FrancophonIA/ELRC3.0 huggingface dataset:
English: Given the prespecified non-inferiority 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.
Slovenian: Ob vnaprej določeni meji ne-manjvrednosti, ki je bila -10 %, je bil Mantel-Haenszlov 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.
English: In the palonosetron 10 mcg/kg, 20 mcg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
Slovenian: V skupinah s palonosetronom 10 mcg/kg, 20 mcg/kg in ondansetroom je bil delež bolnikov s CR0-24h 54,2 %, 59,4 % in 58,6 %.
English: The low total body clearance and large volume of distribution resulted in a terminal elimination halflife in plasma of approximately 40 hours.
Slovenian: Zaradi nizkega očistka in visokega volumna porazdelitve je končni eliminacijski razpolovni čas v plazmi približno 40 ur.
English: A doctor or nurse will normally inject palonosetron accord about 30 minutes before the start of chemotherapy.
Slovenian: Zdravnik ali medicinska sestra bosta običajno zdravilo Palonosetron Accord injicirala 30 minut pred začetkom kemoterapije.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA 8.
English: Palonosetron accord will be given as a slow infusion into a vein.
Slovenian: Zdravilo Palonosetron Accord bodo dajali kot počasno infuzijo v veno.
English: 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.
Slovenian: Znaki lahko vključujejo otekle ustnice, obraz, jezik ali žrelo, oteženo dihanje ali kolaps, lahko bi opazili tudi srbeč, izbokel izpuščaj (koprivnico), pekoč občutek ali bolečino na mestu injekcije.
English: High doses of palonosetron (each dose causing at least 30 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumours, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumours in rats but not in mice.
Slovenian: Visoki odmerki palonosetrona (vsak odmerek 30 krat večji od človeškega terapevtskega odmerka) apliciranih dnevno v obdobju dveh let, so povzročili povišano pojavljanje jetrnih tumorjev, endokrinih neoplazem (v ščitnici, hipofizi, trebušni slinavki in sredici nadledvičnice) in kožnih tumorjev pri podganah, vendar ne pri miših.
English: The underlying mechanisms are not fully understood, but because of the high doses employed and since palonosetron is intended for single application in humans, these findings are not considered relevant for clinical use.
Slovenian: Odgovorni mehanizmi niso znani, vendar ti podatki zaradi visokih uporabljenih odmerkov in nameravane uporabe palonosetrona kot enkratne aplikacije pri ljudeh, klinično niso relevantni.
English: What Palonosetron Accord is and what it is used for 2.
Slovenian: Kaj je zdravilo Palonosetron Accord in za kaj ga uporabljamo 2.
English: Following intravenous administration, an initial decline in plasma concentrations is followed by slow elimination from the body with a mean terminal elimination half-life of approximately 40 hours.
Slovenian: Po intravenski aplikaciji sledi prvotnemu padcu plazemske koncentracije postopna odstranitev iz telesa s srednjim končnim eleminacijskim razpolovnim časom približno 40 ur.
English: It is not recommended to take palonosetron accord in the days following chemotherapy unless you are receiving another chemotherapy cycle.
Slovenian: Zdravila Palonosetron Accord ni priporočljivo jemati v dneh, ki sledijo kemoterapiji, razen če prejemate naslednji ciklus kemoterapije.
English: When the dose was increased from 10 mcg/kg to 20 mcg/kg a dose-proportional increase in mean AUC was observed.
Slovenian: Ko so odmerek zvečali z 10 mcg/kg na 20 mcg/kg, so opazili odmerku sorazmerno zvečanje povprečne AUC.
English: Method of administration For intravenous use.
Slovenian: Način uporabe Za intravensko uporabo.
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 mcg/kg in healthy subjects and in cancer patients.
Slovenian: Srednja maksimalna plazemska koncentracija (Cmax) in površina pod krivuljo koncentracija-čas (AUC0 - ) sta običajno v območju odmerka 0,3-90 mcg/kg pri zdravih osebah in osebah z rakom večinoma proporcionalna odmerku.
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.
Slovenian: Farmakokinetične simulacije kažejo, da je bila celotna izpostavljenost (AUC0-) po 0,25 mg intravenskega palonosetrona, dajanega enkrat na dan 3 zaporedne dni, podobna kot po enkratnem intravenskem odmerku 0,75 mg, čeprav je bila Cmax enkratnega odmerka 0,75 mg višja.
English: It is not known if palonosetron accord is found in breast milk.
Slovenian: Ni znano, ali zdravilo Palonosetron Accord prehaja v materino mleko.
English: 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 %).
Slovenian: 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
English: At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc interval.
