FrancophonIA/ELRC3.0 huggingface dataset:
English: • Discard any unused portion left in the vial.
Slovenian: • Morebitni neporabljeni ostanek v viali zavrzite.
English: Warnings and precautions Talk to your doctor before you are given IMFINZI if:
Slovenian: Opozorila in previdnostni ukrepi Preden dobite zdravilo IMFINZI, se posvetujte z zdravnikom:
English: m includes hepatitis, autoimmune hepatitis, hepatitis toxic, hepatocellular injury, hepatitis acute, and hepatotoxicity.
Slovenian: Vključuje hepatitis, avtoimunski hepatitis, toksični hepatitis, hepatocelularno poškodbo, akutni hepatitis in hepatotoksičnost.
English: 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.
Slovenian: 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.
English: Compliance was similar between the IMFINZI and placebo treatment groups (83% vs 85.1% overall of evaluable forms completed).
Slovenian: 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).
English: • IMFINZI is single-dose.
Slovenian: • Zdravilo IMFINZI je namenjeno za en odmerek.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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 %.
English: IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.
Slovenian: Zdravilo IMFINZI je na voljo v vialah z enim odmerkom in ne vsebuje konzervansov, zato je treba upoštevati aseptičen postopek.
English: Immune-mediated myocarditis
Slovenian: Imunsko pogojeni miokarditis
English: • 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.
Slovenian: • 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.
English: Immune-mediated pneumonitis/interstitial lung disease
Slovenian: Imunsko pogojeni pnevmonitis/intersticijska bolezen pljuč
English: 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.
Slovenian: 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).
English: If you have any of the symptoms listed above, call or see your doctor straight away.
Slovenian: Če imate katerega od zgoraj naštetih simptomov, se nemudoma posvetujte z zdravnikom.
English: Patients should be monitored for abnormal liver tests prior to and periodically during treatment with IMFINZI, and as indicated based on clinical evaluation.
Slovenian: Bolnike je treba redno spremljati glede nenormalnih jetrnih testov pred in med zdravljenjem z zdravilom IMFINZI in kot je indicirano na podlagi kliničnega ovrednotenja.
English: Common includes laryngitis, nasopharyngitis, peritonsillar abscess, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheobronchitis and upper respiratory tract infection.
Slovenian: Vključuje laringitis, nazofaringitis, peritonzilarni absces, faringitis, rinitis, sinuzitis, tonzilitis, traheobronhitis in okužbo zgornjih dihal.
English: What IMFINZI contains The active substance is durvalumab.
Slovenian: Kaj vsebuje zdravilo IMFINZI Učinkovina je durvalumab.
English: 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.
Slovenian: Kot je opisano v literaturi, ima pot PD-1/PD-L1 osrednjo vlogo pri ohranitvi nosečnosti, ker vzdržuje materino imunsko toleranco za plod.
English: Immune-mediated hepatitis
Slovenian: Imunsko pogojeni hepatitis
English: • inflammation of the kidneys: symptoms may include decrease in the amount of urine you pass;
Slovenian: • vnetje ledvic: med simptomi je lahko zmanjšanje količine izločenega urina;
English: e includes autoimmune hypothyroidism and hypothyroidism.
Slovenian: Vključuje avtoimunski hipotiroidizem in hipotiroidizem.
English: Resolution occurred in 13 patients.
Slovenian: Do izboljšanja je prišlo pri 13 bolnikih.
English: 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.
Slovenian: 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.
English: Patients should be monitored for clinical signs and symptoms of type 1 diabetes mellitus.
Slovenian: Bolnike je treba spremljati glede kliničnih znakov in simptomov sladkorne bolezni tipa 1.
English: p includes autoimmune nephritis, tubulointerstitial nephritis, nephritis, glomerulonephritis and glomerulonephritis membranous.
Slovenian: Vključuje avtoimunski nefritis, tubulointerstiticijski nefritis, nefritis, glomerulonefritis in membranski glomerulonefritis.
English: It is unknown whether durvalumab is secreted in human breast milk.
Slovenian: Ni znano, ali se durvalumab pri človeku izloča v materinem mleku.
