FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Nakon primjene jednokratnih oralnih doza (4,5 do 180 mg) rolapitanta, srednja vrijednost terminalnog poluvijeka (t½) rolapitanta bila je u rasponu od 169 do 183 sata (otprilike 7 dana) i nije bila ovisna o dozi.
English: A single dose of 180 mg rolapitant had no significant effects on the pharmacokinetics of midazolam compared to oral midazolam 3 mg alone on Day 1, Day 8 and Day 11.
Croatian: Jednokratna doza od 180 mg rolapitanta nije imala značajne učinke na farmakokinetiku midazolama u usporedbi sa samostalnom peroralnom primjenom 3 mg midazolama 1., 8. i 11. dana.
English: How Varuby works
Croatian: Kako Varuby djeluje
English: Unchanged rolapitant or M19 were not found in pooled urine sample.
Croatian: U zbirnim uzorcima urina nisu pronađeni nepromijenjeni rolapitant niti M19.
English: Varuby contains lactose
Croatian: Varuby sadrži laktozu
English: A dose-dependent increase in mean NK1 receptor occupancy was observed in the dose range from 4.5 mg to 180 mg of rolapitant.
Croatian: O dozi ovisan porast srednje vrijednosti zaposjednutosti NK1 receptora uočen je u rasponu doza od 4,5 mg do 180 mg rolapitanta.
English: Table 1: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase (Studies 1 and 2 - HEC Individual Results)
Croatian: Tablica 1: Udio bolesnika na kemoterapiji cisplatinom u kojih je došlo do odgovora prema terapijskoj skupini i fazi (Ispitivanje 1 i 2HEC odvojeni rezultati)
English: Control (N=666) Rate (%)
Croatian: Kontrola (N = 666) Udio (%)
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Prividni volumen distribucije (Vd/F)
English: Acute
Croatian: Akutno
English: Other side effects:
Croatian: Drugi sastojci su:
English: Angioedema Dermatitis acneiform Dry skin
Croatian: Poremećaji kože i potkožnog tkiva alopecija angioedem akneiformni dermatits suha koža
English: CYP3A4 substrates
Croatian: Supstrati CYP3A4
English: No Significant Nausea (maximum VAS <25 on 0-100 scale)
Croatian: Bez značajne mučnine (najviše < 25 na VAS
English: Concomitant administration of a high fat meal did not significantly affect the pharmacokinetics of rolapitant after administration of 180 mg rolapitant.
Croatian: Istodobno uzimanje obroka s visokim udjelom masnoća nije značajno utjecalo na farmakokinetiku rolapitanta nakon primjene 180 mg rolapitanta.
English: There are no data in patients with severe hepatic impairment.
Croatian: Nema podataka o bolesnicima s teškim oštećenjem funkcije jetre.
English: Highly emetogenic chemotherapy regimen Day 1
Croatian: Režim za jako emetogenu kemoterapiju 1. dan
English: Also contains lactose.
Croatian: Sadrži laktozu.
English: TESARO Bio Netherlands B.V. Joop Geesinkweg 901
Croatian: Joop Geesinkweg 901
English: In combination with St John's wort (see section 4.5)
Croatian: Kombinacija s gospinom travom (vidjeti dio 4.5).
English: Moderately emetogenic chemotherapy regimen Day 1
Croatian: Režim za umjereno emetogenu kemoterapiju 1. dan
English: Breast-feeding is not recommended during treatment with Varuby.
Croatian: Tijekom liječenja lijekom Varuby dojenje se ne preporučuje.
English: Delayed Acute Overall
Croatian: Akutno Ukupno
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.
Croatian: Pri dozi ekvivalentnoj 4,5 mg/kg slobodne baze na dan (približno 0,2 puta preporučene doze za ljude na temelju tjelesne površine) došlo je do smanjenja broja žutih tijela i mjesta implantacije.
English: Over 4,375 patients have been treated with Varuby or a comparator across Phase 1, 2, and 3 clinical studies.
Croatian: U kliničkim ispitivanjima faze 1, 2 i 3 više od 4375 bolesnika bilo je liječeno lijekom Varuby ili lijekom za usporedbu.
English: Each tablet contains 90 mg of rolapitant.
Croatian: Jedna tableta sadrži 90 mg rolapitanta.
English: Standard dose of 5-HT3 receptor antagonist.
Croatian: Uobičajena doza antagonista 5-HT3
English: In a population pharmacokinetic analysis the apparent total clearance (CL/F) of rolapitant was 0.96 L/hour in cancer patients.
