natgillin/translations-raw huggingface dataset:
There was no evidence to suggest a clinically relevant change of avelumab clearance over time in patients with advanced RCC.
Ni bilo dokazov, ki bi pri bolnikih z napredovalim KLC kazali na klinično pomembno spremembo očistka avelumaba v odvisnosti od časa.
Negative (n=31)
Negativen (n = 31)
Tiredness is a very common side effect of Bavencio and can affect your ability to drive or to use machines.
Utrujenost je zelo pogost neželeni učinek zdravila Bavencio in lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving avelumab and should use effective contraception during treatment with avelumab and for at least 1 month after the last dose of avelumab.
Ženske v rodni dobi/kontracepcija Ženskam v rodni dobi je treba svetovati, naj med prejemanjem avelumaba ne zanosijo in naj uporabljajo učinkovito kontracepcijo med zdravljenjem z avelumabom in še vsaj 1 mesec po zadnjem odmerku avelumaba.
Tumour response assessments were performed every 6 weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Tumorski odziv je vsakih 6 tednov ocenil neodvisni odbor za pregled izidov učinkovitosti (IERC, Independent Endpoint Review Committee) po merilih za oceno odgovora na zdravljenje pri čvrstih tumorjih (RECIST, Response Evaluation Criteria in Solid Tumors), v1.1.
This medicine has been given ‘conditional approval'.
Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet“.
The recommended dose of Bavencio in combination with axitinib is 800 mg administered intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.
Priporočeni odmerek zdravila Bavencio v kombinaciji z aksitinibom je 800 mg, ki se daje intravensko, v obliki 60-minutnega infundiranja, na vsaka 2 tedna, in aksitinib v odmerku 5 mg peroralno dvakrat na dan (v razmiku 12 ur) s hrano ali brez nje do napredovanja bolezni ali nesprejemljive toksičnosti.
Bavencio is a clear, colourless to slightly yellow solution.
Bavencio je bistra, brezbarvna do rahlo rumenkasta raztopina.
Withhold until adverse reactions recover to Grade 0-1
Zdravljenje odložite, dokler se neželeni učinki ne vrnejo na stopnjo 0-1
Colitis*, autoimmune colitis*, enterocolitis*, ileus
Občasni kolitis*, avtoimunski kolitis*, enterokolitis*, ileus
Patients should be more frequently monitored for changes in liver function and symptoms as compared to when avelumab is used as monotherapy.
Bolnike je treba bolj pogosto spremljati zaradi pojava spremenjenega delovanja jeter in jetrnih simptomov, kot pa če bi avelumab uporabljali v monoterapiji.
There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations.
Za priporočila o odmerjanju pri bolnikih z zmerno ali hudo okvaro jeter ni dovolj podatkov.
Package leaflet: Information for the patient Bavencio 20 mg/mL concentrate for solution for infusion avelumab This medicine is subject to additional monitoring.
Navodilo za uporabo Bavencio 20 mg/ml koncentrat za raztopino za infundiranje avelumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Hepatitis, hepatotoxicity, immune-mediated hepatitis, liver disorder
Občasni hepatitis, hepatotoksičnost, imunsko pogojeni hepatitis, motnja delovanja jeter
• Feeling less hungry, weight loss
• zmanjšan občutek lakote, izguba telesne mase
For renal cell cancer, Bavencio is to be used in combination with axitinib.
Za raka ledvičnih celic se zdravilo Bavencio uporablja v kombinaciji z aksitinibom.
Type 1 diabetes mellitus Avelumab can cause Type 1 diabetes mellitus, including diabetic ketoacidosis (see section 4.8).
Sladkorna bolezen tipa 1 Avelumab lahko povzroči sladkorno bolezen tipa 1, vključno z diabetično ketoacidozo (glejte poglavje 4.8).
If you stop receiving Bavencio
Če ste prenehali prejemati zdravilo Bavencio
Other clinically important immune-related adverse reactions were reported in less than 1% of patients: myositis, hypopituitarism, uveitis, and Guillain-Barré syndrome (see section 4.8).
