natgillin/translations-raw huggingface dataset:
What ONIVYDE pegylated liposomal is and what it is used for What you need to know before you use ONIVYDE pegylated liposomal How ONIVYDE pegylated liposomal is used Possible side effects 
Kaj je zdravilo ONIVYDE pegilirani liposomski in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ONIVYDE pegilirani liposomski Kako se uporablja zdravilo ONIVYDE pegilirani liposomski
5-FU dose modification as in Table 1 
Sprememba odmerka 5-FU skladno s preglednico 1
The no-observed-adverse-effect level (NOAEL) in rats and dogs following 90 min intravenous infusion of ONIVYDE pegylated liposomal once every 3 weeks for 18 weeks was 155 mg/m 
no-observed-adverse-effect level) pri podganah in psih po 90-minutni intravenski infuziji zdravila ONIVYDE pegilirani liposomski na 3 tedne, kar je trajalo skupaj 18 tednov, je bila 155 mg/m2.
Name and address of the manufacturer(s) responsible for batch release Les Laboratoires Servier Industrie 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
2- [ 4- (2-Hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (HEPES buffer) Sodium chloride 
2- [ 4- (2-hidroksietil)piperazin-1-il] etansulfonska kislina (pufer HEPES) natrijev klorid voda za injekcije
The use of ONIVYDE pegylated liposomal should be avoided in patients with bilirubin > 2.0 mg/dl, or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) or > 5 times ULN if liver metastasis is present (see section 4.4). 
Uporabi zdravila ONIVYDE pegilirani liposomski se je treba izogibati pri bolnikih z vrednostjo bilirubina > 2,0 mg/dl ali > 2,5-kratno zgornjo mejo normalnih vrednosti (ULN) aspartataminotransferaze (AST) in alanin-aminotransferaze (ALT) ali > 5-kratno ULN v primeru prisotnosti jetrnih metastaz (glejte poglavje 4.4).
Chemical and physical stability for the diluted solution for infusion has been demonstrated at 15-25°C for up to 6 hours or in the refrigerator (2ºC-8ºC) for no more than 24 hours. 
Po redčenju Kemijska in fizikalna stabilnost razredčene raztopine za injiciranje pri temperaturi 15 °C-25 °C je dokazana za 6 ur, v hladilniku (2 °C-8 ºC) pa za ne več kot 24 ur.
During your ONIVYDE pegylated liposomal treatment and one month after you should choose an effective birth control method which suits you, to prevent pregnancy in this period of time. 
Med zdravljenjem z zdravilom ONIVYDE pegilirani liposomski in en mesec po tem morate uporabljati vam primerno zanesljivo kontracepcijo, da preprečite zanositev v tem obdobju.
A new cycle of therapy should not begin until the absolute neutrophil count is ≥ 1,500 cells/mm 
Nov cikel zdravljenja se ne sme začeti, dokler absolutno število nevtrofilcev ne doseže ≥ 1.500 celic/mm3
- If you have any further questions, ask your doctor or nurse. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali medicinsko sestro.
Dosage adjustments 
Prilagajanje odmerkov
Patients homozygous for the UGT1A1*28 allele were given a lower initial dose of ONIVYDE pegylated liposomal (see section 4.2). 
Bolniki s homozigotnostjo za alel UGT1A1*28 so prejeli manjši začetni odmerek zdravila ONIVYDE pegilirani liposomski (glejte poglavje 4.2).
In the population pharmacokinetic analysis in patients with ONIVYDE pegylated liposomal using the results of a subset with UGT1A1*28 genotypic testing, in which the analysis adjusted for the lower dose administered to patients homozygous for the UGT1A1*28 allele, patients homozygous (N=14) and non-homozygous (N=244) for this allele had total SN-38 average steady-state concentrations of 1.06 and 0.95 ng/ml, respectively. 
