natgillin/translations-raw huggingface dataset:
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. 
33,7 % bolnikov je prejemalo vsaj 1 predhodno sistemsko zdravljenje proti raku, 90,2 % bolnikov je imelo predhodno operacijo zaradi raka in 67,9 % bolnikov je imelo predhodno obsevanje.
However, systemic corticosteroids or other immunosuppressants can be used after starting cemiplimab to treat immune-related adverse reactions (see sections 4.2). 
Vendar pa je kortikosteroide ali druge imunosupresive mogoče uporabiti po začetku zdravljenja s cemiplimabom za zdravljenje imunsko pogojenih neželenih učinkov (glejte poglavje 4.2).
In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. 
V primeru prevelikega odmerjanja je treba bolnike natančno kontrolirati glede znakov in simptomov neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje.
If you have any questions about your treatment, ask your doctor. 
Če imate o svojem zdravljenju kakšna vprašanja, se pogovorite z zdravnikom.
• Lung problems (pneumonitis) 
• težave s pljuči (pnevmonitis),
Arthritis is a composite term that includes arthritis and polyarthritis. 
Artritis je sestavljen izraz, ki vključuje artritis in poliartritis.
Grade 2 
2. stopnja
EU/1/19/1376/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1376/001
Permanently discontinue 
Trajno prenehajte uporabljati
• Do not co-administer other medicines through the same infusion line. 
• Tega zdravila ne dajajte skupaj z drugimi zdravili po isti infuzijski liniji.
LIBTAYO works by helping your immune system fight your cancer. 
Zdravilo LIBTAYO deluje tako, da telesnemu imunskemu sistemu pomaga premagati raka.
Patients should be managed with hormone replacement therapy (if indicated) and cemiplimab treatment modifications. 
Bolnike je treba voditi s hormonskim nadomestnim zdravljenjem (če je indicirano) in prilagoditvami zdravljenja s cemiplimabom.
Secondary endpoints were duration of response (DOR) by ICR and by investigator assessment (IA), ORR by IA, progression free survival (PFS) by ICR and IA, overall survival (OS), complete response rate (CRR) by ICR, and change in scores in patient reported outcomes on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30). 
Sekundarni opazovani dogodki so bili trajanje odziva (DOR - duration of response) po NCP in po raziskovalčevi oceni (RO), ORR po RO, preživetje brez napredovanja bolezni (PFS - progression free survival) po NCP in RO, celokupno preživetje (OS - overall survival), delež popolnega odziva (CRR - complete response rate) po NCP ter sprememba ocene pri izidih po navedbi bolnikov na podlagi vprašalnika o kakovosti življenja EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire).
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%). 
Skupno 161 (83,4 %) bolnikov je bilo moških in 187 (96,9 %) je bilo belcev, stanje zmogljivosti po ECOG je bilo 0 (44,6 %) ali 1 (55,4 %).
If you stop receiving LIBTAYO 
Če ste prenehali dobivati zdravilo LIBTAYO
For patients with externally visible target lesions (locally advanced CSCC and metastatic CSCC), ORR was determined by a composite endpoint that integrated ICR assessments of radiologic data (RECIST 1.1) and digital medical photography (WHO criteria). 
Pri bolnikih z na zunaj vidnimi ciljnimi lezijami (lokalno napredovali PCKK in metastatski PCKK) so ORR določili na podlagi sestavljenega opazovanega dogodka, ki je združeval ocene NCP radioloških podatkov (RECIST 1.1) in digitalnih medicinskih fotografij (merila Svetovne zdravstvene organizacije).
• you have diabetes 
• če imate sladkorno bolezen,
- Grade 4 adverse reaction (excluding endocrinopathies) - Recurrent severe Grade 3 immune-related adverse reaction - Persistent Grade 2 or 3 immune-related adverse reactions lasting 12 weeks or longer (excluding endocrinopathies) - Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks 
- Neželen učinek 4. stopnje (razen endokrinopatij) - Ponavljajoč se hud imunsko pogojeni neželen učinek 3. stopnje - Dolgotrajni imunsko pogojeni neželeni učinki 2. ali 3. stopnje, ki trajajo 12 tednov ali več (razen endokrinopatij) - Odmerka kortikosteroida v 12 tednih ni mogoče zmanjšati na 10 mg ali manj prednizona (ali enakovredno) na dan
d. Myocarditis is a composite term that includes autoimmune myocarditis and myocarditis. 
d. Miokarditis je sestavljen izraz, ki vključuje avtoimunski miokarditis in miokarditis.
