FrancophonIA/ELRC3.0 huggingface dataset:
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and subsequently for 8 hours at room temperature.
Maltese: Stabbiltà kimika u fiżika waqt l-użu intweriet għal 24 siegħa f'temperatura ta' 2-8°C u sussegwentement għal 8 sigħat f'temperatura ambjentali.
English: These reactions may present as pruritus, rash, urticaria, erythema, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea and tachycardia (see section 4.8).
Maltese: Dawn irreazzjonijiet jistgħu jiġu osservati bħala ħakk, raxx, urtikarja, eritema, irritazzjoni fil-griżmejn, uġigħ orofarinġeali, qtugħ ta' nifs, edema fil-farinġi jew fil-larinġi, fwawar, pressjoni baxxa, deni, għeja, uġigħ ta' ras, sturdament, dardir u takikardija (ara sezzjoni 4.8).
English: No studies have been conducted to investigate the pharmacokinetics of ocrelizumab in children and adolescents <18 years of age.
Maltese: Ma twettqux studji biex jinvestigaw il-farmakokinetika ta' ocrelizumab fi tfal u adolexxenti b'età ta' <18-il sena.
English: Posology:
Maltese: Miġbura:
English: Clinical trial data have shown an association between decreased levels of IgG (and less so for IgM or IgA) and serious infections.
Maltese: Data minn provi kliniċi wriet assoċjazzjoni bejn livelli mnaqqsa ta' IgG (u inqas għal IgM jew IgA) u infezzjonijiet serji.
English: Infusion-related reactions1
Maltese: Infużjoni 1
English: The overall exposure (AUC over the 24 weeks dosing interval) was identical in the 2 x 300 mg in PPMS and 1 x 600 mg in RMS studies, as expected given an identical dose was administered.
Maltese: L-esponiment globali (AUC matul l-intervall ta' dożaġġ ta' 24 ġimgħa) kien identiku fl-istudji b'2 x 300 mg f'PPMS u 1 x 600 mg f'RMS, kif mistenni, peress li ngħatat doża identika.
English: Respiratory Tract Infections
Maltese: Infezzjonijiet fl-Apparat Respiratorju
English: In the placebo-controlled (PPMS) clinical trial, the proportion of Ocrevus patients presenting decreased neutrophils was higher (12.9 %) than placebo patients (10.0 %); among these a higher percentage of patients (4.3%) in the Ocrevus group had Grade 2 or above neutropenia vs 1.3% in the placebo group; approximately 1% of the patients in the Ocrevus group had Grade 4 neutropenia vs 0% in the placebo group.
Maltese: Fil-prova klinika kkontrollata bil-plaċebo (PPMS), il-proporzjon ta' pazjenti fuq Ocrevus li kellhom tnaqqis fin-newtrofili kien ogħla (12.9%) mill-pazjenti fuq plaċebo (10.0%); fosthom perċentwali ogħla ta' pazjenti (4.3%) fil-grupp ta' Ocrevus kellhom newtropenija ta' Grad 2 jew ogħla vs 1.3% fil-grupp tal-plaċebo; madwar 1% tal-pazjenti fil-grupp ta' Ocrevus kellhom newtropenija ta' Grad 4 vs 0% fil-grupp tal-plaċebo.
English: 26.7% and 11.9% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 1.4% experienced severe IRRs.
Maltese: 7% u 11.9% tal-pazjenti ttrattati b'Ocrevus kellhom IRRs ħfief u moderati rispettivament, 1.4% kellhom IRRs severi.
English: No increase was observed in PPMS.
Maltese: Ma ġietx osservata żieda f'PPMS.
English: Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity (see section 5.1).
Maltese: Ocrevus huwa indikat għat-trattament ta' pazjenti adulti bi sklerożi multipla progressiva primarja (PPMS - primary progressive multiple sclerosis) bikrija f'termini ta' tul tal-marda u livell ta' diżabilità, u b'karatteristiċi ta' immaġini partikolari għal attività infjammatorja (ara sezzjoni 5.1).
English: After treatment with Ocrevus over 2 years, the proportion of patients with positive antibody titers against S. pneumoniae, mumps, rubella and varicella were generally similar to the proportions at baseline.
Maltese: Wara trattament b'Ocrevus għal aktar minn sentejn, il-proporzjon ta' pazjenti b'titers ta' antikorpi pożittivi kontra S. pneumoniae, gattone, rubella u variċella ġeneralment kienu simili għallproporzjonijiet fil-linja bażi.
