FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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.
Slovenian: • preprečevanje akutne slabosti in bruhanja, povezanih z visoko emetogenimi kemoterapijami pri zdravljenju raka in preprečevanje slabosti in bruhanja, povezanih z zmerno emetogenimi kemoterapijami pri zdravljenju raka.
English: Dermatitis allergic, pruritus, skin disorder, urticaria
Slovenian: Bolezni kože in podkožja alergijski dermatitis, pruritus, kožna bolezen, koprivnica
English: 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.
Slovenian: Veliki odmerki palonosetrona (vsak odmerek 15-krat večji od človeškega terapevtskega odmerka), aplicirani dnevno v obdobju dveh let, so povzročili zvečano pojavljanje jetrnih tumorjev, endokrinih neoplazem (v ščitnici, hipofizi, trebušni slinavki in sredici nadledvičnice)
English: Aloxi 250 micrograms (n= 189)
Slovenian: Aloxi 250 mikrogramov (n = 189)
English: Age does not affect the pharmacokinetics of palonosetron.
Slovenian: Starost ne vpliva na farmakokinetiko palonosetrona.
English: Electrocardiogram QT prolonged conduction disorder, sinus tachycardia
Slovenian: Srčne bolezni podaljšanje intervala QT v elektrokardiogramu prevodna motnja, sinusna tahikardija
English: 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.
Slovenian: 500 mikrogramov, je bil končni razpolovni čas odstranjevanja palonosetrona iz telesa (t½) 37 ± 12 ur (povprečje ± SD), pri bolnikih z rakom pa 48 ± 19 ur.
English: 0-24 hours
Slovenian: 0-24 ur
English: • fever
Slovenian: • vročina,
English: Aloxi contains sodium
Slovenian: Zdravilo Aloxi vsebuje natrij
English: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,
Slovenian: • preprečevanje akutne slabosti in bruhanja, povezanih z visoko emetogenimi kemoterapijami pri zdravljenju raka,
English: Gender does not affect the pharmacokinetics of palonosetron.
Slovenian: Spol bolnika ne vpliva na farmakokinetiko palonosetrona.
English: It is not recommended you are given Aloxi in the days following chemotherapy unless you are going to have another chemotherapy cycle.
Slovenian: Dajanja zdravila Aloxi v dnevih po kemoterapiji se ne priporoča, razen če boste imeli še en cikel kemoterapije.
English: Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Slovenian: Srčne bolezni tahikardija, bradikardija, prezgodnji utripi, miokardna ishemija, sinusna tahikardija, sinusna aritmija, nadprekatni prezgodnji utripi
English: A lower bound greater than -15 % demonstrates non-inferiority between Aloxi and comparator.
Slovenian: Spodnja meja višja od -15 % dokazuje nemanjvrednost zdravila Aloxi proti primerjanemu zdravilu.
English: p-value c
Slovenian: p-vrednostc
English: Hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects.
Slovenian: Jetrna okvara v primerjavi z zdravimi preiskovanci ne vpliva pomembno na celotni očistek palonosetrona.
English: • The active substance is palonosetron.
Slovenian: • Učinkovina je palonosetron.
English: • abnormal heart rate
Slovenian: • nenormalen srčni utrip,
English: The safety and efficacy of Palonosetron i.v at single doses of 1µg/kg and 3µg/kg was compared in the first clinical study in 150 patients in the following age groups, >28 days to 23 months (7 patients), 2 to 11 years (96 patients), and 12 to 16 years of age (47 patients) undergoing elective surgery.
Slovenian: pri enojnem odmerku 1 µg/kg in 3 µg/kg so primerjali v prvi klinični študiji s 150 bolniki v naslednjih starostnih skupinah: > 28 dni do 23 mesecev (7 bolnikov), 2 do 11 let (96 bolnikov) in 12 do 16 let (47 bolnikov) z elektivno operacijo.
English: Tell your doctor straight away if you notice any of the serious side effects listed above.
Slovenian: Takoj obvestite zdravnika, če opazite katerega koli od zgoraj navedenih resnih neželenih učinkov.
