natgillin/translations-raw huggingface dataset:
Currently available data are described in section 5.1 and section 5.2, but no recommendation on posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
Aloxi should be injected over 30 seconds.
Zdravilo Aloxi je potrebno injicirati v 30 sekundah.
If you are allergic to peanut or soya, do not take this medicine.
Če ste alergični na arašide ali sojo, ne jemljite tega zdravila.
It is unlikely that you will forget to take this medicine.
Najbrž ne boste pozabili vzeti tega zdravila.
Children Do not give this medicine to children
Otroci Tega zdravila ne dajajte otrokom.
It may harm them,
prečiščena voda,
Significance levels at alpha 0.0167 (adjusted for multiple comparisons).
Ravni signifikance pri alfa = 0,0167 (popravljene za multiple primerjave).
• trouble sleeping
• težave s spanjem,
The study was designed to show non-inferiority.
Študija je bila zasnovana tako, da prikaže ne-manjvrednost.
Aloxi is normally given by a doctor or nurse.
Zdravilo Aloxi običajno dajeta zdravnik ali medicinska sestra.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Če predložitev PSUR in posodobitev RMP sovpadata, se ju lahko predloži istočasno.
• This medicine can be taken with or without food.
• To zdravilo lahko vzamete s hrano ali brez nje.
• ringing in the ear
• zvonjenje v ušesih,
Each vial contains one dose.
Ena viala vsebuje en odmerek.
Approximately 62 % of palonosetron is bound to plasma proteins.
Približno 62 % palonosetrona je vezanega na plazemske proteine.
Date of latest renewal: 23 March 2010
Datum zadnjega podaljšanja: 23. marec 2010
This is because we do not know if Aloxi may harm the baby.
To je zato, ker ne vemo, ali bi lahko zdravilo Aloxi škodovalo otroku.
Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
However, in general the antiemetic effect for the 0-24 hour interval was similar throughout the consecutively repeated cycles and the overall safety was maintained during all cycles.
Na splošno rečeno pa je bil antiemetični učinek v obdobju 0-24 ur podoben skozi vse zaporedno ponavljajoče se cikluse, varnost pa je bila v celoti ohranjena med vsemi ciklusi.
• feeling happier than usual or feeling anxious
• bolj veselo razpoloženje kot ponavadi ali občutek anksioznosti,
This medicinal product should be administered by a healthcare professional under appropriate medical supervision.
To zdravilo sme uporabljati samo zdravstveni delavec pod ustreznim medicinskim nadzorom.
• The doctor will work out the right dose based on bodyweight.
• Zdravnik bo določil pravi odmerek na osnovi telesne mase.
Pharmacokinetic information is provided in section 5.2.
Farmakokinetične informacije so navedene v poglavju 5.2.
The total body clearance (L/h/kg) in patients 12 to 17 years old was similar to that in healthy adults.
Celotni telesni očistek (l/h/kg) pri bolnikih, starih 12 do 17 let, je bil podoben kot pri zdravih odraslih.
ATC code: A04AA05
Oznaka ATC: A04AA05.
• you have a blocked bowel or have had repeated constipation in the past
• imate zaporo črevesa ali ste bili v preteklosti večkrat zaprti;
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2005
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 22. marec 2005
Ten percent of patients have a mean terminal elimination half-life greater than 100 hours.
Deset odstotkov bolnikov ima srednji končni eliminacijski razpolovni čas višji od 100 ur.
ondansetron.
ondansetronom.
Complete Response was not formally evaluated for the repeat cycle application.
Celotnega odziva pri uporabi v ponavljajočih se ciklusih niso formalno ocenili.
Therefore, patients with known hypersensitivity to peanut or soya, should be monitored closely for signs of an allergic reaction.
Zato moramo bolnike z znano preobčutljivostjo za arašide ali sojo skrbno spremljati glede znakov alergijske reakcije.
Two paediatric trials were performed.
Opravili so dve pediatrični preskušanji.
Children and Adolescents (aged 1 month to 17 years):
Otroci in mladostniki (stari od 1 meseca do 17 let):
Adults Cancer Patientsb
Odrasli bolniki z rakom b
12 to <17 y µg/kg
12 do <17 let µg/kg
PHARMACEUTICAL FORM AND CONTENTS 1 soft capsule.
