natgillin/translations-raw huggingface dataset:
Hyperthyroidism, adrenal insufficiency, thyroiditis
Pogosti hipertiroidizem, insuficienca nadledvične žleze, tiroiditis
The median duration was not estimable (range: 2 days to more than 6 months).
Mediane trajanja ni bilo možno oceniti (razpon: 2 dni do več kot 6 mesecev).
The median time to onset of immune-related nephritis was 1.2 months (range: 2.9 weeks to 1.8 months).
Mediana časa do nastopa imunsko pogojenega nefritisa je bila 1,2 meseca (razpon: 2,9 tedna do 1,8 meseca).
Immune-related thyroid disorders, immune-related adrenal insufficiency, and Type 1 diabetes mellitus have been reported in patients receiving avelumab (see section 4.8).
Pri bolnikih, ki so prejemali avelumab, so poročali o imunsko pogojenih motnjah delovanja žleze ščitnice, insuficienci nadledvične žleze in sladkorni bolezni tipa 1 (glejte poglavje 4.8).
Of the 88 patients, 65 (74%) were male, the median age was 73 years (range 33 years to 88 years), 81 (92%) patients were Caucasian, and 49 (56%) patients and 39 (44%) patients with an Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1, respectively.
Od 88 bolnikov jih je bilo 65 (74 %) moških, mediana starosti je bila 73 let (razpon 33 let do 88 let), 81 (92 %) bolnikov je bilo belcev in 49 (56 %) bolnikov oz. 39 (44 %) bolnikov je imelo status zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 0 oz. 1.
Patients with active or a history of central nervous system (CNS) metastasis; active or a history of autoimmune disease; a history of other malignancies within the last 5 years; organ transplant; conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C were excluded.
aktivno ali preteklo avtoimunsko bolezenijo; drugimi preteklimi malignimi boleznimi v zadnjih 5 letih; presaditvijo organa; stanji, zaradi katerih je potrebna terapevtska supresija imunskega odziva, ali aktivno okužbo z virusom HIV, hepatitisom B ali C.
Autoimmune thyroiditis, hypophysitis
Občasni avtoimunski tiroiditis, vnetje hipofize
• Redness in the skin
• rdečina kože
Hypersensitivity
Pogosti preobčutljivost
Table 4: Response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part A)*
Preglednica 4: Odziv na avelumab v odmerku 10 mg/kg vsaka 2 tedna pri bolnikih z metastatskim KMC v študiji EMR100070-003 (del A)*
After administration of Bavencio, the line should be flushed with either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection.
Po dajanju zdravila Bavencio morate linijo izprati z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje ali natrijevim kloridom 4,5 mg/ml (0,45 %) raztopino za injiciranje.
Myocarditis*
Redki miokarditis*
Immune-related hepatitis resolved in 9 (56%) of the 16 patients at the time of data cut-off.
Imunsko pogojeni hepatitis je po presečnih podatkih izzvenel pri 9 (56 %) bolnikih od
A new ADA method with improved sensitivity and drug tolerance was used in the RCC population.
KLC so uporabili novo metodo testiranja protiteles proti zdravilu z izboljšano občutljivostjo in toleranco za zdravilo.
Adrenal insufficiency resolved in 4 (44.4%) of the 9 patients at the time of data cut-off.
Insuficienca nadledvične žleze je po presečnih podatkih izzvenela pri 4 (44,4 %) bolnikih od
In this patient population, the most common adverse reactions with avelumab were fatigue (32.4%), nausea (25.1%), diarrhoea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight decreased (16.6%), and vomiting (16.2%).
(25,1 %), driska (18,9 %), zmanjšan apetit (18,4 %), zaprtost (18,4 %), reakcije, povezane z infundiranjem (17,1 %), zmanjšanje telesne mase (16,6 %) in bruhanje (16,2 %).
Of the 39 patients, 30 (77%) were male, the median age was 75 years (range: 47 to 88 years), 33 (85%) were Caucasian, and 31 (79%) and 8 (21%) had an ECOG performance status of 0 and 1 respectively.
Od 39 bolnikov je bilo 30 (77 %) moških, mediana starosti je bila 75 let (razpon: od 47 do 88 let), 33 (85 %) je bilo belcev in 31 (79 %) oz. 8 (21 %) je imelo status zmogljivosti po ECOG 0 oz. 1.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Fatigue has been reported following administration of avelumab (see section 4.8).
Po dajanju avelumaba so poročali o utrujenosti (glejte poglavje 4.8).
