FrancophonIA/ELRC3.0 huggingface dataset:
English: The potential for reproductive toxicity of aprepitant has not been fully characterised, since exposure levels above the therapeutic exposure in humans at the 125 mg/80 mg and 165 mg doses could not be attained in animal studies.
Slovenian: Možnost škodljivega vpliva aprepitanta na sposobnost razmnoževanja ni v celoti raziskana, saj med študijami na živalih niso mogli doseči ravni izpostavljenosti, ki bi bila višja od terapevtske izpostavljenosti pri uporabi 125 mg/80 mg in 165 mg odmerkov pri ljudeh.
English: Aprepitant, when given as a single dose of 200 mg in the fed state (standard light breakfast) on Day 1 with oral dexamethasone, co-administered orally as 12 mg on Day 1 and 8 mg on Days 2 through 4, increased the AUC0-24hr of dexamethasone by 2.1- and 2.3-fold on Days 1 and 2, to a lesser extent (1.4-fold increase) on Day 3, and had no effect on Day 4 (1.1-fold).
Slovenian: Pri uporabi aprepitanta v enkratnem odmerku 200 mg po jedi (standardni lahki zajtrk) 1. dan skupaj s peroralnim deksametazonom 12 mg 1. dan ter 8 mg od drugega do četrtega dne se je povečala vrednost AUC0-24ur deksametazona 1. dan za 2,1-krat, 2. dan za 2,3-krat, 3. dan v manjši meri (1,4-kratno zvečanje), 4. dan pa učinka ni bilo (1,1-kratno).
English: No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).
Slovenian: Pri bolnikih z okvaro ledvic in pri bolnikih s končno odpovedjo ledvic na hemodializi odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Delayed phase No vomiting Overall
Slovenian: Popoln odziv Skupaj Zapoznela faza Brez bruhanja Skupaj
English: Paediatric population: As part of a 3-day regimen, dosing of aprepitant capsules (125/80/80-mg) in adolescent patients (aged 12 through 17 years) achieved an AUC0-24hr above 17 µg•hr/mL on Day 1 with concentrations (Cmin) at the end of Days 2 and 3 above 0.4 µg/mL in a majority of patients.
Slovenian: Pediatrična populacija: V okviru 3-dnevne sheme je bila pri uporabi kapsul aprepitanta (125/80/80 mg) pri mladostnikih (starih od 12 do 17 let) pri večini bolnikov dosežena AUC0-24h nad 17 µg•h/ml 1. dan, koncentracije (Cmin) ob koncu 2. in 3. dne pa so bile nad 0,4 µg/ml.
English: Other side effects Tell the doctor, pharmacist or nurse if you or the child notice any of the following side effects:
Slovenian: Zdravniku, farmacevtu ali medicinski sestri morate povedati, če vi ali otrok opazite katerega od naslednjih neželenih učinkov:
English: PET/aluminium/LLDPE sachets
Slovenian: Vrečke iz PET/aluminija/LLDPE.
English: Acute phase: 0 to 24 hours following initiation of chemotherapy.
Slovenian: Akutna faza: od 0 do 24 ur po začetku kemoterapije.
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 Highly Emetogenic Chemotherapy (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, o katerih so pri zdravljenju z aprepitantom pri odraslih, ki so prejemali zelo emetogeno kemoterapijo (HEC - Highly Emetogenic Chemotherapy), poročali pogosteje kot pri standardni terapiji, so bili: kolcanje (4,6 % v primerjavi z 2,9 %), zvišanje alanin-aminotransferaze (ALT) (2,8 % v primerjavi z 1,1 %), dispepsija (2,6 % v primerjavi z 2,0 %), zaprtje (2,4 % v primerjavi z 2,0 %), glavobol (2,0 % v primerjavi z 1,8 %) ter zmanjšan apetit (2,0 % v primerjavi z 0,5 %).
English: *Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as reactions only thereafter.
Slovenian: *Navzea in bruhanje sta bila parametra učinkovitosti prvih 5 dni po kemoterapiji; o njih so kot o reakcijah poročali šele po tem času.
English: After treatment with EMEND, the doctor may ask you or the child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron) for preventing nausea and vomiting.