FARMACEVTSKA OBLIKA IN VSEBINA 1 mehka kapsula
• you have had heart problems or heart problems run in your family, such as changes in your heart beat (‘QT prolongation')
• imate ali ste imeli težave s srcem ali pa so v vaši družini prisotne težave s srcem, kot so spremembe srčnega ritma (»podaljšan interval QT«);
The AUC was 30 % higher in cancer patients than in healthy subjects.
Pri bolnikih z rakom je bila AUC 30 % večja kot pri zdravih preiskovancih.
Soft capsule.
Mehka kapsula.
Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Priporočljivo je ustrezno opazovanje bolnikov glede simptomov, podobnih serotoninskemu sindromu.
See your doctor straight away if you notice any signs of an allergic reaction.
Takoj pojdite k zdravniku, če opazite kakšne znake alergijske reakcije.
• high levels of sugar in the blood or sugar in the urine
• zvišana koncentracija sladkorja v krvi ali sladkor v urinu,
However, if you think you have forgotten to take your dose, tell your doctor straight away.
Če pa vseeno mislite, da ste pozabili vzeti odmerek, takoj obvestite svojega zdravnika.
Following oral administration, palonosetron is well absorbed with its absolute bioavailability reaching 97 %.
Po peroralni aplikaciji se palonosetron dobro absorbira, njegova absolutna biološka uporabnost doseže 97 %.
Aloxi is indicated in adults for:
Zdravilo Aloxi je indicirano pri odraslih za:
Do not take Aloxi if:
Ne jemljite zdravila Aloxi, če:
• The maximum dose is 1500 micrograms.
• Največji odmerek je 1500 mikrogramov.
• The recommended dose is one capsule (500 micrograms).
• Priporočeni odmerek je ena kapsula (500 mikrogramov).
A total of 670 paediatric surgical patients participated, age 30 days to 16.9 years.
Sodelovalo je vsega skupaj 670 pediatričnih kirurških bolnikov, starih od 30 dni do 16,9 leta.
• you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
• ste alergični na palonosetron ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Do not stop taking this medicine without talking to your doctor.
Ne nehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom.
The safety and efficacy of Aloxi in children aged less than 1 month have not been established.
Varnost in učinkovitost zdravila Aloxi pri otrocih, mlajših od 1 meseca, nista bili dokazani.
No Nausea (Likert Scale)
Brez navzee (Likertova lestvica)
• high levels of certain liver enzymes
• visoke koncentracije nekaterih jetrnih encimov,
Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3-antagonist administration.
Hipokaliemijo in hipomagneziemijo je treba korigirati pred uvedbo antagonistov 5-HT3.
The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%.
Poročali so o naslednjih pogostih ali občasnih neželenih učinkih za palonosetron, o nobenem neželenem učinku niso poročali s pogostnostjo >1 %.
Severe renal impairment reduces renal clearance, however total body clearance in these patients is similar to healthy subjects.
Huda ledvična okvara zmanjša ledvični očistek, vendar je celotni očistek pri teh bolnikih podoben zdravim preiskovancem.
D. CONDITIONS OR RESTRICTIONSWITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
In particular, tell them if you are taking the following medicines:
Še zlasti ju obvestite, če jemljete katero od naslednjih zdravil:
The majority of patients in the study were women (73 %), white (69 %), and naïve to previous chemotherapy (59 %).
Večina bolnikov v študiji je bila ženskega spola (73 %), bele rase (69 %) in predhodno ni prejela kemoterapije (59 %).
In adults, different dose levels are indicated in column title.
Pri odraslih sta različni ravni odmerkov navedeni v glavi stolpcev.
• weakness, feeling tired, fever or flu like symptoms
• šibkost, občutek utrujenosti, vročina ali gripi podobni simptomi,
Aloxi is indicated in paediatric patients 1 month of age and older for:
Zdravilo Aloxi je indicirano pri pediatričnih bolnikih od starosti 1 meseca naprej za:
Children and young people (aged 1 month to 17 years)
Otroci in mladi bolniki (stari 1 mesec do 17 let)
• It is given as an injection into a vein.
• Zdravilo se daje kot injekcija v veno.
Aloxi contains sorbitol and may contain traces of soya This medicine contains 7 mg sorbitol (a type of sugar) in each capsule.
