FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you experience sudden shortness of breath, flushing, nausea, headache, skin rash or hives (itchy rash with swollen red bumps on the skin that appear suddenly), itching, swelling around the eyes, tightness in the chest or throat during the infusion or shortly after it (as the infusion may need to be stopped and you may need to be treated or observed for the side effects) - if you get fever, chills and signs of an infection (as this might require immediate treatment) - if you have severe persistent diarrhoea (liquid and frequent stools)-see section 2
Croatian: - ako osjetite iznenadan nedostatak zraka, navale crvenila, mučninu, glavobolju, kožni osip ili koprivnjaču (iznenadni osip sa svrbežom i otečenim crvenim kvržicama na koži), svrbež, oticanje oko očiju, stezanje u prsnom košu ili grlu tijekom ili ubrzo nakon infuzije (jer će se infuzija možda morati prekinuti, a Vas će morati liječiti ili promatrati radi nuspojava) - ako dobijete vrućicu, zimicu ili druge znakove infekcije (jer za to može biti potrebno hitno liječenje) - ako imate teški i uporan proljev (tekuća i česta stolica) - vidjeti dio 2
English: Total irinotecan
Croatian: Ukupan irinotekan
English: In the limited number of patients with prior exposure to non-liposomal irinotecan, no benefit of ONIVYDE pegylated liposomal has been demonstrated.
Croatian: U ograničenog broja bolesnika koji su prethodno bili izloženi neliposomalnom irinotekanu, nije ustanovljena korist lijeka ONIVYDE pegilirani liposomalni.
English: ONIVYDE pegylated liposomal (irinotecan) must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies.
Croatian: ONIVYDE pegilirani liposomalni (irinotekan) smiju propisivati i primjenjivati bolesnicima samo zdravstveni radnici s iskustvom u primjeni terapija protiv raka.
English: 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).
Croatian: Nuspojave koje se mogu javiti tijekom liječenja lijekom ONIVYDE pegilirani liposomalni sažete su u nastavku i prikazane prema klasifikaciji organskih sustava i kategoriji učestalosti (Tablica 3).
English: ONIVYDE pegylated liposomal, leucovorin and 5-fluorouracil should be administered sequentially.
Croatian: ONIVYDE pegilirani liposomalni, leukovorin i 5-fluorouracil treba primjenjivati sekvencijalno.
English: First occurrence
Croatian: Prvi nastup
English: ONIVYDE pegylated liposomal should be withheld if neutropenic fever occurs or the absolute neutrophil count drops below 1,500 cells/mm
Croatian: Primjenu lijeka ONIVYDE pegilirani liposomalni treba prekinuti ako se pojavi febrilna neutropenija ili apsolutni broj neutrofila padne ispod 1500 stanica/mm3.
English: History of severe hypersensitivity to irinotecan or to any of the excipients listed in section 6.1.
Croatian: 4.3 Kontraindikacije Anamneza teške preosjetljivosti na irinotekan ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Adverse reaction frequency**
Croatian: Učestalost nuspojave**
English: Males should use condoms during ONIVYDE pegylated liposomal treatment and 4 months thereafter.
Croatian: Muškarci trebaju koristiti kondome tijekom liječenja lijekom ONIVYDE pegilirani liposomalni i 4 mjeseca nakon liječenja.
English: MPEG-2000-DSPE Sucrose octasulphate HEPES buffer
Croatian: MPEG-2000-DSPE saharozaoktasulfat
English: Other medicines and ONIVYDE pegylated liposomal
Croatian: Drugi lijekovi i ONIVYDE pegilirani liposomalni
English: Compared to Caucasians, Asian patients were observed with a lower incidence of diarrhoea [14 (19.2%) out of 73 Caucasians had a ≥ Grade 3 diarrhoea, and 1 out of 33 (3.3%) Asians had a ≥ Grade 3 diarrhoea], but a higher incidence and higher severity of neutropenia.
Croatian: U usporedbi s bijelcima, bolesnici azijskog porijekla su imali nižu incidenciju proljeva [14 (19,2%) od 73 bijelca imalo je proljev stupnja ≥ 3, a 1 od 33 (3,3%) Azijata imao je proljev stupnja ≥ 3], ali su imali višu incidenciju i teži stupanj neutropenije.
