FrancophonIA/ELRC3.0 huggingface dataset:
English: Neutropenia§, thrombocytopenia, anaemia, leukopenia
Maltese: §, tromboċitopenija, anemija, lewkopenija
English: A Phase III international, multicentre, open label, randomised, two-stage, three-arm clinical study (BO21004/CLL11) investigating the efficacy and safety of Gazyvaro plus chlorambucil (GClb) compared to rituximab plus chlorambucil (RClb) or chlorambucil (Clb) alone was conducted in patients with previously untreated CLL with comorbidities.
Maltese: III internazzjonali, multiċentriku, open label, randomised, b'żewġ stadji u bi tliet gruppi (BO21004/CLL11) li investiga l-effikaċja u s-sigurtà ta' Gazyvaro flimkien ma ' chlorambucil (GClb) imqabbel ma 'rituximab flimkien ma 'chlorambucil (RClb) jew chlorambucil (Clb) waħdu f'pazjenti b'CLL li ma kinux ikkurati qabel b'komorbiditajiet.
English: The safety and efficacy of Gazyvaro in children and adolescents aged below 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Gazyvaro fi tfal u adolexxenti ta' età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Indolent Non Hodgkin Lymphoma including Follicular Lymphoma
Maltese: Limfoma Mhux ta' Hodgkin Indolenti inkluż Limfoma Follikulari
English: 18.7 months median observation time g
Maltese: Żmien medjan ta' osservazzjoni ta' 18.7 xhur g
English: Grade 3-4 IRRs occurred in 12% of patients.
Maltese: IRRs ta' Grad 3-4 seħħew fi 12% tal-pazjenti .
English: Follicular lymphoma (FL)
Maltese: Limfoma follikulari (FL - follicular lymphoma)
English: Oral analgesic/anti-pyretic2
Maltese: Analġeżiku/antipiretiku orali
English: Tumour lysis syndrome (TLS)
Maltese: Sindrome tal-lisi tat-tumur (TLS - tumour lysis syndrome)
English: Haemorrhagic events and Grade 3-5 haemorrhagic events occurred in 12% and 5% of patients, respectively.
Maltese: Avvenimenti emorraġiċi u avvenimenti emorraġiċi ta' Grad 3-5 seħħew fi 12% u 5% tal-pazjenti, rispettivament.
English: Day 1 (100 mg)
Maltese: Jum 1 (100 mg)
English: Transient elevation in liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase) has been observed shortly after the first infusion of Gazyvaro.
Maltese: Elevazzjoni temporanja fl-enzimi tal-fwied (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase) kienu osservati ftit wara l-ewwel infużjoni ta'
English: Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain magnetic resonance imaging (MRI), and lumbar puncture (cerebrospinal fluid testing for John Cunningham viral DNA).
Maltese: L-evalwazzjoni ta' PML tinkludi, iżda mhix limitata għal, konsultazzjoni ma 'newrologu, immaġini b'riżonanza manjetika (MRI - magnetic resonance imaging) tal-moħħ, u titqiba lumbari (ittestjar tal-fluwidu ċerebrospinali għad-DNA tal-virus John Cunningham).
English: The safety and efficacy of Gazyvaro has not been established in patients with severe renal impairment (CrCl < 30 mL/min) (see sections 4.8 and 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' Gazyvaro ma ġewx determinati f'pazjenti b'indeboliment renali sever (CrCl ta' < 30 mL/min) (ara sezzjonijiet 4.8 u 5.2).
English: Administer at 25 mg/hr over 4 hours.
Maltese: Agħti b'rata ta' 25 mg/siegħa matul 4 sigħat.
English: For instructions on dilution of Gazyvaro before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq id-dilwizzjoni ta' Gazyvaro qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: The median age was 73 years, with 44% being 75 years or older.
Maltese: L-età medjana kienet ta' 73 sena, b'44% b'età ta' 75 sena jew akbar.
English: Kaplan-Meier curves for progression-free survival (PFS) are shown in Figure 5.
Maltese: Kaplan-Meier għas-sopravivenza mingħajr progressjoni (PFS - progression-free survival) huma murija fil-Figura 5.
