FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was ORR assessed by the investigator according to the 2008 IWCLL guidelines.
Maltese: Il-punt aħħari primarju kienet l-ORR ivvalutata mill-investigatur skont il-linji gwida tal-2008 talIWCLL.
English: • fever or, alternatively, a very low body temperature, chest pain, shortness of breath or rapid breathing, shaking, chills, confusion, dizziness, decreased urination and rapid pulse, (possible symptoms of blood infection)
Maltese: • deni jew, inkella, temperatura tal-ġisem baxxa ħafna, uġigħ f'sidrek, qtugħ ta' nifs jew tieħu n nifs f'daqqa, tregħid, dehxiet ta' bard, konfużjoni, mejt, nuqqas ta' awrina u polz mgħaġġel,
English: Previously untreated patients (ofatumumab + chlorambucil)
Maltese: Pazjenti li ma kinux ittrattati minn qabel (ofatumumab + chlorambucil)
English: For the highest dose group, the median time to progression was 15.6 weeks (95% CI: 15,22.6) in the full analysis population, and 23 weeks (CI: 20,31) in responders.
Maltese: Għall-grupp bl-ogħla dożi, iż-żmien medju għallprogressjoni kien ta' 15.6 ġimgħat (95% CI: 15, 22.6) fil-popolazzjoni kollha tal-analiżi, u 23 ġimgħa (CI: 20,31) f'dawk il-pazjenti li wieġbu għall-kura.
English: Number at risks at
Maltese: Ir-riskju gћat-trabi tattwelid mhux eskluż.
English: Arzerra 1000 mg concentrate for solution for infusion 1000 mg dose: Use 1 vial (50 ml total, 50 ml per vial) - Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 50 ml of ofatumumab from the vial and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion.
Maltese: Arzerra 1000 mg konċentrat għal soluzzjoni għall-infużjoni Doża ta' 1000 mg: Uża kunjett 1 (total ta' 50 ml, 50 ml f'kull kunjett) - Iġbed u armi 50 ml minn borża ta' 1000 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%)
English: Arzerra 100 mg concentrate for solution for infusion 300 mg dose: Use 3 vials (15 ml total, 5 ml per vial) - Withdraw and discard 15 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 5 ml of ofatumumab from each of 3 vials and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion.
Maltese: Arzerra 100 mg konċentrat għal soluzzjoni għall-infużjoni Doża ta' 300 mg: Uża 3 kunjetti (total ta' 15 ml, 5 ml f'kull kunjett) - Iġbed u armi 15-il ml minn borża ta' 1000 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%)
English: • Withdraw and discard 15 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Maltese: • Iġbed u armi 15-il ml minn borża ta' 1000 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%)
English: Gender had a modest effect (12%) on ofatumumab central volume of distribution in a cross-study population analysis, with higher Cmax and AUC values observed in female patients (48% of the patients in this analysis were male and 52% were female); these effects are not considered clinically relevant, and no dose adjustment is recommended.
Maltese: Is-sess ma kellux effett kbir (12%) fuq il-volum ċentrali ta' distribuzzjoni ta' ofatumumab f'analiżi talpopolazzjoni cross-study, b'valuri ogħla għal- Cmax u għall-AUC li ġew osservati f'pazjenti nisa (48% tal-pazjenti f'din l-analiżi kienu rġiel u 52% kienu nisa); dawn l-effetti mhumiex ikkunsidrati rilevanti b'mod kliniku, u l-ebda aġġustament fid-doża mhuwa rrakkomandat.
English: • low levels of red blood cells (anaemia).
Maltese: • livelli baxxi ta' ċelluli ħomor tad-demm (anemija).
English: • fluid in the lungs (pulmonary oedema) causing breathlessness
Maltese: • fluwidu fil-pulmuni (edema pulmonari) li jikkawża qtugħ ta' nifs
English: • Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Maltese: • Iġbed u armi 50 ml minn borża ta' 1000 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%)
English: If the coadministration is judged unavoidable, the risks and benefits of vaccinating patients during therapy with ofatumumab should be considered (see section 4.4).
Maltese: Jekk ikun hemm opinjoni li l-għoti tagħhom flimkien ma jistax jiġi evitat, għandhom jitqiesu r-riskji u lbenefiċċji li wieħed ilaqqam pazjenti waqt terapija b'ofatumumab (ara sezzjoni 4.4).
