FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Recommended starting dosage of DUROGESIC based upon daily oral morphine dose (for patients who have a need for opioid rotation or for clinically less stable patients: conversion ratio of oral morphine to transdermal fentanyl is approximately equal to 150:1) 1
Maltese: Tabella 2 qegħda għal pazjenti adulti li jeħtieġu bidla regolari fl-opiojdi jew li huma inqas stabbli b'mod kliniku (proporzjon ta' konverżjoni ta' morfina mill-ħalq għal fentanyl li jgħaddi minn ġol-ġilda hija ekwivalenti għal madwar 150:
English: Erectile dysfunction, Sexual dysfunction
Maltese: Impotenza, Funzjoni sesswali ħażina
English: After the first DUROGESIC application, serum fentanyl concentrations increase gradually, generally leveling off between 12 and 24 hours and remaining relatively constant for the remainder of the 72-hour application period.
Maltese: Wara l-ewwel applikazzjoni ta' DUROGESIC, il-konċentrazzjonijiet ta' fentanyl fis-serum jiżdiedu bil-mod il-mod, ġeneralment jistabilizzaw wara 12 sa 24 siegħa u jibqgħu relattivament kostanti għall kumplament tal-perjodu ta' applikazzjoni ta' 72 siegħa.
English: 95.1%b CI (-3.2%, 24.3%)a
Maltese: 95.1%b CI (−3.2%, 24.
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: 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 Numru ta' Individwi f'Riskju
English: Observation N=513
Maltese: Osservazzjoni N=513
English: − CI = confidence interval.
Maltese: CI = intervall ta' kunfidenza.
English: Pneumocystis jirovecii
Maltese: Pneumocy stis jirovecii
English: ORR, % CR, % Median TTF/PFS/ EFS mo
Maltese: CR, % TTF/PFS/EFS Medjan
English: Pruritis, rash, +alopecia
Maltese: Ħakk, raxx, +alopeċja
English: • Infections, see section 4.4.
Maltese: • Infezzjonijiet, ara sezzjoni 4.4.
English: Treatment difference (rituximabcyclophosphamide)
Maltese: Differenza fil-Kura (rituximab-Cyclophosphamide)
English: Log-rank p value
Maltese: Log-Rank valur p
English: 2 Frequency category derived from post-marketing data.
Maltese: 2 Kategorija ta' frekwenza derivata minn data ta' wara t-tqegħid fis-suq.
English: Post-hoc retrospective laboratory evaluation
Maltese: Evalwazzjoni retrospettiva post hoc tal-laboratorju
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< 0.001, ***p< 0.0001.
English: Observation (N=167)
Maltese: Osservazzjo ni (N = 167)
English: • IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Maltese: • IRRs (inkluż sindrome tar-reħa ta' ċitokina, sindrome tal-lisi tat-tumur), ara sezzjoni 4.4.
English: Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.
Maltese: Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid.
English: EULAR response (%)
Maltese: Rispons EULAR (%)
English: Date of first authorization: 15 June 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Ġunju 2017
English: ACR20 ACR50 ACR70 EULAR response (good/moderate) Mean change in DAS
Maltese: ACR20 ACR50 ACR70 Rispons EULAR (tajjeb/moderat) Bidla medja f'DAS
English: +Myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Maltese: +Infart mijokardijaku 4 u 6, arritmija, +fibrillazjoni atrijali, takikardja, +disturb filqalb
English: This is usually given every 3 week up to 8 times.
Maltese: Din normalment tingħata kull 3 ġimgħat sa 8 darbiet.
English: Depression, nervousness
Maltese: Depressjoni, nervi,
English: CR2) PR2)
Maltese: PR2)
English: • Anxiety, depression
Maltese: • Ansjetà, depressjoni
English: Placebo+MTX Rituximab+MTX (2 x 1,000 mg)
Maltese: Plaċebo+MTX Rituximab+MTX (2 × 1000 mg)
English: • Cardiovascular events, see section 4.4.
Maltese: • Avvenimenti kardjovaskulari, ara sezzjoni 4.4.
English: However, the possible risk for the development of solid tumours cannot be excluded at this time.
Maltese: Iżda, attwalment il-possibbiltà ta' riskju għalliżvilupp ta' tumuri solidi ma jistax jiġi eskluż.