Slovenian: Zdravnik lahko naroči, da vi ali otrok po zdravljenju z zdravilom EMEND nadaljujete z jemanjem drugih zdravil, vključno s kortikosteroidom (kot je deksametazon) in zaviralcem 5HT3 (kot je ondansetron) za preprečevanje navzee in bruhanja.
English: 2-day treatment pack containing: 2 x 80 mg hard capsule 5 x 1 hard capsule
Slovenian: Ovojnina za 2-dnevno zdravljenje vsebuje: 2 x 80 mg trda kapsula 5 x 1 trda kapsula
English: EMEND is given for 3 days as part of a regimen that includes a 5-HT3 antagonist.
Slovenian: Zdravilo EMEND se daje 3 dni po shemi zdravljenja, ki vključuje antagonist 5-HT3.
English: Titanium dioxide (E 171) Indigo carmine (E 132)
Slovenian: Ovojnica kapsule želatina titanov dioksid (E 171) indigotin (E 132)
English: This is not considered to be clinically important.
Slovenian: To ne velja za klinično pomembno.
English: What you need to know before you give EMEND
Slovenian: Kaj morate vedeti, preden boste dali zdravilo EMEND
English: Pour the entire contents of the sachet into the 4.6 mL of water in the mixing cup and snap the lid shut.
Slovenian: Vso vsebino iz vrečke stresite v čašo za mešanje, v kateri je 4,6 ml vode, in čašo zaprite s pokrovčkom.
English: Do not give EMEND: - if the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne dajajte zdravila EMEND: - če je otrok alergičen na aprepitant ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The powder for oral suspension is used in children aged 6 months to less than 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).
Slovenian: Prašek za peroralno suspenzijo se uporablja pri otrocih, starih od 6 mesecev do manj kot 12 let, v kombinaciji z drugimi zdravili za preprečevanje navzee (siljenja na bruhanje) in bruhanja zaradi zdravil proti raku (kemoterapije), ki so močni ali zmerni sprožilniki siljenja na bruhanje in bruhanja (takšni so na primer cisplatin, ciklofosfamid, doksorubicin ali epirubicin).
English: Based on a comparable pharmacokinetic/pharmacodynamic profile, the 1-day oral regimen of EMEND 165 mg is anticipated to have a similar efficacy profile to that of the 1-day regimen of fosaprepitant 150 mg and 3-day regimen of oral aprepitant (see section 5.2)
Slovenian: Glede na primerljiv farmakokinetični/farmakodinamični profil pričakujemo, da ima 1-dnevno peroralno zdravljenje z zdravilom EMEND 165 mg podoben profil učinkovitosti kot 1-dnevno zdravljenje s 150 mg fosaprepitanta in 3-dnevno peroralno zdravljenje z aprepitantom (glejte poglavje 5.2).
English: During continuous treatment with methylprednisolone, the AUC of methylprednisolone may decrease at later time points within 14 days following initiation of the EMEND dose, due to the inducing effect of aprepitant on CYP3A4.
Slovenian: Pri neprekinjenem zdravljenju z metilprednizolonom se lahko pozneje, v času 14 dni po začetku zdravljenja z zdravilom EMEND, vrednost AUC metilprednizolona zmanjša zaradi indukcijskega učinka aprepitanta na CYP3A4.
English: The results show that a higher percentage of post-surgical adults experienced complete response (no emesis and no use of rescue) with aprepitant 40 mg than with ondansetron 4 mg (lower bound of C.I.
Slovenian: Rezultati, prikazani v preglednici 1 kažejo, da je imelo popoln odziv (brez bruhanja in brez rešilnega zdravljenja) večji odstotek post-operativnih odraslih v skupini, ki je prejemala aprepitant 40 mg, kot v skupini, ki je prejemala ondansetron 4 mg (spodnja meja intervala zaupanja (IZ) je 0,0 kar kaže na mejno signifikantnost):
English: The recommended oral dose of EMEND is a single 40 mg dose within 3 hours prior to induction of anaesthesia.
Slovenian: Priporočeni peroralni odmerek zdravila EMEND je enkratni 40 mg odmerek, ki ga bolnik prejme v 3 urah pred uvodom v anestezijo.
