natgillin/translations-raw huggingface dataset:
Cemiplimab can cause severe or life-threatening infusion-related reactions (see section 4.8). 
Cemiplimab lahko povzroči resne ali življenjsko nevarne z infundiranjem povezane reakcije (glejte poglavje 4.8).
• inflammation of brain and spinal cord membranes usually caused by infection • dryness in many parts of the body, from mouth to eyes, nose, throat and the top layers of skin 
• suhost številnih delov telesa, od ust do oči, nosa, žrela in povrhnjih plasti kože
No pharmacokinetic drug-drug interaction studies have been conducted with cemiplimab. 
S cemiplimabom niso izvedli farmakokinetičnih študij medsebojnega delovanja zdravil.
• Kidney problems (nephritis and kidney failure) such as passing water less often than usual, passing blood, swollen ankles and feeling less hungry than normal. 
• Težave z ledvicami (nefritis in odpoved ledvic), na primer manj pogosto odvajanje urina kot po navadi, kri v urinu, otekanje gležnjev in manjši občutek lakote kot po navadi.
laCSCC cemiplimab: 3 mg/kg Q2W (Group 2) (N = 78) 
lnPCKK cemiplimab: 3 mg/kg na 2 tedna (Skupina 2) (N = 78)
Grade 1 or 2 
1. ali 2. stopnja
LIBTAYO is used in adults to treat a type of skin cancer called advanced cutaneous squamous cell carcinoma or CSCC. 
Zdravilo LIBTAYO se uporablja za zdravljenje določene vrste kožnega raka, imenovanega napredovali ploščatocelični karcinom kože (s kratico PCKK).
LIBTAYO 350 mg concentrate for solution for infusion cemiplimab 
LIBTAYO 350 mg koncentrat za raztopino za infundiranje cemiplimab
• Lung problems (pneumonitis) such as new or worsening cough, being short of breath and chest pain. 
• Težave s pljuči (pnevmonitis), na primer novonastali kašelj ali poslabšanje kašlja, ali kratko sapo in bolečine v prsih.
Initiate symptomatic management immediately, including initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper 
Nemudoma uvedite simptomatsko vodenje, vključno z začetnim odmerkom od 1 do 2 mg/kg/dan prednizona (ali enakovredno) in nato postopno zmanjšanje odmerka
Cemiplimab has not been studied in patients with moderate or severe hepatic impairment. 
Cemiplimab ni raziskan pri bolnikih z zmerno ali hudo okvaro jeter.
See ‘Possible side effects' section in section 4. 
Glejte poglavje 4, "Možni neželeni učinki".
LIBTAYO is for intravenous use. 
Zdravilo LIBTAYO je namenjeno intravenski uporabi.
How to store LIBTAYO 6. 
Shranjevanje zdravila LIBTAYO 6.
Animal reproduction studies have not been conducted with cemiplimab (see section 4.6). 
S cemiplimabom niso izvedli študij o vplivu na sposobnost razmnoževanja pri živalih (glejte poglavje 4.6).
Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated 
Začetni odmerek od 1 do 2 mg/kg/dan prednizona (ali enakovredno) in nato postopno zmanjšanje odmerka, ter hormonsko nadomeščanje, kot je klinično indicirano
Among the 42 patients with hypothyroidism, the median time to onset was 4.2 months (range: 15 days to 18.9 months). 
Pri 42 bolnikih s hipotiroidizmom je bil mediani čas do pojava 4,2 meseca (razpon: od 15 dni do 18,9 meseca).
Mix the diluted solution by gentle inversion. 
Razredčeno raztopino premešajte s previdnim obračanjem.
Cemiplimab should be resumed when metabolic control is achieved on insulin replacement or anti-hyperglycaemics (see section 4.2). 
Uporabo cemiplimaba je mogoče nadaljevati, ko je z nadomeščanjem insulina ali z antihiperglikemičnimi zdravili dosežen presnovni nadzor (glejte poglavje 4.2).
Among the 4 patients with type 1 diabetes mellitus, the median time to onset was 2.3 months (range: 28 days to 6.2 months). 
Pri 4 bolnikih s sladkorno boleznijo tipa 1 je bil mediani čas do pojava 2,3 meseca (razpon: od 28 dni do 6,2 meseca).
There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations (see section 5.2). 
