FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pack contains one vial.
Croatian: Jedno pakiranje sadrži jednu bočicu.
English: Your doctor may also prescribe other medicines to help control your side effects.
Croatian: Vaš liječnik može propisati i druge lijekove koji će vam pomoći kontrolirati nuspojave.
English: Patient demographic and entry disease characteristics were well balanced between trial arms.
Croatian: Demografski podaci bolesnika i karakteristike bolesti bili su dobro uravnoteženi između ispitivanih skupina.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stanovišta, lijek je potrebno odmah upotrijebiti.
English: Neutropenia/leukopenia was the most notable important haematological toxicity.
Croatian: Neutropenija/leukopenija je bila najznačajnija hematološka toksičnost.
English: Patients who require further dose reduction should discontinue treatment.
Croatian: Bolesnici kojima je potrebno daljnje smanjenje doze trebaju prekinuti liječenje.
English: Frequencies categories used for adverse reactions are: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000)**.
Croatian: Kategorije učestalosti nuspojava označene su kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100) i rijetko (≥1/10 000 i <1/1000)**.
English: Non-liposomal irinotecan displays a large volume of distribution (138 l/m2).
Croatian: Neliposomalni irinotekan pokazuje veliki volumen distribucije (138 l/m2).
English: 92284 Suresnes cedex France
Croatian: 92284 Suresnes cedex Francuska
English: The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg.
Croatian: Koncentrat ima pH od 7,2 i osmolalnost od 295 mosm/kg.
English: Total SN-38
Croatian: Ukupan SN-38
English: Before you start treatment with ONIVYDE pegylated liposomal, your doctor will perform blood tests (or other medical examinations) to determine the best starting dose for you.
Croatian: Prije početka liječenja lijekom ONIVYDE pegilirani liposomalni, Vaš liječnik će obaviti krvne pretrage (ili druge liječničke preglede) kako bi utvrdio najbolju početnu dozu za Vas.
English: Grade 2
Croatian: Stupanj 2
English: You may receive pre-medication against nausea and vomiting.
Croatian: Možete primiti premedikaciju protiv mučnine i povraćanja.
English: The severity of effects was dose-related and reversible.
Croatian: Težina učinaka bila je povezana s dozom i reverzibilna.
English: • From a microbiological point of view, the product should be used as soon as possible after dilution.
Croatian: • S mikrobiološkog stanovišta, lijek je potrebno upotrijebiti što prije nakon razrjeđivanja.
English: Hypersensitivity reactions, including acute infusion reaction may occur.
Croatian: Mogu se pojaviti reakcije preosjetljivosti, uključujući akutne reakcije na infuziju.
English: Common: Increased bilirubin, Increased alanine aminotransferase, Increased aspartate aminotransferase, Increased international normalised ratio
Croatian: Često: povišen bilirubin, povišena alanin aminotransferaza, povišena aspartat aminotransferaza, povišen međunarodni normalizirani omjer
English: As soon as the first liquid stool occurs, the patient should start drinking large volumes of beverages containing electrolytes.
Croatian: Čim se pojavi prva tekuća stolica, bolesnik treba početi piti veće količine pića koja sadrže elektrolite.
English: ONIVYDE pegylated liposomal must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: ONIVYDE pegilirani liposomalni se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: The LV dose does not require adjustment.
Croatian: Dozu LV nije potrebno prilagođavati.
English: If you have any questions about how ONIVYDE pegylated liposomal works or why this medicine has been prescribed for you, ask your doctor.
Croatian: U slučaju bilo kakvih pitanja o tome kako ONIVYDE pegilirani liposomalni djeluje ili zašto vam je propisan ovaj lijek, obratite se svom liječniku.
English: Irinotecan is a derivative of camptothecin.
Croatian: Irinotekan je derivat kamptotekina.
English: MedDRA* system organ class
Croatian: MedDRA* klasifikacija organskih sustava
English: This prevents the cancer cells from multiplying and growing, and they eventually die.
