natgillin/translations-raw huggingface dataset:
Initiate symptomatic management immediately, including initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Odmah uvesti simptomatsko liječenje, koje uključuje početnu dozu od 1 - 2 mg/kg prednizona ili ekvivalenta na dan, koja se zatim postupno smanjuje
The solution may contain trace amounts of translucent to white particles in a single-use vial.
Otopina u bočici za jednokratnu uporabu može sadržavati prozirne do bijele čestice u tragovima.
Immune-related adverse reactions occurred in 20.1% of patients treated with cemiplimab in clinical trials including Grade 5 (0.7%), Grade 4 (1.2%) and Grade 3 (6.1%).
U 20,1% bolesnika koji su u sklopu kliničkih ispitivanja bili liječeni cemiplimabom javile su se imunološki uzrokovane nuspojave, uključujući nuspojave 5. stupnja (0,7%), 4. stupnja (1,2%) i 3. stupnja težine (6,1%).
Among the 3 patients with adrenal insufficiency, the median time to onset was 11.5 months (range: 10.4 months to 12.3 months).
Među 3 bolesnika s insuficijencijom nadbubrežne žlijezde medijan vremena do nastupa iznosio je 11,5 mjeseci (raspon: 10,4 mjeseca do 12,3 mjeseca).
• Hormone gland problems - especially thyroid, pituitary, adrenal glands and the pancreas
• tegobe sa žlijezdama koje luče hormone - osobito sa štitnjačom, hipofizom, nadbubrežnim žlijezdama i gušteračom
Efficacy results - Study 1540 - metastatic CSCC by dosing group, locally advanced CSCC
Tablica 3: Rezultati za djelotvornost - ispitivanje 1540 - metastatski planocelularni karcinom kože prema doziranju, lokalno uznapredovali planocelularni karcinom kože
Grade 3 or 4 or recurrent Grade 2
3. ili 4. stupanj ili rekurentan događaj 2. stupnja
• Discard the vial if the solution is cloudy, discoloured or contains extraneous particulate matter other than a few translucent-to-white particles.
• Bacite bočicu ako je otopina mutna, ako je promijenila boju ili ako sadrži strane čestice izuzev nekoliko prozirnih do bijelih čestica.
• 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).
• LIBTAYO se mora primijeniti intravenskom infuzijom u trajanju od 30 minuta kroz intravensku liniju sa sterilnim, nepirogenim ugrađenim ili pričvrsnim filtrom male sposobnosti vezanja proteina (veličine pora od 0,2 do 5 mikrometara).
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.
LIBTAYO koncentrat za otopinu za infuziju (sterilni koncentrat) je bistra do blago opalescentna, bezbojna do blijedo žuta sterilna otopina, koja može sadržavati prozirne do bijele čestice u tragovima.
Immune-related endocrinopathies
Imunološki uzrokovane endokrinopatije
Grade 4 or recurrent Grade 3
4. stupanj ili rekurentan događaj 3. stupnja
Hyperthyroidism
Hipertireoza
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).
• tegobe sa žlijezdama koje luče hormone kao što su glavobolja koja ne prolazi ili neuobičajene glavobolje, ubrzani otkucaji srca, pojačano znojenje, osjećaj hladnoće, izrazit umor, omaglica ili nesvjestica, povećanje ili smanjenje tjelesne težine, pojačan osjećaj gladi ili žeđi, opadanje kose, zatvor, produbljivanje glasa, vrlo nizak krvni tlak, učestalije mokrenje nego inače, mučnina ili povraćanje, bol u trbuhu (abdomenu), promjene raspoloženja ili ponašanja (poput smanjenog spolnog nagona, razdražljivosti ili zaboravljivosti)
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.
Budući da je cemiplimab IgG4, postoji mogućnost njegova prijenosa s majke na plod u razvoju.
Cemiplimab has not been studied in patients with moderate or severe hepatic impairment.
Cemiplimab se nije ispitivao u bolesnika s umjerenim ili teškim oštećenjem jetrene funkcije.
• 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
• suhoća različitih dijelova tijela poput usta, očiju, nosa, grla i gornjih slojeva kože
mCSCC cemiplimab: 3 mg/kg Q2W (Group 1) (N = 59)
Metastatski planocelularni karcinom kože Cemiplimab: 3 mg/kg svaka 2 tjedna (1. skupina) (N = 59)
No patient discontinued cemiplimab due to hypothyroidism.
