natgillin/translations-raw huggingface dataset:
* The confidence intervals were calculated with no adjustment for age category (< 55 years, ≥ 55 years) and investigator group, which were included in the primary analysis of odds ratios and logistic models.
* Intervali zaupanja so bili izračunani brez prilagoditve glede na starost (< 55 let, ≥ 55 let) in preiskovano skupino, ki sta bili vključeni v primarno analizo razmerij obetov in logističnih modelov.
EMEND 165 mg is given on Day 1 only, approximately one hour before the start of chemotherapy, as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist.
Zdravilo EMEND 165 mg se daje samo 1. dan, približno eno uro pred začetkom kemoterapije, v sklopu zdravljenja, ki vključuje kortikosteroid in antagonist 5-HT3.
This is because their treatment will need to be changed before starting this medicine.
Otrokovo zdravljenje bo namreč treba pred začetkom uporabe tega zdravila prilagoditi.
- if the child is using ‘terfenadine' or ‘astemizole' (for hay fever and other allergies).
- če otrok uporablja terfenadin ali astemizol (za seneni nahod in druge alergije).
Because of the antiemetic activity of aprepitant, emesis induced by a medicinal product may not be effective.
Sprožitev bruhanja z zdravili zaradi antiemetičnega delovanja aprepitanta morda ne bo učinkovito.
No dose adjustment for EMEND is necessary based on gender.
Odmerka zdravila EMEND ni treba prilagoditi glede na spol.
The half-life of aprepitant is 25 % lower in females as compared with males and its tmax occurs at approximately the same time.
Razpolovni čas aprepitanta je pri ženskah za 25 % krajši kot pri moških, tmax pa je približno enak.
‡Complete response = no vomiting and no use of rescue therapy.
‡Popoln odziv = brez bruhanja in brez rešilnega zdravljenja.
Aprepitant cannot be removed by haemodialysis.
Aprepitanta ni mogoče odstraniti s hemodializo.
Do not give this medicine if any of the above applies to the child and tell the child's doctor if they are using any of the medicines above.
Otroku ne dajte tega zdravila, če kaj od naštetega velja zanj, otrokovemu zdravniku pa morate povedati, če otrok uporablja katero od zgoraj naštetih zdravil.
Start of Therapy
Začetek zdravljenja
What EMEND looks like and contents of the pack The powder for oral suspension is a pink to light pink powder in a single-use sachet.
Izgled zdravila EMEND in vsebina pakiranja Prašek za peroralno suspenzijo je rožnat do svetlorožnat prašek v vrečki za enkratno uporabo.
Instructions for healthcare professionals on the preparation of the oral suspension
Navodila za pripravo peroralne suspenzije za zdravstveno osebje
Excipients with known effect Each sachet contains approximately 125 mg of sucrose and 468.7 mg lactose (as anhydrous).
Pomožne snovi z znanim učinkom Ena vrečka vsebuje približno 125 mg saharoze in 468,7 mg laktoze (kot brezvodne laktoze).
For further information on interaction potential of aprepitant at higher and multiple doses, please refer to the Summary of Product Characteristics for EMEND 80 mg hard capsules and EMEND 125 mg hard capsules.
Za dodatne informacije o interakcijah aprepitanta pri višjih ali večkratnih odmerkih glejte Povzetek glavnih značilnosti zdravila za zdravilo EMEND 80 mg trde kapsule in 125 mg trde kapsule.
EMEND 40 mg is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.
Zdravilo EMEND 40 mg je indicirano za preprečevanje pooperacijske navzee in bruhanja (PONVpostoperative nausea and vomiting) pri odraslih.
It should be noted that systemic exposure in adult male rats was lower than the therapeutic exposure in humans at 40 mg. Consequently, no adequate assessment of potential effects on male fertility in rats can be made.
Treba je opozoriti, da je bila pri odraslih samcih podgan sistemska izpostavljenost manjša od terapevtske izpostavljenosti pri človeku, dosežene s 40 mg odmerkom, zato ni moč ustrezno oceniti učinka na plodnost samcev podgan.
The doctor may have to check the condition of the child's liver during treatment.
Zdravnik bo med zdravljenjem morda moral kontrolirati stanje otrokovih jeter.
For adolescents aged 12-17 years, EMEND is available as capsules containing 80 mg, or 125 mg of aprepitant.
