natgillin/translations-raw huggingface dataset:
No overall differences in safety or effectiveness were observed between these subjects and younger subjects. 
Med temi preiskovanci in mlajšimi preiskovanci na splošno niso opažali razlik v varnosti ali učinkovitosti.
Cemiplimab clearance after the first dose is approximately 0.33 l/day. 
Po prvem odmerku je očistek cemiplimaba približno 0,33 l/dan.
If diluted solution is not administered immediately, it may be stored temporarily either: 
Če razredčene raztopine ne uporabite nemudoma, je lahko prehodno shranjena ali:
Overall in Studies 1423 and 1540, PD-L1 IHC results were available for 75 advanced CSCC patients. 
Skupno so bili v študijah 1423 in 1540 na voljo rezultati IHC PD-L1 za 75 bolnikov z napredovalim PCKK.
• Liver problems (hepatitis) 
• težave z jetri (hepatitis),
• inflammation of the covering of the heart 
• vnetje mrene, ki prekriva srce
• increased liver enzymes in blood, abnormal kidney function test 
• zvišanje jetrnih encimov v krvi, nenormalen izvid preiskave delovanja ledvic
Of these 193 patients, 115 had mCSCC and 78 had laCSCC. 
Od teh 193 bolnikov jih je 115 imelo mPCKK in 78 lnPCKK.
Cemiplimab has no or negligible influence on the ability to drive and use machines. 
Cemiplimab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Clinical activity was observed regardless of tumour PD-L1 expression status. 
Klinično delovanje so opažali ne glede na stanje izraženosti PD-L1 na tumorju.
From time of preparation by diluting in an intravenous bag, LIBTAYO can be stored before use for no more than 8 hours at temperatures up to 25°C, and no more than 24 hours in a refrigerator (2°C to 8°C). 
Od tedaj, ko je zdravilo LIBTAYO pripravljeno z razredčenjem v intravenski vrečki, ga je mogoče pred uporabo shranjevati največ 8 ur pri temperaturi do 25 °C in ne več kot 24 ur v hladilniku (od 2 do 8 °C).
o A reminder that all known or suspected adverse drug reactions (ADRs) can also be reported to local regulatory authorities. 
o Opomnik, da lahko bolnik o vseh znanih ali domnevnih neželenih učinkih zdravila poroča tudi lokalnim regulatornim organom.
The total clearance appears to decrease by approximately 35% over time, resulting in a steady state clearance (CLss) of 0.21 l/day; the decrease in CL is not considered clinically relevant. 
Po vsem sodeč se celotni očistek sčasoma zmanjša za približno 35 %, tako da je očistek v stanju dinamičnega ravnovesja (CLss) 0,21 l/dan; zmanjšanje očistka ne velja za klinično pomembno.
Your doctor will test your blood for certain side effects during your treatment. 
Zdravnik bo med zdravljenjem zaradi določenih neželenih učinkov opravil preiskave krvi.
Do not stop treatment of LIBTAYO unless you have discussed this with your doctor. 
Ne prenehajte zdravljenja z zdravilom LIBTAYO, ne da bi se o tem posvetovali z zdravnikom.
• If you are able to become pregnant, you must use an effective method of contraception to avoid becoming pregnant: while you are being treated with LIBTAYO and for at least 4 months after the last dose. 
• Če lahko zanosite, morate uporabljati učinkovit način kontracepcije za preprečitev nosečnosti: medtem ko prejemate zdravljenje z zdravilom LIBTAYO in vsaj še 4 mesece po zadnjem odmerku.
Data cut-off was Sep 20, 2018 for Groups 1 and 3 patients, and Oct 10, 2018 for Group 2 patients. 
Datum zamejitve podatkov je bil 20. september 2018 za skupini 1 in 3 ter 10. oktober 2018 za skupino 2.
Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm complete response. 
b. Vključuje le bolnike s popolno ozdravitvijo predhodne prizadetosti kože; pri bolnikih z lokalno napredovalim PCKK v študiji 1540 je bila za potrditev popolnega odziva zahtevana biopsija.
The following side effects have been reported in clinical trials of patients with CSCC: Very common (may affect more than 1 in 10 people): 
V kliničnih preskušanjih pri bolnikih s PCKK so poročali o naslednjih neželenih učinkih: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
What LIBTAYO is and what it is used for 2. 
Kaj je zdravilo LIBTAYO in za kaj ga uporabljamo 2.
