natgillin/translations-raw huggingface dataset:
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
The median Tmax for M19 was delayed to 204 hours in patients with mild or moderate hepatic impairment compared to 168 hours in healthy subjects.
Medijan tmax za M19 bio je produljen na 204 sata u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre u usporedbi sa 168 sati u zdravih ispitanika.
180 mg orally; Within 2 hours prior to chemotherapy
180 mg peroralno; unutar 2 sata prije kemoterapije
UGT1A1 and UGT2B7 substrates (e.g. irinotecan and morphine, respectively) Rolapitant modestly inhibited UGT1A1 and UGT2B7 in vitro.
Supstrati UGT1A1 i UGT2B7 (npr. irinotekan odnosno morfin) Rolapitant je in vitro umjereno inhibirao UGT1A1 i UGT2B7.
to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known: frequency cannot be estimated from the available data.
Učestalosti su definirane kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato: učestalost se ne može procijeniti iz dostupnih podataka.
Rolapitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
Rolapitant je selektivni antagonist receptora za tvar P/neurokinin 1 (NK1) u ljudi.
2 film-coated tablets
2 filmom obložene tablete
Rolapitant is eliminated primarily through the hepatobiliary route.
Rolapitant se uglavnom eliminira hepatobilijarnim putem.
What you need to know before you take Varuby Do not take Varuby:
Što morate znati prije nego počnete uzimati Varuby
- 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').
- ako uzimate biljni pripravak koji se naziva gospina trava (Hypericum perforatum) koji se koristi za liječenje depresije i poteškoća sa spavanjem (pogledajte dio 2 pod „Drugi lijekovi i
Rolapitant was highly protein bound to human plasma (99.8%).
Rolapitant se velikim dijelom veže za proteine plazme (99,8 %).
If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek.
In rodents, rolapitant was tested in repeated dose oral toxicity studies up to 26 weeks in duration, and the liver, thyroid, kidneys, epididymis and uterus were identified as target organs.
U glodavaca je u ispitivanjima oralne toksičnosti ponovljenih doza rolapitant ispitivan u trajanju do 26 tjedana, a kao ciljni organi identificirani su jetra, štitnjača, bubrezi, epididimis i uterus.
In pooled samples collected over 2 weeks, 8.3% of the dose was recovered in the urine primarily as metabolites and 37.8% of the dose was recovered in the feces primarily as unchanged rolapitant.
U zbirnim uzorcima, prikupljanima tijekom 2 tjedna, u urinu je pronađeno 8,3 % doze i to primarno u obliku metabolita, a 37,8 % doze pronađeno je u fecesu primarno kao nepromijenjeni rolapitant.
What Varuby is and what it is used for What Varuby is
Što je Varuby i za što se koristi Što je Varuby
5-HT3 receptor antagonist
Antagonist 5-HT3 receptora
The proportion of patients with no impact on daily life was higher in the Varuby group than in the control group (MEC: 73.2% vs. 67.4%; p=0.027).
Varuby nego u kontrolnoj skupini (MEC: 73,2 % napram 67,4 %; p = 0,027).
HEC Study 1
HEC Ispitivanje 1
None
Ništa
In case of overdose, the medicinal product should be discontinued and general supportive treatment and monitoring should be provided.
U slučaju predoziranja treba prekinuti primjenu lijeka, primijeniti opće potporno liječenje te osigurati praćenje.
Taking Varuby before chemotherapy prevents sickness and feelings of sickness.
Uzimanje lijeka Varuby prije kemoterapije sprječava povraćanje i osjećaj mučnine.
Study 3 (MEC)
Ispitivanje 3 - MEC
Limited data in patients aged 75 years and older are available.
Dostupni podaci o bolesnicima u dobi od 75 godina i starijima su ograničeni.
There are no available data on rolapitant use in pregnant women.
Nema dostupnih podataka o primjeni rolapitanta u trudnica.
A total of 1087 patients were randomised to either the rolapitant regimen (N=544) or control therapy (N=543) across Study 1 and Study 2; 1070 patients were included in the evaluation of efficacy; 37% were women and 63% were men.
U Ispitivanju 1 i Ispitivanju 2 ukupno je 1087 bolesnika bilo randomizirano na režim s rolapitantom (N = 544) ili kontrolnu terapiju (N = 543); u procjenu djelotvornosti bilo je uključeno 1070 bolesnika; 37 % su bile žene, a 63 % muškarci.
