FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted the recommended doses for the different posologies as indicated above.
Maltese: Is-CHMP innota d-dożi rrakkomandati għall-pożoloġiji differenti kif indikat hawn fuq.
English: The duration of the active treatment period was only 8 weeks.
Maltese: Id-dewmien tal-perijodu ta' trattament attiv kien biss ta' 8 ġimgħat.
English: The CHMP agreed that the indication treatment of first and recurrent episodes of genital herpes in immunocompetent patients and treatment of recurrent episodes of genital herpes in immunocompromised patients was supported by the available data.
Maltese: Madankollu, huwa qabel li lindikazzjoni ta' suppressjoni tal-ħerpes ġenitali rikorrenti fl-adulti immunokompetenti u immunokompromessi kienet appoġġjata mid-dejta disponibbli.
English: The primary efficacy endpoint was the proportion of patients who had an ocular manifestation during the study (7-day treatment phase and 6month follow-up period).
Maltese: Il-punt tat-tmiem primarju tal-effikaċja kien il-proporzjon ta' pazjenti li kellhom manifestazzjoni okulari matul l-istudju (fażi ta' trattament ta' 7 ijiem u perijodu ta' segwitu ta' 6 xhur).
English: In contrast with toxicological findings, where famciclovir produced testicular toxicity in rats, mice and dogs at doses of at least 150mg/kg, these clinical studies clearly demonstrate that at therapeutic doses of 250mg bid (about 6mg/kg), famciclovir does not affect human spermatogenesis or semen quality.
Maltese: B'kuntrast għas-sejbiet tossikoloġiċi, fejn farmciclovir ipproduċa tossiċità testikolari fil-firien, il-ġrieden u l-klieb b'dożi ta' mill-inqas 150mg/kgm dawn l-istudji kliniċi juru b'mod ċar li b'dożi terapewtiċi ta' 250mg bid (madwar 6mg/kg), farmciclovir ma jaffettwax l-ispermatoġeneżi umana jew il-kwalità tas-semen.
English: The CHMP concluded that the available data supported the efficacy and safety of the selected doses, both, the 125mg bid for treatment of recurrent episodes and the 250bid for suppressive therapy of genital herpes.
Maltese: Is-CHMP ikkonkluda li d-dejta disponibbli appoġġjat l-effikaċja u s-sigurtà tad-dożi magħżulin, ittnejn li huma, il-125mg tid għat-trattament tal-episodji rikorrenti u l-250 bid għat-terapija ta' trażżin tal-ħerpes ġenitali.
English: OPHTALMIC ZOSTER IN IMMUNOCOMPETENT ADULTS
Maltese: Erpete ġenitali f'adulti b'immunokompetenza
English: While both Studies 102 and 195 were small in size and breadth of patients included, the results for suppression of viral recurrence were consistent and extended to both patients with CD4+ cell counts below and above 200 cells/mm3.
Maltese: Filwaqt li kemm Studju 102 kif ukoll 195 kienu żgħar fid-daqs u fil-wisa' talpazjenti inklużi fihom, ir-riżultati tat-trażżin tar-rikorrenza virali kienu konsistenti u estendew għażżewġ pazjenti b'CD4+ l-għadd taċ-ċelloli taħt u fuq il-200 ċellola/mm3.
English: At that time the clinical benefits of aciclovir treatment had been well established and aciclovir was the standard of care for minimizing the ocular complications associated with ophthalmic zoster.
Maltese: Għaldaqstant, minbarra t-terapija b'famciclovir, huwa rrakkomandat li l-pazjenti jużaw prattiċi sesswali aktar siguri.
English: The famciclovir 500mg tid dose regimen was chosen as representing the highest approved dose for herpes zoster in immunocompetent patients.
Maltese: Il-kors tad-doża ta' farmciclovir 500mg tid intgħażel bħala dak li jirrappreżenta d-doża l-iktar approvata għall-ħerpes żoster fil-pazjenti immunokompetenti.
