FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study performed in healthy volunteers, netupitant does not affect the exposure of digoxin, a P-gp substrate, whereas it increases its Cmax by 1.09 fold [90%CI 0.9-1.31].
Croatian: Prema ispitivanju provedenom u zdravih dobrovoljaca, netupitant ne utječe na izloženost digoksinu, supstratu P-gp-a, ali povećava njegov Cmax za 1,09 puta [90% CI 0,9-1,31].
English: The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) should be considered when coadministering these active substances with netupitant/palonosetron capsules.
Croatian: Mogući učinci povećanih plazmatskih koncentracija midazolama ili drugih benzodiazepina metaboliziranih putem CYP3A4 (alprazolam, triazolam) moraju se uzeti u obzir kada se te djelatne tvari primjenjuju istovremeno s netupitant/palonozetron kapsulama.
English: The signs may include tremor, agitation, sweating, myoclonic movements, hypertonia and fever.
Croatian: Znakovi mogu uključivati tremor, agitaciju, znojenje, mioklonične pokrete, hipertoniju i vrućicu.
English: The medicines in Akynzeo attach to the receptors in the nervous system through which serotonin and substance P work: netupitant (an NK1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5HT3 receptor antagonist) blocks certain receptors for serotonin.
Croatian: Lijekovi u Akynzeu vežu se na receptore u živčanom sustavu kroz koje djeluju serotonin i tvar P: netupitant (antagonist receptora NK1) blokira receptore za tvar P, a palonozetron (antagonist receptora 5-HT3) blokira određene receptore za serotonin.
English: Phospholipidosis (foamy macrophages) has been observed with the administration of netupitant after repeated administration in rats and dogs.
Croatian: Fosfolipidoza (pjenasti makrofazi) opažena je uz primjenu netupitanta nakon ponavljane primjene u štakora i pasa.
English: • some chemotherapy medicines - such as docetaxel or etoposide
Croatian: • neke kemoterapijske lijekove - kao što su docetaksel ili etopozid
English: Based on the experience with healthy subjects exposed to oral netupitant 600 mg in combination with palonosetron 1.50 mg the potential acute symptoms of overdose are headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.
Croatian: Na temelju iskustva sa zdravim ispitanicima koji su bili izloženi peroralnom netupitantu u dozi od 600 mg u kombinaciji s palonozetronom od 1,50 mg, mogući akutni simptomi predoziranja su glavobolja, omaglica, konstipacija, anksioznost, palpitacije, euforično raspoloženje i bolovi u nogama.
English: Serotonergic medicinal products (e.g. SSRIs and SNRIs)
Croatian: Serotoninergički lijekovi (npr. SSRI i SNRI)
English: • The other ingredients are microcrystalline cellulose (E460), sucrose lauric acid esters, povidone K-30, croscarmellose sodium, colloidal hydrated silica, sodium stearyl fumarate, magnesium stearate, glycerol monocaprylocaproate (type I), glycerol, polyglyceryl oleate, purified water, butylhydroxyanisole (E320), gelatin, sorbitol, 1,4 sorbitan, titanium dioxide (E171), shellac glaze (partially esterified), yellow, red and black iron oxide (E172), propylene glycol (E1520).
Croatian: • Drugi sastojci su mikrokristalična celuloza (E460), saharozni esteri lauratne kiseline, povidon K-30, umrežena karmelozanatrij, koloidni hidratizirani silicijev dioksid, natrijev stearilfumarat, magnezijev stearat, glicerolmonokaprilokaprat (vrsta I), glicerol, poligliceriloleat, pročišćena voda, butilhidroksianizol (E320), želatina, sorbitol, 1,4 sorbitan, titanijev dioksid (E171), šelakova glazura (djelomično esterificirana), žuti, crveni i crni željezov oksid (E172), propilenglikol (E1520).
English: Netupitant/palonosetron capsules, when given with a single oral dose of 60 μg ethinylestradiol and 300 μg levonorgestrel had no significant effect on the AUC of ethinylestradiol and increased the AUC of levonorgestrel by 1.4-fold; clinical effects on the efficacy of hormonal contraception are unlikely.
