natgillin/translations-raw huggingface dataset:
Renal cell carcinoma (study B9991003)
Karcinom ledvičnih celic (študija B9991003)
The key secondary endpoints were PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PD-L1 expression.
Ključni sekundarni izidi PFS so temeljili na oceni BICR z uporabo kriterijev RECIST v.1.1 in OS neodvisno od izraženosti PD-L1.
Patients with radiological disease progression not associated with significant clinical deterioration, defined as no new or worsening symptoms, no change in performance status for greater than two weeks, and no need for salvage therapy could continue treatment.
Z zdravljenjem so lahko nadaljevali bolniki z radiološko potrjenim napredovanjem bolezni, ki ni bilo povezano s pomembnim kliničnim poslabšanjem, opredeljenim z odsotnostjo novih simptomov ali poslabšanjem simptomov, ohranitvijo statusa zmogljivosti dlje kot dva tedna in odsotnostjo potrebe po rešilnem zdravljenju.
For storage conditions after dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja razredčenega zdravila glejte poglavje 6.3.
Permanently discontinue
Zdravljenje trajno ukinite
Pregnancy There are no or limited data from the use of avelumab in pregnant women.
Nosečnost Podatkov o uporabi avelumaba pri nosečnicah ni oziroma so omejeni.
Patient distribution by Memorial Sloan-Kettering Cancer Center (MSKCC) risk groups was 22% favourable, 65% intermediate, and 11% poor.
Porazdelitev bolnikov glede na skupine tveganja po napovednem modelu Memorial Sloan-Kettering Cancer Center (MSKCC, Memorial Sloan-Kettering Cancer Center) je bila 22 % ugodna, 65 % srednje ugodna in 11 % slaba.
Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of avelumab (see “Description of selected adverse reactions” below).
Večina neželenih učinkov, vključno s hudimi, je po uvedbi ustreznega zdravljenja z zdravili ali prenehanju dajanja avelumaba izzvenela (glejte razdelek "Opis izbranih neželenih učinkov" v nadaljevanju).
Pneumonitis
Pnevmonitis
• Persistent Grade 2 or Grade 3 immune-mediate adverse reactions lasting 12 weeks or longer
• Trdovratni imunsko pogojeni neželeni učinki 2. ali 3. stopnje, ki trajajo 12 tednov ali dlje
Confirmed objective response rate (ORR)
Potrjena stopnja objektivnega odziva (ORR)
The other ingredients are mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”).
Druge sestavine so manitol, koncentrirana ocetna kislina, polisorbat 20, natrijev hidroksid, voda za injekcije (glejte poglavje 2 "Zdravilo Bavencio ima majhno vsebnost natrija").
• Merkel cell carcinoma (MCC), a rare type of skin cancer, when it is metastatic (has spread to other parts of the body).
• karcinoma Merklovih celic (KMC), kar je redka vrsta kožnega raka, kadar gre za metastatsko obliko (razširjeno tudi na druge dele telesa).
Dosing delay or discontinuation may be required based on individual safety and tolerability; see Table 1.
Na podlagi individualne varnosti in prenašanja bo morda treba z odmerkom počakati ali odmerjanje prekiniti; glejte preglednico 1.
Table 3: Adverse reactions in patients treated with avelumab in combination with axitinib in clinical studies B9991002 and B9991003
Preglednica 3: Neželeni učinki pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom v kliničnih študijah B9991002 in B9991003 Pogostnost
Seek urgent medical attention if you experience inflammation in any part of your body or if you have any of the following signs or symptoms, or if they get worse.
Če se vam pojavi vnetje v katerem koli delu vašega telesa ali če imate katerega od naslednjih znakov ali simptomov ali se le-ti poslabšajo, poiščite nujno zdravniško pomoč.
Bavencio is compatible with polyethylene, polypropylene, and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 micrometre.
