natgillin/translations-raw huggingface dataset:
In patients treated with avelumab as monotherapy, Type 1 diabetes mellitus without an alternative aetiology occurred in 0.1% (2/1,738) of patients including two Grade 3 reactions that led to permanent discontinuation of avelumab.
Šećerna bolest tipa 1 U bolesnika liječenih avelumabom kao monoterapijom, šećerna bolest tipa 1 koja nije imala drugi uzrok nastala je u 0,1 % (2/1738) bolesnika uključujući dvije reakcije 3. stupnja koje su dovele do trajnog prestanka primjene avelumaba.
• Signs of type 1 diabetes may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired.
• Znakovi šećerne bolesti tipa 1 mogu uključivati jači osjećaj gladi ili žeđi nego obično,
Adverse reactions reported for 489 patients with advanced RCC treated in two clinical studies with avelumab in combination with axitinib are presented in Table 3.
Tablični popis nuspojava Nuspojave zabilježene u 489 bolesnika s uznapredovalim karcinomom bubrežnih stanica liječenih avelumabom u kombinaciji s aksitinibom u dva klinička ispitivanja prikazane su u tablici
Eight (88.9%) patients with immune-related adrenal insufficiency were treated with corticosteroids and 2 (25%) of the 8 patients received high-dose corticosteroids (≥ 40 mg prednisone or equivalent) for a median of 8 days (range: 5 days to 11 days).
Osam (88,9 %) bolesnika s imunološki posredovanom adrenalnom insuficijencijom liječeno je kortikosteroidima, a 2 (25 %) od tih 8 bolesnika primalo je visoke doze kortikosteroida (≥ 40 mg prednizona ili ekvivalentnog lijeka) tijekom medijana od 8 dana (raspon: od 5 dana do 11 dana).
may include extreme tiredness, rapid heartbeat, increased sweating, changes in mood or behaviour, such as irritability or forgetfulness, feeling cold, very low blood pressure (fainting, dizziness, fatigue, nausea), weight change or headache.
• Znakovi upale žlijezda koje stvaraju hormone (što može utjecati na rad žlijezda) mogu uključivati izrazito jak umor, ubrzane otkucaje srca, pojačano znojenje, promjene raspoloženja ili ponašanja, kao što su razdražljivost ili zaboravljivost, osjećaj hladnoće, vrlo nizak krvni tlak (nesvjestica, omaglica, umor, mučnina), promjenu tjelesne težine ili glavobolju.
The median time to onset of immune-related nephritis was 1.2 months (range: 2.9 weeks to 1.8 months).
Medijan vremena do nastupa imunološki posredovanog nefritisa iznosio je 1,2 mjeseca (raspon: od 2,9 tjedana do 1,8 mjeseci).
Handling instructions An aseptic technique for the preparation of the solution for infusion should be used.
Za pripremu otopine za infuziju potrebno je koristiti aseptičku tehniku.
If you are a woman who could become pregnant, you must use effective contraceptives while you are being treated with Bavencio and for at least 1 month after your last dose.
Ako ste žena koja može zatrudnjeti, morate koristiti učinkovitu kontracepciju dok se liječite lijekom
IV after dilution
Intravenska primjena nakon razrjeđivanja
Severity*
Težina*
Treatment modifications when Bavencio is used in combination with axitinib If ALT or AST ≥ 3 times ULN but < 5 times ULN or total bilirubin ≥ 1.5 times ULN but < 3 times ULN, both Bavencio and axitinib should be withheld until these adverse reactions recover to Grades 0-1.
Ako su ALT ili AST ≥ 3 puta iznad GGN-a, ali < 5 puta iznad GGN-a ili je ukupni bilirubin ≥ 1,5 puta iznad GGN-a, ali < 3 puta iznad GGN-a, potrebno je obustaviti primjenu i lijeka Bavencio i aksitiniba dok se ove nuspojave ne povuku na 0. - 1. stupanj.
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.