Hypothyroidism*
Pogosti hipotiroidizem*
Minimum, maximum (months) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI) ≥ 24 months by K-M, (95% CI) ≥ 36 months by K-M, (95% CI)
≥ 6 mesecev po K-M (95 % IZ) ≥ 12 mesecev po K-M (95 % IZ) ≥ 24 mesecev po K-M (95 % IZ) ≥ 36 mesecev po K-M (95 % IZ)
All 13 patients with immune-related colitis were treated with corticosteroids and 12 (92.3%) of the 13 patients received high-dose corticosteroids for a median of 2.3 weeks (range: 5 days to 4.6 months).
Vseh 13 bolnikov z imunsko pogojenim kolitisom je bilo zdravljenih s kortikosteroidi in 12 (92,3 %) od 13 bolnikov je dobivalo velike odmerke kortikosteroidov za mediano 2,3 tedna (razpon: 5 dni do 4,6 meseca).
The clinical utility of PD-L1 as a predictive biomarker in MCC has not been established.
b Na podlagi podatkov o bolnikih, ki jih je bilo mogoče oceniti za MCV z imunohistokemijo (IHC) Klinična uporabnost PD-L1 kot napovedni biomarker pri KMC ni bila dokazana.
Drug hypersensitivity, hypersensitivity anaphylactic reaction, Type I hypersensitivity
Občasni preobčutljivost na zdravilo, preobčutljivostna anafilaktična reakcija, preobčutljivost tipa I
Patients should be monitored for signs and symptoms of immune-related pneumonitis and causes other than immune-related pneumonitis should be ruled out.
Bolnike je treba spremljati zaradi pojava znakov in simptomov imunsko pogojenega pnevmonitisa in izločiti druge razloge za pnevmonitis.
All 8 patients with immune-related adrenal insufficiency were treated with corticosteroids, 4 (50%) of the 8 patients received high-dose systemic corticosteroids (≥ 40 mg prednisone or equivalent) followed by a taper for a median of 1 day (range: 1 day to 24 days).
Vseh 8 bolnikov z imunsko pogojeno insuficienco nadledvične žleze je bilo zdravljenih s kortikosteroidi, od katerih so bili 4 (50 %) zdravljeni z velikimi odmerki sistemskih kortikosteroidov (≥ 40 mg prednizona ali enakovrednega zdravila), ki mu sledi postopno zmanjševanje za mediano 1 dan (razpon: 1 dan do 24 dni).
Grade 3 or Grade 4 infusion-related reaction
Neželeni učinki 3. ali 4. stopnje, povezani z infundiranjem
Immune-related pneumonitis
Imunsko pogojeni pnevmonitis
In patients treated with avelumab as monotherapy, immune-related myocarditis occurred in less than 1% (5/4,000) of patients across clinical trials in multiple tumour types and in 0.6% (3/489) of patients receiving avelumab in combination with axitinib including 2 (0.4%) patients with fatal outcome.
Pri bolnikih, zdravljenih z avelumabom v monoterapiji, se je imunsko pogojeni miokarditis razvil pri manj kot 1 % (5/4.000) bolnikov v vseh kliničnih študijah pri različnih tipih tumorjev in pri 0,6 % (3/489) bolnikov, zdravljenih z avelumabom v kombinaciji z aksitinibom, vključno z 2 (0,4 %)
Patient distribution by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups was 21% favourable, 62% intermediate, and 16% poor.
Database Consortium) je bila 21 % ugodna, 62 % srednje ugodna in 16 % slaba.
• inflammation of your heart (myocarditis);
• vnetje trebušne slinavke (pankreatitis), • vnetje srca (miokarditis),
Dose reduction according to the axitinib product information should be considered if rechallenging with axitinib.
Pri ponovni uvedbi aksitiniba je treba upoštevati zmanjšanje odmerka skladno z informacijami o zdravilu, ki vsebuje aksitinib.
No dose adjustment is needed for patients with mild hepatic impairment (see section 5.2).
Pri bolnikih z blago okvaro jeter odmerka ni treba prilagajati (glejte poglavje 5.2).
If you suffer from any of these you should seek urgent medical attention:
Če pri sebi opazite kar koli od naslednjega, poiščite nujno zdravniško pomoč: • neželeni učinki, povezani z infuzijo,
Avelumab should be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for Grade 4 immune-related adverse reaction (see section 4.2).
