FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram and SNRIs such as venlafaxine or duloxetine) (see section
Maltese: Kien hemm rapporti tas-sindrome ta' serotonin wara l-użu fl-istess ħin ta' antagonisti ta' 5-HT3 u prodotti mediċinali serotonerġiċi oħrajn (li jinkludu SSRIs bħal fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram jew escitalopram u SNRIs bħal venlafaxine jew duloxetine) (ara sezzjoni 4.4).
English: In the ADME trial, less than 5% of all netupitant-related material was excreted in urine and less than 1% of the netupitant dose was eliminated unchanged in the urine and therefore any accumulation of netupitant or metabolites after a single dose would be negligible.
Maltese: Fil-prova ADME, inqas minn 5% tal-materjal kollu relatat ma' netupitant tneħħa fl-awrina, u inqas minn 1% tad-doża ta' netupitant ġiet eliminata mhux mibdula fl-awrina, u għalhekk, kwalunkwe akkumulazzjoni ta' netupitant jew metaboliti wara doża waħda se tkun negliġibbli.
English: Elimination via both routes was estimated to be complete by Day 29-30 post-dose.
Maltese: It-tneħħija miż-żewġ rotot ġiet stmata li tkun kompluta sa Jum 29-30 wara d-doża.
English: Akynzeo contains sucrose, sorbitol, sodium and may contain traces of soya.
Maltese: Akynzeo fih sucrose, sorbitol, sodium u jista' jkun fih traċċi ta' sojja.
English: Appropriate observation of patients for serotonin syndrome-like symptoms is advised (see section 4.8).
Maltese: Osservazzjoni xierqa ta' pazjenti għal sintomi li jixbhu s-sindrome ta' serotonin hi rakkomandata (ara sezzjoni 4.8).
English: The study demonstrated no clinically important effects on ECG parameters: the largest point estimate of the placebo and baseline corrected QTc interval was 7.0 ms (one-sided upper 95% confidence limit 8.8 ms), observed 16 hours after the administration of supratherapeutic doses (600 mg netupitant and 1.5 mg palonosetron).
Maltese: L-istudju ma wera l-ebda effetti klinikament importanti fuq il-parametri tal-ECG: l-akbar point estimate tal-plaċebo u lintervall QTc ikkoreġut fil-linja bażi kien ta' 7.0 ms (one-sided upper 95% confidence limit 8.8 ms), osservat 16-il siegħa wara l-għoti ta' dożi supraterapewtiċi (600 mg ta' netupitant u 1.5 mg ta' palonosetron).
English: The mean fraction of an oral dose of netupitant excreted unchanged in urine is less than 1%; a total of 3.95% and 70.7% of the radioactive dose was recovered in the urine and faeces, respectively.
Maltese: Il-frazzjoni medja ta' doża orali ta' netupitant imneħħi mhux mibdul fl-awrina hi ta' inqas minn 1%; total ta' 3.95% u 70.7% tad-doża radjuattiva ġiet irkuprata fl-awrina u fl-ippurgar, rispettivament.
English: Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes.
Maltese: Palonosetron jiġi metabolizzat primarjament minn CYP2D6, b'kontribuzzjoni żgħira mill-isoenzimi ta' CYP3A4 u CYP1A2.
English: Palonosetron Degeneration of seminiferous epithelium has been observed in rat study (see section 5.3).
Maltese: Palonosetron Ġiet osservata deġenerazzjoni tal-epitelju seminiferu fi studju fuq il-firien (ara sezzjoni 5.3).
English: Palonosetron is eliminated by multiple routes with approximately 50% metabolized to form two primary metabolites: N-oxide-palonosetron and 6-S-hydroxy-palonosetron.
Maltese: Palonosetron jitneħħa minn rotot multipli b'madwar 50% li jiġi metabolizzat biex jifforma żewġ metaboliti primarji:
English: In vitro metabolism studies have suggested that CYP3A4 and, to a lesser extent, CYP2D6 and CYP2C9 are involved in the metabolism of netupitant.
