FrancophonIA/ELRC3.0 huggingface dataset:
English: Interactions with strong CYP3A4 inhibitors or strong UGT1A1 inhibitors
Croatian: Interakcije sa snažnim inhibitorima CYP3A4 ili snažnim inhibitorima UGT1A1
English: Common: Lymphopenia
Croatian: Često: limfopenija
English: Servier Italia S.p.A. Tel: + 39 (06) 669081
Croatian: Tel: + 39 (06) 669081
English: Dilute with 5% glucose solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection to prepare a solution of the appropriate dose of ONIVYDE pegylated liposomal diluted to a final volume of 500 ml.
Croatian: Razrijedite 5%-tnom otopinom glukoze za injekciju ili 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekciju kako biste pripremili otopinu odgovarajuće doze lijeka ONIVYDE pegilirani liposomalni razrijeđenu do konačnog volumena od 500 ml.
English: Interactions with strong CYP3A4 inducers
Croatian: Interakcije sa snažnim induktorima CYP3A4
English: In the clinical study Grade 3 or Grade 4 diarrhoea occurred in 15 out of 117 patients (12.8%) receiving ONIVYDE pegylated liposomal +5-FU/LV.
Croatian: U kliničkom ispitivanju proljev stupnja 3 ili stupnja 4 javio se u 15 od 117 bolesnika (12,8%) koji su primali ONIVYDE pegilirani liposomalni +5-FU/LV.
English: 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.
Croatian: Preporučena doza i režim liječenja lijekom ONIVYDE pegilirani liposomalni je 70 mg/m2 intravenski tijekom 90 minuta, nakon čega slijedi LV 400 mg/m2 intravenski tijekom 30 minuta, a potom 5-FU 2400 mg/m2 intravenski tijekom 46 sati, primijenjeno svaka 2 tjedna.
English: Each ml of ONIVYDE pegylated liposomal contains 0.144 mmol (3.31 mg) sodium.
Croatian: Jedan ml lijeka ONIVYDE pegilirani liposomalni sadrži 0,144 mmol (3,31 mg) natrija.
English: The disposition of ONIVYDE pegylated liposomal and non-liposomal irinotecan has not been fully elucidated in humans.
Croatian: Eliminacija Dispozicija lijeka ONIVYDE pegilirani liposomalni i neliposomalnog irinotekana u ljudi nije potpuno razjašnjena.
English: Reduce 5-FU dose by 25% (1,800 mg/m
Croatian: Smanjiti dozu 5-FU za 25% (1800 mg/m2)
English: Median is the Kaplan-Meier estimate of the median survival time
Croatian: Medijan je Kaplan-Meierova procjena medijana vremena preživljenja Prema RECIST smjernicama, v 1.1.
English: Liposome encapsulation of irinotecan extends circulation and limits distribution relative to those of the non-liposomal irinotecan.
Croatian: Inkapsulacija irinotekana u liposome produljuje njegovu cirkulaciju i ograničava distribuciju u odnosu na neliposomalni irinotekan.
English: You must not be given ONIVYDE if you are breast-feeding as this may be harmful to your baby.
Croatian: ONIVYDE pegilirani liposomalni ne smijete primiti ako dojite jer može biti štetno za Vašu bebu.
English: In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, 5 of 8 underweight patients experienced a grade 3 or 4 adverse reaction, mostly myelosuppression, while 7 of the 8 patients required dose modification such as dose delay, dose reduction or dose discontinuation (see section 4.4).
Croatian: U kliničkom ispitivanju koje je procjenjivalo ONIVYDE pegilirani liposomalni +5-FU/LV, 5 od 8 pothranjenih bolesnika imalo je nuspojave stupnja 3 ili 4, uglavnom mijelosupresiju, dok je za 7 od 8 bolesnika bila potrebna modifikacija doze kao što je odgađanje doze, smanjenje doze ili prekid doziranja (vidjeti dio 4.4).
English: Pregnant staff should not handle ONIVYDE pegylated liposomal considering the cytotoxic nature of the medicinal product.
Croatian: Trudno osoblje ne smije rukovati lijekom ONIVYDE pegilirani liposomalni imajući u vidu citotoksičnu prirodu ovog lijeka.
