FrancophonIA/ELRC3.0 huggingface dataset:
English: • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Maltese: • Fsada qawwija patoloġika bħal f'ulċera peptika jew emorraġija fil-kranju.
English: Clopidogrel Apotex is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: Clopidogrel Apotex jittieħed mill-adulti biex inaqqas ir-riskju li ċapep tad-demm (trombi) jifformaw flarterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista' jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, carbamazepine, a medicine to treat some forms of epilepsy, moclobemide, medicine to treat depression.
Maltese: - fluconazole jew voriconazole, mediċini li jittrattaw infezzjonijiet tal-fungu, - efavirenz, mediċina għat-trattament tal-infezzjonijiet mill-HIV (virus tal-immunodefiċjenza umana), - carbamazepine, mediċina għat-trattament ta' xi forom tal-epilessija, - moclobemide, mediċina għat-trattament tad-dipressjoni, - repaglinide, mediċina għat-trattament tad-dijabete, - paclitaxel, mediċina għat-trattament tal-kanċer.
English: The patient population included 41.8 % women.
Maltese: Mill-pazjenti kollha, 41.8% kienu nisa.
English: Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.
Maltese: Laggregazzjoni tal-plejtlits stimulata minn agonisti oħra barra ADP tiġi impedita wkoll permezz ta' mblukkar tal-amplifikazzjoni tal-attivazzjoni ta' plejtlits minn ADP meħlus.
English: The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Maltese: Ir-riżultati f'popolazzjonijiet b'karatteristiċi differenti (eż. anġina instabbli jew MI ta' mewġa mhux Q, minn livelli baxxa sa għolja ta' riskju, dijabete, il-bżonn ta' revaskularizzazzjoni, età, sess eċċ.) kienu konsistenti mar-riżultati ta' l-analiżi primarja.
English: Bullous dermatitis (toxic epidermal necrolysis,
Maltese: din il-mediċina (elenkati fis- sezzjoni 6);
English: Common side effects (may affect up to 1 in 10 people: Diarrhoea, abdominal pain, indigestion or heartburn.
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): Dijarrea, uġigħ addominali, indiġestjoni jew qrusa tal-istonku.
English: Apotex Europe B.V. Archimedesweg 2
Maltese: Apotex Europe B.V. Archimedesweg 2 2333 CN, Leiden L-Olanda
English: The mean time between shunt palliation and first administration of study medicinal product was 20 days.
Maltese: Iż-żmien medju bejn id-devjazzjoni kirurġika ta' għajnuna u l-ewwel għotja talprodott mediċinali taħt studju kien ta' 20 ġurnata.
English: Osmlolarity : 260-320 mOsm/l
Maltese: Osmolarità : 260-329 mOsm/l
English: Wessling Hungary Kft Fòti ùt 56, Budapest H-1047, Hungary
Maltese: Wessling Hungary Kft Fòti ùt 56, Budapest H-1047, L-Ungerija
English: Accord Healthcare Limited Ground floor, Sage House 319, Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom
Maltese: Accord Healthcare Limited Ground floor, Sage House 319, Pinner Road, North Harrow Middlesex HA1 4HF
English: AUC0-∞, h.mcg/L t1/2, hours
Maltese: AUC0-∞, h·mcg/L t½, sigħat
English: Adults Cancer Patientsb
Maltese: Pazjenti Adulti bilKanċer b
English: CYP2D6 inducers and inhibitors
Maltese: Inducers u inibituri ta' CYP2D6
English: In the palonosetron 10 mcg/kg, 20 mcg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
Maltese: Fil-gruppi ta' palonosetron 10 mcg/kg, 20 mcg/kg u ta' ondansetron, il-proporzjon ta' pazjenti b'CR0-24 siegħa kien ta' 54.2%, 59.4% u 58.6%.
English: Excipients: mannitol, citric acid monohydrate, sodium citrate ,disodium edetate, sodium hydroxide, hydrochloric acid concentrated, water for injections.
Maltese: Eċċipjenti: mannitol, citric acid monohydrate, sodium citrate, disodium edetate, sodium hydroxide, hydrochloric acid konċentrat, ilma għall-injezzjonijiet.
English: Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin.
Maltese: Kimoterapiji emetoġeniċi mogħtija kienu jinkludu doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, u daunorubicin.
English: Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Maltese: extrasystoles, iskemija mijokardjali, takikardija tas-sinus, arritmija tas sinus, extrasystoles supraventrikulari
English: A total of 670 paediatric surgical patients participated, age 30 days to 16.9 years.
Maltese: Total ta' 670 pazjent pedjatriku kirurġiku pparteċipaw, u kellhom minn 30 jum sa 16.9 snin.
