FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the CHMP maintains its initial opinion that the results of the submitted clinical studies are not sufficient to establish the efficacy of Alcover (sodium oxybate) granules in the maintenance of alcohol abstinence and treatment of alcohol withdrawal syndrome (AWS) as there are several drawbacks in the design of these clinical studies, including open-label designs, small sample size, choice of patient population and absence of clearly defined, statistically significant outcomes, DRL not being recorded at baseline, low dose of comparator, and lack of assessment of effects on seizures or delirium as the most concerning events in alcohol withdrawal.
Maltese: B'mod globali, is-CHMP iżomm l-opinjoni inizjali tiegħu li r-riżultati tal-istudji kliniċi ppreżentati mhumiex biżżejjed biex tiġi stabbilita l-effikaċja ta' Alcover granuli (sodium oxybate) filmanteniment ta' astinenza mill-alkoħol u fil-kura ta' sindrome ta' twaqqif tal-alkoħol (AWS) peress li hemm diversi nuqqasijiet fit-tfassil ta' dawn l-istudji kliniċi, inkluż tfassil ta' tikketta miftuħa, daqs ta' kampjunar żgħir, għażla tal-popolazzjoni tal-pazjenti u nuqqas ta' riżultati definiti b'mod ċar statistikament sinifikanti, DRL li ma ġiex irreġistrat fil-linja bażi, doża baxxa ta' komparatur, nuqqas ta' valutazzjoni tal-effetti fuq l-attakki ta' puplesija jew delirju bħala l-aktar avvenimenti ta' tħassib fit-twaqqif tal-alkoħol.
English: Regarding the safety of Alcover granules, the risk of Abuse / Misuse / Diversion / Overdose / Dependence / CNS / Respiratory Depression in Very High HDRL patients is well-recognized.
Maltese: Fir-rigward tas-sigurtà ta' Alcover granuli, ir-riskju ta' Abbuż / Użu Ħażin / Devjazzjoni / Doża Eċċessiva / Dipendenza / CNS / Dipressjoni Respiratorja f'pazjenti b'HDRL Għoli Ħafna huwa rikonoxxut sew.
English: Finally, it was noticed that it could be anticipated that long-term use of sodium oxybate might have effects on cognitive function.
Maltese: Finalment, ġie nnutat li seta' jiġi antiċipat li użu fit-tul ta' sodium oxybate jista' jkollu effetti fuq ilfunzjoni konjittiva.
English: Risks of abuse / misuse are higher in polymedication users (cocaine or heroin) and/or patients with severe psychiatric comorbidities.
Maltese: Ir-riskji ta' abbuż / użu ħażin huma ogħla f'utenti ta' polimedikazzjoni (kokaina jew eroina) u/jew f'pazjenti b'komorbiditajiet psikjatriċi severi.
English: • The Committee reviewed the totality of the data provided by the applicant in writing and in the oral explanations and related to the efficacy and safety of Alcover and associated names, 750 mg, 1250 mg, 1750 mg granules in sachets in the proposed indications for the maintenance of alcohol abstinence and the treatment of alcohol withdrawal syndrome; The Committee also considered the grounds submitted by the applicant within the re-examination procedure, and the views from an ad-hoc expert group.
Maltese: • Il-Kumitat irreveda t-totalità tad-dejta pprovduta mill-applikant bil-miktub u fl-ispjegazzjonijiet bil-fomm u relatati mal-effikaċja u mas-sigurtà ta' Alcover u l-ismijiet assoċjati, 750 mg, 1250 mg, 1750 mg granuli fi qratas fl-indikazzjonijiet proposti għall-manteniment ta' astinenza mill-alkoħol u għall-kura ta' sindrome ta' twaqqif tal-alkoħol; Il-Kumitat ikkunsidra wkoll irraġunijiet ippreżentati mill-applikant fil-proċedura ta' eżaminazzjoni mill-ġdid, u l-fehmiet millgrupp ta' esperti ad-hoc.