Nijedan bolesnik nije prekinuo liječenje cemiplimabom zbog hipotireoze.
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).
Četiri su bolesnika (0,7%) s imunološki uzrokovanim proljevom ili kolitisom primala visoke doze kortikosteroida tijekom medijana od 29 dana (raspon: 19 dana do 2,0 mjeseca).
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 je bolesnika (1,7%) s imunološki uzrokovanim hepatitisom primalo visoke doze kortikosteroida tijekom medijana od 10,5 dana (raspon: 2 dana do 1,9 mjeseci).
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).
Među 11 bolesnika s imunološki uzrokovanim hepatitisom medijan vremena do nastupa iznosio je 1,0 mjesec (raspon: 7 dana do 4,2 mjeseca), dok je medijan trajanja hepatitisa iznosio 15 dana (raspon: 8 dana do 2,7 mjeseci).
LIBTAYO is for intravenous use.
LIBTAYO je namijenjen za intravensku primjenu.
• rash, itching
• osip, svrbež
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).
Među 22 bolesnika s imunološki uzrokovanim pneumonitisom medijan vremena do nastupa iznosio je 3,8 mjeseci (raspon: 7 dana do 18 mjeseci), dok je medijan trajanja pneumonitisa iznosio 21,5 dana (raspon: 5 dana do 6,5 mjeseci).
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).
U slučaju teških (3. stupnja) ili po život opasnih (4. stupnja) reakcija na infuziju treba prekinuti infuziju i trajno obustaviti primjenu cemiplimaba (vidjeti dio 4.2).
Type 1 Diabetes mellitus
Šećerna bolest tipa 1
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).
Među 12 bolesnika s imunološki uzrokovanim kožnim nuspojavama medijan vremena do nastupa iznosio je 1,5 mjeseci (raspon: 2 dana do 10,9 mjeseci), dok je medijan trajanja kožnih nuspojava iznosio 4,4 mjeseca (raspon: 14 dana do 9,6 mjeseci).
• Discard the vial if the solution is cloudy, discoloured or contains extraneous particulate matter other than trace amounts of translucent-to-white particles.
• Bacite bočicu ako je otopina mutna, ako je promijenila boju ili ako sadrži strane čestice izuzev prozirnih do bijelih čestica u tragovima.
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).
Među 3 bolesnika s imunološki uzrokovanim nefritisom medijan vremena do nastupa iznosio je 1,8 mjeseci (raspon: 29 dana do 4,1 mjeseca), dok je medijan trajanja nefritisa iznosio 18 dana (raspon: 9 dana do 29 dana).
Tabulated list of adverse reactions in patients treated with cemiplimab System organ class preferred term
Tablica 2: Tablični prikaz nuspojava u bolesnika liječenih cemiplimabom Organski sustav
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.
Imunološki uzrokovan pneumonitis javio se u 22 (3,7%) od 591 bolesnika liječenog cemiplimabom, uključujući 2 (0,3%) bolesnika s pneumonitisom 5. stupnja, 2 (0,3%) bolesnika s pneumonitisom 4. stupnja te 6 (1,0%) bolesnika s pneumonitisom 3. stupnja.
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 su bolesnika (0,3%) s imunološki uzrokovanim nefritisom primala visoke doze kortikosteroida tijekom medijana od 1,5 mjeseci (raspon: 16 dana do 2,6 mjeseci).
Cemiplimab should be withheld and anti-hyperglycaemics or insulin should be administered in patients with severe or life-threatening (Grade ≥ 3) hyperglycaemia.
U bolesnika s teškom ili po život opasnom (≥ 3. stupnja) hiperglikemijom treba odgoditi primjenu cemiplimaba te primijeniti antihiperglikemike ili inzulin.
Patients should be managed with cemiplimab treatment modifications and corticosteroids as described above (see section 4.2).
Bolesnike treba zbrinuti prilagodbom liječenja cemiplimabom i primjenom kortikosteroida, kako je prethodno opisano (vidjeti dio 4.2).
One ml contains 50 mg of cemiplimab.
Jedan ml sadrži 50 mg cemiplimaba.
Hypophysitis
Hipofizitis
- 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
2. ili 3. stupnja koja traje 12 tjedana ili dulje (izuzev endokrinopatija) - Nemogućnost smanjenja doze kortikosteroida na ≤ 10 mg prednizona ili ekvivalenta na dan unutar 12 tjedana
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.
