natgillin/translations-raw huggingface dataset:
Aloxi should be used only before chemotherapy administration. 
Aloxi treba primjenjivati samo prije kemoterapije.
Each capsule contains 7 mg sorbitol. 
Jedna kapsula sadrži 7 mg sorbitola.
While this study demonstrated that paediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults (see section 4.8). 
Iako je ovo ispitivanje pokazalo da je za sprječavanje mučnine i povraćanja izazvanih kemoterapijom pedijatrijskim bolesnicima potrebna veća doza palonozetrona nego odraslim bolesnicima, profil sigurnosti podudara se s profilom ustanovljenim u odraslih (vidjeti dio 4.8).
• abnormal heart rate or lack of blood flow to the heart 
• abnormalna brzina srčanih otkucaja ili nedostatan dotok krvi u srce
What Aloxi contains 
Što Aloxi sadrži
• high levels of sugar in the blood or sugar in the urine 
• visoke razine šećera u krvi ili u mokraći
D. CONDITIONS OR RESTRICTIONSWITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
0 - 24 hours 24 - 120 hours 0 - 120 hours Complete Control (Complete Response and No More Than Mild Nausea) 
0 - 24 sata 24 - 120 sati 0 - 120 sati Potpuna kontrola (potpuni odgovor i ne više od blage mučnine)
A specific thorough QT/QTc study was conducted in healthy volunteers for definitive data demonstrating the effect of palonosetron on QT/QTc (see section 5.1). 
Temeljito ispitivanje upravo QT/QTc intervala, provedeno je u zdravih dobrovoljaca kako bi se dobili definitivni podaci o učinku palonozetrona na QT/QTc (vidjeti dio 5.1).
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. 
Ispitivanja na životinjama ne pokazuju izravne ili neizravne štetne učinke na trudnoću, razvoj embrija/fetusa, porođaj ili razvoj nakon rođenja.
6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 
6.4 Posebne mjere pri čuvanju lijeka Lijek ne zahtijeva posebne uvjete čuvanja.
Injection site reaction* 
Reakcija na mjestu uboda*
If you decide not to take Aloxi (or other similar medicines), it is likely your chemotherapy will cause you to feel sick or be sick (nausea and vomiting). 
Ako odlučite da nećete uzimati Aloxi (ili drugi sličan lijek), vjerojatno će Vam kemoterapija uzrokovati osjećaj mučnine ili povraćanje.
Available in packs of 1 vial containing 5 ml of solution. 
Dostupan je u pakiranju od 1 bočice koja sadrži 5 ml otopine.
• Aloxi will be given as a drip (a slow infusion into a vein). 
• Aloxi će biti primijenjen u obliku dripa (spore infuzije u venu).
It works by blocking the action of a chemical called serotonin, which can cause you to feel sick or to vomit. 
Lijek blokira djelovanje kemijske tvari pod nazivom serotonin, što može prouzročiti mučninu ili povraćanje.
• You will normally take the capsule about 60 minutes before the start of your chemotherapy. 
• Kapsula se obično uzima otprilike 60 minuta prije početka kemoterapije.
Aloxi can be taken with or without food. 
Aloxi se može uzimati s hranom ili bez nje.
The amount of unchanged palonosetron excreted in the urine represented approximately 40 % of the administered dose. 
Količina nepromijenjenog palonozetrona izlučenog mokraćom predstavlja približno 40% primijenjene doze.
1 x 5 ml vial 
1 x 5 ml bočica
They are supplied in polyamide/aluminium/PVC blisters containing one or five capsules. 
Isporučuju se se u poliamidnim/aluminijskim/PVC blisterima koji sadrže jednu ili pet kapsula.
It is not known if Aloxi is found in breast milk. 
Nije poznato može li se Aloxi naći u majčinu mlijeku.
Palonosetron was non-inferior versus the comparators in the acute phase of emesis both in moderately and highly emetogenic setting. 
Palonozetron nije bio inferioran u usporedbi s usporednim lijekovima u akutnoj fazi emeze u umjereno i visoko emetogenim okolnostima.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2005 
Datum prvog odobrenja: 22. ožujka 2005.
The highest dose group showed a similar incidence of adverse reactions compared to the other dose groups and no dose response effects were observed. 
Skupina koja je primala najveću dozu pokazala je sličnu učestalost nuspojava kao i skupine koje su primale druge doze, a odgovori na dozu nisu opaženi.
In the unlikely event of overdose with Aloxi, this should be managed with supportive care. 
