natgillin/translations-raw huggingface dataset:
180 mg orally; Within 2 hours prior to chemotherapy
zdravilo Varuby 180 mg peroralno; v 2 urah pred kemoterapijo.
Control (N=535) Rate
kontrola (N = 535) delež vrednost
Varuby should be used with caution in these patients (see section 5.2).
Zdravilo Varuby je treba pri teh bolnikih uporabljati previdno (glejte poglavje 5.2).
Rolapitant is metabolised by CYP3A4 to form a major active metabolite, M19.
Rolapitant se presnavlja predvsem s CYP3A4, pri čemer nastaja glavni aktivni presnovek, M19.
The pharmacokinetics of Varuby was not studied in patients with end-stage renal disease requiring haemodialysis.
Farmakokinetike zdravila Varuby niso raziskali pri bolnikih s končno odpovedjo ledvic, ki zahteva hemodializo.
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
Ovrednoteni so bili tudi naslednji dodatni končni cilji: popoln odziv v akutni fazi (od 0 do 24 ur) in celotni fazi (0 do
If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
Če niste prepričani, se pred jemanjem tega zdravila posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
UGT1A1 and UGT2B7 substrates (e.g. irinotecan and morphine, respectively) Rolapitant modestly inhibited UGT1A1 and UGT2B7 in vitro.
Substrati UGT1A1 in UGT2B7 (npr. irinotekan oziroma morfin)
What Varuby is and what it is used for What Varuby is
Kaj je zdravilo Varuby in za kaj ga uporabljamo Kaj je zdravilo Varuby
Table 2: Proportion of Patients Receiving Moderately Emetogenic Chemotherapy Responding by Treatment Group and Phase
Delež odzivnih bolnikov, ki so prejemali zmerno emetogeno kemoterapijo, po skupinah in fazah zdravljenja
Concomitant administration of a high fat meal did not significantly affect the pharmacokinetics of rolapitant after administration of 180 mg rolapitant.
Sočasno dajanje zelo mastnih obrokov ni pomembno vplivalo na farmakokinetiko rolapitanta po dajanju 180 mg rolapitanta.
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 ni imel učinka na farmakokinetiko kofeina (substrata CYP1A2) pri dajanju peroralnega odmerka 200 mg kofeina skupaj z enkratnim odmerkom 180 mg rolapitanta 1. dan in brez rolapitanta 8. in 15. dan.
Varuby has minor influence on the ability to drive and use machines.
Zdravilo Varuby ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Tabulated list of adverse reactions
Preglednica s seznamom neželenih učinkov
Rolapitant is eliminated primarily through the hepatobiliary route.
Rolapitant se izloča predvsem prek jeter/žolča.
Lactose monohydrate Pregelatinised starch Microcrystalline cellulose (E460) Povidone (K-30) Croscarmellose sodium Colloidal silicon dioxide Magnesium stearate
Vsebina tablete laktoza monohidrat predgelirani škrob mikrokristalna celuloza (E 460) povidon (K-30) premreženi natrijev karmelozat koloidni silicijev dioksid magnezijev stearat
Each tablet contains 90 mg of rolapitant.
Ena tableta vsebuje 90 mg rolapitanta.
Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide Chemotherapy
Zmerno emetogena kemoterapija in kemoterapija s kombinacijami antraciklina in ciklofosfamida Študija 3 (MEC)
Varuby contains the active substance rolapitant.
Zdravilo Varuby vsebuje učinkovino rolapitant.
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.
Še 7 dni po enkratnem peroralnem odmerku rolapitanta so opazili 3-kratno povišanje izpostavljenosti dekstrometorfanu, substratu CYP2D6, lahko pa traja tudi dlje.
What Varuby looks like and contents of the pack
Izgled zdravila Varuby in vsebina pakiranja
Rolapitant (N=535) Rate (%)
Pb rolapitant (N = 535) delež (%)
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.
