FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pre- and postnatal developmental study, at a dose equivalent to half of the recommended human dose, there was a decrease in memory in female pups in a maze test and a decrease in pup body weight (see section 5.3).
Slovenian: V ante- in postnatalni razvojni študiji je pri odmerku, ki je bil enakovreden polovici priporočenega odmerka za človeka, prišlo do zmanjšanja v pomnjenju pri mladičih ženskega spola pri testu z labirintom in do zmanjšane telesne mase mladičev (glejte poglavje 5.3).
English: Effects of other medicinal products on the pharmacokinetics of Varuby
Slovenian: Učinki drugih zdravil na farmakokinetiko zdravila Varuby
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, teratogenic potential, and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti, teratogenega in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: - Film-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), and polysorbate 80.
Slovenian: • filmska obloga tablete: polivinilalkohol, titanov dioksid (E171), makrogol, smukec, indigotin (E132) in polisorbat 80.
English: Following a single dose administration of 180 mg rolapitant under fasting conditions to healthy subjects, rolapitant was measurable in plasma between 30 minutes and the peak plasma concentration (Cmax) for rolapitant which was reached in about 4 hours and mean Cmax was 968 ng/mL (%CV:28%).
Slovenian: Po enkratnem odmerku 180 mg rolapitanta na tešče pri zdravih osebah je bil rolapitant izmerljiv v plazmi po 30 minutah, vrh plazemske koncentracije (Cmax) za rolapitant pa je bil dosežen v približno 4 urah; povprečna Cmax je bila 968 ng/ml (% CV: 28 %).
English: There are limited data in patients with severe renal impairment and no data in patients with end stage renal disease undergoing haemodialysis.
Slovenian: Podatki za bolnike s hudo okvaro ledvic so omejeni, za bolnike s končno odpovedjo ledvic na hemodializi pa jih ni.
English: Increased plasma concentrations of BCRP substrates (e.g. methotrexate, irinotecan, topotecan, mitoxantrone, rosuvastatin, sulfasalazine, doxorubicin, bendamustine) may result in potential adverse reactions.
Slovenian: topotekan, mitoksantron, rosuvastatin, sulfasalazin, doksorubicin, bendamustin) lahko privedejo do morebitnih neželenih učinkov.
English: There are no data in patients with severe hepatic impairment.
Slovenian: Podatkov za bolnike s hudo okvaro jeter ni.
English: Dizziness and fatigue may occur following administration of rolapitant (see section 4.8).
Slovenian: Po dajanju rolapitanta lahko nastopita omotica in utrujenost (glejte poglavje 4.8).
English: If you have symptoms of an allergic reaction, such as sudden shortness of breath, swelling of the lips or tongue or change in taste, swelling of skin or tissue or sudden rash or fever, or faster heartbeats, tell your doctor or nurse immediately.
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1.000 ljudi Če imate simptome alergijske reakcije, kot so nenadna zasoplost, otekle ustnice ali jezik ali sprememba okusa, otekanje kože ali tkiva,nenaden izpuščaj, zvišana telesna temperatura ali pospešen srčni utrip, o tem takoj obvestite zdravnika ali medicinsko sestro.
English: Following administration of a single dose of 180 mg rolapitant to patients with mild hepatic impairment (Child-Pugh Class A), the pharmacokinetics of rolapitant were comparable with those of healthy subjects.
Slovenian: Po enkratnem odmerku 180 mg rolapitanta pri bolnikih z blago okvaro jeter (razred A po Child-Pugh) je bila farmakokinetika rolapitanta primerljiva s farmakokinetiko pri zdravih osebah.
English: In the one-month monkey study, convulsions were observed at 60 mg/kg/day (approximately 5.8 times the recommended human dose on a body surface area basis).
Slovenian: V enomesečni študiji na opicah so opazili krče pri odmerku 60 mg/kg/dan (približno 5,8kratni priporočeni odmerek za človeka na podlagi telesne površine).
English: Angioedema Dermatitis acneiform Dry skin
Slovenian: Bolezni kože in podkožja alopecija angioedem aknam podoben dermatitis suha koža
English: Following single oral doses (4.5 to 180 mg) of rolapitant, the mean terminal half-life (t1/2) of rolapitant ranged from 169 to 183 hours (approximately 7 days) and was independent of dose.
