natgillin/translations-raw huggingface dataset:
Effects on offspring at this dose included decreased postnatal survival, and decreased body weights and body weight gain, and may be related to the maternal toxicity observed.
Vplivi na potomstvo pri tem odmerku bili med drugim zmanjšana stopnja postnatalnega preživetja in zmanjšana telesna masa ter zmanjšan prirast telesne mase, kar je lahko povezano z opaženimi škodljivimi vplivi na mater.
The exposure ratio of M19 to rolapitant was approximately 50% in plasma.
Razmerje izpostavljenosti M19 v primerjavi z rolapitantom v plazmi je bilo približno 50 %.
Of the 1070 patients, 26% were greater than 65 years of age and 3% were greater than 75 years of age.
Od 1.070 bolnikov je bilo 26 % starih več kot 65 let in 3 % starih več kot 75 let.
Of these 1332 patients, 28% were greater than 65 years of age and 6% were greater than 75 years of age.
Med temi 1.332 bolniki je bilo 28 % starih več kot 65 let in 6 % starih več kot 75 let.
Each dose (two tablets) contains 230 mg of lactose.
Odmerek (dve tableti) vsebuje 230 mg laktoze.
If you stop taking Varuby
Če ste prenehali jemati zdravilo Varuby
Single dose = 2 tablets
enkratni odmerek =2 tableti
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.
Varnostni profil pri podaljških študij z več ciklusi zelo in zmerno emetogene kemoterapije na do 6 ciklusov kemoterapije je bil podoben profilu, opaženem v 1. ciklusu.
There are no available data on rolapitant use in pregnant women.
Podatkov o uporabi rolapitanta pri nosečnicah ni na voljo.
Varuby is given as part of a regimen that includes dexamethasone and a 5-HT3 receptor antagonist.
Zdravilo Varuby se daje kot del režima, ki vključuje deksametazon in antagonist receptorja 5-HT3.
180 mg (two tablets) should be administered within 2 hours prior to initiation of each chemotherapy cycle but at no less than 2-week intervals.
180 mg (dve tableti) je treba vzeti 2 uri pred začetkom vsakega ciklusa kemoterapije, vendar vsaj z 2
This medicinal product contains 230 mg of lactose (as monohydrate) per dose (two tablets).
To zdravilo vsebuje 230 mg laktoze (v obliki monohidrata) na odmerek (dve tableti).
Limited data in patients aged 75 years and older are available.
Na voljo so omejeni podatki za bolnike, stare 75 let in starejše.
There are no data on the presence of rolapitant in human milk.
Ni podatkov o prisotnosti rolapitanta v materinem mleku.
Standard dose of 5-HT3 receptor antagonist.
Standardni odmerek antagonista receptorja 5-HT3.
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).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z rolapitantom za vse podskupine pediatrične populacije pri preprečevanju akutne in zapoznele navzee in bruhanja, povezanih z začetnimi in ponovnimi ciklusi visoko emetogenega zdravljenja raka na osnovi cisplatina in zmerno emetogenega zdravljenja raka (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Unchanged rolapitant or M19 were not found in pooled urine sample.
Nespremenjenega rolapitanta ali M19 v zbirnem vzorcu urina niso odkrili.
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.
V študiji 1 in 2 so skupno 1.087 bolnikov naključno razporedili v režim z rolapitantom (N = 544) ali v kontrolno terapijo (N = 543); 1.070 bolnikov je bilo vključenih v ocenjevanje učinkovitosti; 37 % je bilo žensk in 63 % moških.
Day 2 Day 3 Day 4
Dan 2 Dan 3 Dan 4
Control (N=666) Rate (%)
kontrola (N = 666) delež (%)
Contents of the pack and other information What Varuby contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Varuby
If you forget to take Varuby
Če ste pozabili vzeti zdravilo Varuby
Information is insufficient for the effect of severe renal impairment.
Podatkov o učinku hude okvare ledvic ni dovolj.