English: See package leaflet for further information.
Slovenian: Za nadaljnje podatke glejte navodilo za uporabo.
English: 0 - 120 hours
Slovenian: 0 - 120 ur
English: In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Aloxi.
Slovenian: V kliničnih študijah so opažali naslednje neželene učinke, ki jih je mogoče pripisati jemanju zdravila Aloxi.
English: 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.
Slovenian: Predklinične študije kažejo na to, da palonosetron lahko blokira ionske kanalčke udeležene pri ventrikularni de in repolarizaciji, ter s tem podaljša trajanje akcijskega potenciala le v zelo visokih koncentracijah.
English: The safety and efficacy of Palonosetron i.v at single doses of 3 µg/kg and 10 µg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Slovenian: pri enojnem odmerku 3 µg/kg in 10 µg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: >28 dni do 23 mesecev (12 bolnikov), 2 do 11 let (31 bolnikov) in 12 do 17 let (29 bolnikov), ki so prejemali zelo ali zmerno emetogeno kemoterapijo.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija
English: Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock
Slovenian: anafilaktične/anafil aktoidne reakcije in šok
English: What you need to know before you are given Aloxi
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Aloxi
English: 24-120 hours
Slovenian: 24-120 ur
English: Hypotension, hypertension, vein discolouration, vein distended
Slovenian: Žilne bolezni hipotenzija, hipertenzija, vensko razbarvanje, razširitev ven
English: However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval.
Slovenian: Toda, kot pri drugih antagonistih 5-HT3 je potrebna previdnost pri uporabi palonosetrona pri bolnikih,
English: 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.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete katera koli zdravila, ki vplivajo na vaš srčni ritem, saj bi lahko ob sočasnem jemanju z zdravilom Aloxi povzročila težave s srčnim ritmom.
English: Aloxi 500 micrograms soft capsules are plain, light beige, opaque, round to oval soft capsules, filled with a clear yellowish solution.
Slovenian: Izgled zdravila Aloxi in vsebina pakiranja Aloxi 500 mikrogramov mehke kapsule so neoznačene, svetlo sivkastorjave, neprozorne, okrogle do ovalne mehke kapsule, napolnjene z bistro rumenkasto tekočino.
English: The non-inferiority margin was
Slovenian: Meja ne-manjvrednosti je bila 15 %.
English: Very rare ARs°
Slovenian: zelo redki neželeni učinki°
English: Each vial of 5 ml of solution contains 250 micrograms of palonosetron.
Slovenian: Ena viala, v kateri je 5 ml raztopine, vsebuje 250 mikrogramov palonosetrona.
English: 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.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete katera koli zdravila, ki vplivajo na vaš srčni ritem, saj bi lahko ob sočasnem jemanju z zdravilom Aloxi povzročila težave s srčnim ritmom.
English: Aloxi may contain traces of lecithin which comes from soya.
Slovenian: Zdravilo Aloxi lahko vsebuje sledove lecitina iz soje.
English: NAME OF THE MEDICINAL PRODUCT Aloxi 500 micrograms soft capsules
Slovenian: IME ZDRAVILA Aloxi 500 mikrogramov mehke kapsule
English: Tell your doctor if you notice any of the side effects listed above.
Slovenian: Obvestite zdravnika, če opazite katerega koli od zgoraj navedenih neželenih učinkov.
English: How to take Aloxi
Slovenian: Kako jemati zdravilo Aloxi
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Aloxi Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: • impaired vision or eye irritation
Slovenian: • motnje vida ali draženje oči,
English: 0-120 hours
Slovenian: 0-120 ur
English: Each ml of solution contains 50 micrograms palonosetron.
Slovenian: En ml raztopine vsebuje 50 mikrogramov palonosetrona.
English: 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.
Slovenian: Če za vas velja kar koli od zgoraj navedenega (ali pa niste prepričani), se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Aloxi, saj bi lahko ta zdravila ob sočasnem jemanju z zdravilom Aloxi povzročila težave s srčnim ritmom.
English: 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.