English: The pharmacokinetic parameters of total irinotecan and SN-38 analytes, following the administration of ONIVYDE pegylated liposomal 70 mg/m are presented in Table 5.
Croatian: Farmakokinetički parametri analita ukupnog irinotekana i SN-38 nakon primjene lijeka ONIVYDE pegilirani liposomalni 70 mg/m2 prikazani su u Tablici 5.
English: Common: Insomnia
Croatian: Često: nesanica
English: • Aseptic techniques must be followed during the preparation of the infusion.
Croatian: • Tijekom pripreme infuzije moraju se slijediti aseptičke tehnike.
English: Unopened vial 30 months.
Croatian: 30 mjeseci.
English: The use of ONIVYDE pegylated liposomal in patients with significant renal impairment has not been established (see section 5.2).
Croatian: Oštećenje bubrega Primjena lijeka ONIVYDE pegilirani liposomalni u bolesnika sa značajnim oštećenjem bubrega nije ustanovljena (vidjeti dio 5.2).
English: 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).
Croatian: U kliničkom ispitivanju za dokaz učinkovitosti lijeka ONIVYDE pegilirani liposomalni, veće izloženosti ukupnom irinotekanu i SN-38 u plazmi za bolesnike u ispitivanoj skupini koja je primala ONIVYDE pegilirani liposomalni +5-FU/LV bile su povezane s dužim OS i PFS, kao i s većom ORR (stopom objektivnog odgovora).
English: N-(carbonyl-methoxypolyethylene glycol-2000)-1, 2-distearoly-sn-glycero-3-phosphoethanolamine (MPEG-2000-DSPE)
Croatian: N-(karbonil-metoksipolietilenglikol-2000)-1,2-distearoil-sn-glicero-3-fosfoetanolamin (MPEG-2000-DSPE)
English: 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.
Croatian: U kliničkim ispitivanjima neliposomalnog irinotekana primijenjenog u rasporedu doziranja jednom tjedno, bolesnici s umjereno povišenim razinama ukupnog bilirubina u serumu na početku ispitivanja (1,0 do 2,0 mg/dl) imali su značajno veću vjerojatnost da dožive neutropeniju stupnja 3 ili stupnja 4 u prvom ciklusu liječenja od bolesnika čije su razine bilirubina bile manje od 1,0 mg/dl.
English: ONIVYDE pegylated liposomal must not be administered to patients with bowel obstruction, and chronic inflammatory bowel disease, until it is resolved.
Croatian: ONIVYDE pegilirani liposomalni se ne smije primjenjivati bolesnicima s opstrukcijom crijeva i kroničnom upalnom bolesti crijeva, sve dok se ona ne povuče.
English: Median PFS (months) (95% CI)
Croatian: Medijan OS (mjeseci) (95% CI)
English: Fisher's exact test
Croatian: Temeljeno na normalnoj aproksimaciji Fisherov egzaktni test
English: In the clinical study, early diarrhoea onset occurred in 35 patients (29.9%) and cholinergic events occurred in 4 patients (3.4%) receiving ONIVYDE pegylated liposomal +5-FU/LV.
Croatian: U kliničkom ispitivanju, rani nastup proljeva javio se u 35 bolesnika (29,9%), a kolinergički događaji javili su se u 4 bolesnika (3,4%) koji su primali ONIVYDE pegilirani liposomalni +5-FU/LV.
English: Information about drug interactions with ONIVYDE pegylated liposomal is referenced from the published scientific literature for nonliposomal irinotecan.
Croatian: Informacije o interakcijama lijekova s lijekom ONIVYDE pegilirani liposomalni preuzete su iz objavljene znanstvene literature za neliposomalni irinotekan.
English: Progression-Free Survival Death or progression, n (%)
Croatian: Ukupno preživljenje1 Broj smrti, n (%)
English: 2- [ 4- (2-Hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (HEPES buffer) Sodium chloride
Croatian: 2- [ 4- (2-hidroksietil)piperazin-1-il] etansulfonatna kiselina (HEPES pufer) natrijev klorid voda za injekcije
English: The plasma pharmacokinetics of total irinotecan and total SN-38 were evaluated in patients with cancer who received ONIVYDE pegylated liposomal, as a single agent or as part of combination chemotherapy, at doses between 50 and 155 mg/m2.
