FrancophonIA/ELRC3.0 huggingface dataset:
English: While the terminal elimination half-life and mean systemic exposure of palonosetron is increased in the subjects with severe hepatic impairment, this does not warrant dose reduction.
Croatian: Iako su terminalni poluvijek eliminacije i prosječna sistemska izloženost palonosetronu povećani u ispitanika s teškim oštećenjem jetre, smanjenje doze nije potrebno.
English: Palonosetron Hospira will be given as a slow infusion into a vein.
Croatian: Palonosetron Hospira će biti primijenjen u obliku spore infuzije u venu.
English: Pharmacokinetic simulations indicate that the overall exposure (AUC0-∞) of 0.25 mg intravenous palonosetron administered once daily for 3 consecutive days was similar to a single intravenous dose of 0.75 mg, although Cmax of the 0.75 mg single dose was higher.
Croatian: Farmakokinetičke simulacije pokazuju da je sveukupna izloženost (AUC0-) dozi od 0,25 mg palonosetrona intravenski primijenjenog jedanput na dan tijekom 3 uzastopna dana, bila slična jednoj intravenskoj dozi od 0,75 mg, iako je Cmax jedne doze od 0,75 mg bio viši.
English: What Palonosetron Hospira is and what it is used for
Croatian: Što je Palonosetron Hospira i za što se koristi
English: • elevated moods or feelings of anxiousness
Croatian: • pretjerano raspoloženje ili osjećaji tjeskobe
English: • if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Palonosetron Hospira : - ako ste alergični na palonosetron ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc interval.
Croatian: Pri svim ispitivanim dozama, palonosetron nije izazvao klinički značajno produljenje QTc intervala.
English: Hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects.
Croatian: Oštećenje funkcije jetre ne utječe značajno na ukupni tjelesni klirens palonosetrona u usporedbi sa zdravim ispitanicima.
English: The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%.
Croatian: Sljedeće nuspojave su prijavljene kao česte i manje česte tijekom primjene palonosterona, nije bilo prijavljenih s učestalošću >1%.
English: Following single dose intravenous infusion of Palonosetron 20 μg/kg, peak plasma concentrations (CT) reported at the end of the 15 minute infusion were highly variable in all age groups and tended to be lower in patients < 6 years than in older paediatric patients.
Croatian: Nakon jednokratne intravenske infuzije palonosetrona u dozi od 20 µg/kg, vršne koncentracije u plazmi (CT) zabilježene na kraju 15-minutne infuzije bile su visoko varijabilne u svim dobnim skupinama i u bolesnika u dobi <6 godina kretale su se u nižim vrijednostima nego u starijih pedijatrijskih bolesnika.
English: Palonosetron Hospira should be used only before chemotherapy administration.
Croatian: Palonosetron Hospira treba primjenjivati samo prije kemoterapije.
English: Since the 97.5% confidence interval (stratum adjusted Mantel-Haenszel test) of the difference in CR0-24h between palonosetron 20 μg/kg and ondansetron was [-11.7%, 12.4%], the 20 μg/kg palonosetron dose demonstrated non-inferiority to ondansetron.
Croatian: Budući da je interval pouzdanosti od 97,5% (MantelHaenszelov test prilagođen za slojeve) za razliku u CR0-24h između palonosetrona u dozi od 20 µg/kg i ondansetrona iznosio [-11,7%, 12,4%], doza palonosetrona od 20 µg/kg dokazala je neinferiornost prema ondansetronu.
English: Do not use this medicine after the expiry date which is stated on the vial and carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza 'Rok valjanosti' ili kratice ‘EXP'.
English: • weakness, tiredness, fever or flu like symptoms
Croatian: • slabost, umor, vrućica ili simptomi poput gripe
English: The pivotal studies were not designed to assess efficacy of palonosetron in delayed onset nausea and vomiting.
Croatian: Ključna ispitivanja nisu bila osmišljena da bi procijenila djelotvornost palonosetrona u odgođenom početku mučnine i povraćanja.
English: Palonosetron Hospira is indicated in adults for:
Croatian: Palonosetron Hospira je u odraslih indiciran za:
English: Palonosetron Hospira is indicated in paediatric patients 1 month of age and older for:
Croatian: Palonosetron Hospira je indiciran u pedijatrijskih bolesnika u dobi od 1 mjeseca i starijih za:
English: In the unlikely event of overdose with Palonosetron Hospira, this should be managed with supportive care.
