natgillin/translations-raw huggingface dataset:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden boste prejeli to zdravilo.
Manufacturer Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom 
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, Velika Britanija
This leaflet was last revised in month YYYY. 
Navodilo je bilo nazadnje revidirano dne mesec LLLL
Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3 -antagonist administration. 
Hipokaliemijo in hipomagneziemijo je treba korigirati pred uvedbo antagonistov 5-HT3.
The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours. 
Antiemetično učinkovitost so opazovali od 0-24 ur, 24-120 ur in 0- 120 ur.
• high or low blood pressure 
• zvišan ali znižan krvni tlak
• change in the colour of the vein and/or veins becoming larger 
• sprememba barve vene in/ali razširitev ven
• abdominal (stomach) pain 
• bolečine v trebuhu (želodcu)
It is not known whether Palonosetron Hospira will cause any harmful effects when used during pregnancy. 
Ni znano, ali bo zdravilo Palonosetron Hospira povzročilo škodljive učinke med uporabo v nosečnosti.
• weakness, tiredness, fever or flu like symptoms 
• šibkost, utrujenost, vročina ali gripi podobni simptomi
Palonosetron Hospira should be injected over 30 seconds. 
Zdravilo Palonosetron Hospira je potrebno injicirati v 30 sekundah.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including: 
Druga zdravila in zdravilo Palonosetron Hospira Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z:
The signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, you could also notice an itchy, lumpy rash (hives), burning or pain at the site of injection. 
Znaki lahko vključujejo otekle ustnice, obraz, jezik ali žrelo, oteženo dihanje ali kolaps, lahko bi opazili tudi srbeč, izbokel izpuščaj (koprivnico), občutek pečenja ali bolečino na mestu injekcije.
Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060, Liscate (MI), Italy 
Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060 Liscate (MI), Italija
Significance level at α=0.05. 
Hi kvadrat test. Signifikanca je α = 0,05.
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%. 
V skupinah s palonosetronom 10 µg/kg, 20 µg/kg in ondansetroom je bil delež bolnikov s CR0-24h 54,2 %, 59,4 % in 58,6 %.
When the dose was increased from 10 μg/kg to 20 μg/kg a dose-proportional increase in mean AUC was observed. 
Ko so odmerek zvečali z 10 µg/kg na 20 µg/kg, so opazili odmerku sorazmerno zvečanje povprečne AUC.
Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Palonosetron Hospira overdose. 
Raziskave z dializo niso bile opravljene, vendar zaradi velikega volumna porazdelitve, zdravljenje z dializo najverjetneje ni učinkovito pri prevelikem odmerku zdravila Palonosetron Hospira.
Prevention of Chemotherapy Induced Nausea and Vomiting (CINV): 
Preprečevanje s kemoterapijo povzročene navzee inbruhanja (Chemotherapy Induced Nausea and Vomiting - CINV):
Serotonergic Drugs (e.g. SSRIs and SNRIs) 
Serotoninergična zdravila (npr.SSRI in SNRI)
A doctor or nurse will normally inject Palonosetron Hospira about 30 minutes before the start of chemotherapy. 
Zdravnik ali medicinska sestra bosta običajno zdravilo Palonosetron Hospira injicirala 30 minut pred začetkom kemoterapije.
Adults Cancer Patients 
Odrasli bolniki z rakom
Palonosetron is eliminated by dual route, about 40 % eliminated through the kidney and with approximately 50 % metabolised to form two primary metabolites, which have less than 1 % of the 5HT3 receptor antagonist activity of palonosetron. 
Približno 40 % se ga izloči preko ledvic, 50 % pa se ga metabolizira v dva primarna metabolita, ki imata manj kot 1 % aktivnosti antagonista receptorja 5HT3
• abnormal heart rate or lack of blood flow to the heart 
• nenormalna frekvenca srca ali premajhen dotok krvi v srce
If you are pregnant or think you might be, your doctor will not administer Palonosetron Hospira to you unless it is clearly necessary. 
