FrancophonIA/ELRC3.0 huggingface dataset:
English: Week 96 .
Slovenian: 177 tednov).
English: Talk to your doctor or pharmacist before taking Entecavir Accord if you have ever had problems with your kidneys, tell your doctor.
Slovenian: Pred začetkom jemanja zdravila Entecavir Accord se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Among entecavir-treated patients, on-treatment ALT elevations had a median time to onset of 4-5 weeks, generally resolved with continued treatment, and, in a majority of cases, were associated with a ≥ 2 log10/ml reduction in viral load that preceded or coincided with the ALT elevation.
Slovenian: Pri bolnikih, ki so se zdravili z entekavirjem, so se poslabšanja med zdravljenjem pojavila v povprečju po 4 - 5 tednih zdravljenja in so običajno pri nadaljevanju zdravljenja izzvenela.
English: Liver transplant recipients: renal function should be carefully evaluated before and during entecavir therapy in liver transplant recipients receiving cyclosporine or tacrolimus (see section 5.2).
Slovenian: Bolniki s presajenimi jetri: Pri bolnikih s presajenimi jetri, ki se zdravijo s ciklosporinom ali takrolimusom, je treba pred začetkom zdravljenja z entekavirjem skrbno oceniti delovanje ledvic.
English: Entecavir Accord 1 mg film-coated tablets: Pink, triangle shaped, biconvex film-coated tablets debossed with 'J' on one side and '111' on other side.
Slovenian: Entecavir Accord 1 mg filmsko obložene tablete: rožnate barve, bikonveksne in trikotne oblike.
English: Mean serum HBV DNA by PCR was 7.83 log10 copies/ml and mean serum ALT was 100 U/l; 54% of patients were HBeAg positive, and 35% of patients had LVDr substitutions at baseline.
Slovenian: Srednja vrednost HBV DNA (s PCR) v izhodišču je bila 7,83 log10 kopij/ml, srednja vrednost ALT v serumu pa 100 enot/l.
English: Entecavir Accord 0.5 mg film-coated tablets entecavir
Slovenian: Entecavir Accord 0,5 mg filmsko obložene tablete entekavir
English: Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.
Slovenian: Pri pediatričnih bolnikih s kompenzirano boleznijo jeter zaradi HBeAg pozitivnega kroničnega hepatitisa B mora biti serumska vrednost ALT pred uvedbo zdravljenja persistentno povečana vsaj
English: Package leaflet: Information for the user Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets entecavir
Slovenian: Navodilo za uporabo Entecavir Accord 0,5 mg filmsko obložene tablete Entecavir Accord 1 mg filmsko obložene tablete entekavir
English: Entecavir Accord can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Slovenian: Zdravilo Entecavir Accord se lahko uporablja tako pri bolnikih z okvaro jeter, ki še delujejo normalno (kompenzirana bolezen jeter),
English: Laboratory test abnormalities: through week 48 among entecavir-treated patients with decompensated liver disease, none had ALT elevations both > 10 times ULN and > 2 times baseline, and 1% of patients had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
Slovenian: Odstopanja od normalnih vrednosti laboratorijskih preiskav: med 48-tedenskim zdravljenjem pri nobenem od bolnikov, ki so prejemali entekavir, niso poročali o zvišanju vrednosti ALT, ki bi bile več kot 10 krat večje od zgornje meje normalne vrednosti (ULN - Upper Limit of Normal) in sočasno več kot 2 krat večje od izhodiščnih vrednosti.
English: Among entecavir-treated nucleoside naive patients, post-treatment exacerbations had a median time to onset of 23-24 weeks, and most were reported in HBeAg negative patients (see section 4.8).
Slovenian: Pri predhodno z nukleozidi nezdravljenih bolnikih, ki so se zdravili z entekavirjem, so se poslabšanja po zdravljenju pojavila v povprečju 23 - 24 tednov po prekinitvi zdravljenja.