Maltese: Studji in vitro dwar il-metaboliżmu, issuġġerew li CYP3A4 u, fi grad inqas, CYP2D6 and CYP2C9, huma involuti fil-metaboliżmu ta' netupitant.
English: An ECG study was conducted in adult male and female healthy volunteers with oral netupitant either 200 or 600 mg administered in combination with oral palonosetron 0.5 or 1.5 mg, respectively.
Maltese: Studju dwar ECG twettaq fuq voluntiera b'saħħithom, nisa u rġiel adulti, b'netupitant orali jew 200 jew 600 mg mogħti flimkien ma' palonosetron orali 0.5 jew 1.5 mg, rispettivament.
English: A total of 724 patients (99.9%) were treated with cyclophosphamide.
Maltese: Total ta' 907 pazjenti (62.3%) lestew l-estensjoni ta' ċikli multipli sa massimu ta' tmien ċikli ta' kura Total ta' 724 pazjent (99.9%) ġew ikkurati b'cyclophosphamide.
English: OM Pharma Tel: +351 21 470 85 00
Maltese: Tel: +351 21 470 85 00
English: There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs).
Maltese: Kien hemm rapporti ta' sindrome ta' serotonin bl-użu ta' antagonisti ta' 5-HT3 jew waħidhom jew flimkien ma' prodotti mediċinali serotonerġiċi oħrajn (li jinkludu inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin (SSRIs) u inibituri tal-assorbiment mill-ġdid ta' noradrenaline (SNRIs).
English: Chemotherapeutic medicinal products (docetaxel, etoposide, cyclophosphamide) Exposure to docetaxel and etoposide was increased 37% and 21%, respectively, when co-administered with netupitant/palonosetron capsules.
Maltese: L-esponiment għal docetaxel u etoposide żdied b'37% u 21%, rispettivament, meta ngħataw flimkien ma' kapsuli ta' netupitant/palonosetron.
English: In 12 cancer patients given a single oral dose of palonosetron 0.5 mg one hour prior to chemotherapy, Cmax was 0.93 ± 0.34 ng/mL and Tmax was 5.1 ± 5.9 hours.
Maltese: Fi 12-il pazjent bil-kanċer li ngħataw doża waħda orali ta' palonosetron 0.5 mg siegħa qabel il-kimoterapija, is-Cmax kien ta' 0.93 ± 0.34 ng/mL u t-Tmax kien ta' 5.1 ± 5.9 sigħat.
English: Human plasma protein binding of netupitant and its two major metabolites M1 and M3 is > 99% at concentrations ranging from 10 to 1500 ng/mL.
Maltese: It-twaħħil malproteina tal-plażma umana ta' netupitant u ż-żewġ metaboliti maġġuri tiegħu M1 u M3 hu ta' > 99% f'konċentrazzjonijiet li jvarjaw minn 10 sa 1500 ng/mL.
English: The recommended oral dexamethasone dose should be reduced by approximately 50 % when coadministered with netupitant/palonosetron capsules (see section 4.5 and clinical studies administration schedule in section 5.1).
Maltese: Id-doża rakkomandata ta' dexamethasone orali għandha titnaqqas b'madwar 50% meta tingħata flimkien ma' kapsuli ta' netupitant/palonosetron (ara sezzjoni 4.5 u l-iskeda tal-għoti fl-istudji kliniċi f'sezzjoni 5.1).
English: In female subjects (n=18), the mean AUC was 35% higher and the mean Cmax was 26% higher than in male subjects (n=18).
Maltese: F'individwi nisa (n=18), il-medja tal-AUC kienet 35% ogħla u l-medja tas-Cmax kienet 26% ogħla milli f'individwi rġiel (n=18).
