FrancophonIA/ELRC3.0 huggingface dataset:
English: 20 mL vial (colourless Type 1 glass) closed with a stopper (fluororesin laminate), with an aluminum seal with plastic flip-off cap containing 140 mg polatuzumab vedotin.
Maltese: Kunjett ta' 20 mL (ħġieġ tat-Tip 1 mingħajr kulur) magħluq b'tapp (fluororesin laminate), b'siġill talaluminju b'għatu flip-off tal-plastik, li fih 140 mg ta' polatuzumab vedotin.
English: After the first 1.8 mg/kg polatuzumab vedotin dose, the Cmax was 6.82 (± 4.73) ng/mL, the time to maximum plasma concentration is approximately 2.5 days, and the terminal half-life is approximately 4 days.
Maltese: Wara l-ewwel doża ta' 1.8 mg/kg ta' polatuzumab vedotin, is-Cmax kienet ta' 6.82 (± 4.73) ng/mL, iż-żmien sal-konċentrazzjoni massima fil-plażma huwa ta' madwar 2.5 ijiem, u l-half-life terminali hija ta' madwar 4 ijiem.
English: Among the 80 patients who were randomized to receive Polivy plus BR (n=40) or BR alone (n = 40) the majority were white (71%) and male (66%).
Maltese: Fost it-80 pazjent li kienu randomised biex jirċievu Polivy flimkien ma' BR (n=40) jew BR biss (n = 40) ilmaġġoranza kienu bojod (71%) u rġiel (66%).
English: • The active substance is polatuzumab vedotin.
Maltese: • Is-sustanza attiva hi polatuzumab vedotin.
English: Primary reasons patients were not candidates for HSCT included age (40%), insufficient response to salvage therapy (26%) and prior transplant failure (20%).
Maltese: Raġunijiet primarji għaliex il-pazjenti ma kinux kandidati għal HSCT kienu jinkludu l-età (40%), rispons insuffiċjenti għal terapija ta' salvataġġ (26%) u falliment ta' trapjant fil-passat (20%).
English: Using a sterile syringe, slowly inject 7.2 mL of sterile water for injection into the 140 mg Polivy vial to yield a single-dose solution containing 20 mg/mL polatuzumab vedotin.
Maltese: Bl-użu ta' siringa sterili, injetta bil-mod 7.2 mL ta' ilma sterili għall-injezzjoni fil-kunjett ta' 140 mg ta' Polivy biex tikseb soluzzjoni ta' doża waħda li fiha 20 mg/mL ta' polatuzumab vedotin.
English: Serious adverse reactions were reported in 27% of Polivy plus BR treated patients, which includes febrile neutropenia (6.7%), pyrexia (4.4%), and pneumonia (4.4%).
Maltese: Ġew irrappurtati reazzjonijiet avversi serji f'27% tal-pazjenti ttrattati b'Polivy flimkien ma' BR, li jinkludu newtropenija bid-deni (6.7%), deni (4.4%), u pulmonite
English: Bendamustine + rituximab N = 40 Median observation time 22 months
Maltese: Bendamustine + rituximab
English: If the prepared infusion will be transported, remove air from the infusion bag and limit transportation to 30 minutes room temperature (9°C − 25°C) or 24 hours refrigerated (2°C − 8°C).
Maltese: Jekk l-infużjoni ppreparata se tiġi ttrasportata, neħħi l-arja mill-borża għallinfużjoni u llimita t-trasport għal 30 minuta f'temperatura ambjentali (9 °C - 25 °C) jew 24 siegħa fi friġġ (2 °C - 8 °C).
English: Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells.
Maltese: Polatuzumab vedotin huwa konjugat ta' antikorp u mediċina mmirat lejn CD79b li preferenzjalment iwassal sustanza antimitotika potenti (monomethyl auristatin E, jew MMAE) liċ-ċelluli B, u dan jirriżulta fil-qerda ta' ċelluli B malinni.
