FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: O akutni ledvični odpovedi so poročali pri 6 od 117 bolnikov (5,1 %) v veji z zdravilom ONIVYDE pegilirani liposomski +5-FU/LV, pri 10 od 147 (6,8 %) v veji z zdravilom ONIVYDE pegilirani liposomski v monoterapiji in pri 6 od 134 bolnikov (4,5 %) v veji s 5-FU/LV.
English: ONIVYDE pegylated liposomal is supplied as a white to slightly yellow opaque isotonic liposomal dispersion in a glass vial.
Slovenian: Zdravilo ONIVYDE pegilirani liposomski je na voljo kot bela do rumenkasta rahlo motna izotonična liposomska disperzija v stekleni viali.
English: A reticulo-nodular pattern on chest X-ray was observed in a small percentage of patients enrolled in a clinical study with irinotecan.
Slovenian: Pri majhnem odstotku bolnikov, vključenih v klinično študijo z irinotekanom, so opazili retikulonodularni vzorec na rentgenskem posnetku pljuč.
English: Patients randomised to ONIVYDE pegylated liposomal monotherapy received 100 mg/m as an intravenous infusion over 90 minutes every 3 weeks.
Slovenian: Bolniki, randomizirani na zdravilo ONIVYDE pegilirani liposomski v monoterapiji, so ga prejemali v obliki 90-minutne intravenske infuzije v odmerku 100 mg/m2 na 3 tedne.
English: ONIVYDE pegylated liposomal contains sodium, if you are on a controlled sodium diet, see section 2.
Slovenian: Če ste na dieti z nadzorovanim vnosom natrija, glejte poglavje 2.
English: Other medicines and ONIVYDE pegylated liposomal
Slovenian: Druga zdravila in zdravilo ONIVYDE pegilirani liposomski
English: Progression-Free Survival Death or progression, n (%)
Slovenian: Preživetje brez napredovanja1,2 Smrt ali napredovanje, n (%) Mediana PFS (meseci) (95-odstotni IZ)
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.
Slovenian: Razredčeno raztopino za infundiranje lahko pred uporabo do 24 ur hranite v hladilniku (2 °C-8 °C).
English: ONIVYDE pegylated liposomal should be administered before LV followed by 5-FU.
Slovenian: Zdravilo ONIVYDE pegilirani liposomski je treba dajati pred LV, temu pa sledi 5-FU.
English: Very common: Pyrexia, Peripheral oedema, Mucosal inflammation, Fatigue, Asthenia
Slovenian: Zelo pogosti: pireksija, periferni edem, vnetje sluznic, utrujenost, astenija
English: Strong CYP3A4 inducers
Slovenian: Močni induktorji encima CYP3A4
English: The most frequently reported adverse reactions leading to discontinuation were infection and diarrhoea for ONIVYDE pegylated liposomal +5-FU/LV arm, and vomiting and diarrhoea for the monotherapy arm.
Slovenian: Najpogostejša neželena učinka, ki sta privedla do prekinitve zdravljenja, sta bila okužba in driska v veji z zdravilom ONIVYDE pegilirani liposomski +5-FU/LV ter bruhanje in driska v veji z monoterapijo.
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.
Slovenian: pegilirani liposomski, so poročali pri 264 bolnikih z metastatskim adenokarcinomom trebušne slinavke od katerih jih je 147 prejemalo samo zdravilo ONIVYDE pegilirani liposomski (100 mg/m2), 117 pa zdravilo ONIVYDE pegilirani liposomski (70 mg/m2) v kombinaciji s 5-FU/LV.
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.
Slovenian: CYP3A4, kot so antikonvulzivi (fenitoin, fenobarbital ali karbamazepin), rifampicin, rifabutin in šentjanževka, razen če ni drugih terapevtskih možnosti.
English: ONIVYDE pegylated liposomal is for intravenous use.
Slovenian: Zdravilo ONIVYDE pegilirani liposomski je namenjeno za intravensko uporabo.
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).
Slovenian: Bolniki, ki so prestali Whipplovo operacijo, imajo po zdravljenju z zdravilom ONIVYDE pegilirani liposomski v kombinaciji s 5-FU in levkovorinom večje tveganje za resne okužbe (glejte poglavje 4.8).
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.
Slovenian: Anemija 3. ali višje stopnje se je pojavila pri 10,3 % bolnikov, zdravljenih z zdravilom ONIVYDE pegilirani liposomski +5-FU/LV, in pri 6,7 % bolnikov, zdravljenih s 5-FU/LV.
English: ONIVYDE pegylated liposomal is for single use only.