Croatian: U analizi populacijske farmakokinetike prividni ukupni klirens (CL/F) rolapitanta bio je 0,96 l/h u bolesnika s rakom.
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.
Croatian: • Jezgra tablete: laktoza hidrat (pogledajte dio 2 pod „Varuby sadrži laktozu“), prethodno geliran škrob, mikrokristalična celuloza (E460), povidon (K-30), umrežena karmelozanatrij, koloidni silicijev dioksid i magnezijev stearat.
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%.
Croatian: Istodobna primjena 400 mg ketokonazola jednom dnevno tijekom 21 dana nakon jednokratne doze od 90 mg rolapitanta nije značajno utjecala na Cmax rolapitanta, dok se
English: There are no data in patients with severe hepatic impairment (see section 5.2).
Croatian: Nema podataka o bolesnicima s teškim oštećenjem funkcije jetre (vidjeti dio 5.2).
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.
Croatian: Primarna mjera ishoda u oba ispitivanja bila je potpuni odgovor (definiran kao: bez povraćanja i bez primjene lijeka za hitno ublažavanje simptoma) u odgođenoj fazi (> 24 do 120 sati) mučnine i povraćanja uzrokovanih kemoterapijom.
English: Varuby is not recommended in patients who require chronic administration of strong (e.g. rifampicin, carbamazepine, phenobarbital, enzalutamide, phenytoin) or moderate enzyme inducers (e.g. efavirenz, rifabutin) (see section 4.5)
Croatian: Varuby se ne preporučuje u bolesnika koji iziskuju dugotrajnu primjenu jakih (npr. rifampicina, karbamazepina, fenobarbitala, enzalutamida, fenitoina) ili umjerenih induktora enzima (npr. efavirenza, rifabutina) (vidjeti dio 4.5).
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.
Croatian: Primarna mjera ishoda bila je potpuni odgovor (definiran kao: bez povraćanja i bez primjene lijeka za hitno ublažavanje simptoma) u odgođenoj fazi (> 24 do 120 sati) mučnine i povraćanja uzrokovanih kemoterapijom.
English: Varuby should be used with caution in these patients (see section 5.2).
Croatian: U tih bolesnika Varuby treba primjenjivati uz oprez (vidjeti dio 5.2).
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 CINV phase, no significant nausea in each CINV phase and time to first emesis or use of rescue medicinal product.
Croatian: Također su procijenjene i dodatne, unaprijed određene, mjere ishoda: potpuni odgovor u akutnoj fazi (0 do 24 sata) i ukupno (0 do 120 sati); bez povraćanja u svim fazama CINV, bez značajne mučnine u svim fazama CINV i vrijeme proteklo do prvog povraćanja ili primjene lijeka za hitno ublažavanje simptoma.
English: Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide Chemotherapy
Croatian: Umjereno emetogena kemoterapija i kombinacije kemoterapije antraciklinom i ciklofosfamidom Ispitivanje 3 (MEC)
English: Effects of other medicinal products on the pharmacokinetics of Varuby
Croatian: Utjecaj drugih lijekova na farmakokinetiku lijeka Varuby
English: What Varuby is used for
Croatian: Za što se Varuby koristi
English: The safety profile in the multiple-cycle extensions of highly and moderately emetogenic chemotherapy studies for up to 6 cycles of chemotherapy is similar to the profile observed in Cycle 1.
Croatian: Sigurnosni profil u nastavcima ispitivanja jako i umjereno emetogene kemoterapije kroz više ciklusa, sve do 6. ciklusa kemoterapije,
English: Rolapitant (N=535) Rate (%)
Croatian: Rolapitant (N = 535) Udio (%)
English: This medicinal product contains 230 mg of lactose (as monohydrate) per dose (two tablets).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Ovaj lijek sadrži 230 mg laktoze (u obliku hidrata) po dozi (dvije tablete).
English: Oral fungal infection Candidiasis Oral candidiasis
Croatian: Infekcije i infestacije oralna gljivična infekcija kandidijaza oralna kandidijaza
English: Varuby contains lactose.
Croatian: Varuby sadrži laktozu.
English: Figure 2: Kaplan-Meier Plot of Proportions of Patients without Emesis or Use of Rescue Medication (Study 3--MEC)
Croatian: Slika 2: Kaplan-Meeierova krivulja udjela bolesnika bez povraćanja ili primjene lijekova za hitno ublažavanje simptoma (Ispitivanje 3 - MEC)
English: Pack size of two tablets in a polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Croatian: U pakiranju se nalaze dvije tablete u združenom blisteru od polivinilklorid/poliklorotrifluoroetilen/aluminijske folije.