Patient Alert Card 
Opozorilna kartica za bolnika
Concentrate for solution for infusion (sterile concentrate). 
Koncentrat za raztopino za infundiranje (sterilen koncentrat).
The effect of hepatic impairment on the exposure of cemiplimab was evaluated by population PK analysis. 
Vpliv okvare jeter na izpostavljenost cemiplimabu so ovrednotili s populacijsko farmakokinetično analizo.
Concentration data were collected in 548 patients with various solid tumours, including 178 patients with CSCC, who received cemiplimab. 
Podatki o koncentracijah so bili zbrani pri 548 bolnikih z različnimi čvrstimi tumorji, vključno s 178 bolniki s PCKK, ki so prejemali cemiplimab.
ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal. 
Trajno prenehajte uporabljati ALT: alanin-aminotransferaza, AST: aspartat-aminotransferaza, ZMN: zgornja meja normalnih vrednosti.
What you need to know before you use LIBTAYO 3. 
Kaj morate vedeti, preden boste uporabili zdravilo LIBTAYO 3.
o The importance of carrying the Patient Alert Card at all times and to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals). 
o Opomnik, naj ima bolnik opozorilno kartico za bolnika vedno pri sebi in naj jo pokaže na vseh obiskih pri drugih zdravstvenih delavcih razen pri zdravniku, ki je zdravilo predpisal (npr. zdravstveni delavci nujne medicinske pomoči).
Adverse reactions were serious in 8.6% patients and led to permanent discontinuation of cemiplimab in 5.8% of patients. 
Neželeni učinki so bili resni pri 8,6 % bolnikov in so povzročili trajno prenehanje uporabe cemiplimaba pri 5,8 % bolnikov.
Absorption Cemiplimab is administered via the intravenous route and hence is completely bioavailable. 
Absorpcija Cemiplimab se uporablja intravensko, zato je biološka uporabnost popolna.
Preparation 
Priprava
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 
Cemiplimab je popolnoma človeško imunoglobulinsko monoklonsko protitelo G4 (IgG4), ki se veže na receptor programirane celične smrti 1 (PD-1) in blokira njegovo interakcijo z ligandoma PD-L1 in PD-L2.
L-histidine monohydrochloride monohydrate Sucrose 
L-histidinijev monoklorid monohidrat saharoza
A population PK analysis suggests that the following factors have no clinically significant effect on the exposure of cemiplimab: age, gender, body weight, race, cancer type, albumin level, mild hepatic impairment and renal impairment. 
Populacijska farmakokinetična analiza kaže, da naslednji dejavniki ne vplivajo klinično pomembno na izpostavljenost cemiplimabu: starost, spol, telesna masa, rasa, vrsta raka, koncentracija albumina, blaga okvara jeter in okvara ledvic.
• you have had an organ transplant 
• če imate presajen organ,
The MAH shall ensure that in each Member State where LIBTAYO is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use LIBTAYO have access to/are provided with the following educational package: - A patient guide - A patient alert card 
Imetnik dovoljenja za promet z zdravilom mora v vseh državah članicah, kjer bo zdravilo LIBTAYO na trgu, zagotoviti, da bodo vsi zdravstveni delavci, ki bodo predvidoma predpisovali zdravilo LIBTAYO, in vsi bolniki/skrbniki, ki ga bodo predvidoma uporabljali, imeli dostop ali prejeli naslednji paket izobraževalnih gradiv: - Vodnik za bolnika - Opozorilna kartica za bolnika
The MAH should investigate biomarkers in order to confirm that PD-L1 expression is not predictive of efficacy. 
Imetnik dovoljenja za promet z zdravilom mora raziskati biološke označevalce za potrditev, da izraženost PD-L1 ni napovednik učinkovitosti.
Prior to launch of LIBTAYO in each Member State, the 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. 
Pred prihodom zdravila LIBTAYO na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in morebitnimi drugimi vidiki programa.
Hyperthyroidism should be managed according to standard medical practice (see section 4.2). 
Hipertiroidizem je treba voditi v skladu z običajno medicinsko prakso (glejte poglavje 4.2).
All prescribers of LIBTAYO should be familiar with the educational materials and inform the patients about the Patient Alert Card explaining what to do should they experience any symptom of immunerelated adverse reactions and infusion-related reactions. 
