FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure to netupitant (Cmax, AUC0-t and AUC0-∞) compared to matching healthy subjects was 11%, 28% and 19% higher in mild and 70%, 88% and 143% higher in moderate hepaticallyimpaired subjects, respectively.
Croatian: U usporedbi s podudarnim zdravim ispitanicima, izloženost netupitantu (Cmax, AUC0-t i AUC0-∞) bila je 11%, 28% i 19% viša u ispitanika s blagim oštećenjem funkcije jetre i 70%, 88% odnosno 143% viša u onih s umjerenim oštećenjem funkcije jetre.
English: This medicine contains 7 mg of sorbitol in each hard capsule.
Croatian: Ovaj lijek sadrži 7 mg sorbitola u jednoj tvrdoj kapsuli.
English: Palonosetron soft capsule
Croatian: Palonozetron meka kapsula
English: The European Medicines Agency has waived the obligation to submit the results of studies with Akynzeo in all subsets of the paediatric population in prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based and moderately emetogenic cancer chemotherapy (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja s lijekom Akynzeo u svim podskupinama pedijatrijske populacije u sprječavanju akutne i odgođene mučnine i povraćanja povezanih s visoko emetogenom kemoterapijom protiv raka temeljenom na cisplatinu, i umjereno emetogenom kemoterapijom protiv raka (za informacije o pedijatrijskoj primjeni vidjeti dio 4.2).
English: No dosage adjustment is necessary for elderly patients.
Croatian: U starijih bolesnika nije potrebna prilagodba doze.
English: Netupitant was shown to cross the blood brain barrier with a NK1 receptor occupancy of 92.5%, 86.5%, 85.0%, 78.0%, and 76.0% in striatum at 6, 24, 48, 72, and 96 hours, respectively, after administration of 300 mg netupitant.
Croatian: Pokazalo se da netupitant, nakon primjene u dozi od 300 mg, prolazi krvno-moždanu barijeru uz popunjenost receptora NK1 od 92,5%, 86,5%, 85,0%, 78,0% i 76,0% u strijatumu u 6., 24., 48., 72. odnosno 96. satu.
English: The study demonstrated no clinically important effects on ECG parameters: the largest point estimate of the placebo and baseline corrected QTc interval was 7.0 ms (one-sided upper 95% confidence limit 8.8 ms), observed 16 hours after the administration of supratherapeutic doses (600 mg netupitant and 1.5 mg palonosetron).
Croatian: Ispitivanje nije dokazalo klinički važne učinke na EKG parametre: najveća točkovna procjena QTc intervala korigiranog za placebo i početnu vrijednost bila je 7,0 ms (gornja granica jednostranog 95%-tnog intervala pouzdanosti 8,8 ms), opažena 16 sati nakon primjene supraterapijskih doza (600 mg netupitanta i 1,5 mg palonozetrona).
English: Table 3: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase
Croatian: Tablica 3: Udio bolesnika koji su primali kemoterapiju cisplatinom u kojih je postignut odgovor, prema terapijskoj skupini i fazi
English: Very rare cases of anaphylaxis, anaphylactic/anaphylactoid reactions and shock have been reported from the post-marketing use of intravenous palonosetron.
Croatian: Vrlo rijetki slučajevi anafilaksije, anafilaktičnih/anafilaktoidnih reakcija i šoka zabilježeni su tijekom primjene intravenskog palonozetrona nakon stavljanja lijeka u promet.
English: After a single oral 300 mg dose administration in cancer patients, netupitant disposition was characterised by a two compartment model with an estimated median systemic clearance of 20.5 L/h and a large distribution volume in the central compartment (486 L).
Croatian: Nakon jedne peroralne doze netupitanta od 300 mg u bolesnika s rakom, raspoređivanje netupitanta bilo je karakterizirano modelom od dva odjeljka s procijenjenim medijanom sistemskog klirensa od 20,5 l/h i velikim volumenom distribucije u središnjem odjeljku (486 l).
English: The AUC0-24 (Day 1), the AUC24-36 (Day 2) and the AUC84-108 and AUC84-∞ (Day 4) of dexamethasone increased 2.4-fold, with co-administration of 300 mg netupitant.
