FrancophonIA/ELRC3.0 huggingface dataset:
English: In a randomized open-label study in RMS patients (N=102), the percentage of patients with a positive response to tetanus vaccine at 8 weeks after vaccination was 23.9% in the ocrelizumab group compared to 54.5% in the control group (no disease-modifying therapy except interferon-beta).
Maltese: Fi studju open-label li fih il-parteċipanti ntgħażlu b'mod każwali f'pazjenti b'RMS (N=102), ilperċentwali ta' pazjenti b'rispons pożittiv għal vaċċin tat-tetnu 8 ġimgħat wara t-tilqim kien ta' 23.9% fil-grupp ta' ocrelizumab meta mqabbel ma' 54.5% fil-grupp ta' kontroll (mingħajr terapija li timmodifika l-marda jew interferon-beta).
English: Hepatitis B reactivation
Maltese: maqsuma f'2 infużjonijiet
English: Premedication for infusion-related reactions
Maltese: Reazzjonijiet relatati mal-infużjoni
English: Ocrevus is associated with IRRs, which may be related to cytokine release and/or other chemical mediators.
Maltese: Ocrevus huwa assoċjat ma' IRRs, li jistgħu jkunu relatati ma' rilaxx ta' cytokine u/jew medjaturi kimiċi oħra.
English: No incompatibilities between Ocrevus and polyvinyl chloride (PVC) or polyolefin (PO) bags and intravenous administration sets have been observed.
Maltese: Ma kinux osservati inkompatibbiltajiet bejn Ocrevus u boroż tal-polyvinyl chloride (PVC) jew talpolyolefin (PO) u settijiet għall-għoti ġol-vini.
English: The incidence of IRRs was highest during Dose 1, infusion 1 (27.4%,) and decreased with subsequent doses to <10% at Dose 4.
Maltese: L-inċidenza ta' IRRs kienet l-ogħla matul Doża 1, infużjoni 1 (27.4%) u naqset b'Dożi sussegwenti għal <10% f'Doża 4.
English: Hypersensitivity Reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: Please see section 4.2 for populations not studied.
Maltese: Jekk jogħġbok ara sezzjoni 4.2 għall-popolazzjonijiet mhux studjati.
English: Single infusion 600 mg in 500 mL · Initiate the infusion at a rate of 40 mL/hour for 30 minutes
Maltese: 600 mg f'500 mL • Ibda l-infużjoni b'rata ta' 40 mL/siegħa għal 30 minuta
English: The most important and frequently reported adverse drug reactions (ADRs) were IRRs and infections.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADRs - adverse drug reactions) importanti u rrappurtati b'mod frekwenti kienu IRRs u infezzjonijiet.
English: · Current active infection (see section 4.4) · Patients in a severely immunocompromised state (see section 4.4 ).
Maltese: • Pazjenti fi stat immunokompromess b'mod sever (ara sezzjoni 4.4)
English: The extent and duration of B-cell depletion was consistent in the PPMS and RMS trials.
Maltese: L-ammont u t-tul ta' żmien ta' tnaqqis ta' ċelluli B kien konsistenti fil-provi dwar PPMS u RMS.
English: Neutropenia
Maltese: Ocrevus
English: Neither carcinogenicity nor mutagenicity studies have been conducted with ocrelizumab.
Maltese: Tarmix mediċini mal-ilma tad-dranaġġ.
English: In the ocrelizumab MS pivotal studies the administration of corticosteroids for the treatment of relapse was not associated with an increased risk of serious infection.
Maltese: Inti se tirċievi kortikosterojd u antistamina qabel kull infużjoni u tista' tirċievi wkoll mediċini biex inaqqsu d-deni.
English: 21,7% and 10.1% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 2.4% experienced severe IRRs and 0.1% experienced lifethreatening IRRs.
Maltese: 1% tal-pazjenti ttrattati b'Ocrevus kellhom IRRs ħfief u moderati rispettivament, 2.4% kellhom IRRs severi u 0.1% kellhom IRRs ta' periklu għall-ħajja.
English: Event-driven (Minimum 120 weeks and 253 confirmed disability progression events) (Median follow-up time: Ocrevus 3.0 years, Placebo 2.8 years
Maltese: Immexxi mill-avveniment (Minimu ta' 120 ġimgħa u 253 avveniment ta' progressjoni ikkonfermata tad-diżabilità) (Żmien medjan ta' segwitu:
English: Ocrevus must be permanently discontinued in these patients (see section 4.3).