English: Log-rank test
Maltese: Test Log-rank
English: MedDRA System Organ Class (SOC)
Maltese: Organi (SOC - System Organ Class)
English: Age 18-55 years, EDSS of 3.0 to 6.5
Maltese: Età 18-55 sena, EDSS ta' 3.0 sa 6.5
English: Proportion of patients with No Evidence of Disease Activity (NEDA)
Maltese: (NEDA - No Evidence of Disease Activity)5
English: Pharmacotherapeutic group: selective immunosuppressants group, ATC code: L04AA36.
Maltese: Kategorija farmakoterapewtika: grupp ta' immunosoppressanti selettivi, Kodiċi ATC: L04AA36.
English: · The active substance is ocrelizumab.
Maltese: • Is-sustanza attiva hi ocrelizumab.
English: Placebo (n=244)
Maltese: Plaċebo (n=244)
English: Progressive multifocal leukoencephalopathy (PML)
Maltese: Lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy)
English: Infusion-Related Reactions (IRRs)
Maltese: Reazzjonijiet Relatati mal-Infużjoni (IRRs - Infusion-Related Reactions)
English: 300 mg in 250 mL
Maltese: 300 mg f'250 mL
English: Read the SmPC for additional information.
Maltese: Aqra l-SmPC għal informazzjoni addizzjonali.
English: Annualised Relapse Rate (ARR) (primary endpoint)
Maltese: Rata Annwalizzata ta' Rkadar (ARR - Annualised Relapse Rate) (punt finali primarju)
English: It is a type of protein called a ‘monoclonal antibody'.
Maltese: Huwa tip ta' proteina msejħa ‘antikorp monoklonali'.
English: Primary Progressive MS
Maltese: MS Primarja Progressiva
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1231/001 1-vial pack EU/1/17/1231/002 2-vials pack
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1231/0011 pakkett ta' kunjett wieħed EU/1/17/1231/0022 pakkett ta' 2 kunjetti
English: Group A: Ocrevus 600 mg Group B: interferon beta-1a 44 mcg S.C. (IFN)
Maltese: Ocrevus 600 mg Group B: interferon beta-1a 44 mcg S.C.
English: Treatment groups
Maltese: Gruppi ta' trattament
English: Sinusitis, bronchitis, oral herpes, gastroenteritis, respiratory tract infection, viral infection, herpes zoster, conjunctivitis, cellulitis
Maltese: Sinożite, bronkite, herpes orali, gastroenterite, infezzjoni flapparat respiratorju, infezzjoni ikkawżata minn virus, herpes zoster, konġuntivite, ċellulite
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 8 January 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 8 ta' Jannar 2018
English: Mild to Moderate IRRs
Maltese: IRRs Ħfief sa Moderati
English: Study 1: WA21092 (OPERA I)
Maltese: Studju 1: WA21092 (OPERA I)
English: Table 2 ADRs reported with Ocrevus (in RMS or PPMS)
Maltese: Tabella 2 ADRs irrappurtati b'Ocrevus (f'RMS jew PPMS)
English: 18 months
Maltese: 30 minuta
English: See section 4.4 and section 4.8 (subsection ‘Description of selected adverse reactions') for further details.
Maltese: Ara sezzjoni 4.4 u sezzjoni 4.8 (sottosezzjoni ‘Deskrizzjoni ta' reazzjonijiet avversi magħżula') għal aktar dettalji.
English: Study WA25046 ORATORIO (n=732) Study design
Maltese: Studju WA25046 ORATORIO (n=732)
English: WA25046 study]; HR 0.48 [0.25-0.92]; <51 years: HR 0.53 [0.31-0.89]).
Maltese: 52 [0.27-1.00]; ≤ 46 sena [età medjana talistudju WA25046]; HR 0.48 [0.25-0.92]; < 51 sena: HR 0.53 [0.
