natgillin/translations-raw huggingface dataset:
The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks, until disease progression or unacceptable toxicity, or a maximum of 12 months. 
Priporočeni odmerek zdravila IMFINZI je 10 mg/kg v intravenski infuziji v 60 minutah vsaka 2 tedna do napredovanja bolezni ali nesprejemljive toksičnosti oziroma največ 12 mesecev.
• type 1 diabetes: symptoms may include high blood sugar, feeling more hungry or thirsty than usual, passing urine more often than usual; 
• sladkorna bolezen tipa 1: med simptomi so lahko visok krvni sladkor, večja lakota ali žeja kot po navadi, pogostejše odvajanje urina kot po navadi;
h frequency is based on events not observed in the PACIFIC Study but observed in AstraZeneca clinical trials (n=4067). 
Pogostnost se nanaša na dogodke, ki jih niso opažali v študiji PACIFIC, opažali pa so jih v AstraZeneca kliničnih preskušanjih (n = 4067).
Immune-mediated pneumonitis occurred more frequently in patients in the PACIFIC Study who had completed treatment with concurrent chemoradiation within 1 to 42 days prior to initiation of the study (10.7%), than in the other patients in the combined safety database (2.0%). 
Imunsko pogojeni pnevmonitis se je pogosteje pojavil pri bolnikih v študiji PACIFIC, ki so dokončali zdravljenje s sočasno kemoradiacijo od 1 do 42 dni pred začetkom študije (10,7 %), kot pri drugih bolnikih v kombinirani podatkovni bazi varnosti (2,0 %).
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1). 
Zdravilo IMFINZI je kot samostojno zdravljenje indicirano za zdravljenje lokalno napredovalega, neoperabilnega nedrobnoceličnega raka pljuč (NSCLC - “non-small cell lung cancer”) pri odraslih, ki imajo tumorje z ≥ 1 % izraženostjo PD-L1 na tumorskih celicah in pri katerih bolezen ni napredovala po kemoradioterapiji na osnovi platine (glejte poglavje 5.1).
• abnormal kidney function tests (blood creatinine increased) 
• nenormalni izvidi testov delovanja ledvic (zvišanje kreatinina v krvi)
IMFINZI is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults. 
Zdravilo IMFINZI se uporablja za zdravljenje vrste pljučnega raka, imenovanega nedrobnocelični rak pljuč pri odraslih.
IMFINZI contains the active substance durvalumab which is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body. 
Durvalumab je monoklonsko protitelo, torej vrsta beljakovine, pripravljena tako, da v telesu prepozna določeno posebno ciljno snov.
Grade 2 with serum creatinine > 1.5-3 x (ULN or baseline) 
2. stopnja s kreatininom v serumu > 1,5-3 x (ZNM ali izhodiščno)
PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). 
PD-L1 blokira delovanje in aktivacijo celic T z medsebojnim delovanjem s PD-1 in CD80 (B7.1).
Neutralising antibodies (nAbs) against durvalumab were detected in 0.5% (8/1570) of patients. 
Nevtralizirajoča protitelesa (nAbs - “neutralizing antibodies”) proti durvalumabu so ugotovili pri 0,5 % (8/1570)
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately. 
V primeru prevelikega odmerjanja je treba bolnike skrbno spremljati glede znakov in simptomov neželenih učinkov in nemudoma je treba uvesti ustrezno simptomatsko zdravljenje.
Of the 713 patients randomised, 63% of patients provided a tissue sample of sufficient quality and quantity to determine PD-L1 expression and 37% were unknown. 
Izmed 713 randomiziranih bolnikov jih je imelo 63 % na voljo tkivne vzorce zadostne kakovosti in velikosti za ugotavljanje ekspresije PD-L1, pri 37 % bolnikov pa je bil status ekspresije PD-L1 neznan.
Within each system organ class, the adverse drug reactions are presented in decreasing frequency. 
Pri vsakem organskem sistemu so neželeni učinki zdravila navedeni po padajoči pogostnosti.
The safety of IMFINZI (10 mg/kg) has been evaluated in the PACIFIC Study (n = 475) in patients with locally advanced, unresectable NSCLC who had completed treatment with at least 2 cycles of concurrent chemoradiation within 1 to 42 days prior to initiation of the study. 
Varnost zdravila IMFINZI (10 mg/kg) so ovrednotili v študiji PACIFIC (n = 475) pri bolnikih z lokalno napredovalim neoperabilnim NSCLC, ki so opravili zdravljenje z najmanj 2 cikloma sočasne kemoradioterapije od 1 do 42 dni pred vključitvijo v študijo.
