FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical relevance of this effect is not established.
Croatian: Klinička značajnost toga učinka nije ustanovljena.
English: All these reactions were uncommon.
Croatian: Sve ove nuspojave bile su manje česte.
English: Do not take Akynzeo if you are pregnant or if you are a woman of childbearing potential not using contraception.
Croatian: Nemojte uzimati Akynzeo ako ste trudni ili ako ste žena reproduktivne dobi koja ne koristi kontracepciju.
English: The hard capsule is filled with three tablets and one soft capsule.
Croatian: Tvrda kapsula napunjena je s tri tablete i jednom mekom kapsulom.
English: * p-value from Cochran-Mantel-Haenszel test, stratified by age class and region.
Croatian: * p-vrijednost iz Cochran-Mantel-Haenszelova testa, stratificirana prema dobnoj skupini i regiji.
English: Days 2 to 3
Croatian: Od 2. do 3. dana
English: EU/1/15/1001/001 1 hard capsule EU/1/15/1001/002 4x1 hard capsules
Croatian: EU/1/15/1001/001 1 tvrda kapsula EU/1/15/1001/002 4 x 1 tvrda kapsula
English: Stop taking Akynzeo and tell your doctor straight away if you notice the following serious side effectyou may need urgent medical treatment:
Croatian: Prestanite uzimati Akynzeo i odmah obavijestite liječnika ako opazite navedenu ozbiljnu nuspojavumožda Vam je potrebno hitno medicinsko liječenje:
English: If you think you may have taken more than you should, tell your doctor straight away.
Croatian: Mislite li da ste možda uzeli više nego što ste trebali, odmah obavijestite svog liječnika.
English: • Take the capsule about 1 hour before you start your chemotherapy cycle.
Croatian: • Uzmite kapsulu otprilike 1 sat prije početka ciklusa kemoterapije.
English: These effects were not considered clinically important.
Croatian: Ti se učinci nisu smatrali klinički značajnima.
English: If you think you have forgotten to take your dose, tell your doctor straight away.
Croatian: Ako mislite da ste zaboravili uzeti svoju dozu, odmah kažite liječniku.
English: The safety and efficacy of Akynzeo capsules in the paediatric population have not been established.
Croatian: Sigurnost i djelotvornost Akynzeo kapsula u pedijatrijskoj populaciji nisu ustanovljene.
English: When netupitant was administered on Day 8 of a 12-day regimen of digoxin, no changes in digoxin pharmacokinetics were observed.
Croatian: Kada je netupitant primijenjen 8. dana u 12-dnevnom režimu digoksina, nisu opažene promjene u farmakokinetici digoksina.
English: After completion of cycle 1, patients had the option to participate in a multiple-cycle extension, receiving the same treatment as assigned in cycle 1.
Croatian: Nakon završetka 1. ciklusa, bolesnici su mogli izabrati da sudjeluju u produžetku od nekoliko ciklusa, s tim da primaju istu terapiju koja im je dodijeljena u 1. ciklusu.
English: Antiemetic activity of Akynzeo was maintained throughout repeat cycles for those patients continuing in each of the multiple cycles.
Croatian: Antiemetičko djelovanje Akynzea održalo se kroz sve ponavljane cikluse u onih bolesnika koji su nastavili sudjelovanje u svakom od višestrukih ciklusa.
English: • You can take Akynzeo with or without food.
Croatian: • Akynzeo možete uzimati s hranom ili bez nje.
English: Do not take Akynzeo in the days after you have chemotherapy - unless you are about to have another chemotherapy cycle.
Croatian: Nemojte uzimati Akynzeo u dane poslije kemoterapije - osim ako se ne planira da imate drugi kemoterapijski ciklus.
English: If you are allergic to peanut or soya, see your doctor straight away if you notice any signs of an allergic reaction.
Croatian: Ako ste alergični na kikiriki ili soju, odmah se obratite liječniku ako uočite bilo kakve znakove alergijske reakcije.