English: 0.15 mg once daily* OR 0.5 mg every 72 hours
Slovenian: 0,5 mg vsakih 72 ur
English: (see a. Summary of the safety profile and section 5.1)
Slovenian: (glejte poglavje 5.1) pri odraslih:
English: Bottle pack:
Slovenian: Pakiranje v plastenki:
English: Also, patients with decompensated liver disease may be at higher risk for lactic acidosis and for specific renal adverse events such as hepatorenal syndrome.
Slovenian: (ne glede na vzrok), še posebej pri bolnikih, ki so po Child-Turcotte-Pugh-ovi (CTP) lestvici spadali v skupino C. Pri bolnikih z dekompenzirano boleznijo jeter je večje lahko tudi tveganje za pojav laktacidoze in specifičnih neželenih učinkov na ledvicah, na primer hepatorenalnega sindroma.
English: Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment.
Slovenian: Da bi bila korist zdravila popolna, tveganje za pojav odpornosti na zdravljenje pa čim manjše, morate vedno jemati le odmerek, ki vam ga je predpisal zdravnik.
English: * for doses < 0.5 mg entecavir oral solution is recommended.
Slovenian: 0,5 mg vsakih 72 ur * za odmerke < 0,5 mg priporočamo uporabo peroralne raztopine entekavirja.
English: Reductions in HIV RNA have been reported in HIV/HBV co-infected patients receiving entecavir monotherapy without HAART.
Slovenian: Pri bolnikih s sočasno okužbo z virusoma HIV in HBV, ki so se zdravili samo z entekavirjem, brez zdravljenja po režimu HAART, so poročali o zmanjšanju vrednosti HIV RNA.
English: Albumin levels < 2.5 g/dl occurred in 30% of patients, lipase levels > 3 times baseline in 10% and platelets < 50,000/mm3 in 20%.
Slovenian: Pri 10% bolnikov so bile vrednosti lipaze > 3 krat večje od izhodiščnih vrednosti, število trombocitov pa je bilo pri 20% bolnikov < 50.000/mm3.
English: Subjects were randomized (2:1) to receive blinded treatment with entecavir 0.015 mg/kg up to 0.5 mg/day (N = 120) or placebo (N = 60).
Slovenian: 180 z nukleozidi predhodno še nezdravljenimi otroci in mladostniki, starimi od 2 do < 18 let, s HBeAg pozitivno kronično okužbo z virusom hepatitisa B, kompenzirano boleznijo jeter in povečano vrednostjo ALT. Bolnike so randomizirali (2:1) na slepo zdravljenje z entekavirjem v odmerku 0,015 mg/kg do največ 0,5 mg/dan (N = 120) ali placebo (N = 60).
English: At the time of the long-term biopsy, all patients had HBV DNA < 300 copies/ml and 49/57 (86%) had serum ALT ≤ 1 times ULN.
Slovenian: Po dolgotrajnem zdravljenju so imeli vsi bolniki v času biopsije vrednost HBV DNA < 300 kopij/ml.
English: 3 of the 10 patients experienced virologic breakthrough (≥ 1 log10 increase above nadir).
Slovenian: Pri dveh od teh 3 bolnikov je prišlo do povečanja virusnega bremena (glejte preglednico).
English: The active substance is entecavir.
Slovenian: Absorpcija: Absorpcija entekavirja je hitra.
English: Lamivudine-refractory patients (i.e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose in adults is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before and more than 2 hours after a meal) (see section 5.2).
Slovenian: Bolniki, neodzivni na lamivudin (to je z dokazano viremijo med zdravljenjem z lamivudinom ali prisotnostjo mutacij, povezanih z odpornostjo na lamivudin [LVDr]) (glejte poglavji 4.4 in 5.1):
English: For patients originally assigned to entecavir treatment, the reduction in HBV DNA at 48 weeks was -4.20 log10 copies/ml, ALT normalisation had occurred in 37% of patients with abnormal baseline ALT and none achieved HBeAg seroconversion.
