FrancophonIA/ELRC3.0 huggingface dataset:
English: In the small subgroup of patients with deletion 17p, only a positive trend was observed compared to Clb (HR=0.42, p=0.0892); no benefit was observed compared to RClb.
Maltese: Fis-sottogrupp żgħir ta' pazjenti bi tneħħija ta' 17p, kienet osservata biss xejra pożittiva meta mqabbel ma' Clb (HR=0.42, p=0.0892); ma kien osservat l-ebda benefiċċju meta mqabbel ma' RClb.
English: In clinical studies with Gazyvaro, doses ranging from 50 mg up to and including 2,000 mg per infusion have been administered.
Maltese: Fi studji kliniċi b'Gazyvaro, ingħataw dożi li varjaw minn 50 mg sa u inkluż 2,000 mg f'kull infużjoni.
English: Stage 1a compared Gazyvaro plus chlorambucil to chlorambucil alone in 356 patients and Stage 2 compared Gazyvaro plus chlorambucil to rituximab plus chlorambucil in 663 patients.
Maltese: Stadju 1a qabbel Gazyvaro flimkien ma 'chlorambucil ma 'chlorambucil waħdu f'356 pazjent u Stadju 2 qabbel Gazyvaro flimkien ma ' chlorambucil ma 'rituximab flimkien ma 'chlorambucil f'663 pazjenti.
English: · Grade 1-2 (mild to moderate): The infusion rate must be reduced and symptoms treated.
Maltese: • Grad 1-2 (ħfief sa moderati):
English: Median observation time: 20 months
Maltese: Żmien medjan ta' osservazzjoni: 20 xahar
English: Cases of arrhythmias (such as atrial fibrillation and tachyarrhythmia), angina pectoris, acute coronary syndrome, myocardial infarction and heart failure have occurred when treated with Gazyvaro (see section 4.4).
Maltese: Każijiet ta' arritmiji (bħal fibrillazzjoni tal-atriju u takiarritmija), anġina pektoris, sindrome akut talkoronarji, infart mijokardijaku u insuffiċjenza tal-qalb seħħew meta kkurati b'Gazyvaro (ara sezzjoni 4.4).
English: Two infusion bags should be prepared for the infusion on Days 1 and 2 (100 mg for Day 1 and 900 mg for Day 2).
Maltese: Għandhom jiġu ppreparati żewġ boroż tal-infużjoni għall-infużjoni ta' Jiem 1 u 2 (100 mg għal Jum 1 u 900 mg għal Jum 2).
English: Table 7 Summary of efficacy from BO21004/CLL11 study Stage 1a
Maltese: Tabella 7 Sommarju tal-effikaċja minn studju BO21004/CLL11
English: Obinutuzumab, as a glycoengineered antibody, is characterised by enhanced ADCC and ADCP compared to non-glycoengineered antibodies at an equivalent dose.
Maltese: Obinutuzumab, bħala antikorp glycoengineered, huwa kkaratterizzat minn ADCC u ADCP imsaħħa meta mqabbel ma' antikorpi mhux glycoengineered b'doża ekwivalenti.
English: A population pharmacokinetic (PK) model was developed to analyse the PK data in 469 iNHL, 342 CLL and 130 diffuse large B-cell lymphoma (DLBCL) patients from Phase I, Phase II and Phase III studies who received obinutuzumab alone or in combination with chemotherapy.
Maltese: Mudell farmakokinetiku (PK - pharmacokinetic) tal-popolazzjoni kien żviluppat biex janalizza iddejta PK f'469 pazjent b'iNHL, 342 b'CLL u 130 b'limfoma taċ-ċellula B kbira mifruxa (DLBCLdiffuse large B-cell lymphoma) mill-istudji ta' Fażi I, Fażi
English: Molecular remission at end of treatmentd No. of patients included in the analysis MRD negativee (%)
Maltese: Numru ta' pazjenti inklużi fl-analiżi Negattivi għal MRD
English: Patients with renal impairment (CrCl < 50 mL/min) and patients with both Cumulative Illness Rating Scale (CIRS) > 6 and CrCl < 70 mL/min are more at risk of IRRs, including severe IRRs (see section 4.8).