Slovenian: Po enkratnih peroralnih odmerkih (4,5 mg do 180 mg) rolapitanta je bil povprečni končni razpolovni čas (t½) rolapitanta v razponu od 169 do 183 ur (približno 7 dni) in ni bil odvisen od odmerka.
English: 180 mg orally; Within 2 hours prior to chemotherapy
Slovenian: zdravilo Varuby 180 mg peroralno; v 2 urah pred kemoterapijo.
English: Control (N=535) Rate
Slovenian: kontrola (N = 535) delež vrednost
English: Varuby should be used with caution in these patients (see section 5.2).
Slovenian: Zdravilo Varuby je treba pri teh bolnikih uporabljati previdno (glejte poglavje 5.2).
English: Rolapitant is metabolised by CYP3A4 to form a major active metabolite, M19.
Slovenian: Rolapitant se presnavlja predvsem s CYP3A4, pri čemer nastaja glavni aktivni presnovek, M19.
English: The pharmacokinetics of Varuby was not studied in patients with end-stage renal disease requiring haemodialysis.
Slovenian: Farmakokinetike zdravila Varuby niso raziskali pri bolnikih s končno odpovedjo ledvic, ki zahteva hemodializo.
English: The following additional pre-specified endpoints were also evaluated: complete response in the acute phase (0 to 24 hours) and overall phase (0 to 120 hours); no emesis in each
Slovenian: Ovrednoteni so bili tudi naslednji dodatni končni cilji: popoln odziv v akutni fazi (od 0 do 24 ur) in celotni fazi (0 do
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
Slovenian: Če niste prepričani, se pred jemanjem tega zdravila posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: UGT1A1 and UGT2B7 substrates (e.g. irinotecan and morphine, respectively) Rolapitant modestly inhibited UGT1A1 and UGT2B7 in vitro.
Slovenian: Substrati UGT1A1 in UGT2B7 (npr. irinotekan oziroma morfin)
English: What Varuby is and what it is used for What Varuby is
Slovenian: Kaj je zdravilo Varuby in za kaj ga uporabljamo Kaj je zdravilo Varuby
English: TESARO Bio Netherlands B.V. Joop Geesinkweg 901
Slovenian: Joop Geesinkweg 901
English: Table 2: Proportion of Patients Receiving Moderately Emetogenic Chemotherapy Responding by Treatment Group and Phase
Slovenian: Delež odzivnih bolnikov, ki so prejemali zmerno emetogeno kemoterapijo, po skupinah in fazah zdravljenja
English: Concomitant administration of a high fat meal did not significantly affect the pharmacokinetics of rolapitant after administration of 180 mg rolapitant.
Slovenian: Sočasno dajanje zelo mastnih obrokov ni pomembno vplivalo na farmakokinetiko rolapitanta po dajanju 180 mg rolapitanta.
English: Rolapitant had no effects on the pharmacokinetics of caffeine (a CYP1A2 substrate) when an oral dose of 200 mg caffeine was administered with a single dose of 180 mg rolapitant on Day 1, and without rolapitant on Day 8 and Day 15.
Slovenian: Rolapitant ni imel učinka na farmakokinetiko kofeina (substrata CYP1A2) pri dajanju peroralnega odmerka 200 mg kofeina skupaj z enkratnim odmerkom 180 mg rolapitanta 1. dan in brez rolapitanta 8. in 15. dan.
English: Varuby has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Varuby ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Tabulated list of adverse reactions
Slovenian: Preglednica s seznamom neželenih učinkov
English: Rolapitant is eliminated primarily through the hepatobiliary route.
Slovenian: Rolapitant se izloča predvsem prek jeter/žolča.
English: Lactose monohydrate Pregelatinised starch Microcrystalline cellulose (E460) Povidone (K-30) Croscarmellose sodium Colloidal silicon dioxide Magnesium stearate
Slovenian: Vsebina tablete laktoza monohidrat predgelirani škrob mikrokristalna celuloza (E 460) povidon (K-30) premreženi natrijev karmelozat koloidni silicijev dioksid magnezijev stearat
English: Each tablet contains 90 mg of rolapitant.
Slovenian: Ena tableta vsebuje 90 mg rolapitanta.
