FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Aloxi in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Croatian: Djelotvornost lijeka Aloxi u sprječavanju mučnine i povraćanja izazvanih visoko emetogenom kemoterapijom može se povećati dodatnom primjenom kortikosteroida prije kemoterapije.
English: Doses of up to 6 mg have been used in clinical trials.
Croatian: U kliničkim ispitivanjima korištene su doze do 6 mg.
English: Fertility There are no data concerning the effect of palonosetron on fertility.
Croatian: Nema podataka o učinku palonozetrona na plodnost.
English: (≥1/1,000 to <1/100)
Croatian: (≥1/1000 i <1/100)
English: Most patients were non-naïve to chemotherapy (78.5%) across all treatment groups.
Croatian: Većina bolesnika u svim terapijskim skupinama prethodno je primala kemoterapiju (78,5%).
English: Given the pre-specified non-inferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated.
Croatian: Uz prethodno određenu granicu neinferiornosti od -10%, prema Mantel-Haenszelovom statističkom intervalu pouzdanosti za neinferiornost prilagođenom za slojeve za razliku u primarnom ishodu, potpuni odgovor (CR), bio je [-10,5, 1,7%]; dakle, neinferiornost nije dokazana.
English: The non-inferiority margin was
Croatian: Granica neinferiornosti bila je 15%.
English: If you stop taking Aloxi
Croatian: Ako prestanete uzimati Aloxi
English: Metoclopramide
Croatian: Metoklopramid
English: Non-inferiority criteria were met if the lower bound of the 97.5% confidence interval for the difference in Complete Response rates of intravenous palonosetron minus intravenous ondansetron was larger than -15%.
Croatian: Kriteriji neinferiornosti bili su ispunjeni ako je donja granica intervala pouzdanosti od 97,5%, za razliku u stopama potpunog odgovora za intravenski palonozetron minus intravenski ondanzetron, bila veća od -15%.
English: A lower bound greater than -15 % demonstrates non-inferiority between Aloxi and comparator.
Croatian: Donja granica veća od -15% pokazuje neinferiornost između lijeka Aloxi i usporednog lijeka.
English: In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to Aloxi, were headache (9 %) and constipation
Croatian: U kliničkim ispitivanjima u odraslih s dozom od 250 mikrograma (ukupno 633 bolesnika) najčešće opažene nuspojave, barem moguće povezane s primjenom lijeka Aloxi, bile su glavobolja (9%) i konstipacija (5%).
English: There is no experience of palonosetron in human pregnancy.
Croatian: Nema iskustva s palonozetronom u trudnoći u ljudi.
English: Efficacy was based on demonstrating non-inferiority of intravenous palonosetron compared to intravenous ondansetron.
Croatian: Djelotvornost se temeljila na dokazivanju neinferiornosti intravenski primijenjenog palonozetrona u usporedbi s intravenskim ondanzetronom.
English: 500 micrograms palonosetron administered orally approximately one hour before the start of chemotherapy.
Croatian: Doza od 500 mikrograma palonozetrona primijenjenog oralno otprilike jedan sat prije početka kemoterapije.
English: t½, hours
Croatian: AUC0-∞, h·µg/l t½, sati
English: If you are pregnant or think you might be pregnant, your doctor will not use Aloxi unless it is clearly necessary.
Croatian: Ako ste trudni ili mislite da biste mogli biti trudni, liječnik Vam neće primijeniti Aloxi osim ako je to zaista potrebno.
English: Biotransformation Palonosetron is eliminated by dual route, about 40 % eliminated through the kidney and with approximately 50 % metabolised to form two primary metabolites, which have less than 1 % of the 5HT3 receptor antagonist activity of palonosetron.
Croatian: Palonozetron se izlučuje dvojnim putem; oko 40% uklanja se bubregom a približno 50% metaboliziranog lijeka tvori dva primarna metabolita, koji imaju manje od 1% djelovanja palonozetrona kao antagonista 5HT3 receptora.
English: Median half-life was 29.5 hours in overall age groups and ranged from about 20 to 30 hours across age groups after administration of 20 µg/kg.
Croatian: Medijan poluvijeka iznosio je 29,5 sati u svim dobnim skupinama i nakon primjene doze od 20 µg/kg raspon mu je iznosio od otprilike 20 do 30 sati u svim dobnim skupinama.
English: Only limited data from animal studies are available regarding the placental transfer (see section 4.6).
