FrancophonIA/ELRC3.0 huggingface dataset:
English: Given its modest efficacy and the known risks of sibutramine, the statistically robust evidence of an increased risk of non-fatal MI and stroke in patients with CV disease or Type 2 diabetes with sibutramine treatment compared with placebo is therefore of considerable concern.
Maltese: Meta wieħed jikkunsidra l-effikaċja modesta tiegħu u r-riskji magħrufa ta' sibutramine, l-evidenza statistikament b'saħħitha ta' riskju miżjud ta' MI mhux fatali u attakk f'pazjenti b'marda CV jew dijabete tat-Tip 2 bit-trattament b'sibutramine meta mqabbel ma' plaċebo għalhekk hija ta' tħassib konsiderevoli.
English: In conclusion, the CHMP considered that the proposed risk minimisation measures were inadequate to ensure SPC compliance or to adequately minimise the potential cardiovascular and cerebrovascular risks.
Maltese: Bħala konklużjoni, is-CHMP ikkunsidra li l-miżuri għat-tnaqqis tar-riskju proposti kienu inadegwati biex jiżguraw il-konformità mal-SPC jew biex inaqqsu b'mod adegwat irriskji kardjovaskulari u ċerebrovaskulari potenzjali.
English: Sibutramina Argam 15 mg Capsule, hard oral use
Maltese: Sibutramina Argam 15 mg Kapsula, iebsa Għal użu orali
English: During the December 2009 meeting, following the MAHs Oral Explanation, the CHMP therefore adopted a List of Outstanding Issues, asking the MAHs to further discuss, based on the SCOUT data, any potential patient population in which a positive benefit/risk balance could be established, the evidence of any favourable effect of sibutramine treatment compared to placebo and further risk minimisation measures.
Maltese: Matul il-laqgħa ta' Diċembru 2009, wara l-Ispjegazzjoni Orali tal-MAHs, is-CHMP għalhekk adotta Lista ta' Kwistjonijiet Pendenti, biex jitolbu lill-MAHs biex jiddiskutu aktar, fuq ilbażi tad-dejta ta' SCOUT, kwalunkwe popolazzjoni ta' pazjenti potenzjali li fiha jista' jiġi stabbilit bilanċ pożittiv tal-benefiċċji/riskji, l-evidenza ta' kwalunkwe effett favorevoli tat-trattament b'sibutramine meta mqabbel ma' plaċebo u miżuri oħrajn għat-tnaqqis tar-riskji.
English: The CHMP concluded that the benefit/risk balance of sibutramine-containing medicinal products is affected adversely by the results from the SCOUT study and is considered to be negative.
Maltese: Is-CHMP ikkonkluda li l-bilanċ tal-benefiċċji/riskji tal-prodotti mediċinali li fihom sibutramine jiġi affettwat b'mod avvers mir-riżultati tal-istudju SCOUT u huwa kkunsidrat bħala wieħed negattiv.
English: Reductil 10 mg trde kapsule 10 mg Capsule, hard oral use
Maltese: Reductil 10 mg trde kapsule 10 mg Kapsula, iebsa Għal użu orali
English: Reductil 15 mg trde kapsule 15 mg Capsule, hard oral use
Maltese: Reductil 15 mg trde kapsule 15 mg Kapsula, iebsa Għal użu orali
English: Reduxade 10 mg Hartkapseln 10 mg Capsule, hard oral use
Maltese: Reduxade 10 mg Hartkapseln 10 mg Kapsula, iebsa Għal użu orali
English: Reductil 10 mg - Hartkapseln 10 mg Capsule, hard oral use
Maltese: Reductil 10 mg - Hartkapseln 10 mg Kapsula, iebsa Għal użu orali
English: Reductil 15 mg - Hartkapseln 15 mg Capsule, hard oral use
Maltese: Reductil 15 mg - Hartkapseln 15 mg Kapsula, iebsa Għal użu orali
English: Reduxade 15 mg Hartkapseln 15 mg Capsule, hard oral use
Maltese: Reduxade 15 mg Hartkapseln 15 mg Kapsula, iebsa Għal użu orali
English: REDUCTIL 15 mg, capsule 15 mg Capsule, hard oral use
Maltese: REDUCTIL 15 mg, capsule 15 mg Kapsula, iebsa
English: REDUCTIL 10 mg, capsule 10 mg Capsule, hard oral use
Maltese: REDUCTIL 10 mg, capsule 10 mg Kapsula, iebsa
English: Sitrane 10 mg hard capsules 10 mg Capsule, hard oral use
Maltese: Sitrane 10 mg hard Kapsuli
English: The MAHs provided data on improvements in surrogate markers associated with sibutramine treatment but the CHMP noted that despite these effects an increased cardiovascular risk had been observed, and there were no other benefits other than those indirectly related to weight loss.