Slovenian: Pri bolnikih, ki so od začetka prejemali entekavir, so se vrednosti HBV DNA v 48. tednu zmanjšale za -4,20 log10 kopij/ml,
English: *p value vs lamivudine < 0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint.
Slovenian: a bolniki z ovrednoteno histološko sliko v izhodišču (stopnja vnetja in nekroze po Knodell-u v izhodišču ≥ 2)
English: In clinical studies with lamivudine-refractory patients, 4% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
Slovenian: Pri 1% bolnikov so bile vrednosti ALT > 2 krat večje od izhodiščnih vrednosti in sočasno povečane tudi vrednosti skupnega bilirubina, ki so bile > 2 krat večje od zgornje meje normalne vrednosti in > 2 krat večje od izhodiščnih vrednosti.
English: - genotypic ETVrc with virologic breakthrough d
Slovenian: - genotipsko ETVr c s d povečanjem virusnega bremena a
English: Invented name Strength Pharmaceutical Form
Slovenian: Izmišljeno ime Jakost
English: Route of administration Packaging
Slovenian: Način uporabe zdravila
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 11 January 2013
Slovenian: Datum prve odobritve: 11. januar 2008 Datum zadnjega podaljšanja: 11. januar 2013
English: Your doctor may therefore have to monitor the condition of your liver.
Slovenian: Zdravnik bo zato morda moral spremljati stanje vaših jeter.
English: Relationship between concentration and effect
Slovenian: Povezava med koncentracijo in učinkom
English: Difference (95 % CI)
Slovenian: Razlika (95 % IZ)
English: Swirl the vial gently.
Slovenian: Vialo nežno vrtite.
English: Elderly (≥65 years)
Slovenian: Starejši (≥ 65 let)
English: C]-aprepitant.
Slovenian: C]-aprepitanta.
English: Other side effects that have been reported are listed below.
Slovenian: Ostali neželeni učinki o katerih so poročali so navedeni spodaj.
English: Pack sizes: 1 or 10 vials.
Slovenian: Velikost pakiranja: 1 ali 10 vial.
English: The safety profile of aprepitant was evaluated in approximately 6,500 adults and 184 children and adolescents.
Slovenian: Varnostni profil aprepitanta je bil ovrednoten pri približno 6.500 odraslih in 184 otrocih in mladostnikih.
English: **N: Number of adult patients included in the primary analysis of complete response.
Slovenian: **N: Število odraslih bolnikov vključenih v primarno analizo popolnega odziva.
English: NR = Not Reported
Slovenian: NP = ni poročano
English: What IVEMEND is and what it is used for
Slovenian: Kaj je zdravilo IVEMEND in za kaj ga uporabljamo
English: From a microbiological point of view, the medicinal product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po pripravi.
English: Please talk to your doctor or pharmacist if you are taking any of the following medicines:
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete katero koli od naslednjih zdravil:
English: †Difference and confidence interval (CI) were calculated using the method proposed by Miettinen and Nurminen and adjusted for gender.
Slovenian: †Razlika in interval zaupanja (IZ) sta bila izračunana z uporabo metode po Miettinenu in Nurminenu in sta bila prilagojena glede na spol.
English: In the event of overdose, fosaprepitant should be discontinued and general supportive treatment and monitoring should be provided.
Slovenian: V primeru prevelikega odmerjanja je treba dajanje fosaprepitanta prekiniti in uvesti splošno podporno zdravljenje ter nadzor.
English: A summary of the primary and secondary endpoints is shown in Table 7.
Slovenian: Povzetek primarnih in sekundarnih opazovanih dogodkov je prikazan v preglednici 7.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: This effect was not considered clinically important.
Slovenian: Ta učinek ni veljal za klinično pomembnega.
English: CYP3A4 interactions
Slovenian: Interakcije s CYP3A4
English: The safety and efficacy of IVEMEND in infants below 6 months of age have not been established.
