FrancophonIA/ELRC3.0 huggingface dataset:
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy (PML)) and hepatitis C virus.
Maltese: Eżempji ta' dawn l-infezzjonijiet virali serji huma infezzjonijiet ikkawżati mill-virusis tal-herpes (Cytomegalovirus, Virus tal-Varicella Zoster u Virus tal-Herpes Simplex), virus JC (lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy)) u virus tal-epatite Ċ.
English: Significant difference from placebo + MTX at the primary time point: ***p ≤ 0.0001
Maltese: Riżultat wara 24 ġimgħa Differenza sinifikanti mill-plaċebo + MTX fil-punt ta' ħin primarju: ***p ≤ 0.0001
English: Consultation with a neurologist should be considered as clinically indicated.
Maltese: Konsultazzjoni ma' newrologu għandha tiġi kkunsidrata bħala klinikament indikata.
English: What are the signs of getting an infection?
Maltese: X'inhuma s-sinjali li se taqbdek infezzjoni?
English: In a prospective, open label, international, multicentre, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
Maltese: III, 1,193 pazjenti b'limfoma follikulari avanzata mhux ikkurata minn qabel irċevew terapija ta' induzzjoni b'R-CHOP (n = 881), R-CPV (n = 268) jew R-FCM (n = 44), skont l-għażla tal-investigaturi.
English: The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p< 0.0001 Chi-Square test) in the R-CVP group (80.9%) than the CVP group (57.2%).
Maltese: Il-proporzjon ta' pazjenti b'rispons tat-tumur (CR, CRu, PR) kien sinifikattivament ogħla (p< 0.0001 test Chi-Square) fil-grupp ta' R-CVP (80.9%) milli fil-grupp ta' CVP (57.2%).
English: CHOP
Maltese: Xhur
English: In the induction of remission clinical trial, at 6 months, in the rituixmab group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline had low IgA, IgG and IgM levels, respectively, compared to 25%, 50% and 46% in the cyclophosphamide group.
Maltese: Fil-prova klinika dwar l-induzzjoni ta' remissjoni, wara 6 xhur, fil-grupp ta' rituximab, 27%, 58% u 51% tal-pazjenti b'livelli normali ta' immunoglobulina fil-linja bażi kellhom livelli ta' IgA, IgG u IgM baxxi, rispettivament, meta mqabbla ma' 25%, 50% u 46% fil-grupp ta' cyclophosphamide.
English: • Relapsed/refractory follicular lymphoma
Maltese: • Limfoma follikulari li reġgħet tfaċċat/reżistenti
English: The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/ m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
Maltese: Cmax medja (N = 15) kienet ta' 408 µg/mL (firxa, 97-764 µg/mL) wara l-ħames infużjoni ta' 500 mg/ m2 u l-half-life terminali medja kienet ta' 32 ġurnata (firxa, 14-62 ġurnata).
English: Clinical laboratory finding
Maltese: Sejbiet kliniċi tal-laboratorju
English: Very Rare Not known
Maltese: Rari ħafna
English: Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with rituximab.
Maltese: Il-medja tat-titri tal-antikorpi ta' qabel it-terapija kontra sensiela ta' antigens (Streptococcus pneumoniae, influwenza A, ħosba, rubella, varicella) inżammu għal tal-inqas 6 xhur wara kura b'rituximab.
English: The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
Maltese: Il-profil farmakokinetiku ta' rituximab meta mogħti bħala 6 infużjonijiet ta' 375 mg/m2 flimkien ma' 6 ċikli ta' kimoterpija CHOP kien simili għal dak li deher b'rituximab waħdu.
English: Hepatitis B reactivation
Maltese: Infezzjonijiet tal-epatite B
English: Rituximab was administered as two IV infusions separated by an interval of 15 days.
Maltese: Rituximab ngħata bħala żewġ infużjonijiet IV separati b'intervall ta' 15-il jum.
English: The overall safety profile was consistent with the well-established safety profile for rituximab in approved autoimmune indications, including GPA/MPA.
Maltese: Il-profil ta' sigurtà globali kien konsistenti mal-profil ta' sigurtà stabbilit sew għal rituximab f'indikazzjonijiet awtoimmuni approvati, li jinkludu GPA/MPA.
English: During rituximab maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Maltese: Waqt kura ta' manteniment b'rituximab sa sentejn, lewkopenija (5% vs 2%, grad 3/4) u newtropenija (10% vs 4%, grad 3/4) kienu rrappurtati f'inċidenza ogħla meta mqabbel mal-osservazzjoni.