Slovenian: Če za vas velja kar koli od zgoraj navedenega (ali pa niste prepričani), se posvetujte z zdravnikom ali medicinsko sestro, preden vzamete zdravilo Aloxi, saj bi lahko ta zdravila ob sočasnem jemanju z zdravilom Aloxi povzročila težave s srčnim ritmom.
English: 24 - 120 hours
Slovenian: 24 - 120 ur
English: Palonosetron was non-inferior versus the comparators in the acute phase of emesis both in moderately and highly emetogenic setting.
Slovenian: Palonosetron je bil v akutni fazi bruhanja enako učinkovit, tako pri zmerno kot visoko emetogeni kemoterapiji, kot primerjana zdravila.
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: lahko se pojavijo pri največ 1 od 10 ljudi:
English: Talk to your doctor or nurse before you are given Aloxi if:
Slovenian: Pred začetkom prejemanja zdravila Aloxi se posvetujte z zdravnikom ali medicinsko sestro, če:
English: Urinary retention, glycosuria
Slovenian: Bolezni sečil retenca urina, glikozurija
English: No dosage adjustment is necessary based on gender.
Slovenian: Odmerka glede na spol bolnika ni potrebno prilagajati.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aloxi 250 micrograms solution for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Aloxi 250 mikrogramov raztopina za injiciranje palonosetron
English: A lower bound greater that -15 % demonstrates noninferiority between Aloxi oral and comparator Aloxi intravenous c
Slovenian: Spodnja meja, višja od -15 %, dokazuje ne manjvrednost peroralnega zdravila Aloxi proti primerjanemu intravenskemu zdravilu Aloxi.
English: • the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Slovenian: • preprečevanje slabosti in bruhanja, povezanih z zmerno emetogenimi kemoterapijami pri zdravljenju raka.
English: t½, hours
Slovenian: AUC0-∞, h·µg/l t½, ure
English: Single-dose i.v.
Slovenian: Farmakokinetične podatke o enkratnem odmerku i.v.
English: Anxiety, euphoric mood
Slovenian: Psihiatrične motnje anksioznost, evforija
English: No dosage adjustment is necessary in elderly patients.
Slovenian: Pri starejših bolnikih prilagajanje odmerka ni potrebno.
English: Aloxi contains the active substance palonosetron.
Slovenian: Zdravilo Aloxi vsebuje učinkovino palonosetron.
English: Palonosetron does not inhibit or induce cytochrome P450 isoenzymes at clinically relevant concentrations.
Slovenian: Palonosetron pri klinično pomembnih koncentracijah ne inhibira ali inducira citokrom P450 izoencimov.
English: Plain, light beige, opaque, round to oval, soft gelatine capsules, filled with a clear yellowish solution.
Slovenian: Neoznačene, svetlo sivkastorjave, neprozorne, okrogle do ovalne, mehke želatinske kapsule,
English: NAME OF THE MARKETING AUTHORISATION HOLDER Helsinn
Slovenian: IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Helsinn
English: No dose adjustment is necessary for the elderly.
Slovenian: Starejši ljudje Odmerjanja pri starejših ni potrebno prilagoditi.
English: You may feel dizzy or tired after taking this medicine.
Slovenian: Ko vzamete to zdravilo, se boste morda počutili omotične ali utrujene.
English: Aloxi Intravenous 250 micrograms (n=162)
Slovenian: Intravensko zdravilo Aloxi 250 mikrogramov (n=162)
English: Blood bilirubin increased
Slovenian: Preiskave zvišan bilirubin v krvi
English: Aloxi 250 micrograms solution for injection Palonosetron
Slovenian: Navodilo za uporabo Aloxi 250 mikrogramov raztopina za injiciranje palonosetron
English: 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).
Slovenian: Po sočasni uporabi antagonistov serotoninskih 5-HT3 receptorjev in drugih serotoninergičnih zdravil (vključno z SSRI in SNRI) so poročali o serotoninskem sindromu.
English: Glycerol Monocaprylocaproate (type I) Polyglycerol oleate
Slovenian: Vsebina kapsule: glicerol monokaprilat monokaprinat (tip I), poliglicerol oleat, glicerol,
English: Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride).
