FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reactions profiles in adults in the Multiple-Cycle extension of HEC and MEC studies for up to 6 additional cycles of chemotherapy were generally similar to those observed in Cycle 1.
Slovenian: Profili neželenih učinkov pri odraslih so bili v podaljšku HEC in MEC študij z več ciklusi zdravljenja (do 6 dodatnih ciklusov kemoterapije) na splošno podobni tistim po prvem ciklusu.
English: • Pour entire contents of the sachet into the 4.6 mL of water and mix.
Slovenian: • Celotno vsebino vrečke stresite v 4,6 ml vode in zmešajte.
English: * The confidence intervals were calculated with no adjustment for gender and concomitant chemotherapy, which were included in the primary analysis of odds ratios and logistic models.
Slovenian: * Intervali zaupanja so bili izračunani brez prilagoditve glede na spol in na sočasno kemoterapijo, ki sta bila vključena v primarno analizo razmerij obetov in logističnih modelov.
English: During days 9 through 21 in this study, there was as much as a 64 % decrease in ethinyl estradiol trough concentrations and as much as a 60 % decrease in norethindrone trough concentrations.
Slovenian: Med 9. in 21. dnem je v tej študiji prišlo do kar 64 % znižanja koncentracije etinilestradiola tik pred naslednjim odmerkom in do 60 % znižanja koncentracije noretindrona tik pred naslednjim odmerkom.
English: In a study with 2 mg midazolam orally co-administered with 200 mg aprepitant in the fed state (standard light breakfast), the AUC0-∞ of midazolam, a sensitive CYP3A4 substrate, was increased 3.2-fold on Day 1.
Slovenian: V študiji z uporabo 2 mg midazolama peroralno skupaj z 200 mg aprepitanta po jedi (standardni lahki zajtrk) se je vrednost AUC0- midazolama, ki je občutljiv substrat za CYP3A4, 1. dan povečala za 3,2-krat.
English: Control regimen n/m (%)
Slovenian: Kontrolna shema n/m (%)
English: Your doctor has prescribed EMEND, an anti-emetic, to help prevent nausea and vomiting associated with chemotherapy.
Slovenian: Zdravnik vam je predpisal zdravilo EMEND, antiemetik, za preprečevanje navzee (siljenja na bruhanje) in bruhanja zaradi zdravljenja s kemoterapijo.
English: EMEND works by blocking signals to that area and is used to prevent nausea and vomiting after surgery in adults.
Slovenian: Zdravilo EMEND deluje tako, da blokira signale v to področje in se uporablja za preprečevanje navzee (siljenja na bruhanje) in bruhanja po operaciji pri odraslih.
English: Intravenous 2 mg midazolam was given 1 hour after oral administration of a single dose of EMEND 125 mg.
Slovenian: Bolniki so prejeli midazolam v odmerku 2 mg intravensko 1 uro po prejemu enega samega 125 mg peroralnega odmerka zdravila EMEND.
English: If the child misses a dose of this medicine, talk to the doctor.
Slovenian: Če otrok ni dobil enega odmerka tega zdravila, se posvetujte z zdravnikom.
English: The daily dose of dexamethasone on Days 1 and 2 should be reduced by approximately 50 % when co-administered with EMEND 165 mg on Day 1 to achieve exposures of dexamethasone similar to those obtained when given without EMEND 165 mg.
Slovenian: Dnevni odmerek deksametazona na 1. in 2. dan je treba pri sočasni uporabi z zdravilom EMEND 165 mg 1. dan zmanjšati za približno 50 %, da bi bila izpostavljenost deksametazonu podobna kot pri jemanju brez zdravila EMEND 165 mg.
English: Do not give EMEND 80 mg and 125 mg capsules to children under 12 years of age, because the 80 mg and 125 mg capsules have not been studied in this population.
Slovenian: Zdravila EMEND 80 mg in 125 mg kapsule ne dajajte otrokom, mlajšim od 12 let, ker 80 mg in 125 mg kapsule pri tej populaciji niso bile raziskane.
English: There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh class C).
Slovenian: Kliničnih podatkov o farmakokinetiki aprepitanta pri bolnikih s hudo okvaro jeter (razred C po Child-Pugh-ovi klasifikaciji) ni.