English: Post-hoc subgroup analysis by PD-L1 expression
Slovenian: Naknadna analiza podatkov po podskupinah glede na ekspresijo PD-L1
English: Histidine hydrochloride monohydrate Trehalose dihydrate Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi histidin histidinijev klorid monohidrat trehaloza-dihidrat polisorbat 80
English: Immune-mediated myositis/polymyositis
Slovenian: Imunsko pogojeni miozitis/polimiozitis
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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;
Slovenian: • 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;
English: • inflammation of the liver that can cause nausea or feeling less hungry
Slovenian: • vnetje jeter, ki lahko povzroči občutek slabosti s siljenjem na bruhanje ali zmanjšan občutek lakote
English: 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).
Slovenian: 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).
English: Patients with suspected pneumonitis should be evaluated with radiographic imaging and managed as recommended in section 4.2.
Slovenian: Bolnike s sumom na pnevmonitis je treba oceniti z radiografskim slikanjem in ukrepati, kot je priporočeno v poglavju 4.2.
English: Resolution occurred in 23 patients.
Slovenian: Do izboljšanja je prišlo pri 23 bolnikih.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: o includes pruritus generalised and pruritus.
Slovenian: Vključuje generalizirano srbenje in srbenje.
English: The median time to onset was 85 days (range: 9-378 days).
Slovenian: Mediani čas do pojava je bil 85 dni (razpon od 9 do 378 dni).
English: Each vial contains either 500 mg of durvalumab in 10 mL of concentrate or 120 mg of durvalumab in 2.4 mL of concentrate.
Slovenian: Ena viala vsebuje ali 500 mg durvalumaba v 10 ml koncentrata ali 120 mg durvalumaba v 2,4 ml koncentrata.
English: 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.
Slovenian: 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.
English: What IMFINZI looks like and contents of the pack IMFINZI concentrate for solution for infusion is a sterile, preservative-free, clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Slovenian: Izgled zdravila IMFINZI in vsebina pakiranja Zdravilo IMFINZI koncentrat za raztopino za infundiranje je sterilna, bistra do opalescenta, brezbarvna do rumenkasta raztopina, ki ne vsebuje konzervansov in je brez vidnih delcev.
English: Immune-mediated endocrinopathies
Slovenian: Imunsko pogojene endokrinopatije
English: Consider increasing dose of corticosteroids and/or using additional systemic immunosuppressants if there is worsening or no improvement.
Slovenian: Če se stanje ne izboljša ali se poslabša, pride v poštev povečanje odmerka kortikosteroidov in/ali dodatna uporaba sistemskih imunosupresivov.
English: • Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: • Parenteralna zdravila je treba pred uporabo pregledati, da ne vsebujejo delcev in niso obarvana.
English: The median time to onset was 95 days (range: 28-239 days).
Slovenian: Mediani čas do pojava je bil 95 dni (razpon od 28 do 239 dni).
English: This 1 patient received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day) and IMFINZI was not discontinued.
Slovenian: Ta bolnik je prejemal visokoodmerno zdravljenje s kortikosteroidi (vsaj 40 mg prednizona ali ekvivalenta na dan) in zdravila IMFINZI pri njem niso prenehali uporabljati.
English: • decreased secretion of hormones produced by the adrenal glands that can cause tiredness
Slovenian: • zmanjšanje izločanja hormonov, ki nastajajo v nadledvičnih žlezah; posledica je lahko utrujenost
English: IMFINZI 50 mg/ml sterile concentrate durvalumab
Slovenian: IMFINZI 50 mg/ml sterilni koncentrat durvalumab
English: The other ingredients are: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
Slovenian: Druge sestavine zdravila so: histidin, histidinijev klorid monohidrat, trehaloza-dihidrat, polisorbat 80, voda za injekcije.
English: Since the primary elimination pathways of durvalumab are protein catabolism via reticuloendothelial system or target-mediated disposition, no metabolic drug-drug interactions are expected.
Slovenian: Primarni poti odstranjevanja durvalumaba sta katabolizem beljakovin preko retikuloendotelijskega sistema oziroma tarčno posredovano odstranjevanje, zato ni pričakovati presnovnih medsebojnih delovanj med zdravili.
English: PK exposure increased more than dose-proportionally (non-linear PK) at doses < 3 mg/kg, and dose proportionally (linear PK) at doses ≥ 3 mg/kg.