Croatian: Kad su se netupitant/palonozetron kapsule davale s jednom peroralnom dozom od 60 μg etinilestradiola i 300 μg levonorgestrela, nisu imale značajan učinak na AUC etinilestradiola i povećale su AUC levonorgestrela za 1,4 puta; klinički učinci na djelotvornost hormonskih kontraceptiva nisu vjerojatni.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.
Croatian: Ako se nešto od gore navedenog odnosi na Vas (ili niste sigurni), obratite se liječniku, ljekarniku ili medicinskoj sestri prije nego što uzmete Akynzeo.
English: moxifloxacin, haloperidol, chlorpromazine, quetiapine, thioridazine or domperidone
Croatian: kinidin, moksifloksacin, haloperidol, klorpromazin, kvetiapin, tioridazin ili domperidon
English: • palonosetron.
Croatian: • palonozetron.
English: Caution should be exercised in patients with severe hepatic impairment since limited data are available in these patients.
Croatian: Potreban je oprez u bolesnika s teškim oštećenjem funkcije jetre jer su podaci u tih bolesnika ograničeni.
English: • coating of the tongue, difficulty swallowing, dry mouth, belching, abnormal taste after medicine intake
Croatian: • obložen jezik, otežano gutanje, suha usta, podrigivanje, neprirodan okus nakon uzimanja lijeka
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na trudnoću, razvoj embrija/fetusa, parturiciju ili postnatalni razvoj.
English: However, since netupitant/palonosetron capsules contains a 5-HT3 receptor antagonist, caution should be exercised in concomitant use with medicinal products that increase the QT interval or in patients who have or are likely to develop prolongation of the QT interval.
Croatian: Međutim, budući da netupitant/palonozetron kapsule sadrže antagonist receptora 5-HT3, potreban je oprez kad se istovremeno primjenjuju lijekovi koji produljuju QT interval ili u bolesnika koji imaju ili u kojih bi se moglo razviti produljenje QT intervala.
English: Serotonin then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex.
Croatian: Serotonin zatim aktivira receptore 5HT3 smještene na vagusnim aferentnim vlaknima, čime se pobuđuje refleks povraćanja.
English: Titanium dioxide (E171)
Croatian: 1,4 sorbitan titanijev dioksid (E171)
English: • medicines that might cause abnormal heartbeat such as amiodarone, nicardipine, quinidine,
Croatian: • lijekove koji mogu prouzročiti nepravilne srčane otkucaje kao što su amiodaron, nikardipin,
English: Three metabolites have been detected in human plasma at netupitant oral doses of 30 mg and higher (the desmethyl derivative, M1; the N-oxide derivative, M2; the OH-methyl derivative, M3).
Croatian: Kod peroralnih doza netupitanta od 30 mg i više, u ljudskoj plazmi otkrivena su tri metabolita (dezmetil derivat, M1; N-oksid derivat, M2; OH-metil derivat, M3).
English: Co-administration of a single dose of 300 mg netupitant with a dexamethasone regimen (20 mg on Day 1, followed by 8 mg twice daily from Day 2 to Day 4) significantly increased the exposure to dexamethasone in a time and dose dependent manner.
Croatian: Istovremena primjena jedne doze netupitanta od 300 mg s režimom deksametazona (20 mg 1. dana, a zatim 8 mg dvaput na dan od 2. do 4. dana) značajno je povećala izloženost deksametazonu na način ovisan o vremenu i dozi.
English: The proportion of patients with Overall no impact on daily life was 6.3% higher (p value =0.005) in the Akynzeo group (78.5%) than in the palonosetron group (72.1%).
Croatian: Udio bolesnika bez sveukupnog utjecaja na svakodnevni život bio je 6,3% veći (p-vrijednost = 0,005) u skupini koja je primala Akynzeo (78,5%) nego u skupini koja je primala palonozetron (72,1%).
English: Human plasma protein binding of netupitant and its two major metabolites M1 and M3 is > 99% at concentrations ranging from 10 to 1500 ng/mL.