Slovenian: Zdravilo ONIVYDE pegilirani liposomski je samo za enkratno uporabo.
English: You must not be given ONIVYDE if you are breast-feeding as this may be harmful to your baby.
Slovenian: Zdravila ONIVYDE pegilirani liposomski ne smete prejemati, če dojite, ker lahko škoduje otroku.
English: • ONIVYDE pegylated liposomal should be administered before leucovorin followed by 5-fluorouracil.
Slovenian: • Zdravilo ONIVYDE pegilirani liposomski je treba dajati pred lekovorinom, temu pa sledi 5-fluorouracil.
English: Mean baseline albumin level was 3.6 g/dl, and baseline KPS was 90-100 in 55% of patients.
Slovenian: Povprečna izhodiščna raven albumina je bila 3,6 g/dl, izhodiščni rezultat KPS pa je bil 90
English: ONIVYDE pegylated liposomal must not be administered as a bolus injection or an undiluted solution.
Slovenian: ONIVYDE pegilirani liposomski ne smete dajati v obliki bolusne injekcije ali nerazredčene raztopine.
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.
Slovenian: 30-minutno intravensko infuzijo, ki ji je sledila 24-urna intravenska infuzija 5-FU v odmerku 2.000 mg/m2, kar so prejemali 1., 8., 15. in 22. dan 6-tedenskega cikla.
English: - if you are breastfeeding
Slovenian: - če dojite
English: Each ml of ONIVYDE pegylated liposomal contains 0.144 mmol (3.31 mg) sodium.
Slovenian: En mililiter zdravila ONIVYDE pegilirani liposomski vsebuje 0,144 mmol (3,31 mg) natrija.
English: Close monitoring of blood counts is recommended, and the use of myeloid growth factors should be considered for patients with a history of abdominal radiation.
Slovenian: Pri bolnikih s predhodnim obsevanjem trebuha se priporoča skrbno spremljanje krvne slike, treba pa je razmisliti tudi o uporabi mieloidnega rastnega faktorja.
English: Pre-medication
Slovenian: Premedikacija
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%).
Slovenian: Nevtropenija 3. ali višje stopnje je bila pogostejša pri bolnikih, zdravljenih z zdravilom ONIVYDE pegilirani liposomski +5-FU/LV (27,4 %), v primerjavi z bolniki, zdravljenimi s 5-FU/LV (1,5 %).
English: Pregnant staff should not handle ONIVYDE pegylated liposomal.
Slovenian: Nosečnice z zdravilom ONIVYDE pegilirani liposomski ne smejo delati.
English: Servier Italia S.p.A. Tel: + 39 (06) 669081
Slovenian: Tel: + 39 (06) 669081
English: Česká republika Servier s.r.o.
Slovenian: Servier s.r.o.
English: Regular monitoring of complete blood counts should be conducted in patients with total bilirubin of 1.0-2.0 mg/dl.
Slovenian: Pri bolnikih z vrednostjo skupnega bilirubina 1,0-2,0 mg/dl je treba redno nadzirati celotno krvno sliko.
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.
Slovenian: Delež neželenih učinkov, zaradi katerih je prišlo do dokončne prekinitve zdravljenja, je bil 11 % v veji z zdravilom ONIVYDE pegilirani liposomski +5-FU/LV in 12 % v veji z monoterapijo.
English: The population pharmacokinetic analysis suggest that Asians have 56% lower total irinotecan average steady state concentration (3.93 [95%CI: 3.68-4.2] and 1.74 [95%CI: 1.58-1.93] mg/l, respectively) and 8% higher total SN-38 average steady state concentration (0.97 [95%CI: 0.92-1.03] and 1.05 [95%CI: 0.98-1.11] ng/ml, respectively) than Caucasians.
Slovenian: 4,2] oziroma 1,74 [95-odstotni IZ: 1,58 - 1,93] mg/l) in za 8 % višje povprečne koncentracije skupnega SN-38 v dinamičnem ravnovesju (0,97 [95-odstotni IZ: 0,92 - 1,03] oziroma 1,05 [95odstotni IZ: 0,98 - 1,11] ng/ml) kot osebe kavkazijskega porekla.
English: Grade 3 or higher thrombocytopenia occurred in 2.6% of patients treated with ONIVYDE pegylated liposomal +5-FU/LV and 0% in patients treated with 5-FU/LV.
Slovenian: Trombocitopenija 3. ali višje stopnje se je pojavila pri 2,6 % bolnikov, zdravljenih z zdravilom ONIVYDE pegilirani liposomski +5-FU/LV, in pri 0 % bolnikov, zdravljenih s 5-FU/LV.
