FrancophonIA/ELRC3.0 huggingface dataset:
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: • electrocardiogram abnormalities (QT prolongation)
Maltese: • anormalitajiet tal-elettrokardjogramma (titwil tal-QT)
English: PK parameters expressed as Arithmetic mean (SD) 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: Parametri PK espressi bħala Medja Aritmetika (SD) 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: In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤50 mg/m 2, carboplatin, cyclophosphamide ≤1,500 mg/m 2 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) li ngħata minn ġol-vina f'Jum 1, mingħajr dexamethasone.
English: How to store Palonosetron Hospira 6.
Maltese: Kif taħżen Palonosetron Hospira 6.
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: 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 fi 82.7% fil-grupp ta' ondansetron.
English: • high levels of certain liver enzymes
Maltese: • livelli għolja ta' ċerti enzimi tal-fwied
English: Nervous system disorders Headache Dizziness
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras Sturdament
English: A lower bound greater than -15 % demonstrates non-inferiority between palonosetron and comparator.
Maltese: Limitu 'l fuq minn -15% turi nuqqas ta' inferjorità bejn palonosetron u l-komparatur.
English: Dermatitis allergic, pruritus, skin disorder, urticaria
Maltese: Dermatite allerġika, ħakk, disturb fil-ġilda, urtikarja
English: Palonosetron Hospira belongs to a group of medicines known as serotonin (5HT3) antagonists.
Maltese: Palonosetron Hospira jappartjeni għal grupp ta' mediċini magħrufa bħala antagonisti (5HT3) ta' serotonin.
English: 24 - 120 hours 0 - 120 hours
Maltese: 24 - 120 siegħa 0 - 120 siegħa
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 ta' distribuzzjoni ta' madwar 6.9 sa 7.9 l/kg.
English: Elevated transaminases-, electrocardiogram QT prolonged
Maltese: Transaminasi għoljin, QT wiesa' fl-elettrokardjogramm
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini : http://www.ema.europa.eu
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 metabolizzat biex jifforma żewġ metaboliti primarji, li għandhom inqas minn 1% tal-attività talantagonist tar-riċettur 5HT3 ta' palonosetron.
English: Palonosetron 250 micrograms (n= 189)
Maltese: Palonosetron 250 mikrogramma (n= 189)
English: Palonosetron 250 micrograms (n= 185)
Maltese: Palonosetron 250 mikrogramma (n= 185)
English: Single-dose intravenous palonosetron 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 waħidhom ta' palonosetron mogħtija fil-vina nkisbet minn sottosett ta' pazjenti pedjatriċi bil-kanċer (n=280) li rċevew 10 µg/kg jew 20 µg/kg.
English: • The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid (for pH adjustment).
Maltese: • Is-sustanzi l-oħra huma mannitol, disodium edetate, sodium citrate, citric acid monohydrate, ilma għall-injezzjonijiet, sodium hydroxide u hydrochloric acid (għal aġġustament tal-pH).
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 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 wara l-għoti ta' 20 µg/kg.
English: <2 y 2 to <6 y 6 to <12 y 12 to <17 y μg/kg
Maltese: 12 sa <17-il sena μg/kg
English: The safety and efficacy of palonosetron intravenously 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.
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: 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 fixkilx attività kontra t-tumur tal-ħames sustanzi kemoterapewtiċi li kienu ttestjati (cisplatin, cyclophosphamide, cytarabine, doxorubicin u mitomycin C).
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, randomizzata, parallela, bil-plaċebo u kkontrollata pożittivament (moxifloxacin) f'irġiel u nisa adulti.
English: Palonosetron Hospira 250 micrograms solution for injection palonosetron (as hydrochloride)
Maltese: Palonosetron Hospira 250 mikrogramma soluzzjoni għall-injezzjoni palonosetron (bħala hydrochloride)
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: Given the pre-specified noninferiority 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' nuqqas ta' inferjorità speċifikat minn qabel ta' -10%, l-intervall ta' kunfidenza għan-nuqqas ta' inferjorità skont listatistika Mantel-Haenszel aġġustata għall-istratum għad-differenza fil-punt aħħari primarju, irrispons sħiħ (CR), kien ta' [-10.5, 1.7%], u għalhekk in-nuqqas ta' inferjorità ma ntweriex.
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 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: 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, doża totali massima ta' 32 mg) 30 minuta qabel il-bidu ta' kimoterapija emetoġenika matul Ċiklu 1.
English: Gastrointestinal disorders Constipation Diarrhoea
Maltese: Disturbi gastrointestinali
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 tal-eliminazzjoni terminali u lmedja tal-espożizzjoni sistemika ta' palonosetron jiżdiedu f'pazjenti b'indeboliment serju tal-fwied, dan ma jiġġustifikax tnaqqis fid-doża.
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 wrew li CYP2D6 u, fi grad inqas, l-isoenżimi ta' CYP3A4 u CYP1A2, jieħdu parti fil-metaboliżmu ta' palonosetron.
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 rċevew doża waħda ta' palonosetron (3, 10 jew 20 mcg/kg).