English: Arzerra was also given to a group of patients (n=112) with bulky lymphadenopathy (defined as at least one lymph node >5 cm) who were also refractory to fludarabine.
Maltese: Arzerra ingħata wkoll lill-grupp ta' pazjenti (n=112) b'limfadenopatija voluminuża (definita bħala talanqas għoqda waħda tal-limfa >5 ċm) li ma weġbux għal kura bi fludarabine.
English: Best response is a clinical response that did not improve with 3 additional cycles of treatment.
Maltese: L-aħjar rispons huwa rispons kliniku li ma tjiebx wara 3 ċikli addizzjonali ta' kura.
English: Chemical and physical in-use stability has been demonstrated for 48 hours at ambient conditions (less than 25°C).
Maltese: Stabilità kimika u fiżika waqt l-użu intweriet għal perijodu ta' 48 siegħa f'kundizzjonijiet ambjentali (anqas minn 25 °C).
English: During infusion, the rate should be increased every 30 minutes to a maximum of 200 ml/hour (see section 6.6).
Maltese: Waqt l-infużjoni, ir-rata għandha tiżdied kull 30 minuta sar-rata massima ta' 200 ml/siegħa (ara sezzjoni 6.6).
English: The PFS in the monotherapy Arzerra arm was comparable to the results seen with Arzerra monotherapy in study Hx-CD20-406.
Maltese: Il-PFS fil-grupp ta' monoterapija b'Arzerra kienet paragunabbli mar-riżultati osservati bil-monoterapija b'Arzerra fl-istudju Hx-CD20-406.
English: Arzerra is available in packs of 1 vial.
Maltese: Arzerra huwa disponibbli f'pakketti ta' kunjett wieħed.
English: Figure 2 Kaplan-Meier estimates of PFS in relapsed CLL
Maltese: 2 Stimi Kaplan-Meier ta' PFS f'CLL li rkadat
English: Cycle 1 61.4 3560
Maltese: Ċiklu 4 285 65100 15.4
English: Patients with a history of decreased pulmonary function may be at a greater risk for pulmonary complications from severe reactions and should be monitored closely during infusion of Arzerra.
Maltese: Pazjenti bi storja ta' tnaqqis fil-funzjoni tal-pulmuni jista' jkollhom riskju akbar ta' kumplikazzjonijiet fil-pulmuni minn reazzjonijiet avversi u għandhom jiġu mmonitorjati mill-qrib waqt l-infużjoni ta' Arzerra.
English: This dose will be increased, usually to 1000 mg or 2000 mg, for the remaining infusions.
Maltese: Din id-doża se tiżdied, issoltu sa 1000 mg jew 2000 mg, għall-kumplament tal-infużjonijiet.
English: Study OMB115991 evaluated the efficacy of Arzerra in combination with bendamustine in 44 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment.
Maltese: L-istudju OMB115991 evalwa l-effikaċja ta' Arzerra mogħti f'taħlita ma' bendamustine f'44 pazjent b'CLL mhux ikkurata minn qabel meqjusin mhux xierqa għal kura bbażata fuq fludarabine.
English: DATE OF REVISION OF THE TEXT
Maltese: Tabella 5
English: The diluted solution for infusion must be used within 24 hours of preparation.
Maltese: Kwalunkwe soluzzjoni li ma tintużax għandha tintrema 24 siegħa wara l-preparazzjoni.
English: No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min) (see section 5.2).
Maltese: L-ebda aġġustament fiddoża ma huwa rrakkomandat għal indeboliment tal-kliewi minn ħafif sa moderat (tneħħija talkrejatinina >30 ml/min) (ara sezzjoni 5.2).
English: The Arzerra concentrate must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration, using aseptic technique.
Maltese: Il-konċentrat Arzerra għandu jiġi ddilwit f'soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) għallinjezzjoni qabel ma jingħata, billi tintuża t-teknika asettika.
English: Electrolyte abnormalities should be corrected.
Maltese: L-anormalitajiet tal-elettroliti għandhom jiġu rranġati.
English: Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion ofatumumab
Maltese: Arzerra 100 mg konċentrat għal soluzzjoni għall-infużjoni Arzerra 1000 mg konċentrat għal soluzzjoni għall-infużjoni ofatumumab
English: Hypersensitivity to ofatumumab or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal ofatumumab jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Patients with benefit/patients with abnormality at baseline (%) Patients refractory to fludarabine and alemtuzumab
Maltese: Pazjenti b'benefiċċju/pazjenti b'anormalità fil-linja bażi (%) Pazjenti li ma weġbux għal kura bi fludarabine u alemtuzumab
English: No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min).
