FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: AST > ULN ali bilirubin med 1- in 1,5-kratnikom ULN, n = 217) in normalnim delovanjem jeter (bilirubin in AST ≤ ULN, n = 1.388) v populacijski farmakokinetični analizi niso ugotovili.
English: Tubulo-interstitial nephritis*
Slovenian: Bolezni sečil Občasni tubulointersticijski nefritis*
English: Patients should be monitored for signs and symptoms of immune-related myocarditis.
Slovenian: Bolnike je treba spremljati zaradi pojava znakov in simptomov imunsko pogojenega miokarditisa.
English: You will receive Bavencio as an infusion (a drip) into a vein (intravenously) over a period of 1 hour.
Slovenian: Zdravilo Bavencio boste prejeli v obliki enourne infuzije v veno (intravensko).
English: Avelumab has not been studied in patients with moderate hepatic impairment (bilirubin between 1.5 and 3 times ULN) or severe hepatic impairment (bilirubin > 3 times ULN).
Slovenian: Avelumaba niso preučili pri bolnikih z zmerno okvaro jeter (bilirubin med 1,5- in 3-kratnikom ULN)
English: Analysis of progression-free survival (PFS) was based on 39 patients who received at least one dose of avelumab, with median PFS of 9.1 months (95% CI: 1.9, not estimable) and estimated 3-month PFS rate by Kaplan-Meier of 67% (95% CI: 48, 80).
Slovenian: Analiza preživetja brez napredovanja bolezni (PFS) je temeljila na 39 bolnikih, ki so prejeli vsaj en odmerek avelumaba, z mediano PFS 9,1 meseca (95-% IZ: 1,9; ni mogoče oceniti) in ocenjeno 3-mesečno stopnjo PFS po
English: • Signs of inflammation of the lungs (pneumonitis) may be breathing difficulties or cough.
Slovenian: • Znaki vnetja pljuč (pnevmonitis) lahko vključujejo oteženo dihanje ali kašelj.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI
English: Endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia)
Slovenian: Endokrinopatije (hipotiroidizem, hipertiroidizem, insuficienca nadledvične žleze,
English: Administer the solution for infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter as described in section 4.2.
Slovenian: Za dajanje raztopine za infundiranje uporabite sterilen, apirogen, 0,2-mikrometrski linijski ali dodatni filter z zmanjšano vezavo beljakovin, kot je opisano v poglavju 4.2.
English: Autoimmune colitis, autoimmune pancreatitis, enterocolitis, ileus, pancreatitis necrotizing
Slovenian: Občasni avtoimunski kolitis, avtoimunski pankreatitis, enterokolitis, ileus,
English: The median time to onset of immune-related pneumonitis was 3.7 months (range: 2.7 months to 8.6 months).
Slovenian: Mediana časa do nastopa imunsko pogojenega pnevmonitisa je bila 3,7 meseca (razpon: 2,7 meseca do 8,6 mesecev).
English: Adverse reactions Blood and lymphatic system disorders
Slovenian: Neželeni učinki Bolezni krvi in limfatičnega sistema
English: 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)*
Slovenian: Preglednica 6: Naslednja vmesna analiza odziva na avelumab 10 mg/kg vsaka 2 tedna pri bolnikih z metastatskim KMC v študiji EMR100070-003 (del B)*
English: • Sunitinib 50 mg once daily orally for 4 weeks followed by 2 weeks off (N=444) until radiographic or clinical progression or unacceptable toxicity.
Slovenian: • Sunitinib 50 mg enkrat na dan peroralno 4 tedne, katerim sledita 2 tedna brez zdravila (n = 444)
English: Avelumab was discontinued in 4.7% (23/489) of patients due to immune-related hepatitis.
Slovenian: Dajanje avelumaba so prekinili pri 4,7 % (23/489) bolnikov zaradi imunsko pogojenega hepatitisa.
English: Dose modification advice for axitinib when used with Bavencio When Bavencio is administered in combination with axitinib, please refer to the axitinib product information for recommended dose modifications for axitinib.
Slovenian: Kadar se zdravilo Bavencio uporablja v kombinaciji z aksitinibom, za priporočene prilagoditve odmerka za aksitinib upoštevajte informacije o zdravilu, ki vsebuje aksitinib.
English: Lymphopenia, eosinophilia
Slovenian: Občasni limfopenija, eozinofilija
English: Patients should be monitored for changes in liver function and symptoms of immune-related hepatitis and causes other than immune-related hepatitis should be ruled out.
Slovenian: Bolnike je treba spremljati zaradi pojava spremenjenega delovanja jeter in simptomov imunsko pogojenega hepatitisa in izločiti druge razloge za hepatitis.