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).
Zato je potrebna previdnost, kadar se rolapitant kombinira z zdravilom, ki ga presnavlja CYP2D6, zlasti s tistimi, ki imajo ozek terapevtski razpon (npr. propafenon, tamoksifen, metoprolol, ki se uporablja pri srčnem popuščanju, tioridazin, pimozid).
Varuby is given as part of combination therapy (see section 4.2).
Zdravilo Varuby se daje v sklopu kombiniranega zdravljenja (glejte poglavje 4.2).
OCT1 substrates In vitro, rolapitant is not an inhibitor of OCT1 at the tested concentrations up to 20 µM.
Substrati OCT1 Rolapitant in vitro ni zaviralec OCT1 pri preskušenih koncentracijah do 20 µM.
In a mass balance study, the metabolite M19 was the major circulating metabolite.
V študiji masnega ravnovesja je bil presnovek M19 glavni presnovek v obtoku.
Other medicines and Varuby
Druga zdravila in zdravilo Varuby
Dexamethasone 20 mg orally; 30 min prior to chemotherapy
nič deksametazon 20 mg peroralno; 30 minut pred kemoterapijo.
Varuby should be used with caution in these patients (see sections 4.4 and 5.2).
Zdravilo Varuby je treba pri teh bolnikih uporabljati previdno (glejte poglavji 4.4 in 5.2).
Tablets are blue, debossed with T0101 on one side and 100 on the other.
Tablete so modre barve, z vtisnjeno oznako T0101 na eni in 100 na drugi strani.
Rolapitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
Mehanizem delovanja Rolapitant je selektivni antagonist humanih receptorjev P/nevrokinina 1 (NK1).
Rolapitant administered orally to lactating female rats was present in milk.
Rolapitant, peroralno dan podganam v obdobju laktacije, je bil prisoten v mleku.
Decreased appetite Dehydration Hypomagnesaemia
Presnovne in prehranske motnje zmanjšan apetit dehidracija hipomagneziemija
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).
Učinek zmernih induktorjev (kot sta npr. efavirenz, rifabutin) ni dokazan, zato se uporabe rolapitanta pri bolnikih, ki že dobivajo zmeren induktor, ne priporoča (glejte poglavje 4.4).
No Significant Nausea (maximum VAS <25 on 0-100 scale)
VAS < 25 na lestvici 0-100 )
The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in
Ocena za čas do prvega bruhanja v kombinirani analizi je prikazana z diagramom Kaplan-Meier na sliki 1.
Rolapitant, the active substance in Varuby, blocks substance P from attaching to these nerve cells and this helps prevent nausea and vomiting.
Rolapitant, učinkovina v zdravilu Varuby, preprečuje snovi P vezavo na te živčne celice in tako prepreči slabost in bruhanje.
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.
Študije in vitro kažejo, da za rolapitant ni pričakovati, da bo zaviral OATP1B1 pri klinično relevantnih koncentracijah, kažejo pa tudi, da rolapitant ni zaviralec OATP1B3 pri preskušenih koncentracijah do 20 µM.
Table 3: Proportion of Patients Receiving AC or non-AC Chemotherapy Achieving Complete Response
Delež bolnikov, ki so prejemali kemoterapijo z AC ali brez AC in dosegli popoln odziv
At the time the study was designed, AC containing chemotherapy regimens were considered to be moderately emetogenic.
V času načrtovanja študije so kemoterapije, ki so vključevale AC, veljale za zmerno emetogene.
Coadministration of a single dose of 180 mg rolapitant with sulfasalazine, a BCRP substrate, resulted in an approximately 2-fold increase in Cmax and AUC of sulfasalazine.
Sočasna uporaba enkratnega odmerka 180 mg rolapitanta s sulfasalazinom, ki je substrat BCRP, je povzročila približno 2-kratno povečanje Cmax in AUC za sulfasalazin.