Croatian: Kod istovremene primjene netupitanta od 300 mg, vrijednosti AUC0-24 (1. dan), AUC24-36 (2. dan) i AUC84-108 te AUC84-∞ (4. dan) deksametazona povećale su se 2,4 puta.
English: Delayed phase Overall phase No significant nausea Acute phase
Croatian: Bez značajne mučnine Akutna faza nije značajno
English: An increased incidence of positional foetal abnormalities of the limbs and paws, fused sternebrae and agenesis of accessory lung lobe were observed following daily administration of netupitant in rabbits at 10 mg/kg/day and higher during the period of organogenesis.
Croatian: Povećana incidencija položajnih abnormalnosti udova i šapa u fetusa, spojene sternebre i ageneze akcesornog režnja pluća, opažena je nakon svakodnevne primjene netupitanta u kunića u dozi od 10 mg/kg na dan i višoj u razdoblju organogeneze.
English: Furthermore, netupitant may also affect the efficacy of chemotherapeutic agents that need activation by CYP3A4 metabolism.
Croatian: Nadalje, netupitant može također utjecati na djelotvornost kemoterapijskih lijekova kojima je potrebna metabolička aktivacija pomoću izoenzima CYP3A4.
English: Renal excretion for netupitant is negligible.
Croatian: Izlučivanje netupitanta putem bubrega je zanemarivo.
English: In a pilot dose range finding study in rabbits, cleft palate, microphtalmia and aphakia were observed in four foetuses from one litter in the 30 mg/kg/day group.
Croatian: U pilot ispitivanju određivanja raspona doze u kunića, rascjep nepca, mikroftalmija i afakija opaženi su u četiri fetusa iz jednog legla u skupini koja je primala 30 mg/kg na dan.
English: At the time of the study, anthracyclinecyclophosphamide containing chemotherapy regimens were considered to be moderately emetogenic.
Croatian: U vrijeme provedbe ispitivanja, kemoterapijski protokoli koji su sadržavali antraciklin i ciklofosfamid smatrali su se umjereno emetogenim.
English: • medicines for depression or anxiety called SSRIs (selective serotonin re-uptake inhibitors)
Croatian: • lijekove protiv depresije ili tjeskobe, zvane selektivni inhibitori ponovne pohrane serotonina
English: Infections and infestations
Croatian: Infekcije i infestacije cistitis
English: Table 5: Proportion of patients receiving anthracycline and cyclophosphamide chemotherapy responding by treatment group and phase - cycle 1
Croatian: Tablica 5: Udio bolesnika koji su primali kemoterapiju antraciklinom i ciklofosfamidom u kojih je postignut odgovor, po terapijskoj skupini i fazi - 1. ciklus
English: Interaction with CYP3A4 substrates:
Croatian: Interakcija sa supstratima izoenzima CYP3A4:
English: Highly Emetogenic Chemotherapy (HEC) study
Croatian: Ispitivanje visoko emetogene kemoterapije (HEC)
English: There are no data about the use of palonosetron in pregnant women.
Croatian: Nema podataka o primjeni palonozetrona u trudnica.
English: Upper 95% confidence limit of the point estimates of placebo and baseline corrected QTcI was constantly within 10 ms at all time points over 2 days after study substance administration.
Croatian: Gornja granica 95%-tnog intervala pouzdanosti točkovne procjene QTc intervala korigiranog za placebo i početnu vrijednost bila je neprekidno unutar 10 ms u svim vremenskim točkama tijekom 2 dana poslije primjene ispitivane tvari.
English: In vitro data show that netupitant is a P-gp inhibitor.
Croatian: In vitro podaci pokazuju da je netupitant inhibitor P-gp-a.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Croatian: U nekliničkim ispitivanjima zapaženi su učinci samo pri izloženostima koje su znatno veće od maksimalnih izloženosti u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: Pack size containing 1 capsule in an aluminium blister or 4 x 1 hard capsules in aluminium perforated unit dose blisters.
Croatian: Veličina pakiranja od 1 kapsule u aluminijskom blisteru ili 4 x 1 tvrde kapsule u aluminijskom perforiranom blisteru s jediničnim dozama.