Zdravilo Bavencio je združljivo z infuzijskimi vrečami iz polietilena, polipropilena in etilenvinilacetata, steklenicami, infuzijskimi seti iz polivinilklorida in linijskimi filtri z membranami iz polietersulfona z velikostjo por 0,2 mikrometra.
The efficacy and safety of avelumab was investigated in the study EMR100070-003 with two parts.
Učinkovitost in varnost avelumaba je bila raziskana v študiji v dveh delih EMR100070-003.
Positive (n=46)
Pozitiven (n = 46)
A population pharmacokinetic analysis suggested no difference in the total systemic clearance of avelumab based on age, gender, race, PD-L1 status, tumour burden, renal impairment and mild or moderate hepatic impairment.
Populacijska farmakokinetična analiza ne kaže na razlike v celokupnem sistemskem očistku avelumaba na podlagi starosti, spola, rase, statusa PD-L1, tumorskega bremena, okvare ledvic in blage do zmerne okvare jeter.
Of these patients, none experienced immune-related pneumonitis Grade ≥ 3.
Od teh noben bolnik ni imel imunsko pogojenega pnevmonitisa ≥ 3. stopnji.
The exposure of avelumab increased dose-proportionally in the dose range of 10 mg/kg to 20 mg/kg every 2 weeks.
Izpostavljenost avelumabu se je povečevala v odvisnosti od odmerka v razponu odmerkov od 10 mg/kg do 20 mg/kg vsaka 2 tedna.
Prior to launch of Bavencio in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila Bavencio na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa,
In the supplemental analysis, avelumab CL was found to decrease over time: the largest mean maximal reduction (% coefficient of variation [CV%]) from baseline value with different tumour types was approximately 32.1% (CV 36.2%).
V dopolnilni analizi so ugotovili zmanjšanje skupnega sistemskega očistka avelumaba v odvisnosti od časa: največje povprečno maksimalno zmanjšanje (% koeficient variacije [KV%]) od izhodiščne vrednosti pri različnih vrstah tumorjev je bilo približno 32,1 %
• Feeling cold
• občutek hladu
Severity*
Resnost*
It is unknown whether avelumab is excreted in human milk.
Ni znano, ali se avelumab izloča v materino mleko.
The objective response rate (ORR) was 62.1% (95% CI: 42.3, 79.3) with 4 (14%) of patients reported to have a complete response and 14 (48%) to have a partial response.
Stopnja objektivnega odziva je bila 62,1 % (95-% IZ: 42,3; 79,3), pri čemer so za 4 (14 %) bolnike poročali o popolnem odzivu in za 14 (48 %) o delnem odzivu.
Among the 73 patients who were rechallenged with either avelumab (59%) or axitinib (85%) monotherapy or with both (55%), 66% had no recurrence of ALT ≥ 3 times ULN.
Med 73 bolniki, pri katerih so ponovno uvedli avelumab (59 %) ali aksitinib (85 %) v monoterapiji ali zdravljenje z obema (55 %), se pri 66 % ALT ≥ 3-kratniku ULN ni ponovno pojavil.
The pack size is 1 glass vial per carton.
Velikost pakiranja je 1 steklena viala v škatli.
Treatment modification
Spreminjanje zdravljenja
Bavencio will be added to an infusion bag containing a sodium chloride solution before use.
Zdravilo Bavencio bo pred uporabo dodano v infuzijsko vrečo, ki vsebuje raztopino natrijevega klorida.
Data for immune-related adverse reactions for avelumab as a monotherapy are based on 1,650 patients in the phase I study EMR100070-001 in solid tumours and 88 patients in study EMR100070-003, and for avelumab in combination with axitinib are based on 489 patients in study B9991002 and B9991003 (see section 5.1).
Podatki o imunsko pogojenih neželenih učinkih za avelumab v monoterapiji temeljijo na 1.650 bolnikih v študiji faze I EMR100070-001 s čvrstimi tumorji in na 88 bolnikih v študiji EMR100070-003, za avelumab v kombinaciji z aksitinibom pa temeljijo na 489 bolnikih v študijah B9991002 in B9991003 (glejte poglavje 5.1).