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 plazemskih koncentracijah rolapitanta > 15 ng/ml in 348 ng/ml je zasedenost receptorjev NK1 v kortikalnih območjih znašala približno > 50 % oziroma 90 %.
5-HT3 receptor antagonist
nič receptor 5-HT3 antagonist
On Day 2 to 3, patients received 2 mg once daily of oral granisetron.
Od 2. do 3. dne so bolniki enkrat na dan peroralno prejemali 2 mg granisetrona.
CYP2D6 substrates
Substrati CYP2D6
Other side effects:
Druge sestavine so:
The pharmacokinetics of Varuby was not studied in patients with severe hepatic impairment (Child-Pugh Class C).
Farmakokinetike zdravila Varuby niso raziskali pri bolnikih s hudo okvaro jeter (razred C po Child-Pugh).
Rolapitant is a moderate CYP2D6 inhibitor.
Rolapitant je zmeren zaviralec CYP2D6.
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).
Proučevana zdravila so prejeli pred kemoterapijo 1. dne v naslednjih intervalih: rolapitant (1 do 2 uri prej); granisetron in deksametazon (30 minut prej).
In a population pharmacokinetic analysis of rolapitant, the Vd/F was 387 L in cancer patients.
V populacijski farmakokinetični analizi rolapitanta je pri bolnikih z rakom Vd/F znašal 387 l.
The tablets are blue, debossed with T0101 on one side and 100 on the other side.
Tablete so modre barve z vtisnjeno oznako T0101 na eni in 100 na drugi strani.
Rolapitant displays linear PK with exposures increased in a dose-proportional manner.
Rolapitant kaže linearno FK, pri kateri izpostavljenosti rastejo sorazmerno z odmerkom.
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.
V populacijskih farmakokinetičnih analizah očistek kreatinina (CLcr) ob začetni vrednosti ni kazal pomembnega vpliva na farmakokinetiko rolapitanta pri bolnikih z rakom z blago (CLcr: od 60 do 90 ml/min) ali zmerno (CLcr: 30 do 60 ml/min) okvaro ledvic v primerjavi z bolniki z rakom z normalnim delovanjem ledvic.
Due to its strong inducing effect, St John's wort is contraindicated with rolapitant (see section 4.3).
Zaradi svojega močnega indukcijskega učinka je šentjanževka kontraindicirana za uporabo z rolapitantom (glejte poglavje 4.3).
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).
V študiji ante- in postnatalnega razvoja pri podganah so bili škodljivi vplivi na mater očitni na podlagi smrtnosti/stanja umiranja, zmanjšanja telesne mase in porabe hrane, celotne izgube legla, podaljšanega kotenja, skrajšanja brejosti in povečanega števila neizkazanih mest ugnezditve pri odmerku, ki je bil enakovreden 22,5 mg/kg na dan proste baze (približno 1,2-kratni priporočeni odmerek za človeka na podlagi telesne površine).
Taking Varuby before chemotherapy prevents sickness and feelings of sickness.
Jemanje zdravila Varuby pred kemoterapijo prepreči slabost in siljenje na bruhanje.
Rolapitant is an inhibitor of P-glycoprotein (P-gp).
Rolapitant je zaviralec P-glikoproteina (P-gp).
Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults
Preprečevanje zapoznele navzee in bruhanja, povezanih z visoko in zmerno emetogeno kemoterapijo raka pri odraslih.
HEC Study 1
Študija 1 HEC
It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before taking this medicine.
Pomembno je, da zdravniku poveste, da dojite ali nameravate dojiti, preden vzamete to zdravilo.
On Day 2 to 4, patients received 8 mg twice daily of oral dexamethasone.
Od 2. do 4. dne so bolniki dvakrat na dan prejemali 8 mg peroralnega deksametazona.
A dose-dependent increase in mean NK1 receptor occupancy was observed in the dose range from 4.5 mg to 180 mg of rolapitant.
