FrancophonIA/ELRC3.0 huggingface dataset:
English: Azathioprine 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17 Rituximab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3 Number of subjects at risk
Maltese: Numru ta' Individwi b'Irkadar Maġġuri Azathioprine 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17
English: Musculo skeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Maltese: Artralġja / uġigħ muskolu-skeletrali , osteoartrite, bursite
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1(ITT population) Outcome†
Maltese: Tabella 12 Riżultati tar-rispons kliniku fil-ħin tal-punt finali primarju fi Prova 1 (popolazzjoni
English: Treatment Difference (MabTheraCyclophosphamide)
Maltese: Differenza fil-Kura (MabThera- Cyclophosphamide)
English: % HAQ-DI MCID Mean change in FACIT-T
Maltese: HAQ-DI MCID % Bidla medja f'FACIT-T
English: Immunomodulatory drugs may increase the risk of malignancy.
Maltese: Il-mediċini immunomodulatorji jistgħu jżidu r-riskju ta' tumuri malinni.
English: Elderly patients (≥ 65 years):
Maltese: Pazjenti anzjani (≥ 65 sena):
English: Placebo+MTX MabThera+MTX (2 x 1000 mg)
Maltese: Plaċebo+MTX MabThera+MTX
English: Psychiatric disorders depression, nervousness,
Maltese: Depressjoni, nervi,
English: MCID HAQ-DI ≥0.22, MCID SF-36 PHS >5.42, MCID SF-36 MHS >6.33
Maltese: 42, MCID SF-36 MHS >6.33
English: Predicted median Cmax (q2m) µg/mL Predicted median Cmax (q3m) µg/mL
Maltese: Cmax medjan imbassar (q2m) µg/mL Cmax medjan imbassar (q3m) µg/mL
English: A total of 392/3095 (12.7%) patients with rheumatoid arthritis tested positive for ADAin clinical studies following therapy with MabThera.
Maltese: Total ta' 392/3095 (12.7%) pazjent b'artrite rewmatika kienu pożittivi għal ADA fi studji kliniċi wara terapija b'MabThera.
English: Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
Maltese: ORR: rata ta' rispons globali; CR: rispons totali; PR: rispons parzjali
English: µg.day/mL
Maltese: µg.kuljum/mL
English: MabThera is indicated in adults for Non-Hodgkin's lymphoma (NHL):
Maltese: MabThera huwa indikat f'adulti għal limfoma mhux ta' Hodgkin (NHL - Non-Hodgkin's lymphoma):
English: Currently, there are limited data on possible drug interactions with MabThera.
Maltese: Attwalment, hemm data limitata dwar interazzjonijiet possibbli ta' mediċini oħra ma' MabThera.
English: 53-months p=0.029
Maltese: 53-xahar p=0.029
English: Mean change from baseline: Modified total sharp score
Maltese: Punteġġ sharp totali modifikat
English: Yeonsu-gu, Incheon 21987,
Maltese: Samsung BioLogics 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987,
English: Maintenance infusions of MabThera 500 mg were administered at months 12 and 18.
Maltese: Infużjonijiet ta' manteniment ta' MabThera 500 mg ingħataw fix-xhur 12 u 18.
English: Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.
Maltese: ADRs serji oħra irrappurtati jinkludu riattivazzjoni ta' epatite B u PML (ara sezzjoni 4.4.).
English: Table 8: Distribution/Elimination - Pharmacokinetic parameters of MabThera subcutaneous compared to MabThera intravenous Trial BP22333 (SparkThera) Geometric mean Ctrough
Maltese: Tabella 8: Distribuzzjoni/Eliminazzjoni - Parametri farmakokinetiċi ta' MabThera taħt il-ġilda imqabbla ma' MabThera fil-vini Prova BP22333 (SparkThera) Medja ġeometrika ta'
English: • allergic reactions (hypersensitivity),
Maltese: • reazzjonijiet allerġiċi (sensittività eċċessiva),
English: A total of 6/34 (18%) of MabThera treated patients from the maintenance therapy clinical trial developed ADA.
Maltese: Total ta' 6/34 (18%) tal-pazjenti ttrattati b'MabThera mill-prova klinika dwar terapija ta' manteniment żviluppaw ADA.
English: There was no evidence of clinically relevant dependencies of rituximab pharmacokinetics on age and sex.
Maltese: Ma kienx hemm evidenza ta' dipendenzi klinikament rilevanti tal-farmakokinetika ta' rituximab fuq l-età u s-sess.
