FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no treatment-related effects on mating, fertility or embryonic/foetal survival, and no pathological changes in the reproductive organs.
Slovenian: Ugotovili niso nobenih z zdravljenjem povezanih učinkov na parjenje, plodnost ali preživetje zarodka/ploda in nobenih patoloških sprememb reproduktivnih organov.
English: 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 IVEMEND.
Slovenian: Ker povečana izpostavljenost traja kratek čas, zmanjšanja odmerka imunosupresiva na dan uporabe zdravila IVEMEND in dan po njej na podlagi ugotovitev spremljanja terapevtskih odmerkov ne priporočamo.
English: If you get dizzy or get sleepy, avoid driving or using machines after using this medicine (see ‘Possible side effects').
Slovenian: Če ste po zdravljenju s tem zdravilom omotični ali zaspani, se izogibajte upravljanju vozil in strojev (glejte "Možni neželeni učinki").
English: † Complete response = no vomiting and no use of rescue therapy.
Slovenian: † Popoln odziv = brez bruhanja in brez uporabe rešilnega zdravljenja.
English: Ketoconazole increased the terminal half-life of oral aprepitant about 3-fold.
Slovenian: Ketokonazol je povečal končni razpolovni čas peroralnega aprepitanta za približno 3-krat.
English: In laboratory animals, fosaprepitant in non-commercial formulations caused vascular toxicity and hemolysis at concentrations below 1 mg/ml and higher, dependent on the formulation.
Slovenian: Pri laboratorijskih živalih je fosaprepitant v nekomercialnih pripravkih povzročil vaskularno toksičnost in hemolizo pri koncentracijah pod 1 mg/ml ali višjih, odvisno od pripravka.
English: Do not throw away any medicines via wastewater or house hold waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: In clinical studies, various formulations of fosaprepitant have been administered to a total of 2,687 adults including 371 healthy subjects and 2,084 patients, and 199 children and adolescents with chemotherapy induced nausea and vomiting (CINV).
Slovenian: V kliničnih študijah je različne farmacevtske oblike fosaprepitanta prejelo 2.687 odraslih, vključno s 371 zdravimi osebami in 2.084 bolniki, ter 199 otrok in mladostnikov s kemoterapijo povzročenima navzeo in bruhanjem (CINV - chemotherapy induced nausea and vomiting).
English: An alternative dose regimen that may be used with single-day chemotherapy regimens is shown in Table 4.
Slovenian: Alternativna shema odmerjanja, ki jo je mogoče uporabiti ob enodnevnih shemah kemoterapije, je prikazana v preglednici 4.
English: IVEMEND 150 mg is given as part of a combination therapy (see section 4.2).
Slovenian: Zdravilo IVEMEND 150 mg je namenjeno za uporabo v sklopu kombiniranega zdravljenja (glejte poglavje 4.2).
English: - Infusion site reactions (ISR) at or near the infusion site.
Slovenian: - reakcije na ali v bližini mesta infundiranja.
English: The recommended dose is 150 mg administered as an infusion over 20-30 minutes on Day 1, initiated approximately 30 minutes prior to chemotherapy (see section 6.6).
Slovenian: Priporočeni odmerek je 150 mg, ki se aplicira v obliki 20-30-minutne infuzije 1. dan, s pričetkom približno 30 minut pred kemoterapijo (glejte poglavje 6.6).
English: Fosaprepitant must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride.
Slovenian: Fosaprepitanta se ne sme uporabljati skupaj s pimozidom, terfenadinom, z astemizolom ali s cisapridom.
English: Twelve metabolites of aprepitant have been identified in human plasma.
Slovenian: V humani plazmi so identificirali 12 presnovkov aprepitanta.
English: *Reported in patients taking a higher dose of aprepitant.
Slovenian: *O teh neželenih učinkih so poročali pri bolnikih, ki so jemali aprepitant v višjih odmerkih.
English: In vitro studies using human liver microsomes indicate that aprepitant is metabolised primarily by CYP3A4 and potentially with minor contribution by CYP1A2 and CYP2C19.
