natgillin/translations-raw huggingface dataset:
Immune-related skin adverse reactions, defined as requiring use of systemic corticosteroids with no clear alternate aetiology, including severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (some cases with fatal outcome), and other skin reactions such as rash, erythema multiforme, pemphigoid, have been reported in association with cemiplimab treatment (see section 4.8).
Med zdravljenjem s cemiplimabom so poročali o imunsko pogojenih neželenih učinkih na kožo, opredeljenih s potrebo po uporabi sistemskih kortikosteroidov in brez jasne alternativne etiologije; med njimi so bili hudi neželeni učinki na kožo, na primer Stevens-Johnsonov sindrom (SJS) in toksična epidermalna nekroliza (TEN) (v nekaterih primerih s smrtnim izidom), in druge kožne reakcije, na primer izpuščaj, multiformni eritem in pemfigoid (glejte poglavje 4.8).
There was no evidence of an altered pharmacokinetic or safety profile with anti-cemiplimab antibody development.
V primeru pojava protiteles proti cemiplimabu niso ugotovili spremenjenih farmakokinetičnih ali varnostnih značilnosti.
concentrate for solution for infusion 350 mg/7 ml
FARMACEVTSKA OBLIKA IN VSEBINA Koncentrat za raztopino za infundiranje 350 mg/7 ml
Grade 3 or 4 or recurrent Grade 2
3. ali 4. stopnja ali ponovna 2. stopnja
SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Type 1 diabetes mellitus
Sladkorna bolezen tipa 1
At the dosing regimens of 1 mg/kg to 10 mg/kg every two weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway.
Ob odmernih shemah od 1 mg/kg do 10 mg/kg na dva tedna je kinetika cemiplimaba linearna in sorazmerna odmerku; to nakazuje nasičenje poti, v katero je vključeno ciljno mesto.
Grade 3 or 4 (hyperglycaemia)
Sladkorna bolezen tipa 1 3. ali 4. stopnja (hiperglikemija)
• If you are breast-feeding or plan to breast-feed, ask your doctor for advice before you are given this medicine.
• Če dojite ali nameravate dojiti, se posvetujte z zdravnikom, preden dobite to zdravilo.
o The contact details of their LIBTAYO prescriber.
o Kontaktne podatke zdravnika, ki je predpisal zdravilo LIBTAYO.
Grade 3 or 4
3. ali 4. stopnja
Immune-related type 1 diabetes mellitus, including diabetic ketoacidosis, has been observed in patients receiving cemiplimab (see section 4.8).
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojeno sladkorno bolezen tipa 1, vključno z diabetično ketoacidozo (glejte poglavje 4.8).
(including but not limited to meningitis, paraneoplastic encephalomyelitis, arthritis, Guillain-Barre syndrome, encephalitis, chronic inflammatory demyelinating polyradiculoneuropathy, central nervous system inflammation, autoimmune myocarditis, and immune thrombocytopenic purpura, myalgia, Sjogren's syndrome, vasculitis, myasthenia gravis)b
Guillain-Barréjevim sindromom, encefalitisom, kronično vnetno demielinizirajočo poliradikulonevropatijo, vnetjem osrednjega živčevja, avtoimunskim miokarditisom in imunsko trombocitopenično purpuro, mialgijo, Sjögrenovim sindromom, vaskulitisom, miastenijo gravis) b
Among the 12 patients with immune-related skin adverse reactions, the median time to onset was 1.5 months (range: 2 days to 10.9 months) and the median duration was 4.4 months (range: 14 days to 9.6 months).
Pri 12 bolnikih z imunsko pogojenimi kožnimi reakcijami je bil mediani čas do pojava 1,5 meseca (razpon: od 2 dni do 10,9 meseca) in mediano trajanje 4,4 meseca (razpon: od 14 dni do 9,6 meseca).
LIBTAYO does not contain a preservative.
Shranjevanje razredčene raztopine Zdravilo LIBTAYO ne vsebuje konzervansov.
It must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
Dajati ga je treba v intravenski infuziji v obdobju 30 minut po intravenski liniji, ki vsebuje sterilen, nepirogen filter (v sami liniji ali kot dodatek), ki malo veže beljakovine (velikost por od 0,2 do 5 mikronov).
There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations (see section 4.2).