English: · The rate can be increased in 30 mL/hour increments every 30 minutes to a maximum of 180 mL/hour.
Maltese: 30 mL/siegħa kull 30 minuta sa massimu ta' 180 mL/siegħa.
English: Ocrelizumab is a recombinant humanised monoclonal antibody that selectively targets CD20-expressing B cells.
Maltese: Ocrelizumab huwa antikorp monoklonali rikombinanti umanizzat li jimmira b'mod selettiv ċelluli B li jesprimu CD20.
English: Data are available on the effects of tetanus toxoid, 23-valent pneumococcal polysaccharide, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines in patients receiving Ocrevus.
Maltese: Hemm data disponibbli dwar l-effetti ta' tossojde tat-tetnu, 23-valent pneumococcal polysaccharide, neoantiġen ta' keyhole limpet haemocyanin, u vaċċini tal-influwenza tal-istaġun f'pazjenti li jkunu qed jirċievu Ocrevus.
English: In the placebo-controlled study in PPMS, infections occurred in 72.2% of patients receiving Ocrevus vs 69.9% of patients receiving placebo.
Maltese: Fl-istudju kkontrollat bil-plaċebo f'PPMS, infezzjonijiet seħħew fi 72.2% talpazjenti li kienu qed jirċievu Ocrevus vs 69.9% tal-pazjenti li kienu qed jirċievu plaċebo.
English: When initiating Ocrevus after an immunosuppressive therapy or initiating an immunosuppressive therapy after Ocrevus, the potential for overlapping pharmacodynamic effects should be taken into consideration (see section 5.1 Pharmacodynamic effects).
Maltese: Meta jinbeda Ocrevus wara terapija immunosoppressiva jew meta tinbeda terapija immunosoppressiva wara Ocrevus, għandu jiġi kkunsidrat il-potenzjal ta' effetti farmakodinamiċi li jikkoinċidu (ara sezzjoni 5.1 Proprjetajiet farmakodinamiċi).
English: The population pharmacokinetics estimate of the central volume of distribution was 2.78 L. Peripheral volume and inter-compartment clearance were estimated at 2.68 L and 0.294 L/day.
Maltese: Ilvolum periferali u t-tneħħija mill-kompartiment kienu stmati bħala 2.68 L u 0.294
English: Ocrevus 300 mg concentrate for solution for infusion Ocrelizumab
Maltese: Ocrevus 300 mg konċentrat għal soluzzjoni għall-infużjoni ocrelizumab
English: Figure 2: Kaplan-Meier Plot of Time to Onset of Confirmed Disability Progression Sustained for at Least 12 Weeks with the Initial Event of Neurological Worsening Occurring during the Double-blind Treatment Period (WA25046 ITT Population)*
Maltese: Figura 2: Plot Kaplan-Meier tal-Ħin għall-Bidu ta' Progressjoni Kkonfermata tad-Diżabilità Sostnuta għal mill-Inqas 12-il Ġimgħa bl-Avveniment Inizjali ta' Aggravar Newroloġiku Iseħħ waqt il-Perjodu Double-blind tat-Trattament (Popolazzjoni ITT ta' WA25046)*
English: In RMS, a decrease in lymphocyte < LLN was observed in 20.7% of Ocrevus patients compared with 32.6% of patients treated with interferon beta-1a.
Maltese: F'RMS, tnaqqis fil-limfoċiti < LLN ġie osservat f'20.7% tal-pazjenti ttrattati b'Ocrevus meta mqabbel ma' 32.6% tal-pazjenti ttrattati b'interferon beta-1a.
English: Serious infections occurred in 6.2% of patients receiving Ocrevus vs 6.7% of patients receiving placebo.
Maltese: Infezzjonijiet serji seħħew f'6.2% tal-pazjenti li rċevew Ocrevus vs 6.7% tal-pazjenti li rċevew plaċebo.
English: Medicines you will have before you are given Ocrevus Before you are given Ocrevus, you will receive other medicines to prevent or reduce possible side effects such as infusion-related reactions (see sections 2 and 4 for information about infusion-related reactions).
Maltese: Qabel ma tingħata Ocrevus , inti se tirċievi mediċini oħra biex jipprevjenu jew inaqqsu l-effetti sekondarji possibbli bħal reazzjonijiet relatati mal-infużjoni (ara sezzjonijiet 2 u 4 għall-informazzjoni dwar reazzjonijiet relatati mal-infużjoni).
