FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of Aloxi at 20 µg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 µg/kg palonosetron doses via intravenous bolus.
Maltese: Parametri Farmakokinetiċi f'Pazjenti Pedjatriċi bil-Kanċer wara infużjoni ġol-vini ta' Aloxi f'doża ta' 20 µg fuq perjodu ta' 15-il minuta u f'Pazjenti Adulti bil-Kanċer li jirċievu dożi ta' 3 u 10 µg/kg ta' palonosetron permezz ta' bolus ġol-vini.
English: In a multicentre, randomised, double-blind active control clinical trial of 635 patients set to receive moderately emetogenic cancer chemotherapy.
Maltese: Fi prova klinika multiċentrika, li fiha l-individwi ntgħażlu b'mod każwali, double-blind u b'kontroll attiv, li saret fuq 635 pazjent li kienu qed jingħataw kimoterapija moderatament emetoġenika kontra lkanċer.
English: Most patients were non-naïve to chemotherapy (78.5%) across all treatment groups.
Maltese: Il biċċa l-kbira tal-pazjenti kien rċivew kimoterapija fil-passat (78.5%) fil-gruppi kollha ta' kura.
English: In vitro metabolism studies have shown that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 isoenzymes are involved in the metabolism of palonosetron.
Maltese: Studji dwar il-metaboliżmu in vitro urew li CYP2D6 u, fi grad inqas, l-isoenzimi ta' CYP3A4 u CYP1A2, jieħdu parti fil-metaboliżmu ta' palonosetron.
English: Uncommon side effects shown in tests: may affect up to 1 in 100 people
Maltese: Effetti sekondarji mhux komuni murija fit-testijiet: jistgħu jaffettwaw sa 1 minn kull 100 persuna
English: • you have had heart problems or heart problems run in your family, such as changes in your heart beat (‘QT prolongation')
Maltese: • kellek problemi tal-qalb jew jekk hemm problemi tal-qalb fil-familja tiegħek, bħal tibdil fir-rata tat-taħbit tal-qalb (‘QT itwal milli suppost').
English: 24 - 120 hours
Maltese: 24 - 120 siegħa
English: Fertility There are no data concerning the effect of palonosetron on fertility.
Maltese: Fertilità M'hemm l-ebda dejta dwar l-effett ta' palonosetron fuq il-fertilità.
English: The objective was to evaluate the ECG effects of IV administered palonosetron at single doses of 0.25, 0.75 or 2.25 mg in 221 healthy subjects.
Maltese: L-għan kien li jiġu evalwati l-effetti tal-ECG ta' IV palonosetron mogħti f'dożi waħidhom ta' 0.25, 0.75 jew 2.25 mg f'221 persuna b'saħħithom.
English: Following oral administration, palonosetron is well absorbed with its absolute bioavailability reaching 97 %.
Maltese: Wara l-għoti mill-ħalq, palonosetron jiġi assorbit tajjeb bil-bijodisponibilità assoluta tiegħu tilħaq 97 %.
English: Each vial of 5 ml of solution contains 250 micrograms of palonosetron.
Maltese: Kull kunjett ta' 5 ml ta' soluzzjoni fih 250 mikrogramma ta' palonosetron.
English: Hyperbilirubinaemia
Maltese: Żieda fil-bilirubina fid-demm
English: Each capsule contains 500 micrograms palonosetron (as hydrochloride).
Maltese: Kull kapsula fiha 500 mikrogramma ta' palonosetron (bħala hydrochloride).
English: Biotransformation Palonosetron is eliminated by dual route, about 40 % eliminated through the kidney and with approximately 50 % metabolised to form two primary metabolites, which have less than 1 % of the 5HT3 receptor antagonist activity of palonosetron.
Maltese: Palonosetron jitneħħa permezz ta' żewġ rotot, madwar 40 % jitneħħa mill-kliewi u madwar 50 % ikun metabolizzat biex jifforma żewġ metaboliti primarji, li għandhom inqas minn 1 % ta' l-attività ta' l antagonist tar-riċettur 5HT3 ta' palonosetron.