English: IRRs, PN, fatigue, and dizziness may occur during treatment with Polivy (see sections 4.4 and 4.8).
Maltese: Waqt it-trattament b'Polivy jistgħu jseħħu IRRs, PN, għeja, u sturdament (ara sezzjonijiet 4.4. u 4.8).
English: With regard to co-administration of CYP3A-inhibitors see section 4.5.
Maltese: Fir-rigward tal-għoti flimkien ta' inibituri ta' CYP3A ara ssezzjoni 4.5.
English: In addition, no incompatibilities have been observed with infusion sets or infusion aids with product contacting materials of PVC, PE, polyurethane, polybutadiene, acrylonitrile butadiene styrene, polycarbonate, polyetherurethane, fluorinated ethylene propylene, or polytetrafluorethylene and with filter membranes composed of polyether sulfone or polysulfone.
Maltese: Barra minn hekk, ma ġewx osservati inkompatibbiltajiet ma' settijiet tal-infużjoni jew tagħmir ta' għajnuna għallinfużjoni b'materjal li jiġi f'kuntatt mal-prodott tal-PVC, tal-PE, tal-polyurethane, tal-polybutadiene, tal-acrylonitrile butadiene styrene, tal-polycarbonate, tal-polyetherurethane, tal-fluorinated ethylene propylene, jew tal-polytetrafluorethylene u ma' membrani tal-filtri magħmula minn polyether sulfone jew polysulfone.
English: You will be given 6 treatment cycles of Polivy in combination with two other medicines called rituximab and bendamustine.
Maltese: Inti se tingħata 6 ċikli ta' trattament ta' Polivy flimkien ma' żewġ mediċini oħra msejħa rituximab u bendamustine.
English: Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.
Maltese: Polivy flimkien ma' bendamustine u rituximab huwa indikat għat-trattament ta' pazjenti adulti b'limfoma taċ-ċellula B kbira diffuża (DLBCL - diffuse large B-cell lymphoma) li rkadiet/reżistenti li mhumiex kandidati għal trapjant ta' ċelluli staminali ematopojetiċi.
English: In nonclinical studies, polatuzumab vedotin has resulted in testicular toxicity, and may impair male reproductive function and fertility (see section 5.3).
Maltese: Fi studji mhux kliniċi, polatuzumab vedotin wassal għal effett tossiku fuq it-testikoli, u jista' jxekkel il-funzjoni riproduttiva u l-fertilità tal-irġiel (ara sezzjoni 5.3).
English: Polivy must be diluted to a final concentration of 0.72-2.7 mg/mL in an intravenous infusion bag, with a minimum volume of 50 mL, containing 9 mg/mL sodium chloride solution for injection, or 4.5 mg/mL sodium chloride solution for injection, or 5% glucose.
Maltese: Polivy għandu jiġi dilwit għal konċentrazzjoni finali ta' 0.72-2.7 mg/mL f'borża għall-infużjoni fil-vini, b'volum minimu ta' 50 mL, li fiha soluzzjoni għall-injezzjoni ta' 9 mg/mL ta' sodium chloride, jew soluzzjoni għall-injezzjoni ta' 4.5 mg/mL ta' sodium chloride, jew 5% glucose.
English: Polivy is a cancer medicine that contains the active substance polatuzumab vedotin.
Maltese: Polivy huwa mediċina kontra l-kanċer li fiha s-sustanza attiva polatuzumab vedotin.
English: For the next cycle, infuse Polivy over 90 minutes.
Maltese: Għaċ-ċiklu li jmiss, agħti infużjoni ta' Polivy fuq medda ta' 90 minuta.
English: • restart all treatment with a dose reduction of bendamustine from 90 mg/m2 to 70 mg/m2 or 70 mg/m2 to 50 mg/m2.
Maltese: • erġa' ibda t-trattament kollu bi tnaqqis fid-doża ta' bendamustine minn 90 mg/m għal 70 mg/m jew minn 70 mg/m għal
English: When accounting for the influence of baseline covariates the OS HR was adjusted to 0.59.