Uporabo avelumaba je treba trajno prekiniti pri vseh imunsko pogojenih neželenih učinkih 3. stopnje, ki se ponavljajo, in pri imunsko pogojenih neželenih učinkih 4. stopnje (glejte poglavje 4.2).
In patients treated with avelumab as monotherapy, immune-related pancreatitis occurred in less than 1% (1/4,000) of patients across clinical trials in multiple tumour types and in 0.6% (3/489) of patients receiving avelumab in combination with axitinib including 2 (0.4%) patients with fatal outcome.
Pri bolnikih, zdravljenih z avelumabom v monoterapiji, se je imunsko pogojeni pankreatitis razvil pri manj kot 1 % (1/4.000) bolnikov v vseh kliničnih študijah pri različnih tipih tumorjev in pri 0,6 % (3/489) bolnikov, zdravljenih z avelumabom v kombinaciji z aksitinibom, vključno z 2 (0,4 %)
• Signs of type 1 diabetes may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired.
• Znaki sladkorne bolezni tipa 1 lahko vključujejo večji občutek lakote ali žeje kot običajno,
Handling instructions An aseptic technique for the preparation of the solution for infusion should be used.
Za pripravo raztopine za infundiranje uporabljajte aseptično tehniko.
Corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper) should be administered for Grade ≥ 2 nephritis.
Kortikosteroide (začetni odmerek 1 do 2 mg/kg/dan prednizona ali enakovrednega zdravila, ki mu sledi postopno zmanjševanje kortikosteroida) je treba dati za nefritis stopnje ≥ 2.
The median time to onset of immune-related pneumonitis was 2.5 months (range: 3 days to 11 months).
Mediana časa do nastopa imunsko pogojenega pnevmonitisa je bila 2,5 meseca (razpon: 3 dni do 11 mesecev).
Immune-related pancreatitis has been reported in patients receiving avelumab.
Imunsko pogojeni pankreatitis Pri bolnikih, ki so prejemali avelumab, so poročali o imunsko pogojenem pankreatitisu.
• The diluted solution should be mixed by gently inverting the bag in order to avoid foaming or excessive shearing of the solution.
• Razredčeno raztopino premešajte tako, da vrečo nežno obrnete.
Dysphonia, cough, dyspnoea
Zelo pogosti disfonija, kašelj, dispneja
Animal reproduction studies have not been conducted with avelumab.
Študij o delovanju avelumaba na sposobnost razmnoževanja pri živalih niso izvedli.
Bavencio 20 mg/mL concentrate for solution for infusion avelumab
Bavencio 20 mg/ml koncentrat za raztopino za infundiranje avelumab
Nephritis and renal dysfunction
Nefritis in motnje delovanja ledvic
Of the 116 patients, 81 (70%) were male, the median age was 74 years (range: 41 to 93 years), 75 (65%) were Caucasian, and 72 (62%) and 44 (38%) had an ECOG performance status of 0 and 1, respectively.
Od 116 bolnikov je bilo 81 (70 %) moških, mediana starosti je bila 74 let (razpon: od 41 do 93 let), 75 (65 %) je bilo belcev in 72 (62 %) oz. 44 (38 %) je imelo status zmogljivosti po ECOG 0 oz. 1.
The median duration was 1.6 weeks (range: 1 day to more than 9 months).
Mediana trajanja je bila 1,6 tedna (razpon: 1 dan do več kot 9 mesecev).
Rechallenge with Bavencio or axitinib or sequential rechallenge with both Bavencio and axitinib after recovery should be considered.
Po okrevanju je treba razmisliti o ponovni uvedbi zdravljenja z zdravilom Bavencio ali aksitinibom ali zaporedni ponovni uvedbi zdravljenja z zdravilom Bavencio in aksitinibom.
Bavencio 20 mg/mL concentrate for solution for infusion
Bavencio 20 mg/ml koncentrat za raztopino za infundiranje
The median duration was 6 weeks (range: 1 day to more than 14 months).
Mediana trajanja je bila 6 tednov (razpon: 1 dan do več kot 14 mesecev).
Two fatal cases have been reported in patients receiving avelumab (see section 4.8).
Pri bolnikih, ki so prejemali avelumab, so poročali o dveh smrtnih primerih (glejte poglavje 4.8).
Immune-related pneumonitis did not lead to discontinuation of avelumab in any patient.
Pri nobenem bolniku imunsko pogojeni pnevmonitis ni povzročil prekinitve uporabe avelumaba.
If the fourth infusion is completed without an infusion-related reaction, premedication for subsequent doses should be administered at the discretion of the physician.