Podatkov o bolnikih z zmerno ali hudo okvaro jeter ni dovolj, da bi lahko oblikovali priporočila za odmerjanje (glejte poglavje 5.2).
If you miss an appointment 
Če izpustite obisk pri zdravniku
The solution may contain trace amounts of translucent to white particles in a single-use vial. 
Raztopina v viali za enkratno uporabo lahko vsebuje prosojne do bele delce v sledovih.
Among 54 patients with laCSCC, ORR was 35.3% (6/17) in patients with PD-L1 < 1% and 54.1% (20/37) among patients with PD-L1 ≥ 1%. 
Med 54 bolniki z lnPCKK je bil ORR pri bolnikih s PD-L1 < 1 % 35,3 % (6/17) in pri bolnikih s PD-L1 ≥ 1 % 54,1 % (20/37).
Among the 11 patients with hyperthyroidism, the median time to onset was 1.9 months (range: 28 days to 14.8 months). 
Pri 11 bolnikih s hipertiroidizmom je bil mediani čas do pojava 1,9 meseca (razpon: od 28 dni do 14,8 meseca).
Immune-related hypophysitis occurred in 1 (0.2%) of 591 patients receiving cemiplimab. 
Imunsko pogojeni hipofizitis se je pojavil pri 1 (0,2 %) od 591 bolnikov, ki so prejemali cemiplimab.
Justification for not including Braille accepted. 
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
• LIBTAYO is given as a drip into a vein (intravenous infusion). 
• Zdravilo LIBTAYO se daje z intravensko infuzijo ("kapalno") v veno.
• you are allergic to cemiplimab or any of the other ingredients of this medicine (listed in section 6). 
Zdravila LIBTAYO ne smete dobiti: • če ste alergični na cemiplimab ali katero koli sestavino tega zdravila (navedeno v poglavju
It is unknown whether cemiplimab is secreted in human milk. 
Ni znano, ali se cemiplimab izloča v materino mleko.
Among 53 advanced CSCC patients with PD-L1 ≥ 1%, ORR was 54.7% (29/53). 
Med 53 bolniki z napredovalim PCKK in PD-L1 ≥ 1 % je bil ORR po oceni neodvisnega centralnega pregleda 54,7 % (29/53).
Uncommon Respiratory, thoracic and mediastinal disorders Pneumonitis 
Občasni Bolezni dihal, prsnega koša in mediastinalnega prostora Pnevmonitis
Resolution of immune-related diarrhoea or colitis had occurred in 4 (57.1%) of the 7 patients at the time of data cut-off. 
Ob času zamejitve podatkov sta imunsko pogojena driska ali kolitis izzvenela pri 4 (57,1 %) od 7 bolnikov.
• Hormone gland problems - especially thyroid, pituitary, adrenal glands and the pancreas 
• težave s hormonskimi žlezami - zlasti s ščitnico, nadledvičnimi žlezami in trebušno slinavko,
• Type 1 diabetes that may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired. 
• Sladkorna bolezen tipa 1, ki lahko povzroči večjo lakoto ali žejo kot po navadi, potrebo po pogostejšem uriniranju, hujšanje in utrujenost.
Resolution had occurred in 6 (50%) of 12 patients at the time of data cut-off. 
Ob času zamejitve podatkov so te reakcije izzvenele pri 6 (50 %) od 12 bolnikov.
Musculoskeletal and connective tissue disorders: Myalgia, Arthritis d, Sjogren's syndrome 
Bolezni mišično-skeletnega sistema in vezivnega tkiva: mialgija, artritisd, Sjögrenov sindrom Očesne bolezni: keratitis
fast heartbeat, increased sweating, feeling cold, very tired, dizzy or fainting, weight gain or weight loss, feeling more hungry or thirsty than usual, hair loss, constipation, your voice gets deeper, very low blood pressure, passing water more often than usual, nausea or vomiting, stomach (abdomen) pain, changes in mood or behaviour (such as decreased sex drive, being irritable or forgetful). 
• Težave s hormonskimi žlezami, na primer glavobol, ki ne mine, ali nenavaden glavobol, hitro bitje srca, močnejše znojenje, občutek mraza, huda utrujenost, omotica ali omedlevica, povečanje ali zmanjšanje telesne mase, večji občutek lakote ali žeje kot po navadi, izpadanje las, zaprtost, znižanje tona vašega glasu, zelo nizek krvni tlak, odvajanje večje količine urina kot po navadi, slabost ali bruhanje, bolečine v trebuhu, spremembe razpoloženja ali vedenja (npr. zmanjšana spolna sla, razdražljivost ali pozabljivost).