U vrlo malo vjerojatnom slučaju predoziranja Aloxijem, treba pristupiti potpornom liječenju.
The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours. 
Antiemetička aktivnost promatrana je tijekom 0-24 sata, 24-120 sati i 0-120 sati.
Citric acid monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections 
Citratna kiselina hidrat Natrijev hidroksid (za podešavanje pH) Kloridna kiselina (za podešavanje pH) Voda za injekciju
Medicines for depression or anxiety Tell your doctor or nurse if you are taking any medicines for depression or anxiety, including: 
Lijekovi protiv depresije ili tjeskobe Kažite liječniku ili medicinskoj sestri ako uzimate neki lijek protiv depresije ili tjeskobe, uključujući:
Approximately 74 % of patients also received single dose oral or intravenous dexamethasone 30 minutes before chemotherapy. 
Osim toga, približno 74% bolesnika primilo je jednu oralnu ili intravensku dozu deksametazona 30 minuta prije kemoterapije.
The AUC was 30 % higher in cancer patients than in healthy subjects. 
Površina ispod krivulje (AUC) bila je 30% veća u bolesnika s karcinomom nego u zdravih ispitanika.
Following intravenous administration, an initial decline in plasma concentrations is followed by slow elimination from the body with a mean terminal elimination half-life of approximately 40 hours. 
Nakon intravenske primjene, poslije početnog pada koncentracije u plazmi slijedi sporo izlučivanje iz tijela s prosječnim terminalnim poluvijekom eliminacije od otprilike 40 sati.
The underlying mechanisms are not fully understood, but because of the high doses employed and since Aloxi is intended for single application in humans, these findings are not considered relevant for clinical use. 
Osnovni mehanizmi nisu potpuno poznati, ali budući da se radi o visokim dozama, a Aloxi je namijenjen za jednokratnu primjenu u ljudi, ti se nalazi ne smatraju značajnima za kliničku uporabu.
As shown in Table 1, oral Aloxi capsules 500 micrograms demonstrated non-inferiority to the active comparator during the 0 to 24 hour and 0 to 120 hour time intervals; however, for the 24 to 120 hour time period, non-inferiority was not shown. 
Kao što je prikazano u tablici 1, oralne kapsule lijeka Aloxi od 500 mikrograma pokazale su neinferiornost prema aktivnom usporednom lijeku za vrijeme razdoblja od 0 do 24 sata; međutim, u vremenu od 24 do 120 sati, neinferiornost nije ustanovljena.
Adverse reactions were evaluated in paediatric patients receiving palonosetron for up to 4 chemotherapy cycles. 
Nuspojave su procijenjene u pedijatrijskih bolesnika koji su primali palonozetron do 4 kemoterapijska ciklusa.
The following side effects may happen with this medicine: 
Uz ovaj lijek moguće su sljedeće nuspojave:
The objective was to evaluate the ECG effects of IV administered palonosetron at single doses of 0.25, 0.75 or 2.25 mg in 221 healthy subjects. 
Cilj je bio procijeniti učinke i.v. primijenjenog palonozetrona u jednostrukim dozama od 0,25, 0,75 ili 2,25 mg na EKG 221 zdravog ispitanika.
Prevention of Post Operative Nausea and Vomiting (PONV): 
Sprječavanje poslijeoperacijske mučnine i povraćanja (PONV)
• abnormally high or low levels of potassium in the blood 
• abnormalno visoke ili niske razine kalija u krvi
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. 
Iako su terminalni poluvijek eliminacije i prosječna sistemska izloženost palonozetronu povećani u ispitanika s teškim oštećenjem jetre, smanjenje doze nije potrebno.
Urinary retention, glycosuria 
Urinarna retencija, glikozurija
Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Aloxi overdose. 
Ispitivanja dijalize nisu bila provedena, međutim, zbog velikog volumena distribucije, dijaliza se ne čini djelotvornim liječenjem za predoziranje lijekom Aloxi.
In female subjects (n=18), the mean AUC was 35 % higher and the mean Cmax was 26 % higher than in male subjects (n=18). 
U ispitanica (n = 18), prosječna površina ispod krivulje (AUC) bila je 35% veća, a srednja vrijednost Cmax 26% viša nego u ispitanika (n = 18).
• You will be given the medicine about 30 minutes before the start of chemotherapy. 
• Lijek će Vam dati otprilike 30 minuta prije početka kemoterapije.
Elevated transaminases-, electrocardiogram QT prolonged 
Povišene transaminaze, produljen QT elektrokardiograma
The signs may include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop in blood pressure. 