Če se četrto infundiranje zaključi brez neželenih učinkov, povezanih z infundiranjem,
Table 5: Objective response rates by PD-L1 expression and MCV tumour status in patients with metastatic MCC in study EMR100070-003 (Part A)
Preglednica 5: Stopnje objektivnega odziva glede na izraženost PD-L1 in status prisotnosti tumorja MCV pri bolnikih z metastatskim KMC v študiji EMR100070-003 (del A)
• Headache, dizziness
• glavobol, omotica
The median time to onset of immune-related adrenal insufficiency was 2.5 months (range: 1 day to 8 months).
Mediana časa do nastopa imunsko pogojene insuficience nadledvične žleze je bila 2,5 meseca (razpon: 1 dan do 8 mesecev).
Two fatal cases have been reported in patients receiving avelumab in combination with axitinib (see section 4.8).
Pri bolnikih, ki so prejemali avelumab v kombinaciji z aksitinibom, so poročali o dveh smrtnih primerih (glejte poglavje 4.8).
• Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks
• Ponavljajoči imunsko pogojeni neželeni učinki 3. stopnje • Potrebno več kot 12-tedensko zdravljenje s prednizonom ali enakovrednim zdravilom 10 mg na dan
The median time to onset of immune-related hepatitis was 3.2 months (range: 1 week to 15 months).
Mediana časa do nastopa imunsko pogojenega hepatitisa je bila 3,2 meseca (razpon: 1 teden do 15 mesecev).
Avelumab was discontinued in 0.2% (1/489) of patients due to Type 1 diabetes mellitus.
Dajanje avelumaba so prekinili pri 0,2 % (1/489) bolnikov zaradi sladkorne bolezni tipa 1.
Immune-related colitis resolved in 10 (76.9%) of 13 patients at the time of data cut-off.
Imunsko pogojeni kolitis je po presečnih podatkih izzvenel pri 10 (76,9 %) bolnikih od
• Increased liver enzymes in the blood
• zvišana vrednost jetrnih encimov v krvi
Immune-related myocarditis has been reported in patients receiving avelumab.
Imunsko pogojeni miokarditis Pri bolnikih, ki so prejemali avelumab, so poročali o imunsko pogojenem miokarditisu.
Fatigue, chills, asthenia, pyrexia
Zelo pogosti utrujenost, mrzlica, astenija, pireksija,
• Signs of inflammation of the pancreas (pancreatitis) may include abdominal pain, nausea and vomiting.
• Znaki vnetja trebušne slinavke (pankreatitis) lahko vključujejo bolečine v trebuhu, navzeo in bruhanje.
Thrombocytopenia, eosinophilia§
Občasni trombocitopenija, eozinofilija§
• Cough, shortness of breath
• kašelj, kratka sapa
The median time to onset of immune-related hepatitis was 2.3 months (range: 2.1 weeks to 14.5 months).
Mediana časa do nastopa imunsko pogojenega hepatitisa je bila 2,3 meseca (razpon: 2,1 tedna do 14,5 mesecev).
One fatal case has been reported in patients receiving avelumab (see section 4.8).
Pri bolnikih, ki so prejemali avelumab, so poročali o enem smrtnem primeru (glejte poglavje 4.8).
Grade 4 colitis or diarrhoea or recurrent Grade 3 colitis
Kolitis 4. stopnje ali driska ali ponavljajoči kolitis 3. stopnje
Avelumab should be permanently discontinued if immune-related myocarditis is confirmed (see section 4.2).
Pri potrjenem imunsko pogojenem miokarditisu je treba zdravljenje z avelumabom trajno ukiniti (glejte poglavje 4.2).
Of these patients, there was 1 (0.2%) patient with Grade 3 Type 1 diabetes mellitus.
Od teh je imel 1 (0,2 %) bolnik sladkorno bolezen tipa 1 3. stopnje.
In patients treated with avelumab in combination with axitinib, immune-related nephritis occurred in 0.4% (2/489) of patients.
Pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, se je imunsko pogojeni nefritis pojavil pri 0,4 % (2/489) bolnikov.
Avelumab was discontinued in 0.4% (2/489) of patients due to immune-related colitis.
Dajanje avelumaba so prekinili pri 0,4 % (2/489) bolnikov zaradi imunsko pogojenega kolitisa.
For information on the posology of axitinib, please refer to the axitinib product information.
Za informacije o odmerjanju aksitiniba glejte informacije o zdravilu, ki vsebuje aksitinib.
