natgillin/translations-raw huggingface dataset:
Aloxi may be made more effective by the addition of a corticosteroid (a type of medicine that can be used as an anti-emetic).
Učinkovitost zdravila Aloxi se lahko poveča, če pred kemoterapijo dodamo kortikosteroid (še eno zdravilo, ki se lahko uporablja kot antiemetik).
It is not recommended for use in patients below 18 years of age because there is not enough information on its effects in this age group.
Uporaba pri bolnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o učinkih v tej starostni skupini ni priporočena.
The active substance in Aloxi, palonosetron, is a ‘ 5HT3 antagonist’.
Zdravilna učinkovina v zdravilu Aloxi je palonostreon, ki je 5HT3 antagonist.
This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to its receptors in the gut.
To pomeni, da kemični snovi v telesu, imenovani 5- hidroksitriptamin (5HT, znani tudi kot serotonin) prepreči vezavo na receptorje v črevesju.
When it binds to these receptors, 5HT normally causes nausea and vomiting.
Kadar se veže na te receptorje, 5HT običajno povzroči slabost in bruhanje.
By blocking these receptors, Aloxi prevents the nausea and vomiting that often happen after chemotherapy.
Z zaviranjem teh receptorjev zdravilo Aloxi prepreči slabost in bruhanje, ki se pogosto pojavita po kemoterapiji.
Aloxi has been studied in three main studies involving 1,842 adults receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting.
Zdravilo Aloxi je bilo proučevano v treh glavnih študijah, v katerih je 1 842 odraslih prejemalo kemoterapijo, ki bila močan ali zmeren povzročitelj slabosti in bruhanja.
Aloxi, given at two different doses, was compared with other anti-emetics of the same type (ondansetron and dolasetron).
Zdravilo Aloxi v dveh različnih odmerkih je bilo primerjano z drugimi antiemetiki iste vrste (ondansetronom in dolasetronom).
The studies measured the number of patients who did not vomit in the 24 hours after receiving chemotherapy.
Študije so proučevale, koliko bolnikov v 24 urah po prejemu kemoterapije ni imelo napadov bruhanja.
Aloxi was as effective as the other anti-emetics.
Zdravilo Aloxi je bilo tako učinkovito kot drugi antiemetiki.
With chemotherapy that was a strong trigger of nausea and vomiting, 59% of the patients receiving Aloxi did not vomit in the 24 hours after chemotherapy (132 out of 223), compared with 57% of the patients receiving with ondansetron (126 out of 221).
Pri kemoterapijah, ki so močne povzročiteljice slabosti in bruhanja, 59% bolnikov, ki so prejemali zdravilo Aloxi, ni imelo napadov bruhanja v 24 urah po kemoterapiji (132 od 223) v primerjavi s 57% bolnikov, ki so prejemali ondansetron (126 od 221).
With chemotherapy that was a moderate trigger of nausea and vomiting, 81% of the patients receiving Aloxi did not vomit in the 24 hours after chemotherapy (153 out of 189) compared with 69% of those receiving ondansetron (127 out of 185).
Pri kemoterapijah, ki so zmerne povzročiteljice slabosti in bruhanja, 81% bolnikov, ki so prejemali zdravilo Aloxi, ni imelo napadov bruhanja v 24 urah po kemoterapiji (153 od 189) v primerjavi s 69% tistih, ki so prejemali ondansetron (127 od 185).
When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of 191).
Primerjava z dolasetronom je pokazala vrednosti 63% za zdravilo Aloxi (119 bolnikov od 189) in 53% za dolastetron (101 bolnik od 191).
The effectiveness of Aloxi was also seen during repeat cycles of chemotherapy.
Učinkovitost zdravila Aloxi se je pokazala tudi v ponavljajočih se ciklih kemoterapije.
The most common side effects with Aloxi (seen in between 1 and 10 patients in 100) are headache, dizziness, constipation and diarrhoea.
Najpogostejši neželeni učinki zdravila Aloxi (opaženi pri 1 do 10 bolnikih od 100) so glavobol, omotica, zaprtje in driska.
For the full list of all side effects reported with Aloxi, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aloxi, glejte navodilo za uporabo.