Znakovi koji upućuju na alergijsku reakciju mogu uključivati koprivnjaču, osip na koži, svrbež, otežano disanje ili gutanje, oticanje usta, lica, usana, jezika ili grla, a katkad sniženje krvnog tlaka.
• The recommended dose is one capsule (500 micrograms). 
• Preporučena je doza jedna kapsula (500 mikrograma).
Appropriate observation of patients for serotonin syndrome-like symptoms is advised. 
Preporučuje se odgovarajuće praćenje bolesnika zbog moguće pojave simptoma sličnih serotoninskom sindromu.
A high fat meal did not affect the Cmax and AUC of oral palonosetron. 
Obrok s visokim sadržajem masti nije utjecao na Cmax i AUC oralnog palonozetrona.
Aloxi capsules may also contain a trace of lecithin derived from soya. 
Aloxi kapsule mogu također sadržavati lecitin u tragovima dobiven od soje.
• you have a blocked bowel or have had repeated constipation in the past 
• ako imate začepljenje crijeva ili ste prije imali ponavljane zatvore stolice
Cough, dyspnoea, epistaxis 
Kašalj, dispneja, epistaksa
Pharmacokinetic simulations indicate that the overall exposure (AUC0-∞) of 0.25 mg intravenous palonosetron administered once daily for 3 consecutive days was similar to a single intravenous dose of 0.75 mg, although Cmax of the 0.75 mg single dose was higher. 
Farmakokinetičke simulacije pokazuju da je sveukupna izloženost (AUC0-∞) dozi od 0,25 mg palonozetrona intravenski primijenjenog jedanput na dan tijekom 3 uzastopna dana, bila slična jednoj intravenskoj dozi od 0,75 mg, iako je Cmax jedne doze od 0,75 mg bio viši.
Aloxi contains sorbitol. 
Aloxi sadrži sorbitol.
If you take more Aloxi than you should If you think you may have taken more than you should, tell your doctor straight away. 
Mislite li da ste uzeli Aloxi u količini većoj nego što ste trebali, odmah obavijestite svog liječnika.
Capsule shell: Gelatin 
Ovojnica kapsule: Želatina
• medicines for heart problems such as amiodarone, nicardipine, quinidine 
• lijekove protiv srčanih tegoba kao što su amiodaron, nikardipin, kinidin
In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine). 
U farmakokinetičkoj analizi populacije pokazalo se da ne postoji značajan učinak na klirens palonozetrona kada je primijenjen s induktorima CYP2D6 (deksametazon i rifampicin) i inhibitorima (uključujući amjodaron, celekoksib, klorpromazin, cimetidin, doksorubicin, fluoksetin, haloperidol, paroksetin, kinidin, ranitidin, ritonavir, sertralin ili terbinafin).
<2 y 2 to <6 y 6 to <12 y 
< 2 god 2 do < 6 god
• medicines for infections such as moxifloxacin, erythromycin 
• lijekove protiv infekcija kao što su moksifloksacin, eritromicin
The primary efficacy endpoint, Complete Response (CR: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. 
Primarni ishod djelotvornosti, potpuni odgovor (CR: izostanak povraćanja, dizanja želuca i bez primjene antiemetičkog simptomatskog lijeka) tijekom prva 24 sata poslije operacije bilo je postignuto u 78,2% bolesnika u skupini koja je primala palonozetron i 82,7% u skupini koja je primala ondanzetron.
Hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects. 
Oštećenje funkcije jetre ne utječe značajno na ukupni tjelesni klirens palonozetrona u usporedbi sa zdravim ispitanicima.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. 
U nekliničkim ispitivanjima zapaženi su učinci samo pri ekspozicijama dozama koje su znatno veće od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. 
Obavijestite svoga liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Severe renal impairment reduces renal clearance, however total body clearance in these patients is similar to healthy subjects. 
Teška oštećenja smanjuju bubrežni klirens, međutim, ukupni tjelesni klirens u tih bolesnika sličan je onome u zdravih ispitanika.
purified water, butylhydroxyanisole, gelatin, sorbitol, titanium dioxide. 
butilhidroksianizol, želatina, sorbitol, titanijev dioksid.
The pivotal studies were not designed to assess efficacy of palonosetron in delayed onset nausea and vomiting. 
Ključna ispitivanja nisu bila osmišljena da bi procijenila djelotvornost palonozetrona u odgođenom početku mučnine i povraćanja.
• allergic reaction - the signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, an itchy, lumpy rash (hives). 