English: The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Croatian: Utjecaj mučnine i povraćanja na svakodnevni život bolesnika bio je procijenjen na temelju FLIE upitnika (engl.
English: In a pooled analysis, females had a higher netupitant exposure compared to males; there was a 1.31-fold increase in Cmax, a 1.02 fold increase for AUC and a 1.36 fold increase in half-life.
Croatian: U analizi objedinjenih podataka, izloženost netupitantu bila je viša u žena nego u muškaraca; zabilježeno je povećanje od 1,31 puta u Cmax, 1,02 puta za AUC i 1,36 puta u poluvijeku.
English: After administration of a single oral dose of 300 mg netupitant, mean plasma netupitant/plasma radioactivity ratios ranged from 0.13 to 0.49 over 96 h post-dose.
Croatian: Nakon primjene jedne peroralne doze od 300 mg netupitanta, prosječni omjeri netupitanta u plazmi/radioaktivnosti u plazmi kretali su se u rasponu od 0,13 do 0,49 tijekom 96 sati poslije doze.
English: Table1: Adverse reactions System organ class
Croatian: Tablica 1: Nuspojave prema klasifikaciji organskih sustava
English: Administration of the CYP3A4 inducer rifampicin with Akynzeo alone decreased the AUC of netupitant 5.2 fold and Cmax 2.6 fold.
Croatian: Primjena rifampicina, induktora CYP3A4, sa samim Akynzeom smanjila je AUC netupitanta 5,2 puta, a Cmax 2,6 puta.
English: The mean fraction of an oral dose of netupitant excreted unchanged in urine is less than 1%; a total of 3.95% and 70.7% of the radioactive dose was recovered in the urine and faeces, respectively.
Croatian: Prosječna frakcija peroralne doze netupitanta koji se izlučuje nepromijenjen u mokraći manja je od 1%; ukupno 3,95% radioaktivne doze nađeno je u mokraći, a 70,7% u stolici.
English: Netupitant is mainly metabolized by CYP3A4; therefore, co-administration with medicinal products that inhibit or induce CYP3A4 activity may influence plasma concentrations of netupitant.
Croatian: Netupitant se metabolizira uglavnom putem CYP3A4; stoga istovremena primjena s lijekovima koji inhibiraju ili induciraju aktivnost CYP3A4 može utjecati na koncentraciju netupitanta u plazmi.
English: At a dose of 300 mg in humans, netupitant is a substrate and moderate inhibitor of CYP3A4.
Croatian: U dozi od 300 mg netupitant je u ljudi supstrat i umjereni inhibitor CYP3A4.
English: After single oral doses using buffered solution mean maximum palonosetron concentrations (Cmax) and area under the concentration-time curve (AUC0-∞) were dose proportional over the dose range of 3.0 to 80 mcg/kg in healthy subjects.
Croatian: Nakon jedne peroralne doze puferirane otopine, prosječna maksimalna koncentracija palonozetrona (Cmax) i površina ispod krivulje koncentracija-vrijeme (AUC0-∞) bile se proporcionalne dozi za raspon doze od 3,0 do 80 µg/kg u zdravih ispitanika.
English: Akynzeo is taken before the chemotherapy to prevent sickness and feelings of sickness from developing.
Croatian: Akynzeo se uzima prije kemoterapije kako bi se spriječio nastanak mučnine i povraćanja.
English: Shellac glaze (partially esterified) Black iron oxide (E172) Propylene glycol (E1520)
Croatian: Tinta za označavanje šelakova glazura (djelomično esterificirana) željezov oksid, crni (E172) propilenglikol (E1520)
English: Netupitant/palonosetron capsules have moderate influence on the ability to drive and use machines.
Croatian: Netupitant/palonozetron kapsule umjereno utječu na sposobnost upravljanja vozilima i rada sa strojevima.
English: It is unknown whether palonosetron or netupitant are excreted in human milk.
Croatian: Nije poznato izlučuju li se palonozetron ili netupitant u majčino mlijeko.
