natgillin/translations-raw huggingface dataset:
Netupitant/palonosetron capsules, when given with a single oral dose of 60 μg ethinylestradiol and 300 μg levonorgestrel had no significant effect on the AUC of ethinylestradiol and increased the AUC of levonorgestrel by 1.4-fold; clinical effects on the efficacy of hormonal contraception are unlikely. 
Kapsule netupitanta in palonosetrona ob dajanju z enkratnim peroralnim odmerkom 60 μg etinilestradiola in 300 μg levonorgestrela ni imelo znatnega učinka na AUC etinilestradiola in je povečalo AUC levonorgestrela za 1,4-krat; klinični učinki na učinkovitost hormonske kontracepcije niso verjetni.
Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction. 
Zato je treba bolnike z znano preobčutljivostjo na arašide ali sojo skrbno spremljati glede znakov alergijske reakcije.
Studies in animals have shown reproductive toxicity including teratogenic effects in rabbit without safety margin (see section 5.3). 
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja, vključno s teratogenimi učinki brez varnostne meje pri kuncih (glejte poglavje 5.3).
Do not take Akynzeo in the days after you have chemotherapy - unless you are about to have another chemotherapy cycle. 
Zdravila Akynzeo ne vzemite v dneh po opravljeni kemoterapiji, razen če ste tik pred naslednjim načrtovanim ciklom kemoterapije.
Following administration of a single dose of Akynzeo, netupitant is eliminated from the body in a multi-exponential fashion, with an apparent mean elimination half-life of 88 hours in cancer patients. 
Po dajanju enkratnega odmerka zdravila Akynzeo se netupitant izloča iz telesa na multieksponentni način, z navideznim povprečnim razpolovnim časom izločanja 88 ur pri bolnikih z rakom.
Because of the antiemetic activity of netupitant and palonosetron, emesis induced by a medicinal product may not be effective. 
Zaradi antiemetičnega delovanja netupitanta in palonosetrona morda bruhanje, sproženo z zdravilom, ne bo učinkovito.
• medicines that might cause abnormal heartbeat such as amiodarone, nicardipine, quinidine, 
• zdravila, ki lahko povzročijo nenormalen srčni utrip, kot so amiodaron, nikardipin, kinidin,
‘bundle branch block right/left', and ‘atrioventricular block second degree') 
'desnokračni/levokračni blok' in 'atrioventrikularni blok druge stopnje').
• The other ingredients are microcrystalline cellulose (E460), sucrose lauric acid esters, povidone K-30, croscarmellose sodium, colloidal hydrated silica, sodium stearyl fumarate, magnesium stearate, glycerol monocaprylocaproate (type I), glycerol, polyglyceryl oleate, purified water, butylhydroxyanisole (E320), gelatin, sorbitol, 1,4 sorbitan, titanium dioxide (E171), shellac glaze (partially esterified), yellow, red and black iron oxide (E172), propylene glycol (E1520). 
• Druge sestavine so mikrokristalna celuloza (E460), estri saharoze in lavrinske kisline, povidon K-30, premrežen natrijev karmelozat, hidratirani koloidni silicijev dioksid, natrijev stearilfumarat, magnezijev stearat, glicerol monokaprilat monokaprinat (tip I), glicerol, poligliceril oleat, prečiščena voda, butilhidroksianizol (E320), želatina, sorbitol, 1,4 sorbitan, titanov dioksid (E171), glazura iz šelaka (delno estrificiranega), rumeni, rdeči in črni železov oksid (E172), propilenglikol (E1520).
Co-administration of a single dose of 300 mg netupitant with a dexamethasone regimen (20 mg on Day 1, followed by 8 mg twice daily from Day 2 to Day 4) significantly increased the exposure to dexamethasone in a time and dose dependent manner. 
Sočasno dajanje enkratnega 300 mg odmerka netupitanta ob režimu zdravljenja s deksametazonom (20 mg 1. dan, nato pa 8 mg dvakrat dnevno od 2. do 4. dne) je znatno povečalo izpostavljenost deksametazonu v odvisnosti od časa in odmerka.
These metabolites each have less than 1% of the 5-HT3 receptor antagonist activity of palonosetron. 
Vsak od teh dveh presnovkov ima manj kot 1 % antagonističnega učinka na receptorje 5-HT3, ki ga ima palonosetron.
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. 
Povprečna Cmax za M1, M2 oziroma M3 je bila približno11 %, 47 % oziroma 16 % vrednosti izvorne spojine; M2 je imel najmanjšo AUC glede na izvorno spojino (14 %), medtem ko sta AUC presnovkov M1 in M3 dosegali približno 29 % in 33 % AUC izvorne spojine.