Croatian: O prijenosu kroz posteljicu postoje tek ograničeni podaci dobiveni u ispitivanjima na životinjama (vidjeti dio 4.6).
English: Ondansetron 32 milligrams (n= 221)
Croatian: Ondanzetron 32 miligrama (n = 221)
English: 0 - 24 hours
Croatian: 0 - 24 sata
English: Efficacy after palonosetron 10 µg/kg compared to palonosetron 3µg/kg was 54.1% and 37.1% respectively.
Croatian: 10 µg/kg u usporedbi s palonozetronom 3µg/kg bila je 54,1% odnosno 37,1%.
English: Aloxi is indicated in adults for:
Croatian: 4.1 Terapijske indikacije Aloxi je u odraslih indiciran za:
English: In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
Croatian: U nekliničkim ispitivanjima, palonozetron nije inhibirao antitumorsku aktivnost pet testiranih kemoterapeutika (cisplatin, ciklofosfamid, citarabin, doksorubicin i mitomicin C).
English: Aloxi may contain traces of lecithin which comes from soya.
Croatian: Aloxi može u tragovima sadržavati lecitin koji se dobije iz soje.
English: What you need to know before you take Aloxi
Croatian: Što morate znati prije nego počnete uzimati Aloxi
English: Glycerol Titanium dioxide
Croatian: Titanijev dioksid
English: Also contains mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.
Croatian: Također sadrži manitol, dinatrijev edetat, natrijev citrat, citratnu kiselinu hidrat, vodu za injekcije, natrijev hidroksid i kloridnu kiselinu.
English: The safety and efficacy of Aloxi in children have not been established.
Croatian: Pedijatrijska populacija Sigurnost primjene i djelotvornost Aloxija u djece nije ustanovljena.
English: Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 µg /kg and 20 µg /kg dose groups combined.
Croatian: Klirens i volumen distribucije u pedijatrijskih bolesnika izračunati su prilagođeno za težinu, kombinirano za obje dozne skupine od 10 µg/kg i 20 µg/kg.
English: Non-inferiority criteria were met if the lower bound of the twosided 98.3 % confidence interval for the difference in complete response rates of oral palonosetron dose minus approved intravenous formulation was larger than -15 %.
Croatian: Kriteriji neinferiornosti bili su ispunjeni ako je donja granica dvostranog 98,3%-tnog intervala pouzdanosti za razliku u stopama potpunog odgovora na dozu oralnog palonozetrona, nakon oduzimanja odobrene intravenske formulacije bila veća od -15%.
English: Complete Control (Complete Response and No More Than Mild Nausea) p-value c
Croatian: Potpuna kontrola (potpuni odgovor i ne više od blage mučnine)
English: If you are pregnant or think you might be pregnant, your doctor will not give you Aloxi unless it is clearly necessary.
Croatian: Ako ste trudni ili mislite da biste mogli biti trudni, liječnik Vam neće propisati Aloxi osim ako je to zaista potrebno.
English: Butylhydroxyanisole
Croatian: Butilhidroksianizol
English: Pyrexia, infusion site pain, infusion site reaction, pain
Croatian: Pireksija, bol na mjestu primjene infuzije, reakcija na mjestu primjene infuzije, bol
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 ni ne inducira izoenzime citokroma P450 u klinički značajnim koncentracijama.
English: Only limited data from animal studies are available regarding the placental transfer (see section 5.3).
Croatian: O prijenosu kroz posteljicu postoje tek ograničeni podaci dobiveni u ispitivanjima na životinjama (vidjeti dio 5.3).
English: Aloxi pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 µg/kg or 20 µg/kg.
Croatian: Farmakokinetički podaci za jednu i.v. dozu Aloxija dobiveni su iz podskupine pedijatrijskih bolesnika s karcinomom (n = 280) koji su primili 10 µg/kg ili 20 µg/kg.
English: In non-clinical studies palonosetron possesses the ability to block ion channels involved in ventricular de- and re-polarisation and to prolong action potential duration.
Croatian: U nekliničkim ispitivanjima palonozetron ima sposobnost blokade ionskih kanala uključenih u ventrikularnu depolarizaciju i repolaziraciju te može produljiti trajanje akcijskog potencijala.
English: 20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy.
Croatian: Doza od 20 mikrograma/kg palonozetrona (maksimalna ukupna doza ne smije prelaziti 1500 mikrograma) daje se u obliku jedne intravenske infuzije u trajanju od 15 minuta, s početkom od približno 30 minuta prije početka kemoterapije.