English: ONIVYDE pegylated liposomal (irinotecan) is not equivalent to non-liposomal irinotecan formulations and should not be interchanged.
Slovenian: Zdravilo ONIVYDE pegilirani liposomski (irinotekan) ni enakovredno neliposomskim formulacijam irinotekana, zato jih ne smemo zamenjevati.
English: The use of gloves, goggles and protective clothing when handling or administering ONIVYDE pegylated liposomal is recommended.
Slovenian: Med ravnanjem z zdravilom ONIVYDE pegilirani liposomski in njegovim dajanjem priporočamo uporabo rokavic, zaščitnih očal in zaščitnih oblačil.
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.
Slovenian: Zdravilo ONIVYDE pegilirani liposomski skupaj s hrano in pijačo Med zdravljenjem z zdravilom ONIVYDE pegilirani liposomski ne jejte grenivk in ne pijte grenivkinega soka, ker lahko zviša razpoložljivost učinkovine zdravila ONIVYDE pegilirani liposomski v telesu.
English: Very common: Neutropenia, Leukopenia, Anaemia, Thrombocytopenia
Slovenian: Zelo pogosti: nevtropenija, levkopenija, anemija, trombocitopenija Pogosti: limfopenija
English: Common: Insomnia
Slovenian: Pogosti: nespečnost
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).
Slovenian: ONIVYDE pegilirani liposomski in drugih zaviralcev encima CYP3A4 (npr. grenivkinega soka, klaritromicina, indinavirja, itrakonazola, lopinavirja, nefazodona, nelfinavirja, ritonavirja,
English: ONIVYDE pegylated liposomal must only be given by healthcare professionals trained in giving anticancer medicines
Slovenian: Kako se uporablja zdravilo ONIVYDE pegilirani liposomski Zdravilo ONIVYDE pegilirani liposomski smejo dajati samo zdravstveni delavci, usposobljeni za dajanje zdravil za zdravljenje raka.
English: ONIVYDE pegylated liposomal is not equivalent to other non-liposomal irinotecan formulations and should not be interchanged.
Slovenian: Zdravilo ONIVYDE pegilirani liposomski ni enakovredno drugim neliposomskim formulacijam irinotekana, zato jih ne smemo zamenjevati.
English: ONIVYDE pegylated liposomal /5-FU adjustment (for patients not homozygous for UGT1A1*28)
Slovenian: Prilagajanje odmerka zdravila ONIVYDE pegilirani liposomski /5-FU (pri bolnikih, ki niso homozigoti za UGT1A1*28)
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.
Slovenian: 43 mg/m2, drugo zmanjšanje odmerka pa na 35 mg/m2.
English: No carcinogenicity studies have been performed with ONIVYDE pegylated liposomal.
Slovenian: Študij kancerogenosti zdravila ONIVYDE pegilirani liposomski niso izvedli.
English: Type I glass vial with a grey chlorobutyl stopper and an aluminium seal with a flip-off cap, containing 10 ml of concentrate.
Slovenian: 6.5 Vrsta ovojnine in vsebina Viala iz stekla vrste I z 10 ml koncentrata s sivim klorobutilnim zamaškom in aluminijastim pokrovčkom z zaporko, ki se odtrga na poteg (flip-off).
English: Strong CYP3A4 inhibitors and UGT1A1 inhibitors
Slovenian: Močni zaviralci encima CYP3A4 in zaviralci encima UGT1A1
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.
Slovenian: Pri bolnikih z metastatskim adenokarcinomom trebušne slinavke, zdravljenih z zdravilom ONIVYDE pegilirani liposomski, so opazili sepso z nevtropenično vročino in posledičnim septičnim šokom s smrtnim izidom.
English: Non-liposomal irinotecan mean (SD) 125 mg/m
Slovenian: (SD) pri neliposomskem irinotekanu 125 mg/m2 (n=99)c
English: No dose adjustment is recommended in patients with mild to moderate renal impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z blago do zmerno ledvično okvaro prilagoditev odmerka ni potrebna (glejte poglavji 4.4
English: Second occurrence
Slovenian: Drugi pojav
English: A new cycle of therapy should not begin until the adverse reaction resolves to ≤ Grade 1
Slovenian: Nov cikel zdravljenja se ne sme začeti, dokler se neželeni učinek ne umiri do ≤ 1. stopnje
English: If you are given ONIVYDE you should not breast-feed until one month after the last dose.
Slovenian: Če prejemate zdravilo ONIVYDE pegilirani liposomski, lahko začnete dojiti šele en mesec po zadnjem odmerku.
