natgillin/translations-raw huggingface dataset:
No dose adjustment is recommended for elderly patients.
Starejšim bolnikom odmerka ni treba prilagoditi.
LIBTAYO is provided in a 10 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.
Zdravilo LIBTAYO je na voljo v 10-ml vialah iz prozornega stekla tipa 1 s sivim klorobutilnim zamaškom, prevlečenim s FluoroTecom, in pečatno zaporko s snemnim gumbom.
If a woman chooses to be treated with cemiplimab, she should be instructed not to breast-feed while being treated with cemiplimab and for at least 4 months after the last dose.
Če se ženska odloči za zdravljenje s cemiplimabom, ji je treba svetovati, da med zdravljenjem s cemiplimabom in vsaj še 4 mesece po zadnjem odmerku ne sme dojiti.
Marketing Authorisation Holder Regeneron Ireland Designated Activity Company (DAC) Europa House
Imetnik dovoljenja za promet z zdravilom Regeneron Ireland Designated Activity Company (DAC) Europa House
The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L-proline, sucrose, polysorbate 80 and water for injections.
Druge sestavine zdravila so L-histidin, L-histidinijev monohidroklorid monohidrat, L-prolin, saharoza, polisorbat 80 in voda za injekcije.
Patients should be monitored for changes in thyroid function at the start of treatment and periodically during the treatment as indicated based on clinical evaluation (see section 4.8).
Bolnike je treba spremljati glede sprememb delovanja ščitnice na začetku zdravljenja in redno med zdravljenjem, kot je indicirano glede na klinično oceno (glejte poglavje 4.8).
Adrenal insufficiency
Nadledvična insuficienca
Clearance of cemiplimab is linear at doses of 1 mg/kg to 10 mg/kg every two weeks.
Očistek cemiplimaba je ob uporabi odmerkov od 1 mg/kg do 10 mg/kg na dva tedna linearen.
This includes room temperature storage of the infusion solution in the intravenous container and time for administration of the infusion.
Ta čas obsega tako čas shranjevanja raztopine za infundiranje v intravenskem vsebniku na sobni temperaturi kot čas infundiranja zdravila.
Neuropathy peripheral is a composite term that includes neuropathy peripheral and neuritis.
Periferna nevropatija je sestavljen izraz, ki vključuje periferno nevropatijo in nevritis.
• Kidney problems (nephritis and kidney failure)
• težave z ledvicami (nefritis in odpoved ledvic),
Cemiplimab has not been studied in patients with CLcr <25 ml/min (see section 4.2).
Cemiplimab ni raziskan pri bolnikih z očistkom kreatinina < 25 ml/min (glejte poglavje 4.2).
Muscular weakness
Šibkost mišic
No effects on fertility assessment parameters or in the male and female reproductive organs were observed in a 3-month repeat dose fertility assessment study with sexually mature cynomolgus monkeys.
V 3-mesečni študiji za oceno plodnosti med uporabo ponavljajočih se odmerkov zdravila pri spolno zrelih opicah cynomolgus niso ugotovili vpliva na parametre plodnosti ali na reproduktivne organe samcev in samic.
Resolution of pneumonitis had occurred in 14 (63.6%) of the 22 patients at the time of data cut-off.
Ob času zamejitve podatkov je pnevmonitis izzvenel pri 14 (63,6 %) od 22 bolnikov.
Preparation and administration
Priprava in dajanje
The recommended dose is 350 mg cemiplimab, every 3 weeks, administered as an intravenous infusion over 30 minutes.
Priporočeni odmerek cemiplimaba je 350 mg na 3 tedne v 30-minutni intravenski infuziji.
• under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion preparation.
• v hladilniku na temperaturi od 2 do 8 °C za ne več kot 24 ur od časa priprave infuzije.
The median age was 72 years (range: 38 to 96): Seventy-eight (40.4%) patients were 75 years or older, 66 patients (34.2%) were 65 to less than 75 years, and 49 patients (25.4%) were less than 65 years.