English: Patients over 55 years of age were not studied.
Maltese: Pazjenti b'età ta' aktar minn 55 sena ma ġewx studjati.
English: See section 4.4 ‘Treatment of severely immunocompromised patients' for information about the use of immunosuppressants before, during or after Ocrevus treatment.
Maltese: Ara sezzjoni 4.4 ‘Trattament ta' pazjenti immunokompromessi b'mod sever' għal informazzjoni dwar l-użu ta' immunosoppressanti qabel, matul jew wara trattament b'Ocrevus.
English: 4.5 Interaction with other medicinal products and other forms of interaction No formal drug interaction studies have been performed, as no drug interactions are expected via cytochrome P450 enzymes, other metabolising enzymes or transporters.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ma twettaq l-ebda studju formali ta' interazzjoni, peress li mhux mistennija interazzjonijiet talmediċini permezz ta' enzimi taċ-ċitokroma P450, enzimi li jimmetabolizzaw oħrajn jew trasportaturi.
English: MRI Endpoints
Maltese: Punti aħħarin tal-MRI
English: Upper respiratory tract infection, nasopharyngitis, influenza
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq, nażofarinġite, influwenza
English: Mean age (years) Age range (years) at inclusion Gender distribution (% male/% female)
Maltese: Distribuzzjoni tas-sessi (% ta' irġiel/% ta' nisa)
English: In controlled trials there were no fatal IRRs.
Maltese: Fi provi kkontrollati ma kien hemm l-ebda IRRs fatali.
English: In active-controlled (RMS) clinical trials, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 34.3% compared with an incidence of 9.9% in the interferon beta-1a treatment group (placebo infusion).
Maltese: Fi provi kliniċi kkontrollati b'mod attiv (RMS), IRR kienet l-aktar avveniment avvers komuni f'pazjenti ttrattati b'Ocrevus b'inċidenza globali ta' 34.3% meta mqabbel ma' inċidenza ta' 9.9% filgrupp ta' trattament b'interferon beta-1a (infużjoni ta' plaċebo).
English: See under ‘Other medicines and Ocrevus', below for more information.
Maltese: Ara taħt ‘Mediċini oħra u Ocrevus', hawn taħt għal aktar informazzjoni.
English: Key clinical and MRI efficacy results are presented in Table 4 and Figure 1.
Maltese: Riżultati ewlenin tal-effikaċja klinika u tal-MRI huma ppreżentati f'Tabella 4 u Figura 1.
English: The frequency of grade 4 (life-threatening) and grade 5 (fatal) infections was low in all treatment groups, but in PPMS it was higher with Ocrevus compared with placebo for life-threatening (1.6% vs 0.4%) and fatal (0.6% vs 0%) infections.
Maltese: Il-frekwenza ta' infezzjonijiet ta' grad 4 (ta' periklu għall-ħajja) u grad 5 (fatali) kienet baxxa fil-gruppi kollha ta' trattament, iżda f'PPMS kienet ogħla b'Ocrevus meta mqabbel mal-plaċebo għal infezzjonijiet ta' periklu għall-ħajja (1.6% vs 0.4%) u fatali (0.6% vs 0%).
English: The majority of the neutrophil decreases were transient (only observed once for a given patient treated with Ocrevus) and were Grade 1 (<1500 cells/mm3) and 2 (between 1000 and 1500 cells/mm3) in severity.
Maltese: Il-maġġoranza tat-tnaqqis fin-newtrofili kien temporanju (osservat darba biss għal pazjent partikolari 3) u 2 (bejn 1000 u 1500 ċellula/mm 3) fisttrattat b'Ocrevus) u kien ta' Grad 1 (<1500 ċellula/mm severità.
English: An increase in the rate of serious infections was observed in RMS between Years 2 and 3, but not in subsequent years.
Maltese: Ġiet osservata żieda fir-rata ta' infezzjonijiet serji f'RMS bejn is-Snin 2 u 3, iżda mhux fi snin sussegwenti.
English: Based on the limited data available (see section 5.1 and section 5.2), no posology adjustment is needed in patients over 55 years of age.
Maltese: Abbażi tad-data limitata disponibbli (ara sezzjoni 5.1 u sezzjoni 5.2), mhux meħtieġ aġġustament filpożoloġija f'pazjenti li għandhom aktar minn 55 sena.