Croatian: U vrlo malo vjerojatnom slučaju predoziranja Palonosetron Hospirom, treba pristupiti potpornom liječenju.
English: Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines.
Croatian: Budući da palonosetron može izazvati omaglicu, somnolenciju ili umor, bolesnike treba na to upozoriti kada upravljaju vozilima ili rukuju strojevima.
English: Common (may affect up to 1 in 10 people): • headache
Croatian: Često (mogu se javiti u do 1 na 10 osoba): • glavobolja
English: Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes.
Croatian: Palonosetron se uglavnom metabolizira pomoću enzima CYP2D6, uz manji doprinos izoenzima CYP3A4 i CYP1A2.
English: • SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Croatian: • inhibitore ponovne pohrane serotonina i noradrenalina (SNRI) koji se koriste za liječenje depresije i/ili tjeskobe, uključujući venlafaksin, duloksetin.
English: In the palonosetron 10 μg/kg, 20 μg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
Croatian: U skupinama koje su primale palonosetron 10 µg/kg i 20 µg/kg te u skupini koja je primala ondansetron, udio bolesnika s potpunim odgovorom CR0-24h bio je 54,2%, 59,4% i 58,6%.
English: • electrocardiogram abnormalities (QT prolongation)
Croatian: • abnormalnosti elektrokardiograma (produljenje QT intervala).
English: In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
Croatian: U kliničkom ispitivanju nije ustanovljena značajna farmakokinetička interakcija između jedne intravenske doze palonosetrona i koncentracije oralnog metoklopramida, inhibitora CYP2D6, u stanju dinamičke ravnoteže.
English: Corticosteroids Palonosetron has been administered safely with corticosteroids.
Croatian: Kortikosteroidi Palonosetron se sigurno primjenjivao s kortikosteroidima.
English: Table 4: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of palonosetron at 20 μg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 μg/kg palonosetron doses via intravenous bolus.
Croatian: Tablica 4: Farmakokinetički parametri u pedijatrijskih bolesnika s karcinomom nakon intravenske infuzije palonosetrona u dozi od 20 µg/kg tijekom 15 minuta i u odraslih bolesnika s karcinomom koji su primili palonosetron u dozi od 3 i 10 µg/kg u intravenskoj bolus injekciji
English: • SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
Croatian: • selektivne inhibitore ponovne pohrane serotonina (SSRI) koji se koriste za liječenje depresije i/ili tjeskobe, uključujući fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram, escitalopram
English: Non-clinical studies indicate that palonosetron, only at very high concentrations, may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
Croatian: Neklinička ispitivanja pokazuju da palonosetron samo u vrlo visokim koncentracijama može blokirati ionske kanale uključene u ventrikularnu depolarizaciju i repolarizaciju te produljiti trajanje akcijskog potencijala.
English: In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine).
Croatian: U farmakokinetičkoj analizi populacije pokazalo se da ne postoji značajan učinak na klirens palonosetrona kada je primijenjen s induktorima CYP2D6 (deksametazon i rifampicin) i inhibitorima (uključujući amjodaron, celekoksib, klorpromazin, cimetidin, doksorubicin, fluoksetin, haloperidol, paroksetin, kinidin, ranitidin, ritonavir, sertralin ili terbinafin).
English: Other medicines and Palonosetron Hospira
Croatian: Drugi lijekovi i Palonosetron Hospira
English: What Palonosetron Hospira contains
Croatian: Što Palonosetron Hospira sadrži
English: 20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy.
Croatian: Doza od 20 mikrograma/kg palonosetrona (maksimalna ukupna doza ne smije prelaziti 1500 mikrograma) daje se u obliku jedne intravenske infuzije u trajanju od 15 minuta, s početkom od približno 30 minuta prije početka kemoterapije.
English: The efficacy of Palonosetron Hospira in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Croatian: Djelotvornost lijeka Palonosetron Hospira u sprječavanju mučnine i povraćanja izazvanih visoko emetogenom kemoterapijom može se povećati dodatnom primjenom kortikosteroida prije kemoterapije.