English: Excipients: This medicinal product contains 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Maltese: Dan il-prodott mediċinali fih 11.5 mmol (jew 263.2 mg) ta' sodju f'kull vjala ta' 50 mL.
English: In a randomised trial, patients with rheumatoid arthritis treated with rituximab and methotrexate had comparable response rates to tetanus recall antigen (39% vs. 42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs. 82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs. 93%), when given 6 months after rituximab as compared to patients only receiving methotrexate.
Maltese: Fi prova randomised, pazjenti b'artrite rewmatika kkurati b'rituximab u methotrexate kellhom rati ta' rispons komparabbli għat-tetanus recall antigen (39% vs. 42%), u rati mnaqqsa għall-vaċċin ta' polysaccharide pnewmokokkali (43% vs. 82% għal tal-inqas żewġ serotipi ta' antikorpi pnewmokokkali), u KLH neoantigen (47% vs. 93%), meta mogħtija 6 xhur wara rituximab meta mqabbel ma pazjenti li rċevew methotrexate biss.
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manifattur tas-sustanza bioloġika attiva
English: Adverse reactions are listed in Table 2.
Maltese: Lista ta' reazzjonijiet avversi f'tabella
English: A total of 6/34 (18%) of rituximab-treated patients from the maintenance therapy clinical trial developed ADA.
Maltese: Valutazzjonijiet tal-laboratorju Total ta' 6/34 (18%) tal-pazjenti ttrattati b'rituximab mill-prova klinika dwar terapija ta' manteniment żviluppaw ADA.
English: Body system
Maltese: Sistema respiratorja
English: Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported.
Maltese: Kienu rrappuoortati każijiet ta' arritmija ta' grad 3 jew 4 (inkluż takikardija ventrikulari u supraventrikulari) u anġina pectoris waqt l-infużjoni.
English: In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
Maltese: Fl-istudju dwar CLL li reġgħet tfaċċat/refrattarja, s-sopravivenza mingħajr progressjoni (punt finali primarju) medjana kienet ta' 30.6 xhur fil-grupp ta' R-FC u 20.6 xhur fil-grupp ta' FC (p = 0.0002, test log-rank).
English: PHARMACEUTICAL FORM
Maltese: Mundipharma Pharmaceuticals
English: Active, severe infections (see section 4.4).
Maltese: Infezzjonijiet severi, attivi (ara sezzjoni 4.4).
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħżin wara dilwizzjoni tal-prodott mediċinali, ara t-taqsima 6.3.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Ritemvia infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Maltese: F'pazjenti b' granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika f'remissjoni tal marda jew pemphigus vulgaris, medikazzjoni minn qabel b'100 mg methylprednisolone fil-vini għandha tiġi kompluta 30 minuta qabel infużjonijiet ta' Ritemvia biex titnaqqas l-inċidenza u sseverità ta' reazzjonijiet relatati mal-infuzjoni (IRRs - infusion related reactions).
English: Kaplan-Meier estimate of median time to event (months)
Maltese: Stima Kaplan-Meier tal-perjodu medjan sa avveniment (xhur)
English: FU: follow-up; NR: not reached at time of clinical cut off, TNCT: time to next chemotherapy treatment; TNLT: time to next anti lymphoma treatment.
Maltese: FU: segwitu; NR: ma ntlaħaqx fiż-żmien tal-waqfien kliniku, TNCT: żmien sat-trattament bil-kimoterapija li jmiss; TNLT: żmien sat-trattament li jmiss kontra l-limfoma.
English: Ritemvia is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Maltese: Ritemvia huwa indikat għall-kura ta' pazjenti b'limfoma mhux ta' Hodgkin ta ċ-ċellula B kbira mifruxa pożittiva għal CD20 flimkien ma' kimoterapija CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone).
English: The pharmacokinetics of rituximab were assessed following two intravenous (IV) doses of 500 mg and 1000 mg on Days 1 and 15 in four studies.
Maltese: Il-farmakokinetika ta' rituximab kienet evalwata wara żewġ dożi fil-vini (IV) ta' 500 mg u 1,000 mg fi Ġranet 1 u 15 f'erba' studji.
English: There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6% vs. 15.4%).
Maltese: Kien hemm inċidenza ogħla ta' ADRs ta' grad 3/4 f'pazjenti b'bulky disease meta mqabbel ma' pazjenti mingħajr bulky disease (25.6% vs 15.