Croatian: Time se sprječava umnožavanje i rast stanica raka te one na kraju umiru.
English: Therefore, based on results from animal studies and the mechanism of action of irinotecan, ONIVYDE pegylated liposomal should not be used during pregnancy unless clearly necessary.
Croatian: Stoga, na temelju rezultata ispitivanja na životinjama i mehanizma djelovanja irinotekana, ONIVYDE pegilirani liposomalni se ne smije primjenjivati tijekom trudnoće osim ako je to krajnje neophodno.
English: • The active substance is irinotecan.
Croatian: • Djelatna tvar je irinotekan.
English: Very common: Weight decrease
Croatian: Vrlo često: smanjenje tjelesne težine
English: Loperamide should be initiated at first occurrence of poorly formed or loose stools or at the earliest onset of bowel movements more frequent than normal.
Croatian: Primjenu loperamida treba započeti pri prvoj pojavi slabo formirane ili mekane stolice ili na najraniji nastup pražnjenja crijeva češći nego što je normalno.
English: Under these conditions, there was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas.
Croatian: U tim uvjetima, došlo je do značajnog linearnog trenda s dozom za incidenciju kombinacije endometrijskih stromalnih polipa rogova maternice i endometrijskih stromalnih sarkoma.
English: In single and repeated dose toxicity studies in mice, rats and dogs, the target organs of toxicity were the gastrointestinal tract and the hematologic system.
Croatian: U ispitivanjima toksičnosti pojedinačnih i ponovljenih doza na miševima, štakorima i psima, ciljni organi toksičnosti bili su gastrointestinalni trakt i hematološki sustav.
English: Do not interchange.
Croatian: Ne smiju se međusobno zamjenjivati.
English: Excludes asthenia and anorexia; asthenia and Grade 3 anorexia do not require dose adjustment.
Croatian: Isključuje asteniju i anoreksiju; za asteniju i anoreksiju stupnja 3 nije potrebna prilagodba doze.
English: If ONIVYDE pegylated liposomal is used during pregnancy or if the patient becomes pregnant while receiving therapy, the patient should be informed about the potential hazard to the foetus.
Croatian: Ako se ONIVYDE pegilirani liposomalni koristi tijekom trudnoće ili ako bolesnica zatrudni tijekom primanja terapije, bolesnicu treba informirati o mogućim opasnostima za fetus.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: D UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Loperamide should be given until patient is without diarrhoea for at least 12 hours.
Croatian: Loperamid treba davati sve dok bolesnik ne bude bez proljeva najmanje 12 sati.
English: ONIVYDE pegylated liposomal with food and drink
Croatian: ONIVYDE pegilirani liposomalni s hranom i pićem
English: Clearance (CL)
Croatian: Klirens (CL)
English: Patients should be informed about the signs and symptoms of thromboembolism and advised to contact their physician or nurse immediately if any such signs or symptoms should occur.
Croatian: Bolesnike treba upoznati sa znakovima i simptomima tromboembolije te ih je potrebno savjetovati da se u slučaju pojave bilo kojeg od navedenih znakova i simptoma odmah jave svom liječniku ili medicinskoj sestri.
English: The concentrate must be diluted prior to administration and given as single intravenous infusion over 90 minutes.
Croatian: Koncentrat se mora razrijediti prije primjene i dati kao jedna intravenska infuzija tijekom 90 minuta.
English: If diarrhoea persists while patient is on loperamide for more than 24 hours, adding oral antibiotic support (e.g. fluoroquinolone for 7 days) should be considered.
Croatian: Ako proljev ustraje dok je bolesnik na loperamidu dulje od 24 sata, potrebno je razmotriti dodavanje oralnog antibiotika (npr. fluorokinolon tijekom 7 dana).