Slovenian: Varnost in učinkovitost zdravila IVEMEND pri dojenčkih, mlajših od 6 mesecev, nista bili dokazani.
English: Complete response† Delayed phase‡ Complete response† Overall§
Slovenian: Popoln odziv† Zapoznela faza‡ Popoln odziv† Celotna faza§ Akutna faza§§
English: Occupancy of brain NK1 receptors, in this study, correlate well with aprepitant plasma concentrations.
Slovenian: Zasedenost možganskih receptorjev NK1 v tej študiji je v dobri korelaciji s plazemskimi koncentracijami aprepitanta.
English: Although a 32 mg intravenous dose of ondansetron was used in clinical trials, this is no longer the recommended dose.
Slovenian: Čeprav se je v kliničnih preskušanjih uporabljal 32 mg intravenski odmerek ondansetrona, to ni več priporočeni odmerek.
English: If you are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden boste prejeli to zdravilo.
English: For information regarding birth control, see ‘Other medicines and IVEMEND'.
Slovenian: Za podatke glede kontracepcije glejte "Druga zdravila in zdravilo IVEMEND".
English: IVEMEND works by blocking signals to that area, thereby reducing nausea and vomiting.
Slovenian: Zdravilo IVEMEND deluje tako, da blokira signale v to področje, s čimer zmanjšuje navzeo in bruhanje.
English: Gently invert the bag 2-3 times (see ‘How to use IVEMEND').
Slovenian: Vrečko 2 do 3 krat nežno obrnite (glejte "Kako uporabljati zdravilo IVEMEND").
English: If signs or symptoms of local irritation occur, the injection or infusion should be terminated and restarted in another vein.
Slovenian: Če se pojavijo znaki ali simptomi lokalnega draženja, je treba injiciranje ali infundiranje prekiniti in zdravilo aplicirati v drugo veno.
English: Efficacy was based on evaluation of the following composite measures: complete response in both the overall and delayed phases and no vomiting in the overall phase.
Slovenian: Učinkovitost zdravljenja je temeljila na oceni naslednjih sestavljenih meril: popoln odziv v celotni in zapozneli fazi in brez bruhanja v celotni fazi.
English: Do not give IVEMEND to children under 6 months of age or who weigh less than 6 kg, because it has not been studied in this population.
Slovenian: Zdravila IVEMEND ne dajajte otrokom, mlajšim od 6 mesecev ali s telesno maso manj kot 6 kg, ker pri tej populaciji zdravilo ni bilo raziskano.
English: EU/1/07/437/003 1 x 1 vial EU/1/07/437/004 1 x 10 vials
Slovenian: EU/1/07/437/003 1 x 1 viala EU/1/07/437/004 1 x 10 vial
English: Highly Emetogenic Chemotherapy (HEC)
Slovenian: Zelo emetogena kemoterapija (HEC)
English: The contribution of fosaprepitant to the overall antiemetic effect has not fully been characterised, but a transient contribution during the initial phase cannot be ruled out.
Slovenian: Prispevek fosaprepitanta k skupnemu antiemetičnemu delovanju ni povsem pojasnjen, vendar pa prehodnega učinka med uvodno fazo ni možno izključiti.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, ATC code: A04AD12.
Slovenian: Farmakoterapevtska skupina: Antiemetiki in zdravila proti slabosti, oznaka ATC: A04AD12.
English: Therefore, the recommendations for use of IVEMEND with other medicinal products in paediatric patients are based upon adult data from fosaprepitant and aprepitant studies.
Slovenian: Zato priporočila za uporabo zdravila IVEMEND z drugimi zdravili pri pediatričnih bolnikih temeljijo na podatkih iz študij fosaprepitanta in aprepitanta pri odraslih.
English: It belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists".
Slovenian: Spada v skupino zdravil, imenovanih "antagonisti receptorjev za nevrokinin 1 (NK1)".