V populacijski farmakokinetični analizi pri bolnikih, ki so prejemali zdravilo ONIVYDE pegilirani liposomski, pri kateri so uporabili rezultate podskupine z genotipskim testiranjem za UGT1A1*28, kjer so analizo prilagodili glede na manjši odmerek, dan bolnikom s homozigotnostjo za alel UGT1A1*28, so imeli bolniki s homozigotnostjo (N=14) in brez homozigotnosti (N=244) za ta alel povprečno koncentracijo skupnega SN-38 v dinamičnem ravnovesju 1,06 oziroma 0,95 ng/ml.
For patients experiencing late diarrhoea, the median time to late diarrhoea onset was 8 days from the previous dose of ONIVYDE pegylated liposomal. 
Pri bolnikih, pri katerih se je pojavila pozna driska, je bil mediani čas do začetka driske 8 dni od predhodnega odmerka zdravila ONIVYDE pegilirani liposomski.
If the solution contacts mucous membranes, they should be flushed thoroughly with water. 
Če raztopina pride v stik s sluznicami, jih temeljito izperite z vodo.
In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, patients with a prior Whipple procedure had a higher risk of serious infections following treatment with ONIVYDE pegylated liposomal +5-FU/LV [9 of 29 (30%)] compared to 11 of 88 (12.5%) patients with no prior Whipple procedure. 
V klinični študiji, v kateri so vrednotili zdravilo ONIVYDE pegilirani liposomski +5-FU/LV, so imeli bolniki, ki so predhodno prestali Whipplovo operacijo, po zdravljenju z zdravilom ONIVYDE pegilirani liposomski +5-FU/LV večje tveganje za resne okužbe [9 od 29 (30 %)] v primerjavi z 11 od 88 (12,5 %) bolnikov, ki niso prestali Whipplove operacije.
MedDRA* system organ class 
Organski sistem po MedDRA*
Caution should be exercised in patients with hepatic impairment (bilirubin > 2 times upper limit of normal [ULN]; transaminases > 5 times ULN). 
Previdnost je potrebna pri bolnikih z jetrno okvaro (bilirubin > 2-kratna zgornja meja normalnih vrednosti [ULN]; aminotransferaze > 5-kratna ULN).
Patients who are known to be homozygous for UGT1A1*28 and without drug related toxicities during the first cycle of therapy (reduced dose of 50 mg/m2) may have the dose of ONIVYDE pegylated liposomal increased to a total dose of 70 mg/m in subsequent cycles based on individual patient tolerance. 
Pri bolnikih z znano homozigotnostjo za UGT1A1*28, pri katerih se v prvem ciklu zdravljenja (z zmanjšanim odmerkom 50 mg/m2) toksičnost zdravila ne pojavi, se odmerek zdravila ONIVYDE pegilirani liposomski v naslednjih ciklih lahko poveča do skupnega odmerka 70 mg/m2, na podlagi tega, kako ga posamezen bolnik prenaša.
No interaction of ONIVYDE pegylated liposomal (irinotecan) with other medicinal products is known. 
Medsebojno delovanje med zdravilom ONIVYDE pegilirani liposomski (liposomskim irinotekanom) in drugimi zdravili ni znano.
Table 3: Adverse reactions reported with ONIVYDE pegylated liposomal therapy in the NAPOLI-1 clinical study 
Preglednica 3: Neželeni učinki, o katerih so poročali med zdravljenjem z zdravilom ONIVYDE pegilirani liposomski v klinični študiji NAPOLI-1
Uncommon: Oesophagitis, Proctitis 
Občasni: ezofagitis, proktitis
In a population pharmacokinetic analysis, mild-to-moderate renal impairment had no effect on the exposure of total SN-38 after adjusting for BSA. 
V populacijski farmakokinetični analizi blaga do zmerna ledvična okvara ni imela učinka na izpostavljenost SN-38 po prilagoditvi za telesno površino.
The diluted solution for infusion can be stored at ambient temperature (15°C to 25°C)for up to 6 hours or in the refrigerator (2ºC - 8ºC) for no more than 24 hours prior to use. 