Maltese: Ocrevus għandu jitwaqqaf b'mod permanenti f'dawn il-pazjenti (ara sezzjoni 4.3).
English: * All patients in this analysis had a minimum of 120 weeks of follow-up.
Maltese: * Il-pazjenti kollha f'din l-analiżi kellhom minimu ta' 120 ġimgħa ta' segwitu.
English: A hypersensitivity reaction could also occur (acute allergic reaction to medicinal product).
Maltese: Tista' sseħħ ukoll reazzjoni ta' sensittività eċċessiva (reazzjoni allerġika akuta għall-prodott mediċinali).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2. tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Therefore, after Dose 1 it is recommended to administer Ocrevus in a 600 mg single infusion (see section 4.2) to reduce the total number of infusions (with concurrent exposure to prophylactic methylprednisolone and an antihistamine) and the related infusion reactions).
Maltese: Għalhekk, wara Doża 1 huwa rakkomandat li Ocrevus jingħata bħala infużjoni waħda ta' 600 mg (ara sezzjoni 4.2 ) biex jitnaqqas in-numru totali ta' infużjonijiet (b'esponiment fl-istess waqt għal methylprednisolone u antistamina bħala profilassi) u r-reazzjonijiet relatati mal-infużjoni).
English: Malignancies
Maltese: Limfoċiti
English: This is because of a very rare and life-threatening brain infection, called ‘progressive multifocal leukoencephalopathy' (PML), which can cause symptoms similar to those of MS. PML can occur in patients taking medicines like Ocrevus, and other medicines used for treating MS. Tell your partner or carer about your Ocrevus treatment.
Maltese: Dan minħabba infezzjoni rari ħafna u ta' periklu għall-ħajja fil-moħħ, imsejħa ‘Lewkoenċefalopatija Multifokali Progressiva' (PML - Progressive Multifocal Leukoencephalopathy), li tista' tikkawża sintomi simili għal dawk ta' MS.
English: Analysis of patient populations with differing baseline levels of disease activity, including active and highly active disease, showed that the efficacy of Ocrevus on ARR and 12 week CDP was consistent with the overall population.
Maltese: Analiżi ta' popolazzjonijiet ta' pazjenti b'livelli differenti tal-attività tal-marda fil-linja bażi, inkluż marda attiva u attiva ħafna, uriet li l-effikaċja ta' Ocrevus fuq ARR u CDP ta' 12-il ġimgħa kienet konsistenti mal-popolazzjoni globali.
English: Ocrevus is a monoclonal antibody and cleared via catabolism (rather than hepatic metabolism), and a change in dose is not expected to be required for patients with hepatic impairment (see section 5.2).
Maltese: Ocrevus huwa antikorp monoklonali u jitneħħa permezz ta' kataboliżmu (minflok metaboliżmu epatiku), u mhux mistenni li tkun meħtieġa bidla fiddoża għal pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: You must not be given Ocrevus:
Maltese: M'għandekx tingħata Ocrevus:
English: In a randomized open-label study, RMS patients were able to mount humoral responses, although decreased, to tetanus toxoid, 23-valent pneumococcal polysaccharide with or without a booster vaccine, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines.
Maltese: Fi studju open-label li fih il-parteċipanti ntgħażlu b'mod każwali, pazjenti b'RMS setgħu jibnu risponsi umorali, għalkemm imnaqqsa, għal tossojde tat-tetnu, 23-valent pneumococcal polysaccharide b'vaċċin booster jew mingħajru, neoantiġen ta' keyhole limpet haemocyanin, u vaċċini tal-influwenza tal-istaġun.
English: · In Primary Progressive MS (PPMS), Ocrevus helps to slow down the progression of the disease and reduce deterioration in walking speed.
Maltese: • F'MS Progressiva Primarja (PPMS - Primary Progressive Multiple Sclerosis), Ocrevus jgħin biex inaqqas il-progressjoni tal-marda u jnaqqas id-deterjorazzjoni fil-veloċità tal-mixi.
English: Life-threatening IRRs
Maltese: X'fih Ocrevus
English: · This medicine is to be stored in a refrigerator (2oC - 8oC).
Maltese: • Din il-mediċina għandha tinħażen fi friġġ (2oC - 8oC).