English: Subsequent doses of Ritemvia can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Maltese: Dożi sussegwenti ta' Ritemvia jistgħu jiġu infużi b'rata inizjali ta' 100 mg/siegħa, u miżjuda b'żidiet ta' 100 mg/siegħa f'intervalli ta' 30 minuta, sa massimu ta' 400 mg/siegħa.
English: A total of 117 patients (88 with GPA, 24 with MPA, and 5 with renal-limited ANCA-associated vasculitis) in disease remission were randomised to receive azathioprine (59 patients) or rituximab (58 patients) in a prospective, multi-center, controlled, open-label study.
Maltese: Total ta' 117-il pazjent (88 b'GPA, 24 b'MPA, u 5 b'vaskulite assoċjata ma' ANCA limitata għallkliewi) f'remissjoni tal-marda kienu randomised biex jirċievu azathioprine (59 pazjent) jew rituximab (58 pazjent) fi studju prospettiv, b'aktar minn ċentru wieħed, ikkontrollat u open-label.
English: Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial.
Maltese: Dan il-prodott mediċinali fih 2.3 mmol (jew 52.6 mg) ta' sodju f'kull vjala ta' 10 mL.
English: Other medicines and Ritemvia
Maltese: Mediċini oħra u Ritemvia
English: Patients received 2 x 1,000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Maltese: Il-pazjenti rċevew 2 x 1,000 mg ta' rituximab separati b'intervall ta' ġimagħtejn; flimkien ma' methotrexate (10-25 mg/ġimgħa).
English: Cardiac disorders angina pectoris, atrial fibrillation, heart failure,
Maltese: Disturbi fil-qalb anġina pectoris, fibrillazzjoni atrijali,
English: A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to rituximab maintenance therapy (n=167) or observation (n=167).
Maltese: Total ta' 334 pazjent li kisbu remissjoni kompluta jew parzjali wara terapija ta' induzzjoni ġew randomised fi stadju ieħor għal terapija ta' manteniment b'rituximab (n = 167) jew osservazzjoni (n = 167).
English: 3 Reactions occurring during or within 24 hours of infusion.
Maltese: 3 Reazzjonijiet li jseħħu waqt jew sa 24 siegħa wara l-infużjoni.
English: From month 12 to month 18, 8 relapses were observed in the rituximab group compared with four in the cyclophosphamide group.
Maltese: Minn xahar 12 sa xahar 18, kienu osservati 8 rikaduti fil-grupp ta' rituximab meta mqabbel ma' erbgħa fil-grupp ta' cyclophosphamide.
English: Neutropenic events, including severe late onset and persistent neutropenia, have been rarely reported in the post-marketing setting, some of which were associated with fatal infections.
Maltese: Avvenimenti newtropeniċi, inkluż newtropenija severa, ttardjata u persistenti, ġew irrappurtati b'mod rari fl-isfond ta' wara t-tqegħid fis-suq, li wħud minnhom kienu assoċjati ma' infezzjonijiet fatali.
English: Ritemvia 500 mg concentrate for solution for infusion Rituximab
Maltese: Ritemvia 500 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: Mundipharma Pharmaceuticals Limited
Maltese: NAPP Pharmaceuticals
English: Table 14 Physical function and quality of life outcomes at week 24 in Trial 1
Maltese: Tabella 14 Funzjoni fiżika u riżultati tal-kwalità tal-ħajja f'ġimgħa 24 fi prova 1
English: System Organ Class
Maltese: Klassi tas-sistemi utal-organi
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and very rare (< 1/10,000).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), u rari ħafna (< 1/10,000).
English: In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Maltese: Fi studji li vvalutaw rituximab flimkien ma' kimoterapija, l-inċidenza ta' arritmija kardijaka ta' grad 3 u 4, l-aktar arritmija supraventrikolari bħal takikardija u taħbit irregolari/fibrillazzjoni atrijali, kienet ogħla fil-grupp ta' R-CHOP (14-il pazjent, 6.9%) meta mqabbel mal-grupp ta' CHOP (3 pazjenti, 1.5%).