English: Additional adverse reactions were observed in adults treated with the aprepitant (125 mg/80 mg) regimen for chemotherapy induced nausea and vomiting (CINV) and at a greater incidence than with standard therapy: abdominal distension, abdominal pain, acne, anaemia, anxiety, AST increased, asthenia, blood alkaline phosphatase increased, blood sodium decreased, candidiasis, cardiovascular disorder, chest discomfort, cognitive disorder, conjunctivitis, cough, decreased appetite, disorientation, dizziness, duodenal ulcer perforation, dysgeusia, dyspepsia, dysuria, eructation, euphoric mood, faeces hard, fatigue, febrile neutropenia, flatulence, gait disturbance, gastroesophageal reflux disease, glucose urine present, hiccups, hot flush, hyperhidrosis, lethargy, malaise, muscle spasms, muscular weakness, nausea*, neutropenic colitis, neutrophil count decreased, oedema, oropharyngeal pain, palpitations, photosensitivity reaction, pollakiuria, polydipsia, postnasal drip, rash pruritic, red blood cells urine positive, seborrhoea, skin lesion, sneezing, somnolence, staphylococcal infection, stomatitis, throat irritation, tinnitus, urine output increased, vomiting*, weight decreased.
Slovenian: Pri odraslih, ki so se zdravili z aprepitantom zaradi navzee in bruhanja zaradi kemoterapije (CINVchemotherapy induced nausea and vomiting) (režim 125 mg/80 mg), so poročali še o drugih neželenih učinkih, katerih pogostnost je bila večja kot pri standardnem zdravljenju: napihnjen trebuh, bolečine v trebuhu, akne, anemija, anksioznost, zvišanje vrednosti AST, astenija, zvišanje vrednosti alkalne fosfataze v krvi, znižanje vrednosti natrija v krvi, kandidoza, kardiovaskularne motnje, nelagodje v prsnem košu, kognitivne motnje, konjunktivitis, kašelj, zmanjšan apetit, dezorientacija, omotica, perforirajoč duodenalni ulkus, motnje okusa, dispepsija, disurija, spahovanje, evforično razpoloženje, trdo blato, utrujenost, febrilna nevtropenija, flatulenca, motnja hoje, gastroezofagealna refluksna bolezen, prisotnost glukoze v urinu, kolcanje, navali vročine, hiperhidroza, letargija, splošno slabo počutje, mišični spazmi, mišična oslabelost, navzea*, nevtropenični kolitis, zmanjšano število nevtrofilcev, edem, bolečine v ustih in žrelu, palpitacije, fotosenzitivnostna reakcija, polakisurija, polidipsija, zatekanje izcedka iz nosu v žrelo, srbeči izpuščaj, prisotnost rdečih krvnih celic v urinu, seboreja, lezije kože, kihanje, zaspanost, stafilokokne okužbe, stomatitis, draženje žrela, tinitus, povečano izločanje urina, bruhanje*, zmanjšanje telesne mase.
English: Aluminium blister containing one 125 mg capsule and two 80 mg capsules.
Slovenian: Aluminijast pretisni omot, ki vsebuje eno 125 mg kapsulo in dve 80 mg kapsuli.
English: EMEND 40 mg should be used with caution in patients receiving pimozide, terfenadine, astemizole, cisapride, or ergot alkaloid derivatives.
Slovenian: Zdravilo EMEND 40 mg je treba previdno uporabljati pri bolnikih, ki prejemajo pimozid, terfenadin, astemizol, cisaprid ali derivate alkaloidov rženega rožička (ergot alkaloide).
English: In a juvenile toxicity study in rats treated from post natal day 10 to day 63 aprepitant led to an earlier vaginal opening in females from 250 mg/kg b.i.d.
Slovenian: V študiji toksičnosti pri mladih podganah, ki so od 10. do 63. dne po skotitvi dobivale aprepitant, je ta pri samicah povzročil zgodnejše odprtje nožnice pri odmerkih od 250 mg/kg dvakrat na dan in pri samcih zapoznelo ločitev prepucija pri odmerkih od 10 mg/kg dvakrat na dan.