English: Table 5 summarises the PD-L1 expression and MCV status of patients with metastatic MCC in study EMR100070-003 (Part A).
Slovenian: Preglednica 5 povzema izraženost PD-L1 in status prisotnosti MCV pri bolnikih z metastatskim KMC v študiji EMR100070-003 (del A).
English: • Signs of inflammation of the intestines (colitis) may include diarrhoea (loose stools) or more bowel movements than usual, blood in your stools or dark, tarry, sticky stools, or severe stomach (abdomen) pain or tenderness.
Slovenian: • Znaki vnetja črevesja (kolitis) lahko vključujejo drisko (tekoče blato) ali pogostejše odvajanje blata kot običajno, kri v blatu ali temno, katranasto, lepljivo blato ali hude bolečine v trebuhu (abdomnu) ali občutljivost.
English: • Decrease in the number of a type of white blood cells (lymphocytes)
Slovenian: • zmanjšano število vrste levkocitov (limfocitov)
English: The median duration was 2.5 months (range: 1 day to more than 7.4 months).
Slovenian: Mediana trajanja je bila 2,5 meseca (razpon: 1 dan do več kot 7,4 mesecev).
English: 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.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih pri opicah vrste Cynomolgus, ki so intravensko dobivale odmerke 20, 60 ali 140 mg/kg enkrat na teden 1 mesec oz. 3 mesece, ki jim je sledilo 2-mesečno obdobje okrevanja po 3-mesečnem obdobju odmerjanja.V možganih in hrbtenjači opic, ki so bile 3 mesece zdravljene z avelumabom v odmerkih ≥ 20 mg/kg, so opazili perivaskularni mononuklearni celični infiltrat.
English: For Grade 3 or Grade 4 infusion-related reactions, the infusion should be stopped and avelumab should be permanently discontinued (see section 4.2).
Slovenian: Pri neželenih učinkih 3. ali 4. stopnje, povezanih z infundiranjem, je treba infundiranje ustaviti in avelumab trajno ukiniti (glejte poglavje 4.2).
English: In ADA positive patients, there may be an increased risk for infusion-related reactions (about 40% and 25% in ADA ever-positive and ADA never-positive patients, respectively).
Slovenian: Pri bolnikih, ki so imeli pozitiven test za protitelesa proti zdravilu, je morda tveganje za reakcije, povezane z infundiranjem, večje (približno za 40 % oz. 25 %
English: 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.
Slovenian: Kortikosteroide je treba uporabiti (1 do 2 mg/kg/dan prednizona intravensko ali enakovrednega zdravila peroralno) za insuficienco nadledvične žleze stopnje ≥ 3, nato pa odmerek postopoma zmanjševati, dokler ne dosežemo vrednosti ≤ 10 mg/dan.
English: Avelumab should be withheld for Grade 2 or Grade 3 nephritis until resolution to ≤ Grade 1 and permanently discontinued for Grade 4 nephritis.
Slovenian: Uporabo avelumaba je treba odložiti pri nefritisu 2. stopnje ali 3. stopnje, dokler ne izzveni do stopnje ≤ 1, pri nefritisu 4. stopnje pa trajno prekiniti.
English: Thyroid disorders resolved in 7 (7%) of the 98 patients at the time of data cut-off.
Slovenian: Motnje delovanja ščitnice so po presečnih podatkih izzvenele pri 7 (7 %) bolnikih od 98.
English: Blood creatinine increased, amylase increased, lipase increased, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinase increased, blood thyroid stimulating hormone decreased, transaminases increased
Slovenian: Pogosti zvišanje vrednosti kreatinina v krvi, zvišanje vrednosti amilaze, zvišanje vrednosti lipaze, zvišanje vrednosti gama-glutamiltransferaze, zvišanje vrednosti alkalne fosfataze, zvišanje vrednosti kreatin-fosfokinaze v krvi,
English: Patients should be monitored for signs and symptoms of immune-related pancreatitis.
Slovenian: Bolnike je treba spremljati zaradi pojava znakov in simptomov imunsko pogojenega pankreatitisa.
English: 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.
Slovenian: Pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, se je sladkorna bolezen tipa 1 brez alternativne etiologije pojavila pri 1,0 % (5/489) bolnikov.
English: IHC-MCV tumour status
Slovenian: Status prisotnosti MCV v tumorju po IHC
English: 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.
Slovenian: Če sta ALT ali AST ≥ 3-kratniku ULN in < 5-kratniku ULN ali celokupni bilirubin ≥ 1,5-kratniku ULN in < 3-kratniku ULN, je treba zdravljenje z zdravilom Bavencio in aksitinibom odložiti, dokler se ti neželeni učinki ne vrnejo na stopnjo 0-1.