Podatkov o bolnikih z zmerno ali hudo okvaro jeter ni dovolj, da bi omogočali oblikovanje priporočil za odmerjanje (glejte poglavje 4.2).
Ten (1.7%) patients with immune-related hepatitis received high-dose corticosteroids for a median of 10.5 days (range: 2 days to 1.9 months).
Deset (1,7 %) bolnikov z imunsko pogojenim hepatitisom je prejemalo velike odmerke kortikosteroidov mediana 10,5 dneva (razpon: od 2 dni do 1,9 meseca).
• inflammation of the pituitary gland situated at the base of the brain; decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid
• vnetje hipofize, ki leži na spodnji strani možganov, zmanjšano izločanje hormonov nadledvičnih žlez, vnetje ščitnice
• LIBTAYO is for single use only.
• Zdravilo LIBTAYO je namenjeno samo za enkratno uporabo.
Four patients (0.7%) with immune-related diarrhoea or colitis received high-dose corticosteroids for a median of 29 days (range: 19 days to 2.0 months).
Štirje (0,7 %) bolniki z imunsko pogojeno drisko ali kolitisom so prejemali velike odmerke kortikosteroidov mediano 29 dni (razpon: od 19 dni do 2,0 meseca).
Patients should be monitored for signs and symptoms of infusion-related reactions and managed with cemiplimab treatment modifications and corticosteroids.
Bolnike je treba spremljati glede znakov in simptomov z infundiranjem povezanih reakcij in jih voditi s prilagoditvijo zdravljenja s cemiplimabom in s kortikosteroidi.
• LIBTAYO must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
• Zdravilo LIBTAYO je treba dati v intravenski infuziji v obdobju 30 minut po intravenski liniji, ki vsebuje sterilen, nepirogen filter (v sami liniji ali kot dodatek), ki malo veže beljakovine (velikost por od 0,2 do 5 mikronov).
What LIBTAYO looks like and contents of the pack LIBTAYO concentrate for solution for infusion (sterile concentrate) is supplied as a clear to slightly opalescent, colourless to pale yellow sterile solution that may contain trace amounts of translucent to white particles.
Zdravilo LIBTAYO koncentrat za raztopino za infundiranje (sterilen koncentrat) je na voljo kot bistra do rahlo opalescentna, brezbarvna do bledo rumena sterilna raztopina, ki lahko vsebuje prosojne ali bele delce v sledovih.
• Discard the vial if the solution is cloudy, discoloured or contains extraneous particulate matter other than trace amounts of translucent-to-white particles.
• Če je raztopina motna, spremenjene barve ali vsebuje druge delce razen prosojnih do belih delcev v sledovih, vialo zavrzite.
b. Meningitis is a composite term that includes meningitis and meningitis aseptic.
Bolezni prebavil: stomatitis a Vključuje meningitis in aseptični meningitis.
At dosing regimens of 1 mg/kg to 10 mg/kg every 2 weeks and 350 mg every 3 weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway over the dosing interval.
Kinetika cemiplimaba je bila ob odmernih shemah od 1 mg/kg do 10 mg/kg na 2 tedna in 350 mg na 3 tedne linearna in sorazmerna odmerku; to nakazuje nasičenje poti, v kateri je vključeno ciljno mesto, v celotnem odmernem intervalu.
Among the 11 patients with immune-related hepatitis, the median time to onset was 1.0 month (range: 7 days to 4.2 months) and the median duration of hepatitis was 15 days (range: 8 days to 2.7 months).
Pri 11 bolnikih z imunsko pogojenim hepatitisom je bil mediani čas do pojava 1,0 mesec (razpon: od 7 dni do 4,2 meseca) in mediano trajanje hepatitisa 15 dni (razpon: od 8 dni do 2,7 meseca).
Among the 3 patients with immune-related nephritis, the median time to onset was 1.8 months (range: 29 days to 4.1 months) and the median duration of nephritis was 18 days (range: 9 days to 29 days).
Pri 3 bolnikih z imunsko pogojenim nefritisom je bil mediani čas do pojava 1,8 meseca (razpon: od 29 dni do 4,1 meseca) in mediano trajanje nefritisa je bilo 18 dni (razpon: od 9 dni do 29 dni).