Rolapitant doses up to 720 mg have been used in clinical studies without any safety concerns.
U kliničkim ispitivanjima primjenjivane su doze rolapitanta do 720 mg bez ikakvih sigurnosnih rizika.
Talk to your doctor, pharmacist or nurse before taking this medicine if:
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek ako:
Population pharmacokinetic analyses indicated that age, sex and race had no significant impact on the pharmacokinetics of Varuby.
Dob, spol i rasa / etnička pripadnost Analize populacijske farmakokinetike pokazale su da dob, spol i rasa nemaju značajan učinak na farmakokinetiku lijeka Varuby.
In a mass balance study, the metabolite M19 was the major circulating metabolite.
U ispitivanju masene bilance glavni metabolit u cirkulaciji bio je metabolit M19.
- Film-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), and polysorbate 80.
• Filmska ovojnica: polivinilni alkohol, titanijev dioksid (E171), makrogol, talk, indigo carmine (E 132) i polisorbat 80.
At the time the study was designed, AC containing chemotherapy regimens were considered to be moderately emetogenic.
U vrijeme dizajniranja ispitivanja, AC kemoterapija smatrala se umjereno emetogenom.
Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults
Sprječavanje odgođene mučnine i povraćanja povezanih s primjenom jako ili umjereno emetogene kemoterapije raka u odraslih.
Rolapitant is eliminated mainly through the hepatobiliary route, with minor contributions from renal elimination.
Rolapitant se uglavnom eliminira hepatobilijarnim putem, s malim doprinosom eliminacije putem bubrega.
A total of 1332 patients were included in the evaluation of efficacy, 80% were women and 20% were men.
Ukupno su u procjenu djelotvornosti bila uključena 1332 bolesnika; 80 % su bile žene, a
The European Medicines Agency has deferred the obligation to submit the results of studies with rolapitant in all subsets of the paediatric population in prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cisplatin-based cancer therapy and moderately emetogenic cancer therapy (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja rolapitanta u svim podskupinama pedijatrijske populacije za prevenciju akutne i odgođene mučnine i povraćanja povezanih s početnim ili ponavljanim ciklusima jako emetogene kemoterapije raka koja sadrži cisplatin i umjereno emetogene kemoterapije raka (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
There are no data on the presence of rolapitant in human milk.
Nema podataka o prisutnosti rolapitanta u majčinom mlijeku.
Drug metabolising enzymes (and drug transporters) other than CYP3A4 involved in rolapitant hepatobiliary elimination remain to be elucidated.
Još je potrebno razjasniti koji enzimi koji metaboliziraju lijekove (i prijenosnici lijekova) osim CYP3A4 sudjeluju u hepatobilijarnoj eliminaciji rolapitanta.
On Day 2 to 3, patients received 2 mg once daily of oral granisetron.
Od 2. do 3. dana bolesnici su jednom dnevno primali 2 mg granizetrona peroralno.
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.
Zbog toga se preporučuje kliničko praćenje nuspojava te, ako je moguće, biološko praćenje kada se rolapitant primjenjuje u kombinaciji s digoksinom ili drugim supstratima P-gp-a (npr. dabigatranom ili kolhicinom), a posebice u bolesnika s oštećenjem funkcije bubrega.
A total of 1369 patients were randomised to either the rolapitant regimen (N=684) or control therapy (N=685).
Ukupno je 1369 bolesnika bilo randomizirano na režim s rolapitantom (N = 684) ili kontrolnu terapiju
It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before taking this medicine.
Važno je da obavijestite svog liječnika ako dojite ili planirate dojiti prije uzimanja lijeka.
HEC Study 2
HEC Ispitivanje 2
Effects of Varuby on the pharmacokinetics of other active substances
Učinci lijeka Varuby na farmakokinetiku drugih djelatnih tvari
Following multiple oral doses 9 to 45 mg once daily of rolapitant; accumulation of rolapitant was approximately 5-fold.
Nakon višekratnih oralnih doza rolapitanta od 9 do 45 mg jednom dnevno, akumulacija rolapitanta bila je otprilike peterostruka.
Rolapitant is a moderate CYP2D6 inhibitor.
Rolapitant je umjereni inhibitor CYP2D6.
The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in
Procijenjeno vrijeme do prvog povraćanja u kombiniranoj analizi prikazano je Kaplan-Meierovom krivuljom na Slici 1.
At the 180 mg dose of rolapitant, the mean NK1 receptor occupancy in the cortical regions was greater than 90% for at least 120 hours.