Slovenian: V vseh preskušanih odmerkih palonosetron ni induciral klinično pomembnega podaljšanja QT intervala.
English: Noninferiority criteria were met if the lower bound of the 97.5% confidence interval for the difference in Complete Response rates of intravenous palonosetron minus intravenous ondansetron was larger than -15%.
Slovenian: Kriteriji ne-manjvrednosti so bili izpolnjeni, če je bila spodnja meja 97,5-odstotnega intervala za razliko med pogostnostjo popolnega odziva pri intravenskem palonosetronu in pri intravenskem ondansetronu večja kot -15 %.
English: Following single dose intravenous infusion of palonosetron 20 mcg/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.
Slovenian: Po intravenski infuziji palonosetrona v enkratnem odmerku 20 mcg/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, da bi bile manjše pri bolnikih, mlajših od 6 let, kot pri starejših pediatričnih bolnikih.
English: Volume of distribution c,d, L/kg a PK parameters expressed as Geometric Mean (CV) except forT1/2, which is median.
Slovenian: Očistek c, l/h/kg Volumen porazdelitve c, d, l/kg a FK parametri so izraženi kot geometrična sredina (CV), razen T½, ki so mediane vrednosti.
English: SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Slovenian: SNRI (zaviralci privzema serotonina in noradrenalina), ki se uporabljajo za zdravljenje depresivnosti in/ali anksioznosti, vključno z venlafaksinom, duloksetinom.
English: Most patients were non-naive to chemotherapy (78.5%) across all treatment groups.
Slovenian: Večina bolnikov (78,5 %) v vseh zdravljenih skupinah je prej že prejemala kemoterapijo.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Palonosetron Accord is indicated in paediatric patients 1 month of age and older for.
Slovenian: Zdravilo Palonosetron Accord je indicirano pri pediatričnih bolnikih od starosti 1 meseca naprej za:
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.
Slovenian: 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 intravensko shemo odmerjanja ondansetrona.
English: Important information about some of the ingredients of Palonosetron Accord This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Slovenian: Pomembne informacije o nekaterih sestavinah v zdravilu Palonosetron Accord Zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni ‘brez natrija'.
English: These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).
Slovenian: Te so razvrstili kot pogoste (≥1/100 do <1/10) in občasne (≥1/1.000 do <1/100).
English: Driving and using machines Palonosetron accord may cause dizziness or tiredness.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Palonosetron Accord lahko povzroča omotico ali utrujenost.
English: The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 mcg/kg or 3 mcg/kg (88% vs 84%).
Slovenian: Razmerje bolnikov brez bruhanja v 0-72 urah po operaciji je bilo podobno pri uporabi palonosetrona 1 mcg/kg (88 %) in 3 mcg/kg (84 %).
English: Since the 97.5% confidence interval (stratum adjusted Mantel-Haenszel test) of the difference in CR0-24h between palonosetron 20 mcg/kg and ondansetron was [-11.7%, 12.4%], the 20 mcg/kg palonosetron dose demonstrated non-inferiority to ondansetron.
Slovenian: Ker je bil 97,5-odstotni interval zaupanja (stratifikacija prilagojena MantelHaenszelovemu testu) razlike v CR0-24h med palonosetronom 20 mcg/kg in ondansetronom [-11,7 %, 12,4 %], je bil palonosetron v odmerku 20 mcg/kg ne-manjvreden ondansetronu.
English: In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg).
Slovenian: V pediatričnih kliničnih preskušanjih za preprečevanje navzee in bruhanja kot posledica zmerno ali visoko emetogene kemoterapije je 402 bolnikov prejelo enkratni odmerek palonosetrona (3, 10 ali 20 mcg/kg).
English: Corticosteroids Palonosetron has been administered safely with corticosteroids.
Slovenian: Kortikosteroidi Palonosetron je varen pri sočasni uporabi s kortikosteroidi.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni ‘brez natrija'.
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 mcg/kg.
Slovenian: Mediana razpolovna doba v vseh starostnih skupinah skupaj je bila 29,5 ure, v posameznih starostnih skupinah pa je bila po dajanju 20 mcg/kg v mejah od okrog 20 do 30 ur.
English: A lower bound greater than -15 % demonstrates non-inferiority between palonosetron and comparator.
Slovenian: Spodnja meja višja od -15 % dokazuje ne manjvrednost palonosetrona proti primerjanemu zdravilu.
English: These are limited data on the use of palonosetron in the prevention of nausea and vomiting in children under 2 years of age.
Slovenian: Podatkov o uporabi palonosetrona za preprečevanje navzee in bruhanja pri otrocih, mlajših od 2 let, je malo.
English: These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting.