Maltese: Meta titqies l-influwenza tal-kovarjati fil-linja bażi, l-HR ta' OS kien aġġustat għal 0.59.
English: If recovered to Grade ≤ 1 on or before Day 14, restart Polivy at a permanently reduced dose of 1.4 mg/kg.
Maltese: Jekk ikun hemm irkupru għal Grad ≤ 1 nhar jew qabel il-Jum 14, erġa' ibda Polivy b'doża mnaqqsa b'mod permanenti ta' 1.4 mg/kg.
English: Polivy should not be administered in the presence of an active severe infection.
Maltese: Polivy m'għandux jingħata fil-preżenza ta' infezzjoni severa attiva.
English: The efficacy of Polivy was evaluated in an international, multicentre, open-label study (GO29365) which included a randomized cohort of 80 patients with previously treated DLBCL.
Maltese: L-effikaċja ta' Polivy ġiet evalwata fi studju (GO29365) internazzjonali, b'aktar minn ċentru wieħed u open-label li kien jinkludi koorti randomised ta' 80 pazjent b'DLBCL ittrattati fil-passat.
English: Your doctor or nurse will check for side effects during your infusion and for 30 to 90 minutes afterwards.
Maltese: It-tabib jew l-infermier tiegħek se jiċċekkja għal effetti sekondarji matul l-infużjoni tiegħek u għal 30 sa 90 minuta wara.
English: In the Polivy plus BR arm, Grade 3 or higher neutropenia, thrombocytopenia, and anaemia were reported in 40%, 37.8%, and 24.4% of patients, respectively.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi tal-mediċina magħżula Fil-grupp ta' Polivy flimkien ma' BR, ġew irrappurtati newtropenija, tromboċitopenija, u anemija ta' Grad 3 jew ogħla f'40%, 37.8%, u 24.4% tal-pazjenti, rispettivament.
English: Very common weight decreased Common transaminase elevation, lipase increase, hypophosphataemia Injury, poisoning and procedural complications Very Common infusion-related reactionsb a
Maltese: Komuni żieda fit-transaminase, żieda ta' lipase, ipofosfatimja Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Komuni ħafna reazzjonijiet relatati mal-infużjoni b a
English: Progressive multifocal leukoencephalopathy (PML) One case of PML, which was fatal, occurred in one patient treated with Polivy plus bendamustine and obinutuzumab.
Maltese: Lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy) Ġiet irrappurtata PML bi trattament b'Polivy (ara sezzjoni 4.8).
English: Table 4 Summary of ADRs occurring in relapsed or refractory DLBCL patients treated with Polivy in combination with BR Infections and infestations Very common pneumoniaa, herpes virus infectiona, upper respiratory tract infection Common sepsis, cytomegalovirus infection Blood and lymphatic system disorders Very common febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leukopenia, lymphopenia
Maltese: Komuni sepsi, infezzjoni kkawżata minn ċitomegalovirus Disturbi tad-demm u tas-sistema limfatika Komuni ħafna newtropenija bid-deni, newtropenija, tromboċitopenija, anemija, lewkopenija, limfopenija
English: For dose modifications for myelosuppression see Table 2.
Maltese: Għall-modifiki fid-doża għal majelosoppressjoni ara t-Tabella 2.
English: Up to 72 hours refrigerated (2 °C − 8 °C) or up to 8 hours at room temperature (9 °C − 25 °C)
Maltese: Sa 72 siegħa fi friġġ (2 °C - 8 °C) jew sa 8 sigħat f'temperatura ambjentali (9 °C - 25 °C)
English: The recommended dose of Polivy is 1.8 mg/kg, given as an intravenous infusion every 21 days in combination with bendamustine and rituximab for 6 cycles.