Musculoskeletal pain i 
Mišično-skeletna bolečinai
Patients should be managed with cemiplimab treatment modifications and corticosteroids as described above (see section 4.2). 
Bolnike je treba voditi s prilagoditvijo zdravljenja s cemiplimabom in s kortikosteroidi, kot je opisano zgoraj (glejte poglavje 4.2).
• LIBTAYO is for intravenous use. 
• Zdravilo LIBTAYO je namenjeno intravenski uporabi.
Among the 3 patients with adrenal insufficiency, the median time to onset was 11.5 months (range: 10.4 months to 12.3 months). 
Pri 3 bolnikih z nadledvično insuficienco je bil mediani čas do pojava 11,5 meseca (razpon: od 10,4 dni do 12,3 meseca).
• Gut problems (colitis) such as frequent diarrhoea often with blood or mucus, more bowel movements than usual, stools that are black or tarry, and severe stomach (abdomen) pain or tenderness. 
• Težave s črevesjem (kolitis), na primer pogosto drisko (pogosto s krvjo ali sluzjo), pogostejše iztrebljanje kot po navadi, črno ali smolasto blato in močne bolečine v trebuhu ali občutljivost trebuha.
Immune-related skin adverse reactions, defined as requiring use of systemic corticosteroids with no clear alternate aetiology, including severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (some cases with fatal outcome), and other skin reactions such as rash, erythema multiforme, pemphigoid, have been reported in association with cemiplimab treatment (see section 4.8). 
Med zdravljenjem s cemiplimabom so poročali o imunsko pogojenih neželenih učinkih na kožo, opredeljenih s potrebo po uporabi sistemskih kortikosteroidov in brez jasne alternativne etiologije; med njimi so bili hudi neželeni učinki na kožo, na primer Stevens-Johnsonov sindrom (SJS) in toksična epidermalna nekroliza (TEN) (v nekaterih primerih s smrtnim izidom), in druge kožne reakcije, na primer izpuščaj, multiformni eritem in pemfigoid (glejte poglavje 4.8).
There was no evidence of an altered pharmacokinetic or safety profile with anti-cemiplimab antibody development. 
V primeru pojava protiteles proti cemiplimabu niso ugotovili spremenjenih farmakokinetičnih ali varnostnih značilnosti.
concentrate for solution for infusion 350 mg/7 ml 
FARMACEVTSKA OBLIKA IN VSEBINA Koncentrat za raztopino za infundiranje 350 mg/7 ml
Grade 3 or 4 or recurrent Grade 2 
3. ali 4. stopnja ali ponovna 2. stopnja
SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION 
SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Type 1 diabetes mellitus 
Sladkorna bolezen tipa 1
At the dosing regimens of 1 mg/kg to 10 mg/kg every two weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway. 
Ob odmernih shemah od 1 mg/kg do 10 mg/kg na dva tedna je kinetika cemiplimaba linearna in sorazmerna odmerku; to nakazuje nasičenje poti, v katero je vključeno ciljno mesto.
Grade 3 or 4 (hyperglycaemia) 
Sladkorna bolezen tipa 1 3. ali 4. stopnja (hiperglikemija)
• If you are breast-feeding or plan to breast-feed, ask your doctor for advice before you are given this medicine. 
• Če dojite ali nameravate dojiti, se posvetujte z zdravnikom, preden dobite to zdravilo.
o The contact details of their LIBTAYO prescriber. 
o Kontaktne podatke zdravnika, ki je predpisal zdravilo LIBTAYO.
Grade 3 or 4 
3. ali 4. stopnja
Immune-related type 1 diabetes mellitus, including diabetic ketoacidosis, has been observed in patients receiving cemiplimab (see section 4.8). 
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojeno sladkorno bolezen tipa 1, vključno z diabetično ketoacidozo (glejte poglavje 4.8).