Maltese: Pazjenti b'indeboliment renali (CrCl < 50 mL/min) u pazjenti li għandhom kemm Skala Kumulattiva tal-Punteġġ tal-Marda (CIRSCumulative Illness Rating Scale) ta' > 6 kif ukoll CrCl < 70 mL/min għandhom riskju akbar ta' IRRs, inkluż IRRs severi (ara sezzjoni 4.8).
English: 2See section 5.1 for information on bendamustine dose
Maltese: 2 Ara sezzjoni 5.1 għal tagħrif dwar id-doża ta' bendamustine
English: IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Interval * Stratification factors were chemotherapy regimen, FLIPI risk group for follicular lymphoma, geographic region Significance level at this efficacy interim analysis: 0.012 ¶ Data Not Yet Mature.
Maltese: HR: Proporzjon ta' Periklu; CI: Intervalli ta' Kunfidenza * Fatturi ta' stratifikazzjoni kienu l-kors ta' kimoterapija, grupp ta' riskju FLIPI għal limfoma follikulari, reġjun ġeografiku Livell ta' sinifikanza f'din l-analiżi interim tal-effikaċja: 0.012 ¶
English: Your doctor/nurse will monitor you carefully for infusion related reactions.
Maltese: It-tabib/infermier tiegħek se jissorveljawk b'attenzjoni għal reazzjonijiet relatati mal-infużjoni.
English: Withdraw 40 mL of concentrate from the vial and dilute in polyvinyl chloride (PVC) or non-PVC polyolefin infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Iġbed 40 mL ta' konċentrat mill-kunjett u ddilwixxi f'boroż tal-infużjoni tal-polyvinyl chloride (PVC) jew tal-polyolefin mhux PVC li jkun fihom soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: In a phase III, open label, multicentre, randomised clinical study (GAO4753g/GADOLIN), 396 patients with iNHL who had no response during treatment or who progressed within 6 months following the last dose of rituximab or a rituximab-containing regimen (including rituximab monotherapy as part of induction or maintenance treatment) were evaluated.
Maltese: III, open label, multiċentriku u randomised (GAO4753g/GADOLIN), kienu evalwati 396 pazjent b'iNHL li ma kellhom l-ebda rispons matul it-trattament jew li kellhom progressjoni fi żmien 6 xhur wara l-aħħar doża ta' rituximab jew ta' kors li fih rituximab (inklużi monoterapija ta' rituximab bħala parti minn trattament ta' induzzjoni jew ta' manteniment).
English: · medicine to prevent tumour lysis syndrome (such as allopurinol).
Maltese: • mediċini biex jipprevjenu sindrome tal-lisi tat-tumur (bħal allopurinol).
English: Table 5 Follicular lymphoma: Standard infusion rate in the absence of IRRs /hypersensitivity and recommendations in case an IRR occurred with previous infusion
Maltese: Limfoma follikulari (FL - Follicular lymphoma) Tabella 5 Limfoma Follikulari:Rata tal-infużjoni standard fl-assenza ta' IRR/sensittività eċċessiva u rakkomandazzjonijiet f'każ li seħħet IRR mal-infużjoni ta' qabel
English: In patients with underlying cardiac disease, arrhythmias (such as atrial fibrillation and tachyarrhythmia), angina pectoris, acute coronary syndrome, myocardial infarction and heart failure have occurred when treated with Gazyvaro (see section 4.8).
Maltese: F'pazjenti li għandhom mard tal-qalb, seħħew arritmiji (bħal fibrillazzjoni tal-atriju u takiarritmija), anġina pektoris, sindrome koronarju akut, infart mijokardijaku u insuffiċjenza tal-qalb meta kkurati b'Gazyvaro (ara sezzjoni 4.8).
English: Patients with one or more individual organ/system impairment score of 4 as assessed by the CIRS definition, excluding eyes, ears, nose, throat and larynx organ system, were excluded.
