FrancophonIA/ELRC3.0 huggingface dataset:
English: In the case of treatment failure associated with S. aureus, the presence of strains possessing additional virulence factors (such as PantonValentine Leukocidin) should be considered.
Maltese: Fil-każ ta' falliment tat-trattament assoċjat ma' S. aureus, ilpreżenza ta' razez li jkollhom fatturi virulenti addizzjonali (b ħal Panton-Valentine Leukocidin) għandha tkun
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew fi żmien 60 jum minn meta jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Retapamulin ointment should only be used in pregnancy when topical antibacterial therapy is clearly indicated and the use of retapamulin is considered to be preferable to administration of a systemic antibacterial medicinal product.
Maltese: Għandha tingħata attenzjoni għall-gwida uffiċjali dwar l-użu adattat ta' prodotti mediċinali antibatteriċi.
English: Methicillin-resistant Staphylococcus aureus (MRSA) Retapamulin should not be used to treat infections known or thought likely to be due to MRSA (see In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by MRSA.
Maltese: Il-prevalenza ta' reżistenza akkwistata tista' tvarja ġeografikament u biż-żmien fi speċi magħżula, u informazzjoni lokali dwar reżistenza hi mixtieqa, partikolarment fit-trattament ta' infezzjonijiet serji.
English: Abscesses
Maltese: Axxess
English: Altargo ointment contains an antibiotic called retapamulin, which is used on the skin.
Maltese: Ingwent Altargo fih antibijotiku msejjaħ retapamulin, li jintuża fuq il-ġilda.
English: Maternal toxicity was demonstrated at dosages of ≥ 7.2 mg/kg/day corresponding to ≥ 8 times the estimated human exposure (see above).
Maltese: Tossiċita` materna dehret f'dożaġġi ta' ≥ 7.2 mg/kg/kuljum li jikkorrispondu għal ≥ 8 darbiet aktar mill ogħla esponiment stmat fil-bniedem (ara hawn fuq).
English: In monkeys dosed orally (50, 150 or 450 mg/kg) for 14 days there was dose-related emesis.
Maltese: F'xadini li ngħataw dożi (50, 150 jew 450 mg/kg) mill-ħalq għal 14-il ġurnata kien hemm emesi relatata
English: A multicentre, randomised, double-blind, study compared the efficacy of retapamulin ointment to placebo ointment for the treatment of SIOW.
Maltese: Studju randomised, double-blind, multiċentriku, qabbel l-effikaċja tal-ingwent retapamulin ma' ingwent plaċebo għall-kura ta' SIOW. L-istudju, fi tmiemu, ma laħaqx l-iskop primarju li kien ir-rata ta' suċċess klinku meta individwi ġew segwiti (jum 12-14) fil-popolazzjoni Klinika Intenzjoni li Tikkura (ara t-Tabella
English: Irritation
Maltese: Patoġenu
English: In the event of a sensitisation or severe local irritation from the use of retapamulin ointment, treatment should be discontinued, the ointment carefully wiped off, and appropriate alternative therapy for the
Maltese: Fil-każ ta' sensibilizzazzjoni jew irritazzjoni lokali qawwija mill-użu ta' l-ingwent retapamulin, it-trattament għandu jitwaqqaf, l-ingwent għandu jintmesaħ b'attenzjoni u għandha tinbeda terapija alternattiva xierqa
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Maltese: GlaxoSmithKline d.o.o. Tel: + 385 1 6051 999
English: See section 5.2 regarding plasma concentrations of retapamulin observed in patients in different age groups.
Maltese: Ara sezzjoni 5.2 dwar il-konċentrazzjonijiet ta' retapamulin fil-plażma osservati f'pazjenti fi gruppi ta'
English: Application site irritation (including burning sensation)
Maltese: (inkluż sensazzjoni ta' ħruq)
English: Mechanism of resistance
Maltese: Sistemi ta' organi
English: No differences were observed in the in vitro activity of retapamulin versus S. aureus whether the isolates were susceptible or resistant to methicillin.
Maltese: Ma ġietx osservata l-ebda differenza fl-attivita` in vitro ta' retapamulin kontra S. aureus kemm jekk l-iżolati kienu suxxettibbli jew jekk dawn kienu reżistenti għal methicillin.
