natgillin/translations-raw huggingface dataset:
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
utrujenost (42,9 %), navzea (33,5 %), disfonija (32,7 %), zmanjšan apetit (26,0 %), hipotiroidizem (25,2 %), kašelj (23,7 %), glavobol (21,3 %), dispneja (20,9 %) in artralgija (20,9 %).
• Grade 2 or Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above.
• Klinični znaki ali simptomi imunsko pogojenega neželenega učinka 2. ali
Based on the severity of the adverse reaction, avelumab should be withheld and corticosteroids to be administered.
Na podlagi resnosti neželenega učinka je treba uporabo avelumaba odložiti in bolniku dati kortikosteroide.
Each mL of concentrate contains 20 mg of avelumab.
En ml koncentrata vsebuje 20 mg avelumaba.
Serious adverse reactions were immune-related adverse reactions and infusion-related reaction (see section 4.4).
Hudi neželeni učinki so bili imunsko pogojeni neželeni učinki in učinki, povezani z infundiranjem (glejte poglavje 4.4).
Immune-related pneumonitis resolved in 2 (66.7%) of the 3 patients at the time of data cut-off.
Imunsko pogojeni pnevmonitis je po presečnih podatkih izzvenel pri 2 (66,7 %) bolnikih od 3.
• Joint pain, back pain, belly pain, muscle pain
• bolečine v sklepih, bolečine v hrbtu, bolečine v trebuhu, bolečine v mišicah
How you will receive Bavencio
Kako boste prejeli zdravilo Bavencio
The study population characteristics were: median age of 61 years (range: 27.0 to 88.0), 38% of patients were 65 years or older, 75% were male, 75% were White, and the ECOG performance score was 0 (63%) or 1 (37%).
Značilnosti študijske populacije so bile: mediana starost 61 let (razpon: 27,0 do 88,0), 38 % bolnikov je bilo starih 65 let ali starejših, 75 % je bilo moških, 75 % je bilo belcev in ocena zmogljivosti ECOG je bila 0 (63 %) ali 1 (37 %).
For Part A, the major efficacy outcome measure was confirmed best overall response (BOR); secondary efficacy outcome measures included duration of response (DOR), and progression-free survival (PFS).
Za del A je bil za glavno merilo izida učinkovitosti potrjen najboljši celokupni odziv, medtem ko so bila sekundarna merila učinkovitosti trajanje odziva in preživetje brez napredovanja.
Figure 4: Forest plot of progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Slika 4: Drevesni diagram preživetja brez napredovanja bolezni na podlagi ocene BICR pri bolnikih, neodvisno od izraženosti PD-L1
The median duration was not estimable (range: 8 days to more than 23.9 months).
Mediane trajanja ni bilo možno oceniti (razpon: 8 dni do več kot 23,9 meseca).
• Patient Information brochure
• brošuro z informacijami za bolnika
Hypertension, hypotension
Pogosti hipertenzija, hipotenzija
The median duration was 2.6 months (range: 3.3 weeks to more than 7.9 months).
Mediana trajanja je bila 2,6 meseca (razpon: 3,3 tedne do več kot 7,9 mesecev).
Gamma-glutamyltransferase increased, blood alkaline phosphatase increased, amylase increased, lipase increased, blood creatinine increased
Pogosti zvišanje vrednosti gama-glutamiltransferaze, zvišanje vrednosti alkalne fosfataze, zvišanje vrednosti amilaze, zvišanje vrednosti lipaze, zvišanje vrednosti kreatinina v krvi
Part B included patients with histologically confirmed metastatic MCC who were treatment-naïve to systemic therapy in the metastatic setting.
Del B je vključeval bolnike s histološko potrjenim metastatskim
The median duration was 2.8 months (range: 3 days to more than 15.5 months).
Mediana trajanja je bila 2,8 meseca (razpon: 3 dni do več kot 15,5 meseca).
Immune-related myocarditis
Imunsko pogojeni miokarditis
• Patient Alert Card
• Opozorilna kartica za bolnika
Thyroid disorders (hypothyroidism/hyperthyroidism) Thyroid disorders can occur at any time during treatment (see section 4.8).
Motnje delovanja žleze ščitnice se lahko pojavijo kadar koli med zdravljenjem (glejte poglavje 4.8).
The median duration was 2.1 weeks (range: 2 days to 8.9 months).