Anaemia, thrombocytopenia
Pogosti anemija, trombocitopenija
Rare
Občasni
Avelumab should be withheld for Grade 2 immune-related pneumonitis until resolution, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 immune-related pneumonitis (see section 4.2).
Pri imunsko pogojenem pnevmonitisu 2. stopnje je treba uporabo avelumaba odložiti, dokler pojav ne izzveni, medtem ko je treba pri imunsko pogojenem pnevmonitisu 3. stopnje ali 4. stopnje ali ponavljajočem imunsko pogojenem pnevmonitisu 2. stopnje zdravljenje trajno ukiniti (glejte poglavje 4.2).
Autoimmune hepatitis*, acute hepatic failure*, hepatic failure*, hepatitis*
Bolezni jeter, žolčnika in žolčevodov Občasni avtoimunski hepatitis*, akutna odpoved jeter*, odpoved jeter*, hepatitis*
• Numbness, tingling, weakness, burning sensation in arms or legs
• zmanjšano število trombocitov v krvi • odrevenelost, mravljinci, oslabelost, pekoč občutek v rokah in nogah
In patients treated with avelumab as monotherapy, 1.2% (21/1,738) of patients developed immune-related pneumonitis.
Pri bolnikih, zdravljenih z avelumabom v monoterapiji, se je imunsko pogojeni pnevmonitis razvil pri 1,2 % (21/1.738) bolnikov.
Hepatic function abnormal
Pogosti nenormalno delovanje jeter
The median time to onset of thyroid disorders was 2.8 months (range: 3.6 weeks to 19.3 months).
Mediana časa do nastopa imunsko pogojenih motenj delovanja ščitnice je bila 2,8 meseca (razpon: 3,6 tedna do 19,3 meseca).
Immune-related pancreatitis
Imunsko pogojeni pankreatitis
Type 1 diabetes mellitus
Sladkorna bolezen tipa 1:
Of these patients, there was 1 (0.1%) patient with Grade 3 immune-related adrenal insufficiency.
Od teh je imel 1 (0,1 %) bolnik imunsko pogojeno insuficienco nadledvične žleze 3. stopnje.
Diabetes mellitus, Type 1 diabetes mellitus
Občasni sladkorna bolezen, sladkorna bolezen tipa 1
What Bavencio is and what it is used for What you need to know before you use Bavencio How to use Bavencio
Kaj morate vedeti, preden boste uporabili zdravilo Bavencio 3.
All 21 patients with immune-related pneumonitis were treated with corticosteroids and 17 (81%) of the 21 patients were treated with high-dose corticosteroids for a median of 8 days (range: 1 day to
Vseh 21 bolnikov z imunsko pogojenim pnevmonitisom je bilo zdravljenih s kortikosteroidi, od katerih jih je bilo 17 (81 %) zdravljenih z velikimi odmerki kortikosteroidov za mediano 8 dni (razpon: 1 dan do 2,3 mesece).
Immune-related nephritis and renal dysfunction Avelumab can cause immune-related nephritis (see section 4.8).
Avelumab lahko povzroči imunsko pogojeni nefritis (glejte poglavje 4.8).
Of these patients, there were 7 (0.4%) patients with Grade 3 immune-related colitis.
Od teh je imelo 7 (0,4 %) bolnikov imunsko pogojeni kolitis 3. stopnje.
Avelumab was discontinued in 0.3% (6/1,738) of patients due to immune-related pneumonitis.
Dajanje avelumaba so prekinili pri 0,3 % (6/1.738) bolnikov zaradi imunsko pogojenega pnevmonitisa.
Immune-related nephritis and renal dysfunction In patients treated with avelumab as monotherapy, immune-related nephritis occurred in 0.1% (1/1,738) of patients receiving avelumab leading to permanent discontinuation of avelumab.
Pri bolnikih, zdravljenih z avelumabom v monoterapiji, se je imunsko pogojeni nefritis, zaradi katerega je bilo zdravljenje z avelumabom trajno prekinjeno, pojavil pri 0,1 % (1/1.738) bolnikov, ki so dobivali avelumab.
In patients treated with avelumab in combination with axitinib, 6.3% (31/489) of patients developed immune-related hepatitis.
Pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, se je imunsko pogojeni hepatitis razvil pri 6,3 % (31/489) bolnikov.
In patients treated with avelumab as monotherapy, 0.9% (16/1,738) of patients developed immune-related hepatitis.
Pri bolnikih, zdravljenih z avelumabom v monoterapiji, se je imunsko pogojeni hepatitis razvil pri 0,9 % (16/1.738) bolnikov.