The within dosing interval half-life at steady state is 19.4 days. 
Razpolovni čas v stanju dinamičnega ravnovesja je znotraj odmernega intervala 19,4 dneva.
Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. 
Cemiplimab okrepi odzive celic T, vključno s protitumorskimi odzivi, z blokado vezave PD-1 z ligandoma PD-L1 in PD-L2.
Resolution of hepatitis had occurred in 8 (72.7%) of the 11 patients at the time of data cut-off. 
Ob času zamejitve podatkov je hepatitis izzvenel pri 8 (72,7 %) od 11 bolnikov.
• 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. 
• Izvlecite 7 ml (350 mg) iz viale zdravila LIBTAYO in zdravilo prenesite v intravensko infuzijsko vrečko, ki vsebuje 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje ali 5 % (50 mg/ml) raztopino glukoze za injiciranje.
• a cancer medicine called idelalisib • medicines that make your immune system weak - examples include corticosteroids, such as prednisone. 
• zdravila, ki oslabijo imunski sistem - primer takšnih zdravil so kortikosteroidi, na primer prednizon.
Initiate symptomatic management 
Uvedite simptomatsko vodenje
Do not store any unused portion of the infusion solution for re-use. 
Neporabljenega ostanka raztopine za infundiranje ne hranite za poznejšo uporabo.
h. Pruritus is a composite term that includes pruritus and pruritus allergic. 
h. Pruritus je sestavljen izraz, ki vključuje pruritus in alergijski pruritus.
Look out for side effects 
Bodite pozorni na neželene učinke
Grade 2 to 4 
2. do 4. stopnja
Grade ≥3 with AST or ALT >5×ULN or total bilirubin >3×ULN 
≥ 3. stopnja in AST ali ALT > 5 × ZMN ali celokupni bilirubin < 3 × ZMN
Unopened vial Store in a refrigerator (2°C to 8°C). 
Neodprta viala Shranjujte v hladilniku (2-8 °C).
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). 
Odziv tumorja so ocenjevali vsakih 8 ali 9 tednov (vsakih 8 tednov pri bolnikih, ki so prejemali 3 mg/kg na 2 tedna, in vsakih 9 tednov pri tistih, ki so prejemali 350 mg na 3 tedne).
Very common Musculoskeletal and connective tissue disorders Arthralgia 
Zelo pogosti Bolezni mišično-skeletnega sistema in vezivnega tkiva Artralgija
The following clinically significant, immune-related adverse reactions occurred at an incidence of less than 1% of 591 patients treated with cemiplimab. 
Naslednji klinično pomembni imunsko pogojeni neželeni učinki so se pri 591 bolnikih, ki so prejemali cemiplimab, pojavili s pojavnostjo manj kot 1 %.
a Toxicity should be graded with the current version of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). 
a Stopnjo toksičnih učinkov je treba ocenjevati po trenutni različici meril NCI CTCAE (National Cancer
Store in the original container in order to protect from light. 
Shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
Each carton contains 1 glass vial with 7 ml of concentrate. 
Vsaka škatla vsebuje 1 stekleno vialo s 7 ml koncentrata.
Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, Ireland 
Harcourt Street, Dublin 2, Irska
What you need to know before you are given LIBTAYO 
Kaj morate vedeti, preden boste dobili zdravilo LIBTAYO
Type 1 diabetes mellitus a 
Sladkorna bolezen tipa 1a
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
• Skin problems 
• težave s kožo,
No dose adjustment is recommended for elderly patients. 
Starejšim bolnikom odmerka ni treba prilagoditi.
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. 