English: A lower bound greater than -15 % demonstrates non-inferiority between palonosetron and comparator.
Maltese: Lower bound ikbar minn -15 % turi non-inferjorità bejn palonosetron u l-komparatur.
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 ≤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: 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 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) li ngħata minn ġol-vina f'Jum 1, mingħajr dexamethasone.
English: Since the 97.5% confidence interval (stratum adjusted Mantel-Haenszel test) of the difference in CR0-24h between palonosetron 20 mcg/kg and ondansetron was [-11.7%, 12.4%], the 20 mcg/kg palonosetron dose demonstrated non-inferiority to ondansetron.
Maltese: Billi l-intervall ta' kunfidenza ta' 97.5% (test ta' Mantel-Haenszel aġġustat għall-istratum) tad-differenza f'CR0-24 siegħa bejn palonosetron 20 mcg/kg u ondansetron kien ta' [-11.7%, 12.4%], id-doża ta' palonosetron 20 mcg/kg uriet noninferjorità għal ondansetron.
English: Serotonergic Drugs (e.g. SSRIs and SNRIs)
Maltese: Mediċini Serotonerġiċi (eż. SSRIs u SNRIs)
English: Efficacy after palonosetron 10 mcg/kg compared to palonosetron 3mcg/kg was 54.1% and 37.1% respectively.
Maltese: Leffikaċja wara doża ta' 10 mcg/kg ta' palonosetron meta mqabbla ma' doża ta' 3 mcg/kg ta' palonosetron kienet 54.1% u 37.1% rispettivament.
English: The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 mcg/kg or 3 mcg/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 mcg/kg jew 3 mcg/kg ta' palonosetron (88% vs 84%).
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: F'analiżi farmakokinetika tal-popolazzjoni, intwera li ma kien hemm l-ebda effett sinifikanti fuq ittneħħija ta' palonosetron meta jingħata flimkien ma' inducers CYP2D6 (dexamethasone u rifampicin) u inibituri (li jinkludu amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline jew terbinafine).
English: SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Maltese: SNRIs (serotonin noradrenaline reuptake inhibitors - inibituri tal-assorbiment mill-ġdid ta' noradrenaline ta' serotonin) li jintużaw għall-kura tad-depressjoni u/jew ansjetà, li jinkludu venlafaxine, duloxetine.
English: 75 mg), palonosetron 20 mcg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1.
Maltese: 8%), ġew ikkurati b'palonosetron 10 µg/kg (massimu ta' 0.75 mg), palonosetron 20 mcg/kg (massimu ta' 1.5 mg) jew ondansetron (3 x 0.15 mg/kg, doża totali massima ta' 32 mg) 30 minuta qabel il-bidu ta' kimoterapija emetoġenika matul Ċiklu 1.
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 palonosetron, were headache (9 %) and constipation (5 %).
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' palonosetron, kienu wġigħ ta' ras (9 %) u stitikezza (5 %).
English: SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
Maltese: SSRIs (selective serotonin reuptake inhibitors - inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin) li jintużaw għall-kura tad-depressjoni u/jew ansjetà, li jinkludu fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
English: Each vial contains 250 micrograms of palonosetron (as hydrochloride) in 5 ml (50 micrograms/ml).
Maltese: Kull kunjett fih 250 mikrogramma ta' palonosetron (bħala hydrochloride) f'5 ml (50 mikrogrammi/ml).
English: Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes.
Maltese: Palonosetron hu primarjament immetabolizzat minn CYP2D6, b'kontribuzzjoni żgħira mill-isoenzimi CYP3A4 u CYP1A2.
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 irreġistrati fi tliet provi ta' fażi 3, komplew fi studju open label dwar issigurtà u kienu kkurati b'750 mikrogramma ta' palonosetron sa 9 ċikli addizzjonali ta' kimoterapija.
English: When the dose was increased from 10 mcg/kg to 20 mcg/kg a dose-proportional increase in mean AUC was observed.
Maltese: Meta d-doża żdiedet minn 10 mcg/kg għal 20 mcg/kg, ġiet osservata żieda proporzjonali għad-doża fil-medja tal-AUC.
English: Given the prespecified 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 MantelHaenszel aġġustata għall-istratum għad-differenza fil-punt aħħari primarju, ir-rispons sħiħ (CR), kien ta' [-10.5, 1.7%], u għalhekk in-noninferjorità ma ntwerietx.
English: Palonosetron 250 micrograms (n= 189)
Maltese: Palonosetron 250 mikrogramma (n= 185)
English: b PK parameters expressed as Arithmetic mean (SD) c Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 mcg /kg and 20 mcg /kg dose groups combined.