Če ste noseči ali mislite, da ste, vam bo zdravnik dal zdravilo Palonosetron Hospira le v primeru, da je to nujno potrebno.
In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to palonosetron, were headache (9 %) and constipation (5 %). 
V kliničnih študijah pri odraslih pri odmerku 250 mikrogramov (skupaj 633 bolnikov) sta bila najpogostejša neželena učinka, ki ju je mogoče pripisati palonosetronu, glavobol (9 %) in zaprtje (5 %).
Given the pre-specified noninferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated. 
Ob vnaprej določeni meji ne-manjvrednosti, ki je bila -10 %, je bil MantelHaenszlov statistični ne-manjvrednostni interval zaupanja s prilagojeno stratifikacijo za razliko v primarnem kriteriju, popolnem odgovoru (CR), [-10,5, 1,7 %], kar pomeni, da ne-manjvrednost ni bila dokazana.
Palonosetron Hospira will be given as a slow infusion into a vein. 
Zdravilo Palonosetron Hospira bodo dajali kot počasno infuzijo v veno.
Palonosetron Hospira is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adults, adolescents and children over one month of age. 
Zdravilo Palonosetron Hospira se uporablja za preprečevanje slabosti in bruhanja pri kemoterapiji raka pri odraslih bolnikih, mladostnikih in otrocih, starejših od enega meseca.
The underlying mechanisms are not fully understood, but because of the high doses employed and since Palonosetron Hospira is intended for single application in humans, these findings are not considered relevant for clinical use. 
Odgovorni mehanizmi niso znani, vendar ti podatki zaradi visokih uporabljenih odmerkov in nameravane uporabe zdravila Palonosetron Hospira kot enkratne aplikacije pri ljudeh, klinično niso relevantni.
• SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine. 
• SNRI (zaviralci privzema serotonina in noradrenalina), ki se uporabljajo za zdravljenje depresivnosti in/ali anksioznosti, vključno z venlafaksinom, duloksetinom.
CYP2D6 inducers and inhibitors. 
Induktorji in inhibitorji CYP2D6
Palonosetron Hospira is indicated in adults for: 
Zdravilo Palonosetron Hospira je indicirano pri odraslih za:
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. 
Preglednica 4: Farmakokinetični parametri pri pediatričnih bolnikih z rakom po intravenski infuziji palonosetrona s hitrostjo 20 µg/kg v času 15 min in pri odraslih bolnikih z rakom, ki so prejeli odmerka 3 in 10 µg/kg palonosetrona v obliki intravenskega bolusa.
Type I glass vial with a chlorobutyl rubber stopper and aluminium seal. 
Viala iz stekla tipa I z zamaškom iz klorobutilne gume in aluminijasto zaporko.
• high levels of the pigment bilirubin in the blood 
• visoka koncentracija barvila bilirubina v krvi
Palonosetron Hospira is indicated in paediatric patients 1 month of age and older for: 
Zdravilo Palonosetron Hospira je indicirano pri pediatričnih bolnikih od starosti 1 meseca naprej za:
For palonosetron no clinical data on exposed pregnancies are available. 
Za palonosetron ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
• low levels of calcium in the blood 
• znižana koncentracija kalcija v krvi
There are limited data on the use of palonosetron in the prevention of nausea and vomiting in children under 2 years of age. 
Podatkov o uporabi palonosetrona za preprečevanje navzee in bruhanja pri otrocih, mlajših od 2 let, je malo.
• decrease or loss of appetite 
• zmanjšanje ali izguba teka
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. 
Ker je bil 97,5-odstotni interval zaupanja (stratifikacija prilagojena Mantel-Haenszelovemu testu) razlike v CR0-24h med palonosetronom 20 µg/kg in ondansetronom [-11,7 %, 12,4 %], je bil palonosetron v odmerku 20 µg/kg ne-manjvreden ondansetronu.
• if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6). 
Zdravila Palonosetron Hospira ne smete prejeti: - če ste alergični na palonosetron ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• pain at the site of infusion 
• bolečina na mestu infuzije.
It is not known if Palonosetron Hospira is found in breast milk. 