English: Therefore, co-administration of ONIVYDE pegylated liposomal with inducers of CYP3A4 may reduce systemic exposure of ONIVYDE pegylated liposomal.
Croatian: pegilirani liposomalni s induktorima CYP3A4 može smanjiti sustavnu izloženost lijeku ONIVYDE
English: The safety and efficacy of ONIVYDE pegylated liposomal were investigated in a multinational, randomised, open label, controlled clinical trial (NAPOLI-1) that tested two treatment regimens for patients with metastatic pancreatic adenocarcinoma who had documented disease progression after gemcitabine or gemcitabine-containing therapy.
Croatian: randomiziranom, otvorenom, kontroliranom kliničkom ispitivanju (NAPOLI-1) u kojem su se ispitivala dva režima liječenja za bolesnike s metastatskim adenokarcinomom gušterače za koje je dokumentirana progresija bolesti nakon gemcitabina ili terapije koja je sadržavala gemcitabin.
English: Reduce 5-FU dose by an additional 25% (1,350 mg/m
Croatian: Smanjiti dozu 5-FU za dodatnih 25% (1350 mg/m2)
English: The following adverse reactions, considered to be possibly or probably related to the administration of ONIVYDE pegylated liposomal, were reported in 264 patients with metastatic adenocarcinoma of the pancreas, 147 of whom received ONIVYDE pegylated liposomal monotherapy (100 mg/m and 117 received ONIVYDE pegylated liposomal (70 mg/m2) in combination with 5-FU/LV.
Croatian: ONIVYDE pegilirani liposomalni zabilježene su u 264 bolesnika s metastatskim adenokarcinomom gušterače, od kojih je 147 primalo ONIVYDE pegilirani liposomalni kao monoterapiju (100 mg/m2), a 117 je primalo ONIVYDE pegilirani liposomalni (70 mg/m2) u kombinaciji sa 5-FU/LV.
English: [30 of 110 (27.3%)] (see section 5.1).
Croatian: [u 1 bolesnika (0,7%)].
English: There are no data on the impact of ONIVYDE pegylated liposomal on human fertility.
Croatian: Plodnost Nema podataka o učinku lijeka ONIVYDE pegilirani liposomalni na plodnost u ljudi.
English: Marketing Authorisation Holder Les Laboratoires Servier 50, rue Carnot
Croatian: 50, rue Carnot
English: Early onset diarrhoea may be accompanied by cholinergic symptoms such as rhinitis, increased salivation, flushing, diaphoresis, bradycardia, miosis and hyperperistalsis.
Croatian: Rani nastup proljeva može biti popraćen kolinergičkim simptomima kao što su rinitis, povećana salivacija, navale crvenila, dijaforeza, bradikardija, mioza i hiperperistaltika.
English: Uncommon: Hypoxia
Croatian: Manje često: hipoksija
English: Overall Survival Number of deaths, n (%) Median OS (months) (95% CI)
Croatian: Smrt ili progresija, n (%) Medijan PFS (mjeseci) (95% CI)
English: water, soda water, fizzy drinks, soup) to avoid losing too much liquid and salts from your body.
Croatian: Što prije nakon što dobijete prvu tekuću stolicu, počnite piti velike količine rehidracijske tekućine (npr. voda, gazirana voda, gazirana pića, juha) kako biste izbjegli gubljenje previše tekućine i soli iz tijela.
English: A thorough medical history should be obtained in order to identify patients with multiple risk factors in addition to the underlying neoplasm.
Croatian: Potrebno je uzeti detaljnu anamnezu kako bi se otkrili bolesnici koji, uz podležeću neoplazmu, imaju višestruke faktore rizika.
English: Third occurrence
Croatian: Treći nastup
English: Non-liposomal irinotecan and SN-38 were genotoxic in vitro in the chromosomal aberration test on CHO-cells as well as in the in vivo micronucleus test in mice.
Croatian: Neliposomalni irinotekan i SN-38 bili su genotoksični in vitro u testu na kromosomske aberacije na stanicama jajnika kineskog hrčka (engl.