English: Fosaprepitant 150 mg, a lyophilised prodrug of aprepitant for intravenous administration, is also available as a single dose and may be used as an alternative to oral EMEND 165 mg.
Slovenian: V obliki enkratnega odmerka je na voljo tudi fosaprepitant 150 mg, liofilizirano predzdravilo aprepitanta za intravensko uporabo, ki se ga lahko uporabi kot alternativo peroralnemu zdravilu EMEND 165 mg.
English: In a randomised, parallel, double-blind, active-controlled study, fosaprepitant 150 mg (N=1,147) was compared with a 3-day aprepitant regimen (N=1,175) in adult patients receiving a HEC regimen that included cisplatin (≥ 70 mg/m2).
Slovenian: V randomizirani, vzporedni, dvojno slepi, z zdravilno učinkovino nadzorovani študiji so primerjali fosaprepitant 150 mg (N=1.147) s 3-dnevnim režimom zdravljenja z aprepitantom (N=1.175) pri odraslih bolnikih, ki so prejemali zelo emetogeno kemoterapijo, ki je vključevala cisplatin ( 70 mg/m2).
English: Dexamethasone: A single 40 mg dose of aprepitant, when co-administered with a single oral dose of dexamethasone 20 mg, increased the AUC of dexamethasone by 1.45-fold.
Slovenian: Deksametazon: Enkratni 40 mg odmerek aprepitanta pri sočasnem dajanju z enkratnim peroralnim odmerkom deksametazona 20 mg, poveča AUC deksametazona za 1,45-krat.
English: This effect may be expected to be more pronounced for orally administered methylprednisolone.
Slovenian: Verjetno je ta učinek pri peroralnem odmerjanju metilprednizolona izrazitejši.
English: The oral suspension should be prepared and the dose measured by healthcare professionals only.
Slovenian: Peroralno suspenzijo lahko pripravi in odmeri le zdravstveno osebje.
English: EMEND or placebo and ondansetron were administered 1 hour and 30 minutes prior to initiation of chemotherapy, respectively.
Slovenian: Zdravilo EMEND ali placebo so uporabili 1 uro pred začetkom kemoterapije, ondansetron pa 30 minut pred začetkom kemoterapije.
English: Clinical treatment guidelines should be considered as regards the need for prophylactic treatment against postoperative nausea and vomiting (PONV).
Slovenian: Pri presoji o potrebi po profilaktičnem zdravljenju pooperacijske navzee in bruhanja (PONV) je treba upoštevati smernice kliničnega zdravljenja.
English: A dose reduction (50 %) of dexamethasone was required for paediatric patients receiving aprepitant.
Slovenian: Pri pediatričnih bolnikih, ki so prejemali aprepitant, je bilo potrebno zmanjšanje (50 %) odmerka deksametazona.
English: Data are lacking regarding effects on CYP2C8 and CYP2C19.
Slovenian: Podatkov glede učinka na CYP2C8 in na CYP2C19 ni.
English: Effect of aprepitant on the pharmacokinetics of other active substances CYP3A4 inhibition
Slovenian: Učinek aprepitanta na farmakokinetiko drugih zdravilnih učinkovin Inhibicija CYP3A4
English: The total exposure of orally administered CYP3A4 substrates may increase up to approximately 3-fold for 2 days following a single 165 mg dose of EMEND and decreasing to baseline approximately 4 days after dosing of 165 mg EMEND.
Slovenian: Celokupna izpostavitev peroralno vzetim substratom za CYP3A4 se lahko poveča do približno 3-krat za 2 dni po enkratnem 165 mg odmerku zdravila EMEND in pade na izhodiščno približno 4 dni po zaužitju 165 mg zdravila EMEND.
English: During treatment with EMEND, CYP3A4 is inhibited.
Slovenian: Med zdravljenjem z zdravilom EMEND je CYP3A4 inhibiran.
English: Following oral administration of a single 40 mg dose of EMEND in the fasted state, the AUC0- (mean ± SD) was 8.0 ± 2.1 µg • h/mL and the Cmax was 0.7 ± 0.24 µg/mL.
Slovenian: Po peroralnem dajanju enkratnega 40 mg odmerka zdravila EMEND na tešče je bila AUC0- (povprečje ± SD) 8,0 ± 2,1 µg•h/ml, Cmax pa 0,7 ± 0,24 µg/ml.
