FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 Chlorambucil is given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles
Maltese: 1 Chlorambucil jingħata mill-ħalq b'doża ta' 0.5 mg/kg ta' piż tal-ġisem f'Jum 1 u Jum 15 ta' kull ċiklu ta' trattament
English: Following intravenous administration, the volume of distribution of the central compartment (2.98 L in patients with CLL and 2.97 in patients with iNHL), approximates serum volume, which indicates distribution is largely restricted to plasma and interstitial fluid.
Maltese: Wara għoti fil-vini, il-volum ta' distribuzzjoni tal-kompartiment ċentrali (2.98 L f'pazjenti b'CLL u 2.97 f'pazjenti b'iNHL), iqarreb il-volum tas-serum, li jindika li d-distribuzzjoni fil-biċċa l-kbira hija ristretta għall-plażma u għall-fluwidu tal-interstizju.
English: Figure 1 Kaplan-Meier curve of Investigator assessed PFS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Maltese: Kaplan-Meier tal-PFS evalwata mill-Investigatur mill-Istadju 1a f'pazjenti b'CLL (Studju BO21004/CLL11)
English: Progressive multifocal leukoencephalopathy (also called “PML”)
Maltese: Lewkoenċefalopatija multifokali progressiva (imsejħa wkoll “PML” [Progressive multifocal leukoencephalopathy])
English: No. (%) of patients with event Median time to event (months) Hazard ratio (95% CI) p-value (Log-Rank test, stratified b)
Maltese: Numru (%) ta' pazjenti b'avveniment Żmien medjan sal-avveniment (xhur) Proporzjon ta' periklu (CI ta' 95%) Valur p (test Log-Rank, stratifikat b)
English: NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion.
Maltese: IL-PRODOTT MEDIĊINALI Gazyvaro 1,000 mg konċentrat għal soluzzjoni għall-infużjoni.
English: Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative treatment such as urate oxidase (e.g. rasburicase), starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice (see section 4.4).
Maltese: Profilassi għandha tikkonsisti minn idratazzjoni adegwata u għoti ta' urikostatiċi (eż. allopurinol), jew alternattiva addattata bħal urate oxidase (eż. rasburicase), li tibda 12-24 siegħa qabel l-infużjoni ta' Gazyvaro skont prattika standard (ara sezzjoni 4.2).
English: Rate of infusion
Maltese: Rata tal-infużjoni
English: A risk for interactions with other concomitantly used medicinal products cannot be excluded.
Maltese: Ma jistax jiġi eskluż riskju ta' interazzjonijiet ma' prodotti mediċinali oħra użati fl-istess waqt.
English: In addition, exploratory subgroup analyses of PFS across chemotherapy regimens (bendamustine, CHOP and CVP) were consistent with the results seen in the Gazyvaro plus chemotherapy population.
Maltese: Barra dan, analiżi esploratorja ta' sottogrupp tal-PFS tal-korsijiet kollha ta' kimoterapija (bendamustine, CHOP u CVP) kienet konsistenti mar-riżultati osservati filpopolazzjoni ta' Gazyvaro flimkien ma' kimoterapija.
English: In patients treated with G+ B, 79.4% received all six treatment cycles compared to 66.7% of patients in the B arm.
Maltese: F'pazjenti ttrattati b'G+ B, 79.4% rċevew issitt ċikli ta' trattament kollha meta mqabbla ma' 66.7% tal-pazjenti fil-grupp ta' B.
English: IRRs may be clinically indistinguishable from immunoglobulin E (IgE) mediated allergic reactions (e.g. anaphylaxis).
Maltese: L-IRRs klinikament jistgħu ma jingħarfux minn reazzjonijiet allerġiċi medjati mill-immunoglobulina E (IgE) (eż. anafilassi).
English: Figure 3 Kaplan-Meier curve of investigator assessed PFS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Maltese: Kaplan-Meier tal-PFS evalwata mill-investigatur mill-Istadju 2 f'pazjenti b'CLL (Studju BO21004/CLL11)
English: In study GAO4753g/GADOLIN, patients in the bendamustine arm received 6 months of induction treatment only, whereas after the induction period, patients in the Gazyvaro plus bendamustine arm continued with Gazyvaro maintenance treatment.