Zdravilo Aloxi vsebuje sorbitol in lahko vsebuje sledi soje To zdravilo vsebuje 7 mg sorbitola (vrsta sladkorja) v eni kapsuli.
Medicines that can affect your heart beat
Zdravila, ki lahko vplivajo na srčni ritem
The safety and efficacy of Aloxi in children have not been established.
Varnost in učinkovitost zdravila Aloxi pri otrocih še nista bili dokazani.
As there are no data concerning palonosetron excretion in breast milk, breast-feeding should be discontinued during therapy.
Ker ni podatkov o izločanju palonosetrona v materino mleko, je potrebno med zdravljenjem s palonosetronom dojenje prekiniti.
Each capsule contains 7 mg sorbitol.
Ena kapsula vsebuje 7 mg sorbitola.
• You will be given the medicine about 30 minutes before the start of chemotherapy.
• Zdravilo boste dobili približno 30 minut pred začetkom kemoterapije.
5 soft capsules.
5 mehkih kapsul
4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
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.
Učinek palonosetrona na interval QTc so ocenili v dvojno slepem, randomiziranem, paralelnem, s placebom in pozitivno (moksifloksacin) kontroliranem preskušanju na odraslih moških in ženskah.
Adjuvant corticosteroids, including dexamethasone, were administered with chemotherapy in 55% of patients.
Adjuvantne kortikosteroide, vključno z deksametazonom, so dajali skupaj s kemoterapijo pri 55 % bolnikov.
• feeling sleepy or trouble sleeping
• občutek zaspanosti ali težave s spanjem,
* Includes the following: burning, induration, discomfort and pain
*Obsega naslednje: občutek pečenja, zatrdlino, neugodje in bolečino.
In post marketing very rare cases (<1/10,000) of hypersensitivity reactions occurred with palonosetron solution for injection for intravenous use.
Po prihodu zdravila na trg je v zelo redkih primerih (<1/10.000) prišlo do preobčutljivostnih reakcij pri uporabi palonosetrona v obliki raztopine za injiciranje za intravensko uporabo.
There are no apparent differences in volume of distribution when expressed as L/kg.
V volumnu porazdelitve, izraženem v l/kg, ni očitnih razlik.
It works by blocking the action of a chemical called serotonin, which can cause you to feel sick or to vomit.
Deluje tako, da blokira delovanje snovi, imenovane serotonin, ki lahko povzroči siljenje na bruhanje ali bruhanje.
Other medicines and Aloxi
Druga zdravila in zdravilo Aloxi
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).
Pri zdravih prostovoljcih so opravili posebno temeljito študijo QT/QTc, da bi pridobili dokončne podatke, ki bi pokazali učinek palonosetrona na interval QT/QTc (glejte poglavje 5.1).
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Atrioventricular block first degree, atrioventricular block second degree
Srčne bolezni atrioventrikularni blok prve stopnje, atrioventrikularni blok druge stopnje
What Aloxi is and what it is used for
Kaj je zdravilo Aloxi in za kaj ga uporabljamo
Palonosetron at the recommended dose is widely distributed in the body with a volume of distribution of approximately 6.9 to 7.9 l/kg.
Palonosetron se v priporočenem odmerku v telesu v veliki meri porazdeli, z volumnom porazdelitve približno 6,9 do 7,9 l/kg.
• decrease or loss of appetite
• zmanjšanje ali izguba teka,
Any unused solution should be discarded.
Vso neuporabljeno raztopino je potrebno zavreči.
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).
Medtem ko je ta študija pokazala, da je pri pediatričnih bolnikih za preprečevanje navzee in bruhanja, ki ju povzroča kemoterapija, potreben večji odmerek palonosetrona kot pri odraslih, se varnostni profil sklada z uveljavljenim profilom pri odraslih (glejte poglavje 4.8).
PHARMACEUTICAL FORM Solution for injection.
FARMACEVTSKA OBLIKA Raztopina za injiciranje.
In female subjects (n=18), the mean AUC was 35 % higher and the mean Cmax was 26 % higher than in male subjects (n=18).
Pri preiskovankah (n=18) je bila povprečna AUC 35 % večja, povprečna Cmax pa 26 % višja kot pri preiskovancih (n=18).