English: Hospira Enterprises B.V. Randstad 22-11 Almere NL-1316 BN The Netherlands
Croatian: Randstad 22-11 Almere NL-1316 BN Nizozemska
English: Median half-life was 29.5 hours in overall age groups and ranged from about 20 to 30 hours across age groups after administration of 20 μg/kg.
Croatian: Medijan poluvijeka iznosio je 29,5 sati u svim dobnim skupinama i nakon primjene doze od 20 µg/kg raspon mu je iznosio od otprilike 20 do 30 sati u svim dobnim skupinama.
English: A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 μg/kg (maximum 0.75 mg), palonosetron 20 μg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1.
Croatian: Ukupno 493 pedijatrijska bolesnika u dobi od 64 dana do 16,9 godina, koja su primala umjereno (69,2%) ili visoko emetogenu kemoterapiju (30,8%), liječena su palonosetronom u dozi od 10 µg/kg (najviše 0,75 mg), palonosetronom u dozi od 20 µg/kg (najviše 1,5 mg) ili ondansetronom (3 x 0,15 mg/kg , najveća ukupna doza 32 mg) 30 minuta prije početka emetogene kemoterapije u 1. ciklusu.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
English: The efficacy of palonosetron for the prevention of chemotherapy-induced nausea and vomiting in paediatric cancer patients was demonstrated in a second non-inferiority pivotal trial comparing a single intravenous infusion of palonosetron versus an intravenous ondansetron regimen.
Croatian: Djelotvornost palonosetrona u sprječavanju mučnine i povraćanja izazvanih kemoterapijom u pedijatrijskih bolesnika s karcinomom pokazala se u drugom ključnom ispitivanju neinferiornosti u kojemu se jedna intravenska infuzija palonosetrona uspoređivala s intravenskim režimom ondansetrona.
English: As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration.
Croatian: Budući da palonosetron može produljiti vrijeme prolaska sadržaja kroz debelo crijevo, bolesnike s anamnezom konstipacije ili sa znakovima subakutne crijevne opstrukcije treba nakon primjene nadzirati.
English: In non-clinical studies palonosetron possesses the ability to block ion channels involved in ventricular de- and re-polarisation and to prolong action potential duration.
Croatian: U nekliničkim ispitivanjima palonosetron ima sposobnost blokade ionskih kanala uključenih u ventrikularnu depolarizaciju i repolaziraciju te može produljiti trajanje akcijskog potencijala.
English: After a single intravenous bolus administration in healthy subjects the total body clearance of palonosetron was 173 ± 73 ml/min and renal clearance was 53 ± 29 ml/min.
Croatian: U zdravih ispitanika, nakon jedne intravenske primjene u bolusu, ukupni tjelesni klirens palonosetrona iznosio je 173  73 ml/min a bubrežni klirens bio je 53  29 ml/min.
English: What you need to know before you are given Palonosetron Hospira
Croatian: Što morate znati prije nego počnete primjenjivati Palonosetron Hospira
English: Palonosetron does not inhibit or induce cytochrome P450 isoenzymes at clinically relevant concentrations.
Croatian: Palonosetron ne inhibira i ne inducira izoenzime citokroma P450 u klinički značajnim koncentracijama.
English: In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
Croatian: U nekliničkim ispitivanjima, palonosetron nije inhibirao antitumorsku aktivnost pet testiranih kemoterapeutika (cisplatin, ciklofosfamid, citarabin, doksorubicin i mitomicin C).
English: Ondansetron 32 milligrams (n= 221)
Croatian: Ondansetron 32 miligrama (n = 221)
English: Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Croatian: Blago do umjereno oštećenje bubrežne funkcije ne utječe značajno na farmakokinetičke parametre palonosetrona.
English: The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in CINV clinical studies.
Croatian: Učinak palonosetrona na krvni tlak, brzinu srčanih otkucaja i parametre EKG-a uključujući QTc bio je usporediv s učinkom ondansetrona i dolasetrona u kliničkim ispitivanjima kemoterapijom izazvane mučnine i povraćanja.
English: 250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy.
Croatian: 250 mikrograma palonosetrona daje se u obliku jedne intravenske bolus injekcije, približno 30 minuta prije početka kemoterapije.