English: Interaction affecting the use of ONIVYDE pegylated liposomal
Croatian: Interakcije koje utječu na primjenu lijeka ONIVYDE pegilirani liposomalni
English: Common: Pulmonary embolism, Embolism, Deep vein thrombosis Uncommon: Thrombosis
Croatian: Često: plućna embolija, embolija, duboka venska tromboza Manje često: tromboza
English: ONIVYDE pegylated liposomal should be discontinued in patients with a confirmed diagnosis of ILD.
Croatian: Primjenu lijeka ONIVYDE pegilirani liposomalni treba prekinuti u bolesnika s potvrđenom dijagnozom IBP-a.
English: The rates of adverse reactions leading to permanent treatment discontinuation were 11% for the ONIVYDE pegylated liposomal +5-FU/LV arm and 12% for the monotherapy arm.
Croatian: Stopa nuspojava koje su vodile trajnom prekidu liječenja bila je 11% za skupinu ONIVYDE pegilirani liposomalni +5-FU/LV odnosno 12% za skupinu s monoterapijom.
English: Les Laboratoires Servier Tél: + 33 (0)1 55 72 60 00
Croatian: Tél: + 33 (0)1 55 72 60 00
English: Description of selected adverse reactions The following adverse reactions were observed in the NAPOLI-1 clinical study:
Croatian: Sljedeće nuspojave zabilježene su u kliničkom ispitivanju NAPOLI-1:
English: Infusion reactions primarily consisting of rash, urticaria, periorbital oedema or pruritus were reported in patients receiving ONIVYDE pegylated liposomal treatment.
Croatian: Akutne reakcije na infuziju i povezane reakcije Reakcije na infuziju koje se prvenstveno sastoje od osipa, urtikarije, periorbitalnog edema ili svrbeža prijavljene su u bolesnika koji su primali ONIVYDE pegilirani liposomalni.
English: There is no known antidote for overdose of ONIVYDE pegylated liposomal.
Croatian: Nema poznatog protuotrova za predoziranje lijekom ONIVYDE pegilirani liposomalni.
English: No reproductive and developmental toxicity studies have been performed with ONIVYDE pegylated liposomal.
Croatian: Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti s lijekom ONIVYDE pegilirani liposomalni.
English: Talk to your doctor or nurse immediately during treatment with ONIVYDE pegylated liposomal - if you feel sudden shortness of breath, flushing, headache, skin rash or hives (itchy rash with swollen red bumps on the skin that appear suddenly), itching, swelling around the eyes,
Croatian: Obratite se svom liječniku ili medicinskoj sestri odmah tijekom liječenja lijekom ONIVYDE pegilirani liposomalni: - ako osjetite iznenadni nedostatak zraka, navale crvenila, glavobolju, kožni osip ili koprivnjaču
English: ONIVYDE pegylated liposomal should not be administered with strong CYP3A4-enzyme inhibitors (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole).
Croatian: ONIVYDE pegilirani liposomalni se ne smije primjenjivati sa snažnim inhibitorima enzima CYP3A4 (npr. sok od grejpa, klaritromicin, indinavir, itrakonazol, lopinavir, nefazodon, nelfinavir,
English: The cumulative biliary and urinary excretion of irinotecan and its metabolites (SN-38 and SN-38 glucuronide) over a period of 48 hours following administration of non-liposomal irinotecan in two patients ranged from approximately 25% (100 mg/m2) to 50%
Croatian: SN-38 glukuronida) putem žuči i urina tijekom razdoblja od 48 sati nakon primjene neliposomalnog irinotekana u dva bolesnika bilo je u rasponu od oko 25% (100 mg/m2) do 50% (300 mg/m2).
English: 5.2 Pharmacokinetic properties
Croatian: 5.2 Farmakokinetička svojstva Apsorpcija
English: 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.
Croatian: Mijelosupresija (neutropenija/leukopenija, trombocitopenija i anemija) bila je učestalija u skupini koja je primala ONIVYDE pegilirani liposomalni +5-FU/LV u usporedbi s kontrolnom skupinom koja je primala samo 5-FU/LV.