V študiji plodnosti in zgodnjega razvoja zarodka pri samicah podgan je rolapitantijev klorid v peroralnem odmerku, ki je bil enakovreden 9 mg/kg na dan proste baze (približno 0,5-kratni priporočeni odmerek za človeka na podlagi telesne površine), povzročil prehodno zmanjšanje v prirastu materne telesne mase in povečanje incidence izgube pred implantacijo in po njej.
The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Vpliv navzee in bruhanja na vsakdanje življenje bolnikov je bil ocenjen s pomočjo vprašalnika
Breast-feeding is not recommended during treatment with Varuby.
Dojenje se med zdravljenjem z zdravilom Varuby odsvetuje.
Cisplatin-Based Highly Emetogenic Chemotherapy (HEC)
Zelo emetogena kemoterapija (HEC) na osnovi cisplatina Študija 1 in študija 2 (HEC)
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.
V dveh multicentričnih, randomiziranih, dvojno slepih, nadzorovanih kliničnih študijah z vzporednimi skupinami (študija 1 in študija 2) so režim rolapitanta (180 mg rolapitanta, 10 µg/kg intravenskega granisetrona in 20 mg peroralnega deksametazona) primerjali s kontrolno terapijo (placebo, 10 µg/kg intravenskega granisetrona in 20 mg peroralnega deksametazona) na 1. dan pri bolnikih, ki so prejemali režim kemoterapije, ki je vključeval cisplatin ≥ 60 mg/m2.
Pack size of two tablets in a polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Velikost pakiranja je dve tableti v dvojnem pretisnem omotu iz polivinilklorida/poliklorotrifluoroetilena/aluminijeve folije.
Polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Dvojni pretisni omot iz polivinilklorida/poliklorotrifluoroetilena/aluminijeve folije.
CYP3A4 substrates
Substrati CYP3A4
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%.
Sočasna uporaba 400 mg ketokonazola enkrat na dan 21 dni po enkratnem odmerku 90 mg rolapitanta ni znatno vplivala na Cmax rolapitanta, vrednost
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.
Primarni končni cilj obeh študij je bil popoln odziv (opredeljen kot odsotnost epizod bruhanja in uporabe rešilnega zdravila) v zapozneli fazi (od > 24 do 120 ur) navzee in bruhanja zaradi kemoterapije.
CINV phase, no significant nausea in each CINV phase, and time to first emesis or use of rescue medicinal product.
120 ur), brez bruhanja v vsaki fazi CINV, brez znatne navzee v vsaki fazi CINV in čas do prvega bruhanja ali uporabe rešilnega zdravila.
- 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').
• če ste alergični na rolapitant ali katero koli sestavino tega zdravila (navedeno v poglavju 6), • če jemljete zeliščno zdravilo z imenom šentjanževka (Hypericum perforatum), ki se uporablja za zdravljenje depresije in težav s spanjem (glejte »Druga zdravila in zdravilo Varuby« v poglavju 2).
There are limited data in patients with severe renal impairment (see section 5.2).
Bolniki s hudo okvaro ledvic Podatki za bolnike s hudo okvaro ledvic so omejeni (glejte poglavje 5.2).
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).
V študiji 3, multicentrični, randomizirani, dvojno slepi, kontrolirani klinični študiji z vzporednimi skupinami pri zmerno emetogeni kemoterapiji, so režim z rolapitantom (180 mg rolapitant, 2 mg peroralni granisetron in 20 mg peroralni deksametazon) primerjali s kontrolno terapijo (placebo, 2 mg peroralni granisetron in 20 mg peroralni deksametazon) 1. dan pri bolnikih, ki so prejemali režim zmerno emetogene kemoterapije, v okviru katerega je 53 % bolnikov prejemalo kombinacijo antraciklina in ciklofosfamida (AC).
