natgillin/translations-raw huggingface dataset:
No relevant changes of netupitant and palonosetron pharmacokinetics were observed.
Nisu opažene značajne promjene farmakokinetike netupitanta i palonozetrona.
There are no data about the use of netupitant in pregnant women.
Nema podataka o primjeni netupitanta u trudnica.
Netupitant No effect on fertility has been observed in animal studies.
U ispitivanjima na životinjama nije opažen učinak na plodnost.
Netupitant/palonosetron capsules are contraindicated during pregnancy (see section 4.3).
Netupitant/palonozetron kapsule kontraindicirane su tijekom trudnoće (vidjeti dio 4.3).
• you have a blockage in your gut, or you have had constipation in the past • you or one of your close relatives has ever had a heart problem called ‘QT interval prolongation'
• Vi ili netko od Vama bliskih rođaka imali ste tegobe sa srcem pod nazivom „produljenje QT
Acute phase: 0 to 24 hours after anthracycline and cyclophosphamide regimen Delayed phase: 25 to 120 hours after anthracycline and cyclophosphamide regimen Overall: 0 to 120 hours after anthracycline and cyclophosphamide regimen
Akutna faza: od 0 do 24 sata nakon protokola s antraciklinom i ciklofosfamidom Odgođena faza: od 25 do 120 sati nakon protokola s antraciklinom i ciklofosfamidom Cijela faza: od 0 do 120 sati nakon protokola s antraciklinom i ciklofosfamidom
Multiple-cycle safety study in patients receiving either Highly Emetogenic Chemotherapy or Moderately Emetogenic Chemotherapy
Ispitivanje sigurnosti primjene u više ciklusa u bolesnika koji su primali visoko emetogenu kemoterapiju ili umjereno emetogenu kemoterapiju
In single dose oral studies, netupitant was measurable in plasma between 15 minutes and 3 hours after dosing.
U ispitivanjima s jednom peroralnom dozom, netupitant je bio mjerljiv u plazmi između 15 minuta i 3 sata nakon primljene doze.
Caution is recommended when netupitant is combined with an oral substrate of this enzyme (e.g.zidovudine, valproic acid, morphine).
Preporučuje se oprez kada se netupitant kombinira s peroralnim supstratom ovoga enzima (npr. zidovudinom, valproatnom kiselinom, morfinom).
Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction (see section 4.8).
Stoga bolesnike s poznatom preosjetljivošću na kikiriki ili soju treba pomno nadzirati na znakove alergijske reakcije (vidjeti dio 4.8).
Rare
Rijetke
• high levels of certain enzymes, including blood alkaline phosphatase and liver transaminases
• visoke razine nekih enzima, uključujući alkalnu fosfatazu i jetrene transaminaze (prema pretragama krvi)
Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction.
Stoga bolesnike s poznatom preosjetljivošću na kikiriki ili soju treba pomno nadzirati na znakove alergijske reakcije.
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.
Učinci u nekliničkim ispitivanjima temljenim na sigurnosnoj farmakologiji i toksičnosti jedne i ponovljenih doza bili su opaženi samo kod izloženosti koje su se smatrale većima od maksimalne ljudske izloženosti, što ukazuje na mali značaj za kliničku primjenu.
In vitro data shows that netupitant inhibits UGT2B7, the magnitude of such an effect in the clinical setting is not established.
In vitro podaci pokazuju da netupitant inhibira UGT2B7, no veličina takvog učinka nije ustanovljena u kliničkom okruženju.
Exposure to erythromycin and midazolam was increased approximately 1.3 and 2.4 fold, respectively, when each was co-administered with netupitant.
Izloženost eritromicinu povećala se približno 1,3 puta, a midazolamu 2,4 puta kada je svaki od njih primijenjen istovremeno s netupitantom.
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).
U odvojenom ispitivanju, ukupno 413 bolesnika koji su primali početni i ponavljane cikluse kemoterapije (uključujući protokole s karboplatinom, cisplatinom, oksaliplatinom i doksorubicinom) bili su randomizirani i primali su ili Akynzeo (n = 309) ili aprepitant i palonozetron (n = 104).
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.
Nakon primjene jedne doze Akynzea u bolesnika s rakom, netupitant se eliminira iz tijela multieksponencijalno, s prividnim srednjim poluvijekom eliminacije od 88 sati.