Opazili so od odmerka odvisno povečanje povprečne zasedenosti receptorjev NK1 v razponu odmerkov od 4,5 mg do 180 mg rolapitanta.
Study 3 - MEC Rolapitant (N=666) Rate (%)
Študija 3 - MEC rolapitant (N = 666) delež (%)
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.
Pri dajanju 600 mg rifampicina enkrat na dan 7 dni pred enkratnim odmerkom 180 mg rolapitanta in 7 dni po njem, se je njegova povprečna AUC zmanjšala za 87 % in aktivnega presnovka za 89 % v primerjavi z dajanjem samega rolapitanta.
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.
Enkraten odmerek 180 mg rolapitanta ni imel pomembnega vpliva na farmakokinetiko midazolama v primerjavi s samim peroralnim midazolamom 3 mg 1. dan, 8. dan in 11. dan.
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.
Rolapitant je bil preizkušen v študijah peroralne toksičnosti pri glodavcih ob ponavljajočih se odmerkih s trajanjem do 26 tednov, kot ciljni organi pa so bili opredeljeni jetra, ščitnica, ledvice,
Figure 2: Kaplan-Meier Plot of Proportions of Patients without Emesis or Use of Rescue Medication (Study 3--MEC)
Slika 2: Diagram Kaplan-Meier z deleži bolnikov brez bruhanja ali uporabe rešilnega zdravila (študija 3 - MEC)
In combination with St John's wort (see section 4.5)
V kombinaciji s šentjanževko (glejte poglavje 4.5).
Varuby has minor influence on your ability to drive and use machines.
Varuby nekoliko vpliva na vašo sposobnost vožnje in upravljanja strojev.
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.
Akutna faza: 0 do 24 ur po režimu z AC ali brez AC; zapoznela faza: > 24 do 120 ur po režimu z AC ali brez AC; celotna faza: 0 do 120 ur po režimu z AC ali brez AC. b Neprilagojene vrednosti P za test Cochran-Mantel Haenszel, stratificirano po spolu.
Each tablet contains 90 mg of rolapitant (as hydrochloride monohydrate).
Ena tableta vsebuje 90 mg rolapitanta (kot rolapitantijev klorid monohidrat).
HEC Study 2
Študija 2 HEC
Drug metabolising enzymes (and drug transporters) other than CYP3A4 involved in rolapitant hepatobiliary elimination remain to be elucidated.
Vloga encimov, ki zdravilo presnavljajo (in prenašalcev zdravila) in ki poleg CYP3A4 vplivajo na jetrno/žolčno izločanje rolapitanta, ostaja nepojasnjena.
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).
Klinično pomembne interakcije z naslednjimi zdravili niso pričakovane, če se uporabijo z enim odmerkom rolapitanta 180 mg 1. dan in brez rolapitanta 8. dan: repaglinid 0,25 mg (substrat CYP2C8), efavirenz 600 mg (substrat CYP2B6), tolbutamid 500 mg (substrat CYP2C9) ali omeprazol 40 mg (substrat CYP2C19).
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.
so 8,3 % odmerka odkrili v urinu, predvsem v obliki presnovkov, in 37,8 % odmerka v blatu, predvsem v obliki nespremenjenega rolapitanta.
The systemic exposures (Cmax and AUC) to rolapitant increased in a dose-proportional manner when the dose of rolapitant increased from 4.5 mg to 180 mg. With an increase in dose by 4 times from the recommended clinical dose of 180 mg, the Cmax and AUC of rolapitant increased by 3.1 fold and 3.7 fold, respectively.
Sistemske izpostavljenosti (Cmax in AUC) rolapitantu so se povečale sorazmerno z odmerkom, ko se je odmerek rolapitanta zvečal od 4,5 mg do 180 mg. S 4-kratnim povečanjem odmerka glede na priporočeni klinični odmerek 180 mg sta se Cmax in AUC za rolapitant povečala 3,1-krat oziroma
N.S.