Za mladostnike, stare od 12 do 17 let, je zdravilo EMEND na voljo v kapsulah, ki vsebujejo 80 mg ali 125 mg aprepitanta.
Patients were randomised to receive 40 mg aprepitant, 125 mg aprepitant, or 4 mg ondansetron.
Bolniki so bili randomizirani tako, da so prejeli bodisi 40 mg aprepitanta, 125 mg aprepitanta ali 4 mg ondansetrona.
INDIVIDUAL MEASURES
POSAMEZNI MERILI
In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
V kliničnih študijah medsebojnega delovanja aprepitant ni imel klinično pomembnih učinkov na farmakokinetiko ondansetrona, granisetrona ali hidrodolasetrona (aktivnega presnovka dolasetrona).
When dispensing dose(s) to the caregiver, instruct them to refrigerate the oral dispenser(s) until they are ready to administer the dose.
Ko odmerek (odmerke) izdate skrbnikom otroka, jim naročite naj odmernik(e) shranjujejo v hladilniku, dokler niso pripravljeni, da odmerek uporabijo.
- Slowly push the plunger all the way down to give all the medicine in the oral dispenser.
- Počasi potisnite bat do konca da date vso zdravilo iz odmernika.
Due to modest decreases in protein binding of aprepitant in patients with renal disease, the AUC of pharmacologically active unbound aprepitant was not significantly affected in patients with renal impairment compared with healthy subjects.
Zaradi nekoliko manjše vezave aprepitanta na beljakovine pri bolnikih z okvaro ledvic se vrednost AUC farmakološko aktivnega nevezanega aprepitanta v primerjavi z zdravimi preiskovanci ni bistveno spremenila.
Do not give EMEND and tell the doctor or pharmacist if the child is using any of the following medicines (see also under ‘Do not give EMEND').
Otroku ne smete dati zdravila EMEND, zdravniku ali farmacevtu pa morate povedati, če otrok prejema katero od naslednjih zdravil (glejte tudi "Ne dajajte zdravila EMEND").
You may need to use a different or an extra non-hormonal contraceptive during treatment with this medicine and for up to 2 months after treatment has finished.
Morda boste morali med zdravljenjem s tem zdravilom in še do 2 meseca po koncu zdravljenja uporabljati drugo ali dodatno nehormonsko obliko kontracepcije.
EMEND capsules contain sucrose.
Kapsule EMEND vsebujejo saharozo.
Recommended dose of EMEND oral suspension in paediatric patients aged 6 months to less than 12 years
Priporočeni odmerek peroralne suspenzije zdravila EMEND pri pediatričnih bolnikih, starih od 6 mesecev do manj kot 12 let
If you give the child more than you should, contact the doctor straight away.
Če ste otroku dali več zdravila, kot bi smeli, se nemudoma posvetujte z zdravnikom.
This leaflet has been written for the parent or carer who will give this medicine to the child- please read this information carefully.
To navodilo je napisano za starše ali negovalce, ki bodo zdravilo dajali otrokunavodilo natančno preberite!
Adverse reactions were reported in approximately 4 % of adults treated with 40 mg aprepitant compared with approximately 6 % of patients treated with 4 mg ondansetron intravenously.
O neželenih učinkih so poročali pri približno 4 % odraslih, ki so se zdravili z aprepitantom v odmerku 40 mg in pri približno 6 % bolnikov, ki so se zdravili z ondansetronom v odmerku 4 mg intravensko.
No clinically important effect resulted on Day 4 (midazolam AUC0-∞ 1.2-fold increase) and a slight change in midazolam AUC0-∞ was observed on Day 8 (35 % decrease).
4. dan ni bilo nobenega klinično pomembnega učinka (1,2-kratno povečanje vrednosti AUC0- midazolama), 8. dan pa so opazili rahlo spremembo vrednosti AUC0- midazolama (35 % zmanjšanje).
Do not give EMEND powder for oral suspension to children under 6 months of age or who weigh less than 6 kg, or to adolescents between 12 and 18 years, because the powder for oral suspension has not been studied in this population.
Zdravila EMEND prašek za peroralno suspenzijo ne dajajte otrokom, mlajšim od 6 mesecev ali s telesno maso manj kot 6 kg, in prav tako ne mladostnikom, starim od 12 do 18 let, ker prašek za peroralno suspenzijo pri tej populaciji ni bil raziskan.