English: ONIVYDE pegylated liposomal contains sodium
Croatian: ONIVYDE pegilirani liposomalni sadrži natrij
English: Acute renal failure was reported in 6 of 117 patients (5.1%) in the ONIVYDE pegylated liposomal +5-FU/LV arm, 10 of 147 (6.8%) in the ONIVYDE pegylated liposomal monotherapy arm and 6 of 134 patients (4.5%) in the 5-FU/LV arm.
Croatian: Akutno zatajenje bubrega zabilježeno je u 6 od 117 bolesnika (5,1%) u skupini koja je primala ONIVYDE pegilirani liposomalni +5-FU/LV, u 10 od 147 (6,8%) u skupini koja je primila ONIVYDE pegilirani liposomalni kao monoterapiju i u 6 od 134 bolesnika (4,5%) u skupini koja je primala samo 5-FU/LV.
English: 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.
Croatian: UGT1A1*28 genotipskim testiranjem, u kojoj je analiza prilagođena na nižu dozu primijenjenu u bolesnika homozigota za alel UGT1A1*28, bolesnici homozigoti (N=14) i nehomozigoti (N=244) za taj alel imali su prosječne koncentracije ukupnog SN-38 u stanju dinamičke ravnoteže od1,06 odnosno 0,95 ng/ml.
English: Withhold ONIVYDE pegylated liposomal for Grade 2-4 diarrhoea and initiate treatment for diarrhoea.
Croatian: Potrebno je privremeno prekinuti liječenje lijekom ONIVYDE pegilirani liposomalni kod proljeva stupnja 2-4 i započeti liječenje proljeva.
English: s r.o.
Croatian: Servier s.r.o.
English: Grade 3 or higher neutropenia occurred more frequently in patients treated with ONIVYDE pegylated liposomal +5-FU/LV (27.4%) compared to patients treated with 5-FU/LV (1.5%).
Croatian: Neutropenija stupnja 3 ili višeg javila se učestalije u bolesnika koji su primali ONIVYDE pegilirani liposomalni +5-FU/LV (27,4%) u usporedbi s bolesnicima koji su primali samo 5-FU/LV (1,5%).
English: ONIVYDE pegylated liposomal /5-FU adjustment (for patients not homozygous for UGT1A1*28)
Croatian: Prilagodba ONIVYDE pegilirani liposomalni /5-FU (za bolesnike koji nisu homozigoti za UGT1A1*28)
English: Non-liposomal irinotecan mean (SD) 125 mg/m
Croatian: Neliposomalni irinotekan srednja vrijednost (SD) 125 mg/m2 (n=99)c
English: Once the concentrate has been diluted for infusion with 5% glucose solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection, the solution should be used as soon as possible, but may be stored at ambient temperature (15°C to 25°C) for up to 6 hours.
Croatian: (9 mg/ml) otopinom natrijeva klorida za injekciju, otopinu treba koristiti što je prije moguće, ali se može čuvati na sobnoj temperaturi (15°C do 25°C) do najviše 6 sati.
English: Talk to your doctor or nurse before you are given ONIVYDE pegylated liposomal - if you have ever had any liver problems or jaundice - if you have ever had lung disease or have previously received medicines (colony stimulating factors) to increase your blood count or radiation therapy - if you are taking other medicines (see section “Other medicines and ONIVYDE pegylated liposomal”) - if you are planning to have a vaccination as many vaccinations must not be given during chemotherapy - if you are on a controlled sodium diet as this medicine contains sodium.
Croatian: za povećanje broja krvnih stanica ili ste primali terapiju zračenjem - ako uzimate druge lijekove (vidjeti dio „Drugi lijekovi i ONIVYDE pegilirani liposomalni ”) - ako planirate primiti cjepivo jer se mnoga cjepiva ne smiju primiti tijekom kemoterapije - ako ste na dijeti s kontroliranim unosom natrija jer ovaj lijek sadrži natrij.
English: The active substance in ONIVYDE pegylated liposomal is irinotecan (topoisomerase I inhibitor) encapsulated in a lipid bilayer vesicle or liposome.
Croatian: Djelatna tvar lijeka ONIVYDE pegilirani liposomalni je irinotekan (inhibitor topoizomeraze I) inkapsuliran u vezikul s lipidnim dvoslojem, odnosno liposom.
