FrancophonIA/ELRC3.0 huggingface dataset:
English: • The active substance is palonosetron (as hydrochloride).
Maltese: • Is-sustanza attiva hi palonosetron (bħala hydrochloride).
English: Ondansetron 32 milligrams (n= 221)
Maltese: Ondansetron 32 milligramma (n= 221)
English: • medicines for serious mental health problems such as haloperidol, chlorpromazine, quetiapine,
Maltese: • mediċini għal problemi serji ta' saħħa mentali bħal haloperidol, chlorpromazine, quetiapine,
English: Aloxi contains sodium
Maltese: Aloxi fih sodium
English: Posology Adults
Maltese: Pazjenti Adulti bil
English: <2D barcode carrying the unique identifier included>
Maltese: <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: No Nausea (Likert Scale)
Maltese: L-Ebda Dardir (Skala Likert)
English: Efficacy after palonosetron 10 µg/kg compared to palonosetron 3µg/kg was 54.1% and 37.1% respectively.
Maltese: Leffikaċja wara doża ta' 10 µg/kg ta' palonosetron meta mqabbla ma' doża ta' 3 µg/kg ta' palonosetron kienet 54.1% u 37.1% rispettivament.
English: Each capsule contains 7 mg sorbitol.
Maltese: Kull kapsula fiha 7 mg ta' sorbitol.
English: Ondansetron 32 milligrams (n= 185)
Maltese: Ondansetron 32 milligramma (n= 185)
English: 24 - 120 hours 0 - 120 hours No Nausea (Likert Scale)
Maltese: 24 - 120 siegħa 0 - 120 siegħa L-Ebda Dardir (Skala Likert)
English: • medicines for infections such as moxifloxacin, erythromycin
Maltese: • mediċini għall-infezzjonijiet bħal moxifloxacin, erythromycin
English: • The recommended dose is one capsule (500 micrograms).
Maltese: • Id-doża rrakkomandata hija ta' kapsula waħda (500 mikrogramma).
English: • medicines called SSRIs (‘selective serotonin reuptake inhibitors') - such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
Maltese: • mediċini msejħa SSRIs (‘selective serotonin reuptake inhibitors' - inibituri selettivi talassorbiment mill-ġdid ta' serotonin) - bħal fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
English: Citric acid monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Citric acid monohydrate Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH) Ilma għall-injezzjonijiet
English: ≤1,500 mg/m2 and doxorubicin >25 mg/m2, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered intravenously on Day 1, without dexamethasone.
Maltese: ≤1,500 mg/m2 u doxorubicin >25 mg/m2, palonosetron 250 mikrogramma u 750 mikrogramma, kienu mqabbla ma' ondansetron 32 mg (half-life ta' 4 sigħat) jew dolasetron 100 mg (half-life ta' 7.3 sigħat)
English: 24 - 120 hours 0 - 120 hours a Intent-to-treat cohort.
Maltese: 24 - 120 siegħa 0 - 120 siegħa a Koorti bl-intenzjoni-li-tikkura.
English: System organ class
Maltese: Sistema tal-Klassifika talOrgani
English: System Organ Class
Maltese: Sistema tal-klassifika talorgani
English: 0 - 24 hours
Maltese: 0 - 24 siegħa
English: Aloxi 500 micrograms soft capsules Palonosetron
Maltese: Aloxi 500 mikrogramma kapsuli rotob Palonosetron
English: 0-120 hours
Maltese: 0-120 siegħa
English: Prevention of Post Operative Nausea and Vomiting (PONV):
Maltese: Prevenzjoni ta' Nawsja u Rimettar Wara Operazzjoni (PONV):
English: Other medicines and Aloxi
Maltese: Mediċini oħra u Aloxi
English: • The active substance is palonosetron.
Maltese: • Is-sustanza attiva hi palonosetron.
English: • constipation, diarrhoea.
Maltese: • stitikezza, dijarea.
English: Eye irritation, amblyopia
Maltese: Irritazzjoni fl-għajnejn, ambliopija
English: Common ARs (≥1/100 to<1/10)
Maltese: ARs Komuni (≥1/100 sa <1/10)
English: In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤50 mg/m2, carboplatin, cyclophosphamide
Maltese: F'żewġ studji randomised, double-blind b'total ta' 1,132 pazjent li kienu qed jirċievu kimoterapija moderatament emetoġenika li kienet tinkludi cisplatin ≤50 mg/m2, carboplatin, cyclophosphamide
English: 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%).
