FrancophonIA/ELRC3.0 huggingface dataset:
English: ONIVYDE pegylated liposomal is used to treat adult patients with metastatic pancreatic cancer (cancer of the pancreas that has already spread elsewhere in the body) whose previously cancer treatment included a medicine called gemcitabine.
Croatian: ONIVYDE pegilirani liposomalni se koristi za liječenje odraslih bolesnika s metastatskim rakom gušterače (rak gušterače koji se već proširio drugdje u tijelu) čije je prethodno liječenje raka uključivalo lijek pod nazivom gemcitabin.
English: Immunosuppressive effects and vaccines
Croatian: Imunosupresivni učinci i cjepiva
English: This is consistent with the population pharmacokinetic analysis that showed a lower exposure to irinotecan and a higher exposure to its active metabolite SN-38 in Asians than in Caucasians.
Croatian: To je u skladu s populacijskom farmakokinetičkom analizom koja je pokazala manju izloženost irinotekanu i veću izloženost njegovom aktivnom metabolitu SN-38 u Azijata nego u bijelaca.
English: In patients experiencing early diarrhoea, therapeutic and prophylactic atropine should be considered unless contraindicated.
Croatian: U bolesnika koji su imali rani proljev, potrebno je uzeti u obzir terapijsko ili profilaktičko liječenje atropinom, osim u slučaju kad je kontraindicirano.
English: It is unknown whether ONIVYDE pegylated liposomal or its metabolites are excreted into human milk.
Croatian: Nije poznato izlučuju li se ONIVYDE pegilirani liposomalni ili njegovi metaboliti u majčino mlijeko.
English: 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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka ONIVYDE pegilirani liposomalni u svim podskupinama pedijatrijske populacije u liječenju adenokarcinoma gušterače (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Objective Response Rate
Croatian: Stopa objektivnog odgovora2
English: In pregnant rats there was a decrease in placental weight and in the offspring a decrease in foetal viability and increase in behavioural abnormalities.
Croatian: U skotnih štakora došlo je do smanjenja u težini posteljice, a u mladunaca do smanjenja vijabilnosti fetusa i povećanja abnormalnosti u ponašanju.
English: ONIVYDE pegylated liposomal can cause harm to the foetus when administered to the pregnant woman, as the main ingredient irinotecan has been shown to be embryotoxic and teratogenic in animals (see section 5.3).
Croatian: ONIVYDE pegilirani liposomalni može naškoditi fetusu kad se primjenjuje u trudnica, jer je glavni sastojak irinotekan pokazao embriotoksične i teratogene učinke u životinja (vidjeti dio 5.3).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 43mg/10 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 43 mg/10 ml
English: Cholinergic reactions
Croatian: Kolinergičke reakcije
English: Patients with deficient glucuronidation of bilirubin, such as those with Gilbert's syndrome, may be at greater risk of myelosuppression when receiving therapy with ONIVYDE pegylated liposomal.
Croatian: Bolesnici s nedostatnom glukuronidacijom bilirubina, kao što su oni s Gilbertovim sindromom, mogu biti izloženi većem riziku od mijelosupresije tijekom liječenja lijekom ONIVYDE pegilirani liposomalni.
English: Avoid eating grapefruits and drinking grapefruit juice while you are receiving ONIVYDE pegylated liposomal as it may increase the availability of the active substance of ONIVYDE pegylated liposomal in your body.
Croatian: Izbjegavajte jesti grejp i piti sok od grejpa dok primate ONIVYDE pegilirani liposomalni jer to može povećati raspoloživost djelatne tvari lijeka ONIVYDE pegilirani liposomalni u Vašem tijelu.
English: Non-liposomal irinotecan was teratogenic in rats and rabbits at doses below the human therapeutic dose.
Croatian: Neliposomalni irinotekan bio je teratogen u štakora i kunića pri dozama ispod ljudske terapijske doze.
English: Additional outcome measures included Progression Free Survival (PFS) and Objective Response Rate (ORR).
Croatian: Progression Free Survival, PFS) i stopu objektivnog odgovora (engl.
English: Mix the diluted solution by gentle inversion.