Pri manj kot 1 % bolnikov so poročali o klinično pomembnih imunsko pogojenih neželenih dogodkih: miozitis, hipopituitarizem, uveitis in Guillain-Barréjev sindrom (glejte poglavje 4.8).
• Signs of inflammation of the muscles (myositis) may include muscle pain or weakness.
• Znaki vnetja mišic (miozitis) lahko vključujejo mišično bolečino in šibkost.
If refrigerated, allow the diluted solution in the intravenous bags to come to room temperature prior to use.
Pri shranjevanju v hladilniku pred uporabo razredčene raztopine počakajte, da doseže sobno temperaturo.
No studies have been conducted to assess the potential of avelumab for carcinogenicity or genotoxicity.
Študij za oceno kancerogenega in genotoksičnega potenciala avelumaba niso izvedli.
If persistent (greater than 5 days), corticosteroid therapy with prednisone or equivalent followed by a taper should be considered.
Če neželeni učinki ne izginejo (trajajo več kot 5 dni), je treba razmisliti o kortikosteroidnem zdravljenju s prednizonom ali enakovrednim zdravilom, ki mu sledi postopno zmanjševanje.
Positive (n=58) Negative (n=16)
Pozitivna (n = 58) Negativna (n = 16)
Serum creatinine more than 6 times ULN Permanently discontinue
Vrednosti kreatinina v serumu več kot 6-krat večje od ULN
Your doctor will check your general health before and during treatment with Bavencio.
Vaš zdravnik bo pred zdravljenjem z zdravilom Bavencio in med njim preveril vaše splošno zdravstveno stanje.
Very common (may affect more than 1 in 10 people)
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, both Bavencio and axitinib should be permanently discontinued and corticosteroid therapy should be considered.
Če sta ALT ali AST ≥ 5-kratniku ULN ali > 3-kratniku ULN s sočasnim celokupnim bilirubinom ≥ 2-kratniku ULN ali celokupnim bilirubinom ≥ 3-kratniku ULN, je treba zdravilo Bavencio in aksitinib trajno ukiniti in razmisliti o zdravljenju s kortikosteroidi.
Merkel cell carcinoma
Karcinom Merklovih celic
Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).
Zdravilo Bavencio je v kombinaciji z aksitinibom indicirano kot zdravilo prve izbire za zdravljenje odraslih bolnikov z napredovalim karcinomom ledvičnih celic (KLC) (glejte poglavje 5.1).
Positive (n=19) Negative (n=55)
Pozitivna (n = 19) Negativna (n = 55)
Merkel cell carcinoma (study EMR100070-003)
Klinična učinkovitost in varnost Karcinom Merklovih celic (študija EMR100070-003)
The active substance is avelumab.
Učinkovina je avelumab.
What Bavencio looks like and contents of the pack
Izgled zdravila Bavencio in vsebina pakiranja
In patients with ALT ≥ 3 times ULN (Grades 2-4, n=82), ALT resolved to Grades 0-1 in 92%.
Pri bolnikih z ALT ≥ 3-kratnik ULN (2.-4. stopnje, n = 82) se je ALT zmanjšal na 0.-1. stopnjo pri
Tumour samples were evaluated for PD-L1 tumour cell expression, and for Merkel cell polyomavirus (MCV) using an investigational immunohistochemistry (IHC) assay.
V tumorskih vzorcih so izraženost PD-L1 v tumorskih celicah in prisotnost poliomavirusa Merklovih celic (MCV) ocenili z raziskovalnim imunohistokemičnim testom (IHC).
The Kaplan-Meier curve of PFS of the 88 patients (Part A) with metastatic MCC is presented in Figure 1.
Krivulja preživetja brez napredovanja bolezni po metodi Kaplan-Meier je za 88 bolnikov (del A) z metastatskim KMC predstavljena na sliki 1.
Hypothyroidism should be managed with replacement therapy and hyperthyroidism with anti-thyroid medicinal product, as needed.
Hipotiroidizem je treba zdraviti z nadomestnim zdravljenjem, hipertiroidizem pa z zdravili proti hipertiroidizmu.