• alergijska reakcija - znakovi mogu uključivati oticanje usana, lica, jezika ili grla, otežano disanje ili kolaps, osip s uzdignućima na koži praćen svrbežom (koprivnjača).
Somnolence, insomnia, paraesthesia, hypersomnia, peripheral sensory neuropathy 
Somnolencija, nesanica, parestezija, hipersomnija, periferna osjetilna neuropatija
No dosage adjustment is necessary based on gender. 
Nije potrebno prilagođavanje doze u odnosu na spol.
Efficacy was based on demonstrating non-inferiority of oral palonosetron doses compared to the approved intravenous formulation. 
Djelotvornost se temeljila na pokazivanju neinferiornosti doza oralnog palonozetrona u usporedbi s odobrenom intravenskom formulacijom.
• high levels of the pigment ‘bilirubin' (a marker of liver problems) in the blood 
• visoke razine pigmenta bilirubina (biljeg problema s jetrom) u krvi
The effect of palonosetron on QTc interval was evaluated in a double blind, randomised, parallel, placebo and positive (moxifloxacin) controlled trial in adult men and women. 
Učinak palonozetrona na QTc interval procijenjen je u dvostruko slijepom, randomiziranom, usporednom, placebom i pozitivno (moksifloksacin) kontroliranom ispitivanju u odraslih muškaraca i žena.
(≥1/100 to<1/10) 
(≥1/100 i <1/10)
• It is given as an injection into a vein. 
• Primjenjuje se u obliku injekcije u venu.
• medicines called SSRIs (‘selective serotonin reuptake inhibitors') - such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram 
• lijekove koji se nazivaju selektivni inhibitori ponovne pohrane serotonina (engl. selective serotonin reuptake inhibitors, SSRI) - kao što su fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram, escitalopram
• you have had heart problems or heart problems run in your family, such as changes in your heart beat (‘QT prolongation') 
• ako ste imali tegobe sa srcem ili Vam članovi obitelji imaju tegobe sa srcem, kao što su promjene otkucaja srca (produljenje QT intervala)
No case of overdose has been reported. 
Nema zabilježenih slučajeva predoziranja.
Within each frequency grouping, adverse reactions are presented below in order of decreasing seriousness. 
Unutar svake skupine svrstane po učestalosti, nuspojave koje slijede navedene su redoslijedom od veće prema manjoj ozbiljnosti.
Do not take Aloxi if any of the above applies to you. 
Nemojte uzimati Aloxi ako se prethodno navedeno odnosi na Vas.
Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines. 
Budući da palonozetron može izazvati omaglicu, somnolenciju ili umor, bolesnike treba na to upozoriti kada upravljaju vozilima ili rukuju strojevima.
• Single use only, any unused solution should be disposed of. 
• Samo za jednokratnu uporabu, svu neiskorištenu otopinu treba zbrinuti.
Do not take Aloxi if: 
Nemojte uzimati Aloxi:
Single use only 
Samo za jednokratnu uporabu.
Talk to your doctor or pharmacist before taking Aloxi if: 
Obratite se svom liječniku ili ljekarniku prije nego uzmete Aloxi:
Non-clinical studies indicate that palonosetron, only at very high concentrations, may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration. 
Neklinička ispitivanja pokazuju da palonozetron samo u vrlo visokim koncentracijama može blokirati ionske kanale uključene u ventrikularnu depolarizaciju i repolarizaciju te produljiti trajanje akcijskog potencijala.
Although comparative efficacy of palonosetron in multiple cycles has not been demonstrated in controlled clinical studies, 875 patients enrolled in the three phase 3 trials continued in an open label safety study and were treated with palonosetron 750 micrograms for up to 9 additional cycles of chemotherapy. 
Iako se u kontroliranim kliničkim ispitivanjima nije pokazala usporedna djelotvornost palonozetrona u više ciklusa, 875 bolesnika uključena u tri ispitivanja faze 3 nastavila su sudjelovati u otvorenom ispitivanju sigurnosti i liječeni su palonozetronom 750 mikrograma do 9 dodatnih ciklusa kemoterapije.
Elderly people 
Starije osobe
• medicines for serious mental health problems such as haloperidol, chlorpromazine, quetiapine, 
• lijekove protiv ozbiljnih duševnih poremećaja kao što su haloperidol, klorpromazin, kvetiapin,
Aloxi soft capsules: Medicinal product subject to medical prescription. 
Aloxi meke kapsule: Lijek se izdaje na recept.