English: - If you get any side effects, talk to your doctor or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
English: CA Papaellinas Ltd. Τηλ: + 357 22 741 741
Slovenian: Τηλ: + 357 22 741 741
English: Hazard Ratio (95% CI) p-value
Slovenian: Razmerje tveganja (95-odstotni IZ)3 p-vrednost4
English: Withhold ONIVYDE pegylated liposomal for Grade 2-4 diarrhoea and initiate treatment for diarrhoea.
Slovenian: V primeru driske 2.-4. stopnje odložite dajanje zdravila ONIVYDE pegilirani liposomski in uvedite zdravljenje driske.
English: In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, the frequency of ≥ Grade 3 neutropenia in these patients [2 of 7 (28.6%)] was similar to the frequency in patients not homozygous for the UGT1A1*28 allele who received a starting dose of ONIVYDE pegylated liposomal of 70 mg/m
Slovenian: pegilirani liposomski +5-FU/LV, je bila pogostnost nevtropenije ≥ 3. stopnje pri teh bolnikih [2 od 7 (28,6 %)] podobna kot pri bolnikih, ki nimajo homozigotnosti za alel UGT1A1*28 in so prejeli začetni odmerek zdravila ONIVYDE pegilirani liposomski 70 mg/m2 [30 od 110 (27,3 %)] (glejte poglavje 5.1).
English: Irinotecan released from liposome encapsulation follows a similar metabolic pathway reported with non-liposomal irinotecan.
Slovenian: Irinotekan, ki se sprosti iz liposomske inkapsulacije, ima podobno presnovno pot kot neliposomski irinotekan.
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.
Slovenian: - če ste kdaj imeli pljučno bolezen ali ste predhodno prejemali zdravila (kolonije stimulirajoče faktorje) za povečanje števila krvnih celic ali ste se zdravili z obsevanjem, - če jemljete druga zdravila (glejte poglavje „Druga zdravila in zdravilo ONIVYDE pegilirani liposomski “),
English: IV use after dilution
Slovenian: uporaba po razredčenju
English: Dilute with 5% glucose solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection to prepare a dispersion of the appropriate dose of ONIVYDE pegylated liposomal diluted to a final volume of 500 ml.
Slovenian: Zdravilo razredčite s 5-odstotno raztopino glukoze za injiciranje ali 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje in pripravite raztopino z ustreznim odmerkom zdravila ONIVYDE pegilirani liposomski, razredčenega do končnega volumna 500 ml. Razredčeno raztopino premešajte z nežnim obračanjem.
English: ONIVYDE pegylated liposomal must not be administered to patients with bowel obstruction, and chronic inflammatory bowel disease, until it is resolved.
Slovenian: Zdravila ONIVYDE pegilirani liposomski ne smemo dajati bolnikom z zaporo črevesja ali kronično vnetno črevesno boleznijo,
English: A reduced starting dose of ONIVYDE pegylated liposomal (irinotecan) of 50 mg/m should be considered for patients known to be homozygous for the UGT1A1*28 allele (see sections 4.8 and 5.1).
Slovenian: Pri bolnikih z znano homozigotnostjo za alel UGT1A1*28 je treba razmisliti o manjšem začetnem odmerku zdravila ONIVYDE pegilirani liposomski (irinotekana) 50 mg/m2 (glejte poglavji 4.8 in 5.1).
English: Very common (may affect more than 1 in 10 people) - Low levels of white blood cells (neutropenia and leukopenia), Low level of red blood cells
Slovenian: - majhno število belih krvnih celic (nevtropenija in levkopenija), majhno število rdečih krvnih celic (anemija).
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.
Slovenian: Ko koncentrat razredčite za infuzijo s 5-odstotno raztopino glukoze za injiciranje ali 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje, morate raztopino uporabiti čim prej, vendar jo lahko do 6
English: Information about drug interactions with ONIVYDE pegylated liposomal is referenced from the published scientific literature for nonliposomal irinotecan.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatki o medsebojnem delovanju zdravila ONIVYDE pegilirani liposomski z drugimi zdravili izhajajo iz objavljene znanstvene literature za neliposomski irinotekan.
English: Women of childbearing potential should use effective contraception during ONIVYDE pegylated liposomal treatment and 1 month thereafter.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo med zdravljenjem in še 1 mesec po zdravljenju z zdravilom ONIVYDE
English: Complete blood cell count monitoring is recommended during ONIVYDE pegylated liposomal treatment.
Slovenian: Med zdravljenjem z zdravilom ONIVYDE pegilirani liposomski se priporoča nadziranje celotne krvne slike.