English: • ECG (electrocardiogram) problems (called ‘ST segment depression', ‘ST-T segment abnormal'
Croatian: • tegobe vidljive na EKG-u (elektrokardiogramu) (koje se nazivaju depresija ST-segmenta,
English: Furthermore, the population PK study showed no correlation between PK parameters of netupitant and markers of renal dysfunction.
Croatian: Nadalje, ispitivanje populacijske farmakokinetike nije pokazalo korelaciju između farmakokinetičkih parametara netupitanta i biljega poremećaja funkcije bubrega.
English: Palonosetron
Croatian: Palonozetron
English: Netupitant/palonosetron capsules are unlikely to interact with medicinal products which are P-gp substrates.
Croatian: Nije vjerojatna interakcija između netupitant/palonozetron kapsula i lijekova koji su supstrati P-gp-a.
English: This medicine contains less than 1 mmol sodium per (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tvrdoj kapsuli, tj. zanemarive količine natrija.
English: This medicinal product also contains 20 mg of sucrose in each capsule.
Croatian: Ovaj lijek također sadrži 20 mg saharoze u jednoj kapsuli.
English: Palonosetron is eliminated from the body through both renal excretion and metabolic pathways, with the latter mediated via multiple CYP enzymes.
Croatian: Palonozetron se iz tijela eliminira i izlučivanjem putem bubrega i metaboličkim putevima, s tim da kod izlučivanja metaboličkim putevima posreduje više enzima CYP-a.
English: Approximately half the radioactivity administered orally as [14C]-netupitant was recovered from urine and faeces within 120 h of dosing.
Croatian: Približno pola radioaktivnosti primijenjene peroralno kao [14C]-netupitant otkriveno je u mokraći i stolici unutar 120 h od primjene doze.
English: Moreover, this medicinal product should be used with caution in patients receiving concomitant orally administered active substances with a narrow therapeutic range that are primarily metabolized by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine.
Croatian: Nadalje, ovaj lijek treba s oprezom davati bolesnicima koji istovremeno peroralno primaju djelatne tvari uske terapijske širine koje se primarno metaboliziraju putem CYP3A4, kao što su ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanil i kinidin.
English: Administration of the CYP3A4 inhibitor ketoconazole with netupitant/palonosetron capsules increased the AUC of netupitant 1.8 fold and Cmax 1.3 fold when compared to the administration of netupitant/palonosetron capsules alone.
Croatian: Primjena ketokonazola, inhibitora CYP3A4, s netupitant/palonozetron kapsulama povećala je AUC netupitanta 1,8 puta, a Cmax 1,3 puta u usporedbi s primjenom samo netupitant/palonozetron kapsula.
English: In 82 healthy subjects given a single oral dose of netupitant 300 mg, maximum plasma netupitant concentration (Cmax) was 486 ±268 ng/mL (mean ± SD) and median time to maximum concentration (Tmax) was 5.25 hours, the AUC was 15032 ± 6858 h.ng/mL.
Croatian: U 82 zdrava ispitanika koji su primili jednu peroralnu dozu netupitanta od 300 mg, maksimalna koncentracija netupitanta u plazmi (Cmax) bila je 486 ± 268 ng/ml (srednja vrijednost ± SD), medijan vremena do maksimalne koncentracije (Tmax) bio je 5,25 sati, a vrijednost AUC-a bila je 15032 ± 6858 h.ng/ml.
English: In a multicenter, randomized, parallel, double-blind, controlled clinical study of 694 patients, the efficacy and safety of single doses of oral netupitant in combination with oral palonosetron was compared with a single oral dose of palonosetron in cancer patients receiving a chemotherapy regimen that included cisplatin (median dose = 75 mg/m2).
Croatian: U multicentričnom, randomiziranom, dvostruko slijepom, kontroliranom kliničkom ispitivanju sa 694 bolesnika u usporednim skupinama, uspoređena je djelotvornost i sigurnost jednostrukih doza peroralnog netupitanta u kombinaciji s peroralnim palonozetronom i jedne peroralne doze palonozetrona, u bolesnika s rakom na kemoterapijskom protokolu s cisplatinom (medijan doze = 75 mg/m2).