Mediana starost je bila 72 let (razpon: od 38 do 96): 78 (40,4 %) bolnikov je bilo starih 75 let ali več, 66 bolnikov (34,2 %) od 65 do manj kot 75 let in 49 bolnikov (25,4 %) je bilo mlajših od 65 let.
Excipients: L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, sucrose, and water for injections.
Pomožne snovi: L-histidin, L-histidinijev monohidroklorid monohidrat, L-prolin, polisorbat 80, saharoza in voda za injekcije.
Immune-related adverse reactions should be managed with cemiplimab treatment modifications, hormone replacement therapy (if clinically indicated), and corticosteroids.
Za obvladanje imunsko pogojenih neželenih učinkov je treba prilagoditi odmerek cemiplimaba, nadomestno hormonsko zdravljenje (če je klinično indicirano) in kortkosteroide.
• Skin problems such as rash or itching, skin blistering and ulcers in mouth or other mucous membrane.
• Težave s kožo, na primer izpuščaj ali srbenje, mehurje na koži in razjede v ustih ali na drugih sluznicah.
Immune-related adverse reactions led to permanent discontinuation of cemiplimab in 4.4% of patients.
Imunsko pogojeni neželeni učinki so povzročili trajno prenehanje uporabe cemiplimaba pri 4,4 % bolnikov.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA
The efficacy and safety of cemiplimab in patients with metastatic (nodal or distant) CSCC (mCSCC) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation were studied in clinical trial R2810-ONC-1540 (Study 1540).
Učinkovitost in varnost cemiplimaba pri bolnikih z metastatskim (metastaze v bezgavkah ali oddaljene metastaze) PCKK (mPCKK) ali lokalno napredovalim PCKK (lnPCKK), ki niso bili kandidati za kurativni kirurški poseg ali kurativno obsevanje, so raziskali v kliničnem preskušanju R2810-ONC-1540 (študija 1540).
Dosing delay or discontinuation may be required based on individual safety and tolerability.
Glede na varnost in prenašanje pri posameznem bolniku je lahko potrebna odložitev odmerka ali prenehanje uporabe.
In order to confirm the efficacy and safety of cemiplimab for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, the MAH should submit the final study report for Groups 1-3 in the phase 2 pivotal study 1540.
Za potrditev učinkovitosti in varnosti cemiplimaba za zdravljenje bolnikov z metastatskim ali lokalno napredovalim kožnim ploščatoceličnim karcinomom, ki niso kandidati za kurativni kirurški poseg ali kurativno obsevanje, mora imetnik dovoljenja za promet z zdravilom predložiti končno poročilo študije za skupine 1-3 v ključni študiji 2. faze 1540.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa.
There are limited data for LIBTAYO in patients with severe renal impairment CLcr <30 ml/min (see section 5.2).
Podatkov o uporabi zdravila LIBTAYO pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je malo (glejte poglavje 5.2).
Of the 219 patients with mCSCC and laCSCC treated with cemiplimab, 25.1% (55/219) were less than 65 years, 34.2% (75/219) were 65 to less than 75 years, and 40.6% (89/219) were 75 years or older.
Od 219 bolnikov z mPCKK in lnPCKK, zdravljenih s cemiplimabom, je bilo 25,1 % (55/219) mlajših od 65 let, 34,2 % (75/219) je bilo starih od 65 do manj kot 75 let in 40,6 % (89/219) je bilo starih 75 let ali več.
Chronic inflammatory demyelinating polyradiculoneuropathy
Kronična vnetna demielinizirajoča poliradikulonevropatija
f. Hepatitis is a composite term that includes hepatitis and autoimmune hepatitis.
Hepatitis je sestavljen izraz, ki vključuje hepatitis in avtoimunski hepatitis.
If you have any of these effects, talk to your doctor immediately.
Če se vam pojavi kateri od teh neželenih učinkov, se nemudoma posvetujte z zdravnikom.
This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Pogojno dovoljenje za promet Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet”.
• inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired or chest pain
• vnetje srčne mišice, ki se lahko pokaže kot kratka sapa, neredno bitje srca, občutek utrujenosti ali bolečine v prsih
How you are given LIBTAYO 4.
Kako boste dobili zdravilo LIBTAYO 4.