Imunološki posredovan miokarditis U bolesnika liječenih avelumabom kao monoterapijom, imunološki posredovan miokarditis pojavio se u manje od 1 % (5/4000) bolesnika u kliničkim ispitivanjima više vrsta tumora i u 0,6 % (3/489) bolesnika koji su primali avelumab u kombinaciji s aksitinibom, uključujući i 2 (0,4 %) bolesnika sa smrtnim ishodom.
The median duration was 7 weeks (range: 4 days to more than 4 months).
Medijan trajanja iznosio je 7 tjedana (raspon: od 4 dana do više od 4 mjeseca).
Complete response (CR)** n (%) Partial response (PR)** n (%)
Potpuni odgovor (CR)** n (%)
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 tih 116 bolesnika, 81 (70 %) su bili muškarci, medijan dobi iznosio je 74 godine (raspon: od 41 do 93 godina), 75 (65 %) bili su bijelci, a njih 72 (62 %) i 44 (38 %) imalo je ECOG funkcionalni status 0 odnosno 1.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity in Cynomolgus monkeys administered intravenously doses of 20, 60 or 140 mg/kg once a week for1 month and 3 months, followed by a 2-month recovery period after the 3-month dosing period.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza u makaki majmuna kojima su intravenski bile primijenjene doze od 20,
Median in months (95% CI)
medijan, mjeseci (95% CI)
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 tih 39 bolesnika, njih 30 (77 %) bili su muškarci, medijan dobi iznosio je 75 godina (raspon: od 47 do 88 godina), 33 (85 %) bili su bijelci, a 31 (79 %) bolesnik i 8 (21 %) bolesnika imalo je ECOG funkcionalni status 0 odnosno 1.
In patients treated with avelumab in combination with axitinib, immune-related nephritis occurred in 0.4% (2/489) of patients.
U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, imunološki posredovan nefritis nastao je u 0,4 % (2/489) bolesnika.
Based on the severity of the adverse reaction, avelumab should be withheld and corticosteroids to be administered.
Na temelju težine nuspojave, avelumab treba privremeno obustaviti i primijeniti kortikosteroide.
For information on the posology of axitinib, please refer to the axitinib product information.
Za informacije o doziranju aksitiniba, vidjeti informacije o lijeku za aksitinib.
Of these patients, there were 9 (1.8%) patients with Grade 3 immune-related colitis.
Među tim bolesnicima, njih 9 (1,8 %) imalo je imunološki posredovan kolitis 3. stupnja.
Table 6: Subsequent interim analysis of response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part B)*
Tablica 6: Kasnija interim analiza odgovora na avelumab u dozi od 10 mg/kg primijenjenog svaka 2 tjedna u bolesnika s metastatskim karcinomom Merkelovih stanica u ispitivanju EMR100070-003 (dio B)*
No clinically important differences in the clearance of avelumab were found between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin between 1 and 1.5 times ULN, n=217) and normal hepatic function (bilirubin and AST ≤ ULN, n=1,388) in a population PK analysis.
Analizom populacijske farmakokinetike nisu pronađene klinički važne razlike u klirensu avelumaba između bolesnika s blagim oštećenjem funkcije jetre (bilirubin ≤ GGN i AST > GGN ili bilirubin između 1 i 1,5 puta iznad GGN-a n=217) i normalnom funkcijom jetre (bilirubin i AST ≤ GGN,
• Increased muscle enzyme in the blood
• povišeni mišićni enzimi u krvi
Immune-related pneumonitis did not lead to discontinuation of avelumab in any patient.
Imunološki posredovan pneumonitis nije doveo do prekida primjene avelumaba ni u jednog bolesnika.
Table 4: Response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part A)*
Tablica 4: Odgovor na avelumab u dozi od 10 mg/kg svaka 2 tjedna u bolesnika s metastatskim karcinomom Merkelovih stanica u ispitivanju EMR100070-003 (dio A)*
• Patient Alert Card
• Karticu s upozorenjima za bolesnika
Bavencio 20 mg/mL sterile concentrate avelumab
Bavencio 20 mg/ml sterilni koncentrat avelumab i.v. nakon razrjeđivanja
Drug hypersensitivity, hypersensitivity anaphylactic reaction, Type I hypersensitivity
Manje često preosjetljivost na lijek, anafilaktička reakcija preosjetljivosti, preosjetljivost tipa
Dose reduction according to the axitinib product information should be considered if rechallenging with axitinib.