Slovenian: Študije in vitro s humanimi jetrnimi mikrosomi kažejo, da se aprepitant presnavlja predvsem s CYP3A4 in morda le v manjši meri s CYP1A2 in CYP2C19.
English: If necessary, for volumes less than 150 ml, the calculated volume can be transferred to an appropriate size bag or syringe prior to administration by infusion.
Slovenian: Če je izračunana količina manjša od 150 ml, jo je mogoče pred infundiranjem prenesti v vrečko ali brizgo ustrezne velikosti, če je to potrebno.
English: Aprepitant after fosaprepitant administration
Slovenian: Aprepitant po aplikaciji fosaprepitanta
English: **N: Number of adult patients included in the intention to treat population.
Slovenian: **N: Število odraslih bolnikov vključenih v populacijo z-namenom-zdravljenja.
English: IVEMEND should not be administered intramuscularly or subcutaneously (see section 5.3).
Slovenian: Zdravila IVEMEND se ne sme dajati intramuskularno ali subkutano (glejte poglavje 5.3).
English: • 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).
Slovenian: • skupaj z zdravili, ki vsebujejo pimozid (uporablja se za zdravljenje psihiatričnih bolezni), terfenadin ali astemizol (uporabljata se pri zdravljenju senenega nahoda in drugih alergijskih stanj), cisaprid (uporablja se za zdravljenje prebavnih težav).
English: ‡Complete response = no vomiting and no use of rescue therapy.
Slovenian: ‡Popoln odziv = brez bruhanja in brez uporabe rešilnega zdravljenja.
English: Efficacy data in combination with other corticosteroids and 5-HT3 antagonists are limited.
Slovenian: Število podatkov o učinkovitosti pri sočasni uporabi z drugimi kortikosteroidi in antagonisti 5-HT3 je omejeno.
English: Dexamethasone should also be administered in the evenings on Days 3 and 4.
Slovenian: Deksametazon je treba vzeti tudi 3. in 4. dan zvečer.
English: Co-administration with hormonal contraceptives
Slovenian: Sočasna uporaba s hormonskimi kontraceptivi
English: What IVEMEND is and what it is used for What you need to know before you use IVEMEND How to use IVEMEND
Slovenian: Kaj je zdravilo IVEMEND in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo IVEMEND Kako uporabljati zdravilo IVEMEND Možni neželeni učinki
English: Hypersensitivity to the active substance or to polysorbate 80 or any of the other excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino ali polisorbat 80 ali katero koli drugo pomožno snov, navedeno v poglavju 6.1.
English: All paediatric patients
Slovenian: Vsi pediatrični bolniki
English: Hepatic impairment: Fosaprepitant is metabolized in various extrahepatic tissues; therefore hepatic impairment is not expected to alter the conversion of fosaprepitant to aprepitant.
Slovenian: Okvara jeter: Fosaprepitant se presnavlja v številnih ekstrahepatičnih tkivih, zato ne pričakujemo, da bi okvara jeter vplivala na pretvorbo fosaprepitanta v aprepitant.
English: The solution for infusion is given to you by a health care professional, such as a doctor or nurse, via an intravenous infusion (a drip) approximately 30 minutes before you start the chemotherapy treatment in adults or 60 - 90 minutes before you start the chemotherapy treatment in children and adolescents.
Slovenian: Raztopino za infundiranje vam bo dal zdravstveni delavec, na primer zdravnik ali medicinska sestra, v obliki kapljične intravenske infuzije približno 30 minut pred začetkom kemoterapije pri odraslih ali 60-90 minut pred začetkom kemoterapije pri otrocih in mladostnikih.
English: Vascular disorders flushing, thrombophlebitis (predominantly, infusion-site thrombophlebitis)
Slovenian: Žilne bolezni zardevanje, tromboflebitis (predvsem tromboflebitis na mestu infundiranja)
English: • if you are allergic to fosaprepitant, aprepitant, or to polysorbate 80 or any of the other ingredients (listed in section 6).