English: 1 hard capsule 5 x 1 hard capsule
Slovenian: 1 trda kapsula 5 x 1 trda kapsula
English: Cardiac disorders palpitations uncommon bradycardia, cardiovascular disorder rare
Slovenian: Srčne bolezni palpitacije občasni bradikardija, kardiovaskularne motnje redki
English: EMEND increased the AUC of midazolam 25 % on Day 4 and decreased the AUC of midazolam 19 % on Day 8 and 4 % on Day 15.
Slovenian: Zdravilo EMEND je 4. dan povečalo AUC midazolama za 25 %, 8. dan ga je zmanjšalo za 19 %, 15. dan pa za 4 %.
English: The efficacy of the 125 mg powder for oral suspension has not been established in children 12 years of age and older.
Slovenian: Učinkovitost 125 mg praška za peroralno suspenzijo pri otrocih, starih 12 let ali več, ni bila dokazana.
English: Psychiatric disorders anxiety uncommon disorientation, euphoric mood rare
Slovenian: Psihiatrične motnje anksioznost občasni dezorientacija, evforično razpoloženje redki
English: Dexamethasone should also be administered in the evenings on Days 3 and 4.
Slovenian: Deksametazon morajo bolniki dobiti tudi 3. in 4. dan zvečer.
English: Use this medicine within 2 days of getting the medicine from the healthcare provider.
Slovenian: Ko dobite zdravilo od zdravstvenega delavca, ga uporabite v 2 dneh.
English: - Place the tip of the oral dispenser in the child's mouth along in the inner cheek on either the right or left side.
Slovenian: - Konico odmernika dajte otroku v usta in jo usmerite v notranjo stran otrokovega lica,
English: Dizziness and fatigue may occur following administration of EMEND (see section 4.8).
Slovenian: Po zaužitju zdravila EMEND se lahko pojavita omotica in utrujenost (glejte poglavje 4.8).
English: - If the child will have chemotherapy - give this medicine one hour before the start of the chemotherapy session.
Slovenian: - Če bo otrok dobil kemoterapijo, mu dajte zdravilo eno uro pred začetkom kemoterapije.
English: Common side effects (may affect up to 1 in 10 people) are: - increased amount of liver enzymes in your blood.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) so: - zvišana vrednost jetrnih encimov v krvi.
English: EMEND 165 mg is given as part of combination therapy (see section 4.2).
Slovenian: Zdravilo EMEND 165 mg se daje v sklopu kombiniranega zdravljenja (glejte poglavje 4.2).
English: Efficacy was based on evaluation of the following composite measure: complete response (defined as no emetic episodes and no use of rescue therapy) primarily during Cycle 1.
Slovenian: Učinkovitost zdravljenja je temeljila na naslednjem sestavljenem merilu: popoln odziv (opredeljen kot odsotnost bruhanja in brez rešilnega zdravljenja) primarno v 1. ciklusu.
English: One patient in the Aprepitant regimen only had data in the acute phase and was excluded from the overall and delayed phase analyses.
Slovenian: 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.
English: Do not give EMEND 165 mg to children and adolescents under 18 years of age, because the 165 mg capsules have not been studied in this population.
Slovenian: Zdravila EMEND 165 mg ne dajajte otrokom in mladostnikom, mlajšim od 18 let, ker 165 mg kapsule pri tej populaciji niso bile raziskane.
English: If you or the child are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor for advice before taking this medicine.
Slovenian: Če ste vi ali otrok noseči ali dojite, bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: The recommended dose is 125 mg orally once daily one hour before start of chemotherapy on Day 1 and 80 mg orally once daily on Days 2 and 3 in the morning.
Slovenian: Priporočeni odmerek je 125 mg peroralno enkrat dnevno eno uro pred pričetkom kemoterapije 1. dan ter 80 mg peroralno enkrat na dan 2. in 3. dan zjutraj.
English: The recommended oral dose of EMEND is Day 1: - one 125 mg capsule 1 hour before you start your chemotherapy session and
Slovenian: Priporočeni peroralni odmerek zdravila EMEND je 1. dan: - ena 125 mg kapsula 1 uro pred začetkom kemoterapije in
English: How to give EMEND
Slovenian: Kako dajati zdravilo EMEND
English: In a juvenile toxicity study in dogs treated from post natal day 14 to day 42, a decreased testicular weight and Leydig cell size were seen in the males at 6 mg/kg/day and increased uterine weight, hypertrophy of the uterus and cervix, and oedema of vaginal tissues were seen in females from 4 mg/kg/day.