English: ORR - Overall Response Rate
Maltese: ORR - Rata ta' Rispons Globali (Overall Response Rate)
English: A total of 1078 patients responded to induction therapy, of which 1018 were randomised to MabThera maintenance therapy (n=505) or observation (n=513).
Maltese: Total ta' 1078 pazjent irrispondew għal terapija ta' induzzjoni, li minnhom 1018 kienu randomised għal terapija ta' manteniment b'MabThera (n=505) jew għal osservazzjoni (n=513).
English: The overall response rate (ORR) in the intent-to-treat (ITT) population was 48 % (CI95% 41% - 56%) with a 6% complete response (CR) and a 42 % partial response (PR) rate.
Maltese: Ir-rata ta' rispons ġenerali (ORR) fil-popolazzjoni bl-intenzjoni li tiġi trattata (ITT) kienet ta' 48 % (CI95% 41% - 56%) b'rispons komplut (CR) ta' 6% u rata ta' rispons parzjali (PR) ta' 42%.
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01X C02
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: Each mL contains 120 mg of rituximab.
Maltese: Kull mL fih 120 mg rituximab.
English: In the maintenance therapy clinical trial, 30/57 (53%) patients in the MabThera arm experienced infections.
Maltese: Fil-prova klinika dwar terapija ta' manteniment, 30/57 (53%) pazjent fil-grupp ta' MabThera kellhom infezzjonijiet.
English: • Infusion-related reactions (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Maltese: • Reazzjonijiet relatati mal-infużjoni (inkluż sindrome tar-reħa ta' ċitokina, sindrome tal-lisi tat-tumur), ara sezzjoni 4.4.
English: The trial demonstrated non-inferiority of MabThera to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Maltese: Il-prova wriet nuqqas ta' inferjorità ta' MabThera għal cyclophosphamide għal remissjoni kompluta (CR - complete remission) wara 6 xhur (Tabella 16).
English: The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p < 0.0001)
Maltese: It-test statistiku “primarju” għar-“rispons” kien it-test tat-tendenza ta' CR kontra PR kontra l-ebda rispons (p < 0.0001)
English: Korea
Maltese: Il-Korea
English: In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β2 microglobulin, LDH, albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Maltese: Fis-sottogruppi ta' pazjenti kollha (sess, età, IPI aġġustat għall-età, stadju Ann Arbor, ECOG, mikroglobulina β2, LDH, albumina, sintomi B, bulky disease, siti ekstranodali, involvement tal-mudullun), il-proporzjonijiet ta' riskju ta' sopravivenza mingħajr avveniment u ta' sopravivenza globali (R-CHOP imqabbel ma' CHOP) kienu inqas minn 0.83 u 0.95 rispettivament.
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, multicenter, non-inferiority trial.
Maltese: Total ta' 197 pazjent b'età minn 15-il sena 'l fuq bi granulomatosi b'polianġite attiva 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.
English: OS rates,
Maltese: Kura,
English: 10 mL vial - Pack of 2 vials
Maltese: Kunjett ta' 10 mL - Pakkett ta' 2 kunjetti
English: MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Maltese: MabThera huwa indikat għat-trattament ta' pazjenti b'pemphigus vulgaris (PV) moderat sa sever.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 500 mg / 50 mL
Maltese: U KONTENUT Konċentrat għal soluzzjoni għal infużjoni 500 mg / 50 mL
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of MabThera treated patients and 0.27% (2/731) of placebo patients developed severe neutropenia.
Maltese: F'perijodi kkontrollati bil-plaċebo tal-provi kliniċi, 0.94% (13/1382) tal-pazjenti kkurati b'MabThera u 0.27% (2/731) tal-pazjenti fuq plaċebo żviluppaw newtropenija severa.
English: Similar events were observed in the CLL SAWYER trial (BO25341) and were reported in up to 42% of patients in the MabThera subcutaneous arm.
Maltese: Avvenimenti simili kienu osservati fil-prova dwar CLL SAWYER (BO25341) u kienu rrappurtati f'sa 42% tal-pazjenti fil-grupp ta' MabThera taħt il-ġilda.
English: Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001
Maltese: Differenza sinifikanti mill-plaċebo fil-punt ta' ħin primarju: * p < 0.05, **p < 0.001, ***p ≤ 0.0001 MCID HAQ-DI ≥0.22, MCID SF-36
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given MabThera.
Maltese: Huma se josservawk mill-viċin waqt li tkun qed tingħata din il-mediċina.
English: In the induction of remission clinical trial, at 6 months, in the MabThera 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' MabThera, 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: Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more MabThera treated patients treated with MabThera and methotrexate compared to patients treated with methotrexate alone (Table 12).
Maltese: B'mod simili, rispons European League Against Rheumatism (EULAR) tajjeb sa moderat ġie miksub minn ammont sinifikattivament akbar ta' pazjenti kkurati b'MabThera, ikkurati b'MabThera u methotrexate meta mqabbel mal-pazjenti kkurati b'methotrexate waħdu (Tabella 12).
English: Age, gender and WHO performance status had no effect on the pharmacokinetics of MabThera.
Maltese: Età, sess, u WHO performance status ma kellhom l-ebda effett fuq il-farmakokinetika ta' MabThera.
English: Table 2 Efficacy results for SAWYER (BO25341) (Intent to Treat Population)
Maltese: Tabella 2 Riżultati tal-effikaċja għal SAWYER (BO25341) (Popolazzjoni b'Intenzjoni li Tiġi
English: • Cardiovascular disorders, see section 4.4.
Maltese: • Disturbi kardjovaskulari, ara sezzjoni 4.4.
English: Each 10 mL vial contains 2.3 mmol (52.6 mg) sodium.
Maltese: Kull kunjett ta' 10 mL fih 2.3 mmol (52.6 mg) ta' sodium.
English: The estimated median terminal elimination half-life of MabThera was 22 days (range, 6.1 to 52 days).
Maltese: Il-medjan tal-half-life tal-eliminazzjoni terminali stmata ta' MabThera kienet 22 ġurnata (firxa, 6.1 sa 52 ġurnata).
English: ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Maltese: -L-ORR kienet ta' 57% (Intervall ta' kunfidenza (CI) ta' 95%; 41% - 73%; CR 14%, RP 43%) TTP medjan ipproġettat għal pazjenti li rrispondew ta' 19.4 xhur (firxa minn 5.3 sa 38.9 xhur).
English: Clinical laboratory findings
Maltese: Sejbiet kliniċi tal-laboratorju
English: Kaplan-Meier estimated progression-free rates at 12 months were 78 % in the MabThera maintenance group vs. 57 % in the observation group.
Maltese: Stimi Kaplan-Meier tar-rati ta' nuqqas ta' progressjoni wara 12-il xahar kienu 78% fil-grupp ta' manteniment b'MabThera vs 57% fil-grupp ta' osservazzjoni.
English: Number of responders (response rate [%]) ap-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Maltese: Numru ta' individwi li rrispondew (rata ta' rispons [%]) avalur p huwa minn test eżatt ta' Fisher b'korrezzjoni mid-p b intervall ta' kunfidenza ta' 95% huwa intervall ta' Newcombe kkoreġut
English: Very rare side effects (may affect up to 1 in 10, 000 people):
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000):
English: Seronegative (n=101)
Maltese: (n=101)
English: A total of 176 patients with CLL were randomized into the following two treatment groups:
Maltese: Total ta' 176 pazjent b'CLL kienu randomised fiż-żewġ gruppi ta' trattament li ġejjin:
English: Significant difference from placebo + MTX at the primary timepoint: ***p ≤ 0.0001
Maltese: Riżultat wara 24 ġimgħa Differenza sinifikanti mill-plaċebo + MTX fil-punt ta' ħin primarju: ***p ≤ 0.0001
English: 2 vials of 10 mL
Maltese: 2 kunjetti ta' 10 mL
English: Three patients (8%) in the MabThera group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Maltese: Tliet pazjenti (8%) fil-grupp ta' MabThera kellhom total ta' 5 infezzjonijiet serji (pnewmonja kkawżata minn Pneumocystis jirovecii, trombożi infettiva, infezzjoni fl-ispazju bejn id-diski vertebrali, infezzjoni fil-pulmun u sepsis ikkawżata minn Staphylococcus) u pazjent wieħed (3%) fil-grupp b'doża standard ta' prednisone kellu infezzjoni serja (pnewmonja kkawżata minn Pneumocystis jirovecii).
English: PR2)
Maltese: B1
English: MabThera was administered as two IV infusions separated by an interval of 15 days.
Maltese: MabThera ngħata bħala żewġ infużjonijiet IV separati b'intervall ta' 15-il jum.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 100 mg / 10 mL
Maltese: U KONTENUT Konċentrat għal soluzzjoni għal infużjoni 100 mg / 10 mL
English: A total of 117 patients (88 with GPA, 24 with MPA, and 5 with renal-limited ANCA-associated vasculitis) in disease remission were randomized to receive azathioprine (59 patients) or MabThera (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 MabThera (58 pazjent) fi studju prospettiv, b'aktar minn ċentru wieħed, ikkontrollat u open-label.