Vsi zdravniki, ki predpisujejo zdravilo LIBTAYO, morajo dobro poznati izobraževalna gradiva in morajo bolnike seznaniti z opozorilno kartico za bolnika ter jim pojasniti, kaj naj storijo, če se jim pojavi kateri od simptomov kakšnega imunsko pogojenega neželenega učinka ali z infundiranjem povezanih reakcij.
• inflammation of the mouth 
• vnetje v ustih
Cemiplimab is primarily distributed in the vascular system with a volume of distribution at steady-state (Vss) is 5.2 l. 
Cemiplimab se porazdeli predvsem v žilju in volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je 5,2 l.
The most common immune-related adverse reactions were hypothyroidism (7.1%), pneumonitis (3.7%), immune-related skin adverse reactions (2.0%), hyperthyroidism (1.9%) and hepatitis (1.9%) (see “Description of selected adverse reactions” below, Special warnings and precautions for use in section 4.4 and Recommended treatment modifications in section 4.2). 
Najpogostejši imunsko pogojeni neželeni učinki so bili hipotiroidizem (7,1 %), pnevmonitis (3,7 %), imunsko pogojeni neželeni učinki na kožo (2,0 %), hipertiroidizem (1,9 %) in hepatitis (1,9 %) (glejte "Opis izbranih neželenih učinkov", spodaj, Posebna opozorila in previdnostni ukrepi v poglavju 4.4 in Priporočene prilagoditve zdravljenja v poglavju 4.2).
Partial response (PR) Stable disease (SD) Progressive disease (PD) 
Delen odziv (PR) Stabilna bolezen (SD) Progresivna bolezen (PD) Trajanje odziva (DOR)a Mediana (razpon)(meseci)
b Observed with LIBTAYO or with other anti-PD-1/PD-L1 monoclonal antibodies 
b Opaženo z zdravilom LIBTAYO ali z drugimi monoklonskimi protitelesi proti PD-1/PD-L1.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
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. 
Povezava PD-1 z njegovima ligandoma PD-L1 in PD-L2, izraženima na celicah, ki predstavijo antigene, in potencialno izraženima na tumorskih celicah in/ali drugih celicah v mikrookolju tumorja, zavre delovanje celic T, na primer proliferacijo, izločanje citokinov in citotoksično aktivnost.
• If you think you may be allergic, or you are not sure, talk to your doctor before you are given LIBTAYO. 
• če menite, da ste alergični, ali niste prepričani, se posvetujte z zdravnikom, preden boste dobili zdravilo LIBTAYO.
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. 
Študija 1540 je bila odprta, multicentrična študija 2. faze, v katero je bilo vključenih 193 bolnikov z mPCKK ali lnPCKK z medianim časom spremljanja 9,4 meseca v vseh skupinah skupaj.
Listed in Table 2 are adverse reactions by system organ class and by frequency. 
V preglednici 2 so navedeni neželeni učinki po organskih sistemih in pogostnosti.
o A warning message for health care professionals treating the patient at any time, including in conditions of emergency, that the patient is treated with LIBTAYO. 
o Opozorilo zdravnikom, ki kadar koli zdravijo bolnika (vključno s primeri nujnega zdravljenja), da bolnik prejema zdravilo LIBTAYO.
Detailed guidelines for the management of immune-related adverse reactions are described in Table 1. 
Podrobne smernice za obvladovanje imunsko pogojenih neželenih učinkov so opisane v preglednici 1.
The European Medicines Agency has deferred the obligation to submit the results of studies with cemiplimab in all subsets of the paediatric population in the treatment of all conditions included in the category of malignant neoplasms, except haematopoietic and lymphoid tissue (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cemiplimabom za vse podskupine pediatrične populacije za zdravljenje vseh bolezni, vključenih v skupino malignih novotvorb, razen novotvorb hematopoetskega in limfatičnega tkiva (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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. 
Pri bolnikih z blago okvaro jeter (n = 5) (celokupni bilirubin več kot 1,0- do 1,5-kratna zgornja meja normalnih vrednosti [ZMN] in kakršna koli vrednost aspartat-aminotransferaze [AST]) niso ugotovili klinično pomembnih razlik v izpostavljenosti cemiplimabu v primerjavi z bolniki z normalnim delovanjem jeter.
Date of first authorisation: 28 June 2019 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum pridobitve dovoljenja za promet z zdravilom: 28 junij 2019
Musculoskeletal pain is a composite term that includes back pain, musculoskeletal pain, myalgia, neck pain and pain in extremity. 