English: The active substance is rolapitant.
Croatian: Djelatna tvar je rolapitant.
English: Acute phase: 0 to 24 hours after AC or non-AC regimen; Delayed phase: >24 to 120 hours after AC or non-AC regimen; Overall phase: 0 to 120 hours after AC or non-AC regimen b Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test, stratified by sex. N.S.=Not significant (p>0.05) * N.S. after pre-specified multiplicity adjustment.
Croatian: Akutna faza: 0 do 24 sata nakon primanja AC ili drugog režima; odgođena faza: > 24 do 120 sati nakon primanja AC ili drugog režima; ukupno: 0 do 120 sati nakon primanja AC ili drugog režima b Nekorigirane p-vrijednosti dobivene Cochran-Mantel Haenszel testom, stratifcirano prema spolu.
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.
Croatian: Rolapitant nije utjecao na farmakokinetiku kofeina (supstrat CYP1A2) kada se doza od 200 mg kofeina primijenila peroralno uz jednokratnu dozu od 180 mg rolapitanta 1. dana te bez rolapitanta 8. i 15. dana.
English: Varuby 90 mg tablets Rolapitant
Croatian: Varuby 90 mg tablete rolapitant
English: The efficacy and safety of rolapitant with concurrent use of another NK1 receptor antagonist (e.g. aprepitant and a combination of netupitant and palonosetron hydrochloride) is not established and therefore not recommended (see section 4.4).
Croatian: Djelotvornost i sigurnost primjene rolapitanta istodobno s drugim antagonistom NK1 receptora (npr. aprepitantom i kombinacijom netupitanta i palonosetronklorida) nisu ustanovljene te se stoga ne preporučuje (vidjeti dio 4.4).
English: Figure 1: Kaplan-Meier Plot of Proportions of Patients without Emesis or Use of Rescue Medication (Study 1 and Study 2 Combined - HEC)
Croatian: Slika 1: Kaplan-Meierova krivulja udjela bolesnika bez povraćanja ili primjene lijekova za hitno ublažavanje simptoma (Ispitivanje 1 i Ispitivanje 2 zajedno - HEC)
English: Rolapitant (N=271) Rate (%)
Croatian: Rolapitant (N = 271) Udio (%)
English: The efficacy and safety of rolapitant with concurrent use of another NK1 receptor antagonist (e.g. aprepitant and a combination of netupitant and palonosetron hydrochloride) is not established and therefore not recommended (see section 4.5).
Croatian: Djelotvornost i sigurnost primjene rolapitanta istodobno s drugim antagonistom NK1 receptora (npr. aprepitantom ili kombinacijom netupitanta i palonosetronklorida) nisu ustanovljene te se stoga ne preporučuje (vidjeti dio 4.5).
English: Polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Croatian: Združeni blister od polivinilklorid/poliklorotrifluoroetilen/aluminijske folije.
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.
Croatian: U ispitivanju plodnosti i ranog embrionalnog razvoja u ženki štakora, rolapitantklorid je pri oralnoj dozi ekvivalentnoj 9 mg/kg slobodne baze na dan (približno 0,5 puta preporučene doze za ljude na temelju tjelesne površine) uzrokovao prolazno smanjenje prirasta tjelesne težine majki i porast incidencije preimplantacijskih i postimplantacijskih gubitaka.
English: Therefore, caution should be taken when rolapitant is combined with a medicinal product metabolised by CYP2D6, notably those having a narrow therapeutic margin (e.g. propafenone, tamoxifen, metoprolol used in heart failure, thioridazine, pimozide).
Croatian: Zbog toga je potreban oprez pri primjeni rolapitanta u kombinaciji s lijekom koji se metabolizira putem CYP2D6, posebice onim koji ima usku terapijsku širinu (npr. propafenon, tamoksifen,
English: Pack size of two tablets.
Croatian: Veličina pakiranja: dvije tablete.
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).
Croatian: U Ispitivanju 3, multicentričnom, randomiziranom, dvostruko slijepom, kontroliranom kliničkom ispitivanju s paralelnim skupinama pri primjeni umjereno emetogene kemoterapije, uspoređivali su se režim s rolapitantom (180 mg rolapitanta, 2 mg granizetrona peroralno i 20 mg deksametazona peroralno) i kontrolna terapija (placebo, 2 mg granizetrona peroralno i 20 mg deksametazona peroralno) 1. dana u bolesnika koji su primali umjereno emetogen režim kemoterapije, koji je uključivao 53 % bolesnika koji su primali kombinaciju antraciklina i ciklofosfamida (AC).