Slovenian: V študiji toksičnosti pri mladih psih, ki so od 14. do 42. dne postnatalno dobivali aprepitant, so pri samcih opažali manjšo maso testisov in manjšo velikost Leydigovih celic pri odmerku 6 mg/kg/dan, pri samicah pa večjo maso maternice, hipertrofijo maternice in materničnega vratu ter edem nožničnih tkiv pri odmerkih od 4 mg/kg/dan.
English: EMEND powder for oral suspension is given as part of combination therapy (see section 4.2).
Slovenian: Zdravilo EMEND prašek za peroralno suspenzijo se daje v sklopu kombiniranega zdravljenja (glejte poglavje 4.2).
English: Patients with rare hereditary problems of fructose or galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency, or sucrase-isomaltase insufficiency should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo ali galaktozo, malabsorpcijo glukoze/galaktoze, laponsko obliko zmanjšane aktivnosti laktaze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
English: Caution is advised and additional monitoring may be appropriate in patients receiving medicinal products metabolized primarily or partly by CYP3A4 (see section 4.4).
Slovenian: Pri bolnikih, ki dobivajo zdravila, ki se primarno ali delno presnavljajo s CYP3A4 , svetujemo previdnost, lahko je potreben tudi dodaten nadzor (glejte poglavje 4.4).
English: After reconstitution, 1 mL oral suspension contains 25 mg of aprepitant.
Slovenian: Po rekonstituciji 1 ml peroralne suspenzije vsebuje 25 mg aprepitanta.
English: 2 mg/kg orally Maximum dose 80 mg
Slovenian: 2 mg/kg peroralno največji odmerek 80 mg
English: The safety and efficacy of EMEND 165 mg in children and adolescents below 18 years of age has not been established.
Slovenian: Varnost in učinkovitost zdravila EMEND 165 mg pri otrocih in mladostnikih pod 18 let nista bili dokazani.
English: Interaction studies with aprepitant 165 mg and chemotherapeutic medicinal products have not been conducted; however, based on studies with 3-day regimen of oral aprepitant and docetaxel and vinorelbine, EMEND 165 mg is not expected to have a clinically relevant interaction with intravenously administered docetaxel and vinorelbine.
Slovenian: Študije medsebojnega delovanja aprepitanta 165 mg in kemoterapevtikov niso bile izvedene, vendar pa na podlagi študij s 3-dnevno shemo jemanja peroralnega aprepitanta ter docetakselom in vinorelbinom ni pričakovati, da bi zdravilo EMEND 165 mg povzročalo klinično pomembne interakcije z intravensko apliciranima docetakselom in vinorelbinom.
English: EMEND 125 mg and 80 mg hard capsules are supplied in the following pack sizes: - Aluminium blister containing one 80 mg capsule - 2-day treatment pack containing two 80 mg capsules - 5 Aluminium blisters each containing one 80 mg capsule - Aluminium blister containing one 125 mg capsule - 5 Aluminium blisters each containing one 125 mg capsule - 3-day treatment pack containing one 125 mg capsule and two 80 mg capsules
Slovenian: EMEND 125 mg in 80 mg trde kapsule so na voljo v naslednjih pakiranjih: - ena 80 mg kapsula v aluminijastem pretisnem omotu; - dve 80 mg kapsuli v pakiranju za 2 dnevno zdravljenje; - 5 aluminijastih pretisnih omotov, ki vsebujejo po eno 80 mg kapsulo; - ena 125 mg kapsula v aluminijastem pretisnem omotu; - 5 aluminijastih pretisnih omotov, ki vsebujejo po eno 125 mg kapsulo; - v pakiranju za 3-dnevno zdravljenje, ki vsebuje eno 125 mg kapsulo in dve 80 mg kapsuli.
English: What you need to know before you take or give EMEND
Slovenian: Kaj morate vedeti, preden boste vzeli ali dali zdravilo EMEND
English: Standard therapy (N= 406)
Slovenian: Standardno zdravljenje (N = 406)
English: Fill the 5 mL oral dispenser with 4.6 mL of water from the mixing cup.