Šećerna bolest tipa 1 bez alternativne etiologije javila se u 4 (0,7%) od 591 bolesnika, uključujući 3 (0,5%) bolesnika kod kojih je bila 4. stupnja težine i 1 (0,2%) bolesnika kod kojeg je bila 3. stupnja težine.
• Infusion-related reactions
• reakcije na infuziju
Other medicinal products should not be co-administered through the same infusion line.
Istom se infuzijskom linijom ne smiju istodobno primjenjivati drugi lijekovi.
Immune-related type 1 diabetes mellitus, including diabetic ketoacidosis, has been observed in patients receiving cemiplimab (see section 4.8).
U bolesnika koji su primali cemiplimab opažena je imunološki uzrokovana šećerna bolest tipa 1, uključujući dijabetičku ketoacidozu (vidjeti dio 4.8).
Allow the diluted solution to come to room temperature prior to administration.
Prije primjene pričekajte da se razrijeđena otopina ugrije na sobnu temperaturu.
• LIBTAYO is for intravenous use.
• LIBTAYO je namijenjen za intravensku primjenu.
In Groups 1, 2, and 3, median durations of follow-up were 16.5, 9.3, and 8.1 months, respectively.
Medijan trajanja praćenja iznosio je 16,5 mjeseci u 1. skupini, 9,3 mjeseca u 2. skupini te 8,1 mjesec u 3. skupini.
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).
Mora se primijeniti intravenskom infuzijom u trajanju od 30 minuta kroz intravensku liniju sa sterilnim, nepirogenim ugrađenim ili pričvrsnim filtrom male sposobnosti vezanja proteina (veličine pora od 0,2 do 5 mikrometara)
For instructions on dilution of the medicinal product before administration, see section 6.6.
Za upute o razrjeđivanju lijeka prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
Resolution of immune-related diarrhoea or colitis had occurred in 4 (57.1%) of the 7 patients at the time of data cut-off.
Do trenutka prekida prikupljanja podataka imunološki uzrokovan proljev ili kolitis povukao se u 4 (57,1%) od 7 bolesnika.
• Gut problems (colitis)
• crijevne tegobe (kolitis)
• type 1 diabetes that may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired
• šećerna bolest tipa 1, čiji simptomi mogu uključivati pojačan osjećaj gladi ili žeđi, češću potrebu za mokrenjem, gubitak tjelesne težine i umor
Listed in Table 2 are adverse reactions by system organ class and by frequency.
U Tablici 2 nuspojave su navedene prema organskom sustavu i učestalosti.
• Each vial contains 350 mg cemiplimab in 7 ml of concentrate.
• Jedna bočica sadrži 350 mg cemiplimaba u 7 ml koncentrata.
Most immune-related reactions initially manifest during treatment with cemiplimab; however, immune-related adverse reactions can occur after discontinuation of cemiplimab.
Većina imunološki uzrokovanih nuspojava prvi se put pojavi tijekom liječenja cemiplimabom.
Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated
1 - 2 mg/kg prednizona ili ekvivalenta na dan, koja se zatim postupno smanjuje, te hormonska nadomjesna terapija sukladno kliničkoj indikaciji
• One ml of concentrate contains 50 mg of cemiplimab.
• Jedan ml koncentrata sadrži 50 mg cemiplimaba.
Patients should be monitored for signs and symptoms of infusion-related reactions and managed with cemiplimab treatment modifications and corticosteroids.
Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma reakcija na infuziju te ih zbrinuti prilagodbom liječenja cemiplimabom i primjenom kortikosteroida.
One ml of concentrate contains 50 mg of cemiplimab.
Jedan ml koncentrata sadrži 50 mg cemiplimaba.
Immune-related pneumonitis led to permanent discontinuation of cemiplimab in 11 (1.9%) of 591 patients.
Imunološki uzrokovan pneumonitis doveo je do trajnog prekida liječenja cemiplimabom u 11 (1,9%) od 591 bolesnika.
• muscle pain.
• bol u mišićima
See ‘Possible side effects' section in section 4.
Pogledajte dio 4. Moguće nuspojave.
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.
Imunološki uzrokovan hepatitis javio se u 11 (1,9%) od 591 bolesnika liječenog cemiplimabom, uključujući 1 (0,2%) bolesnika s hepatitisom 5. stupnja, 1 (0,2%) bolesnika s hepatitisom 4. stupnja te 9 (1,5%) bolesnika s hepatitisom 3. stupnja.