What Akynzeo is and what it is used for
Što je Akynzeo i za što se koristi
The primary efficacy endpoint was complete response (CR) rate (defined as no emetic episodes, no rescue medication) within 120 hours (overall phase) after the start of the highly emetogenic chemotherapy administration.
Primarni ishod djelotvornosti bila je stopa potpunog odgovora (engl. complete response, CR) (definiran kao stanje bez emetičkih epizoda, bez simptomatske terapije) unutar 120 sati (cijela faza) nakon početka primjene visoko emetogene kemoterapije.
Each hard capsule contains 7 mg of sorbitol and 20 mg of sucrose.
Jedna tvrda kapsula sadrži 7 mg sorbitola i 20 mg saharoze.
such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram
(SSRI) - kao što su fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram ili escitalopram
Reproductive studies in animals with netupitant do not indicate direct or indirect harmful effects with respect to fertility, parturition or postnatal development.
Ispitivanja reprodukcije u životinja s netupitantom ne ukazuju na izravne ili neizravne štetne učinke na plodnost, parturiciju ili postnatalni razvoj.
Palonosetron:
Palonozetron:
Pack size of one hard capsule or 4 x 1 hard capsules in perforated unit dose blisters.
Veličina pakiranja od jedne tvrde kapsule ili 4 x 1 tvrde kapsule u perforiranom pakiranju s jediničnim dozama.
A pregnancy test should be performed on all pre-menopausal women prior to treatment.
Prije liječenja, svim ženama koje nisu u menopauzi treba provesti test na trudnoću.
Hypokalaemia and hypomagnesaemia should be corrected prior to administration.
Prije primjene potrebno je korigirati hipokalemiju i hipomagnezemiju.
Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
želatina titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
As use in patients with severe hepatic impairment may be associated with increased exposure of netupitant, this medicinal product should be used with caution in these patients (see sections 4.4 and
Budući da se primjena u bolesnika s teškim oštećenjem funkcije jetre može povezati s povećanom izloženosti netupitantu, u tih se bolesnika ovaj lijek mora primjenjivati s oprezom (vidjeti dijelove 4.4 i 5.2).
Common adverse reactions reported with netupitant/palonosetron capsules were headache (3.6%), constipation (3.0%) and fatigue (1.2%).
Česte nuspojave zabilježene uz netupitant/palonozetron kapsule bile su glavobolja (3,6%), konstipacija (3,0%) i umor (1,2%).
• infection and inflammation in the bladder (cystitis)
• infekcija i upala mokraćnog mjehura (cistitis)
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
Bilo je izvješća o serotoninskom sindromu nakon istovremene primjene antagonista 5-HT3 i drugih serotoninergičkih lijekova (uključujući SSRI-jeve kao što su fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram ili escitalopram i SNRI-jeve kao što su venlafaksin ili duloksetin) (vidjeti dio
Cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 0.75 mg.
Prijavljeni su slučajevi konstipacije s fekalnom impakcijom, koji su zahtijevali hospitalizaciju, povezani s primjenom palonozetrona u dozi od 0,75 mg.
Therefore, patients should be monitored for increased toxicity of chemotherapeutic agents that are substrates for CYP3A4, including irinotecan.
Stoga je bolesnike potrebno nadzirati zbog povećane toksičnosti kemoterapijskih lijekova koji su supstrati za CYP3A4, uključujući irinotekan.
Delayed phase: 25 to 120 hours post-cisplatin treatment.
Odgođena faza: od 25 do 120 sati poslije terapije cisplatinom.
As such, the oral dexamethasone dose should be reduced by approximately 50% when co-administered with netupitant/palonosetron capsules (see section 4.2).
S obzirom na to, doza peroralnog deksametazona treba biti smanjena za otprilike 50% kada se primjenjuje istovremeno s netupitant/palonozetron kapsulama (vidjeti dio 4.2).
Opaque gelatin capsule of size “0” (length 21.7 mm) with white body and caramel cap with “HE1” printed on the body.
Neprozirna želatinska kapsula veličine „0“ (duljina 21,7 mm), s bijelim tijelom i kapicom boje karamele te oznakom „HE1“ otisnutom na tijelu kapsule.
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.