Pri dozi rolapitanta od 180 mg srednja vrijednost zaposjednutosti NK1 receptora u kortikalnim regijama bila je veća od 90 % tijekom najmanje 120 sati.
- problems walking
• otežano hodanje
How to take Varuby
Kako uzimati Varuby
In a population pharmacokinetic analysis of rolapitant, the Vd/F was 387 L in cancer patients.
U analizi populacijske farmakokinetike rolapitanta Vd/F iznosio je 387 l u bolesnika s rakom.
At rolapitant plasma concentrations of >15 ng/mL and 348 ng/mL, the NK1 receptor occupancies in the cortical regions were approximately >50% and 90% respectively.
Pri koncentraciji rolapitanta u plazmi od > 15 ng/ml i 348 ng/ml, zaposjednutost NK1 receptora u kortikalnim regijama iznosila je približno > 50 %, odnosno 90 %.
Delayed
Odgođeno
Varuby should be used with caution in these patients (see sections 4.4 and 5.2).
U tih bolesnika Varuby treba primjenjivati uz oprez (vidjeti dijelove 4.4 i 5.2).
The effect of moderate inducers (e.g. efavirenz, rifabutin) is not established; therefore, the use of rolapitant in patients already given a moderate inducer is not recommended (see section 4.4).
Učinak umjerenih induktora (npr. efavirenza, rifabutina) nije ustanovljen; stoga se primjena rolapitanta ne preporučuje u bolesnika koji su već primili umjereni induktor (vidjeti dio 4.4).
Varuby has minor influence on the ability to drive and use machines.
Varuby malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Rijetko: mogu se javiti u do 1 na 1000 osoba Ako imate simptome alergijske reakcije kao što su iznenadno otežano disanje, oticanje usnica ili jezika, promjene okusa, oticanje kože ili tkiva, iznenadan osip ili vrućicu ili ubrzane otkucaje srca, odmah se obratite liječniku ili medicinskoj sestri.
On Day 2 to 4, patients received 8 mg twice daily of oral dexamethasone.
Od 2. do 4. dana bolesnici su dva puta dnevno primali 8 mg deksametazona peroralno.
There are limited data in patients with severe renal impairment and no data in patients with end stage renal disease undergoing haemodialysis.
Podaci o bolesnicima s teškim oštećenjem funkcije bubrega su ograničeni, a podataka o bolesnicima u završnom stadiju bubrežne bolesti koji se liječe hemodijalizom nema.
OCT1 substrates In vitro, rolapitant is not an inhibitor of OCT1 at the tested concentrations up to 20 µM.
Supstrati OCT1 Rolapitant in vitro nije inhibitor OCT1 pri ispitivanim koncentracijama do 20 µM.
In vitro studies suggest that rolapitant is not expected to inhibit OATP1B1 at clinically relevant concentrations and rolapitant is not an inhibitor of OATP1B3 at the tested concentrations up to 20 µM.
In vitro ispitivanja pokazuju da se ne očekuje inhibitorno djelovanje rolapitanta na OATP1B1 pri klinički značajnim koncentracijama te da rolapitant nije inhibitor OATP1B3 pri ispitivanim koncentracijama do 20 µM.
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri ako primijetite bilo koju od sljedećih nuspojava:
When 600 mg rifampicin was administered once daily for 7 days before and 7 days after administration of a single dose of 180 mg rolapitant, the mean AUC was reduced by 87% and its active metabolite by 89% compared to administration of rolapitant alone.
Kada se 600 mg rifampicina primjenjivalo jednom dnevno tijekom 7 dana prije i 7 dana poslije primjene jednokratne doze od 180 mg rolapitanta, srednja vrijednost AUC rolapitanta bila je smanjena za 87 %, a njegovog metabolita za 89 % u usporedbi s primjenom rolapitanta samostalno.
Rolapitant is an inhibitor of P-glycoprotein (P-gp).
Rolapitant je inhibitor P-glikoproteina (P-gp-a).
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.
U bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh stadij B), srednja vrijednost Cmax bila je 25 % niža, dok je srednja vrijednost AUC rolapitanta bila slična u usporedbi sa srednjim vrijednostima u zdravih ispitanika.
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).
jednomjesečnom ispitivanju na majmunima konvulzije su uočene pri dozi od 60 mg/kg/dan (približno 5,8 puta preporučene doze za ljude na temelju tjelesne površine).
