natgillin/translations-raw huggingface dataset:
Patients were randomised 2:1 to receive 10 mg/kg IMFINZI (n = 476) or 10 mg/kg placebo (n = 237) via intravenous infusion every 2 weeks for up to 12 months or until unacceptable toxicity or confirmed disease progression.
Bolniki so bili v razmerju 2:1 randomizirani ali na prejemanje zdravila IMFINZI v odmerku 10 mg/kg (n = 476) ali placeba v odmerku 10 mg/kg (n = 237) v obliki intravenske infuzije na 2 tedna do 12 mesecev ali do pojava nesprejemljive toksičnosti ali potrjenega napredovanja bolezni.
If not used immediately, chemical and physical in-use stability of IMFINZI has been demonstrated for no more than 24 hours at 2°C to 8°C or 12 hours at room temperature up to 25°C from the time of vial puncture to the start of administration.
Če zdravilo IMFINZI ni uporabljeno takoj, sta njegova kemijska in fizikalna stabilnost med uporabo dokazani za največ 24 ur na temperaturi od 2 do 8 °C ali 12 ur na sobni temperaturi do 25 °C od časa vboda v vialo do začetka dajanja zdravila.
The primary elimination pathways of durvalumab are protein catabolism via reticuloendothelial system or target mediated disposition.
Primarni poti odstranjevanja durvalumaba sta katabolizem beljakovin preko retikuloendotelijskega sistema oziroma tarčno posredovano odstranjevanje.
• inflammation of the kidneys (nephritis) that can decrease the amount of your urine
• vnetje ledvic (nefritis), ki lahko zmanjša količino urina
Animal studies with durvalumab are not indicative of reproductive toxicity (see section 5.3).
Študije z durvalumabom na živalih ne nakazujejo vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
The following immune-related adverse reactions were reported in less than 1% of patients treated with IMFINZI monotherapy in clinical trials (n = 1889): Myasthenia gravis, myocarditis, myositis, polymyositis.
Naslednji imunski neželeni učinki so bili zabeleženi v kliničnih preizkušanjih (n = 1889) pri manj kot 1 % bolnikov, ki so prejemali samostojno zdravljenje z zdravilom IMFINZI: miastenija gravis, miokarditis, miozitis, polimiozitis.
For myasthenia gravis, if there are signs of muscular weakness or respiratory insufficiency, IMFINZI should be permanently discontinued.
Če se pri miasteniji gravis pojavijo znaki mišične oslabelosti ali respiratorne insuficience, morate zdravilo IMFINZI trajno prenehati uporabljati.
Dose withholding or discontinuation may be required based on individual safety and tolerability.
Glede na individualno varnost in prenašanje je lahko potrebna odložitev odmerka ali prenehanje uporabe zdravila.
• If you have any further questions, ask your doctor.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom.
Patients should be monitored for signs and symptoms of pneumonitis or radiation pneumonitis.
Bolnike je treba spremljati glede znakov in simptomov pnevmonitisa ali radiacijskega pnevmonitisa.
The study demonstrated a statistically significant improvement in OS in the IMFINZI-treated group compared with the placebo group [HR = 0.68 (95% CI: 0.53, 0.87), p = 0.00251].
Študija je dokazala statistično značilno izboljšanje celokupnega preživetja (OS) v skupini z zdravilom IMFINZI v primerjavi s skupino s placebom [HR = 0,68 (95 % IZ: 0,53, 0,87), p = 0,00251].
• serious lung infections (pneumonia)
• resne okužbe pljuč (pljučnica)
l includes alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased and transaminases increased.
Vključuje zvišanje alanin-aminotransferaze, porast aspartat-aminotransferaze, zvišanje jetrnih encimov in zvišanje transaminaz.
In this patient population, the most frequent adverse reactions were cough (40.2% vs 30.3% in placebo), upper respiratory tract infections (26.1% vs 11.5% in placebo) and rash (21.7% vs 12.0% in placebo).
V tej populaciji bolnikov so bili najbolj pogosti neželeni učinki kašelj (40,2 % v primerjavi s 30,3 % pri uporabi placeba), okužbe zgornjih dihal (26,1 % v primerjavi z 11,5 % pri uporabi placeba) in izpuščaj (21,7 % v primerjavi z 12,0 % pri uporabi placeba).