English: Inhibition of the efflux transported BCRP and glucuronidation isozyme UGT2B7 by netupitant and its metabolites is unlikely and, if it occurs, of scarce clinical relevance.
Maltese: L-inibizzjoni tal-BCRP ittrasportat mill-effluss u l-isożima tal-glukuronidazzjoni UGT2B7 minn netupitant u l-metaboliti tiegħu mhijiex probabbli, u jekk isseħħ, ftit għandha rilevanza klinika.
English: It may contain traces of lecithin - which comes from soya.
Maltese: Jista' jkun fih traċċi ta' lecithin - li tiġi mis-sojja.
English: • some chemotherapy medicines - such as docetaxel or etoposide
Maltese: Prodotti mediċinali kimoterapewtiċi (docetaxel, etoposide, cyclophosphamide)
English: Atrioventricular block first degree
Maltese: Kardjomijopatija Imblokk atrijoventrikulari tat-tieni grad
English: Delayed emesis has been associated with the activation of tachykinin family neurokinin 1 (NK1) receptors (broadly distributed in the central and peripheral nervous systems) by substance P. As shown in in vitro and in vivo studies, netupitant inhibits substance P mediated responses.
Maltese: Emesi li tittardja ġiet assoċjata mal-attivazzjoni tar-riċetturi ta' neurokinin 1 (NK1) tal-familja tachykinin (iddistribwiti b'mod wiesa' fis-sistemi nervużi ċentrali u periferali) minn sustanza P.
English: Following administration of a single oral 0.75 mg 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 faeces.
Maltese: Wara l-għoti ta' doża waħda orali ta' 0.75 mg ta' [14C]-palonosetron lil sitt individwi b'saħħithom, 85% sa 93% tar-radjuattività totali tneħħiet fl-awrina, u 5% sa 8% tneħħiet fl-ippurgar.
English: Based on the experience with healthy subjects exposed to oral netupitant 600 mg in combination with palonosetron 1.50 mg the potential acute symptoms of overdose are headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.
Maltese: Abbażi tal-esperjenza b'individwi f'saħħithom li ngħataw netupitant orali 600 mg f'kombinazzjoni ma' palonosetron 1.50 mg, is-sintomi akuti potenzjali ta' doża eċċessiva huma wġigħ ta' ras, sturdament, stitikezza, ansjetà, palpitazzjonijiet, burdata ewforika u wġigħ fir-riġlejn.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose, malassorbiment tal-glucose-galactose jew nuqqas ta' sucrase-isomaltase, m'għandhomx jieħdu din il-mediċina.
English: Exposure to erythromycin and midazolam was increased approximately 1.3 and 2.4 fold, respectively, when each was co-administered with netupitant.
Maltese: L-esponiment għal erythromycin u midazolam żdied b'madwar 1.3 u 2.4 darbiet, rispettivament, meta kull wieħed minnhom ingħata flimkien ma' netupitant.
English: After a single dose of approximately 0.75 mg intravenous palonosetron, the total body clearance of palonosetron in healthy subjects was 160 ± 35 mL/h/kg (mean ± SD) and renal clearance was 66.5± 18.2 mL/h/kg.
Maltese: Wara dożi waħidhom ta' madwar 0.75 mg ta' palonosetron ġol-vini, ittneħħija totali mill-ġisem ta' palonosetron f'individwi b'saħħithom kienet ta' 160 ± 35 mL/h/kg (medja ± SD) u t-tneħħija mill-kliewi kienet ta' 66.5 ± 18.2 mL/h/kg.
English: No clinically relevant pharmacokinetic interactions have been observed between oral netupitant and oral palonosetron.
Maltese: L-ebda interazzjonijiet farmakokinetiċi klinikament rilevanti ma ġew osservati bejn netupitant orali u palonosetron orali.
English: Each hard capsule contains three tablets (300 mg of netupitant), and one soft capsule (palonosetron hydrochloride equivalent to 0.5 milligrams of palonosetron).