English: Ritemvia 100 mg concentrate for solution for infusion Rituximab
Maltese: Ritemvia 100 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: Patients in both arms received 1000 mg of pulse intravenous (IV) methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Maltese: Pazjenti fiż-żewġ gruppi rċevew 1,000 mg ta' methylprednisolone pulse filvini (IV - intravenous) (jew doża ekwivalenti ta' glukokortikojd ieħor) kuljum għal ġurnata sa 3 ijiem, segwit minn prednisone orali (1 mg/kg/jum, sa massimu ta' 80 mg/jum).
English: Dizziness Tremor
Maltese: Tqala u treddigħ
English: Of the 99 patients treated with rituximab, 12 (12%) experienced at least one IRR.
Maltese: Mid-99 pazjent kienu kkurati b'rituximab u 12 (12%) kellhom mill-inqas IRR wieħed.
English: There was no difference between the treatment groups in the incidence of other thromboembolic events.
Maltese: Ma kien hemm l-ebda differenza bejn il-gruppi ta' kura fl-inċidenza ta' avvenimenti tromboembolitiċi oħra.
English: Infections and infestations bacterial infection, viral infections, +bronchitis sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
Maltese: Infezzjonijiet u infestazzjonijiet infezzjonijiet mill-batterja, infezzjonijiet mill-virus, +bronkite sepsi, +pnewmonja, +infezzjoni bid-deni, +herpes zoster, +infezzjoni fl-apparat respiratorju, infezzjoni millmoffa, infezzjonijiet b'etjoloġija mhux magħrufa, +bronkite akuta, +sinusite, epatite B1
English: The ORR was 36% (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Maltese: ORR kienet ta' 36% (CI95% 21% - 51%; CR 3%, PR 33%) b'TTP medjan għal pazjenti li rrispondew ta' 9.6 xhur (firxa minn 4.5 sa 26.
English: Currently, there are limited data on possible drug interactions with rituximab.
Maltese: Attwalment, teżisti informazzjoni limitata dwar l-interazzjonijiet possibbli ta' mediċini oħra ma' rituximab.
English: The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3-15).
Maltese: Ir-rata ta' avvenimenti serji tal-qalb kienet ta' 2.1 għal kull 100 sena ta' pazjent (CI ta' 95% 3-15).
English: Seronegative (n=101)
Maltese: Seronegattivi (n = 101)
English: Psychiatric disorders depression, anxiety
Maltese: Disturbi psikjatriċi depressjoni, ansjetà
English: The safety information collected during post-marketing experience reflects the expected adverse reaction profile as seen in clinical trials for rituximab (see section 4.4).
Maltese: L-informazzjoni ta' sigurtà miġbura matul l-esperjenza ta' wara t-tqegħid fis-suq tirrifletti l-profil ta' reazzjonijiet avversi mistenni kif deher fi provi kliniċi ta' rituximab (ara sezzjoni 4.4).
English: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).
Maltese: Infezzjonijiet serji, fosthom fatalitajiet, jistgħu jseħħu waqt terapija bi rituximab (ara sezzjoni 4.8).
English: 150 patients originally randomised to placebo + MTX in Trial 1 received at least one course of RTX + MTX by one year * p <0.05, ** p < 0.001.
Maltese: 150 pazjent oriġinarjament randomised għal plaċebo + MTX fi Prova 1 irċevew tal-inqas kors wieħed ta' RTX + MTX wara sena * p < 0.05, ** p < 0.001. Abbrevjazzjoni:
English: In the clinical trial on induction of remission, which included 99 rituximab-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197-285) at the 6month primary endpoint.
Maltese: Fil-prova klinika dwar l-induzzjoni ta' remissjoni, li kienet tinkludi 99 pazjent ittrattati b'rituximab, irrata globali ta' infezzjoni kienet ta' madwar 237 għal kull 100 sena ta' pazjent (CI ta' 95% 197-285) fil-punt finali primarju ta' 6 xhur.
English: Patients with non-Hodgkin's lymphoma should then be evaluated for evidence of tumour lysis syndrome including appropriate laboratory tests and, for pulmonary infiltration, with a chest X-ray.
Maltese: Pazjenti b'limfoma mhux ta' Hodgkin imbagħad għandhom jiġu evalwati għall-evidenza tas-sindrome tal-lisi tat-tumur inkluż testijiet tal-laboratorju xierqa, u għall-infiltrati pulmonari, b'X-ray tas-sider.
English: Metabolism and nutritional disorders hypercholesterolemia
Maltese: Disturbi fil metaboliżmu u n nutrizzjoni iperkolesterolimja
English: A total of 23/99 (23%) rituximab-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Maltese: Total ta' 23/99 (23%) pazjent ikkurat b'rituximab mill-prova dwar l-induzzjoni ta' remissjoni kienu pożittivi għal ADA wara 18-il xahar.