Slovenian: Med uporabo odmerkov < 3 mg/kg je farmakokinetična izpostavljenost naraščala bolj kot sorazmerno odmerku (nelinearna farmakokinetika), med uporabo odmerkov ≥ 3 mg/kg pa sorazmerno odmerku (linearna farmakokinetika).
English: Median PFS (95% CI)
Slovenian: mediano PFS (95 % IZ)
English: Upon resolution (Grade 0), corticosteroid taper should be initiated and continued over at least 1 month, after which IMFINZI can be resumed based on clinical judgment.
Slovenian: Ko pride do izboljšanja (do umiritve znakov do stopnje 0), je treba začeti s postopnim zmanjševanjem odmerjanja kortikosteroida in ga zmanjševati v obdobju najmanj 1 meseca, nato pa je mogoče po klinični presoji ponovno začeti z odmerjanjem zdravila IMFINZI.
English: Of the 137 patients, 134 patients received hormone replacement therapy and two patients received high-dose corticosteroids (at least 40 mg prednisone or equivalent per day) for hypothyroidism followed by hormone replacement.
Slovenian: Od 137 bolnikov jih je 134 za hipotiroidizem prejemalo hormonsko nadomestno zdravljenja in dva bolnika sta prejemala visokoodmerne kortikosteroide (vsaj 40 mg prednizona ali ekvivalenta na dan) in nato hormonsko nadomeščanje.
English: For non-immune-mediated adverse reactions, consider withholding IMFINZI for Grade 2 and 3 adverse reactions until ≤ Grade 1 or baseline.
Slovenian: Pri ne-imunsko pogojenih neželenih učinkih velja v primeru 2. ali 3. stopnje izraženosti razmisliti o odložitvi uporabe zdravila IMFINZI do izboljšanja neželenih učinkov na ≤ 1. stopnjo ali na izhodiščno raven.
English: • flu
Slovenian: • gripa
English: Immune-mediated hepatitis should be managed as recommended in section 4.2.
Slovenian: Imunsko pogojeni hepatitis je treba obravnavati, kot je priporočeno v poglavju 4.2.
English: Immune-mediated hypothyroidism and hyperthyroidism (including thyroiditis) occurred in patients receiving IMFINZI, and hypothyroidism may follow hyperthyroidism (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, sta se pojavila imunsko pogojeni hipotiroidizem in hipertiroidizem (vključno s tiroiditisom); hipertiroidizmu lahko sledi hipotiroidizem (glejte poglavje 4.8).
English: Median OS (95% CI)
Slovenian: mediano OS (95 % IZ)
English: Administer the infusion solution intravenously over 60 minutes using a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Slovenian: Raztopino za infundiranje dajte intravensko v 60 minutah skozi sterilen 0,2ali 0,22-mikronski linijski filter z zmanjšano vezavo beljakovin.
English: Patients should be monitored for clinical signs and symptoms of hypophysitis or hypopituitarism.
Slovenian: Bolnike je treba spremljati glede kliničnih znakov in simptomov hipofizitisa ali hipopituitarizma.
English: 10 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a white flip-off aluminium seal containing 500 mg durvalumab.
Slovenian: 10 ml koncentrata v stekleni viali iz stekla tipa 1 z elastomernim zamaškom in belo snemno aluminijsko zaporo; viala vsebuje 500 mg durvalumaba.
English: If you have any of the following, call or see your doctor straight away.
Slovenian: Če se vam pojavi kar koli od naslednjega, se nemudoma posvetujte z zdravnikom.
English: In the placebo group, 11 of the 16 patients received systemic corticosteroids, including 9 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Slovenian: V skupini s placebom je sistemske kortikosteroide prejemalo 11 od 16 bolnikov, vključno z 9 bolniki, ki so prejemali visokoodmerno zdravljenje s kortikosteroidi (vsaj 40 mg prednizona ali ekvivalenta na dan).
English: • Tell your doctor if you are breast-feeding.
Slovenian: • Zdravniku morate povedati, če dojite.
English: Patients should be monitored for signs and symptoms and managed as recommended for other immune-mediated adverse reactions, in section 4.2.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov in ukrepati, kot je priporočeno za druge imunsko pogojene neželene učinke v poglavju 4.2.
English: The median time to onset was 70 days (range: 15-312 days).
Slovenian: Mediani čas do pojava je bil 70 dni (razpon od 15 do 312 dni).