LIBTAYO 350 mg concentrate for solution for infusion.
LIBTAYO 350 mg koncentrat za otopinu za infuziju
laCSCC cemiplimab: 3 mg/kg Q2W (Group 2) (N = 78)
Lokalno uznapredovali planocelularni karcinom kože Cemiplimab: 3 mg/kg svaka 2 tjedna (2. skupina) (N = 78)
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).
Bolesnike treba nadzirati zbog moguće pojave hiperglikemije te znakova i simptoma šećerne bolesti, kada je to indicirano na temelju kliničke ocjene, te ih zbrinuti primjenom oralnih antihiperglikemika ili inzulina i prilagodbom liječenja cemiplimabom (vidjeti dio 4.2).
Infusion-related reactions occurred in 54 (9.1%) of 591 patients treated with cemiplimab including 1 (0.2%) patient with Grade 3 infusion-related reaction.
Reakcije na infuziju javile su se u 54 (9,1%) od 591 bolesnika liječenog cemiplimabom, uključujući 1 (0,2%) bolesnika s reakcijom na infuziju 3. stupnja.
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 je bolesnika (1,5%) s imunološki uzrokovanim kožnim nuspojavama primalo visoke doze kortikosteroida tijekom medijana od 16 dana (raspon: 7 dana do 2,6 mjeseci).
Infusion-related reaction
Reakcija na infuziju
Immune-related hepatitis led to permanent discontinuation of cemiplimab in 5 (0.8%) of 591 patients.
Imunološki uzrokovan hepatitis doveo je do trajnog prekida liječenja cemiplimabom u 5 (0,8%) od 591 bolesnika.
No patient discontinued cemiplimab due to adrenal insufficiency.
Nijedan bolesnik nije prekinuo liječenje cemiplimabom zbog insuficijencije nadbubrežne žlijezde.
Hypothyroidism occurred in 42 (7.1%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hypothyroidism.
Hipotireoza se javila u 42 (7,1%) od 591 bolesnika liječenog cemiplimabom, uključujući 1 (0,2%) bolesnika s hipotireozom 3. stupnja.
Severe and fatal immune-related adverse reactions have been observed with cemiplimab (see section 4.8).
Kod primjene cemiplimaba opažene su teške i smrtonosne imunološki uzrokovane nuspojave (vidjeti dio 4.8).
Resume LIBTAYO when hyperthyroidism returns to Grade 0 to 1 or is otherwise clinically stable
Nastaviti primjenu lijeka LIBTAYO kada se hipertireoza vrati na 0. - 1. stupanj ili je bolesnikovo stanje inače klinički stabilno
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).
Među 7 bolesnika s imunološki uzrokovanim proljevom ili kolitisom medijan vremena do nastupa iznosio je 3,8 mjeseci (raspon: 15 dana do 6,0 mjeseci), dok je medijan trajanja imunološki uzrokovanog proljeva ili kolitisa iznosio 30 dana (raspon: 4 dana do 8,6 mjeseci).
Other immune-related adverse reactions
Druge imunološki uzrokovane nuspojave
• diarrhoea (loose stools).
• proljev (meka stolica)
• If you are able to become pregnant, you must use an effective method of contraception to avoid becoming pregnant: while you are being treated with LIBTAYO and for at least 4 months after the last dose.
• Ako možete zatrudnjeti, morate koristiti učinkovitu metodu kontracepcije da biste izbjegli trudnoću:
It is unknown whether cemiplimab is secreted in human milk.
Nije poznato izlučuje li se cemiplimab u majčino mlijeko.
Severitya
Nuspojava
• 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.
vrućica, umor ili slabost, smetenost, poteškoće s pamćenjem ili pospanost, napadaji, halucinacije (kada čujete glasove ili vidite stvari kojih nema), promjene vida, bol u oku ili crvenilo oka, izrazita mišićna slabost, promjene srčanog ritma poput ubrzanih otkucaja srca ili osjećaja preskakanja ili lupanja srca te modrice na koži ili krvarenje
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.
Imunološki uzrokovane kožne nuspojave javile su se u 12 (2,0%) od 591 bolesnika liječenog cemiplimabom, uključujući 6 (1,0%) bolesnika s imunološki uzrokovanim kožnim nuspojavama 3. stupnja.