English: §Overall = 0 to 120 hours post-initiation of cisplatin chemotherapy.
Slovenian: §Skupaj = 0 do 120 ur po začetku kemoterapije s cisplatinom.
English: Do not take EMEND: - if you or the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila EMEND: - če ste vi ali otrok alergični na aprepitant ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: - If you have any further questions, ask the doctor, pharmacist, or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: After reconstitution: The oral suspension can be kept at room temperature (not above 30°C) for up to 3 hours.
Slovenian: Po rekonstituciji: Peroralno suspenzijo se lahko hrani na sobni temperaturi (do 30 °C) do 3 ure.
English: OUTER PACKAGING - TRIFOLD PACK (CARTON) - 3-day treatment pack
Slovenian: ZUNANJA OVOJNINA - ŠKATLA - pakiranje za 3-dnevno zdravljenje
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
English: The recommended oral dose of EMEND is one 40 mg capsule within 3 hours prior to the start of anaesthesia.
Slovenian: Priporočeni peroralni odmerek zdravila EMEND je ena 40 mg kapsula, ki jo morate zaužiti v 3 urah pred začetkom anestezije.
English: EMEND may have minor influence on the ability to drive and use machines.
Slovenian: Zdravilo EMEND ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: If you or the child feels dizzy or sleepy, avoid driving, riding a bicycle or using machines or tools after taking this medicine (see ‘Possible side effects').
Slovenian: Če vi ali otrok po zaužitju tega zdravila občutite omotico ali zaspanost, se izogibajte vožnji, kolesarjenju, upravljanju strojev ali uporabi orodja.
English: The potential for reproductive toxicity of aprepitant has not been fully characterised, since exposure levels above the therapeutic exposure in humans at the 125 mg/80 mg dose could not be attained in animal studies.
Slovenian: Možnost škodljivega vpliva aprepitanta na sposobnost razmnoževanja ni v celoti raziskana, saj med študijami na živalih niso mogli doseči ravni izpostavljenosti, ki bi bila višja od terapevtske izpostavljenosti pri uporabi 125 mg/80 mg odmerka pri ljudeh.
English: Methylprednisolone: Although the concomitant administration of methylprednisolone with the single 40 mg dose of aprepitant has not been studied, a single 40 mg dose of aprepitant produces a weak inhibition of CYP3A4 and it is not expected to alter the plasma concentrations of methylprednisolone to a clinically significant degree.
Slovenian: Metilprednizolon: Sočasne uporabe metilprednizolona in enkratnega 40 mg odmerka aprepitanta sicer niso raziskovali, vendar pa enkratni 40 mg odmerek aprepitanta povzroči šibko zaviranje CYP3A4.
English: EMEND (40 mg) should be used with caution in patients receiving concomitant administration of pimozide, terfenadine, astemizole, cisapride or ergot alkaloid derivatives.
Slovenian: Zdravilo EMEND (40 mg) je treba uporabljati previdno pri bolnikih, ki sočasno prejemajo pimozid, terfenadin, astemizol, cisaprid ali derivate alkaloidov rženega rožička (ergot alkaloide).
English: Effect of other medicinal products on the pharmacokinetics of aprepitant Concomitant administration of EMEND with active substances that inhibit CYP3A4 activity (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, and protease inhibitors) should be approached cautiously, as the combination is expected to result in several-fold increased plasma concentrations of aprepitant (see section 4.4).
Slovenian: Vpliv drugih zdravil na farmakokinetiko aprepitanta Pri sočasni uporabi zdravila EMEND in zdravilnih učinkovin, ki zavirajo aktivnost CYP3A4 (npr. ketokonazol, itrakonazol, vorikonazol, posakonazol, klaritromicin, telitromicin, nefazodon in zaviralci proteaz) je potrebna previdnost, ker se zaradi kombinacije pričakuje večkratno zvišanje plazemskih koncentracij aprepitanta (glejte poglavje 4.4).
English: There are some medicines that should not be taken with EMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also ‘Do not take EMEND').