• headache.
• glavobol.
Results for the studies on moderately emetogenic chemotherapy and for the study on highly emetogenic chemotherapy are summarised in the following tables.
Rezultati študij pri zmerno in visoko emetogenih kemoterapijah so povzeti v naslednjih tabelah.
<2 y 2 to <6 y 6 to <12 y
<2 leti 2 do <6 let
The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in CINV clinical studies.
Učinki palonosetrona na krvni tlak, srčno frekvenco in parametre EKG, vključno z intervalom QTc, so bile primerljivi z učinki ondansetrona in dolasetrona v kliničnih študijah CINV.
• Do not use this medicine after the expiry date which is stated on the vial and carton after ‘EXP'.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake 'EXP'.
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%.
V skupinah s palonosetronom 10 µg/kg, 20 µg/kg in ondansetronom je bil delež bolnikov s CR0-24h 54,2 %, 59,4 % in 58,6 %.
d Vss is reported for paediatric cancer patients, whereas Vz is reported for adult cancer patients.
Vss je naveden za pediatrične bolnike z rakom, Vz pa je naveden za odrasle bolnike z rakom.
CYP2D6 inducers and inhibitors
Induktorji in inhibitorji CYP2D6
PK parameters expressed as Geometric Mean (CV) except for T½ which is median.
FK parametri so izraženi kot geometrična sredina (CV), razen T½, ki so mediane vrednosti.
• pain at the site of infusion.
• bolečina na mestu infuzije.
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.
Znaki lahko vključujejo koprivnico, kožni izpuščaj, srbečico, oteženo dihanje ali požiranje, otekla usta, obraz, ustnice, jezik ali žrelo in včasih padec krvnega tlaka).
There is no experience of palonosetron in human pregnancy.
Izkušenj s palonosetronom pri človeških nosečnostih ni.
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.
Čeprav sta končni eliminacijski razpolovni čas in povprečna sistemska izpostavljenost bila povečana pri bolnikih z hudo jetrno okvaro, odmerka ni potrebno zmanjšati.
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.
Po intravenski aplikaciji sledi prvotnemu padcu plazemske koncentracije postopna odstranitev iz telesa s srednjim končnim eliminacijskim razpolovnim časom približno 40 ur.
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.
V predkliničnih študijah so učinke opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Uncommon side effects shown in tests: may affect up to 1 in 100 people
Občasni neželeni učinki, ki se pokažejo pri preiskavah: lahko se pojavijo pri največ 1 od 100 ljudi:
These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to
Te so razvrstili kot pogoste (≥1/100 do <1/10) in občasne (≥1/1.000 do <1/100).
Prevention of Post Operative Nausea and Vomiting (PONV):
Preprečevanje pooperativne navzee in bruhanja (Post Operative Nausea and Vomiting - PONV):
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
The low total body clearance and large volume of distribution resulted in a terminal elimination half-life in plasma of approximately 40 hours.
Zaradi nizkega očistka in visokega volumna porazdelitve je končni eliminacijski razpolovni čas v plazmi približno 40 ur.
0 - 24 hours 24 - 120 hours 0 - 120 hours Complete Control (Complete Response and No More Than Mild Nausea)
0 - 24 ur 24 - 120 ur 0 - 120 ur Popolna kontrola (popoln odgovor in le blaga slabost)
When the dose was increased from10 µg/kg to 20 µg/kg a dose-proportional increase in mean AUC was observed.
Ko so odmerek zvečali z 10 µg/kg na 20 µg/kg, so opazili odmerku sorazmerno zvečanje povprečne AUC.
Polyamide/aluminium/PVC blister containing one or five soft capsules.
Pretisni omot iz poliamida/aluminija/PVC, ki vsebuje eno ali pet mehkih kapsul.
Aloxi pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 µg/kg or 20 µg/kg.
danega zdravila Aloxi so pridobili iz podskupine pediatričnih bolnikov z rakom (n=280), ki so prejeli 10 µg/kg ali 20 µg/kg.
• medicines for infections such as moxifloxacin, erythromycin
• zdravila za okužbe, kot sta moksifloksacin in eritromicin;
The pivotal studies were not designed to assess efficacy of palonosetron in delayed onset nausea and vomiting.