English: Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide Chemotherapy
Slovenian: Zmerno emetogena kemoterapija in kemoterapija s kombinacijami antraciklina in ciklofosfamida Študija 3 (MEC)
English: Varuby contains the active substance rolapitant.
Slovenian: Zdravilo Varuby vsebuje učinkovino rolapitant.
English: A 3-fold increase in the exposure of dextromethorphan, a CYP2D6 substrate, was observed 7 days after a single oral dose of rolapitant and may last longer.
Slovenian: Še 7 dni po enkratnem peroralnem odmerku rolapitanta so opazili 3-kratno povišanje izpostavljenosti dekstrometorfanu, substratu CYP2D6, lahko pa traja tudi dlje.
English: What Varuby looks like and contents of the pack
Slovenian: Izgled zdravila Varuby in vsebina pakiranja
English: Rolapitant (N=535) Rate (%)
Slovenian: Pb rolapitant (N = 535) delež (%)
English: In a fertility and early embryonic development study in female rats, rolapitant hydrochloride at an oral dose equivalent to 9 mg/kg per day free base (approximately 0.5 times the recommended human dose on a body surface area basis) caused a transient decrease in maternal body weight gain and increases in the incidence of pre- and post-implantation loss.
Slovenian: V študiji plodnosti in zgodnjega razvoja zarodka pri samicah podgan je rolapitantijev klorid v peroralnem odmerku, ki je bil enakovreden 9 mg/kg na dan proste baze (približno 0,5-kratni priporočeni odmerek za človeka na podlagi telesne površine), povzročil prehodno zmanjšanje v prirastu materne telesne mase in povečanje incidence izgube pred implantacijo in po njej.
English: The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Slovenian: Vpliv navzee in bruhanja na vsakdanje življenje bolnikov je bil ocenjen s pomočjo vprašalnika
English: Breast-feeding is not recommended during treatment with Varuby.
Slovenian: Dojenje se med zdravljenjem z zdravilom Varuby odsvetuje.
English: Cisplatin-Based Highly Emetogenic Chemotherapy (HEC)
Slovenian: Zelo emetogena kemoterapija (HEC) na osnovi cisplatina Študija 1 in študija 2 (HEC)
English: In two multicentre, randomised, double-blind, parallel group, controlled clinical studies (Study 1 and Study 2), the rolapitant regimen (180 mg rolapitant, 10 mcg/kg intravenous granisetron and 20 mg oral dexamethasone) was compared with control therapy (placebo, 10 mcg/kg intravenous granisetron and 20 mg oral dexamethasone) on Day 1 in patients receiving a chemotherapy regimen that included cisplatin ≥60 mg/m2.
Slovenian: V dveh multicentričnih, randomiziranih, dvojno slepih, nadzorovanih kliničnih študijah z vzporednimi skupinami (študija 1 in študija 2) so režim rolapitanta (180 mg rolapitanta, 10 µg/kg intravenskega granisetrona in 20 mg peroralnega deksametazona) primerjali s kontrolno terapijo (placebo, 10 µg/kg intravenskega granisetrona in 20 mg peroralnega deksametazona) na 1. dan pri bolnikih, ki so prejemali režim kemoterapije, ki je vključeval cisplatin ≥ 60 mg/m2.
English: Pack size of two tablets in a polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Slovenian: Velikost pakiranja je dve tableti v dvojnem pretisnem omotu iz polivinilklorida/poliklorotrifluoroetilena/aluminijeve folije.
English: Polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Slovenian: Dvojni pretisni omot iz polivinilklorida/poliklorotrifluoroetilena/aluminijeve folije.
English: CYP3A4 substrates
Slovenian: Substrati CYP3A4
English: Concurrent administration of 400 mg ketoconazole once daily for 21 days following a single 90 mg dose of rolapitant, did not significantly affect the Cmax of rolapitant while the AUC increased by 21%.
Slovenian: Sočasna uporaba 400 mg ketokonazola enkrat na dan 21 dni po enkratnem odmerku 90 mg rolapitanta ni znatno vplivala na Cmax rolapitanta, vrednost
English: The primary endpoint in both studies was complete response (defined as no emetic episodes and no rescue medicinal product) in the delayed phase (>24 to 120 hours) of chemotherapy-induced nausea and vomiting.