English: Percentage change in T2 hyperintense lesion volume, from baseline to Week 120
Maltese: Punti aħħarin tal-MRI Bidla perċentwali fil-volum tal-leżjoni T2 iperintensiva, mil-linja bażi sa Ġimgħa 120
English: Water for Injection
Maltese: Infezzjonijiet u infestazzjonijiet
English: An exploratory analysis identified the following factors associated with risk of serious infections: higher doses of Ocrevus than recommended in MS, other comorbidities, and chronic use of immunosuppressants/corticosteroids.
Maltese: Analiżi esploratorja identifikat il-fatturi li ġejjin assoċjati ma' riskju ta' infezzjonijiet serji: dożi ogħla ta' Ocrevus minn dawk rakkomandati f'MS, komorboditajiet oħra, u użu kroniku ta' immunosoppressanti/kortikosterojdi.
English: Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
Maltese: Tnaqqis temporanju fl-għadd ta' ċelluli B periferali u limfoċitopenija ġew irrappurtati fi trabi mwielda lill-ommijiet esposti għal antikorpi kontra CD20 oħrajn waqt it-tqala.
English: No formal pharmacokinetic study has been conducted.
Maltese: Ma twettaq l-ebda studju formali dwar il-farmakokinetika.
English: · To get the full benefit of Ocrevus, it is important that you receive each infusion when it is due.
Maltese: • Biex tikseb il-benefiċċju sħiħ ta' Ocrevus, huwa importanti li tirċievi kull infużjoni f'waqtha.
English: See section 4.5 and 5.1.
Maltese: Ara sezzjonijiet 4.5 u 5
English: A minimum interval of 5 months should be maintained between each dose of Ocrevus.
Maltese: Għandu jinżamm intervall minimu ta' 5 xhur bejn kull doża ta' Ocrevus.
English: The longest follow up time after the last Ocrevus infusion (Phase II study WA21493, N=51) indicates that the median time to B-cell repletion (return to baseline/LLN whichever occurred first) was 72 weeks (range 27 - 175 weeks).
Maltese: L-itwal żmien ta' segwitu wara l-aħħar infużjoni ta' Ocrevus (Studju ta' Fażi II WA21493, N=51) jindika li l-ħin medjan biex l-għadd ta' ċelluli B jerġa' lura għan-normal (ritorn għal-linja bażi/LLN skont liema jseħħ l-ewwel) kien ta' 72 ġimgħa (firxa 27 - 175 ġimgħa).
English: Your blood B-cells will gradually increase to normal levels.
Maltese: Iċ-ċelluli B tad-demm tiegħek se jiżdiedu gradwalment għallivelli normali.
English: In the active-controlled studies in RMS, infections occurred in 58.5% of patients receiving Ocrevus vs 52.5% of patients receiving interferon beta 1a.
Maltese: Fl-istudji kkontrollati b'mod attiv f'RMS, infezzjonijiet seħħew f'58.5% tal-pazjenti li kienu qed jirċievu Ocrevus vs 52.5% tal-pazjenti li kienu qed jirċievu interferon beta 1a.
English: Mean number of new and/or enlarging T2 hyperintense lesions per MRI scan
Maltese: Numru medju ta' leżjonijiet T2 iperintensi ġodda u/jew li qed jikbru f'kull skan tal-MRI
English: Efficacy and safety of Ocrevus were also evaluated in a randomised, double-blind, placebo-controlled clinical trial in patients with primary progressive MS (Study WA25046) who were early in their disease course according to the main inclusion criteria, i.e. ages 18-55 years, inclusive; EDSS at screening from 3.0 to 6.5 points; disease duration from the onset of MS symptoms less than 10 years in patients with an EDSS at screening ≤5.0 or less than 15 years in patients with an EDSS at screening
Maltese: L-effikaċja u s-sigurtà ta' Ocrevus kienu evalwati wkoll fi prova klinika li fiha l-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollata bi plaċebo f'pazjenti b'MS primarja progressiva (Studju WA25046) li kienu fi stadju bikri tal-kors tal-marda tagħhom skont il-kriterji prinċipali ta' inklużjoni, jiġifieri etajiet ta' 18-55 sena, inklużivi;
English: The incidence of IRRs was highest during the Dose 1, infusion 1 (27.5%) and decreased over time to <10% at Dose 4.
Maltese: L-inċidenza ta' IRRs kienet l-ogħla matul Doża 1, infużjoni 1 (27.5%) u naqset maż-żmien għal <10% f'Doża 4.