Netupitant and combination with palonosetron 
Netupitant in kombinacija s palonosetronom
There are no data about the use of palonosetron in pregnant women. 
Podatkov o uporabi palonosetrona pri nosečnicah ni.
Akynzeo contains sucrose, sorbitol, sodium and may contain traces of soya. 
Zdravilo Akynzeo vsebuje saharozo, sorbitol, natrij in lahko vsebuje sledi soje.
Common adverse reactions reported with netupitant/palonosetron capsules were headache (3.6%), constipation (3.0%) and fatigue (1.2%). 
Pogosti neželeni učinki, o katerih so poročali pri kapsulah netupitanta in palonosetrona, so bili glavobol (3,6 %), zaprtje (3,0 %) in utrujenost (1,2 %).
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. 
Na podlagi izkušenj z zdravimi osebami, ki so bile izpostavljene peroralnemu netupitantu 600 mg v kombinaciji s palonosetronom 1,50 mg, so možni akutni simptomi prevelikega odmerjanja glavobol, omotica, zaprtje, anksioznost, palpitacije, evforično razpoloženje in bolečine v nogah.
• ECG (electrocardiogram) problems (called ‘QT and PR interval prolongation', ‘conduction disorder', ‘tachycardia' and ‘atrioventricular block first degree') 
• težave v EKG (elektrokardiogramu) (ki jim pravimo 'podaljšanje intervala QT in PR', 'motnja prevajanja', 'tahikardija' in 'atrioventrikularni blok prve stopnje');
• spinning sensation (vertigo), feeling dizzy or trouble sleeping (insomnia) 
• občutek vrtenja (vrtoglavica), občutek omotičnosti ali težave s spanjem (nespečnost);
The third major metabolite, M2, is > 97% bound to plasma proteins. 
Tretji glavni presnovek M2 se več kot 97 % veže na beljakovine v plazmi.
Chemotherapy medicines can cause the body to release substances called serotonin and substance P. This stimulates the vomiting centre in the brain, making you feel or be sick. 
Zdravila za kemoterapijo lahko povzročijo, da telo izloča snovi, ki jima pravimo serotonin in snov P. To spodbuja center v možganih, ki je odgovoren za bruhanje, zaradi česar vam je lahko slabo ali bruhate.
The AUC0-24 (Day 1), the AUC24-36 (Day 2) and the AUC84-108 and AUC84-∞ (Day 4) of dexamethasone increased 2.4-fold, with co-administration of 300 mg netupitant. 
AUC0-24 (1. dan), AUC24-36 (2. dan) ter AUC84-108 in AUC84-∞ (4. dan) deksametazona povečale za 2,4-krat.
Approximately half the radioactivity administered orally as [14C]-netupitant was recovered from urine and faeces within 120 h of dosing. 
Približno polovico radioaktivnosti, peroralno dane v obliki [14C]-netupitanta, so odkrili v urinu in blatu v 120 urah od odmerjanja.
• ECG (electrocardiogram) problems (called ‘ST segment depression', ‘ST-T segment abnormal' 
• težave v EKG (imenujejo se 'depresija segmenta ST', 'nenormalen segment ST-T',
Therefore, patients should be monitored for increased toxicity of chemotherapeutic agents that are substrates for CYP3A4, including irinotecan. 
Zaradi tega je treba bolnike spremljati glede povečane toksičnosti kemoterapevtskih zdravil, ki so substrati za CYP3A4, vključno z irinotekanom.
While the terminal elimination half-life and mean systemic exposure of palonosetron is increased in the subjects with severe hepatic impairment, this does not warrant dose reduction. 
Čeprav sta končni razpolovni čas izločanja in povprečna sistemska izpostavljenost palonosetronu pri bolnikih s hudo okvaro jeter povečana, zaradi tega ni potrebna prilagoditev odmerka.
After a single oral 300 mg dose administration in cancer patients, netupitant disposition was characterised by a two compartment model with an estimated median systemic clearance of 20.5 L/h and a large distribution volume in the central compartment (486 L). 
Po dajanju enkratnega peroralnega odmerka 300 mg pri bolnikih z rakom je bil za porazdelitev netupitanta značilen dvorazdelčni model z ocenjenim medianim sistemskim očistkom 20,5 l/uro in velikim volumnom porazdelitve v centralnem razdelku (486 l).
Table 3: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase 
Preglednica 3: Delež odziva bolnikov, ki so prejemali kemoterapijo s cisplatinom, po skupinah zdravljenja in fazah
In vitro data shows that netupitant inhibits UGT2B7, the magnitude of such an effect in the clinical setting is not established. 
