FrancophonIA/ELRC3.0 huggingface dataset:
English: These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmias, conduction disturbances and in patients taking anti-arrhythmic agents or other medicinal products that lead to QT prolongation or electrolyte abnormalities.
Slovenian: To vključuje bolnike z osebno ali rodbinsko anamnezo podaljšanja QT, elektrolitskih motenj, kongestivnega popuščanja srca, bradiaritmij, prevodnih motenj in bolnike, ki jemljejo antiaritmike ali druga zdravila, ki povzročajo podaljšanje intervala QT ali elektrolitske motnje.
English: They are supplied in polyamide/aluminium/PVC blisters containing one or five capsules.
Slovenian: Na voljo so v pretisnih omotih iz poliamida/aluminija/PVC, ki vsebujejo po eno ali pet kapsul.
English: Available in packs of 1 vial containing 5 ml of solution.
Slovenian: Na voljo je v pakiranjih z 1 vialo, ki vsebuje 5 ml raztopine.
English: If you decide not to take Aloxi (or other similar medicines), it is likely your chemotherapy will cause you to feel sick or be sick (nausea and vomiting).
Slovenian: Če se odločite, da zdravila Aloxi (ali drugih podobnih zdravil) ne boste jemali, vas bo zaradi kemoterapije verjetno sililo na bruhanje ali boste bruhali.
English: Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Aloxi overdose.
Slovenian: Raziskave z dializo niso bile opravljene, vendar zaradi velikega volumna porazdelitve, zdravljenje z dializo najverjetneje ni učinkovito pri prevelikem odmerku zdravila Aloxi.
English: • allergic reaction - the signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, an itchy, lumpy rash (hives).
Slovenian: • alergijska reakcija: znaki lahko vključujejo otekanje ustnic, obraza, jezika ali žrela; oteženo dihanje ali kolaps; srbeč, mehurčkast izpuščaj (koprivnica).
English: Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Slovenian: Blaga do zmerna ledvična okvara bistveno ne vpliva na farmakokinetične parametre palonosetrona.
English: (≥1/100 to<1/10)
Slovenian: (≥1/100 do<1/10)
English: Following single dose intravenous infusion of Aloxi 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.
Slovenian: Po intravenski infuziji zdravila Aloxi 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, da bi bile manjše pri bolnikih, mlajših od 6 let, kot pri starejših pediatričnih bolnikih.
English: However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolisers of CYP2D6 substrates.
Slovenian: Vendar pa klinični farmakokinetični parametri niso pomembno različni med bolj in manj učinkovitimi substancami, ki metabolizirajo CYP2D6 substrate.
English: Chi-square test.
Slovenian: c Hi kvadrat test.
English: • you have an imbalance of certain minerals in your blood which has not been treated - such as potassium and magnesium.
Slovenian: • imate v krvi neravnovesje določenih mineralov, na primer kalija in magnezija, zaradi katerega se niste zdravili.
English: Significance level at α=0.05.
Slovenian: c Hi kvadrat test. Signifikanca je α = 0,05.
English: There is no experience of palonosetron in human pregnancy so palonosetron should not be used in pregnant women unless it is considered essential by the physician.
Slovenian: Izkušenj s palonosetronom pri človeških nosečnostih ni, zato naj se palonosetron uporablja pri nosečih ženskah le, če zdravnik meni, da je to nujno potrebno.
English: b PK parameters expressed as Arithmetic mean (SD)
Slovenian: b FK parametri so izraženi kot aritmetična sredina (SD).
English: 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%).
Slovenian: 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 %).
English: Dolasetron 100 milligrams (n= 191)
Slovenian: Dolasetron 100 miligramov (n = 191)
English: purified water, butylhydroxyanisole, gelatin, sorbitol, titanium dioxide.
Slovenian: prečiščena voda, butilhidroksianizol, želatina, sorbitol, titanov dioksid.