English: Furthermore, the number of patients included was quite small, and only Gallimberti showed positive results, whereas the results on abstinence rate in Very High DRL patients from study SMO032/10/03 and Di Bello 1995 are deemed inconclusive.
Maltese: Barra minn hekk, in-numru ta' pazjenti inklużi kien pjuttost żgħir, u Gallimberti biss wera riżultati pożittivi, filwaqt li r-riżultati dwar ir-rata ta' astinenza fil-pazjenti b'DRL Għoli Ħafna mill-istudju SMO032/10/03 u Di Bello 1995 huma meqjusa inkonklużivi.
English: As the objections raised on the efficacy, safety and overall benefit-risk during the procedure were considered to be a potential serious risk to public health and no agreement could be reached during the CMDh procedure, the procedure was referred to the CHMP under Article 29(4) of Directive 2001/83/EC by the RMS Austria.
Maltese: Peress li l-oġġezzjonijiet li tqajmu dwar l-effikaċja, is-sigurtà u l-benefiċċju u r-riskju globali waqt ilproċedura ġew ikkunsidrati li kienu riskju serju potenzjali għas-saħħa pubblika u peress li ma seta' jintlaħaq l-ebda qbil waqt il-proċedura tas-CMDh, il-proċedura ġiet riferuta lis-CHMP skont lArtikolu 29(4) tad-Direttiva 2001/83/KE mill-RMS l-Awstrija.
English: In order to demonstrate the efficacy of sodium oxybate granules in Very High DRL patients - the target population that was identified post-hoc, the applicant performed several post-hoc subgroup analyses and meta-analyses of the data obtained in clinical trials in medium and long-term maintenance of abstinence.
Maltese: Sabiex tintwera l-effikaċja tal-granuli ta' sodium oxybate fil-pazjenti b'DRL Għoli Ħafna - il-popolazzjoni filmira li ġiet identifikata post-hoc, l-applikant wettaq diversi analiżijiet tas-sottogrupp post-hoc u metaanaliżijiet tad-dejta miksuba fil-provi kliniċi fil-manteniment medju u fit-tul tal-astinenza.
English: The results of the submitted efficacy studies cannot be considered to provide sufficiently robust evidence to establish the efficacy of Alcover (sodium oxybate) granules in the maintenance of alcohol abstinence and treatment of alcohol withdrawal syndrome (AWS).
Maltese: Ir-riżultati tal-istudji dwar l-effikaċja ppreżentati ma jistgħux jiġu kkunsidrati li jipprovdu evidenza robusta biżżejjed sabiex tiġi stabbilita l-effikaċja ta' Alcover (sodium oxybate) granuli fil-manteniment ta' astinenza mill-alkoħol u l-kura ta' sindrome ta' twaqqif tal-alkoħol (AWS).
English: The experts considered that the company has generated an interesting hypothesis which requires confirmation in a prospective, well designed trial in the target population.
Maltese: L-esperti kkunsidraw li l-kumpanija ġġenerat ipoteżi interessanti li teħtieġ konferma fi prova prospettiva mfassla sew fil-popolazzjoni fil-mira.
English: Sodium oxybate is a partial agonist on both GABAA and GABAB receptors and also binds with high affinity to GHB-specific receptors.
Maltese: Sodium oxybate huwa agonista parzjali kemm fuq riċetturi ta' GABAA kif ukoll ta' GABAB u jorbot ukoll b'affinità għolja ma' riċetturi speċifiċi għal GHB.
English: While the methodological challenges to run a randomised clinical trial in this field were acknowledged by the experts, they recommended the conduction of a prospective, multicentre placebo-controlled, feasible study in order to confirm the results in the subpopulation of interest.