Razredčeno raztopino za infundiranje lahko hranite pri sobni temperaturi (15 °C-25 °C) do 6 ur ali v hladilniku (2 °C-8 ºC) do 24 ur pred uporabo.
New events (all grade 1 or grade 2) occurred generally early during ONIVYDE pegylated liposomal treatment, with only 2 out of 10 patients noted with events after the fifth dose. 
1. ali 2. stopnje) so se v splošnem pojavili zgodaj med zdravljenjem z zdravilom ONIVYDE pegilirani liposomski, le 2 bolnika od 10 sta neželene učinke doživela po petem odmerku.
ONIVYDE pegylated liposomal treatment should be delayed until diarrhoea resolves to ≤ Grade 1 (2-3 stools/day more than pre-treatment frequency). 
Zdravljenje z zdravilom ONIVYDE pegilirani liposomski je treba odložiti, dokler se driska ne umiri do ≤ 1. stopnje (2-3 odvajanja/dan več kot pred zdravljenjem).
The disposition of ONIVYDE pegylated liposomal and non-liposomal irinotecan has not been fully elucidated in humans. 
Odstranjevanje zdravila ONIVYDE pegilirani liposomski in neliposomskega irinotekana pri človeku še ni popolnoma pojasnjeno.
The analysis included 68 patients with moderate (CLcr 30-59 ml/min), 147 patients with mild (CLcr 60-89 ml/min) renal impairment, and 135 patients with normal renal function (CLcr > 90 ml/min). 
59 ml/min), 147 bolnikov z blago (CLcr 60-89 ml/min) ledvično okvaro in 135 bolnikov z normalnim delovanjem ledvic (CL cr > 90 ml/min).
Camptothecins act as specific inhibitors of the enzyme DNA topoisomerase I. Irinotecan and its active metabolite SN-38 bind reversibly to the topoisomerase I-DNA complex and induce single-strand DNA lesions which block the DNA replication fork and are responsible for the cytotoxicity. 
topoizomeraza I. Irinotekan in njegov aktivni presnovek SN-38 se reverzibilno vežeta na kompleks topoizomeraze I in DNA ter sprožita poškodbe v enoverižni DNA, kar zaustavi replikacijske vilice pri podvajanju DNA in povzroča citotoksičnost.
In the clinical trial demonstrating effectiveness of ONIVYDE pegylated liposomal, higher plasma exposures of total irinotecan and SN-38 for patients in the ONIVYDE pegylated liposomal +5-FU/LV treatment arm were associated with longer OS and PFS as well as with higher ORR (objective response rate). 
V kliničnem preskušanju za dokaz učinkovitosti zdravila ONIVYDE pegilirani liposomski sta bili večja plazemska izpostavljenost skupnemu irinotekanu in SN-38 pri bolnikih v veji zdravljenja z zdravilom ONIVYDE pegilirani liposomski +5-FU/LV povezani z daljšima OS in PFS ter višjim ORR (objektivno stopnjo odziva).
The population pharmacokinetic analysis in 196 male and 157 female patients suggests that gender had no clinically meaningful effect on the exposure to irinotecan and SN-38 after adjusting for body surface area (BSA). 
Populacijska farmakokinetična analiza pri 196 bolnikih in 157 bolnicah kaže, da spol po prilagoditvi za telesno površino (BSA) nima klinično pomembnega učinka na izpostavljenost irinotekanu in
95% CI of Rate 
95-odstotni IZ stopnje5
Based on the drug interaction of non-liposomal irinotecan and ketoconazole, co-administration of ONIVYDE pegylated liposomal with other inhibitors of UGT1A1 (e.g. atazanavir, gemfibrozil, indinavir) may also increase systemic exposure of ONIVYDE pegylated liposomal. 