English: In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
Croatian: U kliničkom ispitivanju nije ustanovljena značajna farmakokinetička interakcija između jedne intravenske doze palonozetrona i koncentracije oralnog metoklopramida, inhibitora enzima CYP2D6,
English: Talk to your doctor or nurse before you are given Aloxi if:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite Aloxi:
English: There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs).
Croatian: Bilo je izvješća o razvoju serotoninskog sindroma uz primjenu antagonista 5-HT3, bilo samih ili u kombinaciji s drugim serotoninergičnim lijekovima, uključujući selektivne inhibitore ponovne pohrane serotonina (SSRI) i inhibitore ponovne pohrane serotonina i noradrenalina (SNRI).
English: • hiccups, passing wind (flatulence), dry mouth or indigestion
Croatian: • štucanje, puštanje vjetrova (nadutost), suhoća usta ili probavne tegobe
English: If you forget to take Aloxi
Croatian: Ako ste zaboravili uzeti Aloxi
English: Although comparative efficacy of palonosetron in multiple cycles has not been demonstrated in controlled clinical trials, 217 patients were enrolled in a multicentre, open label safety study and were treated with palonosetron capsules 750 micrograms for up to 4 cycles of chemotherapy in a total of 654 chemotherapy cycles.
Croatian: Iako u kontroliranim kliničkim ispitivanjima nije dokazana usporedna djelotvornost palonozetrona u više ciklusa, 217 bolesnika bilo je uključeno u multicentrično, otvoreno ispitivanje sigurnosti primjene te su liječeni kapsulama palonozetrona od 750 mikrograma do 4 ciklusa kemoterapije u ukupno 654 kemoterapijskih ciklusa.
English: Constipation, nausea
Croatian: Konstipacija, mučnina
English: The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in CINV clinical studies.
Croatian: Učinak palonozetrona na krvni tlak, brzinu srčanih otkucaja i parametre EKG-a uključujući QTc bio je usporediv s učinkom ondanzetrona i dolazetrona u kliničkim ispitivanjima kemoterapijom izazvane mučnine i povraćanja.
English: It is not recommended to take Aloxi in the days following chemotherapy unless you are going to have another chemotherapy cycle.
Croatian: Ne preporučuje se da primate Aloxi u dane nakon kemoterapije, osim ako ćete primiti još jedan ciklus kemoterapije.
English: even if their signs of illness are the same as yours.
Croatian: Može im naškoditi, čak i ako njihovi znakovi bolesti jednaki Vašima.
English: In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg).
Croatian: U pedijatrijskim kliničkim ispitivanjima sprječavanja mučnine i povraćanja izazvanih umjereno ili visoko emetogenom kemoterapijom, 402 bolesnika primila su jednu dozu palonozetrona (3, 10 ili
English: These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to
Croatian: Klasificirane su kao česte (≥1/100 i <1/10) ili manje česte (≥1/1000 i <1/100).
English: Aloxi 500 micrograms soft capsules are plain, light beige, opaque, round to oval soft capsules, filled with a clear yellowish solution.
Croatian: Aloxi 500 mikrograma meke kapsule glatke su, svijetlo bež, neprozirne, okrugle do ovalne meke kapsule ispunjene bistrom žućkastom otopinom.
English: • impaired vision or eye irritation
Croatian: • oštećen vid ili nadraženost očiju
English: Patients were randomised to either dexamethasone or placebo in addition to their assigned treatment.
Croatian: bolesnici su randomizirani za deksametazon ili placebo.
English: INFORMATION IN BRAILLE Aloxi 500 micrograms
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Aloxi 500 mikrograma
English: The efficacy of Aloxi for the prevention of chemotherapy-induced nausea and vomiting in paediatric cancer patients was demonstrated in a second non-inferiority pivotal trial comparing a single intravenous infusion of palonosetron versus an i.v.
Croatian: Djelotvornost Aloxija u sprječavanju mučnine i povraćanja izazvanih kemoterapijom u pedijatrijskih bolesnika s karcinomom pokazala se u drugom ključnom ispitivanju neinferiornosti u kojemu se jedna intravenska infuzija palonozetrona uspoređivala s intravenskim režimom ondanzetrona.
English: Corticosteroids Palonosetron has been administered safely with corticosteroids.
Croatian: Kortikosteroidi Palonozetron se sigurno primjenjivao s kortikosteroidima.