Zdravilo LIBTAYO je na voljo v 10-ml vialah iz prozornega stekla tipa 1 s sivim klorobutilnim zamaškom, prevlečenim s FluoroTecom, in pečatno zaporko s snemnim gumbom.
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. 
Če se ženska odloči za zdravljenje s cemiplimabom, ji je treba svetovati, da med zdravljenjem s cemiplimabom in vsaj še 4 mesece po zadnjem odmerku ne sme dojiti.
Marketing Authorisation Holder Regeneron Ireland Designated Activity Company (DAC) Europa House 
Imetnik dovoljenja za promet z zdravilom Regeneron Ireland Designated Activity Company (DAC) Europa House
The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L-proline, sucrose, polysorbate 80 and water for injections. 
Druge sestavine zdravila so L-histidin, L-histidinijev monohidroklorid monohidrat, L-prolin, saharoza, polisorbat 80 in voda za injekcije.
Patients should be monitored for changes in thyroid function at the start of treatment and periodically during the treatment as indicated based on clinical evaluation (see section 4.8). 
Bolnike je treba spremljati glede sprememb delovanja ščitnice na začetku zdravljenja in redno med zdravljenjem, kot je indicirano glede na klinično oceno (glejte poglavje 4.8).
Adrenal insufficiency 
Nadledvična insuficienca
Clearance of cemiplimab is linear at doses of 1 mg/kg to 10 mg/kg every two weeks. 
Očistek cemiplimaba je ob uporabi odmerkov od 1 mg/kg do 10 mg/kg na dva tedna linearen.
This includes room temperature storage of the infusion solution in the intravenous container and time for administration of the infusion. 
Ta čas obsega tako čas shranjevanja raztopine za infundiranje v intravenskem vsebniku na sobni temperaturi kot čas infundiranja zdravila.
Neuropathy peripheral is a composite term that includes neuropathy peripheral and neuritis. 
Periferna nevropatija je sestavljen izraz, ki vključuje periferno nevropatijo in nevritis.
• Kidney problems (nephritis and kidney failure) 
• težave z ledvicami (nefritis in odpoved ledvic),
Cemiplimab has not been studied in patients with CLcr <25 ml/min (see section 4.2). 
Cemiplimab ni raziskan pri bolnikih z očistkom kreatinina < 25 ml/min (glejte poglavje 4.2).
Muscular weakness 
Šibkost mišic
No effects on fertility assessment parameters or in the male and female reproductive organs were observed in a 3-month repeat dose fertility assessment study with sexually mature cynomolgus monkeys. 
V 3-mesečni študiji za oceno plodnosti med uporabo ponavljajočih se odmerkov zdravila pri spolno zrelih opicah cynomolgus niso ugotovili vpliva na parametre plodnosti ali na reproduktivne organe samcev in samic.
Resolution of pneumonitis had occurred in 14 (63.6%) of the 22 patients at the time of data cut-off. 
Ob času zamejitve podatkov je pnevmonitis izzvenel pri 14 (63,6 %) od 22 bolnikov.
Preparation and administration 
Priprava in dajanje
The recommended dose is 350 mg cemiplimab, every 3 weeks, administered as an intravenous infusion over 30 minutes. 
Priporočeni odmerek cemiplimaba je 350 mg na 3 tedne v 30-minutni intravenski infuziji.
• under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion preparation. 
• v hladilniku na temperaturi od 2 do 8 °C za ne več kot 24 ur od časa priprave infuzije.
The median age was 72 years (range: 38 to 96): Seventy-eight (40.4%) patients were 75 years or older, 66 patients (34.2%) were 65 to less than 75 years, and 49 patients (25.4%) were less than 65 years. 
Mediana starost je bila 72 let (razpon: od 38 do 96): 78 (40,4 %) bolnikov je bilo starih 75 let ali več, 66 bolnikov (34,2 %) od 65 do manj kot 75 let in 49 bolnikov (25,4 %) je bilo mlajših od 65 let.
Excipients: L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, sucrose, and water for injections. 