Other medicines and IMFINZI
Druga zdravila in zdravilo IMFINZI
Immune-mediated hypothyroidism and hyperthyroidism (including thyroiditis) should be managed as recommended in section 4.2.
Imunsko pogojeni hipotiroidizem in hipertiroidizem (vključno s tiroiditisom) je treba obravnavati, kot je priporočeno v poglavju 4.2.
Adverse drug reactions in patients with locally advanced unresectable NSCLC treated with IMFINZI at 10 mg/kg
Neželeni učinki zdravila pri bolnikih z lokalno napredovalim neoperabilnim NSCLC, zdravljenih z zdravilom IMFINZI v odmerku 10 mg/kg Katera koli stopnja (%)
When you are given IMFINZI, you can have some serious side effects.
Ko dobite zdravilo IMFINZI, se vam lahko pojavijo nekateri resni neželeni učinki.
Permanently discontinue a
trajno prenehajte uporabljati
The study demonstrated a statistically significant improvement in PFS in the IMFINZI-treated group compared with the placebo group [hazard ratio (HR) = 0.52 (95% CI: 0.42, 0.65), p < 0.0001].
Študija je pokazala statistično značilno izboljšanje PFS med prejemniki zdravila IMFINZI v primerjavi s skupino s placebom [razmerje ogroženosti (HR - “hazard ratio”) = 0,52 (95 % IZ: 0,42, 0,65), p < 0,0001].
• underactive function of pituitary gland (hypopituitarism including diabetes insipidus) that can cause tiredness, an increase in the amount of your urine
• premajhno delovanje žleze hipofize (hipopituitarizem, vključno z motnjo imenovano diabetes insipidus), ki lahko povzroči utrujenost in izločanje večje količine urina
• inflammation of the heart
• vnetje srca
One patient also received mycophenolate treatment.
Enega bolnika so zdravili tudi z mikofenolatom.
• muscle pain (myalgia)
• boleče mišice (mialgija)
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe, monoklonska protitelesa.
Resolution occurred in 1 patient.
Do izboljšanja je prišlo pri 1 bolniku.
• swelling of the legs (oedema peripheral)
• otekanje nog (periferni edemi)
Patients should be monitored for clinical signs and symptoms of adrenal insufficiency.
Bolnike je treba spremljati glede kliničnih znakov in simptomov adrenalne insuficience.
Patient reported outcomes
Izidi po navedbi bolnikov
• inflammation of the lungs (pneumonitis)
• vnetje pljuč (pnevmonitis)
• infections of the upper respiratory tract
• okužbe zgornjih dihal
includes lung infection, pneumocystis jirovecii pneumonia, pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia haemophilus, pneumonia klebsiella, pneumonia necrotising, pneumonia pneumococcal and pneumonia streptococcal.
Vključuje okužbo pljuč, pljučnico zaradi pneumocystis jirovecii, pljučnico, adenovirusno pljučnico, bakterijsko pljučnico, citomegalovirusno pljučnico, hemofilusno pljučnico, pljučnico zaradi klebsielle, nekrotizirajočo pljučnico, pnevmokokno pljučnico in streptokokno pljučnico.
The study excluded patients who had progressed following chemoradiation therapy, patients with prior exposure to any anti-PD-1 or anti-PD-L1 antibody, patients with active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids; active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI.
Študija ni vključila bolnikov, ki so napredovali po kemoradiacijskem zdravljenju; bolnikov s predhodno izpostavljenostjo katerim koli protitelesom proti PD-1 ali proti PD-L1; bolnikov z aktivno ali predhodno dokumentirano avtoimunsko boleznijo v 2 letih pred začetkom študije; anamnezo imunske pomanjkljivosti; anamnezo hudih imunsko pogojenih neželenih učinkov; boleznimi, ki so zahtevale sistemsko imunosupresijo, razen fiziološkega odmerka sistemskih kortikosteroidov; aktivno tuberkulozo ali okužbo s hepatitisom B ali C ali HIV; bolnikov, ki so prejeli živo oslabljeno cepivo v 30 dneh pred začetkom zdravljenja z zdravilom
• inflammation or problems of the muscles: symptoms may include muscle pain, or weakness or rapid fatigue of the muscles;
• vnetje mišic ali težave z njimi: med simptomi so lahko bolečine v mišicah, šibkost ali hitra utrujenost mišic;
Immune-mediated adrenal insufficiency or hypophysitis/hypopituitarism
Imunsko pogojena adrenalna insuficienca ali hipofizitis/hipopituitarizem2.-4.