Aloxi should not be used in people who may be hypersensitive (allergic) to palonosetron or any of the other ingredients.
Zdravila Aloxi ne smejo uporabljati osebe, ki utegnejo biti preobčutljive (alergične) na palonosetron ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Aloxi are greater than its risks for the prevention of nausea and vomiting caused by highly and moderately emetogenic cancer chemotherapy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Aloxi pri preprečevanju slabosti in bruhanja, ki ju povzročata močna in zmerna emetogena kemoterapija, večje od z njim povezanih tveganj.
The Committee recommended that Aloxi be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Aloxi odobri dovoljenje za promet.
Other information about Aloxi:
Druge informacije o zdravilu Aloxi:
The European Commission granted a marketing authorisation valid throughout the European Union for Aloxi to Helsinn Birex Pharmaceuticals Ltd. on 22 March 2005.
Evropska komisija je dovoljenje za promet z zdravilom Aloxi, veljavno po vsej Evropski uniji, odobrila družbi Helsinn Birex Pharmaceuticals Ltd. dne 22. marca 2005.
The full EPAR for Aloxi is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) je na voljo tukaj.
This summary was last updated in 01-2009.
Povzetek je bil nazadnje posodobljen 01- 2009.
administration
Velikost pakiranja
Aloxi 250 micrograms solution for injection.
Aloxi 250 mikrogramov raztopina za injiciranje.
One ml of solution contains 50 micrograms palonosetron (as hydrochloride).
1 ml raztopine vsebuje 50 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
Aloxi is indicated for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy
Aloxi je indiciran pri: preprečevanju akutne slabosti in bruhanja, povezanih z visoko emetogenimi kemoterapijami pri zdravljenju raka in preprečevanju slabosti in bruhanja, povezanih z zmerno emetogenimi kemoterapijami pri zdravljenju raka.
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy.
Odmerek 250 mikrogramov palonosetrona dajemo kot enkratni intravenski bolus približno30 minut pred pričetkom kemoterapije.
Aloxi should be injected over 30 seconds.
Aloxi je potrebno injicirati v 30 sekundah.
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 Aloxia pri preprečevanju slabosti in bruhanja, povzročenih z visoko emetogenimi kemoterapijami, se poveča, če pred kemoterapijo dodamo kortikosteroid.
No dosage adjustment is necessary for the elderly.
Odmerjanja pri starejših ni potrebno prilagoditi.
Children and adolescents:
Otroci in adolescenti:
Aloxi is not recommended for use in children below age 18 due to insufficient data.
Zaradi nezadostnih podatkov zdravila Aloxi ni priporočljivo uporabljati pri otrocih, mlajših od 18 let.
Hepatic impaired patients
Bolniki z jetrno okvaro:
2 No dose adjustment is necessary for patients with impaired renal function.
2 Bolniki z ledvično okvaro:
A specific thorough QT/ QTc study was conducted in healthy volunteers for definitive data demonstrating the effect of palonosetron on QT/ QTc.
Pri zdravih prostovoljcih so opravili posebno temeljito študijo QT/ QTc, da bi pridobili dokončne podatke, ki bi pokazali učinek palonosetrona na interval QT/ QTc.
Please refer to 5.1 Pharmacodynamics properties.
Glejte poglavje 5. 1 Farmakodinamične lastnosti.
However, as for other 5-HT3 antagonists, caution should be exercised in the concomitant use of palonosetron with medicinal products that increase the QT interval or in patients who have or are likely to develop prolongation of the QT interval.
Toda, kot pri drugih 5- HT3 antagonistih je potrebna pozornost pri sočasnem jemanju zdravil, ki podaljšajo QT interval ali pri bolnikih, pri katerih se lahko pojavi podaljšan QT interval.
Chemotherapeutic agents: in preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
Kemoterapevtiki: v predkliničnih študijah palonosetron ni inhibiral antitumorske aktivnosti petih preiskovanih kemoterapevtikov (cisplatina, ciklofosfamida, citarabina, doksorubicina in mitomicina C),.
Metoclopramide: 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.
Metoklopramid: klinična študija ni pokazala nobenih pomembnih farmakokinetičnih interakcij po enkratnem intravenskem odmerku palonosetrona in peroralno danem metoklopramidu (ki je CYP2D6 inhibitor) v ravnotežni koncentraciji..