English: Study 2: WA21093 (OPERA II)
Maltese: Studju 2: WA21093 (OPERA II)
English: Cough, catarrh
Maltese: Sogħla, katarru
English: 24% reduction in risk of CDP HR (95% CI): 0.76 (0.59, 0.98); p=0.0321
Maltese: Tnaqqis ta' 24% fir-riskju ta' CDP HR (CI ta' 95%): 0.76 (0.59, 0.98); p=0.0321
English: The 600 mg infusions in RMS and the 2 x 300 mg infusions in PPMS demonstrated consistent PK/PD profiles.
Maltese: L-infużjonijiet ta' 600 mg f'RMS u ż-żewg infużjonijiet x 300 mg f'PPMS urew profili PK/PD konsistenti.
English: Patients in MS trials (WA21092, WA21093 and WA25046) were tested at multiple time points (baseline and every 6 months post treatment for the duration of the trial) for anti-drug antibodies (ADAs).
Maltese: Pazjenti fil-provi dwar MS (WA21092, WA21093 u WA25046) kienu ittestjati fil-punti ta' żmien multipli (fil-linja bażi u kull 6 xhur wara t-trattament matul il-prova kollha) għal antikorpi kontra lmediċina (ADAs - anti-drug antibodies).
English: Severe IRRs
Maltese: IRRs severi
English: Table 4 Key Clinical and MRI Endpoints from Studies WA21092 and WA21093 (RMS)
Maltese: Tabella 4 Punti aħħarin Kliniċi u tal-MRI Ewlenin minn Studji WA21092 u WA21093 (RMS)
English: The terminal elimination half-life of ocrelizumab was 26 days.
Maltese: Il-half-life tal-eliminazzjoni terminali ta' ocrelizumab kienet ta' 26 jum.
English: Table 6 Key Clinical and MRI Endpoints from Study WA25046 (PPMS) Study 3
Maltese: Tabella 6 Punti aħħarin Kliniċi u tal-MRI Ewlenin minn Studju WA25046 (PPMS) Studju 3
English: In active-controlled (RMS) clinical trials, herpes infections were reported more frequently in Ocrevus-treated patients than in interferon-beta-1a treated patients including herpes zoster (2.1% vs 1.0%), herpes simplex, ( 0.7 % vs 0.1 %) oral herpes (3.0% vs 2.2%), genital herpes (0.1% vs 0%) and herpes virus infection (0.1% vs 0%).
Maltese: Fi provi kliniċi kkontrollati b'mod attiv (RMS), infezzjonijiet tal-herpes kienu rrappurtati b'mod aktar frekwenti f'pazjenti ttrattati b'Ocrevus milli f'pazjenti ttrattati b'interferon-beta-1a inklużi herpes zoster (2.1% vs 1.0%), herpes simplex, (0.7% vs 0.1%) herpes orali (3.0% vs 2.2%), herpes ġenitali (0.1% vs 0%) u infezzjoni bil-virus tal-herpes (0.1% vs 0%).
English: Table 3 Study Design, Demographic and Baseline Characteristics Study 1
Maltese: Tabella 3 Disinn tal-Istudju, Karatteristiċi Demografiċi u fil-Linja Bażi Studju 1
English: Do not breast-feed while you are being treated with Ocrevus.
Maltese: Huma se josservawk mill-qrib waqt li tkun qed tingħata din il-mediċina.
English: Geometric mean anti-tetanus toxoid specific antibody titers at 8 weeks were 3.74 and 9.81 IU/ml, respectively.
Maltese: It-titers ġeometriċi medji ta' antikorpi speċifiċi għal tossojde kontra t-tetnu wara 8 ġimgħat kienu ta' 3.74 u 9.81 IU/ml, rispettivament.
English: 10 mL concentrate in a glass vial.
Maltese: 10 mL ta' konċentrat).
English: Following cell surface binding, ocrelizumab selectively depletes CD20-expressing B cells through antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptosis.
Maltese: Wara l-irbit mas-superfiċje taċ-ċellula, ocrelizumab inaqqas b'mod selettiv ċelluli B li jesprimu CD20 permezz ta' fagoċitożi ċellulari dipendenti fuq antikorpi (ADCP - antibody-dependent cellular phagocytosis), ċitotossiċità ċellulari dipendenti fuq antikorpi (ADCC - antibody-dependent cellular cytotoxicity), ċitotossiċità dipendenti fuq komplement (CDC - complement-dependent cytotoxicity), u apoptożi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 300 mg ocrelizumab in 10 ml (30 mg/ml).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 300 mg ocrelizumab f'10 ml (30 mg/ml).
English: Effect on the immune system :
Maltese: Effett fuq is-sistema immuni:
English: · Known active malignancies (see section 4.4)
Maltese: • Infezzjoni attiva attwali (ara sezzjoni 4.4)
English: · Subsequent Doses
Maltese: • Dożi Sussegwenti
English: There are no dedicated PK studies of ocrelizumab in patients ≥55 years due to limited clinical experience (see section 4.2).
Maltese: M'hemm l-ebda studju PK apposta ta' ocrelizumab f'pazjenti b'età ta' ≥ 55 sena minħabba esperjenza klinika limitata (ara sezzjoni 4.2).
English: The overall safety profile of Ocrevus in Multiple Sclerosis is based on data from patients from pivotal clinical trials in MS (RMS and PPMS).
Maltese: Il-profil tas-sigurtà globali ta' Ocrevus fi Sklerożi Multipla huwa bbażat fuq data minn pazjenti minn provi kliniċi importanti ħafna f'MS (RMS u PPMS).
English: · you have ever had hepatitis B or are a carrier of the hepatitis B virus.
Maltese: • qatt kellek epatite B jew inti trasportatur tal-virus tal-epatite B.
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Maltese: Roche Pharma AG Emill-Barell-Strasse 1 D-79639 Grenzach-Wyhlen
English: In the placebo-controlled (PPMS) clinical trial, a higher proportion of patients with oral herpes (2.7% vs 0.8%) were observed in the Ocrevus treatment arm.
Maltese: Fil-prova klinika kkontrollata bil-plaċebo (PPMS), proporzjon ogħla ta' pazjenti b'herpes orali (2.7% vs 0.8%) kien osservat fil-grupp ta' trattament b'Ocrevus.
English: Patients with primary progressive form of MS
Maltese: Pazjenti b'forma primarja progressiva ta' MS
English: · The other ingredients are sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 20 and water for injection.
Maltese: • Is-sustanzi mhux attivi l-oħra huma sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 20 u ilma għall-injezzjoni.
English: In the RMS clinical trials, 39.9% of Ocrevus treated patients and 33.2% interferon beta-1-a treated patients experienced an upper respiratory tract infection and 7.5% of Ocrevus treated patients and 5.2% of interferon beta-1-a treated patients experienced a lower respiratory tract infection.
Maltese: Fil-provi kliniċi dwar RMS, 39.9% tal-pazjenti ttrattati b'Ocrevus u 33.2% tal-pazjenti ttrattati b'interferon beta-1-a kellhom infezzjoni fl-apparat respiratorju ta' fuq u 7.5% tal-pazjenti ttrattati b'Ocrevus u 5.2% tal-pazjenti ttrattati b'interferon beta-1-a kellhom infezzjoni fl-apparat respiratorju t'isfel.
English: If PML is confirmed, treatment must be discontinued permanently.
Maltese: Jekk tiġi kkonfermata PML, it-trattament għandu jitwaqqaf b'mod permanenti.
English: · Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP)
English: Group A: Ocrevus 600 mg Group B: Placebo, in 2:1 randomisation
Maltese: Ocrevus 600 mg Grupp B: Plaċebo, f'għażla b'mod każwali ta' 2:1
English: Ocrevus is not intended to be used in children and adolescents under 18 years old.
Maltese: Ocrevus mhux maħsub biex tintuża fi tfal u adolexxenti ta' età inqas minn 18-il sena.