Maltese: Fl-istudju GAO4753g/ GADOLIN , pazjenti fil-grupp ta' bendamustine irċevew 6 xhur ta' trattament ta' induzzjoni biss, filwaqt li wara l-perjodu ta' induzzjoni, pazjenti fil-grupp ta' Gazyvaro flimkien ma' bendamustine komplew bi trattament ta' Gazyvaro bħala manteniment.
English: In patients treated with Gazyvaro 8 out of 140 patients in the randomised phase and 2 out of 6 in the run in phase tested positive for ATA at 12 months of follow up.
Maltese: F'pazjenti ttrattati b'Gazyvaro 8 minn 140 pazjent fil-fażi randomised u 2 minn 6 pazjenti fil-fażi ta' preparazzjoni kienu pożittivi għal ATA wara 12-il xahar ta' segwitu.
English: Figure 2 Kaplan-Meier curve of OS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Maltese: Kaplan-Meier tal-OS mill-Istadju 1a f'pazjenti b'CLL (Studju BO21004/CLL11)
English: Thrombocytopenia and haemorrhagic events
Maltese: Tromboċitopenija u avvenimenti emorraġiċi
English: Table 2 Dose of Gazyvaro to be administered during 6 treatment cycles each of 28 days duration for patients with CLL
Maltese: Tabella 2 Doża ta' Gazyvaro li għandha tingħata waqt 6 ċikli ta' kura li kull wieħed idum 28
English: The safety and efficacy of Gazyvaro in patients with impaired hepatic function has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Gazyvaro ma ġewx determinati f'pazjenti b'indeboliment fil-funzjoni talfwied.
English: The profile of adverse reactions in patients with FL was consistent with the overall iNHL population in both studies.
Maltese: Il-profil ta' reazzjonijiet avversi f'pazjenti b'FL kien konsistenti mal-popolazzjoni globali ta' iNHLfiż-żewġ studji .
English: In patients who received the recommended measures for prevention of IRRs as described in section 4.2, a decreased incidence of IRRs of all Grades was observed.
Maltese: F'pazjenti li rċevew il-miżuri rakkomandati għall-prevenzjoni ta' IRRs kif deskritt fis-sezzjoni 4.2, kien osservat tnaqqis fl-inċidenza ta' IRRs ta' kull Grad.
English: Based on the FACT-Lym questionnaire collected during treatment and follow-up phases, patients in both treatment arms experienced clinically meaningful improvements in lymphoma-related symptoms as defined by a ³ 3 point increase from baseline in the Lymphoma subscale, a ³ 6 point increase from baseline in the FACT Lym TOI and a ³ 7 point increase from baseline in the FACT Lym Total score.
Maltese: Abbażi tal-kwestjonarju FACT-Lym miġbur matul it-trattament u l-fażijiet ta' segwitu, il-pazjenti fiżżewġ gruppi ta' trattament kellhom esperjenza ta' titjib klinikament sinifikanti fis-sintomi relatati mallimfoma kif definit minn żieda ta' ≥ 3 punti mill-linja bażi fis-sottoskala tal-Limfoma, żieda ta' ≥ 6 punti mil-linja bażi fil-FACT Lym TOI u żieda ta' ≥ 7 punti mil-linja bażi fil-punteġġ FACT Lym Totali.
English: How Gazyvaro works
Maltese: Gazyvaro +
English: Investigator-assessed PFS§ (PFS-INV) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, stratified*) 3 year PFS estimate [95% CI]
Maltese: Valur p (test Log-Rank, stratifikat*) Stima ta' PFS ta' 3 snin [CI ta' 95%]
English: Neutropenia
Maltese: Ċiklu
English: Patients were randomised to 1:1 to receive either Gazyvaro (n=601 patients) or rituximab (n=601 patients) in combination with chemotherapy (bendamustine, CHOP or CVP), followed by Gazyvaro or rituximab maintenance in patients achieving a complete or partial response.
Maltese: Il-pazjenti kienu randomised 1:1 biex jirċievu Gazyvaro (n=601 pazjent) jew rituximab (n=601 pazjent) flimkien ma' kimoterapija (bendamustine, CHOP jew CVP), segwit minn manteniment b'Gazyvaro jew rituximab f'pazjenti li kisbu rispons komplut jew parzjali.