Nakon primjene jedne peroralne doze od 0,75 mg [14C]-palonozetrona u šest zdravih ispitanika, 85% do 93% ukupne radioaktivnosti bilo je izlučeno mokraćom, a 5% do 8% eliminirano stolicom.
The primary efficacy endpoint was the CR rate in the delayed phase, 25-120 hours after the start of the chemotherapy administration.
Primarni ishod djelotvornosti bila je stopa potpunog odgovora u odgođenoj fazi, 25 - 120 sati nakon početka primjene kemoterapije.
Very rare: may affect up to 1 in 10,000 people
Vrlo rijetko: može se javiti u manje od 1 na 10 000 osoba
A total of 1450 patients (Akynzeo n=725; Palonosetron n=725) received study medication.
Ispitivani lijek primilo je ukupno 1450 bolesnika (Akynzeo n = 725; palonozetron n = 725).
Netupitant AUC0-∞ and Cmax increased by 1.1 fold and 1.2 fold, respectively, after a high fat meal.
AUC0-∞ i Cmax netupitanta povećali su se 1,1 puta odnosno 1,2 puta nakon obroka s visokim udjelom masti.
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).
Bilo je izvješća o serotoninskom sindromu uz primjenu antagonista 5-HT3, bilo samih ili u kombinaciji s drugim serotoninergičkim lijekovima (uključujući selektivne inhibitore ponovne pohrane serotonina (SSRI) i inhibitore ponovne pohrane serotonina i noradrenalina (SNRI)).
Netupitant is not a substrate for P-gp.
Netupitant nije supstrat P-gp-a.
This medicinal product can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4.
Ovaj lijek može povećati plazmatske koncentracije istovremeno primjenjivanih lijekova koji se metaboliziraju putem CYP3A4.
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.
Kada se ovaj lijek uzima istovremeno s lijekovima koji induciraju aktivnost CYP3A4, koncentracije netupitanta u plazmi mogu biti snižene, a to može rezultirati smanjenom djelotvornošću.
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 umjereni inhibitor CYP3A4 i može povećati izloženost kemoterapijskim lijekovima koji su supstrati za CYP3A4, npr. docetaksel (vidjeti dio 4.5).
Chemotherapeutic agents that are substrates for CYP3A4
Kemoterapijski lijekovi koji su supstrati za CYP3A4
Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Na temelju ispitivanja in vitro, palonozetron ne inhibira niti ne inducira izoenzime citokroma P450 u klinički važnim koncentracijama.
• The recommended dose is one capsule (each capsule contains 300 mg of netupitant and 0.5 mg of palonosetron).
• Preporučena doza je jedna kapsula (jedna kapsula sadrži 300 mg netupitanta i 0,5 mg palonozetrona).
Overall: 0 to 120 hours post-cisplatin treatment.
Cijela faza: od 0 do 120 sati poslije terapije cisplatinom.
Hard capsule.
Tvrda kapsula
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.
EKG ispitivanje provedeno je u zdravih odraslih dobrovoljaca, muškaraca i žena, s peroralnim netupitantom u dozi od 200 mg ili 600 mg primijenjeno u kombinaciji s peroralnim palonozetronom od 0,5 mg odnosno 1,5 mg.
In addition, eye swelling, dyspnoea and myalgia as adverse reactions have been reported with oral palonosetron but not observed during the development of this medicinal product.
Osim toga, oticanje očiju, dispneja i mialgija zabilježene su kao nuspojave peroralnog palonozetrona, ali nisu opažene tijekom razvoja ovoga lijeka.
Exposure to netupitant (Cmax, AUC0-t and AUC0-∞) compared to matching healthy subjects was 11%, 28% and 19% higher in mild and 70%, 88% and 143% higher in moderate hepaticallyimpaired subjects, respectively.
U usporedbi s podudarnim zdravim ispitanicima, izloženost netupitantu (Cmax, AUC0-t i AUC0-∞) bila je 11%, 28% i 19% viša u ispitanika s blagim oštećenjem funkcije jetre i 70%, 88% odnosno 143% viša u onih s umjerenim oštećenjem funkcije jetre.
This medicine contains 7 mg of sorbitol in each hard capsule.
Ovaj lijek sadrži 7 mg sorbitola u jednoj tvrdoj kapsuli.