English: Of these patients, there were 9 (1.8%) patients with Grade 3 immune-related colitis.
Slovenian: Od teh je imelo 9 (1,8 %) bolnikov imunsko pogojeni kolitis 3. stopnje.
English: Treatment-related adverse reaction
Slovenian: Neželeni učinki zaradi zdravljenja
English: The median duration was 7 weeks (range: 4 days to more than 4 months).
Slovenian: Mediana trajanja je bila 7 tednov (razpon: 4 dni do več kot 4 mesece).
English: Diabetes mellitus*, Type 1 diabetes mellitus*
Slovenian: Občasni sladkorna bolezen*, sladkorna bolezen tipa 1*
English: 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).
Slovenian: Osem (88,9 %) bolnikov z imunsko pogojeno insuficienco nadledvične žleze je bilo zdravljenih s kortikosteroidi in 2 (25 %) od 8 bolnikov sta prejemala velike odmerke kortikosteroidov (≥ 40 mg prednizona ali enakovrednega zdravila) za mediano 8 dni (razpon: 5 dni do
English: • Increase in the number of a type of white blood cells (eosinophils)
Slovenian: • zvišana vrednost jetrnih encimov v krvi • povečano število vrste levkocitov (eozinofilcev)
English: Asthenia, chills, influenza like illness
Slovenian: Pogosti astenija, mrzlica, gripi podobna bolezen
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine (učinkovin)
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN
English: Median PFS, months (95% CI) 3-month PFS rate by K-M, (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier * Efficacy data with a minimum follow-up of 7 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Slovenian: 3-mesečna stopnja PFS po K-M, (95 % IZ) 6-mesečna stopnja PFS po K-M, (95 % IZ) 12-mesečna stopnja PFS po K-M, (95 % IZ) IZ: interval zaupanja; RECIST: merila za oceno odgovora na zdravljenje pri čvrstih tumorjih (Response Evaluation Criteria in Solid Tumours); IERC: neodvisni odbor za pregled izidov učinkovitosti (Independent Endpoint Review Committee); K-M: Kaplan-Meier
English: MARKETING AUTHORISATION HOLDER
Slovenian: Pogojno dovoljenje za promet
English: Serum creatinine more than 1.5 and up to 6 times ULN
Slovenian: 1,5- in do 6-krat večje od ULN
English: Based on a population PK analysis for avelumab as monotherapy and in combination with axitinib, there are no expected clinically meaningful differences in exposure of avelumab between settings administered every 2 weeks at 800 mg or 10 mg/kg.
Slovenian: Na osnovi populacijske FK analize za avelumab v monoterapiji in v kombinaciji z aksitinibom ni pričakovati večjih klinično pomembnih razlik v izpostavljenosti avelumabu med dajanjem na vsaka
English: Minimum, maximum (months) ≥ 3 months by K-M, (95% CI) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI)
Slovenian: ≥ 3 mesece po K-M, (95 % IZ) ≥ 6 mesecev po K-M, (95 % IZ) ≥ 12 mesecev po K-M, (95 % IZ)
English: This is very common.
Slovenian: Pojavljajo se zelo pogosto.
English: The median duration was 1.3 weeks (range: more than 4 days to 1.3 weeks).
Slovenian: Mediana trajanja je bila 1,3 tedna (razpon: več kot 4 dni do 1,3 tedna).
English: 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.
Slovenian: • Znaki vnetja žlez, ki proizvajajo hormone (ki lahko vplivajo na način delovanja žlez), lahko vključujejo hudo utrujenost, hitro bitje srca, povečano znojenje, spremembe razpoloženja ali vedenja, na primer razdražljivost ali pozabljivost, občutek mraza, zelo nizek krvni tlak (omedlevica, omotica, utrujenost, navzea), spremembe v telesni masi ali glavobol.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: • rdečina kože Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: The median duration was not estimable (range: 1 day to more than 26 months).
Slovenian: Mediane trajanja ni bilo možno oceniti (razpon: 1 dan do več kot 26 mesecev).
English: Immune-related endocrinopathies
Slovenian: Imunsko pogojene endokrinopatije
English: • inflammation of your intestines (colitis), diarrhoea (watery, loose or soft stools) or more bowel movements than usual;
Slovenian: • vnetje črevesja (kolitis), driska (vodeno, rahlo ali mehko blato) ali pogostejše odvajanje blata,
English: • Hoarseness, cough, shortness of breath
Slovenian: • hripavost, kašelj, kratka sapa
English: For Grade 1 infusion-related reactions, the infusion rate should be slowed by 50% for the current infusion.