Mišično-skeletne bolečine so sestavljen izraz, ki vključuje bolečine v hrbtu, mišično-skeletne bolečine, mialgijo, bolečine v vratu in bolečine v okončini.
• you have any other medical conditions. 
• če imate kakšno drugo bolezen.
Grade 2 with AST or ALT >3 and ≤5×ULN or total bilirubin >1.5 and ≤3×ULN 
2. stopnja z AST ali ALT > 3- in ≤ 5-kratna ZMN ali celokupni bilirubin > 1,5-in ≤ 3-kratna
Other medicines and LIBTAYO 
Druga zdravila in zdravilo LIBTAYO
Clear to slightly opalescent, colourless to pale yellow solution with a pH of 6.0 and osmolality between 300 and 360 mmol/kg. 
Bistra do rahlo opalescentna, brezbarvna do bledorumena raztopina s pH 6,0 in osmolalnostjo med 300 in 360 mmol/kg.
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. 
V študije niso bili vključeni bolniki, ki so imeli kar koli od naslednjega: avtoimunsko bolezen, ki je zahtevala sistemsko zdravljenje z imunosupresivi v zadnjih 5 letih; anamnezo presaditve parenhimskega organa; anamnezo pnevmonitisa v zadnjih 5 letih; predhodno zdravljenje z zdravili proti PD-1/PD-L1 ali kakšnimi drugimi imunskimi zaviralci kontrolnih točk; akutno okužbo, ki je zahtevala zdravljenje, vključno z znano okužbo s virusom humane imunske pomanjkljivosti ali aktivno okužbo z virusom hepatitisa B ali C; kronično limfocitno levkemijo (KLL); metastaze v možganih ali stanje zmogljivosti ≥ 2 po ECOG (Eastern Cooperative Oncology Group).
Human IgG4 is known to cross the placental barrier and cemiplimab is an IgG4; therefore, cemiplimab has the potential to be transmitted from the mother to the developing foetus. 
Znano je, da humani IgG4 prehajajo skozi placentno pregrado, cemiplimab pa je IgG4 in tako obstaja možnost njegovega prenosa od matere v razvijajoči se plod.
For instructions on dilution of the medicinal product before administration, see section 6.6. 
Za navodila o razredčenju zdravila pred uporabo glejte poglavje 6.6.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Recommended modifications to manage adverse reactions are provided in Table 1. 
Priporočene prilagoditve za obvladovanje neželenih učinkov so prikazane v preglednici 1.
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). 
Varnost cemiplimaba so ovrednotili pri 591 bolnikih z napredovalimi čvrstimi tumorji, vključno z 219 bolniki z napredovalim PCKK, ki so v 2 kliničnih študijah (R2810-ONC-1423 in R2810-ONC-1540) prejemali monoterapijo s cemiplimabom.
Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above 
Klinični znaki ali simptomi imunsko pogojenih neželenih učinkov 3. stopnje, ki niso opisani zgoraj
Women of childbearing potential should use effective contraception during treatment with cemiplimab and for at least 4 months after the last dose of cemiplimab. 
Ženske v rodni dobi morajo med zdravljenjem s cemiplimabom in vsaj še 4 mesece po zadnjem odmerku cemiplimaba uporabljati učinkovito kontracepcijo.
LIBTAYO can cause some serious side effects that you need to tell your doctor about immediately. 
Zdravilo LIBTAYO lahko povzroči nekatere resne neželene učinke; če se pojavijo, morate o njih nemudoma obvestiti zdravnika.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. 
Nosečnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite to zdravilo.
Most immune-related reactions initially manifest during treatment with cemiplimab; however, immune-related adverse reactions can occur after discontinuation of cemiplimab. 
Večina imunsko pogojenih reakcij se prvič pokaže med zdravljenjem s cemiplimabom, vendar se lahko imunsko pogojeni neželeni učinki pojavijo tudi po prenehanju uporabe cemiplimaba.
For patients with metastatic CSCC without externally visible target lesions, ORR was determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1). 
Pri bolnikih z metastatskim PCKK brez na zunaj vidnih ciljnih lezij so ORR določili na podlagi meril RECIST (Response Evaluation Criteria in Solid Tumours) 1.1.
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. 