English: Median TTP:
Maltese: TTF medjan:
English: p-value (Wald test, not adjusted)
Maltese: valur p (test ta' Wald,
English: Rixathon contains the active substance “rituximab”.
Maltese: Rixathon fih is-sustanza attiva “rituximab”.
English: Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections
Maltese: Sodium chloride Sodium hydroxide Hydrochloric acid Ilma għall-injezzjonijiet
English: 100 mg / 10 mL
Maltese: INDIVIDWALI 100 mg / 10 mL
English: Binet stage A Binet stage B Binet stage C CI: Confidence Interval
Maltese: Stadju binet A Stadju binet B
English: Infusion related reactions4, angioedema
Maltese: Reazzjonijiet relatati mal infużjoni4, anġjoedima
English: Herpes virus infection Herpes zoster Oral herpes Conjunctivitis
Maltese: Infezzjonijiet u Infestazzjonijiet Infezzjoni mill-virus herpes Herpes zoster
English: Bronchitis, sinusitis, gastroenteritis, tinea pedis
Maltese: sinożite, gastro enterite, tinea pedis
English: Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
Maltese: ADRs serji oħra rrappurtati jinkludu riattivazzjoni ta' epatite B u PML (ara sezzjoni 4.4.).
English: Ljubljana Verovškova 57
Maltese: Lek Pharmaceuticals d.d. Ljubljana Verovškova 57
English: FC R-FC
Maltese: R-FC
English: Uncommon Rare
Maltese: Rari Ħafna
English: Rixathon is a biosimilar medicinal product.
Maltese: Rixathon huwa prodott mediċinali bijoloġiku simili.
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Maltese: Il-mediċini immunomodulatorji jistgħu jżidu r-riskju ta' tumuri malinni.
English: 500 mg / 50 mL
Maltese: INDIVIDWALI 500 mg / 50 mL
English: Arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Maltese: Artralġja / uġigħ muskoluskeletrali, osteoartrite, bursite
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: pazjenti mingħajr bulky disease (25.6% vs 15.4%).
English: Severe (grade 3/4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Maltese: Newtropenija severa (grad 3/4) kienet irrapportata f'4.2%, anemija f'1.1% u tromboċitopenija f'1.7% tal-pazjenti.
English: Event free survival Response rate (CR, nPR, or PR)
Maltese: Rata ta' rispons (CR, nPR, jew PR)
English: Progression-free survival (PFS)
Maltese: Progressjoni (PFS)
English: Placebo+MTX Rituximab+MTX 2 x 1,000 mg
Maltese: Rituximab+MTX 2 × 1000 mg
English: Lung infiltration
Maltese: Infiltrati filpulmun
English: Final analysis (median FU:9.0 years)
Maltese: (FU medjan: 9.0 snin)
English: Rixathon is indicated in adults for the following indications:
Maltese: Rixathon huwa indikat f'adulti għall-indikazzjonijiet li ġejjin:
English: For non-oncology indications:
Maltese: Għal indikazzjonijiet mhux għall-onkoloġija:
English: Patient subpopulations - rituximab combination therapy
Maltese: Sottopopolazzjonijiet ta' pazjenti - rituximab bħala terapija kombinata
English: Kaplan-Meier estimated progression- free rates at 12 months were 78% in the rituximab 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'rituximab vs 57% fil-grupp ta' osservazzjoni.
English: † Outcome at 24 weeks 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: 18-months p=0.016
Maltese: 18-xahar p = 0.016
English: Primary analysis (median FU: 25 months)
Maltese: (FU medjan: 25 xahar)
English: Aseptic preparation
Maltese: Preparazzjoni asettika
English: Chronic lymphocytic leukaemia (CLL)
Maltese: Lewkimja limfoċitika kronika (CLL)
English: • Infections such as bronchial tube inflammation (bronchitis)
Maltese: • Infezzjonijet bħal infjammazzjoni tat-tubu tal-bronki (bronkite)
English: A total of 392/3,095 (12.7%) patients with rheumatoid arthritis tested positive for ADA in clinical studies following therapy with rituximab.
Maltese: Total ta' 392/3095 (12.7%) pazjent b'artrite rewmatika kienu pożittivi għal ADA fi studji kliniċi wara terapija b'rituximab.