Palonosetron soft capsule
Palonozetron meka kapsula
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).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja s lijekom Akynzeo u svim podskupinama pedijatrijske populacije u sprječavanju akutne i odgođene mučnine i povraćanja povezanih s visoko emetogenom kemoterapijom protiv raka temeljenom na cisplatinu, i umjereno emetogenom kemoterapijom protiv raka (za informacije o pedijatrijskoj primjeni vidjeti dio 4.2).
No dosage adjustment is necessary for elderly patients.
U starijih bolesnika nije potrebna prilagodba doze.
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.
Pokazalo se da netupitant, nakon primjene u dozi od 300 mg, prolazi krvno-moždanu barijeru uz popunjenost receptora NK1 od 92,5%, 86,5%, 85,0%, 78,0% i 76,0% u strijatumu u 6., 24., 48., 72. odnosno 96. satu.
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).
Ispitivanje nije dokazalo klinički važne učinke na EKG parametre: najveća točkovna procjena QTc intervala korigiranog za placebo i početnu vrijednost bila je 7,0 ms (gornja granica jednostranog 95%-tnog intervala pouzdanosti 8,8 ms), opažena 16 sati nakon primjene supraterapijskih doza (600 mg netupitanta i 1,5 mg palonozetrona).
Table 3: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase
Tablica 3: Udio bolesnika koji su primali kemoterapiju cisplatinom u kojih je postignut odgovor, prema terapijskoj skupini i fazi
Very rare cases of anaphylaxis, anaphylactic/anaphylactoid reactions and shock have been reported from the post-marketing use of intravenous palonosetron.
Vrlo rijetki slučajevi anafilaksije, anafilaktičnih/anafilaktoidnih reakcija i šoka zabilježeni su tijekom primjene intravenskog palonozetrona nakon stavljanja lijeka u promet.
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).
Nakon jedne peroralne doze netupitanta od 300 mg u bolesnika s rakom, raspoređivanje netupitanta bilo je karakterizirano modelom od dva odjeljka s procijenjenim medijanom sistemskog klirensa od 20,5 l/h i velikim volumenom distribucije u središnjem odjeljku (486 l).
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.
Kod istovremene primjene netupitanta od 300 mg, vrijednosti AUC0-24 (1. dan), AUC24-36 (2. dan) i AUC84-108 te AUC84-∞ (4. dan) deksametazona povećale su se 2,4 puta.
Delayed phase Overall phase No significant nausea Acute phase
Bez značajne mučnine Akutna faza nije značajno
An increased incidence of positional foetal abnormalities of the limbs and paws, fused sternebrae and agenesis of accessory lung lobe were observed following daily administration of netupitant in rabbits at 10 mg/kg/day and higher during the period of organogenesis.
Povećana incidencija položajnih abnormalnosti udova i šapa u fetusa, spojene sternebre i ageneze akcesornog režnja pluća, opažena je nakon svakodnevne primjene netupitanta u kunića u dozi od 10 mg/kg na dan i višoj u razdoblju organogeneze.
Furthermore, netupitant may also affect the efficacy of chemotherapeutic agents that need activation by CYP3A4 metabolism.
Nadalje, netupitant može također utjecati na djelotvornost kemoterapijskih lijekova kojima je potrebna metabolička aktivacija pomoću izoenzima CYP3A4.
Renal excretion for netupitant is negligible.
Izlučivanje netupitanta putem bubrega je zanemarivo.
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.
U pilot ispitivanju određivanja raspona doze u kunića, rascjep nepca, mikroftalmija i afakija opaženi su u četiri fetusa iz jednog legla u skupini koja je primala 30 mg/kg na dan.
At the time of the study, anthracyclinecyclophosphamide containing chemotherapy regimens were considered to be moderately emetogenic.
U vrijeme provedbe ispitivanja, kemoterapijski protokoli koji su sadržavali antraciklin i ciklofosfamid smatrali su se umjereno emetogenim.
• medicines for depression or anxiety called SSRIs (selective serotonin re-uptake inhibitors)
• lijekove protiv depresije ili tjeskobe, zvane selektivni inhibitori ponovne pohrane serotonina
Infections and infestations
Infekcije i infestacije cistitis
Table 5: Proportion of patients receiving anthracycline and cyclophosphamide chemotherapy responding by treatment group and phase - cycle 1
Tablica 5: Udio bolesnika koji su primali kemoterapiju antraciklinom i ciklofosfamidom u kojih je postignut odgovor, po terapijskoj skupini i fazi - 1. ciklus
Interaction with CYP3A4 substrates:
Interakcija sa supstratima izoenzima CYP3A4:
Highly Emetogenic Chemotherapy (HEC) study
Ispitivanje visoko emetogene kemoterapije (HEC)
There are no data about the use of palonosetron in pregnant women.