English: Polyamide/aluminium/PVC blister containing one or five soft capsules.
Maltese: Huma fornuti f'folji tal-polyamide/aluminju/PVC li jkun fihom kapsula waħda jew ħames kapsuli.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: • The recommended dose of Aloxi is 250 micrograms.
Maltese: • Id-doża rrakkomandata ta' Aloxi hija ta' 250 mikrogramma.
English: Dermatitis allergic, pruritus, skin disorder, urticaria
Maltese: Dermatite allerġika, ħakk,
English: Helsinn Birex Pharmaceuticals Ltd. Damastown
Maltese: Helsinn Birex Pharmaceuticals
English: Chemotherapeutic agents
Maltese: Sustanzi kemoterapewtiċi
English: • impaired vision or eye irritation
Maltese: • indeboliment tal-vista jew irritazzjoni tal-għajnejn
English: Urinary retention, glycosuria
Maltese: taħt il-ġilda
English: Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride).
Maltese: Kull kunjett ta' 5 ml ta' soluzzjoni fih 250 mikrogramma ta' palonosetron (bħala hydrochloride).
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).
Maltese: Kien hemm rapport tas-sindrome ta' serotonin wara l-użu fl-istess ħin ta' antagoisti ta' 5-HT3 u mediċini serotonerġiċi oħrajn (li jinkludu SSRIs u SNRIs).
English: • ECG (electrocardiogram) abnormalities (‘QT prolongation').
Maltese: • anormalitajiet tal-elettrokardjogramm (titwil tal-QT)
English: Aloxi Intravenous 250 micrograms (n=162)
Maltese: 250 mikrogramma (n=162)
English: Pharmacokinetic simulations indicate that the overall exposure (AUC0-∞) of 0.25 mg intravenous palonosetron administered once daily for 3 consecutive days was similar to a single intravenous dose of 0.75 mg, although Cmax of the 0.75 mg single dose was higher.
Maltese: Simulazzjonijiet farmakokinetiċi jindikaw li l-espożizzjoni totali (AUC0-∞) ta' 0.25 mg ta' palonosetron mogħti fil-vina darba kuljum għal tlitt ijiem konsekuttivi kienet simili għal doża waħda ta' 0.75 mg ġol-vina, għalkemm is-Cmax wara doża waħda ta' 0.75 mg kienet ogħla.
English: Helsinn Birex Pharmaceuticals Ltd., Damastown,
Maltese: Ltd., Damastown,
English: As shown in Table 1, oral Aloxi capsules 500 micrograms demonstrated non-inferiority to the active comparator during the 0 to 24 hour and 0 to 120 hour time intervals; however, for the 24 to 120 hour time period, non-inferiority was not shown.
Maltese: Kif muri f'Tabella 1, kapsuli orali ta' Aloxi 500 mikrogramma, urew non-inferjorità għall-komparatur attiv matul l-intervalli ta' ħin ta' 0 sa 24 siegħa u 0 sa 120 siegħa; madankollu, għall-perjodu ta' ħin ta'
English: purified water, butylhydroxyanisole, gelatin, sorbitol, titanium dioxide.
Maltese: ifosfamide, cisplatin, dactinomycin, carboplatin, u daunorubicin.
English: Hyperkalaemia, metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased
Maltese: Iperkalemija, mard metaboliku, ipokalċimja,
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.
Maltese: Wara doża waħda ta' madwar 0.75 mg ta' palonosetron ġolvini, it-tneħħija totali mill-ġisem ta' palonosetron f'pazjenti b'saħħithom kienet ta' 160 ± 35 ml/siegħa/kg (medja ± SD) u t-tneħħija mill-kliewi kienet 66.5 ± 18.2 ml/siegħa/kg.
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.
Maltese: F'pazjenti b'saħħithom li jingħataw kapsuli ta' palonosetron 500 mikrogramma, il-half-life tal-eliminazzjoni terminali (t½) ta' palonosetron kienet ta' 37 ± 12-il siegħa (medja ± SD), u f'pazjenti bil-kanċer, t½ kienet ta' 48 ± 19-il siegħa.
English: • headache.
Maltese: • uġigħ ta' ras.
English: 20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy.
Maltese: 20 mikrogramma/kg (id-doża massima totali m'għandhiex taqbeż 1500 mikrogramma) ta' palonosetron mogħti bħala infużjoni waħda ta' 15-il minuta ġol-vini li tibda madwar 30 minuta qabel il-bidu tal-kimoterapija.
English: At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc interval.
Maltese: Fil-livelli kollha tad-doża li kienu ttestjati, palonosetron ma kkawżax żieda klinikament rilevanti flintervall QTc.
English: In 12 cancer patients given a single oral dose of palonosetron capsules 500 micrograms one hour prior to chemotherapy, Cmax was 0.93 ± 0.34 ng/ml and Tmax was 5.1 ± 5.9 hours.
Maltese: siegħa qabel il-kimoterapija, is-Cmax kienet ta' 0.93 ± 0.34 ng/ml u t-Tmax kien ta' 5.1 ± 5.9 sigħat.
English: Aloxi should be injected over 30 seconds.
Maltese: Aloxi għandu jkun injettat fuq perijodu ta' 30 sekonda.
English: The AUC was 30 % higher in cancer patients than in healthy subjects.
Maltese: AUC kienet 30 % ogħla f'pazjenti bil-kanċer milli f'pazjenti b'saħħithom.
English: 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).
Maltese: Filwaqt li dan l-istudju wera li pazjenti pedjatriċi jeħtieġu doża ogħla ta' palonosetron mill-adulti biex jiġu evitati nawsja u rimettar ikkaġunati mill-kimoterapija, il-profil tas-sigurtà hu konsistenti mal profil stabbilit fl-adulti (ara sezzjoni 4.8).
English: • fever
Maltese: • dardir
English: The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%.
Maltese: Ir-reazzjonijiet avversi komuni jew mhux komuni li ġejjin ġew irrappurtati għal palonosetron, u l-ebda waħda minnhom ma ġiet irrappurtata fi frekwenza ta' >1%.
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 lkanċer u l-prevenzjoni ta' nawsja u rimettar assoċjati ma' kimoterapija moderatament emetoġenika kontra l-kanċer.
English: Aloxi 500 micrograms soft capsules are plain, light beige, opaque, round to oval soft capsules, filled with a clear yellowish solution.
Maltese: Aloxi 500 mikrogramma kapsuli rotob li ma fihom xejn fuqhom, ta' kulur kannella ċar, opaki, tondi sa ovali, mimlija b'soluzzjoni ċara tagħti fl-isfar.
English: For Palonosetron no clinical data on exposed pregnancies are available.
Maltese: Tqala Għal Palonosetron m'hemm l-ebda dejta klinika disponibbli dwar nisa esposti waqt it-tqala.
English: • abdominal (stomach) pain
Maltese: • livelli baxxi ta' calcium fid-demm
English: • The other ingredients are glycerol monocaprylocaproate (type I), polyglycerol oleate, glycerol,
Maltese: • Is-sustanzi l-oħra huma glycerol monocaprylocaproate (tip I), polyglycerol oleate, glycerol, ilma ppurifikat, butylhydroxyanisole, gelatin, sorbitol, titanium dioxide.
English: PK parameters expressed as Geometric Mean (CV) except for T½ which is median.
Maltese: Parametri PK espressi bħala Medja Ġeometrika (CV) ħlief għal T½ li hu medjan.
English: 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.