Podatki in vitro kažejo, da netupitant zavira UGT2B7, velikost tega učinka v kliničnih okoliščinah pa ni bila ugotovljena.
Upper 95% confidence limit of the point estimates of placebo and baseline corrected QTcI was constantly within 10 ms at all time points over 2 days after study substance administration. 
Zgornja meja 95-% intervala zaupanja točkovnih ocen QTcI, korigiranih s placebom in izhodiščno vrednostjo, je bila stalno znotraj 10 ms v vseh časovnih točkah v 2 dneh po dajanju preučevane snovi.
The hard capsules are opaque with a white body and a caramel cap with ‘HE1' printed on the body. 
Trde kapsule so neprozorne z belim telesom in pokrovčkom karamelne barve ter oznako »HE1«, odtisnjeno na telesu.
Opaque gelatin capsule of size “0” (length 21.7 mm) with white body and caramel cap with “HE1” printed on the body. 
Neprozorna želatinasta kapsula velikosti »0« (dolžina 21,7 mm) z belim telesom in pokrovčkom karamelne barve ter oznako »HE1«, odtisnjeno na telesu.
Titanium dioxide (E171) 
1,4 sorbitan titanov dioksid (E171)
Breast-feeding should be discontinued during treatment with this medicinal product and for 1 month after the last dose. 
Med zdravljenjem s tem zdravilom in do 1 mesec po zadnjem odmerku je treba prenehati z dojenjem.
Effects in non-clinical studies based on safety pharmacology and single and repeated dose toxicity were observed only at exposures considered in excess of the maximum human exposure, indicating little relevance to clinical use. 
V predkliničnih študijah na osnovi farmakologije varnosti ter toksičnosti enkratnih in ponavljajočih se odmerkov so učinke opazili samo pri izpostavljenosti, ki je presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
A total of 1450 patients (Akynzeo n=725; Palonosetron n=725) received study medication. 
Preučevano zdravilo je prejelo skupno 1450 bolnikov (Akynzeo n = 725; palonosetron n = 725).
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. 
Po dajanju enkratnega peroralnega 0,75 mg odmerka [14C]-palonosetrona šestim zdravim osebam se je 85 % do 93 % celotne radioaktivnost izločilo v urin in 5 % do 8 % v blato.
The pharmacokinetic profile of netupitant was unchanged when administered in combination with dexamethasone. 
Farmakokinetični profil netupitanta je bil ob dajanju v kombinaciji z deksametazonom nespremenjen.
Reproductive studies in animals with netupitant do not indicate direct or indirect harmful effects with respect to fertility, parturition or postnatal development. 
Študije razmnoževanja z netupitantom na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost, kotitev ali postnatalni razvoj.
• conjunctivitis (a type of eye inflammation) 
• konjuktivitis (vrsta vnetja očesa),
Acute psychosis Mood altered Sleep disorder 
Psihiatrične motnje nespečnost akutna psihoza sprememba razpoloženja motnja spanja
Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction (see section 4.8). 
Zaradi tega je treba bolnike z znano preobčutljivostjo na arašide ali sojo skrbno spremljati glede znakov alergijske reakcije (glejte poglavje 4.8).
Treatment regimens for the Akynzeo and the palonosetron 0.5 mg arms are displayed in Table below. 
Režimi zdravljenja za kraka z zdravilom Akynzeo in palonosetronom 0,5 mg so prikazani v spodnji preglednici.
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. 
Zakasnjeno bruhanje povezujemo z aktivacijo receptorjev za nevrokinin 1 (NK1) iz družine tahikininov (ki so obsežno porazdeljeni po osrednjem in perifernem živčevju) s strani snovi P. Kot so dokazali v študijah in vitro in in vivo, netupitant zavira odzive, ki jih posreduje snov P.
This medicine contains less than 1 mmol sodium per (23 mg) per hard capsule, that is to say essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na trdo kapsulo, kar v bistvu pomeni 'brez natrija'.
Very rare: may affect up to 1 in 10,000 people 
Zelo redki: lahko se pojavijo pri največ 1 od 10.000 bolnikov
Table 5: Proportion of patients receiving anthracycline and cyclophosphamide chemotherapy responding by treatment group and phase - cycle 1 
Preglednica 5: Delež odziva bolnikov, ki so prejemali kemoterapijo z antraciklinom in ciklofosfamidom, po skupinah zdravljenja in fazah - 1. cikel
• infection and inflammation in the bladder (cystitis) 
• okužba in vnetje sečnega mehurja (cistitis),
What Akynzeo is and what it is used for What you need to know before you take Akynzeo How to take Akynzeo 
Kaj je zdravilo Akynzeo in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Akynzeo Kako jemati zdravilo Akynzeo Možni neželeni učinki
• coating of the tongue, difficulty swallowing, dry mouth, belching, abnormal taste after medicine intake 
• obložen jezik, težave s požiranjem, suha usta, kolcanje, nenormalen okus po jemanju zdravila;
• you have any other heart problems • you have been told you have an imbalance of minerals in your blood such as potassium and magnesium that has not been corrected. 