Croatian: Vezanje netupitanta te njegovih dvaju glavnih metabolita M1 i M3 na proteine u ljudskoj plazmi iznosi > 99% pri koncentracijama u rasponu od 10 do 1500 ng/ml.
English: No dosage adjustment is necessary for patients with mild or moderate hepatic impairment (ChildPugh score 5-8).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (Child Pugh rezultat 5-8).
English: Degeneration of seminiferous epithelium was associated with palonosetron following a one month oral repeat dose toxicity study in rats.
Croatian: Degeneracija sjemenskog epitela bila je povezana s palonozetronom nakon mjesec dana ispitivanja toksičnosti ponovljenih peroralnih doze u štakora.
English: Hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects.
Croatian: Oštećenje jetrene funkcije ne utječe značajno na ukupni tjelesni klirens palonozetrona u usporedbi sa zdravim ispitanicima.
English: The hard capsules are opaque with a white body and a caramel cap with ‘HE1' printed on the body.
Croatian: Tvrde kapsule su neprozirne s bijelim tijelom i kapicom boje karamele, s oznakom „HE1“ otisnutom na tijelu.
English: • decreased blood flow to the heart muscle (myocardial ischemia)
Croatian: • smanjeni dotok krvi u srčani mišić (ishemija miokarda)
English: Chemotherapeutic substances produce nausea and vomiting by stimulating the release of serotonin from the enterochromaffin cells of the small intestine.
Croatian: Kemoterapijske tvari uzrokuju mučninu i povraćanje stimulacijom otpuštanja serotonina iz enterokromafinih stanica tankog crijeva.
English: No relevant changes of netupitant and palonosetron pharmacokinetics were observed.
Croatian: Nisu opažene značajne promjene farmakokinetike netupitanta i palonozetrona.
English: There are no data about the use of netupitant in pregnant women.
Croatian: Nema podataka o primjeni netupitanta u trudnica.
English: Netupitant No effect on fertility has been observed in animal studies.
Croatian: U ispitivanjima na životinjama nije opažen učinak na plodnost.
English: Netupitant/palonosetron capsules are contraindicated during pregnancy (see section 4.3).
Croatian: Netupitant/palonozetron kapsule kontraindicirane su tijekom trudnoće (vidjeti dio 4.3).
English: • you have a blockage in your gut, or you have had constipation in the past • you or one of your close relatives has ever had a heart problem called ‘QT interval prolongation'
Croatian: • Vi ili netko od Vama bliskih rođaka imali ste tegobe sa srcem pod nazivom „produljenje QT
English: Acute phase: 0 to 24 hours after anthracycline and cyclophosphamide regimen Delayed phase: 25 to 120 hours after anthracycline and cyclophosphamide regimen Overall: 0 to 120 hours after anthracycline and cyclophosphamide regimen
Croatian: Akutna faza: od 0 do 24 sata nakon protokola s antraciklinom i ciklofosfamidom Odgođena faza: od 25 do 120 sati nakon protokola s antraciklinom i ciklofosfamidom Cijela faza: od 0 do 120 sati nakon protokola s antraciklinom i ciklofosfamidom
English: Multiple-cycle safety study in patients receiving either Highly Emetogenic Chemotherapy or Moderately Emetogenic Chemotherapy
Croatian: Ispitivanje sigurnosti primjene u više ciklusa u bolesnika koji su primali visoko emetogenu kemoterapiju ili umjereno emetogenu kemoterapiju
English: In single dose oral studies, netupitant was measurable in plasma between 15 minutes and 3 hours after dosing.
Croatian: U ispitivanjima s jednom peroralnom dozom, netupitant je bio mjerljiv u plazmi između 15 minuta i 3 sata nakon primljene doze.
English: Caution is recommended when netupitant is combined with an oral substrate of this enzyme (e.g.zidovudine, valproic acid, morphine).
Croatian: Preporučuje se oprez kada se netupitant kombinira s peroralnim supstratom ovoga enzima (npr. zidovudinom, valproatnom kiselinom, morfinom).