• Renal cell carcinoma (RCC), a type of kidney cancer, when it is advanced (has spread beyond the kidney or to other parts of the body).
• karcinoma ledvičnih celic (KLC), kar je vrsta ledvičnega raka, kadar gre za napredovalo obliko (razširjeno izven ledvice ali tudi na druge dele telesa).
Twenty-eight (90.3%) of the 31 patients received high dose corticosteroids for a median of 2.4 weeks (range: 1 day to 10.2 months).
Osemindvajset (90,3 %) od 31 bolnikov je dobivalo visoke odmerke kortikosteroidov za mediano 2,4 tedna (razpon: 1 dan do 10,2 meseca).
In the remaining 1.4% (6/439) of patients, infusion-related reactions occurred after the first 4 infusions and all were of Grade 1 or Grade 2.
Pri preostalih 1,4 % (6/439) bolnikov pa so se neželeni učinki, povezani z infundiranjem, pojavili po prvih 4 infundiranjih, pri čemer so bili vsi 1. ali
Bavencio is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate).
Zdravilo Bavencio je bister in brezbarven do rahlo rumenkast koncentrat za raztopino za infundiranje (sterilni koncentrat).
Systemic inflammatory response syndrome*
Občasni sindrom sistemskega vnetnega odziva*
Do not stop treatment with Bavencio unless you have discussed this with your doctor.
Ne prenehajte se zdraviti z zdravilom Bavencio, če se niste tako dogovorili z zdravnikom.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions.
V primeru prevelikega odmerjanja je treba bolnike skrbno spremljati zaradi pojava znakov in simptomov neželenih učinkov.
Initiate treatment with insulin for Type 1 diabetes mellitus.
Uvesti je treba zdravljenje z insulinom za sladkorno bolezen tipa 1.
Results (N=116)
Rezultati (N = 116)
Overall, 52 (59%) patients were reported to have had 1 prior anti-cancer therapy for MCC, 26 (30%) with 2 prior therapies, and 10 (11%) with 3 or more prior therapies.
Skupaj je 52 (59 %) bolnikov imelo 1 predhodno onkološko zdravljenje KMC, 26 (30 %) bolnikov 2 predhodni zdravljenji in 10 (11 %) bolnikov 3 ali več predhodnih zdravljenj.
• Avelumab 10 mg/kg intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily orally (N=442).
• Avelumab 10 mg/kg v obliki intravenske infuzije vsaka 2 tedna v kombinaciji z aksitinibom v odmerku 5 mg dvakrat na dan peroralno (n = 442).
Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Podrobne smernice za obravnavo imunsko pogojenih neželenih učinkov so opisane v poglavju 4.4.
The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of avelumab, including immune-related pneumonitis, hepatitis, colitis, pancreatitis, myocarditis, thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, nephritis and renal dysfunction, myositis, hypopituitarism, uveitis, GuillainBarre syndrome and infusion related reactions, and how to manage them.
Namen izobraževalnega programa je povečati ozaveščenost in zagotoviti informacije v povezavi z znaki in simptomi določenih pomembnih ugotovljenih tveganj avelumaba, vključno z imunsko pogojenim pnevmonitisom, hepatitisom, kolitisom, pankreatitisom, miokarditisom, motnjami delovanja žleze ščitnice, insuficienco nadledvične žleze, sladkorno boleznijo tipa 1, nefritisom in motnjami delovanja ledvic, miozitisom, hipopituitarizmom, uveitisom, Guillain-Barréjevim sindromom in reakcijah, povezanim z infundiranjem, ter napotki kako obvladovati navedena tveganja.
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
• inflammation of your liver (hepatitis) or other liver problems;
• vnetje jeter (hepatitis) ali druge težave z jetri,
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.