*The confidence intervals were calculated with no adjustment for gender and region, which were included in the primary analysis using logistic models.
*Intervali zaupanja so bili izračunani brez prilagoditve na spol ali področje, ki sta bila vključena v primarno analizo z uporabo logističnih modelov.
The content of each single-use sachet is to be suspended in 4.6 mL of water giving a final concentration of 25 mg per mL.
Vsebino ene vrečke za enkratno uporabo je treba suspendirati v 4,6 ml vode, da je končna koncentracija 25 mg na ml.
Complete response (no emesis and no rescue therapy) Overall (0-120 hours)
Popoln odziv (brez bruhanja in brez rešilnega zdravljenja) Skupaj (0-120 ur)
Figure 2 Time to first vomiting episode from start of chemotherapy administration - paediatric patients in the overall phase-Cycle 1 (Intent to treat population)
Slika 2 Čas do prvega bruhanja od začetka dajanja kemoterapije - pediatrični bolniki v celotni fazi - 1. ciklus (populacija z-namenom-zdravljenja)
When you have finished do not throw away any medicines via wastewater or household waste.
Ko ste končali, zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
For information regarding birth control, see ‘Other medicines and EMEND'.
Za podatke glede kontracepcije glejte poglavje "Druga zdravila in zdravilo EMEND".
In controlled clinical studies in adults receiving general anaesthesia, 564 patients were administered 40 mg aprepitant orally and 538 patients were administered 4 mg ondansetron intravenously.
V nadzorovanih kliničnih študijah pri odraslih s splošno anestezijo je 564 bolnikov prejelo aprepitant v odmerku 40 mg peroralno, 538 bolnikov pa ondansetron v odmerku 4 mg intravensko.
Gender: Following oral administration of a single 125 mg dose of aprepitant, the Cmax for aprepitant is 16 % higher in females as compared with males.
Spol: Po enem peroralnem odmerku 125 mg aprepitanta je Cmax aprepitanta pri ženskah za 16 % višja kot pri moških.
No significant nausea (maximum VAS < 25 mm on a scale of 0-100 mm) Overall (0-120 hours)
Brez pomembne navzee (največja ocena < 25 mm na vizualni analogni lestvici 0-100 mm) Skupaj (0-120 ur)
WHEN: Take one EMEND 80 mg capsule each morning on the next two days.
KDAJ: V naslednjih 2 dneh vzemite eno EMEND 80 mg kapsulo zjutraj.
This combination (i.e. EMEND, ondansetron and dexamethasone) decreased the AUC of oral midazolam 16 % on Day 6, 9 % on Day 8, 7 % on Day 15 and 17 % on Day 22.
Ta kombinacija (to je zdravilo EMEND, ondansetron in deksametazon) je zmanjšala AUC peroralnega midazolama 6. dan za 16 %, 8. dan za 9 %, 15. dan za 7 % in 22. dan za 17 %.
If you have taken too many capsules, contact your doctor immediately.
Če ste vzeli preveč kapsul, se nemudoma posvetujte z zdravnikom.
The safety and efficacy of EMEND powder for oral suspension in infants below 6 months of age or weighing less than 6 kg has not been established.
Varnost in učinkovitost zdravila EMEND prašek za peroralno suspenzijo pri dojenčkih, mlajših od 6 mesecev ali s telesno maso manj kot 6 kg, nista bili dokazani.
The Cmax was 10 % higher on Day 1 and 24 % higher on Day 5 in elderly relative to younger adults.
Cmax je bila pri starejših preiskovancih 1. dan za 10 % višja, 5. dan pa za 24 % višja kot pri mlajših odraslih preiskovancih.
The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in Figure 1.
Oceno časa do prvega bruhanja v kombinirani analizi prikazuje Kaplan-Meierjeva krivulja na sliki 1.
Fill the oral dispenser with the prescribed dose from the mixing cup according to the table below.
Odmernik napolnite s predpisanim odmerkom iz čaše za mešanje glede na spodnjo preglednico.
Tell the doctor if you or the child is taking these medicines since the treatment must be modified before you or the child start taking EMEND.