English: The percentage of patients with seroprotective titers against five influenza strains ranged from 20.0-60.0% and 16.7-43.8% pre-vaccination and at 4 weeks post vaccination from 55.6-80.0% in patients treated with ocrelizumab and 75.0-97.0% in the control group , respectively.
Maltese: .0% u 16.7−43.8% qabel it-tilqim u 4 ġimgħat wara t-tilqim minn 55.6−80.
English: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has been reported in patients treated with anti-CD20 antibodies.
Maltese: Attivazzjoni mill-ġdid tal-virus tal-Epatite B (HBV - Hepatitis B virus), li f'xi każijiet wasslet għal epatite fulminanti, insuffiċjenza tal-fwied u mewt, ġiet irrappurtata f'pazjenti ttrattati b'antikorpi kontra CD20.
English: The pharmacokinetics of ocrelizumab in the MS studies were described by a two compartment model with time-dependent clearance, and with PK parameters typical for an IgG1 monoclonal antibody.
Maltese: Il-farmakokinetika ta' ocrelizumab fl-istudji dwar MS ġiet deskritta minn mudell ta' żewġ kompartimenti bi tneħħija dipendenti fuq il-ħin, u b'parametri PK tipiċi għal antikorp monoklonali
English: *Pre-specified pooled analysis of WA21092 and WA21093
Maltese: WA21092 u WA21093
English: Key clinical and MRI efficacy results are presented in Table 6 and Figure 2.
Maltese: Riżultati ewlenin tal-effikaċja klinika u tal-MRI huma ppreżentati f'Tabella 6 u Figura 2.
English: Results of the pre-specified pooled analyses of time to CDP sustained for at least 12 weeks (40% risk reduction for Ocrevus compared to interferon beta-1a (p=0.0006) were highly consistent with the results sustained for at least 24 weeks (40% risk reduction for Ocrevus compared to interferon beta-1a, p=0.0025).
Maltese: Riżultati tal-analiżi globali speċifikata minn qabel taż-żmien sa CDP sostnuta għal mill-inqas 12-il ġimgħa (tnaqqis fir-riskju ta' 40% għal Ocrevus meta mqabbel ma' interferon beta-1a (p=0.0006) kienu konsistenti ferm mar-riżultati sostnuti għal mill-inqas 24 ġimgħa (tnaqqis fir-riskju ta' 40% għal Ocrevus meta mqabbel ma' interferon beta-1a, p=0.0025).
English: Figure 1: Dose and Schedule of Ocrevus
Maltese: Figura 1: Doża u Skeda ta' Ocrevus
English: In the placebo-controlled (PPMS) clinical trial, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 40.1% compared with an incidence of 25.5% in the placebo group.
Maltese: Fil-prova klinika kkontrollata bil-plaċebo (PPMS), IRR kienet l-aktar avveniment avvers komuni f'pazjenti ttrattati b'Ocrevus b'inċidenza globali ta' 40.1% meta mqabbel ma' inċidenza ta' 25.
English: Solutions of Ocrevus for intravenous administration are prepared by dilution of the drug product into an infusion bag containing isotonic 0.9% sodium chloride (300 mg / 250 mL or 600 mg / 500 mL), to a final drug concentration of approximately 1.2 mg/mL.
Maltese: Soluzzjonijiet ta' Ocrevus għallgħoti ġol-vini huma ppreparati permezz ta' dilwizzjoni tal-prodott mediċinali ġo borża talinfużjoni li jkun fiha 0.9% sodium chloride isotoniku (300 mg/250 mL jew 600 mg/500 mL), għal konċentrazzjoni finali tal-mediċina ta' madwar 1.2 mg/mL.
English: Baseline characteristics
Maltese: Karatteristiċi fil-linja bażi
English: Breast-feeding
Maltese: fid-demm
English: Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).
Maltese: Ocrevus huwa indikat għat-trattament ta' pazjenti adulti b'forom li jirkadu ta' sklerożi multipla (RMS - relapsing multiple sclerosis) b'marda attiva definita minn karatteristiċi kliniċi jew ta' immaġini (ara sezzjoni 5.1).
English: Relative reduction
Maltese: Tnaqqis relattiv
English: · The rate can be increased in 40 mL/hour increments every 30 minutes to a maximum of 200 mL/hour
Maltese: 40 mL/siegħa kull 30 minuta sa massimu ta' 200 mL/siegħa
English: Please refer to section 4.8 for information about the Systemic Inflammatory Response Syndrome (SIRS) that occurred in a patient treated with Ocrevus 2000 mg.
Maltese: Jekk jogħġbok irreferi għas-sezzjoni 4.8 għal informazzjoni dwar is-Sindrome ta' Rispons Infjammatorju Sistemiku (SIRS - Systemic Inflammatory Response Syndrome) li seħħ f'pazjent ittrattat b'Ocrevus 2000 mg.
English: IRR profiles per infusion were also similar, independent of whether the 600 mg dose was administered as a single 600 mg infusion or as two 300 mg infusions separated by two weeks (see sections 4.8 and 5.2), but due to overall more infusions with the 2 x 300 mg regimen, the total number of IRRs were higher.
Maltese: Profili ta' IRR għal kull infużjoni kienu simili wkoll, indipendenti minn jekk iddoża ta' 600 mg ingħatatx bħala infużjoni waħda ta' 600 mg jew bħala żewġ infużjonijiet ta' 300 mg separati b'ġimagħtejn (ara sezzjonijiet 4.8 u 5.2), iżda minħabba għadd globali akbar ta' infużjonijiet bil-kors ta' 2 x 300 mg, in-numru totali ta' IRRs kien ogħla.
English: This is because it has not yet been studied in this age group.
Maltese: Dan minħabba li għadu ma ġiex studjat f'dan il-grupp ta' età.
English: Multiple Sclerosis (MS) affects the central nervous system, especially the nerves in the brain and spinal cord.
Maltese: Sklerożi Multipla (MS - Multiple Sclerosis) taffettwa s-sistema nervuża ċentrali, b'mod speċjali nnervaturi fil-moħħ u s-sinsla tad-dahar.
English: In the active-controlled (RMS) treatment period, a decrease in neutrophils < LNN was observed in 14.7% of Ocrevus patients compared with 40.9% of patients treated with interferon beta-1a.
Maltese: Fil-perjodu ta' trattament ikkontrollat b'mod attiv (RMS), kien osservat tnaqqis fin-newtrofili < LNN f'14.7% tal-pazjenti ttrattati b'Ocrevus meta mqabbel ma' 40.9% tal-pazjenti ttrattati b'interferon beta-1a.
English: The two following premedications must be administered prior to each Ocrevus infusion to reduce the frequency and severity of IRRs: -100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each Ocrevus infusion; -antihistamine approximately 30-60 minutes prior to each Ocrevus infusion; In addition, premedication with an antipyretic (e.g. paracetamol) may also be considered approximately 30-60 minutes prior to each Ocrevus infusion.
Maltese: • Medikazzjoni minn qabel għall IRRs Iż-żewġ medikazzjonijiet minn qabel li ġejjin għandhom jingħataw qabel kull infużjoni ta' Ocrevus biex inaqqsu l-frekwenza u s-severità ta' IRRs: 100 mg methylprednisolone ġol-vini (jew ekwivalenti) bejn wieħed u ieħor 30 minuta qabel kull infużjoni ta' Ocrevus; antistamina madwar 30-60 minuta qabel kull infużjoni ta' Ocrevus; Barra dan, medikazzjonijiet minn qabel b'sustanza kontra d-deni (eż. paracetamol) tista' tiġi kkunsidrata wkoll madwar 30-60 minuta qabel kull infużjoni ta' Ocrevus.
English: Treatment with Ocrevus leads to rapid depletion of CD19+ B cells in blood by 14 days post treatment (first time-point of assessment) as an expected pharmacologic effect.
Maltese: Trattament b'Ocrevus iwassal għal tnaqqis rapidu ta' ċelluli B CD19+ fid-demm sa 14-il jum wara ttrattament (l-ewwel punt ta' żmien tal-valutazzjoni) bħala effett farmakoloġiku mistenni.
English: How to store Ocrevus
Maltese: X'inhu Ocrevus
English: Approximately 1% of the patients in the Ocrevus group had a Grade 3 lymphopenia (between 200 and 500 cells/mm3).
Maltese: Madwar 1% tal-pazjenti fil-grupp ta' 800 ċellula/mm 3).
English: The overall proportion of patients experiencing a serious infection was similar to comparators (see section 4.8).
Maltese: Il-proporzjon globali ta' pazjenti li kellhom infezzjoni serja kien simili għal sustanzi ta' paragun (ara sezzjoni 4.8).
English: The capacity of B-cell reconstitution and preexisting humoral immunity are preserved.
Maltese: Il-kapaċità tarrikostituzzjoni taċ-ċelluli B u l-immunità umorali eżistenti minn qabel huma ppreservati.