English: Toxic Epidermal Necrolysis (Lyell's syndrome), StevensJohnson syndrome5
Maltese: Nekrolisi Tossika talEpidermide (sindrome ta' Lyell), sindrome ta' StevensJohnson5
English: Overall response rate* chi-squared test p value odds ratio (95% CI) Complete response (CR/CRu) rate* chi-squared test p value odds ratio (95% CI)
Maltese: Rata ta' rispons globali* valur p minn test chi-squared proporzjon ta' probbabiltà (CI ta' 95%) Rata ta' rispons komplut (CR/CRu)* valur p minn test chi-squared proporzjon ta' probbabiltà (CI ta' 95r%)
English: Date of most recent infusion: __________ Date of first infusion: ________________ Patient's Name:_____________________ Doctor's Name:_____________________ Doctor's contact details:______________
Maltese: Data tal-aktar infużjoni reċenti:___________ Data tal-ewwel infużjoni:________________
English: • Fungal foot infection (athlete's foot)
Maltese: • Infezzjoni kkawżata mill-moffa fis-saqajn (athlete's foot)
English: A total of 6/34 (18%) of rituximab treated patients from the maintenance therapy clinical trial developed ADA.
Maltese: Total ta' 6/34 (18%) tal-pazjenti ttrattati b'rituximab mill-prova klinika dwar terapija ta' manteniment żviluppaw ADA.
English: Hazard ratio (95% CI)
Maltese: Proporzjon ta' Periklu (CI ta' 95%)
English: 5 Includes fatal cases
Maltese: Inkluż każijiet fatali
English: % SF-36 PHS MCID Mean change in SF-36 MHS % SF-36 MHS MCID † Outcome at 24 weeks Significant difference from placebo at the primary time point: * p < 0.05, ** p < 0.001, *** p ≤ 0.0001 MCID HAQ-DI ≥ 0.22, MCID SF-36 PHS > 5.42, MCID SF-36 MHS > 6.33
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: Rixathon 100 mg sterile concentrate rituximab
Maltese: Rixathon 100 mg konċentrat sterili rituximab
English: Rixathon 500 mg sterile concentrate rituximab
Maltese: Rixathon 500 mg konċentrat sterili rituximab
English: Look out for the following possible signs of infection:
Maltese: Oqgħod attent għas-sinjali possibbli ta' infezzjoni li ġejjin:
English: A total of 1,078 patients responded to induction therapy, of which 1,018 were randomised to rituximab maintenance therapy (n=505) or observation (n=513).
Maltese: 1078 pazjent irrispondew għal terapija ta' induzzjoni, li minnhom 1018 kienu randomised għal terapija ta' manteniment b'rituximab (n = 505) jew għal osservazzjoni (n = 513).
English: An analysis of overall survival confirmed the significant benefit of rituximab maintenance over observation (p=0.0039 log-rank test).
Maltese: Analiżi tas-sopravivenza globali kkonfermat il-vantaġġ sinifikanti ta' manteniment b'rituximab fuq l-osservazzjoni (p = 0.0039 test log-rank).
English: Currently, there are limited data on possible interactions with other medicinal products and rituximab.
Maltese: Attwalment, teżisti informazzjoni limitata dwar l-interazzjonijiet possibbli ma' prodotti mediċinali oħra u rituximab.
English: IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with to those seen for rheumatoid arthritis patients in clinical trials (see section 4.8).
Maltese: IRRs għall-pazjenti bi granulomatosi b'polianġite, polianġite mikroskopika u pemphigus vulgaris kienu konsistenti ma' dawk osservati f'pazjenti b'artrite rewmatika fi provi kliniċi (ara sezzjoni 4.8).
English: A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy.
Maltese: Total ta' 810 pazjent (403 R-FC, 407 FC) għall-istudju primarju (Tabella 10a u Tabella 10b) u 552 pazjent
English: ORR2)
Maltese: CR2)
English: Data from extended follow up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of rituximab maintenance therapy in terms of PFS, EFS, TNLT, and TNCT (Table 7).
Maltese: Data mis-segwitu estiż ta' pazjenti fl-istudju (segwitu medjan ta' 9 snin) ikkonfermat il-benefiċċju fittul ta' terapija ta' manteniment b'rituximab f'termini ta' PFS, EFS, TNLT u TNCT (Tabella 7).
English: In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β2 microglobulin, LDH,
Maltese: aġġustat, skont l-età, stadju ta' Ann Arbor, ECOG, mikroglobulina β2, LDH, albumina, sintomi B,
English: GLSG'00 CHOP, 205 R-CHOP, 223 18
Maltese: R-CHOP, 223 18
English: • The active ingredient in Rixathon is called rituximab.
Maltese: • Is-sustanza attiva f'Rixathon hija msejħa rituximab.
English: 50 mL vial - Pack of 1 or 2 vials.
Maltese: Kunjett ta' 50 mL - Pakkett ta' 1 jew 2 kunjetti.
English: 95% CIb
Maltese: CI ta' 95%b
English: Rituximab maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, >= 60 years), FLIPI score (<=1, 2 or >= 3), induction therapy (R-CHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
Maltese: Kura ta' manteniment b'rituximab ipprovdiet benefiċċju konsistenti fis-sottogruppi kollha ittestjati li kienu definiti minn qabel: sess (maskili, femminili), età (< 60 sena, >=60 sena), punteġġ FLIPI (<=1, 2 jew >=3), terapija ta' induzzjoni (R-CHOP, R-CVP jew R-FCM) u rrispettivament mill kwalità ta' rispons għat-terapija ta' induzzjoni (CR, CRu jew PR).
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: In the induction of remission clinical trial, at 6 months, in the rituximab 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: 10 mL vial - Pack of 2 or 3 vials.
Maltese: Kunjett ta' 10 mL - Pakkett ta' 2 jew 3 kunjetti.
English: In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149 - 470) at the 6-month primary endpoint.
Maltese: Fil-prova klinika dwar l-induzzjoni ta' remissjoni, avvenimenti tal-qalb seħħew b'rata ta' madwar 273 għal kull 100 sena ta' pazjent (CI ta' 95% 149-470) fil-punt finali primarju ta' 6 xhur.
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: Late neutropenia2
Maltese: Newtropenija ttardjata2
English: 42-months p=0.029
Maltese: 42-xahar p = 0.029
English: Packs of 1 or 2 vials.
Maltese: Pakketti ta' 1 jew 2 kunjetti.
English: Packs of 2 or 3 vials.
Maltese: Pakketti ta' 2 jew 3 kunjetti.
English: Rituximab maintenance treatment reduced the risk of death by 56% (95% CI; 22% - 75%).
Maltese: Il-kura ta' manteniment b'rituximab naqqset ir-riskju ta' mewt b'56% (CI ta' 95%;
English: In clinical trials fewer than 1% (17/3,189) of patients experienced a serious IRR.
Maltese: Fi provi kliniċi inqas minn 1% (17/3189) tal-pazjenti kellhom IRR serja.
English: The 50 mL vial contains 500 mg of rituximab (10 mg/mL).
Maltese: Il-kunjett ta' 50 mL fih 500 mg ta' rituximab (10 mg/mL).
English: Rixathon may be used for the treatment of several different conditions in adults.
Maltese: Rixathon jista' jintuża għall-kura ta' diversi kundizzjonijiet differenti fl-adulti.
English: Neutropenia1
Maltese: Newtropenija1
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 Riżultat†
English: In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or rituximab 375 mg/m2 plus CHOP (R-CHOP).
Maltese: Limfoma mhux ta' Hodgkin taċ-ċellula B kbira mxerrda Fi prova tat-tip open label magħmula b'għażla każwali, total ta' 399 pazjent anzjani mhux trattati preċedentement (età -minn 60 sa 80 sena) b'limfoma taċ-ċellula B kbira mxerrda ngħataw kimoterapija CHOP standard (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 sa massimu ta' 2 mg fl-ewwel ġurnata, u prednisolone 40 mg/m2/ġurnata fil-ġranet 1-5) kull 3 ġimgħat għal tmien ċikli, jew rituximab 375 mg/m2 kif ukoll CHOP (R-CHOP).
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01X C02
Maltese: .1 Proprjetajiet farmakodinamiċi Kategorija farmakoterapewtika: sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: Patients could receive 1000 mg IV at the time of relapse (see section 5.1).
Maltese: 1000 mg IV fiż-żmien tal-irkadar (ara sezzjoni 5.1).