English: The final drug concentration after dilution is approximately 1.2 mg/mL.
Maltese: Il-konċentrazzjoni finali tal-mediċina wara d-dilwizzjoni hija madwar 1.2 mg/mL.
English: See section 4.5 and 5.1 for further information about vaccinations.
Maltese: Ara sezzjonijiet 4.5 u 5.1 għal aktar informazzjoni dwar it-tilqim.
English: There is no specific antidote in the event of an overdose; interrupt the infusion immediately and observe the patient for IRRs (see section 4.4).
Maltese: M'hemm l-ebda antidotu speċifiku f'każ ta' doża eċċessiva; interrompi l-infużjoni immedjatament u osserva l-pazjent għal IRRs (ara sezzjoni 4.4).
English: · Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and subsequently 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: Table 1: Dose and Schedule of Ocrevus
Maltese: Tabella 1: Doża u Skeda ta' Ocrevus
English: Clinical Endpoints
Maltese: Punti Aħħarin Kliniċi
English: Concentrate for solution for infusion 300 mg/10 ml
Maltese: Konċentrat għal soluzzjoni għall-infużjoni 300 mg/10 ml
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Maltese: Il-frekwenzi huma definiti bħala 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) u rari ħafna (< 1/10,000).
English: A risk of PML cannot be ruled-out since John Cunningham (JC) virus infection resulting in PML has been observed in patients treated with anti-CD20 antibodies and other MS therapies, and associated with risk factors (e.g. patient population, polytherapy with immunosuppressants).
Maltese: Riskju ta' PML ma jistax jiġi eskluż peress li infezzjoni bil-virus John Cunningham (JC) li twassal għal PML ġiet osservata f'pazjenti ttrattati b'antikorpi kontra CD20 u terapiji għal MS oħrajn, u assoċjati ma' fatturi ta' riskju (eż. popolazzjoni ta' pazjenti, politerapija b'immunosoppressanti).
English: Blood immunoglobulin G decreased
Maltese: Tnaqqis ta' immunoglobulina G
English: Table 5 Study design, demograhics and baseline characteristics for Study WA25046.
Maltese: Disinn tal-istudju, karatteristiċi demografiċi u fil-linja bażi għal Studju WA25046.
English: The majority of these decreases reported in Ocrevus treated patients were Grade 1 (<LLN800 cells/mm3) and 2 (between 500 and 800 cells/mm3) in severity.
Maltese: Il-maġġoranza ta' dan it-tnaqqis rrappurtat f'pazjenti ttrattati b'Ocrevus kien ta' Grad 1 (< LLN3) u 2 (bejn 500 u 800 ċellula/mm 3) fis-severità.
English: 40% reduction in risk of CDP HR (95% CI): 0.60 (0.45, 0.81) (p =0.0006)
Maltese: Tnaqqis ta' 40% fir-riskju ta' CDP HR (CI ta' 95%): 0.60 (0.45, 0.81)
English: Across the RMS and PPMS trials, symptoms associated with IRRs included, but are not limited to: pruritus, rash, urticaria, erythema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, nausea, tachycardia.
Maltese: Matul il-provi dwar RMS u PPMS, sintomi assoċjati ma' IRRs inkludew, iżda ma kinux limitati għal: ħakk, raxx, urtikarja, eritema, fwawar, pressjoni baxxa, deni, għeja, uġigħ ta' ras, sturdament, irritazzjoni fil-gerżuma, uġigħ fil-ħalq u l-farinġi, qtugħ ta' nifs, edema fil-farinġi jew fil-larinġi, dardir, takikardija.
English: Infections included and were not limited to atypical pneumonia and pneumocystis jirovecii pneumonia, varicella pneumonia, tuberculosis, histoplasmosis.
Maltese: Infezzjonijiet inkludew u ma kinux limitati għal pulmonite atipika u pulmonite kkawżata minn pneumocystis jirovecii, pulmonite kkawżata minn varicella, tuberkulożi, istoplasmożi.