Slovenian: Primarni končni cilj obeh študij je bil popoln odziv (opredeljen kot odsotnost epizod bruhanja in uporabe rešilnega zdravila) v zapozneli fazi (od > 24 do 120 ur) navzee in bruhanja zaradi kemoterapije.
English: CINV phase, no significant nausea in each CINV phase, and time to first emesis or use of rescue medicinal product.
Slovenian: 120 ur), brez bruhanja v vsaki fazi CINV, brez znatne navzee v vsaki fazi CINV in čas do prvega bruhanja ali uporabe rešilnega zdravila.
English: - if you take an herbal medicine called St John's wort (Hypericum performatum), used to treat depression and difficulty sleeping (see section 2 under ‘Other medicines and Varuby').
Slovenian: • če ste alergični na rolapitant ali katero koli sestavino tega zdravila (navedeno v poglavju 6), • če jemljete zeliščno zdravilo z imenom šentjanževka (Hypericum perforatum), ki se uporablja za zdravljenje depresije in težav s spanjem (glejte »Druga zdravila in zdravilo Varuby« v poglavju 2).
English: There are limited data in patients with severe renal impairment (see section 5.2).
Slovenian: Bolniki s hudo okvaro ledvic Podatki za bolnike s hudo okvaro ledvic so omejeni (glejte poglavje 5.2).
English: In Study 3, a multicentre, randomised, double-blind, parallel group, controlled clinical study in moderately emetogenic chemotherapy, the rolapitant regimen (180 mg rolapitant, 2 mg oral granisetron and 20 mg oral dexamethasone) was compared with control therapy (placebo, 2 mg oral granisetron and 20 mg oral dexamethasone) on Day 1 in patients receiving a moderately emetogenic chemotherapy regimen that included 53% of patients receiving a combination of anthracycline and cyclophosphamide (AC).
Slovenian: V študiji 3, multicentrični, randomizirani, dvojno slepi, kontrolirani klinični študiji z vzporednimi skupinami pri zmerno emetogeni kemoterapiji, so režim z rolapitantom (180 mg rolapitant, 2 mg peroralni granisetron in 20 mg peroralni deksametazon) primerjali s kontrolno terapijo (placebo, 2 mg peroralni granisetron in 20 mg peroralni deksametazon) 1. dan pri bolnikih, ki so prejemali režim zmerno emetogene kemoterapije, v okviru katerega je 53 % bolnikov prejemalo kombinacijo antraciklina in ciklofosfamida (AC).
English: Rolapitant (N=271) Rate (%)
Slovenian: Pb rolapitant (N = 271) delež (%)
English: - you have severe liver or kidney problems - you need to take certain medicines which may reduce the effectiveness of Varuby, such as: - rifampicin, to treat tuberculosis and other infections - carbamazepine, to treat epilepsy and nerve pain - phenobarbital, to treat epilepsy - enzalutamide, to treat prostate cancer - phenytoin, to treat epilepsy - efavirenz, to treat human immunodeficiency virus (HIV) - rifabutin, to treat tuberculosis and other infections - other medicines that contain an NK1 antagonist, such as aprepitant and a combination of netupitant and palonosetron hydrochloride (for the prevention of nausea and vomiting associated with cancer chemotherapy) (see section 2 under ‘Other medicines and Varuby')
Slovenian: rifampicin za zdravljenje tuberkuloze in drugih okužb, karbamazepin za zdravljenje epilepsije in bolečin živcev, fenobarbital za zdravljenje epilepsije, enzalutamid za zdravljenje raka na prostati, fenitoin za zdravljenje epilepsije, efavirenz za zdravljenje virusne humane imunske pomanjkljivosti (HIV), rifabutin za zdravljenje tuberkuloze in drugih okužb, druga zdravila, ki vsebujejo antagonist NK1, kot je aprepitant in kombinacija netupitanta in palonosetronijevega klorida (za preprečevanje slabosti in bruhanja pri kemoterapiji za zdravljenje raka) (glejte»Druga zdravila in zdravilo Varuby« v poglavju 2).
English: How to take Varuby
Slovenian: Kako uporabljati zdravilo Varuby
English: Rolapitant is an inhibitor of Breast-Cancer-Resistance Protein (BCRP).