Maltese: Waqt li l-isfidi metodoloġiċi biex issir prova klinika randomizzata f'dan il-qasam ġew rikonoxxuti mill-esperti, dawn irrakkomandaw li jsir studju prospettiv, multiċentriku, ikkontrollat mill-plaċebo, affidabbli sabiex jiġu kkonfermati r-riżultati fil-subpopolazzjoni ta' interess.
English: With regards to the identified and potential risks related to the use of Alcover granules, in particular the risks of diversion, abuse, switch of addiction and toxicity if co-administered with alcohol, the Committee considered that the feasibility, proportionality and effectiveness of the proposed risk minimisation measures cannot be deemed evident in the absence of a demonstrated efficacy in the claimed indications.
Maltese: Fir-rigward tar-riskji identifikati u potenzjali relatati mal-użu ta' Alcover granuli, b'mod partikolari r-riskji ta' diverżjoni, abbuż, qlib ta' dipendenza u tossiċità jekk jingħataw flimkien mal-alkoħol, ilKumitat ikkunsidra li l-affidabbiltà, il-proporzjonalità u l-effettività tal-miżuri tal-imminimizzar tarriskju proposti ma jistgħux jitqiesu evidenti fin-nuqqas ta' effikaċja murija fl-indikazzjonijiet dikjarati.
English: • With regards to the identified and potential risks related to the use of Alcover granules in sachets, the Committee considered the proposed risk minimisation measures, mainly to mitigate the potential risk of abuse, switch of addiction/ dependence and withdrawal in the light of the proposed indications;
Maltese: • Fir-rigward tar-riskji identifikati u potenzjali relatati mal-użu ta' Alcover granuli fi qratas, ilKumitat ikkunsidra l-miżuri tal-imminimizzar tar-riskju proposti, prinċipalment biex jimmitigaw ir-riskju potenzjali ta' abbuż, il-qlib tad-dipendenza u t-twaqqif fid-dawl tal-indikazzjonijiet proposti;
English: • The Committee was of the view that the data submitted in support of the efficacy of Alcover granules in sachets in the claimed indications suffers from relevant methodological limitations relating to the design of the studies (such as insufficient sample size, selection of the patient population, post-hoc analyses).
Maltese: • Il-Kumitat kien tal-fehma li d-dejta ppreżentata biex tappoġġja l-effikaċja ta' granuli ta' Alcover granuli fi qratas fl-indikazzjonijiet dikjarati għandha limitazzjonijiet metodoloġiċi rilevanti li jirrelataw mat-tfassil tal-istudji (bħal daqs ta' kampjunar insuffiċjenti, għażla talpopolazzjoni tal-pazjent, analiżijiet post-hoc).
English: The applicant performed a subpopulation analysis (meta-analysis of seven RCTs and observational studies), which was not sufficiently robust to establish efficacy of the medicinal product in the claimed indication.
Maltese: L-applikant wettaq analiżi tas-subpopolazzjoni (metaanaliżi ta' seba' RCTs u studji ta' osservazzjoni), li ma kinitx robusta biżżejjed biex tistabbilixxi l-effikaċja tal-prodott mediċinali fl-indikazzjoni dikjarata.
English: The target population expected to benefit most should be refined based on the data available and expert advice.
Maltese: Il-popolazzjoni fil-mira li mistennija tibbenifika l-aktar għandha tiġi raffinata abbażi tad-data disponibbli u parir espert.
English: Regarding safety, concerns were expressed with regards to the potential risk of misuse/abuse/dependence, and other identified safety issues, which considered too substantial and difficult to mitigate by the proposed RMMs.
Maltese: Fir-rigward tas-sigurtà, kien hemm tħassib espress fir-rigward tar-riskju potenzjali ta' użu ħażin/abbuż/dipendenza, u xi kwistjonijiet tas-sigurtà identifikati oħra, li ġew ikkunsidrati bħala wisq sostanzjali u diffiċli biex jiġu mmitigati mill-RMMs proposti.