Okvara ledvic Vpliv okvare ledvic na izpostavljenost cemiplimabu so ocenili s populacijsko farmakokinetično analizo pri bolnikih z blago (očistek kreatinina od 60 do < 80 ml/min, n = 197), zmerno (očistek kreatinina od 30 do < 60 ml/min, n = 90) ali hudo (očistek kreatinina < 30 ml/min, n = 4) okvaro ledvic.
Version v.4.03 of NCI CTCAE was used to grade toxicity. 
Pogosti Za določanje stopnje toksičnih učinkov so bila uporabljena merila NCI CTCAE, verzija v.4.03.
Efficacy results - Study 1540 - metastatic CSCC by dosing group, locally advanced CSCC 
Preglednica 3: Rezultati učinkovitosti - študija 1540 - metastatski PCKK po odmerni skupini, lokalno napredovali PCKK
Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. 
Cemiplimab je pridobljen s tehnologijo rekombinantne DNA v suspenzijski kulturi celic jajčnika kitajskega hrčka.
• 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 
• začasno vnetje živcev, ki povzroči bolečine, šibkost in ohromelost okončin; motnja, pri kateri mišice postanejo šibke in se zlahka utrudijo
95% CI for ORR Complete response (CR) 
ORR 95 % IZ za ORR
Alanine aminotransferase increased Common Aspartate aminotransferase increased Common Blood alkaline phosphatase increased Common Blood creatinine increased 
Zvišana alanin-aminotransferaza Pogosti Zvišana aspartat-aminotransferaza Pogosti Zvišana alkalna fosfataza v krvi
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. 
S 350 mg na 3 tedne je bila povprečna koncentracija cemiplimaba v stanju dinamičnega ravnovesja med Cmax 168 mg/l in Ctrough 61 mg/l.
Your doctor also may delay your next dose of LIBTAYO or stop your treatment. 
Lahko tudi odloži vaš naslednji odmerek zdravila LIBTAYO ali vaše zdravljenje s tem zdravilom zaključi.
Depending upon the severity of the adverse reaction, cemiplimab should be withheld or permanently discontinued (see section 4.2). 
Odvisno od izrazitosti neželenega učinka je treba uporabo cemiplimaba začasno prekiniti ali za stalno prenehati (glejte poglavje 4.2).
Immune system disorders: Immune thrombocytopenic purpura Vascular disorders: Vasculitis 
Bolezni imunskega sistema: imunsko pogojena idiopatična trombocitopenična purpura Žilne bolezni: vaskulitis
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. 
Uporabi sistemskih kortikosteroidov ali imunosupresivov pred uvedbo cemiplimaba se je treba izogibatirazen fizioloških odmerkov sistemskih kortikosteroidov (≤ 10 mg/dan prednizolona ali enakovredno)ker lahko motijo farmakodinamično aktivnost in učinkovitost cemiplimaba.
• at room temperature up to 25°C for no more than 8 hours from the time of preparation. 
• na sobni temperaturi do 25 °C za ne več kot 8 ur od časa priprave.
For suspected immune-related adverse reactions, patients should be evaluated to confirm an immune-related adverse reaction and to exclude other possible causes. 
V primeru suma na imunsko pogojene neželene učinke je treba bolnike oceniti, da bi potrdili imunsko pogojeni neželen učinek in izključili druge možne vzroke.
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. 
Zdravilo LIBTAYO je kot samostojno zdravljenje (monoterapija) indicirano za zdravljenje odraslih bolnikov z metastatskim ali lokalno napredovalim ploščatoceličnim karcinomom kože (PCKK), ki niso kandidati za kurativni kirurški poseg ali kurativno obsevanje.
• you have lung or breathing problems 
• če imate težave s pljuči ali dihanjem,
Store in a refrigerator (2°C to 8°C). 
Shranjujte v hladilniku (od 2 °C do 8 °C).
LIBTAYO acts on your immune system and may cause inflammation in parts of your body (see the conditions listed in ‘Look out for side effects' in section 2). 
Zdravilo LIBTAYO deluje na imunski sistem in lahko povzroči vnetje v različnih delih telesa (glejte bolezni in motnje, naštete pod naslovom "Bodite pozorni na neželene učinke" v poglavju 2).
How you are given LIBTAYO • LIBTAYO will be given to you in a hospital or clinic - supervised by a doctor experienced in cancer treatment. 
• Zdravilo LIBTAYO vam bodo dali v bolnišnici ali ambulanti pod nadzorstvom zdravnika,