Obvestite zdravnika, če vi ali otrok jemljete katerega od teh zdravil, ker je zdravljenje treba prilagoditi, preden vi ali otrok začnete jemati zdravilo EMEND.
Oral administration of the capsule with a standard light breakfast and a high-fat breakfast resulted in an up to an 8 % and a 47 % increase in AUC0-∞ of aprepitant, respectively.
Po peroralni aplikaciji kapsule skupaj s standardnim lahkim zajtrkom oz. z zajtrkom z visoko vsebnostjo maščob je prišlo do 8 % oz. 47 % povečanja vrednosti AUC0- aprepitanta.
This is because their treatment will need to be changed before starting EMEND: - pimozide - for mental health problems - terfenadine and astemizole - for hay fever and other allergies - cisapride - for problems with digestion
Otrokovo zdravljenje bo namreč treba pred začetkom uporabe zdravila EMEND prilagoditi: - pimozid - za težave z duševnim zdravjem - terfenadin in astemizol - za seneni nahod in druge alergije - cisaprid - za zdravljenje prebavnih težav
Highly Emetogenic Chemotherapy Regimen Day 1
Zelo emetogena kemoterapija 1. dan
In vitro studies using human liver microsomes indicate that aprepitant is metabolised primarily by CYP3A4 and potentially with minor contribution by CYP1A2 and CYP2C19.
Študije in vitro s humanimi jetrnimi mikrosomi kažejo, da se aprepitant presnavlja predvsem s CYP3A4 in morda z manjšim prispevkom CYP1A2 in CYP2C19.
% (95 % CI)
% (95 % IZ)
Given the short duration of increased exposure, dose reduction of the immunosuppressant based on Therapeutic Dose Monitoring is not recommended on the day of and the day after administration of EMEND 165 mg.
Zaradi kratkega trajanja povečane izpostavljenosti zmanjšanja odmerka imunosupresivov na podlagi spremljanja terapevtskih odmerkov (Therapeutic Dose Monitoring) na dan uporabe zdravila EMEND 165 mg in dan po njej ne priporočamo.
Aprepitant is also an inducer of CYP2C9.
Aprepitant je tudi induktor CYP2C9.
Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors.
Aprepitant je selektivni antagonist z visoko afiniteto na humanih receptorjih za substanco P nevrokinin 1 (NK1).
If you or the child has taken too many capsules, contact your doctor immediately.
Če ste vi ali otrok vzeli preveč kapsul, se nemudoma posvetujte z zdravnikom.
Table 4 Number (%) of paediatric patients with complete response and no vomiting by treatment group and phase - Cycle 1 (Intent to treat population)
Preglednica 4 Število (%) pediatričnih bolnikov s popolnim odzivom in brez bruhanja po zdravljenih skupinah in fazi - 1. ciklus (populacija z-namenom-zdravljenja)
EMEND is administered orally 1 hour prior to chemotherapy on Days 1, 2 and 3.
Zdravilo EMEND se uporablja peroralno 1 uro pred kemoterapijo 1., 2. in 3. dan.
Given the short duration of the 3-day regimen and the time-dependent limited changes in exposure, dose reduction of the immunosuppressant is not recommended during the 3 days of co-administration with EMEND.
Zaradi kratkega 3-dnevnega režima in časovno odvisnih manjših sprememb izpostavljenosti zmanjšanja odmerka imunosupresivov med 3-dnevno sočasno uporabo z zdravilom EMEND ne priporočamo.
Using a highly specific NK1-receptor tracer, positron emission tomography (PET) studies in healthy young men have shown that aprepitant penetrates into the brain and occupies NK1 receptors in a doseand plasma-concentration-dependent manner.
S študijami pozitronske emisijske tomografije (PET) pri zdravih mladih moških so z uporabo visoko specifičnega označevalca receptorjev NK1 ugotovili, da aprepitant prodre v možgane in zasede receptorje NK1, pri čemer je stopnja zasedenosti odvisna od odmerka in plazemske koncentracije.
% 95 % C.I.
% 95 % IZ
The mean absolute oral bioavailability of aprepitant is 67 % for the 80 mg capsule and 59 % for the 125 mg capsule.
Povprečna absolutna biološka uporabnost po peroralnem zaužitju 80 mg kapsule aprepitanta je 67 %, pri 125 mg kapsuli pa 59 %.