Maltese: Il-proporzjon ta' pazjenti mingħajr rimettar matul 0-72 siegħa wara l-operazzjoni kien simili wara l-għoti ta' 1 µg/kg jew 3 µg/kg ta' palonosetron (88% vs 84%).
English: Adjuvant corticosteroids, including dexamethasone, were administered with chemotherapy in 55% of patients.
Maltese: Kortikosterojdi adjuvanti, li jinkludu dexamethasone, ingħataw ma' kimoterapija f'55% tal-pazjenti.
English: Also contains mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.
Maltese: TA' EĊĊIPJENTI Fih ukoll mannitol, disodium edetate, sodium citrate, citric acid monohydrate, ilma għall injezzjonijiet, sodium hydroxide u hydrochloric acid.
English: Palonosetron is not mutagenic.
Maltese: Palonosetron mhuwiex mutaġeniku.
English: Please see section 4.2 for information on paediatric use.
Maltese: Jekk jogħġbok ara sezzjoni 4.2 għal informazzjoni dwar l-użu fit-tfal.
English: Doses of up to 6 mg have been used in adult clinical studies.
Maltese: Dożi sa 6 mg intużaw fi studji kliniċi fuq l-adulti.
English: “EXP”.
Maltese: ‘JIS'.
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.
Maltese: Doża waħda ta' 250 mcg, 500 mcg, jew 750 mcg ta' kapsuli orali ta' palonosetron li ngħataw siegħa qabel kimoterapija moderatament emetoġenika, tqabblet ma' doża waħda ta' 250 mcg ta' Aloxi għal ġol-vina mogħti 30 minuta qabel il-kimoterapija.
English: Atrioventricular block first degree, atrioventricular block second degree
Maltese: Imblokk atrijoventrikulari tal-ewwel grad, imblokk atrijoventrikulari tat-tieni grad
English: Dexamethasone was administered prophylactically before chemotherapy in 67 % of patients.
Maltese: Dexamethasone ngħata b'mod profilattiku qabel kimoterapija f'67 % tal-pazjenti.
English: However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolisers of CYP2D6 substrates.
Maltese: Madankollu, il-parametri farmakokinetiċi kliniċi mhumiex differenti b'mod sinifikanti bejn metabolisers batuti u estensivi tas-sottostrati ta' CYP2D6.
English: A lower bound greater than -15 % demonstrates non-inferiority between Aloxi and comparator.
Maltese: Lower bound ikbar minn -15 % turi non-inferjorità bejn Aloxi u l-komparatur.
English: Elimination Following administration of a single oral 750 micrograms dose of [14C]-palonosetron to six healthy subjects, 85 % to 93 % of the total radioactivity was excreted in urine, and 5 % to 8 % was eliminated in feces.
Maltese: Eliminazzjoni Wara l-għoti ta' doża waħda orali ta' 750 mikrogramma ta' [14C]-palonosetron lil sitt individwi b'saħħithom, 85 % sa 93 % tar-radjuattività totali tneħħiet fl-awrina, u 5 % sa 8 % tneħħiet fl-ippurgar.
English: Aloxi contains sorbitol.
Maltese: Aloxi fih is-sorbitol.
English: • You will be given the medicine about 30 minutes before the start of chemotherapy.
Maltese: • Inti se tingħata l-mediċina madwar 30 minuta qabel il-bidu tal-kimoterapija.
English: 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.
Maltese: L-effett ta' palonosetron fuq l-intervall tal-QTc kien evalwat fi prova double blind, randomised, parallela, bil-plaċebo u positive (moxifloxacin) controlled f'irġiel u nisa adulti.
English: In adults, different dose levels are indicated in column title.
Maltese: Fl-adulti, livelli differenti ta' doża huma indikati fl-isem tal kolonna.
English: Complete Response was not formally evaluated for the repeat cycle application.
Maltese: Ir-Rispons Sħiħ ma kienx evalwat formalment għall applikazzjoni ta' ċikli ripetuti.
English: 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).
Maltese: Studju speċifiku u ddettaljat dwar il-QT/QTc sar f'voluntiera b'saħħithom għal dejta definittiva li turi l-effett ta' palonosetron fuq QT/QTc (ara sezzjoni 5.1).