Croatian: Pomiješajte razrijeđenu otopinu blagim preokretanjem.
English: You should not be given ONIVYDE pegylated liposomal if you are pregnant as it may harm the baby.
Croatian: ONIVYDE pegilirani liposomalni ne smijete primiti ako ste trudni jer može naškoditi bebi.
English: 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).
Croatian: Pokazalo se da neliposomalni irinotekan uzrokuje atrofiju muških i ženskih reproduktivnih organa nakon višestrukih dnevnih doza u životinja (vidjeti dio 5.3).
English: Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.
Croatian: Potreban je oprez kako bi se izbjegla ekstravazacija, a mjesto infuzije treba pratiti radi znakova upale.
English: In vitro studies indicate that irinotecan, SN-38 and another metabolite aminopentane carboxylic acid (APC) do not inhibit cytochrome P-450 isozymes.
Croatian: In vitro ispitivanja pokazuju da irinotekan, SN-38 i drugi metabolit aminopentanska karboksilna kiselina (APC) ne inhibiraju izoenzime citokroma P-450.
English: • The other ingredients are: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC); cholesterol, N-(carbonyl-methoxypolyethylene glycol-2000)-1,2-distearoly-sn-glycero-3-phosphoethanolam ine (MPEG-2000-DSPE); Sucrose octasulphate; 2- [4- (2-Hydroxyethyl)piperazin-1-yl]ethanesulfonic acid (HEPES buffer); sodium chloride and water for injections.
Croatian: • Drugi sastojci su: 1,2-distearoil-sn-glicero-3-fosfokolin (DSPC); kolesterol, N-karbonil-metoksipolietilenglikol-2000)-1,2-distearoil-sn-glicero-3-fosfoetanolamin (MPEG-2000-DSPE); saharozaoktasulfat; 2- [4- (2-Hidroksietil)piperazin-1-il]etansulfonatna kiselina (HEPES pufer); natrijev klorid i voda za injekcije.
English: Neutropenic fever/neutropenic sepsis was reported in 6% of Asian patients compared to 1% of Caucasians patients.
Croatian: Neutropenijska vrućica/neutropenijska sepsa prijavljena je u 6% bolesnika azijskog porijekla u usporedbi s 1% bolesnika bijele rase.
English: Very common: Hypokalaemia, Hypomagnesaemia, Dehydration, Decreased appetite
Croatian: Vrlo često: hipokalijemija, hipomagnezijemija, dehidracija, smanjen apetit
English: SN-38 is subsequently conjugated predominantly by the enzyme UDP-glucuronosyl transferase 1A1 (UGT1A1) to form a glucuronide metabolite.
Croatian: SN-38 se naknadno konjugira pretežno enzimom UDP-glukuronoziltransferazom 1A1 (UGT1A1) i formira metabolit glukuronida.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: vrijeme i uvjeti čuvanja lijeka odgovornost su korisnika.
English: The dose concentration and strength are different in comparison to non-liposomal irinotecans.
Croatian: Koncentracija i jačina doze razlikuju se od neliposomalnih irinotekana.
English: New or progressive dyspnoea, cough, and fever should prompt interruption of ONIVYDE pegylated liposomal treatment, pending diagnostic evaluation.
Croatian: Nova ili progresivna dispneja, kašalj i vrućica trebaju potaknuti prekid liječenja lijekom ONIVYDE pegilirani liposomalni do dijagnostičke procjene.
English: Irinotecan is metabolized by carboxylesterase to SN-38.
Croatian: Irinotekan se metabolizira pomoću karboksilesteraze do SN-38.
English: Individuals who are 7/7 homozygous for the UGT1A1*28 allele are at increased risk for neutropenia from non-liposomal irinotecan.
Croatian: Pojedinci koji su 7/7 homozigoti za alel UGT1A1*28 imaju povećan rizik od neutropenije kod primjene neliposomalnog irinotekana.
English: The diluted solution for infusion can be stored in the refrigerator (2°C - 8°C) for no more than 24 hours prior to use.