Pomožne snovi: L-histidin, L-histidinijev monohidroklorid monohidrat, L-prolin, polisorbat 80, saharoza in voda za injekcije.
Immune-related adverse reactions should be managed with cemiplimab treatment modifications, hormone replacement therapy (if clinically indicated), and corticosteroids. 
Za obvladanje imunsko pogojenih neželenih učinkov je treba prilagoditi odmerek cemiplimaba, nadomestno hormonsko zdravljenje (če je klinično indicirano) in kortkosteroide.
• Skin problems such as rash or itching, skin blistering and ulcers in mouth or other mucous membrane. 
• Težave s kožo, na primer izpuščaj ali srbenje, mehurje na koži in razjede v ustih ali na drugih sluznicah.
Immune-related adverse reactions led to permanent discontinuation of cemiplimab in 4.4% of patients. 
Imunsko pogojeni neželeni učinki so povzročili trajno prenehanje uporabe cemiplimaba pri 4,4 % bolnikov.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA
The efficacy and safety of cemiplimab in patients with metastatic (nodal or distant) CSCC (mCSCC) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation were studied in clinical trial R2810-ONC-1540 (Study 1540). 
Učinkovitost in varnost cemiplimaba pri bolnikih z metastatskim (metastaze v bezgavkah ali oddaljene metastaze) PCKK (mPCKK) ali lokalno napredovalim PCKK (lnPCKK), ki niso bili kandidati za kurativni kirurški poseg ali kurativno obsevanje, so raziskali v kliničnem preskušanju R2810-ONC-1540 (študija 1540).
Dosing delay or discontinuation may be required based on individual safety and tolerability. 
Glede na varnost in prenašanje pri posameznem bolniku je lahko potrebna odložitev odmerka ali prenehanje uporabe.
In order to confirm the efficacy and safety of cemiplimab for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, the MAH should submit the final study report for Groups 1-3 in the phase 2 pivotal study 1540. 
Za potrditev učinkovitosti in varnosti cemiplimaba za zdravljenje bolnikov z metastatskim ali lokalno napredovalim kožnim ploščatoceličnim karcinomom, ki niso kandidati za kurativni kirurški poseg ali kurativno obsevanje, mora imetnik dovoljenja za promet z zdravilom predložiti končno poročilo študije za skupine 1-3 v ključni študiji 2. faze 1540.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies. 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa.
There are limited data for LIBTAYO in patients with severe renal impairment CLcr <30 ml/min (see section 5.2). 
Podatkov o uporabi zdravila LIBTAYO pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je malo (glejte poglavje 5.2).
Of the 219 patients with mCSCC and laCSCC treated with cemiplimab, 25.1% (55/219) were less than 65 years, 34.2% (75/219) were 65 to less than 75 years, and 40.6% (89/219) were 75 years or older. 
Od 219 bolnikov z mPCKK in lnPCKK, zdravljenih s cemiplimabom, je bilo 25,1 % (55/219) mlajših od 65 let, 34,2 % (75/219) je bilo starih od 65 do manj kot 75 let in 40,6 % (89/219) je bilo starih 75 let ali več.
Chronic inflammatory demyelinating polyradiculoneuropathy 
Kronična vnetna demielinizirajoča poliradikulonevropatija
f. Hepatitis is a composite term that includes hepatitis and autoimmune hepatitis. 
Hepatitis je sestavljen izraz, ki vključuje hepatitis in avtoimunski hepatitis.
If you have any of these effects, talk to your doctor immediately. 
Če se vam pojavi kateri od teh neželenih učinkov, se nemudoma posvetujte z zdravnikom.
This medicinal product has been authorised under a so-called ‘conditional approval' scheme. 
Pogojno dovoljenje za promet Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet”.
• inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired or chest pain 
• vnetje srčne mišice, ki se lahko pokaže kot kratka sapa, neredno bitje srca, občutek utrujenosti ali bolečine v prsih
How you are given LIBTAYO 4. 
Kako boste dobili zdravilo LIBTAYO 4.