Slovenian: 5-ml odmernik napolnite s 4,6 ml vode iz čaše za mešanje.
English: EMEND 165 mg hard capsules are supplied in cartons in the following pack sizes: - Aluminium blister containing one 165 mg capsule - 6 Aluminium blisters each containing one 165 mg capsule
Slovenian: EMEND 165 mg trde kapsule so na voljo v škatlah v naslednjih velikostih pakiranja: - aluminijast pretisni omot, ki vsebuje eno 165 mg kapsulo - 6 aluminijastih pretisnih omotov, vsak z eno 165 mg kapsulo
English: Although no adverse effects were noted in reproduction studies when adult female animals were exposed 3.5-to 4-fold above the therapeutic exposure in humans at 40 mg, the potential effects on reproduction of alterations in neurokinin regulation are unknown.
Slovenian: Neželenih vplivov na sposobnost razmnoževanja pri sistemski izpostavljenosti odraslih samic, ki je bila 3,5- do 4-krat večja od izpostavljenosti človeka pri 40 mg odmerku niso opazili, vendar pa možni vplivi na sposobnost razmnoževanja zaradi sprememb v nevrokininski regulaciji niso znani.
English: In a second multicentre, randomised, double-blind, parallel-group, clinical study, the aprepitant regimen was compared with standard therapy in 848 adult patients (652 females, 196 males) receiving a chemotherapy regimen that included any intravenous dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin; cyclophosphamide intravenously (< 1,500 mg/m2); or cytarabine intravenously (> 1 g/m2).
Slovenian: V drugi multicentrični, randomizirani, dvojno slepi, klinični študiji z vzporednima skupinama so primerjali aprepitant s standardno obliko zdravljenja pri 848 odraslih bolnikih (652 žensk, 196 moških) na kemoterapiji, ki je vključevala intravenski odmerek oksaliplatina, karboplatina, epirubicina, idarubicina, ifosfamida, irinotekana, davnorubicina, doksorubicina, ciklofosfamid intravensko (< 1500 mg/m2) ali citarabin intravensko (> 1 g/m2).
English: If you are the parent of a child taking EMEND, please read this information carefully.
Slovenian: Če ste starš otroka, ki jemlje zdravilo EMEND, natančno preberite navodilo!
English: Do not give EMEND 40 mg to children and adolescents under 18 years of age, because the 40 mg capsules have not been studied in this population.
Slovenian: Zdravila EMEND 40 mg ne dajajte otrokom in mladostnikom, mlajšim od 18 let, ker 40 mg kapsule pri tej populaciji niso bile raziskane.
English: Aprepitant plasma concentrations achieved with the 3-day regimen of EMEND in adults are predicted to provide greater than 95 % occupancy of brain NK1 receptors.
Slovenian: Predvidevajo, da plazemske koncentracije aprepitanta, ki jih dosežemo s 3 dni trajajočim zdravljenjem z zdravilom EMEND pri odraslih, zagotavljajo več kot 95-odstotno zasedenost možganskih receptorjev NK1.
English: Of the paediatric patients, 29 % in the aprepitant regimen and 28 % in the control regimen used dexamethasone as part of the regimen in Cycle 1.
Slovenian: Kot del sheme je v 1. ciklusu uporabljalo deksametazon 29 % pediatričnih bolnikov, ki so prejemali shemo z aprepitantom, in 28 % tistih, ki so prejemali kontrolno shemo.
English: The safety and efficacy of the 80 mg and 125 mg capsules have not been demonstrated in children less than 12 years of age.
Slovenian: Varnost in učinkovitost 80 mg in 125 mg kapsul pri otrocih, mlajših od 12 let, nista bili dokazani.
English: Discard all the unused water remaining in the mixing cup.
Slovenian: Vso vodo, ki je preostala v čaši za mešanje, zavržite.
English: The oral suspension may be taken with or without food.
Slovenian: Bolniki lahko peroralno suspenzijo vzamejo s hrano ali brez nje.
English: The effect of aprepitant on the plasma concentrations of intravenously administered CYP3A4 substrates is expected to be smaller.