Maltese: Pazjenti b'punteġġ ta' indeboliment ta' organu/sistema individwali wieħed/waħda jew aktar ta' 4 kif evalwat mid-definizzjoni CIRS, eskluż l-għajnejn, ilwidnejn, l-imnieħer, is-sistema tal-organi tal-griżmejn u larinġi, kienu esklużi.
English: Day 2 (or Day 1 continued) (900 mg)
Maltese: Jum 2 (jew Jum 1 ikompli) (900 mg)
English: Cases of prolonged neutropenia (2% in the Gazyvaro plus chlorambucil arm and 4% in the rituximab plus chlorambucil arm) and late onset neutropenia (16% in the Gazyvaro plus chlorambucil arm and 12% in the rituximab plus chlorambucil arm) were also reported (see section 4.4).
Maltese: Kienu rrappurtati wkoll każijiet ta' newtropenija fittul (2% fil-grupp ta' Gazyvaro flimkien ma 'chlorambucil u 4% fil-grupp ta' rituximab flimkien ma' chlorambucil) u newtropenija b'bidu ttardjat (16% fil-grupp ta' Gazyvaro flimkien ma' chlorambucil u 12% fil-grupp ta' rituximab flimkien ma' chlorambucil) (ara sezzjoni 4.4).
English: Gazyvaro + chlorambucil N= 238
Maltese: chlorambucil N= 238
English: · Six 21-day cycles in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP), followed by 2 additional cycles of Gazyvaro alone or · Eight 21-day cycles in combination with cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone (CVP).
Maltese: • Tmien ċikli ta' 21 jum flimkien ma' cyclophosphamide, vincristine, u prednisone/prednisolone/methylprednisolone (CVP).
English: Tumour lysis syndrome, hyperuricaemia, hypokalaemia
Maltese: Sindrome tal-lisi tat-tumur, iperuriċemija, ipokalimja
English: Poloxamer 188
Maltese: L01XC15
English: Prophylaxis and premedication for infusion related reactions (IRRs)
Maltese: Profilassi u medikazzjoni minn qabel għal reazzjonijiet relatati mal-infużjoni (IRRs - infusion related reactions)
English: Most frequently reported (≥ 5%) symptoms associated with an IRR were nausea, vomiting, diarrhoea, headache, dizziness, fatigue, chills, pyrexia, hypotension, flushing, hypertension, tachycardia, dyspnoea, and chest discomfort.
Maltese: Is-sintomi assoċjati ma' IRR irrappurtati l-aktar frekwenti (≥ 5%) kienu dardir, rimettar, dijarea, uġigħ ta' ras, sturdament , għeja, sirdat, deni, pressjoni baxxa, fwawar, pressjoni għolja, takikardija, qtugħ ta' nifs,u skomdu fis-sider .
English: Median observation time: 22 months
Maltese: Żmien medjan ta' osservazzjoni: 22 xahar
English: The incidence of haemorrhagic events was similar across all treatment arms.
Maltese: L-inċidenza ta' avvenimenti emorraġiċi kienet simili fost il-gruppi kollha ta' trattament.
English: Gazyvaro was given by intravenous infusion as a dose of 1,000 mg on Days 1, 8 and 15 of Cycle 1, on Day 1 of subsequent cycles.
Maltese: Gazyvaro ingħata bħala infużjoni fil-vini bħala doża ta' 1,000 mg f'Jiem 1, 8 u 15 ta' Ċiklu 1, u f'Jum 1 ta' ċikli sussegwenti.
English: These patients experienced more serious adverse events, adverse events leading to death and adverse events leading to treatment withdrawal than patients with a CrCl ≥ 50 mL/min (see section 4.2 and 5.2).
Maltese: Dawn il-pazjenti kellhom aktar avvenimenti avversi serji, avvenimenti avversi li jwasslu għall-mewt u avvenimenti avversi li jwasslu għal waqfien tat-trattament minn pazjenti b'CrCl ta' ≥ 50 mL/min (ara sezzjoni 4.2 u 5.2).