Croatian: Razrijeđena otopina za infuziju može se čuvati u hladnjaku (2°C - 8°C) ne duže od 24 sata prije uporabe.
English: For patients experiencing late diarrhoea, the median time to late diarrhoea onset was 8 days from the previous dose of ONIVYDE pegylated liposomal.
Croatian: Za bolesnike koji su imali kasni proljev, medijan vremena do pojave kasnog proljeva bio je 8 dana od prethodne doze lijeka ONIVYDE pegilirani liposomalni.
English: 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.
Croatian: Kemijska i fizička stabilnost razrijeđene otopine za infuziju dokazana je na temperaturi od 15-25°C najviše 6 sati ili u hladnjaku (2ºC-8ºC) ne više od 24 sata.
English: Patients with risk factors should be closely monitored for respiratory symptoms before and during ONIVYDE pegylated liposomal therapy.
Croatian: Bolesnike s čimbenicima rizika potrebno je pomno pratiti radi respiratornih simptoma prije i tijekom liječenja lijekom ONIVYDE pegilirani liposomalni.
English: If you have experienced sweating, abdominal cramping and salivation together with early frequent and liquid stools in previous treatments with ONIVYDE pegylated liposomal, you may receive additional medicines before ONIVYDE pegylated liposomal to prevent or reduce this in the following treament cycles.
Croatian: Ako ste doživjeli znojenje, grčeve u trbuhu i salivaciju (slinjenje) zajedno s ranim čestim i tekućim stolicama u prethodnim liječenjima lijekom ONIVYDE pegilirani liposomalni, možete primiti dodatne lijekove prije no što primite ONIVYDE pegilirani liposomalni kako bi se to spriječilo ili smanjilo u sljedećim ciklusima liječenja.
English: In clinical trials, ONIVYDE pegylated liposomal was administered at doses up to 210 mg/m to patients with various cancers.
Croatian: U kliničkim ispitivanjima ONIVYDE pegilirani liposomalni je primijenjen u dozama do 210 mg/m2 u bolesnika s različitim vrstama raka.
English: Concentrate for solution for infusion.
Croatian: Koncentrat za otopinu za infuziju.
English: Common: Hypotension
Croatian: Često: hipotenzija
English: Patients with UGT1A1 allele
Croatian: Bolesnici s alelom UGT1A1
English: In a pooled analysis from 353 patients, higher plasma SN-38 Cmax was associated with increased likelihood of experiencing neutropenia, and higher plasma total irinotecan Cmax was associated with increased likelihood of experiencing diarrhoea.
Croatian: U objedinjenoj analizi podataka od 353 bolesnika, viši Cmax SN-38 u plazmi bio je povezan s povećanom vjerojatnošću dobivanja neutropenije, a viši Cmax ukupnog irinotekana u plazmi bio je povezan s većom vjerojatnošću dobivanja proljeva.
English: Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: History of prior abdominal radiation increases the risk of severe neutropenia and febrile neutropenia following ONIVYDE pegylated liposomal treatment.
Croatian: Anamneza prethodnog zračenja abdomena povećava rizik od teške neutropenije i febrilne neutropenije nakon liječenja lijekom ONIVYDE pegilirani liposomalni.
English: Maximum supportive care should be instituted to prevent dehydration due to diarrhoea and to treat any infectious complications.
Croatian: Potrebno je provesti maksimalne suportivne mjere kako bi se spriječila dehidracija uslijed proljeva te liječila svaka infektivnua komplikacija.
English: infection) - telaprevir (a medicine used to treat a liver disease called hepatitis C) - nefazodone (a medicine used to treat depression, low mood) - gemfibrozil (medicine used to treat high fat levels in the blood)
Croatian: - telaprevir (lijek koji se primjenjuje za liječenje bolesti jetre koja se zove hepatitis C) - nefazodon (lijek koji se primjenjuje za liječenje depresije i lošeg raspoloženja) - gemfibrozil (lijek koji se primjenjuje za liječenje visokih razina masnoće u krvi)
English: The plasma protein binding of ONIVYDE pegylated liposomal is negligible (< 0.44% of total irinotecan in ONIVYDE pegylated liposomal).
