natgillin/translations-raw huggingface dataset:
• a medicine for feeling or being sick (nausea and vomiting) called domperidone.
• lijek protiv mučnine i povraćanja pod nazivom domperidon.
Aloxi Intravenous 250 micrograms (n=162)
Aloxi intravenski 250 mikrograma (n = 162)
• jerky body movements
• nevoljni pokreti tijela
Ondansetron 32 milligrams (n= 185)
Ondanzetron 32 miligrama (n = 185)
Tell your doctor if you notice any of the side effects listed above.
Obratite se liječniku ako opazite neku od gore navedenih nuspojava.
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.
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.
Aloxi 250 micrograms (n= 189)
Aloxi 250 mikrograma (n = 189)
• Do not use this medicine after the expiry date which is stated on the blister and carton after
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „Rok valjanosti“.
Single use only, any unused solution should be discarded.
Samo za jednokratnu uporabu, neiskorištenu otopinu treba zbrinuti.
If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Ako niste sigurni, obratite se liječniku ili ljekarniku prije nego što primite ovaj lijek.
° From post-marketing experience
Na temelju iskustva nakon stavljanja lijeka u promet
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.
Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.
Palonozetron se sigurno primjenjivao s analgeticima, antiemeticima/sredstvima protiv mučnine, spazmoliticima i antikolinergičkim lijekovima.
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.
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.
• coughing or shortness of breath
• kašalj ili nedostatak zraka
Method of administration For intravenous use.
Za intravensku primjenu.
The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%.
Za palonozetron su zabilježene sljedeće česte ili manje česte nuspojave, a učestalost nijedne od njih nije bila veća od 1%.
If you are not sure, talk to your doctor or nurse before you are given this medicine.
Ako niste sigurni, obratite se liječniku ili medicinskoj sestri prije nego što primite ovaj lijek.
24 - 120 hours 0 - 120 hours a Intent-to-treat cohort.
24 - 120 sati 0 - 120 sati a Kohorta s namjerom liječenja.
thioridazine
tioridazin
Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap.
I sa silikoniziranim gumenim čepom od klorbutila i aluminijskom kapicom.
• ECG (electrocardiogram) abnormalities (‘QT prolongation').
• odstupanja od normalnog elektrokardiograma (produljenje QT intervala).
• 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 karcinoma i za sprječavanje mučnine i povraćanja povezanih s umjereno emetogenom kemoterapijom karcinoma.
• The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.
• Pomoćne tvari su manitol, dinatrijev edetat, natrijev citrat, citratna kiselina hidrat i voda za injekcije, natrijev hidroksid i kloridna kiselina.
Adjuvant corticosteroids, including dexamethasone, were administered with chemotherapy in 55% of patients.
Uz kemoterapiju u 55% bolesnika primijenjeni su adjuvantni kortikosteroidi, uključujući deksametazon.
These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmias, conduction disturbances and in patients taking anti-arrhythmic agents or other medicinal products that lead to QT prolongation or electrolyte abnormalities.
kongestivnim zatajenjem srca, bradiaritmijama, poremećajima provodljivosti te u bolesnika koji uzimaju antiaritmike ili druge lijekove koji dovode do produljenja QT intervala ili nepravilnosti elektrolita.
NAME OF THE MARKETING AUTHORISATION HOLDER Helsinn
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Helsinn
Table 4: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of Aloxi at 20 µg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 µg/kg palonosetron doses via intravenous bolus.
Tablica 4: Farmakokinetički parametri u pedijatrijskih bolesnika s karcinomom nakon intravenske infuzije Aloxija u dozi od 20 µg/kg tijekom 15 minuta i u odraslih bolesnika s karcinomom koji su primili palonozetron u dozi od 3 i 10 µg/kg u intravenskoj bolus injekciji
Aloxi is used in adults, adolescents and children over one month of age to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy.
Aloxi se primjenjuje u odraslih osoba, adolescenata i djece starije od mjesec dana kako bi se spriječila pojava mučnine i povraćanja prilikom liječenja raka kemoterapijom.
Dermatitis allergic, pruritic rash
Alergijski dermatitis, pruritus,
5 soft capsules.
5 kapsula, mekih
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 µg/kg (maximum 0.75 mg), palonosetron
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 - 120 hours
0 - 120 sati
24 - 120 hours
24 - 120 sati
Table 2: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of Aloxi at 20 µg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 µg/kg palonosetron doses via intravenous bolus.