Croatian: Farmakokinetika ukupnog irinotekana i ukupnog SN-38 u plazmi ocijenjena je u bolesnika s rakom koji su primali ONIVYDE pegilirani liposomalni kao monoterapiju ili kao dio kombinirane kemoterapije u dozama između 50 i 155 mg/m2.
English: ONIVYDE pegylated liposomal should be administered before LV followed by 5-FU.
Croatian: ONIVYDE pegilirani liposomalni je potrebno primijeniti prije LV, nakon kojeg slijedi 5-FU.
English: White to slightly yellow opaque isotonic liposomal dispersion.
Croatian: Bijela do blago žuta neprozirna izotonična liposomalna disperzija.
English: If you are given ONIVYDE you should not breast-feed until one month after the last dose.
Croatian: Ako primate ONIVYDE pegilirani liposomalni ne biste smjeli dojiti mjesec dana nakon zadnje doze.
English: ONIVYDE pegylated liposomal should not be administered with strong UGT1A inhibitors (e.g. atazanavir, gemfibrozil, indinavir) unless there are no therapeutic alternatives.
Croatian: ONIVYDE pegilirani liposomalni se ne smije primjenjivati sa snažnim inhibitorima UGT1A (npr. atazanavir, gemfibrozil, indinavir) osim ako ne postoje terapijske alternative.
English: Non-liposomal irinotecan caused atrophy of male reproductive organs both in rats and dogs after multiple daily doses of 20 mg/kg and 0.4 mg/kg, respectively.These effects were reversible upon cessation of treatment.
Croatian: Neliposomalni irinotekan uzrokovao je atrofiju muških reproduktivnih organa u štakora i u pasa nakon višestrukih dnevnih doza od 20 mg/kg odnosno 0,4 mg/kg.
English: Interstitial Lung Disease (ILD)-like events leading to fatalities have occurred in patients receiving non-liposomal irinotecan.
Croatian: Događaji nalik na intersticijsku bolest pluća (IBP) koji su doveli do smrtnih slučajeva zabilježeni su u bolesnika koji su primali neliposomalni irinotekan.
English: Patients homozygous for the UGT1A1*28 allele were given a lower initial dose of ONIVYDE pegylated liposomal (see section 4.2).
Croatian: Bolesnici homozigoti za alel UGT1A1*28 primili su manju početnu dozu lijeka ONIVYDE pegilirani liposomalni (vidjeti dio 4.2).
English: Caution should be exercised when using ONIVYDE pegylated liposomal in patients with body mass index < 18.5 kg/m
Croatian: Potreban je oprez pri primjeni lijeka ONIVYDE pegilirani liposomalni u bolesnika s indeksom tjelesne mase <18,5 kg/m2.
English: Following Grade 3 or 4 diarrhoea, the subsequent dose of ONIVYDE pegylated liposomal should be reduced, (see section 4.2).
Croatian: Nakon proljeva stupnja 3 ili 4, sljedeće doze lijeka ONIVYDE pegilirani liposomalni treba smanjiti (vidjeti dio 4.2).
English: ONIVYDE pegylated liposomal is a liposomal formulation of irinotecan with different pharmacokinetic properties compared to non-liposomal irinotecan.
Croatian: ONIVYDE pegilirani liposomalni je liposomalna formulacija irinotekana s različitim farmakokinetičkim svojstvima u usporedbi s neliposomalnim irinotekanom.
English: In a population pharmacokinetic analysis, mild-to-moderate renal impairment had no effect on the exposure of total SN-38 after adjusting for BSA.
Croatian: U populacijskoj farmakokinetičkoj analizi, blago do umjereno oštećenje bubrega nije utjecalo na izloženost ukupnom SN-38 nakon prilagođavanja za površinu tijela.
English: 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.
Croatian: Razrijeđena otopina za infuziju može se čuvati na sobnoj temperaturi (15°C do 25°C) do najviše 6 sati ili u hladnjaku (2ºC - 8ºC) ne duže od 24 sata prije uporabe.
English: SN-38 is approximately 1,000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumour cell lines.
