natgillin/translations-raw huggingface dataset:
Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 5.2).
Podatkov o bolnikih s hudo okvaro ledvic je premalo, da bi lahko sklepali o tej skupini bolnikov (glejte poglavje 5.2).
Patients were enrolled regardless of their tumour PD-L1 expression level.
Bolniki so bili vključeni v študijo ne glede na stopnjo ekspresije PD-L1 v njihovem tumorju.
• a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis).
• stanje, pri katerem mišice postanejo oslabele in se hitro utrudijo (miastenija gravis)
The recommended dose is 10 mg of durvalumab per kilogram of your body weight.
Priporočeni odmerek je 10 mg durvalumaba na kilogram telesne mase.
Across all studies, IMFINZI was administered at a dose of 10 mg/kg every 2 weeks.
V vseh študijah so zdravilo IMFINZI uporabljali v odmerku 10 mg/kg na 2 tedna.
includes cough and productive cough.
Vključuje kašelj in produktiven kašelj.
If not used immediately, the total time from vial puncture to start of the administration should not exceed 24 hours at 2 ºC to 8 ºC or 12 hours at room temperature (up to 25 ºC).
Če zdravilo ni uporabljeno takoj, celotni čas od vboda v vialo do začetka infundiranja ne sme preseči 24 ur na temperaturi od 2 do 8 ºC ali 12 ur na sobni temperaturi (do 25 ºC).
After withhold, IMFINZI can be resumed within 12 weeks if the adverse reactions improved to ≤ Grade 1 and the corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day.
Po odložitvi uporabe je mogoče zdravilo IMFINZI znova začeti uporabljati v času 12 tednov, če se neželeni učinki izboljšajo na ≤ 1. stopnjo in je odmerek kortikosteroida zmanjšan na ≤ 10 mg prednizona ali ekvivalenta na dan.
It is available in packs containing either 1 glass vial of 2.4 mL of concentrate or 1 glass vial of 10 mL of concentrate.
Na voljo je v pakiranjih, ki vsebujejo bodisi 1 stekleno vialo z 2,4 ml koncentrata ali 1 stekleno vialo z 10 ml koncentrata.
PD-L1 Unknown
Neznan status PD-L1
The data for the following immune-mediated adverse reactions reflect the combined safety database of 1889 patients which includes the PACIFIC Study and two additional studies (a multi-cohort, open-label clinical trial in patients with advanced solid tumours, and an open-label study in patients with locally advanced or metastatic NSCLC).
Podatki za naslednje imunsko pogojene neželene učinke odražajo podatke iz kombinirane podatkovne baze o varnosti za 1889 bolnikov, kar vključuje podatke iz študije PACIFIC in dveh dodatnih študij (multikohortnega, odprtega kliničnega preizkušanja pri bolnikih z napredovalimi parenhimskimi tumorji ter odprte študije pri bolnikih z lokalno napredovalim ali metastatskim NSCLC).
IMFINZI should be discontinued for Grade 4 adverse reactions (with the exception of Grade 4 laboratory abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms and clinical judgment).
Z uporabo zdravila IMFINZI je treba prenehati v primeru neželenih učinkov 4. stopnje (razen v primeru laboratorijskih nepravilnosti 4. stopnje, pri katerih naj odločitev o prekinitvi uporabe zdravila temelji na spremljajočih kliničnih znakih oziroma simptomih in na klinični presoji zdravnika).
Table 2 lists the incidence of adverse reactions in patients with locally advanced, unresectable NSCLC in the PACIFIC Study, based on the frequency of that adverse reaction type regardless of investigator assessed causality.
Preglednica 2 navaja pojavnost neželenih učinkov pri bolnikih z lokalno napredovalim neoperabilnim NSCLC v študiji PACIFIC glede na pogostnost posameznega neželenega učinka, ne glede na raziskovalčevo oceno vzročnosti.
There is no information on overdose with durvalumab.
Informacij o prevelikem odmerjanju durvalumaba ni.
IMFINZI works by helping your immune system fight your cancer.
Zdravilo IMFINZI deluje tako, da imunskemu sistemu pomaga premagati raka.
Data from patients with moderate and severe hepatic impairment are limited.
Podatkov pri bolnikih z zmerno ali hudo okvaro jeter je malo.
Upon improvement to ≤ Grade 1, corticosteroid taper should be initiated and continued over at least 1 month.
Po izboljšanju na ≤ 1. stopnjo je treba začeti s postopnim zmanjševanjem kortikosteroida in ga zmanjševati v obdobju vsaj 1 meseca.
Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1).
Durvalumab je popolnoma človeško imunoglobulinsko monoklonsko protitelo G1-kapa (IgG1κ), ki selektivno blokira medsebojno delovanje PD-L1 s PD-1 in CD80 (B7.1).
Number of patients at risk
Število bolnikov, izpostavljenih tveganju
The European Medicines Agency has deferred the obligation to submit the results of studies with durvalumab in all subsets of the paediatric population in the treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z durvalumabom za vse skupine pediatrične populacije za zdravljenje malignih novotvorb (razen tumorjev osrednjega živčevja ter novotvorb hematopoetskega in limfatičnega tkiva) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm etiology or exclude alternate etiologies.