English: Grade 3/4
Maltese: Grad 3/4
English: Age, race, and gender
Maltese: Età, razza u sess
English: Day 1 (as per standard medical practice)
Maltese: Jum 1 (skont prassi medika standard)
English: See section 5.2 for available data from in vitro studies.
Maltese: Ara sezzjoni 5.2 għal dejta disponibbli minn studji in vitro.
English: • The active substance is gemtuzumab ozogamicin.
Maltese: • Is-sustanza attiva hi gemtuzumab ozogamicin.
English: Total bilirubin > 2 × ULN and AST and/or ALT > 2.5 × ULN
Maltese: Bilirubina totali > 2 × ULN u AST u/jew ALT > 2.5 × ULN
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1277/001
Maltese: EU/1/18/1277/001
English: Consolidation Course 2a,b
Maltese: Kors ta' Konsolidazzjoni a,b
English: Discontinue MYLOTARG (see section 4.4).
Maltese: Waqqaf MYLOTARG (ara sezzjoni 4.4).
English: Consolidation
Maltese: Konsolidazzjoni
English: Probability (%) calculated by the product-limit method; CI calculated from the log log transformation of survival probability using a normal approximation and the Greenwood formula.
Maltese: Probabbiltà (%) ikkalkulata mill-metodu prodott-limitu; CI kkalkulat mittrasformazzjoni log-log ta' probabbiltà ta' sopraviveza permezz ta' approssimazzjoni normali u l-formula Greenwood.
English: f. Overall response difference; CI based on Santner and Snell method.
Maltese: Differenza fir-rispons globali; CI bbażat fuq il-metodu Santner u Snell.
English: Infusion related reactions (including anaphylaxis)
Maltese: Reazzjonijiet relatati mal-infużjoni (inkluż anafilassi)
English: Tumour lysis syndrome (TLS)
Maltese: Sindrome ta' liżi tat-tumur (TLS)
English: Combinationa
Maltese: Kombinazzjoni
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is a substrate of P-glycoprotein (P-gp).
Maltese: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide huwa substrat ta' glikoproteina-P (P-gp).
English: Abbreviations: C=cytarabine; D=daunorubicin; GO=gemtuzumab ozogamicin; mITT=modified intent-to-treat.
Maltese: D=daunorubicin; GO=gemtuzumab ozogamicin; mITT=intenzjoni li tittratta modifikata.
English: In the combination therapy study ALFA-0701, clinically relevant serious adverse reactions were hepatotoxicity, including VOD/SOS (3.8%), haemorrhage (9.9%), severe infection (41.2%), and tumour lysis syndrome (1.5%).
Maltese: Fl-istudju ta' terapija kombinata ALFA-0701, reazzjonijiet avversi serji klinikament rilevanti kienu epatotossiċità, inkluż VOD/SOS (3.8%), emorraġija (9.9%), infezzjoni severa (41.2%), u sindrome ta' liżi tat-tumur (1.5%).
English: The primary endpoint was event-free survival (EFS).
Maltese: Il-punt aħħari primarju kien sopravivenza mingħajr avvenimenti (EFS - event-free survival).
English: c. 2-sided p-value from the log-rank test.
Maltese: c. valur-p miż-żewġ naħat mit-test log-rank.
English: b: Fractionated dosing refers to MYLOTARG dose of 3 mg/m2 on days 1, 4, 7.
Maltese: b: Dożaġġ frazzjonat jirreferi għal doża ta' MYLOTARG ta' 3 mg/ m f'jiem 1, 4, 7.
English: Overall response % [95% CI]e CR
Maltese: Rispons globali % [CI ta' 95%] CR
English: 5 studies; N per study (range) 12-30; 28.4%
Maltese: Infezzjoni 5 studji; N għal kull studju (firxa) 12-30; 28.4%
English: Hepatotoxicity, including hepatic VOD/SOS
Maltese: Epatotossiċità, inkluż VOD/SOS
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
Maltese: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
English: g. Based on Fisher's exact test.