Two (0.3%) patients with immune-related nephritis received high-dose corticosteroids for a median of 1.5 months (range: 16 days to 2.6 months).
Dva (0,3 %) bolnika z imunsko pogojenim nefritisom sta prejemala velike odmerke kortikosteroidov mediano 1,5 meseca (razpon: od 16 dni do 2,6 meseca).
Type 1 diabetes mellitus without an alternative aetiology occurred in 4 (0.7%) of 591 patients including 3 (0.5%) patients with Grade 4 and 1 (0.2%) patient with Grade 3 type 1 diabetes mellitus.
Sladkorna bolezen tipa 1 brez alternativne etiologije se je pojavila pri 4 (0,7 %) od 591 bolnikov, vključno s 3 (0,5 %) bolniki s sladkorno boleznijo tipa 1 4. stopnje in 1 (0,2 %) 3. stopnje.
Other medicinal products should not be co-administered through the same infusion line.
Po isti infuzijski liniji se ne sme istočasno dajati drugih zdravil.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with cemiplimab treatment (see section 4.4).
V povezavi z zdravljenjem s cemiplimabom so bili opisani hudi kožni neželeni učinki, vključno s Stevens-Johnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN) (glejte poglavje 4.4).
• you have liver problems
• če imate težave z jetri,
Grade 2 or 3
2. ali 3. stopnja
• One ml of concentrate contains 50 mg of cemiplimab.
• En mililiter koncentrata vsebuje 50 mg cemiplimaba.
Immune-related pneumonitis occurred in 22 (3.7%) of 591 patients receiving cemiplimab, including 2 (0.3%) patients with Grade 5, 2 (0.3%) patients with Grade 4, and 6 (1.0%) patients with Grade 3 pneumonitis.
Imunsko pogojeni pnevmonitis se je pojavil pri 22 (3,7 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 2 (0,3 %) bolnikoma s pnevmonitisom 5. stopnje, 2 (0,3 %) s pnevmonitisom 4. stopnje in 6 (1,0 %) s pnevmonitisom 3. stopnje.
Among the 22 patients with immune-related pneumonitis, the median time to onset was 3.8 months (range: 7 days to 18 months) and the median duration of pneumonitis was 21.5 days (range: 5 days to 6.5 months).
Pri 22 bolnikih z imunsko pogojenim pnevmonitisom je bil mediani čas do pojava 3,8 meseca (razpon: od 7 dni do 18 mesecev) in mediano trajanje pnevmonitisa 21,5 dneva (razpon: od 5 dni do 6,5 meseca).
Patients should be monitored for abnormal liver tests prior to and periodically during treatment as indicated based on clinical evaluation and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Bolnike je treba spremljati glede nenormalnih jetrnih testov pred zdravljenjem in redno med zdravljenjem, kot je indicirano glede na klinično oceno, ter jih voditi s prilagoditvami zdravljenja s cemiplimabom in s kortikosteroidi (glejte poglavje 4.2).
Endocrine disorders Hypothyroidism
Bolezni endokrinega sistema Hipotiroidizem
Among the 7 patients with immune-related diarrhoea or colitis, the median time to onset was 3.8 months (range: 15 days to 6.0 months) and the median duration of immune-related diarrhoea or colitis was 30 days (range: 4 days to 8.6 months).
Pri 7 bolnikih z imunsko drisko ali kolitisom je bil mediani čas do pojava 3,8 meseca (razpon: od 15 dni do 6,0 mesecev) in mediano trajanje imunsko pogojene driske ali kolitisa je bilo 30 dni (razpon: od 4 dni do 8,6 meseca).
No clinically important differences in the exposure of cemiplimab were found between patients with renal impairment and patients with normal renal function.
Med bolniki z okvaro ledvic in bolniki z normalnim delovanjem ledvic niso ugotovili klinično pomembnih razlik v izpostavljenosti cemiplimabu.
Cases of SJS, fatal TEN and stomatitis occurred following 1 dose of cemiplimab in patients with prior exposure to idelalisib, who were participating in a clinical trial evaluating cemiplimab in Non-Hodgkin Lymphoma (NHL), and who had recent exposure to sulfa containing antibiotics (see section 4.8).
