natgillin/translations-raw huggingface dataset:
• 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).
• 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).
• medicines for heart problems such as amiodarone, nicardipine, quinidine
• zdravila za težave s srcem, kot so amiodaron, nikardipin in kvinidin;
Therefore, Aloxi capsules may be taken without regard to meals.
Zato lahko bolniki jemljejo kapsule zdravila Aloxi ne glede na obroke.
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.
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.
(≥1/1,000 to <1/100)
(≥1/1.000 do <1/100)
Doses of up to 6 mg have been used in adult clinical studies.
V kliničnih študijah pri odraslih so uporabljali odmerke do 6 mg.
Aloxi should be used only before chemotherapy administration.
Zdravilo Aloxi se sme uporabiti samo pred dajanjem kemoterapije.
Medicines for depression or anxiety Tell your doctor or nurse if you are taking any medicines for depression or anxiety, including:
Zdravila za depresijo ali anksioznost Obvestite zdravnika ali medicinsko sestro, če jemljete katera koli zdravila za depresijo ali anksioznost, vključno z:
Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15 Ireland
Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15 Irska
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.
• abnormal electrical impulses in the heart
• otekline okrog oči, • nenormalni električni impulzi v srcu,
• medicines called SSRIs (‘selective serotonin reuptake inhibitors') - such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• zdravili, imenovanimi SSRI (»selektivni zaviralci privzema serotonina«), kot so fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram, escitalopram;
Within each frequency grouping, adverse reactions are presented below in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
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.
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.
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).
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).
Complete Response (No Emesis and No Rescue Medication)
Popoln odziv (brez bruhanja in dodatnega zdravila)
Approximately 74 % of patients also received single dose oral or intravenous dexamethasone 30 minutes before chemotherapy.
Približno 74 % bolnikov je 30 minut pred kemoterapijo prejelo tudi enkraten peroralen ali intravenski odmerek deksametazona.
• ECG (electrocardiogram) abnormalities (‘QT prolongation').
• nenormalnosti elektrokardiograma (EKG) (»podaljšanje intervala QT«)
Do not take Aloxi if any of the above applies to you.
Ne jemljite zdravila Aloxi, če za vas velja kar koli od zgoraj navedenega.
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.
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.
Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 µg /kg and 20 µg /kg dose groups combined.
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.
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.
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
• change in the colour of the vein and veins becoming larger
• sprememba barve vene in razširitev ven,
• You will normally take the capsule about 60 minutes before the start of your chemotherapy.
• Kapsule zdravila Aloxi boste običajno vzeli približno 60 minut pred začetkom kemoterapije.
24 - 120 hours 0 - 120 hours No Nausea (Likert Scale)
24 - 120 ur 0 - 120 ur Brez slabosti (Likertova lestvica)
No safety concerns were raised in either treatment group.
V nobeni skupini zdravljenja ni bilo varnostnih pomislekov.
• medicines for serious mental health problems such as haloperidol, chlorpromazine, quetiapine,
• zdravila za resne težave z duševnim zdravjem, kot so haloperidol, klorpromazin, kvetiapin in tioridazin;
Please see section 4.2 for information on paediatric use.
Za informacije o pediatrični uporabi glejte poglavje 4.2.
• low levels of calcium in the blood
• znižana koncentracija kalcija v krvi,
Headache
bolečina
• abnormally high or low levels of potassium in the blood
• nenormalno visoka ali nizka koncentracija kalija v krvi,
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.
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.
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.
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.
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.
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
Prevention of Chemotherapy Induced Nausea and Vomiting (CINV):
Preprečevanje s kemoterapijo povzročene navzee in bruhanja (Chemotherapy Induced Nausea and Vomiting - CINV):
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.
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.
• The recommended dose of Aloxi is 250 micrograms.
Odrasli • Priporočeni odmerek zdravila Aloxi je 250 mikrogramov.
Chemotherapeutic medicinal products
Kemoterapevtska zdravila
A high fat meal did not affect the Cmax and AUC of oral palonosetron.
Masten obrok ni vplival na Cmax in AUC peroralnega palonosetrona.
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
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.
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.
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).
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
Elevated transaminases-, electrocardiogram QT prolonged
Preiskave zvišane transaminazeelektrokardiogram - podaljšan QT interval
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni »brez natrija«.
Doses of up to 6 mg have been used in clinical trials.
V kliničnih študijah so uporabljali odmerke do 6 mg.
• Aloxi will be given as a drip (a slow infusion into a vein).
• Zdravilo Aloxi bodo dajali kot kapalno infuzijo (počasno infuzijo v veno).
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.