U slučaju ponovnog uvođenja aksitiniba, treba razmotriti sniženje doze u skladu s informacijama o lijeku za aksitinib.
The median time to onset of thyroid disorders was 2.8 months (range: 3.6 weeks to 19.3 months).
Medijan vremena do nastupa poremećaja štitne žlijezde iznosio je 2,8 mjeseci (raspon: od 3,6 tjedana do 19,3 mjeseca).
Avelumab was discontinued in 4.7% (23/489) of patients due to immune-related hepatitis.
Primjena avelumaba prekinuta je zbog imunološki posredovanog hepatitisa u 4,7 % (23/489) bolesnika.
Your doctor may
Liječnik Vam može:
Of these patients, there was 1 (0.2%) patient with Grade 3 Type 1 diabetes mellitus.
Među njima je bio 1 (0,2 %) bolesnik s 3. stupnjem šećerne bolesti tipa 1.
If you are breast-feeding, tell your doctor.
Ako dojite, obavijestite liječnika.
Based on the severity of the adverse reaction, avelumab should be withheld and corticosteroids administered.
Na temelju težine nuspojave, primjenu avelumaba treba privremeno obustaviti i primijeniti kortikosteroide.
Immune-related pancreatitis
Imunološki posredovan pankreatitis
Table 5: Objective response rates by PD-L1 expression and MCV tumour status in patients with metastatic MCC in study EMR100070-003 (Part A)
Tablica 5: Stope objektivnog odgovora prema ekspresiji PD-L1 i MCV tumorskom statusu bolesnika s metastatskim karcinomom Merkelovih stanica u ispitivanju EMR100070-003 (dio A)
Grade 4 colitis or diarrhoea or recurrent Grade 3 colitis
Kolitis ili proljev 4. stupnja ili rekurentni kolitis 3. stupnja
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).
Svih 8 bolesnika s imunološki posredovanom adrenalnom insuficijencijom bilo je liječeno kortikosteroidima, a 4 (50 %) od tih 8 bolesnika primilo je visoke doze sistemskih kortikosteroida (≥ 40 mg prednizona ili ekvivalentni lijek) koje su postupno snižene tijekom medijana od 1 dana (raspon: od 1 dana do 24 dana).
• Red, itchy, scaly patches on the skin, acne-like rash
• crvene, ljuskave mrlje na koži koje svrbe, osip nalik aknama • oticanje ruku, stopala ili nogu
The median time to onset of immune-related adrenal insufficiency was 2.5 months (range: 1 day to 8 months).
Medijan vremena do nastupa imunološki posredovane adrenalne insuficijencije iznosio je 2,5 mjeseci (raspon: od 1 dana do 8 mjeseci).
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).
Svih 13 bolesnika s imunološki posredovanim kolitisom bilo je liječeno kortikosteroidima, a 12 (92,3 %) od 13 bolesnika primalo je visoke doze kortikosteroida tijekom medijana od 2,3 tjedna (raspon: od 5 dana do 4,6 mjeseci).
In this patient population, the most common adverse reactions were diarrhoea (62.8%), hypertension (49.3%), fatigue (42.9%), nausea (33.5%), dysphonia (32.7%), decreased appetite (26.0%), hypothyroidism (25.2%), cough (23.7%), headache (21.3%), dyspnoea (20.9%), and arthralgia
(42,9%), mučnina (33,5%), disfonija (32,7%), smanjeni apetit (26,0%), hipotireoza (25,2%), kašalj
Bavencio 20 mg/mL concentrate for solution for infusion avelumab
Bavencio 20 mg/ml koncentrat za otopinu za infuziju avelumab
Patient distribution by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups was 21% favourable, 62% intermediate, and 16% poor.