Slovenian: • če ste alergični na fosaprepitant, aprepitant, polisorbat 80 ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6),
English: IVEMEND is incompatible with any solutions containing divalent cations (e.g., Ca
Slovenian: Zdravilo IVEMEND je inkompatibilno z raztopinami, ki vsebujejo dvovalentne katione (npr. Ca Mg
English: Concomitant administration of fosaprepitant with herbal preparations containing St. John's Wort (Hypericum perforatum) is not recommended.
Slovenian: Sočasne uporabe fosaprepitanta in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), ne priporočamo.
English: Co-administration with pimozide, terfenadine, astemizole or cisapride (see section 4.5).
Slovenian: Sočasna uporaba pimozida, terfenadina, astemizola ali cisaprida (glejte poglavje 4.5).
English: In adults (18 years of age and older), the recommended dose of IVEMEND is 150 mg fosaprepitant on Day 1 (day of chemotherapy).
Slovenian: Pri odraslih (starih 18 let ali več) je priporočeni odmerek zdravila IVEMEND 150 mg fosaprepitanta 1. dan (dan kemoterapije).
English: powder for solution for infusion 1 vial
Slovenian: prašek za raztopino za infundiranje 1 viala
English: Plasma concentrations of fosaprepitant are below quantifiable levels within 30 minutes of the completion of infusion.
Slovenian: Plazemske koncentracije fosaprepitanta so v 30 minutah po koncu infuzije manjše od določljivih vrednosti.
English: Immune system disorders hypersensitivity reactions including anaphylactic reactions not known
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami neznana
English: At the end of the follow-up period (post-dose day 8), up to slight local subacute inflammation was noted following paravenous and intramuscular administration and additional up to moderate focal muscle degeneration/necrosis with muscle regeneration following intramuscular administration.
Slovenian: Po končanem obdobju spremljanja (8. dan po odmerku) so po paravenski in intramuskularni aplikaciji opazili do največ rahlo lokalno subakutno vnetje, po intramuskularni aplikaciji pa še do največ zmerno žariščno degeneracijo/nekrozo mišic z mišično regeneracijo.
English: These studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Te študije niso pokazale neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: The following information was derived from studies conducted with oral aprepitant and studies conducted with intravenous single-dose fosaprepitant co-administered with dexamethasone, midazolam, or diltiazem.
Slovenian: Naslednje informacije so povzete iz študij, izvedenih s peroralnim aprepitantom, in iz študij, izvedenih z enim intravenskim odmerkom fosaprepitanta v kombinaciji z deksametazonom, midazolamom ali diltiazemom.
English: Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older.
Slovenian: Preprečevanje navzee in bruhanja, povezanih z zelo in zmerno emetogeno kemoterapijo rakavih bolezni pri odraslih in pediatričnih bolnikih, starih 6 mesecev ali več.
English: The majority of severe ISRs, including thrombophlebitis and vasculitis, were reported with concomitant vesicant (e.g., anthracycline-based) chemotherapy administration, particularly when associated with extravasation.
Slovenian: O večini hudih reakcij na mestu infundiranja, vključno s tromboflebitisom in vaskulitisom, so poročali pri sočasni uporabi kemoterapije z vezikanti (na primer na osnovi antraciklinov), še posebej v povezavi z ekstravazacijo.
English: The brain has a specific area that controls nausea and vomiting.
Slovenian: V možganih je določeno področje, ki nadzira navzeo (siljenje na bruhanje) in bruhanje.
English: Effect of fosaprepitant on the pharmacokinetics of other active substances CYP3A4 inhibition
Slovenian: Vpliv fosaprepitanta na farmakokinetiko drugih zdravilnih učinkovin Zaviranje CYP3A4
English: 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.
Slovenian: Zaradi nekoliko manjše vezave aprepitanta na beljakovine pri bolnikih z okvaro ledvic, se AUC farmakološko aktivnega nevezanega zdravila v primerjavi z zdravimi preiskovanci ni bistveno spremenila.