What LIBTAYO contains The active substance is cemiplimab:
Kaj vsebuje zdravilo LIBTAYO Zdravilna učinkovina je cemiplimab:
Immune-related skin reaction or other immune-related adverse reactions in patients with prior treatment with idelalisib
Imunsko pogojene kožne reakcije ali drugi imunsko pogojeni neželeni učinki pri bolnikih, predhodno zdravljenih z idelalisibom2.
The most common symptoms of infusion-related reaction were nausea, pyrexia, vomiting, abdominal pain, chills and flushing.
Najpogostejši simptomi z infundiranjem povezanih reakcij so bili navzea, zvišana telesna temperatura, bruhanje, bolečine v trebuhu, mrzlica in zardevanje.
Grades 1-5
1.-5. stopnja
• Do not breast-feed while you are being treated with LIBTAYO and for at least 4 months after the last dose.
• Med zdravljenjem z zdravilom LIBTAYO in vsaj še 4 mesece po njegovem zadnjem odmerku ne smete dojiti.
Hyperthyroidism
Hipertiroidizem
In the 193 patients in the efficacy analysis, the objective response rate by ICR (95% CI) was 40.8% (27.0%, 55.8%) in patients less than 65 years, 48.5% (36.0%, 61.1%) in patients 65 to less than 75 years, and 42.3% (31.2%, 54.0%) in patients 75 years or older.
Pri 193 bolnikih v analizi učinkovitosti je bil objektivni delež odziva po NCP (95 % IZ) 40,8 % (27,0 %, 55,8 %) pri bolnikih, mlajših od 65 let, 48,5 % (36,0 %, 61,1 %) pri bolnikih, starih od 65 do manj kot 75 let, in 42,3 % (31,2 %, 54,0 %) pri bolnikih, starih 75 let ali več.
• cough, inflammation of the lungs
• kašelj, vnetje pljuč
Other fatal and life-threatening immune-related adverse reactions have been observed in patients receiving cemiplimab including paraneoplastic encephalomyelitis and meningitis (see section 4.8 for other immune-related adverse reactions).
Pri bolnikih, ki so prejemali cemiplimab, so opažali še druge življenjsko nevarne in smrtne imunsko pogojene neželene učinke, med njimi paraneoplastični encefalomielitis in meningitis (glejte poglavje 4.8 za druge imunsko pogojene neželene učinke).
• Problems in other parts of the body such as headache or stiff neck, fever, feeling tired or weak, confusion, memory problems or feeling sleepy, fits (seizures), seeing or hearing things that are not really there (hallucinations), changes in eyesight, eye pain or redness, severe muscle weakness, changes in heartbeat, such as beating fast or seeming to skip a beat or pounding sensation and bruises on the skin or bleeding.
• Težave v drugih delih telesa, na primer glavobol ali togost vratu, zvišano telesno temperaturo, občutek utrujenosti ali šibkosti, zmedenost, težave s spominom ali zaspanost, napade krčev (konvulzije), videnje ali slišanje stvari, ki jih v resnici ni (halucinacije), spremembe vida, bolečino v očeh ali pordelost oči, hudo šibkost mišic, spremembe srčnega utripa, npr. hiter srčni utrip, navidezno preskakovanje ali občutek razbijanja ter podplutbe ali krvavitve na koži.
Immune thrombocytopenic purpura
Imunsko pogojena trombocitopenična purpura
Cardiac Disorders: Myocarditis c, Pericarditis
Srčne bolezni: miokarditisc, perikarditis
Resolution of nephritis had occurred in all patients at the time of data cut-off.
Ob času zamejitve podatkov je nefritis izzvenel pri vseh bolnikih.
In order to confirm the efficacy and safety of cemiplimab for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, the MAH should provide interim data of a single-arm trial in the same population [study 1540 group 6].