Rolapitant (N=271) Rate (%)
Pb rolapitant (N = 271) delež (%)
- 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')
rifampicin za zdravljenje tuberkuloze in drugih okužb, karbamazepin za zdravljenje epilepsije in bolečin živcev, fenobarbital za zdravljenje epilepsije, enzalutamid za zdravljenje raka na prostati, fenitoin za zdravljenje epilepsije, efavirenz za zdravljenje virusne humane imunske pomanjkljivosti (HIV), rifabutin za zdravljenje tuberkuloze in drugih okužb, druga zdravila, ki vsebujejo antagonist NK1, kot je aprepitant in kombinacija netupitanta in palonosetronijevega klorida (za preprečevanje slabosti in bruhanja pri kemoterapiji za zdravljenje raka) (glejte»Druga zdravila in zdravilo Varuby« v poglavju 2).
How to take Varuby
Kako uporabljati zdravilo Varuby
Rolapitant is an inhibitor of Breast-Cancer-Resistance Protein (BCRP).
Substrati BCRP Rolapitant je zaviralec proteina za odpornost proti raku dojke (Breast-Cancer-Resistance Protein
Non-AC
Brez AC
Varuby in patients who require chronic administration of strong inducers (e.g. rifampicin, carbamazepine, enzalutamide, phenytoin) is not recommended (see section 4.4).
Uporabe zdravila Varuby se ne priporoča pri bolnikih, ki potrebujejo dolgotrajno dajanje močnih induktorjev (kot so npr. rifampicin, karbamazepin, enzalutamid, fenitoin) (glejte poglavje 4.4).
Varuby contains lactose
Zdravilo Varuby vsebuje laktozo
- problems walking
• težave pri gibanju,
Contents of the pack and other information
Shranjevanje zdravila Varuby Vsebina pakiranja in dodatne informacije
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.
Primarni končni cilj je bil popoln odziv (opredeljen kot odsotnost epizod bruhanja in uporabe rešilnega zdravila) v zapozneli fazi (> 24 do 120 ur) navzee in bruhanja zaradi kemoterapije.
Control (N=262)
kontrola (N = 262) delež vrednost
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 odmerku, ki ustreza 4,5 mg/kg na dan proste baze (približno 0,2-kratni priporočeni odmerek za človeka na osnovi telesne površine), je prišlo do zmanjšanja v številu rumenih telesc in mest ugnezditve.
Pack size of two tablets.
Velikost pakiranja sta dve tableti.
Moderately emetogenic chemotherapy regimen Day 1
Režim zmerno emetogene kemoterapije Dan 1
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.
• jedro tablete: laktoza monohidrat (glejte»Zdravilo Varuby vsebuje laktozo« v poglavju 2), predgelirani škrob, mikrokristalna celuloza (E460), povidon (K-30), premreženi natrijev karmelozat, koloidni silicijev dioksid in magnezijev stearat.
See the Summary of Product Characteristics for the co-administered 5-HT3 receptor antagonist for appropriate dosing information.
Za informacije o pravilnem odmerjanju glejte povzetek glavnih značilnosti zdravila za sočasno uporabljeni antagonist receptorja 5-HT3.
No dose adjustment is necessary for patients with mild or moderate renal impairment.
Prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro ledvic ni potrebna.
Talk to your doctor, pharmacist or nurse before taking this medicine if:
Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
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 ni imel pomembnega vpliva na farmakokinetiko intravenskega ondansetrona, ko je bil ta uporabljen isti dan z enkratnim odmerkom 180 mg rolapitanta.
There are no data in patients with severe hepatic impairment (see section 5.2).
Bolniki s hudo okvaro jeter Podatki za bolnike s hudo okvaro jeter niso na voljo (glejte poglavje 5.2).
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.
Ko je mati prejela odmerek, ki je bil enakovreden 9 mg/kg na dan rolapitanta proste baze (približno 0,5-kratni priporočeni odmerek za človeka na podlagi telesne površine), je prišlo do zmanjšanega spomina pri mladičih ženskega spola pri testu z labirintom in do zmanjšane telesne mase mladičev.
The active substance is rolapitant.
Učinkovina je rolapitant.