English: IVEMEND should be used with caution in these patients (see sections 4.4 and 5.2).
Slovenian: Pri teh bolnikih je treba zdravilo IVEMEND uporabljati previdno (glejte poglavji 4.4 in 5.2).
English: How to use IVEMEND
Slovenian: Kako uporabljati zdravilo IVEMEND
English: fosaprepitant dose were also observed following an oral dose of [
Slovenian: C]-fosaprepitanta so bili opaženi tudi po peroralnem odmerku [
English: Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin (vesicant) with side effects, including pain, swelling and redness.
Slovenian: Najhujše reakcije na mestu infundiranja so se pojavile pri določeni vrsti kemoterapevtskih zdravil, ki lahko povzročijo opeklino ali mehurje na koži (vezikanti) s stranskimi učinki, vključno z bolečino, otekanjem in rdečino.
English: Adults The entire volume of the prepared infusion bag (150 ml) should be administered.
Slovenian: Odrasli Infundirati je treba celotno količino (150 ml) v pripravljeni vrečki za infundiranje.
English: In human washed blood cells also evidence of hemolysis was found with non-commercial formulations at fosaprepitant concentrations of 2.3 mg/ml and higher, although tests in human whole blood were negative.
Slovenian: V spranih človeških krvnih celicah so ob uporabi nekomercialnih pripravkov ugotovili tudi znake hemolize pri koncentraciji fosaprepitanta 2,3 mg/ml ali več, testi na polni človeški krvi pa so bili negativni.
English: 2 mg/kg intravenously OR 2 mg/kg orally (EMEND oral suspension)
Slovenian: 2 mg/kg intravensko ALI 2 mg/kg peroralno (peroralna suspenzija EMEND)
English: Investigations blood pressure increased uncommon
Slovenian: Preiskave zvišan krvni tlak občasni
English: Paediatric patients 12 years and older
Slovenian: Pediatrični bolniki, stari 12 let ali več
English: Safety data following the administration of the 3-day IV/oral/oral regimen were also included.
Slovenian: Vključeni so bili tudi podatki o varnosti po uporabi 3-dnevne i.v./p.o./p.o.
English: Gender No dose adjustment is necessary based on gender (see section 5.2).
Slovenian: Spol Odmerka ni treba prilagoditi glede na spol (glejte poglavje 5.2).
English: 2 - < 6 years old
Slovenian: 2 - < 6 let
English: Maximum dose 80 mg
Slovenian: največji odmerek 80 mg
English: In an additional active-controlled clinical study in 1,169 adult patients receiving aprepitant and HEC, the adverse reactions profile was generally similar to that seen in the other HEC studies with aprepitant.
Slovenian: V dodatni z zdravilno učinkovino nadzorovani klinični študiji pri 1.169 odraslih bolnikih, ki so prejemali aprepitant in zelo emetogeno kemoterapijo, je bil profil neželenih učinkov na splošno podoben tistemu v drugih HEC študijah z aprepitantom.
English: The metabolism of aprepitant occurs largely via oxidation at the morpholine ring and its side chains and the resultant metabolites were only weakly active.
Slovenian: Presnova aprepitanta poteka večinoma z oksidacijo na morfolinskem obroču in na njegovih stranskih verigah; aktivnost tako nastalih presnovkov je šibka.
English: IVEMEND can affect other medicines both during and after treatment with IVEMEND.
Slovenian: Zdravilo IVEMEND lahko vpliva na delovanje drugih zdravil, tako med kot po koncu zdravljenja z njim.
English: There are some medicines that should not be taken with IVEMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also ‘Do not use IVEMEND').
Slovenian: Nekaterih zdravil se skupaj z zdravilom IVEMEND ne sme uporabljati (kot so pimozid, terfenadin, astemizol in cisaprid) ali pa je treba njihov odmerek prilagoditi (glejte tudi "Zdravila IVEMEND ne smete prejeti").