English: Gazyvaro contains the active substance obinutuzumab, which belongs to a group of medicines called “monoclonal antibodies”.
Maltese: Gazyvaro fih is-sustanza attiva obinutuzumab li tagħmel parti minn grupp ta' mediċini msejjħa “antikorpi monoklonali”.
English: In nonclinical studies, obinutuzumab induces direct cell death and mediates antibody dependent cellular cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP) through recruitment of FcɣRIII positive immune effector cells.
Maltese: Fi studji mhux kliniċi, obinutuzumab jikkaġuna mewta diretta taċ-ċelluli u jwassal għal ċitotossiċità ċellulari dipendenti mill-antikorpi (ADCC - antibody dependent cellular cytotoxicity) u fagoċitosi ċellulari dipendenti mill-antikorpi (ADCP - antibody dependent cellular phagocytosis) permezz ta' reklutaġġ ta' ċelluli ta' rispons immuni pożittivi għal FcɣRIII.
English: In the pivotal BO21004/CLL11 study, 46% (156 out of 336) of patients with CLL treated with Gazyvaro plus chlorambucil were 75 years or older (median age was 74 years).
Maltese: BO21004/CLL11, 46% (156 minn 336) tal-pazjenti b'CLL ikkurati b'Gazyvaro flimkien ma' chlorambucil kellhom 75 sena jew aktar (età medjana kienet ta' 74 sena).
English: Patients who experience neutropenia should be closely monitored with regular laboratory tests until resolution.
Maltese: Pazjenti li jkollhom newtropenija għandhom jiġu mmonitorjati mill-qrib b'testijiet regolari tal-laboratorju sakemm ifiequ.
English: R-Chemo: Rituximab plus chemotherapy, G-Chemo: Gazyvaro plus chemotherapy, HR: hazard ratio, CI: confidence interval
Maltese: Gazyvaro flimkien ma' kimoterapija, HR: proporzjon ta' periklu, CI: intervall ta' kunfidenza
English: These patients experienced more serious adverse events and adverse events leading to death than patients with a CrCl ≥ 50 mL/min (see section 4.2, 4.4 and 5.2).
Maltese: Dawn il-pazjenti kellhom aktar avvenimenti avversi serji u avvenimenti avversi li jwasslu għall-mewt minn pazjenti b'CrCl ta' ≤ 50 mL/min (ara sezzjoni 4.2, 4.4 u 5.2).
English: For storage conditions of the infusion bags see section 6.3.
Maltese: Għallkondizzjonijiet ta' ħażna tal-boroż tal-infużjoni ara sezzjoni 6.3.
English: The observed improvement in OS seen with G+B was supported by a stratified HR for OS of 0.62 (95% CI: 0.39, 0.98) in this post hoc analysis.
Maltese: F'din l-analiżi post hoc it-titjib osservat f'OS muri b'G+B kien appoġġjat minn HR stratifikat għal OS ta' 0.62 (CI ta' 95%: 0.39, 0.98).
English: Respiratory symptoms such as bronchospasm, larynx and throat irritation, wheezing, laryngeal oedema and cardiac symptoms such as atrial fibrillation have also been reported (see section 4.4).
Maltese: Sintomi respiratorji bħal bronkospażmu, irritazzjoni fil-larinġi u filgriżmejn, tħarħir, edima fil-larinġi u sintomi kardijaċi bħal fibrillazzjoni tal-atriju kienu irrappurtati wkoll (ara sezzjoni 4.4).