What Varuby is used for
Za kaj uporabljamo zdravilo Varuby
Day 3
Dan 3
Control (N=273) Rate
kontrola (N = 273) delež vrednost
The following adverse reactions were observed in a pooled analysis of the Highly Emetogenic Chemotherapy (HEC) and Moderately Emetogenic Chemotherapy (MEC) studies.
V skupni analizi študij visoko emetogene kemoterapije (Highly Emetogenic Chemotherapy - HEC) in zmerno emetogene kemoterapije (Moderately Emetogenic Chemotherapy - MEC) so opazili naslednje neželene učinke.
Delayed Overall
Zapoznela faza
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kolcanje dispneja
The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer therapy:
Priporočeni so naslednji režimi za preprečevanje navzee in bruhanja, povezanih z emetogeno kemoterapijo raka pri odraslih: Režim visoko emetogene kemoterapije
Efficacy Endpointsa
Končni cilji učinkovitostia
Varuby contains lactose.
Zdravilo Varuby vsebuje laktozo.
Following multiple oral doses 9 to 45 mg once daily of rolapitant; accumulation of rolapitant was approximately 5-fold.
45 mg rolapitanta enkrat na dan se je rolapitant nakopičil približno 5-kratno.
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.
Če se rolapitant daje v kombinaciji z digoksinom ali z drugimi substrati P-gp (kot sta npr. dabigatran ali kolhicin), je zato priporočljivo klinično in po možnosti tudi biološko spremljanje neželenih učinkov,
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.
Pri bolnikih z zmerno okvaro jeter (razred B po Child-Pugh) je bila povprečna Cmax rolapitanta nižja za 25 %,
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.
Snov P se v možganih veže na živčne celice v centru za bruhanje, zaradi česar vas sili na bruhanje ali pa dejansko bruhate.
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.
[14C]-rolapitanta so v povprečju 14,2 % (razpon od 9 % do 20 %) in 73 % (razpon od 52 % do 89 %)
International Normalised Ratio increased Leukopenia
Bolezni krvi in limfatičnega sistema nevtropenija povečano mednarodno normalizirano razmerje levkopenija zmanjšano število nevtrofilcev trombocitopenija
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.
N. Z. = ni značilno (p > 0,05) Ocena za čas do prvega bruhanja ali uporabe rešilnega zdravila pri bolnikih, ki prejemajo režim MEC,
In vivo, rolapitant is not expected to exhibit any inhibitory or inducing effect on CYP3A4.
Za rolapitant in vivo ni pričakovano, da bi imel kakršen koli zaviralni ali spodbujevalni učinek na
Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Obloga tablete polivinilalkohol titanov dioksid (E171) makrogol smukec indigotin (E 132) polisorbat 80
Varuby helps prevent feeling sick and being sick when you have chemotherapy.
Zdravilo Varuby preprečuje slabost in siljenje na bruhanje pri kemoterapiji.
Varuby 90 mg film-coated tablets
Varuby 90 mg filmsko obložene tablete
Rolapitant is eliminated mainly through the hepatobiliary route, with minor contributions from renal elimination.
Rolapitant se izloča prek jeter/žolča, v manjši meri se izloča skozi ledvice.
No dose adjustment is needed in patients with mild or moderate hepatic impairment.
Prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro jeter ni potrebna.
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 odmerku 180 mg rolapitanta je bila povprečna zasedenost receptorjev NK1 v kortikalnih območjih nad
Adverse reactions per system organ class
Neželeni učinki glede na organski sistem Organski sistem Pogosti
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).
V študiji plodnosti podganjih samic in zgodnjega razvoja zarodka so opazili zmanjšano število rumenih telesc in mest ugnezditve (glejte poglavje 5.3).
Delayed Acute Overall
Zapoznela faza Akutna faza Celotna faza
Varuby 90 mg film-coated tablets Rolapitant
Varuby 90 mg filmsko obložene tablete rolapitant
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.
med drugim 1.567 oseb v študijah CINV (s kemoterapijo povzročena navzea in bruhanje).