Slovenian: Pričakuje se manjši vpliv aprepitanta na plazemske koncentracije intravensko uporabljenih substratov za CYP3A4.
English: If the child could not take the whole dose, call the child's healthcare provider.
Slovenian: Če otrok ne more zaužiti celotnega odmerka, se posvetujte z otrokovim zdravnikom.
English: Aprepitant regimen (N= 433)
Slovenian: Aprepitant (N = 433)
English: Additionally, no significant nausea in the overall period (0 to 120 hours post-chemotherapy) was evaluated as an exploratory endpoint, and in the acute and delayed phases as a post-hoc analysis.
Slovenian: Poleg tega je bil eksploratorni opazovani dogodek opredeljen kot brez pomembne navzee v celotnem obdobju (0 do 120 ur po kemoterapiji) ter v post-hoc analizi akutne in zapoznele faze.
English: Complete response: No emesis and no use of rescue Difference (%) calculated as Aprepitant 40 mg minus Ondansetron 4 mg Difference (%) and 95 % C.I.
Slovenian: Popoln odziv: Brez bruhanja in brez rešilnega zdravljenja Razlika (%) izračunana kot aprepitant 40 mg minus ondansetron 4 mg Razlika (%) in 95-odstotni IZ izračunan z uporabo stratificirane Miettinen-Nurminen metode in Cochran-Mantel-Haeszel mer
English: Hepatic impairment: Mild hepatic impairment (Child-Pugh class A) does not affect the pharmacokinetics of aprepitant to a clinically relevant extent.
Slovenian: Okvara jeter: Blaga okvara jeter (razred A po Child-Pugh-ovi klasifikaciji) na farmakokinetiko aprepitanta ne vpliva v tolikšni meri, da bi bilo to klinično pomembno.
English: Following a single 165 mg aprepitant dose, a transient moderate increase for two days possibly followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 (e.g., cyclosporine, tacrolimus, everolimus and sirolimus) is expected.
Slovenian: Po enkratnem 165 mg odmerku aprepitanta dva dni pričakujemo prehodno zmerno povečanje, nato pa morda blago zmanjšanje izpostavljenosti imunosupresivom, ki se presnavljajo s CYP3A4 (npr. ciklosporin, takrolimus, everolimus in sirolimus).
English: - This medicine has been prescribed for you or the child only.
Slovenian: - Zdravilo je bilo predpisano vam ali vašemu otroku osebno in ga ne smete dajati drugim.
English: Concomitant administration of EMEND with herbal preparations containing St. John's Wort (Hypericum perforatum) is not recommended.
Slovenian: Sočasno uporabo zdravila EMEND in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), odsvetujemo.
English: - The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropylcellulose
Slovenian: - Druge sestavine zdravila so: saharoza, mikrokristalna celuloza (E 460), hidroksipropilceluloza
English: For CYP2C9 and CYP3A4 substrates the induction is transient with a maximum effect reached after 3-5 days.
Slovenian: Za substrate CYP2C9 in CYP3A4 je indukcija prehodna, največji učinek pa je dosežen v 3-5 dneh.
English: EMEND 80 mg capsule
Slovenian: EMEND 80 mg kapsula
English: EMEND causes a transient mild induction of CYP2C9, CYP3A4 and glucuronidation approximately one week after treatment.
Slovenian: Zdravilo EMEND povzroči prehodno blago indukcijo CYP2C9, CYP3A4 in glukuronidacije približno en teden po zdravljenju.
English: There were no margins to clinically relevant exposure.
Slovenian: Meje za klinično pomembno izpostavljenost ni bilo.
English: Pre-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij toksičnosti pri enkratnem in ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: EMEND 125 mg capsule
Slovenian: EMEND 125 mg kapsula
English: Day 1: - Give this medicine one hour before the start of the chemotherapy session.
Slovenian: 1. dan: - Zdravilo dajte otroku eno uro pred začetkom kemoterapije.
English: The safety and efficacy of EMEND 40 mg in children and adolescents below 18 years of age has not yet been established.
Slovenian: Varnost in učinkovitost zdravila EMEND 40 mg pri otrocih in mladostnikih pod 18 let nista bili dokazani.
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 morajo bolniki dobiti 1. dan 30 minut pred kemoterapijo, od 2. do 4. dne pa zjutraj.