BCRP substrates
Supstrati BCRP-a
Study medicinal products were administered prior to chemotherapy on Day 1 at the following intervals: rolapitant (1 to 2 hours prior); granisetron and dexamethasone (30 minutes prior).
Ispitivani lijekovi primijenjeni su 1. dana kemoterapije, i to sa sljedećim razmacima prije kemoterapije: rolapitant (1 do 2 sata prije); granizetron i deksametazon (30 minuta prije).
Rolapitant is metabolised by CYP3A4 to form a major active metabolite, M19.
Rolapitant se metabolizira putem CYP3A4 u glavni aktivni metabolit M19.
Rolapitant displays linear PK with exposures increased in a dose-proportional manner.
Rolapitant pokazuje linearnu farmakokinetiku s porastom izloženosti proporcionalnim dozi.
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).
U prenatalnim i postnatalnim razvojnim ispitivanjima, pri dozama ekvivalentnim polovici preporučene doze u ljudi, došlo je do slabljenja pamćenja u ženske mladunčadi u testu s labirintom te do smanjenja tjelesne težine mladunčadi (vidjeti dio 5.3).
In vitro studies suggest that rolapitant is not an inhibitor of CYP2E1.
In vitro ispitivanja pokazuju da rolapitant nije inhibitor CYP2E1.
In population pharmacokinetic analyses, creatinine clearance (CLcr) at baseline did not show a significant effect on rolapitant pharmacokinetics in cancer patients with mild (CLcr: 60 to 90 mL/min) or moderate (CLcr: 30 to 60 mL/min) renal impairment compared to cancer patients with normal kidney function.
U analizama populacijske farmakokinetike početna vrijednost klirensa kreatinina (ClCr) nije značajno utjecala na farmakokinetiku rolapitanta u bolesnika oboljelih od raka koji imaju blago (ClCr: 60 do 90 ml/min) ili umjereno (ClCr: 30 do 60 ml/min) oštećenje funkcije bubrega u usporedbi s bolesnicima oboljelima od raka koji imaju normalnu funkciju bubrega.
Table 2: Proportion of Patients Receiving Moderately Emetogenic Chemotherapy Responding by Treatment Group and Phase
Tablica 2: Udio bolesnika koji su primali umjereno emetogenu kemoterapiju u kojih je došlo do odgovora prema terapijskoj skupini i fazi
Table 3: Proportion of Patients Receiving AC or non-AC Chemotherapy Achieving Complete Response
Tablica 3: Udio bolesnika koji su primali AC ili drugu kemoterapiju i postigli potpuni odgovor
The apparent volume of distribution (Vd/F) was 460 L in healthy subjects, indicating an extensive tissue distribution of rolapitant.
bio je 460 l u zdravih ispitanika, što upućuje na opsežnu tkivnu distribuciju rolapitanta.
No clinically significant effect was seen on the pharmacokinetics of rolapitant when ketoconazole, a strong CYP3A4 inhibitor was administered with rolapitant.
Nije uočen klinički značajan utjecaj na farmakokinetiku rolapitanta kada se uz njega primijenio ketkonazol, jak inhibitor CYP3A4.
Each tablet contains 90 mg of rolapitant (as hydrochloride monohydrate).
Jedna tableta sadrži 90 mg rolapitanta (u obliku rolapitantklorid hidrata).
No clinically significant interaction is expected with the following medicinal products when administered with a single dose of 180 mg rolapitant on Day 1 and without rolapitant on Day 8: repaglinide 0.25 mg (a CYP2C8 substrate), efavirenz 600 mg (a CYP2B6 substrate), tolbutamide 500 mg (a CYP2C9 substrate) or omeprazole 40 mg (a CYP2C19 substrate).
Ne očekuje se klinički značajna interakcija sa sljedećim lijekovima kada se primjenjuju uz jednokratnu dozu rolapitanta od 180 mg 1. dana te bez rolapitanta 8. dana: repaglinid od 0,25 mg (supstrat CYP2C8), efavirenz od 600 mg (supstrat CYP2B6), tolbutamid od 500 mg (supstrat CYP2C9) ili omeprazol od 40 mg (supstrat CYP2C19).
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.
Nakon peroralne primjene jednokratne doze od 180 mg [14C]-rolapitanta, prosječno je 14,2 % (raspon 9 % do 20 %) i 73 % (raspon 52 % do 89 %) doze pronađeno u urinu odnosno fecesu tijekom 6 tjedana.
In vivo, rolapitant is not expected to exhibit any inhibitory or inducing effect on CYP3A4.