Consortium, IMDC) bila je sljedeća: 21% povoljno, 62% srednje i 16% loše.
What Bavencio is and what it is used for What you need to know before you use Bavencio How to use Bavencio
Što morate znati prije nego počnete primjenjivati Bavencio
The median duration was 1.6 weeks (range: 1 day to more than 9 months).
Medijan trajanja iznosio je 1,6 tjedana (raspon: od 1 dan do više od 9 mjeseci).
Avelumab pharmacokinetics (PK) was assessed using a population PK approach for avelumab as monotherapy and avelumab in combination with axitinib.
Farmakokinetika avelumaba u monoterapiji i avelumaba u kombinaciji s aksitinibom procijenjena je metodom populacijske farmakokinetike.
Common (may affect up to 1 in 10 people)
Često (mogu se javiti u najviše 1 na 10 osoba)
Due date
2 godine
Rash*, pruritus*, rash maculo-papular*, dry skin
Poremećaji kože i potkožnog tkiva Često osip*, pruritus*, makulopapulozni osip*, suha koža
Table 5 summarises the PD-L1 expression and MCV status of patients with metastatic MCC in study EMR100070-003 (Part A).
sažeto su prikazani ekspresija PD-L1 i MCV status bolesnika s metastatskim karcinomom Merkelovih stanica u ispitivanju EMR100070-003 (dio A).
In patients treated with avelumab in combination with axitinib, Type 1 diabetes mellitus without an alternative aetiology occurred in 1.0% (5/489) of patients.
U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, šećerna bolest tipa 1 koja nije imala drugi uzrok nastala je u 1,0 % (5/489) bolesnika.
Acute kidney injury
Često akutno oštećenje bubrega
Adverse reactions reported for 88 patients with metastatic MCC and for 1,650 patients in a phase I study in solid tumours are presented in Table 2.
Nuspojave zabilježene u 88 bolesnika s metastatskim karcinomom Merkelovih stanica i u 1650 bolesnika sa solidnim tumorima u ispitivanju faze I prikazane su u tablici 2. U oba se ispitivanja avelumab primjenjivao u dozi od 10 mg/kg svaka 2 tjedna.
Avelumab was discontinued in 0.2% (1/489) of patients due to Type 1 diabetes mellitus.
Primjena avelumaba prekinuta je zbog šećerne bolesti tipa 1 u 0,2 % (1/489) bolesnika.
N=77b
N=77b pozitivan (n=46)
Bavencio 20 mg/mL concentrate for solution for infusion
Bavencio 20 mg/ml koncentrat za otopinu za infuziju
The median time to onset of immune-related pneumonitis was 2.5 months (range: 3 days to 11 months).
Medijan vremena do nastupa imunološki posredovanog pneumonitisa iznosio je 2,5 mjeseci (raspon: od 3 dana do 11 mjeseci).
• inflammation of your intestines (colitis), diarrhoea (watery, loose or soft stools) or more bowel movements than usual;
• upala crijeva (kolitis), proljev (vodenaste, rijetke ili mekane stolice) ili učestalija stolica nego obično • upala gušterače (pankreatitis)
Immune-related nephritis did not lead to discontinuation of avelumab in any patient.
Imunološki posredovan nefritis nije doveo do prekida primjene avelumaba ni u jednog bolesnika.
Uncommon (may affect up to 1 in 100 people)
Manje često (mogu se javiti u najviše 1 na 100 osoba)
The median duration was 6 weeks (range: 1 day to more than 14 months).
Medijan trajanja iznosio je 6 tjedana (raspon: od 1 dana do više od 14 mjeseci).
Corticosteroids should be administered (1 to 2 mg/kg/day prednisone intravenously or oral equivalent) for Grade ≥ 3 adrenal insufficiency followed by a taper until a dose of less than or equal to 10 mg/day has been reached.
(1 do 2 mg/kg na dan prednizona intravenski ili peroralni ekvivalent) i potom postupno snižavati dozu sve dok se ne dosegne doza od 10 mg/dan ili niža.
No dose adjustment is needed for patients with mild or moderate renal impairment (see section 5.2).
U bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
No dose adjustment is needed for patients with mild hepatic impairment (see section 5.2).
U bolesnika s blagim oštećenjem funkcije jetre nije potrebna prilagodba doze (vidjeti dio 5.2).
Immune-related nephritis and renal dysfunction Avelumab can cause immune-related nephritis (see section 4.8).
Avelumab može uzrokovati imunološki posredovan nefritis (vidjeti dio 4.8).
In patients treated with avelumab as monotherapy, 1.2% (21/1,738) of patients developed immune-related pneumonitis.
U bolesnika liječenih avelumabom kao monoterapijom, 1,2 % (21/1738) bolesnika razvilo je imunološki posredovan pneumonitis.
Avelumab should be withheld for Grade 2 hepatotoxicity until resolution and permanently discontinued for Grade 3 or Grade 4 hepatotoxicity.
Primjenu avelumaba kod hepatotoksičnosti 2. stupnja treba privremeno obustaviti do njezina povlačenja te trajno prekinuti kod hepatotoksičnosti 3. i 4. stupnja.
Two fatal cases have been reported in patients receiving avelumab in combination with axitinib (see section 4.8).
U bolesnika koji su primali avelumab u kombinaciji s aksitinibom zabilježena su dva smrtna slučaja (vidjeti dio 4.8).
Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, Guillain-Barré syndrome)
hipopituitarizam, uveitis, Guillain-Barréov sindrom)
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).
Primjenu avelumaba potrebno je trajno prekinuti kod svake imunološki posredovane nuspojave 3. stupnja koja se ponavlja te kod imunološki posredovane nuspojave 4. stupnja (vidjeti dio 4.2).
Myocarditis*
Rijetko miokarditis*
In patients treated with avelumab as monotherapy, 0.5% (8/1,738) of patients developed immune-related adrenal insufficiency.
U bolesnika liječenih avelumabom kao monoterapijom, 0,5 % (8/1738) bolesnika razvilo je imunološki posredovanu adrenalnu insuficijenciju.
• Cough, shortness of breath
• kašalj, nedostatak zraka
The median time to onset of immune-related hepatitis was 3.2 months (range: 1 week to 15 months).
Medijan vremena do nastupa imunološki posredovanog hepatitisa iznosio je 3,2 mjeseca (raspon: od 1 tjedna do 15 mjeseci).
The median time to onset of immune-related hepatitis was 2.3 months (range: 2.1 weeks to 14.5 months).
Medijan vremena do nastupa imunološki posredovanog hepatitisa iznosio je 2,3 mjeseca (raspon: od 2,1 tjedna do 14,5 mjeseci).
In patients treated with avelumab in combination with axitinib, 6.3% (31/489) of patients developed immune-related hepatitis.
U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, 6,3 % (31/489) bolesnika razvilo je imunološki posredovan hepatitis.
Treatment-related adverse reaction
Nuspojava povezana s liječenjem
Two fatal cases have been reported in patients receiving avelumab (see section 4.8).
U bolesnika koji su primali avelumab zabilježena su dva smrtna slučaja (vidjeti dio 4.8).
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).
Svih 26 bolesnika s imunološki posredovanim kolitisom bilo je liječeno kortikosteroidima, a 15 (58 %) od tih 26 bolesnika primalo je visoke doze kortikosteroida tijekom medijana od 19 dana (raspon: od 1 dana do 2,3 mjeseca).
• Skin rash, itching
• kožni osip, svrbež
Patients should be monitored for signs and symptoms of immune-related colitis and causes other than immune-related colitis should be ruled out.
Bolesnike je potrebno pratiti zbog mogućih znakova i simptoma imunološki posredovanog kolitisa te je potrebno isključiti druge uzroke osim imunološki posredovanog kolitisa.
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
Svi bolesnici s imunološki posredovanim pneumonitisom, njih ukupno 21, bili su liječeni kortikosteroidima, a 17 (81 %) bolesnika od tih 21 bilo je liječeno visokom dozom kortikosteroida tijekom medijana od 8 dana (raspon: od 1 dana do 2,3 mjeseca).
Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab (see section 4.8).
U bolesnika koji primaju avelumab zabilježene su reakcije povezane s infuzijom, koje mogu biti teške (vidjeti dio 4.8).
Avelumab should be withheld for Grade 2 immune-related hepatitis until resolution and permanently discontinued for Grade 3 or Grade 4 immune-related hepatitis (see section 4.2).
Kod imunološki posredovanog hepatitisa 2. stupnja potrebno je privremeno obustaviti primjenu avelumaba do njegovog povlačenja, a trajno prekinuti kod imunološki posredovanog hepatitisa 3. ili 4. stupnja (vidjeti dio 4.2).
Lymphopenia, eosinophilia
Manje često limfopenija, eozinofilija
Complete response (CR) n (%) Partial response (PR) n (%)
stopa objektivnog odgovora (ORR) n (%) (95% CI) potpuni odgovor (CR) n (%) djelomični odgovor (PR) n (%)
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).
Svih 16 bolesnika s imunološki posredovanim hepatitisom bilo je liječeno kortikosteroidima, a 15 (94 %) od tih 16 bolesnika primalo je visoke doze kortikosteroida tijekom medijana od 14 dana (raspon: od 1 dana do 2,5 mjeseci).
The following side effects have been reported in clinical trials with avelumab alone:
U kliničkim ispitivanjima u kojima se avelumab primjenjivao sam zabilježene su sljedeće nuspojave:
• Increased liver enzymes in the blood
• povišeni jetreni enzimi u krvi
Back pain, arthralgia
Vrlo često bol u leđima, artralgija
Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
(engl. antibody-dependent cell-mediated cytotoxicity, ADCC).
In patients treated with avelumab in combination with axitinib, 1.8% (9/489) of patients developed immune-related adrenal insufficiency.
U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, 1,8 % (9/489) bolesnika razvilo je imunološki posredovanu adrenalnu insuficijenciju.
Administer the infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or addon filter.
Primijenite infuziju kroz sterilni, nepirogeni filtar s niskom sposobnošću vezanja proteina, veličine pora 0,2 mikrometra koji je ugrađen ili pričvršćen na liniju.
Diarrhoea, nausea, constipation, vomiting, abdominal pain
Poremećaji probavnog sustava Vrlo često proljev, mučnina, konstipacija, povraćanje, bol u abdomenu
Alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood creatine phosphokinase increased*, transaminases increased*
Često povišena gama-glutamil transferaza, povišena alkalna fosfataza u krvi, povišena amilaza, povišena lipaza, povišen kreatinin u krvi Manje često povišena alanin aminotransferaza (ALT)*, povišena aspartat aminotransferaza (AST)*, povišena kreatin fosfokinaza u krvi*, povišene transaminaze*
Of these patients, there was 1 (0.1%) patient with Grade 3 immune-related adrenal insufficiency.
Među tim bolesnicima, u 1 (0,1 %) je bolesnika imunološki posredovana adrenalna insuficijencija bila 3. stupnja.
One fatal case has been reported in patients receiving avelumab (see section 4.8).
U bolesnika koji su primali avelumab zabilježen je jedan smrtni slučaj (vidjeti dio 4.8).
In patients treated with avelumab in combination with axitinib, 2.7% (13/489) of patients developed immune-related colitis.
U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, 2,7 % (13/489) bolesnika razvilo je imunološki posredovan kolitis.
Avelumab was discontinued in 0.3% (6/1,738) of patients due to immune-related pneumonitis.
Primjena avelumaba prekinuta je zbog imunološki posredovanog pneumonitisa u 0,3 % (6/1738) bolesnika.
Nephritis and renal dysfunction
Nefritis i poremećaj funkcije bubrega
Avelumab should be permanently discontinued if immune-related myocarditis is confirmed (see section 4.2).
Ako se imunološki posredovan miokarditis potvrdi, primjenu avelumaba potrebno je trajno prekinuti (vidjeti dio 4.2).
• Dryness in the mouth
• suhoća usta