CYP2D6 inducers and inhibitors: 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).
Induktorji in inhibitorji CYP2D6: 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).
Corticosteroids: palonosetron has been administered safely with corticosteroids.
Kortikosteroidi: palonosetron je varen pri sočasni uporabi s kortikosteroidi.
Other medicinal products: palonosetron has been administered safely with analgesics, antiemetic/ antinauseants, antispasmodics and anticholinergic medicinal products.
Druga zdravila: palonosetron je varen pri sočasnem jemanju z analgetiki, antiemetiki/ zdravili proti slabosti, spazmolitiki in antiholinergiki.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj.
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).
3 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.
3 Izkušenj s palonosetronom pri človeških nosečnostih ni, zato naj se palonosetron uporablja pri nosečih ženskah le, če zdravnik meni, da je to nujno potrebno.
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 o teh učinkih opozoriti.
In clinical studies 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 (5%).
V kliničnih študijah pri odmerku 250 mikrogramov (skupaj 633 bolnikov) sta bila najpogostejša neželena učinka, ki ju je mogoče pripisati Aloxiu, glavobol (9%) in zaprtje (5%).
In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Aloxi.
V kliničnih študijah so opažali naslednje neželene učinke, ki jih je mogoče pripisati jemanju Aloxia.
These were classified as common (between 1% and 10%) or uncommon (between 0.1% and 1%).
Te so razvrstili kot pogoste (med 1% in 10%) in občasne (med 0, 1% in 1%).
4
Vrsta organskega sistema Presnovne in prehranske motnje Psihiatrične motnje
(> 1/ 100 to < 1/ 10)
pogosti neželeni učinki (> 1/ 100 do < 1/ 10)
(> 1/ 1,000 to < 1/ 100)
občasni neželeni učinki (> 1/ 1000 do < 1/ 100) hiperkaliemija, presnovne motnje, hipokalciemija, hipokaliemija, anoreksija, hiperglikemija, zmanjšanje apetita anksioznost, evforija
Psychiatric disorders
glavobol
Anxiety, euphoric mood
zaspanost, nespečnost,
Nervous system disorders
Očesne bolezni Ušesne bolezni, vključno z motnjami labirinta Srčne bolezni Žilne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Headache Dizziness
vrtoglavica
Eye irritation, amblyopia Motion sickness, tinnitus Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
parastezije, hipersomnija, periferna senzorna neuropatija draženje oči, ambliopija morska bolezen, zvonjenje v ušesih tahikardija, bradikardija, prezgodnji utripi, miokardna ishemija, sinusna tahikardiija, sinusna aritmija, nadprekatni prezgodnji utripi hipotenzija, hipertenzija, vensko razbarvanje, razširitev ven kolcanje
Hypotension, hypertension, vein discolouration, vein distended
zaprtje
Respiratory, thoracic and mediastinal disorders
dispepsija, bolečine v trebuhu,
Gastrointestinal disorders Hepato-biliary disorders Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders
Bolezni jeter, žolčnika in žolčevodov Bolezni kože in podkožja Bolezni mišično- skeletnega sistema in vezivnega tkiva Bolezni sečil Splošne težave in spremembe na mestu aplikacije Preiskave
Constipation Diarrhoea
driska
Renal and urinary disorders General disorders and administration site conditions Investigations
bolečine v zgornjem delu trebuha, suha usta, napihnjenost hiperbilirubinemija alergični dermatitis, srbeč izpuščaj artralgija retenca urina, glikozurija astenija, zvišana telesna temperatura, utrujenost, občutek vročine, gripi podobna bolezen povišane transaminaze, elektrokardiogram – podaljšan QT interval
Urinary retention, glycosuria Asthenia, pyrexia, fatigue, feeling hot, influenza like illness Elevated transaminases,, electrocardiogram QT prolonged
4
Very rare cases (< 1/ 10,000) of hypersensitivity reactions and injection site reactions (burning, induration, discomfort and pain) were reported from post-marketing experience.