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.
Croatian: Povećana koncentracija supstrata CYP2D6 u plazmi može uzrokovati nuspojave 7 dana nakon jednokratne oralne doze rolapitanta uočeno je trostruko povećanje izloženosti dekstrometorfanu, supstratu CYP2D6, a taj bi učinak mogao trajati i dulje.
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.
Croatian: U dva multicentrična, randomizirana, dvostruko slijepa, kontrolirana klinička ispitivanja s paralelnim skupinama (Ispitivanje 1 i Ispitivanje 2) uspoređivali su se režim s rolapitantom (180 mg rolapitanta, 10 μg/kg granizetrona intravenski i 20 mg deksametazona peroralno) i kontrolna terapija (placebo, 10 μg/kg granizetrona intravenski i 20 mg deksametazona peroralno) 1. dana u bolesnika koji su primali kemoterapijski režim koji je uključivao cisplatin ≥ 60 mg/m2.
English: The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer therapy:
Croatian: Za sprječavanje mučnine i povraćanja povezanih s emetogenom terapijom raka preporučuju se sljedeći režimi:
English: Varuby helps prevent feeling sick and being sick when you have chemotherapy.
Croatian: Varuby pomaže spriječiti nastanak mučnine i povraćanja dok primate kemoterapiju.
English: No dose adjustment is needed in patients with mild or moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
English: Varuby in patients who require chronic administration of strong inducers (e.g. rifampicin, carbamazepine, enzalutamide, phenytoin) is not recommended (see section 4.4).
Croatian: Varuby se ne preporučuje u bolesnika koji iziskuju dugotrajnu primjenu jakih induktora enzima (npr. rifampicina, karbamazepina, enzalutamida, fenitoina) (vidjeti dio 4.4).
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.
Croatian: Pri dozi rolapitanta ekvivalentnoj 9 mg/kg slobodne baze na dan davanoj majci (približno 0,5 puta preporučene doze za ljude na temelju tjelesne površine) došlo je do oštećenja pamćenja u ženske mladunčadi u testu s labirintom te do smanjenja tjelesne težine mladunčadi.
English: Patients with severe hepatic impairment
Croatian: Bolesnici s teškim oštećenjem funkcije bubrega
English: Rolapitant is an inhibitor of Breast-Cancer-Resistance Protein (BCRP).
Croatian: Rolapitant je inhibitor proteina rezistencije raka dojke (engl.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: No dose adjustment is necessary for patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: Delayed phase: >24 to 120 hours postcisplatin treatment; Acute phase: 0 to 24 hours post-cisplatin treatment; Overall phase: 0 to 120 hours postcisplatin treatment b Unadjusted P-values are obtained from Cochran-Mantel Haenszel test, stratified for sex. c Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test, stratified by study and sex. N.S.=Not significant (p>0.05) *Not significant after applying pre-specified multiplicity adjustment.
Croatian: Odgođena faza: > 24 do 120 sati nakon liječenja cisplatinom; akutna faza: 0 do 24 sata nakon liječenja cisplatinom; ukupno: 0 do 120 sati nakon liječenja cisplatinom b Nekorigirane p-vrijednosti dobivene Cochran-Mantel Haenszel testom, stratifcirane prema spolu.
English: Dizziness and fatigue may occur following administration of rolapitant (see section 4.8).
Croatian: Nakon primjene rolapitanta mogu se javiti omaglica i umor (vidjeti dio 4.8).
English: Varuby is used to help prevent adults with cancer feeling sick (nauseous) or being sick (vomiting) while having cancer treatment chemotherapy.
Croatian: Varuby se koristi kao pomoć u sprječavanju mučnine ili povraćanja u odraslih koji imaju rak za vrijeme primanja kemoterapije, liječenja za rak.
English: Information is insufficient for the effect of severe renal impairment.
Croatian: Za procjenu utjecaja teškog oštećenja funkcije bubrega podaci nisu dovoljni.
English: Increased plasma concentrations of BCRP substrates (e.g. methotrexate, irinotecan, topotecan, mitoxantrone, rosuvastatin, sulfasalazine, doxorubicin, bendamustine) may result in potential adverse reactions.