(including but not limited to meningitis, paraneoplastic encephalomyelitis, arthritis, Guillain-Barre syndrome, encephalitis, chronic inflammatory demyelinating polyradiculoneuropathy, central nervous system inflammation, autoimmune myocarditis, and immune thrombocytopenic purpura, myalgia, Sjogren's syndrome, vasculitis, myasthenia gravis)b 
Guillain-Barréjevim sindromom, encefalitisom, kronično vnetno demielinizirajočo poliradikulonevropatijo, vnetjem osrednjega živčevja, avtoimunskim miokarditisom in imunsko trombocitopenično purpuro, mialgijo, Sjögrenovim sindromom, vaskulitisom, miastenijo gravis) b
Among the 12 patients with immune-related skin adverse reactions, the median time to onset was 1.5 months (range: 2 days to 10.9 months) and the median duration was 4.4 months (range: 14 days to 9.6 months). 
Pri 12 bolnikih z imunsko pogojenimi kožnimi reakcijami je bil mediani čas do pojava 1,5 meseca (razpon: od 2 dni do 10,9 meseca) in mediano trajanje 4,4 meseca (razpon: od 14 dni do 9,6 meseca).
LIBTAYO does not contain a preservative. 
Shranjevanje razredčene raztopine Zdravilo LIBTAYO ne vsebuje konzervansov.
It must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size). 
Dajati ga je treba v intravenski infuziji v obdobju 30 minut po intravenski liniji, ki vsebuje sterilen, nepirogen filter (v sami liniji ali kot dodatek), ki malo veže beljakovine (velikost por od 0,2 do 5 mikronov).
There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations (see section 4.2). 
Podatkov o bolnikih z zmerno ali hudo okvaro jeter ni dovolj, da bi omogočali oblikovanje priporočil za odmerjanje (glejte poglavje 4.2).
Ten (1.7%) patients with immune-related hepatitis received high-dose corticosteroids for a median of 10.5 days (range: 2 days to 1.9 months). 
Deset (1,7 %) bolnikov z imunsko pogojenim hepatitisom je prejemalo velike odmerke kortikosteroidov mediana 10,5 dneva (razpon: od 2 dni do 1,9 meseca).
• inflammation of the pituitary gland situated at the base of the brain; decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid 
• vnetje hipofize, ki leži na spodnji strani možganov, zmanjšano izločanje hormonov nadledvičnih žlez, vnetje ščitnice
• LIBTAYO is for single use only. 
• Zdravilo LIBTAYO je namenjeno samo za enkratno uporabo.
Four patients (0.7%) with immune-related diarrhoea or colitis received high-dose corticosteroids for a median of 29 days (range: 19 days to 2.0 months). 
Štirje (0,7 %) bolniki z imunsko pogojeno drisko ali kolitisom so prejemali velike odmerke kortikosteroidov mediano 29 dni (razpon: od 19 dni do 2,0 meseca).
Patients should be monitored for signs and symptoms of infusion-related reactions and managed with cemiplimab treatment modifications and corticosteroids. 
Bolnike je treba spremljati glede znakov in simptomov z infundiranjem povezanih reakcij in jih voditi s prilagoditvijo zdravljenja s cemiplimabom in s kortikosteroidi.
• LIBTAYO must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size). 
• Zdravilo LIBTAYO je treba dati v intravenski infuziji v obdobju 30 minut po intravenski liniji, ki vsebuje sterilen, nepirogen filter (v sami liniji ali kot dodatek), ki malo veže beljakovine (velikost por od 0,2 do 5 mikronov).
What LIBTAYO looks like and contents of the pack LIBTAYO concentrate for solution for infusion (sterile concentrate) is supplied as a clear to slightly opalescent, colourless to pale yellow sterile solution that may contain trace amounts of translucent to white particles. 
Zdravilo LIBTAYO koncentrat za raztopino za infundiranje (sterilen koncentrat) je na voljo kot bistra do rahlo opalescentna, brezbarvna do bledo rumena sterilna raztopina, ki lahko vsebuje prosojne ali bele delce v sledovih.
• Discard the vial if the solution is cloudy, discoloured or contains extraneous particulate matter other than trace amounts of translucent-to-white particles. 
• Če je raztopina motna, spremenjene barve ali vsebuje druge delce razen prosojnih do belih delcev v sledovih, vialo zavrzite.
b. Meningitis is a composite term that includes meningitis and meningitis aseptic. 
Bolezni prebavil: stomatitis a Vključuje meningitis in aseptični meningitis.
At dosing regimens of 1 mg/kg to 10 mg/kg every 2 weeks and 350 mg every 3 weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway over the dosing interval. 