English: • Severe allergy (hypersensitivity)
Maltese: • Allerġija severa (sensittività eċċessiva)
English: Date of first authorisation: 27th June 2006 Date of latest renewal: 18th April 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 27 ta' Ġunju 2006 Data tal-aħħar tiġdid: 18 ta' April 2016
English: Alemtuzumab has profound prolonged immunosuppressive effects.
Maltese: Alemtuzumab għandu effetti immunosoppressivi profondi fit-tul.
English: Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate
Maltese: Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride
English: Anti-JCV antibody prevalence in the EU was reported as ranging from 48.8% to 69.5% in the EU in a cross sectional study of MS patients irrespective of treatment.
Maltese: Il-prevalenza ta' antikorpi kontra JCV fl-UE kienet irrappurtata li tvarja minn 48.8% sa 69.5% fl-UE fi studju trasversali ta' pazjenti b'MS irrispettivament mill-kura.
English: • Keep alert card with the them after discontinuation • Reporting of side effects
Maltese: • Iżommu l-karta ta' allarm fuqhom wara t-twaqqif • Rappurtar tal-effetti sekondarji
English: • Switching usually occurred after 1 year (median of 25 standard interval doses) in the secondary definition
Maltese: • Il-qlib normalment iseħħ wara sena (medjan ta' 25 doża ta' intervall standard) fid-definizzjoni sekondarja
English: − Impaired vision
Maltese: − Indeboliment fil-vista
English: Monotherapy; randomised double-blind placebo-controlled parallel-group trial for 120 weeks
Maltese: Monoterpija; prova randomised, double-blind, ikkontrollata bil plaċebo, fi gruppi parallel, li dam 120 ġimgħa
English: Sodium chloride Polysorbate 80 (E433) Water for injections
Maltese: Polysorbate 80 (E433) Ilma għall-injezzjonijiet
English: • A description of PML, potential symptoms and management of PML
Maltese: • Deskrizzjoni ta' PML, sintomi potenzjali u mmaniġġjar ta' PML
English: Rate ratio 0.32 CI95% 0.26 ; 0.40
Maltese: Proporzjon tar-rata 0.32 CI95% 0.26; 0.40
English: sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
Maltese: sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) u ilma għall-injezzjoni.
English: • Possibility of other opportunistic infections
Maltese: • Possibbiltà ta' infezzjonijiet opportunistiċi oħrajn
English: Biogen Netherlands B.V. Prins Mauritslaan 13
Maltese: Biogen Netherlands B.V. Prins Mauritslaan 13 1171 LP Badhoevedorp L-Olanda
English: Use of plasmapheresis (PLEX) or intravenous immunoglobulin (IVIg) can affect meaningful interpretation of serum antiJCV antibody testing.
Maltese: plażmaferesi (PLEX) jew immunoglobulina ġol-vini (IVIg) jista' jaffettwa l-interpretazzjoni utli tal ittestjar għal antikorpi kontra JCV fis-serum.
English: Analysis of STRATIFY JCV showed the prevalence of anti-JCV antibodies to be approximately 55%.
Maltese: antikorpi kontra JCV hija madwar 55%.
English: The mean ± SD steady-state clearance was 13.1 ± 5.0 ml/h, with a mean ± SD half-life of 16 ± 4 days.
Maltese: 13.1 ± 5.0 ml/h, b' medja ± SD tal-half-life ta' 16 ± 4 ġranet.
English: Currently available data are described in sections 4.8 and 5.1
Maltese: Data disponibbli hija deskritta fis-sezzjonijiet 4.8 u 5
English: Rate ratio 0.33 CI95% 0.26 ; 0.41
Maltese: Proporzjon tar-rata 0.33 CI95% 0.26; 0.41
English: 15 ml concentrate in a vial (type I glass) with a stopper (chlorobutyl rubber) and a seal (aluminium) with a flip-off cap.
Maltese: 15 ml ta' konċentrat f'kunjett (ħġieġ tat-tip I) b'tapp (lasktu chlorobutyl) u siġill (aluminju) b'għatu flip-off.
English: concentrate for solution for infusion 1 x 15 ml vial
Maltese: Kunjett 1 x 15 ml
English: A post-marketing meta-analysis was conducted using data from 621 paediatric MS patients treated with TYSABRI (median age 17 years, range was 7-18 years, 91% aged ≥14 years).