• če so vam povedali, da imate neravnovesje mineralov (na primer kalija ali magnezija) v krvi, ki še ni urejeno.
In a separate study, a total of 413 patients undergoing initial and repeat cycles of chemotherapy (including carboplatin, cisplatin, oxaliplatin, and doxorubicin regimens), were randomized to receive either Akynzeo (n=309) or aprepitant and palonosetron (n=104). 
V ločeni študiji je bilo skupno 413 bolnikov, ki so prejemali začetne ali ponovljene cikle kemoterapije (vključno z režimi s karboplatinom, cisplatinom, oksaliplatinom in doksorubicinom), randomizirano v skupino za prejemanje zdravila Akynzeo (n = 309) ali skupino za prejemanje aprepitanta in palonosetrona (n = 104).
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). 
Priporočeni peroralni odmerek deksametazona je treba ob sočasni uporabi s kapsulami netupitanta in palonosetrona zmanjšati za približno 50 % (glejte poglavje 4.5 in načrt dajanja zdravil v kliničnih študijah v poglavju 5.1).
• chest pain (not related to the heart) 
• bolečine v prsih (ki niso povezane s srcem),
Adverse reactions are listed below by MedDRA body system organ class and frequency. 
Neželeni učinki so navedeni spodaj po organskih sistemih in pogostnosti po MedDRA.
Netupitant was shown to cross the blood brain barrier with a NK1 receptor occupancy of 92.5%, 86.5%, 85.0%, 78.0%, and 76.0% in striatum at 6, 24, 48, 72, and 96 hours, respectively, after administration of 300 mg netupitant. 
NK1 92,5 %, 86,5 %, 85,0 %, 78,0 % oziroma 76,0 % v striatumu po 6, 24, 48, 72 oziroma 96 urah, in sicer po dajanju 300 mg netupitanta.
What you need to know before you take Akynzeo 
Kaj morate vedeti, preden boste vzeli zdravilo Akynzeo
Interaction with CYP3A4 substrates: 
Medsebojno delovanje s substrati za CYP3A4:
Chemotherapeutic agents that are substrates for CYP3A4 
Kemoterapevtska zdravila, ki so substrati za CYP3A4
Netupitant/palonosetron capsules should not be used during breast-feeding. 
Kapsule netupitanta in palonosetrona se med dojenjem ne smejo uporabljati.
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). 
Študija ni pokazala klinično pomembnih učinkov na parametre EKG: največja točkovna ocena intervala QTc, korigirana s placebom in izhodiščno vrednostjo, je bila 7,0 ms (zgornja meja 95-% enostranskega intervala zaupanja je bila 8,8 ms), opažena 16 ur po dajanju supraterapevtskih odmerkov (600 mg netupitanta in 1,5 mg palonosetrona).
Netupitant No effect on fertility has been observed in animal studies. 
Pri študijah na živalih niso opazili vpliva na plodnost.
The European Medicines Agency has waived the obligation to submit the results of studies with Akynzeo in all subsets of the paediatric population in prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based and moderately emetogenic cancer chemotherapy (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Akynzeo za vse podskupine pediatrične populacije za preprečevanje akutne in zakasnjene navzee in bruhanja pri zelo emetogeni kemoterapiji na osnovi cisplatina in zmerno emetogeni kemoterapiji za zdravljenje raka (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Furthermore, netupitant may also affect the efficacy of chemotherapeutic agents that need activation by CYP3A4 metabolism. 
Poleg tega lahko netupitant vpliva tudi na učinkovitost kemoterapevtskih zdravil, pri katerih je potrebna aktivacija prek presnove s CYP3A4.
Therefore, Akynzeo can be administered without dosage adjustment in patients with renal impairment. 
Zato lahko zdravilo Akynzeo brez prilagoditve odmerka dajemo bolnikom z okvaro ledvic.
Highly Emetogenic Chemotherapy (HEC) study 
Študija zelo emetogene kemoterapije (HEC)
The medicines in Akynzeo attach to the receptors in the nervous system through which serotonin and substance P work: netupitant (an NK1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5HT3 receptor antagonist) blocks certain receptors for serotonin. 