Duration of response (DOR)
Trajanje odzivaa (DOR)
Excipients: Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections.
Pomožne snovi: manitol, koncentrirana ocetna kislina, polisorbat 20, natrijev hidroksid, voda za injekcije.
• Signs of inflammation of the kidney may include abnormal kidney function tests, urinating less than usual, blood in your urine, or swelling in your ankles.
• Znaki vnetja ledvic lahko vključujejo nenormalne teste delovanja ledvic, manj pogostejše uriniranje kot običajno, kri v urinu ali otekline v gležnjih.
Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of Bavencio.
Bolnike je treba pred prvimi 4 infuzijami zdravila Bavencio premedicirati z antihistaminikom in paracetamolom.
How to use Bavencio
Kako uporabljati zdravilo Bavencio
Weight decreased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased
Zelo pogosti zmanjšanje telesne mase, zvišanje vrednosti alanin-aminotransferaze (ALT), zvišanje vrednosti aspartat-aminotransferaze (AST)
PD-L1 status was determined by immunohistochemistry.
Status PD-L1 so ocenili z imunohistokemičnim testom.
Adrenal insufficiency*, hyperthyroidism*, thyroiditis*, autoimmune thyroiditis*, adrenocortical insufficiency acute*, autoimmune hypothyroidism*, hypopituitarism*
Občasni insuficienca nadledvične žleze*, hipertiroidizem*, tiroiditis*, avtoimunski tiroiditis*, akutna adrenokortikalna insuficienca*, avtoimunski hipotiroidizem*, hipopituitarizem*
Table 4 summarises efficacy endpoints in patients receiving avelumab at the recommended dose for study EMR100070-003, Part A, with a minimum follow-up of 36 months.
V preglednici 4 so povzeti izidi učinkovitosti pri bolnikih, ki so prejemali priporočene odmerke avelumaba, za študijo EMR100070-003, del A, z najkrajšim spremljanjem 36 mesecev.
Avelumab should be withheld and antihyperglycaemics in patients with Grade ≥ 3 hyperglycaemia should be administered.
Uporabo avelumaba je treba odložiti in bolnikom s hiperglikemijo stopnje ≥ 3 dati zdravila za zdravljenje hiperglikemije.
The prespecified interim analysis for Part B included 39 patients who received at least one dose of avelumab and 29 patients with a minimum 13 weeks of follow-up at the time of the data cut-off (cut-off date 24 March 2017).
Vnaprej določena vmesna analiza za del B je vključevala 39 bolnikov, ki so prejeli najmanj en odmerek avelumaba, in 29 bolnikov z najmanj 13-tedenskim spremljanjem v času zbiranja presečnih podatkov
Check with your doctor or nurse before you receive Bavencio if:
Preden prejmete zdravilo Bavencio, morate z vašim zdravnikom ali medicinsko sestro preveriti, ali:
Alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood creatine phosphokinase increased*, transaminases increased*
Občasni zvišanje vrednosti alanin-aminotransferaze (ALT)*, zvišanje vrednosti aspartataminotransferaze (AST)*, zvišanje vrednosti kreatin-fosfokinaze v krvi*, zvišanje vrednosti transaminaz*
Drug eruption, erythema multiforme, psoriasis
Občasni izpuščaj zaradi zdravila, multiformni eritem, psoriaza
Patients who tolerated axitinib 5 mg twice daily without Grade 2 or greater axitinib-related adverse events for 2 consecutive weeks could increase to 7 mg and then subsequently to 10 mg twice daily.
Bolniki, ki so aksitinib v odmerku 5 mg dvakrat na dan prenašali 2 zaporedna tedna brez neželenih učinkov 2. stopnje ali višje stopnje, pogojenih z aksitinibom, so lahko odmerek povečali na 7 mg in nato postopoma na 10 mg dvakrat na dan. Za obvladovanje toksičnosti so jemanje aksitiniba lahko prekinili ali odmerek zmanjšali na 3 mg dvakrat na dan in kasneje na 2 mg dvakrat na dan.