Croatian: Vezanje lijeka ONIVYDE pegilirani liposomalni za proteine plazme je zanemarivo (<0,44% ukupnog irinotekana u lijeku ONIVYDE pegilirani liposomalni).
English: 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.
Croatian: U slučaju povećanja doze lijeka ONIVYDE pegilirani liposomalni na 70 mg/m2 ako se podnosi u sljedećim ciklusima, preporučene izmjene doze trebaju slijediti Tablicu 1
English: 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
Croatian: Razina pri kojoj nisu zapaženi štetni učinci (NOAEL) u štakora i pasa nakon 90 min intravenske infuzije lijeka ONIVYDE pegilirani liposomalni jednom svaka 3 tjedna tijekom 18 tjedana bila je 155 mg/m2.
English: Cytotoxic: handle with caution and special disposal.
Croatian: Citotoksično: rukovati s oprezom; posebno zbrinjavanje.
English: ONIVYDE pegylated liposomal is not recommended for use in adolescents and children below the age of 18 years.
Croatian: Ne preporučuje se primjena lijeka ONIVYDE pegilirani liposomalni u djece i adolescenata mlađih od 18 godina.
English: 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).
Croatian: Populacijska farmakokinetička analiza u 196 muškaraca i 157 žena upućuje na to da spol nema klinički značajan učinak na izloženost irinotekanu i SN-38 nakon prilagođavanja za površinu tijela.
English: In animal models, ONIVYDE pegylated liposomal has been shown to extend plasma levels of irinotecan and prolong the exposure to the active metabolite SN-38 at the site of the tumour.
Croatian: U životinjskih modela ONIVYDE pegilirani liposomalni je pokazao da produžuje prisutnost irinotekana u plazmi i prolongira izloženost aktivnom metabolitu SN-38 na mjestu tumora.
English: ONIVYDE pegylated liposomal is used in combination with other cancer medicines, called 5-fluorouracil and leucovorin.
Croatian: ONIVYDE pegilirani liposomalni se koristi u kombinaciji s drugim lijekovima protiv raka koji se zovu 5-fluorouracil i leukovorin.
English: Forty-one percent (41%) of patients treated with ONIVYDE pegylated liposomal across the clinical program were ≥ 65 years.
Croatian: Starije osobe Četrdeset i jedan posto (41%) bolesnika liječenih lijekom ONIVYDE pegilirani liposomalni u cijelom kliničkom programu bilo je u dobi
English: Underweight patients (body mass index < 18.5 kg/m2)
Croatian: Pothranjeni bolesnici (indeks tjelesne mase <18,5 kg/m2)
English: 95% CI of Rate
Croatian: 95% CI stope5
English: Co-administration of ONIVYDE pegylated liposomal +5-FU/LV does not alter the pharmacokinetics of ONIVYDE pegylated liposomal based on the population pharmacokinetic analysis.
Croatian: Istodobna primjena ONIVYDE pegilirani liposomalni +5-FU/LV ne mijenja farmakokinetiku lijeka ONIVYDE pegilirani liposomalni na temelju populacijske farmakokinetičke analize.
English: Patients receiving concomitant non-liposomal irinotecan and ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased SN-38 exposure by 109%.
Croatian: Bolesnici koji istodobno primaju neliposomalni irinotekan i ketokonazol, CYP3A4 i UGT1A1 inhibitor, imaju povećanje izloženosti metabolitu SN-38 od 109%.
English: 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).
Croatian: Primjenu lijeka ONIVYDE pegilirani liposomalni treba izbjegavati u bolesnika s razinom bilirubina > 2,0 mg/dl ili vrijednostima aspartat aminotransferaze (AST) i alanin aminotransferaze (ALT) > 2,5 puta iznad gornje granice normale (GGN) ili > 5 puta GGN ako su prisutne metastaze u jetri (vidjeti dio 4.4).
English: No findings indicative of CNS related toxicity were observed in the repeated dose toxicity studies in rats.
Croatian: Nisu zabilježeni nalazi koji ukazuju na toksičnost povezanu sa središnjim živčanim sustavom u ispitivanjima toksičnosti ponovljenih doza na štakorima.