Pri bolnikih, predhodno izpostavljenih idelalisibu, ki so sodelovali v kliničnem preskušanju za ovrednotenje cemiplimaba pri ne-Hodgkinovem limfomu (NHL) in so bili nedavno izpostavljeni antibiotikom s sulfatom, so se po 1 odmerku cemiplimaba pojavili primeri SJS, TEN s smrtnim izidom in stomatitisa (glejte poglavje 4.8).
• Each vial contains 350 mg cemiplimab in 7 ml of concentrate.
• Ena viala vsebuje 350 mg cemiplimaba v 7 ml koncentrata.
LIBTAYO is for single use only.
Zdravilo LIBTAYO je namenjeno samo za enkratno uporabo.
Patients should be monitored for hyperglycaemia and signs and symptoms of diabetes as indicated based on clinical evaluation and managed with oral anti-hyperglycaemics or insulin and cemiplimab treatment modifications (see section 4.2).
Bolnike je treba spremljati glede hiperglikemije ter znakov in simptomov sladkorne bolezni, kot je indicirano glede na klinično ovrednotenje, in jih voditi s peroralnimi antihiperglikemičnimi zdravili ali insulinom ter prilagoditvijo zdravljenja s cemiplimabom (glejte poglavje 4.2).
In Groups 1, 2, and 3, median durations of follow-up were 16.5, 9.3, and 8.1 months, respectively.
Mediano je trajalo spremljanje v skupini 1 16,5 meseca, v skupini 2 9,3 meseca in v skupini 3 8,1 meseca.
• Visually inspect the medicinal product for particulate matter and discoloration prior to administration.
• Zdravilo pred aplikacijo preglejte glede delcev ali obarvanja.
Infusion-related reaction led to permanent discontinuation of cemiplimab in 2 (0.3%) patients.
Z infundiranjem povezane reakcije so povzročile trajno prenehanje uporabe cemiplimaba pri 2 (0,3 %) bolnikih.
a. Type 1 diabetes mellitus is a composite term that includes diabetes mellitus, diabetic ketoacidosis and type 1 diabetes mellitus.
Sladkorna bolezen tipa 1 je sestavljen izraz, ki vključuje sladkorno bolezen, diabetično ketoacidozo in sladkorno bolezen tipa 1. b. Meningitis je sestavljen izraz, ki vključuje meningitis in aseptični meningitis.
(Grade 4), Paraneoplastic encephalomyelitis (Grade 5), Guillain-Barre syndrome, central nervous system inflammation, Chronic inflammatory demyelinating polyradiculoneuropathy, Encephalitis b, Myasthenia gravis, Neuropathy peripheral.
Barréjev sindrom, vnetje osrednjega živčevja, kronična vnetna demielinizirajoča poliradikulonevropatija, encefalitisb, miastenija gravis, periferna nevropatija
Nine patients (1.5%) with immune-related skin adverse reactions received high-dose corticosteroids for a median of 16 days (range: 7 days to 2.6 months).
Devet (1,5 %) bolnikov z imunsko pogojenimi kožnimi reakcijami je prejemalo velike odmerke kortikosteroidov mediano 16 dni (razpon: od 7 dni do 2,6 meseca).
Resume LIBTAYO when hyperthyroidism returns to Grade 0 to 1 or is otherwise clinically stable
Nadaljujte uporabo zdravila LIBTAYO, ko se hipertiroidizem vrne na 0. ali 1. stopnjo ali je sicer klinično stabilen
Additional intervention
Prilagoditev odmerka Dodatno ukrepanje
k. Fatigue is a composite term that includes fatigue and asthenia.
k. Utrujenost je sestavljen izraz, ki vključuje utrujenost in astenijo.
LIBTAYO is a clear to slightly opalescent, colourless to pale yellow solution that may contain trace amounts of translucent to white particles
Zdravilo LIBTAYO je bistra do rahlo opalescentna ter brezbarvna do bledo rumena raztopina, ki lahko vsebuje prosojne ali bele delce v sledovih.
LIBTAYO 350 mg concentrate for solution for infusion.
LIBTAYO 350 mg koncentrat za raztopino za infundiranje
• Visually inspect medicinal product for particulate matter and discoloration prior to administration.
• Zdravilo pred dajanjem preglejte glede delcev ali obarvanja.
• infusion-related reactions
• z infundiranjem povezane reakcije
Hypothyroidism occurred in 42 (7.1%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hypothyroidism.