Since the 97.5% confidence interval (stratum adjusted MantelHaenszel test) of the difference in CR0-24h between palonosetron 20 µg/kg and ondansetron was [11.7%, 12.4%], the 20 µg/kg palonosetron dose demonstrated non-inferiority to ondansetron. 
Budući da je interval pouzdanosti od 97,5% (Mantel-Haenszelov test prilagođen za slojeve) za razliku u CR0-24h između palonozetrona u dozi od 20 µg/kg i ondanzetrona iznosio [-11,7%, 12,4%], doza palonozetrona od 20 µg/kg dokazala je neinferiornost prema ondanzetronu.
Elimination After a single intravenous dose of 10 micrograms/kg [14C]-palonosetron, approximately 80 % of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40 % of the administered dose, as unchanged active substance. 
Nakon jedne intravenske doze od 10 mikrograma/kg [14C]-palonozetrona, otprilike 80% doze izluči se unutar 144 sata u mokraći, pri čemu palonozetron predstavlja približno 40% primijenjene doze kao nepromijenjena djelatna tvar.
In clinical studies at a dose of 500 micrograms (total 161 patients) the most frequently observed adverse reaction, at least possibly related to Aloxi, was headache (3.7 %). 
U kliničkim ispitivanjima s dozom od 500 mikrograma (ukupno 161 bolesnik) najčešće opažena nuspojava, barem moguće povezana s lijekom Aloxi, bila je glavobolja (3,7%).
Motion sickness, tinnitus 
Bolest kretanja, tinitus
What Aloxi is and what it is used for What you need to know before you take Aloxi How to take Aloxi 
Što je Aloxi i za što se koristi Što morate znati prije nego počnete primati Aloxi Kako ćete primati Aloxi
Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15 Ireland 
Damastown, Mulhuddart, Dublin 15 Irska
This belongs to a group of medicines called ‘serotonin (5HT3) antagonists'. 
Pripada skupini lijekova pod nazivom „antagonisti serotonina (5HT3)“.
Results for the studies on moderately emetogenic chemotherapy and for the study on highly emetogenic chemotherapy are summarised in the following tables. 
Rezultati ispitivanja umjereno emetogene kemoterapije i ispitivanja visoko emetogene kemoterapije sažeto su prikazani u tablicama koje slijede.
The primary efficacy endpoint was Complete Response in the acute phase of the first cycle of chemotherapy, defined as no vomiting, no retching, and no rescue medication in the first 24 hours after starting chemotherapy. 
Primarni ishod djelotvornosti bio je potpuni odgovor u akutnoj fazi prvog ciklusa kemoterapije, definiran kao izostanak povraćanja, bez dizanja želuca i bez simptomatskog lijeka u prva 24 sata nakon početka kemoterapije.
• Do not use this medicine after the expiry date which is stated on the vial and carton after ‘EXP'. 
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti“ ili „EXP“.
Therefore, palonosetron should not be used in pregnant women unless it is considered essential by the physician. 
Stoga palonozetron ne smiju uzimati trudnice, osim ako liječnik smatra da je to prijeko potrebno.
• medicines called SNRIs (‘serotonin noradrenaline reuptake inhibitors') - such as venlafaxine, duloxetine (can lead to the development of serotonin syndrome and should be used with caution). 
• lijekove koji se nazivaju inhibitori ponovne pohrane serotonina i noradrenalina (engl. serotonin noradrenaline reuptake inhibitors, SNRI) - kao što su venlafaksin, duloksetin (oni mogu dovesti do razvoja serotoninskog sindroma i potrebno ih je uzimati s oprezom).
In the palonosetron 10 µg/kg, 20 µg/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%.
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, 
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,
As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration. 
Budući da palonozetron može produljiti vrijeme prolaska sadržaja kroz debelo crijevo, bolesnike s anamnezom konstipacije ili sa znakovima subakutne crijevne opstrukcije treba nakon primjene nadzirati.
b PK parameters expressed as Arithmetic mean (SD) 
b Farmakokinetički parametri izraženi kao aritmetička sredina (SD).
In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Aloxi. 
U kliničkim ispitivanjima, opažene su sljedeće nuspojave koje su možda ili vjerojatno bile povezane s primjenom lijeka Aloxi.
However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolisers of CYP2D6 substrates. 
Međutim, klinički farmakokinetički parametri između sporih i brzih metabolizatora supstrata CYP2D6 nisu značajno različiti.
No pharmacokinetic data in haemodialysis patients are available. 
Ne postoje farmakokinetički podaci za bolesnike na hemodijalizi.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETNG AUTHORISATION 
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET