natgillin/translations-raw huggingface dataset:
The efficacy of palonosetron 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. 
Djelotvornost lijeka Palonosetron Accord u sprječavanju mučnine i povraćanja izazvanih visoko emetogenom kemoterapijom može se povećati dodatnom primjenom kortikosteroida prije kemoterapije.
Hyperkalaemia, metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased 
Hiperkalijemija, metabolički poremećaji, hipokalcijemija, hipokalijemija, anoreksija, hiperglikemija, smanjeni apetit
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. 
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.
When the dose was increased from 10 mcg/kg to 20 mcg/kg a dose-proportional increase in mean AUC was observed. 
Kada je doza povećana s 10 µg/kg na 20 µg/kg opažen je porast srednje vrijednosti AUC-a proporcionalan dozi.
Palonosetron Accord should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration. 
Palonosetron Accord se ne smije primjenjivati za sprječavanje ili liječenje mučnine i povraćanja u dane nakon kemoterapije, osim ako je to povezano sa sljedećom primjenom kemoterapije.
- low levels of calcium in the blood - high levels of the pigment bilirubin in the blood - high levels of certain liver enzymes - elevated moods or feeling of anxiousness - sleepiness or trouble sleeping - decrease or loss of appetite - weakness, tiredness, fever or flu like symptoms - numbness, burning, prickling or tingling sensations on the skin - itchy skin rash - impaired vision or eye irritation - motion sickness - ringing in the ear - hiccups, flatulence, dry mouth or indigestion - abdominal (stomach) pain - difficulty urinating - joint pain - electrocardiogram abnormalities (QT prolongation) 
Manje često mogu se javiti u do 1 na 100 osoba - visoki ili niski krvni tlak - abnormalna brzina srčanih otkucaja ili nedostatan dotok krvi u srce - promjene boje vene i/ili proširenje vena - abnormalno visoke ili niske razine kalija u krvi - visoke razine šećera u krvi ili u mokraći - niske razine kalcija u krvi - visoke razine pigmenta bilirubina u krvi - visoke razine određenih jetrenih enzima - pretjerano raspoloženje ili osjećaji tjeskobe - pospanost ili poteškoće sa spavanjem - smanjenje ili gubitak apetita - slabost, umor, vrućica ili simptomi poput gripe - utrnulost, osjećaj žarenja, bockanje, trnci po koži - kožni osip popraćen svrbežom - oštećen vid ili nadraženost očiju - bolest kretanja / putovanja - zvonjava u uhu - štucanje, plinovi u crijevima (flatulencija), suhoća usta ili probavne tegobe - bol u trbuhu (želucu) - teškoće pri mokrenju - bol u zglobovima - abnormalnosti elektrokardiograma (produljenje QT intervala).
In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤50 mg/m2, carboplatin, cyclophosphamide ≤1,500 mg/m2 and doxorubicin >25 mg/m2, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered intravenously on Day 1, without dexamethasone. 
U dva randomizirana, dvostruko slijepa ispitivanja na ukupno 1132 bolesnika na umjereno emetogenoj kemoterapiji koja je uključivala cisplatin ≤50 mg/m2, karboplatin, ciklofosfamid 1500 mg/m2 i doksorubicin 25 mg/m2, uspoređivan je palonozetron 250 mikrograma i 750 mikrograma s ondanzetronom 32 mg (poluvijek 4 sata) ili dolazetronom 100 mg (poluvijek 7,3 sata) primijenjeno intravenski na dan 1, bez deksametazona.
The primary efficacy variable was the proportion of patients with a complete response (CR, defined as no emetic episode and no rescue medication) during the first 24 hours after the start of chemotherapy administration. 
Varijabla primarne djelotvornosti bila je udio bolesnika s potpunim odgovorom (CR (engl. complete response), definiranim kao nepostojanje emetičke epizode i bez simptomatskog lijeka) tijekom prvih 24 sata nakon početka primjene kemoterapije.
The efficacy of palonosetron 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 intravenous ondansetron regimen. 
Djelotvornost palonozetrona u sprječavanju mučnine i povraćanja izazvanih kemoterapijom u pedijatrijskih bolesnika s rakom pokazala se u drugom ključnom ispitivanju neinferiornosti u kojemu se jedna intravenska infuzija palonozetrona uspoređivala s intravenskim režimom ondanzetrona.
