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.
Slovenian: 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.
English: Date of first authorisation: 28 June 2019
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum pridobitve dovoljenja za promet z zdravilom: 28 junij 2019
English: Musculoskeletal pain is a composite term that includes back pain, musculoskeletal pain, myalgia, neck pain and pain in extremity.
Slovenian: Mišično-skeletne bolečine so sestavljen izraz, ki vključuje bolečine v hrbtu, mišično-skeletne bolečine, mialgijo, bolečine v vratu in bolečine v okončini.
English: • you have any other medical conditions.
Slovenian: • če imate kakšno drugo bolezen.
English: Grade 2 with AST or ALT >3 and ≤5×ULN or total bilirubin >1.5 and ≤3×ULN
Slovenian: 2. stopnja z AST ali ALT > 3- in ≤ 5-kratna ZMN ali celokupni bilirubin > 1,5-in ≤ 3-kratna
English: Other medicines and LIBTAYO
Slovenian: Druga zdravila in zdravilo LIBTAYO
English: Clear to slightly opalescent, colourless to pale yellow solution with a pH of 6.0 and osmolality between 300 and 360 mmol/kg.
Slovenian: Bistra do rahlo opalescentna, brezbarvna do bledorumena raztopina s pH 6,0 in osmolalnostjo med 300 in 360 mmol/kg.
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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o razredčenju zdravila pred uporabo glejte poglavje 6.6.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Recommended modifications to manage adverse reactions are provided in Table 1.
Slovenian: Priporočene prilagoditve za obvladovanje neželenih učinkov so prikazane v preglednici 1.
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).
Slovenian: 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.
English: Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above
Slovenian: Klinični znaki ali simptomi imunsko pogojenih neželenih učinkov 3. stopnje, ki niso opisani zgoraj
English: Women of childbearing potential should use effective contraception during treatment with cemiplimab and for at least 4 months after the last dose of cemiplimab.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem s cemiplimabom in vsaj še 4 mesece po zadnjem odmerku cemiplimaba uporabljati učinkovito kontracepcijo.
English: LIBTAYO can cause some serious side effects that you need to tell your doctor about immediately.
Slovenian: Zdravilo LIBTAYO lahko povzroči nekatere resne neželene učinke; če se pojavijo, morate o njih nemudoma obvestiti zdravnika.
English: 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.
Slovenian: Nosečnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite to zdravilo.
English: Most immune-related reactions initially manifest during treatment with cemiplimab; however, immune-related adverse reactions can occur after discontinuation of cemiplimab.
Slovenian: Večina imunsko pogojenih reakcij se prvič pokaže med zdravljenjem s cemiplimabom, vendar se lahko imunsko pogojeni neželeni učinki pojavijo tudi po prenehanju uporabe cemiplimaba.
English: For patients with metastatic CSCC without externally visible target lesions, ORR was determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Slovenian: 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.
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.
Slovenian: 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.
English: Version v.4.03 of NCI CTCAE was used to grade toxicity.
Slovenian: Pogosti Za določanje stopnje toksičnih učinkov so bila uporabljena merila NCI CTCAE, verzija v.4.03.
English: Danmark Sanofi A/S Tlf: +45 45 16 70 00
Slovenian: Sanofi A/S Tlf: +45 45 16 70 00
English: Efficacy results - Study 1540 - metastatic CSCC by dosing group, locally advanced CSCC
Slovenian: Preglednica 3: Rezultati učinkovitosti - študija 1540 - metastatski PCKK po odmerni skupini, lokalno napredovali PCKK
English: Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.
Slovenian: Cemiplimab je pridobljen s tehnologijo rekombinantne DNA v suspenzijski kulturi celic jajčnika kitajskega hrčka.
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
Slovenian: • začasno vnetje živcev, ki povzroči bolečine, šibkost in ohromelost okončin; motnja, pri kateri mišice postanejo šibke in se zlahka utrudijo
English: 95% CI for ORR Complete response (CR)
Slovenian: ORR 95 % IZ za ORR
English: Alanine aminotransferase increased Common Aspartate aminotransferase increased Common Blood alkaline phosphatase increased Common Blood creatinine increased
Slovenian: Zvišana alanin-aminotransferaza Pogosti Zvišana aspartat-aminotransferaza Pogosti Zvišana alkalna fosfataza v krvi
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.
Slovenian: 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.
English: Your doctor also may delay your next dose of LIBTAYO or stop your treatment.
Slovenian: Lahko tudi odloži vaš naslednji odmerek zdravila LIBTAYO ali vaše zdravljenje s tem zdravilom zaključi.
