natgillin/translations-raw huggingface dataset:
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
Tell your doctor straight away if you notice any of the following serious side effects:
Odmah se obratite liječniku ako opazite neku od sljedećih ozbiljnih nuspojava:
Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Tahikardija, bradikardija, ekstrasistole, ishemija miokarda, sinusna tahikardija, sinusna aritmija, supraventrikularne ekstrasistole
PHARMACEUTICAL FORM AND CONTENTS 1 soft capsule.
OBLIK I SADRŽAJ 1 kapsula, meka
Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Blago do umjereno oštećenje bubrežne funkcije ne utječe značajno na farmakokinetičke parametre palonozetrona.
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.
Djelotvornost lijeka Aloxi u sprječavanju mučnine i povraćanja izazvanih visoko emetogenom kemoterapijom može se povećati dodatnom primjenom kortikosteroida prije kemoterapije.
Doses of up to 6 mg have been used in clinical trials.
U kliničkim ispitivanjima korištene su doze do 6 mg.
Fertility There are no data concerning the effect of palonosetron on fertility.
Nema podataka o učinku palonozetrona na plodnost.
(≥1/1,000 to <1/100)
(≥1/1000 i <1/100)
Most patients were non-naïve to chemotherapy (78.5%) across all treatment groups.
Većina bolesnika u svim terapijskim skupinama prethodno je primala kemoterapiju (78,5%).
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.
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.
The non-inferiority margin was
Granica neinferiornosti bila je 15%.
If you stop taking Aloxi
Ako prestanete uzimati Aloxi
Metoclopramide
Metoklopramid
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%.
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%.
A lower bound greater than -15 % demonstrates non-inferiority between Aloxi and comparator.
Donja granica veća od -15% pokazuje neinferiornost između lijeka Aloxi i usporednog lijeka.
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
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%).
There is no experience of palonosetron in human pregnancy.
Nema iskustva s palonozetronom u trudnoći u ljudi.
Efficacy was based on demonstrating non-inferiority of intravenous palonosetron compared to intravenous ondansetron.
Djelotvornost se temeljila na dokazivanju neinferiornosti intravenski primijenjenog palonozetrona u usporedbi s intravenskim ondanzetronom.
500 micrograms palonosetron administered orally approximately one hour before the start of chemotherapy.
Doza od 500 mikrograma palonozetrona primijenjenog oralno otprilike jedan sat prije početka kemoterapije.
t½, hours
AUC0-∞, h·µg/l t½, sati
If you are pregnant or think you might be pregnant, your doctor will not use Aloxi unless it is clearly necessary.
Ako ste trudni ili mislite da biste mogli biti trudni, liječnik Vam neće primijeniti Aloxi osim ako je to zaista potrebno.
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.
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.
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.
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.
Only limited data from animal studies are available regarding the placental transfer (see section 4.6).
O prijenosu kroz posteljicu postoje tek ograničeni podaci dobiveni u ispitivanjima na životinjama (vidjeti dio 4.6).
Ondansetron 32 milligrams (n= 221)
Ondanzetron 32 miligrama (n = 221)
0 - 24 hours
0 - 24 sata
Efficacy after palonosetron 10 µg/kg compared to palonosetron 3µg/kg was 54.1% and 37.1% respectively.
10 µg/kg u usporedbi s palonozetronom 3µg/kg bila je 54,1% odnosno 37,1%.
Aloxi is indicated in adults for:
4.1 Terapijske indikacije Aloxi je u odraslih indiciran za:
In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
U nekliničkim ispitivanjima, palonozetron nije inhibirao antitumorsku aktivnost pet testiranih kemoterapeutika (cisplatin, ciklofosfamid, citarabin, doksorubicin i mitomicin C).
Aloxi may contain traces of lecithin which comes from soya.
Aloxi može u tragovima sadržavati lecitin koji se dobije iz soje.
What you need to know before you take Aloxi
Što morate znati prije nego počnete uzimati Aloxi
Glycerol Titanium dioxide
Titanijev dioksid
Also contains mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.
Također sadrži manitol, dinatrijev edetat, natrijev citrat, citratnu kiselinu hidrat, vodu za injekcije, natrijev hidroksid i kloridnu kiselinu.
The safety and efficacy of Aloxi in children have not been established.
Pedijatrijska populacija Sigurnost primjene i djelotvornost Aloxija u djece nije ustanovljena.
Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 µg /kg and 20 µg /kg dose groups combined.
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.
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 %.
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%.
Complete Control (Complete Response and No More Than Mild Nausea) p-value c
Potpuna kontrola (potpuni odgovor i ne više od blage mučnine)
If you are pregnant or think you might be pregnant, your doctor will not give you Aloxi unless it is clearly necessary.
Ako ste trudni ili mislite da biste mogli biti trudni, liječnik Vam neće propisati Aloxi osim ako je to zaista potrebno.
Butylhydroxyanisole
Butilhidroksianizol
Pyrexia, infusion site pain, infusion site reaction, pain
Pireksija, bol na mjestu primjene infuzije, reakcija na mjestu primjene infuzije, bol
Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Na temelju ispitivanja in vitro, palonozetron ne inhibira ni ne inducira izoenzime citokroma P450 u klinički značajnim koncentracijama.