In vivo se ne očekuje nikakvo inhibitorno ili indukcijsko djelovanje rolapitanta na CYP3A4.
Decreased appetite Dehydration Hypomagnesaemia
Poremećaji metabolizma i prehrane smanjen apetit dehidracija hipomagnezijemija
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
Rolapitant administered orally to lactating female rats was present in milk.
Rolapitant je nakon peroralne primjene tijekom laktacije bio prisutan u mlijeku ženki štakora.
The pharmacokinetics of Varuby was not studied in patients with end-stage renal disease requiring haemodialysis.
Farmakokinetika lijeka Varuby nije ispitivana u bolesnika u završnom stadiju bubrežne bolesti koji zahtijeva hemodijalizu.
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.
Nakon primjene jednokratne doze od 180 mg rolapitanta u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh stadij A) farmakokinetika rolapitanta bila je usporediva s onom u zdravih ispitanika.
Study 3 - MEC Rolapitant (N=666) Rate (%)
Ispitivanje 3 - MEC Rolapitant (N = 666)
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%).
Nakon primjene jednokratne doze od 180 mg rolapitanta natašte u zdravih ispitanika rolapitant je bio mjerljiv u plazmi unutar 30 minuta, vršna koncentracija u plazmi (Cmax) dosegnuta je za otprilike 4 sata, a srednja vrijednost Cmax iznosila je 968 ng/ml (CV %: 28 %).
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.
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.
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.
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.
How Varuby works
Kako Varuby djeluje
Unchanged rolapitant or M19 were not found in pooled urine sample.
U zbirnim uzorcima urina nisu pronađeni nepromijenjeni rolapitant niti M19.
Varuby contains lactose
Varuby sadrži laktozu
A dose-dependent increase in mean NK1 receptor occupancy was observed in the dose range from 4.5 mg to 180 mg of rolapitant.
O dozi ovisan porast srednje vrijednosti zaposjednutosti NK1 receptora uočen je u rasponu doza od 4,5 mg do 180 mg rolapitanta.
Table 1: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase (Studies 1 and 2 - HEC Individual Results)
Tablica 1: Udio bolesnika na kemoterapiji cisplatinom u kojih je došlo do odgovora prema terapijskoj skupini i fazi (Ispitivanje 1 i 2HEC odvojeni rezultati)
Control (N=666) Rate (%)
Kontrola (N = 666) Udio (%)
MARKETING AUTHORISATION NUMBER(S)
Prividni volumen distribucije (Vd/F)
Acute
Akutno
Other side effects:
Drugi sastojci su:
Angioedema Dermatitis acneiform Dry skin
Poremećaji kože i potkožnog tkiva alopecija angioedem akneiformni dermatits suha koža
CYP3A4 substrates
Supstrati CYP3A4
No Significant Nausea (maximum VAS <25 on 0-100 scale)
Bez značajne mučnine (najviše < 25 na VAS
Concomitant administration of a high fat meal did not significantly affect the pharmacokinetics of rolapitant after administration of 180 mg rolapitant.
Istodobno uzimanje obroka s visokim udjelom masnoća nije značajno utjecalo na farmakokinetiku rolapitanta nakon primjene 180 mg rolapitanta.
There are no data in patients with severe hepatic impairment.
Nema podataka o bolesnicima s teškim oštećenjem funkcije jetre.
Highly emetogenic chemotherapy regimen Day 1
Režim za jako emetogenu kemoterapiju 1. dan
Also contains lactose.
Sadrži laktozu.
In combination with St John's wort (see section 4.5)
Kombinacija s gospinom travom (vidjeti dio 4.5).
Moderately emetogenic chemotherapy regimen Day 1
Režim za umjereno emetogenu kemoterapiju 1. dan
Breast-feeding is not recommended during treatment with Varuby.
Tijekom liječenja lijekom Varuby dojenje se ne preporučuje.
Delayed Acute Overall
Akutno Ukupno
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.
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.
Over 4,375 patients have been treated with Varuby or a comparator across Phase 1, 2, and 3 clinical studies.
U kliničkim ispitivanjima faze 1, 2 i 3 više od 4375 bolesnika bilo je liječeno lijekom Varuby ili lijekom za usporedbu.
Each tablet contains 90 mg of rolapitant.
Jedna tableta sadrži 90 mg rolapitanta.
Standard dose of 5-HT3 receptor antagonist.
Uobičajena doza antagonista 5-HT3