Maltese: Waqt li l-half-life ta' l-eliminazzjoni terminali u l medja ta' l-espożizzjoni sistemika ta' palonosetron jiżdiedu f'pazjenti b'indeboliment serju tal-fwied, dan ma jiġġustifikax tnaqqis fid-doża.
English: • dizziness
Maltese: • tinfaraġ
English: Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 µg /kg and 20 µg /kg dose groups combined.
Maltese: Tneħħija u Volum ta' distribuzzjoni f'pazjenti pedjatriċi ġew ikkalkulati aġġustati għall-piż miż-żewġ gruppi tad-doża ta' 10 µg /kg u 20 µg /kg kombinati.
English: Aloxi capsules may also contain a trace of lecithin derived from soya.
Maltese: Il-kapsuli Aloxi jista' jkun fihom ukoll traċċa ta' lecithin li jiġi mis-sojja.
English: Mean maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞) are generally dose-proportional over the dose range of 0.3-90 μg/kg in healthy subjects and in cancer patients.
Maltese: Ilmedja tal-konċentrazzjoni massima tal-plażma (Cmax) u ż-żona taħt il-kurva ta' konċentrazzjoni-ħin (AUC0-∞) huma ġeneralment proporzjonali għad-doża fuq il-firxa tad-doża ta' 0.3-90 μg/kg f'pazjenti b'saħħithom u f'pazjenti bil-kanċer.
English: Aloxi may contain traces of lecithin which comes from soya.
Maltese: Din il-mediċina jista' jkun fiha traċċa ta' lecithin li jiġi mis-sojja.
English: Available in packs of 1 vial containing 5 ml of solution.
Maltese: Disponibbli f'pakketti ta' kunjett wieħed li jkun fih 5 ml ta' soluzzjoni.
English: 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.
Maltese: Madankollu, b'mod ġenerali, l-effett ta' kontra r-rimettar (antiemetiku) għall-intervall ta' ħin bejn 0-24 siegħa, kien simili matul ċikli ripetuti b'mod konsekuttiv, u s-sigurtà totali nżammet matul iċ-ċikli kollha.
English: This belongs to a group of medicines called ‘serotonin (5HT3) antagonists'.
Maltese: Dan jappartjeni għal grupp ta' mediċini msejħa ‘antagonisti (5HT3) ta' serotonin'.
English: Prevention of Chemotherapy Induced Nausea and Vomiting (CINV):
Maltese: Popolazzjoni pedjatrika Prevenzjoni ta' Nawsja u Rimettar Ikkaġunati minn Kimoterapija (CINV):
English: Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Maltese: Indeboliment tal-kliewi li jkun minn ħafif sa moderat ma jaffettwax b'mod sinifikanti l-parametri farmakokinetiċi ta' palonosetron.
English: 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.
Maltese: Fi studji mhux kliniċi, palonosetron wera li għandu l-abbiltà li jimblokka l-kanali tal-ijoni involuti fiddi- u fir-ri-polarizzazzjoni ventrikulari u li jtawwal l-azzjoni potenzjali.
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),
English: No pharmacokinetic data in haemodialysis patients are available.
Maltese: L-ebda informazzjoni farmakokinetika f'pazjenti li qegħdin fuq l-emodijaliżi mhi disponibbli.
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: madwar 6.9 sa 7.9 l/kg.
English: For Palonosetron, no clinical data on exposed pregnancies are available.
Maltese: Tqala Għal palonosetron, m'hemm l-ebda dejta klinika disponibbli dwar nisa esposti waqt it-tqala.
English: Aloxi is indicated in adults for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Maltese: Aloxi hu indikat fl-adulti għall-prevenzjoni ta' dardir u rimettar akut assoċjat ma' kimoterapija moderatament emetoġenika tal-kanċer.
English: Age does not affect the pharmacokinetics of palonosetron.
Maltese: L-età ma taffettwax il-farmakokinetika ta' palonosetron.
English: palonosetron (1 µg/kg, max 0.075 mg) versus i.v.
