natgillin/translations-raw huggingface dataset:
In a population pharmacokinetic analysis the apparent total clearance (CL/F) of rolapitant was 0.96 L/hour in cancer patients.
U analizi populacijske farmakokinetike prividni ukupni klirens (CL/F) rolapitanta bio je 0,96 l/h u bolesnika s rakom.
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.
• 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.
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%.
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
There are no data in patients with severe hepatic impairment (see section 5.2).
Nema podataka o bolesnicima s teškim oštećenjem funkcije jetre (vidjeti dio 5.2).
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.
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.
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)
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).
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.
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.
Varuby should be used with caution in these patients (see section 5.2).
U tih bolesnika Varuby treba primjenjivati uz oprez (vidjeti dio 5.2).
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.
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.
Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide Chemotherapy
Umjereno emetogena kemoterapija i kombinacije kemoterapije antraciklinom i ciklofosfamidom Ispitivanje 3 (MEC)
Effects of other medicinal products on the pharmacokinetics of Varuby
Utjecaj drugih lijekova na farmakokinetiku lijeka Varuby
What Varuby is used for
Za što se Varuby koristi
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.
Sigurnosni profil u nastavcima ispitivanja jako i umjereno emetogene kemoterapije kroz više ciklusa, sve do 6. ciklusa kemoterapije,
Rolapitant (N=535) Rate (%)
Rolapitant (N = 535) Udio (%)
This medicinal product contains 230 mg of lactose (as monohydrate) per dose (two tablets).
Pomoćna(e) tvar(i) s poznatim učinkom Ovaj lijek sadrži 230 mg laktoze (u obliku hidrata) po dozi (dvije tablete).
Oral fungal infection Candidiasis Oral candidiasis
Infekcije i infestacije oralna gljivična infekcija kandidijaza oralna kandidijaza
Varuby contains lactose.
Varuby sadrži laktozu.
Figure 2: Kaplan-Meier Plot of Proportions of Patients without Emesis or Use of Rescue Medication (Study 3--MEC)
Slika 2: Kaplan-Meeierova krivulja udjela bolesnika bez povraćanja ili primjene lijekova za hitno ublažavanje simptoma (Ispitivanje 3 - MEC)
Pack size of two tablets in a polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
U pakiranju se nalaze dvije tablete u združenom blisteru od polivinilklorid/poliklorotrifluoroetilen/aluminijske folije.
The active substance is rolapitant.
Djelatna tvar je rolapitant.
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 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.
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.
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.
Varuby 90 mg tablets Rolapitant
Varuby 90 mg tablete rolapitant
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).
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).
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: Kaplan-Meierova krivulja udjela bolesnika bez povraćanja ili primjene lijekova za hitno ublažavanje simptoma (Ispitivanje 1 i Ispitivanje 2 zajedno - HEC)
Rolapitant (N=271) Rate (%)
Rolapitant (N = 271) Udio (%)
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).
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).
Polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Združeni blister od polivinilklorid/poliklorotrifluoroetilen/aluminijske folije.
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.
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.
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).
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,
Pack size of two tablets.
Veličina pakiranja: dvije tablete.
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).
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).
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.
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.
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.
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.
The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer therapy:
Za sprječavanje mučnine i povraćanja povezanih s emetogenom terapijom raka preporučuju se sljedeći režimi:
Varuby helps prevent feeling sick and being sick when you have chemotherapy.
Varuby pomaže spriječiti nastanak mučnine i povraćanja dok primate kemoterapiju.
No dose adjustment is needed in patients with mild or moderate hepatic impairment.
Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
Varuby in patients who require chronic administration of strong inducers (e.g. rifampicin, carbamazepine, enzalutamide, phenytoin) is not recommended (see section 4.4).
Varuby se ne preporučuje u bolesnika koji iziskuju dugotrajnu primjenu jakih induktora enzima (npr. rifampicina, karbamazepina, enzalutamida, fenitoina) (vidjeti dio 4.4).
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.
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.