Mediana trajanja je bila 2,1 tedna (razpon: 2 dni do 8,9 mesecev).
• Brief introduction to Bavencio treatment
• Kratek opis gradiva in njegov namen • Kratka predstavitev zdravljenja z zdravilom Bavencio
• Inflammation of the eye
• vnetje očesa
Immune-related pneumonitis resolved in 12 (57%) of the 21 patients at the time of data cut-off.
Imunsko pogojeni pnevmonitis je po presečnih podatkih izzvenel pri 12 (57 %) bolnikih od 21.
Headache, dizziness, neuropathy peripheral
Pogosti glavobol, omotičnost, periferna nevropatija
Figure 3: Kaplan-Meier estimates for progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Slika 3: Ocena preživetja po metodi Kaplan-Meier brez napredovanja bolezni na podlagi ocene BICR pri bolnikih, neodvisno od izraženosti PD-L1
Of the 480 patients with at least one valid ADA result at any time point treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily, 453 were evaluable for treatment-emergent ADA and 66 (14.6%) tested positive.
Med 480 bolniki z vsaj enim veljavnim rezultatom testa za protitelesa proti zdravilu kadar koli med zdravljenjem z avelumabom 10 mg/kg v obliki intravenske infuzije vsaka 2 tedna v kombinaciji z aksitinibom v odmerku 5 mg dvakrat na dan, je bilo protitelesa proti zdravilu zaradi zdravljenja možno oceniti pri 453 bolnikih.
All 2 patients with immune-related nephritis were treated with high-dose corticosteroids for a median of 1.1 weeks (range: 3 days to 1.9 weeks).
Oba 2 bolnika z imunsko pogojenim nefritisom sta bila zdravljena z visokimi odmerki kortikosteroidov za mediano 1,1 tedna (razpon: 3 dni do 1,9 tedna).
• or stop your treatment with Bavencio altogether.
• odloži naslednji odmerek zdravila Bavencio • ali ustavi vaše zdravljenje z zdravilom Bavencio.
Immune-related colitis resolved in 18 (70%) of 26 patients at the time of data cut-off.
Imunsko pogojeni kolitis je po presečnih podatkih izzvenel pri 18 (70 %) bolnikih od 26.
In patients treated with avelumab as monotherapy, 6% (98/1,738) of patients developed immune-related thyroid disorders, including 90 (5%) patients with hypothyroidism, 7 (0.4%) with hyperthyroidism, and 4 (0.2%) with thyroiditis.
Pri bolnikih, zdravljenih z avelumabom v monoterapiji, so se pri 6 % (98/1.738) bolnikov razvile imunsko pogojene motnje delovanja ščitnice, vključno z 90 (5 %) bolniki s hipotiroidizmom, 7 (0,4 %) s hipertiroidizmom in 4 (0,2 %) s tiroiditisom.
Of these patients, there was 1 (0.1%) patient with a fatal outcome, 1 (0.1%) patient with Grade 4, and 5 (0.3%) patients with Grade 3 immune-related pneumonitis.
Od teh je 1 (0,1 %) bolnik umrl, 1 (0,1 %) bolnik je imel imunsko pogojeni pnevmonitis 4. stopnje, 5 (0,3 %) bolnikov pa 3. stopnje.
All 3 patients with immune-related pneumonitis were treated with high-dose corticosteroids for a median of 3.3 months (range: 3 weeks to 22.3 months).
Vsi 3 bolniki z imunsko pogojenim pnevmonitisom so bili zdravljeni z velikimi odmerki kortikosteroidov za mediano 3,3 meseca (razpon: 3 tedni do 22,3 meseca).
Administration of avelumab and axitinib was permitted beyond RECIST-defined disease progression based on investigator's assessment of the patient's benefit-risk and clinical condition, including performance status, clinical symptoms, adverse events and laboratory data.
Dajanje avelumaba in aksitiniba je bilo dovoljeno po napredovanju bolezni, opredeljenem v RECIST, na podlagi preiskovalčeve ocene koristi in tveganja za
If you miss a dose of Bavencio
Če ste izpustili odmerek zdravila Bavencio
Avelumab should be resumed when the immune-related adverse reaction returns to Grade 1 or less following corticosteroid taper.
Uporabo avelumaba je treba nadaljevati po postopnem zmanjševanju dajanja kortikosteroidov, ko se imunsko pogojeni neželeni učinek vrne na 1. stopnjo ali manj.