English: No dedicated pharmacokinetic study has been conducted in patients with hepatic impairment.
Slovenian: Posebne farmakokinetične študije pri bolnikih z jetrno okvaro niso izvedli.
English: No dedicated pharmacokinetic study has been conducted in patients with renal impairment.
Slovenian: Posebne farmakokinetične študije pri bolnikih z ledvično okvaro niso izvedli.
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.
Slovenian: Če pride do ekstravazacije, se priporoča izpiranje mesta z 9 mg/ml (0,9 %)
English: Following recovery to Grade 1 diarrhoea, resume ONIVYDE pegylated liposomal at a reduced dose (see section 4.2).
Slovenian: Po okrevanju do driske 1. stopnje zdravljenje z zdravilom ONIVYDE pegilirani liposomski nadaljujte z zmanjšanimi odmerki (glejte poglavje 4.2).
English: Non-liposomal irinotecan was teratogenic in rats and rabbits at doses below the human therapeutic dose.
Slovenian: Neliposomski irinotekan je bil v odmerkih, manjših od terapevtskega odmerka pri človeku, teratogen za podgane in kunce.
English: A new cycle of therapy should not begin until nausea/vomiting resolves to ≤ Grade 1 or baseline
Slovenian: Nov cikel zdravljenja se ne sme začeti, dokler se navzea/bruhanje ne umiri do ≤ 1. stopnje ali do izhodiščne vrednosti
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.
Slovenian: Nasprotno so bolniki, stari > 75 let (n=12), pri zdravljenju z zdraviloma ONIVYDE pegilirani liposomski +5-FU/LV
English: Uncommon (may affect up to 1 in 100 people) - Systemic body inflammation, caused by infection of the gall bladder and bile ducts (biliary sepsis) - Allergic reaction to ONIVYDE pegylated liposomal (the active substance or the excipients) - Diminished availability of oxygen to the body tissues - Inflammation of the oesophagus (food pipe) - Formation or presence of a blood clot within a blood vessel - vein or artery (thrombosis) - Inflammation of the lining of the rectum (the end of the large intestine) - Type of rash, characterised by appearance of a flat, red area on the skin covered with bumps
Slovenian: - alergijske reakcije na zdravilo ONIVYDE pegilirani liposomski (učinkovino ali pomožne snovi), - zmanjšana razpoložljivost kisika za telesna tkiva, - vnetje požiralnika, - nastanek ali prisotnost krvnega strdka v žili - veni ali arteriji (tromboza)
English: Patients receiving concomitant non-liposomal irinotecan and ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased SN-38 exposure by 109%.
Slovenian: Bolniki, ki sočasno prejemajo neliposomski irinotekan in ketokonazol, zaviralec encimov CYP3A4 in
English: N=353 refers to all the subjects included in the population PK analysis Values are obtained from published data [Schaaf LJ et al. Clin Cancer Res. 2006 Jun 15;12:3782-91]
Slovenian: AUC = površina pod krivuljo plazemske koncentracije (ekstrapolirana do neskončnosti pri zdravilu ONIVYDE pegilirani liposomski in AUC24h pri neliposomskem irinotekanu) Cmax= najvišja plazemska koncentracija t1/2 efektivni= efektivne razpolovne dobe aVrednosti so ocenjene iz populacijske FK-analize bN=353 se nanaša na vse preiskovance v populacijski FK-analizi cVrednosti so pridobljene iz objavljenih podatkov [Schaaf LJ et al. Clin Cancer Res. 2006 Jun 15;12:3782-91]
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%
Slovenian: z žolčem in urinom v 48 urah po dajanju neliposomskega irinotekana pri dveh bolnikih je bilo v razponu med približno 25 % (100 mg/m2) in 50 % (300 mg/m2).
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,
Slovenian: - če nenadoma občutite zadihanost, pordelost, glavobol, kožni izpuščaj ali koprivnico (srbeč izpuščaj z nenadnim pojavom otečenih rdečih bunkic na koži), srbečico, otekanje okrog oči,
English: A new cycle of therapy should not begin until adverse event resolves to ≤ Grade 1
Slovenian: Nov cikel zdravljenja se ne sme začeti, dokler se neželeni učinek ne umiri do ≤ 1. stopnje Prvi pojav
English: If you have any questions about how ONIVYDE pegylated liposomal works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate dodatna vprašanja o načinu delovanja zdravila ONIVYDE pegilirani liposomski ali o tem,
English: Reduce ONIVYDE pegylated liposomal dose to 50 mg/m
Slovenian: Odmerek zdravila ONIVYDE pegilirani liposomski zmanjšajte na 50 mg/m2