Ni znano, ali zdravilo Palonosetron Hospira prehaja v materino mleko.
What Palonosetron Hospira looks like and contents of the pack Palonosetron Hospira solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with a chlorobutyl rubber stopper and aluminium cap, which contains 5 ml of the solution. 
Izgled zdravila Palonosetron Hospira in vsebina pakiranja Raztopina za injiciranje zdravila Palonosetron Hospira je bistra, brezbarvna raztopina, na voljo je v pakiranju, v katerem je ena viala iz stekla tipa I z zamaškom iz klorobutilne gume in aluminijasto zaporko, ki vsebuje 5 ml raztopine.
• elevated moods or feelings of anxiousness 
• obdobja vznesenega razpoloženja ali občutki zaskrbljenosti
It is not recommended to receive Palonosetron Hospira in the days following chemotherapy unless you are receiving another chemotherapy cycle. 
Zdravila Palonosetron Hospira ni priporočljivo jemati v dneh, ki sledijo kemoterapiji, razen če prejemate naslednji ciklus kemoterapije.
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. 
Mediana razpolovna doba v vseh starostnih skupinah skupaj je bila 29,5 ure, v posameznih starostnih skupinah pa je bila po dajanju 20 µg/kg v mejah od okrog 20 do 30 ur.
Paediatric Cancer Patients 
Pediatrični bolniki z rakom
The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 μg/kg or 3 μg/kg (88% vs 84%). 
Razmerje bolnikov brez bruhanja v 0-72 urah po operaciji je bilo podobno pri uporabi palonosetrona 1 µg/kg (88 %) in 3 µg/kg (84 %).
What you need to know before you are given Palonosetron Hospira 
Kaj morate vedeti, preden boste prejeli zdravilo Palonosetron Hospira
Volume of distribution c, d, 
Očistek c, l/h/kg Volumen porazdelitve c, d
• abnormally high or low levels of potassium in the blood 
• nenormalno visoka ali nizka koncentracija kalija v krvi
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni ‘brez natrija'
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. 
Vsega skupaj 493 pediatričnih bolnikov, starih od 64 dni do 16,9 let, ki so prejemali zmerno (69,2 %) ali visoko emetogeno kemoterapijo (30,8 %), so zdravili s palonosteronom 10 µg/kg (največji odmerek 0,75 mg), palonosetronom 20 µg/kg (največji odmerek 1,5 mg) ali ondansetronom (3 x 0,15 mg/kg , največji celotni odmerek 32 mg) 30 minut pred začetkom emetogene kemoterapije med ciklom 1.
Palonosetron Hospira should be used only before chemotherapy administration. 
Zdravilo Palonosetron Hospira se sme uporabiti samo pred dajanjem kemoterapije.
• electrocardiogram abnormalities (QT prolongation) 
• nenormalnosti elektrokardiograma (podaljšanje intervala QT)
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. 
Učinkovitost palonosetrona za preprečevanje navzee in bruhanja, ki ju povzroča kemoterapija, pri pediatričnih bolnikih z rakom, so pokazali v drugem ključnem preskušanju ne-manjvrednosti, v katerem so primerjali enkratno intravensko infuzijo palonosetrona z i.v.
Palonosetron Hospira belongs to a group of medicines known as serotonin (5HT3) antagonists. 
Zdravilo Palonosetron Hospira spada v skupino zdravil, znanih pod imenom antagonisti serotoninskih 5HT3 receptorjev.
In the unlikely event of overdose with Palonosetron Hospira, this should be managed with supportive care. 
V malo verjetnem primeru prevelikega odmerka zdravila Palonosetron Hospira je potrebno le podporno zdravljenje.
• sleepiness or trouble sleeping 
• zaspanost ali nespečnost
<2 y 2 to <6 y 6 to <12 y 12 to <17 y μg/kg 
2 do <6 let6 do <12 let
Paediatric population No case of overdose has been reported in paediatric clinical studies. 
V pediatričnih kliničnih študijah niso poročali o nobenem primeru prevelikega odmerjanja.