English: Ocrelizumab is a recombinant humanised anti-CD20 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Maltese: Ocrelizumab huwa antikorp monoklonali rikombinanti umanizzat kontra CD20 magħmul f'ċelluli talOvarju tal-Ħamster Ċiniż permezz ta' teknoloġija ta' DNA rikombinanti.
English: The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion (Table 1).
Maltese: Id-doża tal-bidu ta' 600 mg tingħata bħala żewġ infużjonijiet separati ġol-vini; l-ewwel bħala infużjoni ta' 300 mg, segwita ġimagħtejn wara mit-tieni infużjoni ta' 300 mg (Tabella 1).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of ocrelizumab in milk (for details see section 5.3).
Maltese: Data farmakodinamika/tossikoloġika disponibbli fl-annimali wriet tneħħija ta' ocrelizumab fil-ħalib (għal dettalji ara sezzjoni 5.3).
English: Patients with mild hepatic impairment were included in clinical trials.
Maltese: Pazjenti b'indeboliment ħafif tal-kliewi kienu inklużi fil-provi kliniċi.
English: The effect on the immune system of these medicines with Ocrevus could be too strong.
Maltese: L-effett fuq issistema immuni ta' dawn il-mediċini ma' Ocrevus jista' jkun qawwi wisq.
English: In PPMS, patients with swallowing difficulties are at a higher risk of aspiration pneumonia.
Maltese: F'PPMS, il-pazjenti li għandhom diffikultajiet biex jibilgħu jinsabu f'riskju ogħla ta' pulmonite kkawżata minn aspirazzjoni.
English: Each infusion will last about 3 hours 30 minutes.
Maltese: Din ir-rata mnaqqsa għandha tinżamm għal mill-inqas 30 minuta.
English: Due to the potential depletion of B cells in infants of mothers who have been exposed to Ocrevus during pregnancy, it is recommended that vaccination with live or live-attenuated vaccines should be delayed until B-cell levels have recovered; therefore, measuring CD19-positive B-cell levels, in neonates and infants, prior to vaccination is recommended It is recommended that all vaccinations other than live or live-attenuated should follow the local immunisation schedule and measurement of vaccine-induced response titers should be considered to check whether individuals have mounted a protective immune response because the efficacy of the vaccination may be decreased.
Maltese: Huwa rakkomandat li t-tilqim kollu minbarra dak ħaj jew ħaj u attenwat għandu jsegwi skeda ta' immunizzazzjoni lokali u għandu jiġi kkunsidrat kejl ta' titers ta' rispons indotti mill-vaċċin biex jiġi ċċekkjat jekk l-individwi bnewx rispons immuni protettiv peress li l-effikaċja tat-tilqim tista' tkun imnaqqsa.
English: Proportion of patients with Gd enhancing T1 lesions Mean EDSS*
Maltese: Pazjenti li qatt ma ħadu DMT qabel (%)**
English: The results of these studies show that Ocrevus significantly suppressed relapses, sub-clinical disease activity measured by MRI, and disease progression compared with interferon beta-1a 44mcg subcutaneous.
Maltese: Ir-riżultati ta' dawn l-istudji juru li Ocrevus irażżan b'mod sinifikanti l-irkadar, l-attività sottoklinika tal-marda mkejla permezz tal-MRI, u l-progressjoni tal-marda meta mqabbel ma' nterferon beta-1a 44 mcg taħt il-ġilda.
English: 1 Defined as an increase of ≥ 1.0 point from the baseline EDSS score for patients with baseline score of 5.5 or less, or ≥ 0.5 when the baseline score is > 5.5, Kaplan-Meier estimates at Week 120.
Maltese: (p=0.0206) Definita bħala żieda ta' ≥ 1.0 punt mill-punteġġ fil-linja bażi tal-EDSS għal pazjenti b'punteġġ fil-linja bażi ta' 5.5 jew inqas, jew ta' ≥ 0.5 meta l-punteġġ fil-linja bażi huwa > 5.5, stimi Kaplan-Meier f'Ġimgħa 120.
English: Caution should be exercised when prescribing Ocrevus taking into consideration the pharmacodynamics of other disease modifying MS therapies.
Maltese: Għandu jkun hemm kawtela meta jiġi preskritt Ocrevus filwaqt li jiġu kkunsidrati l-farmakodinamiċi ta' terapiji għal MS oħrajn li jimmodifikaw il-marda.