Corticosteroids should be considered for Grade ≥ 2 events (see section 4.2).
Pri dogodkih ≥ 2. stopnji je treba razmisliti o uporabi kortikosteroidov (glejte poglavje 4.2).
Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Bolnike je treba spremljati zaradi pojava hiperglikemije ali drugih znakov in simptomov sladkorne bolezni.
Liver function test increased
Občasni zvišanje vrednosti jetrnih testov
Immune-related hepatitis resolved in 27 (87.1%) of the 31 patients at the time of data cut-off.
Imunsko pogojeni hepatitis je po presečnih podatkih izzvenel pri 27 (87,1 %) bolnikih od 31.
This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
Steady-state exposure was approximately uniform over a wide range of body weights (30 to 204 kg) for body weight normalised dosing.
Izpostavljenost v stanju dinamičnega ravnovesja je bila približno enakomerna ne glede na telesno maso (30 do 204 kg) pri odmerjanju, normaliziranem glede na telesno maso.
Confirmed myocarditis
Potrjeni miokarditis
Response rate, CR+PR** n (%) (95% CI)
Stopnja odziva, CR + PR** n (%) (95 % IZ)
Adrenal insufficiency resolved in 1 patient with corticoid treatment at the time of data cut-off.
Insuficienca nadledvične žleze je po presečnih podatkih izzvenela pri 1 bolniku na kortikosteroidnem zdravljenju.
These results indicate a potential risk, based on its mechanism of action, that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Ti izsledki kažejo, glede na mehanizem delovanja avelumaba, na možno tveganje za poškodbe ploda, vključno s povečanjem stopnje splava ali mrtvorojenosti, pri dajanju avelumaba med nosečnostjo.
No interaction studies have been conducted with avelumab.
Študij medsebojnega delovanja z avelumabom niso izvedli.
12-month PFS rate by K-M, (95% CI)** 52.4% (47.4, 57.2) 18-month PFS rate by K-M, (95% CI)** 43.9% (38.8, 49.0)
12-mesečna stopnja PFS po K-M, (95 % IZ)** 52,4 % (47,4; 57,2) 39,2 % (34,1; 44,2) 18-mesečna stopnja PFS po K-M, (95 % IZ)** 43,9 % (38,8; 49,0) 29,3 % (24,2; 34,6)
Withhold until adverse reactions recover to Grade 0-1; restart infusion with a 50% slower rate
Zdravljenje odložite, dokler se neželeni učinki ne vrnejo na stopnjo 0-1; ponovno začnite infundirati s 50 %
The safety of avelumab as monotherapy has been evaluated in 1,738 patients with solid tumours including metastatic MCC receiving 10 mg/kg every 2 weeks of avelumab in clinical studies.
Povzetek varnostnega profila Varnost avelumaba v monoterapiji so ocenili pri 1.738 bolnikih s čvrstimi tumorji, vključno z metastatskim KMC, ki so v kliničnih študijah dobivali avelumab v odmerku 10 mg/kg vsaka 2 tedna.
Patients should be monitored for signs and symptoms of infusion-related reactions including pyrexia, chills, flushing, hypotension, dyspnoea, wheezing, back pain, abdominal pain, and urticaria.
Bolnike je treba spremljati zaradi pojava znakov in simptomov neželenih učinkov, povezanih z infundiranjem, vključno s pireksijo, mrzlico, vročinski oblivi, hipotenzijo, dispnejo, piskajočim dihanjem, bolečinami v hrbtu, bolečinami v trebuhu in urtikarijo.
Dry mouth, colitis
Pogosti suha usta, kolitis
Grade 3 or Grade 4 pneumonitis or recurrent Grade 2 pneumonitis
Pnevmonitis 3. ali 4. stopnje ali ponavljajoči pnevmonitis 2. stopnje
Objective response rate (ORR) n (%) (95% CI)
Stopnja objektivnega odziva (ORR) n (%) (95 % IZ)
Table 7: Efficacy results from study B9991003 in patients irrespective of PD-L1 expression Efficacy endpoints (Based on BICR assessment)
Preglednica 7: Rezultati učinkovitosti iz študije B9991003 pri bolnikih, neodvisno od izraženosti PD-L1
The European Medicines Agency has waived the obligation to submit the results of studies with Bavencio in all subsets of the paediatric population for the treatment of Merkel cell carcinoma and renal cell carcinoma (see section 4.2 for information on paediatric use).
