natgillin/translations-raw huggingface dataset:
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,
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,