Maltese: L-ebda aġġustament fid-doża ma huwa rrakkomandat għal indeboliment minn ħafif sa moderat tal-kliewi (tneħħija tal-krejatinina >30 ml/min).
English: Flush line before and after ofatumumab administration with sodium chloride 9 mg/ml (0.9%) solution for injection to avoid this.
Maltese: Laħlaħ il-pajp qabel u wara l-għoti ta' ofatumumab b'soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) għall-injezzjoni biex tevita dan.
English: • Use a reliable method of contraception to avoid becoming pregnant while you are being treated with Arzerra, and for 12 months after your last dose of Arzerra.
Maltese: • Uża metodu ta' kontraċezzjoni ta' min jafdaħ biex tevita li tinqabad tqila waqt li tkun qed tieħu kura b'Arzerra, u għal mill-inqas 12-il xahar wara li tieħu l-aħħar doża ta' Arzerra.
English: Of these 223 patients, 95 patients were refractory to fludarabine and alemtuzumab therapy (defined as failure to achieve at least a partial response with fludarabine or alemtuzumab treatment or disease progression within 6 months of the last dose of fludarabine or alemtuzumab).
Maltese: Minn dawn il223 pazjent, 95 pazjent ma weġbux għal terapija bi fludarabine u alemtuzumab (definita bħala nuqqas ta' suċċess li jinkiseb mill-anqas rispons parzjali b'kura bi fludarabine jew alemtuzumab jew progressjoni tal-marda fi żmien 6 xhur mill-aħħar doża ta' fludarabine jew alemtuzumab).
English: Cardiovascular
Maltese: Pożoloġija
English: Arzerra contains ofatumumab, which belongs to a group of medicines called monoclonal antibodies.
Maltese: Arzerra fih ofatumumab, li jagħmel parti minn grupp ta' mediċini msejħa antikorpi monoklonali.
English: IRC-assessed primary and subgroup analyses of PFS, months
Maltese: Analiżijiet primarji u tassottogrupp ivvalutati mill-IRC talPFS, xhur
English: Limited data are available in the heterogeneous non-white population and in patients with an ECOG performance status of 2.
Maltese: Dejta limitata hija disponibbli fil-popolazzjoni eteroġenera mhux bajda u f'pazjenti bi stat ta' ħila ta' ECOG ta' 2.
English: • throat pain or irritation
Maltese: • uġigħ jew irritazzjoni fil-griżmejn
English: Since ofatumumab may cause foetal B-cell depletion, effective contraception (methods that result in less than 1% pregnancy rates) has to be used during Arzerra therapy and for 12 months after the last Arzerra dose.
Maltese: Minħabba li ofatumumab jista' jwassal għal deplezzjoni taċ-ċellula B fil-fetu, għandu jintuża kontraċettiv effettiv (metodi li jwasslu għal rata ta' tqala ta' inqas minn 1%) waqt it-trattament b'Arzerra u għal mill-inqas 12-il xahar wara li tittieħed l-aħħar doża ta' Arzerra.
English: Premedication schedule for Arzerra
Maltese: Qabel ma tiddilwi Arzerra
English: As anticipated, a reduction in the IgG humoral immune response to keyhole limpet haemocyanin was noted, but there were no effects on delayed-type hypersensitivity responses.
Maltese: Kif antiċipat, tnaqqis fir-rispons immuni umorali tal-IgG għal haemocyanin tal-imħara keyhole kien innutat, iżda ma kien hemm l-ebda effetti fuq ir-risponsi ta' sensittivita eċċessiva tat-tip li jdumu biex jidhru.
English: You need to take this into account if you are on a controlled sodium diet.
Maltese: Dan għandu jitqies minn pazjenti li qegħdin fuq dieta ta' kontoll ta' sodium.