Resolution occurred in 42 patients.
Do izboljšanja je prišlo pri 42 bolnikih.
The effect of moderate hepatic impairment (bilirubin > 1.5 to 3 x ULN and any AST) or severe hepatic impairment (bilirubin > 3.0 x ULN and any AST) on the pharmacokinetics of durvalumab is unknown; however, as IgG monoclonal antibodies are not primarily cleared via hepatic pathways, a change in hepatic function is not expected to influence durvalumab exposure.
Vpliv zmerne okvare jeter (bilirubin > 1,5 x do 3 x ZNM ne glede na AST) ali hude okvare jeter (bilirubin > 3x ZNM ne glede na AST) na farmakokinetiko durvalumaba ni znan, ker pa se monoklonska protitelesa IgG ne odstranjujejo primarno preko jeter, ni pričakovati, da bi sprememba delovanja jeter vplivala na izpostavljenost durvalumabu.
d includes gingivitis, oral infection, periodontitis, pulpitis dental, tooth abscess and tooth infection.
Vključuje gingivitis, okužbo v ustih, periodontitis, zobni pulpitis, zobni absces in zobno okužbo.
Due to minor involvement of hepatic processes in the clearance of durvalumab no dose adjustment of IMFINZI is recommended for patients with hepatic impairment as no difference in exposure is expected (see section 5.2).
Ker so procesi v jetrih le v majhni meri vključeni v odstranjevanje durvalumaba iz telesa, bolnikom z okvaro jeter odmerka zdravila IMFINZI ni treba prilagoditi, ker ni pričakovati razlik v izpostavljenosti (glejte poglavje 5.2).
• inflammation of the muscle
• vnetje mišic
Of 451 patients with PD L1 expression available, 67% were TC ≥ 1% [PD-L1 TC 1-24% (32%), PD L1 TC ≥ 25% (35%)] and 33% were TC < 1%.
Izmed 451 bolnikov, za katere so bili na voljo podatki o ekspresiji PD-L1, je bila pri 67 % ta prisotna na ≥ 1 % tumorskih celic (TC) [PD-L1 TC 1-24 % (pri 32 %), PD-L1 TC ≥ 25 % (pri 35 %)], pri 33 % bolnikov pa je bila prisotna na < 1 % tumorskih celic.
Twenty-six of the 34 patients received medical therapy (thiamazole, carbimazole, propylthiouracil or beta-blocker), 12 patients received thyroxine when hyperthyroidism transitioned to hypothyroidism, 12 patients received systemic corticosteroids and 3 of the 12 patients received high-dose systemic corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
26 od 34 bolnikov je prejemalo zdravila (tiamazol, karbimazol, propiltiouracil ali blokator beta), 12 bolnikov je po prehodu hipertiroidizma v hipotiroidizem prejemalo tiroksin, 12 bolnikov je prejemalo sistemske kortikosteroide in 3 od teh
Resolution occurred in 18 patients.
Do izboljšanja je prišlo pri 18 bolnikih.
Driving and using machines IMFINZI is not likely to affect you being able to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo IMFINZI vplivalo na vašo sposobnost upravljanja vozil in strojev.
The use of systemic corticosteroids or immunosuppressants before starting durvalumab, except physiological dose of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent), is not recommended because of their potential interference with the pharmacodynamic activity and efficacy of durvalumab.
Razen fizioloških odmerkov sistemskih kortikosteroidov (≤ 10 mg na dan prednizona ali ekvivalenta) pred uvedbo durvalumaba ni priporočljivo uporabljati sistemskih kortikosteroidov ali imunosupresivov, ker lahko vplivajo na farmakodinamično aktivnost in učinkovitost durvalumaba.
• Discard any unused portion left in the vial.
• Morebitni neporabljeni ostanek v viali zavrzite.
Warnings and precautions Talk to your doctor before you are given IMFINZI if:
Opozorila in previdnostni ukrepi Preden dobite zdravilo IMFINZI, se posvetujte z zdravnikom:
m includes hepatitis, autoimmune hepatitis, hepatitis toxic, hepatocellular injury, hepatitis acute, and hepatotoxicity.