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 %
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 %).
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 %).
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.
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.
In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
V predkliničnih študijah palonosetron ni inhibiral antitumorske aktivnosti petih preiskovanih kemoterapevtikov (cisplatina, ciklofosfamida, citarabina, doksorubicina in mitomicina C).
Somnolence, insomnia, paraesthesia, hypersomnia, peripheral sensory neuropathy
parastezije, hipersomnija, periferna senzorna nevropatija
• high levels of the pigment ‘bilirubin' (a marker of liver problems) in the blood
• zvišana raven barvila bilirubina (označevalec težav z jetri) v krvi,
If you take more Aloxi than you should If you think you may have taken more than you should, tell your doctor straight away.
Če mislite, da ste mogoče vzeli več zdravila, kot bi smeli, takoj obvestite svojega zdravnika.
What Aloxi looks like and contents of the pack
Izgled zdravila Aloxi in vsebina pakiranja
The amount of unchanged palonosetron excreted in the urine represented approximately 40 % of the administered dose.
Količina nespremenjenega palonosetrona, izločenega v urinu, je predstavljala približno
The second paediatric trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing i.v.
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.
Butylhydroxyanisole
butilhidroksianizol.
UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included> 18.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
It is not known if Aloxi is found in breast milk.
Ni znano, ali zdravilo Aloxi prehaja v materino mleko.
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.
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.
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
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
Only limited data from animal studies are available regarding the placental transfer (see section 5.3).
O prehodu skozi placento je na voljo le omejena količina podatkov, pridobljenih v študijah na živalih (glejte poglavje 5.3).
LIST OF EXCIPIENTS Also contains sorbitol.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi sorbitol.
palonosetron (1 µg/kg, max 0.075 mg) versus I.V.
palonosetron (1 µg/kg, največji odmerek 0,075 mg) z i.v.
Aloxi can be taken with or without food.
Zdravilo Aloxi se lahko jemlje s hrano ali brez nje.
Upon opening of the vial, use immediately and discard any unused solution.
5 let Po odprtju viale zdravilo takoj porabite in vso neporabljeno raztopino zavrzite.
If you are pregnant or think you might be pregnant, your doctor will not use Aloxi unless it is clearly necessary.
Če ste noseči ali menite, da bi lahko bili noseči, zdravnik ne bo uporabil zdravila Aloxi, razen če je to nujno potrebno.
Adverse reactions were evaluated in paediatric patients receiving palonosetron for up to 4 chemotherapy cycles.
Neželene učinke so ocenjevali pri pediatričnih bolnikih, ki so prejemali palonosetron do 4
No new safety concerns were raised in either treatment group.
V nobeni od zdravljenih skupin se ni pojavilo nobeno novo skrb vzbujajoče vprašanje glede varnosti.
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.
Odgovorni mehanizmi niso znani, vendar ti podatki zaradi visokih uporabljenih odmerkov in nameravane uporabe zdravila Aloxi kot enkratne aplikacije pri ljudeh, klinično niso relevantni.
In the unlikely event of overdose with Aloxi, this should be managed with supportive care.
V malo verjetnem primeru prevelikega odmerka zdravila Aloxi je potrebno le podporno zdravljenje.
Therefore, palonosetron should not be used in pregnant women unless it is considered essential by the physician.
Zato naj se palonosetron uporablja pri nosečih ženskah le, če zdravnik meni, da je to nujno potrebno.
Aloxi soft capsules: Medicinal product subject to medical prescription.
Aloxi mehke kapsule: Predpisovanje in izdaja zdravila je le na recept.
• abdominal (stomach) pain
• bolečine v trebuhu (želodcu),
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.
Srednja maksimalna plazemska koncentracija (Cmax) in površina pod krivuljo koncentracija-čas (AUC0 - ∞) sta običajno v območju odmerka 0,3-90 µg/kg pri zdravih osebah in osebah z rakom večinoma proporcionalna odmerku.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Aloxi solution for injection: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Aloxi raztopina za injiciranje: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom
Non-inferiority criteria were met if the lower bound of the twosided 98.3 % confidence interval for the difference in complete response rates of oral palonosetron dose minus approved intravenous formulation was larger than -15 %.
Merila ne-manjvrednosti so bila izpolnjena, če je bila spodnja meja dvosmernega 98,3-odstotnega intervala zaupanja za razliko v celotnih odzivnostih na peroralni odmerek palonosetrona minus odobreni intravenski pripravek večja od -15 %.