V primeru domnevnih imunsko pogojenih neželenih učinkov je treba opraviti ustrezno ovrednotenje za potrditev etiologije oziroma izključitev druge etiologije.
The efficacy of IMFINZI was evaluated in the PACIFIC Study, a randomised, double-blind, placebo-controlled, multicentre study in 713 patients with locally advanced, unresectable NSCLC.
Učinkovitost zdravila IMFINZI so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani multicentrični študiji PACIFIC pri 713 bolnikih z lokalno napredovalim neoperabilnim NSCLC.
Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation.
Selektivna blokada medsebojnih delovanj PD-L1/PD-1 in PD-L1/CD80 izboljša protitumorske imunske odzive in poveča aktivacijo celic T.
Throughout the duration of the study to Week 48, there was no clinically meaningful difference between IMFINZI and placebo groups in symptoms, functioning and HRQoL (as assessed by a difference of greater than or equal to 10 points).
Med potekom študije do 48. tedna med skupino z zdravilom IMFINZI in skupino s placebom ni bilo klinično pomembne razlike v simptomih, funkciji in zdravstveni kakovosti življenja (ocenjeno na podlagi razlike 10 točk ali več).
Talk to your doctor straight away if you get any of the side effects listed above.
Nemudoma se posvetujte z zdravnikom, če se vam pojavi kateri od zgoraj navedenih neželenih učinkov.
Concentrate for solution for infusion (sterile concentrate).
koncentrat za raztopino za infundiranje (sterilen koncentrat)
When you get IMFINZI, you can have some serious side effects (see section 2).
Ko dobite zdravilo IMFINZI, se vam lahko pojavijo nekateri resni neželeni učinki (glejte poglavje 2).
Age (19-96 years), body weight (34-149 kg), gender, positive anti-drug antibody (ADA) status, albumin levels, LDH levels, creatinine levels, soluble PD-L1, tumour type, race or ECOG status had no clinically significant effect on the PK of durvalumab.
Starost (19-96 let), telesna masa (34-149 kg), spol, pozitivna protitelesa proti zdravilu (ADA), koncentracija albumina, koncentracija LDH, koncentracija kreatinina, topni PD-L1, vrsta tumorja, rasa in stanje ECOG niso klinično pomembno vplivali na farmakokinetiko durvalumaba.
Radiation pneumonitis is frequently observed in patients receiving radiation therapy to the lung and the clinical presentation of pneumonitis and radiation pneumonitis is very similar.
Pri bolnikih, zdravljenih z radioterapijo pljuč, je pogost radiacijski pnevmonitis in klinična slika pnevmonitisa in radiacijskega pnevmonitisa je zelo podobna.
• you have liver problems.
• če imate težave z jetri.
• you have lung problems or breathing problems;
• če imate težave s pljuči ali dihanjem;
Data from NSCLC patients 75 years of age or older are limited.
Za bolnike z NSCLC, ki so stari 75 let ali več, je na voljo le malo podatkov.
Number of patients at risk Month
Število bolnikov izpostavljenih tveganju Mesec
Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system.
Ekspresija liganda za programirano celično smrt 1 (PD-L1 - “programmed cell death ligand-1”) je adaptiven imunski odziv, ki se tumorjem pomaga izogniti, da bi jih imunski sistem zaznal in odstranil.
PFS and OS results are summarised in Figures 3, 4, 5 and 6.
Rezultati preživetja brez napredovanja bolezni (PFS) in celokupnega preživetja (OS) so prikazani na slikah 3, 4, 5 in 6.
Of the 1570 patients who were treated with IMFINZI 10 mg/kg every 2 weeks and evaluable for the presence of anti-drug antibodies (ADAs), 2.9% (45/1570) of patients tested positive for treatment-emergent ADAs.
Od 1570 bolnikov, zdravljenih na 2 tedna z zdravilom IMFINZI v odmerku 10 mg/kg in ocenljivih za prisotnost pozitivnih protiteles proti zdravilu (ADAs - “anti-drug antibodies”,), je bilo 2,9 % (45/1570) testiranih bolnikov pozitivnih za ADA, nastala med zdravljenjem.
Additional subgroup analyses were conducted to evaluate the efficacy by tumour PD-L1 expression (≥ 25%, 1-24%, ≥ 1%, < 1%) and for patients whose PD-L1 status cannot be established (PD-L1 unknown).
Za vrednotenje učinkovitosti glede na tumorsko ekspresijo PD-L1 so izvedli dodatno analizo podatkov po podskupinah (≥ 25 %, 1-24 %, ≥ 1 %, < 1 %) in pri bolnikih, pri katerih statusa PD-L1 ni bilo mogoče ugotoviti (neznan status PD-L1).
The most frequent Grade 3-4 adverse reaction was pneumonia (6.5% vs 5.6% in placebo).
Najbolj pogost neželeni učinek 3.-4. stopnje je bila pljučnica (6,5 % v primerjavi s 5,6 % pri uporabi placeba).
OS Number of deaths (%) Median (months) (95% CI)
OS Število smrti (%) Mediana (meseci) (95 % IZ)
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.