Slovenian: Nekaterih zdravil med zdravljenjem z zdravilom EMEND ne smete jemati (kot so pimozid, terfenadin, astemizol in cisaprid), pri nekaterih pa je treba prilagoditi odmerek (glejte tudi "Ne jemljite zdravila EMEND").
English: One sachet, two oral dispensers, one cap and one mixing cup.
Slovenian: prašek za peroralno suspenzijo Ena vrečka, dva odmernika, ena zaporka in ena čaša za mešanje.
English: As a moderate inhibitor of CYP3A4, aprepitant (125 mg/80 mg) can increase plasma concentrations of co-administered active substances that are metabolised through CYP3A4.
Slovenian: Kot zmerni zaviralec CYP3A4 lahko aprepitant (125 mg/80 mg) zviša plazemske koncentracije sočasno uporabljenih zdravilnih učinkovin, ki se presnavljajo s CYP3A4.
English: This increase is not considered clinically relevant.
Slovenian: To povečanje ne velja za klinično pomembno.
English: Gender No dose adjustment is necessary based on gender (see section 5.2).
Slovenian: Spol Odmerka ni treba prilagoditi glede na spol bolnika (glejte poglavje 5.2).
English: EMEND increased the AUC of midazolam, a sensitive CYP3A4 substrate, 2.3-fold on Day 1 and 3.3-fold on Day 5, when a single oral dose of 2 mg midazolam was co-administered on Days 1 and 5 of a regimen of EMEND 125 mg on Day 1 and 80 mg/day on Days 2 to 5.
Slovenian: Zdravilo EMEND je povečalo AUC midazolama, ki je občutljiv substrat za CYP3A4, in sicer za 2,3-krat 1. dan in za 3,3-krat 5. dan po enem peroralnem odmerku midazolama 2 mg 1. in 5. dan zdravljenja z zdravilom EMEND po shemi 125 mg 1. dan in 80 mg/dan od 2. do 5. dne.
English: Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1.
Slovenian: Deksametazon morajo bolniki dobiti 1. dan 30 minut pred kemoterapijo.
English: The recommended dose of capsules of EMEND is 125 mg orally on Day 1 and 80 mg orally on Days 2 and 3.
Slovenian: Priporočeni odmerek kapsul zdravila EMEND je 125 mg peroralno 1. dan in 80 mg peroralno 2. in 3. dan.
English: Rare: may affect up to1 in 1,000 people - difficulty thinking, lack of energy, changes in taste - sensitivity of the skin to sun, excessive sweating, oily skin, sores on the skin, itchy rash,
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov - težave pri razmišljanju, pomanjkanje energije, spremembe okusa - občutljivost kože na sonce, prekomerno znojenje, mastna koža, razjede na koži, srbeč izpuščaj,
English: EMEND capsules are used in adults and adolescents from the age of 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).
Slovenian: Kapsule zdravila EMEND se uporabljajo pri odraslih in mladostnikih od 12. leta dalje v kombinaciji z drugimi zdravili za preprečevanje navzee (siljenja na bruhanje) in bruhanja zaradi zdravil proti raku (kemoterapije), ki so močni ali zmerni sprožilniki siljenja na bruhanje in bruhanja (takšni so na primer cisplatin, ciklofosfamid, doksorubicin ali epirubicin).
English: Each carton contains one sachet with the powder for oral suspension, one 1 ml and one 5 mL oral dispenser (polypropylene with silicone o-ring), one cap, and one mixing cup (polypropylene).
Slovenian: Vsaka škatla vsebuje eno vrečko s praškom za peroralno suspenzijo, en 1-ml in en 5-ml odmernik (iz polipropilena s silikonskim o-obročkom), eno zaporko in eno čašo za mešanje (iz polipropilena).
English: Standard therapy (N= 524)
Slovenian: Standardno zdravljenje (N = 524)
English: The reduction in risk for a vomiting episode over the 0 to 24 hour period with aprepitant 40 mg relative to ondansetron 4 mg was 53.3 % (95 % C.I.
Slovenian: Znižanje tveganja za epizodo bruhanja v času 0-24 ur z aprepitantom 40 mg glede na ondansetron 4 mg je bilo 53,3 % (95-odstotni IZ: 35,3 do 66,3) v analizi, ki nadzoruje bolnike v času rešilnega zdravljenja.