Slovenian: Ena viala (5 mililitrov raztopine) vsebuje 250 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
English: 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.
Slovenian: Študija ni pokazala nikakršnega učinka na trajanje intervala QT/QTc ali na kakšen drug EKG interval v odmerkih do 2,25 mg.
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: lahko se pojavijo pri največ 1 od 100 ljudi:
English: 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,
Slovenian: V randomizirani, dvojno slepi študiji, v kateri je sodelovalo 667 bolnikov, ki so prejemali visoko emetogeno kemoterapijo, ki je vključevala cisplatin >60 mg/m2, ciklofosfamid >1500 mg/m2 in dakarbazin, so primerjali odmerka 250 mikrogramov in 750 mikrogramov palonosetrona v primerjavi z ondansetronom 32 mg, danim prvi dan kemoterapije.
English: NAME OF THE MEDICINAL PRODUCT Aloxi 250 micrograms solution for injection Palonosetron (as hydrochloride)
Slovenian: Aloxi 250 mikrogramov raztopina za injiciranje palonosetron (v obliki palonosetronijevega klorida)
English: Capsule content:
Slovenian: Pomožne snovi:
English: Eye irritation, amblyopia
Slovenian: Očesne bolezni draženje oči, ambliopija
English: Each capsule contains 500 micrograms palonosetron (as hydrochloride).
Slovenian: Ena kapsula vsebuje 500 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
English: Helsinn Birex Pharmaceuticals Limited.
Slovenian: Helsinn Birex Pharmaceuticals Limited Damastown
English: Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Slovenian: Glede na in vitro raziskave, palonosetron v klinično pomembnih koncentracijah ne inhibira ali inducira izoencima citokrom P450.
English: Disodium edetate
Slovenian: PRETISNI OMOT
English: • Single use only, any unused solution should be disposed of.
Slovenian: • Za enkratno uporabo, vso preostalo raztopino zavrzite.
English: 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.
Slovenian: Pri 36 zdravih osebah obeh spolov, ki so prejele enkraten peroralni odmerek palonosetrona v obliki 500-mikrogramskih kapsul, je bila najvišja koncentracija palonosetrona v plazmi (Cmax) 0,81 ±
English: What Aloxi contains
Slovenian: Kaj vsebuje zdravilo Aloxi
English: a Intent-to-treat cohort.
Slovenian: Kohorta z namenom zdravljenja.
English: • constipation, diarrhoea.
Slovenian: • zaprtje, driska.
English: ° From post-marketing experience
Slovenian: °Iz izkušenj po prihodu zdravila na trg.
English: 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.
Slovenian: Po enkratnem odmerku približno 0,75 mg intravenskega palonosetrona je bil celotni telesni očistek palonosetrona pri zdravih preiskovancih 160
English: 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.
Slovenian: V multicentrični, randomizirani, dvojno slepi klinični študiji z aktivnimi kontrolami, v kateri je sodelovalo 635 bolnikov, ki naj bi dobili zmerno emetogeno kemoterapijo raka, so primerjali enkraten odmerek peroralnih kapsul palonosetrona 250 mikrogramov, 500 mikrogramov in 750 mikrogramov, eno uro pred zmerno emetogeno kemoterapijo, z enkratnim odmerkom 250 mikrogramov zdravila Aloxi, danega intravensko 30 minut pred kemoterapijo.
English: Cardiac disorders
Slovenian: Kortikosteroidi
English: Other side effects Tell your doctor if you notice any of the following side effects:
Slovenian: Obvestite zdravnika, če opazite katerega koli od naslednjih neželenih učinkov:
English: Sodium citrate
Slovenian: OVOJNINAH VIALA
English: Two cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 750 micrograms.
Slovenian: V povezavi z jemanjem palonosetrona 750 mikrogramov so poročali o dveh primerih s konstipacijo in zaprtjem z blatom, ki sta potrebovala hospitalizacijo.