English: Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.
Croatian: Palonosetron se sigurno primjenjivao s analgeticima, antiemeticima/sredstvima protiv mučnine, spazmoliticima i antikolinergičkim lijekovima.
English: Palonosetron Hospira should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
Croatian: Palonosetron Hospira se ne smije primjenjivati za sprječavanje ili liječenje mučnine i povraćanja u dane nakon kemoterapije, osim ako je to povezano sa sljedećom primjenom kemoterapije.
English: • The active substance is palonosetron (as hydrochloride).
Croatian: • Djelatna tvar je palonosetron (u obliku palonosetronklorida).
English: Also contains: mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide, hydrochloric acid.
Croatian: Također sadrži manitol, dinatrijev edetat, natrijev citrat, citratnu kiselinu hidrat, vodu za injekcije, natrijev hidroksid i kloridnu kiselinu.
English: The safety and efficacy of palonosetron intravenously at single doses of 1 μg/kg and 3 μg/kg was compared in the first clinical study in 150 patients in the following age groups, >28 days to 23 months (7 patients), 2 to 11 years (96 patients), and 12 to 16 years of age (47 patients) undergoing elective surgery.
Croatian: Sigurnost i djelotvornost palonosetrona u jednokratnim i.v. dozama od 1 µg/kg i 3 µg/kg uspoređivala se u prvom kliničkom ispitivanju provedenom na 150 bolesnika dobnih skupina >28 dana do 23 mjeseca (7 bolesnika), 2 do 11 godina (96 bolesnika) i 12 do 16 godina (47 bolesnika) koji su podvrgnuti elektivnom kirurškom zahvatu.
English: Single-dose intravenous palonosetron pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 μg/kg or 20 μg/kg.
Croatian: Farmakokinetički podaci za jednu i.v. dozu palonosetrona dobiveni su iz podskupine pedijatrijskih bolesnika s karcinomom (n = 280) koji su primili 10 µg/kg ili 20 µg/kg.
English: • difficulty urinating
Croatian: • teškoće pri mokrenju
English: In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤50 mg/m 2, carboplatin, cyclophosphamide ≤1,500 mg/m 2 and doxorubicin >25 mg/m2, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered intravenously on Day 1, without dexamethasone.
Croatian: U dva randomizirana, dvostruko slijepa ispitivanja na ukupno 1132 bolesnika na umjereno emetogenoj kemoterapiji koja je uključivala cisplatin ≤50 mg/m2, karboplatin, ciklofosfamid 1500 mg/m2 i doksorubicin 25 mg/m2, uspoređivan je palonosetron 250 mikrograma i 750 mikrograma s ondansetronom 32 mg (poluvijek 4 sata) ili dolasetronom 100 mg (poluvijek 7,3 sata) primijenjeno intravenski na dan 1, bez deksametazona.
English: The safety and efficacy of palonosetron intravenously at single doses of 3 μg/kg and 10 μg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Croatian: Sigurnost i djelotvornost palonosetrona u jednokratnim i.v. dozama od 3 µg/kg i 10 µg/kg ispitivane su u prvom kliničkom ispitivanju provedenom na 72 bolesnika dobnih skupina >28 dana do 23 mjeseca (12 bolesnika), 2 do 11 godina (31 bolesnik) i 12 do 17 godina (29 bolesnika) koji su primali visoko ili umjereno emetogenu kemoterapiju.
English: After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45
Croatian: Nakon intravenske primjene palonosetrona 0,25 mg jedanput na dan tijekom 3 dana u 12 zdravih ispitanika, prosječna vrijednost ( SD) porasta koncentracije palonosetrona u plazmi od 1. do 3. dana iznosila je 110  45%.
English: Type I glass vial with a chlorobutyl rubber stopper and aluminium seal.
Croatian: I sa gumenim čepom od klorbutila i aluminijskom kapicom.
English: Gender does not affect the pharmacokinetics of palonosetron.
Croatian: Spol Spol ne utječe na farmakokinetiku palonosetrona.
English: Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin.
Croatian: Primijenjene emetogene kemoterapije uključivale su doksorubicin, ciklofosfamid (<1500 mg/m ifosfamid, cisplatin, daktinomicin, karboplatin i daunorubicin.