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. 
danega palonosetrona so pridobili iz podskupine pediatričnih bolnikov z rakom (n=280), ki so prejeli 10 µg/kg ali 20 µg/kg.
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram; 
• SSRI (selektivni zaviralci privzema serotonina), ki se uporabljajo za zdravljenje depresivnosti in/ali anksioznosti, vključno s fluoksetinom, paroksetinom, sertralinom, fluvoksaminom, citalopramom, escitalopramom;
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. 
Zdravilo Palonosetron Hospira se ne sme uporabljati za preprečevanje ali zdravljenje navzee in bruhanja v dneh po kemoterapiji, razen če se ne uporabi zaradi dajanja naslednje kemoterapije.
Also contains: mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide, hydrochloric acid. 
Vsebuje tudi: manitol, dinatrijev edetat, natrijev citrat, citronsko kislino monohidrat, vodo za injekcije, natrijev hidroksid, klorovodikovo kislina.
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. 
Učinkovitost zdravila Palonosetron Hospira pri preprečevanju slabosti in bruhanja, povzročenih z visoko emetogenimi kemoterapijami, se poveča, če pred kemoterapijo dodamo kortikosteroid.
Efficacy after palonosetron 10 μg/kg compared to palonosetron 3 μg/kg was 54.1% and 37.1% respectively. 
Učinkovitost po dajanju palonosetrona 10 µg/kg je bila 54,1 % in učinkovitost palonosetrona 3 µg/kg je bila 37,1 %.
What Palonosetron Hospira is and what it is used for 
Kaj je zdravilo Palonosetron Hospira in za kaj ga uporabljamo
A lower bound greater than -15 % demonstrates non-inferiority between palonosetron and comparator. 
Spodnja meja višja od -15 % dokazuje ne- manjvrednost zdravila Palonosetron Hospira proti primerjanemu zdravilu.
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. 
pri enojnem odmerku 3 µg/kg in 10 µg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: >28 dni do 23 mesecev (12 bolnikov), 2 do 11 let (31 bolnikov) in 12 do 17 let (29 bolnikov), ki so prejemali zelo ali zmerno emetogeno kemoterapijo.
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. 
pri enojnem odmerku 1 µg/kg in 3 µg/kg so primerjali v prvi klinični študiji s 150 bolniki v naslednjih starostnih skupinah: > 28 dni do 23 mesecev (7 bolnikov), 2 do 11 let (96 bolnikov) in 12 do 16 let (47 bolnikov) z elektivno operacijo.
24 - 120 hours 0 - 120 hours 
24 - 120 ur 0 - 120 ur
Palonosetron Hospira may cause dizziness or tiredness. 
Zdravilo Palonosetron Hospira lahko povzroča omotico ali utrujenost.
Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin. 
Emetogene kemoterapije, ki so jih uporabljali, so vključevale doksorubicin, ciklofosfamid (<1500 mg/m ifosfamid, cisplatin, daktinomicin, karboplatin in davnorubicin.
Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34 %. 
Po intravenskem dajanju palonosetrona v odmerku 0,25 mg vsak drugi dan je po 3 odmerkih pri 11 bolnikih z rakom mod koncentracija v plazmi od 1. do 5. dne povprečno (± SD) zrasla za 42 ± 34 %.
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. 
Po intravenski infuziji zdravila Palonosetron Hospira v enkratnem odmerku 20 µg/kg so bile najvišje koncentracije v plazmi (CT) na koncu 15-minutne infuzije v vseh starostnih skupinah zelo variabilne, so se pa nagibale k temu,
Uncommon ARs (≥1/1,000 to <1/100) 
občasni neželeni učinki (≥1/1.000 do <1/100)
Each vial contains 250 micrograms palonosetron (as hydrochloride) in 5 ml (50 micrograms/ml) 
Ena viala vsebuje 250 mikrogramov palonosetrona (v obliki palonosetronijeveg klorida) v 5 ml (50 mikrogramov/ml).
Important information about some of the ingredients of Palonosetron Hospira This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'. 