English: It is anticipated that IVEMEND would cause less or no greater induction of CYP2C9, CYP3A4, and glucuronidation than that caused by the administration of the 3-day oral aprepitant regimen, for which a transient induction with its maximum effect 6-8 days after first aprepitant dose has been observed.
Slovenian: Pričakujemo, da zdravilo IVEMEND povzroči manjšo ali pa vsaj ne večje indukcije CYP2C9, CYP3A4 in glukuronidacije v primerjavi s 3-dnevnim režimom zdravljenja s peroralnim aprepitantom, pri katerem so opazili prehodno indukcijo z največjim učinkom 6-8 dni po prvem odmerku aprepitanta.
English: The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see section 6.2).
Slovenian: Zdravila ne smete pripravljati ali mešati z raztopinami, za katere ni bila dokazana fizikalna in kemična kompatibilnost (glejte poglavje 6.2).
English: The safety profile of the 3-day IV fosaprepitant regimen in paediatric patients is expected to be similar to that of the 1-day fosaprepitant regimen as the low daily trough levels do not significantly increase the exposures on subsequent days.
Slovenian: Varnostni profil 3-dnevne intravenske sheme fosaprepitanta je pri pediatričnih bolnikih predvidoma podoben kot pri 1-dnevni shemi fosaprepitanta, saj nizke dnevne najnižje koncentracije v naslednjih dneh izpostavljenosti bistveno ne povečajo.
English: Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4.
Slovenian: Deksametazon je treba vzeti 1. dan 30 minut pred kemoterapijo ter od 2. do 4. dne zjutraj.
English: After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml) (see section 6.6).
Slovenian: Po rekonstituciji in redčenju 1 ml raztopine vsebuje 1 mg fosaprepitanta (1 mg/ml) (glejte poglavje 6.6).
English: The frequency categories in the table are based on studies in adults; the observed frequencies in the paediatric studies were similar or lower.
Slovenian: Kategorije pogostnosti v preglednici temeljijo na študijah pri odraslih; v študijah pri pediatričnih bolnikih so bile opažene pogostnosti podobne ali manjše.
English: Carcinogenic potential in rodents was only investigated with orally administered aprepitant.
Slovenian: Kancerogeni potencial je bil pri glodavcih ovrednoten le pri peroralnem dajanju aprepitanta.
English: In patients 12 years and older, the volume to be administered is calculated as follows:
Slovenian: Za bolnike, stare 12 let ali več, je treba količino za infundiranje izračunati tako:
English: In patients 6 months to less than 12 years, the volume to be administered is calculated as follows:
Slovenian: Za bolnike, stare od 6 mesecev do manj kot 12 let, je treba količino za infundiranje izračunati tako:
English: In the performed safety pharmacology and repeated dose toxicity studies with dogs, fosaprepitant Cmax and aprepitant AUC values were up to 3 times and 40 times, respectively, higher than clinical values.
Slovenian: V izvedenih študijah farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih na psih, je bila vrednost Cmax fosaprepitanta do 3-krat večja od klinične vrednosti, vrednost AUC aprepitanta pa do 40-krat večja od klinične vrednosti.
English: The terminal half-life of aprepitant following a 150 mg intravenous dose of fosaprepitant was approximately 11 hours.
Slovenian: Končni razpolovni čas aprepitanta po 150 mg intravenskem odmerku fosaprepitanta je bil približno 11 ur.
English: IVEMEND is used in adults, adolescents, and children aged 6 months or older in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that is a strong or moderate trigger of nausea and vomiting.
Slovenian: Zdravilo IVEMEND se uporablja pri odraslih, mladostnikih in otrocih, starih 6 mesecev ali več, v kombinaciji z drugimi zdravili za preprečevanje navzee (siljenja na bruhanje) in bruhanja zaradi kemoterapije (zdravljenje raka), ki je močan ali zmeren povzročitelj siljenja na bruhanje in bruhanja.
English: Therefore, breast-feeding is not recommended during treatment with IVEMEND.
Slovenian: Zato med zdravljenjem z zdravilom IVEMEND dojenje ni priporočljivo.