English: • anaphylactic reaction including anaphylactic shock, where symptoms include breathlessness or difficulty breathing, wheezing or coughing, light-headedness, dizziness, changes in levels of consciousness, hypotension, with or without mild generalised itching, skin reddening, swelling of the face and/or throat, blue discolouration of the lips, tongue or skin
Maltese: • reazzjoni anafilattika li tinkludi xokk anafilattiku, fejn is-sintomi jinkludu qtugħ ta' nifs jew diffikultà biex tieħu n-nifs, tisfir jew sogħla, sturdament, mejt, mhux dejjem tħossok konxju ta' x'qed jiġri madwarek bl-istess livell, pressjoni baxxa, b'ħakk ħafif ġeneralizzat jew le, ħmura fil-ġilda, nefħa fil-wiċċ u/jew griżmejn, xofftejn, ilsien jew ġilda jikħalu
English: Figure 1 Kaplan-Meier estimates of IRC-assessed PFS in previously untreated CLL
Maltese: Stimi Kaplan-Meier tal-PFS ivvalutata mill-IRC f'CLL mhux ittrattata minn qabel
English: Discontinuation of HBV antiviral therapy should be discussed with physicians with expertise in managing hepatitis B.
Maltese: It-twaqqif ta' terapija antivirali kontra l-HBV għandu jiġi diskuss ma' tobba b'esperjenza flimmaniġġjar tal-epatite B.
English: IgG1 molecules such as ofatumumab are catabolised by ubiquitous proteolytic enzymes, which are not restricted to hepatic tissue; therefore, changes in hepatic function are unlikely to have any effect on the elimination of ofatumumab.
Maltese: Molekuli ta' IgG1 bħal ofatumumab huma kkatabolizzati minn enzimi proteolitiċi li jinstabu kullimkien, li mhumiex ristretti għat-tessut tal-fwied; għalhekk, tibdil fil-funzjoni tal-fwied mhuwiex mistenni li jkollu xi effet fuq l-eliminazzjoni ta' ofatumumab.
English: Arzerra is indicated for the treatment of CLL in adult patients who are refractory to fludarabine and alemtuzumab.
Maltese: Arzerra huwa indikat għall-kura ta' CLL f'pazjenti adulti li ma weġbux għal kura bi fludarabine u alemtuzumab.
English: Infusion rate (ml/hour)
Maltese: Ir-rata tal-infużjoni (ml/siegħa)
English: Laboratory monitoring
Maltese: Monitoraġġ tal-laboratorju
English: • increase in potassium, phosphate and uric acid in the blood that can cause kidney problems (tumour lysis syndrome) The symptoms of this condition include:
Maltese: • żieda fil-potassium, fil-phosphate u fil-uric acid fid-demm li jistgħu jikkawżaw problemi filkliewi (sindrome ta' diżintegrazzjoni tat-tumur)
English: No data comparing Arzerra in combination with bendamustine or with chlorambucil versus a rituximab based regimen such as rituximab with chlorambucil is available.
Maltese: M'hemm ebda dejta li tqabbel Arzerra f'kombinazzjoni ma' bendamustine jew ma' chlorambucil meta mqabbel ma' reġimen ibbażat fuq rituximab bħal rituximab b'chlorambucil disponibbli.
English: If you have not been previously treated for CLL you will have a maximum of 13 infusions.
Maltese: Jekk qabel ma ngħatajtx kura għal CLL ser tingħata massimu ta' 13-il infużjoni.
English: The overall response rate (ORR) including complete response (CR) was also assessed by an IRC using the 2008 IWCLL guidelines.
Maltese: Ir-rata ta' rispons globali (ORR - overall response rate) kienet evalwata wkoll minn
English: Arzerra 1000 mg is available in a pack containing 1 vial.
Maltese: Arzerra 1000 mg huwa disponibbli f'pakkett li fih kunjett 1 u żewġ settijiet ta' estensjoni.
English: Febrile neutropenia, thrombocytopenia,
Maltese: Newtropenija, anemija
English: Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of adult patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Maltese: Arzerra mogħti f'taħlita ma' chlorambucil jew bendamustine huwa indikat għall-kura ta' pazjenti adulti b'CLL li ma ngħatawx terapija minn qabel u li mhumiex eliġibbli għal terapija bbażata fuq fludarabine.
English: Neutropenia
Maltese: Tilqim
English: Patients received treatment for a maximum of 6 cycles.
Maltese: Il-pazjenti ngħataw kura għal massimu ta' 6 ċikli.
English: 1) Cycle for which the pharmacokinetic parameters are presented in this table.
Maltese: 1) Ċiklu li għalih il-parametri farmakokinetiċi jinsabu ppreżentati f'din it-tabella.
English: Of the 1,168 patients receiving ofatumumab in clinical trials for CLL, the most frequently observed ADRs were infusion-related reactions which occurred in 711 patients (61%) at any time during treatment.