English: Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with this medicinal product.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom terapije i još do mjesec dana nakon liječenja ovim lijekom.
English: Effect of ketoconazole and rifampicin
Croatian: Učinak ketokonazola i rifampicina
English: Absolute netupitant bioavailability data are not available in humans; based on data from two studies with intravenous netupitant, the bioavailability in humans is estimated to be greater than 60%.
Croatian: Nema podataka za apsolutnu bioraspoloživost netupitanta u ljudi; na temelju podataka iz dva ispitivanja s intravenskim netupitantom, procijenjeno je da je bioraspoloživost u ljudi veća od 60%.
English: There was a supra-proportional increase in Cmax and AUC parameters for doses from 10 mg to 300 mg.
Croatian: Postojao je supra-proporcionalan porast u parametrima Cmax i AUC za doze od 10 mg do 300 mg.
English: Days 2 to 4
Croatian: Od 2. do 4. dana
English: • sudden nervous breakdown, change in mood
Croatian: • iznenadni živčani slom, promjena raspoloženja
English: Caution should be exercised when using this medicinal product in patients over 75 years, due to the long half-life of the active substances and the limited experience in this population.
Croatian: Potreban je oprez kada se ovaj lijek primjenjuje u bolesnika starijih od 75 godina zbog dugog poluvijeka djelatnih tvari i ograničenog iskustva s tom populacijom.
English: • you are allergic to netupitant or palonosetron, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na netupitant ili palonozetron ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: There have also been reports of serotonin syndrome.
Croatian: Zabilježeni su i slučajevi serotoninskog sindroma.
English: If you decide not to take Akynzeo (or another similar medicine), your chemotherapy is likely to make you feel sick and be sick.
Croatian: Ako odlučite da nećete uzimati Akynzeo (ili neki drugi sličan lijek), moguće je da ćete zbog kemoterapije osjećati mučninu i povraćati.
English: Of these, 1438 patients (98.8%) completed cycle 1 and 1286 patients (88.4%) continued treatment in the multiple-cycle extension.
Croatian: Od njih, 1438 bolesnika (98,8%) završilo je 1. ciklus, a 1286 bolesnika (88,4%) nastavilo je liječenje u produžetku od više ciklusa.
English: A summary of the key results from this study is shown in Table below.
Croatian: Ključni rezultati iz ovog ispitivanja sažeto su prikazani u tablici ispod.
English: M1, M2 and M3 metabolites were all shown to be pharmacologically active in an animal pharmacodynamic model, where M3 was most potent and M2 least active.
Croatian: Svi metaboliti M1, M2 i M3 pokazali su se farmakološki djelatnim u životinjskom modelu farmakodinamike, pri čemu je M3 bio najpotentiji, a M2 najmanje djelatan.
English: In case of overdose, the medicinal product should be discontinued and general supportive treatment and monitoring should be provided.
Croatian: U slučaju predoziranja, primjenu lijeka treba prekinuti i pristupiti općem potpornom liječenju uz praćenje.
English: No common adverse reactions are attributable to netupitant, the new component of the fixed combination.
Croatian: Nema čestih nuspojava koje se mogu pripisati netupitantu, novoj komponenti fiksne kombinacije.
English: All patients received a single oral dose of dexamethasone.
Croatian: Svi bolesnici primili su jednu peroralnu dozu deksametazona.
English: In a population PK study, patients with a reduced creatinine clearance (CLCR) also had a reduced palonosetron clearance, but this reduction would not result in a significant change in palonosetron exposure.
Croatian: U ispitivanju populacijske farmakokinetike, bolesnici sa smanjenim klirensom kreatinina (CLCR) imali su također smanjeni klirens palonozetrona, ali to smanjenje ne bi trebalo rezultirati značajnom promjenom u izloženosti palonozetronu.
English: What Akynzeo looks like and contents of the pack
Croatian: Kako Akynzeo izgleda i sadržaj pakiranja
English: Plasma concentrations followed a first order absorption process and reached Cmax in approximately 5 hours.