English: Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Maltese: Kull ml ta' soluzzjoni fih 50 mikrogramma ta' palonosetron (bħala hydrochloride).
English: Electrocardiogram QT prolonged conduction disorder, sinus tachycardia
Maltese: Titwil tal-QT flelettrokardjogramma, disturb fil-konduzzjoni, takikardija tassinus
English: Other medicines and Palonosetron Hospira
Maltese: Mediċini oħra u Palonosetron Hospira
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 l-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: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC code: A04AA05
Maltese: Antiemetiċi u kontra d-dardir, antagonisti ta' serotonin (5HT3).
English: Hyperkalaemia, metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased
Maltese: Iperkalemija, mard metaboliku, ipokalċemija, ipokalemija, anoressija, ipergliċemija, nuqqas ta' aptit
English: Headache
Maltese: Ġol-vini
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: Palonosetron Hospira 250 micrograms solution for injection palonosetron
Maltese: Palonosetron Hospira 250 mikrogramma soluzzjoni għall-injezzjoni palonosetron
English: The safety and efficacy of palonosetron intravenously at single doses of 1 μg/kg and 3 μg/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 mal-ewwel studju kliniku li sar fuq 150 pazjent f'dawn il-gruppi ta' età, minn >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 Hospira should be injected over 30 seconds.
Maltese: Palonosetron Hospira għandu jkun injettat fuq perjodu ta' 30 sekonda.
English: Palonosetron Hospira250 micrograms solution for injection.
Maltese: Palonosetron Hospira 250 mikrogramma soluzzjoni għall-injezzjoni.
English: • if you have acute bowel obstruction or a history of repeated constipation;
Maltese: • jekk għandek ostruzzjoni akuta fl-imsaren jew storja medika ta' stitikezza ripetuta;
English: In clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron.
Maltese: Fi studji kliniċi, ir-reazzjonijiet avversi (adverse reactions - ARs) li ġejjin kienu osservati bħala possibbilment jew probabbilment relatati ma' palonosetron.
English: Τηλ.
Maltese: • tinfaraġ
English: Urinary retention, glycosuria
Maltese: Zaventem, Il-Belġju
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 μg/kg, max
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-nuqqas ta' inferjorità ta' dożi waħidhom, li qabbel i.v. palonosetron (1 µg/kg, massimu ta' 0.075 mg) ma' ondansetron mogħti filvina.
English: Dexamethasone was administered prophylactically before chemotherapy in 67 % of patients.
Maltese: Dexamethasone ingħata b'mod profilattiku qabel kimoterapija f'67% tal-pazjenti.
English: How to store Palonosetron Hospira
Maltese: X'fih Palonosetron Hospira
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 perjodu ta' 0-24 siegħa, 24-120 siegħa u 0-120 siegħa.
English: • if you are using Palonosetron Hospira in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin,
Maltese: taħbit tal-qalb mhux floku bħal amiodarone, nicardipine, quinidine, moxifloxacin,
English: Most patients were non-naïve to chemotherapy (78.5%) across all treatment groups.
Maltese: Il-biċċa l-kbira tal-pazjenti kien rċevew kimoterapija fil-passat (78.5%) fil-gruppi kollha ta' kura.
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, palonosetron
Maltese: F'żewġ studji randomizzati, 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: For palonosetron no clinical data on exposed pregnancies are available.
Maltese: Għal palonosetron m'hemm l-ebda dejta klinika disponibbli dwar nisa esposti waqt it-tqala.
English: A doctor or nurse will normally inject Palonosetron Hospira about 30 minutes before the start of chemotherapy.
Maltese: Tabib jew ners normalment għandhom jinjettaw Palonosetron Hospira madwar 30 minuta qabel il-bidu tal-kimoterapija.
English: 0 - 24 hours 24 - 120 hours 0 - 120 hours Complete Control (Complete Response and No More Than Mild Nausea)
Maltese: 0 - 24 siegħa 24 - 120 siegħa 0 - 120 siegħa Kontroll Sħiħ (Rispons Sħiħ u b'Forsi Dardir Ħafif)
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 %.
Maltese: Wara l-għoti ġol-vina ta' palonosetron 0.25 mg darba kull jumejn għal tlett ijiem fi 11-il pazjent b'kanċer testikulari, il-medja (± SD) taż-żieda tal-konċentrazzjoni fil-plażma minn Jum 1 sa Jum 5 kienet ta' 42 ± 34%.
English: • nosebleed
Maltese: Il-Belġju
English: Each ml of solution contains 50 micrograms palonosetron.
Maltese: Kull ml ta' soluzzjoni fih 50 mikrogramma ta' palonosetron.
English: • abdominal (stomach) pain
Maltese: • uġigħ fis-sit tal-infużjoni
English: Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17
Maltese: Boulevard de la Plaine 17
English: Avara Liscate Pharmaceutical Services S.p.A.