Maltese: b Parametri PK espressi bħala Medja Aritmetika (SD) ċ Tneħħija u Volum ta' distribuzzjoni f'pazjenti pedjatriċi ġew ikkalkulati aġġustati għall-piż miż-żewġ gruppi tad-doża ta' 10 mcg /kg u 20 mcg /kg kombinati.
English: The primary efficacy endpoint, Complete Response (CR: no 1o0miting, 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: Sħiħ (CR: l-ebda rimettar, l-ebda dardir, u l-ebda mediċina antiemetika ta' 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: 2 to <6 y 6 to <12 y 12 to <17 y 3.0 mcg/kg 10 mcg/kg
Maltese: 12 sa <17-il sena mcg/kg mcg/kg N=3 N=5
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 mcg/kg (maximum 0.
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.
English: How to store Palonosetron Accord
Maltese: Tiħux Palonosetron Accord
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 mcg/kg.
Maltese: Il-medjan tal-half-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 mcg/kg.
English: Single-dose intravenous palonosetron pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 mcg/kg or 20 mcg/kg.
Maltese: Dejta farmakokinetika dwar dożi minn ġol-vina waħidhom ta' palonosetron nkisbet minn sottosett ta' pazjenti pedjatriċi bil-kanċer (n=280) li rċivew 10 mcg/kg jew 20 mcg/kg.
English: pH : Between 3.0 to 3.9
Maltese: Soluzzjoni ċara u mingħajr kulur. pH : Bejn 3.0 u 3.9
English: The second paediatric, trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing intravenous palonosetron (1 mcg/kg, max 0.075 mg) versus intravenous.
Maltese: It-tieni prova pedjatrika kien studju multiċentriku, double-blind, double-dummy, li fih il-parteċipanti ntgħażlu b'mod każwali, grupp parallel, b'kontroll attiv, dwar in-noninferjorità ta' dożi waħidhom, li qabbel palonosetron mogħti fil-vina (1 µg/kg, massimu ta' 0.075 mg) kontra ondansetron mogħti ġolvina.
English: 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.
Maltese: Palonosetron, fid-doża rrakkomandata, hu ddistribwit ħafna fil-ġisem b'volum tad-distribuzzjoni ta' madwar 6.9 sa 7.9 l/kg.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26th May 2016
Maltese: Mejju 26, 2016
English: N=7
Maltese: N=7 N=10 N=6 N=5
English: Palonosetron Accord 250 micrograms solution for injection palonosetron
Maltese: Palonosetron Accord 250 mikrogramma soluzzjoni għall-injezzjoni palonosetron
English: What Palonosetron Accord contains - The active substance is palonosetron (as hydrochloride).
Maltese: Is-sustanza attiva hi palonosetron (bħala hydrochloride).
English: b The study was designed to show non-inferiority.
Maltese: b L-istudju kien maħsub biex juri non-inferjorità.
English: 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.
Maltese: Palonosetron jitneħħa permezz ta' rotta doppja, madwar 40 % jitneħħa mill-kliewi u madwar 50 % ikun immetabolizzat biex jifforma żewġ metaboliti primarji, li għandhom inqas minn 1 % ta' l-attività ta' l-antagonist tar-riċettur 5HT3 ta' palonosetron.
English: The safety and efficacy of palonosetron intravenously at single doses of 3 mcg/kg and 10 mcg/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 mcg/kg u 10 mcg/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: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/5 ml
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 250 mcg/5 ml
English: Palonosetron Accord 250 micrograms solution for injection palonosetron (as hydrochloride)
Maltese: Palonosetron Accord 250 mikrogramma soluzzjoni għall-injezzjoni palonosetron (bħala hydrochloride)
English: Important information about some of the ingredients of Palonosetron Accord This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Maltese: Informazzjoni importanti dwar xi ingredjenti ta' Palonosetron Accord Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ ħielsa mis-sodium'.
English: Sodium hydroxide (for pH adjustment), Hydrochloric acid, concentrated (for pH adjustment), Water for injections.
Maltese: Sodium hydroxide (għal aġġustament tal-pH), Hydrochloric acid konċentrat (għal aġġustament tal-pH) Ilma għall-injezzjonijiet.
English: The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours.
Maltese: L-attività tal-mediċini ta' kontra d-dardir u r-rimettar (antiemetiċi) kienet osservata matul perijodu ta' 0-24 siegħa, 24-120 siegħa u 0-120 siegħa.
English: Dermatitis, allergic, pruritus, skin disorder, urticaria.