English: In the pivotal BO21004/CLL11 study, 27% (90 out of 336) of patients treated with Gazyvaro plus chlorambucil had moderate renal impairment (CrCl < 50 mL/min).
Maltese: BO21004/CLL11, 27% (90 minn 336) tal-pazjenti ikkurati b'Gazyvaro flimkien ma ' chlorambucil kellhom indeboliment renali moderat (CrCl < 50 mL/min).
English: EQ-5D utility scores were similar at baseline, during treatment and follow-up.
Maltese: Il-punteġġi tal-utilità ta' EQ-5D kienu simili fil-linja bażi, matul it-trattament u s-segwitu.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC15
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: The most frequently reported coexisting medical conditions (using a cut off of 30% or higher), in the MedDRA body systems are: Vascular disorders (73%), Cardiac disorders (46%), Gastrointestinal disorders (38%), Metabolism and nutrition disorders (40%), Renal and urinary disorders (38%), Musculoskeletal and connective tissue disorders (33%).
Maltese: Disturbi vaskulari (73%), Disturbi fil-qalb (46%), disturbi gastrointestinali (38%), Disturbi fil-metaboliżmu u n-nutrizzjoni (40%), Disturbi fil-kliewi u fis-sistema urinarja (38%) Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: No post-baseline HAHA (Human Anti-Human Antibody) were observed in patients with iNHL treated in study GAO4753g/GADOLIN.
Maltese: Ma ġie osservat l-ebda HAHA (Human Anti-Human Antibody - Antikorp Uman Antiuman) wara llinja bażi f'pazjenti b'iNHL ittrattata fl-istudju GAO4753g/GADOLIN.
English: Chronic Lymphocytic Leukaemia
Maltese: Lewkimja limfoċitika kronika (CLL - chronic lymphocytic leukaemia)
English: Pharmacokinetic data in patients with severe renal impairment (CrCl 15-29 mL/min) is limited (n=8), therefore no dose recommendations can be made.
Maltese: Dejta farmakokinetika f'pazjenti b'indeboliment renali sever (CrCl 15-29 mL/min) hija limitata (n=8), għalhekk ma jistgħux isiru rakkomandazzjonijiet ta' doża.
English: No formal drug-drug interaction studies have been performed, although limited drug-drug interaction sub-studies have been undertaken for Gazyvaro with bendamustine, CHOP, fludarabine and cyclophosphamide (FC), and chlorambucil.
Maltese: Ma twettaq l-ebda studju formali ta' interazzjoni bejn mediċina u oħra, għalkemm twettqu sotto-studji limitati ta' interazzjoni bejn mediċina u oħra għal Gazyvaro ma' bendamustine, CHOP, fludarabine u cyclophosphamide (FC), u chlorambucil.
English: The most common Grade 3-5 adverse reactions were neutropenia (10%), and anaemia, febrile neutropenia, thrombocytopenia, sepsis, upper respiratory tract infection, and urinary tract infection (all at 1%).
Maltese: L-aktar reazzjonijiet avversi ta' Grad 3-5 komuni kienu newtropenija (10%), u anemija, newtropenija bid-deni, tromboċitopenija, sepsis, infezzjoni fl-apparat respiratorju ta' fuq, u infezzjoni fl-apparat tal-awrina (kollha ta' 1%).
English: Administer at 50 mg/hr.
Maltese: Agħti b'rata ta' 50 mg/siegħa.
English: Results of subgroup analyses
Maltese: Riżultati ta' analiżi ta' sottogrupp
English: In patients with FLIPI score 0-1 (low risk), no difference between Gazyvaro plus chemotherapy and rituximab plus chemotherapy was observed (INV-assessed PFS HR 1.17 (95%CI 0.63;2.19, 40 PFS events).
Maltese: F'pazjenti b'punteġġ FLIPI ta' 0-1 (riskju baxx), ma kienet osservata l-ebda differenza bejn Gazyvaro flimkien ma' kimoterapija u rituximab flimkien ma' kimoterapija (HR għal PFS evalwata minn INV ta' 1.17 (CI ta' 95%: 0.63; 2.19, 40 każ ta' PFS).