Maltese: Ibbażat fuq test eżatt ta' Fisher.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 April 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' April 2018
English: Eligible patients were between 50 and 70 years of age with previously untreated de novo AML (Study ALFA-0701).
Maltese: Il-pazjenti eliġibbli kienu ta' età bejn 50 u 70 sena b'AML de novo li ma ġietx ikkurata preċedentement (Studju ALFA-0701).
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to inhibit the activities of P-gp, breast cancer resistance protein (BCRP), bile salt export pump (BSEP), multidrug resistance associated protein (MRP) 2, multidrug and toxin extrusion protein (MATE)1 and MATE2K, organic anion transporter (OAT)1 and OAT3, organic cation transporter (OCT)1 and OCT2, and organic anion transporting polypeptide (OATP)1B1 and OATP1B3 at clinically relevant concentrations.
Maltese: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide kellu potenzjal baxx li jinduċi l-attivitajiet ta' P-gp, proteina ta' reżistenza għall-kanċer tas-sider (BCRP, breast cancer resistance protein), pompa ta' esportazzjoni tal-melħ tal-bila (BSEP, bile salt export pump), proteina assoċjata mar-reżistenza għal ħafna mediċini (MRP, multidrug resistance-associated protein) 2, proteina ta' estrużjoni ta' ħafna mediċini u tat-tossini (MATE, multidrug and toxin extrusion protein)1 u MATE2K, trasportatur anijoniku organiku (OAT)1 u OAT3, trasportatur katjoniku organiku (OCT)1 u OCT2, u trasportaturi ta' polypeptide trasportanti anijoniku organiku (OATP)1B1 u OATP1B3 b'konċentrazzjonijiet klinikament rilevanti.
English: As with all therapeutic proteins, there is potential for immunogenicity.
Maltese: Bħal kull proteina terapewtika, hemm potenzjal għall-immunoġeniċità.
English: The analysis included 405 patients in the following NCI ODWG impairment status categories: mild (B1, n=58 and B2, n=19), moderate (C, n=6), and normal hepatic function (n=322) (see section 4.2).
Maltese: L-analiżi inkludiet 405 pazjent fil-kategoriji tal-istatus ta' indeboliment ta' NCI ODWG li ġejjin: ħafif (B1, n=58 u B2, n=19), moderat (C, n=6), u funzjoni epatika normali (n=322) (ara sezzjoni 4.2).
English: The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: 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), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma ppreżentati skont is-sistema tal-klassifika tal-organi (SOC) u l-kategoriji ta' frekwenza, definiti bl-użu tal-konvenzjoni li ġejja: komuni ħafna ( 1/10), komuni ( 1/100 sa < 1/10), mhux komuni ( 1/1,000 sa < 1/100), rari ( 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Hepatotoxicity, including hepatic venoocclusive disease/sinusoidal obstruction syndrome (VOD/SOS)
Maltese: Epatotossiċità, inkluż marda tal-fwied venookklużiva/sindrome ta' ostruzzjoni sinusojdali (VOD/SOS)
English: In the combination setting, the response rate was 49.0% with non-fractionated MYLOTARG (3 studies) and 38.8% with fractionated MYLOTARG (2 studies).
Maltese: Fil-kuntest ta' kombinazzjoni, ir-rata ta' rispons kienet ta' 49.0% b'MYLOTARG mhux frazzjonat (3 studji) u 38.8% b'MYLOTARG frazzjonat (2 studji).
English: CD33 expression on AML blasts by flow cytometry harmonised from local laboratory results was determined in 194/271 (71.6%) patients overall.
Maltese: L-espressjoni tas-CD33 fuq il-blasts tal-AMl minn ċitometrija tal-fluss armonizzata mir-riżultati tallaboratorju lokali ġiet determinata f'194/271 (71.6%) pazjent globalment.