English: Primary endpoint Investigator-assessed PFS (PFS-INV)a Number (%) of patients with event Median time to event (months) Hazard ratio (95% CI) p-value (Log-Rank test, stratifiedb) Key secondary endpoints IRC-assessed PFS (PFS-IRC)a Number (%) of patients with event Median time to event (months) Hazard ratio (95% CI) p-value (Log-Rank test, stratifiedb) End of treatment response rate No. of patients included in the analysis Responders (%) Non-responders (%) Difference in response rate, (95% CI) p-value (Chi-squared Test) No. of complete responders c
Maltese: Differenza fir-rati ta' MRD, (CI ta' 95%) Sopravivenza mingħajr avveniment Numru (%) ta' pazjenti b'avveniment Żmien medjan sal-avveniment (xhur) Proporzjon ta' periklu (CI ta' 95%) Valur p (test Log-Rank, stratifikat b) Żmien sa terapija ġdida kontra l-lewkimja
English: respectively at Cycle 6 and AUC and Cmax in iNHL of 13172 µg•d/mL and 635.7 µg/mL in females and 9769 µg•d/mL and 481.3 µg/mL in males, respectively), indicating that there is no need to dose adjust based on gender.
Maltese: 9769 µg•d/mL u 481.3 µg/mL fl-irġiel, rispettivament), li jindika li m'hemmx bżonn ta' aġġustament fid-doża bbażat fuq is-sess.
English: For patients with CLL the recommended dose of Gazyvaro in combination with chlorambucil is shown in Table 2.
Maltese: Għall-pazjenti b'CLL id-doża rakkomandata ta' Gazyvaro f'kombinazzjoni ma' chlorambucil tidher f'Tabella 2.
English: Only the highest frequency observed in the trials is reported (based on studies BO21004/previously untreated CLL, BO21223/previously untreated advanced iNHL and GAO4753g/rituximab refractory iNHL)
Maltese: L-ogħla frekwenza osservata fil-provi biss hija rrappurtata (ibbażata fuq studji BO21004/CLL mhux ittrattata minn qabel, BO21223/Inhl avvanzata mhux ittrattata qabel u GAO4753g/iNHL li ma rrispondietx għal rituximab)
English: Patients who are considered to be at risk of TLS (e.g. patients with a high tumour burden and/or a high circulating lymphocyte count [> 25 x 109/L] and/or renal impairment [CrCl < 70 mL/min]) should receive prophylaxis.
Maltese: Pazjenti kkunsidrati li għandhom riskju ta' TLS (eż. pazjenti b'piż ta' tumur kbir u/jew għadd għoli ta' limfoċiti fiċ-ċirkolazzjoni [> 25 x 109/l] u/jew indeboliment renali [CrCl < 70 mL/min]) għandhom jirċievu profilassi.
English: Chronic lymphocytic leukaemia (in combination with chlorambucil1)
Maltese: Lewkimja limfoċitika kronika (f'kombinazzjoni ma' chlorambucil1)
English: Prophylaxis and premedication for tumour lysis syndrome (TLS)
Maltese: Profilassi u medikazzjoni minn qabel għas-sindrome ta' lisi tat-tumur (TLS - tumor lysis syndrome)
English: Day 2 for CLL only
Maltese: Jum 2 għal CLL biss
English: This subgroup comprised 21% (253/1202) of the FL ITT population and experienced 16.3% (40/245) of the PFS events.
Maltese: Dan is-sottogrupp kien jinkludi 21% (253/1202) tal-popolazzjoni FL ITT (n=1202) u esperjenzaw 16.
English: The demographic data and baseline characteristics were well balanced between the treatment arms (median age 63 years, the majority were Caucasian [88%] and male [58%]).
Maltese: Id-dejta demografika u l-karatteristiċi fil-linja bażi kienu bbilanċjati tajjeb bejn il-gruppi ta' trattament (età medjana ta' 63 sena, il-maġġoranza kienu Kawkasi [88%] u rġiel [58%]).
English: To prepare the 2 infusion bags, withdraw 40 mL of concentrate from the vial and dilute 4 mL into a 100 mL PVC or non-PVC polyolefin infusion bag and the remaining 36 mL in a 250 mL PVC or non-PVC polyolefin infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Biex jiġu ppreparati ż-żewġ boroż għall-infużjoni, iġbed 40 mL ta' konċentrat mill-kunjett u ddilwixxi 4 mL f'borża tal-infużjoni tal-PVC jew tal-polyolefin mhux PVC ta' 100 mL u s-36 mL li jkun fadal f'borża tal-infużjoni tal-PVC jew tal-polyolefin mhux PVC ta '250 mL li jkun fihom soluzzjoni għallinjezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: Gazyvaro is available in a pack containing 1 glass vial.
