitnim zatvaračem s flip-off kapicom.
English: Engagement of PD-1 with its ligands PD-L1 and PD-L2, which are expressed by antigen presenting cells and may be expressed by tumour cells and/or other cells in the tumour microenvironment, results in inhibition of T cell function such as proliferation, cytokine secretion, and cytotoxic activity.
Croatian: Vezivanje PD-1 za ligande PD-L1 i PD-L2, koji se eksprimiraju na antigen-prezentirajućim stanicama, a mogu se eksprimirati i na tumorskim stanicama i/ili drugim stanicama u tumorskom mikrookruženju, dovodi do inhibicije funkcije T-stanica, kao što su proliferacija, lučenje citokina i citotoksična aktivnost.
English: (Grade 4), Paraneoplastic encephalomyelitis (Grade 5), Guillain-Barre syndrome, central nervous system inflammation, Chronic inflammatory demyelinating polyradiculoneuropathy, Encephalitis b, Myasthenia gravis, Neuropathy peripheral.
Croatian: (4. stupnja), paraneoplastični encefalomijelitis (5. stupnja), Guillain-Barréov sindrom, upala u središnjem živčanom sustavu, kronična upalna demijelinizirajuća poliradikuloneuropatija, encefalitis b, miastenija gravis, periferna neuropatija
English: Neuropathy peripheral is a composite term that includes neuropathy peripheral and neuritis.
Croatian: c Periferna neuropatija skupni je pojam koji obuhvaća perifernu neuropatiju i neuritis.
English: The most common symptoms of infusion-related reaction were nausea, pyrexia, vomiting, abdominal pain, chills and flushing.
Croatian: Najčešći simptomi reakcije na infuziju bili su mučnina, pireksija, povraćanje, bol u abdomenu, zimica i navale crvenila.
English: a Toxicity should be graded with the current version of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events, NCI-CTCAE).
English: Version v.4.03 of NCI CTCAE was used to grade toxicity.
Croatian: Za ocjenu stupnja toksičnosti koristila se verzija 4.03 NCI CTCAE kriterija.
English: Study 1540 was a phase 2, open-label, multi-centre study that had enrolled 193 patients with mCSCC or laCSCC with a combined median follow-up time of 9.4 months total.
Croatian: Ispitivanje 1540 bilo je otvoreno, multicentrično ispitivanje faze 2, koje je obuhvatilo 193 bolesnika s metastatskim ili lokalno uznapredovalim planocelularnim karcinomom kože i u kojem je objedinjeni medijan praćenja iznosio ukupno 9,4 mjeseca.
English: Concentration data were collected in 548 patients with various solid tumours, including 178 patients with CSCC, who received cemiplimab.
Croatian: Podaci o koncentraciji lijeka prikupljeni su u 548 bolesnika s različitim vrstama solidnih tumora koji su primali cemiplimab, uključujući 178 bolesnika s planocelularnim karcinomom kože.
English: Patients should be managed with hormone replacement therapy (if indicated) and cemiplimab treatment modifications.
Croatian: Bolesnike treba liječiti hormonskom nadomjesnom terapijom (ako je to indicirano) i prilagoditi liječenje cemiplimabom.
English: In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Croatian: U slučaju predoziranja bolesnike treba pažljivo nadzirati zbog moguće pojave znakova ili simptoma nuspojava te treba uvesti odgovarajuće simptomatsko liječenje.
English: Any unused portion of the infusion solution should not be re-used and should be disposed in accordance with local requirements.
Croatian: Preostala neupotrijebljena otopina za infuziju ne smije se ponovno upotrijebiti, već je treba baciti sukladno nacionalnim propisima.
English: Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm complete response.
Croatian: Uključuje samo bolesnike kod kojih su prethodno zahvaćeni dijelovi kože potpuno zacijeljeli; u bolesnika s lokalno uznapredovalim planocelularnim karcinomom kože u ispitivanju 1540 potpuni odgovor morao se potvrditi biopsijom.
English: • Withdraw 7 ml (350 mg) from the vial of LIBTAYO and transfer into an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Croatian: • Iz bočice izvucite 7 ml (350 mg) lijeka LIBTAYO i prenesite ga u vrećicu za intravensku infuziju koja sadrži otopinu natrijeva klorida za injekcije od 9 mg/ml (0,9%) ili otopinu glukoze za injekcije od 50 mg/ml (5%).
English: Marketing Authorisation Holder Regeneron Ireland Designated Activity Company (DAC) Europa House
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Regeneron Ireland Designated Activity Company (DAC) Europa House
English: Musculoskeletal pain is a composite term that includes back pain, musculoskeletal pain, myalgia, neck pain and pain in extremity.
Croatian: i Mišićno-koštana bol skupni je pojam koji obuhvaća bol u leđima, bol u mišićima i kostima, mialgiju, bol u vratu i bol u ekstremitetu.
English: Immune-related adverse reactions should be managed with cemiplimab treatment modifications, hormone replacement therapy (if clinically indicated), and corticosteroids.
Croatian: Imunološki uzrokovane nuspojave treba zbrinuti prilagodbom liječenja cemiplimabom te primjenom hormonske nadomjesne terapije (ako je to klinički indicirano) i kortikosteroida.
English: Cases of SJS, fatal TEN and stomatitis occurred following 1 dose of cemiplimab in patients with prior exposure to idelalisib, who were participating in a clinical trial evaluating cemiplimab in Non-Hodgkin Lymphoma (NHL), and who had recent exposure to sulfa containing antibiotics (see section 4.8).
Croatian: Slučajevi SJS-a, TEN-a sa smrtnim ishodom i stomatitisa zabilježeni su nakon primjene 1 doze cemiplimaba u bolesnika prethodno liječenih idelalisibom koji su sudjelovali u kliničkom ispitivanju u kojem se ocjenjivala primjena cemiplimaba kod ne-Hodgkinova limfoma (NHL) i koji su nedavno bili izloženi antibioticima koji sadrže sulfa skupine (vidjeti dio 4.8).
English: h. Pruritus is a composite term that includes pruritus and pruritus allergic.
Croatian: Pruritus je skupni pojam koji obuhvaća pruritus i alergijski pruritus.