English: ONIVYDE pegylated liposomal may influence your ability to drive and use machines (as you may be sleepy, dizzy and exhausted with the use of ONIVYDE pegylated liposomal).
Croatian: ONIVYDE pegilirani liposomalni može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima (jer možete biti pospani, ošamućeni i iscrpljeni s primjenom lijeka ONIVYDE pegilirani liposomalni).
English: There have been reports of overdosage with non-liposomal irinotecan at doses up to approximately twice the recommended therapeutic dose of irinotecan, which may be fatal.
Croatian: Zabilježeni su slučajevi predoziranja neliposomalnim irinotekanom pri dozama do otprilike dva puta višim od preporučene terapijske doze irinotekana, što može biti smrtonosno.
English: Patients should be aware of the risk of neutropenia and the significance of fever.
Croatian: Bolesnici moraju biti svjesni rizika od pojave neutropenije i značaja vrućice.
English: Irinotecan belongs to a group of cancer medicines called ‘topoisomerase inhibitors'.
Croatian: Irinotekan spada u skupinu lijekova protiv raka pod nazivom ‘inhibitori topoizomeraze'.
English: No data are available in patients with total bilirubin more than 2 times the ULN.
Croatian: Nema dostupnih podataka u bolesnika s ukupnim bilirubinom većim od 2 puta GGN.
English: ONIVYDE pegylated liposomal must not be used instead of other medicines containing irinotecan because it behaves differently when it is contained in the liposomes than when it is given in its free form.
Croatian: ONIVYDE pegilirani liposomalni se ne smije koristiti umjesto drugih lijekova koji sadrže irinotekan jer se ponaša drugačije kad je sadržan u liposomima nego kada se primjenjuje u slobodnom obliku.
English: Patients should have loperamide (or equivalent) readily available to begin treatment for late diarrhoea.
Croatian: Bolesnicima treba biti lako dostupan loperamid (ili ekvivalent) za početak liječenja kasnog proljeva.
English: Hepatic, renal, respiratory or other toxicities
Croatian: Hepatičke, renalne, respiratorne ili druge2 toksičnosti
English: During your ONIVYDE pegylated liposomal treatment and one month after you should choose an effective birth control method which suits you, to prevent pregnancy in this period of time.
Croatian: Tijekom liječenja lijekom ONIVYDE pegilirani liposomalni i jedan mjesec nakon toga trebate odabrati učinkovitu metodu kontrole začeća koja Vam odgovara kako biste u tom razdoblju spriječili trudnoću.
English: Liposome forming lipids
Croatian: Lipidi koji formiraju liposome
English: If loose stools persist, contact your doctor.
Croatian: Ako se mekane stolice nastave, javite se svom liječniku.
English: Early onset diarrhoea, typically appearing ≤ 24 hours after dose administration, can occur and is usually transient.
Croatian: Rani nastup proljeva, koji se tipično javlja ≤ 24 sata nakon primjene doze, može se pojaviti i obično je prolazan.
English: Toxicity grade (value) by NCI CTCAE v 4.01
Croatian: (vrijednost) prema NCI CTCAE v 4.01
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1130/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1130/001
English: In case of cholinergic symptoms atropine should be administered.
Croatian: U slučaju kolinergičkih simptoma potrebno je primijeniti atropin.
English: - if you have a history of a severe allergy to irinotecan, or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste dosada imali tešku alergiju na irinotekan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako dojite
English: Intravenous use after dilution.
Croatian: Intravenska primjena nakon razrjeđivanja.
English: Neutropenia/leukopenia
Croatian: Neutropenija/leukopenija
English: New events (all grade 1 or grade 2) occurred generally early during ONIVYDE pegylated liposomal treatment, with only 2 out of 10 patients noted with events after the fifth dose.
Croatian: Novi događaji (svi stupnja 1 ili stupnja 2) pojavili su se općenito rano tijekom liječenja lijekom ONIVYDE pegilirani liposomalni, uz samo 2 od 10 bolesnika s događajima nakon pete doze.