What LIBTAYO contains The active substance is cemiplimab: 
Kaj vsebuje zdravilo LIBTAYO Zdravilna učinkovina je cemiplimab:
Immune-related skin reaction or other immune-related adverse reactions in patients with prior treatment with idelalisib 
Imunsko pogojene kožne reakcije ali drugi imunsko pogojeni neželeni učinki pri bolnikih, predhodno zdravljenih z idelalisibom2.
The most common symptoms of infusion-related reaction were nausea, pyrexia, vomiting, abdominal pain, chills and flushing. 
Najpogostejši simptomi z infundiranjem povezanih reakcij so bili navzea, zvišana telesna temperatura, bruhanje, bolečine v trebuhu, mrzlica in zardevanje.
Grades 1-5 
1.-5. stopnja
• Do not breast-feed while you are being treated with LIBTAYO and for at least 4 months after the last dose. 
• Med zdravljenjem z zdravilom LIBTAYO in vsaj še 4 mesece po njegovem zadnjem odmerku ne smete dojiti.
Hyperthyroidism 
Hipertiroidizem
In the 193 patients in the efficacy analysis, the objective response rate by ICR (95% CI) was 40.8% (27.0%, 55.8%) in patients less than 65 years, 48.5% (36.0%, 61.1%) in patients 65 to less than 75 years, and 42.3% (31.2%, 54.0%) in patients 75 years or older. 
Pri 193 bolnikih v analizi učinkovitosti je bil objektivni delež odziva po NCP (95 % IZ) 40,8 % (27,0 %, 55,8 %) pri bolnikih, mlajših od 65 let, 48,5 % (36,0 %, 61,1 %) pri bolnikih, starih od 65 do manj kot 75 let, in 42,3 % (31,2 %, 54,0 %) pri bolnikih, starih 75 let ali več.
• cough, inflammation of the lungs 
• kašelj, vnetje pljuč
Other fatal and life-threatening immune-related adverse reactions have been observed in patients receiving cemiplimab including paraneoplastic encephalomyelitis and meningitis (see section 4.8 for other immune-related adverse reactions). 
Pri bolnikih, ki so prejemali cemiplimab, so opažali še druge življenjsko nevarne in smrtne imunsko pogojene neželene učinke, med njimi paraneoplastični encefalomielitis in meningitis (glejte poglavje 4.8 za druge imunsko pogojene neželene učinke).
• Problems in other parts of the body such as headache or stiff neck, fever, feeling tired or weak, confusion, memory problems or feeling sleepy, fits (seizures), seeing or hearing things that are not really there (hallucinations), changes in eyesight, eye pain or redness, severe muscle weakness, changes in heartbeat, such as beating fast or seeming to skip a beat or pounding sensation and bruises on the skin or bleeding. 
• Težave v drugih delih telesa, na primer glavobol ali togost vratu, zvišano telesno temperaturo, občutek utrujenosti ali šibkosti, zmedenost, težave s spominom ali zaspanost, napade krčev (konvulzije), videnje ali slišanje stvari, ki jih v resnici ni (halucinacije), spremembe vida, bolečino v očeh ali pordelost oči, hudo šibkost mišic, spremembe srčnega utripa, npr. hiter srčni utrip, navidezno preskakovanje ali občutek razbijanja ter podplutbe ali krvavitve na koži.
Immune thrombocytopenic purpura 
Imunsko pogojena trombocitopenična purpura
Cardiac Disorders: Myocarditis c, Pericarditis 
Srčne bolezni: miokarditisc, perikarditis
Resolution of nephritis had occurred in all patients at the time of data cut-off. 
Ob času zamejitve podatkov je nefritis izzvenel pri vseh bolnikih.
In order to confirm the efficacy and safety of cemiplimab for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, the MAH should provide interim data of a single-arm trial in the same population [study 1540 group 6]. 