Maltese: Mill-1,168 pazjent li ngħataw ofatumumab waqt provi kliniċi għal CLL, l-iktar ADRs osservati spiss kienu reazzjonijiet relatati ma' infużjonijiet li seħħew f'711-il pazjent (61%) fi kwalunkwe żmien matul il-kura.
English: Table 4 Summary of clinical improvement with a minimum duration of 2 months in refractory patients with abnormalities at baseline
Maltese: Sommarju tat-titjib kliniku li dam minimu ta' xahrejn f'pazjenti refrattarji b'anormalitajiet fil-linja bażi
English: IRC-assessed secondary outcome
Maltese: Effetti sekondarji komuni ħafna
English: The duration of response was 16 weeks (CI: 13, 19) and the time to next CLL therapy was 52.4 weeks (CI: 36.9 - non-estimable).
Maltese: It-tul ta' żmien kemm dam ir-rispons kien ta' 16-il ġimgħa (CI: 13, 19) u ż-żmien għal kura ta' CLL li kien imiss kien ta' 52.4 ġimgħa (CI: 36.9ma jistax jiġi stmat).
English: PFS based on local (investigator) assessment was consistent with the primary endpoint and resulted in a ~11-month improvement in median PFS (OFA+FC 27.2 months versus 16.8 months for FC; HR=0.66 (95% CI: 0.51, 0.85, p=0.0009).
Maltese: PFS ibbażata fuq evalwazzjoni lokali (investigatur) kienet konsistenti mal-punt finali primarju u wasslet għal titjib ta' ~11-il xahar f'PFS medjana (OFA+FC 27.2 xhur kontra 16.8 xhur għal FC;
English: For the first infusion, administer over 4.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below:
Maltese: Għall-ewwel infużjoni, agħti fuq 4.5 sigħat (ara sezzjoni 4.2), minn linja periferali jew minn katiter fuq ġewwa, skont l-iskeda ta' hawn taħt:
English: Patients received Arzerra as monthly intravenous infusions (cycle 1 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days) in combination with intravenous bendamustine 90 mg/m on days 1 and 2 every 28 days.
Maltese: Il-pazjenti rċivew Arzerra bħala infużjoni ġol-vina fix-xahar (ċiklu 1 300 mg fil-jum 1 u 1000 mg fil-jum 8; ċikli sussegwenti: 1000 mg fil-jum 1 kull 28 jum) mogħti f'taħlita ma' bendamustine 90 mg/m ġol-vina filjiem 1 u 2 kull 28 jum.
English: CARTON
Maltese: Manifattur
English: Median time to progression was longer for the OFA+FC arm versus FC (42.1 months versus 26.8 months; HR: 0.63; 95% CI: 0.45-0.87).
Maltese: Żmien medjan sa progressjoni kien itwal għall-grupp ta' OFA+FC kontra FC (42.1 xhur kontra 26.8 xhur;
English: Each vial contains 100 mg ofatumumab in 5 ml.
Maltese: Kull kunjett fih 100 mg ofatumumab f'5 ml.
English: • blocked nose.
Maltese: • imnieħer misdud.
English: Baseline calculated creatinine clearance was not found to be a significant factor on ofatumumab pharmacokinetics in a cross-study population analysis in patients with calculated creatinine clearance values ranging from 26 to 287 ml/min.
Maltese: It-tneħħija tal-krejatinina kkalkulata fil-linja bażi ma nstabitx li kienet fattur sinifikanti fuq ilfarmakokinetika ta' ofatumumab f'analiżi cross-study ta' popolazzjoni f'pazjenti b'valuri kkalkulati għat-tneħħija tal-krejatinina fuq medda bejn 26 u 287 ml/min.
English: Vascular disorders
Maltese: Skeda tal-infużjoni
English: Ofatumumab plus
Maltese: Eċċipjent b'effett magħruf
English: • breathlessness, cough
Maltese: • qtugħ ta' nifs, sogħla
English: Each glass vial is closed with a rubber stopper and aluminium over-seal, and contains 5 ml of concentrate (100 mg of ofatumumab).
Maltese: Konċentrat għal soluzzjoni għall-infużjoni. 100 mg/5 ml
English: 8 weekly infusions followed by 4 monthly infusions th dose 827
Maltese: 8 ġimgħat segwiti b'4 infużjonijiet kull xahar
English: • low levels of white blood cells (neutropenia)
Maltese: • livelli baxxi ta' ċelluli bojod tad-demm (newtropenija)
English: There were no fatal infusionrelated reactions (see section 4.4).