English: There was insufficient data in patients with severe renal impairment (CLcr < 30 ml/min) to assess its effect on pharmacokinetics (see sections 4.2 and 4.4).
Croatian: Nedovoljno je podataka u bolesnika s teškim oštećenjem bubrega (CLcr <30 ml/min) kako bi se procijenio utjecaj na farmakokinetiku (vidjeti dijelove 4.2 i 4.4).
English: Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake "EXP".
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: B UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Direct measurement of irinotecan shows that 95% of irinotecan remains liposome-encapsulated during circulation.
Croatian: Direktno mjerenje liposomalnog irinotekana pokazuje da 95% irinotekana ostaje inkapsulirano u liposomima tijekom cirkulacije.
English: Risk factors include pre-existing lung disease, use of pneumotoxic medicinal products, colony stimulating factors or having previously received radiation therapy.
Croatian: Čimbenici rizika uključuju postojeću bolest pluća, primjenu pneumotoksičnih lijekova, faktora stimulacije kolonija ili prethodno primanje terapije zračenjem.
English: ONIVYDE pegylated liposomal contains sodium, if you are on a controlled sodium diet, see section 2.
Croatian: ONIVYDE pegilirani liposomalni sadrži natrij, ako ste na dijeti s kontroliranim unosom natrija, vidjeti dio 2.
English: If diarrhoea persists for more than 48 hours, stop loperamide, monitor and replace fluid electrolytes and continue antibiotic support until resolution for accompanying symptoms.
Croatian: Ako proljev potraje dulje od 48 sati, prekinite primjenu loperamida, pratite i nadomjestite elektrolite iz tekućine te nastavite s antibiotskom potporom dok se prateći simptomi ne povuku.
English: ONIVYDE pegylated liposomal is given as a drip (infusion) into a vein, which should take at least 90 minutes and should be given as a single dose.
Croatian: ONIVYDE pegilirani liposomalni se daje kao kapanje (infuzija) u venu, koje traje najmanje 90 minuta i treba se dati kao jedna doza.
English: UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity such as the UGT1A1*28 polymorphism.
Croatian: Aktivnost UGT1A1 je smanjena u osoba s genetskim polimorfizmima koji dovode do smanjene aktivnosti enzima, kao što je UGT1A1*28 polimorfizam.
English: In safety pharmacology studies in dogs, ONIVYDE pegylated liposomal had no effect on cardiovascular, hemodynamic, electrocardiographic, or respiratory parameters at doses up to 18 mg/kg or 360 mg/m
Croatian: U ispitivanjima sigurnosne farmakologije na psima, ONIVYDE pegilirani liposomalni nije imao učinak na kardiovaskularne, hemodinamičke, elektrokardiografske ili respiratorne parametre pri dozama do 18 mg/kg ili 360 mg/m2.
English: Cmax ng/ml t1/2 effective h
Croatian: Cmax ng/ml t1/2 efektivni h
English: The most significant adverse reactions reported were severe neutropenia and severe diarrrhoea.
Croatian: Najznačajnije prijavljene nuspojave bile su teška neutropenija i teški proljev.
English: Patients should not breast-feed until one month after the last dose.
Croatian: Bolesnice ne smiju dojiti mjesec dana nakon zadnje doze.
English: Within each system organ class and frequency category, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake klase organskog sustava i kategorije učestalosti, nuspojave su navedene prema sve manjoj ozbiljnosti.
English: This was not seen in morphologically normal pups.
Croatian: To nije zapaženo u morfološki normalnih mladunaca.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX19
Croatian: Farmakoterapijska skupina: antineoplastici, drugi antineoplastici, ATK oznaka: L01XX19 Mehanizam djelovanja
English: Disease characteristics included 68% of patients with liver metastases and 31% with lung metastases; 12% of patients had no prior lines of metastatic therapy, 56 % of patients had 1 prior line of metastatic therapy, 32% of patients had 2 or more prior lines of metastatic therapy.