Ondansetron 32 milligrams (n= 221)
Ondansetron 32 miligramov (n = 221)
If you forget to take Aloxi
Če ste pozabili vzeti zdravilo Aloxi
Clearance c, L/h/kg Volume of distribution c, d, L/kg 6.08
Volumen porazdelitve c, d, l/kg a
For Palonosetron no clinical data on exposed pregnancies are available.
Za palonosetron ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Aloxi contains sorbitol.
Zdravilo Aloxi vsebuje sorbitol.
If you are pregnant or think you might be pregnant, your doctor will not give you Aloxi unless it is clearly necessary.
Če ste noseči ali menite, da bi lahko bili noseči, vam zdravnik ne bo dal zdravila Aloxi, razen če je to nujno potrebno.
Method of administration For intravenous use.
Za intravensko uporabo.
Efficacy after palonosetron 10 µg/kg compared to palonosetron 3µg/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 %.
INFORMATION IN BRAILLE Aloxi 500 micrograms
PODATKI V BRAILLOVI PISAVI Aloxi 500 mikrogramov
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 %.
• a medicine for feeling or being sick (nausea and vomiting) called domperidone.
• zdravilo proti siljenju na bruhanje (navzei) ali bruhanju, imenovano domperidon.
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.
Klinična študija ni pokazala nobenih pomembnih farmakokinetičnih interakcij po enkratnem intravenskem odmerku palonosetrona in peroralno danem metoklopramidu (ki je CYP2D6 inhibitor) v ravnotežni koncentraciji.
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 Aloxi, were headache (9 %) and constipation
V kliničnih študijah pri odraslih pri odmerku 250 mikrogramov (skupaj 633 bolnikov) sta bila najpogostejša neželena učinka, ki ju je mogoče pripisati zdravilu Aloxi, glavobol (9 %) in zaprtje
No case of overdose has been reported in paediatric clinical studies.
V pediatričnih kliničnih študijah niso poročali o nobenem primeru prevelikega odmerjanja.
Efficacy was based on demonstrating non-inferiority of intravenous palonosetron compared to intravenous ondansetron.
Učinkovitost je temeljila na prikazu ne-manjvrednosti intravenskega palonosetrona v primerjavi z intravenskim ondansetronom.
The efficacy of Aloxi 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 Aloxi pri preprečevanju slabosti in bruhanja, povzročenih z visoko emetogenimi kemoterapijami, se poveča, če pred kemoterapijo dodamo kortikosteroid.
No pharmacokinetic data in haemodialysis patients are available.
Za bolnike na hemodializi ni farmakokinetičnih podatkov.
500 micrograms palonosetron administered orally approximately one hour before the start of chemotherapy.
500 mikrogramov palonosetrona damo peroralno približno eno uro pred pričetkom kemoterapije.
Although comparative efficacy of palonosetron in multiple cycles has not been demonstrated in controlled clinical trials, 217 patients were enrolled in a multicentre, open label safety study and were treated with palonosetron capsules 750 micrograms for up to 4 cycles of chemotherapy in a total of 654 chemotherapy cycles.
Čeprav v kontroliranih kliničnih študijah niso dokazali primerjalne učinkovitosti palonosetrona v multiplih ciklusih, je bilo 217 bolnikov vključenih v multicentrično odprto študijo varnosti in so prejemali kapsule palonosetrona 750 mikrogramov v največ 4 ciklusih kemoterapije, celotno število ciklusov kemoterapije pa je bilo 654.
Most patients were non-naïve to chemotherapy (78.5%) across all treatment groups.
Večina bolnikov (78,5 %) v vseh zdravljenih skupinah je prej že prejemala kemoterapijo.
Also contains mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.
Vsebuje tudi manitol, dinatrijev edetat, natrijev citrat, citronsko kislino monohidrat, vodo za injekcije, natrijev hidroksid in klorovodikovo kislino.
What Aloxi is and what it is used for What you need to know before you take Aloxi How to take Aloxi
Kaj je zdravilo Aloxi in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Aloxi Kako uporabljati zdravilo Aloxi
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
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 palonosetronom 10 µg/kg (največji odmerek 0,75 mg), palonosetronom 20 µg/kg (največji odmerek 1,5 mg) ali ondansetronom
Aloxi should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
Zdravilo Aloxi se ne sme uporabljati za preprečevanje ali zdravljenje navzee in bruhanja v dneh po kemoterapiji, razen če se ne uporabi zaradi dajanja naslednje kemoterapije.
No safety concerns were raised at either dose level.
Pri nobeni stopnji odmerka ni bilo varnostnih pomislekov.
Fertility There are no data concerning the effect of palonosetron on fertility.
Ni podatkov o vplivu palonosetrona na plodnost.