Maltese: Id-doża rakkomandata ta' Polivy hija ta' 1.8 mg/kg, mogħtija bħala infużjoni fil-vini kull 21 jum flimkien ma' bendamustine u rituximab għal 6 ċikli.
English: No studies have been conducted to investigate the pharmacokinetics of polatuzumab vedotin in the paediatric population (<18 years old).
Maltese: Ma twettaq l-ebda studju biex tiġi investigata l-farmakokinetika ta' polatuzumab vedotin filpopolazzjoni pedjatrika (<18-il sena).
English: Thrombocytopenia events led to discontinuation of treatment in 11.1% of patients in the Polivy plus BR arm and 5.1% of patients in the BR arm. No patients discontinued treatment due to anaemia in either the Polivy plus BR arm or BR arm.
Maltese: Avvenimenti ta' tromboċitopenija wasslu għal waqfien tat-trattament fi 11.1% tal-pazjenti fil-grupp ta' Polivy flimkien ma' BR u f'5.1% tal-pazjenti fil-grupp ta' BR.
English: This includes run-in phase patients (n=6) and randomized patients (n=39) who received Polivy in combination with bendamustine and rituximab (BR) compared to randomized patients (n=39) who received BR alone.
Maltese: Din tinkludi pazjenti fil-fażi ta' tħejjija (n=6) u pazjenti randomised (n=39) li rċevew Polivy flimkien ma' bendamustine u rituximab (BR) meta mqabbla ma' pazjenti randomised (n=39) li rċevew BR biss.
English: • you think you have an infection or have had long-lasting or repeated infections such as herpes (see “Infections” in section 4).
Maltese: • taħseb li għandek infezzjoni jew kellek infezzjonijiet fit-tul jew ripetuti bħal herpes (ara “Infezzjonijiet” fis-sezzjoni 4).
English: If not recovered to Grade ≤ 1 on or before Day 14, discontinue Polivy.
Maltese: Jekk ma jkunx hemm irkupru għal Grad ≤ 1 nhar jew qabel il-Jum 14, waqqaf Polivy.
English: Polivy contains a cytotoxic component which is covalently attached to the monoclonal antibody.
Maltese: Polivy fih komponent ċitotossiku li jintrabat b'mod kovalenti mal-antikorp monoklonali.
English: Each vial contains 140 milligrams (mg) polatuzumab vedotin.
Maltese: Kull kunjett fih 140 milligramma (mg) ta' polatuzumab vedotin.
English: Total Polivy dose (mL) to be further diluted = Polivy dose (mg/kg) X patient's weight (kg)
Maltese: Doża ta' Polivy (mg/kg) X piż tal-pazjent (kg) Konċentrazzjoni tal-kunjett rikostitwit (20 mg/mL)
English: One patient (2.2%) in the Polivy plus BR arm discontinued treatment due to infection compared to 5.1% of patients in the BR arm.
Maltese: Pazjenti wieħed (2.2%) filgrupp ta' Polivy flimkien ma' BR waqqaf it-trattament minħabba infezzjoni meta mqabbel ma' 5.1% tal-pazjenti fil-grupp ta' BR.
English: If ANC recovers to > 1000/µL after Day 7:
Maltese: Jekk l-ANC jirkupra għal > 1000/µL wara l-Jum 7:
English: • numbness
Maltese: • tingiż
English: • vomitting
Maltese: • rimettar
English: Very common pruritis
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Exposures of unconjugated MMAE, the cytotoxic component of polatuzumab vedotin, increased dose proportionally over the 0.1 to 2.4 mg/kg polatuzumab vedotin dose range.
Maltese: L-esponimenti għal MMAE mhux ikkonjugata, il-komponent ċitotossiku ta' polatuzumab vedotin, żdiedu b'mod proporzjonali għad-doża fuq il-firxa tad-doża ta' 0.1 sa 2.4 mg/kg ta' polatuzumab vedotin.
English: Polatuzumab vedotin did not prolong the mean QTc interval to any clinically relevant extent based on ECG data from two open-label studies in patients with previously treated B-cell malignancies at the recommended dosage.