Maltese: Twettqet metaanaliżi wara t-tqegħid fis-suq bl-użu ta' data minn 621 pazjent pedjatriku b'MS ikkurati b'TYSABRI (età medjana ta' 17-il sena, il-medda kienet 7-18-il sena, 91% kellhom ≥14-il sena).
English: Acute retinal necrosis (ARN) is a rare fulminant viral infection of the retina caused by the family of herpes viruses (e.g. varicella zoster).
Maltese: Nekrożi retinali akuta (ARN, acute retinal necrosis) hi infezzjoni virali rari fulminanti tar-retina kkawżata mill-familja tal-viruses tal-herpes (eż. varicella zoster).
English: The effect of natalizumab on reproduction was evaluated in 5 studies, 3 in guinea pigs and 2 in cynomolgus monkeys.
Maltese: L-effett ta' natalizumab fuq ir-riproduzzjoni kienet evalwata f'5 studji, 3 fil-fniek ta' l-indi u 2 f'xadini cynomolgus.
English: Patients with a treatment history of immunosuppressant medications are at increased risk for PML.
Maltese: Pazjenti bi storja medika ta' mediċini immunosoppressanti huma f'riskju miżjud għal PML.
English: • Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o Opportunistic infections (other than PML):
Maltese: • Informazzjoni li infezzjonijiet mhux tipiċi/opportunistiċi, b'mod partikolari PML, jistgħu jseħħu b'TYSABRI inkluż:
English: The analysis explored the effects of selected covariates including body weight, age, gender, hepatic and renal function, and presence of anti-natalizumab antibodies upon pharmacokinetics.
Maltese: L-analiżi esplorat l-effetti ta' kovarjanti magħżula inkluż piż tal-ġisem, eta', sess, funżjoni tal-fwied u tal-kliewi, u l-preżenza ta' antikorpi għal natalizumab fuq il-farmakokinetika.
English: The presence of persistent antinatalizumab antibodies increased natalizumab clearance approximately 3-fold, consistent with reduced serum natalizumab concentrations observed in persistently antibody-positive patients, (see section 4.8).
Maltese: darbiet, konsistenti ma' tnaqqis fil-konċentrazzjonijiet fis-serum ta' natalizumab osservati f'pazjenti li kellhom antikorpi persistenti, (ara sezzjoni 4.8).
English: • Risk management plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)f
English: o Description of MRI protocols for baseline, routine screening and in case of PML suspicion o Anti-JCV antibody testing, frequency of testing, interpretation of qualitative and quantitative results, seroprevalence of JCV-antibodies and seroconversion rate over time o Diagnosis and prognosis of symptomatic and asymptomatic PML
Maltese: o Ittestjar ta' antikorpi kontra JCV, il-frekwenza tal-ittestjar, l-interpretazzjoni tar-riżultati kwalitattivi u kwantitattivi, is-seroprevalenza ta' antikorpi kontra JCV u r-rata ta'
English: During treatment with TYSABRI, small reductions in haemoglobin (mean decrease 0.6 g/dl), haematocrit (mean decrease 2%) and red blood cell counts (mean decrease 0.1 x 106/l) were seen.
Maltese: Waqt kura b'TYSABRI, kien hemm tnaqqis żgħir fl-emoglobina (tnaqqis medju ta' 0.6 g/dl), ematokrita (tnaqqis medju ta' 2%) u fl-għadd taċ-ċelluli ħomor fid-demm (tnaqqis medju ta' 0.1 x 106/l).
English: o Description of PML and incidence.
Maltese: o Deskrizzjoni ta' PML u l-inċidenza.
English: Interim analysis of results (as of May 2015) from the ongoing TYSABRI Observational Program (TOP), a phase 4, multicentre, single-arm study (n=5770) demonstrated that patients switching from beta interferon (n= 3255) or glatiramer acetate (n= 1384) to TYSABRI showed a sustained, significant decrease in annualised relapse rate (p< 0.0001).
Maltese: (n = 5770), uriet li pazjenti li jaqilbu minn beta interferon (n = 3255) jew GA ( n = 1,384) għal TYSABRI, urew tnaqqis sinifikanti u sostnut fir-rata ta' rikaduta annwalizzata (p< 0.0001).
English: TYSABRI is contraindicated in combination with other DMTs (see section 4.3).
Maltese: TYSABRI huwa kontra-indikat flimkien ma' DMTs oħrajn (ara sezzjoni 4.3).