Vključuje hepatitis, avtoimunski hepatitis, toksični hepatitis, hepatocelularno poškodbo, akutni hepatitis in hepatotoksičnost.
Mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 to 1.5 × ULN and any AST) had no clinically significant effect on the PK of durvalumab.
Blaga okvara jeter (bilirubin ≤ ZNM in AST > ZNM ali bilirubin > 1,0 do 1,5 × ZNM in kakršen koli AST) ni klinično pomembno vplivala na farmakokinetiko durvalumaba.
Compliance was similar between the IMFINZI and placebo treatment groups (83% vs 85.1% overall of evaluable forms completed).
Sodelovalnost je bila v skupini z zdravilom IMFINZI zelo podobna kot v skupini s placebom (v celoti 83 % v prvi in 85,1 % v drugi na podlagi izpolnjenih obrazcev, ki jih je bilo mogoče oceniti).
• IMFINZI is single-dose.
• Zdravilo IMFINZI je namenjeno za en odmerek.
PD-L1 testing for patients with locally advanced NSCLC Patients with locally advanced NSCLC should be evaluated for treatment based on the tumour expression of PD-L1 confirmed by a validated test (section 5.1).
Testiranje na prisotnost PD-L1 pri bolnikih z lokalno napredovalim nedrobnoceličnim rakom pljuč Bolnike z lokalno napredovalim nedrobnoceličnim rakom pljuč je treba za zdravljenje izbrati na podlagi izraženosti PD-L1, ugotovljene z validirano testno metodo (glejte poglavje 5.1).
Overall the safety profile of durvalumab in PD-L1 TC ≥ 1% subgroup was consistent with the intent to treat population, as was the PD-L1 TC < 1% subgroup.
Celokupen varnostni profil durvalumaba v podskupini bolnikov z ekspresijo PD-L1 TC ≥ 1 % se je ujemal z varnostnim profilom populacije z namenom zdravljenja (“intent to treat population”), enako velja tudi za varnostni profil v podskupini bolnikov z ekspresijo PD-L1 TC < 1 %.
IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.
Zdravilo IMFINZI je na voljo v vialah z enim odmerkom in ne vsebuje konzervansov, zato je treba upoštevati aseptičen postopek.
Immune-mediated myocarditis
Imunsko pogojeni miokarditis
• Administer the infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
• Raztopino za infundiranje dajte intravensko v 60 minutah po intravenski liniji, v kateri je sterilen 0,2- ali 0,22-mikronski linijski filter z zmanjšano vezavo beljakovin.
Immune-mediated pneumonitis/interstitial lung disease
Imunsko pogojeni pnevmonitis/intersticijska bolezen pljuč
The median time to onset in the IMFINZI-treated group was 53 days (range: 1-341 days) vs. 55.5 days (range: 0-231 days) in the placebo group.
Mediani časa do pojava je bil v skupini z zdravilom IMFINZI 53 dni (razpon od 1 do 341 dni) in v skupini s placebom 55,5 dneva (razpon od 0 do 231 dni).
If you have any of the symptoms listed above, call or see your doctor straight away.
Če imate katerega od zgoraj naštetih simptomov, se nemudoma posvetujte z zdravnikom.
Patients should be monitored for abnormal liver tests prior to and periodically during treatment with IMFINZI, and as indicated based on clinical evaluation.
Bolnike je treba redno spremljati glede nenormalnih jetrnih testov pred in med zdravljenjem z zdravilom IMFINZI in kot je indicirano na podlagi kliničnega ovrednotenja.
Common includes laryngitis, nasopharyngitis, peritonsillar abscess, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheobronchitis and upper respiratory tract infection.
Vključuje laringitis, nazofaringitis, peritonzilarni absces, faringitis, rinitis, sinuzitis, tonzilitis, traheobronhitis in okužbo zgornjih dihal.
What IMFINZI contains The active substance is durvalumab.
Kaj vsebuje zdravilo IMFINZI Učinkovina je durvalumab.
As reported in the literature, the PD-1/PD-L1 pathway plays a central role in preserving pregnancy by maintaining maternal immune tolerance to the foetus, and in mouse allogeneic pregnancy models disruption of PD-L1 signalling was shown to result in an increase in foetal loss.