English: Do not take Aloxi if:
Maltese: Tiħux Aloxi jekk:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2005
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Marzu, 2005
English: Aloxi pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 µg/kg or 20 µg/kg.
Maltese: Dejta farmakokinetika dwar dożi i.v. waħidhom ta' Aloxi nkisbet minn sottosett ta' pazjenti pedjatriċi bil-kanċer (n=280) li rċivew 10 µg/kg jew 20 µg/kg.
English: When the dose was increased from10 µg/kg to 20 µg/kg a dose-proportional increase in mean AUC was observed.
Maltese: Meta d-doża żdiedet minn 10 µg/kg għal 20 µg/kg, ġiet osservata żieda proporzjonali għad-doża fil-medja tal-AUC.
English: Aloxi is indicated in adults for:
Maltese: Aloxi hu indikat fl-adulti għal:
English: The total body clearance (L/h/kg) in patients 12 to 17 years old was similar to that in healthy adults.
Maltese: It-tneħħija totali mill-ġisem (L/h/kg) f'pazjenti li kellhom minn 12 sa 17-il sena kienet simili għal dik f'adulti b'saħħithom.
English: 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.
Maltese: Minħabba l-marġni ta' noninferjorità speċifikat minn qabel ta' -10%, l-intervall ta' kunfidenza għal noninferjorità statistika Mantel-Haenszel aġġustata għall-istratum għad-differenza fil-punt aħħari primarja, ir-rispons sħiħ (CR), kien ta' [-10.5, 1.7%], u għalhekk in-noninferjorità ma ntwerietx.
English: 0 - 120 hours
Maltese: 0 - 120 siegħa
English: Currently available data are described in section 5.1 and section 5.2, but no recommendation on posology can be made.
Maltese: Dejta disponibbli hi deskritta fis sezzjoni 5.1 u 5.2 imma l-ebda rakkomandazzjoni fuq il-pożoloġija ma tista' tingħata.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5HT3) antagonists, ATC code: A04AA05
Maltese: Antiemetiċi u kontra d-dardir, antagonisti ta' serotonin (5HT3), Kodiċi ATC:
English: a Intent-to-treat cohort.
Maltese: a Koorti bl-intenzjoni-li-tikkura.
English: <2 y 2 to <6 y 6 to <12 y
Maltese: 6 sa <12-il sena
English: 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.
Maltese: Billi lintervall ta' kunfidenza ta' 97.5% (test ta' Mantel-Haenszel aġġustat għall-istratum) tad-differenza f'CR0-24 siegħa bejn palonosetron 20 µg/kg u ondansetron kien ta' [-11.7%, 12.4%], id-doża ta'
English: 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
Maltese: Fi studji kliniċi fl-adulti b'doża ta' 250 mikrogramma (total ta' 633 pazjent), l-iktar reazzjonijiet avversi li kienu osservati b'mod frekwenti, li kienu mill-inqas possibbilment relatati ma' Aloxi, kienu wġigħ ta' ras (9 %) u stitikezza (5 %).
English: Dermatitis allergic, pruritic rash
Maltese: Dermatite allerġika, raxx bil-ħakk
English: In female subjects (n=18), the mean AUC was 35 % higher and the mean Cmax was 26 % higher than in male subjects (n=18).
Maltese: Fin nisa, (n=18), il-medja tal-AUC kienet 35 % ogħla u l-medja tas-Cmax kienet 26 % ogħla milli fl-irġiel (n=18).
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeltriċi u tat-tessuti konnettivi
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.
Maltese: F'36 raġel u mara b'saħħithom li ngħataw doża waħda orali ta' kapsuli palonosetron 500 mikrogramma, il-konċentrazzjoni massima ta' palonosetron fil-plażma (Cmax) kienet ta' 0.81 ± 0.17 ng/ml (medja ± SD) u l-ħin sal-konċentrazzjoni massima (Tmax) kien ta' 5.1 ± 1.7 sigħat.
English: • The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.
Maltese: • Is-sustanzi l-oħra huma mannitol, disodium edetate, sodium citrate, citric acid monohydrate, u ilma għall-injezzjonijiet, sodium hydroxide u hydrochloric acid.