English: Only limited data from animal studies are available regarding the placental transfer (see section 4.6).
Slovenian: O prehodu skozi placento je na voljo le malo podatkov iz študij na živalih (glejte poglavje 4.6).
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.
Slovenian: V nekliničnih študijah ima palonosetron sposobnost blokiranja ionskih kanalčkov, ki so vpleteni v ventrikularno depolarizacijo in repolarizacijo, in podaljšanja trajanja akcijskega potenciala.
English: Patients were randomised to either dexamethasone or placebo in addition to their assigned treatment.
Slovenian: Bolnike so randomizirali v skupino, ki je prejemala deksametazon, in skupino, ki je prejemala placebo, poleg tega pa so prejemali tudi za sebe določeno zdravljenje.
English: • medicines called SNRIs (‘serotonin noradrenaline reuptake inhibitors') - such as venlafaxine, duloxetine (can lead to the development of serotonin syndrome and should be used with caution).
Slovenian: • zdravili, imenovanimi SNRI (»zaviralci privzema serotonina in noradrenalina«), kot sta venlafaksin in duloksetin (to lahko privede do serotoninskega sindroma, zato je pri uporabi potrebna previdnost).
English: • medicines for heart problems such as amiodarone, nicardipine, quinidine
Slovenian: • zdravila za težave s srcem, kot so amiodaron, nikardipin in kvinidin;
English: Therefore, Aloxi capsules may be taken without regard to meals.
Slovenian: Zato lahko bolniki jemljejo kapsule zdravila Aloxi ne glede na obroke.
English: The efficacy of Aloxi 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 i.v.
Slovenian: Učinkovitost zdravila Aloxi 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.
English: (≥1/1,000 to <1/100)
Slovenian: (≥1/1.000 do <1/100)
English: Doses of up to 6 mg have been used in adult clinical studies.
Slovenian: V kliničnih študijah pri odraslih so uporabljali odmerke do 6 mg.
English: Aloxi should be used only before chemotherapy administration.
Slovenian: Zdravilo Aloxi se sme uporabiti samo pred dajanjem kemoterapije.
English: Medicines for depression or anxiety Tell your doctor or nurse if you are taking any medicines for depression or anxiety, including:
Slovenian: Zdravila za depresijo ali anksioznost Obvestite zdravnika ali medicinsko sestro, če jemljete katera koli zdravila za depresijo ali anksioznost, vključno z:
English: Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15 Ireland
Slovenian: Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15 Irska
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.
Slovenian: 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.
English: • abnormal electrical impulses in the heart
Slovenian: • otekline okrog oči, • nenormalni električni impulzi v srcu,
English: • medicines called SSRIs (‘selective serotonin reuptake inhibitors') - such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
Slovenian: • zdravili, imenovanimi SSRI (»selektivni zaviralci privzema serotonina«), kot so fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram, escitalopram;
English: Within each frequency grouping, adverse reactions are presented below in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: The primary efficacy endpoint, Complete Response (CR: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group.
Slovenian: Primarni kriterij učinkovitosti, popolni odziv (CR: brez bruhanja, brez siljenja na bruhanje in brez rešilnega zdravila) med prvimi 24 urami po operaciji je doseglo 78,2 % bolnikov v skupini s palonosetronom in 82,7 % v skupini z ondansetronom.
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).
Slovenian: Populacijska farmakokinetična analiza ni pokazala pomembnega vpliva na očistek palonosetrona pri sočasnem jemanju CYP2D6 induktorjev (deksametazona in rifampicina) ali inhibitorjev (vključno z amiodaronom, celekoksibom, klorpromazinom, cimetidinom, doksorubicinom, fluoksetinom, haloperidolom, paroksetinom, kvinidinom, ranitidinom, ritonavirjem, sertralinom ali terbinafinom).