English: You will be given a total dose of 600 mg of Ocrevus every 6 months.
Maltese: Inti se tingħata doża totali ta' 600 mg ta' Ocrevus kull 6 xhur.
English: Treatment of severely immunocompromised patients
Maltese: Trattament ta' pazjenti immunokompromessi b'mod sever
English: The following side effects have been reported with Ocrevus:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati b'Ocrevus:
English: Infusion 1 300 mg in 250 mL · Initiate the infusion at a rate of 30 mL/hour for 30 minutes
Maltese: 300 mg f'250 mL • Ibda l-infużjoni b'rata ta' 30 mL/siegħa għal 30 minuta
English: Positive response to ³5 serotypes in 23-PPV at 4 weeks after vaccination was 71.6% in the ocrelizumab group and 100% in the control group.
Maltese: Ir-rispons pożittiv għal ≥5 serotipi fi 23-PPV 4 ġimgħat wara t-tilqim kien ta' 71.6% fil-grupp ta' ocrelizumab u 100% fil-grupp ta' kontroll.
English: In MS, the immune system (the body's defence system) works incorrectly and attacks a protective layer (called myelin sheath) around nerve cells and causes inflammation.
Maltese: F'MS, is-sistema immuni (is-sistema ta' difiża tal-ġisem) ma taħdimx tajjeb u tattakka saff protettiv (imsejjaħ myelin sheath) madwar iċ-ċelluli tan-nerv u tikkawża infjammazzjoni.
English: · After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line.
Maltese: • Wara d-dilwizzjoni, Ocrevus jingħata bħala infużjoni ġol-vini permezz ta' linja apposta.
English: · you are taking medicines for high blood pressure.
Maltese: • qed tieħu mediċini għall-pressjoni għolja.
English: · Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms.
Maltese: • Sensittività eċċessiva tista' tkun diffiċli biex tingħaraf minn IRR f'termini ta' sintomi.
English: Serious infections occurred in 1.3% of patients receiving Ocrevus vs 2.9% of patients receiving interferon beta 1a.
Maltese: Infezzjonijiet serji seħħew f'1.3% tal-pazjenti li kienu qed jirċievu Ocrevus vs 2.9% tal-pazjenti li kienu qed jirċievu interferon beta 1a.
English: The table 2 summarises the ADRs that have been reported in association with the use of Ocrevus in 1311 patients (3054 patient years) during the controlled treatment periods of MS clinical trials.
Maltese: It-tabella 2 tagħti sommarju tal-ADRs li kienu rrappurtati b'rabta mal-użu ta' Ocrevus f'1311il pazjent (3054 sena ta' pazjent) matul il-perjodi kkontrollati tat-trattament tal-provi kliniċi ta' MS.
English: Ocrevus is used to treat adults with: · Relapsing forms of multiple sclerosis (RMS) · Early primary progressive multiple sclerosis (PPMS)
Maltese: • Sklerożi Multipla Progressiva Primarja (PPMS - Primary Progressive Multiple Sclerosis) bikrija
English: NEDA defined as absence of protocol defined relapses, 12-week Confirmed Disability Progression (CDP), and any MRI activity (either Gd-enhancing T1 lesions, or new or enlarging T2 lesions) during the whole 96-week treatment.
Maltese: NEDA definita bħala nuqqas ta' rikaduti definiti fil-protokoll, Progressjoni Kkonfermata tad-Diżabilità (CDPConfirmed Disability Progression) ta' 12-il ġimgħa, u kull attività osservata b'MRI (leżjonijiet T1 osservati aktar b'Gd, jew leżjonijiet T2 ġodda jew li qed jikbru) waqt it-trattament kollu ta' 96 ġimgħa.
English: Patients with positive serology (i.e. negative for HBsAg and positive for HB core antibody (HBcAb +); carriers of HBV (positive for surface antigen, HBsAg+) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Maltese: Pazjenti b'seroloġija pożittiva (jiġifieri negattivi għal HBsAg u pożittivi għall-antikorpi tal-qalba ta' HB (HBcAb +); trasportaturi ta' HBV (pożittivi għall-antiġen tal-wiċċ, HBsAg+) għandhom jikkonsultaw esperti fil-mard tal-fwied qabel il-bidu tat-trattament u għandhom jiġu mmonitorjati u mmaniġġjati skont standards mediċi lokali għall-prevenzjoni ta' attivazzjoni mill-ġdid tal-Epatite B.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., it is essentially sodium-free.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.