Kot je opisano v literaturi, ima pot PD-1/PD-L1 osrednjo vlogo pri ohranitvi nosečnosti, ker vzdržuje materino imunsko toleranco za plod.
Immune-mediated hepatitis
Imunsko pogojeni hepatitis
• inflammation of the kidneys: symptoms may include decrease in the amount of urine you pass;
• vnetje ledvic: med simptomi je lahko zmanjšanje količine izločenega urina;
e includes autoimmune hypothyroidism and hypothyroidism.
Vključuje avtoimunski hipotiroidizem in hipotiroidizem.
Resolution occurred in 13 patients.
Do izboljšanja je prišlo pri 13 bolnikih.
Patients with the following were excluded from the PACIFIC Study: a baseline ECOG performance score ≥ 2; active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent); active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI.
Bolniki, ki niso bili vključeni v klinična preizkušanja V študijo PACIFIC niso bili vključeni bolniki z naslednjimi značilnostmi: izhodiščno oceno zmogljivosti ECOG ≥ 2; aktivno ali predhodno dokumentirano avtoimunsko boleznijo v 2 letih pred začetkom študije; anamnezo imunske pomanjkljivosti; anamnezo hudih imunsko pogojenih neželenih učinkov; boleznimi, ki so zahtevale sistemsko imunosupresijo, razen fiziološkega odmerka sistemskih kortikosteroidov (≤ 10 mg na dan prednizona ali ekvivalenta); aktivno tuberkulozo ali okužbo s hepatitisom B ali C ali HIV; bolniki, ki so prejeli živo oslabljeno cepivo v 30 dneh pred začetkom zdravljenja z zdravilom IMFINZI ali v 30 dneh po začetku.
Patients should be monitored for clinical signs and symptoms of type 1 diabetes mellitus.
Bolnike je treba spremljati glede kliničnih znakov in simptomov sladkorne bolezni tipa 1.
p includes autoimmune nephritis, tubulointerstitial nephritis, nephritis, glomerulonephritis and glomerulonephritis membranous.
Vključuje avtoimunski nefritis, tubulointerstiticijski nefritis, nefritis, glomerulonefritis in membranski glomerulonefritis.
It is unknown whether durvalumab is secreted in human breast milk.
Ni znano, ali se durvalumab pri človeku izloča v materinem mleku.
Post-hoc subgroup analysis by PD-L1 expression
Naknadna analiza podatkov po podskupinah glede na ekspresijo PD-L1
Histidine hydrochloride monohydrate Trehalose dihydrate Polysorbate 80
6.1 Seznam pomožnih snovi histidin histidinijev klorid monohidrat trehaloza-dihidrat polisorbat 80
Immune-mediated myositis/polymyositis
Imunsko pogojeni miozitis/polimiozitis
In patients treated with durvalumab in the PACIFIC Study, the proportion of patients who experienced a laboratory abnormality worsening from baseline was as follows: 38.5% (all Grades), 2.3% (Grades 3-4) for alanine aminotransferase increased, 36.0% (all Grades), 2.8% (Grade 3-4) for aspartate aminotransferase increased, 16.3% (all Grades) for creatinine increased, 26.5% (all Grades) for TSH elevated > ULN and above baseline, 31.9% (all Grades) for TSH decreased < LLN and below baseline.
Med bolniki, zdravljenimi z durvalumabom v študiji PACIFIC, so bili deleži bolnikov, ki so se jim v primerjavi z izhodiščem pojavila poslabšanja laboratorijskih nepravilnosti: 38,5 % (vse stopnje), 2,3 % (3.-4. stopnja) za zvišanje alanin-aminotransferaze, 36,0 % (vse stopnje), 2,8 % (3.-4. stopnja) za zvišanje aspartat-aminotransferaze, 16,3 % (vse stopnje) za zvišanje kreatinina, 26,5 % (vse stopnje) za zvišanje TSH > ZNM in nad izhodiščno vrednost, 31,9 % (vse stopnje) za znižanje TSH < SNM in pod izhodiščno vrednost.
Mild (creatinine clearance (CrCL) 60 to 89 mL/min) and moderate renal impairment (creatinine clearance (CrCL) 30 to 59 mL/min) had no clinically significant effect on the PK of durvalumab.The effect of severe renal impairment (CrCL 15 to 29 mL/min) on the PK of durvalumab is unknown.