N. Z.
In a population pharmacokinetic analysis the apparent total clearance (CL/F) of rolapitant was 0.96 L/hour in cancer patients.
populacijski farmakokinetični analizi je navidezni celotni očistek (CL/F) rolapitanta pri bolnikih z rakom znašal 0,96 l/uro.
Rolapitant is metabolised by CYP3A4 to form a major active metabolite, M19 (C4-pyrrolidinehydroxylated rolapitant).
Rolapitant se presnavlja s CYP3A4 in pri tem tvori glavni aktivni presnovek, M19 (C4-pirolidin-hidroksiliran rolapitant).
In a three-month rat study, clonic convulsions were observed in a single animal at 125 mg/kg/day (approximately 6 times the recommended human dose on a body surface area basis).
V trimesečni študiji na podganah so pri eni sami živali opazili klonične krče pri odmerku 125 mg/kg/dan (približno 6-kratni priporočeni odmerek za človeka na podlagi telesne površine).
Varuby is used to help prevent adults with cancer feeling sick (nauseous) or being sick (vomiting) while having cancer treatment chemotherapy.
Zdravilo Varuby uporabljamo za pomoč pri preprečevanju siljenja na bruhanje (slabosti) ali bruhanja pri odraslih bolnikih z rakom med zdravljenjem raka s kemoterapijo.
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.
Ovrednoteni so bili tudi dodatni vnaprej določeni končni cilji: popoln odziv v akutni fazi (od 0 do 24 ur) in celotni fazi (0 do 120 ur); brez bruhanja v vsaki fazi CINV, brez znatne navzee v vsaki fazi CINV in čas do prvega bruhanja ali uporabe rešilnega zdravila.
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.
204 ur pri bolnikih z blago do zmerno okvaro jeter v primerjavi s 168 urami pri zdravih osebah.
Effects of Varuby on the pharmacokinetics of other active substances
Učinki zdravila Varuby na farmakokinetiko drugih učinkovin
See package leaflet for further information.
Glejte navodilo za uporabo za dodatne informacije.
Figure 1: Kaplan-Meier Plot of Proportions of Patients without Emesis or Use of Rescue Medication (Study 1 and Study 2 Combined - HEC)
Slika 1: Diagram Kaplan-Meier z deleži bolnikov brez bruhanja ali uporabe rešilnega zdravila (kombinirani študiji 1 in 2 - HEC)
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).
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).
Effects of other medicinal products on the pharmacokinetics of Varuby
Učinki drugih zdravil na farmakokinetiko zdravila Varuby
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, teratogenic potential, and carcinogenic potential.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti, teratogenega in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
- Film-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), and polysorbate 80.
• filmska obloga tablete: polivinilalkohol, titanov dioksid (E171), makrogol, smukec, indigotin (E132) in polisorbat 80.
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%).
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 %).
There are limited data in patients with severe renal impairment and no data in patients with end stage renal disease undergoing haemodialysis.
Podatki za bolnike s hudo okvaro ledvic so omejeni, za bolnike s končno odpovedjo ledvic na hemodializi pa jih ni.
Increased plasma concentrations of BCRP substrates (e.g. methotrexate, irinotecan, topotecan, mitoxantrone, rosuvastatin, sulfasalazine, doxorubicin, bendamustine) may result in potential adverse reactions.
topotekan, mitoksantron, rosuvastatin, sulfasalazin, doksorubicin, bendamustin) lahko privedejo do morebitnih neželenih učinkov.
There are no data in patients with severe hepatic impairment.
Podatkov za bolnike s hudo okvaro jeter ni.
Dizziness and fatigue may occur following administration of rolapitant (see section 4.8).
Po dajanju rolapitanta lahko nastopita omotica in utrujenost (glejte poglavje 4.8).
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.
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.
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.
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.
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).
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).
Angioedema Dermatitis acneiform Dry skin
Bolezni kože in podkožja alopecija angioedem aknam podoben dermatitis suha koža
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.
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.