Croatian: SN-38 je oko 1000 puta potentniji od irinotekana kao inhibitor topoizomeraze
English: In the intent to treat (all randomised) population, the median age was 63 years (range 31-87 years), 57 % were males, and 61% were Caucasian and 33% were Asian.
Croatian: (raspon 31-87 godina), 57% su bili muškarci, 61% bijelci i 33% Azijati.
English: Common: Hypoglycaemia, Hyponatraemia, Hypophosphataemia
Croatian: Često: hipoglikemija, hiponatrijemija, hipofosfatemija
English: The metabolic conversion of irinotecan to the active metabolite SN-38 is mediated by carboxylesterase enzymes.
Croatian: Metaboličku konverziju irinotekana do aktivnog metabolita SN-38 posreduju enzimi karboksilesteraze.
English: Aseptic techniques must be followed during the preparation of the infusion.
Croatian: Tijekom pripreme infuzije moraju se slijediti aseptičke tehnike.
English: ONIVYDE pegylated liposomal must not be administered as a bolus injection or an undiluted solution.
Croatian: ONIVYDE pegilirani liposomalni se ne smije primijeniti kao bolus injekcija ili nerazrijeđena otopina.
English: 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).
Croatian: U usporedbi s bijelcima, azijatski bolesnici imaju povećan rizik od teške i febrilne neutropenije nakon liječenja lijekom ONIVYDE pegilirani liposomalni +5-FU/LV (vidjeti dijelove 4.8 i 5.2).
English: • 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.
Croatian: • ONIVYDE pegilirani liposomalni se isporučuje kao sterilna liposomalna disperzija u koncentraciji od 4,3 mg/ml i mora se razrijediti prije primjene.
English: Patients randomised to 5-FU/LV received leucovorin 200 mg/m intravenously over 30 minutes, followed by 5-FU 2,000 mg/m intravenously over 24 hours, administered on Days 1, 8, 15 and 22 of a 6 week cycle.
Croatian: Bolesnici randomizirani za 5-FU/LV primili su leukovorin 200 mg/m2 intravenski tijekom 30 minuta, a potom 5-FU 2000 mg/m2 intravenski tijekom 24 sata, primijenjeno 1., 8., 15. i 22. dana 6-ero tjednog ciklusa.
English: Caution should be exercised in patients with hepatic impairment (bilirubin > 2 times upper limit of normal [ULN]; transaminases > 5 times ULN).
Croatian: Potreban je oprez u bolesnika s oštećenjem jetre (bilirubin >2 puta veći od gornje granice normalne vrijednosti [GGN]; transaminaze
English: 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.
Croatian: Bolesnici s prethodnim Whippleovim postupkom U kliničkom ispitivanju koje je procjenjivalo ONIVYDE pegilirani liposomalni +5-FU/LV, bolesnici koji su prethodno imali Whippleov postupak imali su veći rizik od ozbiljnih infekcija nakon liječenja lijekom ONIVYDE pegilirani liposomalni +5-FU/LV [9 od 29 (30%)] u usporedbi sa 11 od 88 (12,5%) bolesnika koji prethodno nisu imali Whippleov postupak.
English: Febrile neutropenia (body temperature > 38°C and neutrophil count ≤ 1,000 cells/mm³) should be urgently treated in the hospital with broad-spectrum intravenous antibiotics.
Croatian: i broj neutrofila ≤1000 stanica/mm³) mora se hitno liječiti u bolnici intravenskim antibioticima širokog spektra.
English: The most common serious adverse reactions (≥ 2%) of ONIVYDE pegylated liposomal therapy were diarrhoea, vomiting, febrile neutropenia, nausea, pyrexia, sepsis, dehydration, septic shock, pneumonia, acute renal failure, and thrombocytopenia.
Croatian: Najčešće ozbiljne nuspojave (≥2%) terapije lijekom ONIVYDE pegilirani liposomalni bile su proljev, povraćanje, febrilna neutropenija, mučnina, vrućica, sepsa, dehidracija, septički šok, upala pluća, akutno zatajenje bubrega te trombocitopenija.
English: Irinotecan released from liposome encapsulation follows a similar metabolic pathway reported with non-liposomal irinotecan.
Croatian: Irinotekan oslobođen iz liposoma slijedi sličan metabolički put zabilježen za neliposomalni irinotekan.