English: Complete Response (No Emesis and No Rescue Medication)
Slovenian: Popoln odziv (brez bruhanja in dodatnega zdravila)
English: Approximately 74 % of patients also received single dose oral or intravenous dexamethasone 30 minutes before chemotherapy.
Slovenian: Približno 74 % bolnikov je 30 minut pred kemoterapijo prejelo tudi enkraten peroralen ali intravenski odmerek deksametazona.
English: • ECG (electrocardiogram) abnormalities (‘QT prolongation').
Slovenian: • nenormalnosti elektrokardiograma (EKG) (»podaljšanje intervala QT«)
English: Do not take Aloxi if any of the above applies to you.
Slovenian: Ne jemljite zdravila Aloxi, če za vas velja kar koli od zgoraj navedenega.
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: Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 µg /kg and 20 µg /kg dose groups combined.
Slovenian: Očistek in volumen porazdelitve pri pediatričnih bolnikih sta bila izračunana za skupino, združeno iz skupin z odmerkoma 10 µg /kg in 20 µg /kg, popravljeni za telesno maso.
English: Biotransformation 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.
Slovenian: 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
English: • change in the colour of the vein and veins becoming larger
Slovenian: • sprememba barve vene in razširitev ven,
English: • You will normally take the capsule about 60 minutes before the start of your chemotherapy.
Slovenian: • Kapsule zdravila Aloxi boste običajno vzeli približno 60 minut pred začetkom kemoterapije.
English: 24 - 120 hours 0 - 120 hours No Nausea (Likert Scale)
Slovenian: 24 - 120 ur 0 - 120 ur Brez slabosti (Likertova lestvica)
English: No safety concerns were raised in either treatment group.
Slovenian: V nobeni skupini zdravljenja ni bilo varnostnih pomislekov.
English: • medicines for serious mental health problems such as haloperidol, chlorpromazine, quetiapine,
Slovenian: • zdravila za resne težave z duševnim zdravjem, kot so haloperidol, klorpromazin, kvetiapin in tioridazin;
English: Please see section 4.2 for information on paediatric use.
Slovenian: Za informacije o pediatrični uporabi glejte poglavje 4.2.
English: • low levels of calcium in the blood
Slovenian: • znižana koncentracija kalcija v krvi,
English: Headache
Slovenian: bolečina
English: • abnormally high or low levels of potassium in the blood
Slovenian: • nenormalno visoka ali nizka koncentracija kalija v krvi,
English: The primary efficacy endpoint was Complete Response in the acute phase of the first cycle of chemotherapy, defined as no vomiting, no retching, and no rescue medication in the first 24 hours after starting chemotherapy.
Slovenian: Primarni kriterij učinkovitosti je bil popoln odziv v akutni fazi prvega cikla kemoterapije, ki so ga definirali kot brez bruhanja, brez siljenja na bruhanje in brez rešilnega zdravila v prvih 24 urah po začetku kemoterapije.
English: Elimination 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.
Slovenian: Po enojnem intravenskem odmerku 10 mikrogramov/kg [14C] - palonosetrona, se 80 % odmerka v 144 urah izloči v urinu, kjer je 40 % danega odmerka palonosetrona aktivna nespremenjena substanca.
English: As shown in Table 1, oral Aloxi capsules 500 micrograms demonstrated non-inferiority to the active comparator during the 0 to 24 hour and 0 to 120 hour time intervals; however, for the 24 to 120 hour time period, non-inferiority was not shown.
Slovenian: Kot kaže preglednica 1, so bile 500-mikrogramske peroralne kapsule zdravila Aloxi ne-manjvredne aktivnemu primerjanemu zdravilu v časovnem obdobju od 0 do 24 ur in od 0 do 120 ur; za obdobje 24
English: Prevention of Chemotherapy Induced Nausea and Vomiting (CINV):
Slovenian: Preprečevanje s kemoterapijo povzročene navzee in bruhanja (Chemotherapy Induced Nausea and Vomiting - CINV):
English: Since the 97.5% confidence interval (stratum adjusted MantelHaenszel 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.