Croatian: Povećane koncentracije supstrata BCRP-a (npr. metotreksata, irinotekana, topotekana, mitoksantrona, rosuvastatina, sulfasalazina, doksorubicina, bendamustina) u plazmi mogu dovesti do nuspojava Istodobna primjena jednokratne doze od 180 mg rolapitanta sa sulfasalazinom, supstratom BCRP-a, dovela je do približno dvostrukog porasta Cmax i AUC sulfasalazina.
English: See the Summary of Product Characteristics for the co-administered 5-HT3 receptor antagonist for appropriate dosing information.
Croatian: Za informacije o odgovarajućem doziranju antagonista 5-HT3 receptora pogledajte sažetak opisa svojstava lijeka koji će se istodobno primjenjivati.
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.
Croatian: Rolapitant nije značajno utjecao na farmakokinetiku ondanzetrona primijenjenog intravenski konkomitantno s jednokratnom dozom rolapitanta od 180 mg istog dana.
English: Control (N=535) Rate
Croatian: Kontrola (N = 535) Udio (%)
English: Decreases in the number of corpora lutea and implantation sites were observed in the female rat fertility and early embryonic development study (see section 5.3).
Croatian: U ispitivanju plodnosti ženki štakora i ranog embrionalnog razvoja uočeno je smanjenje broja žutih tijela i mjesta implantacije (vidjeti dio 5.3).
English: There are limited data in patients with severe renal impairment (see section 5.2).
Croatian: Podaci o bolesnicima s teškim oštećenjem funkcije bubrega su ograničeni (vidjeti dio 5.2).
English: Control (N=273) Rate
Croatian: Kontrola (N = 273) Udio (%)
English: In a pre- and post-natal development rat study, maternal toxicity was evident based on mortality/moribund condition, decreased body weight and food consumption, total litter loss, prolonged parturition, decreased length of gestation, and increased number of unaccounted for implantation sites at a dose equivalent to 22.5 mg/kg per day free base (approximately 1.2 times the recommended human dose on a body surface area basis).
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja na štakorima, maternalna toksičnost pri dozi ekvivalentnoj 22,5 mg/kg slobodne baze na dan (približno 1,2 puta preporučene doze za ljude na temelju tjelesne površine) očitovala se kao smrtnost / moribundno stanje, smanjenje tjelesne težine i konzumacije hrane, gubitak cijelog legla, produljeno koćenje, kraća gestacija i povećan broj implantacijskih mjesta s nedostajućim plodom (engl. number of unaccounted for implantation sites).
English: Rolapitant (N=264) Rate (%)
Croatian: Rolapitan t (N = 264) Udio (%)
English: Rolapitant had no significant effects on the pharmacokinetics of dexamethasone when oral dexamethasone was administered on Days 1 to 3 after a single 180 mg dose of rolapitant was coadministered on Day 1.
Croatian: Rolapitant nije značajno utjecao na farmakokinetiku deksametazona kada se deksametazon primjenjivao peroralno od 1. do 3. dana nakon jednokratne doze rolapitanta od 180 mg istodobno primijenjene 1. dana.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Croatian: Ovojnica tablete polivinilni alkohol titanijev dioksid (E171) makrogol talk indigo carmine (E 132) polisorbat 80
English: The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Croatian: Utjecaj mučnine i povraćanja na svakodnevni život bolesnika procijenjen je upitnikom za procjenu mučnine i povraćanja uzrokovanih kemoterapijom (engl.
English: The mechanism of the significant difference of half-lives observed between the rat and monkey (6-8 h) and human (7 days) is not elucidated.
Croatian: (6-8 h) i ljudi (7 dana) još nije razjašnjen.
English: Package leaflet: Information for the patient Varuby 90 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za bolesnika Varuby 90 mg filmom obložene tablete rolapitant
English: Lactose monohydrate Pregelatinised starch Microcrystalline cellulose (E460) Povidone (K-30) Croscarmellose sodium Colloidal silicon dioxide Magnesium stearate
Croatian: povidon (K-30) umrežena karmelozanatrij koloidni silicijev dioksid magnezijev stearat
English: Due to its strong inducing effect, St John's wort is contraindicated with rolapitant (see section 4.3).
Croatian: Primjena gospine trave s rolapitantom je kontraindicirana zbog njezinog jakog inducirajućeg djelovanja (vidjeti dio 4.3).
English: Figure 1.
Croatian: PRILOG II.
English: P-Valuea
Croatian: P-vrijednostb