Maltese: PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX
English: Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock
Maltese: Sensittività eċċessiva, anafilassi, reazzjonijiet u xokk anafilattiku/anafilattojde
English: • if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal palonosetron jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
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 sinifikanti farmakokinetika bejn doża waħda ta' palonosetronom ġol-vina u konċentrazzjoni fl-istat fiss ta' metoclopramide orali, li hu inibitur ta' CYP2D6.
English: Type I glass vial with a chlorobutyl rubber stopper and aluminium seal.
Maltese: Kunjett tal-ħġieġ tat-Tip I b'tapp tal-lastku tal-chlorobutyl u siġill tal-aluminju.
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-joni involuti fiddipolarizzazzjoni u fir-ripolarizzazzjoni ventrikulari u li jtawwal l-azzjoni potenzjali.
English: The efficacy of palonosetron for the prevention of chemotherapy-induced nausea and vomiting in paediatric cancer patients was demonstrated in a second non-inferiority pivotal trial comparing a single intravenous infusion of palonosetron versus an intravenous ondansetron regimen.
Maltese: L-effikaċja ta' palonosetron għall-prevenzjoni ta' nawsja u rimettar ikkaġunati mill-kimoterapija f'pazjenti pedjatriċi bil-kanċer intweriet fit-tieni prova importanti ħafna dwar in-nuqqas ta' inferjorità li qabblet infużjoni waħda ġol-vini ta' palonosetron ma' kors ta' ondansetron mogħti fil-vina.
English: Noninferiority criteria were met if the lower bound of the 97.5% confidence interval for the difference in Complete Response rates of intravenous palonosetron minus intravenous ondansetron was larger than -15%.
Maltese: Il-kriterji tan-nuqqas ta' inferjorità ġew issodisfati jekk il-lower bound tal-intervall ta' kunfidenza ta' 97.5% għad-differenza fir-rati ta' Rispons
English: Somnolence, insomnia, paraesthesia, hypersomnia, peripheral sensory neuropathy
Maltese: Ngħas, nuqqas ta' rqad, parestesija, irqad esaġerat, newropatija tas-sensi periferali
English: 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: C]-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: 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: Wara l-għoti ġol-vina ta' palonosetron 0.25 mg darba kuljum għal tlett ijiem fi 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: Following single dose intravenous infusion of Palonosetron 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: Wara linfużjoni ġol-vini ta' doża waħda ta' Palonosetron 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: Children and Adolescents (aged 1 month to 17 years):
Maltese: Tfal u Adolexxenti (li jkollhom minn xahar sa 17-il sena):
English: Hyperbilirubinaemia
Maltese: Pazjenti Pedjatriċi bil-Kanċer
English: • itchy skin rash
Maltese: Reazzjoni fis-sit talinjezzjoni*
English: Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron
Maltese: Tabella 2: Perċentwali ta' pazjenti a li jirrispondu skont il-grupp tal-kura u l-fażi fl-Istudju dwar il-Kimoterapija Moderatament Emetoġenika mqabbla ma' dolasetron
English: The efficacy of Palonosetron Hospira in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Maltese: Dan il-prodott mediċinali għandu jingħata minn professjonist fil-qasam tal-kura tas-saħħa taħt superviżjoni medika adattata.
English: Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis).
Maltese: Tuberkulożi hija infezzjoni kkawżata mill-batterju Mycobacterium tuberculosis (M. tuberculosis).
English: Further information on Deltyba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Deltyba tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Deltyba contains the active substance delamanid.
Maltese: Deltyba fih is-sustanza attiva delamanid.
English: The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis.
Maltese: Issustanza attiva f'Deltyba delamanid, hija antibijotiku attiv kontra M. tuberculosis.
English: Deltyba received a marketing authorisation valid throughout the European Union on 28 April 2014.
Maltese: Deltyba rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea fit-28 ta'April 2014.
English: Deltyba has been given ‘conditional authorisation'.
Maltese: Deltyba ngħata ‘awtorizzazzjoni kondizzjonali'.
English: Other information about Deltyba
Maltese: Informazzjoni oħra dwar Deltyba
English: The effects of Deltyba have been looked at in one main study involving 481 adults with tuberculosis resistant to standard treatments.
Maltese: Ingħatat ħarsa lejn l-effetti ta' Deltyba fi studju ewlieni wieħed li involva 481 adult b'tuberkulożi reżistenti għal kuri standard.
English: The most common side effects with Deltyba (which may affect more than 1 patient in 10) are nausea, vomiting, headache, insomnia (sleeping problems), dizziness, tinnitus (ringing or buzzing in the ears), blood tests showing low potassium levels in the blood, gastritis (inflammation of the stomach lining), decreased appetite and weakness.
Maltese: L-effetti sekondarji l-aktar komuni b'Deltyba (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma dardir, rimettar, uġigħ ta' ras, insomnja (problemi tal-irqad), sturdament, tinnitu (ċempil jew żarżir filwidnejn), testijiet tad-demm li juru livelli baxxi ta' potassju fid-demm, gastrite (infjammazzjoni tal-kisi tal-istonku), tnaqqis fl-aptit u dgħjufija.