Na podlagi medsebojnega delovanja neliposomskega irinotekana in ketokonazola lahko tudi sočasno dajanje zdravila ONIVYDE pegilirani liposomski in drugih zaviralcev encima UGT1A1 (npr. atazanavira, gemfibrozila, indinavirja) poveča sistemsko izpostavljenost zdravilu ONIVYDE pegilirani liposomski.
A new cycle of therapy should not begin until diarrhoea resolves to ≤ Grade 1 (2-3 stools/day more than pre-treatment frequency). 
Nov cikel zdravljenja se ne sme začeti, dokler se driska ne umiri do ≤ 1. stopnje (2-3 odvajanja/dan več kot pred zdravljenjem).
ONIVYDE pegylated liposomal is not recommended for use in adolescents and children below the age of 18 years. 
Otroci in mladostniki Uporaba zdravila ONIVYDE pegilirani liposomski pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
The trial was designed to assess the clinical efficacy and safety of ONIVYDE pegylated liposomal monotherapy or ONIVYDE pegylated liposomal +5-FU/LV compared to an active control arm of 5-FU/LV. 
Preskušanje je bilo zasnovano za ocenjevanje klinične učinkovitosti in varnosti zdravila ONIVYDE pegilirani liposomski v monoterapiji ali zdravila ONIVYDE pegilirani liposomski +5-FU/LV v primerjavi z aktivno kontrolno vejo 5-FU/LV.
One millilitre of this medicine contains 0.144 mmol (3.31 mg) sodium-keep this in mind if you are on a controlled sodium diet. 
Zdravilo ONIVYDE pegilirani liposomski vsebuje natrij En mililiter tega zdravila vsebuje 0,144 mmol (3,31 mg) natrija - to upoštevajte, če ste na dieti z nadzorovanim vnosom natrija.
Patients with hyperbilirubinaemia had higher concentrations for total SN-38 (see section 5.2) and therefore the risk of neutropenia is increased. 
Bolniki s hiperbilirubinemijo so imeli povišane koncentracije skupnega SN-38 (glejte poglavje 5.2),
How to store ONIVYDE pegylated liposomal Contents of the pack and other information 
Shranjevanje zdravila ONIVYDE pegilirani liposomski Vsebina pakiranja in dodatne informacije
• ONIVYDE pegylated liposomal is a cytotoxic medicinal product and caution should be exercised in handling it. 
• Zdravilo ONIVYDE pegilirani liposomski je citotoksično zdravilo, zato je pri ravnanju z njim potrebna previdnost.
Common: Hypoglycaemia, Hyponatraemia, Hypophosphataemia 
Pogosti: hipoglikemija, hiponatriemija, hipofosfatemija
The recommended dose and regimen of ONIVYDE pegylated liposomal is 70 mg/m intravenously over 90 minutes, followed by LV 400 mg/m intravenously over 30 minutes, followed by 5-FU 2,400 mg/m intravenously over 46 hours, administered every 2 weeks. 
Priporočeni odmerek in režim odmerjanja zdravila ONIVYDE pegilirani liposomski je 70 mg/m2 intravensko 90 minut, čemur sledi LV 400 mg/m2 intravensko 30 minut in nato 5-FU 2400 mg/m2 intravensko 46 ur, vsaka 2 tedna.
Reduce 5-FU dose by an additional 25% (1,350 mg/m 
Odmerek 5-FU zmanjšajte za dodatnih 25 % (1.350 mg/m2)
White to slightly yellow opaque isotonic liposomal dispersion. 
Bela do rumenkasta motna izotonična liposomska disperzija.
The median time to nadir for ≥ Grade 3 neutropenia is 23 (range 8-104) days post first dose of treatment with ONIVYDE pegylated liposomal. 
Mediana časa do najnižje vrednosti pri nevtropeniji ≥ 3. stopnje je 23 (razpon 8 - 104) dni po prvem odmerku zdravila ONIVYDE pegilirani liposomski.
Therefore, co-administration of ONIVYDE pegylated liposomal with inducers of CYP3A4 may reduce systemic exposure of ONIVYDE pegylated liposomal. 