English: Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction (see section 4.8).
Croatian: Stoga bolesnike s poznatom preosjetljivošću na kikiriki ili soju treba pomno nadzirati na znakove alergijske reakcije (vidjeti dio 4.8).
English: Rare
Croatian: Rijetke
English: • high levels of certain enzymes, including blood alkaline phosphatase and liver transaminases
Croatian: • visoke razine nekih enzima, uključujući alkalnu fosfatazu i jetrene transaminaze (prema pretragama krvi)
English: Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction.
Croatian: Stoga bolesnike s poznatom preosjetljivošću na kikiriki ili soju treba pomno nadzirati na znakove alergijske reakcije.
English: Effects in non-clinical studies based on safety pharmacology and single and repeated dose toxicity were observed only at exposures considered in excess of the maximum human exposure, indicating little relevance to clinical use.
Croatian: Učinci u nekliničkim ispitivanjima temljenim na sigurnosnoj farmakologiji i toksičnosti jedne i ponovljenih doza bili su opaženi samo kod izloženosti koje su se smatrale većima od maksimalne ljudske izloženosti, što ukazuje na mali značaj za kliničku primjenu.
English: In vitro data shows that netupitant inhibits UGT2B7, the magnitude of such an effect in the clinical setting is not established.
Croatian: In vitro podaci pokazuju da netupitant inhibira UGT2B7, no veličina takvog učinka nije ustanovljena u kliničkom okruženju.
English: Exposure to erythromycin and midazolam was increased approximately 1.3 and 2.4 fold, respectively, when each was co-administered with netupitant.
Croatian: Izloženost eritromicinu povećala se približno 1,3 puta, a midazolamu 2,4 puta kada je svaki od njih primijenjen istovremeno s netupitantom.
English: In a separate study, a total of 413 patients undergoing initial and repeat cycles of chemotherapy (including carboplatin, cisplatin, oxaliplatin, and doxorubicin regimens), were randomized to receive either Akynzeo (n=309) or aprepitant and palonosetron (n=104).
Croatian: U odvojenom ispitivanju, ukupno 413 bolesnika koji su primali početni i ponavljane cikluse kemoterapije (uključujući protokole s karboplatinom, cisplatinom, oksaliplatinom i doksorubicinom) bili su randomizirani i primali su ili Akynzeo (n = 309) ili aprepitant i palonozetron (n = 104).
English: Following administration of a single dose of Akynzeo, netupitant is eliminated from the body in a multi-exponential fashion, with an apparent mean elimination half-life of 88 hours in cancer patients.
Croatian: Nakon primjene jedne doze Akynzea u bolesnika s rakom, netupitant se eliminira iz tijela multieksponencijalno, s prividnim srednjim poluvijekom eliminacije od 88 sati.
English: What Akynzeo is and what it is used for
Croatian: Što je Akynzeo i za što se koristi
English: The primary efficacy endpoint was complete response (CR) rate (defined as no emetic episodes, no rescue medication) within 120 hours (overall phase) after the start of the highly emetogenic chemotherapy administration.
Croatian: Primarni ishod djelotvornosti bila je stopa potpunog odgovora (engl. complete response, CR) (definiran kao stanje bez emetičkih epizoda, bez simptomatske terapije) unutar 120 sati (cijela faza) nakon početka primjene visoko emetogene kemoterapije.
English: Each hard capsule contains 7 mg of sorbitol and 20 mg of sucrose.
Croatian: Jedna tvrda kapsula sadrži 7 mg sorbitola i 20 mg saharoze.
English: such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram
Croatian: (SSRI) - kao što su fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram ili escitalopram
English: Reproductive studies in animals with netupitant do not indicate direct or indirect harmful effects with respect to fertility, parturition or postnatal development.
Croatian: Ispitivanja reprodukcije u životinja s netupitantom ne ukazuju na izravne ili neizravne štetne učinke na plodnost, parturiciju ili postnatalni razvoj.