Slovenian: Substrati BCRP Rolapitant je zaviralec proteina za odpornost proti raku dojke (Breast-Cancer-Resistance Protein
English: Non-AC
Slovenian: Brez AC
English: Day 2
Slovenian: Dan 2
English: Varuby in patients who require chronic administration of strong inducers (e.g. rifampicin, carbamazepine, enzalutamide, phenytoin) is not recommended (see section 4.4).
Slovenian: Uporabe zdravila Varuby se ne priporoča pri bolnikih, ki potrebujejo dolgotrajno dajanje močnih induktorjev (kot so npr. rifampicin, karbamazepin, enzalutamid, fenitoin) (glejte poglavje 4.4).
English: Varuby contains lactose
Slovenian: Zdravilo Varuby vsebuje laktozo
English: - problems walking
Slovenian: • težave pri gibanju,
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Varuby Vsebina pakiranja in dodatne informacije
English: The primary endpoint was complete response (defined as no emetic episodes and no rescue medicinal product) in the delayed phase (>24 to 120 hours) of chemotherapy-induced nausea and vomiting.
Slovenian: Primarni končni cilj je bil popoln odziv (opredeljen kot odsotnost epizod bruhanja in uporabe rešilnega zdravila) v zapozneli fazi (> 24 do 120 ur) navzee in bruhanja zaradi kemoterapije.
English: Control (N=262)
Slovenian: kontrola (N = 262) delež vrednost
English: At a dose equivalent to 4.5 mg/kg per day free base (approximately 0.2 times the recommended human dose on a body surface area basis), there were decreases in the number of corpora lutea and implantation sites.
Slovenian: Pri odmerku, ki ustreza 4,5 mg/kg na dan proste baze (približno 0,2-kratni priporočeni odmerek za človeka na osnovi telesne površine), je prišlo do zmanjšanja v številu rumenih telesc in mest ugnezditve.
English: Pack size of two tablets.
Slovenian: Velikost pakiranja sta dve tableti.
English: Varuby 90 mg tablets Rolapitant
Slovenian: Varuby 90 mg tablete rolapitant
English: Moderately emetogenic chemotherapy regimen Day 1
Slovenian: Režim zmerno emetogene kemoterapije Dan 1
English: The other ingredients are: - Tablet core: lactose monohydrate (see section 2 under ‘Varuby contains lactose'), pregelatinised starch, microcrystalline cellulose (E460), povidone (K-30), croscarmellose sodium, colloidal silicon dioxide and magnesium stearate.
Slovenian: • jedro tablete: laktoza monohidrat (glejte»Zdravilo Varuby vsebuje laktozo« v poglavju 2), predgelirani škrob, mikrokristalna celuloza (E460), povidon (K-30), premreženi natrijev karmelozat, koloidni silicijev dioksid in magnezijev stearat.
English: See the Summary of Product Characteristics for the co-administered 5-HT3 receptor antagonist for appropriate dosing information.
Slovenian: Za informacije o pravilnem odmerjanju glejte povzetek glavnih značilnosti zdravila za sočasno uporabljeni antagonist receptorja 5-HT3.
English: No dose adjustment is necessary for patients with mild or moderate renal impairment.
Slovenian: Prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro ledvic ni potrebna.
English: Talk to your doctor, pharmacist or nurse before taking this medicine if:
Slovenian: Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
English: Rolapitant had no significant effects on the pharmacokinetics of intravenous ondansetron when concomitantly administered with a single 180 mg dose of rolapitant on the same day.
Slovenian: Rolapitant ni imel pomembnega vpliva na farmakokinetiko intravenskega ondansetrona, ko je bil ta uporabljen isti dan z enkratnim odmerkom 180 mg rolapitanta.
English: There are no data in patients with severe hepatic impairment (see section 5.2).
Slovenian: Bolniki s hudo okvaro jeter Podatki za bolnike s hudo okvaro jeter niso na voljo (glejte poglavje 5.2).
English: At a maternal dose equivalent to 9 mg/kg per day rolapitant free base (approximately 0.5 times the recommended human dose on a body surface area basis), there was a decrease in memory in female pups in a maze test and a decrease in pup body weight.