Moderately Emetogenic Chemotherapy Regimen Day 1
Zmerno emetogena kemoterapija 1. dan
EMEND 125 mg/80 mg is given as part of combination therapy (see section 4.2).
Zdravilo EMEND 125 mg/80 mg se daje v sklopu kombiniranega zdravljenja (glejte poglavje 4.2).
It can also be stored refrigerated (between 2°C and 8°C) for up to 72 hours.
Shranjuje se lahko tudi v hladilniku (med 2 °C in 8 °C) do 72 ur.
No dose reduction was required for paediatric patients receiving the control regimen.
Pediatričnim bolnikom, ki so prejemali kontrolno shemo, odmerka ni bilo treba zmanjšati.
Based on interaction studies with tolbutamide and oral contraceptives, total exposure of concomitantly administered active substances metabolised by CYP2C9 or CYP3A4 may be reduced up to 15-30 %.
Na podlagi študij interakcij s tolbutamidom in peroralnimi kontraceptivi se lahko celokupna izpostavljenost sočasno uporabljenim zdravilnim učinkovinam, ki se presnavljajo s CYP2C9 ali CYP3A4, zmanjša za do
Side effects for which the frequency is not known: - Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction).
Neželeni učinki z neznano pogostnostjo so: - Stevens-Johnsonov sindrom/toksična epidermalna nekroliza (redka huda kožna reakcija)
One patient in the Aprepitant regimen only had data in the acute phase and was excluded from the overall and delayed phase analyses; one patient in the Standard regimen only had data in the delayed phase and was excluded from the overall and acute phase analyses.
Za enega bolnika, ki je prejemal aprepitant, so na voljo le podatki iz akutne faze zdravljenja in je bil izključen iz celotne analize in analize podaljšane faze; za enega bolnika, ki je prejemal običajno zdravljenje, so na voljo le podatki iz podaljšane faze in je bil izključen iz celotne analize in analize akutne faze.
- if the child is using ‘cisapride' - (for problems with digestion).
- če otrok uporablja cisaprid - (za zdravljenje prebavnih težav).
Your doctor will ask you to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron) for preventing nausea and vomiting the following three days.
Zdravnik vam bo naročil, da nadaljujete z jemanjem drugih zdravil, vključno s kortikosteroidom (kot je deksametazon) in zaviralcem 5HT3 (kot je ondasetron) za preprečevanje navzee in bruhanja še naslednje tri dni.
In healthy young adults, the increase in AUC0- was 26 % greater than dose proportional between 80 mg and 125 mg single doses administered in the fed state.
Pri zdravih mladih odraslih je bilo povečanje AUC0- za 26 % višje od razmerja odmerkov med posameznima 80 mg in 125 mg odmerkoma, ki so ju preiskovanci prejeli siti.
- with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems).
- skupaj z zdravili, ki vsebujejo pimozid (ki se uporablja za zdravljenje psihiatričnih bolezni), terfenadin ali astemizol (ki se uporabljata za zdravljenje senenega nahoda in drugih alergij) ali cisaprid (ki se uporablja za zdravljenje prebavnih težav).
The mixture will be cloudy pink to light pink.
Mešanica bo motna in rožnata do svetlorožnata.
Each sachet of EMEND for oral suspension contains 125 mg of aprepitant which is to be suspended in 4.6 mL of water giving a final concentration of 25 mg/mL.
Ena vrečka zdravila EMEND za peroralno suspenzijo vsebuje 125 mg aprepitanta, ki ga je potrebno suspendirati v 4,6 ml vode, da je končna koncentracija 25 mg/ml.
In 2 multicentre, randomised, double-blind, active comparator-controlled, parallel-group phase III clinical studies in adults, aprepitant was compared with ondansetron for the prevention of PONV in 1,658 patients undergoing open abdominal surgery.
V 2 multicentričnih, randomiziranih, dvojno slepih, s primerjalno zdravilno učinkovino nadzorovanih kliničnih študijah vzporednih skupin III. faze pri odraslih, so pri preprečevanju PONV aprepitant primerjali z ondansetronom pri 1.658 bolnikih z operacijo na odprti trebušni votlini.
EMEND should be used with caution in these patients (see section 5.2).
Pri teh bolnikih je treba zdravilo EMEND uporabljati previdno (glejte poglavje 5.2).