Slovenian: Ta zdravila so sposobna blokirati delovanje kemijske snovi, ki se imenuje serotonin in ki lahko povzroča slabost s siljenjem na bruhanje (navzeo) in bruhanje.
English: Palonosetron Accord should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
Slovenian: Zdravilo Palonosetron Accord se ne sme uporabljati za preprečevanje ali zdravljenje navzee in bruhanja v dneh po kemoterapiji, razen če se uporabi zaradi dajanja naslednje kemoterapije.
English: What you need to know before you are given Palonosetron Accord 3.
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Palonosetron Accord 3.
English: Single-dose intravenous palonosetron pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 mcg/kg or 20 mcg/kg.
Slovenian: Farmakokinetične podatke o enkratnem odmerku intravensko danega palonosetrona so pridobili iz podskupine pediatričnih bolnikov z rakom (n=280), ki so prejeli 10 mcg/kg ali 20 mcg/kg.
English: What Palonosetron Accord looks like and contents of the pack Palonosetron Accord solution for injection is a clear, colourless solution supplied in a 6 ml glass vial, closed with chlorobutyl rubber stopper and sealed with a flip-off aluminium seal.
Slovenian: Izgled zdravila Palonosetron Accord in vsebina pakiranja Raztopina za injiciranje zdravila Palonosetron Accord je bistra, brezbarvna raztopina, na voljo v eni 6 ml viali iz stekla, zaprti z zamaškom iz klorobutilne gume in zapečateni z aluminijastim pokrovčkom.
English: The safety and efficacy of palonosetron intravenously at single doses of 1mcg/kg and 3mcg/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.
Slovenian: Varnost in učinkovitost palonosetrona intravensko pri enojnem odmerku 1 mcg/kg in 3 mcg/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.
English: Table 4: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of palonosetron at 20 mcg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 mcg/kg palonosetron doses via intravenous bolus.
Slovenian: Preglednica 4 Farmakokinetični parametri pri pediatričnih bolnikih z rakom po intravenski infuziji palonosetrona s hitrostjo 20 mcg/kg v času 15 min in pri odraslih bolnikih z rakom, ki so prejeli odmerka 3 in 10 mcg/kg palonosetrona v obliki intravenskega bolusa.
English: What you need to know before you are given Palonosetron Accord
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Palonosetron Accord
English: Palonosetron Accord belongs to a group of medicines known as serotonin (5HT3) antagonists.
Slovenian: Zdravilo Palonosetron Accord spada v skupino zdravil, znanih pod imenom antagonisti serotoninskih 5-HT3 receptorjev.
English: No dose adjustment is necessary for the elderly.
Slovenian: Odmerjanja pri starejših ni potrebno prilagoditi.
English: The safety and efficacy of palonosetron intravenously at single doses of 3 mcg/kg and 10 mcg/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.
Slovenian: Varnost in učinkovitost palonosetrona intravensko pri enojnem odmerku 3 mcg/kg in 10 mcg/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.
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.
Slovenian: Po enkratnem intravenskem bolusu danem zdravim preiskovancem je očistek palonosetrona 173  29 ml/min in ledvični očistek 53  29 ml/min.
English: In the unlikely event of overdose with palonosetron , this should be managed with supportive care.
Slovenian: V malo verjetnem primeru prevelikega odmerka palonosetrona je potrebno le podporno zdravljenje.
English: The efficacy of palonosetron 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.
Slovenian: Učinkovitost palonosetrona pri preprečevanju slabosti in bruhanja, povzročenih z visoko emetogenimi kemoterapijami, se poveča, če pred kemoterapijo dodamo kortikosteroid.
English: What Palonosetron Accord is and what it is used for
Slovenian: Kaj je zdravilo Palonosetron Accord in za kaj ga uporabljamo
English: 6 ml Type I tubular clear glass vial, closed with chlorobutyl rubber stopper and sealed with a flip-off aluminium seal.
Slovenian: 6 ml cevasta viala iz prozornega stekla tipa I, zaprta z zamaškom iz klorobutilne gume in zapečatena z aluminijastim pokrovčkom.
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 mcg/kg, max 0.075 mg) versus intravenous.
Slovenian: 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 intravenski palonosetron (1 µg/kg, največji odmerek 0,075 mg) z intravenskim ondansetronom.
English: Accord Healthcare Limited Ground floor, Sage House 319, Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom
Slovenian: 319, Pinner Road, North Harrow Middlesex HA1 4HF Velika Britanija
English: Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Slovenian: Srčne bolezni tahikardija, bradikardija, ekstrasistole, miokardna ishemija, sinusna tahikardiija, sinusna aritmija, supraventrikularne ekstrasistole
English: Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin.