English: In healthy subjects given palonosetron capsules 500 micrograms, 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 500 mikrograma, terminalni poluvijek (t½) eliminacije palonozetrona bio je 37 ± 12 sati (srednja vrijednost ± SD), a u bolesnika s karcinomom t½ je bio 48 ± 19 sati.
English: • abdominal (stomach) pain
Croatian: • bol u trbuhu (želucu)
English: Glycerol Monocaprylocaproate (type I) Polyglycerol oleate
Croatian: Glicerolkaprilokaprat (tip I) Poliglicerololeat Glicerol
English: Dolasetron 100 milligrams (n= 191)
Croatian: Dolazetron 100 miligrama (n = 191)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Aloxi solution for injection: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Aloxi otopina za injekciju: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
English: • abnormal electrical impulses in the heart
Croatian: • oticanje očiju • abnormalni električni impulsi srca
English: Aloxi should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
Croatian: Aloxi se ne smije primjenjivati za sprječavanje ili liječenje mučnine i povraćanja u dane nakon kemoterapije, osim ako je to povezano sa sljedećom primjenom kemoterapije.
English: • abnormal heart rate
Croatian: • abnormalna brzina srčanih otkucaja
English: Doses of up to 6 mg have been used in adult clinical studies.
Croatian: U kliničkim ispitivanjima u odraslih korištene su doze do 6 mg.
English: Blood bilirubin increased
Croatian: Povišen bilirubin u krvi
English: palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg administered intravenously on Day 1.
Croatian: uspoređivan je palonozetron 250 mikrograma i 750 mikrograma s ondanzetronom 32 mg primijenjeno intravenski na dan 1.
English: Following single dose intravenous infusion of Aloxi 20 µg/kg, peak plasma concentrations (CT) reported at the end of the 15 minute infusion were highly variable in all age groups and tended to be lower in patients < 6 years than in older paediatric patients.
Croatian: Nakon jednokratne intravenske infuzije Aloxija u dozi od 20 µg/kg, vršne koncentracije u plazmi (CT) zabilježene na kraju 15-minutne infuzije, bile su visoko varijabilne u svim dobnim skupinama i u bolesnika u dobi <6 godina kretale su se u nižim vrijednostima nego u starijih pedijatrijskih bolesnika.
English: At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc interval.
Croatian: Pri svim ispitivanim dozama, palonozetron nije izazvao klinički značajno produljenje QTc intervala.
English: In 36 healthy male and female subjects given a single oral dose of palonosetron capsules 500 micrograms, maximum plasma palonosetron concentration (Cmax) was 0.81 ± 0.17 ng/ml (mean ± SD) and time to maximum concentration (Tmax) was 5.1 ± 1.7 hours.
Croatian: U 36 zdravih muškaraca i žena koji su primili jednu oralnu dozu palonozetrona u kapsuli od 500 mikrograma, maksimalna koncentracija palonozetrona u plazmi (Cmax) bila je 0,81 ± 0,17 ng/ml (srednja vrijednost ± SD), a vrijeme do maksimalne koncentracije (tmax) iznosilo je 5,1 ± 1,7 sati.
English: After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45 %.
Croatian: Nakon intravenske primjene palonozetrona 0,25 mg jedanput na dan tijekom 3 dana u 12 zdravih ispitanika, prosječna vrijednost (± SD) porasta koncentracije palonozetrona u plazmi od 1. do 3. dana iznosila je 110 ± 45%.
English: A lower bound greater that -15 % demonstrates noninferiority between Aloxi oral and comparator Aloxi intravenous c
Croatian: Donja granica veća od -15% pokazuje neinferiornost između oralnog Aloxija i intravenskog usporednog Aloxija.
English: Polyamide/aluminium/PVC blister containing one or five soft capsules.
Croatian: 6.5 Vrsta i sadržaj spremnika Poliamid/aluminij/PVC blister koji sadrži jednu ili pet mekih kapsula.
English: Posology Adults
Croatian: Doziranje Odrasli
English: No safety concerns were raised in either treatment group.
Croatian: Ni u jednoj liječenoj skupini nije bila ugrožena sigurnost.
English: Hyperkalaemia, metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased
Croatian: hipokalcijemija, hipokalijemija, anoreksija, hiperglikemija, smanjeni apetit
English: Plain, light beige, opaque, round to oval, soft gelatine capsules, filled with a clear yellowish solution.
Croatian: Glatka, svijetlo bež, neprozirna, okrugla do ovalna, meka želatinska kapsula ispunjena bistrom žućkastom otopinom.