English: Progressive multifocal leukoencephalopathy (PML)
Maltese: Lewkoenċefalopatija multifokali progressiva
English: Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p< 0.0001 log-rank test).
Maltese: Il-kura ta' manteniment b'rituximab wasslet għal titjib klinikament rilevanti u statistikament sinifikanti fil-punt finali primarju, PFS, (żmien mill-għażla każwali tal-manteniment sar-rikaduta, progressjoni tal-marda jew mewt) meta pparagunata ma' osservazzjoni waħedha (p< 0.0001 log-rank test).
English: Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among rituximab-treated PV patients, with a ≥ 2% absolute difference in incidence between the rituximab-treated group and the standard-dose prednisone group up to month 24.
Maltese: Ir-reazzjonijiet avversi tal-mediċina ppreżentati fit-Tabella 5 kienu avvenimenti avversi li seħħew b'rata ta' ≥ 5% fost il-pazjenti b'PV ittrattati b'rituximab, b'differenza assoluta ta' ≥ 2% fl-inċidenza bejn il-grupp ittrattat b'rituximab u l-grupp b'doża standard ta' prednisone sa xahar 24.
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab.
Maltese: Każijiet ta' attivazzjoni mill-ġdid tal-epatite B, inkluż dawk b'riżultat fatali, kienu rrappurtati f'pazjenti b'artrite rewmatika, granulomatosi b'polianġite u polianġite mikroskopika li kienu qed jirċievu rituximab.
English: Remission-induction therapy included IV prednisone, administered as per the investigator's discretion, preceded in some patients by methylprednisolone pulses, and pulse cyclophosphamide until remission was attained after 4 to 6 months.
Maltese: Terapija ta' induzzjoni ta' remissjoni kienet tinkludi prednisone IV, mogħti skont id-diskrezzjoni talinvestigatur, ippreċedut f'xi pazjenti minn methylprednisolone pulses, u pulse cyclophosphamide sakemm inkisbet remissjoni wara 4 sa 6 xhur.
English: Ritemvia may be used for the treatment of several different conditions in adults.
Maltese: Ritemvia jista' jintuża għall-kura ta' diversi kundizzjonijiet differenti fl-adulti.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
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), rari ħafna (< 1/10,000) u mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: This compares favourably with the TTP achieved after the prior course of rituximab (12.4 months).
Maltese: Dan jikkompara b'mod favorevoli ma' TTP milħuq wara l-kors preċedenti ta' rituximab (12.4 xhur).
English: In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC 71%).
Maltese: Fl-istudju primarju dwar CCL, pazjent fl-istadju Binet Ċ kellhom aktar avvenimenti avversi fil-grupp R-FC meta mqabbel mal-grupp FC (R-FC 83% vs.
English: Units 2100, 2110, 2010, 2120, 2130 and 2500 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY, UK
Maltese: Units 2100, 2110, 2010, 2120, 2130 and 2500
English: Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences.
Maltese: Rituximab huwa antikorp monoklonali kimeriku magħmul permezz ta' inġinerija ġenetika mill-ġurdien u l-bniedem li jirrappreżenta immunoglobulina glikosilata b'sekwenzi ta' reġġjun kostanti ta' IgG1 uman, u sekwenzi ta' reġjun varjabbli ta' light-chain u heavy-chain tal-ġrieden.
English: Ritemvia is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Maltese: Ritemvia huwa indikat għat-trattament ta' pazjenti b'pemphigus vulgaris (PV) moderat sa sever.
English: During the treatment course in studies with rituximab in combination with chemotherapy, grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Maltese: Waqt ilkors ta' kura fi studji b'rituximab flimkien ma' kimoterapija, lewkopenija ta' grad 3/4 (R-CHOP 88% vs CHOP 79%, R-FC 23% vs FC 12%), newtropenija (R-CVP 24% vs CVP 14%;
English: A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicentre, non-inferiority trial.
Maltese: Total ta' 197 pazjent b'età minn 15-il sena 'l fuq bi granulomatosi b'polianġite attiva b'mod severa (75%) u polianġite mikroskopika (24%) kienu rreġistrati u kkurati fi prova b'paragun attiv, randomised, double-blind, b'aktar minn ċentru wieħed, dwar nuqqas ta' inferjorità.