Maltese: Il-MAHs ipprovdew dejta dwar titjib fil-markaturi ta' sostituzzjoni assoċjati mat-trattament b'sibutramine iżda s-CHMP innota li minkejja dawn l-effetti, ġie osservat riskju kardjovaskulari miżjud, u ma kien hemm l-ebda benefiċċju ieħor aktar minn dawk relatati indirettament mat-tnaqqis fil-piż.
English: Reductil 10 mg Hartkapseln 10 mg Capsule, hard oral use
Maltese: Reductil 10 mg Hartkapseln 10 mg Kapsula, iebsa Għal użu orali
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SIBUTRAMINECONTAINING MEDICINAL PRODUCTS (SEE ANNEX I)
Maltese: TAL-PRODOTTI MEDIĊINALI LI FIHOM SIBUTRAMINE (ARA L-ANNESS I)
English: GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS
Maltese: U RAĠUNIJIET GĦAS-SOSPENSJONI TALAWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ
English: Reductil 15 mg Hartkapseln 15 mg Capsule, hard oral use
Maltese: Reductil 15 mg Hartkapseln 15 mg Kapsula, iebsa Għal użu orali
English: Sitrane 15 mg hard capsules 15 mg Capsule, hard oral use
Maltese: Sitrane 15 mg hard Kapsuli
English: ANNEX I LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)
Maltese: U ID-DETENTUR(I) TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI (EU/EEA)
English: Comparing sibutramine-treated responders and placebo-treated non-responders (although this comparison may be influenced by behavioural differences including compliance to diet and exercise and is not a logical or scientific comparison to make) provides the most favourable benefit/risk for sibutramine.
Maltese: It-tqabbil bejn persuni trattati b'sibutramine li rreaġixxew u persuni trattati bi plaċebo li ma rreaġixxewx (għalkemm dan it-tqabbil jista' jiġi influwenzat minn differenzi fl-imġiba inkluż losservanza għad-dieta u l-eżerċizzju u mhuwiex tqabbil loġiku jew xjentifiku li għandu jsir) jipprovdi l-benefiċċju/riskju l-aktar favorevoli għal sibutramine.
English: Reductil 10 mg hard capsules 10 mg Capsule, hard oral use
Maltese: Reductil 10 mg hard Kapsuli 10 mg Kapsula, iebsa Għal użu orali
English: Reductil 15 mg hard capsules 15 mg Capsule, hard oral use
Maltese: Reductil 15 mg hard Kapsuli 15 mg Kapsula, iebsa Għal użu orali
English: U kabelovny 130, 102 37 Prague 10
Maltese: Republika Ċeka Zentiva, k.s. U kabelovny 130, 102 37 Prague 10
English: Sibutramine treatment of all patients during the Lead-in Phase may have contributed to the smaller difference in weight loss between sibutramine and placebo-treated patients observed in the SCOUT trial compared to previous studies.