Zato sočasno dajanje zdravila ONIVYDE pegilirani liposomski in induktorjev encima CYP3A4 lahko zmanjša sistemsko izpostavljenost zdravilu ONIVYDE pegilirani liposomski.
Interaction affecting the use of ONIVYDE pegylated liposomal 
Interakcije, ki vplivajo na uporabo zdravila ONIVYDE pegilirani liposomski
Early onset diarrhoea may be accompanied by cholinergic symptoms such as rhinitis, increased salivation, flushing, diaphoresis, bradycardia, miosis and hyperperistalsis. 
Zgodnjo drisko lahko spremljajo holinergični simptomi, kot so rinitis, povečano slinjenje, zardevanje, diaforeza, bradikardija, mioza in hiperperistaltika.
In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, 5 of 8 underweight patients experienced a Grade 3 or 4 adverse reactions, mostly myelosuppression, while 7 of the 8 patients required dose modification such as dose delay, dose reduction or dose discontinuation. 
V klinični študiji, v kateri so vrednotili zdravilo ONIVYDE pegilirani liposomski +5-FU/LV, je 5 od 8 bolnikov s premajhno telesno maso doživelo neželeni učinek 3. ali 4. stopnje, večinoma mielosupresijo, medtem ko je bila pri 7 od 8 bolnikov potrebna sprememba odmerjanja, na primer odložitev odmerka, zmanjšanje odmerka ali prekinitev odmerjanja.
ONIVYDE pegylated liposomal is a liposomal formulation of irinotecan with different pharmacokinetic properties compared to non-liposomal irinotecan. 
Zdravilo ONIVYDE pegilirani liposomski je liposomska formulacija irinotekana z drugačnimi farmakokinetičnimi lastnostmi, kot jih ima neliposomski irinotekan.
Intravenous use after dilution. 
intravenska uporaba po razredčenju
Immune system disorders Uncommon: Hypersensitivity 
Bolezni imunskega sistema Občasni: preobčutljivost
There are no data on the impact of ONIVYDE pegylated liposomal on human fertility. 
Plodnost Ni podatkov o vplivu zdravila ONIVYDE pegilirani liposomski na plodnost pri človeku.
Compared to Caucasian patients, Asian patients have an increased risk of severe and febrile neutropenia following treatment with ONIVYDE pegylated liposomal +5-FU/LV (see sections 4.8 and 5.2). 
V primerjavi z bolniki kavkazijskega porekla imajo bolniki azijskega porekla po zdravljenju z zdraviloma ONIVYDE pegilirani liposomski +5-FU/LV večje tveganje za hudo in febrilno nevtropenijo (glejte poglavji 4.8 in 5.2).
ONIVYDE pegylated liposomal is largely confined to vascular fluid. 
da je zdravilo ONIVYDE pegilirani liposomski večinoma omejeno na žilno tekočino.
First occurrence 
Prvi pojav
No findings indicative of CNS related toxicity were observed in the repeated dose toxicity studies in rats. 
V študijah toksičnosti s ponavljajočimi odmerki pri podganah niso opazil znakov, ki bi kazali na toksičnost, povezano s CŽS.
Rate Difference (95% CI) p-value 
Razlika v stopnji (95-odstotni IZ)5 p-vrednost6
Liposome encapsulation of irinotecan extends circulation and limits distribution relative to those of the non-liposomal irinotecan. 
Liposomska inkapsulacija irinotekana podaljša čas v obtoku in omeji porazdelitev v primerjavi z neliposomskim irinotekanom.
ONIVYDE pegylated liposomal is a cancer medicine that contains the active substance irinotecan. 
Zdravilo ONIVYDE pegilirani liposomski je zdravilo za zdravljenje raka in vsebuje učinkovino irinotekan.
Dose adjustments, as summarised in Table 1 and Table 2, are recommended to manage Grade 3 or 4 toxicities related to ONIVYDE pegylated liposomal. 