Maltese: Polatuzumab vedotin ma tawwalx l-intervall medju tal-QTc sa xi punt klinikament rilevanti abbażi ta' data tal-ECG minn żewġ studji open-label f'pazjenti b'tumuri malinni taċ-ċellula B ittrattati fil-passat bid-dożaġġ rakkomandat.
English: Based on a population PK analysis, the conjugate (acMMAE) is primarily eliminated by non-specific linear clearance pathway with a value of 0.9 L/day.
Maltese: Abbażi ta' analiżi tal-PK tal-popolazzjoni, il-konjugat (acMMAE) jiġi eliminat primarjament minn passaġġ ta' tneħħija lineari mhux speċifiku b'valur ta' 0.9
English: Very common neuropathy peripheral, peripheral sensory neuropathy, dizziness Common gait disturbance, paraesthesia, hypoaesthesia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna ipokalimija, ipokalċimija, ipoalbuminemija, nuqqas ta' aptit Disturbi fis-sistema nervuża Komuni ħafna newropatija periferali, newropatija periferali sensorja, sturdament
English: Upon binding CD79b, polatuzumab vedotin is rapidly internalized and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE.
Maltese: Meta jintrabat ma' CD79b, polatuzumab vedotin jiġi internalizzat b'mod rapidu u s-sustanza li torbot tinqasam millproteases liżożomali biex tippermetti twassil intraċellulari ta' MMAE.
English: Defined as all adverse reactions reported as related to study treatment within 24 hours after treatment infusion Uncommon, rare and very rare ADRs: none
Maltese: 24 siegħa wara l-infużjoni tat-trattament ADRs mhux komuni, rari u rari ħafna: xejn
English: Caution is advised in case of concomitant treatment with CYP3A4 inhibitor.
Maltese: Indutturi qawwija ta' CYP3A4
English: Due to limited clinical experience in patients treated with 1.8 mg/kg Polivy at a total dose >240 mg, it is recommended not to exceed the dose 240 mg/cycle.
Maltese: Minħabba esperjenza klinika limitata f'pazjenti ttrattati b'1.8 mg/kg ta' Polivy b'doża totali ta' > 240 mg, huwa rakkomandat li ma tinqabiżx id-doża ta' 240 mg/ċiklu.
English: Grade 3-4 Thrombocytopenia
Maltese: Newtropenija ta' Grad 3-4
English: Per studied population in mild hepatic impairment (defined as AST or ALT >1.0 to 2.5 × ULN or total bilirubin >1.0 to 1.5 × ULN), there was a 40% increase in unconjugated MMAE exposure, which was not deemed clinically significant.
Maltese: (Fil-popolazzjoni studjata b'indeboliment ħafif tal-fwied (iddefinit bħala AST jew ALT >1.0 sa 2.5 × ULN jew bilirubina totali >1.0 sa 1.5 × ULN), kien hemm żieda ta' 40% fl-esponiment għal MMAE mhux ikkonjugata, li ma tqisitx bħala klinikament sinifikanti).
English: When administered with Polivy, the recommended dose of bendamustine is 90 mg/m2/day on Day 1 and Day 2 of each cycle and the recommended dose of rituximab is 375 mg/m2 on Day 1 of each cycle.
Maltese: Meta jingħataw ma' Polivy, id-doża rakkomandata ta' bendamustine hija ta' 90 mg/m2/jum fil-Jum 1 u l-Jum 2 ta' kull ċiklu u d-doża rakkomandata ta' rituximab hija ta' 375 mg/m fil-Jum 1 ta' kull ċiklu.
English: • feeling tired (anaemia)
Maltese: • tħossok għajjien (anemija)
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: The active substance in Polivy is made up of a monoclonal antibody linked to MMAE, a substance that can kill cancer cells.