English: 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.
Maltese: salvataġġ) matul l-ewwel 24 siegħa wara l-operazzjoni, inkiseb fi 78.2% tal-pazjenti fil-grupp ta' palonosetron u 82.7% fil-grupp ta' ondansetron.
English: Aloxi 250 micrograms (n= 189)
Maltese: Aloxi 250 mikrogramma (n= 189)
English: Uncommon ARs (≥1/1,000 to <1/100)
Maltese: ARs Mhux Komuni (≥1/1,000 sa <1/100)
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose, m'għandhomx jieħdu dan il-prodott mediċinali.
English: 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.
Maltese: Għalkemm l-effikaċja komparattiva ta' palonosetron f'ċikli multipli ma ntwerietx fi provi kliniċi kkontrollati, 217-il pazjent ġew irreġistrati fi studju multiċentriku u open label dwar is-sigurtà, u kienu kkurati b'kapsuli palonosetron ta' 750 mikrogramma għal sa 4 ċikli ta' kimoterapija f'total ta' 654 ċiklu ta' kimoterapija.
English: The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours.
Maltese: attività ta' mediċini kontra r-rimettar (antiemetiċi) kienet osservata matul perjodu ta' 0-24 siegħa, 24-120 siegħa u 0-120 siegħa.
English: 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.
Maltese: Għalkemm l-effikaċja komparattiva ta' palonosetron f'ċikli multipli ma ntwerietx fi studji kliniċi kkontrollati, 875 pazjent rreġistrati fi tliet provi ta' fażi 3, komplew fi studju open label dwar is-sigurtà u kienu kkurati b'750 mikrogramma ta' palonosetron sa 9 ċikli addizzjonali ta' kimoterapija.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists.
Maltese: Antiemetiċi u kontra d-dardir, antagonisti ta' serotonin (5HT3).
English: 0-24 hours
Maltese: 0-24 siegħa
English: Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Maltese: Hi rakkomandata osservazzjoni adattata ta' pazjenti għal sintomi li jixbhu lis-sindrome ta' serotonin.
English: 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).
Maltese: Kien hemm rapporti tas-sindrome ta' serotonin bl-użu ta' antagonisti ta' 5-HT3 jew waħdu jew flimkien ma' mediċini serotonerġiċi oħrajn (li jinkludu inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin (SSRI) u inibituri tal-assorbiment mill-ġdid ta' serotonin noradrenaline (SNRIs).
English: 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).
Maltese: Fil-provi kliniċi pedjatriċi għall-prevenzjoni ta' nawsja u rimettar ikkaġunati minn kimoterapija moderatament emetoġenika jew emetoġenika ħafna, 402 pazjenti rċivew doża waħda ta' palonosetron (3, 10 jew 20 mcg/kg).
English: Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron Aloxi 250 micrograms (n= 185)
Maltese: Tabella 1: Proporzjon ta' pazjentia li rrispondew skont il-grupp ta' kura u l-fażi Aloxi Orali 500 mikrogramma (n=160)
English: Cough, dyspnoea, epistaxis
Maltese: Kif għandek tuża Aloxi
English: Aloxi 250 micrograms solution for injection Palonosetron
Maltese: Aloxi 250 mikrogramma soluzzjoni għall-injezzjoni Palonosetron
English: 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).
Maltese: u inibituri (li jinkludu amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline jew terbinafine).
English: 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.
Maltese: Dawn il-kondizzjonijiet jinkludu pazjenti bi storja medika personali jew tal-familja ta' titwil tal-QT, anormalitajiet fl-elettroliti, insuffiċjenza konġestiva tal-qalb, bradiarritmiji, disturbi tal-konduzzjoni u f'pazjenti li jkunu qed jieħdu mediċini kontra l-arritmiji jew prodotti mediċinali oħrajn li jwasslu għal titwil tal-QT jew anormalitajiet fl-elettroliti.
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.
Maltese: Is-sigurtà u l-effikaċja ta' Palonosetron mogħti ġol-vina f'dożi waħidhom ta' 1 µg/kg u 3 µg/kg ġew ipparagunati l-ewwel studju kliniku li sar fuq 150 pazjent f'dawn il-gruppi ta' età, >28 jum sa 23 xahar (7 pazjenti), minn sentejn sa 11-il sena (96 pazjent), u minn 12 sa 16-il sena (47 pazjent), li kienet saritilhom operazzjoni mhux obbligatorja.