English: Chemotherapeutic agents
Slovenian: Kemoterapevtiki
English: Nervous system disorders Headache Dizziness
Slovenian: Bolezni živčevja glavobol omotica, diskinezija
English: NAME OF THE MEDICINAL PRODUCT Aloxi 250 micrograms solution for injection.
Slovenian: IME ZDRAVILA Aloxi 250 mikrogramov raztopina za injiciranje
English: Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, flatulence
Slovenian: Bolezni prebavil zaprtje driska dispepsija, bolečine v trebuhu, bolečine v zgornjem delu trebuha, suha usta, napihnjenost
English: Purified water
Slovenian: • oteženo odvajanje vode,
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RETRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Injection site reaction*
Slovenian: reakcija na mestu infuzije,
English: Table 1: Percentage of patients a responding by treatment group and phase in the Moderately
Slovenian: Preglednica 1: Odstotek bolnikova, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in stopnjo zdravljenja v študiji zmerno emetogene kemoterapije v primerjavi z ondansetronom
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/306/003
English: Very rare: may affect up to 1 in 10,000 people • Burning, pain or redness at the injection site
Slovenian: Pogosti: lahko se pojavijo pri največ 1 od 10 ljudi: • glavobol.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/306/002
English: You may feel dizzy or tired after being given this medicine.
Slovenian: Ko dobite to zdravilo, se boste morda počutili omotične ali utrujene.
English: Paediatric patients
Slovenian: Pediatrični bolniki z rakoma
English: No dose adjustment is necessary for patients with impaired hepatic function.
Slovenian: Jetrna okvara Pri bolnikih z jetrno okvaro odmerjanja ni potrebno prilagajati.
English: No dosage adjustment is necessary in patients with renal insufficiency.
Slovenian: Pri bolnikih z ledvično insuficienco ni potrebno prilagajati odmerka.
English: 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 %.
Slovenian: bolnikih z rakom mod koncentracija v plazmi od 1. do 5. dne povprečno (± SD) zrasla za 42 ± 34 %.
English: PC:
Slovenian: vrednost pc
English: • shortness of breath
Slovenian: • slabost s siljenjem na bruhanje,
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom.
English: 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)
Slovenian: Preglednica 3: Odstotek bolnikova, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in stopnjo zdravljenja v študiji visoko emetogene kemoterapije v primerjavi z ondansetronom
English: No dose adjustment is necessary for patients with impaired renal function.
Slovenian: Pri bolnikih z ledvično okvaro odmerjanja ni potrebno prilagajati.
English: Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or think you might be.
Slovenian: Če ste noseči ali menite, da bi lahko bili noseči, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
English: Ask your doctor or nurse for advice before being given this medicine if you are pregnant or think you might be.
Slovenian: Če ste noseči ali menite, da bi lahko bili noseči, se posvetujte z zdravnikom ali medicinsko sestro, preden dobite to zdravilo.
English: Palonosetron
Slovenian: Odmerjanje
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Slovenian: En ml raztopine vsebuje 50 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
English: Package leaflet: Information for the patient
Slovenian: Shranjevanje zdravila Aloxi Vsebina pakiranja in dodatne informacije
English: Children and young people Common: may affect up to 1 in 10 people
Slovenian: Zelo redki: lahko se pojavijo pri največ 1 od 10.000 ljudi:
English: • motion sickness
Slovenian: • omotica,
English: Arthralgia
Slovenian: Plodnost
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja alergični dermatitis, srbeč izpuščaj
English: The safety and efficacy of Palonosetron i.v at single doses of 3µg/kg and 10µg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Slovenian: pri enojnem odmerku 3 µg/kg in 10 µg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: >28 dni do 23 mesecev
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 micrograms palonosetron (as hydrochloride).
Slovenian: Ena kapsula vsebuje 500 mikrogramov palonosetrona (v obliki klorida).
English: For how long?
Slovenian: Kako dolgo?
English: 82.7% of these patients completed the study.
Slovenian: 82,7 % teh bolnikov je dokončalo študijo.
English: It has not been determined whether they respond differently than younger patients.
Slovenian: Ni bilo ugotovljeno, ali se odzivajo drugače kot mlajši bolniki.