Slovenian: Pri neželenih učinkih 1. stopnje, povezanih z infundiranjem, je treba hitrost infundiranja zmanjšati za
English: Bavencio has to be diluted 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.
Slovenian: Zdravilo Bavencio je treba razredčiti z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje ali natrijevim kloridom 4,5 mg/ml (0,45 %) raztopino za injiciranje.
English: It is administered over 60 minutes as an intravenous infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter.
Slovenian: Zdravilo se daje v obliki 60 minutnega intravenskega infundiranja z uporabo sterilnega, apirogenega, 0,2-mikrometrskega linijskega ali dodatnega filtra z zmanjšano vezavo beljakovin.
English: Hyperthyroidism, adrenal insufficiency, thyroiditis
Slovenian: Pogosti hipertiroidizem, insuficienca nadledvične žleze, tiroiditis
English: The median duration was not estimable (range: 2 days to more than 6 months).
Slovenian: Mediane trajanja ni bilo možno oceniti (razpon: 2 dni do več kot 6 mesecev).
English: The median time to onset of immune-related nephritis was 1.2 months (range: 2.9 weeks to 1.8 months).
Slovenian: Mediana časa do nastopa imunsko pogojenega nefritisa je bila 1,2 meseca (razpon: 2,9 tedna do 1,8 meseca).
English: Immune-related thyroid disorders, immune-related adrenal insufficiency, and Type 1 diabetes mellitus have been reported in patients receiving avelumab (see section 4.8).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Autoimmune thyroiditis, hypophysitis
Slovenian: Občasni avtoimunski tiroiditis, vnetje hipofize
English: • Redness in the skin
Slovenian: • rdečina kože
English: Hypersensitivity
Slovenian: Pogosti preobčutljivost
English: Table 4: Response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part A)*
Slovenian: Preglednica 4: Odziv na avelumab v odmerku 10 mg/kg vsaka 2 tedna pri bolnikih z metastatskim KMC v študiji EMR100070-003 (del A)*
English: 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.
Slovenian: 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.
English: Myocarditis*
Slovenian: Redki miokarditis*
English: Immune-related hepatitis resolved in 9 (56%) of the 16 patients at the time of data cut-off.
Slovenian: Imunsko pogojeni hepatitis je po presečnih podatkih izzvenel pri 9 (56 %) bolnikih od
English: A new ADA method with improved sensitivity and drug tolerance was used in the RCC population.
Slovenian: KLC so uporabili novo metodo testiranja protiteles proti zdravilu z izboljšano občutljivostjo in toleranco za zdravilo.
English: Adrenal insufficiency resolved in 4 (44.4%) of the 9 patients at the time of data cut-off.
Slovenian: Insuficienca nadledvične žleze je po presečnih podatkih izzvenela pri 4 (44,4 %) bolnikih od
English: 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%).
Slovenian: (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 %).
English: 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.
Slovenian: 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.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Fatigue has been reported following administration of avelumab (see section 4.8).
Slovenian: Po dajanju avelumaba so poročali o utrujenosti (glejte poglavje 4.8).
English: Hypothyroidism*
Slovenian: Pogosti hipotiroidizem*
English: 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)
Slovenian: ≥ 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)
English: 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).
Slovenian: 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).
English: The clinical utility of PD-L1 as a predictive biomarker in MCC has not been established.
Slovenian: 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.
English: Drug hypersensitivity, hypersensitivity anaphylactic reaction, Type I hypersensitivity
Slovenian: Občasni preobčutljivost na zdravilo, preobčutljivostna anafilaktična reakcija, preobčutljivost tipa I
English: Patients should be monitored for signs and symptoms of immune-related pneumonitis and causes other than immune-related pneumonitis should be ruled out.
Slovenian: Bolnike je treba spremljati zaradi pojava znakov in simptomov imunsko pogojenega pnevmonitisa in izločiti druge razloge za pnevmonitis.
English: 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).
Slovenian: 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).
English: Grade 3 or Grade 4 infusion-related reaction
Slovenian: Neželeni učinki 3. ali 4. stopnje, povezani z infundiranjem
English: Immune-related pneumonitis
Slovenian: Imunsko pogojeni pnevmonitis
English: 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.
Slovenian: 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 %)
English: Patient distribution by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups was 21% favourable, 62% intermediate, and 16% poor.
Slovenian: Database Consortium) je bila 21 % ugodna, 62 % srednje ugodna in 16 % slaba.
English: • inflammation of your heart (myocarditis);
Slovenian: • vnetje trebušne slinavke (pankreatitis), • vnetje srca (miokarditis),