Osrednje študije niso bile zasnovane tako, da ocenjujejo učinkovitost palonosetrona pri odloženem nastopu slabosti in bruhanja.
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.
To vključuje bolnike z osebno ali rodbinsko anamnezo podaljšanja QT, elektrolitskih motenj, kongestivnega popuščanja srca, bradiaritmij, prevodnih motenj in bolnike, ki jemljejo antiaritmike ali druga zdravila, ki povzročajo podaljšanje intervala QT ali elektrolitske motnje.
They are supplied in polyamide/aluminium/PVC blisters containing one or five capsules.
Na voljo so v pretisnih omotih iz poliamida/aluminija/PVC, ki vsebujejo po eno ali pet kapsul.
Available in packs of 1 vial containing 5 ml of solution.
Na voljo je v pakiranjih z 1 vialo, ki vsebuje 5 ml raztopine.
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).
Če se odločite, da zdravila Aloxi (ali drugih podobnih zdravil) ne boste jemali, vas bo zaradi kemoterapije verjetno sililo na bruhanje ali boste bruhali.
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.
Raziskave z dializo niso bile opravljene, vendar zaradi velikega volumna porazdelitve, zdravljenje z dializo najverjetneje ni učinkovito pri prevelikem odmerku zdravila Aloxi.
• 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: znaki lahko vključujejo otekanje ustnic, obraza, jezika ali žrela; oteženo dihanje ali kolaps; srbeč, mehurčkast izpuščaj (koprivnica).
Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Blaga do zmerna ledvična okvara bistveno ne vpliva na farmakokinetične parametre palonosetrona.
(≥1/100 to<1/10)
(≥1/100 do<1/10)
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.
Po intravenski infuziji zdravila Aloxi v enkratnem odmerku 20 µg/kg so bile najvišje koncentracije v plazmi (CT) na koncu 15-minutne infuzije v vseh starostnih skupinah zelo variabilne, so se pa nagibale k temu, da bi bile manjše pri bolnikih, mlajših od 6 let, kot pri starejših pediatričnih bolnikih.
However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolisers of CYP2D6 substrates.
Vendar pa klinični farmakokinetični parametri niso pomembno različni med bolj in manj učinkovitimi substancami, ki metabolizirajo CYP2D6 substrate.
Chi-square test.
c Hi kvadrat test.
• you have an imbalance of certain minerals in your blood which has not been treated - such as potassium and magnesium.
• imate v krvi neravnovesje določenih mineralov, na primer kalija in magnezija, zaradi katerega se niste zdravili.
Significance level at α=0.05.
c Hi kvadrat test. Signifikanca je α = 0,05.
There is no experience of palonosetron in human pregnancy so palonosetron should not be used in pregnant women unless it is considered essential by the physician.
Izkušenj s palonosetronom pri človeških nosečnostih ni, zato naj se palonosetron uporablja pri nosečih ženskah le, če zdravnik meni, da je to nujno potrebno.
b PK parameters expressed as Arithmetic mean (SD)
b FK parametri so izraženi kot aritmetična sredina (SD).
The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 µg/kg or 3 µg/kg (88% vs 84%).
Razmerje bolnikov brez bruhanja v 0-72 urah po operaciji je bilo podobno pri uporabi palonosetrona 1 µg/kg (88 %) in 3 µg/kg (84 %).
Dolasetron 100 milligrams (n= 191)
Dolasetron 100 miligramov (n = 191)
purified water, butylhydroxyanisole, gelatin, sorbitol, titanium dioxide.
prečiščena voda, butilhidroksianizol, želatina, sorbitol, titanov dioksid.
Only limited data from animal studies are available regarding the placental transfer (see section 4.6).
O prehodu skozi placento je na voljo le malo podatkov iz študij na živalih (glejte poglavje 4.6).
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.
V nekliničnih študijah ima palonosetron sposobnost blokiranja ionskih kanalčkov, ki so vpleteni v ventrikularno depolarizacijo in repolarizacijo, in podaljšanja trajanja akcijskega potenciala.
Patients were randomised to either dexamethasone or placebo in addition to their assigned treatment.
Bolnike so randomizirali v skupino, ki je prejemala deksametazon, in skupino, ki je prejemala placebo, poleg tega pa so prejemali tudi za sebe določeno zdravljenje.