Maltese: Gazyvaro huwa disponibbli f'pakkett li fih kunjett tal-ħġieġ wieħed.
English: Patients (CLL) with both CIRS > 6 and CrCl < 70 mL/min are more at risk of infections, including severe infections (see section 4.8).
Maltese: Pazjenti (CLL) li għandhom kemm CIRS > 6 kif ukoll CrCl < 70 mL/min għandhom riskju akbar ta' infezzjonijiet, inkluż infezzjonijiet severi (ara sezzjoni 4.8).
English: Dysuria, urinary incontinence
Maltese: Disurja, inkontinenza tal-awrina
English: Tumour lysis syndrome, hypokalaemia
Maltese: Sindrome tal-lisi tat-tumur, ipokalimja
English: Cases of hepatitis B reactivation have been reported in patients treated with Gazyvaro (see section 4.4).
Maltese: Każijiet ta' attivazzjoni mill-ġdid tal-epatite B kienu irrappurtati f'pazjenti kkurati b'Gazyvaro (ara sezzjoni 4.4).
English: One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL.
Maltese: Kunjett wieħed ta' 40 mL konċentrat fih 1,000 mg obinutuzumab, li jikkorrispondu għal konċentrazzjoni ta' 25 mg/mL qabel id-dilwizzjoni.
English: Progressive multifocal leukoencephalopathy PML has been reported in patients treated with Gazyvaro (see section 4.4).
Maltese: Lewkoenċefalopatija multifokali progressiva PML kienet irrappurtata f'pazjent ikkurati b'Gazyvaro (ara sezzjoni 4.4).
English: Compared to Type I antibodies, obinutuzumab, a Type II antibody, is characterised by an enhanced direct cell death induction with a concomitant reduction in CDC at an equivalent dose.
Maltese: Imqabbel mal-antikorpi tat-Tip I, obinutuzumab, antikorp tat-Tip II, huwa kkaratterizzat minn induzzjoni msaħħa ta' mewta diretta taċ-ċelluli bi tnaqqis fl-istess waqt f'CDC b'doża ekwivalenti.
English: · Six 28-day cycles in combination with bendamustine2 or,
Maltese: • Sitt ċikli ta' 28 jum flimkien ma' bendamustine jew,
English: IRC-assessed PFS (PFS-IRC) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, stratified*) Time to next anti-lymphoma therapy# Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, stratified*) Overall Survival
Maltese: PFS evalwata minn IRC (PFS-IRC) Numru (%) ta' pazjenti b'avveniment HR [CI ta' 95%] Valur p (test Log-Rank, stratifikat*) Żmien sat-terapija li jmiss kontra llimfoma#
English: All Grades Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL)
Maltese: iNHL)segwit minn Gazyvaro bħala manteniment (iNHL)
English: Arthralgia, back pain, musculoskeletal chest pain, bone pain
Maltese: Artralġja, uġigħ fid-dahar, uġigħ muskoluskeletali fis-sider, uġigħ flgħadam
English: Patients with a high tumour burden and/or a high circulating lymphocyte count (> 25 x 109/L) and/or renal impairment (CrCl < 70 mL/min) are considered at risk of TLS and should receive prophylaxis.
Maltese: Pazjenti b'piż ta' tumur kbir u/jew għadd għoli ta' limfoċiti fiċ-ċirkolazzjoni (> 25 x 109/L) u/jew indeboliment renali (CrCl < 70 mL/min) huma kkunsidrati f'riskju ta' TLS u għandhom jirċievu profilassi.
English: Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen (study GAO4753g/GADOLIN).
Maltese: Pazjenti b'limfoma follikulari li ma rrispondewx jew li kellhom progressjoni matul jew sa 6 xhur wara trattament b'rituximab jew b'kors li fih rituximab (studju GAO4753g/GADOLIN).