• tooth and mouth soft tissue infections 
• okužbe zob in mehkih tkiv v ustih
The PK of durvalumab was studied in 1902 patients with solid tumours with doses ranging from 0.1 to 20 mg/kg administered intravenously once every two, three or four weeks. 
Farmakokinetiko durvalumaba so proučili pri 1902 bolnikih s parenhimskimi tumorji med uporabo odmerkov od 0,1 do 20 mg/kg intravensko enkrat na dva, tri ali štiri tedne.
However, systemic corticosteroids or other immunosuppressants can be used after starting durvalumab to treat immune-related adverse reactions (see section 4.4). 
Vendar pa je mogoče kortikosteroide ali druge imunosupresive uporabiti po začetku zdravljenja z durvalumabom za zdravljenje imunsko pogojenih neželenih učinkov (glejte poglavje 4.4).
Women of childbearing potential should use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab. 
Ženske v rodni dobi morajo med zdravljenjem z durvalumabom in vsaj še 3 mesece po zadnjem odmerku durvalumaba uporabljati učinkovito kontracepcijo.
(95% CI) HR (95% CI) p-value p < 0.0001 
(95 % IZ) HR (95 % IZ) Vrednost p p < 0,0001
• abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased) 
• nenormalni jetrni testi (zvišanje aspartat-aminotransferaze, zvišanje alanin-aminotransferaze)
120 mg/2.4 ml 500 mg/10 ml 1 vial 
120 mg/2,4 ml 500 mg/10 ml 1 viala
IMFINZI is most commonly associated with immune-mediated adverse reactions. 
Zdravilo IMFINZI je najpogosteje povezano z imunsko pogojenimi neželenimi učinki.
includes infusion related reaction and urticaria with onset on the day of dosing or 1 day after dosing. 
Vključuje z infundiranjem povezano reakcijo in urtikarijo s pojavom na dan uporabe zdravila ali 1 dan po uporabi zdravila.
Adverse drug reactions are listed according to system organ class in MedDRA. 
Neželeni učinki so navedeni po organskih sistemih MedDRA.
Baseline demographics of the overall study population were as follows: male (70%), age ≥ 65 years (45%), age ≥ 75 years (8%), White (69%), Asian (27%), other (4%), current smoker (16%), past-smoker (75%), never smoker (9%), ECOG Performance Status 0 (49%), ECOG Performance Status 1 (51%). 
Izhodiščne demografske značilnosti celotne študijske populacije so bile: moški (70 %), starost ≥ 65 let (45 %), starost ≥ 75 let (8 %), belci (69 %), Azijci (27 %), drugo (4 %), trenutni kadilci (16 %), nekdanji kadilci (75 %), nikoli kadilci (9 %), stanje zmogljivosti po ECOG 0 (49 %), stanje zmogljivosti po ECOG 1 (51 %).
Resolution occurred for 27 patients in the IMFINZI treated group vs 6 in placebo. 
Do izboljšanja je prišlo pri 27 bolnikih v skupini z zdravilom IMFINZI in pri 6 bolnikih v skupini s placebom.
In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery, at exposure levels approximately 18 times higher than those observed at the clinical dose of 10 mg/kg of durvalumab (based on AUC), was associated with placental transfer but not with maternal toxicity or effects on embryofoetal development, pregnancy outcome or postnatal development. 
V študijah sposobnosti razmnoževanja pri živalih je bila uporaba durvalumaba pri nosečih opicah cynomolgus od potrjene nosečnosti do poroda ob izpostavljenosti, ki je bila (na podlagi AUC) približno 18-krat večja od izpostavljenosti ob kliničnem odmerku 10 mg/kg durvalumaba, povezana s prehodom skozi placento, ne pa z maternalno toksičnostjo ali učinki na embrio-fetalni razvoj, izid nosečnosti ali poporodni razvoj.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. 
Znotraj vsake razvrstitve pogostnosti so neželeni učinki zdravila navedeni po padajoči resnosti.
By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation and cytokine production. 
Z vezavo na svoje receptorje PD-L1 zmanjša citotoksično aktivnost celic T, njihovo proliferacijo in nastajanje citokinov.
Initiate thyroid hormone replacement as clinically indicated 
stopnja brez sprememb uvedite nadomeščanje ščitničnih hormonov, kot je klinično indicirano
Durvalumab does not induce antibody dependent cell-mediated cytotoxicity (ADCC). 
Durvalumab ne inducira od protiteles odvisne celično posredovane citotoksičnosti (ADCC - “antibody dependent cell-mediated cytotoxicity”).