Maltese: Ma kien hemm ebda reazzjoni fatali b'rabta mal-infużjoni (ara sezzjoni 4.4).
English: Anaphylactic reactions (including anaphylactic shock)*
Maltese: Reazzjonijiet anafilattiċi (li jinkludu xokk anafilattiku)*
English: Reactivation has also occurred in patients who appear to have resolved hepatitis B infection (i.e. HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [antiHBs] positive).
Maltese: Ir-riattivazzjoni seħħet ukoll f'pazjenti li dehru li kellhom infezzjoni tal-epatite B riżolta (jiġifieri negattivi għal HBsAg, pożittivi għal anti-HBc, u pożittivi għall-antikorpi tal-wiċċ tal-epatite B [anti-HBs]).
English: • if you are allergic (hypersensitive) to ofatumumab or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għal ofatumumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: • If you have persistent stomach pain, see your doctor as soon as possible.
Maltese: • Jekk ikollok uġigħ persistenti fl-istonku, ara lit-tabib tiegħek kemm jista' jkun malajr.
English: Increases above 5 msec were observed in the median/mean QT/QTc intervals in the pooled analysis.
Maltese: Ma ġiet osservata ebda bidla kbira fl-intervall medju tal-QTc (jiġifieri >20 millisekonda).
English: Ofatumumab may cause foetal B-cell depletion based on findings from animal studies and on its mechanism of action (see section 5.1).
Maltese: Ma dehru l-ebda differenzi sostanzjali relatati mal-età fis-sigurtà u l-effikaċja (ara sezzjoni 5.1).
English: If the preceding infusion(s) has (have) been completed without severe infusion related ADRs, the subsequent infusions can start at a rate of 25 ml/h and should be increased every 30 minutes up to a maximum of 400 ml/h (see section 6.6).
Maltese: Jekk l-infużjoni(jiet) ta' qabel ingħatat (ingħataw) mingħajr ma seħħew ADRs severi relatati malinfużjoni, l-infużjonijiet sussegwenti jistgħu jibdew b'rata ta' 25 ml/h u għandhom jiżdiedu kull 30 minuta sa massimu ta' 400 ml/h (ara sezzjoni 6.6).
English: Treatment with Arzerra (when given as 4 once-weekly infusions), led to a 50% objective response rate in the highest dose group (1st dose: 500 mg; 2nd, 3rd and 4th dose: 2,000 mg) and included 12 partial remissions and one nodular partial remission.
Maltese: Kura b'Arzerra (meta tingħata bħala 4 infużjonijiet darba fil-ġimgħa), wasslet għal rata ta' rispons oġġettiv ta' 50% fil-grupp bl-ogħla doża (l-ewwel doża: 500 mg; it-tieni doża, it-tielet doża u r-raba' doża: 2,000 mg) u kienet tinkludi 12-il rkupru parzjali u rkupru wieħed nodulari parzjali.
English: As ofatumumab is a monoclonal antibody, genotoxicity and carcinogenicity studies have not been conducted with ofatumumab.
Maltese: Minn aspett mikrobijoloġiku, il-prodott mediċinali għandu jintuża immedjatament.
English: The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complementdependent cytotoxicity and resultant lysis of tumour cells.
Maltese: L-irbit ta' ofatumumab mal-epitope l-aktar qrib tal-membrana tal-molekula CD20 jinduċi reklutaġġ u attivazzjoni tar-rotta tal-komplement fis-superfiċje taċ-ċellula, li twassal għal ċitotossiċità li tiddependi mill-komplement u tirriżulta f'diżintegrazzjoni taċ-ċelluli tat-tumur.
English: Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL.
Maltese: Arzerra huwa indikat flimkien ma' fludarabine u cyclophosphamide għat-trattament ta' pazjenti adulti b'CLL li rkadat.
English: • Subsequent cycles (until best response or a maximum of 12 cycles): 1000 mg on day 1 every
Maltese: • Ċikli sussegwenti (sal-aħjar rispons jew massimu ta' 12-il ċiklu): 1000 mg f'jum 1 kull 28 jum.
English: Age, gender and race
Maltese: Età, sess u razza
English: Snapshot date: 02Oct2015
Maltese: Data tal-ġbir tad-dejta: 02Ott2015
English: Final Clinical Study Report:
Maltese: Rapport ta' Studju Kliniku Finali:
English: Proton pump inhibitors (PPIs)
Maltese: Inibituri tal-proton pump (PPIs)