In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥ 60 mg/m2, cyclophosphamide > 1,500 mg/m2 and dacarbazine, palonosetron 250 
U randomiziranom, dvostruko slijepom ispitivanju na ukupno 667 bolesnika na visoko emetogenoj kemoterapiji koja je uključivala cisplatin ≥60 mg/m2, ciklofosfamid >1500 mg/m2 i dakarbazin,
In the palonosetron 10 mcg/kg, 20 mcg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%. 
U skupinama koje su primale palonozetron 10 µg/kg i 20 µg/kg te u skupini koja je primala ondanzetron, udio bolesnika s potpunim odgovorom CR0-24h bio je 54,2%, 59,4% i 58,6%.
Eye irritation, amblyopia 
Nadraženost očiju, ambliopija
micrograms and 750 micrograms were compared with ondansetron 32 mg administered intravenously on Day 1. 
uspoređivan je palonozetron 250 mikrograma i 750 mikrograma s ondanzetronom 32 mg primijenjeno intravenski na dan 1.
Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin. 
Primijenjene emetogene kemoterapije uključivale su doksorubicin, ciklofosfamid (<1500 mg/m2), ifosfamid, cisplatin, daktinomicin, karboplatin i daunorubicin.
METHOD AND ROUTE(S) OF ADMINISTRATION Single use only. 
5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za jednokratnu upotrebu.
Osmlolarity : 260-320 mOsm/l 
Bistra, bezbojna otopina. pH vrijednost: između 3,0 i 3,9 Osmolalnost: 260-320 mOsm/l
Table 4: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of palonosetron at 20 mcg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 mcg/kg palonosetron doses via intravenous bolus. 
Tablica 4: Farmakokinetički parametri u pedijatrijskih bolesnika s rakom nakon intravenske infuzije palonozetrona u dozi od 20 µg/kg tijekom 15 minuta i u odraslih bolesnika s rakom koji su primili palonozetron u dozi od 3 i 10 µg/kg u intravenskoj bolus injekciji
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. 
250 mikrograma palonozetrona daje se u obliku jedne intravenske bolus injekcije, približno 30 minuta prije početka kemoterapije.
Allergic reactions to palonosetron accord 
Alergijske reakcije na Palonosetron Accord.
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 mcg/kg. 
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.
Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock 
Preosjetljivost, anafilaksija, anafilaktične/anafilaktoidne reakcije i šok
OTHER SPECIAL WARNING(S), IF NECESSARY 
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO 8. ROK VALJANOSTI
Palonosetron does not inhibit or induce cytochrome P450 isoenzymes at clinically relevant concentrations. 
Palonozetron ne inhibira i ne inducira izoenzime citokroma P450 u klinički značajnim koncentracijama.
The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in CINV clinical studies. 
Učinak palonozetrona na krvni tlak, brzinu srčanih otkucaja i parametre EKG-a uključujući QTc bio je usporediv s učinkom ondanzetrona i dolasetrona u kliničkim ispitivanjima kemoterapijom izazvane mučnine i povraćanja.
The safety and efficacy of palonosetron intravenously at single doses of 1mcg/kg and 3mcg/kg was compared in the first clinical study in 150 patients in the following age groups, >28 days to 23 months (7 patients), 2 to 11 years (96 patients), and 12 to 16 years of age (47 patients) undergoing elective surgery. 
Sigurnost i djelotvornost palonozetrona u jednokratnim intravenskim dozama od 1 µg/kg i 3 µg/kg uspoređivala se u prvom kliničkom ispitivanju provedenom na 150 bolesnika dobnih skupina >28 dana do 23 mjeseca (7 bolesnika), 2 do 11 godina (96 bolesnika) i 12 do 16 godina (47 bolesnika) koji su podvrgnuti elektivnom kirurškom zahvatu.
Cardiac disorder 
Srčani poremećaji
- If you are using palonosetron accord in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, 
Ako Palonosetron Accord primjenjujete dodatno uz druge lijekove koji mogu prouzročiti abnormalni srčani ritam, kao što su amiodaron, nikardipin, kinidin, moksifloksacin, eritromicin, haloperidol, klorpromazin, kvetiapin, tioridazin, domperidon.
The safety and efficacy of palonosetron intravenously at single doses of 3 mcg/kg and 10 mcg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy. 