Blaga (očistek kreatinina (CrCL) od 60 do 89 ml/min) in zmerna (očistek kreatinina (CrCL) od 30 do 59 ml/min) okvara ledvic nista klinično pomembno vplivali na farmakokinetiko durvalumaba.
• inflammation of glands (especially the thyroid, adrenal, pituitary and pancreas): symptoms may include fast heart rate, extreme tiredness, weight gain or weight loss, dizziness or fainting, hair loss, feeling cold, constipation, headaches that will not go away or unusual headaches;
• vnetje žlez (zlasti ščitnice, nadledvične žleze, hipofize in trebušne slinavke): med simptomi so lahko hitro bitje srca, izredna utrujenost, povečanje ali zmanjšanje telesne mase, omotica ali omedlevica, izpadanje las, občutek hladu, zaprtost, glavoboli, ki ne minejo, ali neobičajni glavoboli;
• inflammation of the liver that can cause nausea or feeling less hungry
• vnetje jeter, ki lahko povzroči občutek slabosti s siljenjem na bruhanje ali zmanjšan občutek lakote
In the PACIFIC Study, in patients who had completed treatment with at least 2 cycles of concurrent chemoradiation within 1 to 42 days prior to initiation of the trial, pneumonitis or radiation pneumonitis occurred in 161 (33.9%) patients in the IMFINZI-treated group and 58 (24.8%) in the placebo group, including Grade 3 (3.4% vs 3.0%) and Grade 5 (1.1% vs 1.7%) (see section 4.8).
V študiji PACIFIC sta se pri bolnikih, ki so opravili zdravljenje z najmanj 2 cikloma sočasne kemoradioterapije od 1 do 42 dni pred začetkom preizkušanja, pnevmonitis ali radiacijski pnevmonitis pojavila pri 161 (33,9 %) bolnikih v skupini z zdravilom IMFINZI in pri 58 (24,8 %) bolnikih v skupini s placebom, vključno s 3. stopnjo (3,4 % in 3,0 %) in 5. stopnjo (1,1 % in 1,7 %) (glejte poglavje 4.8).
Patients with suspected pneumonitis should be evaluated with radiographic imaging and managed as recommended in section 4.2.
Bolnike s sumom na pnevmonitis je treba oceniti z radiografskim slikanjem in ukrepati, kot je priporočeno v poglavju 4.2.
Resolution occurred in 23 patients.
Do izboljšanja je prišlo pri 23 bolnikih.
Based on its mechanism of action, durvalumab has the potential to impact maintenance of pregnancy, and in a mouse allogeneic pregnancy model, disruption of PD-L1 signaling was shown to result in an increase in foetal loss.
Podatkov o uporabi durvalumaba pri nosečnicah ni. Glede na mehanizem delovanja durvalumab lahko vpliva na vzdrževanje nosečnosti; v alogenskem modelu nosečnosti pri miših je bilo ugotovljeno, da moteno signaliziranje PD-L1 poveča izgubo plodov.
All 7 patients received systemic corticosteroids; 2 of the 7 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Vseh 7 bolnikov je prejemalo sistemske kortikosteroide; 2 od teh 7 bolnikov sta prejemala visokoodmerno zdravljenje s kortikosteroidi (vsaj 40 mg prednizona ali ekvivalenta na dan).
o includes pruritus generalised and pruritus.
Vključuje generalizirano srbenje in srbenje.
The median time to onset was 85 days (range: 9-378 days).
Mediani čas do pojava je bil 85 dni (razpon od 9 do 378 dni).
Each vial contains either 500 mg of durvalumab in 10 mL of concentrate or 120 mg of durvalumab in 2.4 mL of concentrate.
Ena viala vsebuje ali 500 mg durvalumaba v 10 ml koncentrata ali 120 mg durvalumaba v 2,4 ml koncentrata.
Patients had completed at least 2 cycles of definitive platinum-based chemotherapy with radiation therapy within 1 to 42 days prior to initiation of the study and had a ECOG performance status of 0 or 1.
Bolniki so dokončali vsaj 2 cikla definitivne kemoterapije na osnovi platine skupaj z radioterapijo od 1 do 42 dni pred začetkom študije in so imeli stanje zmogljivosti 0 ali 1 po ECOG. 92 bolnikov je prejelo celokupni odmerek od 54 do 66 Gy obsevanja.