Zdravili, ki ju vsebuje zdravilo Akynzeo, se pritrdita na receptorje v živčevju, prek katerih delujeta serotonin in snov P: netupitant (ki je antagonist receptorjev NK1) zavira receptorje za snov P, palonosetron (ki je antagonist receptorjev 5-HT3) pa zavira določene receptorje za serotonin.
This medicinal product should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range (see section 4.5). 
To zdravilo je treba uporabljati previdno pri bolnikih, ki sočasno peroralno prejemajo učinkovine, ki se primarno presnavljajo prek CYP3A4 in imajo ozko terapevtsko območje (glejte poglavje 4.5).
Serotonin then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex. 
Serotonin nato aktivira receptorje 5-HT3 na vagalnih aferentnih vlaknih in s tem sproža refleks bruhanja.
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). 
V multicentrični, randomizirani, paralelni, dvojno slepi, aktivno nadzorovani klinični študiji s 694 bolniki so primerjali učinkovitost in varnost enkratnih odmerkov peroralnega netupitanta v kombinaciji s peroralnim palonosetronom in enkratnega peroralnega odmerka palonosetrona pri bolnikih z rakom, ki so prejemali režim kemoterapije, ki je vključeval cisplatin (mediani odmerek = 75 mg/m2).
• decreased blood flow to the heart muscle (myocardial ischemia) 
• zmanjšan dotok krvi v srčno mišico (miokardna ishemija),
Primary endpoint Complete response Overall phase Major secondary endpoints Complete response Acute phase Delayed phase No emesis Acute phase Delayed phase Overall phase No significant nausea Acute phase Delayed phase Overall phase Acute phase: 0 to 24 hours post-cisplatin treatment. 
Primarni kriterij Popoln odziv Celotna faza Glavni sekundarni kriteriji Popoln odziv Akutna faza Zakasnjena faza Brez bruhanja Akutna faza Zakasnjena faza Celotna faza Brez znatne navzee Akutna faza Zakasnjena faza
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. 
Zaviranje izločevalnega prenašalca BCRP in glukuronidacijskega izocima UGT2B7 s strani netupitanta in njegovih presnovkov ni verjetno, če pa do njega pride, ima zelo majhno klinično pomembnost.
Table 2: Oral Antiemetic treatment regimen -- HEC study 
Preglednica 2: Režim peroralnega antiemetičnega zdravljenja -- študija HEC
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. 
V združeni analizi je bila izpostavljenost netupitantu pri ženskah večja kot pri moških; Cmax je bila večja za 1,31-krat, AUC za 1,02-krat in razpolovni čas za 1,36-krat.
Do not take Akynzeo if: 
Ne jemljite zdravila Akynzeo:
When this medicinal product is used concomitantly with medicinal products that induce CYP3A4 activity, netupitant plasma concentrations could be reduced and this may result in decreased efficacy. 
Pri sočasni uporabi tega zdravila in zdravil, ki spodbujajo delovanje CYP3A4, lahko pride do znižanja plazemskih koncentracij netupitanta, kar lahko privede do zmanjšane učinkovitosti.
In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines: 
Še posebej opozorite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete katero od naslednjih zdravil:
What Akynzeo is and what it is used for 
Kaj je zdravilo Akynzeo in za kaj ga uporabljamo
Netupitant is a moderate inhibitor of CYP3A4 and can increase the exposure of chemotherapeutic agents that are substrates for CYP3A4 e.g. docetaxel (see section 4.5). 
Netupitant je zmeren zaviralec CYP3A4 in lahko poveča izpostavljenost kemoterapevtskim zdravilom, ki so substrati za CYP3A4, npr. docetakselu (glejte poglavje 4.5).
Moderately Emetogenic Chemotherapy (MEC) study 
Študija zmerno emetogene kemoterapije (MEC)
No relevant changes of netupitant and palonosetron pharmacokinetics were observed. 
Relevantnih sprememb farmakokinetike netupitanta in palonosetrona niso opazili.
This medicinal product can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4. 
To zdravilo lahko zviša plazemske koncentracije sočasno uporabljenih zdravil, ki se presnavljajo prek CYP3A4.
Palonosetron is eliminated from the body through both renal excretion and metabolic pathways, with the latter mediated via multiple CYP enzymes. 
Palonosetron se izloča iz telesa prek ledvičnega izločanja in presnovnih poti, ki jih posreduje več encimov CYP.
Primary endpoint Complete response 
Primarni kriterij Popoln odziv
• feeling hot, reddening of the face or other areas of the skin (feeling flushed) 
• občutek vročine, pordelost obraza ali drugih predelov kože (napad rdečice),