English: Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro.
Maltese: Bendamustine ngħata fil-vini f'Jiem 1 u 2 għaċ-ċikli ta' trattament kollha (Ċikli 1-6) b'doża ta' 90 mg/m2/jum meta ngħata flimkien ma' Gazyvaro.
English: Chlorambucil was given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles (1 to 6).
Maltese: Chlorambucil ingħata b'mod orali b'doża ta' 0.5 mg/kg ta' piż tal-ġisem f'Jum 1 u Jum 15 taċ-ċikli kollha ta' kura (1 sa 6).
English: All subsequent infusions for CLL and FL
Maltese: infużjonijiet sussegwenti kollha għal CLL u FL
English: From the population PK model, after the Cycle 6 Day 1 infusion in CLL patients, the estimated median Cmax value was 465.7 μg/mL and AUC(τ) value was 8961 μg•d/mL and in iNHL patients the estimated median Cmax value was
Maltese: Mill-mudell PK tal-popolazzjoni, wara l-infużjoni ta' Ċiklu 6 Jum 1 f'pazjenti b'CLL, il-valur medjan ta' Cmax smat kien ta' 465.7 μg/mL u l-valur ta' AUC(τ) kien ta' 8961 μg•d/mL u f'pazjenti b'iNHL il-valur medjan stmat ta' Cmax kien ta' 539.3 μg/mL u l-valur tal-AUC(τ) kien ta' 10956 μg•jum/mL.
English: The median time from initial diagnosis was 3 years and the median number of prior therapies was 2 (range 1 to 10); 44% of patients had received 1 prior therapy and 34% of patients had received 2 prior therapies.
Maltese: Iż-żmien medjan mid-dijanjosi inizjali kien 3 snin u nnumru medjan ta' terapiji minn qabel kien ta' 2 (firxa ta' 1 sa 10); 44% tal-pazjenti kienu rċevew terapija waħda minn qabel u 34% tal-pazjenti kienu rċevew 2 terapiji minn qabel.
English: Other medicines and Gazyvaro
Maltese: Mediċini oħra u Gazyvaro
English: Posology
Maltese: Kύπρος
English: EXPIRY DATE
Maltese: Fl-istudju
English: The B-cell counts returned to normal levels, and immunologic function was restored within 6 months post-partum.
Maltese: L-għadd ta' ċelluli B reġgħa lura għal-livelli normali, u l-funzjoni immunoloġika ġiet restawrata fi żmien 6 xhur wara t-twelid.
English: ● a hole in the stomach or intestines (gastrointestinal perforation, especially in cases where the cancer affects the gastrointestinal tubes)
Maltese: ● toqba fl-istonku jew fl-imsaren (perforazzjoni gastrointestinali, speċjalment f'każijiet fejn ilkanċer jaffettwa t-tubi gastrointestinali)
English: IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, MRD: Minimal Residual Disease, NR = Not reached a Defined as the time from randomisation to the first occurrence of progression, relapse or death from any cause as assessed by the investigator b stratified by Binet stage at baseline c Includes 11 patients in the GClb arm with a complete response with incomplete marrow recovery d Blood and bone marrow combined e MRD negativity is defined as a result below 0.0001 f Includes MRD positive patients and patients who progressed or died before the end of treatment g Median observation time for overall survival (OS) data corresponds to 62.5 months median observation time in Stage 1a and to 59.4 months median observation time in Stage 2.
Maltese: Jinkludi pazjenti pożittivi għal MRD u pazjenti li kellhom progressjoni jew mietu qabel it-tmiem tal-kura g Id-data taż-żmien medjan ta' osservazzjoni għas-sopravivenza globali (OS - overall survival) tikkorrispondi għal 62.5 xhur ta' żmien medjan ta' osservazzjoni fi Stadju 1a u għal 59.4 xhur ta' żmien medjan ta' osservazzjoni fi Stadju 2.
English: Cough, oropharyngeal pain
Maltese: Popolazzjoni pedjatrika
English: Dose of Gazyvaro
Maltese: Doża ta' Gazyvaro
English: Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative such as a urate oxidase (e.g. rasburicase) starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice.