Zdravilo Palonosetron Hospira vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni ‘brez natrija'.
In clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron. 
V kliničnih študijah so opažali naslednje neželene učinke, ki jih je mogoče pripisati jemanju palonosetrona.
• abnormal heart rate 
• nenormalen srčni utrip
• The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid (for pH adjustment). 
Druge sestavine zdravila so manitol, dinatrijev edetat, natrijev citrat, citronska kislina monohidrat, voda za injekcije, natrijev hidroksid in klorovodikova kislina (za prilagoditev pH).
Common (may affect up to 1 in 10 people): • headache 
Pogosti (lahko se pojavi pri manj kot 1 od 10 ljudi): • glavobol
Children and Adolescents (aged 1 month to 17 years) The doctor will decide the dose, depending on bodyweight, however the maximum dose is 1500 micrograms. 
Zdravnik bo določil odmerek, odvisen od telesne mase, največji odmerek pa je 1500 mikrogramov.
• numbness, burning, prickling or tingling sensations on the skin 
• odrevenelost, občutek pečenja, zbadanja ali mravljinčenja na koži
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 
Po intravenskem dajanju palonosetrona 12 zdravim osebam v odmerku 0,25 mg enkrat na dan 3 dni je koncentracija palonosetrona v plazmi od 1. do 3. dne povprečno (± SD) zrasla za 110 ± 45 %.
Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles 
Srčne bolezni tahikardija, bradikardija, prezgodnji utripi, miokardna ishemija, sinusna tahikardiija, sinusna aritmija, nadprekatni prezgodnji utripi
Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines. 
Ker lahko palonosetron povzroči vrtoglavico, zaspanost in utrujenost, je potrebno bolnike, ki upravljajo s stroji, in voznike na te učinke opozoriti.
However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval. 
Toda, kot pri drugih 5-HT3 antagonistih je potrebna previdnost pri uporabi palonosetrona pri bolnikih,
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. 
C] - palonosetrona, se 80 % odmerka v 144 urah izloči v urinu, kjer je 40 % danega odmerka palonosetrona aktivna nespremenjena substanca.
The recommended dose of Palonosetron Hospira is 250 micrograms given as a rapid injection into a vein. 
Odrasli Priporočeni odmerek zdravila Palonosetron Hospira 250 mikrogramov se daje kot hitra injekcija v veno.
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 
Drugo pediatrično preskušanje je bila multicentrična, dvojno slepa, dvojno zakrita randomizirana študija ne-manjvrednosti s paralelnimi skupinami, aktivnimi kontrolami in enkratnim odmerkom, v kateri so primerjali i.v.
• diarrhoea 
• potovalna bolezen
Uncommon (may affect up to 1 in 100 people): 
Občasni (lahko se pojavijo pri manj kot 1 od 100 ljudi):
Common (may affect up to 1 in 10 people): 
Pogosti (lahko se pojavijo pri manj kot 1 od 10 ljudi):
• impaired vision or eye irritation 
• motnje vida ali draženje oči
• hiccups, flatulence, dry mouth or indigestion 
• kolcanje, vetrovi, suha usta ali slaba prebava
Intent-to-treat cohort. 
Kohorta z namenom zdravljenja.
Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock 
Bolezni imunskega sistema preobčutljivost, anafilaksija, anafilaktične/ anafilaktoidne reakcije in šok
Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC code: A04AA05 
Farmakoterapevtska skupina: Antiemetiki in zdravila proti slabosti, antagonisti serotoninskih 5-HT3 receptorjev.
In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥60 mg/m2, cyclophosphamide >1,500 mg/m2 and dacarbazine, palonosetron 
V randomizirani, dvojno slepi študiji, v kateri je sodelovalo 667 bolnikov, ki so prejemali visoko emetogeno kemoterapijo, ki je vključevala cisplatin >60 mg/m2, ciklofosfamid >1500 mg/m2 in dakarbazin, so primerjali odmerka 250 mikrogramov in 750 mikrogramov palonosetrona v primerjavi z ondansetronom 32 mg, danim prvi dan kemoterapije.