Only limited data from animal studies are available regarding the placental transfer (see section 5.3).
O prijenosu kroz posteljicu postoje tek ograničeni podaci dobiveni u ispitivanjima na životinjama (vidjeti dio 5.3).
Aloxi pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 µg/kg or 20 µg/kg.
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.
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.
U nekliničkim ispitivanjima palonozetron ima sposobnost blokade ionskih kanala uključenih u ventrikularnu depolarizaciju i repolaziraciju te može produljiti trajanje akcijskog potencijala.
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.
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.
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.
U kliničkom ispitivanju nije ustanovljena značajna farmakokinetička interakcija između jedne intravenske doze palonozetrona i koncentracije oralnog metoklopramida, inhibitora enzima CYP2D6,
Talk to your doctor or nurse before you are given Aloxi if:
Obratite se svom liječniku ili medicinskoj sestri prije nego primite Aloxi:
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).
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).
• hiccups, passing wind (flatulence), dry mouth or indigestion
• štucanje, puštanje vjetrova (nadutost), suhoća usta ili probavne tegobe
If you forget to take Aloxi
Ako ste zaboravili uzeti Aloxi
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.
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.
Constipation, nausea
Konstipacija, mučnina
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 dolazetrona u kliničkim ispitivanjima kemoterapijom izazvane mučnine i povraćanja.
It is not recommended to take Aloxi in the days following chemotherapy unless you are going to have another chemotherapy cycle.
Ne preporučuje se da primate Aloxi u dane nakon kemoterapije, osim ako ćete primiti još jedan ciklus kemoterapije.
even if their signs of illness are the same as yours.
Može im naškoditi, čak i ako njihovi znakovi bolesti jednaki Vašima.
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).
U pedijatrijskim kliničkim ispitivanjima sprječavanja mučnine i povraćanja izazvanih umjereno ili visoko emetogenom kemoterapijom, 402 bolesnika primila su jednu dozu palonozetrona (3, 10 ili
These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to
Klasificirane su kao česte (≥1/100 i <1/10) ili manje česte (≥1/1000 i <1/100).
Aloxi 500 micrograms soft capsules are plain, light beige, opaque, round to oval soft capsules, filled with a clear yellowish solution.
Aloxi 500 mikrograma meke kapsule glatke su, svijetlo bež, neprozirne, okrugle do ovalne meke kapsule ispunjene bistrom žućkastom otopinom.
• impaired vision or eye irritation
• oštećen vid ili nadraženost očiju
Patients were randomised to either dexamethasone or placebo in addition to their assigned treatment.
bolesnici su randomizirani za deksametazon ili placebo.
INFORMATION IN BRAILLE Aloxi 500 micrograms
16. PODACI NA BRAILLEOVOM PISMU Aloxi 500 mikrograma
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.
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.
Corticosteroids Palonosetron has been administered safely with corticosteroids.
Kortikosteroidi Palonozetron se sigurno primjenjivao s kortikosteroidima.
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.
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.
• abdominal (stomach) pain
• bol u trbuhu (želucu)
Glycerol Monocaprylocaproate (type I) Polyglycerol oleate
Glicerolkaprilokaprat (tip I) Poliglicerololeat Glicerol
Dolasetron 100 milligrams (n= 191)
Dolazetron 100 miligrama (n = 191)
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).
Aloxi otopina za injekciju: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
• abnormal electrical impulses in the heart
• oticanje očiju • abnormalni električni impulsi srca
Aloxi should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
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.
• abnormal heart rate
• abnormalna brzina srčanih otkucaja
Doses of up to 6 mg have been used in adult clinical studies.
U kliničkim ispitivanjima u odraslih korištene su doze do 6 mg.
Blood bilirubin increased
Povišen bilirubin u krvi
palonosetron 250 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.
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.
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.
At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc interval.
Pri svim ispitivanim dozama, palonozetron nije izazvao klinički značajno produljenje QTc intervala.
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.
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.
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%.
A lower bound greater that -15 % demonstrates noninferiority between Aloxi oral and comparator Aloxi intravenous c
Donja granica veća od -15% pokazuje neinferiornost između oralnog Aloxija i intravenskog usporednog Aloxija.
Polyamide/aluminium/PVC blister containing one or five soft capsules.
6.5 Vrsta i sadržaj spremnika Poliamid/aluminij/PVC blister koji sadrži jednu ili pet mekih kapsula.
Posology Adults
Doziranje Odrasli
No safety concerns were raised in either treatment group.
Ni u jednoj liječenoj skupini nije bila ugrožena sigurnost.
Hyperkalaemia, metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased
hipokalcijemija, hipokalijemija, anoreksija, hiperglikemija, smanjeni apetit
Plain, light beige, opaque, round to oval, soft gelatine capsules, filled with a clear yellowish solution.
Glatka, svijetlo bež, neprozirna, okrugla do ovalna, meka želatinska kapsula ispunjena bistrom žućkastom otopinom.
No data are available for patients with end stage renal disease undergoing haemodialysis.
Ne postoje podaci o bolesnicima sa završnim stadijem bubrežne bolesti na hemodijalizi.
Hypotension, hypertension, vein discolouration, vein distended
Hipotenzija, hipertenzija, diskoloracija vena, distenzija vena