English: Effects on laboratory tests
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: o A stratification of the risk of developing PML based on the identified risk factors and presentation of the PML risk in a given time interval of treatment as well as the cumulative PML risk o PML risk estimates algorithm summarizes PML risk by anti- John Cunningham virus (JCV) antibody status, prior IS use and duration of treatment (by year of treatment) and stratifies this risk by index value when applicable.
Maltese: Kura b'immunosoppressanti qabel l-użu ta' TYSABRI o Stratifikazzjoni tar-riskju ta' żvilupp ta' PML ibbażat fuq il-fatturi ta' riskju identifikati u l-preżentazzjoni tar-riskju ta' PML f'intervall ta' ħin partikulari ta' kura kif ukoll ir riskju kumulattiv ta' PML o L-algoritmu tal-istimi tar-riskju ta' PML jagħti sommarju tar-riskju ta' PML skont listatus ta' antikorp kontra l-virus John Cunningham (JCV, John Cunningham virus), użu IS preċedenti u t-tul tal-kura (skont is-sena tal-kura) u jikklassifika dan ir-riskju skont ilvalur tal-indiċi meta jkun applikabbli.
English: • A reminder of where to report side effects
Maltese: • Tfakkira ta' fejn wieħed jista' jirrapporta l-effetti sekondarji
English: • Progressive multifocal leukoencephalopathy (PML)
Maltese: • Lewkoenċefalopatija multifokali progressiva (PML)
English: − Prolonged dizziness
Maltese: Proċedura ta'
English: TYSABRI 300 mg concentrate for solution for infusion
Maltese: TYSABRI 300 mg konċentrat għal soluzzjoni għall-infużjoni
English: Prior treatment with immunosuppressive or immunomodulatory therapies
Maltese: Kura fil-passat b'terapiji immunosoppressivi jew immunomodulatorji
English: Clinical neurologic deterioration in patients with PML and/or JCV GCN may be caused by JCVmediated destruction of CNS tissue, or upon restoration of immune function, by an intracerebral immune inflammatory reaction known as immune reconstitution inflammatory syndrome (IRIS).
Maltese: Id-deterjorament newroloġiku kliniku f'pazjenti b'PML u/jew JCV GCN jista' jiġi kkawżat minn qerda medjata minn JCV tat-tessut tas-CNS (central nervous system - sistema nervuża ċentrali), jew mal-irkupru tal-funzjoni immuni, minħabba reazzjoni infjammatorja immuni intraċerebrali magħrufa bħala sindrome infjammatorju tar-rikostituzzjoni immuni (IRIS).
English: • Inform about an ongoing study assessing the efficacy, tolerability and safety of switching to EID after at least 12 months on approved dosing.
Maltese: • Għandha tingħata informazzjoni dwar studju li għadu għaddej li qed jevalwa l-effikaċja, ittollerabilità u s-sigurtà ta' li wieħed jaqleb għal EID wara mill-inqas 12-il xahar ta' dożaġġ approvat.
English: Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, doubleblind studies.
Maltese: Data dwar is-sigurtà u l-effikaċja ta' natalizumab wara sentejn kienet iġġenerata minn studji kkontrollati u double-blind.
English: Remove flip-off cap from the vial.
Maltese: Neħħi l għatu flip-off mill-kunjett.
English: Within this analysis, a limited subset of patients with data available prior to treatment (158 of the 621 patients) demonstrated a reduction in ARR from 1.466 (95% CI 1.337, 1.604) prior to treatment to 0.110 (95% CI 0.094, 0.128).
Maltese: F'din l-analiżi, sottosett limitat ta' pazjenti b'data dwar disponibbli qabel il-kura (158 mis-621 pazjent), wera tnaqqis fl-ARR minn 1.466 (95% CI 1.337, 1.604) qabel il-kura għal 0.110 (95% CI
English: For storage conditions after dilution of the medicinal product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: • Information on PML and IRIS including the risk of developing PML during TYSABRI
Maltese: • Tagħrif dwar PML u IRIS inkluż ir-riskju ta' żvilupp ta' PML waqt kura b' TYSABRI
English: • Present data from PK/PD/efficacy modelling from the RESTORE study which indicates that risk of return of MS disease activity more likely with increased body weight (>80kg) or longer dosing intervals (>7 weeks).