English: ONIVYDE pegylated liposomal is for intravenous use.
Croatian: ONIVYDE pegilirani liposomalni je namijenjen za intravensku primjenu.
English: You can also report side effects directly via the national reporting system listed in
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: Following recovery to Grade 1 diarrhoea, resume ONIVYDE pegylated liposomal at a reduced dose (see section 4.2).
Croatian: Nakon oporavka na proljev stupnja 1, treba nastaviti primjenu lijeka ONIVYDE pegilirani liposomalni u smanjenoj dozi (vidjeti dio 4.2).
English: Renal impairment and acute renal failure have been identified, usually in patients who become volume depleted from nausea/vomiting and/or diarrhoea.
Croatian: Oštećenje bubrega i akutno zatajenje bubrega identificirani su uglavnom u bolesnika s deplecijom volumena zbog mučnine/povraćanja i/ili proljeva.
English: ONIVYDE pegylated liposomal must only be given by healthcare professionals trained in giving anticancer medicines
Croatian: Kako se ONIVYDE pegilirani liposomalni primjenjuje ONIVYDE pegilirani liposomalni smije dati samo zdravstveni radnik obučen za davanje lijekova protiv raka
English: A new cycle of therapy should not begin until the adverse reaction resolves to ≤ Grade 1
Croatian: Novi ciklus liječenja ne smije se započinjati sve dok se nuspojava ne povuče na ≤ stupanj 1
English: Nausea/vomiting
Croatian: Mučnina/povraćanje
English: ONIVYDE pegylated liposomal (irinotecan) is not equivalent to non-liposomal irinotecan formulations and should not be interchanged.
Croatian: ONIVYDE pegilirani liposomalni (irinotekan) nije ekvivalentan neliposomalnim formulacijama irinotekana te se ne smiju međusobno zamjenjivati.
English: ONIVYDE 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: Table 2: Recommended dose modifications for ONIVYDE pegylated liposomal +5-FU/LV for Grade 3-4 toxicities in patients homozygous for UGT1A1*28
Croatian: Tablica 2: Preporučene modifikacije doze za ONIVYDE pegilirani liposomalni +5-FU/LV za toksičnosti stupnja 3-4 u bolesnika koji su homozigoti za UGT1A1*28
English: ONIVYDE pegylated liposomal is not equivalent to other non-liposomal irinotecan formulations and should not be interchanged.
Croatian: ONIVYDE pegilirani liposomalni nije ekvivalentan drugim neliposomalnim formulacijama irinotekana te se ne smiju međusobno zamjenjivati.
English: METHOD AND ROUTE OF ADMINISTRATION For single use only.
Croatian: Samo za jednokratnu uporabu.
English: Consideration should be given to substituting with non-enzyme inducing therapies at least 2 weeks prior to initiation of ONIVYDE pegylated liposomal therapy (see section 4.5).
Croatian: Potrebno je razmotriti zamjenu terapijama koje ne induciraju enzim najmanje 2 tjedna prije započinjanja terapije lijekom ONIVYDE
English: • ONIVYDE pegylated liposomal is a cytotoxic medicinal product and caution should be exercised in handling it.
Croatian: • ONIVYDE pegilirani liposomalni je citotoksični lijek s kojim je potrebno oprezno rukovati.
English: ONIVYDE pegylated liposomal should not be administered with strong CYP3A4-enzyme inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John's wort unless there are no therapeutic alternatives.
Croatian: CYP3A4 kao što su antikonvulzivi (fenitoin, fenobarbital ili karbamazepin), rifampicin, rifabutin i gospina trava osim ako ne postoje terapijske alternative.
English: Hazard Ratio (95% CI) p-value
Croatian: Omjer hazarda (95% CI)3 p-vrijednost4
English: Rate Difference (95% CI) p-value
Croatian: Razlika stopa (95% CI)5
English: ONIVYDE pegylated liposomal is supplied as a white to slightly yellow opaque isotonic liposomal dispersion in a glass vial.
Croatian: Kako ONIVYDE pegilirani liposomalni izgleda i sadržaj pakiranja ONIVYDE pegilirani liposomalni se isporučuje kao bijela do blago žuta neprozirna izotonična liposomalna disperzija u staklenoj bočici.