Hipotiroidizem se je pojavil pri 42 (7,1 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 1 (0,2 %) bolnikom s hipotiroidizmom 3. stopnje.
Tabulated list of adverse reactions in patients treated with cemiplimab System organ class preferred term
Preglednica 2: Seznam neželenih učinkov pri bolnikih, zdravljenih s cemiplimabom, v preglednici
Immune-related pneumonitis led to permanent discontinuation of cemiplimab in 11 (1.9%) of 591 patients.
Imunsko pogojeni pnevmonitis je povzročil trajno prenehanje uporabe cemiplimaba pri 11 (1,9 %) od 591 bolnikov.
Encephalitis
Encefalitis
Animal reproduction studies have not been conducted with cemiplimab.
S cemiplimabom niso izvedli študij o vplivu na sposobnost razmnoževanja pri živalih.
Immune-related hypophysitis has been observed in patients receiving cemiplimab (see section 4.8).
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojeni hipofizitis (glejte poglavje 4.8).
Each vial contains 350 mg of cemiplimab in 7 ml.
Ena viala vsebuje 350 mg cemiplimaba v 7 ml.
Immune-related hepatitis occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 5, 1 (0.2%) patient with Grade 4, and 9 (1.5%) patients with Grade 3 immune-related hepatitis.
Imunsko pogojeni hepatitis se je pojavil pri 11 (1,9 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 1 (0,2 %) bolnikom z imunsko pogojenim hepatitisom 5. stopnje, 1 (0,2 %) 4. stopnje in 9 (1,5 %) 3. stopnje.
Immune-related nephritis
Imunsko pogojeni nefritis
Hrvatska sanofi-aventis Croatia d.o.o.
România sanofi-aventis Croatia d.o.o.
• diarrhoea (loose stools).
• driska (redko blato)
Dose modification
Prilagoditve odmerka
6 months
6.3 Rok uporabnosti
severe nausea or vomiting, pain on right side of your stomach (abdomen), feeling sleepy, dark urine (the colour of tea), bleeding or bruising more easily than normal and feeling less hungry than usual.
• Težave z jetri (hepatitis), na primer porumenelost kože ali očesnih beločnic, huda slabost (siljenje na bruhanje) ali bruhanje, bolečine na desni strani trebuha, zaspanost, temen urin (takšne barve kot čaj), večjo nagnjenost k podplutbam ali krvavitvam kot po navadi in manjši občutek lakote kot po navadi.
Skin and subcutaneous skin disorders Rashg
Bolezni kože in podkožja Izpuščajg
The infusion should be stopped and cemiplimab should be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions (see section 4.2).
V primeru hudih (3. stopnja) ali življenjsko nevarnih (4. stopnja) z infundiranjem povezanih reakcij je treba infundiranje končati in zdravljenje s cemiplimabom trajno prenehati (glejte poglavje 4.2).
Immune-related skin adverse reactions occurred in 12 (2.0%) of 591 patients receiving cemiplimab including 6 (1.0%) patients with Grade 3 immune-related skin adverse reactions.
Imunsko pogojeni neželeni učinki na kožo so se pojavili pri 12 (2,0 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno s 6 (1,0 %) bolniki z imunsko pogojenimi kožnimi neželenimi učinki 3. stopnje.
22 advanced CSCC patients with PD-L1 < 1%, ORR per independent central review was 40.9% (9/22).
Med 22 bolniki z napredovalim PCKK in PD-L1 < 1 % je bil ORR po oceni neodvisnega centralnega pregleda
Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
2. stopnja, ki traja več kot 1 teden, 3. stopnja ali sum na StevensJohnsonov sindrom (SJS) ali toksično epidermalno nekrolizo (TEN)
Hyperthyroidism occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hyperthyroidism.
Hipertiroidizem se je pojavil pri 11 (1,9 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 1 (0,2 %) bolnikom s hipertiroidizmom 3. stopnje.
Specific metabolism studies were not conducted because cemiplimab is a protein.
Cemiplimab je beljakovina, zato specifičnih študij presnove niso izvedli.
How to store LIBTAYO
Shranjevanje zdravila LIBTAYO
No patient discontinued cemiplimab due to hyperthyroidism.
Zaradi hipertiroidizma ni cemiplimaba prenehal uporabljati noben bolnik.