Prilagajanje odmerkov, kot je navedeno v preglednicah 1 in 2, se priporoča za obvladovanje toksičnosti 3. ali 4. stopnje,
In clinical studies of non-liposomal irinotecan administered on a weekly dosage schedule, patients with modestly elevated baseline serum total bilirubin levels (1.0 to 2.0 mg/dl) had a significantly greater likelihood of experiencing first cycle Grade 3 or Grade 4 neutropenia than those with bilirubin levels that were less than 1.0 mg/dl. 
Bolniki z jetrno okvaro V kliničnih študijah z neliposomskim irinotekanom, danim v obliki tedenskega odmerjanja, so imeli bolniki z zmerno zvišanimi ravnmi izhodiščnega skupnega bilirubina v serumu (1,0 do 2,0 mg/dl) pomembno večjo verjetnost, da v prvem ciklu doživijo nevtropenijo 3. ali 4. stopnje, kot bolniki z ravnmi bilirubina pod 1,0 mg/dl. Bolniki s predhodno Whipplovo operacijo
In case of a dose increase of ONIVYDE pegylated liposomal to 70 mg/m if tolerated in subsequent cycles, recommended dose modifications should follow Table 1. 
Če se odmerek zdravila ONIVYDE pegilirani liposomski poveča na 70 mg/m2 in če ga bolniki v naslednjih ciklih dobro prenašajo, naj se pri spremembi priporočenega odmerka upošteva Preglednica 1.
No dose adjustment is recommended. 
Prilagoditev odmerka ni potrebna.
tightness in the chest or throat during or shortly after your infusion - if you experience fever, chills or other symptoms of infection - if you get diarrhoea with frequent liquid stools and cannot control this after 12 to 24 hours of treatment (see below) - if you get breathlessness or cough. 
tiščanje v prsih ali grlu med infuzijo ali kmalu po njej, - če se pojavi povišana telesna temperatura, mrzlica ali drugi simptomi okužbe, - če se pojavi driska s pogostim odvajanjem tekočega blata, ki je ni mogoče obvladati v 12 do 24
Early onset diarrhoea may also be accompanied by cholinergic symptoms that can include rhinitis, increased salivation, flushing, diaphoresis, bradycardia, miosis and hyperperistalsis that can induce abdominal cramping. 
Zgodnjo drisko lahko spremljajo holinergični simptomi, ki lahko vključujejo rinitis, povečano slinjenje, zardevanje, diaforezo, bradikardijo, miozo in hiperperistaltiko, ki lahko povzroči trebušne krče.
Reduce 5-FU dose by 25% (1,800 mg/m 
Odmerek 5-FU zmanjšajte za 25 % (1.800 mg/m
Early onset diarrhoea, typically appearing ≤ 24 hours after dose administration, can occur and is usually transient. 
praviloma v ≤ 24 urah po odmerku, ki je običajno prehodne narave.
A total of 417 patients were randomised to the ONIVYDE pegylated liposomal +5-FU/LV arm (N=117), ONIVYDE pegylated liposomal monotherapy arm (N=151) and 5-FU/LV arm (N=149). 
Skupaj je bilo randomiziranih 417 bolnikov, in sicer v vejo z zdravilom ONIVYDE pegilirani liposomski+5-FU/LV (N=117), v vejo z zdravilom ONIVYDE pegilirani liposomski v monoterapiji (N=151) in vejo s 5-FU/LV (N=149).
ONIVYDE pegylated liposomal has moderate influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo ONIVYDE pegilirani liposomski ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
• ONIVYDE pegylated liposomal is supplied as a sterile liposomal dispersion at a concentration of 4.3 mg/ml and must be diluted prior to administration. 
• Zdravilo ONIVYDE pegilirani liposomski je na voljo kot sterilna liposomska disperzija v koncentraciji 4,3 mg/ml, ki jo morate pred uporabo razredčiti.
Renal impairment and acute renal failure have been identified, usually in patients who became volume depleted from severe vomiting and/or diarrhoea. 