Maltese: It-trattament b'sibutramine tal-pazjenti kollha matul il-Fażi talBidu seta' kkontribwixxa għad-differenza aktar żgħira fit-tnaqqis fil-piż bejn il-pazjenti trattati b'sibutramine u bi plaċebo osservata fil-prova SCOUT meta mqabbla ma studji preċedenti.
English: Other beneficial effects on patients with regards to other system organ classes have not convincingly been shown.
Maltese: Effetti ta' benefiċċju oħrajn fuq pazjenti fir-rigward ta' klassifika tas-sistema tal-organi ma ntwerewx b'mod konvinċenti.
English: • The Committee considered that the cardiovascular safety concerns are not adequately counterbalanced by the beneficial effects of sibutramine as, on average, the weight loss achieved with the drug is modest, and may not be sustained after cessation of treatment,
Maltese: • Il-Kumitat ikkunsidra li t-tħassib dwar is-sigurezza kardjovaskulari mhuwiex kontrobilanċjat b'mod adegwat bl-effetti ta' benefiċċju ta' sibutramine għaliex, bħala medja, it-tnaqqis fil-piż miksub bil-mediċina huwa wieħed modest, u jista' jkun li ma jinżammx wara li jitwaqqaf ittrattament,
English: CR = Complete Remission
Maltese: RK = Remissjoni Kompleta
English: EU/1/06/334/001 3 vials EU/1/06/334/002 4 vials EU/1/06/334/003 10 vials EU/1/06/334/004 20 vials EU/1/06/334/005 1 vial
Maltese: EU/1/06/334/001 3 kunjetti EU/1/06/334/002 4 kunjetti EU/1/06/334/003 10 kunjetti EU/1/06/334/004 20 kunjett EU/1/06/334/005 1 kunjett
English: 1 vial 3 vials 4 vials 10 vials 20 vials
Maltese: 1 kunjett 3 kunjetti 4 kunjetti 10 kunjetti 20 kunjett
English: Adsorption and distribution
Maltese: Adsorbiment u distribuzzjoni
English: Concentrate (ml)*
Maltese: Konċentrat sterili (ml)*
English: Estimates based on non-compartmental analysis (n = 14 / n = 14)
Maltese: Estimi bbażati fuq analiżi non-kompartmentali (n = 14 / n = 14)
English: Date of latest renewal: 14 January 2016
Maltese: Data tal-aħħar tiġdid: 14 Jannar 2016.
English: België/Belgique/Belgien/ Sanofi Belgium Tél/Tel: + 32 2 710 54 00
Maltese: België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 2 710 54 00
English: Date of first authorisation: 29 May 2006.
Maltese: Data tal-ewwel awtorizzazzjoni: 29 Mejju 2006.
English: (59%), febrile neutropaenia (35%), headache (24%), rash (21%), diarrhoea (20%), pruritus (20%), pyrexia (19%), palmar-plantar erythrodysaesthesia syndrome (15%), fatigue (14%), anxiety (12%), mucosal inflammation (11%), and flushing (11%).
Maltese: uġigħ ta' ras (24%), raxx (21%), dijarea (20%), ħakk (20%), deni (19%), sindrome ta' eritrodisestesija palmar-plantar (15%), għeja kbira (14%), ansjetà (12%), infjammazzjoni tal-mukuża (11%), u fwawar
English: Other medicines and Evoltra
Maltese: Mediċini oħra u Evoltra
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Mediċini: http://www.ema.europa.eu/.
English: Each box contains 1, 3, 4, 10 or 20 vials, but not all pack sizes may be marketed.
Maltese: Kull kaxxa fiha 1, 3, 4, 10, u 20 kunjett, imma jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: 10.8 l/h/m
Maltese: 10.8 1/h/m2
English: Each box contains 1, 3, 4, 10 or 20 vials.
Maltese: Kull kaxxa fiha 1, 3, 4, 10 jew 20 kunjett.