Avelumab should be permanently discontinued if immune-related pancreatitis is confirmed (see section 4.2).
Pri potrjenem imunsko pogojenem pankreatitisu je treba zdravljenje z avelumabom trajno ukiniti (glejte poglavje 4.2).
Patients should be monitored for signs and symptoms of adrenal insufficiency during and after treatment.
Bolnike je treba med zdravljenjem in po njem spremljati zaradi pojava znakov in simptomov insuficience nadledvične žleze.
Fertility studies have not been conducted with avelumab.
Študij vpliva avelumaba na plodnost niso izvedli.
Avelumab should be withheld for Grade 2 hepatotoxicity until resolution and permanently discontinued for Grade 3 or Grade 4 hepatotoxicity.
Pri hepatotoksičnosti 2. stopnje je treba uporabo avelumaba odložiti, dokler pojav ne izzveni, pri hepatotoksičnosti 3. stopnje ali 4. stopnje pa je treba zdravljenje trajno ukiniti.
Grade 2 infusion-related reaction
Neželeni učinki 2. stopnje, povezani z infundiranjem
Concentrate for solution for infusion (sterile concentrate).
koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra, brezbarvna do rumenkasta raztopina.
Rash pruritic*, erythema*, rash generalised*, psoriasis*, rash erythematous*, rash macular*, rash papular*, dermatitis exfoliative*, erythema multiforme*, pemphigoid*, pruritus generalised*, eczema, dermatitis
Občasni pruritični izpuščaj*, eritem*, generalizirani izpuščaj*, psoriaza*, eritematozni izpuščaj*, makularni izpuščaj*, papularni izpuščaj*, eksfoliativni dermatitis*,
Diarrhoea, nausea, constipation, vomiting, abdominal pain
Zelo pogosti diareja, navzea, zaprtje, bruhanje, bolečine v trebuhu
Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related hepatitis.
Dajanje avelumaba so prekinili pri 0,5 % (9/1.738) bolnikov zaradi imunsko pogojenega hepatitisa.
Immune-related colitis Immune-related colitis has been reported in patients receiving avelumab (see section 4.8).
Imunsko pogojeni kolitis Pri bolnikih, ki so prejemali avelumab, so poročali o imunsko pogojenem kolitisu (glejte poglavje 4.8).
Adverse reactions Infections and infestations
Infekcijske in parazitske bolezni
The median time to onset of immune-related colitis was 2.1 months (range: 2 days to 11 months).
Mediana časa do nastopa imunsko pogojenega kolitisa je bila 2,1 meseca (razpon: 2 dni do 11 mesecev).
The median time to onset of immune-related colitis was 5.1 months (range: 2.3 weeks to 14 months).
Mediana časa do nastopa imunsko pogojenega kolitisa je bila 5,1 meseca (razpon: 2,3 tedna do 14 mesecev).
• Dryness in the mouth
• bolečine v mišicah
Efficacy endpoints (Part B) (per RECIST v1.1, IERC)
(po RECIST v1.1, IERC)
All 16 patients with immune-related hepatitis treated with corticosteroids and 15 (94%) of the 16 patients received high-dose corticosteroids for a median of 14 days (range: 1 day to 2.5 months).
Vseh 16 bolnikov z imunsko pogojenim hepatitisom je bilo zdravljenih s kortikosteroidi, od katerih jih je bilo 15 (94 %) zdravljenih z velikimi odmerki kortikosteroidov za mediano 14 dni (razpon: 1 dan do 2,5 meseca).
Patients should be monitored for signs and symptoms of immune-related colitis and causes other than immune-related colitis should be ruled out.
Bolnike je treba spremljati zaradi pojava znakov in simptomov imunsko pogojenega kolitisa in izločiti druge razloge za kolitis.
Type 1 diabetes mellitus did not resolve in any of the patients at the time of data cut-off.
Sladkorna bolezen tipa I po presečnih podatkih ni izzvenela pri nobenem od bolnikov.
All 26 patients with immune-related colitis were treated with corticosteroids and 15 (58%) of the 26 patients received high-dose corticosteroids for a median of 19 days (range: 1 day to 2.3 months).
Vseh 26 bolnikov z imunsko pogojenim kolitisom je bilo zdravljenih s kortikosteroidi, od katerih jih je bilo 15 (58 %) zdravljenih z velikimi odmerki kortikosteroidov za mediano 19 dni (razpon: 1 dan do 2,3 meseca).