Neželeni učinki, o katerih so poročali pri 489 bolnikih z napredovalim KLC, zdravljenih v dveh kliničnih študijah z avelumabom v kombinaciji z aksitinibom, so predstavljeni v preglednici 3.
• Increases or decreases in blood pressure
• zmanjšan ali zvišan krvni tlak
Grade 2 pneumonitis
Pnevmonitis 2. stopnje
Do not drive or use machines after you have received Bavencio if you are not feeling well enough.
Po tem, ko dobite zdravilo Bavencio, ne vozite in ne upravljajte strojev, če se ne počutite dovolj dobro.
Bavencio has a low sodium content
Zdravilo Bavencio ima majhno vsebnost natrija
• Flu-like illness (includes feeling of fever, muscle aches)
• gripi podobna bolezen (vključno z občutkom povišane telesne temperature, bolečinami v mišicah)
Do not breast-feed while receiving Bavencio and for at least 1 month after your last dose.
Med prejemanjem zdravila Bavencio in še vsaj 1 mesec po zadnjem odmerku ne dojite.
Infusion related reaction * Immune-related adverse reaction based on medical review § Reaction only observed from study EMR 100070-003 (Part B) after the data cut-off of the pooled analysis, hence frequency estimated
Zelo pogosti reakcije, povezane z infundiranjem * Imunsko pogojeni neželeni učinek na osnovi medicinskega pregleda § Reakcijo so opazili le v študiji EMR100070-003 (Del B) glede na presečne podatke iz združene analize, zato je pogostnost ocenjena
• problems with your kidneys;
• težave z ledvicami,
If corticosteroids are used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Če se za zdravljenje neželenega učinka uporabijo kortikosteroidi, jih je treba ob izboljšanju zmanjševati postopoma, vsaj 1 mesec.
Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
Avelumab je humano monoklonsko protitelo IgG1, usmerjeno proti imunomodulacijskemu proteinskemu ligandu PD-L1 celične površine, ki je pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka.
** CIs are derived using the log-log transformation with back transformation to untransformed scale.
* 1−stranska vrednost p na osnovi log-rank stratifikacije ** IZ so izpeljani z uporabo log-log transformacije s povratno transformacijo v netransformirano lestvico.
Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1).
Avelumab je humano imunoglobulinsko monoklonsko protitelo G1 (IgG1), usmerjeno proti ligandu programirane celične smrti 1 (PD-L1).
• problems with your hormone producing glands (the thyroid, adrenal and pituitary glands) that may affect how these glands work;
• težave z žlezami, v katerih nastajajo hormoni (ščitnica, nadledvična žleza in hipofiza), kar lahko vpliva na delovanje teh žlez,
Three patients were reported to be overdosed with 5% to 10% above the recommended dose of avelumab.
O prevelikem odmerjanju s 5 % do 10 % nad priporočenim odmerkom avelumaba so poročali pri treh bolnikih.
In both studies, avelumab was administered at 10 mg/kg every 2 weeks.
V obeh študijah so avelumab dajali v odmerku 10 mg/kg vsaka 2 tedna.
In clinical trials, 98.6% (433/439) of patients with infusion-related reactions had a first infusion-related reaction during the first 4 infusions of which 2.7% (12/439) were Grade ≥ 3.
V kliničnih preskušanjih se je pri 98,6 % (433/439) bolnikov z neželenimi učinki, povezanimi z infundiranjem, prvi neželeni učinek, povezan z infundiranjem, pojavil med prvimi 4 infundiranji, pri čemer jih je bilo 2,7 % (12/439) stopnje ≥ 3.