English: You will always be given Ocrevus as a drip (intra-venous infusion)
Maltese: Inti se tingħata Ocrevus dejjem bħala dripp (infużjoni ġol-vini)
English: It is recommended to verify the patient's immune status before dosing since severely immunocompromised patients (e.g. with lymphopenia, neutropenia, hypogammaglobulinemia) should not be treated (see sections 4.3 and 4.8).
Maltese: Huwa rakkomandat li jiġi vverifikat l-istat immuni tal-pazjent qabel id-dożaġġ peress li pazjenti immunokompromessi b'mod sever (eż. b'limfopenija, newtropenija, ipogammaglobulinemija) m'għandhomx jiġu ttrattati (ara sezzjonijiet 4.3 u 4.8).
English: Patients with relapsing forms of MS Disease history at screening At least two relapses within the prior two years or one relapse within the prior year; EDSS* between 0 and 5.5, inclusive
Maltese: Mill-inqas żewġ rikaduti fis-sentejn preċedenti jew rikaduta waħda fis-sena preċedenti; EDSS* bejn 0 u 5.5, inklużivi
English: Out of 1311 patients treated with Ocrevus, 12 (~1%) tested positive for treatment-emergent ADAs, of which 2 patients tested positive for neutralising antibodies.
Maltese: Minn 1311-il pazjent ittrattati b'Ocrevus, 12 (~1%) ittestjaw pożittivi għall-ADAs li tfaċċaw mat-trattament, li minnhom 2 pazjenti ttestjaw pożittivi għall-antikorpi li jinnewtralizzaw.
English: For the B cell counts, CD19 is used, as the presence of Ocrevus interferes with the recognition of CD20 by the assay.
Maltese: Għall-għadd taċ-ċelluli B, jintuża CD19, peress li l-preżenza ta' Ocrevus tinterferixxi mal-għarfien ta' CD20 mill-assaġġ.
English: The proportion of respiratory tract infections was higher in Ocrevus treated patients compared to interferon beta-1-a and placebo.
Maltese: Il-proporzjon ta' infezzjonijiet fl-apparat respiratorju kien ogħla f'pazjenti ttrattati b'Ocrevus meta mqabbel ma' interferon beta-1-a u plaċebo.
English: Patients receiving Ocrevus (Group A) were given 600 mg every 6 months (Dose 1 as 2 x 300 mg intravenous infusions, administered 2 weeks apart, and subsequent doses were administered as a single 600 mg intravenous infusion).
Maltese: Pazjenti li kienu qed jirċievu Ocrevus (Grupp A) ingħataw 600 mg kull 6 xhur (Doża 1 bħala 2 infużjonijiet x 300 mg ġol-vini, mogħtija ġimagħtejn bogħod minn xulxin, u dożi sussegwenti ingħataw bħala infużjoni waħda ta' 600 mg ġol-vini).
English: · Periodic safety update reports
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: · If you are treated with Ocrevus for primary progressive multiple sclerosis, and you have swallowing difficulties, Ocrevus may increase the risk of severe pneumonia.
Maltese: • Jekk qed tiġi ttrattat b'Ocrevus għal sklerożi multipla progressiva primarja, u għandek diffikultajiet biex tibla', Ocrevus jista' jżid ir-riskju ta' pulmonite severa.
English: In a pre- and post-natal development study in cynomolgus monkeys, administration of ocrelizumab from gestation day 20 to approximately 5 weeks postpartum was associated with glomerulopathy, lymphoid follicle formation in bone marrow, lymphoplasmacytic renal inflammation, and decreased testicular weight in offspring.
Maltese: CD20 huwa antiġen tas-superfiċje taċ-ċelluli li jinstab fuq prekursuri taċ-ċelluli B, ċelluli B maturi u tal-memorja iżda mhux espress fuq ċelluli staminali limfatiċi u ċelluli tal-plażma.
English: It is unknown whether ocrelizumab/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk ocrelizumab/metaboliti jiġux eliminati fil-ћalib tal-bniedem.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ocrelizumab, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal ocrelizumab, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: See section 5.1.
Maltese: Ara sezzjoni 5
English: One patient, who received 2000 mg of Ocrevus, died of systemic inflammatory response syndrome (SIRS) of unknown etiology, following a magnetic resonance imaging (MRI) examination 12 weeks after the last infusion; an anaphylactoid reaction to the MRI gadolinium-contrast agent could have contributed to the SIRS.