English: Table 9 Summary of efficacy in patients with FL# from GAO4753g/GADOLIN study
Maltese: Tabella 9 Sommarju tal-effikaċja f'pazjenti b'FL#minn studju GAO4753g/GADOLIN
English: In addition, in vivo, obinutuzumab mediates a low degree of complement dependent cytotoxicity (CDC).
Maltese: Barra dan, in vivo, obinutuzumab jikkaġuna grad baxx ta' ċitotossiċità dipendenti fuq il-komplement (CDC - complement dependent cytotoxicity).
English: 1See section 5.1 for information on chlorambucil dose
Maltese: Ara sezzjoni 5.1 għal tagħrif dwar id-doża ta' chlorambucil
English: Fifty-seven percent received bendamustine, 33% received CHOP, and 10% received CVP chemotherapy.
Maltese: Sebgħa u ħamsin fil-mija rċevew bendamustine, 33% irċevew CHOP, u 10% irċevew kimoterapija CVP.
English: · Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Results of the progression free survival (PFS) subgroup analysis (i.e. sex, age, Binet stages, CrCl, CIRS score, beta2-microglobulin, IGVH status, chromosomal abnormalities, lymphocyte count at baseline) were consistent with the results seen in the overall Intent-to-Treat population.
Maltese: Riżultati tal-analiżi tas-sottogrupp tas-sopravivenza mingħajr progressjoni (PFS - progression free survival) (i.e. sess, età, stadji Binet, CrCl, punteġġ CIRS, beta2-microglobulin, stat
English: Patients with FL Grade 3b were excluded from the study.
Maltese: Pazjenti b'FL ta' Grad 3b kienu esklużi millistudju.
English: Patients with inadequate liver function (National Cancer Institute - Common Terminology Criteria for Adverse Events Grade 3 liver function tests (AST, ALT > 5 x ULN for > 2 weeks; bilirubin > 3 x ULN) and renal function (CrCl < 30 mL/min) were excluded.
Maltese: Pazjenti b'funzjoni epatika inadegwata (Istitut Nazzjonali tal-Kanċer - Kriterji ta' Terminoloġija Komuni għall-Avvenimenti Avversi skont testijiet tal-funzjoni tal-fwied ta' Grad 3 (AST, ALT > 5 x ULN għal > ġimagħtejn; bilirubina > 3 x ULN) u funzjoni renali inadegwata (CrCl < 30 mL/min)) kienu esklużi.
English: 40 mL concentrate in a 50 mL vial (clear Type I glass) with stopper (butyl rubber).
Maltese: 40 mL ta' konċentrat f'kunjett ta' 50 mL (ħġieġ ċar tat-Tip I) b'tapp (lasktu butyl).
English: 22.8 months median observation time g
Maltese: Żmien medjan ta' osservazzjoni ta' 22.8 xhur g
English: Day 8 (1,000 mg)
Maltese: Jum 8 (1,000 mg)
English: At a minimum this should include hepatitis B surface antigen (HBsAg) status and hepatitis B core antibody (HBcAb) status.
Maltese: Bħala minimu dan għandu jinkludi l-istat tal-antiġen tas-superfiċje talepatite B ) HbsAg - hepatitis B surface antigen) u l-istat tal-antikorp tal-qalba tal-epatite B (HbcAbhepatitis B core antibody).
English: The incidence of infection was 38% in the Gazyvaro plus chlorambucil arm and 37% in the rituximab plus chlorambucil arm (with Grade 3-5 events reported in 12% and 14%, respectively and fatal events reported in < 1% in both treatment arms).
Maltese: L-inċidenza ta' infezzjoni kienet ta' 38% fil-grupp ta' Gazyvaro flimkien ma' chlorambucil u ta' 37% fil-grupp ta' rituximab flimkien ma' chlorambucil (b'avvenimenti ta' Grad 3-5 irrappurtati fi 12% u 14%, rispettivament u avvenimenti fatali rrappurtati f'< 1% fiż-żewġ gruppi ta 'kura).