Sigurnost i djelotvornost primjene jedne intravenske doze palonozetrona od 3 µg/kg i 10 µg/kg ispitivane su u prvom kliničkom ispitivanju provedenom na 72 bolesnika dobnih skupina >28 dana do 23 mjeseca (12 bolesnika), 2 do 11 godina (31 bolesnik) i 12 do 17 godina (29 bolesnika) koji su primali visoko ili umjereno emetogenu kemoterapiju.
Each vial contains 250 micrograms of palonosetron (as hydrochloride) in 5 ml (50 micrograms/ml). 
Jedna bočica sadrži 250 mikrograma palonozetrona (u obliku palonozetronklorida) u 5 ml (50 mikrograma/ml).
Asthenia, pyrexia, fatigue, feeling hot, influenza like illness 
Astenija, pireksija, umor, osjećaj vrućine, simptomi slični gripi
Single-dose intravenous palonosetron pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 mcg/kg or 20 mcg/kg. 
Farmakokinetički podaci za jednu intravensku dozu palonozetrona dobiveni su iz podskupine pedijatrijskih bolesnika s rakom (n = 280) koji su primili 10 µg/kg ili 20 µg/kg.
Adults The recommended dose of palonosetron accord is 250 micrograms given as a rapid injection into a vein. 
Preporučena doza lijeka Palonosetron Accord je 250 mikrograma primijenjenog u obliku brze injekcije u venu.
Talk to your doctor, pharmacist or nurse before using Palonosetron Accord. 
Ako dojite, obratite se svom liječniku ili ljekarniku za savjet prije nego primijenite Palonosetron Accord.
The second paediatric, trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing intravenous palonosetron (1 mcg/kg, max 0.075 mg) versus intravenous. 
Drugo pedijatrijsko ispitivanje bilo je multicentrično, dvostruko slijepo, dvostruko maskirano, randomizirano ispitivanje neinferiornosti s aktivnom kontrolom, provedeno na usporednim skupinama, u kojemu se jedna doza intravenskog palonozetrona (1 µg/kg, najviše 0,075 mg) uspoređivala s intravenskim ondanzetronom.
The signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, you could also notice an itchy, lumpy rash (hives), burning or pain at the site of injection. 
Znakovi koji upućuju na alergijsku reakciju mogu uključivati oticanje usana, lica, jezika ili grla, poteškoće s disanjem ili nesvjesticu, odnosno razvoj osipa uz prisutan svrbež (koprivnjača), žarenje ili bol na mjestu uboda injekcije.
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 % 
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%.
Driving and using machines Palonosetron accord may cause dizziness or tiredness. 
Palonosetron Accord može uzrokovati omaglicu ili umor.
d Vss is reported for paediatric cancer patients, whereas Vz is reported for adult cancer patients. 
d Volumen distribucije u stanju dinamičke ravnoteže (Vss) naveden je za pedijatrijske bolesnike s rakom, a konačni volumen distribucije (Vz) za odrasle bolesnike s rakom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26th May 2016 
DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
If you have any further questions, ask your doctor or pharmacist or nurse. 
Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
• 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. 
• sprječavanje akutne mučnine i povraćanja povezanih s visoko emetogenom kemoterapijom raka i za sprječavanje mučnine i povraćanja povezanih s umjereno emetogenom kemoterapijom raka.
- The other ingredients are mannitol, disodium edetate (refer section 2 for sodium content), sodium citrate, citric acid monohydrate, sodium hydroxide (refer section 2 for sodium content), hydrochloric acid, concentrated and water for injections. 
Drugi sastojci su manitol, dinatrijev edetat (za sadržaj natrija pogledajte dio 2), natrijev citrat, citratna kiselina hidrat, natrijev hidroksid (za sadržaj natrija pogledajte dio 2), kloridna kiselina, koncentrirana i voda za injekcije.
Single use only, any unused solution should be discarded. 
Samo za jednokratnu uporabu, svu neiskorištenu otopinu treba zbrinuti.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'. 
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
How to store Palonosetron Accord 
Kako čuvati Palonosetron Accord
Electrocardiogram, QT prolonged conduction disorder, sinus tachycardia 
Produljen QT elektrokardiograma, poremećaj provodljivosti, sinusna tahikardija
6 ml Type I tubular clear glass vial, closed with chlorobutyl rubber stopper and sealed with a flip-off aluminium seal. 
Cjevasta prozirna bočica (staklo tip I) od 6 ml, zatvorena gumenim čepom od klorbutila i aluminijskim zaštitnim zatvaračem
Single use only, any unused solution should be disposed of. 