English: The potential effects on reproduction of alterations in neurokinin regulation are unknown.
Slovenian: Možni učinki zaradi sprememb regulacije nevrokininov na sposobnost razmnoževanja niso znani.
English: Aprepitant is not excreted unchanged in urine.
Slovenian: Aprepitant se ne izloča z urinom v nespremenjeni obliki.
English: P-Value
Slovenian: p-vrednost
English: These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy.
Slovenian: Te preobčutljivostne reakcije so se običajno odzvale na prekinitev infuzije in ustrezno zdravljenje.
English: The estimated time to first emesis is depicted by the Kaplan-Meier plot in Figure 1.
Slovenian: Ocenjeni čas do prvega bruhanja prikazuje Kaplan-Meierjeva krivulja na Sliki 1.
English: Therefore, there is no evidence of interaction with the use of IVEMEND 150 mg and 5-HT3 antagonists.
Slovenian: Zato ni dokazov o medsebojnem delovanju pri uporabi zdravila IVEMEND 150 mg in antagonistov 5-HT3.
English: Other medicines and IVEMEND
Slovenian: Druga zdravila in zdravilo IVEMEND
English: 1-Day Regimen of Fosaprepitant in Adults
Slovenian: 1-dnevna shema fosaprepitanta pri odraslih
English: It is not known whether IVEMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine.
Slovenian: Ni znano, ali se zdravilo IVEMEND izloča v materino mleko, zato med zdravljenjem s tem zdravilom dojenje ni priporočljivo.
English: The efficacy of fosaprepitant was evaluated based on the primary and secondary endpoints listed in Table 8 and was shown to be superior to the control regimen with regard to complete response in the delayed and overall phases.
Slovenian: Učinkovitost fosaprepitanta je bila ocenjena na osnovi primarnih in sekundarnih opazovanih dogodkov, navedenih v preglednici 8, in se je izkazala za boljšo od kontrolne sheme zdravljenja glede na popoln odziv v zapozneli in celotni fazi.
English: It is not known whether aprepitant is excreted in human milk.
Slovenian: Ni znano, ali se aprepitant izloča v materino mleko.
English: For additional information on the co-administration with corticosteroids, see section 4.5.
Slovenian: Za dodatne podatke o sočasni uporabi s kortikosteroidi glejte poglavje 4.5.
English: Aprepitant is highly protein bound, with a mean of 97 %.
Slovenian: Aprepitant se močno veže na beljakovine, povprečno 97 %.
English: A population pharmacokinetic analysis of aprepitant in paediatric patients (aged 6 months through 17 years) suggests that gender and race have no clinically meaningful effect on the pharmacokinetics of aprepitant.
Slovenian: Analiza populacijske farmakokinetike aprepitanta pri pediatričnih bolnikih (starih od 6 mesecev do 17 let) kaže, da spol in rasa nimata klinično pomembnega vpliva na farmakokinetiko aprepitanta.
English: What you need to know before you use IVEMEND
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo IVEMEND
English: The safety profile of fosaprepitant in adult and paediatric patients was generally similar to that observed with aprepitant.
Slovenian: Varnostni profil fosaprepitanta pri odraslih in pediatričnih bolnikih je bil na splošno podoben tistemu za aprepitant.
English: Haemodialysis conducted 4 or 48 hours after dosing had no significant effect on the pharmacokinetics of aprepitant; less than 0.2 % of the dose was recovered in the dialysate.
Slovenian: Hemodializa, izvedena 4 ali 48 ur po odmerjanju, ni pomembno vplivala na farmakokinetiko aprepitanta; v dializatu se je izločilo manj kot 0,2 % odmerka.
English: Rifampicin decreased the mean terminal half-life of oral aprepitant by 68 %.
Slovenian: Rifampicin je zmanjšal povprečni končni razpolovni čas peroralnega aprepitanta za 68 %.