English: 172 l/m
Maltese: 172 1/m2
English: 28.8 l/h/m
Maltese: 28.8 1/h/m2
English: (If the use of a 0.2 micrometre syringe filter is not feasible, the concentrate should be pre-filtered with a 5 micrometre filter, diluted and then administered through a 0.22 micrometre in-line filter.)
Maltese: (Jekk l-użu ta' filtru ta' sirinġa ta' 0.2 mikrometru ma jistax jintuża, il-konċentrat għandu jkun pre-filtrat b'filtru ta' 5 mikrometru, dilwit u imbagħad mogħti permezz ta' filtru in-linja ta' 0.22 mikrometru.)
English: In addition, 50/113 patients receiving clofarabine had at least severely (at least US NCI CTC Grade 3) elevated ALT, 36/100 elevated AST and 15/114 elevated bilirubin levels.
Maltese: Barra minn dan, 50/113-il pazjent li ngħataw clofarabine kellhom ta' l-anqas ALT elevat b'mod qawwi (ta' l-anqas Grad 3 ta' CTC tal-NCI ta' l-US), 36/100 AST elevat u 15/114 livelli elevati tal bilirubin.
English: The most frequent haematological laboratory abnormalities observed in patients treated with clofarabine were anaemia (83.3%; 95/114); leucopaenia (87.7%; 100/114); lymphopaenia (82.3%; 93/113), neutropaenia (63.7%; 72/113), and thrombocytopaenia (80.7%; 92/114).The majority of these events were of grade  3.
Maltese: Fit-testijiet tad-demm fil-laboratorju, l-iktar anormalitajiet frekwenti li kienu osservati f'pazjenti kkurati bi clofarabine kienu anemija (83.3%; 95/114); lewkopenija (87.7%; 100/114); limfopenija
English: Sixty-four patients of 115 (55.7%) experienced at least one vascular disorders adverse event.
Maltese: Erba' u sittin pazjent minn 115 (55.7 %) kellhom ta' l-anqas każ avvers wieħed ta' disturbi vaskulari.
English: • An M2 bone marrow ( 5% and ≤ 25% blasts) and appearance of normal progenitor cells
Maltese: • Mudullun tal-għadma M2 (≥ 5% u ≤ 25% ċelluli primittivi) u d-dehra ta' ċelluli normali proġenitriċi
English: These effects included bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells in rats at exaggerated exposure levels (150 mg/m2/day), and cell degeneration of the epididymis and degeneration of the seminiferous epithelium in dogs at clinically relevant exposure levels (> 7.5 mg/m2/day clofarabine).
Maltese: Dawn l-effetti kienu jinkludu deġenerazzjoni bilaterali ta' epiteljum seminiferus bi spermatidi miżmuma u atrofija ta' ċelluli interstitjali fil-firien f'livelli esaġerati ta' esponiment (150 mg/m2/kuljum) u deġenerazzjoni ta' cellula ta' l-epididimis u deġenerazzjoni ta' l-epiteljum seminiferus fil-klieb f'livelli ta' esponiment relevanti kliniku (≥ 7.5 mg/m2/kuljum ta' clofarabine).
English: Delayed ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at the only dose used of 225 mg/m2/day clofarabine.
Maltese: Atrofija ovarjana postposta jew deġenerazzjoni u apoptożi mukosali uterina kienu osservati fi ġrieden feminili fil-livell ta' l-unika doża li ntużat ta' 225 mg/m2/kuljum ta' clofarabine.
English: Common: Tumour lysis syndrome*
Maltese: Komuni: Sindrome ta' l-lisi tat-tumur*
English: How to store Evoltra
Maltese: X'fih Evoltra
English: Paasheuvelweg 251105 BP Amsterdam The Netherlands Manufacturer
Maltese: Genzyme Europe BV Paasheuvelweg 25 1105 BP Amsterdam L-Olanda
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, ATC code: L01BB06.