Samo za jednokratnu uporabu, neiskorištenu otopinu treba zbrinuti.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms of palonosetron (as hydrochloride). 
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine sadrži 50 mikrograma palonozetrona (u obliku palonozetronklorida).
How Palonosetron Accord is given 
Kako se primjenjuje Palonosetron Accord
Excipients: mannitol, citric acid monohydrate, sodium citrate ,disodium edetate, sodium hydroxide, hydrochloric acid concentrated, water for injections. 
Pomoćne tvari: manitol, citratna kiselina hidrat, dinatrijev edetat, natrijev citrat, natrijev hidroksid, koncentrirana kloridna kiselina, voda za injekcije.
• the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, 
• sprječavanje akutne mučnine i povraćanja povezanih s visoko emetogenom kemoterapijom raka,
Mean maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞) are generally dose-proportional over the dose range of 0.3-90 mcg/kg in healthy subjects and in cancer patients. 
U zdravih ispitanika i u bolesnika s rakom, prosječna maksimalna koncentracija u plazmi (Cmax) i površina ispod krivulje koncentracija-vrijeme (AUC0-) obično su proporcionalne dozi u rasponu doze od 0,3-90 μg/kg.
CLINICAL PARTICULARS 4.1 Therapeutic indications Palonosetron Accord is indicated in adults for: 
Palonosetron Accord je u odraslih indiciran za:
Age does not affect the pharmacokinetics of palonosetron. 
Dob ne utječe na farmakokinetiku palonozetrona.
b PK parameters expressed as Arithmetic mean (SD) c Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 mcg /kg and 20 mcg /kg dose groups combined. 
c Klirens i volumen distribucije u pedijatrijskih bolesnika izračunati su prilagođeno za težinu, kombinirano za obje dozne skupine od 10 g/kg i 20 g/kg.
Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34 %. 
U 11 bolesnika s rakom testisa, nakon intravenske primjene palonozetrona 0,25 mg jednom svaki drugi dan kroz 3 doze, prosječna vrijednost ( SD) porasta koncentracije u plazmi od 1. dana do 5. dana iznosila je 42  34%.
Table 3: Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron 
Tablica 1: Postotak bolesnikaa s odgovorom po skupinama liječenja i fazi u ispitivanju umjereno emetogene kemoterapije u odnosu na ondanzetron
Adults Cancer Patientsb 
Odrasli bolesnici s rakomb
Headache, Dizziness 
Glavobolja, Vrtoglavica
Dermatitis, allergic, pruritus, skin disorder, urticaria. 
Alergijski dermatitis, pruritus, kožni poremećaj, urtikarija
Palonosetron 250 micrograms (n= 189) 
Palonozetron 250 mikrograma (n = 189)
What Palonosetron Accord contains - The active substance is palonosetron (as hydrochloride). 
Što Palonosetron Accord sadrži Djelatna tvar je palonozetron (u obliku palonozetronklorida).
One vial of 5 ml of solution contains 250 micrograms of palonosetron. 
Jedna bočica otopine od 5 ml sadrži 250 mikrograma palonozetrona.
In vitro metabolism studies have shown that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 isoenzymes are involved in the metabolism of palonosetron. 
Metabolička in vitro ispitivanja pokazala su da je u metabolizam palonozetrona uključen enzim CYP2D6, a u manjoj mjeri izoenzimi CYP3A4 i CYP1A2.
Each ml of solution contains 50 micrograms of palonosetron. 
Jedan ml otopine sadrži 50 mikrograma palonozetrona.
There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs). 
Bilo je izvješća o razvoju serotoninskog sindroma nakon istodobne primjene antagonista 5-HT3 i drugih serotoninergičnih lijekova (uključujući selektivne inhibitore ponovne pohrane serotonina (SSRI) i inhibitore ponovne pohrane serotonina i noradrenalina (SNRI)).
The study demonstrated no effect on QT/QTc interval duration as well as any other ECG interval at doses up to 2.25 mg. No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarisation. 
Ispitivanjem nije ustanovljen učinak na trajanje intervala QT/QTc, a također ni na bilo koji drugi interval EKG-a pri dozama do 2,25 mg.
A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 mcg/kg (maximum 0. 