Primeri hipersenzitivnosti in reakcij na mestu aplikacije (pekoč občutek, zatrdline, nelagodje in bolečina) so bili poročani v post- marketinških iskušnjah in so se pojavljali zelo redko (< 1/ 10000).
Doses of up to 6 mg have been used in clinical trials.
V kliničnih raziskavah so uporabljali odmerke do 6 mg.
The highest dose group showed a similar incidence of adverse events compared to the other dose groups and no dose response effects were observed.
Učinkov odvisnih od odmerka niso opazili.
In the unlikely event of overdose with Aloxi, this should be managed with supportive care.
V malo verjetnem primeru prevelikega odmerka Aloxia, je potrebno le podporno zdravljenje.
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.
Raziskave z dializo niso bile opravljene, vendar zaradi velikega volumna porazdelitve, zdravljenje z dializo najverjetneje ni učinkovito pri prevelikem odmerku Aloxia.
Antiemetics and antinauseants, serotonin (5HT3) antagonists.
Antiemetiki in zdravila proti slabosti, serotoninski (5HT3) antagonisti.
A04AA05
A04AA05..
5 Palonosetron is a selective high-affinity receptor antagonist of the 5HT3 receptor.
Palonosetron je selektivni antagonist 5HT3 receptorjev z visoko afiniteto.
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 ≤ 1,500 mg/ m2 and doxorubicin > 25 mg/ m2, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered intravenously on Day 1, without dexamethasone.
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 ≤ 1500 mg/ m2 in doksorubicin > 25 mg/ m2, so primerjali odmerka palonosetrona 250 mikrogramov in 750 mikrogramov v primerjavi z ondansetronom 32 mg (razpolovni čas 4 ure) ali dolasetronom 100 mg (razpolovni čas 7, 3 ure) danih intravensko prvi dan kemoterapije, brez deksametazona.
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 250 micrograms and 750 micrograms were compared with ondansetron 32 mg administered intravenously on Day 1.
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.
Dexamethasone was administered prophylactically before chemotherapy in 67% of patients.
67% bolnikov je prejemalo deksametazon profilaktično pred kemoterapijo.
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.
Although comparative efficacy of palonosetron in multiple cycles has not been demonstrated in controlled clinical trials, 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 raziskav, nadaljevalo v odprti študiji varnosti in so prejemali palonosetron 750 mikrogramov še v 9 dodatnih ciklusih kemoterapije.
Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus ondansetron
5 Odstotek bolnikova, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in Tabela 1: stopnjo zdravljenja v študiji zmerno emetogene kemoterapije v primerjavi z ondansetronom.
Ondansetron
Ondansetron 32
micrograms (n= 189)%
mikrogramov (n = 189)%
32 milligrams (n= 185)%
miligramov (n = 185)%
97.5% CI b
[1, 8%, 22, 8%]
0 – 24 hours
19, 0
81.0
69, 3
68.6
50, 3
12.4
19, 0
[1.8%, 22.8%]
[7, 4%, 30, 7%]
24 – 120 hours 0 – 120 hours
24 – 120 ur 0 – 120 ur
Complete Control (Complete Response and No More Than Mild Nausea)
p- vrednostc Brez slabosti (Likertova lestvica)
p-value c
0 – 24 ur
0 – 24 hours 76.2 65.4 24 – 120 hours 66.7 50.3 0 – 120 hours 63.0 44.9 No Nausea (Likert Scale)
60, 3
10.8 16.4 18.1
56, 8
0 – 120 hours Intent-to-treat cohort.
24 – 120 ur 0 – 120 ur
The study was designed to show non-inferiority.
Kohorta z namenom zdravljenja. b Študija je bila zasnovana tako, da prikaže ne- manjvrednost.
A lower bound greater than – 15% demonstrates non-inferiority between Aloxi and comparator. c Chi-square test.
Spodnja meja višja od – 15% dokazuje ne - manjvrednost Aloxia proti primerjanemu zdravilu. c Hi kvadrat test.
Significance level at α =0.05.
Signifikanca je α = 0, 05.
6 Table 2:
6 Tabela 2:
Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron
Odstotek bolnikova, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in stopnjo zdravljenja v študiji zmerno emetogene kemoterapije v primerjavi z dolasetronom.