Maltese: Kull kapsula iebsa fiha tliet pilloli (300 mg ta' netupitant), u kapsula waħda ratba (palonosetron hydrochloride, ekwivalenti għal 0.5 milligrammi ta' palonosetron).
English: • ECG (electrocardiogram) problems (called ‘ST segment depression', ‘ST-T segment abnormal'
Maltese: • problemi fl-ECG (elettrokardjogramma) (imsejħa ‘depressjoni tal-ST segment', ‘ST-T segment anormali' ‘imblokk tal-bundle branch tal-lemin/tax-xellug', u ‘imblokk atrijoventrikulari tat tieni grad').
English: After administration of a single oral dose of 300 mg netupitant, mean plasma netupitant/plasma radioactivity ratios ranged from 0.13 to 0.49 over 96 h post-dose.
Maltese: Wara l-għoti ta' doża waħda orali ta' 300 mg ta' netupitant, ilmedja tal-proporzjonijiet ta' netupitant fil-plażma/radjuattività fil-plażma, varjat minn 0.13 sa 0.49 fuq perjodu ta' 96 siegħa wara d-doża.
English: Limited data exist in patients with severe hepatic impairment (Child Pugh score ≥9).
Maltese: Teżisti dejta limitata f'pazjenti b'indeboliment sever tal-fwied (punteġġ Child Pugh ta' ≥9).
English: Limited data exist in patients with severe hepatic impairment (Child Pugh score ≥ 9).
Maltese: Teżisti dejta limitata f'pazjenti b'indeboliment sever tal-fwied (punteġġ Child Pugh ta' ≥ 9).
English: Overall: 0 to 120 hours post-cisplatin treatment.
Maltese: Globali: 0 sa 120 siegħa wara l-kura b'cisplatin.
English: Moderately Emetogenic Chemotherapy (MEC) study
Maltese: Studju dwar Kimoterapija Kontra l-Kanċer Moderatament Emetoġenika (Moderately Emetogenic Chemotherapy (MEC))
English: Netupitant/palonosetron capsules are contraindicated during pregnancy (see section 4.3).
Maltese: Il-kapsuli ta' netupitant/palonosetron huma kontra-indikati waqt it-tqala (ara sezzjoni 4.3).
English: Each hard capsule contains 300 mg of netupitant and palonosetron hydrochloride equivalent to 0.5 mg of palonosetron.
Maltese: Kull kapsula iebsa fiha 300 mg ta' netupitant u palonosetron hydrochloride, ekwivalenti għal 0.5 mg ta' palonosetron.
English: Abdominal pain
Maltese: Problemi biex torqod
English: Mean Cmax was approximately 11%, 47% and 16% of the parent for M1, M2 and M3 respectively; M2 had the lowest AUC relative to the parent (14%) whereas M1 and M3 AUC were approximately 29% and 33% of the parent, respectively.
Maltese: M2 kellu l-inqas AUC meta mqabbel mal-kompost ġenitur (14%) filwaqt li l-AUC ta' M1 u M3 kienet ta' madwar 29% and 33% ta' dik tal-kompost ġenitur, rispettivament.
English: Moreover, this medicinal product should be used with caution in patients receiving concomitant orally administered active substances with a narrow therapeutic range that are primarily metabolized by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine.
Maltese: Madankollu, dan il-prodott mediċinali għandu jintuża b'kawtela f'pazjenti li fl-istess ħin b'mod orali qegħdin jingħataw sustanzi attivi b'firxa terapewtika dejqa li huma metabolizzati primarjament minn CYP3A4, bħal cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl u quinidine.
English: Bundle branch block right Mitral valve incompetence Myocardial ischaemia Ventricular extrasystoles
Maltese: Iskemija mijokardijaka Extrasystoles ventrikulari
English: Other medicines and Akynzeo
Maltese: Mediċini oħra u Akynzeo
English: In a multicenter, randomized, parallel, double-blind, controlled clinical study of 694 patients, the efficacy and safety of single doses of oral netupitant in combination with oral palonosetron was compared with a single oral dose of palonosetron in cancer patients receiving a chemotherapy regimen that included cisplatin (median dose = 75 mg/m2).