English: Interaction between oral netupitant and oral palonosetron:
Croatian: Interakcija između peroralnog netupitanta i peroralnog palonozetrona:
English: • The active substances are palonosetron and netupitant.
Croatian: • Djelatne tvari su palonozetron i netupitant.
English: • medicines with a narrow therapeutic range that are primarily metabolized by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl,
Croatian: • lijekove uske terapijske širine koji se razgrađuju prvenstveno putem CYP3A4, kao što su ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanil ili kinidin
English: Limited data exist in patients with severe hepatic impairment (Child Pugh score ≥ 9).
Croatian: Ograničeni su podaci u bolesnika s teškim oštećenjem funkcije jetre (Child Pugh rezultat ≥ 9).
English: This medicinal product should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range (see section 4.5).
Croatian: Ovaj lijek treba primjenjivati s oprezom u bolesnika koji istovremeno peroralno primaju djelatne tvari koje se metaboliziraju primarno putem CYP3A4 te imaju usku terapijsku širinu (vidjeti dio 4.5).
English: In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Croatian: Osobito je važno da liječnika, ljekarnika ili medicinsku sestru obavijestite ako uzimate neki od sljedećih lijekova:
English: A high fat meal did not affect the Cmax and AUC of oral palonosetron.
Croatian: Obrok s visokim sadržajem masti nije utjecao na Cmax i AUC peroralnog palonozetrona.
English: Total systemic exposure to intravenous palonosetron increased by approximately 28% in patients with severe impairment relative to healthy subjects.
Croatian: Ukupna sistemska izloženost intravenskom palonozetronu povećala se za približno 28% u bolesnika s teškim oštećenjem funkcije bubrega u odnosu na zdrave ispitanike.
English: When netupitant/palonosetron capsules are used concomitantly with another CYP3A4 inhibitor, netupitant plasma concentrations could be elevated.
Croatian: Kada se netupitant/palonozetron kapsule uzimaju istovremeno s drugim inhibitorom CYP3A4, koncentracije netupitanta u plazmi mogu biti povišene.
English: Dialysis studies have not been performed.
Croatian: Nisu provedena ispitivanja uklanjanja dijalizom.
English: Renal clearance is not a significant elimination route for netupitant-related entities.
Croatian: Klirens putem bubrega nije značajan put eliminacije za tvari povezane s netupitantom.
English: In vitro data suggests that netupitant inhibits the efflux of transporter BCRP.
Croatian: In vitro podaci upućuju na to da netupitant inhibira efluks prijenosnika BCRP.
English: Non-clinical studies indicate that netupitant and its metabolites and the combination with palonosetron only at very high concentrations may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
Croatian: Neklinička ispitivanja pokazuju da netupitant i njegovi metaboliti te kombinacija s palonozetronom, samo u vrlo visokim koncentracijama mogu blokirati ionske kanale uključene u ventrikularnu depolarizaciju i repolarizaciju te produljiti trajanje akcijskog potencijala.
English: In a multicenter, randomized, parallel, double-blind, active-controlled, superiority study, the efficacy and safety of a single oral dose of Akynzeo was compared with a single oral dose of palonosetron 0.5 mg in cancer patients scheduled to receive the first cycle of an anthracycline and cyclophosphamide regimen for the treatment of a solid malignant tumor.
Croatian: Ispitivanje umjereno emetogene kemoterapije (MEC) U multicentričnom, randomiziranom, dvostruko slijepom ispitivanju superiornosti na usporednim skupinama s aktivnom kontrolom, djelotvornost i sigurnost jedne peroralne doze Akynzea uspoređena je s jednom peroralnom dozom palonozetrona od 0,5 mg u bolesnika s rakom, za koje je bio planiran prvi ciklus protokola s antraciklinom i ciklofosfamidom za liječenje solidnog zloćudnog tumora.
English: • problems with the muscles in your heart (cardiomyopathy)
Croatian: • tegobe sa srčanim mišićem (kardiomiopatija)
English: No data from animal studies with netupitant are available regarding placental transfer and lactation.
Croatian: Nema podataka iz ispitivanja na životinjama za netupitant s obzirom na prijenos kroz posteljicu i laktaciju.