Croatian: Koncentracije u plazmi slijedile su proces apsorpcije prema kinetici prvog reda i dosegle Cmax za otprilike 5 sati.
English: • chest pain (not related to the heart)
Croatian: • bol u prsištu (koja nije povezana sa srcem)
English: All patients were additionally treated with either doxorubicin (68.0%) or epirubicin (32.0%).
Croatian: Svi bolesnici bili su dodatno liječeni ili doksorubicinom (68,0%) ili epirubicinom (32,0%).
English: • you have any other heart problems • you have been told you have an imbalance of minerals in your blood such as potassium and magnesium that has not been corrected.
Croatian: • rečeno Vam je da imate neravnotežu minerala u krvi kao što su natrij i magnezij, koja nije ispravljena.
English: The third major metabolite, M2, is > 97% bound to plasma proteins.
Croatian: Treći glavni metabolit, M2, vezan je za proteine plazme > 97%.
English: Patients continued into the Multiple-Cycle extension for up to 7 additional cycles of chemotherapy.
Croatian: Bolesnici su nastavili u produžetku od više ciklusa do 7 dodatnih ciklusa kemoterapije.
English: • erythromycin - to treat bacterial infections
Croatian: • eritromicin - za liječenje bakterijskih infekcija
English: However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolizers of CYP2D6 substrates.
Croatian: Međutim, klinički farmakokinetički parametri nisu značajno različiti između slabih i jakih metabolizatora supstrata CYP2D6.
English: It is not excluded that this effect may be more marked, and then clinically relevant, in cancer patients, notably those having abnormal renal function.
Croatian: Nije isključeno da ovaj učinak možda bude i izraženiji, a time i klinički značajan u bolesnika s rakom, a osobito onih s poremećenom funkcijom bubrega.
English: • conjunctivitis (a type of eye inflammation)
Croatian: • konjunktivitis (vrsta upale oka)
English: Elimination via both routes was estimated to be complete by Day 29-30 post-dose.
Croatian: Procijenjeno je da je eliminacija na oba načina završila do 29.30. dana nakon doze.
English: What Akynzeo is and what it is used for What you need to know before you take Akynzeo How to take Akynzeo
Croatian: Što je Akynzeo i za što se koristi Što morate znati prije nego počnete uzimati Akynzeo Kako uzimati Akynzeo
English: • sleep problems
Croatian: • teškoće sa spavanjem
English: One 300 mg/0.5 mg capsule should be administered approximately one hour prior to the start of each chemotherapy cycle.
Croatian: Jednu kapsulu od 300 mg/0,5 mg treba primijeniti otprilike jedan sat prije početka svakog ciklusa kemoterapije.
English: Breast-feeding should be discontinued during treatment with this medicinal product and for 1 month after the last dose.
Croatian: Dojenje treba prekinuti tijekom liječenja ovim lijekom i još 1 mjesec nakon zadnje doze.
English: 1 hard capsule 4x1 hard capsules
Croatian: 1 tvrda kapsula 4 x 1 tvrda kapsula
English: Since it may induce dizziness, somnolence or fatigue, patients should be cautioned not to drive or use machines if such symptoms occur.
Croatian: Budući da mogu izazvati omaglicu, somnolenciju ili umor, bolesnike treba upozoriti da ne upravljaju vozilima i ne rukuju strojevima ako im se pojave takvi simptomi.
English: Following oral administration, palonosetron is well absorbed with its absolute bioavailability reaching 97%.
Croatian: Nakon peroralne primjene, palonozetron se dobro apsorbira uz svoju apsolutnu bioraspoloživost koja doseže 97%.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate,nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti/EXP“.
English: Effect of other medicinal products on the pharmacokinetics of Akynzeo
Croatian: Učinak drugih lijekova na farmakokinetiku Akynzea
English: • ketoconazole - to treat Cushing's syndrome
Croatian: • ketokonazol - za liječenje Cushingova sindroma
English: Alu/Alu blister.