Dolasetron
Dolasetron 100
micrograms (n= 185)%
mikrogramov (n = 185)%
100 milligrams (n= 191)%
miligramov (n = 191)%
52.9
52. 9
24 – 120 hours 0 – 120 hours
24 – 120 ur
54.0 46.0
54, 0
38.7 34.0
38, 7
15.3 12.0
15, 3
[3.4%, 27.1%] [0.3%, 23.7%]
[3, 4%, 27, 1%]
Response and No More
0 – 120 ur
Than Mild Nausea)
46, 0
p-value c
34, 0
0 – 24 hours
12, 0
57.1
[0, 3%, 23, 7%]
47.6
p -
No Nausea (Likert Scale)
p- vrednostc Brez slabosti (Likertova lestvica)
Intent-to-treat cohort. b The study was designed to show non-inferiority.
Kohorta z namenom zdravljenja. b Študija je bila zasnovana tako, da prikaže ne- manjvrednost.
A lower bound greater than – 15% demonstrates non-inferiority between Aloxi and comparator. c Chi-square test.
Spodnja meja višja od – 15% dokazuje ne - manjvrednost Aloxia proti primerjanemu zdravilu.. c Hi kvadrat test.
Significance level at α =0.05.
Signifikanca je α = 0, 05
Table 3:
7 Tabela 3:
Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron
Odstotek bolnikova, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in stopnjo zdravljenja v študiji visoko emetogene kemoterapije v primerjavi z ondansetronom.
(n= 223)%
mikrogramov (n = 223)%
(n= 221)%
32 miligramov (n = 221)%
97.5% CI b
0 – 24 ur
0 – 24 hours 59.2 57.0 24 – 120 hours 45.3 38.9
59, 2
0 – 120 hours
24 – 120 ur
40.8
45, 3
33.0
38, 9
7.8
6, 4
[-2.9%, 18.5%]
[- 4, 6%, 17, 3%]
Complete Control (Complete
0 – 120 ur
Response and No More
[- 2, 9%, 18, 5%]
Than Mild Nausea)
Popolna kontrola (popoln odgovor in le blaga slabost) d tc
p-value c
p -
0 – 24 hours 24 – 120 hours 0 – 120 hours No Nausea (Likert Scale)
0 – 24 ur 56, 5 51, 6 24 – 120 ur 40, 8 35, 3 0 – 120 ur 37, 7 29, 0 Brez slabosti (Likertova lestvica)
0 – 24 hours 24 – 120 hours 0 – 120 hours a
0 – 24 ur 53, 8 49, 3 24 – 120 ur 35, 4 32, 1 0 – 120 ur 33, 6 32, 1 Kohorta z namenom zdravljenja.
Intent-to-treat cohort. b The study was designed to show non-inferiority.
Študija je bila zasnovana tako, da prikaže ne- manjvrednost.
A lower bound greater than – 15% demonstrates non-inferiority between Aloxi and comparator. c Chi-square test.
Spodnja meja višja od – 15% dokazuje ne - manjvrednost Aloxia proti primerjanemu zdravilu c Hi kvadrat test.
7 The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in CINV clinical trials.
Učinki palonosetrona na krvni tlak, srčno frekvenco in parametre EKG, vključno z intervalom QTc, so bile primerljivi z učinki ondansetrona in dolasetrona v kliničnih preskušanjih CINV.
The objective was to evaluate the ECG effects of IV administered palonosetron at single doses of 0.25, 0.75 or 2.25 mg in 221 healthy subjects.
Namen je bil oceniti učinke i. v. danega palonosetrona v enkratnih odmerkih po 0, 25, 0, 75 ali 2, 25 mg na EKG pri 221 zdravih osebah.
The study demonstrated no effect on QT/ QTc interval duration as well as any other ECG interval at doses up to 2.25 mg.
Študija ni pokazala nikakršnega učinka na trajanje intervala QT/ QTc ali na kakšen drug EKG interval v odmerkih do 2, 25 mg.
Absorption 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.
Absorbcija Po intravenski aplikaciji sledi prvotnemu padcu plazemske koncentracije postopna odstranitev iz telesa s srednjim končnim eleminacijskim razpolovnim časom približno 40 ur.
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 μ g/ 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.