English: Patients were between 19 and 79 years of age and had not received prior therapies for pemphigus.
Maltese: 79 sena u ma kinux irċevew terapiji għal pemphigus fil-passat.
English: 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 flapparat respiratorju, infezzjoni mill-moffa, infezzjonijiet b'etjoloġija mhux magħrufa,
English: Elderly patients (≥ 65 years)
Maltese: Pazjenti anzjani (≥ 65 sena):
English: Study Treatment, N
Maltese: Studju Kura, N
English: Granulomatosis with polyangiitis and microscopic polyangiitis Rixathon, 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: Rixathon, 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: Serious viral infection2
Maltese: Infezzjoni serja ikkawżata minn virus2
English: 2 vials of 10 mL 3 vials of 10 mL
Maltese: 100 mg / 10 mL 2 kunjetti ta' 10 mL 3 kunjetti ta' 10 mL
English: Rixathon 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: Rixathon huwa indikat għall-kura ta' pazjenti b'limfoma mhux ta' Hodgkin taċ-ċellula B kbira f'mifruxa pożittiva għal CD20 flimkien ma' kimoterapija CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone).
English: Chemical and physical stability of Rixathon diluted in 5% glucose solution has been demonstrated for 24 hours at 2°C - 8°C and subsequently 12 hours at room temperature (≤25°C).
Maltese: Stabbiltà kimika u fiżika ta' Rixathon dilwit f'soluzzjoni ta' 5% glucose ġiet murija għal 24 siegħa f'temperatura ta' 2°C - 8°C u sussegwentement għal 12-il siegħa f'temperatura tal-kamra (≤25°C).
English: • The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections (see section 2).
Maltese: • Is-sustanzi l-oħra huma sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid u ilma għall-injezzjonijiet (ara sezzjoni 2).
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 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: • After aseptic dilution in sodium chloride solution:
Maltese: • Wara dilwizzjoni asettika f'soluzzjoni ta' sodium chloride:
English: Consultation with a Neurologist should be considered as clinically indicated.
Maltese: Konsultazzjoni ma' Newrologu għandha tiġi kkunsidrata bħala klinikament indikata.
English: Body System
Maltese: Sistema respiratorja
English: PML, reactivation of hepatitis B
Maltese: PML, attivazzjoni mill ġdid tal epatite B
English: Severe bullous skin reactions, StevensJohnson Syndrome toxic epidermal necrolysis (Lyell's Syndrome)
Maltese: sindrome ta' StevensJohnson, nekrolisi tossika talepidermide (sindrome ta' Lyell)7
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 benefiċcju sinifikanti fuq CVP għall-punt finali primarju, iż żmien sal-falliment tal-kura (27 xahar vs. 6.6 xhur, p < 0.0001, test log-rank).
English: In placebo-controlled periods of clinical trials, 0.94% (13/1,382) of rituximab treated patients and 0.27% (2/731) of placebo patients developed severe neutropenia.
Maltese: F'perjodi kkontrollati bil-plaċebo tal-provi kliniċi, 0.94% (13/1382) tal-pazjenti kkurati b'rituximab u 0.27% (2/731) tal-pazjenti fuq plaċebo żviluppaw newtropenija severa.
English: Respirator y failure4
Maltese: Insuffiċjenza respiratorja4
English: Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12).
Maltese: rispons European League Against Rheumatism (EULAR) tajjeb sa moderat ġie miksub minn ammont sinifikattivament akbar ta' pazjenti kkurati b'rituximab, ikkurati b'rituximab u methotrexate meta mqabbel mal-pazjenti kkurati b'methotrexate waħdu (Tabella 12).
English: Decreased IgG levels4
Maltese: Livelli mnaqqsa ta' IgG4
English: Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Maltese: Rituximab jintrabat speċifikament mal-antiġen trasmembran, CD20, fosfoproteina mhux glikosilat, li jinsab fuq limfoċiti pre-B u B maturi.
English: Rixathon contains sodium
Maltese: Rixathon fih is-sodium
English: 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
Maltese: bulky disease, siti ekstranodali, involvement tal-mudullun), il-proporzjon tar-riskju għal sopravivenza mingħajr episodji u ta' sopravivenza ġenerali (R-CHOP ikkumparat ma' CHOP) kienu inqas minn 0.83 u 0.95 rispettivament.