Patients with severe hepatic impairment
Bolesnici s teškim oštećenjem funkcije bubrega
Rolapitant is an inhibitor of Breast-Cancer-Resistance Protein (BCRP).
Rolapitant je inhibitor proteina rezistencije raka dojke (engl.
Name and address of the manufacturer(s) responsible for batch release
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
No dose adjustment is necessary for patients with mild or moderate renal impairment.
Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
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.
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.
Dizziness and fatigue may occur following administration of rolapitant (see section 4.8).
Nakon primjene rolapitanta mogu se javiti omaglica i umor (vidjeti dio 4.8).
Varuby is used to help prevent adults with cancer feeling sick (nauseous) or being sick (vomiting) while having cancer treatment chemotherapy.
Varuby se koristi kao pomoć u sprječavanju mučnine ili povraćanja u odraslih koji imaju rak za vrijeme primanja kemoterapije, liječenja za rak.
Information is insufficient for the effect of severe renal impairment.
Za procjenu utjecaja teškog oštećenja funkcije bubrega podaci nisu dovoljni.
Increased plasma concentrations of BCRP substrates (e.g. methotrexate, irinotecan, topotecan, mitoxantrone, rosuvastatin, sulfasalazine, doxorubicin, bendamustine) may result in potential adverse reactions.
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.
See the Summary of Product Characteristics for the co-administered 5-HT3 receptor antagonist for appropriate dosing information.
Za informacije o odgovarajućem doziranju antagonista 5-HT3 receptora pogledajte sažetak opisa svojstava lijeka koji će se istodobno primjenjivati.
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.
Rolapitant nije značajno utjecao na farmakokinetiku ondanzetrona primijenjenog intravenski konkomitantno s jednokratnom dozom rolapitanta od 180 mg istog dana.
Control (N=535) Rate
Kontrola (N = 535) Udio (%)
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).
U ispitivanju plodnosti ženki štakora i ranog embrionalnog razvoja uočeno je smanjenje broja žutih tijela i mjesta implantacije (vidjeti dio 5.3).
There are limited data in patients with severe renal impairment (see section 5.2).
Podaci o bolesnicima s teškim oštećenjem funkcije bubrega su ograničeni (vidjeti dio 5.2).
Control (N=273) Rate
Kontrola (N = 273) Udio (%)
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).
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).
Rolapitant (N=264) Rate (%)
Rolapitan t (N = 264) Udio (%)
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.
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.
Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Ovojnica tablete polivinilni alkohol titanijev dioksid (E171) makrogol talk indigo carmine (E 132) polisorbat 80
The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Utjecaj mučnine i povraćanja na svakodnevni život bolesnika procijenjen je upitnikom za procjenu mučnine i povraćanja uzrokovanih kemoterapijom (engl.
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.
(6-8 h) i ljudi (7 dana) još nije razjašnjen.
Package leaflet: Information for the patient Varuby 90 mg film-coated tablets
Uputa o lijeku: Informacije za bolesnika Varuby 90 mg filmom obložene tablete rolapitant
Lactose monohydrate Pregelatinised starch Microcrystalline cellulose (E460) Povidone (K-30) Croscarmellose sodium Colloidal silicon dioxide Magnesium stearate
povidon (K-30) umrežena karmelozanatrij koloidni silicijev dioksid magnezijev stearat
Due to its strong inducing effect, St John's wort is contraindicated with rolapitant (see section 4.3).
Primjena gospine trave s rolapitantom je kontraindicirana zbog njezinog jakog inducirajućeg djelovanja (vidjeti dio 4.3).
Figure 1.
PRILOG II.
P-Valuea
P-vrijednostb
The pharmacokinetics of Varuby was not studied in patients with severe hepatic impairment (Child-Pugh Class C).
Farmakokinetika lijeka Varuby nije ispitivana u bolesnika s teškim oštećenjem funkcije jetre
Arthralgia Back pain Muscular weakness Rhabdomyolysis
Poremećaji uha i labirinta hipoakuzija tinitus
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja štucanje dispneja
Varuby 90 mg film-coated tablets Rolapitant
Varuby 90 mg filmom obložene tablete rolapitant
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.