IHC: Immunohistochemistry; MCV: Merkel cell polyomavirus; ORR: objective response rate a Based on data from patients evaluable for PD-L1 b Based on data from patients evaluable for MCV by immunohistochemistry (IHC)
IHC: imunohistokemija; MCV: poliomavirus Merklovih celic; ORR: stopnja objektivnega odziva a Na podlagi podatkov o bolnikih, ki jih je bilo mogoče oceniti za PD-L1
Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
Pokazalo se je, da avelumab inducira tudi z naravnimi celicami ubijalkami posredovano tumorsko citolizo z mehanizmom citotoksičnosti, posredovane s protitelesi (ADCC, antibody-dependent cell-mediated cytotoxicity).
Objective response rate (ORR)
Stopnja objektivnega odziva (ORR)
Oedema peripheral, influenza like illness
Pogosti periferni edem, gripi podobna bolezen
• Decreased kidney function
• zmanjšano delovanje ledvic
Results (N=88)
Rezultati (n = 88)
2.3 months).
11 dni).
Based on data available, including the low incidence of immunogenicity, the impact of ADA on pharmacokinetics, efficacy and safety is uncertain, while the impact of neutralizing antibodies (nAb) is unknown.
Vpliv protiteles proti zdravilu na farmakokinetiko, učinkovitost in varnost na podlagi razpoložljivih podatkov, vključno z nizko pojavnostjo imunogenosti, ni dokončno ugotovljen, medtem ko vpliv nevtralizirajočih protiteles ni znan.
• inflammation of your muscles (myositis).
• vnetje mišic (miozitis).
Before you receive Bavencio
Preden dobite zdravilo Bavencio
When avelumab 10 mg/kg was administered in combination with axitinib 5 mg, the respective exposures of avelumab and axitinib were unchanged compared to the single agents.
Kadar je bil avelumab 10 mg/kg dan v kombinaciji z aksitinibom 5 mg, so bile vsakokratne izpostavljenosti avelumabu in aksitinibu nespremenjene v primerjavi s posameznim zdravilom.
For Part B, the major efficacy outcome measure was durable response, defined as objective response (complete response (CR) or partial response (PR)) with a duration of at least 6 months; secondary outcome measures included BOR, DOR, PFS, and OS.
Za del B je bilo glavno merilo izida učinkovitosti trajen odziv, opredeljen kot objektivni odziv (popolni odziv (CR) ali delni odziv (PR)) s trajanjem najmanj 6 mesecev; sekundarna merila učinkovitosti pa so
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Overall, there was no evidence of altered pharmacokinetic profile, increased incidence of infusion reactions or effects on efficacy with anti-avelumab antibody development.
S pojavom protiteles proti avelumabu na splošno ni bilo dokazov za spremembo farmakokinetičnega profila, povečanje pogostnosti reakcij, povezanih z infundiranjem, ali vplivov na učinkovitost.
However, in murine models of pregnancy, blockade of PD-L1 signalling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3).
Na modelih brejosti pri miših se je pokazalo, da blokada signaliziranja PD-L1 okvari toleranco za plod in poveča pogostnost izgube ploda (glejte poglavje 5.3).
All 31 patients with immune-related hepatitis were treated for hepatitis including 30 (96.8%) patients treated with corticosteroids and 1 patient with a non-steroidal immunosuppressant.
Vseh 31 bolnikov z imunsko pogojenim hepatitisom je bilo zdravljenih za hepatitis, vključno s 30 (96,8 %) bolniki, zdravljenimi s kortikosteroidi, in 1 bolnikom, zdravljenim z nesteroidnimi imunosupresivi.
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the diluted solution should be infused immediately.
Z mikrobiološkega vidika je treba razredčeno raztopino takoj infundirati, razen če metoda redčenja zmanjša tveganje za mikrobiološko kontaminacijo.
Patients with prior systemic therapy directed at advanced or metastatic RCC; prior systemic immunotherapy treatment with IL-2, IFN-α, anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or active brain metastasis; active autoimmune disease that might deteriorate when receiving an immunostimulatory agents; a history of other malignancies within the last 5 years; organ transplant were ineligible.