English: Day 15 (1,000 mg)
Maltese: Jum 15 (1,000 mg)
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≤ 1/10), komuni (≤ 1/100 sa < 1/10), mhux komuni (≤ 1/1,000 sa < 1/100), rari (≤ 1/10,000 sa < 1/1,000), u rari ħafna (< 1/10,000).
English: Patients were randomised 1:1 to receive either bendamustine (B) alone (n = 202) or Gazyvaro in combination with bendamustine (G+B) (n = 194) for 6 cycles, each of 28 days duration.
Maltese: Il-pazjenti kienu randomised 1:1 biex jirċievu bendamustine (B) waħdu (n = 202) jew Gazyvaro flimkien ma' bendamustine (G+B) (n = 194) għal 6 ċikli, kull wieħed b'tul ta' 28 ġurnata.
English: (INV-assessed, CT) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (Cochran-Mantel-Haenszel test) Complete Response (CR) Partial Response (PR)
Maltese: Dawk li rrispondew (%) (CR/PR) Differenza fir-rata ta' rispons (CI ta' 95%) Valur p (test Cochran-Mantel-Haenszel)
English: Cough§
Maltese: Sogħla§
English: Patients with a CrCl < 30 mL/min were excluded from the study (see section 5.1).
Maltese: Pazjenti b'CrCl ta' < 30 mL/min kienu esklużi mill-istudju (ara sezzjoni 5.1).
English: Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with Gazyvaro (see section 4.8).
Maltese: Lewkoenċefalopatija multifokali progressiva (PML) kienet irrappurtata f'pazjenti kkurati b'Gazyvaro (ara sezzjoni 4.8).
English: Motor symptoms with corticospinal tract findings (e.g. muscular weakness, paralysis and sensory disturbances), sensory abnormalities, cerebellar symptoms, and visual field defects are common.
Maltese: Sintomi motorji b'sejbiet fl-apparat kortikospinali (eż. dgħufija fil-muskoli, paralisi u disturbi fis-sensi), anormalitajiet fis-sensi, sintomi ċerebellari, u difetti fil-kamp viżiv huma komuni.
English: The demographic data and baseline characteristics of the patient population were well balanced between the treatment arms; median age was 59 years, 81% were Caucasian, 53% were female, 79% had a FLIPI score of ≥ 2 and 7% had Stage II (bulky), 35% had Stage III and 57% had Stage IV disease, 44% had bulky disease (> 7 cm), 34% had at least one B-symptom at baseline and 97% had an ECOG performance status of 0-1 at baseline.
Maltese: Id-dejta demografika u l-karatteristiċi fil-linja bażi tal-popolazzjoni ta' pazjenti kienu bbilanċjati tajjeb bejn il-gruppi ta' trattament; età medjana kienet ta' 59 sena, 81% kienu Kawkasi, 53% kienu nisa, 79% kellhom punteġġ FLIPI ta' ≥ 2 u 7% kellhom marda fi Stadju II (massa kbira), 35% kellhom marda fi Stadju III u 57% kellhom marda fi Stadju IV, 44% kellhom marda b'massa kbira (> 7 ċm), 34% kellhom tal-anqas sintomu B wieħed fil-linja bażi u 97% kellhom stat ta' prestazzjoni ta' ECOG ta' 0-1 fil-linja bażi.
English: Musculoskeletal and connective tissue disorders Very common
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna
English: Size of PVC or non-PVC polyolefin infusion bag
Maltese: Daqs tal-borża tal-infużjoni tal-PVC jew tal-polyolefin mhux PVC
English: Oral herpes, rhinitis, pharyngitis, lung infection, influenza nasopharyngitis
Maltese: Herpes orali, rinite, farinġite, infezzjoni fil-pulmun, influwenza, nażofarinġite
English: The majority of the patients in study GAO4753g had FL (81.1%).
Maltese: Il-maġġoranza tal-pazjenti fl-istudju GAO4753g kellhom FL (81.1%).
English: Do not use other diluents such as glucose (5%) solution (see section 6.2).