English: Therefore, co-administration of ONIVYDE pegylated liposomal with other inhibitors of CYP3A4 (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) may increase systemic exposure of ONIVYDE pegylated liposomal.
Croatian: Stoga, istodobna primjena lijeka ONIVYDE pegilirani liposomalni s drugim inhibitorima CYP3A4 (npr. sok od grejpa, klaritromicin, indinavir, itrakonazol, lopinavir, nefazodon, nelfinavir, ritonavir, sakvinavir, telaprevir,
English: Pregnant staff should not handle ONIVYDE pegylated liposomal.
Croatian: Trudno osoblje ne smije rukovati lijekom ONIVYDE pegilirani liposomalni.
English: Renal impairment and acute renal failure have been identified, usually in patients who became volume depleted from severe vomiting and/or diarrhoea.
Croatian: Oštećenje bubrega i akutno zatajenje bubrega identificirani su uglavnom u bolesnika s deplecijom volumena zbog teškog povraćanja i/ili proljeva.
English: Diarrhoea is a very common adverse reaction leading to colitis, ileus, gastroenteritis, fatigue, dehydration, weight loss, renal toxicities, hyponatraemia, and hypokalaemia.
Croatian: Proljev je vrlo česta nuspojava koja dovodi do kolitisa, ileusa, gastroenteritisa, umora, dehidracije,
English: Water for injections See leaflet for further information.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: Grade 3 or higher anaemia occurred in 10.3% of patients treated with ONIVYDE pegylated liposomal +5-FU/LV and in 6.7% of patients treated with 5-FU/LV.
Croatian: Anemija stupnja 3 ili višeg javila se u 10,3% bolesnika koji su primali ONIVYDE pegilirani liposomalni +5-FU/LV i u 6,7% bolesnika koji su primali samo 5-FU/LV.
English: Type I glass vial with a grey chlorobutyl stopper and an aluminium seal with a flip-off cap, containing 10 ml of concentrate.
Croatian: I sa sivim klorobutilnim čepom i aluminijskim prstenom s flip-off poklopcem,
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: A PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: CA Papaellinas Ltd. Τηλ: + 357 22 741 741
Croatian: Τηλ: + 357 22 741 741
English: 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.
Croatian: Bolesnicima za koje je poznato da su homozigoti za UGT1A1*28 i nemaju toksičnosti povezane s lijekom tijekom prvog ciklusa liječenja (smanjena doza od 50 mg/m2) doza lijeka ONIVYDE
English: A new cycle of therapy should not begin until the platelet count is ≥ 100,000 platelets/mm
Croatian: Novi ciklus liječenja ne smije se započinjati sve dok broj trombocita nije ≥100 000 trombocita/mm3
English: Sepsis with neutropenic fever and consequent septic shock with fatal outcome has been observed in patients with metastatic pancreatic adenocarcinoma treated with ONIVYDE pegylated liposomal.
Croatian: U bolesnika s metastatskim adenokarcinomom gušterače koji su liječeni lijekom ONIVYDE pegilirani liposomalni zabilježena je sepsa s neutropenijskom vrućicom te posljedičnim septičkim šokom sa smrtnim ishodom.
English: How to handle and dispose of ONIVYDE pegylated liposomal
Croatian: Kako rukovati i zbrinuti ONIVYDE pegilirani liposomalni
English: Strong CYP3A4 inducers
Croatian: Snažni induktori CYP3A4
English: Table 1: Recommended dose modifications for ONIVYDE pegylated liposomal +5-FU/LV for Grade 3-4 toxicities for patients not homozygous for UGT1A1*28
Croatian: Tablica 1: Preporučene modifikacije doze za ONIVYDE pegilirani liposomalni +5-FU/LV za toksičnosti stupnja 3-4 u bolesnika koji nisu homozigoti za UGT1A1*28
English: 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.
Croatian: +5-FU/LV, 5 od 8 pothranjenih bolesnika imalo je nuspojave stupnja 3 ili 4, uglavnom mijelosupresiju, dok je za 7 od 8 bolesnika bila potrebna modifikacija doze kao što je odgađanje doze, smanjenje doze ili prekid doziranja.