Maltese: Profilassi għandha tikkonsisti minn idratazzjoni adegwata u għoti ta' urikostatiċi (eż. allopurinol), jew alternattiva addattata bħal urate oxidase (eż. rasburicase), li tibda 12-24 siegħa qabel il-bidu ta' infużjoni ta' Gazyvaro skont prattika standard.
English: Skin and subcutaneous tissue disorders Very common
Maltese: Riżultati tal-analiżi tas-sottogrupp
English: Management of IRRs (all indications)
Maltese: Immaniġġjar ta' IRRs (l-indikazzjonijiet kollha)
English: · Continue to use effective contraception for 18 months after stopping treatment with Gazyvaro.
Maltese: • Kompli uża kontraċezzjoni effettiva għal 18-il xahar wara li twaqqaf it-trattament b'Gazyvaro.
English: The overall incidence of haemorrhagic events was similar in the Gazyvaro treated arm and in the rituximab treated arm.
Maltese: L-inċidenza globali ta' avvenimenti emorraġiċi kienet simili fil-grupp ikkurat b'Gazyvaro u fil-grupp ikkurat b'rituximab.
English: Renal and Urinary Disorders Common
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Komuni
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Maltese: Roche Pharma AG Emil-Barell-Strasse 1
English: In the population pharmacokinetic analysis, gender was found to be a covariate which explains some of the inter-patient variability, with a 22% greater steady state clearance (CLss) and a 19% greater volume of distribution (V) in males.
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni, is-sess instab li huwa kovarjant li jispjega ftit millvarjabilità ta' bejn il-pazjenti, bi tneħħija fi stat fiss (CLss - steady state clearance) ogħla bi 22% u volum ta' distribuzzjoni (V) ogħla b'19% fl-irġiel.
English: The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered over Day 1 and Day 2 (or Day 1 continued), and on Day 8 and Day 15 of the first 28 day treatment cycle.
Maltese: Id-doża rakkomandata ta' Gazyvaro f'kombinazzjoni ma' chlorambucil hija 1,000 mg mogħtija matul Jum 1 u Jum 2, (jew Jum 1 ikompli), u f'Jum 8 u Jum 15 tal-ewwel ċiklu ta' kura ta' 28 jum.
English: Contents of the pack and other information What Gazyvaro contains · The active substance is obinutuzumab: 1,000 mg/40 mL per vial corresponding to a concentration before dilution of 25 mg/mL.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed ta' 40 mL ta' konċentrat fih 1,000 mg obinutuzumab, li jikkorrispondi għal konċentrazzjoni qabel il-dilwizzjoni ta' 25 mg/mL.
English: No Grade 5 events of thrombocytopenia were reported.
Maltese: Ma kienux irrappurtati avvenimenti ta' tromboċitopenija ta' Grad 5.
English: The population pharmacokinetic analysis of obinutuzumab showed that creatinine clearance does not affect pharmacokinetics of obinutuzumab.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni ta' obinutuzumab uriet li t-tneħħija tal-krejatinina ma taffettwax il-farmakokinetika ta' obinutuzumab.
English: The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered on Day 1 of each cycle.
Maltese: Id-doża rakkomandata ta' Gazyvaro f'kombinazzjoni ma' chlorambucil hija 1,000 mg mogħtija f'Jum 1 ta' kull ċiklu.
English: PML is a very rare and life-threatening brain infection that has been reported with Gazyvaro.
Maltese: PML hija infezzjoni fil-moħħ rari ħafna u ta' periklu għall-ħajja li ġiet irrappurtata b'Gazyvaro.
English: In repeat-dose toxicity studies in cynomolgus monkeys obinutuzumab had no adverse effects on male and female reproductive organs.
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti f'xadini cynomolgus, obinutuzumab ma kellu l-ebda effett avvers fuq l-organi riproduttivi maskili u femminili.
English: Chronic lymphocytic leukaemia (CLL, in combination with chlorambucil1)
Maltese: Lewkimja limfoċitika kronika (CLL - chronic lymphocytic leukaemia, f'kombinazzjoni ma' chlorambucil
English: The median estimated CrCl was 62 mL/min and 66% of all patients had a CrCl < 70 mL/min.