Maltese: Tużax dilwenti oħrajn bħal soluzzjoni ta' glucose (5%) (ara sezzjoni 6.2).
English: No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance [CrCl] 30-89 mL/min) (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment renali ħafif sa moderat (tneħħija talkreatinina [CrCl - creatinine clearance] ta' 30-89 mL/min) (ara sezzjoni 5.2).
English: Gazyvaro can be used in adults to treat two different types of cancer
Maltese: Gazyvaro jista' jintuża fl-adulti biex jittratta żewġ tipi differenti ta' kanċer
English: No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
Maltese: Ma kinux osservati effetti avversi fuq l-organi riproduttivi maskili u femminili fi studji dwar l-effett tossiku minn dożi ripetuti f'xadini cynomolgus (ara sezzjoni 5.3).
English: For management of symptomatic adverse events (including IRRs), see paragraph below (Management of IRRs or section 4.4).
Maltese: Għall-immaniġġjar ta' avvenimenti avversi sintomatiċi (inklużi IRRs), ara l-paragrafu hawn taħt (Immaniġġjar ta' IRRs jew sezzjoni 4.4).
English: With a median observation time of 24.1 months for FL patients, 48 patients (28.1%) in the B arm and 30 patients (18.3%) in the G+B arm had died.
Maltese: Bi żmien medjan ta' osservazzjoni ta' 24.1 xhur għall-pazjenti b'FL, 48 pazjent (28.1%) fil-grupp ta' B u 30 pazjent (18.3%) fil-grupp ta' G+B kienu mietu.
English: Cycles 2, 3, 4, 5 and 6 this will be just one dose of Gazyvaro in the 28 days: · Day 1 - full dose (1,000 mg).
Maltese: Ċikli 2, 3, 4, 5 u 6 - dan se jkun biss doża waħda ta' Gazyvaro fi 28 jum:
English: In a 26-week cynomolgus monkey study, hypersensitivity reactions were noted and attributed to the foreign recognition of the humanised antibody in cynomolgus monkeys (0.7-6 times the clinical exposure based on Cmax and AUC at steady state after weekly administration of 5, 25, and 50 mg/kg).
Maltese: Fi studju ta' 26 ġimgħa f'xadini cynomolgus, reazzjonijiet ta' sensittività eċċessiva kienu nnutati u attribwiti għall-għarfien barrani tal-antikorp umanizzat f'xadini cynomolgus (0.7-6 darbiet lesponiment kliniku ibbażat fuq Cmax u l-AUC fi stat fiss wara għoti ta' kull ġimgħa ta' 5, 25, u 50 mg/kg).
English: No formal pharmacokinetic study has been conducted in patients with hepatic impairment.
Maltese: Ma sarux studji farmakokinetiċi formali f'pazjenti b'indeboliment epatiku.
English: Patients with a CrCl < 40 mL/min were excluded from the studies (see section 5.1).
Maltese: Pazjenti b'CrCl ta' < 40 mL/min kienu esklużi mill-istudji (ara sezzjoni 5.1).
English: Day 1
Maltese: Ċiklu 1
English: Trehalose dihydrate
Maltese: Wara d-dilwizzjoni
English: #with a higher incidence (difference of ≥ 2% between the treatment arms).
Maltese: #b'inċidenza ogħla (differenza ta' ≥ 2% bejn il-gruppi ta' trattament).
English: The incidence of IRRs with subsequent infusions was 3% with the second 1,000 mg dose and 1% thereafter.
Maltese: L-inċidenza ta 'IRRs b'infużjonijiet sussegwenti kienet ta' 3% bit-tieni doża ta' 1,000 mg u ta' 1% wara dan.
English: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with anti-CD20 antibodies including Gazyvaro (see section 4.8).
Maltese: Attivazzjoni mill-ġdid tal-virus tal-epatite B (HBV - Hepatitis B virus), li f'xi każijiet wasslet għallepatite fulminanti, insuffiċjenza epatika u mewt, tista' sseħħ f'pazjenti kkurati b'antikorpi kontra CD20 inkluż Gazyvaro (ara sezzjoni 4.8).