Za potrditev učinkovitosti in varnosti cemiplimaba za zdravljenje bolnikov z metastatskim ali lokalno napredovalim kožnim ploščatoceličnim karcinomom, ki niso kandidati za kurativni kirurški poseg ali kurativno obsevanje, mora imetnik dovoljenja za promet z zdravilom predložiti vmesne podatke preskušanja z eno samo skupino v tej populaciji [študija 1540, skupina 6].
o Description of the main signs or symptoms of the immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, nephritis and other irARs) and infusion related reactions, and the importance of notifying their treating physician immediately if symptoms occur.
o Opis glavnih znakov ali simptomov imunsko pogojenih neželenih učinkov (pnevmonitis, kolitis, hepatitis, endokrinopatije, imunsko pogojeni neželeni učinki na kožo, nefritis in drugi imunsko pogojeni neželeni učinki) in z infundiranjem povezanih reakcij, ter navedbo o pomenu takojšnjega obveščanja lečečega zdravnika v primeru pojava teh simptomov.
mCSCC cemiplimab: 350 mg Q3W (Group 3) (N = 56)
mPCKK cemiplimab: 350 mg na 3 tedne (Skupina 3) (N = 56)
Nervous system disorders Paraneoplastic encephalomyelitis
Bolezni živčevja Paraneoplastični encefalomielitis
Grade 4 or recurrent Grade 3
4. stopnja ali ponovna 3. stopnja
The increase of spontaneous abortion and/or resorption in animals with restricted PD-L1 expression (knock-out or anti-PD1 / PD-L1 monoclonal antibodies) has been shown in both mice and monkeys.
Pri miših in pri opicah so ob omejeni izraženosti PD-L1 (zaradi izbitja ["knockout"] ali monoklonskih protiteles proti PD1/PD-L1) ugotovili povečanje spontanih splavov in/ali resorpcij zarodka.
LIBTAYO has no or minor influence on your ability to drive and use machines.
Zdravilo LIBTAYO le malo vpliva na sposobnost upravljanja vozil in strojev ali sploh ne vpliva nanjo.
Five out of 398 patients (1.3%) administered cemiplimab developed treatment-emergent antibodies, with 1 out of 398 patients (0.3%) exhibiting persistent antibody responses.
Petim od 398 bolnikov (1,3 %), ki so prejemali cemiplimab, so se pojavila med zdravljenjem nastala protitelesa; 1 od 398 bolnikov (0,3 %) je imel trajen odziv protiteles.
Eighteen patients (3.0%) received high-dose corticosteroids for a median of 8.5 days (range: 1 day to 5.9 months).
Osemnajst (3,0 %) bolnikov je prejemalo velike odmerke kortikosteroidov mediano 8,5 dneva (razpon: od 1 dneva do 5,9 meseca).
Among 21 mCSCC patients, ORR was 60% (3/5) in patients with PD-L1 < 1% and 56.3% (9/16) among patients with PD-L1 ≥ 1%.
Med 21 bolniki z mPCKK je bil ORR pri bolnikih s PD-L1 < 1 % 60 % (3/5) in pri bolnikih s PD-L1 ≥ 1 % 56,3 % (9/16).
Meningitis b
Meningitisb
Allow the diluted solution to come to room temperature prior to administration.
Pred uporabo pustite, da se razredčena raztopina ogreje na sobno temperaturo.
mCSCC cemiplimab: 3 mg/kg Q2W (Group 1) (N = 59)
mPCKK cemiplimab: 3 mg/kg na 2 tedna (Skupina 1) (N = 59)
Median follow-up was 16.5 months for the mCSCC 3 mg/kg every 2 weeks group, 9.3 months for the laCSCC 3 mg/kg every 2 weeks group and 8.1 months for the mCSCC 350 mg every 3 weeks group.
V skupini z mPCKK in odmerkom 3 mg/kg na 2 tedna je bil mediani čas spremljanja 16,5 meseca, v skupini z lnPCKK in odmerkom 3 mg/kg na 2 tedna 9,3 meseca ter v skupini z mPCKK in odmerkom 350 mg na 3 tedne 8,1 meseca.
Grades 3-5
3.-5. stopnja
No studies have been performed to test the potential of cemiplimab for carcinogenicity or genotoxicity.
Študij za testiranje karcinogenosti ali genotoksičnosti cemiplimaba niso izvedli.
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.