English: Because of the potential for serious adverse reactions of ONIVYDE pegylated liposomal in breast-feeding infants, ONIVYDE pegylated liposomal is contraindicated during breast-feeding (see section 4.3).
Croatian: Zbog potencijalnih ozbiljnih nuspojava lijeka ONIVYDE pegilirani liposomalni kod dojenčadi na majčinom mlijeku, lijek ONIVYDE pegilirani liposomalni je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: Very common: Neutropenia, Leukopenia, Anaemia, Thrombocytopenia
Croatian: Vrlo često: neutropenija, leukopenija, anemija, trombocitopenija
English: ONIVYDE pegylated liposomal treatment should be delayed until diarrhoea resolves to ≤ Grade 1 (2-3 stools/day more than pre-treatment frequency).
Croatian: Liječenje lijekom ONIVYDE pegilirani liposomalni treba odgoditi sve dok se proljev ne povuče na ≤ stupanj 1 (2-3 stolice/dan više od učestalosti prije liječenja).
English: Strong CYP3A4 inhibitors and UGT1A1 inhibitors
Croatian: Snažni inhibitori CYP3A4 i inhibitori UGT1A1
English: In a population pharmacokinetic analysis, patients with baseline total bilirubin concentrations of 1-2 mg/dl (n=19) had average steady state concentrations for total SN-38 that were increased by 37% (0.98 [95%CI: 0.94-1.02] and 1.29 [95%CI: 1.11-1.5] ng/ml, respectively) compared to patients with baseline bilirubin concentrations of < 1 mg/dl (n=329); however, there was no effect of elevated ALT/AST concentrations on total SN-38 concentrations.
Croatian: U populacijskoj farmakokinetičkoj analizi, bolesnici s početnom koncentracijom ukupnog bilirubina od 1-2 mg/dl (n=19) imali su prosječne koncentracije ukupnog SN-38 u stanju dinamičke ravnoteže koje su se povećale za 37% (0,98 [95%CI: 0,94-1,02] odnosno 1,29 [95%CI: 1,11-1,5] ng/ml) u usporedbi s bolesnicima s početnom koncentracijom bilirubina < 1 mg/dl (n=329); međutim, nije bilo utjecaja povišenih koncentracija ALT/AST na koncentracije ukupnog SN-38.
English: ONIVYDE pegylated liposomal and do not dose escalate to 70 mg/m 2, the recommended first dose reduction is to 43 mg/m and the second dose reduction is to 35 mg/m 2.
Croatian: Za bolesnike koji započinju liječenje dozom od 50 mg/m2 lijeka ONIVYDE pegilirani liposomalni i ne povećavaju dozu na 70 mg/m2, preporučeno prvo smanjenje doze je na 43 mg/m2, a drugo smanjenje doze je na 35 mg/m2.
English: Dose adjustments, as summarised in Table 1 and Table 2, are recommended to manage Grade 3 or 4 toxicities related to ONIVYDE pegylated liposomal.
Croatian: Prilagodba doza, kako je sažeto u Tablici 1 i Tablici 2, preporučuje se za liječenje toksičnosti stupnja 3 ili 4 povezane s lijekom
English: The median time to nadir for ≥ Grade 3 neutropenia is 23 (range 8-104) days post first dose of treatment with ONIVYDE pegylated liposomal.
Croatian: Medijan vremena do pojave najnižih vrijednosti za ≥stupanj 3 neutropenije je 23 (raspon 8-104) dana nakon prve doze liječenja lijekom ONIVYDE pegilirani liposomalni.
English: A new cycle of therapy should not begin until the absolute neutrophil count is ≥ 1,500 cells/mm
Croatian: Novi ciklus liječenja ne smije se započinjati sve dok apsolutni broj neutrofila nije ≥1500 stanica/mm3
English: In patients receiving ONIVYDE pegylated liposomal +5-FU/LV, the incidence of ≥ Grade 3 neutropenia was higher among Asian patients [18 of 33 (55%)] compared to Caucasians patients [13 of 73 (18%)].
Croatian: U bolesnika koji su primali ONIVYDE pegilirani liposomalni +5-FU/LV, incidencija neutropenije stupnja ≥ 3 bila je veća među bolesnicima azijskog porijekla [18 od 33 (55%)] u usporedbi s bolesnicima bijele rase [13 od 73 (18%)].