Maltese: Aġenti antineoplastiċi, antimetaboliti, Kodiċi ATC:
English: Concentrate for solution for infusion 20 mg/20 ml
Maltese: INDIVIDWALI 20 mg/20 ml
English: It should be filtered through a sterile 0.2 micrometre syringe filter and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
Maltese: Għandha tkun filtrata permezz ta' filter ta' sirinġa sterili ta' 0.2 mikrometru u mbagħad dilwita b'infuzjoni għal ġol-vina ta' sodium chloride ta' 9 mg/ml (0.9%) biex tipproduċi volum totali skond leżempji li ngħataw fit-tabella t'hawn taħt.
English: PR = Partial Remission
Maltese: RP = Remissjoni Parzjali
English: Each vial of Evoltra contains 180 mg of sodium chloride.
Maltese: Kull kunjett ta' Evoltra fih 180 mg ta' sodium chloride.
English: Genzyme Limited 37 Hollands Road Haverhill Suffolk
Maltese: 37 Hollands Road Haverhill, Suffolk CB9 8PU Ir-Renju Unit
English: Thirteen events of tumour lysis syndrome, capillary leak syndrome or SIRS have been reported; SIRS (2 events; both were considered to be serious), capillary leak syndrome (4 events; 3 of which were considered serious and related) and tumour lysis syndrome (7 events; 6 of which were considered related and 3 of which were serious).
Maltese: Tlettax-il avveniment tas-sindrome tal-lisi tattumur, sindrome tat-tnixxija kapillari jew SIRS kienu rrappurtati; SIRS (2 każi; it-tnejn kienu meqjusa bħala serji), sindrom ta' nixxija kapillari (4 każi; 3 minnhom kienu kkunsidrati li huma serji u marbuta mal-mediċina), u sindrom ta' lysis ta' tumur (7 każi; 6 minnhom kienu kkunsidrati li kienu marbuta mal-mediċina u 3 minnhom kienu serji).
English: The threshold for developmental toxicity was considered to be 6 mg/m 2/day in rats and 1.2 mg/m 2/day in rabbits.
Maltese: 6 mg/m2/kuljum fil-firien u 1.2 mg/m2/kuljum fil-fniek.
English: In addition, clofarabine possesses greater resistance to cellular degradation by adenosine deaminase and decreased susceptibility to phosphorolytic cleavage than other active substances in its class whilst the affinity of clofarabine triphosphate for DNA polymerase  and ribonucleotide reductase is similar to or greater than that of deoxyadenosine triphosphate.
Maltese: Barra minn dan, clofarabine fih reżistenza akbar għad-degradazzjoni ċellulari b'adenosin deaminejs u suxxettibilità mnaqqsa għal qsim fosforolitiku minn sustanzi attivi oħra fil-klassi tiegħu waqt li laffinità ta' clofarabine triphosphate għad-DNA polymerejs α u ribonukleotijd reduktejs hi simili għal jew akbar minn dik ta' deoxyadenosine triphosphate.
English: Before Evoltra is given to you, it will be diluted in a sodium chloride solution (salt and water).
Maltese: Qabel ma tingħata Evoltra, hi ser tkun dilwita f'soluzzjoni ta' sodium chloride (melħ u ilma).
English: Forty-one patients of 115 (35.7%) experienced at least one renal and urinary disorders adverse event.
Maltese: Wieħed u erbgħin pazjent minn 115 (35.7 %) esperjenzaw ta' l-anqas każ avvers wieħed ta' disturbi fil-kliewi u tas-sistema urinarja.
English: Adverse reactions are listed by system organ class and frequency (very common ( 1/10); common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100; rare ( 1/10,000 to < 1/1,000) and very rare (< 1/10,000)) in the table below.
Maltese: (komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100); rari
English: Plasma protein binding Serum albumin Elimination:  half-life of clofarabine
Maltese: Irbit tal-proteina fil-plażma Serum albumin
English: Pericardial effusion and pericarditis were reported as an adverse event in 9% (10/115) of patients.