English: ONIVYDE pegylated liposomal has moderate influence on the ability to drive and use machines.
Croatian: ONIVYDE pegilirani liposomalni umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: This active substance is held in tiny lipid (fatty) particles called liposomes.
Croatian: Djelatna tvar je čuvana u malim lipidnim (masnim) česticama koje se nazivaju liposomi.
English: It is also especially important that you tell your doctor if you are also taking the following medicines, since they reduce the availability of irinotecan in your body: - phenytoin, phenobarbital or carbamazepine (medicines used to treat convulsions and falls) - rifampicin and rifabutin (medicines used to treat tuberculosis) - St. John´s wort (a plant based medicine used to treat depression and low mood) - as ONIVYDE pegylated liposomal should not be given to you together with these medicines.
Croatian: Također je posebno važno da svom liječniku kažete ako uzimate sljedeće lijekove, jer oni smanjuju raspoloživost irinotekana u Vašem tijelu: - fenitoin, fenobarbital ili karbamazepin (lijekovi koji se koriste za liječenje konvulzija i padova) - rifampicin i rifabutin (lijekovi koji se primjenjuju za liječenje tuberkuloze) - gospina trava (lijek na biljnoj bazi koji se primjenjuje za liječenje depresije i lošeg raspoloženja)
English: After you have been given ONIVYDE pegylated liposomal you will be given two other medicines, leucovorin and 5-fluorouracil.
Croatian: Nakon što ste primili ONIVYDE pegilirani liposomalni, primit ćete druga dva lijeka, leukovorin i 5-fluorouracil.
English: 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).
Croatian: Analiza je obuhvatila 68 bolesnika s umjerenim (CLcr 30-59 ml/min), 147 bolesnika s blagim (CLcr 60-89 ml/min) oštećenjem bubrega te 135 bolesnika s normalnom funkcijom bubrega (CLcr >90 ml/min).
English: NCI CTCAE v 4.0 = National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Croatian: Prekinuti liječenje NCI CTCAE v 4.0= Zajednički kriteriji terminologije za nuspojave Nacionalnog instituta za rak verzija 4.0
English: ONIVYDE pegylated liposomal should be discontinued in case of severe hypersensitivitiy reactions.
Croatian: Primjenu lijeka ONIVYDE pegilirani liposomalni treba prekinuti u slučaju teških reakcija preosjetljivosti.
English: Table 3: Adverse reactions reported with ONIVYDE pegylated liposomal therapy in the NAPOLI-1 clinical study
Croatian: Tablica 3: Nuspojave prijavljene uz liječenje lijekom ONIVYDE pegilirani liposomalni u kliničkom ispitivanju NAPOLI-1
English: 5-FU dose modification as in Table 1
Croatian: Modifikacija doze 5-FU prema Tablici 1
English: The primary outcome measure was Overall Survival (OS).
Croatian: Overall Survival, OS).
English: - If you have any further questions, ask your doctor or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili medicinskoj sestri.
English: Patients should be made aware of the risk of delayed diarrhoea which can be debilitating and, on rare occasions, life threatening since persistent loose or watery stools can result in dehydration, electrolyte imbalance, colitis, gastrointestinal (GI) ulceration, infection or sepsis.
Croatian: Bolesnike treba upozoriti na rizik od kasne pojave proljeva koji može biti iscrpljujući i, u rijetkim slučajevima, opasan po život jer perzistentno mekane ili vodenaste stolice mogu dovesti do dehidracije, neravnoteže elektrolita, kolitisa, gastrointestinalnog
English: ONIVYDE pegylated liposomal is for single use only.
Croatian: ONIVYDE pegilirani liposomalni je samo za jednokratnu uporabu.
English: Onivyde pegylated liposomal has been associated with thromboembolic events such as pulmonary embolism, venous thrombosis and arterial thromboembolism.
Croatian: Primjena lijeka ONIVYDE pegilirani liposomalni povezana je s tromboembolijskim događajima kao što su plućna embolija, venska tromboza i arterijska tromboembolija.