English: Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
Slovenian: Pomožne snovi: histidin, histidinijev klorid monohidrat, trehaloza-dihidrat, polisorbat 80, voda za injekcije.
English: Initiate treatment with insulin as clinically indicated
Slovenian: 2.-4. stopnja brez sprememb uvedite zdravljenje z insulinom, kot je klinično indicirano
English: IMFINZI was discontinued in 26 patients.
Slovenian: Zdravilo IMFINZI so prenehali uporabljati pri 26 bolnikih.
English: IMFINZI was discontinued in 8 patients.
Slovenian: Zdravilo IMFINZI so prenehali uporabljati pri 8 bolnikih.
English: Immune-mediated type 1 diabetes mellitus
Slovenian: Imunsko pogojena sladkorna bolezen tipa 1
English: Resolution occurred in 2 patients.
Slovenian: Do izboljšanja je prišlo pri 2 bolnikih.
English: If you miss an appointment to get IMFINZI
Slovenian: Če izpustite obisk pri zdravniku, ko bi morali dobiti zdravilo IMFINZI
English: Grade 1 or 2 Interrupt or slow the rate of infusion
Slovenian: 1. ali 2. stopnja infundiranje prekinite ali upočasnite hitrost v poštev pride premedikacija za preprečitev infuzijskih reakcij v prihodnje
English: The median time to onset was 141 days (range: 70-265 days).
Slovenian: Mediani čas do pojava je bil 141 dni (razpon od 70 do 265 dni).
English: In the IMFINZI-treated group, 44 of the 51 patients received systemic corticosteroids, including 28 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day), and 2 patients also received infliximab.
Slovenian: V skupini z zdravilom IMFINZI je sistemske kortikosteroide prejemalo 44 od 51 bolnikov, vključno z 28 bolniki, ki so prejemali visokoodmerno zdravljenje s kortikosteroidi (vsaj 40 mg prednizona ali ekvivalenta na dan), 2 bolnika pa sta prejemala tudi infliksimab.
English: Forty-five of the 79 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day), and 2 patients also received infliximab.
Slovenian: 45 od 79 bolnikov je prejemalo visokoodmerno zdravljenje s kortikosteroidi (vsaj 40 mg prednizona ali ekvivalenta na dan), 2 bolnika pa sta prejemala tudi infliksimab.
English: Immune-mediated rash or dermatitis
Slovenian: Imunsko pogojeni izpuščaj ali dermatitis
English: • inflammation of the liver: symptoms may include nausea or vomiting, feeling less hungry, pain on the right side of your stomach, yellowing of skin or whites of eyes, drowsiness, dark urine or bleeding or bruising more easily than normal;
Slovenian: • vnetje jeter: med simptomi so lahko slabost v želodcu (siljenje na bruhanje) ali bruhanje, manj občutka lakote, bolečine na desni strani trebuha, porumenelost kože ali očesnih beločnic, zaspanost, temen urin ali nagnjenost h krvavitvam ali podplutbam, ki je večja kot normalno;
English: Hypothyroidism and hyperthyroidism
Slovenian: Hipotiroidizem in hipertiroidizem
English: • Infusion-related reactions: symptoms may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing dizziness, or fever.
Slovenian: • z infundiranjem povezane reakcije: med simptomi so lahko mrzlica ali tresenje, srbenje ali izpuščaj, zardevanje, kratka sapa ali piskajoče dihanje, omotica ali vročina.
English: How you are given IMFINZI
Slovenian: Kako boste dobili zdravilo IMFINZI
English: Negligible levels of durvalumab was found in milk of cynomolgous monkey on Day 28 after birth.
Slovenian: V mleku opic cynomolgus so 28. dan po rojstvu ugotovili zanemarljivo raven koncentracije durvalumaba.
English: IMFINZI was discontinued due to type 1 diabetes mellitus.
Slovenian: Zaradi sladkorne bolezni tipa 1 so zdravilo IMFINZI prenehali uporabljati.
English: Patients should be monitored for signs and symptoms of infusion related reactions.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov z infundiranjem povezanih reakcij.
English: • hoarse voice (dysphonia)
Slovenian: • hripavost (disfonija)
English: Mix diluted solution by gentle inversion.
Slovenian: Razredčeno raztopino premešajte s previdnim obračanjem.