Tablica 2: Farmakokinetički parametri u pedijatrijskih bolesnika s karcinomom nakon intravenske infuzije Aloxija u dozi od 20 µg/kg tijekom 15 minuta i u odraslih bolesnika s karcinomom koji su primili palonozetron u dozi od 3 i 10 µg/kg u intravenskoj bolus injekciji
Hepatic impairment
Glavobolja Vrtoglavica
A single-dose of 250 mcg, 500 mcg, or 750 mcg oral palonosetron capsules given one hour prior to moderately emetogenic chemotherapy was compared to a single-dose of 250 mcg intravenous Aloxi given 30 minutes prior to chemotherapy.
Jednostruke doze kapsula oralnog palonozetrona od 250 mikrograma, 500 mikrograma ili 750 mikrograma davane jedan sat prije umjereno emetogene kemoterapije, uspoređene su s jednom dozom od 250 mikrograma Aloxija intravenski primijenjenog 30 minuta prije kemoterapije.
98.3 % CIb
98,3%-tni CI b
Gender does not affect the pharmacokinetics of palonosetron.
Spol ne utječe na farmakokinetiku palonozetrona.
Helsinn Birex Pharmaceuticals Ltd. Damastown
Helsinn Birex Pharmaceuticals Ltd.
No case of overdose has been reported in paediatric clinical studies.
U pedijatrijskim kliničkim ispitivanjima nije zabilježen nijedan slučaj predoziranja.
Chemotherapeutic agents
Kemoterapeutici
No dose adjustment is necessary for the elderly.
Za starije osobe nije potrebno prilagođavati dozu.
Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, flatulence
Dispepsija, bol u donjem dijelu trbuha, bol u gornjem dijelu trbuha, suha usta, flatulencija
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 µg/kg (maximum 0.75 mg), palonosetron 20 µg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1.
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 ,
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Aloxi.
Ako se nešto od prethodno navedenog odnosi na Vas (ili niste sigurni), obratite se liječniku ili medicinskoj sestri prije nego što primite Aloxi.
Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes.
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Palonozetron se uglavnom metabolizira pomoću enzima CYP2D6, uz manji doprinos izoenzima CYP3A4 i CYP1A2.
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 µg/kg in healthy subjects.
U zdravih ispitanika, nakon jednokratnih oralnih doza uz korištenje puferirane otopine, prosječne maksimalne koncentracije palonozetrona (Cmax) i površina ispod krivulje koncentracijavrijeme (AUC0-∞) bile se proporcionalne dozi u rasponu doze od 3,0 do 80 µg/kg.
• the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,
• sprječavanje akutne mučnine i povraćanja povezanih s visoko emetogenom kemoterapijom karcinoma,
Aloxi 500 micrograms soft capsules Palonosetron
Aloxi 500 mikrograma meke kapsule palonozetron
Dexamethasone was administered prophylactically before chemotherapy in 67 % of patients.
Prije kemoterapije, u 67% bolesnika profilaktički je primijenjen deksametazon.
Aloxi is indicated in adults for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Aloxi je u odraslih indiciran za sprječavanje mučnine i povraćanja povezanih s umjereno emetogenom kemoterapijom karcinoma.
Common: may affect up to 1 in 10 people
Često: mogu se pojaviti u do 1 na 10 osoba
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%.
NAME OF THE MEDICINAL PRODUCT Aloxi 500 micrograms soft capsules
NAZIV LIJEKA Aloxi 500 mikrograma meke kapsule
When the dose was increased from10 µg/kg to 20 µg/kg a dose-proportional increase in mean AUC was observed.
Kada je doza povećana s 10 µg/kg na 20
• weakness, feeling tired, fever or flu like symptoms
• slabost, osjećaj umora, vrućica ili simptomi poput gripe • utrnulost, osjećaj žarenja, bockanje, trnci po koži
Upon opening of the vial, use immediately and discard any unused solution.
5 godina Nakon otvaranja bočice, otopinu odmah upotrijebite, a svu neiskorištenu otopinu zbrinite.
High doses of palonosetron (each dose causing at least 30 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumours, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumours in rats but not in mice.
Visoke doze palonozetrona (jedna doza najmanje 30 puta veća od doze primijenjene u terapijske svrhe u čovjeka) primijenjene svakodnevno tijekom dvije godine prouzročile su povećanu učestalost tumora jetre, neoplazme endokrinog sustava (u štitnjači, hipofizi, gušterači,
Aloxi contains sodium
Aloxi sadrži natrij
• decrease or loss of appetite
• osjećaj pospanosti ili poteškoće sa spavanjem • smanjenje ili gubitak apetita
Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists.