Slovenian: 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.
English: Metoclopramide
Slovenian: Metoklopramid
English: • The recommended dose of Aloxi is 250 micrograms.
Slovenian: Odrasli • Priporočeni odmerek zdravila Aloxi je 250 mikrogramov.
English: Chemotherapeutic medicinal products
Slovenian: Kemoterapevtska zdravila
English: A high fat meal did not affect the Cmax and AUC of oral palonosetron.
Slovenian: Masten obrok ni vplival na Cmax in AUC peroralnega palonosetrona.
English: The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours.
Slovenian: Antiemetično učinkovitost so opazovali od 0-24 ur, 24-120 ur in 0
English: Aloxi is used in adults, adolescents and children over one month of age to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy.
Slovenian: Zdravilo Aloxi se uporablja pri odraslih bolnikih, mladostnikih in otrocih, starejših od enega meseca, da pomaga preprečiti siljenje na bruhanje (navzeo) ali bruhanje pri zdravljenju raka, ki mu pravimo kemoterapija.
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
English: Elevated transaminases-, electrocardiogram QT prolonged
Slovenian: Preiskave zvišane transaminazeelektrokardiogram - podaljšan QT interval
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni »brez natrija«.
English: Doses of up to 6 mg have been used in clinical trials.
Slovenian: V kliničnih študijah so uporabljali odmerke do 6 mg.
English: • Aloxi will be given as a drip (a slow infusion into a vein).
Slovenian: • Zdravilo Aloxi bodo dajali kot kapalno infuzijo (počasno infuzijo v veno).
English: Elimination Following administration of a single oral 750 micrograms dose of [14C]-palonosetron to six healthy subjects, 85 % to 93 % of the total radioactivity was excreted in urine, and 5 % to 8 % was eliminated in feces.
Slovenian: Po dajanju enkratnega peroralnega odmerka 750 mikrogramov [14C]-palonosetrona šestim zdravim preiskovancem se je 85 % do 93 % celotne radioaktivnosti odstranilo iz telesa z urinom, 5 % do 8 %
English: In clinical studies at a dose of 500 micrograms (total 161 patients) the most frequently observed adverse reaction, at least possibly related to Aloxi, was headache (3.7 %).
Slovenian: V kliničnih študijah pri odmerku 500 mikrogramov (skupaj 161 bolnikov) je bil najpogostejši neželeni učinek, ki ga je mogoče pripisati zdravilu Aloxi, glavobol (3,7 %).
English: Although comparative efficacy of palonosetron in multiple cycles has not been demonstrated in controlled clinical studies, 875 patients enrolled in the three phase 3 trials continued in an open label safety study and were treated with palonosetron 750 micrograms for up to 9 additional cycles of chemotherapy.
Slovenian: Čeprav v kontroliranih kliničnih študijah niso dokazali primerjalne učinkovitosti palonosetrona v multiplih ciklusih, je 875 bolnikov, vključenih v tretje faze 3-eh preskušanj, nadaljevalo v odprti študiji varnosti in so prejemali palonosetron 750 mikrogramov še v 9 dodatnih ciklusih kemoterapije.
English: In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
Slovenian: V predkliničnih študijah palonosetron ni inhibiral antitumorske aktivnosti petih preiskovanih kemoterapevtikov (cisplatina, ciklofosfamida, citarabina, doksorubicina in mitomicina C).
English: Somnolence, insomnia, paraesthesia, hypersomnia, peripheral sensory neuropathy
Slovenian: parastezije, hipersomnija, periferna senzorna nevropatija
English: • high levels of the pigment ‘bilirubin' (a marker of liver problems) in the blood
Slovenian: • zvišana raven barvila bilirubina (označevalec težav z jetri) v krvi,
English: If you take more Aloxi than you should If you think you may have taken more than you should, tell your doctor straight away.