Bolniki s predhodnim sistemskim zdravljenjem napredovalega ali metastatskega KLC, predhodnim sistemskim imunskim zdravljenjem z IL-2, IFN-α, anti-PD-1, anti-PD-L1, ali anti-CTLA-4 protitelesi ali z aktivnimi možganskimi metastazami, aktivno avtoimunsko boleznijo, ki bi se pri zdravljenju z imunostimulatorji lahko poslabšala, drugimi malignimi obolenji v zadnjih 5 letih, transplantacijo organa niso bili primerni.
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.
Neželeni učinki, o katerih so poročali pri 88 bolnikih z metastatskim KMC in pri 1.650 bolnikih v študiji faze I s čvrstimi tumorji, so predstavljeni v preglednici 2.
Avelumab pharmacokinetics (PK) was assessed using a population PK approach for avelumab as monotherapy and avelumab in combination with axitinib.
Farmakokinetiko (FK) avelumaba so ocenili z uporabo populacijskega FK pristopa za avelumab v monoterapiji in v kombinaciji z aksitinibom.
AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
AST ali ALT, ki je več kot 5-krat večja od ULN, ali vrednost celokupnega bilirubina, ki je več kot 3-krat večja od
Hepatotoxicity occurred in patients treated with avelumab in combination with axitinib with higher than expected frequencies of Grade 3 and Grade 4 ALT and AST elevation compared to avelumab alone (see section 4.8).
Hepatotoksičnost (v kombinaciji z aksitinibom) Hepatotoksičnost se je pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, pojavila z večjimi pogostnostmi zvišanja vrednosti ALT in AST 3. stopnje in 4. stopnje od pričakovanih, v primerjavi z uporabo samo avelumaba (glejte poglavje 4.8).
For suspected immune-related adverse reactions, ensure adequate evaluation to confirm aetiology or to rule out other causes.
Pri sumu na imunsko pogojene neželene učinke zagotovite ustrezen pregled za potrditev etiologije bolezni ali izključitev drugih vzrokov.
Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Zdravilo Bavencio je indicirano kot monoterapija za zdravljenje odraslih bolnikov z metastatskim karcinomom Merklovih celic (KMC).
Median, months (95% CI)
Mediana, meseci (95 % IZ)
Treatment with avelumab should be resumed when metabolic control is achieved on insulin replacement therapy.
Zdravljenje z avelumabom je treba nadaljevati, ko je dosežena presnovna urejenost z nadomestnim zdravljenjem z insulinom.
• Red, itchy, scaly patches on the skin
• rdeče, srbeče, luskaste zaplate na koži
Fatigue, pyrexia, oedema peripheral
Zelo pogosti utrujenost, pireksija, periferni edem
Efficacy results are presented in Table 7 and Figure 3 based on a data cut-off date of 28 January 2019.
Rezultati učinkovitosti so predstavljeni v preglednici 7 in sliki 3 na osnovi presečnih podatkov z dne
In case of recurrence of Grade 1 or Grade 2 infusion-related reaction, the patient may continue to receive avelumab under close monitoring, after appropriate infusion rate modification and premedication with paracetamol and antihistamine (see section 4.2).
Pri ponovnem pojavu neželenih učinkov 1. ali 2. stopnje, povezanih z infundiranjem, lahko bolnik avelumab prejema še naprej, ob natančnem spremljanju, po ustrezni spremembi hitrosti infundiranja in premedikaciji s paracetamolom in antihistaminikom (glejte poglavje 4.2).
Bavencio contains the active substance avelumab, a monoclonal antibody (a type of protein) that attaches to a specific target in the body called PD-L1.
Zdravilo Bavencio vsebuje učinkovino avelumab, ki je monoklonsko protitelo (vrsta beljakovine), ki se veže na določene tarče v telesu, imenovane PD-L1.
Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, Guillain-Barré syndrome)
Drugi imunsko pogojeni neželeni učinki (vključno z miozitisom, hipopituitarizmom, uveitisom, GuillainBarréjevim sindromom)