English: Depending upon the severity of the adverse reaction, cemiplimab should be withheld or permanently discontinued (see section 4.2).
Slovenian: Odvisno od izrazitosti neželenega učinka je treba uporabo cemiplimaba začasno prekiniti ali za stalno prenehati (glejte poglavje 4.2).
English: Immune system disorders: Immune thrombocytopenic purpura Vascular disorders: Vasculitis
Slovenian: Bolezni imunskega sistema: imunsko pogojena idiopatična trombocitopenična purpura Žilne bolezni: vaskulitis
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.
Slovenian: 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.
English: • at room temperature up to 25°C for no more than 8 hours from the time of preparation.
Slovenian: • na sobni temperaturi do 25 °C za ne več kot 8 ur od časa priprave.
English: For suspected immune-related adverse reactions, patients should be evaluated to confirm an immune-related adverse reaction and to exclude other possible causes.
Slovenian: V primeru suma na imunsko pogojene neželene učinke je treba bolnike oceniti, da bi potrdili imunsko pogojeni neželen učinek in izključili druge možne vzroke.
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.
Slovenian: 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.
English: • you have lung or breathing problems
Slovenian: • če imate težave s pljuči ali dihanjem,
English: Store in a refrigerator (2°C to 8°C).
Slovenian: Shranjujte v hladilniku (od 2 °C do 8 °C).
English: 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).
Slovenian: 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).
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.
Slovenian: • Zdravilo LIBTAYO vam bodo dali v bolnišnici ali ambulanti pod nadzorstvom zdravnika,
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.
Slovenian: 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.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting cemiplimab to treat immune-related adverse reactions (see sections 4.2).
Slovenian: Vendar pa je kortikosteroide ali druge imunosupresive mogoče uporabiti po začetku zdravljenja s cemiplimabom za zdravljenje imunsko pogojenih neželenih učinkov (glejte poglavje 4.2).
English: In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Slovenian: V primeru prevelikega odmerjanja je treba bolnike natančno kontrolirati glede znakov in simptomov neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje.
English: If you have any questions about your treatment, ask your doctor.
Slovenian: Če imate o svojem zdravljenju kakšna vprašanja, se pogovorite z zdravnikom.
English: • Lung problems (pneumonitis)
Slovenian: • težave s pljuči (pnevmonitis),
English: Arthritis is a composite term that includes arthritis and polyarthritis.
Slovenian: Artritis je sestavljen izraz, ki vključuje artritis in poliartritis.
English: Grade 2
Slovenian: 2. stopnja
English: EU/1/19/1376/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1376/001
English: Permanently discontinue
Slovenian: Trajno prenehajte uporabljati
English: • Do not co-administer other medicines through the same infusion line.
Slovenian: • Tega zdravila ne dajajte skupaj z drugimi zdravili po isti infuzijski liniji.
English: LIBTAYO works by helping your immune system fight your cancer.
Slovenian: Zdravilo LIBTAYO deluje tako, da telesnemu imunskemu sistemu pomaga premagati raka.
English: Patients should be managed with hormone replacement therapy (if indicated) and cemiplimab treatment modifications.
Slovenian: Bolnike je treba voditi s hormonskim nadomestnim zdravljenjem (če je indicirano) in prilagoditvami zdravljenja s cemiplimabom.
English: 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).
Slovenian: 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).
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%).
Slovenian: 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 %).
English: If you stop receiving LIBTAYO
Slovenian: Če ste prenehali dobivati zdravilo LIBTAYO
English: 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).
Slovenian: 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).
English: • you have diabetes
Slovenian: • če imate sladkorno bolezen,
English: - 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
Slovenian: - 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
English: d. Myocarditis is a composite term that includes autoimmune myocarditis and myocarditis.
Slovenian: d. Miokarditis je sestavljen izraz, ki vključuje avtoimunski miokarditis in miokarditis.
English: The within dosing interval half-life at steady state is 19.4 days.
Slovenian: Razpolovni čas v stanju dinamičnega ravnovesja je znotraj odmernega intervala 19,4 dneva.
English: Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
Slovenian: Cemiplimab okrepi odzive celic T, vključno s protitumorskimi odzivi, z blokado vezave PD-1 z ligandoma PD-L1 in PD-L2.
English: Resolution of hepatitis had occurred in 8 (72.7%) of the 11 patients at the time of data cut-off.
Slovenian: Ob času zamejitve podatkov je hepatitis izzvenel pri 8 (72,7 %) od 11 bolnikov.