Maltese: Il-punteġġ ta' komorbidità medjan kien ta' 8 u 76% tal-pazjenti rreġistrati kellhom punteġġ ta' komorbidità ta' aktar minn 6. CrCl medjana stmata kienet ta' 62 mL/min u 66% tal-pazjenti kollha kellhom CrCl < 70 mL/min.
English: Premedication to reduce the risk of IRRs is outlined in Table 1.
Maltese: Medikazzjoni minn qabel biex jitnaqqas ir-riskju ta' IRRs hija deskritta fit-Tabella 1.
English: No studies have been conducted to investigate the pharmacokinetics of obinutuzumab in paediatric patients.
Maltese: Ma sarux studji biex jinvestigaw il-farmakokinetika ta' obinutuzumab f'pazjenti pedjatriċi.
English: IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, NR = Not Reached # Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen *Stratification factors for analysis were refractory type (rituximab monotherapy vs. rituximab + chemotherapy) and prior therapies (≤ 2 vs > 2).
Maltese: Il-pazjenti kienu stratifikati skont ir-reġjun, sottotip ta' iNHL (follikulari kontra mhux follikulari), tip li ma rrispondietx għal rituximab (kemm jekk ma rrispondietx għal monoterapija preċedenti ta' rituximab jew għal rituximab flimkien ma' kimoterapija) u n-numru ta' terapiji preċedenti (≤ 2 kontra > 2).
English: Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro or 120 mg/m2/day when given alone.
Maltese: Bendamustine ingħata fil-vini f'Jiem 1 u 2 taċ-ċikli kollha ta' trattament (Ċikli 1-6) b'doża ta' 90 mg/m2/jum meta ngħata flimkien ma' Gazyvaro jew 120 mg/m2/jum meta ngħata waħdu.
English: You must not be given Gazyvaro if:
Maltese: M'għandekx tingħata Gazyvaro jekk:
English: Figure 7 Kaplan-Meier curve of OS in patients with FL # (Study GAO4753g/GADOLIN)
Maltese: (Studju GAO4753g/GADOLIN)
English: Lymph node pain
Maltese: FULJETT TA' TAGĦRIF
English: Keep the vial in the outer carton in order to protect from light.
Maltese: Likwidu ċar, bla kulur sa kemxejn fil-kannella.
English: GAO4753g/GADOLIN) that occurred at a higher incidence (difference of ≥ 2%) compared to the relevant comparator arm in at least one pivotal study in: · Patients with CLL receiving Gazyvaro plus chlorambucil compared with chlorambucil alone or rituximab plus chlorambucil (study BO21004/CLL11) · Patients with previously untreated iNHL receiving Gazyvaro plus chemotherapy (bendamustine, CHOP, CVP) followed by Gazyvaro maintenance in patients achieving a response, compared to rituximab plus chemotherapy followed by rituximab maintenance in patients achieving a response (study BO21223/GALLIUM) · Patients with iNHL who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen receiving Gazyvaro plus bendamustine, followed by Gazyvaro maintenance in some patients, compared to bendamustine alone (study GAO4753g/GADOLIN) The incidences presented in Table 6 (all grades and Grades 3-5) are the highest incidence of that ADR reported from any of the three studies.
Maltese: • Pazjenti b'iNHL li ma kellhom l-ebda rispons għal jew li kellhom progressjoni matul jew sa 6 xhur wara trattament b'rituximab jew b'kors li fih rituximab li kienu qed jirċievu Gazyvaro flimkien ma' bendamustine, segwit f'xi pazjenti minn Gazyvaro bħala manteniment, imqabbel ma 'bendmustine waħdu (studju GAO4753g/ GADOLIN)
English: Roche AB
Maltese: ANNESS II
English: Obinutuzumab elimination comprises two parallel pathways which describe clearance, a linear clearance pathway and a non-linear clearance pathway which changes as a function of time.
Maltese: L-eliminazzjoni ta' obinutuzumab tinkludi żewġ rotot paralleli li jiddeskrivu t-tneħħija, rotta ta' tneħħija lineari u rotta ta' tneħħija mhux lineari li tinbidel bħala funzjoni tal-ħin.
English: In animal models obinutuzumab mediates potent B-cell depletion and antitumour efficacy.
Maltese: Ma ġietx stabbilita relazzjoni ċara bejn tromboċitopenija u avvenimenti emorraġiċi.