Slovenian: Če mislite, da ste mogoče vzeli več zdravila, kot bi smeli, takoj obvestite svojega zdravnika.
English: What Aloxi looks like and contents of the pack
Slovenian: Izgled zdravila Aloxi in vsebina pakiranja
English: The amount of unchanged palonosetron excreted in the urine represented approximately 40 % of the administered dose.
Slovenian: Količina nespremenjenega palonosetrona, izločenega v urinu, je predstavljala približno
English: The second paediatric trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing i.v.
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 i.v.
English: Butylhydroxyanisole
Slovenian: butilhidroksianizol.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included> 18.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
English: It is not known if Aloxi is found in breast milk.
Slovenian: Ni znano, ali zdravilo Aloxi prehaja v materino mleko.
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.
Slovenian: 20 mikrogramov/kg (največji skupni odmerek ne sme preseči 1500 mikrogramov) palonosetrona, danega v obliki ene 15-minutne intravenske infuzije, ki se začne približno 30 minut pred začetkom kemoterapije.
English: In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤50 mg/m2, carboplatin, cyclophosphamide
Slovenian: V dveh randomiziranih, dvojno slepih študijah v katerih je sodelovalo 1132 bolnikov, ki so prejemali zmerno emetogeno kemoterapijo, ki je vključevala cisplatin ≤50 mg/m2, karboplatin, ciklofosfamid
English: Only limited data from animal studies are available regarding the placental transfer (see section 5.3).
Slovenian: O prehodu skozi placento je na voljo le omejena količina podatkov, pridobljenih v študijah na živalih (glejte poglavje 5.3).
English: LIST OF EXCIPIENTS Also contains sorbitol.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi sorbitol.
English: palonosetron (1 µg/kg, max 0.075 mg) versus I.V.
Slovenian: palonosetron (1 µg/kg, največji odmerek 0,075 mg) z i.v.
English: Aloxi can be taken with or without food.
Slovenian: Zdravilo Aloxi se lahko jemlje s hrano ali brez nje.
English: Upon opening of the vial, use immediately and discard any unused solution.
Slovenian: 5 let Po odprtju viale zdravilo takoj porabite in vso neporabljeno raztopino zavrzite.
English: If you are pregnant or think you might be pregnant, your doctor will not use Aloxi unless it is clearly necessary.
Slovenian: Če ste noseči ali menite, da bi lahko bili noseči, zdravnik ne bo uporabil zdravila Aloxi, razen če je to nujno potrebno.
English: Adverse reactions were evaluated in paediatric patients receiving palonosetron for up to 4 chemotherapy cycles.
Slovenian: Neželene učinke so ocenjevali pri pediatričnih bolnikih, ki so prejemali palonosetron do 4
English: No new safety concerns were raised in either treatment group.
Slovenian: V nobeni od zdravljenih skupin se ni pojavilo nobeno novo skrb vzbujajoče vprašanje glede varnosti.
English: The underlying mechanisms are not fully understood, but because of the high doses employed and since Aloxi 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 zdravila Aloxi kot enkratne aplikacije pri ljudeh, klinično niso relevantni.
English: In the unlikely event of overdose with Aloxi, this should be managed with supportive care.
Slovenian: V malo verjetnem primeru prevelikega odmerka zdravila Aloxi je potrebno le podporno zdravljenje.
English: Therefore, palonosetron should not be used in pregnant women unless it is considered essential by the physician.
Slovenian: Zato naj se palonosetron uporablja pri nosečih ženskah le, če zdravnik meni, da je to nujno potrebno.
English: Aloxi soft capsules: Medicinal product subject to medical prescription.
Slovenian: Aloxi mehke kapsule: Predpisovanje in izdaja zdravila je le na recept.
English: • abdominal (stomach) pain
Slovenian: • bolečine v trebuhu (želodcu),