Croatian: Karakteristike bolesti obuhvatile su 68% bolesnika s metastazama na jetri i 31% s metastazama na plućima; 12% bolesnika nije prethodno primalo terapiju za metastatsku bolest, 56% bolesnika prethodno je primilo jednu liniju terapije za metastatsku bolest, 32% bolesnika prethodno je primilo 2 ili više linija terapije za metastatsku bolest.
English: The urinary excretion of non-liposomal irinotecan is 11% to 20%; SN-38 < 1%; and SN-38 glucuronide is 3%.
Croatian: Izlučivanje neliposomalnog irinotekana putem urina iznosi 11% do 20%; SN-38 <1%; a SN-38 glukuronida 3%.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: C OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: After dilution
Croatian: Nakon razrjeđivanja
English: Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France
Croatian: 50, rue Carnot 92284 Suresnes cedex
English: It is recommended that patients receive pre-medication with standard doses of dexamethasone (or an equivalent corticosteroid) together with a 5-HT3 antagonist (or other antiemetic) at least 30 minutes prior to ONIVYDE pegylated liposomal infusion.
Croatian: Preporučuje se da bolesnici prime premedikaciju standardnim dozama deksametazona (ili ekvivalentnog kortikosteroida) zajedno sa 5-HT3 antagonistom (ili drugim antiemetikom) najmanje 30 minuta prije primanja infuzije lijeka ONIVYDE pegilirani liposomalni.
English: Each pack contains one vial with 10 ml of concentrate.
Croatian: Jedno pakiranje sadrži jednu bočicu sa 10 ml koncentrata.
English: 43 mg/10 ml
Croatian: 43 mg/10 ml 1 bočica
English: One millilitre of this medicine contains 0.144 mmol (3.31 mg) sodium-keep this in mind if you are on a controlled sodium diet.
Croatian: Jedan mililitar ovog lijeka sadrži 0,144 mmol (3,31 mg) natrija - imajte to na umu ako ste na dijeti s kontroliranim unosom natrija.
English: In patients who experienced severe haematological events, a dose reduction or treatment discontinuation is recommended (see section 4.2).
Croatian: Kod bolesnika koji su imali teške hematološke događaje preporučuje se smanjenje doze ili prekid liječenja (vidjeti dio 4.2).
English: l/m t1/2 effective h
Croatian: t1/2 efektivni h
English: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Cholesterol
Croatian: 1,2-distearoil-sn-glicero-3-fosfokolin (DSPC) kolesterol
English: Mean baseline albumin level was 3.6 g/dl, and baseline KPS was 90-100 in 55% of patients.
Croatian: Srednja početna razina albumina bila je 3,6 g/dl, a početni KPS bio je 90-100 u 55% bolesnika.
English: Abbreviations: 5-FU/LV=5-fluorouracil/leucovorin; CI=confidence interval
Croatian: Skraćenice: 5-FU/LV=5-fluorouracil/leukovorin; CI=interval pouzdanosti Slika 1 Ukupno preživljenje
English: Les Laboratoires Servier Industrie 905 Route de Saran 45520 Gidy
Croatian: 905 Route de Saran 45520 Gidy
English: No dose adjustment is recommended.
Croatian: Prilagodba doze se ne preporučuje.
English: Patients with hyperbilirubinaemia had higher concentrations for total SN-38 (see section 5.2) and therefore the risk of neutropenia is increased.
Croatian: Bolesnici s hiperbilirubinemijom imali su veće koncentracije ukupnog metabolita SN-38 (vidjeti dio 5.2), a time je povećan rizik od neutropenije.
English: Dose modifications for leukopenia and thrombocytopenia are based on NCI CTCAE toxicity grading and are the same as recommended for neutropenia above.