Slovenian: Ko je mati prejela odmerek, ki je bil enakovreden 9 mg/kg na dan rolapitanta proste baze (približno 0,5-kratni priporočeni odmerek za človeka na podlagi telesne površine), je prišlo do zmanjšanega spomina pri mladičih ženskega spola pri testu z labirintom in do zmanjšane telesne mase mladičev.
English: The active substance is rolapitant.
Slovenian: Učinkovina je rolapitant.
English: What Varuby is used for
Slovenian: Za kaj uporabljamo zdravilo Varuby
English: Day 3
Slovenian: Dan 3
English: Control (N=273) Rate
Slovenian: kontrola (N = 273) delež vrednost
English: The following adverse reactions were observed in a pooled analysis of the Highly Emetogenic Chemotherapy (HEC) and Moderately Emetogenic Chemotherapy (MEC) studies.
Slovenian: V skupni analizi študij visoko emetogene kemoterapije (Highly Emetogenic Chemotherapy - HEC) in zmerno emetogene kemoterapije (Moderately Emetogenic Chemotherapy - MEC) so opazili naslednje neželene učinke.
English: Delayed Overall
Slovenian: Zapoznela faza
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kolcanje dispneja
English: The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer therapy:
Slovenian: Priporočeni so naslednji režimi za preprečevanje navzee in bruhanja, povezanih z emetogeno kemoterapijo raka pri odraslih: Režim visoko emetogene kemoterapije
English: Efficacy Endpointsa
Slovenian: Končni cilji učinkovitostia
English: Varuby contains lactose.
Slovenian: Zdravilo Varuby vsebuje laktozo.
English: Following multiple oral doses 9 to 45 mg once daily of rolapitant; accumulation of rolapitant was approximately 5-fold.
Slovenian: 45 mg rolapitanta enkrat na dan se je rolapitant nakopičil približno 5-kratno.
English: Therefore, clinical monitoring of adverse reactions and, if possible, biological monitoring are recommended when rolapitant is combined with digoxin or with other P-gp substrates (e.g. dabigatran or colchicine), and in particular in patients with renal impairment.
Slovenian: Če se rolapitant daje v kombinaciji z digoksinom ali z drugimi substrati P-gp (kot sta npr. dabigatran ali kolhicin), je zato priporočljivo klinično in po možnosti tudi biološko spremljanje neželenih učinkov,
English: In patients with moderate hepatic impairment (Child-Pugh Class B), the mean Cmax was 25% lower while mean AUC of rolapitant was similar compared to those of healthy subjects.
Slovenian: Pri bolnikih z zmerno okvaro jeter (razred B po Child-Pugh) je bila povprečna Cmax rolapitanta nižja za 25 %,
English: Chemotherapy can cause the body to release “substance P.” Substance P attaches to nerve cells in the brain's vomiting centre and makes you feel sick or be sick.
Slovenian: Snov P se v možganih veže na živčne celice v centru za bruhanje, zaradi česar vas sili na bruhanje ali pa dejansko bruhate.
English: Following administration of a single oral 180-mg dose of [14C]-rolapitant, on average 14.2% (range 9% to 20%) and 73% (range 52% to 89%) of the dose was recovered in the urine and feces, respectively over 6 weeks.
Slovenian: [14C]-rolapitanta so v povprečju 14,2 % (razpon od 9 % do 20 %) in 73 % (razpon od 52 % do 89 %)
English: International Normalised Ratio increased Leukopenia
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija povečano mednarodno normalizirano razmerje levkopenija zmanjšano število nevtrofilcev trombocitopenija
English: Overall a Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test. N.S.=Not significant (p>0.05) The estimated time to first emesis or use of rescue medicinal product in patients receiving a MEC regimen is depicted by the Kaplan-Meier plot in Figure 2.
Slovenian: N. Z. = ni značilno (p > 0,05) Ocena za čas do prvega bruhanja ali uporabe rešilnega zdravila pri bolnikih, ki prejemajo režim MEC,
English: In vivo, rolapitant is not expected to exhibit any inhibitory or inducing effect on CYP3A4.
Slovenian: Za rolapitant in vivo ni pričakovano, da bi imel kakršen koli zaviralni ali spodbujevalni učinek na