Maltese: Is-sustanza attiva f'Polivy hija magħmula minn antikorp monoklonali marbut ma' MMAE, sustanza li tista' toqtol iċ-ċelluli tal-kanċer.
English: The administration of Polivy in patients with moderate or severe hepatic impairment (bilirubin greater than 1.5 × upper limit of normal [ULN]) should be avoided.
Maltese: L-għoti ta' Polivy f'pazjenti b'indeboliment moderat jew sever tal-fwied (bilirubina ogħla minn 1.5 × il-limitu ta' fuq tan-normal [ULN - upper limit of normal]) għandu jiġi evitat.
English: Musculoskeletal disorders
Maltese: Disturbi muskoluskeletriċi Komuni artralġja
English: The primary endpoint of the study was complete response (CR) rate at end of treatment (6-8 weeks after Day 1 of Cycle 6 or last study treatment) as assessed by PET-CT by an Independent Review Committee (IRC).
Maltese: Il-punt finali primarju tal-istudju kien ir-rata ta' rispons sħiħ (CR - complete response) fi tmiem ittrattament (6-8 ġimgħat wara l-Jum 1 taċ-Ċiklu 6 jew l-aħħar trattament tal-istudju) kif evalwat permezz ta' PET-CT minn Kumitat ta' Rieżami Indipendenti (IRC - Independent Review Committee).
English: Drug interactions with concomitant medicines that are CYP3A4 inhibitors, substrates or inducers and co-medications that are P-gp inhibitors
Maltese: Interazzjonijiet ma' mediċini mogħtija fl-istess waqt li huma inibituri, substrati jew indutturi ta' CYP3A4 u komedikazzjonijiet li huma inibituri ta' P-gp
English: Severity of IRR on Day 1 of any cycle
Maltese: Severità ta' IRR fil-Jum 1 ta' kwalunkwe ċiklu
English: Overall survival (OS) was an exploratory endpoint which was not type 1 error controlled.
Maltese: Sopravivenza globali (OS - overall survival) kienet punt finali esploratorju li ma kienx ikkontrollat bi żball tat-tip 1.
English: Table 3: Polivy, bendamustine and rituximab dose modifications for Infusion-related reactions (IRRs)
Maltese: Għall-modifiki fid-doża għal Reazzjonijiet relatati mal-infużjoni ara t-Tabella 3. Tabella 3: Modifiki fid-doża ta' polivy, bendamustine u rituximab għal Reazzjonijiet relatati mal-infużjoni (IRRs - Infusion-related reactions)
English: • infusion-related reactions
Maltese: • reazzjonijiet relatati mal-infużjoni.
English: In the absence of infusion-related symptoms, the rate of infusion may be escalated in increments of 50 mg/hour every 30 minutes.
Maltese: Fin-nuqqas ta' sintomi relatati mal-infużjoni, ir-rata tal-infużjoni tista' tiżdied b'żidiet ta' 50 mg/siegħa kull 30 minuta.
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 72 hours refrigerated (2 °C − 8 °C) and up to 24 hours at room temperature (9 °C − 25 °C).
Maltese: L-istabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita ġiet murija sa 72 siegħa fi friġġ (2 °C - 8 °C) u sa 24 siegħa f'temperatura ambjentali (9 °C - 25 °C).
English: In both rats and cynomolgus monkeys, the predominant systemic toxicities associated with administration of MMAE and polatuzumab vedotin included reversible bone marrow toxicity and associated peripheral blood cell effects.
Maltese: Kemm fil-firien kif ukoll fix-xadini cynomolgus, l-effetti tossiċi sistemiċi predominanti assoċjati malgħoti ta' MMAE u polatuzumab vedotin kienu jinkludu effett tossiku riversibbli fuq il-mudullun u effetti assoċjati fuq iċ-ċelluli tad-demm periferali.