Bavencio za vse podskupine pediatrične populacije za zdravljenje karcinoma Merklovih celic in karcinoma ledvičnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In order to confirm the efficacy for chemotherapy-naïve treated patients, the MAH should submit the final results of study EMR 100070-003 - Part B.
Za potrditev učinkovitosti pri bolnikih, ki se predhodno še niso zdravili s kemoterapijo, mora imetnik dovoljenja za promet z zdravilom predložiti končne rezultate študije EMR100070-003 - Del B.
This is common.
To je občasno.
Patients with the following conditions were excluded from clinical trials: active 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.
Bolniki, ki so bili iz kliničnih študij izključeni Iz kliničnih preskušanj so bili izključeni bolniki z naslednjimi stanji: aktivnimi zasevki v osrednjem živčnem sistemu (OŽS); aktivno ali avtoimunsko boleznijo v preteklosti; drugimi malignimi boleznimi v preteklih 5 letih; presaditvijo organa; stanji, zaradi katerih je potrebna terapevtska supresija imunskega odziva, ali aktivno okužbo z virusom HIV, hepatitisom B ali C.
Neuropathy peripheral
Pogosti periferna nevropatija
Figure 1: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part A, minimum follow-up of 36 months)
Slika 1: Ocene preživetja po metodi Kaplan-Meier brez napredovanja bolezni po RECIST v1.1, IERC (del A, najkrajše spremljanje 36 mesecev)
Table 6 summarises the subsequent interim analysis of efficacy endpoints including an estimate of the 6-month rates by Kaplan-Meier for DOR and PFS, in patients receiving avelumab at the recommended dose for study EMR100070-003, Part B.
V preglednici 6 so povzete naslednje vmesne analize izidov učinkovitosti, vključno z ocenjenimi 6-mesečnimi stopnjami trajanja odziva in PFS po Kaplan-Meierju pri bolnikih, ki so prejemali priporočene odmerke avelumaba, za študijo EMR100070-003, del B.
Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Bolnike je treba spremljati zaradi pojava kliničnih znakov in simptomov endokrinopatij.
No clinically important differences in the clearance of avelumab were found between patients with mild (glomerular filtration rate (GFR) 60 to 89 mL/min, Cockcroft-Gault Creatinine Clearance (CrCL); n=623), moderate (GFR 30 to 59 mL/min, n=320) and patients with normal (GFR ≥ 90 mL/min, n=671) renal function.
Cockcroft- Gaultovi oceni (CrCL); n = 623), zmerno okvaro delovanja ledvic (GFR 30 do 59 ml/min, n = 320) in bolniki z normalnim (GFR ≥ 90 ml/min, n = 671) delovanjem ledvic niso ugotovili.
Figure 2: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part B, N=116)
Slika 2: Ocene preživetja po metodi Kaplan-Meier brez napredovanja bolezni po RECIST v1.1, IERC (del B, N = 116)
In patients treated with avelumab in combination with axitinib, 24.7% (121/489) of patients developed immune-related thyroid disorders, including 111 (22.7%) patients with hypothyroidism, 17 (3.5%) with hyperthyroidism, and 7 (1.4%) with thyroiditis.
Pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, so se pri 24,7 % (121/489) bolnikov razvile imunsko pogojene motnje delovanja ščitnice, vključno s 111 (22,7 %) bolniki s hipotiroidizmom, 17 (3,5 %) s hipertiroidizmom in 7 (1,4 %) s tiroiditisom.
Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss.
Pokazalo se je, da blokada signaliziranja PD-L1 na modelih brejih miši prekine toleranco za plod in poveča pogostnost izgube ploda.
The safety of avelumab in combination with axitinib has been evaluated in 489 patients with advanced RCC receiving 10 mg/kg avelumab every 2 weeks and axitinib 5 mg orally twice daily in two clinical studies.