Ugotovljeni sta bili ledvična okvara in akutna ledvična odpoved, večinoma pri bolnikih s pomanjkanjem volumna zaradi hudega bruhanja in/ali driske.
ONIVYDE pegylated liposomal, leucovorin and 5-fluorouracil should be administered sequentially. 
Zdravilo ONIVYDE pegilirani liposomski, levkovorin in 5-fluorouracil je treba dajati zaporedno.
The European Medicines Agency has waived the obligation to submit the results of studies with ONIVYDE pegylated liposomal in all subsets of the paediatric population in treatment of adenocarcinoma of the pancreas (see section 4.2 for information on paediatric use). 
ONIVYDE pegilirani liposomski za vse podskupine pediatrične populacije za zdravljenje adenokarcinoma trebušne slinavke (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
For non-liposomal irinotecan, in rats treated once a week during 13 weeks at the maximum dose of 150 mg/m², no treatment related tumours were reported 91 weeks after the end of treatment. 
Pri neliposomskem irinotekanu pri podganah, ki so 13 tednov enkrat tedensko dobivale največji odmerek 150 mg/m², 91
Non-liposomal irinotecan was shown to cause atrophy of male and female reproductive organs after multiple daily irinotecan doses in animals (see section 5.3). 
da neliposomski irinotekan po večkratnih dnevnih odmerkih irinotekana pri živalih povzroča atrofijo reproduktivnih organov samcev in samic (glejte poglavje 5.3).
Myelosuppression (neutropenia/leukopenia, thrombocytopenia and, anaemia) was more common in the ONIVYDE pegylated liposomal +5-FU/LV arm compared to the 5-FU/LV control arm. 
Mielosupresija (nevtropenija/levkopenija, trombocitopenija in anemija) je bila pogostejša v veji z zdravilom ONIVYDE pegilirani liposomski +5-FU/LV v primerjavi s kontrolno vejo 5-FU/LV.
Thrombocytopenia Leukopenia 
Trombocitopenija Levkopenija
Males should use condoms during ONIVYDE pegylated liposomal treatment and 4 months thereafter. 
Moški morajo med zdravljenjem in 4 mesece po zdravljenju z zdravilom ONIVYDE pegilirani liposomski uporabljati kondome.
The adverse reactions that may occur during treatment with ONIVYDE pegylated liposomal are summarised below and are presented by system organ class and frequency category (Table 3). 
so povzeti spodaj in so navedeni po organskem sistemu in pogostnosti (preglednica 3).
MPEG-2000-DSPE Sucrose octasulphate HEPES buffer 
MPEG-2000-DSPE saharozni oktasulfat pufer HEPES natrijev klorid voda za injekcije
Patients with risk factors should be closely monitored for respiratory symptoms before and during ONIVYDE pegylated liposomal therapy. 
Pri bolnikih z dejavniki tveganja je treba pred zdravljenjem z zdravilom ONIVYDE pegilirani liposomski in po njem skrbno nadzirati respiratorne simptome.
The active substance in ONIVYDE pegylated liposomal is irinotecan (topoisomerase I inhibitor) encapsulated in a lipid bilayer vesicle or liposome. 
Učinkovina zdravila ONIVYDE pegilirani liposomski je irinotekan (zaviralec topoizomeraze I), inkapsuliran v vezikel z lipidnim dvoslojem oziroma liposom.
Patients with severe bone marrow failure should not be treated with ONIVYDE pegylated liposomal. 
Bolnikov s hudo odpovedjo kostnega mozga ne smemo zdraviti z zdravilom ONIVYDE pegilirani liposomski.
water, soda water, fizzy drinks, soup) to avoid losing too much liquid and salts from your body. 
Ob prvem pojavu tekočega blata začnite piti večje količine rehidracijske tekočine (npr. vode, gazirane vode, gazirane pijače, juhe), da preprečite preveliko izgubo tekočine in soli iz telesa.