Maltese: • Għandha tiġi ppreżentata dejta mill-immudellar tal-PK/PD/effikaċja mill-istudju RESTORE li tindika li hemm probabbilità ogħla tar-riskju li terġa' titfaċċa l-attività tal-marda MS jekk ikun hemm żieda fil-piż tal-ġisem (>80 kg) jew intervalli bejn id-dożaġġi itwal (>7 ġimgħat).
English: Serious adverse events were evaluated in 621 MS paediatric patients included in a meta-analysis (see also Section 5.1).
Maltese: Avvenimenti avversi serji ġew evalwati f'621 pazjent pedjatriku b'MS li kienu inklużi f'metaanaliżi
English: The safety and efficacy of TYSABRI in children and adolescents up to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' TYSABRI fit-tfal u adolexxenti li għandhom sa 18-il sena għadhom ma ġewx determinati s'issa.
English: Intravenous use.
Maltese: immunoabsorption).
English: The clinical worsening is a result of local inflammatory reaction, including oedema, and manifests as a worsening of neurological symptoms including hemiparesis, ataxia, speech abnormalities, visual disturbance, cognitive/behavioural changes and seizure (dependent on the site of IRIS).
Maltese: L-aggravar kliniku huwa riżultat ta' reazzjoni infjammatorja lokali, inkluż edema, u jimmanifesta bħala aggaravar ta' sintomi newroloġiċi li jinkludu emipareżi, atassija, diskors anormali, disturb fil-vista, bidliet konjittivi/fl-imġiba u attakk ta' puplesija (skont is-sit ta' IRIS).
English: Hypersensitivity to natalizumab or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal natalizumab jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: In the postmarketing setting, the risk of PML has been well characterized over the first 6 years of treatment with the identification of different levels of PML risk in different patient subgroups.
Maltese: Fil-kuntest ta' wara t-tqegħid fis-suq, ir-riskju ta' PML ġie kkaratterizzat sewwa matul l-ewwel 6 snin tal-kura bl-identifikazzjoni ta' livelli differenti ta' riskju ta' PML f'sottogruppi differenti tal-pazjenti.
English: JC virus is a common virus which infects many people but does not normally cause noticeable illness.
Maltese: Il-virus JC huwa virus komuni li jinfetta ħafna nies iżda normalment ma jikkawżax mard li jidher.
English: Information about extended interval dosing (EID)
Maltese: Informazzjoni dwar l-intervall imtawwal bejn id-dożaġġi (EID, extended interval dosing)
English: Increases from baseline for lymphocytes, monocytes, eosinophils and basophils ranged from 35% to 140% for individual cell types but mean cell counts remained within normal ranges.
Maltese: Żjieda mill-linja bażi ta' limfoċiti, monoċiti, eżinofili u bażofili varjat minn 35% sa 140% għal kull tip ta' ċellula individwali iżda l-għadd medju taċ-ċelluli baqa'
English: Some cases have occurred in patients with central nervous system (CNS) herpes infections (e.g. herpes meningitis and encephalitis).
Maltese: Xi każijiet seħħew f'pazjenti b'infezzjonijiet tal-herpes fis-sistema nervuża ċentrali (CNS, central nervous system) (eż. meninġite u enċefalite kkawżati mill-herpes).
English: In patients treated with TYSABRI, IRIS has occurred within days to several weeks after TYSABRI removal by plasma exchange (PLEX) or immunoabsorption (IA).
Maltese: F'pazjenti kkurati b'TYSABRI, IRIS seħħ f'temp ta' jiem sa bosta ġimgħat wara t-tneħħija ta' TYSABRI permezz tal-iskambju tal-plażma (PLEX, plasma exchange) jew immunoassorbiment (IA,
English: 1 Progression of disability was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS >=1.0 sustained for 12 or 24 weeks or at least a 1.5 point increase on the EDSS from a baseline EDSS =0 sustained for 12 or 24 weeks.
Maltese: (p<0.001) 1 Progressjoni tad-diżabilità kienet definita bħala żjieda ta' l-inqas punt fuq l-EDSS mill-linja bażika ta' EDSS >=1.0 miżmum għal 12 jew 24 ġimgħa jew ta' l-inqas żjieda ta' punt u nofs fuq l-EDSS milllinja bażika ta' EDSS =0 miżmum għal 12 jew 24 ġimgħa.
English: The interim analysis showed a lower risk of PML in patients treated with EID (hazard ratio = 0.06 95% CI of hazard ratio = 0.01- 0.22).