English: Key Endpoints
Maltese: Punti finali sekondarji
English: Gazyvaro will be stored by the healthcare professionals at the hospital or clinic.
Maltese: Gazyvaro se jinħażen minn professjonisti fil-kura tas-saħħa fi sptar jew klinika.
English: No Grade 3-5 IRRs were reported beyond the first 1,000 mg infusions of Cycle 1.
Maltese: Ma kinux irrappurtati IRRs ta' Grad 3-5 wara l-ewwel infużjonijiet ta' 1,000 mg ta' Ċiklu 1.
English: NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Maltese: TAL-PRODOTT MEDIĊINALI Gazyvaro 1,000 mg, konċentrat għal soluzzjoni għall-infużjoni obinutuzumab
English: The metabolism of obinutuzumab has not been directly studied.
Maltese: Il-metaboliżmu ta' obinutuzumab ma ġiex studjat direttament.
English: Urinary tract infection, pneumonia, lung infection, upper respiratory tract infection, sinusitis, herpes zoster
Maltese: Infezzjoni fl-apparat tal-awrina, pulmonite, infezzjoni fil-pulmun, infezzjoni fl-apparat respiratorju ta' fuq, sinożite, herpes zoster
English: However, in patients with FL the addition of Gazyvaro to bendamustine delayed the time to worsening of health-related quality of life as measured by the FACT-Lym TOI score by 2.2 months (median 5.6 versus 7.8 months for B and G+B respectively HR = 0.83; 95% CI: 0.60, 1.13).
Maltese: TOI bi 2.2 xhur (medjan 5.6 kontra 7.8 xhur għal B u G+B rispettivament HR = 0.83; CI ta' 95%: 0.60, 1.13).
English: The studies BO21223/GALLIUM and GAO4753g/GADOLIN enrolled patients with iNHL including FL.
Maltese: u GAO4753g/GADOLIN irreġistraw pazjenti b'iNHL inkluż FL.
English: However, weekly obinutuzumab dosing from post-coitum day 20 to delivery resulted in complete depletion of B-cells in infant monkeys at weekly intravenous obinutuzumab doses of 25 and 50 mg/kg (2-5 times the clinical exposure based on Cmax and AUC).
Maltese: Madankollu, dożaġġ ta' kull ġimgħa ta' obinutuzumab minn jum 20 wara l-kopulazzjoni sat-twelid wassal għal tnaqqis komplut taċ-ċelluli B fil-frieħ tax-xadini b'dożi ta' kull ġimgħa ta' obinutuzumab fil-vini ta' 25 u 50 mg/kg (2-5 darbiet l-esponiment kliniku ibbażat fuq Cmax u AUC).
English: Instructions on the rate of infusion are shown in Tables 4-5.
Maltese: Istruzzjonijiet dwar ir-rata tal-infużjoni huma murija f'Tabelli 4 u 5.
English: Dyspepsia, colitis, haemorrhoids Diarrhoea, colitis
Maltese: Dispepsja, kolite, murliti
English: While the clinical significance of HAHA is not known, a potential correlation between HAHA and clinical course cannot be ruled out.
Maltese: Filwaqt li s-sinifikanza klinika ta' HAHA mhix magħrufa, ma tistax tiġi eskluża korrelazzjoni potenzjali bejn HAHA u kors kliniku.
English: Neutropenia and infections
Maltese: Newtropenija u infezzjonijiet
English: Patients with renal impairment (CrCl < 50 mL/min) are more at risk of thrombocytopenia (see section 4.8).
Maltese: Pazjenti b'indeboliment renali (CrCl < 50 mL/min) għandhom riskju akbar ta' tromboċitopenija (ara sezzjoni 4.8).