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.
Slovenian: • 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.
English: • a cancer medicine called idelalisib • medicines that make your immune system weak - examples include corticosteroids, such as prednisone.
Slovenian: • zdravila, ki oslabijo imunski sistem - primer takšnih zdravil so kortikosteroidi, na primer prednizon.
English: Initiate symptomatic management
Slovenian: Uvedite simptomatsko vodenje
English: Do not store any unused portion of the infusion solution for re-use.
Slovenian: Neporabljenega ostanka raztopine za infundiranje ne hranite za poznejšo uporabo.
English: h. Pruritus is a composite term that includes pruritus and pruritus allergic.
Slovenian: h. Pruritus je sestavljen izraz, ki vključuje pruritus in alergijski pruritus.
English: Look out for side effects
Slovenian: Bodite pozorni na neželene učinke
English: Grade 2 to 4
Slovenian: 2. do 4. stopnja
English: Grade ≥3 with AST or ALT >5×ULN or total bilirubin >3×ULN
Slovenian: ≥ 3. stopnja in AST ali ALT > 5 × ZMN ali celokupni bilirubin < 3 × ZMN
English: Unopened vial Store in a refrigerator (2°C to 8°C).
Slovenian: Neodprta viala Shranjujte v hladilniku (2-8 °C).
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).
Slovenian: 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).
English: Very common Musculoskeletal and connective tissue disorders Arthralgia
Slovenian: Zelo pogosti Bolezni mišično-skeletnega sistema in vezivnega tkiva Artralgija
English: The following clinically significant, immune-related adverse reactions occurred at an incidence of less than 1% of 591 patients treated with cemiplimab.
Slovenian: Naslednji klinično pomembni imunsko pogojeni neželeni učinki so se pri 591 bolnikih, ki so prejemali cemiplimab, pojavili s pojavnostjo manj kot 1 %.
English: a Toxicity should be graded with the current version of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Slovenian: a Stopnjo toksičnih učinkov je treba ocenjevati po trenutni različici meril NCI CTCAE (National Cancer
English: Store in the original container in order to protect from light.
Slovenian: Shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
English: Each carton contains 1 glass vial with 7 ml of concentrate.
Slovenian: Vsaka škatla vsebuje 1 stekleno vialo s 7 ml koncentrata.
English: Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, Ireland
Slovenian: Harcourt Street, Dublin 2, Irska
English: What you need to know before you are given LIBTAYO
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo LIBTAYO
English: Type 1 diabetes mellitus a
Slovenian: Sladkorna bolezen tipa 1a
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Slovenian: 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.
English: • Skin problems
Slovenian: • težave s kožo,
English: No dose adjustment is recommended for elderly patients.
Slovenian: Starejšim bolnikom odmerka ni treba prilagoditi.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Marketing Authorisation Holder Regeneron Ireland Designated Activity Company (DAC) Europa House
Slovenian: Imetnik dovoljenja za promet z zdravilom Regeneron Ireland Designated Activity Company (DAC) Europa House
English: The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L-proline, sucrose, polysorbate 80 and water for injections.
Slovenian: Druge sestavine zdravila so L-histidin, L-histidinijev monohidroklorid monohidrat, L-prolin, saharoza, polisorbat 80 in voda za injekcije.
English: 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).
Slovenian: 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).
English: Adrenal insufficiency
Slovenian: Nadledvična insuficienca
English: Clearance of cemiplimab is linear at doses of 1 mg/kg to 10 mg/kg every two weeks.
Slovenian: Očistek cemiplimaba je ob uporabi odmerkov od 1 mg/kg do 10 mg/kg na dva tedna linearen.
English: This includes room temperature storage of the infusion solution in the intravenous container and time for administration of the infusion.
Slovenian: Ta čas obsega tako čas shranjevanja raztopine za infundiranje v intravenskem vsebniku na sobni temperaturi kot čas infundiranja zdravila.
English: Neuropathy peripheral is a composite term that includes neuropathy peripheral and neuritis.
Slovenian: Periferna nevropatija je sestavljen izraz, ki vključuje periferno nevropatijo in nevritis.
English: • Kidney problems (nephritis and kidney failure)
Slovenian: • težave z ledvicami (nefritis in odpoved ledvic),
English: Cemiplimab has not been studied in patients with CLcr <25 ml/min (see section 4.2).
Slovenian: Cemiplimab ni raziskan pri bolnikih z očistkom kreatinina < 25 ml/min (glejte poglavje 4.2).
English: Muscular weakness
Slovenian: Šibkost mišic