Croatian: Al/Al blister
English: • spinning sensation (vertigo), feeling dizzy or trouble sleeping (insomnia)
Croatian: • vrtoglavica (vertigo), osjećaj omaglice ili teškoće sa spavanjem (nesanica)
English: A total of 907 patients (62.3%) completed the multiple-cycle extension up to a maximum of eight treatment cycles.
Croatian: Ukupno 907 bolesnika (62,3%) završilo je produžetak ispitivanja od više ciklusa, do najviše osam ciklusa liječenja.
English: The ratios were time dependent with values decreasing gradually beyond 24 h post-dose, indicating that netupitant is being rapidly metabolized.
Croatian: Omjeri su ovisili o vremenu s tim da su se vrijednosti postupno smanjivale nakon više od 24 sata poslije doze, što ukazuje da se netupitant brzo metabolizira.
English: Erythromycin and Midazolam
Croatian: Eritromicin i midazolam
English: The AUC was 30% higher in cancer patients than in healthy subjects.
Croatian: Vrijednost AUC-a bila je 30% veća u u bolesnika s rakom nego u zdravih ispitanika.
English: • modifications (or disturbances) in heart rhythm
Croatian: • promjene (ili poremećaji) srčanog ritma
English: If you take more Akynzeo than you should
Croatian: Ako uzmete više Akynzea nego što ste trebali
English: Palonosetron has a volume of distribution of approximately 8.3 ± 2.5 L/kg.
Croatian: Palonozetron ima volumen distribucije od približno 8,3 ± 2,5 l/kg.
English: Studies in animals have shown reproductive toxicity including teratogenic effects in rabbit without safety margin (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, uključujući teratogene učinke u kunića bez granice sigurnosti (vidjeti dio 5.3).
English: • feeling hot, reddening of the face or other areas of the skin (feeling flushed)
Croatian: • osjećaj vrućine, crvenilo lica ili drugih područja kože (osjećaj navale crvenila)
English: Recent guidance has updated these regimens to highly emetogenic.
Croatian: Novijim smjernicama ovi su protokoli promijenjeni u visoko emetogene.
English: You may feel dizzy or tired after taking Akynzeo.
Croatian: Možete osjećati omaglicu ili umor nakon što ste uzeli Akynzeo.
English: (shown in blood tests)
Croatian: (prema pretragama krvi)
English: The significance of these findings in humans is unknown.
Croatian: Značajnost tih nalaza u ljudi nije poznata.
English: The underlying mechanisms are not fully understood, but because of the high doses employed and since the medicinal product is intended for single application in humans, these findings are not considered relevant for clinical use.
Croatian: Osnovni mehanizmi nisu sasvim poznati, ali budući da se radilo o visokim dozama, a ovaj lijek je namijenjen za jednokratnu primjenu u ljudi, ti se nalazi ne smatraju značajnim za kliničku primjenu.
English: Appropriate observation of patients for serotonin syndrome-like symptoms is advised (see section 4.8).
Croatian: Savjetuje se odgovarajuće promatranje bolesnika zbog simptoma sličnih serotoninskom sindromu (vidjeti dio 4.8).
English: The amount of unchanged palonosetron excreted in the urine represented approximately 40% of the administered dose.
Croatian: Količina nepromijenjenog palonozetrona izlučenog mokraćom predstavljala je približno 40% primijenjene doze.
English: Akynzeo contains sucrose, sorbitol, sodium and may contain traces of soya.
Croatian: Akynzeo sadrži saharozu, sorbitol, natrij i može sadržavati tragove soje.
English: • midazolam - a sedative used to treat anxiety
Croatian: • midazolam - sedativ koji se koristi za liječenje tjeskobe
English: In the ADME trial, less than 5% of all netupitant-related material was excreted in urine and less than 1% of the netupitant dose was eliminated unchanged in the urine and therefore any accumulation of netupitant or metabolites after a single dose would be negligible.