Maltese: Fi studju kliniku multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali, parallel, double-blind u kkontrollat, li sar fuq 694 pazjent, l-effikaċja u s-sigurtà ta' dożi waħidhom ta' netupitant orali flimkien ma' palonosetron orali, tqabblu ma' doża waħda orali ta' palonosetron f'pazjenti bil-kanċer li kienu qed jirċievu kors ta' kimoterapija li kien jinkludi cisplatin (doża medjana = 75 mg/m
English: Each hard capsule contains 300 milligrams of netupitant and 0.5 milligrams of palonosetron (as hydrochloride).
Maltese: Kull kapsula iebsa fiha 300 milligramma ta' netupitant u 0.5 milligramma ta' palonosetron (bħala hydrochloride).
English: The proportion of patients with Overall no impact on daily life was 6.3% higher (p value =0.005) in the Akynzeo group (78.5%) than in the palonosetron group (72.1%).
Maltese: Il-proporzjon ta' pazjenti mingħajr l-ebda impatt Globali fuq il-ħajja ta' kuljum kien 6.3% ogħla (valur p = 0.005) fil-grupp ta' Akynzeo (78.5%) milli fil-grupp ta' palonosetron (72.1%).
English: Effect of ketoconazole and rifampicin
Maltese: Effetti sekondarji oħrajn
English: • The recommended dose is one capsule (each capsule contains 300 mg of netupitant and 0.5 mg of palonosetron).
Maltese: • Id-doża rakkomandata hija ta' kapsula waħda (kull kapsula fiha 300 mg ta' netupitant u 0.5 mg ta' palonosetron).
English: This medicinal product also contains 20 mg of sucrose in each capsule.
Maltese: Dan il-prodott mediċinali fih ukoll 20 mg sucrose f'kull kapsula.
English: 135 patients who received a single oral dose (netupitant 300 mg and palonosetron 0.5 mg) and 136 patients who received oral palonosetron 0.5 mg alone.
Maltese: L-effikaċja ta' Akynzeo ġiet evalwata f'135 pazjent li rċivew doża waħda orali (netupitant 300 mg u palonosetron 0.5 mg) u 136 pazjent li rċivew palonosetron orali 0.5 mg waħdu.
English: These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmia, conduction disturbances and in patients taking anti-arrhythmic medicinal products or other medicinal products that lead to QT prolongation or electrolyte abnormalities.
Maltese: Dawn il-kundizzjonijiet jinkludu pazjenti bi storja medika personali jew tal-familja ta' titwil tal-QT, anormalitajiet fl-elettroliti, insuffiċjenza konġestiva tal-qalb, bradiarritmija, disturbi tal-konduzzjoni, u f'pazjenti li jkunu qed jieħdu prodotti mediċinali antiarritmiċi jew prodotti mediċinali oħrajn li jwasslu għal titwil tal-QT jew anormalitajiet fl-elettroliti.
English: • conjunctivitis (a type of eye inflammation)
Maltese: • konġuntivite (tip ta' infjammazzjoni fl-għajnejn)
English: Phospholipidosis (foamy macrophages) has been observed with the administration of netupitant after repeated administration in rats and dogs.
Maltese: Fosfolipidosi (makrofaġi birragħwa) ġiet osservata bl-għoti ta' netupitant wara l-għoti ripetut fil-firien u l-klieb.
English: In 36 healthy male and female subjects given a single oral dose of 0.5 mg palonosetron, maximum plasma concentration (Cmax) was 0.81 ± 1.66 ng/mL (mean ± SD) and time to maximum concentration (Tmax) was 5.1 ± 1.7 hours.