English: Ocrevus is a humanised monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.
Maltese: Ocrevus huwa antikorp monoklonali umanizzat ta' sottotip tal-immunoglobulina G1 u immunoglobulini huma magħrufa li jgħaddu mill-barriera tal-plaċenta.
English: Other medicines and Ocrevus
Maltese: Mediċini oħra u Ocrevus
English: Ocrevus contains the active substance ‘ocrelizumab'.
Maltese: Ocrevus fih is-sustanza attiva ‘ocrelizumab'.
English: In other auto-immune conditions, use of Ocrevus concomitantly with immunosuppressive medications (e.g. chronic corticosteroids, non-biologic and biologic disease-modifying antirheumatic drugs [DMARDS], mycophenolate mofetil, cyclophosphamide, azathioprine) resulted in an increase of serious infections, including opportunistic infections.
Maltese: F'kondizzjonijiet awto-immuni oħrajn, l-użu ta' Ocrevus flimkien ma' mediċini immunosoppressivi (eż. kortikosterojdi kroniċi, mediċini anti-rewmatiċi li jimmodifikaw il-marda [DMARDs - diseasemodifying antirheumatic drugs] mhux bijoloġiċi u bijoloġiċi, mycophenolate mofetil, cyclophosphamide, azathioprine) wassal għal żieda ta' infezzjonijiet serji, inkluż infezzjonijiet opportunistiċi.
English: Patients in Group B were administered Interferon beta-1a (Rebif) 44 mcg via subcutaneous injection 3 times per week.
Maltese: Pazjenti fi Grupp B ingħataw Interferon beta-1a (Rebif) 44 mcg permezz ta' injezzjoni taħt il-ġilda 3 darbiet fil-ġimgħa.
English: Evaluation including Magnetic Resonance Imaging (MRI) scan preferably with contrast (compared with pre-treatment MRI), confirmatory cerebro-spinal fluid (CSF) testing for John Cunningham (JC) Viral Deoxyribonucleic acid (DNA) and repeat neurological assessments, should be considered.
Maltese: Għandha tiġi kkunsidrata valutazzjoni inkluż skan b'Immaġini b'Riżonanza Manjetika (MRI - Magnetic Resonance Imaging) preferibbilment b'kuntrast (imqabbel ma' MRI qabel it-trattament), ittestjar ta' konferma tal-fluwidu ċerebro-spinali (CSF - cerebro-spinal fluid) għal Deoxyribonucleic acid (DNA) tal-Virus John Cunningham (JC) u valutazzjonijiet newroloġiċi ripetuti.
English: See sections 4.4 and 4.5.
Maltese: Ara sezzjonijiet 4.4 u 4.5.
English: Ocrevus contains sodium
Maltese: Ocrevus fih is-sodium
English: Mean age (years) Age range (years) at inclusion Gender distribution (% male/% female) Mean/Median disease duration since PPMS diagnosis (years) Mean EDSS
Maltese: Distribuzzjoni tas-sessi (% ta' irġiel/% ta' nisa) Tul medju/medjan tal-marda mid-dijanjosi ta' PPMS (snin) EDSS medja
English: Pack size of 1 or 2 vials.
Maltese: Daqs tal-pakkett ta' kunjett 1 jew 2 kunjetti.
English: Patients with a history of congestive heart failure (New York Heart Association III & IV) were not studied.
Maltese: Pazjenti bi storja ta' insuffiċjenza konġestiva tal-qalb (New York Heart Association III &
English: In the PPMS clinical trial, 48.8% of Ocrevus treated patients and 42.7% of patients who received placebo experienced an upper respiratory tract infection, and 9.9% of Ocrevus treated patients and 9.2% of patients who received placebo experienced a lower respiratory tract infection.