English: After a single intravenous bolus administration in healthy subjects the total body clearance of palonosetron was 173 ± 73 ml/min and renal clearance was 53 ± 29 ml/min.
Maltese: Wara l-għoti ta' doża bolus waħda ġol-vina f'persuni b'saħħithom, it-tneħħija totali ta' palonosetron mill-ġisem kienet ta' 173 ± 73 ml/min u t-tneħħija mill-kliewi kienet ta' 53 ± 29 ml/min.
English: • high levels of the pigment ‘bilirubin' (a marker of liver problems) in the blood
Maltese: • livelli għolja tal-pigment bilirubin fid-demm (jista' jindika problemi tal-fwied)
English: In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
Maltese: Fi studji ta' qabel l-użu kliniku, palonosetron ma fixkelx attività kontra t-tumur tal-ħames sustanzi kemoterapewtiċi li kienu ttestjati (cisplatin, cyclophosphamide, cytarabine, doxorubicin u mitomycin C).
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,
Maltese: Fi studju randomised, double-blind b'total ta' 667 pazjent li kienu qed jingħataw kimoterapija emetoġenika qawwija li kienet tinkludi cisplatin ≥ 60 mg/m2, cyclophosphamide > 1,500 mg/m2 u dacarbazine, palonosetron 250 mikrogramma u 750 mikrogramma kienu mqabbla ma' ondansetron
English: A total of 670 paediatric surgical patients participated, age 30 days to 16.9 years.
Maltese: pazjent pedjatriku kirurġiku pparteċipaw, u kellhom minn 30 jum sa 16.9 snin.
English: In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Aloxi.
Maltese: Fl-istudji kliniċi, ir-reazzjonijiet avversi (adverse reactions - ARs) li ġejjin kienu osservati bħala possibbilment jew probabbilment relatati ma' Aloxi.
English: 24-120 hours
Maltese: 24-120 siegħa
English: The majority of patients in the study were women (73 %), white (69 %), and naïve to previous chemotherapy (59 %).
Maltese: Il-maġġoranza tal-pazjenti fl istudju kienu nisa (73 %), bojod (69 %), u li qatt ma kienu rċivew kimoterapija fil-passat (59 %).
English: 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.
Maltese: Il-medjan talhalf-life kien ta' 29.5 sigħat fil-gruppi ta' età globali u varja minn madwar 20 sa 30 siegħa fil-gruppi kollha ta' età l-wara l-għoti ta' 20 µg/kg.
English: BATCH NUMBER
Maltese: Kanċer b
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.
Maltese: Is-sigurtà u l-effikaċja ta' Palonosetron mogħti fil-vina f'dożi waħidhom ta' 3 µg/kg u 10 µg/kg ġew investigati fl-ewwel studju kliniku li sar fuq 72 pazjent f'dawn il-gruppi ta' età, >28 jum sa 23 xahar (12-il pazjent), minn sentejn sa 11-il sena (31 pazjent), u minn 12 sa 17-il sena (29 pazjent), li kienu qed jingħataw kimoterapija li kienet emetoġenika ħafna jew moderatament emetoġenika.
English: • 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).
Maltese: • mediċini msejħa SNRIs (‘serotonin noradrenaline reuptake inhibitors' - inibituri tal-assorbiment mill-ġdid ta' noradrenaline ta' serotonin) bħal venlafaxine, duloxetine (jistgħu jwasslu għall iżvilupp tas-sindrome ta' serotonin u għandhom jintużaw b'kawtela).
English: 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.
Maltese: Eliminazzjoni Wara doża waħda ta' 10 mikrogrammi/kg ta' [14C]-palonosetron fil-vina, madwar 80 % tad-doża kienet eliminata fl-awrina bħala sustanza attiva mhux mibdula fi żmien 144 siegħa, li jirrappreżenta madwar 40 % tad-doża mogħtija.
English: A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 µg/kg (maximum 0.75 mg), palonosetron
Maltese: Total ta' 493 pazjenti pedjatriċi, li kellhom minn 64 jum sa 16.9 snin, li kienu qed jirċievu kimoterapija moderatament emetoġenika (69.2%) jew emetoġenika ħafna (30.