Kinetika cemiplimaba je bila ob odmernih shemah od 1 mg/kg do 10 mg/kg na 2 tedna in 350 mg na 3 tedne linearna in sorazmerna odmerku; to nakazuje nasičenje poti, v kateri je vključeno ciljno mesto, v celotnem odmernem intervalu.
Among the 11 patients with immune-related hepatitis, the median time to onset was 1.0 month (range: 7 days to 4.2 months) and the median duration of hepatitis was 15 days (range: 8 days to 2.7 months). 
Pri 11 bolnikih z imunsko pogojenim hepatitisom je bil mediani čas do pojava 1,0 mesec (razpon: od 7 dni do 4,2 meseca) in mediano trajanje hepatitisa 15 dni (razpon: od 8 dni do 2,7 meseca).
Among the 3 patients with immune-related nephritis, the median time to onset was 1.8 months (range: 29 days to 4.1 months) and the median duration of nephritis was 18 days (range: 9 days to 29 days). 
Pri 3 bolnikih z imunsko pogojenim nefritisom je bil mediani čas do pojava 1,8 meseca (razpon: od 29 dni do 4,1 meseca) in mediano trajanje nefritisa je bilo 18 dni (razpon: od 9 dni do 29 dni).
Two (0.3%) patients with immune-related nephritis received high-dose corticosteroids for a median of 1.5 months (range: 16 days to 2.6 months). 
Dva (0,3 %) bolnika z imunsko pogojenim nefritisom sta prejemala velike odmerke kortikosteroidov mediano 1,5 meseca (razpon: od 16 dni do 2,6 meseca).
Type 1 diabetes mellitus without an alternative aetiology occurred in 4 (0.7%) of 591 patients including 3 (0.5%) patients with Grade 4 and 1 (0.2%) patient with Grade 3 type 1 diabetes mellitus. 
Sladkorna bolezen tipa 1 brez alternativne etiologije se je pojavila pri 4 (0,7 %) od 591 bolnikov, vključno s 3 (0,5 %) bolniki s sladkorno boleznijo tipa 1 4. stopnje in 1 (0,2 %) 3. stopnje.
Other medicinal products should not be co-administered through the same infusion line. 
Po isti infuzijski liniji se ne sme istočasno dajati drugih zdravil.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with cemiplimab treatment (see section 4.4). 
V povezavi z zdravljenjem s cemiplimabom so bili opisani hudi kožni neželeni učinki, vključno s Stevens-Johnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN) (glejte poglavje 4.4).
• you have liver problems 
• če imate težave z jetri,
Grade 2 or 3 
2. ali 3. stopnja
• One ml of concentrate contains 50 mg of cemiplimab. 
• En mililiter koncentrata vsebuje 50 mg cemiplimaba.
Immune-related pneumonitis occurred in 22 (3.7%) of 591 patients receiving cemiplimab, including 2 (0.3%) patients with Grade 5, 2 (0.3%) patients with Grade 4, and 6 (1.0%) patients with Grade 3 pneumonitis. 
Imunsko pogojeni pnevmonitis se je pojavil pri 22 (3,7 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 2 (0,3 %) bolnikoma s pnevmonitisom 5. stopnje, 2 (0,3 %) s pnevmonitisom 4. stopnje in 6 (1,0 %) s pnevmonitisom 3. stopnje.
Among the 22 patients with immune-related pneumonitis, the median time to onset was 3.8 months (range: 7 days to 18 months) and the median duration of pneumonitis was 21.5 days (range: 5 days to 6.5 months). 
Pri 22 bolnikih z imunsko pogojenim pnevmonitisom je bil mediani čas do pojava 3,8 meseca (razpon: od 7 dni do 18 mesecev) in mediano trajanje pnevmonitisa 21,5 dneva (razpon: od 5 dni do 6,5 meseca).
Patients should be monitored for abnormal liver tests prior to and periodically during treatment as indicated based on clinical evaluation and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2). 
Bolnike je treba spremljati glede nenormalnih jetrnih testov pred zdravljenjem in redno med zdravljenjem, kot je indicirano glede na klinično oceno, ter jih voditi s prilagoditvami zdravljenja s cemiplimabom in s kortikosteroidi (glejte poglavje 4.2).