Croatian: Modifikacije doze za leukopeniju i trombocitopeniju temelje se na ocjenjivanju stupnja toksičnosti prema NCI CTCAE kriterijima i iste su kao gore navedene preporuke za neutropeniju.
English: Common: Hypoalbuminaemia
Croatian: Često: hipoalbuminemija
English: Myelosuppression/neutropenia
Croatian: Mijelosupresija/neutropenija
English: Grade 3 or Grade 4 (< 1,000 cells/mm3) or
Croatian: Stupanj 3 ili stupanj 4 (< 1000 stanica/mm3) ili neutropenijska vrućica
English: For non-liposomal irinotecan, in rats treated once a week during 13 weeks at the maximum dose of 150 mg/m², no treatment related tumours were reported 91 weeks after the end of treatment.
Croatian: Za neliposomalni irinotekan, u štakora liječenih jednom tjedno tijekom 13 tjedana maksimalnom dozom od 150 mg/m², nisu prijavljeni tumori povezani s liječenjem 91 tjedan nakon završetka tretmana.
English: Strong CYP3A4 inhibitors should be discontinued at least 1 week prior to starting ONIVYDE pegylated liposomal therapy.
Croatian: Primjenu snažnih inhibitora CYP3A4 treba prekinuti najmanje 1 tjedan prije započinjanja terapije lijekom ONIVYDE pegilirani liposomalni.
English: Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.
Croatian: Liječenje metastatskog adenokarcinoma gušterače, u kombinaciji s 5-fluorouracilom (5-FU) i leukovorinom (LV), u odraslih bolesnika čija je bolest progredirala nakon terapije temeljene na gemcitabinu.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Općenito
English: Caution is required when ONIVYDE pegylated liposomal is given in combination with other hepatotoxic medicinal products, especially in patients with pre-existing hepatic impairment.
Croatian: Oprez je potreban kada se ONIVYDE pegilirani liposomalni daje u kombinaciji s drugim hepatotoksičnim lijekovima, naročito u bolesnika s već postojećim oštećenjem jetre.
English: Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic medicinal products including ONIVYDE pegylated liposomal may result in serious or fatal infections; therefore vaccination with a live vaccine should be avoided.
Croatian: Primjena živih ili živih atenuiranih cjepiva u bolesnika imunokompromitiranih kemoterapeuticima, uključujući ONIVYDE pegilirani liposomalni, mogla bi rezultirati ozbiljnim ili fatalnim infekcijama; stoga se cijepljenje živim cjepivima mora izbjegavati.
English: In rats, pups born from treated animals and having external abnormalities showed a decrease in fertility.
Croatian: Kod štakora, mladunčad rođena od liječenih životinja koja je imala vanjske abnormalnosti pokazala je smanjenu plodnost.
English: Diarrhoea can occur early (onset in ≤ 24 hours after starting ONIVYDE pegylated liposomal) or late (> 24 hours) (see section 4.8).
Croatian: Proljev se može pojaviti rano (pojava ≤ 24 nakon započinjanja primjene lijeka ONIVYDE pegilirani liposomalni) ili kasno (> 24 sata) (vidjeti dio 4.8).
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: This needs to be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir kod bolesnika na dijeti s kontroliranim unosom natrija.
English: For Grade 1 and 2 toxicities there are no dose modifications recommended.
Croatian: Za toksičnosti stupnja 1 i 2 ne preporučuje se prilagodba doze.
English: If the solution contacts mucous membranes, they should be flushed thoroughly with water.
Croatian: Ako otopina dođe u doticaj sa sluznicama, potrebno ih je temeljito isprati vodom.
English: The plasma protein binding of non-liposomal irinotecan is moderate (30% to 68%), and SN-38 is highly bound to human plasma proteins (approximately 95%).
Croatian: Vezanje neliposomalnog irinotekana za proteine plazme je umjereno (30% do 68%), a SN-38 se u velikoj mjeri veže za proteine ljudske plazme (oko 95%).