Maltese: 8%), ġew ikkurati b'palonosetron 10 µg/kg (massimu ta' 0.75 mg), palonosetron 20 µg/kg (massimu ta' 1.5 mg) jew ondansetron (3 x 0.15 mg/kg,
English: • you have an imbalance of certain minerals in your blood which has not been treated - such as potassium and magnesium.
Maltese: • għandek żbilanċ ta' ċerti minerali fid-demm li ma ġiex ikkurat - bħal potassium u magnesium.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Maltese: Kull ml ta' soluzzjoni fih 50 mikrogramma ta' palonosetron (bħala hydrochloride).
English: Aloxi is used in adults, adolescents and children over one month of age to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy.
Maltese: Aloxi jintuża fl-adulti, adolexxenti u tfal li jkollhom aktar minn xahar, biex tgħinek biex ma tħossokx imdardar jew tirremetti (dardir u rimettar) meta tkun qed tirċievi trattamenti kontra l-kanċer imsejħa kimoterapija.
English: Aloxi contains sorbitol and may contain traces of soya This medicine contains 7 mg sorbitol (a type of sugar) in each capsule.
Maltese: Din il-mediċina fiha 7 mg ta' sorbitol (tip ta' zokkor) f'kull kapsula.
English: Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.
Maltese: Palonosetron ingħata b'mod sigur ma' prodotti mediċinali analġesiċi, mediċini ta' kontra d-dardir u rrimettar, mediċini antispażmodiċi u antikolinerġiċi.
English: Adults Cancer Patientsb
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI 5
English: In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
Maltese: Fi studju kliniku, ma ntweriet l-ebda interazzjoni farmakokinetika sinifikanti bejn doża waħda ta' palonosetron ġol-vina u konċentrazzjoni fl-istat fiss ta' metoclopramide orali, li hu inibitur ta' CYP2D6.
English: After single oral doses using buffered solution mean maximum palonosetron concentrations (Cmax) and area under the concentration-time curve (AUC0-∞) were dose proportional over the dose range of 3.0 to 80 µg/kg in healthy subjects.
Maltese: Wara l-għoti ta' dożi waħidhom bl-użu ta' soluzzjoni buffered, il-medja tal-konċentrazzjonijiet massimi ta' palonosetron (Cmax) u ż-żona taħt il-kurva ta' konċentrazzjoni-ħin (AUC0-∞) kienu proporzjonali għad-doża fuq il-medda tad-doża ta' 3.0 sa 80 μg/kg f'pazjenti b'saħħithom.
English: • feeling sick (nausea)
Maltese: <sentejn sentejn sa <6 snin
English: p-valuec
Maltese: U L-UŻU
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
English: • itchy skin rash or hives
Maltese: • taħbit mhux normali tal-qalb
English: They are supplied in polyamide/aluminium/PVC blisters containing one or five capsules.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folja tal-polyamide/aluminju/PVC li fiha kapsula waħda jew ħames kapsuli rotob.
English: • If you get any side effects, talk to your doctor or nurse.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-infermier tiegħek.
English: IV use
Maltese: ANNESS III
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.
Maltese: Fi studji mhux kliniċi, palonosetron wera li għandu l-abbiltà li jimblokka l-kanali tal-joni involuti fid-di- u firri-polarizzazzjoni ventrikulari u li jtawwal l-azzjoni potenzjali.
English: Eye swelling
Maltese: Ż-ŻGĦAR EWLENIN
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/306/001
English: A lower bound greater that -15 % demonstrates noninferiority between Aloxi oral and comparator Aloxi intravenous c
Maltese: a Koorti bl-intenzjoni-li-tikkura b L-istudju kien maħsub biex juri non-inferjorità. Lower bound ikbar minn -15 % juri non-inferjorità bejn Aloxi orali u l-komparatur Aloxi ġol-vina.
English: 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.