English: The 3-day oral aprepitant regimen resulted in an about 30-35 % reduction in AUC of CYP2C9 substrates and up to a 64 % decrease in ethinyl estradiol trough concentrations.
Slovenian: Pri 3-dnevnem režimu zdravljenja s peroralnim aprepitantom se je AUC substratov za CYP2C9 zmanjšala za približno 30-35 %, koncentracija etinilestradiola tik pred naslednjim odmerkom pa za do 64 %.
English: Instructions of how to reconstitute and dilute IVEMEND 150 mg
Slovenian: Navodila za rekonstitucijo in redčenje zdravila IVEMEND 150 mg
English: • Volume to administer (ml) = recommended dose (mg/kg) x weight (kg) o Note: Do not exceed maximum doses (see section 4.2).
Slovenian: • Količina za apliciranje (ml) = priporočeni odmerek (mg/kg) x telesna masa (kg) o Opomba: Ne prekoračite največjih odmerkov (glejte poglavje 4.2).
English: The most common adverse reactions reported at a greater incidence in adults treated with the aprepitant regimen than with standard therapy in patients receiving HEC were: hiccups (4.6 % versus 2.9 %), alanine aminotransferase (ALT) increased (2.8 % versus 1.1 %), dyspepsia (2.6 % versus 2.0 %), constipation (2.4 % versus 2.0 %), headache (2.0 % versus 1.8 %), and decreased appetite (2.0 % versus 0.5 %).
Slovenian: Najpogostejši neželeni učinki pri zelo emetogeni kemoterapiji (HEC), o katerih so pri odraslih, ki so se zdravili z aprepitantom, poročali pogosteje kot pri bolnikih med standardno obliko zdravljenja so: kolcanje (4,6 % proti 2,9 %), zvišana vrednost alanin aminotransferaze (ALT ) (2,8 % proti 1,1 %), dispepsija (2,6 % proti 2,0 %), zaprtje (2,4 % proti 2,0 %), glavobol (2,0 % proti 1,8 %) in zmanjšan apetit (2,0 % proti 0,5 %).
English: Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant (see section 5.2).
Slovenian: Fosaprepitant je predzdravilo aprepitanta, ki se po intravenski aplikaciji hitro pretvori v aprepitant (glejte poglavje 5.2).
English: The powder is reconstituted and diluted before use.
Slovenian: Pred uporabo je treba prašek raztopiti in razredčiti.
English: 12 - 17 years old 115mg, 80mg, 80mg
Slovenian: 115 mg, 80 mg, 80 mg
English: Additionally, in a placebo-controlled clinical trial in adult patients receiving MEC, safety was evaluated for 504 patients receiving a single dose of IVEMEND 150 mg compared to 497 patients receiving the control regimen.
Slovenian: Poleg tega so v s placebom nadzorovanem kliničnem preskušanju pri odraslih bolnikih, ki so prejemali MEC, ovrednotili varnost pri 504 bolnikih, ki so prejeli enkraten odmerek zdravila IVEMEND 150 mg, in pri 497 bolnikih, ki so prejeli kontrolno shemo zdravljenja.
English: The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see Summary of Product Characteristic (SmPC), section 6.2).
Slovenian: Zdravila ne smete pripravljati ali mešati z raztopinami, za katere ni bila dokazana fizikalna in kemična kompatibilnost (glejte poglavje 6.2 Povzetka glavnih značilnosti zdravila (SmPC)).
English: In patients with ESRD undergoing haemodialysis, the AUC0- of total aprepitant decreased by 42 % and Cmax decreased by 32 %.
Slovenian: Pri bolnikih s končno ledvično odpovedjo na hemodializi je bila AUC0- celokupnega aprepitanta za 42 % manjša, Cmax pa za 32 % nižja.
English: Because of the antiemetic activity of aprepitant, emesis induced by a medicinal product may not be effective.
Slovenian: Zaradi antiemetičnega delovanja aprepitanta zdravljenje z zdravili za spodbujanje bruhanja lahko ne bo učinkovito.