English: Thrombocytopenia Leukopenia
Croatian: Trombocitopenija Leukopenija
English: Key eligibility criteria for patients with metastatic adenocarcinoma of the pancreas in the NAPOLI-1 clinical study were Karnofsky Performance Status (KPS) ≥ 70, normal bilirubin level, transaminase levels ≤ 2.5 times the ULN or ≤ 5 times the ULN for patients with liver metastases and albumin ≥ 3.0 g/dl.
Croatian: Ključni kriteriji podobnosti za bolesnike s metastatskim adenokarcinomom gušterače u kliničkom ispitivanju NAPOLI-1 bili su Karnofsky opći status (KPS) ≥70, normalna razina bilirubina, razine transaminaze ≤ 2,5 puta GGN ili ≤ 5 puta GGN za bolesnike s metastazama u jetri i albuminom
English: Conversely, patients > 75 years (n=12) experienced more frequent serious adverse reactions, dose delay, dose reduction and discontinuation compared to patients ≤ 75 years (n=105) when treated with ONIVYDE pegylated liposomal +5-FU/LV in the pancreatic adenocarcinoma study.
Croatian: bolesnici >75 godina (n=12) imali su učestalije ozbiljne nuspojave, odgađanje doze, smanjivanje doze i prekid liječenja u usporedbi s bolesnicima ≤ 75 godina (n=105) kad su primali ONIVYDE pegilirani liposomalni +5-FU/LV u ispitivanju adenokarcinoma gušterače.
English: No interaction of ONIVYDE pegylated liposomal (irinotecan) with other medicinal products is known.
Croatian: Nisu poznate interakcije lijeka ONIVYDE pegilirani liposomalni (irinotekan) s drugim lijekovima.
English: It blocks an enzyme called topoisomerase I, which is involved in the division of cell DNA.
Croatian: Irinotekan blokira enzim koji se zove topoizomeraza I, koji je uključen u podjelu stanične DNK.
English: Should extravasation occur, flushing the site with sodium chloride 9 mg/ml (0.9%) solution for injection and/or sterile water and applications of ice are recommended.
Croatian: Ako dođe do ekstravazacije, preporučuje se ispiranje mjesta 0,9%-tnom (9 mg/ml) otopinom za injekciju natrijeva klorida i/ili sterilnom vodom, te primjena leda.
English: Patients receiving concomitant non-liposomal irinotecan and CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital or carbamazepine have substantially reduced exposure to irinotecan (AUC reduction by 12% with St John's wort, 57%-79% with phenytoin, phenobarbital, or carbamazepine) and SN-38 (AUC reduction by 42% with St John's wort, 36%-92% with phenytoin phenobarbital, or carbamazepine).
Croatian: Bolesnici koji istodobno primaju neliposomalni irinotekan i antikonvulzive koji induciraju enzim CYP3A4, fenitoin, fenobarbital ili karbamazepin, imaju znatno smanjenu izloženost irinotekanu (smanjenje AUC za 12% s gospinom travom, 57%-79% s fenitoinom, fenobarbitalom ili karbamazepinom) i metabolitu SN-38 (smanjenje AUC za 42% s gospinom travom, 36%-92% s fenitoinom, fenobarbitalom ili karbamazepinom).
English: Table 5: Summary of mean (±standard deviation) total irinotecan and total SN-38 Analyte PK parameters
Croatian: Tablica 5: Sažetak srednjih vrijednosti (±standardna devijacija) ukupnog irinotekana i ukupnog SN-38
English: Grade 3 or higher and serious treatment emergent adverse reactions were more frequent in patients < 65 years (84.1% and 50.8%) compared to patients ≥ 65 years (68.5 % and 44.4%).
Croatian: < 65 godina (84,1% i 50,8%) u usporedbi s bolesnicima ≥ 65 godina (68,5 % i 44,4%).
English: ONIVYDE pegylated liposomal is not recommended for use in patients with severe renal impairment (CLcr < 30 ml/min).
Croatian: Ne preporučuje se primjena lijeka ONIVYDE pegilirani liposomalni u bolesnika s teškim oštećenjem bubrega (CLcr <30 ml/min).