English: N-acetyl gamma calicheamicin is covalently attached to the antibody via an AcBut (4-(4-acetylphenoxy) butanoic acid) linker.
Maltese: N-acetyl gamma calicheamicin teħel b'mod kovalenti mal-antikorp permezz ta' AcBut (4-(4-acetylphenoxy) butanoic acid) linker.
English: EFS and OS analysed by cytogenetic risk classification and cytogenetic/molecular risk classification are presented in Table 9 and Table 10 below.
Maltese: EFS analizzata mill-klassifika tar-riskju ċitoġenetiku u l-klassifika tarriskju ċitoġenetiku/molekulari hija ppreżentata f'Tabella 9 u 10 hawn taħt.
English: Overall, 59.0% and 65.3% of patients had documented favourable/intermediate-risk disease by the National Comprehensive Cancer Network (NCCN) and European LeukaemiaNet (ELN) 2010 risk classifications, respectively.
Maltese: B'mod globali, 59.0% u 65.3% tal-pazjenti kellhom marda ta' riskju favorevoli/intermedju dokumentata millklassifiki ta' riskju tan-Netwerk ta' Kanċer Komprensiv Nazzjonali (NCCN, National Comprehensive Cancer Network) u mil-LewkimjaNet Ewropea (ELN, European LeukaemiaNet) 2010, rispettivament.
English: a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer-Crowley method with log-log transformation.
Maltese: Medjan stmat bil-metodu Kaplan-Meier; CI bbażat fuq il-metodu Brookmeyer-Crowley bi trasformazzjoni log-log.
English: Effect of other medicinal products on gemtuzumab ozogamicin
Maltese: Effett ta' prodotti mediċinali oħra fuq gemtuzumab ozogamicin
English: S ys tem organ clas s Frequency
Maltese: Sistema tal-klassifika tal-organi Frekwenza
English: a. See Table 3 and Table 4 for additional dose modification information.
Maltese: Ara Tabella 3 u Tabella 4 għal informazzjoni addizzjonali dwar modifikazzjoni fid-doża.
English: Few patients (13.7%) had low CD33 expression (less than 30% of blasts).
Maltese: Ftit pazjenti (13.7%) kellhom espressjoni tas-CD33 baxxa (inqas minn 30% tal-blasts).
English: b. Estimated from Kaplan-Meier curve.
Maltese: Stmat mill-kurva Kaplan-Meier.
English: Persistent neutropenia
Maltese: Newtropenija persistenti
English: Overall survival by AML risk classifications from study ALFA-0701 (mITT Population) MYLOTARG + daunorubicin + cytarabine daunorubicin + cytarabine
Maltese: Sopravivenza mingħajr avvenimenti mill-evalwazzjoni tal-investigatur skont ilklassifiki tar-riskju ta' AML mill-istudju ALFA-0701 (Populazzjoni mITT) MYLOTARG + daunorubicin + cytarabine daunorubicin + cytarabine
English: Interactions with other medicinal products
Maltese: Interazzjonijiet mediċinali
English: Kaplan-Meier plot of event-free survival by investigator assessment from study ALFA-0701 (mITT population)
Maltese: Plot ta' Kaplan-Meier għal sopravivenza mingħajr avvenimenti mill-evalwazzjoni tal-investigatur minn studju ALFA-0701 (popolazzjoni mITT)
English: After reconstitution (see section 6.6), the concentrated solution contains 1 mg/mL gemtuzumab ozogamicin.
Maltese: Wara r-rikostituzzjoni (ara sezzjoni 6.6), is-soluzzjoni konċentrata fiha 1 mg/mL gemtuzumab ozogamicin.
English: Investigations *** Very common
Maltese: Investigazzjonijiet *** Komuni ħafna
English: (13.0%), Upper respiratory tract infection (4.3%), Bacterial infection (3.6%), Viral infection (24.2%), Gastrointestinal infection (3.3%), Skin infection (7.9%), and Other infections (19.5%).