Adrenal insufficiency has been observed in patients receiving cemiplimab (see section 4.8).
Pri bolnikih, ki so prejemali cemiplimab, so opažali nadledvično insuficienco (glejte poglavje 4.8).
Eye disorders Keratitis
Očesne bolezni Keratitis
Cemiplimab should be interrupted or the rate of infusion slowed for mild or moderate infusion-related reactions.
V primeru blagih do zmernih z infundiranjem povezanih reakcij je treba infundiranje cemiplimaba prekiniti ali hitrost infundiranja upočasniti.
Skin adverse reactions
Kožni neželeni učinki
Rash is a composite term that includes rash maculo-papular, rash, dermatitis, rash generalised, dermatitis bullous, drug eruption, erythema, pemphigoid, psoriasis, rash erythematous, rash macular, rash pruritic and skin reaction.
generaliziran izpuščaj, bulozni dermatitis, medikamentozno erupcijo, eritem, pemfigoid, psoriazo,
Patients should be managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Bolnike je treba voditi s prilagoditvami zdravljenja s cemiplimabom in s kortikosteroidi (glejte poglavje 4.2).
Immune-related nephritis occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 2 (0.3%) patients with Grade 3 immune-related nephritis.
Imunsko pogojeni nefritis se je pojavil pri 3 (0,5 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 2 (0,3 %) bolnikoma z imunsko pogojenim nefritisom 3. stopnje.
Once prepared, administer the diluted solution immediately.
Ko je razredčena raztopina pripravljena, jo nemudoma uporabite.
Interrupt or slow rate of infusion
Prekinite infundiranje ali zmanjšajte hitrost infundiranja
LIBTAYO is a clear to slightly opalescent, colourless to pale yellow solution that may contain trace amounts of translucent to white particles.
Zdravilo LIBTAYO je bistra do rahlo opalescentna ter brezbarvna do bledorumena raztopina, ki lahko vsebuje prosojne ali bele delce v sledovih.
Initial dose of 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
Začetni odmerek od 2 do 4 mg/kg/dan prednizona (ali enakovredno) in nato postopno zmanjšanje odmerka
Similar exposures to cemiplimab are achieved with the doses of 350 mg every 3 weeks and 3 mg/kg every 2 weeks.
Z odmerkoma 350 mg na 3 tedne in 3 mg/kg na 2 tedna je bila dosežena podobna izpostavljenost cemiplimabu.
Fatigue has been reported following treatment with cemiplimab (see section 4.8).
Po zdravljenju s cemiplimabom so poročali o utrujenosti (glejte poglavje 4.8).
Cemiplimab should be withheld and anti-hyperglycaemics or insulin should be administered in patients with severe or life-threatening (Grade ≥ 3) hyperglycaemia.
Pri bolnikih s hudo ali smrtno nevarno (≥ 3. stopnja) hiperglikemijo je treba zdravljenje s cemiplimabom prekiniti in uporabiti antihiperglikemična zdravila ali insulin.
Immune-related hepatitis led to permanent discontinuation of cemiplimab in 5 (0.8%) of 591 patients.
Zaradi imunsko pogojenega hepatitisa je trajno prenehalo uporabljati cemiplimab 5 (0,8 %) od 591 bolnikov.
Immune-related adverse reactions can occur with cemiplimab.
Med uporabo cemiplimaba se lahko pojavijo imunsko pogojeni neželeni učinki.
• joint pain, swelling, polyarthritis and joint effusion
• bolečine v sklepih, oteklost sklepov, poliartritis in izliv v sklepih
Immune-related endocrinopathies, defined as treatment-emergent endocrinopathies with no clear alternate aetiology, have been observed in patients receiving cemiplimab (see section 4.8).
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojene endokrinopatije, opredeljene kot med zdravljenjem nastale endokrinopatije brez jasne alternativne etiologije (glejte poglavje 4.8).
Immune-related diarrhoea or colitis occurred in 7 (1.2%) of 591 patients receiving cemiplimab including 2 (0.3%) with Grade 3 immune-related diarrhoea or colitis.
Imunsko pogojena driska ali kolitis sta se pojavila pri 7 (1,2 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 2 (0,3 %) bolnikoma, ki sta imela imunsko drisko ali kolitis 3. stopnje.