English: Significance levels were defined as * p<0.05, **p<0.001, ***p<0.0001.
Maltese: Livelli ta' sinifikanza kienu definiti bħala * p<0.05, **p<0.
English: c) Rheumatoid arthritis
Maltese: ċ) Artrite Rewmatika
English: Seronegative (n=106)
Maltese: (n=106)
English: MabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Maltese: MabThera, flimkien ma' glukokortikojdi, huwa indikat għat-trattament ta' pazjenti adulti bi granulomatosi b'polianġite (ta' Wegener) (GPA - granulomatosis with polyangiitis) attiva u severa u polianġite mikroskopika (MPA - microscopic polyangiitis).
English: In the PV population, 5 (13%) patients in the MabThera group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the MabThera group and 33 (92%) patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
Maltese: Fil-popolazzjoni b'PV, 5 (13%) pazjenti fil-grupp ta' MabThera u 3 (8%) pazjenti fil-grupp ta' prednisone standard kellhom marda moderata u 33 (87%) pazjent fil-grupp ta' MabThera u 33 (92%) pazjent fil-grupp b'doża standard ta' prednisone kellhom marda severa skont is-severità tal-marda ddefinita mill-kriterji ta' Harman.
English: Look out for the following possible signs of infection:
Maltese: Oqgħod attent għas-sinjali possibbli ta' infezzjoni li ġejjin: :
English: MabThera is indicated in adults for the following indications:
Maltese: MabThera huwa indikat f'adulti għall-indikazzjonijiet li ġejjin:
English: Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium.
Maltese: Kull kunjett ta' 50 mL fih 11.5 mmol (263.2 mg) ta' sodium.
English: CHOP (R-CHOP).
Maltese: R-CHOP,
English: In SAWYER trial (BO25341) the incidence of treatment-induced/enhanced anti-rituximab antibodies was similar in the two treatment arms; 15% intravenous vs. 12% subcutaneous.
Maltese: Fil-prova SAWYER (BO25341) l-inċidenza ta' antikorpi kontra rituximab indotti/imsaħħa mit-trattament kienet simili fiż-żewġ gruppi ta' trattament; 15% għoti fil-vini kontra 12% għoti taħt il-ġilda.
English: Of 356 patients evaluated for ADA, 1.1 % (4 patients) were positive.
Maltese: Minn 356 pazjent evalwati għal ADA, 1.1 % (4 pazjenti) kienu pożittivi.
English: arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Maltese: , arritmija, +fibrillazjoni atrijali, takikardja, +disturb fil-qalb
English: A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 2a and Table 2b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 3) were analysed for efficacy.
Maltese: Total ta' 810 pazjenti (403 R-FC, 407 FC) għall-istudju primarju (Tabella 2a u Tabella 2b) u 552 pazjent (276 R-FC, 276 FC) għall-istudju dwar CLL li reġgħet tfaċċat/ma rrispondietx għat-trattament (Tabella 3) kienu analizzati għall-effikaċja.
English: Date of most recent infusion: ____________ Date of first infusion: ___________________ Patient's Name:________________________ Doctor's Name:________________________ Doctor's contact details:_________________
Maltese: Isem it-Tabib:________________________ Dettalji ta' kuntatt tat-Tabib:_________________
English: In clinical trial BO22334, an effect was observed between body size and exposure ratios reported in cycle 7, between rituximab subcutaneous formulation 1400 mg q3w and rituximab intravenous formulation 375 mg/m2 q3w with Ctrough ratios of 2.29, 1.31, and 1.41 in patients with low, medium and high BSA, respectively (low BSA ≤ 1.70 m2; 1.70 m2 < medium BSA < 1.90 m2; high BSA
Maltese: Fil-prova klinika BO22334, kien osservat effett bejn id-daqs tal-ġisem u l-proporzjonijiet ta' esponiment irrappurtati f'ċiklu 7, bejn il-formulazzjoni għall-għoti taħt il-ġilda ta' rituximab 1400 mg q3w u l-formulazzjoni għall-għoti fil-vini ta' rituximab 375 mg/m2 q3w bi proporzjonijiet ta' Ctrough ta' 2.29, 1.31, u 1.41 f'pazjenti b'BSA baxxa, medja u għolja, rispettivament (BSA baxxa ≤ 1.70 m2; 1.70 m
English: An analysis of overall survival confirmed the significant benefit of MabThera maintenance over observation (p=0.0039 log-rank test).