English: No data are available for patients with end stage renal disease undergoing haemodialysis.
Croatian: Ne postoje podaci o bolesnicima sa završnim stadijem bubrežne bolesti na hemodijalizi.
English: Hypotension, hypertension, vein discolouration, vein distended
Croatian: Hipotenzija, hipertenzija, diskoloracija vena, distenzija vena
English: • a medicine for feeling or being sick (nausea and vomiting) called domperidone.
Croatian: • lijek protiv mučnine i povraćanja pod nazivom domperidon.
English: Aloxi Intravenous 250 micrograms (n=162)
Croatian: Aloxi intravenski 250 mikrograma (n = 162)
English: • jerky body movements
Croatian: • nevoljni pokreti tijela
English: Ondansetron 32 milligrams (n= 185)
Croatian: Ondanzetron 32 miligrama (n = 185)
English: Tell your doctor if you notice any of the side effects listed above.
Croatian: Obratite se liječniku ako opazite neku od gore navedenih nuspojava.
English: In 12 cancer patients given a single oral dose of palonosetron capsules 500 micrograms 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 karcinomom koji su primili jednu oralnu dozu palonozetrona u kapsuli od 500 mikrograma jedan sat prije kemoterapije, Cmax je iznosio 0,93 ± 0,34 ng/ml a tmax 5,1 ± 5,9 sati.
English: Aloxi 250 micrograms (n= 189)
Croatian: Aloxi 250 mikrograma (n = 189)
English: • Do not use this medicine after the expiry date which is stated on the blister and carton after
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „Rok valjanosti“.
English: Single use only, any unused solution should be discarded.
Croatian: Samo za jednokratnu uporabu, neiskorištenu otopinu treba zbrinuti.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Croatian: Ako niste sigurni, obratite se liječniku ili ljekarniku prije nego što primite ovaj lijek.
English: ° From post-marketing experience
Croatian: Na temelju iskustva nakon stavljanja lijeka u promet
English: After a single intravenous bolus administration in healthy subjects the total body clearance of palonosetron was 173 ± 73 ml/min and renal clearance was 53 ± 29 ml/min.
Croatian: U zdravih ispitanika, nakon jedne intravenske primjene u bolusu, ukupni tjelesni klirens palonozetrona iznosio je 173 ± 73 ml/min a bubrežni klirens bio je 53 ± 29 ml/min.
English: Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.
Croatian: Palonozetron se sigurno primjenjivao s analgeticima, antiemeticima/sredstvima protiv mučnine, spazmoliticima i antikolinergičkim lijekovima.
English: After a single-dose of approximately 0.75 mg intravenous palonosetron, the total body clearance of palonosetron in healthy subjects was 160 ± 35 ml/h/kg (mean ± SD) and renal clearance was 66.5 ± 18.2 ml/h/kg.
Croatian: Nakon jedne doze od približno 0,75 mg intravenski primijenjenog palonozetrona, ukupni tjelesni klirens palonozetrona u zdravih ispitanika iznosio je 160 ± 35 ml/h/kg (srednja vrijednost ± SD), a bubrežni klirens 66,5 ± 18,2 ml/h/kg.
English: • coughing or shortness of breath
Croatian: • kašalj ili nedostatak zraka
English: Method of administration For intravenous use.
Croatian: Za intravensku primjenu.
English: The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%.
Croatian: Za palonozetron su zabilježene sljedeće česte ili manje česte nuspojave, a učestalost nijedne od njih nije bila veća od 1%.
English: If you are not sure, talk to your doctor or nurse before you are given this medicine.
Croatian: Ako niste sigurni, obratite se liječniku ili medicinskoj sestri prije nego što primite ovaj lijek.
English: 24 - 120 hours 0 - 120 hours a Intent-to-treat cohort.
Croatian: 24 - 120 sati 0 - 120 sati a Kohorta s namjerom liječenja.
English: thioridazine
Croatian: tioridazin
English: Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap.
Croatian: I sa silikoniziranim gumenim čepom od klorbutila i aluminijskom kapicom.
English: • ECG (electrocardiogram) abnormalities (‘QT prolongation').
Croatian: • odstupanja od normalnog elektrokardiograma (produljenje QT intervala).
English: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Croatian: • sprječavanje akutne mučnine i povraćanja povezanih s visoko emetogenom kemoterapijom karcinoma i za sprječavanje mučnine i povraćanja povezanih s umjereno emetogenom kemoterapijom karcinoma.