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)
rifampicin, karbamazepin, fenobarbital, enzalutamid, fenitoin) ali zmernih encimskih induktorjev (npr. efavirenz, rifabutin) (glejte poglavje 4.5).
In vitro studies suggest that rolapitant is not an inhibitor of CYP2E1.
Študije in vitro kažejo, da rolapitant ni zaviralec
Overall
Celotna faza
How Varuby works
Kako deluje zdravilo Varuby
Oral fungal infection Candidiasis Oral candidiasis
Infekcijske in parazitske bolezni glivična okužba ust kandidoza kandidoza ust
Balance disorder Movement disorder Syncope
Bolezni živčevja glavobol omotičnost motnje pozornosti disgevzija somnolenca motnje ravnotežja motnje gibanja sinkopa
No clinically significant effect was seen on the pharmacokinetics of rolapitant when ketoconazole, a strong CYP3A4 inhibitor was administered with rolapitant.
Pri sočasni uporabi ketokonazola, močnega zaviralca CYP3A4, in rolapitanta niso opazili klinično pomembnega učinka na farmakokinetiko rolapitanta.
Other CYPs
Druge učinkovine CYP
Serious side effects:
Resni neželeni učinki
No Emesis
PRETISNI OMOTI
- feeling dizzy, difficulty concentrating, lack of energy, feeling sleepy (somnolence) or trouble sleeping (insomnia) - stomach problems including stomach discomfort, bloating, nausea, pain, indigestion, and diarrhoea - low levels of white blood cells which fight infections (shown in blood tests) - infection in the mouth - mouth sores - decreased appetite - hiccups - weakness
• omotičnost, težave s koncentracijo, pomanjkanje energije, občutek zaspanosti (dremavost) ali težave s spanjem (nespečnost),
How to store Varuby
Shranjevanje zdravila Varuby
Abdominal distension Abdominal pain Stomatitis
Psihiatrične motnje nespečnost anksioznost bruksizem
Study 1 and Study 2 (HEC)
(študiji 1 in 2 - ločeno prikazani rezultati HEC)
83.7 73.7 0.005 83.4 79.5 N.S.
85,7 N. Z.
A 70% increase in Cmax and 30% increase in AUC of digoxin, a P-gp substrate, were observed when administered with a single dose of 180 mg rolapitant.
Ob sočasnem dajanju z enkratnim odmerkom 180 mg rolapitanta so opazili 70-% povečanje Cmax in 30-% povečanje AUC za digoksin, substrat P-gp.
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta naglušnost tinitus
Metabolism and nutrition disorders
obmodek in maternica.
Name and address of the manufacturer(s) responsible for batch release
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij
Delayed Acute
Zapoznela faza Akutna faza
Constipation Diarrhoea Dyspepsia
Srčne bolezni pospešen srčni utrip
Heart rate increased
Odmerjanje Odrasli
Rolapitant (N=264) Rate (%)
Študija 1 in študija 2 združeno rolapitant (N = 264) delež (%)
Arthralgia Back pain Muscular weakness Rhabdomyolysis
Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija artralgija bolečine v hrbtu mišična oslabelost rabdomioliza
Uncommon: may affect up to 1 in 100 people - sore or painful muscles
Občasni: pojavijo se lahko pri največ 1 od 100 ljudi:
Rolapitant This medicine is subject to additional monitoring.
Navodilo za uporabo Varuby 90 mg filmsko obložene tablete rolapitant Za to zdravilo se izvaja dodatno spremljanje varnosti.
Patients with severe hepatic impairment
zlasti pri bolnikih z okvaro ledvic.
Hypoacusis Tinnitus
Neptunus 12
Nervous system disorders
• mišična oslabelost,
86.4 79.4 0.035 90.0 85.7 N.S.
68,9 N. Z.
73.5 64.9 0.034 74.5 68.9 N.S.
79,5 N. Z.
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).
aprepitanta in kombinacije netupitanta in palonosetronijevega klorida) ni dokazana, zato tega ne priporočamo (glejte poglavje 4.5).