English: The recommended dose of Palonosetron Hospira is 250 micrograms given as a rapid injection into a vein.
Croatian: Preporučena doza lijeka Palonosetron Hospira je 250 mikrograma primijenjenog u obliku brze injekcije u venu.
English: Paediatric population No case of overdose has been reported in paediatric clinical studies.
Croatian: U pedijatrijskim kliničkim ispitivanjima nije zabilježen nijedan slučaj predoziranja.
English: 24 - 120 hours 0 - 120 hours
Croatian: 24 - 120 sati 0 - 120 sati a
English: • jerky body movements
Croatian: • trzaji tijela
English: Palonosetron Hospira may cause dizziness or tiredness.
Croatian: Palonosetron Hospira može uzrokovati omaglicu ili umor.
English: Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Croatian: Na temelju ispitivanja in vitro, palonosetron ne inhibira ni ne inducira izoenzime citokroma P450 u klinički značajnim koncentracijama.
English: Dermatitis allergic, pruritus, skin disorder, urticaria
Croatian: Alergijski dermatitis, pruritus, kožni poremećaj, urtikarija
English: • low levels of calcium in the blood
Croatian: • niske razine kalcija u krvi
English: Electrocardiogram QT prolonged conduction disorder, sinus tachycardia
Croatian: Produljen QT elektrokardiograma, poremećaj provodljivosti, sinusna tahikardija
English: Age does not affect the pharmacokinetics of palonosetron.
Croatian: Dob ne utječe na farmakokinetiku palonosetrona.
English: Mean maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞) are generally dose-proportional over the dose range of 0.3-90 μg/kg in healthy subjects and in cancer patients.
Croatian: U zdravih ispitanika i u bolesnika s karcinomom, prosječna maksimalna koncentracija u plazmi (Cmax) i površina ispod krivulje koncentracija-vrijeme (AUC0-) obično su proporcionalne dozi u rasponu doze od 0,3-90 μg/kg.
English: Talk to your doctor or pharmacist before you are given Palonosetron Hospira:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego primijenite Palonosetron Hospira
English: Ondansetron 32 milligrams (n= 185)
Croatian: Ondansetron 32 miligrama (n = 185)
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC code: A04AA05
Croatian: Farmakoterapijska skupina: Antiemetici i sredstva protiv mučnine, antagonisti serotonina (5HT3).
English: After a single intravenous dose of 10 micrograms/kg [14C]-palonosetron, approximately 80 % of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40 % of the administered dose, as unchanged active substance.
Croatian: C]-palonosetrona, otprilike 80% doze izluči se unutar 144 sata u mokraći, pri čemu palonosetron predstavlja približno 40% primijenjene doze kao nepromijenjena djelatna tvar.
English: Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron
Croatian: Tablica 2: Postotak bolesnika a s odgovorom po skupinama liječenja i fazi u ispitivanju umjereno emetogene kemoterapije u odnosu na dolasetron
English: • hiccups, flatulence, dry mouth or indigestion
Croatian: • štucanje, plinovi u crijevima (flatulencija), suhoća usta ili probavne tegobe
English: PK parameters expressed as Arithmetic mean (SD) Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 μg /kg and 20 μg /kg dose groups combined.
Croatian: Klirens i volumen distribucije u pedijatrijskih bolesnika izračunati su prilagođeno za težinu, kombinirano za obje dozne skupine od 10 g/kg i 20 g/kg.
English: The second paediatric trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing intravenous palonosetron (1 μg/kg, max
Croatian: Drugo pedijatrijsko ispitivanje bilo je multicentrično, dvostruko slijepo, dvostruko maskirano, randomizirano ispitivanje neinferiornosti s aktivnom kontrolom, provedeno na usporednim skupinama, u kojemu se jedna doza i.v. palonosetrona (1 µg/kg, najviše 0,075 mg) uspoređivala s i.v. ondansetronom.
English: • if you are using Palonosetron Hospira in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin,
Croatian: - Ako uz Palonosetron Hospira primjenjujete druge lijekove koji mogu prouzročiti abnormalni srčani ritam, kao što su amiodaron, nikardipin, kinidin, moksifloksacin, eritromicin, haloperidol, klorpromazin, kvetiapin, tioridazin, domperidon.