Nema podataka o primjeni palonozetrona u trudnica.
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.
Gornja granica 95%-tnog intervala pouzdanosti točkovne procjene QTc intervala korigiranog za placebo i početnu vrijednost bila je neprekidno unutar 10 ms u svim vremenskim točkama tijekom 2 dana poslije primjene ispitivane tvari.
In vitro data show that netupitant is a P-gp inhibitor.
In vitro podaci pokazuju da je netupitant inhibitor P-gp-a.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
U nekliničkim ispitivanjima zapaženi su učinci samo pri izloženostima koje su znatno veće od maksimalnih izloženosti u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
Pack size containing 1 capsule in an aluminium blister or 4 x 1 hard capsules in aluminium perforated unit dose blisters.
Veličina pakiranja od 1 kapsule u aluminijskom blisteru ili 4 x 1 tvrde kapsule u aluminijskom perforiranom blisteru s jediničnim dozama.
The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Utjecaj mučnine i povraćanja na svakodnevni život bolesnika bio je procijenjen na temelju FLIE upitnika (engl.
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.
U analizi objedinjenih podataka, izloženost netupitantu bila je viša u žena nego u muškaraca; zabilježeno je povećanje od 1,31 puta u Cmax, 1,02 puta za AUC i 1,36 puta u poluvijeku.
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.
Nakon primjene jedne peroralne doze od 300 mg netupitanta, prosječni omjeri netupitanta u plazmi/radioaktivnosti u plazmi kretali su se u rasponu od 0,13 do 0,49 tijekom 96 sati poslije doze.
Table1: Adverse reactions System organ class
Tablica 1: Nuspojave prema klasifikaciji organskih sustava
Administration of the CYP3A4 inducer rifampicin with Akynzeo alone decreased the AUC of netupitant 5.2 fold and Cmax 2.6 fold.
Primjena rifampicina, induktora CYP3A4, sa samim Akynzeom smanjila je AUC netupitanta 5,2 puta, a Cmax 2,6 puta.
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.
Prosječna frakcija peroralne doze netupitanta koji se izlučuje nepromijenjen u mokraći manja je od 1%; ukupno 3,95% radioaktivne doze nađeno je u mokraći, a 70,7% u stolici.
Netupitant is mainly metabolized by CYP3A4; therefore, co-administration with medicinal products that inhibit or induce CYP3A4 activity may influence plasma concentrations of netupitant.
Netupitant se metabolizira uglavnom putem CYP3A4; stoga istovremena primjena s lijekovima koji inhibiraju ili induciraju aktivnost CYP3A4 može utjecati na koncentraciju netupitanta u plazmi.
At a dose of 300 mg in humans, netupitant is a substrate and moderate inhibitor of CYP3A4.
U dozi od 300 mg netupitant je u ljudi supstrat i umjereni inhibitor CYP3A4.
After single oral doses using buffered solution mean maximum palonosetron concentrations (Cmax) and area under the concentration-time curve (AUC0-∞) were dose proportional over the dose range of 3.0 to 80 mcg/kg in healthy subjects.
Nakon jedne peroralne doze puferirane otopine, prosječna maksimalna koncentracija palonozetrona (Cmax) i površina ispod krivulje koncentracija-vrijeme (AUC0-∞) bile se proporcionalne dozi za raspon doze od 3,0 do 80 µg/kg u zdravih ispitanika.
Akynzeo is taken before the chemotherapy to prevent sickness and feelings of sickness from developing.
Akynzeo se uzima prije kemoterapije kako bi se spriječio nastanak mučnine i povraćanja.
Shellac glaze (partially esterified) Black iron oxide (E172) Propylene glycol (E1520)
Tinta za označavanje šelakova glazura (djelomično esterificirana) željezov oksid, crni (E172) propilenglikol (E1520)
Netupitant/palonosetron capsules have moderate influence on the ability to drive and use machines.
Netupitant/palonozetron kapsule umjereno utječu na sposobnost upravljanja vozilima i rada sa strojevima.