English: Patients with renal impairment (CrCl < 50 mL/min) are more at risk of neutropenia (see section 4.8).
Maltese: Pazjenti b'indeboliment renali (CrCl < 50 mL/min) għandhom riskju akbar ta' newtropenija (ara sezzjoni 4.8).
English: Oral analgesic/anti-pyretic2 Anti-histaminic medicine3
Maltese: Analġeżiku/antipiretiku orali Mediċina antistaminika
English: For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.
Maltese: Għallkura ta' TLS, ikkoreġi l-anormalitajiet tal-elettroliti, immonitorja l-funzjoni tal-kliewi u l-bilanċ talfluwidi, u agħti kura ta' appoġġ, inkluż dijalisi kif indikat.
English: · Before each infusion of Gazyvaro, you will be given medicines which help to reduce possible infusion related reactions or “tumour lysis syndrome”.
Maltese: • Qabel kull infużjoni ta' Gazyvaro, se tingħata mediċini li jgħinu biex inaqqsu reazzjonijiet relatati mal-infużjoni possibbli jew “sindrome tal-lisi tat-tumur”.
English: Upper respiratory tract infection, sinusitis§, , urinary tract infection, pneumonia§ ,herpes zoster§
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq, sinożite§, infezzjoni flapparat tal-awrina, pulmonite herpes zoster§
English: In order to reduce the rate of infusion related reactions in patients, an amendment was implemented and 140 patients received the first Gazyvaro dose administered over 2 days (Day 1 [100 mg] and Day 2 [900 mg]) (see section 4.2 and 4.4).
Maltese: Sabiex titnaqqas ir-rata ta' reazzjonijiet relatati malinfużjoni fil-pazjenti, ġiet implimentata emenda u 140 pazjent irċevew l-ewwel doża ta' Gazyvaro mogħtija fuq jumejn (Jum 1 [100 mg] u Jum 2 [900 mg]) (ara sezzjoni 4.2 u 4.4).
English: Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRs in patients with CLL and FL (see section 4.4)
Maltese: Tabella 1 Medikazzjoni minn qabel li għandha tingħata qabel infużjoni ta' Gazyvaro biex jitnaqqas ir-riskju ta' IRRs f'pazjenti b'CLL u FL (ara sezzjoni 4.4)
English: Hyperuricaemia
Maltese: Il-Ġermanja
English: Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, assay robustness to quantities of Gazyvaro/antibody in the circulation, sample handling, timing of sample collection, concomitant medicines and underlying disease.
Maltese: Riżultati tta' analiżi tal-immunoġeniċità huma dipendenti ħafna fuq diversi fatturi fosthom sensittività u speċifiċità tal-analiżi, metodu tal-analiżi, robustezza tal-analiżi għall-kwantitajiet ta' Gazyvaro/antikorp fiċ-ċirkolazzjoni, immaniġġjar tal-kampjuni, il-ħin tal-ġbir tal-kampjuni, mediċini fl-istess waqt u mard eżistenti.
English: · Use an effective method of contraception while being treated with Gazyvaro.
Maltese: • Uża metodu effettiv ta' kontraċezzjoni waqt li tkun qed tiġi ttrattat b'Gazyvaro.
English: Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)
Maltese: Gazyvaro flimkien ma' kimoterapija, segwit minn Gazyvaro bħala terapija ta' manteniment f'pazjenti li jilħqu rispons, huwa indikat għat-trattament ta' pazjenti b'FL avanzata mhux ittrattata minn qabel (ara sezzjoni 5.1).
English: Based on a subgroup analysis in previously untreated follicular lymphoma, the efficacy in FLIPI low risk (0-1) patients is currently inconclusive (see section 5.1).
Maltese: Abbażi ta' analiżi f'sottogrupp b'limfoma follikulari mhux ittrattata minn qabel, l-effikaċja f'pazjenti b'riskju baxx ta' FLIPI (0-1) hija attwalment inkonklużiva (ara sezzjoni 5.1).