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Antiemetici i sredstva protiv mučnine, antagonisti serotonina (5HT3).
0-120 hours
0-120 sati.
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 tumours, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumours in rats but not in mice.
Visoke doze palonozetrona (jedna doza najmanje 15 puta veća od doze primijenjene u terapijske svrhe u čovjeka) primijenjene svakodnevno tijekom dvije godine prouzročile su povećanu učestalost tumora jetre, neoplazme endokrinog sustava (u štitnjači, hipofizi, gušterači,
How to take Aloxi
Kako uzimati Aloxi
Tell your doctor or pharmacist if you are taking any medicines that affect your heart beat - this is because they could cause heart beat problems when taken with Aloxi.
Obavijestite svog liječnika ili ljekarnika ako uzimate neki lijek koji utječe na otkucaje srca - to je potrebno zato što bi takvi lijekovi mogli prouzročiti tegobe s otkucajima srca kada se uzimaju s Aloxijem.
Uncommon side effects shown in tests: may affect up to 1 in 100 people
Manje česte nuspojave koje su se pokazale u pretragama: mogu se pojaviti u do 1 na 100 osoba • visoki ili nizak krvni tlak
Tell your doctor or nurse if you are taking any medicines that affect your heart beat - this is because they could cause a heart beat problem when taken with Aloxi.
Obavijestite svog liječnika ili medicinsku sestru ako uzimate neki lijek koji utječe na otkucaje srca - to je potrebno zato što bi takvi lijekovi mogli prouzročiti tegobe s otkucajima srca kada se uzimaju s Aloxijem.
LIST OF EXCIPIENTS Also contains sorbitol.
Sadrži također sorbitol.
• The other ingredients are glycerol monocaprylocaproate (type I), polyglycerol oleate, glycerol,
• Drugi sastojci su glicerolkaprilokaprat (tip I), poliglicerololeat, glicerol, pročišćena voda,
If any of the above applies to you (or you are not sure), talk to your doctor or nurse before taking Aloxi - this is because these medicines could cause a heart beat problem when taken with Aloxi.
Ako se nešto od prethodno navedenog odnosi na Vas (ili niste sigurni), obratite se liječniku ili medicinskoj sestri prije nego što primite Aloxi - to je potrebno zato što bi ti lijekovi mogli prouzročiti tegobe s otkucajima srca kada se uzimaju s Aloxijem.
≤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.
Table 3: Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron Aloxi 250 micrograms (n= 223)
Tablica 3: Postotak bolesnikaa s odgovorom prema skupinama liječenja i fazi u ispitivanju visoko emetogene kemoterapije u odnosu na ondanzetron Aloxi 250 mikrograma (n = 223)
For Palonosetron no clinical data on exposed pregnancies are available.
Nema kliničkih podataka o izloženosti palonozetronu u trudnoći.
Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron Aloxi 250 micrograms (n= 185)
Tablica 2: Postotak bolesnika a s odgovorom po skupinama liječenja i fazi u ispitivanju umjereno emetogene kemoterapije u odnosu na dolazetron Aloxi 250 mikrograma (n = 185)
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,
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
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 micrograms palonosetron (as hydrochloride).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 500 mikrograma palonozetrona (u obliku palonozetronklorida).
Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock
anafilaktične/anafilaktoidne reakcije i šok
Age does not affect the pharmacokinetics of palonosetron.
Starije osobe Dob ne utječe na farmakokinetiku palonozetrona.
What you need to know before you are given Aloxi
Što morate znati prije nego počnete primati Aloxi
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.
(CR (engl. complete response), definiranim kao nepostojanje emetičke epizode i bez simptomatskog lijeka) tijekom prvih 24 sata nakon početka primjene kemoterapije.
Each vial of 5 ml of solution contains 250 micrograms of palonosetron.
Jedna bočica otopine od 5 ml sadrži 250 mikrograma palonozetrona.
d Vss is reported for paediatric cancer patients, whereas Vz is reported for adult cancer patients.
Volumen distribucije u stanju dinamičke ravnoteže (Vss) naveden je za pedijatrijske bolesnike s karcinomom, a konačni volumen distribucije (Vz) za odrasle bolesnike s karcinomom.
Each ml of solution contains 50 micrograms palonosetron.
Jedan ml otopine sadrži 50 mikrograma palonozetrona.