Dosing delay or discontinuation may be required based on individual safety and tolerability.
Ovisno o sigurnosti i podnošljivosti lijeka u pojedinog bolesnika, možda će biti potrebno odgoditi ili prekinuti primjenu lijeka.
Immune-related adverse reactions (see section 4.4) Immune-related pneumonitis
Imunološki uzrokovane nuspojave (vidjeti dio 4.4)
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.
• jetrene tegobe (hepatitis) kao što su žuta boja kože ili bjeloočnica, jaka mučnina ili povraćanje, bol na desnoj strani trbuha (abdomena), pospanost, tamna mokraća (boje čaja), veća sklonost krvarenju ili nastanku modrica nego inače i manji osjećaj gladi nego inače
Patients should be managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Bolesnike treba zbrinuti prilagodbom liječenja cemiplimabom i primjenom kortikosteroida (vidjeti dio 4.2).
Immune-related adverse reactions can occur with cemiplimab.
Kod primjene cemiplimaba mogu se javiti imunološki uzrokovane nuspojave.
Storage of diluted solution
Čuvanje razrijeđene otopine
Skin adverse reactions
Kožne nuspojave
Initial dose of 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
Početna doza od 2 - 4 mg/kg prednizona ili ekvivalenta na dan, koja se zatim postupno smanjuje
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.
Imunološki uzrokovan proljev ili kolitis javio se u 7 (1,2%) od 591 bolesnika liječenog cemiplimabom, uključujući 2 (0,3%) bolesnika s imunološki uzrokovanim proljevom ili kolitisom 3. stupnja.
Hyperthyroidism occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hyperthyroidism.
Hipertireoza se javila u 11 (1,9%) od 591 bolesnika liječenog cemiplimabom, uključujući 1 (0,2%) bolesnika s hipertireozom 3. stupnja.
Dose modification
Prilagodbe doze
Diarrhoea is a composite term that includes diarrhoea and colitis.
e Proljev je skupni pojam koji obuhvaća proljev i kolitis.
Each vial contains 350 mg of cemiplimab in 7 ml.
Jedna bočica sadrži 350 mg cemiplimaba u 7 ml.
Resume LIBTAYO if hypophysitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or is otherwise clinically stable
Nastaviti primjenu lijeka LIBTAYO ako se hipofizitis poboljša do 0. - 1. stupnja i ostane na toj razini nakon smanjenja doze kortikosteroida na ≤ 10 mg prednizona ili ekvivalenta na dan ili ako je bolesnikovo stanje inače klinički stabilno
Endocrine disorders Hypothyroidism
Poremećaji štitnjače (hipotireoza/hipertireoza)
Resolution had occurred in 6 (50%) of 12 patients at the time of data cut-off.
Do trenutka prekida prikupljanja podataka kožne su se nuspojave povukle u 6 (50%) od 12 bolesnika.
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).
Mora se primjenjivati intravenskom infuzijom u trajanju od 30 minuta, kroz intravensku liniju sa sterilnim, nepirogenim ugrađenim ili pričvrsnim filtrom male sposobnosti vezanja proteina (veličine pora od 0,2 do 5 mikrometara).
Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Početna doza od 1 - 2 mg/kg prednizona ili ekvivalenta na dan, koja se zatim postupno smanjuje
Immune-related hypophysitis has been observed in patients receiving cemiplimab (see section 4.8).
U bolesnika koji su primali cemiplimab opažen je imunološki uzrokovan hipofizitis (vidjeti dio 4.8).
Adrenal insufficiency has been observed in patients receiving cemiplimab (see section 4.8).
U bolesnika koji su primali cemiplimab opažena je insuficijencija nadbubrežne žlijezde (vidjeti dio 4.8).
• Kidney problems (nephritis and kidney failure)
• bubrežne tegobe (nefritis i zatajivanje bubrega)
Immune-related endocrinopathies, defined as treatment-emergent endocrinopathies with no clear alternate aetiology, have been observed in patients receiving cemiplimab (see section 4.8).
U bolesnika koji su primali cemiplimab opažene su imunološki uzrokovane endokrinopatije, definirane kao endokrinopatije koje su se javile tijekom liječenja i nisu imale jasnu drugu etiologiju (vidjeti dio 4.8).
Duration of response (DOR)
Trajanje odgovora a
• inflammation of the liver
• upala jetre
Infusion-related reactions
Reakcije na infuziju