Rash*, pruritus*, rash maculo-papular*, dry skin
Pogosti izpuščaj*, pruritus*, makulopapularni izpuščaj*, suha koža
Bavencio contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Zdravilo Bavencio vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Of these patients, there were 2 (0.1%) patients with a fatal outcome, and 11 (0.6%) patients with Grade 3 immune-related hepatitis.
Od teh sta 2 (0,1 %) bolnika umrla, 11 (0,6 %) bolnikov pa je imelo imunsko pogojeni hepatitis 3. stopnje.
Immune-related hepatitis
Imunsko pogojeni hepatitis
Thyroid disorders resolved in 15 (12.4%) of the 121 patients at the time of data cut-off.
Motnje delovanja ščitnice so po presečnih podatkih izzvenele pri 15 (12,4 %) bolnikih od
Immune-related nephritis resolved in 1 (50%) of the 2 patients at the time of data cut-off.
Imunsko pogojeni nefritis je po presečnih podatkih izzvenel pri 1 (50 %) bolniku od 2.
Of these patients, there were 18 (3.7%) patients with Grade 3 and 3 (0.6%) patients with Grade 4 immune-related hepatitis.
Od teh je imelo 18 (3,7 %) bolnikov imunsko pogojeni hepatitis 3. stopnje, 3 (0,6 %) bolniki pa 4. stopnje.
• Bowel occlusion
• zapora črevesa
No dose adjustment is needed for patients with mild or moderate renal impairment (see section 5.2).
Pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
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.
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.
Tubulo-interstitial nephritis*
Bolezni sečil Občasni tubulointersticijski nefritis*
Patients should be monitored for signs and symptoms of immune-related myocarditis.
Bolnike je treba spremljati zaradi pojava znakov in simptomov imunsko pogojenega miokarditisa.
You will receive Bavencio as an infusion (a drip) into a vein (intravenously) over a period of 1 hour.
Zdravilo Bavencio boste prejeli v obliki enourne infuzije v veno (intravensko).
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).
Avelumaba niso preučili pri bolnikih z zmerno okvaro jeter (bilirubin med 1,5- in 3-kratnikom ULN)
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).
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
• Signs of inflammation of the lungs (pneumonitis) may be breathing difficulties or cough.
• Znaki vnetja pljuč (pnevmonitis) lahko vključujejo oteženo dihanje ali kašelj.
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI
Endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia)
Endokrinopatije (hipotiroidizem, hipertiroidizem, insuficienca nadledvične žleze,
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.
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.
Autoimmune colitis, autoimmune pancreatitis, enterocolitis, ileus, pancreatitis necrotizing
Občasni avtoimunski kolitis, avtoimunski pankreatitis, enterokolitis, ileus,
The median time to onset of immune-related pneumonitis was 3.7 months (range: 2.7 months to 8.6 months).
Mediana časa do nastopa imunsko pogojenega pnevmonitisa je bila 3,7 meseca (razpon: 2,7 meseca do 8,6 mesecev).
Adverse reactions Blood and lymphatic system disorders
Neželeni učinki Bolezni krvi in limfatičnega sistema
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)*
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)*
• Sunitinib 50 mg once daily orally for 4 weeks followed by 2 weeks off (N=444) until radiographic or clinical progression or unacceptable toxicity.
• Sunitinib 50 mg enkrat na dan peroralno 4 tedne, katerim sledita 2 tedna brez zdravila (n = 444)
Avelumab was discontinued in 4.7% (23/489) of patients due to immune-related hepatitis.
Dajanje avelumaba so prekinili pri 4,7 % (23/489) bolnikov zaradi imunsko pogojenega hepatitisa.
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.
Kadar se zdravilo Bavencio uporablja v kombinaciji z aksitinibom, za priporočene prilagoditve odmerka za aksitinib upoštevajte informacije o zdravilu, ki vsebuje aksitinib.
Lymphopenia, eosinophilia
Občasni limfopenija, eozinofilija
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.
Bolnike je treba spremljati zaradi pojava spremenjenega delovanja jeter in simptomov imunsko pogojenega hepatitisa in izločiti druge razloge za hepatitis.
Table 5 summarises the PD-L1 expression and MCV status of patients with metastatic MCC in study EMR100070-003 (Part A).