Maltese: Fil-prova klinika dwar PPMS, 48.8% tal-pazjenti ttrattati b'Ocrevus u 42.7% tal-pazjenti li rċevew plaċebo kellhom infezzjoni fl-apparat respiratorju ta' fuq u 9.9% tal-pazjenti ttrattati b'Ocrevus u 9.2% tal-pazjenti li rċevew plaċebo kellhom infezzjoni fl-apparat respiratorju t'isfel.
English: Figure 1: 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 (Pooled WA21092 and WA21093 ITT Population)*
Maltese: Figura 1: 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' WA21092 u WA21093 Globali)*
English: What is Multiple Sclerosis
Maltese: X'inhi Sklerożi Multipla
English: The respiratory tract infections reported in patients treated with Ocrevus were predominately mild to moderate (80 - 90 %).
Maltese: L-infezzjonijiet fl-apparat respiratorju rrappurtati f'pazjenti ttrattati b'Ocrevus fil-biċċa l-kbira kienu ħfief sa moderati (80-90%).
English: Efficacy and safety of Ocrevus were evaluated in two randomised, double-blind, double-dummy, active comparator-controlled clinical trials (WA21092 and WA21093), with identical design, in patients with relapsing forms of MS (in accordance with McDonald criteria 2010) and evidence of disease activity (as defined by clinical or imaging features) within the previous two years.
Maltese: L-effikaċja u s-sigurtà ta' Ocrevus ġew evalwati f'żewġ provi li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, double-dummy, ikkontrollati b'mod attiv b'sustanza ta' paragun (WA21092 u WA21093), b'disinn identiku, f'pazjenti b'forom ta' MS li jirkadu (skont il-kriterji McDonald 2010) u evidenza ta' attività tal-marda (kif definita minn karatteristiċi kliniċi jew ta' immaġini) matul issentejn preċedenti.
English: 1 vial
Maltese: DOŻA 1
English: Relative Increase2
Maltese: Żieda Relattiva2
English: In PPMS, a decrease in lymphocytes <LLN was observed in 26.3% of Ocrevus treated patients vs 11.7% of placebo-treated patients.
Maltese: F'PPMS, tnaqqis fil-limfoċiti < LLN ġie osservat f'26.3% tal-pazjenti ttrattati b'Ocrevus vs 11.7% tal-pazjenti ttrattati bil-plaċebo.
English: Pre-specified non-powered subgroup analysis of the the primary endpoint suggests that patients who are younger or those with T1 Gd-enhancing lesions at baseline receive a greater treatment benefit than patients who are older or without T1 Gd-enhancing lesions (≤ 45 years: HR 0.64 [0.45, 0.92], >45 years: HR 0.88 [0.62, 1.26]; with T1 Gd-enhancing lesions at baseline: HR 0.65 [0.40-1.06], without T1 Gd-enhancing lesions at baseline: HR 0.84 [0.62-1.13]).
Maltese: Analiżi tas-sottogrupp speċifikat minn qabel mhux powered tal-punt finali primarju tissuġġerixxi li pazjenti li huma iżgħar jew dawk b'leżjonijiet T1 osservati aktar b'Gd fil-linja bażi jirċievu benefiċċju tat-trattament akbar minn pazjenti li huma akbar fl-età jew mingħajr leżjonijiet T1 osservati aktar b'Gd ≤ 45 sena: HR 0.64 [0.45, 0.92], > 45 sena: HR 0.88 [0.
English: Area under the curve (AUCτ) after the 4th dose of 600 mg ocrelizumab was 3510 µg/mL•day, and mean maximum concentration (Cmax) was 212 µg/mL in RMS (600 mg infusion) and 141 µg/mL in PPMS (300 mg infusions).
Maltese: L-erja taħt ilkurva (AUCτ - area under the curve) wara r-raba' doża ta' 600 mg ocrelizumab kienet 3510 µg/mL•jum, u l-konċentrazzjoni massima medja (Cmax) kienet 212 µg/mL f'RMS (infużjoni ta' 600 mg) u 141 µg/mL f'PPMS (infużjonijiet ta' 300 mg).