Maltese: Pazjent wieħed, li rċieva 2000 mg ta' Ocrevus, miet bis-sindrome ta' rispons infjammatorju sistemiku (SIRS - systemic inflammatory response syndrome) ta' etjoloġija mhux magħrufa, wara eżami b'immaġini b'riżonanza manjetika (MRI - magnetic resonance imaging) 12-il ġimgħa wara l-aħħar infużjoni; reazzjoni anafilattojda għas-sustanza ta' kuntrast li fiha gadolinju tal-MRI setgħet ikkontribwixxiet għall-SIRS.
English: Defined as decrease of ≥ 1.0 point from the baseline EDSS score for patients with baseline EDSS score ≥ 2 and ≤ 5.5, or ≥0.5 when the baseline score is > 5.5.
Maltese: Definit bħala tnaqqis ta' ≥ 1.0 punt mill-punteġġ fil-linja bażi tal-EDSS għall-pazjenti b'punteġġ fil-linja bażi talEDSS ta' ≥ 2 u ≤ 5.5, jew ≥ 0.5 meta l-punteġġ fil-linja bażi jkun > 5
English: IRRs can occur within 24 hours of the infusion.
Maltese: IRRs jistgħu jseħħu fi żmien 24 siegħa wara l-infużjoni.
English: Patients with active HBV (i.e. an active infection confirmed by positive results for HBsAg and anti HB testing) should not be treated with Ocrevus.
Maltese: Pazjenti b'HBV attiv (jiġifieri infezzjoni attiva kkonfermata b'riżultati pożittivi għallittestjar għal HBsAg u anti-HB) m'għandhomx jiġu ttrattati b'Ocrevus.
English: Subsequent Doses
Maltese: Dożi Sussegwenti
English: Dose Modifications during Treatment
Maltese: Modifikazzjonijiet fid-Doża waqt it-Trattament
English: There is limited clinical trial experience with doses higher than the approved intravenous dose of Ocrevus.
Maltese: Hemm esperjenza limitata minn provi kliniċi b'dożi ogħla mid-doża ġol-vini approvata ta' Ocrevus.
English: · The next 600 mg doses of Ocrevus will be given as a single infusion.
Maltese: • Id-dożi ta' 600 mg ta' Ocrevus li jmiss se jingħataw bħala infużjoni waħda.
English: Type 1 acute hypersensitivity reactions (IgE-mediated) may be clinically indistinguishable from IRR symptoms.
Maltese: Reazzjonijiet ta' sensittività eċċessiva akuta tat-tip 1 (medjata minn IgE) jistgħu ma jingħarfux klinikament minn sintomi ta' IRR.
English: · The diluted infusion solution must be administered using an infusion set with a 0.2 or 0.22 micron in-line filter.
Maltese: • Is-soluzzjoni għall-infużjoni dilwita għandha tingħata permezz ta' sett għall-infużjoni b'filtru fil-pajp ta' 0.2 jew 0.22 mikroni.
English: The metabolism of Ocrevus has not been directly studied, as antibodies are cleared principally by catabolism (i.e. breakdown into peptides and amino acids).
Maltese: Il-metaboliżmu ta' Ocrevus ma ġiex studjat b'mod dirett, peress li antikorpi jitneħħew b'mod prinċipali permezz ta' kataboliżmu (jiġifieri jitkissru f'peptides u aċidi amminiċi).
English: During the infusion: · The following measures need to be taken for patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation: their infusion must be interrupted immediately and permanently symptomatic treatment must be administered the patient must be monitored until the pulmonary symptoms have resolved because initial improvement of clinical symptoms could be followed by deterioration · Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms.
Maltese: Wara lgħoti ta' trattament sintomatiku, immonitorja l-pazjent sakemm is-sintomi pulmonari jgħaddu peress li titjib inizjali ta' sintomi kliniċi jista' jiġi segwit minn deterjorament.
English: Percentage change in Timed 25-Foot Walk from baseline to Week 120 Relative reduction in progression rate of walking time
Maltese: Bidla perċentwali fil-Mixja ta' 25 Pied b'Ħin Miżmum mil-linja bażi sa Ġimgħa 120
English: In patients treated with ocrelizumab a booster vaccine (13-PCV) given 4 weeks after 23-PPV did not markedly enhance the response to 12 serotypes
Maltese: F'pazjenti ttrattati b'ocrelizumab, vaċċin booster (13-PCV) mogħti 4 ġimgħat
English: There is no experience in patients with moderate and severe renal impairment.
Maltese: M'hemm l-ebda esperjenza f'pazjenti b'indeboliment moderat u sever tal-kliewi.