Preglednica 5 povzema izraženost PD-L1 in status prisotnosti MCV pri bolnikih z metastatskim KMC v študiji EMR100070-003 (del A).
• 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.
• 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.
• Decrease in the number of a type of white blood cells (lymphocytes)
• zmanjšano število vrste levkocitov (limfocitov)
The median duration was 2.5 months (range: 1 day to more than 7.4 months).
Mediana trajanja je bila 2,5 meseca (razpon: 1 dan do več kot 7,4 mesecev).
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.
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.
For Grade 3 or Grade 4 infusion-related reactions, the infusion should be stopped and avelumab should be permanently discontinued (see section 4.2).
Pri neželenih učinkih 3. ali 4. stopnje, povezanih z infundiranjem, je treba infundiranje ustaviti in avelumab trajno ukiniti (glejte poglavje 4.2).
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).
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 %
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.
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.
Avelumab should be withheld for Grade 2 or Grade 3 nephritis until resolution to ≤ Grade 1 and permanently discontinued for Grade 4 nephritis.
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.
Thyroid disorders resolved in 7 (7%) of the 98 patients at the time of data cut-off.
Motnje delovanja ščitnice so po presečnih podatkih izzvenele pri 7 (7 %) bolnikih od 98.
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
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,
Patients should be monitored for signs and symptoms of immune-related pancreatitis.
Bolnike je treba spremljati zaradi pojava znakov in simptomov imunsko pogojenega pankreatitisa.
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.
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.
IHC-MCV tumour status
Status prisotnosti MCV v tumorju po IHC
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.
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.
Of these patients, there were 9 (1.8%) patients with Grade 3 immune-related colitis.
Od teh je imelo 9 (1,8 %) bolnikov imunsko pogojeni kolitis 3. stopnje.
Treatment-related adverse reaction
Neželeni učinki zaradi zdravljenja
The median duration was 7 weeks (range: 4 days to more than 4 months).
Mediana trajanja je bila 7 tednov (razpon: 4 dni do več kot 4 mesece).
Diabetes mellitus*, Type 1 diabetes mellitus*
Občasni sladkorna bolezen*, sladkorna bolezen tipa 1*
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).
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
• Increase in the number of a type of white blood cells (eosinophils)
• zvišana vrednost jetrnih encimov v krvi • povečano število vrste levkocitov (eozinofilcev)
Asthenia, chills, influenza like illness
Pogosti astenija, mrzlica, gripi podobna bolezen
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine (učinkovin)
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN
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)
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
MARKETING AUTHORISATION HOLDER
Pogojno dovoljenje za promet
Serum creatinine more than 1.5 and up to 6 times ULN
1,5- in do 6-krat večje od ULN
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.
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
Minimum, maximum (months) ≥ 3 months by K-M, (95% CI) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI)
≥ 3 mesece po K-M, (95 % IZ) ≥ 6 mesecev po K-M, (95 % IZ) ≥ 12 mesecev po K-M, (95 % IZ)
This is very common.
Pojavljajo se zelo pogosto.
The median duration was 1.3 weeks (range: more than 4 days to 1.3 weeks).
Mediana trajanja je bila 1,3 tedna (razpon: več kot 4 dni do 1,3 tedna).
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.
• 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.
Uncommon (may affect up to 1 in 100 people)
• rdečina kože Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
The median duration was not estimable (range: 1 day to more than 26 months).
Mediane trajanja ni bilo možno oceniti (razpon: 1 dan do več kot 26 mesecev).
Immune-related endocrinopathies
Imunsko pogojene endokrinopatije
• inflammation of your intestines (colitis), diarrhoea (watery, loose or soft stools) or more bowel movements than usual;
• vnetje črevesja (kolitis), driska (vodeno, rahlo ali mehko blato) ali pogostejše odvajanje blata,
• Hoarseness, cough, shortness of breath
• hripavost, kašelj, kratka sapa
For Grade 1 infusion-related reactions, the infusion rate should be slowed by 50% for the current infusion.
Pri neželenih učinkih 1. stopnje, povezanih z infundiranjem, je treba hitrost infundiranja zmanjšati za
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.
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.
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.
Zdravilo se daje v obliki 60 minutnega intravenskega infundiranja z uporabo sterilnega, apirogenega, 0,2-mikrometrskega linijskega ali dodatnega filtra z zmanjšano vezavo beljakovin.