Slovenian: Emetogene kemoterapije, ki so jih uporabljali, so vključevale doksorubicin, ciklofosfamid (<1500 mg/m2), ifosfamid, cisplatin, daktinomicin, karboplatin in davnorubicin.
English: The highest dose group showed a similar incidence of adverse reactions compared to the other dose groups and no dose response effects were observed.
Slovenian: V skupini z najvišjim odmerkom je pogostost neželenih učinkov bila podobna pogostosti pri drugih skupinah odmerka.
English: Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.
Slovenian: Palonosetron je varen pri sočasnem jemanju z analgetiki, antiemetiki/zdravili proti slabosti, spazmolitiki in antiholinergiki.
English: Efficacy after palonosetron 10 mcg/kg compared to palonosetron 3mcg/kg was 54.1% and 37.1% respectively.
Slovenian: Učinkovitost po dajanju palonosetrona 10 mcg/kg je bila 54,1 % in učinkovitost palonosetrona 3 mcg/kg je bila 37,1 %.
English: SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
Slovenian: SSRI (selektivni zaviralci privzema serotonina), ki se uporabljajo za zdravljenje depresivnosti in/ali anksioznosti, vključno s fluoksetinom, paroksetinom, sertralinom, fluvoksaminom, citalopramom, escitalopramom;
English: Somnolence, insomnia, paraesthesia, hypersomnia, peripheral sensory neuropathy
Slovenian: Bolezni živčevja glavobol vrtoglavica zaspanost, nespečnost, parastezije, hipersomnija, periferna senzorna nevropatija
English: Other medicines and Palonosetron Accord
Slovenian: Druga zdravila in zdravilo Palonosetron Accord
English: Pack size of one vial
Slovenian: Pakiranje z 1 vialo.
English: 2 to <6 y 6 to <12 y 12 to <17 y 3.0 mcg/kg 10 mcg/kg
Slovenian: 12 do <17 let mcg/kg mcg/kg N=3 N=5 N=7 N=10 N=6 N=5
English: ° From post-marketing experience * Includes the following: burning, induration, discomfort and pain
Slovenian: *Obsega naslednje: občutek pečenja, zatrdlino, neugodje in bolečino.
English: Excipients: mannitol, citric acid monohydrate, sodium citrate ,disodium edetate, sodium hydroxide, hydrochloric acid concentrated, water for injections.
Slovenian: Pomožne snovi: manitol, citronska kislina monohidrat, natrijev citrat, dinatrijev edetat, natrijev hidroksid, klorovodikova kislina, koncentrirana, voda za injekcije.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Palonosetron Accord is indicated in adults for:
Slovenian: Zdravilo Palonosetron Accord je indicirano pri odraslih za:
English: - The other ingredients are mannitol, disodium edetate (refer section 2 for sodium content), sodium citrate, citric acid monohydrate, sodium hydroxide (refer section 2 for sodium content), hydrochloric acid, concentrated and water for injections.
Slovenian: Druge sestavine zdravila so manitol, dinatrijev edetat (za vsebnost natrija glejte poglavje 2), natrijev citrat, citronska kislina monohidrat, natrijev hidroksid (za vsebnost natrija glejte poglavje 2), klorovodikova kislina, koncentrirana, in voda za injekcije.
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 %
Slovenian: 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 %.
English: 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 %.
Slovenian: 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 %.
English: Prevention of Post Operative Nausea and Vomiting (PONV):
Slovenian: Preprečevanje pooperativne navzee in bruhanja (Post Operative Nausea and Vomiting - PONV): Opravili so dve pediatrični preskušanji.
English: Adults The recommended dose of palonosetron accord is 250 micrograms given as a rapid injection into a vein.
Slovenian: Priporočeni odmerek zdravila Palonosetron Accord 250 mikrogramov se daje kot hitra injekcija v veno.
English: These may affect up to 1 in 10,000 people
Slovenian: Lahko se pojavijo pri manj kot 1 od 10.000 bolnikov
English: Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines.
Slovenian: Ker lahko palonosetron povzroči omotico, zaspanost in utrujenost, je potrebno bolnike, ki upravljajo s stroji in voznike na te učinke opozoriti.
English: In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron.
Slovenian: V kliničnih študijah so opažali naslednje neželene učinke, ki jih je mogoče pripisati jemanju palonosetrona.
English: • The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Slovenian: • preprečevanje akutne slabosti in bruhanja, povezanih z visoko emetogenimi kemoterapijami pri zdravljenju raka in preprečevanje slabosti in bruhanja, povezanih z zmerno emetogenimi kemoterapijami pri zdravljenju raka.