Maltese: Effużjoni perikardjali u perikardite kienu rrapportati bħala każ avvers f'9% (10/115) tal-pazjenti.
English: Each 20 ml vial contains 20 mg of clofarabine
Maltese: Kull kunjett ta' 20 ml fih 20 mg ta' clofarabine
English: Although transplantation rate was not a study endpoint, 10/61 patients (16%) went on to receive a HSCT after treatment with clofarabine (3 after achieving a CR, 2 after a CRp, 3 after a PR, 1 patient that was considered a treatment failure by the IRRP and 1 that was considered not evaluable by the IRRP).
Maltese: Għalkemm ir-rata ta' trapjanti ma kienx l-għan aħħari ta' l-istudju, 10/61 pazjenti (16 %) komplew sejrin u rċevew HSCT wara t trattament bil-clofarabine (3 wara li kisbu RK, 2 wara RKp, 3 wara RP, pazjent 1 li kien meqjus li m'għaddiex mit-trattament mill-IRRP u 1 kien meqjus li ma jistax jiġi evalwat mill-IRRP).
English: Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide
Maltese: Pazjenti li fil-passat sarilhom trapjant ematopoietiku ta' ċelluli staminali (HSCT) jistgħu jkunu f'riskju ogħla għal epatotossiċità li hi suġġestiva ta' mard okklużiv tal-vini (VOD) wara l-kura bi clofarabine (40 mg/m2) meta jintuża flimkien ma' etoposide (100 mg/m2) u cyclophosphamide (440 mg/m2).
English: Four renal adverse events in 115 patients were considered to be related to clofarabine, none of which were serious; haematuria (3 events) and acute renal failure (1 event) (see sections 4.3 and 4.4).
Maltese: Erba' avvenimenti avversi tal-kliewi f'115-il pazjent kienu meqjusa li kienu marbuta ma' clofarabine, fejn l-ebda wieħed minnhom ma kien serju; ematurja (3 każi) u insuffiċjenza akut talkliewi (każ 1) (ara sezzjonijiet 4.3 u 4.4).
English: Evoltra 1 mg/ml concentrate for solution for infusion clofarabine
Maltese: TAL-PRODOTT MEDIĊINALI Evoltra 1 mg/ml konċentrat għal solużjoni għall-infużjoni clofarabine
English: Increases in postimplantation loss, reduced foetal body weights and decreased litter sizes together with increases in the number of malformations (gross external, soft tissue) and skeletal alterations (including retarded ossification) were reported in rats receiving doses which produced approximately 2 to 3 fold the clinical exposure (54 mg/m2/day) and in rabbits receiving 12 mg/m 2/day clofarabine.
Maltese: Żidiet fit-telf ta' postimplantazzjoni, nuqqas fil-piż tal-ġisem foetali u tnaqqis fid-daqs tal-boton flimkien ma' żieda fin-numru ta' malformazzjonijiet (esterni grossi, tessuti rotob), tibdil skeletrali (inkluż ossifikazzjoni ritardata) kienu rrapportati filfirien li kienu qed jirċievu dożi li pproduċew madwar bejn 2 sa 3 darbiet ta' esponiment kliniku (54 mg/m2/kuljum) u fi fniek li kienu qed jirċievu 12 mg/m2/kuljum ta' clofarabine.
English: • The use of prophylactic steroids (e.g., 100 mg/m hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak.
Maltese: • L-użu ta' sterojdi profilattiċi (eż., 100 mg/m2 ta' hydrocortisone f'Jiem 1 sa 3), jista' jkun ta'
English: Evoltra 1 mg/ml concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Evoltra 1 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: If persistent leukaemia is not evident, it is recommended that the dose for the next cycle be reduced by 25% of the previous dose following recovery of ANC to ≥ 0.75 × 10
Maltese: Jekk il-lewkimja persistenti mhix evidenti, hu rrakkomandat lid-doża għaċ-ċiklu li jmiss għandha titnaqqas b'25% tad doża preċedenti wara l-irkuprar ta' l-ANC għal ≥ 0.75 × 109/l.