English: Palonosetron:
Croatian: Palonozetron:
English: Pack size of one hard capsule or 4 x 1 hard capsules in perforated unit dose blisters.
Croatian: Veličina pakiranja od jedne tvrde kapsule ili 4 x 1 tvrde kapsule u perforiranom pakiranju s jediničnim dozama.
English: A pregnancy test should be performed on all pre-menopausal women prior to treatment.
Croatian: Prije liječenja, svim ženama koje nisu u menopauzi treba provesti test na trudnoću.
English: Hypokalaemia and hypomagnesaemia should be corrected prior to administration.
Croatian: Prije primjene potrebno je korigirati hipokalemiju i hipomagnezemiju.
English: Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Croatian: želatina titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: As use in patients with severe hepatic impairment may be associated with increased exposure of netupitant, this medicinal product should be used with caution in these patients (see sections 4.4 and
Croatian: Budući da se primjena u bolesnika s teškim oštećenjem funkcije jetre može povezati s povećanom izloženosti netupitantu, u tih se bolesnika ovaj lijek mora primjenjivati s oprezom (vidjeti dijelove 4.4 i 5.2).
English: Common adverse reactions reported with netupitant/palonosetron capsules were headache (3.6%), constipation (3.0%) and fatigue (1.2%).
Croatian: Česte nuspojave zabilježene uz netupitant/palonozetron kapsule bile su glavobolja (3,6%), konstipacija (3,0%) i umor (1,2%).
English: • infection and inflammation in the bladder (cystitis)
Croatian: • infekcija i upala mokraćnog mjehura (cistitis)
English: There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram and SNRIs such as venlafaxine or duloxetine) (see section
Croatian: Bilo je izvješća o serotoninskom sindromu nakon istovremene primjene antagonista 5-HT3 i drugih serotoninergičkih lijekova (uključujući SSRI-jeve kao što su fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram ili escitalopram i SNRI-jeve kao što su venlafaksin ili duloksetin) (vidjeti dio
English: Cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 0.75 mg.
Croatian: Prijavljeni su slučajevi konstipacije s fekalnom impakcijom, koji su zahtijevali hospitalizaciju, povezani s primjenom palonozetrona u dozi od 0,75 mg.
English: Therefore, patients should be monitored for increased toxicity of chemotherapeutic agents that are substrates for CYP3A4, including irinotecan.
Croatian: Stoga je bolesnike potrebno nadzirati zbog povećane toksičnosti kemoterapijskih lijekova koji su supstrati za CYP3A4, uključujući irinotekan.
English: Delayed phase: 25 to 120 hours post-cisplatin treatment.
Croatian: Odgođena faza: od 25 do 120 sati poslije terapije cisplatinom.
English: As such, the oral dexamethasone dose should be reduced by approximately 50% when co-administered with netupitant/palonosetron capsules (see section 4.2).
Croatian: S obzirom na to, doza peroralnog deksametazona treba biti smanjena za otprilike 50% kada se primjenjuje istovremeno s netupitant/palonozetron kapsulama (vidjeti dio 4.2).
English: Opaque gelatin capsule of size “0” (length 21.7 mm) with white body and caramel cap with “HE1” printed on the body.
Croatian: Neprozirna želatinska kapsula veličine „0“ (duljina 21,7 mm), s bijelim tijelom i kapicom boje karamele te oznakom „HE1“ otisnutom na tijelu kapsule.
English: Following administration of a single oral 0.75 mg dose of [14C]-palonosetron to six healthy subjects, 85% to 93% of the total radioactivity was excreted in urine, and 5% to 8% was eliminated in faeces.
Croatian: Nakon primjene jedne peroralne doze od 0,75 mg [14C]-palonozetrona u šest zdravih ispitanika, 85% do 93% ukupne radioaktivnosti bilo je izlučeno mokraćom, a 5% do 8% eliminirano stolicom.
English: The primary efficacy endpoint was the CR rate in the delayed phase, 25-120 hours after the start of the chemotherapy administration.