Endocrine disorders Hypothyroidism 
Bolezni endokrinega sistema Hipotiroidizem
Among the 7 patients with immune-related diarrhoea or colitis, the median time to onset was 3.8 months (range: 15 days to 6.0 months) and the median duration of immune-related diarrhoea or colitis was 30 days (range: 4 days to 8.6 months). 
Pri 7 bolnikih z imunsko drisko ali kolitisom je bil mediani čas do pojava 3,8 meseca (razpon: od 15 dni do 6,0 mesecev) in mediano trajanje imunsko pogojene driske ali kolitisa je bilo 30 dni (razpon: od 4 dni do 8,6 meseca).
No clinically important differences in the exposure of cemiplimab were found between patients with renal impairment and patients with normal renal function. 
Med bolniki z okvaro ledvic in bolniki z normalnim delovanjem ledvic niso ugotovili klinično pomembnih razlik v izpostavljenosti cemiplimabu.
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). 
Pri bolnikih, predhodno izpostavljenih idelalisibu, ki so sodelovali v kliničnem preskušanju za ovrednotenje cemiplimaba pri ne-Hodgkinovem limfomu (NHL) in so bili nedavno izpostavljeni antibiotikom s sulfatom, so se po 1 odmerku cemiplimaba pojavili primeri SJS, TEN s smrtnim izidom in stomatitisa (glejte poglavje 4.8).
• Each vial contains 350 mg cemiplimab in 7 ml of concentrate. 
• Ena viala vsebuje 350 mg cemiplimaba v 7 ml koncentrata.
LIBTAYO is for single use only. 
Zdravilo LIBTAYO je namenjeno samo za enkratno uporabo.
Patients should be monitored for hyperglycaemia and signs and symptoms of diabetes as indicated based on clinical evaluation and managed with oral anti-hyperglycaemics or insulin and cemiplimab treatment modifications (see section 4.2). 
Bolnike je treba spremljati glede hiperglikemije ter znakov in simptomov sladkorne bolezni, kot je indicirano glede na klinično ovrednotenje, in jih voditi s peroralnimi antihiperglikemičnimi zdravili ali insulinom ter prilagoditvijo zdravljenja s cemiplimabom (glejte poglavje 4.2).
In Groups 1, 2, and 3, median durations of follow-up were 16.5, 9.3, and 8.1 months, respectively. 
Mediano je trajalo spremljanje v skupini 1 16,5 meseca, v skupini 2 9,3 meseca in v skupini 3 8,1 meseca.
• Visually inspect the medicinal product for particulate matter and discoloration prior to administration. 
• Zdravilo pred aplikacijo preglejte glede delcev ali obarvanja.
Infusion-related reaction led to permanent discontinuation of cemiplimab in 2 (0.3%) patients. 
Z infundiranjem povezane reakcije so povzročile trajno prenehanje uporabe cemiplimaba pri 2 (0,3 %) bolnikih.
a. Type 1 diabetes mellitus is a composite term that includes diabetes mellitus, diabetic ketoacidosis and type 1 diabetes mellitus. 
Sladkorna bolezen tipa 1 je sestavljen izraz, ki vključuje sladkorno bolezen, diabetično ketoacidozo in sladkorno bolezen tipa 1. b. Meningitis je sestavljen izraz, ki vključuje meningitis in aseptični meningitis.
(Grade 4), Paraneoplastic encephalomyelitis (Grade 5), Guillain-Barre syndrome, central nervous system inflammation, Chronic inflammatory demyelinating polyradiculoneuropathy, Encephalitis b, Myasthenia gravis, Neuropathy peripheral. 
Barréjev sindrom, vnetje osrednjega živčevja, kronična vnetna demielinizirajoča poliradikulonevropatija, encefalitisb, miastenija gravis, periferna nevropatija
Nine patients (1.5%) with immune-related skin adverse reactions received high-dose corticosteroids for a median of 16 days (range: 7 days to 2.6 months). 
Devet (1,5 %) bolnikov z imunsko pogojenimi kožnimi reakcijami je prejemalo velike odmerke kortikosteroidov mediano 16 dni (razpon: od 7 dni do 2,6 meseca).
Resume LIBTAYO when hyperthyroidism returns to Grade 0 to 1 or is otherwise clinically stable 
Nadaljujte uporabo zdravila LIBTAYO, ko se hipertiroidizem vrne na 0. ali 1. stopnjo ali je sicer klinično stabilen
Additional intervention 
Prilagoditev odmerka Dodatno ukrepanje