English: Embryo-foetal toxicity
Maltese: GĦAMLA FARMAĊEWTIKA
English: Polivy 140 mg powder for concentrate for solution for infusion polatuzumab vedotin
Maltese: Polivy 140 mg trab għal konċentrat għal soluzzjoni għall-infużjoni polatuzumab vedotin
English: This mechanism is consistent with the pharmacological effect of MMAE as a microtubule disrupting agent.
Maltese: Dan il-mekkaniżmu huwa konsistenti mal-effett farmakoloġiku ta' MMAE bħala sustanza li tfixkel il-mikrotubulu.
English: How to store Polivy
Maltese: X'fih Polivy
English: This patient had three prior lines of therapy that included anti-CD20 antibodies.
Maltese: Dan il-pazjent kellu tliet linji ta' terapija minn qabel li kienu jinkludu antikorpi kontra CD20.
English: Infections, including pneumonia and other types of infections, were reported in 53.3% of patients in the Polivy plus BR arm and 51.3% of patients in the BR arm.
Maltese: Ġew irrappurtati infezzjonijiet, inkluż pulmonite u tipi oħra ta' infezzjonijiet, fi 53.3% tal-pazjenti filgrupp ta' Polivy flimkien ma' BR u f'51.3% tal-pazjenti fil-grupp ta' BR. Fil-grupp ta' Polivy flimkien ma' BR, ġew irrappurtati infezzjonijiet serji fi 28.9% tal-pazjenti u ġew irrappurtati infezzjonijiet fatali fi 8.9% tal-pazjenti.
English: • The usual starting dose is 1.8 mg for each kilogram of your body weight.
Maltese: • Id-doża normali tal-bidu hija ta' 1.8 mg għal kull kilogramma ta' piż tal-ġisem tiegħek.
English: The levels of MMAE metabolites have not been measured in human plasma.
Maltese: Il-livelli ta' metaboliti ta' MMAE ma ġewx imkejla fil-plażma tal-bniedem.
English: • If you have peripheral neuropathy, your doctor may lower your dose to 1.4 mg for each kilogram of your body weight.
Maltese: • Jekk għandek newropatija periferali, it-tabib tiegħek jista' jnaqqas id-doża tiegħek għal 1.4 mg għal kull kilogramma ta' piż tal-ġisem tiegħek.
English: The initial dose of Polivy should be administered as a 90-minute intravenous infusion.
Maltese: Id-doża inizjali ta' Polivy għandha tingħata bħala infużjoni fil-vini fuq medda ta' 90 minuta.
English: • abdominal (belly) pain
Maltese: • uġigħ fl-addome (fiż-żaqq)
English: Serious cases of hepatic toxicity that were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, have occurred in patients treated with Polivy (see section 4.8).
Maltese: Każijiet serji ta' effett tossiku fuq il-fwied li kienu konsistenti ma' ħsara epatoċellulari, inklużi żidiet fit-transaminases u/jew fil-bilirubina, seħħew f'pazjenti ttrattati b'Polivy (ara sezzjoni 4.8).
English: NAME OF THE MEDICINAL PRODUCT Polivy 140 mg powder for concentrate for solution for infusion.
Maltese: Polivy 140 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: The pharmacokinetics (PK) of rituximab and bendamustine are not affected by co-administration with polatuzumab vedotin.
Maltese: Il-farmakokinetika (PK - pharmacokinetics) ta' rituximab u bendamustine mhijiex affettwata minn għoti flimkien ma' polatuzumab vedotin.
English: Reactivation of latent infections has been reported.
Maltese: Ġiet irrappurtata attivazzjoni mill-ġdid ta' infezzjonijiet latenti.
English: • common cold
Maltese: • tidher pallidu
English: Based on population PK analysis, the predicted acMMAE concentration at the end of cycle 6 is approximately 80% of the theoretical steadystate value.
Maltese: Abbażi tal-analiżi tal-PK tal-popolazzjoni, il-konċentrazzjoni mbassra ta' acMMAE fl-aħħar taċ-ċiklu 6 hija ta' madwar 80% tal-valur teoretiku fi stat fiss.