Maltese: F'36 raġel u mara rġiel u nisa b'saħħithom li ngħataw doża waħda orali ta' 0.5 mg palonosetron, ilkonċentrazzjoni massima ta' palonosetron fil-plażma (Cmax) kienet ta' 0.81 ± 1.66 ng/mL (medja ± SD) u l-ħin sal-konċentrazzjoni massima (Tmax) kien ta' 5.1 ± 1.7 sigħat.
English: Administration of the CYP3A4 inducer rifampicin with Akynzeo alone decreased the AUC of netupitant 5.2 fold and Cmax 2.6 fold.
Maltese: L-għoti tal-induttur ta' CYP3A4 rifampicin ma' Akynzeo waħdu, naqqas l-AUC ta' netupitant b'5.2 darbiet u s-Cmax bi 2.6 darbiet.
English: Hard capsule content:
Maltese: Qoxra tal-kapsula iebsa:
English: In a pilot dose range finding study in rabbits, cleft palate, microphtalmia and aphakia were observed in four foetuses from one litter in the 30 mg/kg/day group.
Maltese: Fi studju pilota dwar is-sejbien tal-medda tad-doża li sar fuq il-fniek, cleft palate, mikroftalmija u afakija ġew osservati f'erba' feti minn boton wieħed ta' frieħ fil-grupp li ngħata 30 mg/kg/jum.
English: This medicinal product may contain a trace of lecithin derived from soya.
Maltese: Dan il-prodott mediċinali jista' jkun fih traċċa ta' lecithin li jiġi mis-sojja.
English: This medicine contains less than 1 mmol sodium per (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull kapsula iebsa, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: No common adverse reactions are attributable to netupitant, the new component of the fixed combination.
Maltese: L-ebda reazzjonijiet avversi komuni ma ġew attribwiti għal netupitant, il-komponent il-ġdid talkombinazzjoni fissa.
English: In single dose oral studies, netupitant was measurable in plasma between 15 minutes and 3 hours after dosing.
Maltese: Fi studji dwar doża orali waħda, netupitant seta' jitkejjel fil-plażma bejn 15-il minuta u 3 sigħat wara d-dożaġġ.
English: Total systemic exposure to intravenous palonosetron increased by approximately 28% in severe renal impairment relative to healthy subjects.
Maltese: Esponiment sistemiku totali għal palonosetron ġol-vini żdied b'madwar 28% f'pazjenti b'indeboliment sever meta mqabbel ma' individwi b'saħħithom.
English: • numbness, blurred vision
Maltese: • tmewwit, vista mċajpra
English: Conjunctivitis Vision blurred
Maltese: Konġuntivite Vista mċajpra
English: Administration of the CYP3A4 inhibitor ketoconazole with netupitant/palonosetron capsules increased the AUC of netupitant 1.8 fold and Cmax 1.3 fold when compared to the administration of netupitant/palonosetron capsules alone.
Maltese: L-għoti tal-inibitur ta' CYP3A4 ketoconazole kapsuli ta' netupitant/palonosetron, żied l-AUC ta' netupitant b'1.8 darbiet u s-Cmax b'1.3 darbiet meta mqabbel mal-għoti ta' kapsuli ta' netupitant/palonosetron waħidhom.
English: In a pooled analysis, females had a higher netupitant exposure compared to males; there was a 1.31-fold increase in Cmax, a 1.02 fold increase for AUC and a 1.36 fold increase in half-life.
Maltese: F'analiżi miġbura, in-nisa kellhom esponiment ogħla għal netupitant meta mqabbla mal-irġiel; kien hemm żieda ta' 1.31-darbiet fis-Cmax, żieda ta' 1.02 darbiet għall-AUC u żieda ta' 1.36 darbiet fil-halflife.
English: Very rare (<1/10,000),
Maltese: Rari ħafna (<1/10,000),
English: Netupitant is mainly metabolized by CYP3A4; therefore, co-administration with medicinal products that inhibit or induce CYP3A4 activity may influence plasma concentrations of netupitant.