Croatian: Primarni ishod djelotvornosti bila je stopa potpunog odgovora u odgođenoj fazi, 25 - 120 sati nakon početka primjene kemoterapije.
English: Very rare: may affect up to 1 in 10,000 people
Croatian: Vrlo rijetko: može se javiti u manje od 1 na 10 000 osoba
English: A total of 1450 patients (Akynzeo n=725; Palonosetron n=725) received study medication.
Croatian: Ispitivani lijek primilo je ukupno 1450 bolesnika (Akynzeo n = 725; palonozetron n = 725).
English: Netupitant AUC0-∞ and Cmax increased by 1.1 fold and 1.2 fold, respectively, after a high fat meal.
Croatian: AUC0-∞ i Cmax netupitanta povećali su se 1,1 puta odnosno 1,2 puta nakon obroka s visokim udjelom masti.
English: There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs).
Croatian: Bilo je izvješća o serotoninskom sindromu uz primjenu antagonista 5-HT3, bilo samih ili u kombinaciji s drugim serotoninergičkim lijekovima (uključujući selektivne inhibitore ponovne pohrane serotonina (SSRI) i inhibitore ponovne pohrane serotonina i noradrenalina (SNRI)).
English: Helsinn Birex Pharmaceuticals Ltd. Damastown,
Croatian: Helsinn Birex Pharmaceuticals Ltd.
English: Netupitant is not a substrate for P-gp.
Croatian: Netupitant nije supstrat P-gp-a.
English: This medicinal product can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4.
Croatian: Ovaj lijek može povećati plazmatske koncentracije istovremeno primjenjivanih lijekova koji se metaboliziraju putem CYP3A4.
English: When this medicinal product is used concomitantly with medicinal products that induce CYP3A4 activity, netupitant plasma concentrations could be reduced and this may result in decreased efficacy.
Croatian: Kada se ovaj lijek uzima istovremeno s lijekovima koji induciraju aktivnost CYP3A4, koncentracije netupitanta u plazmi mogu biti snižene, a to može rezultirati smanjenom djelotvornošću.
English: Netupitant is a moderate inhibitor of CYP3A4 and can increase the exposure of chemotherapeutic agents that are substrates for CYP3A4 e.g. docetaxel (see section 4.5).
Croatian: Netupitant je umjereni inhibitor CYP3A4 i može povećati izloženost kemoterapijskim lijekovima koji su supstrati za CYP3A4, npr. docetaksel (vidjeti dio 4.5).
English: Chemotherapeutic agents that are substrates for CYP3A4
Croatian: Kemoterapijski lijekovi koji su supstrati za CYP3A4
English: Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Croatian: Na temelju ispitivanja in vitro, palonozetron ne inhibira niti ne inducira izoenzime citokroma P450 u klinički važnim koncentracijama.
English: • The recommended dose is one capsule (each capsule contains 300 mg of netupitant and 0.5 mg of palonosetron).
Croatian: • Preporučena doza je jedna kapsula (jedna kapsula sadrži 300 mg netupitanta i 0,5 mg palonozetrona).
English: Overall: 0 to 120 hours post-cisplatin treatment.
Croatian: Cijela faza: od 0 do 120 sati poslije terapije cisplatinom.
English: Hard capsule.
Croatian: Tvrda kapsula
English: An ECG study was conducted in adult male and female healthy volunteers with oral netupitant either 200 or 600 mg administered in combination with oral palonosetron 0.5 or 1.5 mg, respectively.
Croatian: EKG ispitivanje provedeno je u zdravih odraslih dobrovoljaca, muškaraca i žena, s peroralnim netupitantom u dozi od 200 mg ili 600 mg primijenjeno u kombinaciji s peroralnim palonozetronom od 0,5 mg odnosno 1,5 mg.
English: In addition, eye swelling, dyspnoea and myalgia as adverse reactions have been reported with oral palonosetron but not observed during the development of this medicinal product.
Croatian: Osim toga, oticanje očiju, dispneja i mialgija zabilježene su kao nuspojave peroralnog palonozetrona, ali nisu opažene tijekom razvoja ovoga lijeka.