English: Evoltra may harm both male and female reproductive organs.
Maltese: Evoltra għandha mnejn tagħmel ħsara lill-organi riproduttivi maskili u dawk feminili.
English: Excipient with known effect Each 20 ml vial contains 180 mg of sodium chloride.
Maltese: Kull kunjett ta' 20 ml fih 180 mg ta' sodium chloride.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il portal elettroniku Ewropew tal-mediċini.
English: Sanofi S.p.A Tel: +39 02 39394275
Maltese: Tel: +39 02 39394275
English: Clinical efficacy: To enable systematic evaluation of the responses seen in patients, an unblinded Independent Response Review Panel (IRRP) determined the following response rates based on definitions produced by the Children's Oncology Group:
Maltese: Reviżjoni tar-Rispons Indipendenti (IRRP) mhux għami, iddetermina dawn ir-rati ta' risponsi li ġejjin ibbażati fuq id-definizzjonijiet ipproduċuti mill-Grupp ta' l-Onkoloġija tat-Tfal:
English: Intravenous infusion of 52 mg/m clofarabine produced equivalent exposure across a wide range of weights.
Maltese: Infużjoni għal ġol-vini ta' 52 mg/m2 ta' clofarabine ipproduċiet esponiment ekwivalenti li kien mifrux fuq firxa wiesgħa ta' piżijiet.
English: Each vial contains 180 mg of salt (sodium chloride).
Maltese: Kull kunjett fih 180 mg ta' melħ (sodium chloride).
English: 9/l.
Maltese: IL-PROVVISTA U L
English: Adverse reactions considered to be related to clofarabine reported at frequencies ≥ 1/1,000 (i.e. in > 1/115 patients) in clinical trials and post-marketing
Maltese: Reazzjonijiet avversi meqjusa bħala marbuta ma' clofarabine irrapportati fi frekwenzi ≥ 1/100 (p.e. f'> 1/115 pazjenti) fi studji kliniċi u wara t-tqegħid fis-suq
English: Evoltra is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Maltese: Evoltra jintuża biex jikkura tfal (≥ sena), teenagers u żgħażagħ sa 21 sena li jbatu minn lewkimja akuta limfoblastika (ALL) meta trattamenti oħra li ntużaw qabel ma ħadmux jew ma baqgħux jaħdmu.
English: Dosing commenced at 11.25 with escalation to 15, 30, 40, 52 and 70 mg/m2/day by intravenous infusion for 5 days every
Maltese: b'eskalazzjoni għal 15, 30, 40, 52 u 70 mg/m2/kuljum b'infużjoni għal ġol-vini għal 5 ġranet minn kull 2 sa 6 ġimgħat dejjem jiddependi mit-tossiċità u r-rispons.
English: Genzyme Limited
Maltese: Genzyme Ltd.
English: Genotoxicity studies demonstrated that clofarabine was not mutagenic in the bacterial reverse mutation assay, but did induce clastogenic effects in the non-activated chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells and in the in vivo rat micronucleus assay.
Maltese: Studji ta' ġenotossiċità wrew li clofarabine ma kienx mutaġeniku fl-analiżi tal-mutazzjoni riversibbli tal-bakterja, imma induċa effetti klastoġeniċi fl'aberrazzjoni tal-analiżi tal-kromożomi mhux attivati fiċ-ċelluli ta' l-Ovarji tal-Hamster Ċiniż (CHO) u f'analiżi in vivo mikronuklejuż fil-far.
English: Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine
Maltese: Disa' mis-17 ilpazjent ALL kienu kkurati bi clofarabine b'doża ta' 52 mg/m2/kuljum ta' clofarabine.