Aprepitant (125 mg/80 mg) is a substrate, a moderate inhibitor, and an inducer of CYP3A4.
Aprepitant (125 mg/80 mg) je substrat, zmerni zaviralec in induktor CYP3A4.
The AUC0-∞ of aprepitant following oral administration of 165 mg was equivalent to the AUC0-∞ of 150 mg fosaprepitant administered intravenously, while the Cmax was 2.4-fold lower.
Vrednost AUC0- aprepitanta po peroralni aplikaciji 165 mg odmerka je bila ekvivalentna vrednosti AUC0- 150 mg fosaprepitanta, apliciranega intravensko, Cmax pa je bila 2,4-krat nižja.
Studies evaluating the use of aprepitant in paediatric patients are on-going (see section 4.2 for information on paediatric use).
Študije za ovrednotenje uporabe aprepitanta pri pediatričnih bolnikih so v teku (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
If any of the above apply to the child (or you are not sure), talk to the doctor, pharmacist or nurse before giving this medicine.
Če kar koli od naštetega velja za otroka (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden daste to zdravilo.
Concomitant intake of a 40 mg dose with a standard breakfast decreased the aprepitant Cmax by 18 % but did not affect AUC.
Pri jemanju 40 mg odmerka skupaj z običajnim zajtrkom se zmanjša le Cmax aprepitanta za 18 %, vrednost AUC pa se ne spremeni.
A summary of the primary and secondary endpoints is shown in Table 4.
Povzetek primarnih in sekundarnih opazovanih dogodkov je prikazan v preglednici 4.
The potential for effects of aprepitant on fertility has not been fully characterised because exposure levels above the therapeutic exposure in humans could not be attained in animal studies.
Možnost vpliva aprepitanta na plodnost ni v celoti raziskana, saj med študijami na živalih niso mogli doseči ravni izpostavljenosti, ki bi bila višja od terapevtske izpostavljenosti pri človeku.
In a randomised, double-blind, active comparator-controlled clinical study that included 302 children and adolescents (aged 6 months to 17 years) receiving moderately or highly emetogenic chemotherapy, the aprepitant regimen was compared to a control regimen for the prevention of CINV.
V randomizirani, dvojno slepi, s primerjalno zdravilno učinkovino nadzorovani klinični študiji, ki je vključevala 302 otrok in mladostnikov (starih od 6 mesecev do 17 let), ki so prejemali zmerno ali zelo emetogeno kemoterapijo, so primerjali shemo z aprepitantom in kontrolno shemo za preprečevanje navzee in bruhanja zaradi kemoterapije (CINV).
An additional study was completed with intravenous administration of midazolam and EMEND.
Dokončana je bila tudi dodatna študija, v kateri so bolniki prejeli midazolam intravensko in zdravilo EMEND.
Start on the day after your chemotherapy.
Z zdravljenjem začnite dan po kemoterapiji.
Take the EMEND capsule on the first day of your chemotherapy cycle, together with other medicines, to prevent nausea and vomiting.
Vzemite kapsulo zdravila EMEND 1. dan kemoterapije skupaj z drugimi zdravili za preprečevanje navzee in bruhanja.
The median peak plasma concentration (Cmax) was approximately 1.3 µg/mL on Day 1, occurring at approximately 4 hours.
Mediana najvišja koncentracija v plazmi (Cmax) je bila 1. dan približno 1,3 µg/ml in je bila dosežena po približno 4 urah.
In patients with severe renal impairment, the AUC0- of total aprepitant (unbound and protein bound) decreased by 21 % and Cmax decreased by 32 %, relative to healthy subjects.
Pri bolnikih s hudo okvaro ledvic je bila vrednost AUC0- celokupnega aprepitanta (nevezanega in vezanega na beljakovine) za 21 % manjša, Cmax pa je bila za 32 % nižja kot pri zdravih preiskovancih.
Aprepitant does not seem to interact with the P-glycoprotein transporter, as suggested by the lack of interaction of aprepitant with digoxin.
Kaže, da aprepitant ne vstopa v interakcije z digoksinom, kar nakazuje, da nima interakcij s P-glikoproteinskim prenašalcem.
1 hard capsule 6 x 1 hard capsule
1 trda kapsula 6 x 1 trda kapsula