Croatian: U ispitivanju ADME, manje od 5% svih tvari povezanih s netupitantom izlučeno je u mokraći, a manje od 1% doze netupitanta izlučeno je nepromijenjeno u mokraći te bi stoga sva akumulacija netupitanta ili metabolita nakon jedne doze trebala biti zanemariva.
English: Also tell your doctor, pharmacist or nurse if you are taking any of the following medicines as your doctor may need to change the dose of these other medicines:
Croatian: Također, obavijestite liječnika, ljekarnika ili medicinsku sestru ako uzimate bilo koji od navedenih lijekova jer Vam liječnik možda treba promijeniti dozu ovih drugih lijekova:
English: However, due to the large volume of distribution of palonosetron and netupitant, dialysis is unlikely to be an effective treatment for overdose.
Croatian: Međutim, zbog velikog volumena distribucije palonozetrona i netupitanta, nije vjerojatno da je dijaliza učinkoviti način liječenja predoziranja.
English: These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmia, conduction disturbances and in patients taking anti-arrhythmic medicinal products or other medicinal products that lead to QT prolongation or electrolyte abnormalities.
Croatian: Ova stanja uključuju bolesnike s osobnom ili obiteljskom anamnezom produljenog QT intervala, poremećajem elektrolita, kongestivnim zatajenjem srca, bradiaritmijom, poremećajima provodljivosti te u bolesnika koji uzimaju antiaritmike ili druge lijekove koji dovode do produljenja QT intervala ili poremećaja elektrolita.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
Croatian: Ako niste sigurni, obratite se liječniku, ljekarniku ili medicinskoj sestri prije nego što uzmete ovaj lijek.
English: Netupitant is not mutagenic.
Croatian: Netupitant nije mutagen.
English: Mean Cmax was approximately 11%, 47% and 16% of the parent for M1, M2 and M3 respectively; M2 had the lowest AUC relative to the parent (14%) whereas M1 and M3 AUC were approximately 29% and 33% of the parent, respectively.
Croatian: Srednja vrijednost Cmax bila je približno 11%, 47% i 16% ishodišnog spoja za M1, M2 odnosno M3; M2 je imao najniži AUC u odnosu na ishodišni spoj (14%) dok su M1 i M3 imali AUC približno 29% odnosno 33% ishodišnog spoja.
English: These metabolites each have less than 1% of the 5-HT3 receptor antagonist activity of palonosetron.
Croatian: Svaki od ovih metabolita ima manje od 1% djelovanja palonozetrona kao antagonista receptora 5-HT3.
English: While the terminal elimination half-life and mean systemic exposure of palonosetron is increased in the subjects with severe hepatic impairment, this does not warrant dose reduction.
Croatian: Iako su terminalni poluvijek eliminacije i srednja sistemska izloženost palonestronu povećani u ispitanika s teškim oštećenjem jetre, to ne zahtijeva sniženje doze.
English: The pharmacokinetics of palonosetron or netupitant has not been studied in subjects with end-stage renal disease requiring hemodialysis and no data on the effectiveness or safety of netupitant/palonosetron capsules in these patients are available.
Croatian: Farmakokinetika palonozetrona ili netupitanta nije ispitana u bolesnika sa završnim stadijem bolesti bubrega kojima je potrebna hemodijaliza, te nema podataka o djelotvornosti ili sigurnosti primjene netupitant/palonozetron kapsula u tih bolesnika.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom sukrazaizomaltaza ne bi smjeli uzimati ovaj lijek.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5-HT3) antagonists; ATC code: A04AA55
Croatian: Farmakoterapijska skupina: Antiemetici i lijekovi protiv mučnine, antagonisti serotonina (5-HT3), ATK oznaka: A04AA55
English: Post-marketing data indicates that the adverse reactions profile is generally similar to that seen in clinical trials.
Croatian: Podaci dobiveni nakon stavljanja lijeka u promet pokazuju da je profil nuspojava uglavnom sličan onome u kliničkim ispitivanjima.