English: Delayed phase: 25 to 120 hours following initiation of chemotherapy.
Slovenian: Zapoznela faza: od 25 do 120 ur po začetku kemoterapije.
English: †, vomiting gastroesophageal reflux disease, abdominal pain, dry mouth, flatulence uncommon duodenal ulcer perforation, stomatitis, abdominal distension, faeces hard, neutropenic colitis rare
Slovenian: †, bruhanje gastroezofagealna refluksna bolezen, bolečine v trebuhu, suha usta, flatulenca občasni perforacija duodenalnega ulkusa, stomatitis, napihnjen trebuh, trdo blato, nevtropenični kolitis redki
English: Nervous system disorders headache common dizziness, somnolence uncommon cognitive disorder, lethargy, dysgeusia rare
Slovenian: Bolezni živčevja glavobol pogosti omotica, zaspanost občasni kognitivne motnje, letargija, dizgevzija redki
English: EMEND may have minor influence on the ability to ride a bicycle and use machines.
Slovenian: Zdravilo EMEND ima lahko blag vpliv na sposobnost vožnje s kolesom in upravljanja s stroji.
English: Table 3 Percent of adult patients responding by treatment group and phase for Study 2 - Cycle 1 Moderately Emetogenic Chemotherapy
Slovenian: Preglednica 3 Odstotek odraslih bolnikov z odzivom po zdravljenih skupinah in fazi v študiji 2 - 1. ciklus Zmerno emetogena kemoterapija
English: Standard therapy (N= 424)
Slovenian: Standardno zdravljenje (N = 424)
English: Tell the doctor, pharmacist or nurse if the child is using, has recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo.
English: If you or the child have been told by your doctor that you or the child have an intolerance to some sugars, contact the doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da vi ali otrok ne prenašate nekaterih sladkorjev, se pred začetkom jemanja zdravila pogovorite z zdravnikom.
English: In pharmacokinetic studies, EMEND, when given as a regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3, did not influence the pharmacokinetics of docetaxel administered intravenously on Day 1 or vinorelbine administered intravenously on Day 1 or Day 8.
Slovenian: V farmakokinetičnih študijah zdravilo EMEND, ki so ga dajali po shemi 125 mg 1. dan in 80 mg/dan 2. in 3. dan, ni vplivalo na farmakokinetiko docetaksela, danega intravensko 1. dan, ali vinorelbina, danega intravensko 1. ali 8. dan.
English: These differences are not considered clinically meaningful.
Slovenian: Te razlike ne veljajo za klinično pomembne.
English: PRIMARY ENDPOINT Complete response
Slovenian: PRIMARNI OPAZOVANI DOGODEK Popoln odziv
English: Read all of this leaflet carefully before you start using this medicine because it contains important information.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: What EMEND contains - The active substance is aprepitant.
Slovenian: Kaj vsebuje zdravilo EMEND - Zdravilna učinkovina je aprepitant.
English: EMEND contains sucrose and lactose
Slovenian: Zdravilo EMEND vsebuje saharozo in laktozo
English: BLISTER TEXT
Slovenian: BESEDILO NA PRETISNEM OMOTU
English: - This medicine has been prescribed for the child only.
Slovenian: - Zdravilo je bilo predpisano za otroka osebno in ga ne smete dajati drugim.
English: A summary of the key study results from the combined analysis is shown in Table 1.
Slovenian: Povzetek ključnih rezultatov kombinirane analize je prikazan v preglednici 1.
English: The aprepitant regimen in combination with an ondansetron/dexamethasone regimen (see section 4.2) was compared with standard therapy (placebo in combination with ondansetron 8 mg orally (twice on Day 1, and every 12 hours on Days 2 and 3) plus dexamethasone 20 mg orally on Day 1).
Slovenian: Aprepitant v kombinaciji z ondansetronom/deksametazonom (glejte poglavje 4.2) so primerjali s standardno obliko zdravljenja (placebo v kombinaciji z ondansetronom 8 mg peroralno (dvakrat 1. dan in vsakih 12 ur 2. in 3. dan) in deksametazon 20 mg peroralno 1. dan).