Sistemska izloženost (Cmax i AUC) rolapitantu porasla je proporcionalno dozi kada je doza rolapitanta povećana s 4,5 mg na 180 mg.
Varuby 90 mg film-coated tablets
Varuby 90 mg filmom obložene tablete
Rolapitant, the active substance in Varuby, blocks substance P from attaching to these nerve cells and this helps prevent nausea and vomiting.
P na te živčane stanice, a to pomaže u sprječavanju mučnine i povraćanja.
These include: - propafenone (used to treat irregular or abnormal heart beat) - tamoxifen (used to treat breast cancer) - metoprolol (used to treat high blood pressure and heart conditions) - thioridazine (used to treat psychiatric conditions like schizophrenia) - pimozide (used to treat psychiatric conditions like schizophrenia) - morphine (used to treat moderate to severe pain) - methotrexate (used to treat cancer, psoriasis, and rheumatoid arthritis) - irinotecan (used to treat cancer) - topotecan (used to treat cancer) - mitoxantrone (used to treat cancer) - sulfasalazine (used to treat bowel disease and rheumatoid arthritis) - doxorubicin (used in cancer chemotherapy) - bendamustine (used in the treatment of leukaemia) - digoxin (used to treat heart conditions) - dabigatran (used to prevent blood clots) - colchicine (used to treat gout) - medicines called ‘statins,' such as atorvastatin, fluvastatin, rosuvastatin and simvastatin, that are used in the treatment of high levels of fats (such as cholesterol) in the blood - bosentan (used to treat high blood pressure in the pulmonary artery) - fexofenadine (used to treat allergy symptoms)
- tioridazin (koristi se za liječenje psihijatrijskih bolesti kao što je shizofrenija) - pimozid (koristi se za liječenje psihijatrijskih bolesti kao što je shizofrenija) - morfin (koristi se za liječenje umjerenih do teških bolova) - metotreksat (koristi se za liječenje raka, psorijaze i reumatoidnog artritisa) - irinotekan (koristi se za liječenje raka) - topotekan (koristi se za liječenje raka)
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.
Tvar P se veže na živčane stanice u centru za povraćanje u mozgu te tako uzrokuje mučninu i povraćanje.
Constipation Diarrhoea Dyspepsia
Krvožilni poremećaji hipertenzija
Control (N=262)
Kontrola (N = 262) Udio (%)
International Normalised Ratio increased Leukopenia
Poremećaji krvi i limfnog sustava neutropenija povećan međunarodni normalizirani omjer leukopenija smanjen broj neutrofila trombocitopenija
- 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')
rifabutin za liječenje tuberkuloze i drugih infekcija drugi lijekovi koji sadrže antagonist NK1 receptora kao što su aprepitant i kombinacija netupitanta i palonosetronklorida (za sprječavanje mučnine i povraćanja povezanih s kemoterapijom raka) (pogledajte dio 2 pod „Drugi lijekovi i Varuby“)
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.
Procijenjeno vrijeme do prvog povraćanja ili primjene lijeka za hitno ublažavanje simptoma u bolesnika koji su primali režim MEC prikazano je Kaplan-Meierovom krivuljom na Slici 2.
Ondansetron
Ondanzetron
A total of 2,798 subjects received oral rolapitant at any dose, including 1,567 subjects in the CINV (chemotherapy-induced nausea and vomiting) studies.
Ukupno je 2798 ispitanika primilo rolapitant peroralno u bilo kojoj dozi,
Cisplatin-Based Highly Emetogenic Chemotherapy (HEC)
Highly Emetogenic Chemotherapy, HEC) i umjereno emetogene kemoterapije (engl.
Balance disorder Movement disorder Syncope
Poremećaji živčanog sustava glavobolja omaglica poremećaj pažnje disgeuzija somnolencija poremećaj ravnoteže poremećaj pokreta sinkopa