English: Because of the antiemetic activity of netupitant and palonosetron, emesis induced by a medicinal product may not be effective.
Croatian: Zbog antimetičkog djelovanja netupitanta i palonozetrona, emeza potaknuta lijekom možda neće biti učinkovita.
English: High doses of palonosetron (each dose causing at least 15 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumors, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumors in rats but not in mice.
Croatian: Visoke doze palonozetrona (svaka doza uzrokovala je izloženost najmanje 15 puta veću od terapijske izloženosti u čovjeka) primijenjene svakodnevno tijekom dvije godine, uzrokovale su povećanu stopu tumora jetre, neoplazmi endokrinog sustava (u štitnjači, hipofizi, gušterači, moždini nadbubrežnih žlijezda) i tumora kože u štakora, ali ne u miševa.
English: In female subjects (n=18), the mean AUC was 35% higher and the mean Cmax was 26% higher than in male subjects (n=18).
Croatian: U žena (n = 18), srednja vrijednost AUC-a bila je 35% viša, a srednja vrijednost Cmax 26% viša nego u muškaraca (n = 18).
English: Women of childbearing potential should not be pregnant or become pregnant while on treatment with netupitant/palonosetron capsules.
Croatian: Žene reproduktivne dobi ne smiju biti trudne ili zatrudnjeti dok se liječe netupitant/palonozetron kapsulama.
English: Palonosetron is eliminated by multiple routes with approximately 50% metabolized to form two primary metabolites: N-oxide-palonosetron and 6-S-hydroxy-palonosetron.
Croatian: Palonozetron se eliminira višestrukim putevima, s tim da se približno 50% metabolizira i tvori dva primarna metabolita: N-oksid-palonozetron i 6-S-hidroksi-palonozetron.
English: Other medicines and Akynzeo
Croatian: Drugi lijekovi i Akynzeo
English: Palonosetron is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors.
Croatian: Palonozetron je antagonist receptora 5-HT3, koji ima veliki afinitet vezanja za taj receptor, a mali ili nikakav afinitet za druge receptore.
English: This medicine contains sucrose, sorbitol, sodium and may contain soya - see section 2 for more information.
Croatian: Ovaj lijek sadrži saharozu, sorbitol i natrij te može sadržavati soju - za više informacija pogledajte dio 2.
English: Palonosetron 0.5 mg
Croatian: Palonozetron 0,5 mg
English: Primary endpoint Complete response Overall phase Major secondary endpoints Complete response Acute phase Delayed phase No emesis Acute phase Delayed phase Overall phase No significant nausea Acute phase Delayed phase Overall phase Acute phase: 0 to 24 hours post-cisplatin treatment.
Croatian: Primarni ishod Potpuni odgovor Cijela faza Glavni sekundarni ishodi Potpuni odgovor Akutna faza Odgođena faza Bez emeze Akutna faza Odgođena faza Cijela faza Bez značajne mučnine Akutna faza Odgođena faza Cijela faza Akutna faza: od 0 do 24 sata poslije terapije cisplatinom.
English: Acute psychosis Mood altered Sleep disorder
Croatian: Psihijatrijski poremećaji nesanica akutna psihoza promijenjeno raspoloženje poremećaj spavanja
English: Maximum concentrations and total exposure of netupitant were increased in subjects with mild (n=8), moderate (n=8), and severe (n=2) hepatic impairment compared to matching healthy subjects, although there was pronounced individual variability in both hepatically-impaired and healthy subjects.
Croatian: Maksimalna koncentracija i ukupna izloženost netupitantu bile su povećane u ispitanika s blagim (n = 8), umjerenim (n = 8) i teškim (n = 2) oštećenjem funkcije jetre u usporedbi s podudarnim zdravim ispitanicima, iako je postojala naglašena individualna varijabilnost i u ispitanika s oštećenjem funkcije jetre i u zdravih ispitanika.