If you have any further questions about your treatment, ask your doctor. 
Če imate dodatna vprašanja o zdravljenju, se posvetujte z zdravnikom.
Grade 3 with serum creatinine > 3 x baseline or > 3-6 x ULN; Grade 4 with serum creatinine > 6 x ULN 
3. stopnja s kreatininom v serumu > 3 x izhodiščno ali > 3-6 x ZNM; 4. stopnja s kreatininom v serumu > 6 x ZNM
Do not use if this medicine is cloudy, discoloured or contains visible particles. 
Zdravila ne uporabite, če je motno, spremenjene barve ali vsebuje vidne delce.
Guidelines for management of immune-mediated adverse reactions are described in Table 1 (see section 4.4). 
Smernice za obvladovanje imunsko pogojenih neželenih učinkov so opisane v preglednici 1 (glejte poglavje 4.4).
• If you are a woman who could become pregnant you must use effective birth control while you are being treated with IMFINZI and for at least 3 months after your last dose. 
• Če ste ženska, ki bi lahko zanosila, morate uporabljati učinkovit način za uravnavanje nosečnosti (kontracepcijo) med zdravljenjem z zdravilom IMFINZI in vsaj še 3 mesece po zadnjem odmerku tega zdravila.
The overall incidence of Grade 3 or 4 adverse reactions was 12.8% in the IMFINZI arm vs 9.8% in placebo. 
Pojavnost vseh neželenih učinkov 3. ali 4. stopnje je bila 12,8 % v skupini z zdravilom IMFINZI v primerjavi z 9,8 % v skupini s placebom.
Based on population PK analysis that included 1878 patients in the dose range of ≥ 10 mg/kg every 2 weeks, the geometric mean steady state volume of distribution (Vss) was 5.64 L. Durvalumab clearance (CL) decreased over time resulting in a geometric mean steady state clearance (CLss) of 8.16 mL/h at Day 365; the decrease in CLss was not considered clinically relevant. 
Na podlagi populacijske farmakokinetične analize, ki je zajela 1878 bolnikov v razponu odmerkov ≥ 10 mg/kg na 2 tedna, je bila geometrična sredina volumna porazdelitve v stanju dinamičnega ravnovesja (Vss) 5,64 l. Očistek (CL) durvalumaba se je sčasoma zmanjšal, tako da je bila geometrična sredina očistka v stanju dinamičnega ravnovesja (CLss) 365. dan 8,16 ml/h; zmanjšanje CLss ni bilo ocenjeno kot klinično pomembno.
c fatal pneumonitis and fatal pneumonia were reported at similar rate between the IMFINZI-treated group and placebo group in the PACIFIC Study; fatal hepatitis and fatal polymyositis were reported in other clinical trials. 
O pnevmonitisu s smrtnim izidom in pljučnici s smrtnim izidom so poročali pri približno enakem deležu bolnikov, zdravljenih z zdravilom IMFINZI, in bolnikov, ki so prejemali placebo, v študiji PACIFIC; o hepatitisu s smrtnim izidom in o polimiozitisu s smrtnim izidom so poročali v drugih kliničnih študijah.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
• Your doctor will give you IMFINZI through an infusion (drip) into your vein for about 
• Zdravnik vam bo dal zdravilo IMFINZI vsaka 2 tedna v infuziji (skozi cevko) v veno;
The two primary endpoints of the study were progression-free survival (PFS) and overall survival (OS) of IMFINZI vs. placebo. 
Dva cilja študije sta bila preživetje brez napredovanja bolezni (PFS - “progression-free survival”) in celokupno preživetje (OS - “overall survival”) med prejemniki zdravila IMFINZI v primerjavi s prejemniki placeba.
Any unused medicine or waste material should be disposed of in accordance with local requirements. 
Neporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
• Withdraw the required volume of concentrate from the vial(s) and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection, to prepare a diluted solution with a final concentration ranging from 1 to 15 mg/mL. 
• Izvlecite potrebno količino koncentrata iz vial(e) in ga prenesite v intravensko vrečko, ki vsebuje 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje ali 5 % (50 mg/ml) raztopino glukoze za injiciranje, za pripravo razredčene raztopine s končno koncentracijo od 1 do 15 mg/ml.
Durvalumab may cause foetal harm when administered to a pregnant woman and is not recommended during pregnancy and in women of childbearing potential not using effective contraception during treatment and for at least 3 months after the last dose. 
Pri nosečnici uporabljeni durvalumab lahko škoduje plodu in ga ni priporočljivo uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije med zdravljenjem in vsaj še 3 mesece po zadnjem odmerku.
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.