Maltese: Dermatite allerġika, ħakk, disturb fil-ġilda, urtikarja
English: Palonosetron Accord should be injected over 30 seconds.
Maltese: Palonosetron Accord għandu jkun injettat fuq perijodu ta' 30 sekonda.
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: 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 rċievew doża waħda ta' palonosetron (3, 10 jew 20 mcg/kg).
English: Hyperkalaemia, metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased
Maltese: Iperkalemija, mard metaboliku, ipokalċimja, ipokalemija, anoreksja, ipergliċemija, nuqqas t'aptit
English: - low levels of calcium in the blood - high levels of the pigment bilirubin in the blood - high levels of certain liver enzymes - elevated moods or feeling of anxiousness - sleepiness or trouble sleeping - decrease or loss of appetite - weakness, tiredness, fever or flu like symptoms - numbness, burning, prickling or tingling sensations on the skin - itchy skin rash - impaired vision or eye irritation - motion sickness - ringing in the ear - hiccups, flatulence, dry mouth or indigestion - abdominal (stomach) pain - difficulty urinating - joint pain - electrocardiogram abnormalities (QT prolongation)
Maltese: - pressjoni tad-demm għolja jew baxxa - taħbit mhux normali tal-qalb jew nuqqas ta' influss ta' demm fil-qalb - tibdil fil-kulur tal-vina u/jew il-vini jikbru - ikun hemm livelli għolja jew baxxi b'mod anormali ta' potassium fid-demm - livelli għolja ta' zokkor fid-demm jew zokkor fl-awrina - livelli baxxi ta' calcium fid-demm - livelli għolja tal-bilirubina fid-demm, li għandha kulur safrani - livelli għolja ta' ċerti enzimi tal-fwied - burdati ta' ferħ jew tħossok anzjuż/a - irqad żejjed jew problemi biex torqod - tnaqqis jew telf tal-aptit - dgħjufija, għeja, deni jew sintomi bħal tal-influwenza.
English: Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Maltese: Hi rrakkomandata osservazzjoni adattata ta' pazjenti għal sintomi li jixbhu lis-sindrome ta' serotonin.
English: Cough, dyspnoea, epistaxis
Maltese: Kull kunjett fih doża waħda.
English: Table 4: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of palonosetron at 20 mcg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 mcg/kg palonosetron doses via intravenous bolus.
Maltese: Parametri Farmakokinetiċi f'Pazjenti Pedjatriċi bil-Kanċer wara infużjoni ġol-vini ta' palonosetron f'doża ta' 20 mcg fuq perijodu ta' 15-il minuta u f'Pazjenti Adulti bil-Kanċer li jirċievu dożi ta' 3 u 10 mcg/kg ta' palonosetron permezz ta' bolus ġol-vini.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms of palonosetron (as hydrochloride).
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni fih 50 mikrogramma ta' palonosetron (bħala hydrochloride).
English: HA1 4HF
Maltese: TAGĦRIF
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The safety and efficacy of palonosetron intravenously at single doses of 1mcg/kg and 3mcg/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 mcg/kg u 3 mcg/kg ġew ipparagunati fl-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: Palonosetron Accord belongs to a group of medicines known as serotonin (5HT3) antagonists.
Maltese: Palonosetron Accord jappartjeni għal grupp ta' mediċini magħrufa bħala antagonisti (5HT3) ta' serotonin.
English: Common ARs (≥1/100 to<1/10)
Maltese: ARs Komuni (1/100 sa <1/10)
English: One vial of 5 ml of solution contains 250 micrograms of palonosetron.
Maltese: Kunjett wieħed ta' 5 ml ta' soluzzjoni fih 250 mikrogramma ta' palonosetron.
English: In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron.
Maltese: Fl-istudji kliniċi, ir-reazzjonijiet avversi (adverse reactions - ARs) li ġejjin kienu osservati bħala possibbilment jew probabbilment relatati ma' palonosetron.
English: Allergic reactions to palonosetron accord
Maltese: Mediċini oħra u Palonosetron Accord
English: N=13
Maltese: N=6 N=14 N=13 N=19 N=6 N=5
English: Prevention of Chemotherapy Induced Nausea and Vomiting (CINV):
Maltese: Prevenzjoni ta' Nawsja u Rimettar Ikkaġunati minn Kimoterapija (CINV):
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.
Maltese: • il-prevenzjoni ta' nawsja u rimettar akuti assoċjati ma' kimoterapija emetoġenika ħafna kontra l kanċer u l-prevenzjoni ta' nawsja u rimettar assoċjati ma' kimoterapija moderatament emetoġenika kontra l-kanċer.