English: Hazard ratio (95% CI) p-value (Log-Rank test, stratified b)
Maltese: Proporzjon ta' periklu (CI ta' 95%) Valur p (test Log-Rank, stratifikat b)
English: After dilution, chemical and physical stability have been demonstrated in sodium chloride 9 mg/mL (0.9%) solution for injection at concentrations of 0.4 mg/mL to 20 mg/mL for 24 hours at 2°C to 8°C
Maltese: Wara d-dilwizzjoni, stabilità kimika u fiżika ntweriet f'soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride f'konċentrazzjonijiet ta' 0.4 mg/mL sa 20 mg/mL għal 24 siegħa f'temperatura ta' 2°C sa 8°C segwit minn 48 siegħa (inkluż il-ħin tal-infużjoni) f'≤ 30°C.
English: In the pivotal studies (BO21223/GALLIUM, GAO4753g/GADOLIN) in iNHL, patients 65 years or older experienced more serious adverse events and adverse events leading to withdrawal or death than patients < 65 years of age.
Maltese: Fl-istudji pivitali (BO21223/GALLIUM, GAO4753g/GADOLIN) dwar iNHL, pazjenti b'età ta' 65 sena jew aktar kellhom aktar każijiet avversi serji u każijiet avversi li jwasslu għal waqfien tattrattament jew mewt milli minn pazjenti b'età ta' < 65 sena.
English: Figure 5 Kaplan-Meier curve of INV-assessed progression-free survival in patients with previously untreated FL (Study BO21223/GALLIUM)
Maltese: Kaplan-Meier tas-sopravivenza mingħajr progressjoni evalwata millinvestigatur f'pazjenti b'FL mhux ittrattata minn qabel (Studju BO21223/GALLIUM)
English: The primary analysis based on independent Review Committee (IRC) assessment demonstrated a statistically significant - 45% reduction in the risk of disease progression or death, in patients with iNHL receiving G+B followed by Gazyvaro maintenance, compared with patients receiving bendamustine alone.
Maltese: L-analiżi primarja bbażata fuq valutazzjoni minn Kumitat ta' Analiżi indipendenti (IRC - independent Review Committee) uriet tnaqqis statistikament sinifikanti ta' 45% fir-riskju ta' progressjoni tal-marda jew mewt, f'pazjenti b'iNHL li kienu qed jirċievu G+B segwit minn Gazyvaro bħala manteniment, meta mqabbla ma' pazjenti li kienu qed jirċievu bendamustine waħdu.
English: TLS has been reported with Gazyvaro.
Maltese: TLS kienet irrappurtata b'Gazyvaro.
English: It should be given as an intravenous infusion through a dedicated line after dilution (see section 6.6).
Maltese: Huwa għandu jingħata bħala infużjoni fil-vini permezz ta' linja apposta wara d-dilwizzjoni (ara sezzjoni 6.6).
English: The incidence of IRRs was 66% with the infusion of the first 1,000 mg of Gazyvaro (20% of patients experiencing a Grade 3-4 IRR).
Maltese: L-inċidenza ta' IRRs kienet ta' 66% bl-infużjoni tal-ewwel 1,000 mg ta'Gazyvaro (20% tal-pazjenti kellhom
English: However, results from the population analysis have shown that the differences in exposure are not significant (with an estimated median AUC and Cmax in CLL patients of 11282 µg•d/mL and 578.9 µg/mL in females and 8451 µg•d/mL and 432.5 µg/mL in males,
Maltese: Madankollu, riżultati mill-analiżi tal-popolazzjoni wrew li d-differenzi fl-esponiment mhumiex sinifikanti (bi stima tal-AUC u Cmax medjana f'pazjenti b'CLL ta' 11282 µg•d/mL u 578.9 µg/mL fin-nisa u 8451 µg•d/mL u 432.5 µg/mL fl-irġiel, rispettivament f'Ċiklu 6 u AUC u Cmax f'iNHL ta' 13172 µg•d/mL u 635.7 µg/mL fin-nisa u
English: Table 6 Summary of ADRs reported with a higher incidence (difference of ≥2% versus the comparator arm) in patients# receiving Gazyvaro + chemotherapy* System organ class
Maltese: Tabella 6 Sommarju ta' ADRs irrappurtati b'inċidenza ogħla (differenza ta' ≤ 2% kontra l grupp ta' paragun) f'pazjenti#