Ukupno 493 pedijatrijska bolesnika u dobi od 64 dana do 16,9 godina, koja su primala umjereno (69,2%) ili visoko emetogenu kemoterapiju (30,8%), liječena su palonozetronom u dozi od 10 µg/kg (najviše 0,75 mg), palonozetronom u dozi od 20 µg/kg (najviše 1,5 mg) ili ondanzetronom (3 x 0,15 mg/kg , najveća ukupna doza 32 mg) 30 minuta prije početka emetogene kemoterapije u 1. ciklusu.
a Intent-to-treat cohort. 
a Kohorta s namjerom liječenja.
ondansetron. 
U venu.
- Dizziness - jerky body movement - abnormal heart rate - cough and shortness of breath - nose bleed - itchy skin rash or hives - fever - pain at the site of infusion 
Manje često mogu se javiti u do 1 na 100 osoba) - omaglica - trzaji tijela - abnormalna brzina srčanih otkucaja - kašalj ili nedostatak zraka - krvarenje iz nosa - kožni osip popraćen svrbežom ili koprivnjača - vrućica - bol na mjestu davanja infuzije.
Constipation Diarrhoea Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, 
Dispepsija, bol u donjem dijelu trbuha, bol u gornjem dijelu trbuha, suha usta, flatulencija
• the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. 
• sprječavanje mučnine i povraćanja povezanih s umjereno emetogenom kemoterapijom raka.
Palonosetron Accord 250 micrograms solution for injection palonosetron 
Palonosetron Accord 250 mikrograma otopina za injekciju palonozetron
24 - 120 hours 0 - 120 hours a Intent-to-treat cohort. 
0 - 120 sati a Kohorta s namjerom liječenja.
Ask your doctor or pharmacist for advice before using any medicine if you are pregnant or think you might be. 
Ako ste trudni ili mislite da biste mogli biti, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
Each vial of 5 ml of solution contains 250 micrograms of palonosetron (as hydrochloride). 
Jedna bočica otopine od 5 ml sadrži 250 mikrograma palonozetrona (u obliku palonozetronklorida).
Dermatitis allergic, pruritic rash 
Alergijski dermatitis, pruritički osip
4.2 Posology and method of administration Palonosetron Accord should be used only before chemotherapy administration. 
Palonosetron Accord treba primjenjivati samo prije primjene kemoterapije.
Common ARs (≥1/100 to<1/10) 
Česte nuspojave (1/100 i <1/10)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Palonosetron Accord 250 micrograms solution for injection palonosetron (as hydrochloride) 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Palonosetron Accord 250 mikrograma otopina za injekciju palonozetron (u obliku palonozetronklorida) i.v. primjena
Uncommon ARs (≥1/1,000 to <1/100) 
Manje česte nuspojave (1/1000 i <1/100)
Palonosetron Accord 250 micrograms solution for injection palonosetron (as hydrochloride) 
Palonosetron Accord 250 mikrograma otopina za injekciju palonozetron (u obliku palonozetronklorida)
NAME OF THE MEDICINAL PRODUCT Palonosetron Accord 250 micrograms solution for injection 
NAZIV LIJEKA Palonosetron Accord 250 mikrograma otopina za injekciju.
Sodium hydroxide (for pH adjustment), Hydrochloric acid, concentrated (for pH adjustment), Water for injections. 
6.1 Popis pomoćnih tvari manitol, citratna kiselina hidrat, natrijev citrat, dinatrijev edetat, natrijev hidroksid (za podešavanje pH), kloridna kiselina, koncentrirana (za podešavanje pH), voda za injekcije.
AUC0-∞, h.mcg/L t1/2, hours 
Klirensc, l/h/kg
How Palonosetron Accord is given 4. 
Kako se primjenjuje Palonosetron Accord 4. Moguće nuspojave
Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron Palonosetron 
Tablica 2: Postotak bolesnikaa s odgovorom po skupinama liječenja i fazi u ispitivanju umjereno emetogene kemoterapije u odnosu na dolazetron Palonozetron 250 mikrograma (n = 185)
SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram. 
Obavijestite svoga liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući: - selektivne inhibitore ponovne pohrane serotonina (SSRI) koji se koriste za liječenje depresije i/ili tjeskobe, uključujući fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram, escitalopram - inhibitore ponovne pohrane serotonina i noradrenalina (SNRI) koji se koriste za liječenje depresije i/ili tjeskobe, uključujući venlafaksin, duloksetin.
Paediatric Cancer Patientsa 
Pedijatrijski bolesnici s rakoma