Medicines for depression or anxiety Tell your doctor or pharmacist if you are taking any medicines for depression or anxiety, including:
Obavijestite svog liječnika ili ljekarnika ako uzimate neki lijek protiv depresije ili tjeskobe,
NAME OF THE MEDICINAL PRODUCT Aloxi 250 micrograms solution for injection.
NAZIV LIJEKA Aloxi 250 mikrograma otopina za injekciju.
Aloxi contains sorbitol and may contain traces of soya This medicine contains 7 mg sorbitol (a type of sugar) in each capsule.
Jedna kapsula ovog lijeka sadrži 7 mg sorbitola (vrsta šećera).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aloxi 250 micrograms solution for injection
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Aloxi 250 mikrograma otopina za injekciju palonozetron i.v. uporaba
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine sadrži 50 mikrograma palonozetrona (u obliku palonozetronklorida).
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 μg/kg in healthy subjects and in cancer patients.
U zdravih ispitanika i u bolesnika s karcinomom, 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.
Other side effects Tell your doctor if you notice any of the following side effects:
Obratite se liječniku ako opazite neku od sljedećih nuspojava:
Adults Cancer Patientsb
Pedijatrijski bolesnici s karcinomoma Odrasli bolesnici s karcinomomb
a Intent-to-treat cohort.
Kohorta s namjerom liječenja.
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 repolarization.
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.
Serotonergic Drugs (e.g. SSRIs and SNRIs) 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)).
Aloxi 250 micrograms solution for injection Palonosetron
Aloxi 250 mikrograma otopina za injekciju Palonozetron (u obliku palonozetronklorida)
Each capsule contains 500 micrograms palonosetron (as hydrochloride).
Jedna kapsula sadrži 500 mikrograma palonozetrona (u obliku palonozetronklorida).
Two cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 750 micrograms.
Povezano s primjenom palonozetrona u dozi od 750 mikrograma, zabilježena su dva slučaja konstipacije s fekalnom impakcijom, koja su zahtijevala hospitalizaciju.
• the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
• sprječavanje mučnine i povraćanja povezanih s umjereno emetogenom kemoterapijom karcinoma.
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Aloxi - this is because these medicines could cause heart beat problems when taken with Aloxi.
Ako se nešto od prethodno navedenog odnosi na Vas (ili niste sigurni), obratite se liječniku ili ljekarniku prije nego što uzmete Aloxi - to je potrebno zato što bi ti lijekovi mogli prouzročiti tegobe s otkucajima srca kada se uzimaju s Aloxijem.
Uncommon: may affect up to 1 in 100 people
Manje često: mogu se pojaviti u do 1 na 100 osoba
Elimination Following administration of a single oral 750 micrograms dose of [14C]-palonosetron to six healthy subjects, 85 % to 93 % of the total radioactivity was excreted in urine, and 5 % to 8 % was eliminated in feces.
85% do 93% ukupne radioaktivnosti izlučilo se mokraćom, a 5% do 8% eliminirano je stolicom.
Aloxi contains the active substance palonosetron.
Aloxi sadrži djelatnu tvar palonozetron.
No dose adjustment is necessary for patients with impaired hepatic function.
Prilagođavanje doze za bolesnike s bubrežnom insuficijencijom nije potrebno.
How to store Aloxi
Kako čuvati Aloxi
Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5HT3) antagonists, ATC code: A04AA05
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Antiemetici i sredstva protiv mučnine, antagonisti serotonina (5HT3),
In post marketing very rare cases (<1/10,000) of hypersensitivity reactions occurred with palonosetron solution for injection for intravenous use.
(<1/10 000) primjene otopine palonozetrona za intravensku uporabu.
• high levels of the pigment bilirubin in the blood
• niske razine kalcija u krvi • visoke razine pigmenta bilirubina u krvi
• pain at the site of infusion.
• bol na mjestu davanja infuzije.
Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride).
Jedna bočica otopine od 5 ml sadrži 250 mikrograma palonozetrona (u obliku palonozetronklorida).
See your doctor straight away if you notice any signs of an allergic reaction.
U slučaju da uočite bilo kakve znakove alergijske reakcije odmah otiđite svom liječniku.
20 µg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1.
0,75 mg), palonozetronom u dozi od 20 µg/kg (najviše 1,5 mg) ili ondanzetronom (3 x 0,15 mg/kg ,
MARKETING AUTHORISATION NUMBER EU/1/04/306/001
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/306/001