English: Common: Dyspnoea, Dysphonia
Croatian: Često: dispneja, disfonija
English: A new cycle of therapy should not begin until diarrhoea resolves to ≤ Grade 1 (2-3 stools/day more than pre-treatment frequency).
Croatian: Novi ciklus liječenja ne smije se započinjati sve dok se proljev ne povuče na ≤ stupanj 1 (2-3 stolice/dan više od učestalosti prije liječenja).
English: Patients with a history of a Whipple procedure have a higher risk of serious infections following ONIVYDE pegylated liposomal in combination with 5-FU and leucovorin (see section 4.8).
Croatian: Bolesnici s anamnezom Whippleovog postupka izloženi su većem riziku od ozbiljnih infekcija nakon liječenja lijekom ONIVYDE pegilirani liposomalni u kombinaciji sa 5-FU i leukovorinom (vidjeti dio 4.8).
English: One ml of concentrate contains 0.144 mmol (3.31 mg) sodium.
Croatian: Pomoćna tvar s poznatim učinkom Jedan ml koncentrata sadržava 0,144 mmol (3,31 mg) natrija.
English: Second occurrence
Croatian: Drugi nastup
English: Pre-medication
Croatian: Premedikacija
English: There are no adequate data on the use of ONIVYDE pegylated liposomal in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni lijeka ONIVYDE pegilirani liposomalni u trudnica.
English: Do not use ONIVYDE pegylated liposomal:
Croatian: Nemojte primjenjivati ONIVYDE pegilirani liposomalni:
English: 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
Croatian: Što je ONIVYDE pegilirani liposomalni i za što se koristi Što morate znati prije nego počnete primjenjivati ONIVYDE pegilirani liposomalni
English: Caution should be exercised in patients receiving concurrent administration of ONIVYDE pegylated liposomal with irradiation.
Croatian: Potreban je oprez u bolesnika koji primaju ONIVYDE pegilirani liposomalni istovremeno sa zračenjem.
English: 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.
Croatian: Svrha ispitivanja bila je procjena kliničke djelotvornosti i sigurnosti lijeka ONIVYDE pegilirani liposomalni u monoterapiji ili režima ONIVYDE pegilirani liposomalni +5-FU/LV u usporedbi s aktivnom kontrolnom skupinom koja je primala 5-FU/LV.
English: Patients randomised to ONIVYDE pegylated liposomal monotherapy received 100 mg/m as an intravenous infusion over 90 minutes every 3 weeks.
Croatian: Bolesnici randomizirani za monoterapiju lijekom ONIVYDE pegilirani liposomalni primili su 100 mg/m2 putem intravenske infuzije tijekom 90 minuta svaka 3 tjedna.
English: • ONIVYDE pegylated liposomal should be administered before leucovorin followed by 5-fluorouracil.
Croatian: • ONIVYDE pegilirani liposomalni je potrebno primijeniti prije leukovorina, nakon kojeg slijedi 5-fluorouracil.
English: Women of childbearing potential should use effective contraception during ONIVYDE pegylated liposomal treatment and 1 month thereafter.
Croatian: Žene reproduktivne dobi/kontracepcija u muškaraca i žena Žene reproduktivne dobi trebaju koristiti učinkovitu kontracepciju tijekom liječenja lijekom ONIVYDE pegilirani liposomalni i 1 mjesec nakon liječenja.
English: The diluted solution is clear to slightly white to slightly opalescent and free from visible particles.
Croatian: Razrijeđena otopina je bistra do blago bijela ili blago opalescentna i bez vidljivih čestica.
English: 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.
Croatian: Rani nastup proljeva može također biti popraćen kolinergičkim simptomima koji mogu uključivati rinitis, povećanu salivaciju, navale crvenila, dijaforezu, bradikardiju, miozu i hiperperistaltiku koja može prouzročiti grčeve u abdomenu.
English: ONIVYDE pegylated liposomal /5-FU adjustment (for patients homozygous for UGT1A1*28 without previous increase to 70 mg/m
Croatian: Prilagodba ONIVYDE pegilirani liposomalni /5-FU (za bolesnike koji su homozigoti za UGT1A1*28) bez prethodnog povećanja3 na 70 mg/m2)