Maltese: 5%), Infezzjoni fl-apparat respiratorju t'isfel (13.0%), Infezzjoni fl-apparat respiratorju ta' fuq (4.3%), Infezzjoni batterika (3.6%), Infezzjoni virali (24.2%), Infezzjoni gastrointestinali (3.3%), Infezzjoni tal-ġilda (7.9%), u Infezzjonijiet oħra (19.5%).
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 3, 6, and 9
Maltese: 3 mg/m2/doża (sa massimu ta' kunjett wieħed ta' 5 mg) f'Jiem 3, 6 u 9
English: Infection*a
Maltese: *a
English: Dose modification of MYLOTARG is recommended based on individual safety and tolerability (see section 4.4).
Maltese: Il-modifikazzjoni fid-doża ta' MYLOTARG hija rakkomandata abbażi tas-sigurtà u tat-tollerabilità individwali (ara sezzjoni 4.4).
English: Pfizer Ελλάς A.E. Τηλ: +30 210 6785 800
Maltese: Τηλ: +30 210 6785 800
English: The median study size was 15 patients, with a range of 5-105 patients.
Maltese: Id-daqs medju tal-istudju kien ta' 15-il pazjent, b'medda ta' 5-105 pazjenti.
English: The number of patients with persistent thrombocytopenia remained similar across treatment courses (8 [7.4%] patients at the induction phase and 8 [8.5%] patients at the consolidation 1 phase and 10 [13.2%] patients at the consolidation 2 phase).
Maltese: In-numru ta' pazjenti bi tromboċitopenija persistenti baqa' simili fil-korsijiet ta' kura (8 [7.4%] pazjenti fil-fażi ta' induzzjoni u 8 [8.5%] pazjenti fil-fażi ta' konsolidazzjoni 1 u 10 [13.2%] pazjenti fil-fażi ta' konsolidazzjoni 2).
English: • Inflammation of the oesophagus (swallowing tube)
Maltese: • Infjammazzjoni tal-esofagu (tubu minn fejn tibla')
English: The secondary endpoints included CR and CRp rates, relapse-free survival (RFS), overall survival (OS), and safety of the combination DA with or without MYLOTARG.
Maltese: Il-punti aħħarin sekondarji inkludew ir-rati ta' CR u CRp, sopravivenza mingħajr rikaduta (RFS, relapse-free survival), is-sopravivenza globali (OS, overall survival), u s-sigurtà tal-kombinazzjoni DA ma' jew mingħajr MYLOTARG.
English: Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; SOS=sinusoidal obstruction syndrome; ULN=upper limit of normal; VOD=venoocclusive disease.
Maltese: SOS=sindrome ta' ostruzzjoni sinusojdali; ULN=limitu ta' fuq tan-normal; VOD=marda venookklużiva.
English: In the combination therapy study in patients with previously untreated de novo AML treated with fractionated doses of gemtuzumab ozogamicin in combination with chemotherapy, Grade 3/4 decreases in leukocytes, neutrophils, and platelets were observed in 131 (100%), 124 (96.1%), and 131 (100%) patients, respectively.
Maltese: Fl-istudju ta' terapija kombinata f'pazjenti b'AML de novo li ma ġietx ikkurata preċedentement li ġew ikkurati b'dożi frazzjonati ta' gemtuzumab ozogamicin flimkien mal-kimoterapija, ġie osservat tnaqqis ta' Grad 3/4 fil-lewkoċiti, fin-newtrofili u fil-plejtlits f'131 (100%), 124 (96.1%), u 131 (100%) pazjent, rispettivament.
English: • It is recommended that the infusion container be made of polyvinyl chloride (PVC) with DEHP, or polyolefin (polypropylene and/or polyethylene).
Maltese: • Huwa rakkomandat li l-kontenitur tal-infużjoni jsir minn polyvinyl chloride (PVC) b'DEHP, jew polyolefin (polypropylene u/jew polyethylene).