English: Before treatment with this medicine, tell your doctor if you have liver disease because the liver is important in breaking down the medicine in the body.
Slovenian: Pred zdravljenjem s tem zdravilom obvestite zdravnika, če imate bolezen jeter, ker jetra sodelujejo pri presnovi zdravila v telesu.
English: IVEMEND should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila IVEMEND se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno.
English: Additionally, concomitant administration with irinotecan should be approached with particular caution as the combination might result in increased toxicity.
Slovenian: Poleg tega je previdnost še posebej potrebna pri sočasni uporabi irinotekana, saj se lahko pri sočasni uporabi poveča toksični učinek.
English: IVEMEND may have minor influence on the ability to drive and use machines.
Slovenian: Zdravilo IVEMEND ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors.
Slovenian: Aprepitant je selektivni antagonist z veliko afiniteto na humanih receptorjih za substanco P nevrokinin 1 (NK1).
English: Stop taking IVEMEND and see a doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment: - Hives, rash, itching, difficulty breathing or swallowing, or a serious decrease of blood pressure (frequency not known, cannot be estimated from the available data); these are signs of a serious allergic reaction.
Slovenian: Prenehajte jemati zdravilo IVEMEND in pojdite takoj k zdravniku, če opazite katerega od naslednjih neželenih učinkov, ki so lahko resni in zaradi katerih boste lahko nujno potrebovali zdravljenje: - koprivnico, izpuščaj, srbenje, težave z dihanjem ali požiranjem, ali občutno znižanje krvnega tlaka (neznana pogostnost, ni je mogoče oceniti iz razpoložljivih podatkov); to so znaki hude alergijske reakcije.
English: 80 mg intravenously OR 80 mg orally (EMEND capsules)
Slovenian: 80 mg intravensko ALI 80 mg peroralno (kapsule EMEND)
English: • Volume to administer (ml) equals the recommended dose (mg)
Slovenian: • Količina za apliciranje (ml) je enaka priporočenemu odmerku (mg)
English: However, it should be noted that the value of the toxicity studies carried out with rodents, rabbits and monkeys, including the reproduction toxicity studies, are limited since systemic exposures to fosaprepitant and aprepitant were only similar or even lower than therapeutic exposure in adult humans.
Slovenian: Vendar pa je treba izpostaviti, da je vrednost študij toksičnosti, izvedenih na glodavcih, kuncih in opicah, vključno s študijami vplivov na sposobnost razmnoževanja, omejena, saj je bila sistemska izpostavljenost fosaprepitantu in aprepitantu le podobna ali celo manjša od sistemske izpostavljenosti pri odraslih ljudeh pri uporabi terapevtskih odmerkov.
English: Discard any remaining solution and waste material.
Slovenian: Vso preostalo raztopino in odpadni material zavrzite.
English: For fosaprepitant and aprepitant no clinical data on exposed pregnancies are available.
Slovenian: Za fosaprepitant in aprepitant ni na voljo kliničnih podatkov za nosečnice, ki so bile izpostavljene zdravilu.
English: This medicine should not be used during pregnancy unless clearly necessary.
Slovenian: Med nosečnostjo se tega zdravila ne sme uporabljati, če to ni nujno potrebno.
English: Moderately Emetogenic Chemotherapy (MEC)
Slovenian: Zmerno emetogena kemoterapija (MEC)
English: IVEMEND contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Slovenian: Zdravilo IVEMEND vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
English: Data are lacking regarding effects on CYP2C8 and CYP2C19.
Slovenian: Podatki o učinkih na CYP2C8 in CYP2C19 niso na voljo.
English: There were no margins to clinically relevant exposure of aprepitant.
Slovenian: Meje za klinično pomembno izpostavljenost aprepitantu ni bilo.
English: For short term treatment, these findings are considered unlikely to be clinically relevant.
Slovenian: Za kratkotrajno uporabo ti izsledki niso klinično pomembni.