English: In healthy subjects given palonosetron capsules 0.5 mg, the terminal elimination half-life (t½) of palonosetron was 37 ± 12 hours (mean ± SD), and in cancer patients, t½ was 48 ± 19 hours.
Croatian: U zdravih ispitanika koji su uzeli kapsule palonozetrona od 0,5 mg, terminalni poluvijek eliminacije (t½) palonozetrona iznosio je 37 ± 12 sati (srednja vrijednost ± SD), a u bolesnika s rakom, t½ je bio 48 ± 19 sati.
English: Neither netupitant nor palonosetron have been evaluated in patients with end-stage renal disease.
Croatian: Primjena netupitanta i primjena palonozetrona nisu procijenjene u bolesnika sa završnim stadijem bubrežne bolesti.
English: The symptoms of overdose may include headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.
Croatian: Simptomi predoziranja mogu uključivati glavobolju, omaglicu, zatvor, tjeskobu, lupanje srca (palpitacije), euforično raspoloženje i bolove u nogama.
English: No specific studies were performed to evaluate netupitant in patients with renal impairment.
Croatian: Nisu provedena posebna ispitivanja za procjenu netupitanta u bolesnika s oštećenjem funkcije bubrega.
English: Capsule shell Gelatin
Croatian: Ovojnica kapsule želatina glicerol sorbitol
English: In 12 cancer patients given a single oral dose of palonosetron 0.5 mg one hour prior to chemotherapy, Cmax was 0.93 ± 0.34 ng/mL and Tmax was 5.1 ± 5.9 hours.
Croatian: U 12 bolesnika s rakom koji su primili jednu peroralnu dozu palonozetrona u dozi od 0,5 mg jedan sat prije kemoterapije, Cmax je iznosio 0,93 ± 0,34 ng/ml, a Tmax 5,1 ± 5,9 sati.
English: Netupitant/palonosetron capsules should not be used during breast-feeding.
Croatian: Netupitant/palonozetron kapsule ne smiju se primjenjivati u razdoblju dojenja.
English: If you stop taking Akynzeo
Croatian: Ako prestanete uzimati Akynzeo
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava neutropenija leukopenija leukocitoza limfocitoza
English: Hard capsule content:
Croatian: Sadržaj tvrde kapsule:
English: In humans, netupitant is eliminated mainly by hepatic metabolism mediated by CYP3A4 with a marginal renal excretion.
Croatian: U ljudi, netupitant se eliminira uglavnom metabolizmom u jetri posredovanim pomoću CYP3A4 uz minimalno izlučivanje putem bubrega.
English: Akynzeo 300 mg/0.5 mg hard capsules netupitant/palonosetron
Croatian: Akynzeo 300 mg / 0,5 mg tvrde kapsule netupitant/palonozetron
English: Delayed phase
Croatian: Odgođena faza Cijela faza
English: By blocking the actions of substance P and serotonin in this way, the medicines help prevent the stimulation of the vomiting centre and the resulting sickness.
Croatian: P i serotonina, lijek pomaže u sprječavanju poticanja centra za povraćanje i posljedične mučnine.
English: If you forget to take Akynzeo
Croatian: Ako ste zaboravili uzeti Akynzeo
English: Talk to your doctor, pharmacist or nurse before taking Akynzeo if: • you have liver problems
Croatian: Obratite se liječniku, ljekarniku ili medicinskoj sestri prije nego što uzmete Akynzeo ako:
English: ‘bundle branch block right/left', and ‘atrioventricular block second degree')
Croatian: abnormalan ST-T segment, blok desnog/lijevog snopa grane i atrioventrikularni blok drugog stupnja).
English: As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration (see section
Croatian: Budući da palonozetron može produljiti vrijeme prolaska stolice kroz debelo crijevo, bolesnike s anamnezom konstipacije ili znakovima subakutne crijevne opstrukcije treba nakon primjene nadzirati (vidjeti dio 4.8).
English: No consistent effect was seen with cyclophosphamide after netupitant co-administration.
Croatian: Takav učinak nije opažen s ciklofosfamidom nakon istovremene primjene s netupitantom.