English: Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).
Maltese: Gazyvaro flimkien ma' chlorambucil hu indikat għall-kura ta' pazjenti adulti b'CLL mhux ikkurata qabel u b'komorbiditajiet li jagħmluhom mhux adattati għal doża sħiħa ta' terapija bbażata fuq fludarabine (ara sezzjoni 5.1).
English: The incidence of thrombocytopenia was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm (16% vs. 7%) especially during the first cycle.
Maltese: L-inċidenza ta' tromboċitopenija kienet ogħla fil-grupp ta' Gazyvaro flimkien ma 'chlorambucil meta mqabbel mal-grupp ta' rituximab flimkien ma' chlorambucil (16% vs. 7%) speċjalment matul l-ewwel ċiklu.
English: Figure 4 Kaplan-Meier curve of OS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Maltese: Kaplan-Meier tal-OS minn Stadju 2 f'pazjenti b'CLL (Studju BO21004/CLL11)
English: increase in potassium, phosphate or uric acid - which can cause kidney problems (part of tumour lysis syndrome)
Maltese: żieda fil-potassium, phosphate jew uric acid - li jistgħu jikkawżaw problemi fil-kliewi
English: White blood cell count decreased, neutrophil count decreased
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD ILPROVVISTA
English: The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered over Day 1 and Day 2, (or Day 1 continued), and on Day 8 and Day 15 of the first 28 day treatment cycle.
Maltese: Id-doża rakkomandata ta' Gazyvaro f'kombinazzjoni ma' chlorambucil hija ta' 1,000 mg mogħtija fuq Jum 1 u Jum 2, (jew Jum 1 ikompli), u f'Jum 8 u Jum 15 tal-ewwel ċiklu ta' kura ta' 28 jum.
English: Gazyvaro is used together with another medicine for cancer called chlorambucil.
Maltese: Gazyvaro jintuża flimkien ma 'mediċina oħra għall-kanċer imsejħa chlorambucil.
English: · If you get any side effects, talk to your doctor or nurse.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-infermier tiegħek.
English: The incidences presented in the following sections if referring to iNHL are the highest incidence of that ADR reported from either pivotal study (BO21223/GALLIUM, GAO4753g/GADOLIN).
Maltese: L-inċidenzi ppreżentati fis-sezzjonijiet li ġejjin jekk jirreferu għal iNHL huma l-ogħla inċidenza ta' dik l-ADR irrappurtata minn kwalunkwe studju pivitali (BO21223/GALLIUM, GAO4753g/GADOLIN).
English: Median was not reached at time of analysis # not adjusted for multiplicity **Assessed as per modified Cheson 2007 criteria ‡ End of Induction = end of induction phase, does not include monotherapy maintenance
Maltese: **Evalwat skont kriterji modifikati Cheson 2007 ‡
English: · red eye · cold sores · depression, anxiety · night sweats · flu (influenza) · weight increase · lymph node pain · runny or blocked nose · eczema · nose or throat inflammation · pain in mouth or throat
Maltese: • tħarħir, diffikultà biex tieħu nifs, tagħfis fis-sider jew irritazzjoni fil-griżmejn
English: Animal studies have shown secretion of obinutuzumab in breast milk (see section 5.3).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti anzjani (ara sezzjoni 5.2).
English: The rate of infusion can be escalated in increments up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr.
Maltese: Ir-rata tal-infużjoni tista' tiżdied f'inkrementi sa 50 mg/siegħa kull 30 minuta sa rata massima ta' 400 mg/siegħa.
English: 2 Bendamustine is given intravenously on Days 1 and 2 of all treatment cycles (Cycles 1-6) at 90 mg/m2/day; CHOP and CVP according to standard regimens
Maltese: 2 Bendamustine jingħata fil-vini f'Jiem 1 u 2 ta' kull ċiklu ta' trattament (Ċikli 1-6) b'doża ta' 90 mg/m2/jum;
English: Constipation, haemorrhoids
Maltese: Dijarea, kolite
English: 3 e.g. 50 mg diphenhydramine
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: Nasopharyngitis, rhinitis, influenza, oral herpes
Maltese: Konġestjoni fl-imnieħer, rinoreja, uġigħ orofarinġali