Maltese: Il-maġġoranza (85%) tal-pazjenti li ngħataw dożi ta' EID ingħataw id-dożaġġ approvat għal ≥1 sena qabel ma' nqalbu fuq EID. L-analiżi wriet tnaqqis klinikament u statistikament sinifikanti fir-riskju ta' PML f'pazjenti kkurati b'EID (proporzjon ta' perikolu= 0.06) (95% CI tal proporzjon għall-periklu = 0.01- 0.22).
English: In a pre-specified, retrospective analysis of US anti-JCV antibody positive TYSABRI patients (TOUCH registry), the risk of PML was compared between patients treated with the approved dosing interval and patients treated with extended interval dosing as identified in the last 18 months of exposure (EID, average dosing intervals of approximately 6 weeks).
Maltese: F'analiżi speċifikata minn qabel, retrospettiva, dwar pazjenti mill-Istati Uniti kkurati b'TYSABRI u pożittivi għall-antikorpi kontra JCV (Registru ta' TOUCH), ir-riskju ta' PML ġie mqabbel bejn pazjenti kkurati bl-intervall bejn id-dożaġġi approvat u pazjenti kkurati b'intervall estiż bejn id dożaġġi kif identifikat fl-aħħar 18-il xahar ta' esponiment (EID, intervalli medji bejn id-dożaġġi ta' madwar 6 ġimgħat).
English: • Present the results of the TOUCH analysis which showed clinically and statistically significant reduction in PML risk in patients who are treated with EID (dosing interval 6 weeks) compared to Standard interval dosing (dosing interval 4 weeks).
Maltese: • Għandhom jiġu ppreżentati r-riżultati tal-analiżi TOUCH li wriet tnaqqis klinikament u statistikament sinifikanti fir-riskju ta' PML f'pazjenti li jkunu kkurati b'EID (intervall bejn id dożaġġi ta' 6 ġimgħat) meta mqabbel ma' Intervall bejn id-dożaġġi standard (intervall bejn iddożaġġi ta' 4 ġimgħat).
English: • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1)
Maltese: • Pazjenti li għandhom marda attiva ħafna għalkemm kors sħiħ u adegwat ta' kura b' mill-inqas terapija li timmodifika l-marda (DMT) waħda (għall-eċċezzjonijiet u informazzjoni dwar perjodi ta' tneħħija (washout periods) ara sezzjonijiet 4.4 u 5
English: Use of TYSABRI has been associated with an increased risk of PML, an opportunistic infection caused by JC virus, which may be fatal or result in severe disability.
Maltese: L-użu ta' TYSABRI kien assoċjat ma' żjieda fir-riskju ta' PML, infezzjoni opportunistika kkawżata mill-virus JC, li tista' tkun fatali jew twassal għal diżabilità severa.
English: Although JC viral load in the CSF might be expected to decline in the setting of IRIS, it is also possible that due to the breakdown of the blood brain barrier (BBB) and release of JCV from cells lysed during IRIS, it can be increased.
Maltese: (BBB, blood brain barrier) u r-rilaxx ta' JCV minn ċelluli ddiżintegrati (lysed) matul IRIS, jista'
English: See section 4.8 for how to report adverse reactions
Maltese: Ara sezzjoni 4.8 dwar kif għandhom jiġu rappurtati reazzjonijiet avversi.
English: Mean EDSS scores remained stable over 5 years.
Maltese: Il-punteġġi medji ta' EDSS baqgħu stabbli matul 5 snin.
English: treatment stratified by prior treatment with immunosuppressants and JCV infection.
Maltese: stratifikat skont kura minn qabel b'immunosoppressanti u infezzjoni mill-JCV.
English: • Present data from PK/PD/efficacy modelling from clinical trial data that suggests efficacy of 6 week dosing more similar to 4 weeks if occurs >1 year of 4 weekly treatment
Maltese: • Għandha tiġi ppreżentata dejta mill-immudellar tal-PK/PD/effikaċja minn dejta tal-provi kliniċi li tissuġġerixxi effikaċja ta' dożaġġ ta' 6 xhur aktar simili għal ta' 4 ġimgħat jekk iseħħ >sena ta' kura kull 4 ġimgħat
English: Discussion of PML in TYSABRI Treated Patients
Maltese: Diskussjoni dwar PML f'Pazjenti Kkurati b'TYSABRI