Za potrditev učinkovitosti in varnosti cemiplimaba za zdravljenje bolnikov z metastatskim ali lokalno napredovalim kožnim ploščatoceličnim karcinomom, ki niso kandidati za kurativni kirurški poseg ali kurativno obsevanje, mora imetnik dovoljenja za promet z zdravilom predložiti vmesne podatke preskušanja z eno samo skupino v tej populaciji [študija 1540, skupina 6].
o Description of the main signs or symptoms of the immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, nephritis and other irARs) and infusion related reactions, and the importance of notifying their treating physician immediately if symptoms occur. 
o Opis glavnih znakov ali simptomov imunsko pogojenih neželenih učinkov (pnevmonitis, kolitis, hepatitis, endokrinopatije, imunsko pogojeni neželeni učinki na kožo, nefritis in drugi imunsko pogojeni neželeni učinki) in z infundiranjem povezanih reakcij, ter navedbo o pomenu takojšnjega obveščanja lečečega zdravnika v primeru pojava teh simptomov.
mCSCC cemiplimab: 350 mg Q3W (Group 3) (N = 56) 
mPCKK cemiplimab: 350 mg na 3 tedne (Skupina 3) (N = 56)
Nervous system disorders Paraneoplastic encephalomyelitis 
Bolezni živčevja Paraneoplastični encefalomielitis
Grade 4 or recurrent Grade 3 
4. stopnja ali ponovna 3. stopnja
The increase of spontaneous abortion and/or resorption in animals with restricted PD-L1 expression (knock-out or anti-PD1 / PD-L1 monoclonal antibodies) has been shown in both mice and monkeys. 
Pri miših in pri opicah so ob omejeni izraženosti PD-L1 (zaradi izbitja ["knockout"] ali monoklonskih protiteles proti PD1/PD-L1) ugotovili povečanje spontanih splavov in/ali resorpcij zarodka.
LIBTAYO has no or minor influence on your ability to drive and use machines. 
Zdravilo LIBTAYO le malo vpliva na sposobnost upravljanja vozil in strojev ali sploh ne vpliva nanjo.
Five out of 398 patients (1.3%) administered cemiplimab developed treatment-emergent antibodies, with 1 out of 398 patients (0.3%) exhibiting persistent antibody responses. 
Petim od 398 bolnikov (1,3 %), ki so prejemali cemiplimab, so se pojavila med zdravljenjem nastala protitelesa; 1 od 398 bolnikov (0,3 %) je imel trajen odziv protiteles.
Eighteen patients (3.0%) received high-dose corticosteroids for a median of 8.5 days (range: 1 day to 5.9 months). 
Osemnajst (3,0 %) bolnikov je prejemalo velike odmerke kortikosteroidov mediano 8,5 dneva (razpon: od 1 dneva do 5,9 meseca).
Among 21 mCSCC patients, ORR was 60% (3/5) in patients with PD-L1 < 1% and 56.3% (9/16) among patients with PD-L1 ≥ 1%. 
Med 21 bolniki z mPCKK je bil ORR pri bolnikih s PD-L1 < 1 % 60 % (3/5) in pri bolnikih s PD-L1 ≥ 1 % 56,3 % (9/16).
Meningitis b 
Meningitisb
Allow the diluted solution to come to room temperature prior to administration. 
Pred uporabo pustite, da se razredčena raztopina ogreje na sobno temperaturo.
mCSCC cemiplimab: 3 mg/kg Q2W (Group 1) (N = 59) 
mPCKK cemiplimab: 3 mg/kg na 2 tedna (Skupina 1) (N = 59)
Median follow-up was 16.5 months for the mCSCC 3 mg/kg every 2 weeks group, 9.3 months for the laCSCC 3 mg/kg every 2 weeks group and 8.1 months for the mCSCC 350 mg every 3 weeks group. 
V skupini z mPCKK in odmerkom 3 mg/kg na 2 tedna je bil mediani čas spremljanja 16,5 meseca, v skupini z lnPCKK in odmerkom 3 mg/kg na 2 tedna 9,3 meseca ter v skupini z mPCKK in odmerkom 350 mg na 3 tedne 8,1 meseca.
Grades 3-5 
3.-5. stopnja
No studies have been performed to test the potential of cemiplimab for carcinogenicity or genotoxicity. 
Študij za testiranje karcinogenosti ali genotoksičnosti cemiplimaba niso izvedli.