Maltese: Netupitant jiġi metabolizzat primarjament minn CYP3A4; għalhekk, l-għoti flimkien ma' prodotti mediċinali li jinibixxu jew jinduċu l-attività ta' CYP3A4, tista' tinfluwenza l-konċentrazzjonijiet ta' netupitant fil-plażma.
English: Following oral administration, palonosetron is well absorbed with its absolute bioavailability reaching 97%.
Maltese: Wara l-għoti mill-ħalq, palonosetron jiġi assorbit tajjeb bil-bijodisponibilità assoluta tiegħu li tilħaq 97%.
English: Highly Emetogenic Chemotherapy (HEC) study
Maltese: Studju dwar Kimoterapiji Kontra l-Kanċer Emetoġenika b'Mod Qawwi (Highly Emetogenic Chemotherapy (HEC))
English: • itchy skin rash
Maltese: Ħakk Raxx
English: All patients received a single oral dose of dexamethasone.
Maltese: Il-pazjenti kollha rċivew doża waħda orali ta' dexamethasone.
English: In healthy subjects given palonosetron capsules 0.5 mg, the terminal elimination half-life (t½) of palonosetron was 37 ± 12 hours (mean ± SD), and in cancer patients, t½ was 48 ± 19 hours.
Maltese: F'individwi b'saħħithom li ngħataw kapsuli ta' palonosetron ta' 0.5 mg, il-half-life tal-eliminazzjoni terminali (t½) ta' palonosetron kienet ta' 37 ± 12 siegħa (medja ± SD), u f'pazjenti bil-kanċer, it-t½ kienet ta' 48 ± 19-il siegħa.
English: Palonosetron has a volume of distribution of approximately 8.3 ± 2.5 L/kg.
Maltese: Palonosetron għandu volum ta' distribuzzjoni ta' madwar 8.3 ± 2.5
English: Hypoaesthesia Somnolence
Maltese: Croscarmellose sodium
English: As such, the oral dexamethasone dose should be reduced by approximately 50% when co-administered with netupitant/palonosetron capsules (see section 4.2).
Maltese: Għaldaqstant, id-doża ta' dexamethasone orali għandha titnaqqas b'madwar 50% meta tingħata flimkien ma' kapsuli ta' netupitant/palonosetron (ara sezzjoni 4.2).
English: Maximum concentrations and total exposure of netupitant were increased in subjects with mild (n=8), moderate (n=8), and severe (n=2) hepatic impairment compared to matching healthy subjects, although there was pronounced individual variability in both hepatically-impaired and healthy subjects.
Maltese: Il-konċentrazzjonijiet massimi u l-esponiment totali ta' netupitant żdiedu f'individwi b'indeboliment ħafif (n=8), moderat (n=8), u sever (n=2) tal-fwied meta pparagunat ma' individwi f'saħħithom mqabbla, għalkemm kien hemm varjabbiltà individwali notevoli kemm f'individwi b'indeboliment talfwied kif ukoll f'individwi b'saħħithom.
English: Akynzeo should not be taken by children and adolescents under 18 years.
Maltese: Akynzeo m'għandux jittieħed minn tfal u adolexxenti taħt l-età ta' 18-il sena.
English: Alu/Alu blister.
Maltese: Għal użu orali.
English: In vitro data suggests that netupitant inhibits the efflux of transporter BCRP.
Maltese: Dejta in vitro tissuġġerixxi li netupitant jinibixxi l-effluss tat-trasportatur BCRP.
English: Animal data do not indicate direct or indirect harmful effects of palonosetron with the respect to reproductive toxicity (see section
Maltese: Dejta mill-annimali ma wrietx effetti diretti jew indiretti tossiċi ta' palonosetron fuq is-sistema riproduttiva (ara 5.3).