Varnost avelumaba v kombinaciji z aksitinibom so ocenili pri 489 bolnikih z napredovalim KLC, ki so v dveh kliničnih študijah dobivali avelumab v odmerku 10 mg/kg vsaka 2 tedna in aksitinib v odmerku 5 mg peroralno dvakrat na dan.
Table 2: Adverse reactions in patients treated with avelumab as monotherapy in clinical study EMR100070-003 and adverse reactions from a phase I study (EMR100070-001) in solid tumours
Preglednica 2: Neželeni učinki pri bolnikih, zdravljenih z avelumabom v monoterapiji v klinični študiji EMR100070-003, in neželeni učinki iz študije faze I (EMR100070-001) za čvrste tumorje
There are insufficient data in patients with severe renal impairment for dosing recommendations.
Za priporočila o odmerjanju pri bolnikih s hudo okvaro ledvic ni dovolj podatkov.
The patients had no symptoms, did not require any treatment for the overdose, and continued on avelumab therapy.
Bolniki niso imeli simptomov in jih ni bilo treba zdraviti zaradi prevelikega odmerka.
The recommended dose of Bavencio as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks.
Priporočeni odmerek zdravila Bavencio v monoterapiji je 800 mg, ki se daje intravensko, v obliki 60-minutnega infundiranja, na vsaka 2 tedna.
• Signs of liver problems, including inflammation of the liver (hepatitis) may include yellowing of your skin (jaundice) or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual, tiredness or abnormal liver function tests.
• Znaki težav z jetri, vključno z vnetjem jeter (hepatitisom), lahko vključujejo porumenelost kože (zlatenica) ali beločnic, močno siljenje na bruhanje ali bruhanje, bolečine na desni strani trebuha (abdomna), dremavost, temen urin (barve čaja), krvavitev ali pogostejše nastajanje modric kot običajno, zmanjšan občutek lakote kot običajno, utrujenost ali nenormalni testi delovanja jeter.
Complete response (CR) n (%) Partial response (PR) n (%)
Popolni odziv (CR) n (%) Delni odziv (PR) n (%)
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.
Pri bolnikih, zdravljenih z avelumabom v monoterapiji, se je sladkorna bolezen tipa 1 brez alternativne etiologije pojavila pri 0,1 % (2/1.738) bolnikov, vključno z dvema reakcijama 3. stopnje, zaradi katerih je bilo dajanje avelumaba trajno prekinjeno.
These results indicate a potential risk that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Ti izsledki kažejo na možno tveganje za poškodbe ploda, vključno s povečanjem stopnje splava ali mrtvorojenosti, pri dajanju avelumaba med nosečnostjo.
For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes.
Pri sumu na imunsko pogojene neželene učinke je treba z ustrezno oceno potrditi njihovo etiologijo ali izključiti druge vzroke.
Bavencio 20 mg/mL sterile concentrate avelumab
Bavencio 20 mg/ml sterilni koncentrat avelumab i.v.
The median time to onset of Type 1 diabetes mellitus was 1.9 months (range: 1.1 months to 7.3 months).
Mediana časa do nastopa sladkorne bolezni tipa 1 je bila 1,9 meseca (razpon: 1,1 meseca do 7,3 meseca).
• Signs of infusion-related reactions such as shortness of breath or wheezing, chills or shaking,
• Znaki neželenih učinkov, povezanih z infundiranjem, kot so kratka sapa ali piskajoče dihanje,
Complete response (CR)** n (%) Partial response (PR)** n (%)
Popolni odziv (CR)** n (%) Delni odziv (PR)** n (%)
Of 1,738 patients treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks, 1,627 were evaluable for treatment-emergent anti-drug antibodies (ADA) and 96 (5.9%) tested positive.
Med 1.738 bolniki, zdravljenimi z avelumabom 10 mg/kg v obliki intravenske infuzije vsaka 2 tedna, je bilo protitelesa proti zdravilu zaradi zdravljenja možno oceniti pri 1.627 bolnikih.