Maltese: Analiżi tas-sopravivenza globali kkonfermat il-vantaġġ sinifikanti ta' manteniment b'MabThera fuq l-osservazzjoni (p=0.0039 test log-rank).
English: In the SABRINA trial (BO22334) the incidence of treatment-induced/enhanced anti-rituximab antibodies was low and similar in the intravenous and subcutaneous groups (1.9% vs. 2%, respectively).
Maltese: Fil-prova SABRINA (BO22334) l-inċidenza ta' antikorpi kontra rituximab indotti/imsaħħa mit-trattament kienet baxxa u simili fil-gruppi ta' għoti fil-vini u ta' għoti taħt il-ġilda (1.9% vs. 2%, rispettivament).
English: CRR - Complete Response Rate
Maltese: CRR - Rata ta' Rispons Komplut (Complete Response Rate)
English: Progression-‑ -free survival (PFS)
Maltese: Sopravivenza mingħajr progressjoni (PFS)
English: In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following MabThera.
Maltese: F'pazjenti b'artrite rewmatika, 283 pazjent irċevew terapija sussegwenti b'DMARD bijoloġiku wara MabThera.
English: A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to MabThera 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'MabThera (n=167) jew osservazzjoni (n=167).
English: ORR a
Maltese: Ġimgħa
English: The information provided in the section 4.4 pertains to the use of MabThera subcutaneous formulation in the approved indications Treatment of non Hodgkin lymphoma (strength 1400 mg) and Treatment of CLL (strength 1600 mg).
Maltese: L-informazzjoni pprovduta fis-sezzjoni 4.4 hija relatata mal-użu tal-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera fl-indikazzjonijiet approvati Trattament ta' limfoma mhux ta' Hodgkin (qawwa ta' 1400 mg) u Trattament ta' CLL (qawwa ta' 1600 mg).
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: L-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: Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
Maltese: Infezzjonijiet serji, fosthom fatalitajiet, jistgħu jseħħu waqt terapija b'MabThera (ara sezzjoni 4.8).
English: Patients in both arms received 1000mg 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 1000 mg ta' methylprednisolone pulse fil-vini (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: Geometric mean AUCτ cycle 2 (q3m)
Maltese: Medja ġeometrika tal-AUCτ ċiklu 2 (q3m)
English: R-CVP led to a significant benefit over CVP for the primary endpoint, time to treatment failure (27 months vs. 6.6 months, p < 0.0001, log-rank test).
Maltese: R-CVP wassal għal benefiċċju sinifikanti fuq CVP għall-punt finali primarju, iż-żmien sa falliment tal-kura (27 xahar kontra 6.6 xhur, p < 0.0001, test log-rank).
English: Infections and infestations bacterial infections, viral infections, +bronchitis sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
Maltese: Sepsi, +pnewmonja, +infezzjoni bid-deni, +herpes zoster, +infezzjoni fl-apparat respiratorju, infezzjoni mill-moffa, infezzjonijiet b'etjoloġija mhux magħrufa, +bronkite akuta, +sinusite, epatite B1
English: MabThera induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Maltese: MabThera jikkaġuna tnaqqis taċ-ċellula B f'madwar 70-80% tal-pazjenti, iżda kien assoċjat ma' tnaqqis fl-immunoglobulini fis-serum f'minoranza ta' pazjenti biss.
English: MabThera 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: MabThera huwa indikat għall-kura ta' pazjenti b'limfoma mhux ta' Hodgkin taċ-ċellula B kbira mifruxa pożittiva għal CD20 flimkien ma' kimoterapija CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone).
English: Based on popPK analysis an absolute bioavailability of 71% was estimated.
Maltese: Ibbażat fuq analiżi tal-PK tal-popolazzjoni kienet stmata bijodisponibilità assoluta ta' 71%.
English: Seropositive (n=506)
Maltese: (n=506)
English: In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of MabThera.
Maltese: Barra dan, ma kien hemm l-ebda effett evidenti ta' fludarabine u cyclophosphamide fuq il-farmakokinetika ta' MabThera.
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 x 1000 mg, IV, 2 weeks apart), were similar with a mean maximum serum concentration of 369 µg/mL and a mean terminal half-life of 19.2 days.
Maltese: Il-parametri farmakokinetiċi (PK) fil-popolazzjoni li rrispondiet b'mod inadegwat għall-mediċini kontra TNF, bl-użu tal-istess reġim ta' dożaġġ (2 x 1000 mg, IV, ġimagħtejn 'il bogħod minn xulxin), kienu simili b'konċentrazzjoni massima medja fis-serum ta' 369 µg/mL u half-life terminali medja ta' 19.2-il ġurnata.