Maltese: Fi studji li mhumiex kliniċi, l-effetti dehru biss wara esponimenti meqjusa ferm aktar għolja millmassimu ta' esponiment fil-bniedem, li juru ftit li xejn rilevanza għall-użu kliniku.
English: Talk to your doctor or nurse before you are given Aloxi if:
Maltese: Kellem lit-tabib jew l-infermiera tiegħek qabel tingħata Aloxi jekk:
English: Uncommon ARs
Maltese: ARs Mhux Komuni
English: High doses of palonosetron (each dose causing at least 30 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.
Maltese: Dożi qawwija ta' palonosetron (kull doża li tikkawża mill-inqas 30 darba dak li jintuża fil-bnedmin) mogħtija kuljum għal sentejn, ikkawżat rata miżjuda ta' tumuri tal-fwied, neoplażmi endokrinali (fit-tirojde, pitwitarji, fil-frixa, fil-medulla adrenali) u tumuri tal ġilda fil-firien iżda mhux fil-ġrieden.
English: Ten percent of patients have a mean terminal elimination half-life greater than 100 hours.
Maltese: Għaxra fil-mija tal-pazjenti jkollhom medja tal-half-life ta' l-eliminazzjoni terminali akbar minn 100 siegħa.
English: 250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy.
Maltese: 250 mikrogramma ta' palonosetron mogħtija bħala bolus wieħed ġol-vina madwar 30 minuta qabel ilbidu tal-kimoterapija.
English: • abnormal heart rate
Maltese: GĦAMLA KWALITATTIVA
English: Anxiety, euphoric mood
Maltese: Disturbi fl-għajnejn
English: After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45 %.
Maltese: 12-il persuna b'saħħithom, il-medja (± SD) taż-żieda tal-konċentrazzjoni ta' palonosetron fil-plażma minn Jum 1 sa Jum 5 kienet ta' 110 ± 45 %.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aloxi 250 micrograms solution for injection
Maltese: Informazzjoni għall-utent Aloxi 250 mikrogramma soluzzjoni għall-injezzjoni
English: Palonosetron does not inhibit or induce cytochrome P450 isoenzymes at clinically relevant concentrations.
Maltese: Palonosetron ma jinibixxix jew jikkaġuna isoenzimi taċ-ċitokrom P450 f'konċentrazzjonijiet li huma klinikament relevanti.
English: Arthralgia
Maltese: KUNJETT
English: These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to
Maltese: sa <1/10) jew mhux komuni (≥1/1,000 sa <1/100).
English: CYP2D6 inducers and inhibitors
Maltese: Studji dwar il-metaboliżmu in vitro urew li CYP2D6 u,
English: The overall safety was maintained during all cycles.
Maltese: Is-sigurtà globali nżammet matul iċ-ċikli kollha.
English: • headache, feeling dizzy,
Maltese: • uġigħ ta' ras, tħossok sturdut,
English: Gender does not affect the pharmacokinetics of palonosetron.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni.
English: 20 µg/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: doża totali massima ta' 32 mg) 30 minuta qabel il-bidu ta' kimoterapija emetoġenika matul Ċiklu 1.
English: Hiccups
Maltese: Kodiċi
English: NAME OF THE MEDICINAL PRODUCT Aloxi 250 micrograms solution for injection.
Maltese: Aloxi 250 mikrogramma soluzzjoni għall-injezzjoni.
English: • It is given as an injection into a vein.
Maltese: • Tingħata bħala injezzjoni ġo vina.
English: 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.
Maltese: doża waħda ta' Aloxi 20 µg/kg, il-konċentrazzjonijiet massimi fil-plażma (CT) irrappurtati fit-tmiem tal-infużjoni ta' 15-il minuta kienu varjabbli ħafna fil-gruppi kollha ta' età, u kellhom tendenza li jkunu iktar baxxi f'pazjenti ta' < 6 snin milli f'pazjenti pedjatriċi li kellhom aktar żmien.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/306/002